[Title 42 CFR I]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[From the U.S. Government Printing Office]


42PUBLIC HEALTH12008-10-012008-10-01falsePUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMANICHAPTER IPUBLIC HEALTH
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES




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                    SUBCHAPTER A--GENERAL PROVISIONS
Part                                                                Page
1               [Reserved]

2               Confidentiality of alcohol and drug abuse 
                    patient records.........................           7
2a              Protection of identity--research subjects...          26
3               [Reserved]

4               National Library of Medicine................          31
5               Designation of health professional(s) 
                    shortage areas..........................          34
6               Federal tort claims act coverage of certain 
                    grantees and individuals................          52
7               Distribution of reference biological 
                    standards and biological preparations...          53
8               Certification of opioid treatment program...          54
                         SUBCHAPTER B--PERSONNEL
21              Commissioned officers.......................          76
22              Personnel other than commissioned officers..          86
23              National Health Service Corps...............          87
24              Senior Biomedical Research Service..........          96
               SUBCHAPTER C--MEDICAL CARE AND EXAMINATIONS
31              Medical care for certain personnel of the 
                    Coast Guard, National Ocean Survey, 
                    Public Health Service, and former 
                    Lighthouse Service......................         100
32              Medical care for persons with Hansen's 
                    disease and other persons in emergencies         105
34              Medical examination of aliens...............         106
35              Hospital and station management.............         112
37              Specifications for medical examinations of 
                    underground coal miners.................         120

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38              Disaster assistance for crisis counseling 
                    and training............................         133
                          SUBCHAPTER D--GRANTS
50              Policies of general applicability...........         138
51              Requirements applicable to the protection 
                    and advocacy for individuals with mental 
                    illness program.........................         151
51a             Project grants for maternal and child health         163
51b             Project grants for preventive health 
                    services................................         166
51c             Grants for community health services........         173
51d             Mental health and substance abuse emergency 
                    response procedures.....................         188
51e-51g         [Reserved]

52              Grants for research projects................         193
52a             National Institutes of Health center grants.         197
52b             National Institutes of Health construction 
                    grants..................................         202
52c             Minority Biomedical Research Support Program         210
52d             National Cancer Institute Clinical Cancer 
                    Education Program.......................         213
52e             National Heart, Lung, and Blood Institute 
                    grants for prevention and control 
                    projects................................         216
52h             Scientific peer review of research grant 
                    applications and research and 
                    development contract projects...........         219
53              Grants, loans and loan guarantees for 
                    construction and modernization of 
                    hospitals and medical facilities........         225
54              Charitable Choice regulations applicable to 
                    States receiving Substance Abuse 
                    Prevention and Treatment block grants 
                    and/or Projects for Assistance in 
                    Transition from Homelessness grants.....         233
54a             Charitable Choice regulations applicable to 
                    States, local governments and religious 
                    organizations receiving discretionary 
                    funding under Title V of the Public 
                    Health Service Act, 42 U.S.C. 290aa, et 
                    seq., for substance abuse prevention and 
                    treatment services......................         236
55a             Program grants for Black Lung clinics.......         241
56              Grants for migrant health services..........         243
57              Grants for construction of teaching 
                    facilities, educational improvements, 
                    scholarships and student loans..........         263
58              Grants for training of public health and 
                    allied health personnel.................         305
59              Grants for family planning services.........         305
59a             National Library of Medicine grants.........         314

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60              Health Education Assistance Loan Program....         318
            SUBCHAPTER E--FELLOWSHIPS, INTERNSHIPS, TRAINING
61              Fellowships.................................         350
62              National Health Service Corps Scholarship 
                    and Loan Repayment Programs.............         355
63              Traineeships................................         373
63a             National Institutes of Health training 
                    grants..................................         376
64              National Library of Medicine training grants         380
64a             Obligated service for mental health 
                    traineeships............................         382
65              National Institute of Environmental Health 
                    Sciences hazardous waste worker training         386
65a             National Institute of Environmental Health 
                    Sciences hazardous substances basic 
                    research and training grants............         389
66              National Research Service Awards............         393
67              Agency for Health Care Policy and Research 
                    grants and contracts....................         400
68a             National Institutes of Health (NIH) Clinical 
                    Research Loan Repayment Program for 
                    Individuals from Disadvantaged 
                    Backgrounds (CR-LRP)....................         410
68c             National Institute of Child Health and Human 
                    Development Contraception and 
                    Infertility Research Loan Repayment 
                    Program.................................         415
             SUBCHAPTER F--QUARANTINE, INSPECTION, LICENSING
70              Interstate quarantine.......................         421
71              Foreign quarantine..........................         423
72              [Reserved]

73              Select agents and toxins....................         434
75              Standards for the accreditation of 
                    educational programs for and the 
                    credentialing of radiologic personnel...         450
   SUBCHAPTER G--OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED 
                               ACTIVITIES
80              Administrative functions, practices, and 
                    procedures..............................         463
81              Guidelines for determining probability of 
                    causation under the energy employees 
                    occupational illness compensation 
                    program act of 2000.....................         464
82              Methods for conducting dose reconstruction 
                    under the Energy Employees Occupational 
                    Illness Compensation Program Act of 2000         471

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83              Procedures for designating classes of 
                    employees as members of the special 
                    exposure cohort under the Energy 
                    Employees Occupational Illness 
                    Compensation Program Act of 2000........         482
84              Approval of Respiratory Protective Devices..         494
85              Requests for health hazard evaluations......         558
85a             Occupational safety and health 
                    investigations of places of employment..         563
86              Grants for education programs in 
                    occupational safety and health..........         568
87              National Institute for Occupational Safety 
                    and Health Research and demonstration 
                    grants..................................         576
SUBCHAPTER H--HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS 
                   SUBSTANCES RELEASES AND FACILITIES
90              Administrative functions, practices, and 
                    procedures..............................         579
93              Public health service policies on research 
                    misconduct..............................         583
                         SUBCHAPTER I [RESERVED]
                         SUBCHAPTER J--VACCINES
100             Vaccine injury compensation.................         612
102             Smallpox compensation program...............         617
110             [Reserved]

               SUBCHAPTER K--HEALTH RESOURCES DEVELOPMENT
121             Organ Procurement and Transplantation 
                    Network.................................         645
124             Medical facility construction and 
                    modernization...........................         656
125-129         [Reserved]

                  SUBCHAPTER L--COMPASSIONATE PAYMENTS
130             Ricky Ray Hemophilia Relief Fund Program....         692
131-135         [Reserved]

  SUBCHAPTER M--INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
136             Indian health...............................         725
136a            Indian health...............................         759
137             Tribal self-governance......................         767
138-199         [Reserved]

  Editorial Note: Nomenclature changes to chapter I appear at 67 FR 
36549, May 24, 2002.

[[Page 7]]



                     SUBCHAPTER A_GENERAL PROVISIONS



                            PART 1 [RESERVED]



PART 2_CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS--Table of 

Contents




                         Subpart A_Introduction

Sec.
2.1 Statutory authority for confidentiality of drug abuse patient 
          records.
2.2 Statutory authority for confidentiality of alcohol abuse patient 
          records.
2.3 Purpose and effect.
2.4 Criminal penalty for violation.
2.5 Reports of violations.

                      Subpart B_General Provisions

2.11 Definitions.
2.12 Applicability.
2.13 Confidentiality restrictions.
2.14 Minor patients.
2.15 Incompetent and deceased patients.
2.16 Security for written records.
2.17 Undercover agents and informants.
2.18 Restrictions on the use of identification cards.
2.19 Disposition of records by discontinued programs.
2.20 Relationship to State laws.
2.21 Relationship to Federal statutes protecting research subjects 
          against compulsory disclosure of their identity.
2.22 Notice to patients of Federal confidentiality requirements.
2.23 Patient access and restrictions on use.

              Subpart C_Disclosures With Patient's Consent

2.31 Form of written consent.
2.32 Prohibition on redisclosure.
2.33 Disclosures permitted with written consent.
2.34 Disclosures to prevent multiple enrollments in detoxification and 
          maintenance treatment programs.
2.35 Disclosures to elements of the criminal justice system which have 
          referred patients.

              Subpart D_Disclosures Without Patient Consent

2.51 Medical emergencies.
2.52 Research activities.
2.53 Audit and evaluation activities.

          Subpart E_Court Orders Authorizing Disclosure and Use

2.61 Legal effect of order.
2.62 Order not applicable to records disclosed without consent to 
          researchers, auditors and evaluators.
2.63 Confidential communications.
2.64 Procedures and criteria for orders authorizing disclosures for 
          noncriminal purposes.
2.65 Procedures and criteria for orders authorizing disclosure and use 
          of records to criminally investigate or prosecute patients.
2.66 Procedures and criteria for orders authorizing disclosure and use 
          of records to investigate or prosecute a program or the person 
          holding the records.
2.67 Orders authorizing the use of undercover agents and informants to 
          criminally investigate employees or agents of a program.

    Authority: Sec. 408 of Pub. L. 92-255, 86 Stat. 79, as amended by 
sec. 303 (a), (b) of Pub L. 93-282, 83 Stat. 137, 138; sec. 4(c)(5)(A) 
of Pub. L. 94-237, 90 Stat. 244; sec. 111(c)(3) of Pub. L. 94-581, 90 
Stat. 2852; sec. 509 of Pub. L. 96-88, 93 Stat. 695; sec. 973(d) of Pub. 
L. 97-35, 95 Stat. 598; and transferred to sec. 527 of the Public Health 
Service Act by sec. 2(b)(16)(B) of Pub. L. 98-24, 97 Stat. 182 and as 
amended by sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290ee-3) 
and sec. 333 of Pub. L. 91-616, 84 Stat. 1853, as amended by sec. 122(a) 
of Pub. L. 93-282, 88 Stat. 131; and sec. 111(c)(4) of Pub. L. 94-581, 
90 Stat. 2852 and transferred to sec. 523 of the Public Health Service 
Act by sec. 2(b)(13) of Pub. L. 98-24, 97 Stat. 181 and as amended by 
sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290dd-3), as 
amended by sec. 131 of Pub. L. 102-321, 106 Stat. 368, (42 U.S.C. 290dd-
2).

    Source: 52 FR 21809, June 9, 1987, unless otherwise noted.



                         Subpart A_Introduction



Sec. 2.1  Statutory authority for confidentiality of drug abuse patient 

records.

    The restrictions of these regulations upon the disclosure and use of 
drug abuse patient records were initially authorized by section 408 of 
the Drug Abuse Prevention, Treatment, and Rehabilitation Act (21 U.S.C. 
1175). That section as amended was transferred by Pub. L. 98-24 to 
section 527 of the Public Health Service Act which is codified

[[Page 8]]

at 42 U.S.C. 290ee-3. The amended statutory authority is set forth 
below:

           Sec. 290ee-3. Confidentiality of patient records.

    (a) Disclosure authorization
    Records of the identity, diagnosis, prognosis, or treatment of any 
patient which are maintained in connection with the performance of any 
drug abuse prevention function conducted, regulated, or directly or 
indirectly assisted by any department or agency of the United States 
shall, except as provided in subsection (e) of this section, be 
confidential and be disclosed only for the purposes and under the 
circumstances expressly authorized under subsection (b) of this section.
    (b) Purposes and circumstances of disclosure affecting consenting 
patient and patient regardless of consent
    (1) The content of any record referred to in subsection (a) of this 
section may be disclosed in accordance with the prior written consent of 
the patient with respect to whom such record is maintained, but only to 
such extent, under such circumstances, and for such purposes as may be 
allowed under regulations prescribed pursuant to subsection (g) of this 
section.
    (2) Whether or not the patient, with respect to whom any given 
record referred to in subsection (a) of this section is maintained, 
gives his written consent, the content of such record may be disclosed 
as follows:
    (A) To medical personnel to the extent necessary to meet a bona fide 
medical emergency.
    (B) To qualified personnel for the purpose of conducting scientific 
research, management audits, financial audits, or program evaluation, 
but such personnel may not identify, directly or indirectly, any 
individual patient in any report of such research, audit, or evaluation, 
or otherwise disclose patient identities in any manner.
    (C) If authorized by an appropriate order of a court of competent 
jurisdiction granted after application showing good cause therefor. In 
assessing good cause the court shall weigh the public interest and the 
need for disclosure against the injury to the patient, to the physician-
patient relationship, and to the treatment services. Upon the granting 
of such order, the court, in determining the extent to which any 
disclosure of all or any part of any record is necessary, shall impose 
appropriate safeguards against unauthorized disclosure.
    (c) Prohibition against use of record in making criminal charges or 
investigation of patient
    Except as authorized by a court order granted under subsection 
(b)(2)(C) of this section, no record referred to in subsection (a) of 
this section may be used to initiate or substantiate any criminal 
charges against a patient or to conduct any investigation of a patient.
    (d) Continuing prohibition against disclosure irrespective of status 
as patient
    The prohibitions of this section continue to apply to records 
concerning any individual who has been a patient, irrespective of 
whether or when he ceases to be a patient.
    (e) Armed Forces and Veterans' Administration; interchange of 
records; report of suspected child abuse and neglect to State or local 
authorities
    The prohibitions of this section do not apply to any interchange of 
records--
    (1) within the Armed Forces or witrhin those components of the 
Veterans' Administration furnishing health care to veterans, or
    (2) between such components and the Armed Forces.
    The prohibitions of this section do not apply to the reporting under 
State law of incidents of suspected child abuse and neglect to the 
appropriate State or local authorities.
    (f) Penalty for first and subsequent offenses
    Any person who violates any provision of this section or any 
regulation issued pursuant to this section shall be fined not more than 
$500 in the case of a first offense, and not nore than $5,000 in the 
case of each subsequent offense.
    (g) Regulations; interagency consultations; definitions, safeguards, 
and procedures, including procedures and criteria for issuance and scope 
of orders
    Except as provided in subsection (h) of this section, the Secretary, 
after consultation with the Administrator of Veterans' Affairs and the 
heads of other Federal departments and agencies substantially affected 
thereby, shall prescribe regulations to carry out the purposes of this 
section. These regulations may contain such definitions, and may provide 
for such safeguards and procedures, including procedures and criteria 
for the issuance and scope of orders under subsection (b)(2)(C) of this 
section, as in the judgment of the Secretary are necessary or proper to 
effectuate the purposes of this section, to prevent circumvention or 
evasion thereof, or to facilitate compliance therewith.

(Subsection (h) was superseded by section 111(c)(3) of Pub. L. 94-581. 
The responsibility of the Administrator of Veterans' Affairs to write 
regulations to provide for confidentiality of drug abuse patient records 
under Title 38 was moved from 21 U.S.C. 1175 to 38 U.S.C. 4134.)



Sec. 2.2  Statutory authority for confidentiality of alcohol abuse patient 

records.

    The restrictions of these regulations upon the disclosure and use of 
alcohol

[[Page 9]]

abuse patient records were initially authorized by section 333 of the 
Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and 
Rehabilitation Act of 1970 (42 U.S.C. 4582). The section as amended was 
transferred by Pub. L. 98-24 to section 523 of the Public Health Service 
Act which is codified at 42 U.S.C. 290dd-3. The amended statutory 
authority is set forth below:

            Sec. 290dd-3. Confidentiality of patient records

    (a) Disclosure authorization
    Records of the identity, diagnosis, prognosis, or treatment of any 
patient which are maintained in connection with the performance of any 
program or activity relating to alcoholism or alcohol abuse education, 
training, treatment, rehabilitation, or research, which is conducted, 
regulated, or directly or indirectly assisted by any department or 
agency of the United States shall, except as provided in subsection (e) 
of this section, be confidential and be disclosed only for the purposes 
and under the circumstances expressly authorized under subsection (b) of 
this section.
    (b) Purposes and circumstances of disclosure affecting consenting 
patient and patient regardless of consent
    (1) The content of any record referred to in subsection (a) of this 
section may be disclosed in accordance with the prior written consent of 
the patient with respect to whom such record is maintained, but only to 
such extent, under such circumstances, and for such purposes as may be 
allowed under regulations prescribed pursuant to subsection (g) of this 
section.
    (2) Whether or not the patient, with respect to whom any given 
record referred to in subsection (a) of this section is maintained, 
gives his written consent, the content of such record may be disclosed 
as follows:
    (A) To medical personnel to the extent necessary to meet a bona fide 
medical emergency.
    (B) To qualified personnel for the purpose of conducting scientific 
research, management audits, financial audits, or program evaluation, 
but such personnel may not identify, directly or indirectly, any 
individual patient in any report of such research, audit, or evaluation, 
or otherwise disclose patient identities in any manner.
    (C) If authorized by an appropriate order of a court of competent 
jurisdiction granted after application showing good cause therefor. In 
assessing good cause the court shall weigh the public interest and the 
need for disclosure against the injury to the patient, to the physician-
patient relationship, and to the treatment services. Upon the granting 
of such order, the court, in determining the extent to which any 
disclosure of all or any part of any record is necessary, shall impose 
appropriate safeguards against unauthorized disclosure.
    (c) Prohibition against use of record in making criminal charges or 
investigation of patient
    Except as authorized by a court order granted under subsection 
(b)(2)(C) of this section, no record referred to in subsection (a) of 
this section may be used to initiate or substantiate any criminal 
charges against a patient or to conduct any investigation of a patient.
    (d) Continuing prohibition against disclosure irrespective of status 
as patient
    The prohibitions of this section continue to apply to records 
concerning any individual who has been a patient, irrespective of 
whether or when he ceases to be a patient.
    (e) Armed Forces and Veterans' Administration; interchange of record 
of suspected child abuse and neglect to State or local authorities
    The prohibitions of this section do not apply to any interchange of 
records--
    (1) within the Armed Forces or within those components of the 
Veterans' Administration furnishing health care to veterans, or
    (2) between such components and the Armed Forces.

The prohibitions of this section do not apply to the reporting under 
State law of incidents of suspected child abuse and neglect to the 
appropriate State or local authorities.

    (f) Penalty for first and subsequent offenses
    Any person who violates any provision of this section or any 
regulation issued pursuant to this section shall be fined not more than 
$500 in the case of a first offense, and not more than $5,000 in the 
case of each subsequent offense.
    (g) Regulations of Secretary; definitions, safeguards, and 
procedures, including procedures and criteria for issuance and scope of 
orders
    Except as provided in subsection (h) of this section, the Secretary 
shall prescribe regulations to carry out the purposes of this section. 
These regulations may contain such definitions, and may provide for such 
safeguards and procedures, including procedures and criteria for the 
issuance and scope of orders under subsection(b)(2)(C) of this section, 
as in the judgment of the Secretary are necessary or proper to 
effectuate the purposes of this section, to prevent circumvention or 
evasion thereof, or to facilitate compliance therewith.

(Subsection (h) was superseded by section 111(c)(4) of Pub. L. 94-581. 
The responsibility of the Administrator of Veterans' Affairs to write 
regulations to provide for confidentiality of alcohol abuse patient 
records under Title 38 was moved from 42 U.S.C. 4582 to 38 U.S.C. 4134.)

[[Page 10]]



Sec. 2.3  Purpose and effect.

    (a) Purpose. Under the statutory provisions quoted in Sec. Sec. 2.1 
and 2.2, these regulations impose restrictions upon the disclosure and 
use of alcohol and drug abuse patient records which are maintained in 
connection with the performance of any federally assisted alcohol and 
drug abuse program. The regulations specify:
    (1) Definitions, applicability, and general restrictions in subpart 
B (definitions applicable to Sec. 2.34 only appear in that section);
    (2) Disclosures which may be made with written patient consent and 
the form of the written consent in subpart C;
    (3) Disclosures which may be made without written patient consent or 
an authorizing court order in subpart D; and
    (4) Disclosures and uses of patient records which may be made with 
an authorizing court order and the procedures and criteria for the entry 
and scope of those orders in subpart E.
    (b) Effect. (1) These regulations prohibit the disclosure and use of 
patient records unless certain circumstances exist. If any circumstances 
exists under which disclosure is permitted, that circumstance acts to 
remove the prohibition on disclosure but it does not compel disclosure. 
Thus, the regulations do not require disclosure under any circumstances.
    (2) These regulations are not intended to direct the manner in which 
substantive functions such as research, treatment, and evaluation are 
carried out. They are intended to insure that an alcohol or drug abuse 
patient in a federally assisted alcohol or drug abuse program is not 
made more vulnerable by reason of the availability of his or her patient 
record than an individual who has an alcohol or drug problem and who 
does not seek treatment.
    (3) Because there is a criminal penalty (a fine--see 42 U.S.C. 
290ee-3(f), 42 U.S.C. 290dd-3(f) and 42 CFR 2.4) for violating the 
regulations, they are to be construed strictly in favor of the potential 
violator in the same manner as a criminal statute (see M. Kraus & 
Brothers v. United States, 327 U.S. 614, 621-22, 66 S. Ct. 705, 707-08 
(1946)).



Sec. 2.4  Criminal penalty for violation.

    Under 42 U.S.C. 290ee-3(f) and 42 U.S.C. 290dd-3(f), any person who 
violates any provision of those statutes or these regulations shall be 
fined not more than $500 in the case of a first offense, and not more 
than $5,000 in the case of each subsequent offense.



Sec. 2.5  Reports of violations.

    (a) The report of any violation of these regulations may be directed 
to the United States Attorney for the judicial district in which the 
violation occurs.
    (b) The report of any violation of these regulations by a methadone 
program may be directed to the Regional Offices of the Food and Drug 
Administration.



                      Subpart B_General Provisions



Sec. 2.11  Definitions.

    For purposes of these regulations:
    Alcohol abuse means the use of an alcoholic beverage which impairs 
the physical, mental, emotional, or social well-being of the user.
    Drug abuse means the use of a psychoactive substance for other than 
medicinal purposes which impairs the physical, mental, emotional, or 
social well-being of the user.
    Diagnosis means any reference to an individual's alcohol or drug 
abuse or to a condition which is identified as having been caused by 
that abuse which is made for the purpose of treatment or referral for 
treatment.
    Disclose or disclosure means a communication of patient indentifying 
information, the affirmative verification of another person's 
communication of patient identifying information, or the communication 
of any information from the record of a patient who has been identified.
    Informant means an individual:
    (a) Who is a patient or employee of a program or who becomes a 
patient or employee of a program at the request of a law enforcement 
agency or official: and
    (b) Who at the request of a law enforcement agency or official 
observes one or more patients or employees of

[[Page 11]]

the program for the purpose of reporting the information obtained to the 
law enforcement agency or official.
    Patient means any individual who has applied for or been given 
diagnosis or treatment for alcohol or drug abuse at a federally assisted 
program and includes any individual who, after arrest on a criminal 
charge, is identified as an alcohol or drug abuser in order to determine 
that individual's eligibility to participate in a program.
    Patient identifying information means the name, address, social 
security number, fingerprints, photograph, or similar information by 
which the identity of a patient can be determined with reasonable 
accuracy and speed either directly or by reference to other publicly 
available information. The term does not include a number assigned to a 
patient by a program, if that number does not consist of, or contain 
numbers (such as a social security, or driver's license number) which 
could be used to identify a patient with reasonable accuracy and speed 
from sources external to the program.
    Person means an individual, partnership, corporation, Federal, State 
or local government agency, or any other legal entity.
    Program means:
    (a) An individual or entity (other than a general medical care 
facility) who holds itself out as providing, and provides, alcohol or 
drug abuse diagnosis, treatment or referral for treatment; or
    (b) An identified unit within a general medical facility which holds 
itself out as providing, and provides, alcohol or drug abuse diagnosis, 
treatment or referral for treatment; or
    (c) Medical personnel or other staff in a general medical care 
facility whose primary function is the provision of alcohol or drug 
abuse diagnosis, treatment or referral for treatment and who are 
identified as such providers. (See Sec. 2.12(e)(1) for examples.)
    Program director means:
    (a) In the case of a program which is an individual, that 
individual:
    (b) In the case of a program which is an organization, the 
individual designated as director, managing director, or otherwise 
vested with authority to act as chief executive of the organization.
    Qualified service organization means a person which:
    (a) Provides services to a program, such as data processing, bill 
collecting, dosage preparation, laboratory analyses, or legal, medical, 
accounting, or other professional services, or services to prevent or 
treat child abuse or neglect, including training on nutrition and child 
care and individual and group therapy, and
    (b) Has entered into a written agreement with a program under which 
that person:
    (1) Acknowledges that in receiving, storing, processing or otherwise 
dealing with any patient records from the progams, it is fully bound by 
these regulations; and
    (2) If necessary, will resist in judicial proceedings any efforts to 
obtain access to patient records except as permitted by these 
regulations.
    Records means any information, whether recorded or not, relating to 
a patient received or acquired by a federally assisted alcohol or drug 
program.
    Third party payer means a person who pays, or agrees to pay, for 
diagnosis or treatment furnished to a patient on the basis of a 
contractual relationship with the patient or a member of his family or 
on the basis of the patient's eligibility for Federal, State, or local 
governmental benefits.
    Treatment means the management and care of a patient suffering from 
alcohol or drug abuse, a condition which is identified as having been 
caused by that abuse, or both, in order to reduce or eliminate the 
adverse effects upon the patient.
    Undercover agent means an officer of any Federal, State, or local 
law enforcement agency who enrolls in or becomes an employee of a 
program for the purpose of investigating a suspected violation of law or 
who pursues that purpose after enrolling or becoming employed for other 
purposes.

[52 FR 21809, June 9, 1987, as amended by 60 FR 22297, May 5, 1995]



Sec. 2.12  Applicability.

    (a) General--(1) Restrictions on disclosure. The restrictions on 
disclosure in

[[Page 12]]

these regulations apply to any information, whether or not recorded, 
which:
    (i) Would identify a patient as an alcohol or drug abuser either 
directly, by reference to other publicly available information, or 
through verification of such an identification by another person; and
    (ii) Is drug abuse information obtained by a federally assisted drug 
abuse program after March 20, 1972, or is alcohol abuse information 
obtained by a federally assisted alcohol abuse program after May 13, 
1974 (or if obtained before the pertinent date, is maintained by a 
federally assisted alcohol or drug abuse program after that date as part 
of an ongoing treatment episode which extends past that date) for the 
purpose of treating alcohol or drug abuse, making a diagnosis for that 
treatment, or making a referral for that treatment.
    (2) Restriction on use. The restriction on use of information to 
initiate or substantiate any criminal charges against a patient or to 
conduct any criminal investigation of a patient (42 U.S.C. 290ee-3(c), 
42 U.S.C. 290dd-3(c)) applies to any information, whether or not 
recorded which is drug abuse information obtained by a federally 
assisted drug abuse program after March 20, 1972, or is alcohol abuse 
information obtained by a federally assisted alcohol abuse program after 
May 13, 1974 (or if obtained before the pertinent date, is maintained by 
a federally assisted alcohol or drug abuse program after that date as 
part of an ongoing treatment episode which extends past that date), for 
the purpose of treating alcohol or drug abuse, making a diagnosis for 
the treatment, or making a referral for the treatment.
    (b) Federal assistance. An alcohol abuse or drug abuse program is 
considered to be federally assisted if:
    (1) It is conducted in whole or in part, whether directly or by 
contract or otherwise by any department or agency of the United States 
(but see paragraphs (c)(1) and (c)(2) of this section relating to the 
Veterans' Administration and the Armed Forces);
    (2) It is being carried out under a license, certification, 
registration, or other authorization granted by any department or agency 
of the United States including but not limited to:
    (i) Certification of provider status under the Medicare program;
    (ii) Authorization to conduct methadone maintenance treatment (see 
21 CFR 291.505); or
    (iii) Registration to dispense a substance under the Controlled 
Substances Act to the extent the controlled substance is used in the 
treatment of alcohol or drug abuse;
    (3) It is supported by funds provided by any department or agency of 
the United States by being:
    (i) A recipient of Federal financial assistance in any form, 
including financial assistance which does not directly pay for the 
alcohol or drug abuse diagnosis, treatment, or referral activities; or
    (ii) Conducted by a State or local government unit which, through 
general or special revenue sharing or other forms of assistance, 
receives Federal funds which could be (but are not necessarily) spent 
for the alcohol or drug abuse program; or
    (4) It is assisted by the Internal Revenue Service of the Department 
of the Treasury through the allowance of income tax deductions for 
contributions to the program or through the granting of tax exempt 
status to the program.
    (c) Exceptions--(1) Veterans' Administration. These regulations do 
not apply to information on alcohol and drug abuse patients maintained 
in connection with the Veterans' Administration provisions of hospital 
care, nursing home care, domiciliary care, and medical services under 
title 38, United States Code. Those records are governed by 38 U.S.C. 
4132 and regulations issued under that authority by the Administrator of 
Veterans' Affairs.
    (2) Armed Forces. These regulations apply to any information 
described in paragraph (a) of this section which was obtained by any 
component of the Armed Forces during a period when the patient was 
subject to the Uniform Code of Military Justice except:
    (i) Any interchange of that information within the Armed Forces; and
    (ii) Any interchange of that information between the Armed Forces 
and

[[Page 13]]

those components of the Veterans Administration furnishing health care 
to veterans.
    (3) Communication within a program or between a program and an 
entity having direct administrative control over that program. The 
restrictions on disclosure in these regulations do not apply to 
communications of information between or among personnel having a need 
for the information in connection with their duties that arise out of 
the provision of diagnosis, treatment, or referral for treatment of 
alcohol or drug abuse if the communications are
    (i) Within a program or
    (ii) Between a program and an entity that has direct administrative 
control over the program.
    (4) Qualified Service Organizations. The restrictions on disclosure 
in these regulations do not apply to communications between a program 
and a qualified service organization of information needed by the 
organization to provide services to the program.
    (5) Crimes on program premises or against program personnel. The 
restrictions on disclosure and use in these regulations do not apply to 
communications from program personnel to law enforcement officers 
which--
    (i) Are directly related to a patient's commission of a crime on the 
premises of the program or against program personnel or to a threat to 
commit such a crime; and
    (ii) Are limited to the circumstances of the incident, including the 
patient status of the individual committing or threatening to commit the 
crime, that individual's name and address, and that individual's last 
known whereabouts.
    (6) Reports of suspected child abuse and neglect. The restrictions 
on disclosure and use in these regulations do not apply to the reporting 
under State law of incidents of suspected child abuse and neglect to the 
appropriate State or local authorities. However, the restrictions 
continue to apply to the original alcohol or drug abuse patient records 
maintained by the program including their disclosure and use for civil 
or criminal proceedings which may arise out of the report of suspected 
child abuse and neglect.
    (d) Applicability to recipients of information--(1) Restriction on 
use of information. The restriction on the use of any information 
subject to these regulations to initiate or substantiate any criminal 
charges against a patient or to conduct any criminal investigation of a 
patient applies to any person who obtains that information from a 
federally assisted alcohol or drug abuse program, regardless of the 
status of the person obtaining the information or of whether the 
information was obtained in accordance with these regulations. This 
restriction on use bars, among other things, the introduction of that 
information as evidence in a criminal proceeding and any other use of 
the information to investigate or prosecute a patient with respect to a 
suspected crime. Information obtained by undercover agents or informants 
(see Sec. 2.17) or through patient access (see Sec. 2.23) is subject 
to the restriction on use.
    (2) Restrictions on disclosures--Third party payers, administrative 
entities, and others. The restrictions on disclosure in these 
regulations apply to:
    (i) Third party payers with regard to records disclosed to them by 
federally assisted alcohol or drug abuse programs;
    (ii) Entities having direct administrative control over programs 
with regard to information communicated to them by the program under 
Sec. 2.12(c)(3); and
    (iii) Persons who receive patient records directly from a federally 
assisted alcohol or drug abuse program and who are notified of the 
restrictions on redisclosure of the records in accordance with Sec. 
2.32 of these regulations.
    (e) Explanation of applicability--(1) Coverage. These regulations 
cover any information (including information on referral and intake) 
about alcohol and drug abuse patients obtained by a program (as the 
terms ``patient'' and ``program'' are defined in Sec. 2.11) if the 
program is federally assisted in any manner described in Sec. 2.12(b). 
Coverage includes, but is not limited to, those treatment or 
rehabilitation programs, employee assistance programs, programs within 
general hospitals, school-based programs, and private practitioners who 
hold themselves out as

[[Page 14]]

providing, and provide alcohol or drug abuse diagnosis, treatment, or 
referral for treatment. However, these regulations would not apply, for 
example, to emergency room personnel who refer a patient to the 
intensive care unit for an apparent overdose, unless the primary 
function of such personnel is the provision of alcohol or drug abuse 
diagnosis, treatment or referral and they are identified as providing 
such services or the emergency room has promoted itself to the community 
as a provider of such services.
    (2) Federal assistance to program required. If a patient's alcohol 
or drug abuse diagnosis, treatment, or referral for treatment is not 
provided by a program which is federally conducted, regulated or 
supported in a manner which constitutes Federal assistance under Sec. 
2.12(b), that patient's record is not covered by these regulations. 
Thus, it is possible for an individual patient to benefit from Federal 
support and not be covered by the confidentiality regulations because 
the program in which the patient is enrolled is not federally assisted 
as defined in Sec. 2.12(b). For example, if a Federal court placed an 
individual in a private for-profit program and made a payment to the 
program on behalf of that individual, that patient's record would not be 
covered by these regulations unless the program itself received Federal 
assistance as defined by Sec. 2.12(b).
    (3) Information to which restrictions are applicable. Whether a 
restriction is on use or disclosure affects the type of information 
which may be available. The restrictions on disclosure apply to any 
information which would identify a patient as an alcohol or drug abuser. 
The restriction on use of information to bring criminal charges against 
a patient for a crime applies to any information obtained by the program 
for the purpose of diagnosis, treatment, or referral for treatment of 
alcohol or drug abuse. (Note that restrictions on use and disclosure 
apply to recipients of information under Sec. 2.12(d).)
    (4) How type of diagnosis affects coverage. These regulations cover 
any record of a diagnosis identifying a patient as an alcohol or drug 
abuser which is prepared in connection with the treatment or referral 
for treatment of alcohol or drug abuse. A diagnosis prepared for the 
purpose of treatment or referral for treatment but which is not so used 
is covered by these regulations. The following are not covered by these 
regulations:
    (i) Diagnosis which is made solely for the purpose of providing 
evidence for use by law enforcement authorities; or
    (ii) A diagnosis of drug overdose or alcohol intoxication which 
clearly shows that the individual involved is not an alcohol or drug 
abuser (e.g., involuntary ingestion of alcohol or drugs or reaction to a 
prescribed dosage of one or more drugs).

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987, as amended at 60 
FR 22297, May 5, 1995]



Sec. 2.13  Confidentiality restrictions.

    (a) General. The patient records to which these regulations apply 
may be disclosed or used only as permitted by these regulations and may 
not otherwise be disclosed or used in any civil, criminal, 
administrative, or legislative proceedings conducted by any Federal, 
State, or local authority. Any disclosure made under these regulations 
must be limited to that information which is necessary to carry out the 
purpose of the disclosure.
    (b) Unconditional compliance required. The restrictions on 
disclosure and use in these regulations apply whether the holder of the 
information believes that the person seeking the information already has 
it, has other means of obtaining it, is a law enforcement or other 
official, has obtained a subpoena, or asserts any other justification 
for a disclosure or use which is not permitted by these regulations.
    (c) Acknowledging the presence of patients: Responding to requests. 
(1) The presence of an identified patient in a facility or component of 
a facility which is publicly identified as a place where only alcohol or 
drug abuse diagnosis, treatment, or referral is provided may be 
acknowledged only if the patient's written consent is obtained in 
accordance with subpart C of these regulations or if an authorizing 
court order is entered in accordance with subpart E of these 
regulations. The regulations permit acknowledgement of the presence of 
an identified patient in a facility or part of a facility if the

[[Page 15]]

facility is not publicy identified as only an alcohol or drug abuse 
diagnosis, treatment or referral facility, and if the acknowledgement 
does not reveal that the patient is an alcohol or drug abuser.
    (2) Any answer to a request for a disclosure of patient records 
which is not permissible under these regulations must be made in a way 
that will not affirmatively reveal that an identified individual has 
been, or is being diagnosed or treated for alcohol or drug abuse. An 
inquiring party may be given a copy of these regulations and advised 
that they restrict the disclosure of alcohol or drug abuse patient 
records, but may not be told affirmatively that the regulations restrict 
the disclosure of the records of an identified patient. The regulations 
do not restrict a disclosure that an identified individual is not and 
never has been a patient.



Sec. 2.14  Minor patients.

    (a) Definition of minor. As used in these regulations the term 
``minor'' means a person who has not attained the age of majority 
specified in the applicable State law, or if no age of majority is 
specified in the applicable State law, the age of eighteen years.
    (b) State law not requiring parental consent to treatment. If a 
minor patient acting alone has the legal capacity under the applicable 
State law to apply for and obtain alcohol or drug abuse treatment, any 
written consent for disclosure authorized under subpart C of these 
regulations may be given only by the minor patient. This restriction 
includes, but is not limited to, any disclosure of patient identifying 
information to the parent or guardian of a minor patient for the purpose 
of obtaining financial reimbursement. These regulations do not prohibit 
a program from refusing to provide treatment until the minor patient 
consents to the disclosure necessary to obtain reimbursement, but 
refusal to provide treatment may be prohibited under a State or local 
law requiring the program to furnish the service irrespective of ability 
to pay.
    (c) State law requiring parental consent to treatment. (1) Where 
State law requires consent of a parent, guardian, or other person for a 
minor to obtain alcohol or drug abuse treatment, any written consent for 
disclosure authorized under subpart C of these regulations must be given 
by both the minor and his or her parent, guardian, or other person 
authorized under State law to act in the minor's behalf.
    (2) Where State law requires parental consent to treatment the fact 
of a minor's application for treatment may be communicated to the 
minor's parent, guardian, or other person authorized under State law to 
act in the minor's behalf only if:
    (i) The minor has given written consent to the disclosure in 
accordance with subpart C of these regulations or
    (ii) The minor lacks the capacity to make a rational choice 
regarding such consent as judged by the program director under paragraph 
(d) of this section.
    (d) Minor applicant for services lacks capacity for rational choice. 
Facts relevant to reducing a threat to the life or physical well being 
of the applicant or any other individual may be disclosed to the parent, 
guardian, or other person authorized under State law to act in the 
minor's behalf if the program director judges that:
    (1) A minor applicant for services lacks capacity because of extreme 
youth or mental or physical condition to make a rational decision on 
whether to consent to a disclosure under subpart C of these regulations 
to his or her parent, guardian, or other person authorized under State 
law to act in the minor's behalf, and
    (2) The applicant's situation poses a substantial threat to the life 
or physical well being of the applicant or any other individual which 
may be reduced by communicating relevant facts to the minor's parent, 
guardian, or other person authorized under State law to act in the 
minor's behalf.



Sec. 2.15  Incompetent and deceased patients.

    (a) Incompetent patients other than minors--(1) Adjudication of 
incompetence. In the case of a patient who has been adjudicated as 
lacking the capacity, for any reason other than insufficient age, to 
manage his or her own affairs, any consent which is required under these 
regulations may be given by the

[[Page 16]]

guardian or other person authorized under State law to act in the 
patient's behalf.
    (2) No adjudication of incompetency. For any period for which the 
program director determines that a patient, other than a minor or one 
who has been adjudicated incompetent, suffers from a medical condition 
that prevents knowing or effective action on his or her own behalf, the 
program director may exercise the right of the patient to consent to a 
disclosure under subpart C of these regulations for the sole purpose of 
obtaining payment for services from a third party payer.
    (b) Deceased patients--(1) Vital statistics. These regulations do 
not restrict the disclosure of patient identifying information relating 
to the cause of death of a patient under laws requiring the collection 
of death or other vital statistics or permitting inquiry into the cause 
of death.
    (2) Consent by personal representative. Any other disclosure of 
information identifying a deceased patient as an alcohol or drug abuser 
is subject to these regulations. If a written consent to the disclosure 
is required, that consent may be given by an executor, administrator, or 
other personal representative appointed under applicable State law. If 
there is no such appointment the consent may be given by the patient's 
spouse or, if none, by any responsible member of the patient's family.



Sec. 2.16  Security for written records.

    (a) Written records which are subject to these regulations must be 
maintained in a secure room, locked file cabinet, safe or other similar 
container when not in use; and
    (b) Each program shall adopt in writing procedures which regulate 
and control access to and use of written records which are subject to 
these regulations.



Sec. 2.17  Undercover agents and informants.

    (a) Restrictions on placement. Except as specifically authorized by 
a court order granted under Sec. 2.67 of these regulations, no program 
may knowingly employ, or enroll as a patient, any undercover agent or 
informant.
    (b) Restriction on use of information. No information obtained by an 
undercover agent or informant, whether or not that undercover agent or 
informant is placed in a program pursuant to an authorizing court order, 
may be used to criminally investigate or prosecute any patient.

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987]



Sec. 2.18  Restrictions on the use of identification cards.

    No person may require any patient to carry on his or her person 
while away from the program premises any card or other object which 
would identify the patient as an alcohol or drug abuser. This section 
does not prohibit a person from requiring patients to use or carry cards 
or other identification objects on the premises of a program.



Sec. 2.19  Disposition of records by discontinued programs.

    (a) General. If a program discontinues operations or is taken over 
or acquired by another program, it must purge patient identifying 
information from its records or destroy the records unless--
    (1) The patient who is the subject of the records gives written 
consent (meeting the requirements of Sec. 2.31) to a transfer of the 
records to the acquiring program or to any other program designated in 
the consent (the manner of obtaining this consent must minimize the 
likelihood of a disclosure of patient identifying information to a third 
party); or
    (2) There is a legal requirement that the records be kept for a 
period specified by law which does not expire until after the 
discontinuation or acquisition of the program.
    (b) Procedure where retention period required by law. If paragraph 
(a)(2) of this section applies, the records must be:
    (1) Sealed in envelopes or other containers labeled as follows: 
``Records of [insert name of program] required to be maintained under 
[insert citation to statute, regulation, court order or other legal 
authority requiring that records be kept] until a date not later than 
[insert appropriate date]''; and
    (2) Held under the restrictions of these regulations by a 
responsible person who must, as soon as practicable

[[Page 17]]

after the end of the retention period specified on the label, destroy 
the records.



Sec. 2.20  Relationship to State laws.

    The statutes authorizing these regulations (42 U.S.C. 290ee-3 and 42 
U.S.C. 290dd-3) do not preempt the field of law which they cover to the 
exclusion of all State laws in that field. If a disclosure permitted 
under these regulations is prohibited under State law, neither these 
regulations nor the authorizing statutes may be construed to authorize 
any violation of that State law. However, no State law may either 
authorize or compel any disclosure prohibited by these regulations.



Sec. 2.21  Relationship to Federal statutes protecting research subjects 

against compulsory disclosure of their identity.

    (a) Research privilege description. There may be concurrent coverage 
of patient identifying information by these regulations and by 
administrative action taken under: Section 303(a) of the Public Health 
Service Act (42 U.S.C. 242a(a) and the implementing regulations at 42 
CFR part 2a); or section 502(c) of the Controlled Substances Act (21 
U.S.C. 872(c) and the implementing regulations at 21 CFR 1316.21). These 
``research privilege'' statutes confer on the Secretary of Health and 
Human Services and on the Attorney General, respectively, the power to 
authorize researchers conducting certain types of research to withhold 
from all persons not connected with the research the names and other 
identifying information concerning individuals who are the subjects of 
the research.
    (b) Effect of concurrent coverage. These regulations restrict the 
disclosure and use of information about patients, while administrative 
action taken under the research privilege statutes and implementing 
regulations protects a person engaged in applicable research from being 
compelled to disclose any identifying characteristics of the individuals 
who are the subjects of that research. The issuance under subpart E of 
these regulations of a court order authorizing a disclosure of 
information about a patient does not affect an exercise of authority 
under these research privilege statutes. However, the research privilage 
granted under 21 CFR 291.505(g) to treatment programs using methadone 
for maintenance treatment does not protect from compulsory disclosure 
any imformation which is permitted to be disclosed under those 
regulations. Thus, if a court order entered in accordance with subpart E 
of these regulations authorizes a methadone maintenance treatment 
program to disclose certain information about its patients, that program 
may not invoke the research privilege under 21 CFR 291.505(g) as a 
defense to a subpoena for that information.



Sec. 2.22  Notice to patients of Federal confidentiality requirements.

    (a) Notice required. At the time of admission or as soon threreafter 
as the patient is capable of rational communication, each program shall:
    (1) Communicate to the patient that Federal law and regulations 
protect the confidentiality of alcohol and drug abuse patient records; 
and
    (2) Give to the patient a summary in writing of the Federal law and 
regulations.
    (b) Required elements of written summary. The written summary of the 
Federal law and regulations must include:
    (1) A general description of the limited circumstances under which a 
program may acknowledge that an individual is present at a facility or 
disclose outside the program information identifying a patient as an 
alcohol or drug abuser.
    (2) A statement that violation of the Federal law and regulations by 
a program is a crime and that suspected violations may be reported to 
appropriate authorities in accordance with these regulations.
    (3) A statement that information related to a patient's commission 
of a crime on the premises of the program or against personnel of the 
program is not protected.
    (4) A statement that reports of suspected child abuse and neglect 
made under State law to appropriate State or local authorities are not 
protected.
    (5) A citation to the Federal law and regulations.
    (c) Program options. The program may devise its own notice or may 
use the

[[Page 18]]

sample notice in paragraph (d) to comply with the requirement to provide 
the patient with a summary in writing of the Federal law and 
regulations. In addition, the program may include in the written summary 
information concerning State law and any program policy not inconsistent 
with State and Federal law on the subject of confidentiality of alcohol 
and drug abuse patient records.
    (d) Sample notice.

        Confidentiality of Alcohol and Drug Abuse Patient Records

    The confidentiality of alcohol and drug abuse patient records 
maintained by this program is protected by Federal law and regulations. 
Generally, the program may not say to a person outside the program that 
a patient attends the program, or disclose any information identifying a 
patient as an alcohol or drug abuser Unless:
    (1) The patient consents in writing:
    (2) The disclosure is allowed by a court order; or
    (3) The disclosure is made to medical personnel in a medical 
emergency or to qualified personnel for research, audit, or program 
evaluation.
    Violation of the Federal law and regulations by a program is a 
crime. Suspected violations may be reported to appropriate authorities 
in accordance with Federal regulations.
    Federal law and regulations do not protect any information about a 
crime committed by a patient either at the program or against any person 
who works for the program or about any threat to commit such a crime.
    Federal laws and regulations do not protect any information about 
suspected child abuse or neglect from being reported under State law to 
appropriate State or local authorities.

(See 42 U.S.C. 290dd-3 and 42 U.S.C. 290ee-3 for Federal laws and 42 CFR 
part 2 for Federal regulations.)

(Approved by the Office of Management and Budget under control number 
0930-0099)



Sec. 2.23  Patient access and restrictions on use.

    (a) Patient access not prohibited. These regulations do not prohibit 
a program from giving a patient access to his or her own records, 
including the opportunity to inspect and copy any records that the 
program maintains about the patient. The program is not required to 
obtain a patient's written consent or other authorization under these 
regulations in order to provide such access to the patient.
    (b) Restriction on use of information. Information obtained by 
patient access to his or her patient record is subject to the 
restriction on use of his information to initiate or substantiate any 
criminal charges against the patient or to conduct any criminal 
investigation of the patient as provided for under Sec. 2.12(d)(1).



              Subpart C_Disclosures With Patient's Consent



Sec. 2.31  Form of written consent.

    (a) Required elements. A written consent to a disclosure under these 
regulations must include:
    (1) The specific name or general designation of the program or 
person permitted to make the disclosure.
    (2) The name or title of the individual or the name of the 
organization to which disclosure is to be made.
    (3) The name of the patient.
    (4) The purpose of the disclosure.
    (5) How much and what kind of information is to be disclosed.
    (6) The signature of the patient and, when required for a patient 
who is a minor, the signature of a person authorized to give consent 
under Sec. 2.14; or, when required for a patient who is incompetent or 
deceased, the signature of a person authorized to sign under Sec. 2.15 
in lieu of the patient.
    (7) The date on which the consent is signed.
    (8) A statement that the consent is subject to revocation at any 
time except to the extent that the program or person which is to make 
the disclosure has already acted in reliance on it. Acting in reliance 
includes the provision of treatment services in reliance on a valid 
consent to disclose information to a third party payer.
    (9) The date, event, or condition upon which the consent will expire 
if not revoked before. This date, event, or condition must insure that 
the consent will last no longer than reasonably necessary to serve the 
purpose for which it is given.
    (b) Sample consent form. The following form complies with paragraph 
(a) of this section, but other elements may be added.


[[Page 19]]


1. I (name of patient) [squ] Request [squ] Authorize:
2. (name or general designation of program which is to make the 
disclosure)
________________________________________________________________________
3. To disclose: (kind and amount of information to be disclosed)
________________________________________________________________________
4. To: (name or title of the person or organization to which disclosure 
is to be made)
________________________________________________________________________
5. For (purpose of the disclosure)
________________________________________________________________________
6. Date (on which this consent is signed)
________________________________________________________________________
7. Signature of patient
________________________________________________________________________
8. Signature of parent or guardian (where required)
________________________________________________________________________
9. Signature of person authorized to sign in lieu of the patient (where 
required)
________________________________________________________________________
10. This consent is subject to revocation at any time except to the 
extent that the program which is to make the disclosure has already 
taken action in reliance on it. If not previously revoked, this consent 
will terminate upon: (specific date, event, or condition)

    (c) Expired, deficient, or false consent. A disclosure may not be 
made on the basis of a consent which:
    (1) Has expired;
    (2) On its face substantially fails to conform to any of the 
requirements set forth in paragraph (a) of this section;
    (3) Is known to have been revoked; or
    (4) Is known, or through a reasonable effort could be known, by the 
person holding the records to be materially false.

(Approved by the Office of Management and Budget under control number 
0930-0099)



Sec. 2.32  Prohibition on redisclosure.

    Notice to accompany disclosure. Each disclosure made with the 
patient's written consent must be accompanied by the following written 
statement:

    This information has been disclosed to you from records protected by 
Federal confidentiality rules (42 CFR part 2). The Federal rules 
prohibit you from making any further disclosure of this information 
unless further disclosure is expressly permitted by the written consent 
of the person to whom it pertains or as otherwise permitted by 42 CFR 
part 2. A general authorization for the release of medical or other 
information is NOT sufficient for this purpose. The Federal rules 
restrict any use of the information to criminally investigate or 
prosecute any alcohol or drug abuse patient.

[52 FR 21809, June 9, 1987; 52 FR 41997, Nov. 2, 1987]



Sec. 2.33  Disclosures permitted with written consent.

    If a patient consents to a disclosure of his or her records under 
Sec. 2.31, a program may disclose those records in accordance with that 
consent to any individual or organization named in the consent, except 
that disclosures to central registries and in connection with criminal 
justice referrals must meet the requirements of Sec. Sec. 2.34 and 
2.35, respectively.



Sec. 2.34  Disclosures to prevent multiple enrollments in detoxification and 

maintenance treatment programs.

    (a) Definitions. For purposes of this section:
    Central registry means an organization which obtains from two or 
more member progams patient identifying information about individuals 
applying for maintenance treatment or detoxification treatment for the 
purpose of avoiding an individual's concurrent enrollment in more than 
one program.
    Detoxification treatment means the dispensing of a narcotic drug in 
decreasing doses to an individual in order to reduce or eliminate 
adverse physiological or psychological effects incident to withdrawal 
from the sustained use of a narcotic drug.
    Maintenance treatment means the dispensing of a narcotic drug in the 
treatment of an individual for dependence upon heroin or other morphine-
like drugs.
    Member program means a detoxification treatment or maintenance 
treatment program which reports patient identifying information to a 
central registry and which is in the same State as that central registry 
or is not more than 125 miles from any border of the State in which the 
central registry is located.
    (b) Restrictions on disclosure. A program may disclose patient 
records to a central registry or to any detoxification or maintenance 
treatment program not more than 200 miles away for the purpose of 
preventing the multiple enrollment of a patient only if:

[[Page 20]]

    (1) The disclosure is made when:
    (i) The patient is accepted for treatment;
    (ii) The type or dosage of the drug is changed; or
    (iii) The treatment is interrupted, resumed or terminated.
    (2) The disclosure is limited to:
    (i) Patient identifying information;
    (ii) Type and dosage of the drug; and
    (iii) Relevant dates.
    (3) The disclosure is made with the patient's written consent 
meeting the requirements of Sec. 2.31, except that:
    (i) The consent must list the name and address of each central 
registry and each known detoxification or maintenance treatment program 
to which a disclosure will be made; and
    (ii) The consent may authorize a disclosure to any detoxification or 
maintenance treatment program established within 200 miles of the 
program after the consent is given without naming any such program.
    (c) Use of information limited to prevention of multiple 
enrollments. A central registry and any detoxification or maintenance 
treatment program to which information is disclosed to prevent multiple 
enrollments may not redisclose or use patient identifying information 
for any purpose other than the prevention of multiple enrollments unless 
authorized by a court order under subpart E of these regulations.
    (d) Permitted disclosure by a central registry to prevent a multiple 
enrollment. When a member program asks a central registry if an 
identified patient is enrolled in another member program and the 
registry determines that the patient is so enrolled, the registry may 
disclose--
    (1) The name, address, and telephone number of the member program(s) 
in which the patient is already enrolled to the inquiring member 
program; and
    (2) The name, address, and telephone number of the inquiring member 
program to the member program(s) in which the patient is already 
enrolled. The member programs may communicate as necessary to verify 
that no error has been made and to prevent or eliminate any multiple 
enrollment.
    (e) Permitted disclosure by a detoxification or maintenance 
treatment program to prevent a multiple enrollment. A detoxification or 
maintenance treatment program which has received a disclosure under this 
section and has determined that the patient is already enrolled may 
communicate as necessary with the program making the disclosure to 
verify that no error has been made and to prevent or eliminate any 
multiple enrollment.



Sec. 2.35  Disclosures to elements of the criminal justice system which have 

referred patients.

    (a) A program may disclose information about a patient to those 
persons within the criminal justice system which have made participation 
in the program a condition of the disposition of any criminal 
proceedings against the patient or of the patient's parole or other 
release from custody if:
    (1) The disclosure is made only to those individuals within the 
criminal justice system who have a need for the information in 
connection with their duty to monitor the patient's progress (e.g., a 
prosecuting attorney who is withholding charges against the patient, a 
court granting pretrial or posttrial release, probation or parole 
officers responsible for supervision of the patient); and
    (2) The patient has signed a written consent meeting the 
requirements of Sec. 2.31 (except paragraph (a)(8) which is 
inconsistent with the revocation provisions of paragraph (c) of this 
section) and the requirements of paragraphs (b) and (c) of this section.
    (b) Duration of consent. The written consent must state the period 
during which it remains in effect. This period must be reasonable, 
taking into account:
    (1) The anticipated length of the treatment;
    (2) The type of criminal proceeding involved, the need for the 
information in connection with the final disposition of that proceeding, 
and when the final disposition will occur; and
    (3) Such other factors as the program, the patient, and the 
person(s) who will receive the disclosure consider pertinent.
    (c) Revocation of consent. The written consent must state that it is 
revocable upon the passage of a specified amount of time or the 
occurrence of a specified,

[[Page 21]]

ascertainable event. The time or occurrence upon which consent becomes 
revocable may be no later than the final disposition of the conditional 
release or other action in connection with which consent was given.
    (d) Restrictions on redisclosure and use. A person who receives 
patient information under this section may redisclose and use it only to 
carry out that person's official duties with regard to the patient's 
conditional release or other action in connection with which the consent 
was given.



              Subpart D_Disclosures Without Patient Consent



Sec. 2.51  Medical emergencies.

    (a) General Rule. Under the procedures required by paragraph (c) of 
this section, patient identifying information may be disclosed to 
medical personnel who have a need for information about a patient for 
the purpose of treating a condition which poses an immediate threat to 
the health of any individual and which requires immediate medical 
intervention.
    (b) Special Rule. Patient identifying information may be disclosed 
to medical personnel of the Food and Drug Administration (FDA) who 
assert a reason to believe that the health of any individual may be 
threatened by an error in the manufacture, labeling, or sale of a 
product under FDA jurisdiction, and that the information will be used 
for the exclusive purpose of notifying patients or their physicians of 
potential dangers.
    (c) Procedures. Immediately following disclosure, the program shall 
document the disclosure in the patient's records, setting forth in 
writing:
    (1) The name of the medical personnel to whom disclosure was made 
and their affiliation with any health care facility;
    (2) The name of the individual making the disclosure;
    (3) The date and time of the disclosure; and
    (4) The nature of the emergency (or error, if the report was to 
FDA).

(Approved by the Office of Management and Budget under control number 
0930-0099)



Sec. 2.52  Research activities.

    (a) Patient identifying information may be disclosed for the purpose 
of conducting scientific research if the program director makes a 
determination that the recipient of the patient identifying information:
    (1) Is qualified to conduct the research;
    (2) Has a research protocol under which the patient identifying 
information:
    (i) Will be maintained in accordance with the security requirements 
of Sec. 2.16 of these regulations (or more stringent requirements); and
    (ii) Will not be redisclosed except as permitted under paragraph (b) 
of this section; and
    (3) Has provided a satisfactory written statement that a group of 
three or more individuals who are independent of the research project 
has reviewed the protocol and determined that:
    (i) The rights and welfare of patients will be adequately protected; 
and
    (ii) The risks in disclosing patient identifying information are 
outweighed by the potential benefits of the research.
    (b) A person conducting research may disclose patient identifying 
information obtained under paragraph (a) of this section only back to 
the program from which that information was obtained and may not 
identify any individual patient in any report of that research or 
otherwise disclose patient identities.

[52 FR 21809, June 9, 1987, as amended at 52 FR 41997, Nov. 2, 1987]



Sec. 2.53  Audit and evaluation activities.

    (a) Records not copied or removed. If patient records are not copied 
or removed, patient identifying information may be disclosed in the 
course of a review of records on program premises to any person who 
agrees in writing to comply with the limitations on redisclosure and use 
in paragraph (d) of this section and who:
    (1) Performs the audit or evaluation activity on behalf of:
    (i) Any Federal, State, or local governmental agency which provides 
financial assistance to the program or is

[[Page 22]]

authorized by law to regulate its activities; or
    (ii) Any private person which provides financial assistance to the 
program, which is a third party payer covering patients in the program, 
or which is a quality improvement organization performing a utilization 
or quality control review; or
    (2) Is determined by the program director to be qualified to conduct 
the audit or evaluation activities.
    (b) Copying or removal of records. Records containing patient 
identifying information may be copied or removed from program premises 
by any person who:
    (1) Agrees in writing to:
    (i) Maintain the patient identifying information in accordance with 
the security requirements provided in Sec. 2.16 of these regulations 
(or more stringent requirements);
    (ii) Destroy all the patient identifying information upon completion 
of the audit or evaluation; and
    (iii) Comply with the limitations on disclosure and use in paragraph 
(d) of this section; and
    (2) Performs the audit or evaluation activity on behalf of:
    (i) Any Federal, State, or local governmental agency which provides 
financial assistance to the program or is authorized by law to regulate 
its activities; or
    (ii) Any private person which provides financial assistance to the 
program, which is a third part payer covering patients in the program, 
or which is a quality improvement organization performing a utilization 
or quality control review.
    (c) Medicare or Medicaid audit or evaluation. (1) For purposes of 
Medicare or Medicaid audit or evaluation under this section, audit or 
evaluation includes a civil or administrative investigation of the 
program by any Federal, State, or local agency responsible for oversight 
of the Medicare or Medicaid program and includes administrative 
enforcement, against the program by the agency, of any remedy authorized 
by law to be imposed as a result of the findings of the investigation.
    (2) Consistent with the definition of program in Sec. 2.11, program 
includes an employee of, or provider of medical services under, the 
program when the employee or provider is the subject of a civil 
investigation or administrative remedy, as those terms are used in 
paragraph (c)(1) of this section.
    (3) If a disclosure to a person is authorized under this section for 
a Medicare or Medicaid audit or evaluation, including a civil 
investigation or administrative remedy, as those terms are used in 
paragraph (c)(1) of this section, then a quality improvement 
organization which obtains the information under paragraph (a) or (b) 
may disclose the information to that person but only for purposes of 
Medicare or Medicaid audit or evaluation.
    (4) The provisions of this paragraph do not authorize the agency, 
the program, or any other person to disclose or use patient identifying 
information obtained during the audit or evaluation for any purposes 
other than those necessary to complete the Medicare or Medicaid audit or 
evaluation activity as specified in this paragraph.
    (d) Limitations on disclosure and use. Except as provided in 
paragraph (c) of this section, patient identifying information disclosed 
under this section may be disclosed only back to the program from which 
it was obtained and used only to carry out an audit or evaluation 
purpose or to investigate or prosecute criminal or other activities, as 
authorized by a court order entered under Sec. 2.66 of these 
regulations.



          Subpart E_Court Orders Authorizing Disclosure and Use



Sec. 2.61  Legal effect of order.

    (a) Effect. An order of a court of competent jurisdiction entered 
under this subpart is a unique kind of court order. Its only purpose is 
to authorize a disclosure or use of patient information which would 
otherwise be prohibited by 42 U.S.C. 290ee-3, 42 U.S.C. 290dd-3 and 
these regulations. Such an order does not compel disclosure. A subpoena 
or a similar legal mandate must be issued in order to compel disclosure. 
This mandate may be entered at the same time as and accompany an 
authorizing court order entered under these regulations.

[[Page 23]]

    (b) Examples. (1) A person holding records subject to these 
regulations receives a subpoena for those records: a response to the 
subpoena is not permitted under the regulations unless an authorizing 
court order is entered. The person may not disclose the records in 
response to the subpoena unless a court of competent jurisdiction enters 
an authorizing order under these regulations.
    (2) An authorizing court order is entered under these regulations, 
but the person authorized does not want to make the disclosure. If there 
is no subpoena or other compulsory process or a subpoena for the records 
has expired or been quashed, that person may refuse to make the 
disclosure. Upon the entry of a valid subpoena or other compulsory 
process the person authorized to disclose must disclose, unless there is 
a valid legal defense to the process other than the confidentiality 
restrictions of these regulations.

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987]



Sec. 2.62  Order not applicable to records disclosed without consent to 

researchers, auditors and evaluators.

    A court order under these regulations may not authorize qualified 
personnel, who have received patient identifying information without 
consent for the purpose of conducting research, audit or evaluation, to 
disclose that information or use it to conduct any criminal 
investigation or prosecution of a patient. However, a court order under 
Sec. 2.66 may authorize disclosure and use of records to investigate or 
prosecute qualified personnel holding the records.



Sec. 2.63  Confidential communications.

    (a) A court order under these regulations may authorize disclosure 
of confidential communications made by a patient to a program in the 
course of diagnosis, treatment, or referral for treatment only if:
    (1) The disclosure is necessary to protect against an existing 
threat to life or of serious bodily injury, including circumstances 
which constitute suspected child abuse and neglect and verbal threats 
against third parties;
    (2) The disclosure is necessary in connection with investigation or 
prosecution of an extremely serious crime, such as one which directly 
threatens loss of life or serious bodily injury, including homicide, 
rape, kidnapping, armed robbery, assault with a deadly weapon, or child 
abuse and neglect; or
    (3) The disclosure is in connection with litigation or an 
administrative proceeding in which the patient offers testimony or other 
evidence pertaining to the content of the confidential communications.
    (b) [Reserved]



Sec. 2.64  Procedures and criteria for orders authorizing disclosures for 

noncriminal purposes.

    (a) Application. An order authorizing the disclosure of patient 
records for purposes other than criminal investigation or prosecution 
may be applied for by any person having a legally recognized interest in 
the disclosure which is sought. The application may be filed separately 
or as part of a pending civil action in which it appears that the 
patient records are needed to provide evidence. An application must use 
a fictitious name, such as John Doe, to refer to any patient and may not 
contain or otherwise disclose any patient identifying information unless 
the patient is the applicant or has given a written consent (meeting the 
requirements of these regulations) to disclosure or the court has 
ordered the record of the proceeding sealed from public scrunity.
    (b) Notice. The patient and the person holding the records from whom 
disclosure is sought must be given:
    (1) Adequate notice in a manner which will not disclose patient 
identifying information to other persons; and
    (2) An opportunity to file a written response to the application, or 
to appear in person, for the limited purpose of providing evidence on 
the statutory and regulatory criteria for the issuance of the court 
order.
    (c) Review of evidence: Conduct of hearing. Any oral argument, 
review of evidence, or hearing on the application must be held in the 
judge's chambers or in some manner which ensures that patient 
identifying information is not disclosed to anyone other than a party to 
the proceeding, the patient, or the person holding the record, unless 
the patient requests an open hearing in a

[[Page 24]]

manner which meets the written consent requirements of these 
regulations. The proceeding may include an examination by the judge of 
the patient records referred to in the application.
    (d) Criteria for entry of order. An order under this section may be 
entered only if the court determines that good cause exists. To make 
this determination the court must find that:
    (1) Other ways of obtaining the information are not available or 
would not be effective; and
    (2) The public interest and need for the disclosure outweigh the 
potential injury to the patient, the physician-patient relationship and 
the treatment services.
    (e) Content of order. An order authorizing a disclosure must:
    (1) Limit disclosure to those parts of the patient's record which 
are essential to fulfill the objective of the order;
    (2) Limit disclosure to those persons whose need for information is 
the basis for the order; and
    (3) Include such other measures as are necessary to limit disclosure 
for the protection of the patient, the physician-patient relationship 
and the treatment services; for example, sealing from public scrutiny 
the record of any proceeding for which disclosure of a patient's record 
has been ordered.



Sec. 2.65  Procedures and criteria for orders authorizing disclosure and use 

of records to criminally investigate or prosecute patients.

    (a) Application. An order authorizing the disclosure or use of 
patient records to criminally investigate or prosecute a patient may be 
applied for by the person holding the records or by any person 
conducting investigative or prosecutorial activities with respect to the 
enforcement of criminal laws. The application may be filed separately, 
as part of an application for a subpoena or other compulsory process, or 
in a pending criminal action. An application must use a fictitious name 
such as John Doe, to refer to any patient and may not contain or 
otherwise disclose patient identifying information unless the court has 
ordered the record of the proceeding sealed from public scrutiny.
    (b) Notice and hearing. Unless an order under Sec. 2.66 is sought 
with an order under this section, the person holding the records must be 
given:
    (1) Adequate notice (in a manner which will not disclose patient 
identifying information to third parties) of an application by a person 
performing a law enforcement function;
    (2) An opportunity to appear and be heard for the limited purpose of 
providing evidence on the statutory and regulatory criteria for the 
issuance of the court order; and
    (3) An opportunity to be represented by counsel independent of 
counsel for an applicant who is a person performing a law enforcement 
function.
    (c) Review of evidence: Conduct of hearings. Any oral argument, 
review of evidence, or hearing on the application shall be held in the 
judge's chambers or in some other manner which ensures that patient 
identifying information is not disclosed to anyone other than a party to 
the proceedings, the patient, or the person holding the records. The 
proceeding may include an examination by the judge of the patient 
records referred to in the application.
    (d) Criteria. A court may authorize the disclosure and use of 
patient records for the purpose of conducting a criminal investigation 
or prosecution of a patient only if the court finds that all of the 
following criteria are met:
    (1) The crime involved is extremely serious, such as one which 
causes or directly threatens loss of life or serious bodily injury 
including homicide, rape, kidnapping, armed robbery, assault with a 
deadly weapon, and child abuse and neglect.
    (2) There is a reasonable likelihood that the records will disclose 
information of substantial value in the investigation or prosecution.
    (3) Other ways of obtaining the information are not available or 
would not be effective.
    (4) The potential injury to the patient, to the physician-patient 
relationship and to the ability of the program to provide services to 
other patients is outweighed by the public interest and the need for the 
disclosure.
    (5) If the applicant is a person performing a law enforcement 
function that:
    (i) The person holding the records has been afforded the opportunity 
to be

[[Page 25]]

represented by independent counsel; and
    (ii) Any person holding the records which is an entity within 
Federal, State, or local government has in fact been represented by 
counsel independent of the applicant.
    (e) Content of order. Any order authorizing a disclosure or use of 
patient records under this section must:
    (1) Limit disclosure and use to those parts of the patient's record 
which are essential to fulfill the objective of the order;
    (2) Limit disclosure to those law enforcement and prosecutorial 
officials who are responsible for, or are conducting, the investigation 
or prosecution, and limit their use of the records to investigation and 
prosecution of extremely serious crime or suspected crime specified in 
the application; and
    (3) Include such other measures as are necessary to limit disclosure 
and use to the fulfillment of only that public interest and need found 
by the court.

[52 FR 21809, June 9, 1987; 52 FR 42061, Nov. 2, 1987]



Sec. 2.66  Procedures and criteria for orders authorizing disclosure and use 

of records to investigate or prosecute a program or the person holding the 

records.

    (a) Application. (1) An order authorizing the disclosure or use of 
patient records to criminally or administratively investigate or 
prosecute a program or the person holding the records (or employees or 
agents of that program or person) may be applied for by any 
administrative, regulatory, supervisory, investigative, law enforcement, 
or prosecutorial agency having jurisdiction over the program's or 
person's activities.
    (2) The application may be filed separately or as part of a pending 
civil or criminal action against a program or the person holding the 
records (or agents or employees of the program or person) in which it 
appears that the patient records are needed to provide material 
evidence. The application must use a fictitious name, such as John Doe, 
to refer to any patient and may not contain or otherwise disclose any 
patient identifying information unless the court has ordered the record 
of the proceeding sealed from public scrutiny or the patient has given a 
written consent (meeting the requirements of Sec. 2.31 of these 
regulations) to that disclosure.
    (b) Notice not required. An application under this section may, in 
the discretion of the court, be granted without notice. Although no 
express notice is required to the program, to the person holding the 
records, or to any patient whose records are to be disclosed, upon 
implementation of an order so granted any of the above persons must be 
afforded an opportunity to seek revocation or amendment of that order, 
limited to the presentation of evidence on the statutory and regulatory 
criteria for the issuance of the court order.
    (c) Requirements for order. An order under this section must be 
entered in accordance with, and comply with the requirements of, 
paragraphs (d) and (e) of Sec. 2.64 of these regulations.
    (d) Limitations on disclosure and use of patient identifying 
information: (1) An order entered under this section must require the 
deletion of patient identifying information from any documents made 
available to the public.
    (2) No information obtained under this section may be used to 
conduct any investigation or prosecution of a patient, or be used as the 
basis for an application for an order under Sec. 2.65 of these 
regulations.



Sec. 2.67  Orders authorizing the use of undercover agents and informants to 

criminally investigate employees or agents of a program.

    (a) Application. A court order authorizing the placement of an 
undercover agent or informant in a program as an employee or patient may 
be applied for by any law enforcement or prosecutorial agency which has 
reason to believe that employees or agents of the program are engaged in 
criminal misconduct.
    (b) Notice. The program director must be given adequate notice of 
the application and an opportunity to appear and be heard (for the 
limited purpose of providing evidence on the statutory and regulatory 
criteria for the issuance of the court order), unless the application 
asserts a belief that:

[[Page 26]]

    (1) The program director is involved in the criminal activities to 
be investigated by the undercover agent or informant; or
    (2) The program director will intentionally or unintentionally 
disclose the proposed placement of an undercover agent or informant to 
the employees or agents who are suspected of criminal activities.
    (c) Criteria. An order under this section may be entered only if the 
court determines that good cause exists. To make this determination the 
court must find:
    (1) There is reason to believe that an employee or agent of the 
program is engaged in criminal activity;
    (2) Other ways of obtaining evidence of this criminal activity are 
not available or would not be effective; and
    (3) The public interest and need for the placement of an undercover 
agent or informant in the program outweigh the potential injury to 
patients of the program, physician-patient relationships and the 
treatment services.
    (d) Content of order. An order authorizing the placement of an 
undercover agent or informant in a program must:
    (1) Specifically authorize the placement of an undercover agent or 
an informant;
    (2) Limit the total period of the placement to six months;
    (3) Prohibit the undercover agent or informant from disclosing any 
patient identifying information obtained from the placement except as 
necessary to criminally investigate or prosecute employees or agents of 
the program; and
    (4) Include any other measures which are appropriate to limit any 
potential disruption of the program by the placement and any potential 
for a real or apparent breach of patient confidentiality; for example, 
sealing from public scrutiny the record of any proceeding for which 
disclosure of a patient's record has been ordered.
    (e) Limitation on use of information. No information obtained by an 
undercover agent or informant placed under this section may be used to 
criminally investigate or prosecute any patient or as the basis for an 
application for an order under Sec. 2.65 of these regulations.



PART 2a_PROTECTION OF IDENTITY_RESEARCH SUBJECTS--Table of Contents




Sec.
2a.1 Applicability.
2a.2 Definitions.
2a.3 Application; coordination.
2a.4 Contents of application; in general.
2a.5 Contents of application; research projects in which drugs will be 
          administered.
2a.6 Issuance of Confidentiality Certificates; single project 
          limitation.
2a.7 Effect of Confidentiality Certificate.
2a.8 Termination.

    Authority: Sec. 3(a), Pub. L. 91-513 as amended by sec. 122(b), Pub. 
L. 93-282; 84 Stat. 1241 (42 U.S.C. 242a(a)), as amended by 88 Stat. 
132.

    Source: 44 FR 20384, Apr. 4, 1979, unless otherwise noted.



Sec. 2a.1  Applicability.

    (a) Section 303(a) of the Public Health Service Act (42 U.S.C. 
242a(a)) provides that ``[t]he Secretary [of Health and Human Services] 
may authorize persons engaged in research on mental health, including 
research on the use and effect of alcohol and other psychoactive drugs, 
to protect the privacy of individuals who are the subject of such 
research by withholding from all persons not connected with the conduct 
of such research the names or other identifying characteristics of such 
individuals. Persons so authorized to protect the privacy of such 
individuals may not be compelled in any Federal, State, or local civil, 
criminal, administrative, legislative, or other proceedings to identify 
such individuals.'' The regulations in this part establish procedures 
under which any person engaged in research on mental health including 
research on the use and effect of alcohol and other psychoactive drugs 
(whether or not the research is federally funded) may, subject to the 
exceptions set forth in paragraph (b) of this section, apply for such an 
authorization of confidentiality.
    (b) These regulations do not apply to:
    (1) Authorizations of confidentiality for research requiring an 
Investigational New Drug exemption under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or to approved new 
drugs, such as methadone, requiring continuation of long-

[[Page 27]]

term studies, records, and reports. Attention is called to 21 CFR 
291.505(g) relating to authorizations of confidentiality for patient 
records maintained by methadone treatment programs.
    (2) Authorizations of confidentiality for research which are related 
to law enforcement activities or otherwise within the purview of the 
Attorney General's authority to issue authorizations of confidentiality 
pursuant to section 502(c) of the Controlled Substances Act (21 U.S.C. 
872(c)) and 21 CFR 1316.21.
    (c) The Secretary's regulations on confidentiality of alcohol and 
drug abuse patient records (42 CFR part 2) and the regulations of this 
part may, in some instances, concurrently cover the same transaction. As 
explained in 42 CFR 2.24 and 2.24-1, 42 CFR part 2 restricts voluntary 
disclosures of information from applicable patient records while a 
Confidentiality Certificate issued pursuant to the regulations of this 
part protects a person engaged in applicable research from being 
compelled to disclose identifying characteristics of individuals who are 
the subject of such research.



Sec. 2a.2  Definitions.

    (a) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (b) Person means any individual, corporation, government, or 
governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    (c) Research means systematic study directed toward new or fuller 
knowledge and understanding of the subject studied. The term includes, 
but is not limited to, behavioral science studies, surveys, evaluations, 
and clinical investigations.
    (d) Drug has the meaning given that term by section 201(g)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
    (e) Controlled drug means a drug which is included in schedule I, 
II, III, IV, or V of part B of the Controlled Substances Act (21 U.S.C. 
811-812).
    (f) Administer refers to the direct application of a drug to the 
body of a human research subject, whether such application be by 
injection, inhalation, ingestion, or any other means, by (1) a qualified 
person engaged in research (or, in his or her presence, by his or her 
authorized agent), or (2) a research subject in accordance with 
instructions of a qualified person engaged in research, whether or not 
in the presence of a qualified person engaged in research.
    (g) Identifying characteristics refers to the name, address, any 
identifying number, fingerprints, voiceprints, photographs or any other 
item or combination of data about a research subject which could 
reasonably lead directly or indirectly by reference to other information 
to identification of that research subject.
    (h) Psychoactive drug means, in addition to alcohol, any drug which 
has as its principal action an effect on thought, mood, or behavior.



Sec. 2a.3  Application; coordination.

    (a) Any person engaged in (or who intends to engage in) the research 
to which this part applies, who desires authorization to withhold the 
names and other identifying characteristics of individuals who are the 
subject of such research from any person or authority not connected with 
the conduct of such research may apply to the Office of the Director, 
National Institute on Drug Abuse, the Office of the Director, National 
Institute of Mental Health, or the Office of the Director, National 
Institute on Alcohol Abuse and Alcoholism, 5600 Fishers Lane, Rockville, 
Maryland 20857 for an authorization of confidentiality.
    (b) If there is uncertainty with regard to which Institute is 
appropriate or if the research project falls within the purview of more 
than one Institute, an application need be submitted only to one 
Institute. Persons who are uncertain with regard to the applicability of 
these regulations to a particular type of research may apply for an 
authorization of confidentiality under the regulations of this part to 
one of the Institutes. Requests which are within the scope of the 
authorities described

[[Page 28]]

in Sec. 2a.1(b) will be forwarded to the appropriate agency for 
consideration and the person will be advised accordingly.
    (c) An application may accompany, precede, or follow the sumission 
of a request for DHHS grant or contract assistance, though it is not 
necessary to request DHHS grant or contract assistance in order to apply 
for a Confidentiality Certificate. If a person has previously submitted 
any information required in this part in connection with a DHHS grant or 
contract, he or she may substitute a copy of information thus submitted, 
if the information is current and accurate. If a person requests a 
Confidentiality Certificate at the same time he or she submits an 
application for DHHS grant or contract assistance, the application for a 
Confidentiality Certificate may refer to the pertinent section(s) of the 
DHHS grant or contract application which provide(s) the information 
required to be submitted under this part. (See Sec. Sec. 2a.4 and 
2a.5.)
    (d) A separate application is required for each research project for 
which an authorization of confidentiality is requested.



Sec. 2a.4  Contents of application; in general.

    In addition to any other pertinent information which the Secretary 
may require, each application for an authorization of confidentiality 
for a research project shall contain:
    (a) The name and address of the individual primarily responsible for 
the conduct of the research and the sponsor or institution with which he 
or she is affiliated, if any. Any application from a person affiliated 
with an institution will be considered only if it contains or is 
accompanied by documentation of institutional approval. This 
documentation may consist of a written statement signed by a responsible 
official of the institution or of a copy of or reference to a valid 
certification submitted in accordance with 45 CFR part 46.
    (b) The location of the research project and a description of the 
facilities available for conducting the research, including the name and 
address of any hospital, institution, or clinical laboratory facility to 
be utilized in connection with the research.
    (c) The names, addresses, and summaries of the scientific or other 
appropriate training and experience of all personnel having major 
responsibilities in the research project and the training and experience 
requirements for major positions not yet filled.
    (d) An outline of the research protocol for the project including a 
clear and concise statement of the purpose and rationale of the research 
project and the general research methods to be used.
    (e) The date on which research will begin or has begun and the 
estimated date for completion of the project.
    (f) A specific request, signed by the individual primarily 
responsible for the conduct of the research, for authority to withhold 
the names and other identifying characteristics of the research subjects 
and the reasons supporting such request.
    (g) An assurance (1) From persons making application for a 
Confidentiality Certificate for a research project for which DHHS grant 
or contract support is received or sought that they will comply with all 
the requirements of 45 CFR part 46, ``Protection of Human Subjects,'' or
    (2) From all other persons making application that they will comply 
with the informed consent requirements of 45 CFR 46.103(c) and document 
legally effective informed consent in a manner consistent with the 
principles stated in 45 CFR 46.110, if it is determined by the 
Secretary, on the basis of information submitted by the person making 
application, that subjects will be placed at risk. If a modification of 
paragraphs (a) or (b) of 45 CFR 46.110 is to be used, as permitted under 
paragraph (c) of that section, the applicant will describe the proposed 
modification and submit it for approval by the Secretary.
    (h) An assurance that if an authorization of confidentiality is 
given it will not be represented as an endorsement of the research 
project by the Secretary or used to coerce individuals to participate in 
the research project.
    (i) An assurance that any person who is authorized by the Secretary 
to protect the privacy of research subjects

[[Page 29]]

will use that authority to refuse to disclose identifying 
characteristics of research subjects in any Federal, State, or local 
civil, criminal, administrative, legislative, or other proceedings to 
compel disclosure of the identifying characteristics of research 
subjects.
    (j) An assurance that all research subjects who participate in the 
project during the period the Confidentiality Certificate is in effect 
will be informed that:
    (1) A Confidentiality Certificate has been issued;
    (2) The persons authorized by the Confidentiality Certificate to 
protect the identity of research subjects may not be compelled to 
identify research subjects in any civil, criminal, administrative, 
legislative, or other proceedings whether Federal, State, or local;
    (3) If any of the following conditions exist the Confidentiality 
Certificate does not authorize any person to which it applies to refuse 
to reveal identifying information concerning research subjects:
    (i) The subject consents in writing to disclosure of identifying 
information,
    (ii) Release is required by the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of 
Federal Regulations), or
    (iii) Authorized personnel of DHHS request identifying information 
for audit or program evaluation of a research project funded by DHHS or 
for investigation of DHHS grantees or contractors and their employees or 
agents carrying out such a project. (See Sec. 2a.7(b));
    (4) The Confidentiality Certificate does not govern the voluntary 
disclosure of identifying characteristics of research subjects;
    (5) The Confidentiality Certificate does not represent an 
endorsement of the research project by the Secretary.
    (k) An assurance that all research subjects who enter the project 
after the termination of the Confidentiality Certificate will be 
informed that the authorization of confidentiality has ended and that 
the persons authorized to protect the identity of research subjects by 
the Confidentiality Certificate may not rely on the Certificate to 
refuse to disclose identifying characteristics of research subjects who 
were not participants in the project during the period the Certificate 
was in effect. (See Sec. 2a.8(c)).



Sec. 2a.5  Contents of application; research projects in which drugs will be 

administered.

    (a) In addition to the information required by Sec. 2a.4 and any 
other pertinent information which the Secretary may require, each 
application for an authorization of confidentiality for a research 
project which involves the administering of a drug shall contain:
    (1) Identification of the drugs to be administered in the research 
project and a description of the methods for such administration, which 
shall include a statement of the dosages to be administered to the 
research subjects;
    (2) Evidence that individuals who administer drugs are authorized to 
do so under applicable Federal and State law; and
    (3) In the case of a controlled drug, a copy of the Drug Enforcement 
Administration Certificate of Registration (BND Form 223) under which 
the research project will be conducted.
    (b) An application for an authorization of confidentiality with 
respect to a research project which involves the administering of a 
controlled drug may include a request for exemption of persons engaged 
in the research from State or Federal prosecution for possession, 
distribution, and dispensing of controlled drugs as authorized under 
section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and 
21 CFR 1316.22. If the request is in such form, and is supported by such 
information, as is required by 21 CFR 1316.22, the Secretary will 
forward it, together with his or her recommendation that such request be 
approved or disapproved, for the consideration of the Administrator of 
the Drug Enforcement Administration.



Sec. 2a.6  Issuance of Confidentiality Certificates; single project 

limitation.

    (a) In reviewing the information provided in the application for a 
Confidentiality Certificate, the Secretary will take into account:

[[Page 30]]

    (1) The scientific or other appropriate training and experience of 
all personnel having major responsibilities in the research project;
    (2) Whether the project constitutes bona fide ``research'' which is 
within the scope of the regulations of this part; and
    (3) Such other factors as he or she may consider necessary and 
appropriate. All applications for Confidentiality Certificates shall be 
evaluated by the Secretary through such officers and employees of the 
Department and such experts or consultants engaged for this purpose as 
he or she determines to be appropriate.
    (b) After consideration and evaluation of an application for an 
authorization of confidentiality, the Secretary will either issue a 
Confidentiality Certificate or a letter denying a Confidentiality 
Certificate, which will set forth the reasons for such denial, or will 
request additional information from the person making application. The 
Confidentiality Certificate will include:
    (1) The name and address of the person making application;
    (2) The name and address of the individual primarily responsible for 
conducting the research, if such individual is not the person making 
application;
    (3) The location of the research project;
    (4) A brief description of the research project;
    (5) A statement that the Certificate does not represent an 
endorsement of the research project by the Secretary;
    (6) The Drug Enforcement Administration registration number for the 
project, if any; and
    (7) The date or event upon which the Confidentiality Certificate 
becomes effective, which shall not be before the later of either the 
commencement of the research project or the date of issuance of the 
Certificate, and the date or event upon which the Certificate will 
expire.
    (c) A Confidentiality Certificate is not transferable and is 
effective only with respect to the names and other identifying 
characteristics of those individuals who are the subjects of the single 
research project specified in the Confidentiality Certificate. The 
recipient of a Confidentiality Certificate shall, within 15 days of any 
completion or discontinuance of the research project which occurs prior 
to the expiration date set forth in the Certificate, provide written 
notification to the Director of the Institute to which application was 
made. If the recipient determines that the research project will not be 
completed by the expiration date set forth in the Confidentiality 
Certificate he or she may submit a written request for an extension of 
the expiration date which shall include a justification for such 
extension and a revised estimate of the date for completion of the 
project. Upon approval of such a request, the Secretary will issue an 
amended Confidentiality Certificate.
    (d) The protection afforded by a Confidentiality Certificate does 
not extend to significant changes in the research project as it is 
described in the application for such Certificate (e.g., changes in the 
personnel having major responsibilities in the research project, major 
changes in the scope or direction of the research protocol, or changes 
in the drugs to be administered and the persons who will administer 
them). The recipient of a Confidentiality Certificate shall notify the 
Director of the Institute to which application was made of any proposal 
for such a significant change by submitting an amended application for a 
Confidentiality Certificate in the same form and manner as an original 
application. On the basis of such application and other pertinent 
information the Secretary will either:
    (1) Approve the amended application and issue an amended 
Confidentiality Certificate together with a Notice of Cancellation 
terminating original the Confidentiality Certificate in accordance with 
Sec. 2a.8; or
    (2) Disapprove the amended application and notify the applicant in 
writing that adoption of the proposed significant changes will result in 
the issuance of a Notice of Cancellation terminating the original 
Confidentiality Certificate in accordance with Sec. 2a.8.



Sec. 2a.7  Effect of Confidentiality Certificate.

    (a) A Confidentiality Certificate authorizes the withholding of the 
names and other identifying characteristics of

[[Page 31]]

individuals who participate as subjects in the research project 
specified in the Certificate while the Certificate is in effect. The 
authorization applies to all persons who, in the performance of their 
duties in connection with the research project, have access to 
information which would identify the subjects of the research. Persons 
so authorized may not, at any time, be compelled in any Federal, State, 
or local civil, criminal, administrative, legislative, or other 
proceedings to identify the research subjects encompassed by the 
Certificate, except in those circumstances specified in paragraph (b) of 
this section.
    (b) A Confidentiality Certificate granted under this part does not 
authorize any person to refuse to reveal the name or other identifying 
characteristics of any research subject in the following circumstances:
    (1) The subject (or, if he or she is legally incompetent, his or her 
guardian) consents, in writing, to the disclosure of such information,
    (2) Authorized personnel of DHHS request such information for audit 
or program evaluation of a research project funded by DHHS or for 
investigation of DHHS grantees or contractors and their employees or 
agents carrying out such a project. (See 45 CFR 5.71 for confidentiality 
standards imposed on such DHHS personnel), or
    (3) Release of such information is required by the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations promulgated 
thereunder (title 21, Code of Federal Regulations).
    (c) Neither a Confidentiality Certificate nor the regulations of 
this part govern the voluntary disclosure of identifying characteristics 
of research subjects.



Sec. 2a.8  Termination.

    (a) A Confidentiality Certificate is in effect from the date of its 
issuance until the effective date of its termination. The effective date 
of termination shall be the earlier of:
    (1) The expiration date set forth in the Confidentiality 
Certificate; or
    (2) Ten days from the date of mailing a Notice of Cancellation to 
the applicant, pursuant to a determination by the Secretary that the 
research project has been completed or discontinued or that retention of 
the Confidentiality Certificate is otherwise no longer necessary or 
desirable.
    (b) A Notice of Cancellation shall include: an identification of the 
Confidentiality Certificate to which it applies; the effective date of 
its termination; and the grounds for cancellation. Upon receipt of a 
Notice of Cancellation the applicant shall return the Confidentiality 
Certificate to the Secretary.
    (c) Any termination of a Confidentiality Certificate pursuant to 
this section is operative only with respect to the names and other 
identifying characteristics of individuals who begin their participation 
as research subjects after the effective date of such termination. (See 
Sec. 2a.4(k) requiring researchers to notify subjects who enter the 
project after the termination of the Confidentiality Certificate of 
termination of the Certificate). The protection afforded by a 
Confidentiality Certificate is permanent with respect to subjects who 
participated in research during any time the authorization was in 
effect.

                            PART 3 [RESERVED]



PART 4_NATIONAL LIBRARY OF MEDICINE--Table of Contents




Sec.
4.1 Programs to which these regulations apply.
4.2 Definitions.
4.3 Purpose of the Library.
4.4 Use of Library facilities.
4.5 Use of materials from the collections.
4.6 Reference, bibliographic, reproduction, and consultation services.
4.7 Fees.
4.8 Publication of the Library and information about the Library.

    Authority: 42 U.S.C. 216, 286.

    Source: 56 FR 29188, June 26, 1991, unless otherwise noted.



Sec. 4.1  Programs to which these regulations apply.

    (a) The regulations of this part govern access to the National 
Library of Medicine's facilities and library collections and the 
availability of its bibliographic, reproduction, reference, and

[[Page 32]]

related services. These functions are performed by the Library directly 
for the benefit of the general public and health-sciences professionals 
as required by sections 465(b) (3)-(6) of the Act (42 U.S.C. 286(b) (3)-
(6)).
    (b) The regulations of this part do not apply to:
    (1) The Library's internal functions relating to the acquisition and 
preservation of materials and the organization of these materials as 
required by sections 465(b) (1) and (2) of the Act (42 U.S.C. 286(b) (1) 
and (2)).
    (2) The availability of ``records'' under the Freedom of Information 
Act or the Privacy Act of 1974 (5 U.S.C. 552, 552a). These matters are 
covered in 45 CFR parts 5 and 5b.
    (3) Federal assistance for medical libraries and other purposes 
which are authorized by sections 469-477 of the Act (42 U.S.C. 286b to 
286b-8). (See parts 59a, 61 and 64 of this chapter.)
    (4) The availability of facilities, collections, and related 
services of Regional Medical Libraries established or maintained under 
the authority in section 475 of the Act (42 U.S.C. 286b-6). (See part 
59a, subpart B of this chapter.)



Sec. 4.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Collections means all books, periodicals, prints, audiovisual 
materials, films, videotapes, recordings, manuscripts, and other 
resource materials of the library. It does not include data processing 
tapes or programs used solely for internal processing activities to 
generate reference materials, nor does it include ``records'' of the 
Library as defined in 45 CFR 5.5. Records of the Library are available 
in accordance with the regulations under the Freedom of Information Act 
and Privacy Act of 1974. (See 45 CFR parts 5 and 5b.)
    Director means the Director of the National Library of Medicine or 
the Director's delegate.
    Health-sciences professional means any person engaged in: (1) The 
administration of health activities; (2) the provision of health 
services; or (3) research, teaching, or education concerned with the 
advancement of medicine or other sciences related to health or 
improvement of the public health.
    Historical collection means: (1) Materials in the collections 
published or printed prior to 1914; (2) manuscripts and prints; (3) the 
archival film collection; and (4) other materials of the collections 
which, because of age, or unique or unusual value, require special 
handling, storage, or protection for their preservation, as determined 
by the Director.
    Library means the National Library of Medicine, established by 
section 465 of the Act (42 U.S.C. 286).
    Regional Medical Library means a medical library established or 
maintained as a regional medical library under section 475 of the Act 
(42 U.S.C. 286b-6).



Sec. 4.3  Purpose of the Library.

    The purpose of the Library is to assist the advancement of medical 
and related sciences and aid the dissemination and exchange of 
scientific and other information important to the progress of medicine 
and the public health. The Library acquires and maintains library 
materials pertinent to medicine, including audiovisual materials; 
compiles, publishes, and disseminates catalogs, indices, and 
bibliographies of these materials, as appropriate; makes available 
materials, through loan or otherwise; provides reference and other 
assistance to research; and engages in other activities in furtherance 
of this purpose.



Sec. 4.4  Use of Library facilities.

    (a) General. The Library facilities are available to any person 
seeking to make use of the collections. The Director may prescribe 
reasonable rules to assure the most effective use of facilities by 
health-sciences professionals and to protect the collections from misuse 
or damage. These rules must be consistent with the regulations in this 
part and applicable Department regulations and policies on 
nondiscrimination.
    (b) Reading rooms. Public reading rooms are available for obtaining 
and reading materials from the collections. The Director may prescribe 
reasonable rules designed to provide adequate

[[Page 33]]

reading space and orderly conditions and procedures.
    (c) Study rooms. Upon request a limited number of study rooms may be 
made available to individuals requiring extensive use of Library 
materials. Requests for study rooms shall be addressed in writing to the 
Director. The Director shall give priority, in the following order, for 
study room use to:
    (1) Persons engaged in ``special scientific projects'' under section 
473 of the Act (42 U.S.C. 286b-4),
    (2) Health-sciences professionals, and
    (3) The general public.



Sec. 4.5  Use of materials from the collections.

    (a) Unrestricted materials. Except as otherwise provided in this 
section, materials from the collections are generally available to any 
interested person only in facilities provided by the Library for this 
purpose. The Director may prescribe additional reasonable rules to 
assure the most effective use of the Library's resources by health-
sciences professionals and to protect the collections from misuse or 
damage. The rules must be consistent with the regulations in this part 
and applicable Department regulations and policies on nondiscrimination. 
Materials in the collections are available upon each request which 
assures, to the Director's satisfaction, that the materials will be 
safeguarded from misuse, damage, loss, or misappropriation, and will be 
returned promptly after use or upon request of the Library.
    (b) Restricted materials--(1) Historical collection. Materials from 
the historical collection are available only as the Director may permit 
to assure their maximum preservation and protection. Copies of these 
materials may be made available in the form of microfilm and other 
copies, for which reasonable fees may be charged.
    (2) Gifts. Materials in the collections are available only in 
accordance with any limitations imposed as a condition of the 
acquisition of those materials, whether the acquisition was by gift or 
purchase.
    (c) Loans--(1) General. Requests for loans of materials must assure 
the Library that (i) the materials will be safeguarded from misuse, 
damage, loss, or misappropriation and (ii) the materials will be 
returned promptly after use or upon request of the Library. The Library 
may provide copies in lieu of original materials, which need not be 
returned unless otherwise stated at the time of the loan.
    (2) Loans of audiovisual materials. Audiovisual materials are 
available for loan under the same general terms as printed materials.
    (3) Loans to other libraries. Upon request materials or copies are 
available for use through libraries of public or private agencies or 
institutions. The requesting library must assure that it has first 
exhausted its own collection resources, those of other local libraries 
in the geographic area, and those of the Regional Medical Library 
network (including Regional and Resource Libraries) before making a 
request for a loan.
    (4) Loans to health-sciences professionals. The Director may make 
loans of materials directly to health-sciences professionals. An 
individual wishing a loan of library materials must assure to the 
satisfaction of the Director that the individual is geographically 
isolated, in terms of distance or available transportation, from medical 
literature resources likely to contain the desired material.

(Approved by the Office of Management and Budget under control number 
0925-0276)



Sec. 4.6  Reference, bibliographic, reproduction, and consultation services.

    (a) General. To the extent resources permit, the Library will make 
available, upon request, reference, bibliographic, reproduction, and 
consultation services. Priority will be given to requests from health-
sciences professionals for services not reasonably available through 
local or regional libraries.
    (b) Specialized bibliographic services. The Director may provide 
bibliographies on individually selected medical or scientific topics 
upon request where it is consistent with the Library's purpose. The 
Director may publish and make available for general distribution by the 
Library, bibliographic searches determined to be of general interest. 
The Library may also produce

[[Page 34]]

and distribute a limited number of bibliographies on topics of general 
interest to public or nonprofit health-related professional societies, 
research organizations, and other group users. These bibliographies may 
be produced on a regularly recurring or intermittent basis under 
contract between the Library and public or nonprofit agencies, when 
determined in each case by the Director to be necessary to assure more 
effective distribution of the bibliographic information.
    (c) Information retrieval system computer tapes. To the extent 
Library resources permit and in order to further the Library's purpose, 
the Director may make available upon request by agencies, organizations, 
and institutions copies of all or part of the Library's magnetic tapes.



Sec. 4.7  Fees.

    The Director may charge reasonable fees for any service provided by 
the Library under this part, in accordance with a schedule available at 
the Library upon request, which are designed to recover all or a portion 
of the cost to the Library of providing the service.



Sec. 4.8  Publication of the Library and information about the Library.

    Lists of bibliographies, Library publications sold by the Government 
Printing Office, necessary application forms, and other information 
concerning the organization, operation, functions, and services of the 
Library, are available from the National Library of Medicine, Bethesda, 
Maryland 20894.



PART 5_DESIGNATION OF HEALTH PROFESSIONAL(S) SHORTAGE AREAS--Table of Contents




Sec.
5.1 Purpose.
5.2 Definitions.
5.3 Procedures for designation of health professional(s) shortage areas.
5.4 Notification and publication of designations and withdrawals.

Appendix A to Part 5--Criteria for Designation of Areas having Shortages 
          of Primary Medical Care Professional(s)
Appendix B to Part 5--Criteria for Designation of Areas having Shortages 
          of Dental Professional(s)
Appendix C to Part 5--Criteria for Designation of Areas Having Shortages 
          of Mental Health Professionals
Appendix D to Part 5--Criteria for Designation of Areas having Shortages 
          of Vision Care Professional(s)
Appendix E to Part 5--Criteria for Designation of Areas having Shortages 
          of Podiatric Professional(s)
Appendix F to Part 5--Criteria for Designation of Areas having Shortages 
          of Pharmacy Professional(s)
Appendix G to Part 5--Criteria for Designation of Areas having Shortages 
          of Veterinary Professional(s)

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690 
(42 U.S.C. 216); sec. 332 of the Public Health Service Act, 90 Stat. 
2270-2272 (42 U.S.C. 254e).

    Source: 45 FR 76000, Nov. 17, 1980, unless otherwise noted.



Sec. 5.1  Purpose.

    These regulations establish criteria and procedures for the 
designation of geographic areas, population groups, medical facilities, 
and other public facilities, in the States, as health professional(s) 
shortage areas.



Sec. 5.2  Definitions.

    Act means the Public Health Service Act, as amended.
    Health professional(s) shortage area means any of the following 
which the Secretary determines has a shortage of health professional(s): 
(1) An urban or rural area (which need not conform to the geographic 
boundaries of a political subdivision and which is a rational area for 
the delivery of health services); (2) a population group; or (3) a 
public or nonprofit private medical facility.
    Health service area means a health service area whose boundaries 
have been designated by the Secretary, under section 1511 of the Act, 
for purposes of health planning activities.
    Health systems agency or HSA means the health systems agency 
designated, under section 1515 of the Act, to carry out health planning 
activities for a specific health service area.
    Medical facility means a facility for the delivery of health 
services and includes: (1) A community health center, public health 
center, outpatient medical facility, or community mental health center; 
(2) a hospital, State mental hospital, facility for long-term

[[Page 35]]

care, or rehabilitation facility; (3) a migrant health center or an 
Indian Health service facility; (4) a facility for delivery of health 
services to inmates in a U.S. penal or correctional institution (under 
section 323 of the Act) or a State correctional institution; (5) a 
Public Health Service medical facility (used in connection with the 
delivery of health services under section 320, 321, 322, 324, 325, or 
326 of the Act); or (6) any other Federal medical facility.
    Metropolitan area means an area which has been designated by the 
Office of Management and Budget as a standard metropolitan statistical 
area (SMSA). All other areas are ``non-metropolitan areas.''
    Poverty level means the povery level as defined by the Bureau of the 
Census, using the poverty index adopted by a Federal Interagency 
Committee in 1969, and updated each year to reflect changes in the 
Consumer Price Index.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department to whom the authority 
involved has been delegated.
    State includes, in addition to the several States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, 
the Virgin Islands, Guam, American Samoa, and the Trust Territory of the 
Pacific Islands.
    State health planning and development agency or SHPDA means a State 
health planning and development agency designated under section 1521 of 
the Act.



Sec. 5.3  Procedures for designation of health professional(s) shortage areas.

    (a) Using data available to the Department from national, State, and 
local sources and based upon the criteria in the appendices to this 
part, the Department will annually prepare listings (by State and health 
service area) of currently designated health professional(s) shortage 
areas and potentially designatable areas, together with appropriate 
related data available to the Department. Relevant portions of this 
material will then be forwarded to each health systems agency, State 
health planning and development agency, and Governor, who will be asked 
to review the listings for their State, correct any errors of which they 
are aware, and offer their recommendations, if any, within 90 days, as 
to which geographic areas, population groups, and facilities in areas 
under their jurisdiction should be designated. An information copy of 
these listings will also be made available, upon request, to interested 
parties for their use in providing comments or recommendations to the 
Secretary and/or to the appropriate HSA, SHPDA, or Governor.
    (b) In addition, any agency or individual may request the Secretary 
to designate (or withdraw the designation of) a particular geographic 
area, population group, or facility as a health professional(s) shortage 
area. Each request will be forwarded by the Secretary to the appropriate 
HSA, SHPDA, and Governor, who will be asked to review it and offer their 
recommendations, if any, within 30 days. An information copy will also 
be made available to other interested parties, upon request, for their 
use in providing comments or recommendations to the Secretary and/or to 
the appropriate HSA, SHPDA, or Governor.
    (c) In each case where the designation of a public facility 
(including a Federal medical facility) is under consideration, the 
Secretary will give written notice of the proposed designation to the 
chief administrative officer of the facility, who will be asked to 
review it and offer their recommendations, if any, within 30 days.
    (d) After review of the available information and consideration of 
the comments and recommendations submitted, the Secretary will designate 
health professional(s) shortage areas and withdraw the designation of 
any areas which have been determined no longer to have a shortage of 
health professional(s).



Sec. 5.4  Notification and publication of designations and withdrawals.

    (a) The Secretary will give written notice of the designation (or 
withdrawal of designation) of a health professional(s) shortage area, 
not later than 60 days from the date of the designation (or withdrawal 
of designation), to:

[[Page 36]]

    (1) The Governor of each State in which the area, population group, 
medical facility, or other public facility so designated is in whole or 
in part located;
    (2) Each HSA for a health service area which includes all or any 
part of the area, population group, medical facility, or other public 
facility so designated;
    (3) The SHPDA for each State in which the area, population group, 
medical facility, or other public facility so designated is in whole or 
in part located; and
    (4) Appropriate public or nonprofit private entities which are 
located in or which have a demonstrated interest in the area so 
designated.
    (b) The Secretary will periodically publish updated lists of 
designated health professional(s) shortage areas in the Federal 
Register, by type of professional(s) shortage. An updated list of areas 
for each type of professional(s) shortage will be published at least 
once annually.
    (c) The effective date of the designation of an area shall be the 
date of the notification letter to the individual or agency which 
requested the designation, or the date of publication in the Federal 
Register, whichever comes first.
    (d) Once an area is listed in the Federal Register as a designated 
health professional(s) shortage area, the effective date of any later 
withdrawal of the area's designation shall be the date when notification 
of the withdrawal, or an updated list of designated areas which does not 
include it, is published in the Federal Register.



  Sec. Appendix A to Part 5--Criteria for Designation of Areas Having 

            Shortages of Primary Medical Care Professional(s)

                        Part I--Geographic Areas

    A. Federal and State Correctional Institutions.
    1. Criteria.
    Medium to maximum security Federal and State correctional 
institutions and youth detention facilities will be designated as having 
a shortage of primary medical care professional(s) if both the following 
criteria are met:
    (a) The institution has at least 250 inmates.
    (b) The ratio of the number of internees per year to the number of 
FTE primary care physicians serving the institution is at least 1,000:1.
    Here the number of internees is defined as follows:
    (i) If the number of new inmates per year and the average length-of-
stay are not specified, or if the information provided does not indicate 
that intake medical examinations are routinely performed upon entry, 
then--Number of internees=average number of inmates.
    (ii) If the average length-of-stay is specified as one year or more, 
and intake medical examinations are routinely performed upon entry, 
then--Number of internees=average number of inmates+(0.3)xnumber of new 
inmates per year.
    (iii) If the average length-of-stay is specified as less than one 
year, and intake examinations are routinely performed upon entry, then--
Number of internees=average number of inmates+(0.2)x(1+ALOS/2)xnumber of 
new inmates per year where ALOS=average length-of-stay (in fraction of 
year). (The number of FTE primary care physicians is computed as in part 
I, section B, paragraph 3 above.)
    2. Determination of Degree of Shortage.
    Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of 
internees to primary care physicians, as follows:
    Group 1--Institutions with 500 or more inmates and no physicians.
    Group 2--Other institutions with no physicians and institutions with 
R greater than (or equal to) 2,000:1.
    Group 3--Institutions with R greater than (or equal to) 1,000:1 but 
less than 2,000:1.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Areas for the Delivery of Primary Medical Care Services.
    (a) The following areas will be considered rational areas for the 
delivery of primary medical care services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 30 minutes travel time of each other.
    (ii) A portion of a county, or an area made up of portions of more 
than one county, whose population, because of topography, market or 
transportation patterns, distinctive population characteristics or other 
factors, has limited access to contiguous area resources, as measured 
generally by a travel time greater than 30 minutes to such resources.
    (iii) Established neighborhoods and communities within metropolitan 
areas which display a strong self-identity (as indicated

[[Page 37]]

by a homogeneous socioeconomic or demographic structure and/or a 
tradition of interaction or interdependency), have limited interaction 
with contiguous areas, and which, in general, have a minimum population 
of 20,000.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 30 minutes travel time:
    (i) Under normal conditions with primary roads available: 20 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 15 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
25 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 30 minutes travel time.
    2. Population Count.
    The population count used will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, with 
the following adjustments, where appropriate:
    (a) Adjustments to the population for the differing health service 
requirements of various age-sex population groups will be computed using 
the table below of visit rates for 12 age-sex population cohorts. The 
total expected visit rate will first be obtained by multiplying each of 
the 12 visit rates in the table by the size of the area population 
within that particular age-sex cohort and adding the resultant 12 visit 
figures together. This total expected visit rate will then be divided by 
the U.S. average per capita visit rate of 5.1, to obtain the adjusted 
population for the area.

----------------------------------------------------------------------------------------------------------------
                                                                                    Age groups
                                                                 -----------------------------------------------
                               Sex                                 Under                                  65 and
                                                                     5     5-14    15-24   25-44   45-64   over
----------------------------------------------------------------------------------------------------------------
Male............................................................     7.3     3.6     3.3     3.6     4.7     6.4
Female..........................................................     6.4     3.2     5.5     6.4     6.5     6.8
----------------------------------------------------------------------------------------------------------------

    (b) The effect of transient populations on the need of an area for 
primary care professional(s) will be taken into account as follows:
    (i) Seasonal residents, i.e., those who maintain a residence in the 
area but inhabit it for only 2 to 8 months per year, may be included but 
must be weighted in proportion to the fraction of the year they are 
present in the area.
    (ii) Other tourists (non-resident) may be included in an area's 
population but only with a weight of 0.25, using the following formula: 
Effective tourist contribution to population=0.25x(fraction of year 
tourists are present in area)x(average daily number of tourists during 
portion of year that tourists are present).
    (iii) Migratory workers and their families may be included in an 
area's population, using the following formula: Effective migrant 
contribution to population=(fraction of year migrants are present in 
area)x(average daily number of migrants during portion of year that 
migrants are present).
    3. Counting of Primary Care Practitioners.
    (a) All non-Federal doctors of medicine (M.D.) and doctors of 
osteopathy (D.O.) providing direct patient care who practice principally 
in one of the four primary care specialities--general or family 
practice, general internal medicine, pediatrics, and obstetrics and 
gynecology--will be counted. Those physicians engaged solely in 
administration, research, and teaching will be excluded. Adjustments for 
the following factors will be made in computing the number of full-time-
equivalent (FTE) primary care physicians:
    (i) Interns and residents will be counted as 0.1 full-time 
equivalent (FTE) physicians.
    (ii) Graduates of foreign medical schools who are not citizens or 
lawful permanent residents of the United States will be excluded from 
physician counts.
    (iii) Those graduates of foreign medical schools who are citizens or 
lawful permanent residents of the United States, but do not have 
unrestricted licenses to practice medicine, will be counted as 0.5 FTE 
physicians.
    (b) Practitioners who are semi-retired, who operate a reduced 
practice due to infirmity or other limiting conditions, or who provide 
patient care services to the residents of the area only on a part-time 
basis will be discounted through the use of full-time equivalency 
figures. A 40-hour work week will be used as the standard for 
determining full-time equivalents in these cases. For practitioners 
working less than a 40-hour week, every four (4) hours (or \1/2\ day) 
spent providing patient care, in either ambulatory or inpatient 
settings, will be counted as 0.1 FTE (with numbers obtained for FTE's 
rounded to the nearest 0.1 FTE), and each physician providing patient 
care 40 or more hours a week will be counted as 1.0 FTE physician. (For 
cases where data are available only for the number of hours providing 
patient care in office settings, equivalencies will be provided in 
guidelines.)
    (c) In some cases, physicians located within an area may not be 
accessible to the population of the area under consideration. Allowances 
for physicians with restricted practices can be made, on a case-by-case 
basis. However, where only a portion of the population of the area 
cannot access existing primary care resources in the area, a population 
group designation may be more appropriate (see part II of this 
appendix).
    (d) Hospital staff physicians involved exclusively in inpatient care 
will be excluded.

[[Page 38]]

The number of full-time equivalent physicians practicing in organized 
outpatient departments and primary care clinics will be included, but 
those in emergency rooms will be excluded.
    (e) Physicians who are suspended under provisions of the Medicare-
Medicaid Anti-Fraud and Abuse Act for a period of eighteen months or 
more will be excluded.
    4. Determination of Unusually High Needs for Primary Medical Care 
Services.
    An area will be considered as having unusually high needs for 
primary health care services if at least one of the following criteria 
is met:
    (a) The area has more than 100 births per year per 1,000 women aged 
15-44.
    (b) The area has more than 20 infant deaths per 1,000 live births.
    (c) More than 20% of the population (or of all households) have 
incomes below the poverty level.
    5. Determination of Insufficient Capacity of Existing Primary Care 
Providers.
    An area's existing primary care providers will be considered to have 
insufficient capacity if at least two of the following criteria are met:
    (a) More than 8,000 office or outpatient visits per year per FTE 
primary care physician serving the area.
    (b) Unusually long waits for appointments for routine medical 
services (i.e., more than 7 days for established patients and 14 days 
for new patients).
    (c) Excessive average waiting time at primary care providers (longer 
than one hour where patients have appointments or two hours where 
patients are treated on a first-come, first-served basis).
    (d) Evidence of excessive use of emergency room facilities for 
routine primary care.
    (e) A substantial proportion (2/3 or more) of the area's physicians 
do not accept new patients.
    (f) Abnormally low utilization of health services, as indicated by 
an average of 2.0 or less office visits per year on the part of the 
area's population.
    6. Contiguous Area Considerations.
    Primary care professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant, 
overutilized or inaccessible to the population of the area under 
consideration if one of the following conditions prevails in each 
contiguous area:
    (a) Primary care professional(s) in the contiguous area are more 
than 30 minutes travel time from the population center(s) of the area 
being considered for designation (measured in accordance with paragraph 
B.1(b) of this part).
    (b) The contiguous area population-to-full-time-equivalent primary 
care physician ratio is in excess of 2000:1, indicating that 
practitioners in the contiguous area cannot be expected to help 
alleviate the shortage situation in the area being considered for 
designation.
    (c) Primary care professional(s) in the contiguous area are 
inaccessible to the population of the area under consideration because 
of specified access barriers, such as:
    (i) Significant differences between the demographic (or socio-
economic) characteristics of the area under consideration and those of 
the contiguous area, indicating that the population of the area under 
consideration may be effectively isolated from nearby resources. This 
isolation could be indicated, for example, by an unusually high 
proportion of non-English-speaking persons.
    (ii) A lack of economic access to contiguous area resources, as 
indicated particularly where a very high proportion of the population of 
the area under consideration is poor (i.e., where more than 20 percent 
of the population or the households have incomes below the poverty 
level), and Medicaid-covered or public primary care services are not 
available in the contiguous area.
    C. Determination of Degree of Shortage.
    Designated areas will be assigned to degree-of-shortage groups, 
based on the ratio (R) of population to number of full-time equivalent 
primary care physicians and the presence or absence of unusually high 
needs for primary health care services, according to the following 
table:

------------------------------------------------------------------------
                                    High needs not        High needs
                                       indicated           indicated
------------------------------------------------------------------------
Group 1.........................  No physicians.....  No physicians; or
                                                       R=5,00
                                                       0
Group 2.........................  R=5,000  5,000R<
                                                       l=4,000
Group 3.........................  5,000R<  4,000R<
                                   l=4,000.            l=3,500
Group 4.........................  4,000R<  3,500R<
                                   l=3,500.            l=3,000
------------------------------------------------------------------------

    D. Determination of size of primary care physician shortage. Size of 
Shortage (in number of FTE primary care physicians needed) will be 
computed using the following formulas:
    (1) For areas without unusually high need or insufficient capacity:
Primary care physician shortage=area population/3,500-number of FTE 
primary care physicians
    (2) For areas with unusually high need or insufficient capacity:
Primary care physician shortage=area population/3,000-number of FTE 
primary care physicians

                       Part II--Population Groups

    A. Criteria.
    1. In general, specific population groups within particular 
geographic areas will be designated as having a shortage of primary 
medical care professional(s) if the following three criteria are met:
    (a) The area in which they reside is rational for the delivery of 
primary medical care

[[Page 39]]

services, as defined in paragraph B.1 of part I of this appendix.
    (b) Access barriers prevent the population group from use of the 
area's primary medical care providers. Such barriers may be economic, 
linguistic, cultural, or architectural, or could involve refusal of some 
providers to accept certain types of patients or to accept Medicaid 
reimbursement.
    (c) The ratio of the number of persons in the population group to 
the number of primary care physicians practicing in the area and serving 
the population group is at least 3,000 : 1.
    2. Indians and Alaska Natives will be considered for designation as 
having shortages of primary care professional(s) as follows:
    (a) Groups of members of Indian tribes (as defined in section 4(d) 
of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are 
automatically designated.
    (b) Other groups of Indians or Alaska Natives (as defined in section 
4(c) of Pub. L. 94-437) will be designated if the general criteria in 
paragraph A are met.
    B. Determination of Degree of Shortage.
    Each designated population group will be assigned to a degree-of-
shortage group, based on the ratio (R) of the group's population to the 
number of primary care physicians serving it, as follows:

Group 1--No physicians or R5,000.
Group 2--5,000R=4,000.
Group 3--4,000R=3,500.
Group 4--3,500R=3,000.

    Population groups which have received ``automatic'' designation will 
be assigned to degree-of-shortage group 4 if no information on the ratio 
of the number of persons in the group to the number of FTE primary care 
physicians serving them is provided.
    C. Determination of size of primary care physician shortage. Size of 
shortage (in number of primary care physicians needed) will be computed 
as follows:
    Primary care physician shortage=number of persons in population 
group/3,000-number of FTE primary care physicians

                          Part III--Facilities

    A. Federal and State Correctional Institutions.
    1. Criteria.
    Medium to maximum security Federal and State correctional 
institutions and youth detention facilities will be designated as having 
a shortage of primary medical care professional(s) if both the following 
criteria are met:
    (a) The institution has at least 250 inmates.
    (b) The ratio of the number of internees per year to the number of 
FTE primary care physicians serving the institution is at least 1,000:1. 
(Here the number of internees is the number of inmates present at the 
beginning of the year plus the number of new inmates entering the 
institution during the year, including those who left before the end of 
the year; the number of FTE primary care physicians is computed as in 
part I, section B, paragraph 3 above.)
    2. Determination of Degree of Shortage.
    Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of 
internees to primary care physicians, as follows:

Group 1--Institutions with 500 or more inmates and no physicians.
Group 2--Other institutions with no physicians and institutions with 
R=2,000.
Group 3--Institutions with 2,000R=1,000.

    B. Public or Non-Profit Medical Facilities.
    1. Criteria.
    Public or non-profit private medical facilities will be designated 
as having a shortage of primary medical care professional(s) if:
    (a) the facility is providing primary medical care services to an 
area or population group designated as having a primary care 
professional(s) shortage; and
    (b) the facility has insufficient capacity to meet the primary care 
needs of that area or population group.
    2. Methodology
    In determining whether public or nonprofit private medical 
facilities meet the criteria established by paragraph B.1 of this Part, 
the following methodology will be used:
    (a) Provision of Services to a Designated Area or Population Group.
    A facility will be considered to be providing services to a 
designated area or population group if either:
    (i) A majority of the facility's primary care services are being 
provided to residents of designated primary care professional(s) 
shortage areas or to population groups designated as having a shortage 
of primary care professional(s); or
    (ii) The population within a designated primary care shortage area 
or population group has reasonable access to primary care services 
provided at the facility. Reasonable access will be assumed if the area 
within which the population resides lies within 30 minutes travel time 
of the facility and non-physical barriers (relating to demographic and 
socioeconomic characteristics of the population) do not prevent the 
population from receiving care at the facility.
    Migrant health centers (as defined in section 319(a)(1) of the Act) 
which are located in areas with designated migrant population groups and 
Indian Health Service facilities are assumed to be meeting this 
requirement.
    (b) Insufficient capacity to meet primary care needs.
    A facility will be considered to have insufficient capacity to meet 
the primary care needs of the area or population it serves if at

[[Page 40]]

least two of the following conditions exist at the facility:
    (i) There are more than 8,000 outpatient visits per year per FTE 
primary care physician on the staff of the facility. (Here the number of 
FTE primary care physicians is computed as in Part I, Section B, 
paragraph 3 above.)
    (ii) There is excessive usage of emergency room facilities for 
routine primary care.
    (iii) Waiting time for appointments is more than 7 days for 
established patients or more than 14 days for new patients, for routine 
health services.
    (iv) Waiting time at the facility is longer than 1 hour where 
patients have appointments or 2 hours where patients are treated on a 
first-come, first-served basis.
    3. Determination of Degree of Shortage.
    Each designated medical facility will be assigned to the same 
degree-of-shortage group as the designated area or population group 
which it serves.

[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8737, Mar. 2, 1989; 57 
FR 2480, Jan. 22, 1992]



  Sec. Appendix B to Part 5--Criteria for Designation of Areas Having 
                   Shortages of Dental Professional(s)

                        Part I--Geographic Areas

    A. Federal and State Correctional Institutions.
    1. Criteria
    Medium to maximum security Federal and State correctional 
institutions and youth detention facilities will be designated as having 
a shortage of dental professional(s) if both the following criteria are 
met:
    (a) The institution has at least 250 inmates.
    (b) The ratio of the number of internees per year to the number of 
FTE dentists serving the institution is at least 1,500:1.
    Here the number of internees is defined as follows:
    (i) If the number of new inmates per year and the average length-of-
stay are not specified, or if the information provided does not indicate 
that intake dental examinations are routinely performed by dentists upon 
entry, then--Number of internees=average number of inmates.
    (ii) If the average length-of-stay is specified as one year or more, 
and intake dental examinations are routinely performed upon entry, 
then--Number of internees=average number of inmates+number of new 
inmates per year.
    (iii) If the average length-of-stay is specified as less than one 
year, and intake dental examinations are routinely performed upon entry, 
then--Number of internees=average number of inmates+\1/
3\x(1+2xALOS)xnumber of new inmates per year where ALOS=average length-
of-stay (in fraction of year).

(The number of FTE dentists is computed as in part I, section B, 
paragraph 3 above.)

    2. Determination of Degree of Shortage.
    Designated correctional institutions will be assigned to degree-of-
shortage groups based on the number of inmates and/or the ratio (R) of 
internees to dentists, as follows:
    Group 1--Institutions with 500 or more inmates and no dentists.
    Group 2--Other institutions with no dentists and institutions with R 
greater than (or equal to) 3,000:1.
    Group 3--Institutions with R greater than (or equal to) 1,500:1 but 
less than 3,000:1.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Area for the Delivery of Dental Services.
    (a) The following areas will be considered rational areas for the 
delivery of dental health services:
    (i) A county, or a group of several contiguous counties whose 
population centers are within 40 minutes travel time of each other.
    (ii) A portion of a county (or an area made up of portions of more 
than one county) whose population, because of topography, market or 
transportation patterns, distinctive population characteristics, or 
other factors, has limited access to contiguous area resources, as 
measured generally by a travel time of greater than 40 minutes to such 
resources.
    (iii) Established neighborhoods and communities within metropolitan 
areas which display a strong self-identity (as indicated by a homogenous 
socioeconomic or demographic structure and/or a traditional of 
interaction or intradependency), have limited interaction with 
contiguous areas, and which, in general, have a minimum population of 
20,000.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 40 minutes travel time.
    2. Population Count.
    The population count use will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, with 
the following adjustments:

[[Page 41]]

    (a) Seasonal residents, i.e., those who maintain a residence in the 
area but inhabit it for only 2 to 8 months per year, may be included but 
must be weighted in proportion to the fraction of the year they are 
present in the area.
    (b) Migratory workers and their families may be included in an 
area's population using the following formula: Effective migrant 
contribution to population=(fraction of year migrants are present in 
area)x(average daily number of migrants during portion of year that 
migrants are present).
    3. Counting of Dental Practitioners.
    (a) All non-Federal dentists providing patient care will be counted, 
except in those areas where it is shown that specialists (those dentists 
not in general practice or pedodontics) are serving a larger area and 
are not addressing the general dental care needs of the area under 
consideration.
    (b) Full-time equivalent (FTE) figures will be used to reflect 
productivity differences among dental practices based on the age of the 
dentists, the number of auxiliaries employed, and the number of hours 
worked per week. In general, the number of FTE dentists will be computed 
using weights obtained from the matrix in Table 1, which is based on the 
productivity of dentists at various ages, with different numbers of 
auxiliaries, as compared with the average productivity of all dentists. 
For the purposes of these determinations, an auxiliary is defined as any 
non-dentist staff employed by the dentist to assist in operation of the 
practice.

     Table 1--Equivalency Weights, by Age and Number of Auxiliaries
------------------------------------------------------------------------
                                            <55    55-59   60-64    65+
------------------------------------------------------------------------
No auxiliaries..........................     0.8     0.7     0.6     0.5
One auxiliary...........................     1.0     0.9     0.8     0.7
Two auxiliaries.........................     1.2     1.0     1.0     0.8
Three auxiliaries.......................     1.4     1.2     1.0     1.0
Four or more auxiliaries................     1.5     1.5     1.3     1.2
------------------------------------------------------------------------

    If information on the number of auxiliaries employed by the dentist 
is not available, Table 2 will be used to compute the number of full-
time equivalent dentists.

                  Table 2--Equivalency Weights, by Age
------------------------------------------------------------------------
                                            55     55-59   60-64    65+
------------------------------------------------------------------------
Equivalency weights.....................     1.2     0.9     0.8     0.6
------------------------------------------------------------------------

    The number of FTE dentists within a particular age group (or age/
auxiliary group) will be obtained by multiplying the number of dentists 
within that group by its corresponding equivalency weight. The total 
supply of FTE dentists within an area is then computed as the sum of 
those dentists within each age (or age/auxiliary) group.
    (c) The equivalency weights specified in tables 1 and 2 assume that 
dentists within a particular group are working full-time (40 hours per 
week). Where appropriate data are available, adjusted equivalency 
figures for dentists who are semi-retired, who operate a reduced 
practice due to infirmity or other limiting conditions, or who are 
available to the population of an area only on a part-time basis will be 
used to reflect the reduced availability of these dentists. In computing 
these equivalency figures, every 4 hours (or \1/2\ day) spent in the 
dental practice will be counted as 0.1 FTE except that each dentist 
working more than 40 hours a week will be counted as 1.0. The count 
obtained for a particular age group of dentists will then be multiplied 
by the appropriate equivalency weight from table 1 or 2 to obtain a 
full-time equivalent figure for dentists within that particular age or 
age/auxiliary category.
    4. Determination of Unusually High Needs for Dental Services.
    An area will be considered as having unusually high needs for dental 
services if at least one of the following criteria is met:
    (a) More than 20% of the population (or of all households) has 
incomes below the poverty level.
    (b) The majority of the area's population does not have a 
fluoridated water supply.
    5. Determination of Insufficient Capacity of Existing Dental Care 
Providers.
    An area's existing dental care providers will be considered to have 
insufficient capacity if at least two of the following criteria are met:
    (a) More than 5,000 visits per year per FTE dentist serving the 
area.
    (b) Unusually long waits for appointments for routine dental 
services (i.e., more than 6 weeks).
    (c) A substantial proportion (\2/3\ or more) of the area's dentists 
do not accept new patients.
    6. Contiguous Area Considerations.
    Dental professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant, 
overutilized or inaccessible to the population of the area under 
consideration if one of the following conditions prevails in each 
contiguous area:
    (a) Dental professional(s) in the contiguous area are more than 40 
minutes travel time from the center of the area being considered for 
designation (measured in accordance with Paragraph B.1.(b) of this 
part).
    (b) Contiguous area population-to-(FTE) dentist ratios are in excess 
of 3,000 : 1, indicating that resources in contiguous areas cannot be 
expected to help alleviate the shortage situation in the area being 
considered for designation.
    (c) Dental professional(s) in the contiguous area are inaccessible 
to the population of the

[[Page 42]]

area under consideration because of specified access barriers, such as:
    (i) Significant differences between the demographic (or 
socioeconomic) characteristics of the area under consideration and those 
of the contiguous area, indicating that the population of the area under 
consideration may be effectively isolated from nearby resources. Such 
isolation could be indicated, for example, by an unusually high 
proportion of non-English-speaking persons.
    (ii) A lack of economic access to contiguous area resources, 
particularly where a very high proportion of the population of the area 
under consideration is poor (i.e., where more than 20 percent of the 
population or of the households have incomes below the poverty level) 
and Medicaid-covered or public dental services are not available in the 
contiguous area.
    C. Determination of Degree of Shortage.
    The degree of shortage of a given geographic area, designated as 
having a shortage of dental professional(s), will be determined using 
the following procedure:
    Designated areas will be assigned to degree-of-shortage groups, 
based on the ratio (R) of population to number of full-time-equivalent 
dentists and the presence or absence of unusually high needs for dental 
services, or insufficient capacity of existing dental care providers 
according to the following table:

------------------------------------------------------------------------
                                     High needs or
                                     insufficient        High needs or
                                     capacity not        insufficient
                                       indicated      capacity indicated
------------------------------------------------------------------------
Group 1.........................  No dentists.......  No dentists or
                                                       R=8,00
                                                       0.
Group 2.........................  R=8,000  8,000R<
                                                       l=6,000.
Group 3.........................  8,000R<  6,000R<
                                   l=6,000.            l=5,000.
Group 4.........................  6,000R<  5,000R<
                                   l=5,000.            l=4,000.
------------------------------------------------------------------------

    D. Determination of size of dental shortage. Size of Dental Shortage 
(in number of FTE dental practitioners needed) will be computed using 
the following formulas:
    (1) For areas without unusually high need:
Dental shortage=area population/5,000-number of FTE dental practitioners
    (2) For areas with unusually high need:
Dental shortage=area population/4,000-number of FTE dental practitioners

                       Part II--Population Groups

    A. Criteria.
    1. In general, specified population groups within particular 
geographic areas will be designated as having a shortage of dental care 
professional(s) if the following three criteria are met:
    a. The area in which they reside is rational for the delivery of 
dental care services, as defined in paragraph B.1 of part I of this 
appendix.
    b. Access barriers prevent the population group from use of the 
area's dental providers.
    c. The ratio (R) of the number of persons in the population group to 
the number of dentists practicing in the area and serving the population 
group is at least 4,000:1.
    2. Indians and Alaska Natives will be considered for designation as 
having shortages of dental professional(s) as follows:
    (a) Groups of members of Indian tribes (as defined in section 4(d) 
of Pub. L. 94-437, the Indian Health Care Improvement Act of 1976) are 
automatically designated.
    (b) Other groups of Indians or Alaska Natives (as defined in section 
4(c) of Pub. L. 94-437) will be designated if the general criteria in 
paragraph 1 are met.
    B. Determination of Degree of Shortage.
    Each designated population group will be assigned to a degree-of-
shortage group as follows:

Group 1--No dentists or R=8,000.
Group 2--8,000R=6,000.
Group 3--6,000R=5,000.
Group 4--5,000R=4,000.

Population groups which have received ``automatic'' designation will be 
assigned to degree-of-shortage group 4 unless information on the ratio 
of the number of persons in the group to the number of FTE dentists 
serving them is provided.
    C. Determination of size of dental shortage. Size of dental shortage 
will be computed as follows:
Dental shortage=number of persons in population group/4,000-number of 
FTE dental practitioners

                          Part III--Facilities

    A. Federal and State Correctional Institutions.
    1. Criteria.
    Medium to maximum security Federal and State correctional 
institutions and youth detention facilities will be designated as having 
a shortage of dental professional(s) if both the following criteria are 
met:
    (a) The institution has at least 250 inmates.
    (b) The ratio of the number of internees per year to the number of 
FTE dentists serving the institution is at least 1,500:1. (Here the 
number of internees is the number of inmates present at the beginning of 
the year plus the number of new inmates entering the institution during 
the year, including those who left before the end of the year; the 
number of FTE dentists is computed as in part I, section B, paragraph 3 
above.)
    2. Determination of Degree-of-Shortage.
    Designated correctional institutions will be assigned to degree-of-
shortage groups as follows, based on number of inmates and/or the ratio 
(R) of internees to dentists:


[[Page 43]]


Group 1--Institutions with 500 or more inmates and no dentists.
Group 2--Other institutions with no dentists and institutions with R 
 3,000.
Group 3--Institutions with 3,000  R  1,500.

    B. Public or Non-Profit Private Dental Facilities.
    1. Criteria.
    Public or nonprofit private facilties providing general dental care 
services will be designated as having a shortage of dental 
professional(s) if both of the following criteria are met:
    (a) The facility is providing general dental care services to an 
area or population group designated as having a dental professional(s) 
shortage; and
    (b) The facility has insufficent capacity to meet the dental care 
needs of that area or population group.
    2. Methodology.
    In determining whether public or nonprofit private facilities meet 
the criteria established by paragraph B.1. of this part, the following 
methodology will be used:
    (a) Provision of Services to a Designated Area or Population Group.
    A facility will be considered to be providing services to an area or 
population group if either:
    (i) A majority of the facility's dental care services are being 
provided to residents of designated dental professional(s) shortage 
areas or to population groups designated as having a shortage of dental 
professional(s); or
    (ii) The population within a designated dental shortage area or 
population group has reasonable access to dental services provided at 
the facility. Reasonable access will be assumed if the population lies 
within 40 minutes travel time of the facility and non-physical barriers 
(relating to demographic and socioeconomic characteristics of the 
population) do not prevent the population from receiving care at the 
facility.
    Migrant health centers (as defined in section 319(a)(1) of the Act) 
which are located in areas with designated migrant population groups and 
Indian Health Service facilities are assumed to be meeting this 
requirement.
    (b) Insufficient Capacity To Meet Dental Care Needs.
    A facility will be considered to have insufficient capacity to meet 
the dental care needs of a designated area or population group if either 
of the following conditions exists at the facility.
    (i) There are more than 5,000 outpatient visits per year per FTE 
dentist on the staff of the facility. (Here the number of FTE dentists 
is computed as in part I, section B, paragraph 3 above.)
    (ii) Waiting time for appointments is more than 6 weeks for routine 
dental services.
    3. Determination of Degree of Shortage.
    Each designated dental facility will be assigned to the same degree-
of-shortage group as the designated area or population group which it 
serves.

[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8738, Mar. 2, 1989; 57 
FR 2480, Jan. 22, 1992]



  Sec. Appendix C to Part 5--Criteria for Designation of Areas Having 

                Shortages of Mental Health Professionals

                        Part I--Geographic Areas

    A. Criteria. A geographic area will be designated as having a 
shortage of mental health professionals if the following four criteria 
are met:
    1. The area is a rational area for the delivery of mental health 
services.
    2. One of the following conditions prevails within the area:
    (a) The area has--
    (i) A population-to-core-mental-health-professional ratio greater 
than or equal to 6,000:1 and a population-to-psychiatrist ratio greater 
than or equal to 20,000:1, or
    (ii) A population-to-core-professional ratio greater than or equal 
to 9,000:1, or
    (iii) A population-to-psychiatrist ratio greater than or equal to 
30,000:1;
    (b) The area has unusually high needs for mental health services, 
and has--
    (i) A population-to-core-mental-health-professional ratio greater 
than or equal to 4,500:1 and
    A population-to-psychiatrist ratio greater than or equal to 
15,000:1, or
    (ii) A population-to-core-professional ratio greater than or equal 
to 6,000:1, or
    (iii) A population-to-psychiatrist ratio greater than or equal to 
20,000:1;
    3. Mental health professionals in contiguous areas are overutilized, 
excessively distant or inaccessible to residents of the area under 
consideration.

    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Areas for the Delivery of Mental Health Services.
    (a) The following areas will be considered rational areas for the 
delivery of mental health services:
    (i) An established mental health catchment area, as designated in 
the State Mental Health Plan under the general criteria set forth in 
section 238 of the Community Mental Health Centers Act.
    (ii) A portion of an established mental health catchment area whose 
population, because of topography, market and/or transportation patterns 
or other factors, has limited access to mental health resources in the

[[Page 44]]

rest of the catchment area, as measured generally by a travel time of 
greater than 40 minutes to these resources.
    (iii) A county or metropolitan area which contains more than one 
mental health catchment area, where data are unavailable by individual 
catchment area.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 40 minutes travel time.
    2. Population Count.
    The population count used will be the total permanent resident 
civilian population of the area, excluding inmates of institutions.
    3. Counting of mental health professionals. (a) All non-Federal core 
mental health professionals (as defined below) providing mental health 
patient care (direct or other, including consultation and supervision) 
in ambulatory or other short-term care settings to residents of the area 
will be counted. Data on each type of core professional should be 
presented separately, in terms of the number of full-time-equivalent 
(FTE) practitioners of each type represented.
    (b) Definitions:
    (i) Core mental health professionals or core professionals includes 
those psychiatrists, clinical psychologists, clinical social workers, 
psychiatric nurse specialists, and marriage and family therapists who 
meet the definitions below.
    (ii) Psychiatrist means a doctor of medicine (M.D.) or doctor of 
osteopathy (D.O.) who
    (A) Is certified as a psychiatrist or child psychiatrist by the 
American Medical Specialities Board of Psychiatry and Neurology or by 
the American Osteopathic Board of Neurology and Psychiatry, or, if not 
certified, is ``broad-eligible'' (i.e., has successfully completed an 
accredited program of graduate medical or osteopathic education in 
psychiatry or child psychiatry); and
    (B) Practices patient care psychiatry or child psychiatry, and is 
licensed to do so, if required by the State of practice.
    (iii) Clinical psychologist means an individual (normally with a 
doctorate in psychology) who is practicing as a clinical or counseling 
psychologist and is licensed or certified to do so by the State of 
practice; or, if licensure or certification is not required in the State 
of practice, an individual with a doctorate in psychology and two years 
of supervised clinical or counseling experience. (School psychologists 
are not included.)
    (iv) Clinical social worker means an individual who--
    (A) Is certified as a clinical social worker by the American Board 
of Examiners in Clinical Social Work, or is listed on the National 
Association of Social Workers' Clinical Register, or has a master's 
degree in social work and two years of supervised clinical experience; 
and
    (B) Is licensed to practice as a social worker, if required by the 
State of practice.
    (v) Psychiatric nurse specialist means a registered nurse (R.N.) 
who--
    (A) Is certified by the American Nurses Association as a psychiatric 
and mental health clinical nurse specialist, or has a master's degree in 
nursing with a specialization in psychiatric/mental health and two years 
of supervised clinical experience; and
    (B) Is licensed to practice as a psychiatric or mental health nurse 
specialist, if required by the State of practice.
    (vi) Marriage and family therapist means an individual (normally 
with a master's or doctoral degree in marital and family therapy and at 
least two years of supervised clinical experience) who is practicing as 
a marital and family therapist and is licensed or certified to do so by 
the State of practice; or, if licensure or certification is not required 
by the State of practice, is eligible for clinical membership in the 
American Association for Marriage and Family Therapy.
    (c) Practitioners who provide patient care to the population of an 
area only on a part-time basis (whether because they maintain another 
office elsewhere, spend some of their time providing services in a 
facility, are semi-retired, or operate a reduced practice for other 
reasons), will be counted on a partial basis through the use of full-
time-equivalency calculations based on a 40-hour week. Every 4 hours (or 
\1/2\ day) spent providing patient care services in ambulatory or 
inpatient settings will be counted as 0.1 FTE, and each practitioner 
providing patient care for 40 or more hours per week as 1.0 FTE. Hours 
spent on research, teaching, vocational or educational counseling, and 
social services unrelated to mental health will be excluded; if a 
practitioner is located wholly or partially outside the service area, 
only those services actually provided within the area are to be counted.
    (d) In some cases, practitioners located within an area may not be 
accessible to the general population of the area under consideration. 
Practitioners working in restricted facilities will be included on an 
FTE basis

[[Page 45]]

based on time spent outside the facility. Examples of restricted 
facilities include correctional institutions, youth detention 
facilities, residential treatment centers for emotionally disturbed or 
mentally retarded children, school systems, and inpatient units of State 
or county mental hospitals.
    (e) In cases where there are mental health facilities or 
institutions providing both inpatient and outpatient services, only 
those FTEs providing mental health services in outpatient units or other 
short-term care units will be counted.
    (f) Adjustments for the following factors will also be made in 
computing the number of FTE providers:
    (i) Practitioners in residency programs will be counted as 0.5 FTE.
    (ii) Graduates of foreign schools who are not citizens or lawful 
permanent residents of the United States will be excluded from counts.
    (iii) Those graduates of foreign schools who are citizens or lawful 
permanent residents of the United States, and practice in certain 
settings, but do not have unrestricted licenses to practice, will be 
counted on a full-time-equivalency basis up to a maximum of 0.5 FTE.
    (g) Practitioners suspended for a period of 18 months or more under 
provisions of the Medicare-Medicaid Anti-Fraud and Abuse Act will not be 
counted.
    4. Determination of unusually high needs for mental health services. 
An area will be considered to have unusually high needs for mental 
health services if one of the following criteria is met:
    (a) 20 percent of the population (or of all households) in the area 
have incomes below the poverty level.
    (b) The youth ratio, defined as the ratio of the number of children 
under 18 to the number of adults of ages 18 to 64, exceeds 0.6.
    (c) The elderly ratio, defined as the ratio of the number of persons 
aged 65 and over to the number of adults of ages 18 to 64, exceeds 0.25.
    (d) A high prevalence of alcoholism in the population, as indicated 
by prevalence data showing the area's alcoholism rates to be in the 
worst quartile of the nation, region, or State.
    (e) A high degree of substance abuse in the area, as indicated by 
prevalence data showing the area's substance abuse to be in the worst 
quartile of the nation, region, or State.
    5. Contiguous area considerations. Mental health professionals in 
areas contiguous to an area being considered for designation will be 
considered excessively distant, overutilized or inaccessible to the 
population of the area under consideration if one of the following 
conditions prevails in each contiguous area:
    (a) Core mental health professionals in the contiguous area are more 
than 40 minutes travel time from the closest population center of the 
area being considered for designation (measured in accordance with 
paragraph B.1(b) of this part).
    (b) The population-to-core-mental-health-professional ratio in the 
contiguous area is in excess of 3,000:1 and the population-to-
psychiatrist ratio there is in excess of 10,000:1, indicating that core 
mental health professionals in the contiguous areas are overutilized and 
cannot be expected to help alleviate the shortage situation in the area 
for which designation is being considered. (If data on core mental 
health professionals other than psychiatrists are not available for the 
contiguous area, a population-to-psychiatrist ratio there in excess of 
20,000:1 may be used to demonstrate overutilization.)
    (c) Mental health professionals in contiguous areas are inaccessible 
to the population of the requested area due to geographic, cultural, 
language or other barriers or because of residency restrictions of 
programs or facilities providing such professionals.
    C. Determination of degree of shortage. Designated areas will be 
assigned to degree-of-shortage groups according to the following table, 
depending on the ratio (RC) of population to number of FTE 
core-mental-health-service providers (FTEC); the ratio 
(RP) of population to number of FTE psychiatrists 
(FTEP); and the presence or absence of high needs:

                        High Needs Not Indicated

Group 1--FTEC=0 and FTEP=0
Group 2--RC gte * 6,000:1 and FTEP=0
Group 3--RC gte 6,000:1 and RP gte 20,000
Group 4(a)--For psychiatrist placements only: All other areas with 
FTEP=0 or RP gte 30,000
Group 4(b)--For other mental health practitioner placements: All other 
areas with RC gte 9,000:1.

    * Note: ``gte'' means ``greater than or equal to''.

                          High Needs Indicated

Group 1--FTEC=0 and FTEP=0
Group 2--RC gte 4,500:1 and FTEP=0
Group 3--RC gte 4,500:1 and RP gte 15,000
Group 4(a)--For psychiatrist placements only: All other areas with 
FTEP=0 or RP gte 20,000
Group 4(b)--For other mental health practitioner placements: All other 
areas with RC gte 6,000:1.
    D. Determination of Size of Shortage. Size of Shortage (in number of 
FTE professionals needed) will be computed using the following formulas:
    (1) For areas without unusually high need:

Core professional shortage=area population/6,000-number of FTE core 
professionals

[[Page 46]]

Psychiatrist shortage=area population/20,000-number of FTE psychiatrists

    (2) For areas with unusually high need:

Core professional shortage=area population/4,500-number of FTE core 
professionals
Psychiatrist shortage=area population/15,000-number of FTE psychiatrists

                       Part II--Population Groups

    A. Criteria. Population groups within particular rational mental 
health service areas will be designated as having a mental health 
professional shortage if the following criteria are met:
    1. Access barriers prevent the population group from using those 
core mental health professionals which are present in the area; and
    2. One of the following conditions prevails:
    (a) The ratio of the number of persons in the population group to 
the number of FTE core mental health professionals serving the 
population group is greater than or equal to 4,500:1 and the ratio of 
the number of persons in the population group to the number of FTE 
psychiatrists serving the population group is greater than or equal to 
15,000:1; or,
    (b) The ratio of the number of persons in the population group to 
the number of FTE core mental health professionals serving the 
population group is greater than or equal to 6,000:1; or,
    (c) The ratio of the number of persons in the population group to 
the number of FTE psychiatrists serving the population group is greater 
than or equal to 20,000:1.
    B. Determination of degree of shortage. Designated population groups 
will be assigned to the same degree-of-shortage groups defined in part 
I.C of this appendix for areas with unusually high needs for mental 
health services, using the computed ratio (RC) of the number 
of persons in the population group to the number of FTE core mental 
health service providers (FTEC) serving the population group, 
and the ration (RP) of the number of persons in the 
population group to the number of FTE psychiatrists (FTEP) 
serving the population group.
    C. Determination of size of shortage. Size of shortage will be 
computed as follows:
Core professional shortage=number of persons in population group/4,500-
number of FTE core professionals
Psychiatrist shortage=number of persons in population group/15,000-
number of FTE psychiatrists

                          Part III--Facilities

    A. Federal and State Correctional Institutions
    1. Criteria.
    Medium to maximum security Federal and State correctional 
institutions for adults or youth, and youth detention facilities, will 
be designated as having a shortage of psychiatric professional(s) if 
both of the following criteria are met:
    (a) The institution has more than 250 inmates, and
    (b) The ratio of the number of internees per year to the number of 
FTE psychiatrists serving the institution is at least 2,000:1. (Here the 
number of internees is the number of inmates or residents present at the 
beginning of the year, plus the number of new inmates or residents 
entering the institution during the year, including those who left 
before the end of the year; the number of FTE psychiatrists is computed 
as in part I, section B, paragraph 3 above.)
    2. Determination of Degree of Shortage.
    Correctional facilities and youth detention facilities will be 
assigned to degree-of-shortage groups, based on the number of inmates 
and/or the ratio (R) of internees to FTE psychiatrists, as follows:

    Group 1--Facilities with 500 or more inmates or residents and no 
psychiatrist.
    Group 2--Other facilities with no psychiatrists and facilities with 
500 or more inmates or residents and R3,000.
    Group 3--All other facilities.

    B. State and County Mental Hospitals.
    1. Criteria.
    A State or county hospital will be designated as having a shortage 
of psychiatric professional(s) if both of the following criteria are 
met:
    (a) The mental hospital has an average daily inpatient census of at 
least 100; and
    (b) The number of workload units per FTE psychiatrists available at 
the hospital exceeds 300, where workload units are calculated using the 
following formula:
    Total workload units = average daily inpatient census + 2 x (number 
of inpatient admissions per year) + 0.5 x (number of admissions to day 
care and outpatient services per year).
    2. Determination of Degree of Shortage.
    State or county mental hospitals will be assigned to degree-of-
shortage groups, based on the ratio (R) of workload units to number of 
FTE psychiatrists, as follows:

    Group 1--No psychiatrists, or R1,800.
    Group 2--1,800R1,200.
    Group 3--1,200R600.
    Group 4--600R300.

    C. Community Mental Health Centers and Other Public or Nonprofit 
Private Facilities.
    1. Criteria.
    A community mental health center (CMHC), authorized by Pub. L. 94-
63, or other public or nonprofit private facility providing mental 
health services to an area or population group, may be designated as 
having a shortage of psychiatric professional(s) if the facility is 
providing (or is responsible for providing) mental health services to an 
area or population group designated as having a

[[Page 47]]

mental health professional(s), and the facility has insufficient 
capacity to meet the psychiatric needs of the area or population group.
    2. Methodology.
    In determining whether CMHCs or other public or nonprofit private 
facilities meet the criteria established in paragraph C.1 of this Part, 
the following methodology will be used.
    (a) Provision of Services to a Designated Area or Population Group.
    The facility will be considered to be providing services to a 
designated area or population group if either:
    (i) A majority of the facility's mental health services are being 
provided to residents of designated mental health professional(s) 
shortage areas or to population groups designated as having a shortage 
of mental health professional(s); or
    (ii) The population within a designated psychiatric shortage area or 
population group has reasonable access to mental health services 
provided at the facility. Such reasonable access will be assumed if the 
population lies within 40 minutes travel time of the facility and 
nonphysical barriers (relating to demographic and socioeconomic 
characteristics of the population) do not prevent the population from 
receiving care at the facility.
    (b) Responsibility for Provision of Services.
    This condition will be considered to be met if the facility, by 
Federal or State statute, administrative action, or contractual 
agreement, has been given responsibility for providing and/or 
coordinating mental health services for the area or population group, 
consistent with applicable State plans.
    (c) Insufficient capacity to meet mental health service needs. A 
facility will be considered to have insufficient capacity to meet the 
mental health service needs of the area or population it serves if:
    (i) There are more than 1,000 patient visits per year per FTE core 
mental health professional on staff of the facility, or
    (ii) There are more than 3,000 patient visits per year per FTE 
psychiatrist on staff of the facility, or
    (iii) No psychiatrists are on the staff and this facility is the 
only facility providing (or responsible for providing) mental health 
services to the designated area or population.
    3. Determination of Degree-of-Shortage.
    Each designated facility will be assigned to the same degree-of-
shortage group as the designated area or population group which it 
serves.

[45 FR 76000, Nov. 17, 1980, as amended at 54 FR 8738, Mar. 2, 1989; 57 
FR 2477, Jan. 22, 1992]



  Sec. Appendix D to Part 5--Criteria for Designation of Areas Having 

                Shortages of Vision Care Professional(s)

                        Part I--Geographic Areas

    A. Criteria.
    A geographic area will be designated as having a shortage of vision 
care professional(s) if the following three criteria are met:
    1. The area is a rational area for the delivery of vision care 
services.
    2. The estimated number of optometric visits supplied by vision care 
professional(s) in the area is less than the estimated requirements of 
the area's population for these visits, and the computed shortage is at 
least 1,500 optometric visits.
    3. Vision care professional(s) in contiguous areas are excessively 
distant, overutilized, or inaccessible to the population of the area 
under consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this part, the following methodology will be used:
    1. Rational Areas for the Delivery of Vision Care Services.
    (a) The following areas will be considered rational areas for the 
delivery of vision care services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 40 minutes travel time of each other;
    (ii) A portion of a county (or an area made up of portions of more 
than one county) whose population, because of topography, market or 
transportation patterns, or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 40 minutes to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 40 minutes travel time.
    2. Determination of Estimated Requirement for Optometric Visits.
    The number of optometric visits required by an area's population 
will be estimated by multiplying each of the following visit rates by 
the size of the population within that particular age group and then 
adding the figures obtained together.

[[Page 48]]



----------------------------------------------------------------------------------------------------------------
                                              Annual number of optometric visits required per person, by age
                                         -----------------------------------------------------------------------
                   Age                                                                                  60 and
                                           Under 20      20-29       30-39       40-49       50-59       over
----------------------------------------------------------------------------------------------------------------
Number of visits........................        0.11        0.20        0.24        0.35        0.41        0.48
----------------------------------------------------------------------------------------------------------------

    For geographic areas where the age distribution of the population is 
not known, it will be assumed that the percentage distribution, by age 
groups, for the area is the same as the distribution for the county of 
which it is a part.
    (3) Determination of Estimated Supply of Optometric Visits.
    The estimated supply of optometric services will be determined by 
use of the following formula:

    Optometric visits supplied = 3,000 x (number of optometrists under 
65)
    Optometric visits supplied + 2,000 x (number of optometrists 65 and 
over)
    Optometric visits supplied + 1,500 x (number of ophthamologists)

    (4) Determination of Size of Shortage.
    Size of shortage (in number of optometric visits) will be computed 
as follows:
    Optometric visit shortage = visits required - visits supplied
    (5) Contiguous Area Considerations.
    Vision care professional(s) in area contiguous to an area being 
considered for designation will be considered execessively distant, 
overutilized or inaccessible to the population of the area if one of the 
following conditions prevails in each contiguous area:
    (a) Vision care professional(s) in the contiguous area are more than 
40 minutes travel time from the center of the area being considered for 
designation (measured in accordance with paragraph B.1(b) of this part).
    (b) The estimated requirement for vision care services in the 
contiguous area exceeds the estimated supply of such services there, 
based on the requirements and supply calculations previously described.
    (c) Vision care professional(s) in the contiguous area are 
inaccessible to the population of the area because of specified access 
barriers (such as economic or cultural barriers).
    C. Determination of Degree-of-Shortage.
    Designated areas (and population groups) will be assigned to degree-
of-shortage groups, based on the ratio of optometric visits supplied to 
optometric visits required for the area (or group), as follows:

    Group 1--Areas (or groups) with no optometric visits being supplied 
(i.e., with no optometrists or ophthalmologists).
    Group 2--Areas (or groups) where the ratio of optometric visits 
supplied to optometric visits required is less than 0.5.
    Group 3--Areas (or groups) where the ratio of optometric visits 
supplied to optometric visits required is between 0.5 and 1.0.

                       Part II--Population Groups

    A. Criteria.
    Population groups within particular geographic areas will be 
designated if both the following criteria are met:
    (1) Members of the population group do not have access to vision 
care resources within the area (or in contiguous areas) because of non-
physical access barriers (such as economic or cultural barriers).
    (2) The estimated number of optometric visits supplied to the 
population group (as determined under paragraph B.3 of part I of this 
Appendix) is less than the estimated number of visits required by that 
group (as determined under paragraph B.2 of part I of this Appendix), 
and the computed shortage is at least 1,500 optometric visits.
    B. Determination of Degree of Shortage.
    The degree of shortage of a given population group will be 
determined in the same way as described for areas in paragraph C of part 
I of this appendix.



  Sec. Appendix E to Part 5--Criteria for Designation of Areas Having 

                 Shortages of Podiatric Professional(s)

                        Part I--Geographic Areas

    A. Criteria.
    A geographic area will be designated as having a shortage of 
podiatric professional(s) if the following three criteria are met:
    1. The area is a rational area for the delivery of podiatric 
services.
    2. The area's ratio of population to foot care practitioners is at 
least 28,000:1, and the computed podiatrist shortage to meet this ratio 
is at least 0.5.
    3. Podiatric professional(s) in contiguous areas are overutilized, 
excessively distant, or inaccessible to the population of the area under 
consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this Part, the following methodology will be used:
    1. Rational Areas for the Delivery of Podiatric Services.
    (a) The following areas will be considered rational areas for the 
delivery of podiatric services:

[[Page 49]]

    (i) A county or a group of contiguous counties whose population 
centers are within 40 minutes travel time of each other.
    (ii) A portion of a county, or an area made up of portions of more 
than one county, whose population, because of topography, market and/or 
transportation patterns or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 40 minutes from its population center to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the area 
corresponding to 40 minutes travel time.
    2. Population Count.
    The population count used will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, 
adjusted by the following formula to take into account the differing 
utilization rates of podiatric services by different age groups within 
the population:

Adjusted population=total population x (1 + 2.2 x (percent of population 
          65 and over) - 0.44 x (percent of population under 17)).

    3. Counting of Foot Care Practitioners.
    (a) All podiatrists providing patient care will be counted. However, 
in order to take into account productivity differences in podiatric 
practices associated with the age of the podiatrists, the following 
formula will be utilized:

Number of FTE podiatrists = 1.0 x (podiatrists under age 55)
+ .8 x (podiatrists age 55 and over)

    (b) In order to take into account the fact that orthopedic surgeons 
and general and family practitioners devote a percentage of their time 
to foot care, the total available foot care practitioners will be 
computed as follows:

Number of foot care practitioners = number of FTE podiatrists
+ .15 x (number of orthopedic surgeons)
+ .02 x (number of general and family practioners).

    4. Determination of Size of Shortage.
    Size of shortage (in number of FTE podiatrists) will be computed as 
follows:

Podiatrist shortage = adjusted population/28,000 - number of FTE foot 
          care practitioners.

    5. Contiguous Area Considerations.
    Podiatric professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant, 
overutilized or inaccessible to the population of the area under 
consideration if one of the following conditions prevails in each 
contiguous area:
    (a) Podiatric professional(s) in the contiguous area are more than 
40 minutes travel time from the center of the area being considered for 
designation.
    (b) The population-to-foot care practitioner ratio in the contiguous 
areas is in excess of 20,000 : 1, indicating that contiguous area 
podiatric professional(s) cannot be expected to help alleviate the 
shortage situation in the area for which designation is requested.
    (c) Podiatric professional(s) in the contiguous area are 
inaccessible to the population of the area under consideration because 
of specified access barriers (such as economic or cultural barriers).
    C. Determination of Degree of Shortage.
    Designated areas will be assigned to groups, based on the ratio (R) 
of adjusted population to number of foot care practitioners, as follows:

Group 1 Areas with no foot care practitioners, and areas with R 
           50,000 and no podiatrists.
Group 2 Other areas with R  50,000.
Group 3 Areas with 50,000  R  28,000.



  Sec. Appendix F to Part 5--Criteria for Designation of Areas Having 

                  Shortages of Pharmacy Professional(s)

                        Part I--Geographic Areas

    A. Criteria.
    A geographic area will be designated as having a shortage of 
pharmacy professional(s) if the following three criteria are met:
    1. The area is a rational area for the delivery of pharmacy 
services.
    2. The number of pharmacists serving the area is less than the 
estimated requirement for pharmacists in the area, and the computed 
pharmacist shortage is at least 0.5.
    3. Pharmacists in contiguous areas are overutilized or excessively 
distant from the population of the area under consideration.
    B. Methodology.
    In determining whether an area meets the criteria established by 
paragraph A of this Part, the following methodology will be used:
    1. Rational Areas for the Delivery of Pharmacy Services.

[[Page 50]]

    (a) The following areas will be considered rational areas for the 
delivery of pharmacy services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 30 minutes travel time of each other; and
    (ii) A portion of a county, or an area made up of portions of more 
than one county, whose population, because of topography, market or 
transportation patterns or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 30 minutes to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 30 minutes travel time:
    (i) Under normal conditions with primary roads available: 20 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 15 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
25 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the area 
corresponding to 30 minutes travel time.
    2. Counting of Pharmacists.
    All active pharmacists within the area will be counted, except those 
engaged in teaching, administration, or pharmaceutical research.
    3. Determination of Estimated Requirement for Pharmacists.
    (a) Basic estimate. The basic estimated requirement for pharmacists 
will be calculated as follows:

Basic pharmacist requirement = .15 x (resident civilian population/
          1,000) + .035 x (total number of physicians engaged in patient 
          care in the area).

    (b) Adjusted estimate. For areas with less than 20,000 persons, the 
following adjustment is made to the basic estimate to compensate for the 
lower expected productivity of small practices.

Estimated pharmacist requirement = (2 - population/20,000) x basic 
          pharmacist requirement.

    4. Size of Shortage Computation.
    The size of the shortage will be computed as follows:

Pharmacist shortage = estimated pharmacist requirement - number of 
          pharmacists available.

    5. Contiguous Area Considerations.
    Pharmacists in areas contiguous to an area being considered for 
designation will be considered excessively distant or overutilized if 
either:
    (a) Pharmacy professional(s) in contiguous areas are more than 30 
minutes travel time from the center of the area under consideration, or
    (b) The number of pharmacists in each contiguous area is less than 
or equal to the estimated requirement for pharmacists for that 
contiguous area (as computed above).
    C. Determination of Degree-of-Shortage.
    Designated areas will be assigned to degree-of-shortage groups, 
based on the proportion of the estimated requirement for pharmacists 
which is currently available in the area, as follows:

    Group 1--Areas with no pharmacists.
    Group 2--Areas where the ratio of available pharmacists to 
pharmacists required is less than 0.5.
    Group 3--Areas where the ratio of available pharmacists to 
pharmacists required is between 0.5 and 1.0.



  Sec. Appendix G to Part 5--Criteria for Designation of Areas Having 

                 Shortages of Veterinary Professional(s)

                        Part I--Geographic Areas

    A. Criteria for Food Animal Veterinary Shortage.
    A geographic area will be designated as having a shortage of food 
animal veterinary professional(s) if the following three criteria are 
met:
    1. The area is a rational area for the delivery of veterinary 
services.
    2. The ratio of veterinary livestock units to food animal 
veterinarians in the area is at least 10,000 : 1, and the computed food 
animal veterinarian shortage to meet this ratio is at least 0.5.
    3. Food animal veterinarians in contiguous areas are overutilized or 
excessively distant from the population of the area under consideration.
    B. Criteria for Companion Animal Veterinary Shortage.
    A geographic area will be designated as having a shortage of 
companion animal veterinary professional(s) if the following three 
criteria are met:
    1. The area is a rational area for the delivery of veterinary 
services.
    2. The ratio of resident civilian population to number of companion 
animal veterinarians in the area is at least 30,000 : 1 and the computed 
companion animal veterinary shortage to meet this ratio is at least 0.5.
    3. Companion animal veterinarians in contiguous areas are 
overutilized or excessively distant from the population of the area 
under consideration.
    C. Methodology.
    In determining whether an area meets the criteria established by 
paragraphs A and B of this part, the following methodology will be used:

[[Page 51]]

    1. Rational Areas for the Delivery of Veterinary Services.
    (a) The following areas will be considered rational areas for the 
delivery of veterinary services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 40 minutes travel time of each other.
    (ii) A portion of a county (or an area made up of portions of more 
than one county) which, because of topography, market and/or 
transportation patterns or other factors, has limited access to 
contiguous area resources, as measured generally by a travel time of 
greater than 40 minutes to these resources.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    2. Determination of Number of Veterinary Livestock Units (VLU) 
Requiring Care.
    Since various types of food animals require varying amounts of 
veterinary care, each type of animal has been assigned a weight 
indicating the amount of veterinary care it requires relative to that 
required by a milk cow. Those weights are used to compute the number of 
``Veterinary Livestock Units'' (VLU) for which veterinary care is 
required.
    The VLU is computed as follows:

Veterinary Livestock Units (VLU)=(number of milk cows)
+.2x(number of other cattle and calves)
+.05x(number of hogs and pigs)
+.05x(number of sheep)
+.002x(number of poultry).

    3. Counting of Food Animal Veterinarians.
    The number of food animal veterinarians is determined by weighting 
the number of veterinarians within each of several practice categories 
according to the average fraction of practice time in that category 
which is devoted to food animal veterinary care, as follows:

Number of Food Animal Veterinarians=(number of veterinarians in large 
          animal practice, exclusively)
+(number of veterinarians in bovine practice, exclusively)
+(number of veterinarians in poultry practice, exclusively)
+.75x(mixed practice veterinarians with greater than 50% of practice in 
          large animal care)
+.5x(mixed practice veterinarians with approximately 50% of practice in 
          large animal care)
+.25x(mixed practice veterinarians with less than 50% of practice in 
          large animal care).

    4. Counting of Companion Animal Veterinarians (that is, those who 
provide services for dogs, cats, horses, and any other animals 
maintained as companions to the owner rather than as food animals).
    The number of full-time equivalent companion animal veterinarians is 
determined by weighting the number of veterinarians within each of 
several practice categories by the average portion of their practice 
which is devoted to companion animal care by the practitioners within 
that category, as follows:

Number of Companion Animal Veterinarians=(number of veterinarians in 
          large animal practice, exclusively)
+(number of veterinarians in equine practice, exclusively)
+.75x(mixed practice veterinarians with greater than 50% of practice in 
          small animal care)
+.5x(mixed practice veterinarians with approximately 50% of practice in 
          small animal care)
+.25x(mixed practice veterinarians with less than 50% of practice in 
          small animal care).

    5. Size of Shortage Computation.
    The size of shortage will be computed as follows:
    (a) Food animal veterinarian shortage=(VLU/10,000)-(number of food 
animal veterinarians).
    (b) Companion animal veterinarian shortage=(resident civilian pop./
30,000)-(number of companion animal veterinarians).
    6. Contiguous Area Considerations.
    Veterinary professional(s) in areas contiguous to an area being 
considered for designation will be considered excessively distant from 
the population of the area or overutilized if one of the following 
conditions prevails in each contiguous area:
    (a) Veterinary professional(s) in the contiguous area are more than 
60 minutes travel time from the center of the area being considered for 
designation (measured in accordance with paragraph C.1.(b) of this 
part).
    (b) In the case of food animal veterinary professional(s), the VLU-
to-food animal veterinarian ratio in the contiguous area is in excess of 
5,000 : 1.
    (c) In the case of companion animal veterinary professional(s), the 
population-to-companion animal veterinarian ratio in the contiguous area 
is in excess of 15,000 : 1.
    C. Determination of Degree-of-Shortage.
    Designated areas will be assigned to degree-of-shortage groups as 
follows:

    Group 1--Areas with a food animal veterinarian shortage and no 
veterinarians.

[[Page 52]]

    Group 2--Areas (not included above) with a food animal veterinarian 
shortage and no food animal veterinarians.
    Group 3--All other food animal veterinarian shortage areas.
    Group 4--All companion animal shortage areas (not included above) 
having no veterinarians.
    Group 5--All other companion animal shortage areas.



PART 6_FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS--

Table of Contents




Sec.
6.1 Applicability.
6.2 Definitions.
6.3 Eligible entities.
6.4 Covered individuals.
6.5 Deeming process for eligible entities.
6.6 Covered acts and omissions.

    Authority: Sections 215 and 224 of the Public Health Service Act, 42 
U.S.C. 216 and 233.

    Source: 60 FR 22532, May 8, 1995, unless otherwise noted.



Sec. 6.1  Applicability.

    This part applies to entities and individuals whose acts and 
omissions related to the performance of medical, surgical, dental, or 
related functions are covered by the Federal Tort Claims Act (28 U.S.C. 
1346(b) and 2671-2680) in accordance with the provisions of section 
224(g) of the Public Health Service Act (42 U.S.C. 233(g)).



Sec. 6.2  Definitions.

    Act means the Public Health Service Act, as amended.
    Attorney General means the Attorney General of the United States and 
any other officer or employee of the Department of Justice to whom the 
authority involved has been delegated.
    Covered entity means an entity described in Sec. 6.3 which has been 
deemed by the Secretary, in accordance with Sec. 6.5, to be covered by 
this part.
    Covered individual means an individual described in Sec. 6.4.
    Effective date as used in Sec. 6.5 and Sec. 6.6 refers to the date 
of the Secretary's determination that an entity is a covered entity.
    Secretary means the Secretary of Health and Human Services (HHS) and 
any other officer or employee of the Department of HHS to whom the 
authority involved has been delegated.
    Subrecipient means an entity which receives a grant or a contract 
from a covered entity to provide a full range of health services on 
behalf of the covered entity.



Sec. 6.3  Eligible entities.

    (a) Grantees. Entities eligible for coverage under this part are 
public and nonprofit private entities receiving Federal funds under any 
of the following grant programs:
    (1) Section 329 of the Act (relating to grants for migrant health 
centers);
    (2) Section 330 of the Act (relating to grants for community health 
centers);
    (3) Section 340 of the Act (relating to grants for health services 
for the homeless); and
    (4) Section 340A of the Act (relating to grants for health services 
for residents of public housing).
    (b) Subrecipients. Entities that are subrecipients of grant funds 
described in paragraph (a) of this section are eligible for coverage 
only if they provide a full range of health care services on behalf of 
an eligible grantee and only for those services carried out under the 
grant funded project.



Sec. 6.4  Covered individuals.

    (a) Officers and employees of a covered entity are eligible for 
coverage under this part.
    (b) Contractors of a covered entity who are physicians or other 
licensed or certified health care practitioners are eligible for 
coverage under this part if they meet the requirements of section 
224(g)(5) of the Act.
    (c) An individual physician or other licensed or certified health 
care practitioner who is an officer, employee, or contractor of a 
covered entity will not be covered for acts or omissions occurring after 
receipt by the entity employing such individual of notice of a final 
determination by the Attorney General that he or she is no longer 
covered by this part, in accordance with section 224(i) of the Act.



Sec. 6.5  Deeming process for eligible entities.

    Eligible entities will be covered by this part only on and after the 
effective

[[Page 53]]

date of a determination by the Secretary that they meet the requirements 
of section 224(h) of the Act. In making such determination, the 
Secretary will receive such assurances and conduct such investigations 
as he or she deems necessary.



Sec. 6.6  Covered acts and omissions.

    (a) Only acts and omissions occurring on and after the effective 
date of the Secretary's determination under Sec. 6.5 and before the 
later date specified in section 224(g)(3) of the Act are covered by this 
part.
    (b) Only claims for damage for personal injury, including death, 
resulting from the performance of medical, surgical, dental, or related 
functions are covered by this part.
    (c) With respect to covered individuals, only acts and omissions 
within the scope of their employment (or contract for services) are 
covered. If a covered individual is providing services which are not on 
behalf of the covered entity, such as on a volunteer basis or on behalf 
of a third-party (except as described in paragraph (d) of this section), 
whether for pay or otherwise, acts and omissions which are related to 
such services are not covered.
    (d) Only acts and omissions related to the grant-supported activity 
of entities are covered. Acts and omissions related to services provided 
to individuals who are not patients of a covered entity will be covered 
only if the Secretary determines that:
    (1) The provision of the services to such individuals benefits 
patients of the entity and general populations that could be served by 
the entity through community-wide intervention efforts within the 
communities served by such entity;
    (2) The provision of the services to such individuals facilitates 
the provision of services to patients of the entity; or
    (3) Such services are otherwise required to be provided to such 
individuals under an employment contract or similar arrangement between 
the entity and the covered individual.
    (e) Examples. The following are examples of situations within the 
scope of paragraph (d) of this section:
    (1) A community health center deemed to be a covered entity 
establishes a school-based or school-linked health program as part of 
its grant supported activity. Even though the students treated are not 
necessarily registered patients of the center, the center and its health 
care practitioners will be covered for services provided, if the 
Secretary makes the determination in paragraph (d)(1) of this section.
    (2) A migrant health center requires its physicians to obtain staff 
privileges at a community hospital. As a condition of obtaining such 
privileges, and thus being able to admit the center's patients to the 
hospital, the physicians must agree to provide occasional coverage of 
the hospital's emergency room. The Secretary would be authorized to 
determine that this coverage is necessary to facilitate the provision of 
services to the grantee's patients, and that it would therefore be 
covered by paragraph (d)(2) of this section.
    (3) A homeless health services grantee makes arrangements with local 
community providers for after-hours coverage of its patients. The 
grantee's physicians are required by their employment contracts to 
provide periodic cross-coverage for patients of these providers, in 
order to make this arrangement feasible. The Secretary may determine 
that the arrangement is within the scope of paragraph (d)(3) of this 
section.

[60 FR 22532, May. 8, 1995; 60 FR 36073, July 13, 1995]



PART 7_DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL 

PREPARATIONS--Table of Contents




Sec.
7.1 Applicability.
7.2 Establishment of a user charge.
7.3 Definitions.
7.4 Schedule of charges.
7.5 Payment procedures.
7.6 Exemptions.

    Authority: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); title 
V of the Independent Offices Appropriation Act of 1952 (31 U.S.C. 9701); 
and sec. 352 of the Public Health Service Act, as amended (42 U.S.C. 
263).

    Source: 52 FR 11073, Apr. 7, 1987, unless otherwise noted.

[[Page 54]]



Sec. 7.1  Applicability.

    The provisions of this part are applicable to private entities 
requesting from the Centers for Disease Control (CDC) reference 
biological standards and biological preparations for use in their 
laboratories.



Sec. 7.2  Establishment of a user charge.

    Except as otherwise provided in Sec. 7.6, a user charge shall be 
imposed to cover the cost to CDC of producing and distributing reference 
biological standards and biological preparations.



Sec. 7.3  Definitions.

    Biological standards means a uniform and stable reference biological 
substance which allows measurements of relative potency to be made and 
described in a common currency of international and national units of 
activity.
    Biological preparations means a reference biological substance which 
may be used for a purpose similar to that of a standard, but which has 
been established without a full collaborative study, or where a 
collaborative study has shown that it is not appropriate to establish 
the preparation as an international standard.



Sec. 7.4  Schedule of charges.

    The charges imposed in Sec. 7.2 are based on the amount published 
in CDC's price list of available products. These charges will reflect 
direct costs (such as salaries and equipment), indirect costs (such as 
rent, telephone service, and a proportionate share of management and 
administrative costs), and the costs of particular ingredients. Charges 
may vary over time and between different biological standards or 
biological preparations, depending upon the cost of ingredients and the 
complexity of production. An up-to-date schedule of charges is available 
from the Biological Products Branch, Center for Infectious Diseases, 
Centers for Disease Control, 1600 Clifton Road, Atlanta, Georgia 30333.



Sec. 7.5  Payment procedures.

    The requester may obtain information on terms of payment and a fee 
schedule by writing the ``Centers for Disease Control,'' Financial 
Management Office, Buckhead Facility, Room 200, Centers for Disease 
Control, 1600 Clifton Road, Atlanta, Georgia 30333.



Sec. 7.6  Exemptions.

    State and local health departments, governmental institutions (e.g., 
State hospitals and universities), the World Health Organization, and 
ministries of health of foreign governments may be exempted from paying 
user charges, when using biological standards or biological preparations 
for public health purposes.



PART 8_CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents




                         Subpart A_Accreditation

Sec.
8.1 Scope.
8.2 Definitions.
8.3 Application for approval as an accreditation body.
8.4 Accreditation body responsibilities.
8.5 Periodic evaluation of accreditation bodies.
8.6 Withdrawal of approval of accreditation bodies.

             Subpart B_Certification and Treatment Standards

8.11 Opioid treatment program certification.
8.12 Federal opioid treatment standards.
8.13 Revocation of accreditation and accreditation body approval.
8.14 Suspension or revocation of certification.
8.15 Forms.

Subpart C_Procedures for Review of Suspension or Proposed Revocation of 
    OTP Certification, and of Adverse Action Regarding Withdrawal of 
                    Approval of an Accreditation Body

8.21 Applicability.
8.22 Definitions.
8.23 Limitation on issues subject to review.
8.24 Specifying who represents the parties.
8.25 Informal review and the reviewing official's response.
8.26 Preparation of the review file and written arguments.
8.27 Opportunity for oral presentation.
8.28 Expedited procedures for review of immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written communications by reviewing official and 
          calculation of deadlines.

[[Page 55]]

8.31 Authority and responsibilities of the reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative action; exhaustion of 
          administrative remedies.

    Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-
23, 300x-27(a), 300y-11.

    Source: 66 FR 4090, Jan. 17, 2001, unless otherwise note.



                         Subpart A_Accreditation



Sec. 8.1  Scope.

    The regulations in this part establish the procedures by which the 
Secretary of Health and Human Services (the Secretary) will determine 
whether a practitioner is qualified under section 303(g) of the 
Controlled Substances Act (21 U.S.C. 823(g)) to dispense opioid drugs in 
the treatment of opioid addiction. These regulations also establish the 
Secretary's standards regarding the appropriate quantities of opioid 
drugs that may be provided for unsupervised use by individuals 
undergoing such treatment (21 U.S.C. 823(g)(1)). Under these 
regulations, a practitioner who intends to dispense opioid drugs in the 
treatment of opioid addiction must first obtain from the Secretary or by 
delegation, from the Administrator, Substance Abuse and Mental Health 
Services Administration (SAMHSA), a certification that the practitioner 
is qualified under the Secretary's standards and will comply with such 
standards. Eligibility for certification will depend upon the 
practitioner obtaining accreditation from an accreditation body that has 
been approved by SAMHSA. These regulations establish the procedures 
whereby an entity can apply to become an approved accreditation body. 
This part also establishes requirements and general standards for 
accreditation bodies to ensure that practitioners are consistently 
evaluated for compliance with the Secretary's standards for opiate 
addiction treatment with an opioid agonist treatment medication.



Sec. 8.2  Definitions.

    The following definitions apply to this part:
    Accreditation means the process of review and acceptance by an 
accreditation body.
    Accreditation body means a body that has been approved by SAMHSA 
under Sec. 8.3 to accredit opioid treatment programs using opioid 
agonist treatment medications.
    Accreditation body application means the application filed with 
SAMHSA for purposes of obtaining approval as an accreditation body, as 
described in Sec. 8.3(b).
    Accreditation elements mean the elements or standards that are 
developed and adopted by an accreditation body and approved by SAMHSA.
    Accreditation survey means an onsite review and evaluation of an 
opioid treatment program by an accreditation body for the purpose of 
determining compliance with the Federal opioid treatment standards 
described in Sec. 8.12.
    Accredited opioid treatment program means an opioid treatment 
program that is the subject of a current, valid accreditation from an 
accreditation body approved by SAMHSA under Sec. 8.3(d).
    Certification means the process by which SAMHSA determines that an 
opioid treatment program is qualified to provide opioid treatment under 
the Federal opioid treatment standards.
    Certification application means the application filed by an opioid 
treatment program for purposes of obtaining certification from SAMHSA, 
as described in Sec. 8.11(b).
    Certified opioid treatment program means an opioid treatment program 
that is the subject of a current, valid certification under Sec. 8.11.
    Comprehensive maintenance treatment is maintenance treatment 
provided in conjunction with a comprehensive range of appropriate 
medical and rehabilitative services.
    Detoxification treatment means the dispensing of an opioid agonist 
treatment medication in decreasing doses to an individual to alleviate 
adverse physical or psychological effects incident to withdrawal from 
the continuous or sustained use of an opioid drug and as a method of 
bringing the individual to a drug-free state within such period.
    Federal opioid treatment standards means the standards established 
by the

[[Page 56]]

Secretary in Sec. 8.12 that are used to determine whether an opioid 
treatment program is qualified to engage in opioid treatment. The 
Federal opioid treatment standards established in Sec. 8.12 also 
include the standards established by the Secretary regarding the 
quantities of opioid drugs which may be provided for unsupervised use.
    For-cause inspection means an inspection of an opioid treatment 
program by the Secretary, or by an accreditation body, that may be 
operating in violation of Federal opioid treatment standards, may be 
providing substandard treatment, or may be serving as a possible source 
of diverted medications.
    Interim maintenance treatment means maintenance treatment provided 
in conjunction with appropriate medical services while a patient is 
awaiting transfer to a program that provides comprehensive maintenance 
treatment.
    Long-term detoxification treatment means detoxification treatment 
for a period more than 30 days but not in excess of 180 days.
    Maintenance treatment means the dispensing of an opioid agonist 
treatment medication at stable dosage levels for a period in excess of 
21 days in the treatment of an individual for opioid addiction.
    Medical director means a physician, licensed to practice medicine in 
the jurisdiction in which the opioid treatment program is located, who 
assumes responsibility for administering all medical services performed 
by the program, either by performing them directly or by delegating 
specific responsibility to authorized program physicians and healthcare 
professionals functioning under the medical director's direct 
supervision.
    Medical and rehabilitative services means services such as medical 
evaluations, counseling, and rehabilitative and other social programs 
(e.g., vocational and educational guidance, employment placement), that 
are intended to help patients in opioid treatment programs become and/or 
remain productive members of society.
    Medication unit means a facility established as part of, but 
geographically separate from, an opioid treatment program from which 
licensed private practitioners or community pharmacists dispense or 
administer an opioid agonist treatment medication or collect samples for 
drug testing or analysis.
    Opiate addiction is defined as a cluster of cognitive, behavioral, 
and physiological symptoms in which the individual continues use of 
opiates despite significant opiate-induced problems. Opiate dependence 
is characterized by repeated self-administration that usually results in 
opiate tolerance, withdrawal symptoms, and compulsive drug-taking. 
Dependence may occur with or without the physiological symptoms of 
tolerance and withdrawal.
    Opioid agonist treatment medication means any opioid agonist drug 
that is approved by the Food and Drug Administration under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
the treatment of opiate addiction.
    Opioid drug means any drug having an addiction-forming or addiction-
sustaining liability similar to morphine or being capable of conversion 
into a drug having such addiction-forming or addiction-sustaining 
liability.
    Opioid treatment means the dispensing of an opioid agonist treatment 
medication, along with a comprehensive range of medical and 
rehabilitative services, when clinically necessary, to an individual to 
alleviate the adverse medical, psychological, or physical effects 
incident to opiate addiction. This term encompasses detoxification 
treatment, short-term detoxification treatment, long-term detoxification 
treatment, maintenance treatment, comprehensive maintenance treatment, 
and interim maintenance treatment.
    Opioid treatment program or ``OTP'' means a program or practitioner 
engaged in opioid treatment of individuals with an opioid agonist 
treatment medication.
    Patient means any individual who undergoes treatment in an opioid 
treatment program.
    Program sponsor means the person named in the application for 
certification described in Sec. 8.11(b) as responsible for the 
operation of the opioid treatment program and who assumes responsibility 
for all its employees, including any practitioners, agents, or

[[Page 57]]

other persons providing medical, rehabilitative, or counseling services 
at the program or any of its medication units. The program sponsor need 
not be a licensed physician but shall employ a licensed physician for 
the position of medical director.
    Registered opioid treatment program means an opioid treatment 
program that is registered under 21 U.S.C. 823(g).
    Short-term detoxification treatment means detoxification treatment 
for a period not in excess of 30 days.
    State Authority is the agency designated by the Governor or other 
appropriate official designated by the Governor to exercise the 
responsibility and authority within the State or Territory for governing 
the treatment of opiate addiction with an opioid drug.
    Treatment plan means a plan that outlines for each patient 
attainable short-term treatment goals that are mutually acceptable to 
the patient and the opioid treatment program and which specifies the 
services to be provided and the frequency and schedule for their 
provision.



Sec. 8.3  Application for approval as an accreditation body.

    (a) Eligibility. Private nonprofit organizations or State 
governmental entities, or political subdivisions thereof, capable of 
meeting the requirements of this part may apply for approval as an 
accreditation body.
    (b) Application for initial approval. Three copies of an 
accreditation body application form [SMA-163] shall be submitted to 
SAMHSA at rm. 12-105, 5600 Fishers Lane, Rockville, MD 20857, and marked 
ATTENTION: OTP Certification Program. SAMHSA will consider and accept 
the electronic submission of these materials when electronic submission 
systems are developed and available. Accreditation body applications 
shall include the following information and supporting documentation:
    (1) Name, address, and telephone number of the applicant and a 
responsible official for the accreditation body. The application shall 
be signed by the responsible official;
    (2) Evidence of the nonprofit status of the applicant (i.e., of 
fulfilling Internal Revenue Service requirements as a nonprofit 
organization) if the applicant is not a State governmental entity or 
political subdivision;
    (3) A set of the accreditation elements or standards and a detailed 
discussion showing how the proposed accreditation elements or standards 
will ensure that each OTP surveyed by the applicant is qualified to meet 
or is meeting each of the Federal opioid treatment standards set forth 
in Sec. 8.12;
    (4) A detailed description of the applicant's decisionmaking 
process, including:
    (i) Procedures for initiating and performing onsite accreditation 
surveys of OTPs;
    (ii) Procedures for assessing OTP personnel qualifications;
    (iii) Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTPs during 
the accreditation process, including a request for a complete history of 
prior accreditation activities and a statement that all information and 
data submitted in the application for accreditation is true and 
accurate, and that no material fact has been omitted;
    (iv) Policies and procedures for notifying OTPs and SAMHSA of 
deficiencies and for monitoring corrections of deficiencies by OTPs;
    (v) Policies and procedures for suspending or revoking an OTP's 
accreditation;
    (vi) Policies and procedures that will ensure processing of 
applications for accreditation and applications for renewal of 
accreditation within a timeframe approved by SAMHSA; and
    (vii) A description of the applicant's appeals process to allow OTPs 
to contest adverse accreditation decisions.
    (5) Policies and procedures established by the accreditation body to 
avoid conflicts of interest, or the appearance of conflicts of interest, 
by the applicant's board members, commissioners, professional personnel, 
consultants, administrative personnel, and other representatives;
    (6) A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership,

[[Page 58]]

and the identification of at least one licensed physician on the 
applicant's staff;
    (7) A description of the applicant's training policies;
    (8) Fee schedules, with supporting cost data;
    (9) Satisfactory assurances that the body will comply with the 
requirements of Sec. 8.4, including a contingency plan for 
investigating complaints under Sec. 8.4(e);
    (10) Policies and procedures established to protect confidential 
information the applicant will collect or receive in its role as an 
accreditation body; and
    (11) Any other information SAMHSA may require.
    (c) Application for renewal of approval. An accreditation body that 
intends to continue to serve as an accreditation body beyond its current 
term shall apply to SAMHSA for renewal, or notify SAMHSA of its 
intention not to apply for renewal, in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of an 
accreditation body's term of approval, the body shall inform SAMHSA in 
writing of its intent to seek renewal.
    (2) SAMHSA will notify the applicant of the relevant information, 
materials, and supporting documentation required under paragraph (b) of 
this section that the applicant shall submit as part of the renewal 
procedure.
    (3) At least 3 months before the date of expiration of the 
accreditation body's term of approval, the applicant shall furnish to 
SAMHSA three copies of a renewal application containing the information, 
materials, and supporting documentation requested by SAMHSA under 
paragraph (c)(2) of this section.
    (4) An accreditation body that does not intend to renew its approval 
shall so notify SAMHSA at least 9 months before the expiration of the 
body's term of approval.
    (d) Rulings on applications for initial approval or renewal of 
approval. (1) SAMHSA will grant an application for initial approval or 
an application for renewal of approval if it determines the applicant 
substantially meets the accreditation body requirements of this subpart.
    (2) If SAMHSA determines that the applicant does not substantially 
meet the requirements set forth in this subpart. SAMHSA will notify the 
applicant of the deficiencies in the application and request that the 
applicant resolve such deficiencies within 90 days of receipt of the 
notice. If the deficiencies are resolved to the satisfaction of SAMHSA 
within the 90-day time period, the body will be approved as an 
accreditation body. If the deficiencies have not been resolved to the 
satisfaction of SAMHSA within the 90-day time period, the application 
for approval as an accreditation body will be denied.
    (3) If SAMHSA does not reach a final decision on a renewal 
application before the expiration of an accreditation body's term of 
approval, the approval will be deemed extended until SAMHSA reaches a 
final decision, unless an accreditation body does not rectify 
deficiencies in the application within the specified time period, as 
required in paragraph (d)(2) of this section.
    (e) Relinquishment of approval. An accreditation body that intends 
to relinquish its accreditation approval before expiration of the body's 
term of approval shall submit a letter of such intent to SAMHSA, at the 
address in paragraph (b) of this section, at least 9 months before 
relinquishing such approval.
    (f) Notification. An accreditation body that does not apply for 
renewal of approval, or is denied such approval by SAMHSA, relinquishes 
its accreditation approval before expiration of its term of approval, or 
has its approval withdrawn, shall:
    (1) Transfer copies of records and other related information as 
required by SAMHSA to a location, including another accreditation body, 
and according to a schedule approved by SAMHSA; and
    (2) Notify, in a manner and time period approved by SAMHSA, all OTPs 
accredited or seeking accreditation by the body that the body will no 
longer have approval to provide accreditation services.
    (g) Term of approval. An accreditation body's term of approval is 
for a period not to exceed 5 years.

[[Page 59]]

    (h) State accreditation bodies. State governmental entities, 
including political subdivisions thereof, may establish organizational 
units that may act as accreditation bodies, provided such units meet the 
requirements of this section, are approved by SAMHSA under this section, 
and have taken appropriate measures to prevent actual or apparent 
conflicts of interest, including cases in which State or Federal funds 
are used to support opioid treatment services.



Sec. 8.4  Accreditation body responsibilities.

    (a) Accreditation surveys and for cause inspections. (1) 
Accreditation bodies shall conduct routine accreditation surveys for 
initial, renewal, and continued accreditation of each OTP at least every 
3 years.
    (2) Accreditation bodies must agree to conduct for-cause inspections 
upon the request of SAMHSA.
    (3) Accreditation decisions shall be fully consistent with the 
policies and procedures submitted as part of the approved accreditation 
body application.
    (b) Response to noncompliant programs. (1) If an accreditation body 
receives or discovers information that suggests that an OTP is not 
meeting Federal opioid treatment standards, or if survey of the OTP by 
the accreditation body otherwise demonstrates one or more deficiencies 
in the OTP, the accreditation body shall as appropriate either require 
and monitor corrective action or shall suspend or revoke accreditation 
of the OTP, as appropriate based on the significance of the 
deficiencies.
    (i) Accreditation bodies shall either not accredit or shall revoke 
the accreditation of any OTP that substantially fails to meet the 
Federal opioid treatment standards.
    (ii) Accreditation bodies shall notify SAMHSA as soon as possible 
but in no case longer than 48 hours after becoming aware of any practice 
or condition in an OTP that may pose a serious risk to public health or 
safety or patient care.
    (iii) If an accreditation body determines that an OTP is 
substantially meeting the Federal opioid treatment standards, but is not 
meeting one or more accreditation elements, the accreditation body shall 
determine the necessary corrective measures to be taken by the OTP, 
establish a schedule for implementation of such measures, and notify the 
OTP in writing that it must implement such measures within the specified 
schedule in order to ensure continued accreditation. The accreditation 
body shall verify that the necessary steps are taken by the OTP within 
the schedule specified and that all accreditation elements are being 
substantially met or will be substantially met.
    (2) Nothing in this part shall prevent accreditation bodies from 
granting accreditation, contingent on promised programmatic or 
performance changes, to OTPs with less substantial violations. Such 
accreditation shall not exceed 12 months. OTPs that have been granted 
such accreditation must have their accreditation revoked if they fail to 
make changes to receive unconditional accreditation upon resurvey or 
reinspection.
    (c) Recordkeeping. (1) Accreditation bodies shall maintain records 
of their accreditation activities for at least 5 years from the creation 
of the record. Such records must contain sufficient detail to support 
each accreditation decision made by the accreditation body.
    (2) Accreditation bodies shall establish procedures to protect 
confidential information collected or received in their role as 
accreditation bodies that are consistent with, and that are designed to 
ensure compliance with, all Federal and State laws, including 42 CFR 
part 2.
    (i) Information collected or received for the purpose of carrying 
out accreditation body responsibilities shall not be used for any other 
purpose or disclosed, other than to SAMHSA or its duly designated 
representatives, unless otherwise required by law or with the consent of 
the OTP.
    (ii) Nonpublic information that SAMHSA shares with the accreditation 
body concerning an OTP shall not be further disclosed except with the 
written permission of SAMHSA.
    (d) Reporting. (1) Accreditation bodies shall provide to SAMHSA any 
documents and information requested by

[[Page 60]]

SAMHSA within 5 days of receipt of the request.
    (2) Accreditation bodies shall make a summary of the results of each 
accreditation survey available to SAMHSA upon request. Such summaries 
shall contain sufficient detail to justify the accreditation action 
taken.
    (3) Accreditation bodies shall provide SAMHSA upon request a list of 
each OTP surveyed and the identity of all individuals involved in the 
conduct and reporting of survey results.
    (4) Accreditation bodies shall submit to SAMHSA the name of each OTP 
for which the accreditation body accredits conditionally, denies, 
suspends, or revokes accreditation, and the basis for the action, within 
48 hours of the action.
    (5) Notwithstanding any reports made to SAMHSA under paragraphs 
(d)(1) through (d)(4) of this section, each accreditation body shall 
submit to SAMHSA semiannually, on January 15 and July 15 of each 
calendar year, a report consisting of a summary of the results of each 
accreditation survey conducted in the past year. The summary shall 
contain sufficient detail to justify each accreditation action taken.
    (6) All reporting requirements listed in this section shall be 
provided to SAMHSA at the address specified in Sec. 8.3(b).
    (e) Complaint response. Accreditation bodies shall have policies and 
procedures to respond to complaints from SAMHSA, patients, facility 
staff, and others, within a reasonable period of time but not more than 
5 days of the receipt of the complaint. Accreditation bodies shall also 
agree to notify SAMHSA within 48 hours of receipt of a complaint and 
keep SAMHSA informed of all aspects of the response to the complaint.
    (f) Modifications of accreditation elements. Accreditation bodies 
shall obtain SAMHSA's authorization prior to making any substantive 
(i.e., noneditorial) change in accreditation elements.
    (g) Conflicts of interest. The accreditation body shall maintain and 
apply policies and procedures that SAMHSA has approved in accordance 
with Sec. 8.3 to reduce the possibility of actual conflict of interest, 
or the appearance of a conflict of interest, on the part of individuals 
who act on behalf of the accreditation body. Individuals who participate 
in accreditation surveys or otherwise participate in the accreditation 
decision or an appeal of the accreditation decision, as well as their 
spouses and minor children, shall not have a financial interest in the 
OTP that is the subject of the accreditation survey or decision.
    (h) Accreditation teams. (1) An accreditation body survey team shall 
consist of healthcare professionals with expertise in drug abuse 
treatment and, in particular, opioid treatment. The accreditation body 
shall consider factors such as the size of the OTP, the anticipated 
number of problems, and the OTP's accreditation history, in determining 
the composition of the team. At a minimum, survey teams shall consist of 
at least two healthcare professionals whose combined expertise includes:
    (i) The dispensing and administration of drugs subject to control 
under the Controlled Substances Act (21 U.S.C. 801 et seq.);
    (ii) Medical issues relating to the dosing and administration of 
opioid agonist treatment medications for the treatment of opioid 
addiction;
    (iii) Psychosocial counseling of individuals undergoing opioid 
treatment; and
    (iv) Organizational and administrative issues associated with opioid 
treatment programs.
    (2) Members of the accreditation team must be able to recuse 
themselves at any time from any survey in which either they or the OTP 
believes there is an actual conflict of interest or the appearance of a 
conflict of interest.
    (i) Accreditation fees. Fees charged to OTPs for accreditation shall 
be reasonable. SAMHSA generally will find fees to be reasonable if the 
fees are limited to recovering costs to the accreditation body, 
including overhead incurred. Accreditation body activities that are not 
related to accreditation functions are not recoverable through fees 
established for accreditation.

[[Page 61]]

    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different OTPs.
    (2) At SAMHSA's request, accreditation bodies shall provide to 
SAMHSA financial records or other materials, in a manner specified by 
SAMHSA, to assist in assessing the reasonableness of accreditation body 
fees.



Sec. 8.5  Periodic evaluation of accreditation bodies.

    SAMHSA will evaluate periodically the performance of accreditation 
bodies primarily by inspecting a selected sample of the OTPs accredited 
by the accrediting body and by evaluating the accreditation body's 
reports of surveys conducted, to determine whether the OTPs surveyed and 
accredited by the accreditation body are in compliance with the Federal 
opioid treatment standards. The evaluation will include a determination 
of whether there are major deficiencies in the accreditation body's 
performance that, if not corrected, would warrant withdrawal of the 
approval of the accreditation body under Sec. 8.6.



Sec. 8.6  Withdrawal of approval of accreditation bodies.

    If SAMHSA determines that an accreditation body is not in 
substantial compliance with this subpart, SAMHSA shall take appropriate 
action as follows:
    (a) Major deficiencies. If SAMHSA determines that the accreditation 
body has a major deficiency, such as commission of fraud, material false 
statement, failure to perform a major accreditation function 
satisfactorily, or significant noncompliance with the requirements of 
this subpart, SAMHSA shall withdraw approval of that accreditation body.
    (1) In the event of a major deficiency, SAMHSA shall notify the 
accreditation body of the agency's action and the grounds on which the 
approval was withdrawn.
    (2) An accreditation body that has lost its approval shall notify 
each OTP that has been accredited or is seeking accreditation that the 
accreditation body's approval has been withdrawn. Such notification 
shall be made within a time period and in a manner approved by SAMHSA.
    (b) Minor deficiencies. If SAMHSA determines that the accreditation 
body has minor deficiencies in the performance of an accreditation 
function, that are less serious or more limited than the types of 
deficiencies described in paragraph (a) of this section, SAMHSA will 
notify the body that it has 90 days to submit to SAMHSA a plan of 
corrective action. The plan must include a summary of corrective actions 
and a schedule for their implementation. SAMHSA may place the body on 
probationary status for a period of time determined by SAMHSA, or may 
withdraw approval of the body if corrective action is not taken.
    (1) If SAMHSA places an accreditation body on probationary status, 
the body shall notify all OTPs that have been accredited, or that are 
seeking accreditation, of the accreditation body's probationary status 
within a time period and in a manner approved by SAMHSA.
    (2) Probationary status will remain in effect until such time as the 
body can demonstrate to the satisfaction of SAMHSA that it has 
successfully implemented or is implementing the corrective action plan 
within the established schedule, and the corrective actions taken have 
substantially eliminated all identified problems.
    (3) If SAMHSA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, SAMHSA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all OTPs that have been accredited, or are seeking accreditation, of the 
accreditation body's loss of SAMHSA approval within a time period and in 
a manner approved by SAMHSA.
    (c) Reapplication. (1) An accreditation body that has had its 
approval withdrawn may submit a new application for approval if the body 
can provide information to SAMHSA to establish that the problems that 
were grounds for withdrawal of approval have been resolved.
    (2) If SAMHSA determines that the new application demonstrates that 
the

[[Page 62]]

body satisfactorily has addressed the causes of its previous 
unacceptable performance, SAMHSA may reinstate approval of the 
accreditation body.
    (3) SAMHSA may request additional information or establish 
additional conditions that must be met before SAMHSA approves the 
reapplication.
    (4) SAMHSA may refuse to accept an application from a former 
accreditation body whose approval was withdrawn because of fraud, 
material false statement, or willful disregard of public health.
    (d) Hearings. An opportunity to challenge an adverse action taken 
regarding withdrawal of approval of an accreditation body shall be 
addressed through the relevant procedures set forth in subpart C of this 
part, except that the procedures in Sec. 8.28 for expedited review of 
an immediate suspension would not apply to an accreditation body that 
has been notified under paragraph (a) or (b) of this section of the 
withdrawal of its approval.



             Subpart B_Certification and Treatment Standards



Sec. 8.11  Opioid treatment program certification.

    (a) General. (1) An OTP must be the subject of a current, valid 
certification from SAMHSA to be considered qualified by the Secretary 
under section 303(g)(1) of the Controlled Substances Act (21 U.S.C. 
823(g)(1)) to dispense opioid drugs in the treatment of opioid 
addiction. An OTP must be determined to be qualified under section 
303(g)(1) of the Controlled Substances Act, and must be determined to be 
qualified by the Attorney General under section 303(g)(1), to be 
registered by the Attorney General to dispense opioid agonist treatment 
medications to individuals for treatment of opioid addiction.
    (2) To obtain certification from SAMHSA, an OTP must meet the 
Federal opioid treatment standards in Sec. 8.12, must be the subject of 
a current, valid accreditation by an accreditation body or other entity 
designated by SAMHSA, and must comply with any other conditions for 
certification established by SAMHSA.
    (3) Certification shall be granted for a term not to exceed 3 years, 
except that certification may be extended during the third year if an 
application for accreditation is pending.
    (b) Application for certification. Three copies of an application 
for certification must be submitted by the OTP to the address identified 
in Sec. 8.3(b). SAMHSA will consider and accept the electronic 
submission of these materials when electronic submission systems are 
developed and available. The application for certification shall 
include:
    (1) A description of the current accreditation status of the OTP;
    (2) A description of the organizational structure of the OTP;
    (3) The names of the persons responsible for the OTP;
    (4) The addresses of the OTP and of each medication unit or other 
facility under the control of the OTP;
    (5) The sources of funding for the OTP and the name and address of 
each governmental entity that provides such funding; and
    (6) A statement that the OTP will comply with the conditions of 
certification set forth in paragraph (f) of this section.
    (7) The application shall be signed by the program sponsor who shall 
certify that the information submitted in the application is truthful 
and accurate.
    (c) Action on application. (1) Following SAMHSA's receipt of an 
application for certification of an OTP, and after consultation with the 
appropriate State authority regarding the qualifications of the 
applicant, SAMHSA may grant the application for certification, or renew 
an existing certification, if SAMHSA determines that the OTP has 
satisfied the requirements for certification or renewal of 
certification.
    (2) SAMHSA may deny the application if SAMHSA determines that:
    (i) The application for certification is deficient in any respect;
    (ii) The OTP will not be operated in accordance with the Federal 
opioid treatment standards established under Sec. 8.12;
    (iii) The OTP will not permit an inspection or a survey to proceed, 
or will not permit in a timely manner access to relevant records or 
information; or

[[Page 63]]

    (iv) The OTP has made misrepresentations in obtaining accreditation 
or in applying for certification.
    (3) Within 5 days after it reaches a final determination that an OTP 
meets the requirements for certification, SAMHSA will notify the Drug 
Enforcement Administration (DEA) that the OTP has been determined to be 
qualified to provide opioid treatment under section 303(g)(1) of the 
Controlled Substances Act.
    (d) Transitional certification. OTPs that before May 18, 2001 were 
the subject of a current, valid approval by FDA under 21 CFR, part 291 
(contained in the 21 CFR parts 200 to 299 edition, revised as of July 1, 
2000), are deemed to be the subject of a current valid certification for 
purposes of paragraph (a)(11) of this section. Such ``transitional 
certification'' will expire on August 17, 2001 unless the OTP submits 
the information required by paragraph (b) of this section to SAMHSA on 
or before August 17, 2001. In addition to this application, OTPs must 
certify with a written statement signed by the program sponsor, that 
they will apply for accreditation within 90 days of the date SAMHSA 
approves the second accreditation body. Transitional certification, in 
that case, will expire on May 19, 2003. SAMHSA may extend the 
transitional certification of an OTP for up to one additional year 
provided the OTP demonstrates that it has applied for accreditation, 
that an accreditation survey has taken place or is scheduled to take 
place, and that an accreditation decision is expected within a 
reasonable period of time (e.g., within 90 days from the date of 
survey). Transitional certification under this section may be suspended 
or revoked in accordance with Sec. 8.14.
    (e) Provisional certification. (1) OTPs that have no current 
certification from SAMHSA, but have applied for accreditation with an 
accreditation body, are eligible to receive a provisional certification 
for up to 1 year. To receive a provisional certification, an OTP shall 
submit the information required by paragraph (b) of this section to 
SAMHSA along with a statement identifying the accreditation body to 
which the OTP has applied for accreditation, the date on which the OTP 
applied for accreditation, the dates of any accreditation surveys that 
have taken place or are expected to take place, and the expected 
schedule for completing the accreditation process. A provisional 
certification for up to 1 year will be granted, following receipt of the 
information described in this paragraph, unless SAMHSA determines that 
patient health would be adversely affected by the granting of 
provisional certification.
    (2) An extension of provisional certification may be granted in 
extraordinary circumstances or otherwise to protect public health. To 
apply for a 90-day extension of provisional certification, an OTP shall 
submit to SAMHSA a statement explaining its efforts to obtain 
accreditation and a schedule for obtaining accreditation as 
expeditiously as possible.
    (f) Conditions for certification. (1) OTPs shall comply with all 
pertinent State laws and regulations. Nothing in this part is intended 
to limit the authority of State and, as appropriate, local governmental 
entities to regulate the use of opioid drugs in the treatment of opioid 
addiction. The provisions of this section requiring compliance with 
requirements imposed by State law, or the submission of applications or 
reports required by the State authority, do not apply to OTPs operated 
directly by the Department of Veterans Affairs, the Indian Health 
Service, or any other department or agency of the United States. Federal 
agencies operating OTPs have agreed to cooperate voluntarily with State 
agencies by granting permission on an informal basis for designated 
State representatives to visit Federal OTPs and by furnishing a copy of 
Federal reports to the State authority, including the reports required 
under this section.
    (2) OTPs shall allow, in accordance with Federal controlled 
substances laws and Federal confidentiality laws, inspections and 
surveys by duly authorized employees of SAMHSA, by accreditation bodies, 
by the DEA, and by authorized employees of any relevant State or Federal 
governmental authority.
    (3) Disclosure of patient records maintained by an OTP is governed 
by the provisions of 42 CFR part 2, and

[[Page 64]]

every program must comply with that part. Records on the receipt, 
storage, and distribution of opioid agonist treatment medications are 
also subject to inspection under Federal controlled substances laws and 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). 
Federally-sponsored treatment programs are subject to applicable Federal 
confidentiality statutes.
    (4) A treatment program or medication unit or any part thereof, 
including any facility or any individual, shall permit a duly authorized 
employee of SAMHSA to have access to and to copy all records on the use 
of opioid drugs in accordance with the provisions of 42 CFR part 2.
    (5) OTPs shall notify SAMHSA within 3 weeks of any replacement or 
other change in the status of the program sponsor or medical director.
    (6) OTPs shall comply with all regulations enforced by the DEA under 
21 CFR chapter II, and must be registered by the DEA before 
administering or dispensing opioid agonist treatment medications.
    (7) OTPs must operate in accordance with Federal opioid treatment 
standards and approved accreditation elements.
    (g) Conditions for interim maintenance treatment program approval. 
(1) Before a public or nonprofit private OTP may provide interim 
maintenance treatment, the program must receive the approval of both 
SAMHSA and the chief public health officer of the State in which the OTP 
operates.
    (2) Before SAMHSA may grant such approval, the OTP must provide 
SAMHSA with documentation from the chief public health officer of the 
State in which the OTP operates demonstrating that:
    (i) Such officer does not object to the providing of interim 
maintenance treatment in the State;
    (ii) The OTP seeking to provide such treatment is unable to place 
patients in a public or nonprofit private comprehensive treatment 
program within a reasonable geographic area within 14 days of the time 
patients seek admission to such programs;
    (iii) The authorization of the OTP to provide interim maintenance 
treatment will not otherwise reduce the capacity of comprehensive 
maintenance treatment programs in the State to admit individuals 
(relative to the date on which such officer so certifies); and
    (iv) The State certifies that each individual enrolled in interim 
maintenance treatment will be transferred to a comprehensive maintenance 
treatment program no later than 120 days from the date on which each 
individual first requested treatment, as provided in section 1923 of the 
Public Health Service Act (21 U.S.C. 300x-23).
    (3) SAMHSA will provide notice to the OTP denying or approving the 
request to provide interim maintenance treatment. The OTP shall not 
provide such treatment until it has received such notice from SAMHSA.
    (h) Exemptions. An OTP may, at the time of application for 
certification or any time thereafter, request from SAMHSA exemption from 
the regulatory requirements set forth under this section and Sec. 8.12. 
An example of a case in which an exemption might be granted would be for 
a private practitioner who wishes to treat a limited number of patients 
in a non-metropolitan area with few physicians and no rehabilitative 
services geographically accessible and requests exemption from some of 
the staffing and service standards. The OTP shall support the rationale 
for the exemption with thorough documentation, to be supplied in an 
appendix to the initial application for certification or in a separate 
submission. SAMHSA will approve or deny such exemptions at the time of 
application, or any time thereafter, if appropriate. SAMHSA shall 
consult with the appropriate State authority prior to taking action on 
an exemption request.
    (i) Medication units, long-term care facilities and hospitals. (1) 
Certified OTPs may establish medication units that are authorized to 
dispense opioid agonist treatment medications for observed ingestion. 
Before establishing a medication unit, a certified OTP must notify 
SAMHSA by submitting form SMA-162. The OTP must also comply with the 
provisions of 21 CFR part 1300 before establishing a medication unit. 
Medication units shall comply with all pertinent state laws and 
regulations.

[[Page 65]]

    (2) Certification as an OTP under this part will not be required for 
the maintenance or detoxification treatment of a patient who is admitted 
to a hospital or long-term care facility for the treatment of medical 
conditions other than opiate addiction and who requires maintenance or 
detoxification treatment during the period of his or her stay in that 
hospital or long-term care facility. The terms ``hospital'' and ``long-
term care facility'' as used in this section are to have the meaning 
that is assigned under the law of the State in which the treatment is 
being provided. Nothing in this section is intended to relieve hospitals 
and long-term care facilities from the obligation to obtain registration 
from the Attorney General, as appropriate, under section 303(g) of the 
Controlled Substances Act.

[66 FR 4090, Jan. 17, 2001, as amended at 66 FR 15347, Mar. 19, 2001]



Sec. 8.12  Federal opioid treatment standards.

    (a) General. OTPs must provide treatment in accordance with the 
standards in this section and must comply with these standards as a 
condition of certification.
    (b) Administrative and organizational structure. An OTP's 
organizational structure and facilities shall be adequate to ensure 
quality patient care and to meet the requirements of all pertinent 
Federal, State, and local laws and regulations. At a minimum, each OTP 
shall formally designate a program sponsor and medical director. The 
program sponsor shall agree on behalf of the OTP to adhere to all 
requirements set forth in this part and any regulations regarding the 
use of opioid agonist treatment medications in the treatment of opioid 
addiction which may be promulgated in the future. The medical director 
shall assume responsibility for administering all medical services 
performed by the OTP. In addition, the medical director shall be 
responsible for ensuring that the OTP is in compliance with all 
applicable Federal, State, and local laws and regulations.
    (c) Continuous quality improvement. (1) An OTP must maintain current 
quality assurance and quality control plans that include, among other 
things, annual reviews of program policies and procedures and ongoing 
assessment of patient outcomes.
    (2) An OTP must maintain a current ``Diversion Control Plan'' or 
``DCP'' as part of its quality assurance program that contains specific 
measures to reduce the possibility of diversion of controlled substances 
from legitimate treatment use and that assigns specific responsibility 
to the medical and administrative staff of the OTP for carrying out the 
diversion control measures and functions described in the DCP.
    (d) Staff credentials. Each person engaged in the treatment of 
opioid addiction must have sufficient education, training, and 
experience, or any combination thereof, to enable that person to perform 
the assigned functions. All physicians, nurses, and other licensed 
professional care providers, including addiction counselors, must comply 
with the credentialing requirements of their respective professions.
    (e) Patient admission criteria.--(1) Maintenance treatment. An OTP 
shall maintain current procedures designed to ensure that patients are 
admitted to maintenance treatment by qualified personnel who have 
determined, using accepted medical criteria such as those listed in the 
Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), that 
the person is currently addicted to an opioid drug, and that the person 
became addicted at least 1 year before admission for treatment. In 
addition, a program physician shall ensure that each patient voluntarily 
chooses maintenance treatment and that all relevant facts concerning the 
use of the opioid drug are clearly and adequately explained to the 
patient, and that each patient provides informed written consent to 
treatment.
    (2) Maintenance treatment for persons under age 18. A person under 
18 years of age is required to have had two documented unsuccessful 
attempts at short-term detoxification or drug-free treatment within a 
12-month period to be eligible for maintenance treatment. No person 
under 18 years of age may be admitted to maintenance treatment unless a 
parent, legal guardian, or responsible adult designated by

[[Page 66]]

the relevant State authority consents in writing to such treatment.
    (3) Maintenance treatment admission exceptions. If clinically 
appropriate, the program physician may waive the requirement of a 1-year 
history of addiction under paragraph (e)(1) of this section, for 
patients released from penal institutions (within 6 months after 
release), for pregnant patients (program physician must certify 
pregnancy), and for previously treated patients (up to 2 years after 
discharge).
    (4) Detoxification treatment. An OTP shall maintain current 
procedures that are designed to ensure that patients are admitted to 
short- or long-term detoxification treatment by qualified personnel, 
such as a program physician, who determines that such treatment is 
appropriate for the specific patient by applying established diagnostic 
criteria. Patients with two or more unsuccessful detoxification episodes 
within a 12-month period must be assessed by the OTP physician for other 
forms of treatment. A program shall not admit a patient for more than 
two detoxification treatment episodes in one year.
    (f) Required services.--(1) General. OTPs shall provide adequate 
medical, counseling, vocational, educational, and other assessment and 
treatment services. These services must be available at the primary 
facility, except where the program sponsor has entered into a formal, 
documented agreement with a private or public agency, organization, 
practitioner, or institution to provide these services to patients 
enrolled in the OTP. The program sponsor, in any event, must be able to 
document that these services are fully and reasonably available to 
patients.
    (2) Initial medical examination services. OTPs shall require each 
patient to undergo a complete, fully documented physical evaluation by a 
program physician or a primary care physician, or an authorized 
healthcare professional under the supervision of a program physician, 
before admission to the OTP. The full medical examination, including the 
results of serology and other tests, must be completed within 14 days 
following admission.
    (3) Special services for pregnant patients. OTPs must maintain 
current policies and procedures that reflect the special needs of 
patients who are pregnant. Prenatal care and other gender specific 
services or pregnant patients must be provided either by the OTP or by 
referral to appropriate healthcare providers.
    (4) Initial and periodic assessment services. Each patient accepted 
for treatment at an OTP shall be assessed initially and periodically by 
qualified personnel to determine the most appropriate combination of 
services and treatment. The initial assessment must include preparation 
of a treatment plan that includes the patient's short-term goals and the 
tasks the patient must perform to complete the short-term goals; the 
patient's requirements for education, vocational rehabilitation, and 
employment; and the medical, psychosocial, economic, legal, or other 
supportive services that a patient needs. The treatment plan also must 
identify the frequency with which these services are to be provided. The 
plan must be reviewed and updated to reflect that patient's personal 
history, his or her current needs for medical, social, and psychological 
services, and his or her current needs for education, vocational 
rehabilitation, and employment services.
    (5) Counseling services. (i) OTPs must provide adequate substance 
abuse counseling to each patient as clinically necessary. This 
counseling shall be provided by a program counselor, qualified by 
education, training, or experience to assess the psychological and 
sociological background of patients, to contribute to the appropriate 
treatment plan for the patient and to monitor patient progress.
    (ii) OTPs must provide counseling on preventing exposure to, and the 
transmission of, human immunodeficiency virus (HIV) disease for each 
patient admitted or readmitted to maintenance or detoxification 
treatment.
    (iii) OTPs must provide directly, or through referral to adequate 
and reasonably accessible community resources, vocational 
rehabilitation, education, and employment services for patients who 
either request such services or who have been determined by the program 
staff to be in need of such services.

[[Page 67]]

    (6) Drug abuse testing services. OTPs must provide adequate testing 
or analysis for drugs of abuse, including at least eight random drug 
abuse tests per year, per patient in maintenance treatment, in 
accordance with generally accepted clinical practice. For patients in 
short-term detoxification treatment, the OTP shall perform at least one 
initial drug abuse test. For patients receiving long-term detoxification 
treatment, the program shall perform initial and monthly random tests on 
each patient.
    (g) Recordkeeping and patient confidentiality. (1) OTPs shall 
establish and maintain a recordkeeping system that is adequate to 
document and monitor patient care. This system is required to comply 
with all Federal and State reporting requirements relevant to opioid 
drugs approved for use in treatment of opioid addiction. All records are 
required to be kept confidential in accordance with all applicable 
Federal and State requirements.
    (2) OTPs shall include, as an essential part of the recordkeeping 
system, documentation in each patient's record that the OTP made a good 
faith effort to review whether or not the patient is enrolled any other 
OTP. A patient enrolled in an OTP shall not be permitted to obtain 
treatment in any other OTP except in exceptional circumstances. If the 
medical director or program physician of the OTP in which the patient is 
enrolled determines that such exceptional circumstances exist, the 
patient may be granted permission to seek treatment at another OTP, 
provided the justification for finding exceptional circumstances is 
noted in the patient's record both at the OTP in which the patient is 
enrolled and at the OTP that will provide the treatment.
    (h) Medication administration, dispensing, and use. (1) OTPs must 
ensure that opioid agonist treatment medications are administered or 
dispensed only by a practitioner licensed under the appropriate State 
law and registered under the appropriate State and Federal laws to 
administer or dispense opioid drugs, or by an agent of such a 
practitioner, supervised by and under the order of the licensed 
practitioner. This agent is required to be a pharmacist, registered 
nurse, or licensed practical nurse, or any other healthcare professional 
authorized by Federal and State law to administer or dispense opioid 
drugs.
    (2) OTPs shall use only those opioid agonist treatment medications 
that are approved by the Food and Drug Administration under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
the treatment of opioid addiction. In addition, OTPs who are fully 
compliant with the protocol of an investigational use of a drug and 
other conditions set forth in the application may administer a drug that 
has been authorized by the Food and Drug Administration under an 
investigational new drug application under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act for investigational use in the treatment of 
opioid addiction. Currently the following opioid agonist treatment 
medications will be considered to be approved by the Food and Drug 
Administration for use in the treatment of opioid addiction:
    (i) Methadone;
    (ii) Levomethadyl acetate (LAAM); and
    (iii) Buprenorphine and buprenorphine combination products that have 
been approved for use in the treatment of opioid addiction.
    (3) OTPs shall maintain current procedures that are adequate to 
ensure that the following dosage form and initial dosing requirements 
are met:
    (i) Methadone shall be administered or dispensed only in oral form 
and shall be formulated in such a way as to reduce its potential for 
parenteral abuse.
    (ii) For each new patient enrolled in a program, the initial dose of 
methadone shall not exceed 30 milligrams and the total dose for the 
first day shall not exceed 40 milligrams, unless the program physician 
documents in the patient's record that 40 milligrams did not suppress 
opiate abstinence symptoms.
    (4) OTPs shall maintain current procedures adequate to ensure that 
each opioid agonist treatment medication used by the program is 
administered and dispensed in accordance with its approved product 
labeling. Dosing and administration decisions shall be made by a program 
physician familiar with

[[Page 68]]

the most up-to-date product labeling. These procedures must ensure that 
any significant deviations from the approved labeling, including 
deviations with regard to dose, frequency, or the conditions of use 
described in the approved labeling, are specifically documented in the 
patient's record.
    (i) Unsupervised or ``take-home'' use. To limit the potential for 
diversion of opioid agonist treatment medications to the illicit market, 
opioid agonist treatment medications dispensed to patients for 
unsupervised use shall be subject to the following requirements.
    (1) Any patient in comprehensive maintenance treatment may receive a 
single take-home dose for a day that the clinic is closed for business, 
including Sundays and State and Federal holidays.
    (2) Treatment program decisions on dispensing opioid treatment 
medications to patients for unsupervised use beyond that set forth in 
paragraph (i)(1) of this section, shall be determined by the medical 
director. In determining which patients may be permitted unsupervised 
use, the medical director shall consider the following take-home 
criteria in determining whether a patient is responsible in handling 
opioid drugs for unsupervised use.
    (i) Absence of recent abuse of drugs (opioid or nonnarcotic), 
including alcohol;
    (ii) Regularity of clinic attendance;
    (iii) Absence of serious behavioral problems at the clinic;
    (iv) Absence of known recent criminal activity, e.g., drug dealing;
    (v) Stability of the patient's home environment and social 
relationships;
    (vi) Length of time in comprehensive maintenance treatment;
    (vii) Assurance that take-home medication can be safely stored 
within the patient's home; and
    (viii) Whether the rehabilitative benefit the patient derived from 
decreasing the frequency of clinic attendance outweighs the potential 
risks of diversion.
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is responsible in handling opioid drugs, the 
following restrictions apply:
    (i) During the first 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) is limited to a single 
dose each week and the patient shall ingest all other doses under 
appropriate supervision as provided for under the regulations in this 
subpart.
    (ii) In the second 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) is two doses per week.
    (iii) In the third 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) is three doses per 
week.
    (iv) In the remaining months of the first year, a patient may be 
given a maximum 6-day supply of take-home medication.
    (v) After 1 year of continuous treatment, a patient may be given a 
maximum 2-week supply of take-home medication.
    (vi) After 2 years of continuous treatment, a patient may be given a 
maximum one-month supply of take-home medication, but must make monthly 
visits.
    (4) No medications shall be dispensed to patients in short-term 
detoxification treatment or interim maintenance treatment for 
unsupervised or take-home use.
    (5) OTPs must maintain current procedures adequate to identify the 
theft or diversion of take-home medications, including labeling 
containers with the OTP's name, address, and telephone number. Programs 
also must ensure that take-home supplies are packaged in a manner that 
is designed to reduce the risk of accidental ingestion, including child-
proof containers (see Poison Prevention Packaging Act, Public Law 91-601 
(15 U.S.C. 1471 et seq.)).
    (j) Interim maintenance treatment. (1) The program sponsor of a 
public or nonprofit private OTP may place an individual, who is eligible 
for admission to comprehensive maintenance treatment, in interim 
maintenance treatment if the individual cannot be placed in a public or 
nonprofit private comprehensive program within a reasonable geographic 
area and within 14 days

[[Page 69]]

of the individual's application for admission to comprehensive 
maintenance treatment. An initial and at least two other urine screens 
shall be taken from interim patients during the maximum of 120 days 
permitted for such treatment. A program shall establish and follow 
reasonable criteria for establishing priorities for transferring 
patients from interim maintenance to comprehensive maintenance 
treatment. These transfer criteria shall be in writing and shall 
include, at a minimum, a preference for pregnant women in admitting 
patients to interim maintenance and in transferring patients from 
interim maintenance to comprehensive maintenance treatment. Interim 
maintenance shall be provided in a manner consistent with all applicable 
Federal and State laws, including sections 1923, 1927(a), and 1976 of 
the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-
11).
    (2) The program shall notify the State health officer when a patient 
begins interim maintenance treatment, when a patient leaves interim 
maintenance treatment, and before the date of mandatory transfer to a 
comprehensive program, and shall document such notifications.
    (3) SAMHSA may revoke the interim maintenance authorization for 
programs that fail to comply with the provisions of this paragraph (j). 
Likewise, SAMHSA will consider revoking the interim maintenance 
authorization of a program if the State in which the program operates is 
not in compliance with the provisions of Sec. 8.11(g).
    (4) All requirements for comprehensive maintenance treatment apply 
to interim maintenance treatment with the following exceptions:
    (i) The opioid agonist treatment medication is required to be 
administered daily under observation;
    (ii) Unsupervised or ``take-home'' use is not allowed;
    (iii) An initial treatment plan and periodic treatment plan 
evaluations are not required;
    (iv) A primary counselor is not required to be assigned to the 
patient;
    (v) Interim maintenance cannot be provided for longer than 120 days 
in any 12-month period; and
    (vi) Rehabilitative, education, and other counseling services 
described in paragraphs (f)(4), (f)(5)(i), and (f)(5)(iii) of this 
section are not required to be provided to the patient.

[66 FR 4090, Jan. 17, 2001, as amended at 68 FR 27939, May 22, 2003]



Sec. 8.13  Revocation of accreditation and accreditation body approval.

    (a) SAMHSA action following revocation of accreditation. If an 
accreditation body revokes an OTP's accreditation, SAMHSA may conduct an 
investigation into the reasons for the revocation. Following such 
investigation, SAMHSA may determine that the OTP's certification should 
no longer be in effect, at which time SAMHSA will initiate procedures to 
revoke the facility's certification in accordance with Sec. 8.14. 
Alternatively, SAMHSA may determine that another action or combination 
of actions would better serve the public health, including the 
establishment and implementation of a corrective plan of action that 
will permit the certification to continue in effect while the OTP seeks 
reaccreditation.
    (b) Accreditation body approval. (1) If SAMHSA withdraws the 
approval of an accreditation body under Sec. 8.6, the certifications of 
OTPs accredited by such body shall remain in effect for a period of 1 
year after the date of withdrawal of approval of the accreditation body, 
unless SAMHSA determines that to protect public health or safety, or 
because the accreditation body fraudulently accredited treatment 
programs, the certifications of some or all of the programs should be 
revoked or suspended or that a shorter time period should be established 
for the certifications to remain in effect. SAMHSA may extend the time 
in which a certification remains in effect under this paragraph on a 
case-by-case basis.
    (2) Within 1 year from the date of withdrawal of approval of an 
accreditation body, or within any shorter period of time established by 
SAMHSA, OTPs currently accredited by the accreditation body must obtain 
accreditation from another accreditation body. SAMHSA may extend the 
time period for obtaining reaccreditation on a case-by-case basis.

[[Page 70]]



Sec. 8.14  Suspension or revocation of certification.

    (a) Revocation. Except as provided in paragraph (b) of this section, 
SAMHSA may revoke the certification of an OTP if SAMHSA finds, after 
providing the program sponsor with notice and an opportunity for a 
hearing in accordance with subpart C of this part, that the program 
sponsor, or any employee of the OTP:
    (1) Has been found guilty of misrepresentation in obtaining the 
certification;
    (2) Has failed to comply with the Federal opioid treatment standards 
in any respect;
    (3) Has failed to comply with reasonable requests from SAMHSA or 
from an accreditation body for records, information, reports, or 
materials that are necessary to determine the continued eligibility of 
the OTP for certification or continued compliance with the Federal 
opioid treatment standards; or
    (4) Has refused a reasonable request of a duly designated SAMHSA 
inspector, Drug Enforcement Administration (DEA) Inspector, State 
Inspector, or accreditation body representative for permission to 
inspect the program or the program's operations or its records.
    (b) Suspension. Whenever SAMHSA has reason to believe that 
revocation may be required and that immediate action is necessary to 
protect public health or safety, SAMHSA may immediately suspend the 
certification of an OTP before holding a hearing under subpart C of this 
part. SAMHSA may immediately suspend as well as propose revocation of 
the certification of an OTP before holding a hearing under subpart C of 
this part if SAMHSA makes a finding described in paragraph (a) of this 
section and also determines that:
    (1) The failure to comply with the Federal opioid treatment 
standards presents an imminent danger to the public health or safety;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the failure to comply with the 
Federal opioid treatment standards was intentional or was associated 
with fraud.
    (c) Written notification. In the event that SAMHSA suspends the 
certification of an OTP in accordance with paragraph (b) of this section 
or proposes to revoke the certification of an OTP in accordance with 
paragraph (a) of this section, SAMHSA shall promptly provide the sponsor 
of the OTP with written notice of the suspension or proposed revocation 
by facsimile transmission, personal service, commercial overnight 
delivery service, or certified mail, return receipt requested. Such 
notice shall state the reasons for the action and shall state that the 
OTP may seek review of the action in accordance with the procedures in 
subpart C of this part.
    (d)(1) If SAMHSA suspends certification in accordance with paragraph 
(b) of this section:
    (i) SAMHSA will immediately notify DEA that the OTP's registration 
should be suspended under 21 U.S.C. 824(d); and
    (ii) SAMHSA will provide an opportunity for a hearing under subpart 
C of this part.
    (2) Suspension of certification under paragraph (b) of this section 
shall remain in effect until the agency determines that:
    (i) The basis for the suspension cannot be substantiated;
    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The OTP's certification shall be revoked.



Sec. 8.15  Forms.

    (a) SMA-162--Application for Certification to Use Opioid Agonist 
Treatment Medications for Opioid Treatment.
    (b) SMA-163--Application for Becoming an Accreditation Body under 
Sec. 8.3.

[[Page 71]]



Subpart C_Procedures for Review of Suspension or Proposed Revocation of 

    OTP Certification, and of Adverse Action Regarding Withdrawal of 

                    Approval of an Accreditation Body



Sec. 8.21  Applicability.

    The procedures in this subpart apply when:
    (a) SAMHSA has notified an OTP in writing that its certification 
under the regulations in subpart B of this part has been suspended or 
that SAMHSA proposes to revoke the certification; and
    (b) The OTP has, within 30 days of the date of the notification or 
within 3 days of the date of the notification when seeking an expedited 
review of a suspension, requested in writing an opportunity for a review 
of the suspension or proposed revocation.
    (c) SAMHSA has notified an accreditation body of an adverse action 
taken regarding withdrawal of approval of the accreditation body under 
the regulations in subpart A of this part; and
    (d) The accreditation body has, within 30 days of the date of the 
notification, requested in writing an opportunity for a review of the 
adverse action.



Sec. 8.22  Definitions.

    The following definitions apply to this subpart C.
    (a) Appellant means:
    (1) The treatment program which has been notified of its suspension 
or proposed revocation of its certification under the regulations of 
this part and has requested a review of the suspension or proposed 
revocation, or
    (2) The accreditation body which has been notified of adverse action 
regarding withdrawal of approval under the regulations of this subpart 
and has requested a review of the adverse action.
    (b) Respondent means SAMHSA.
    (c) Reviewing official means the person or persons designated by the 
Secretary who will review the suspension or proposed revocation. The 
reviewing official may be assisted by one or more HHS officers or 
employees or consultants in assessing and weighing the scientific and 
technical evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.



Sec. 8.23  Limitation on issues subject to review.

    The scope of review shall be limited to the facts relevant to any 
suspension, or proposed revocation, or adverse action, the necessary 
interpretations of the facts the regulations, in the subpart, and other 
relevant law.



Sec. 8.24  Specifying who represents the parties.

    The appellant's request for review shall specify the name, address, 
and phone number of the appellant's representative. In its first written 
submission to the reviewing official, the respondent shall specify the 
name, address, and phone number of the respondent's representative.



Sec. 8.25  Informal review and the reviewing official's response.

    (a) Request for review. Within 30 days of the date of the notice of 
the suspension or proposed revocation, the appellant must submit a 
written request to the reviewing official seeking review, unless some 
other time period is agreed to by the parties. A copy must also be sent 
to the respondent. The request for review must include a copy of the 
notice of suspension, proposed revocation, or adverse action, a brief 
statement of why the decision to suspend, propose revocation, or take an 
adverse action is incorrect, and the appellant's request for an oral 
presentation, if desired.
    (b) Acknowledgment. Within 5 days after receiving the request for 
review, the reviewing official will send an acknowledgment and advise 
the appellant of the next steps. The reviewing official will also send a 
copy of the acknowledgment to the respondent.



Sec. 8.26  Preparation of the review file and written arguments.

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. The 
procedures for development of the review

[[Page 72]]

file and submission of written argument are:
    (a) Appellant's documents and brief. Within 30 days after receiving 
the acknowledgment of the request for review, the appellant shall submit 
to the reviewing official the following (with a copy to the respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation of 
appellant's certification or to take adverse action regarding withdrawal 
of approval of the accreditation body is incorrect (appellant's brief).
    (b) Respondent's documents and brief. Within 30 days after receiving 
a copy of the acknowledgment of the request for review, the respondent 
shall submit to the reviewing official the following (with a copy to the 
appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification, or approval as 
an accreditation body, tabbed and organized chronologically, and 
accompanied by an index identifying each document. Only essential 
documents should be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension, proposed revocation, or 
adverse action (respondent's brief).
    (c) Reply briefs. Within 10 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive documentation. The reviewing official may take any 
appropriate steps to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.
    (f) Discovery. The use of interrogatories, depositions, and other 
forms of discovery shall not be allowed.



Sec. 8.27  Opportunity for oral presentation.

    (a) Electing oral presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decisionmaking process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide for 
an oral presentation at the official's own initiative or at the request 
of the respondent.
    (b) Presiding official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral presentation.
    (c) Preliminary conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues; stipulations 
and admissions; limitations on evidence and witnesses that will be 
presented at the hearing; time allotted for each witness and the hearing 
altogether; scheduling the hearing; and any other matter that will 
assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding official 
may, at the presiding official's discretion, produce a written document 
summarizing the conference or transcribe the conference, either of which 
will be made a part of the record.
    (d) Time and place of oral presentation. The presiding official will 
attempt to schedule the oral presentation within 45 days of the date 
appellant's request for review is received or within 15 days of 
submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.

[[Page 73]]

    (e) Conduct of the oral presentation.--(1) General. The presiding 
official is responsible for conducting the oral presentation. The 
presiding official may be assisted by one or more HHS officers or 
employees or consultants in conducting the oral presentation and 
reviewing the evidence. While the oral presentation will be kept as 
informal as possible, the presiding official may take all necessary 
steps to ensure an orderly proceeding.
    (2) Burden of proof/standard of proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend, propose revocation, or take adverse action is 
appropriate. The appellant, however, has a responsibility to respond to 
the respondent's allegations with evidence and argument to show that the 
respondent is incorrect.
    (3) Admission of evidence. The rules of evidence do not apply and 
the presiding official will generally admit all testimonial evidence 
unless it is clearly irrelevant, immaterial, or unduly repetitious. Each 
party may make an opening and closing statement, may present witnesses 
as agreed upon in the pre-hearing conference or otherwise, and may 
question the opposing party's witnesses. Since the parties have ample 
opportunity to prepare the review file, a party may introduce additional 
documentation during the oral presentation only with the permission of 
the presiding official. The presiding official may question witnesses 
directly and take such other steps necessary to ensure an effective and 
efficient consideration of the evidence, including setting time 
limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing the 
motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of justice or making of false statements. 
Obstruction of justice or the making of false statements by a witness or 
any other person may be the basis for a criminal prosecution under 18 
U.S.C. 1001 or 1505.
    (g) Post-hearing procedures. At the presiding official's discretion, 
the presiding official may require or permit the parties to submit post-
hearing briefs or proposed findings and conclusions. Each party may 
submit comments on any major prejudicial errors in the transcript.



Sec. 8.28  Expedited procedures for review of immediate suspension.

    (a) Applicability. When the Secretary notifies a treatment program 
in writing that its certification has been immediately suspended, the 
appellant may request an expedited review of the suspension and any 
proposed revocation. The appellant must submit this request in writing 
to the reviewing official within 10 days of the date the OTP received 
notice of the suspension. The request for review must include a copy of 
the suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is incorrect, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing official's response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review file and briefs. Within 10 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, tabbed, indexed, and organized chronologically; and

[[Page 74]]

    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official in accordance 
with Sec. 8.27(a), the presiding official will attempt to schedule the 
oral presentation within 20 to 30 days of the date of appellant's 
request for review at a time and place determined by the presiding 
official following consultation with the parties. The presiding official 
may hold a pre-hearing conference in accordance with Sec. 8.27(c) and 
will conduct the oral presentation in accordance with the procedures of 
Sec. Sec. 8.27(e), (f), and (g).
    (e) Written decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7 to 10 days of the date of 
the oral presentation or within 3 days of the date on which the 
transcript is received or the date of the last submission by either 
party, whichever is later. All other provisions set forth in Sec. 8.33 
apply.
    (f) Transmission of written communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between either party and the 
reviewing official shall be sent by facsimile transmission, personal 
service, or commercial overnight delivery service.



Sec. 8.29  Ex parte communications.

    Except for routine administrative and procedural matters, a party 
shall not communicate with the reviewing or presiding official without 
notice to the other party.



Sec. 8.30  Transmission of written communications by reviewing official and calculation of deadlines.

    (a) Timely review. Because of the importance of a timely review, the 
reviewing official should normally transmit written communications to 
either party by facsimile transmission, personal service, or commercial 
overnight delivery service, or certified mail, return receipt requested, 
in which case the date of transmission or day following mailing will be 
considered the date of receipt. In the case of communications sent by 
regular mail, the date of receipt will be considered 3 days after the 
date of mailing.
    (b) Due date. In counting days, include Saturdays, Sundays, and 
holidays. However, if a due date falls on a Saturday, Sunday, or Federal 
holiday, then the due date is the next Federal working day.



Sec. 8.31  Authority and responsibilities of the reviewing official.

    In addition to any other authority specified in this subpart C, the 
reviewing official and the presiding official, with respect to those 
authorities involving the oral presentation, shall have the authority to 
issue orders; examine witnesses; take all steps necessary for the 
conduct of an orderly hearing; rule on requests and motions; grant 
extensions of time for good reasons; dismiss for failure to meet 
deadlines or other requirements; order the parties to submit relevant 
information or witnesses; remand a case for further action by the 
respondent; waive or modify these procedures in a specific case, usually 
with notice to the parties; reconsider a decision of the reviewing 
official where a party promptly alleges a clear error of fact or law; 
and to take any other action necessary to resolve disputes in accordance 
with the objectives of the procedures in this subpart.



Sec. 8.32  Administrative record.

    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.



Sec. 8.33  Written decision.

    (a) Issuance of decision. The reviewing official shall issue a 
written decision upholding or denying the suspension, proposed 
revocation, or adverse action. The decision will set forth the reasons 
for the decision and describe the basis

[[Page 75]]

for that decision in the record. Furthermore, the reviewing official may 
remand the matter to the respondent for such further action as the 
reviewing official deems appropriate.
    (b) Date of decision. The reviewing official will attempt to issue 
the decision within 15 days of the date of the oral presentation, the 
date on which the transcript is received, or the date of the last 
submission by either party, whichever is later. If there is no oral 
presentation, the decision will normally be issued within 15 days of the 
date of receipt of the last reply brief. Once issued, the reviewing 
official will immediately communicate the decision to each party.
    (c) Public notice and communications to the Drug Enforcement 
Administration (DEA). (1) If the suspension and proposed revocation of 
OTP certification are upheld, the revocation of certification will 
become effective immediately and the public will be notified by 
publication of a notice in the Federal Register. SAMHSA will notify DEA 
within 5 days that the OTP's registration should be revoked.
    (2) If the suspension and proposed revocation of OTP certification 
are denied, the revocation will not take effect and the suspension will 
be lifted immediately. Public notice will be given by publication in the 
Federal Register. SAMHSA will notify DEA within 5 days that the OTP's 
registration should be restored, if applicable.



Sec. 8.34  Court review of final administrative action; exhaustion of 

administrative remedies.

    Before any legal action is filed in court challenging the 
suspension, proposed revocation, or adverse action, respondent shall 
exhaust administrative remedies provided under this subpart, unless 
otherwise provided by Federal law. The reviewing official's decision, 
under Sec. 8.28(e) or Sec. 8.33(a), constitutes final agency action as 
of the date of the decision.

[[Page 76]]



                         SUBCHAPTER B_PERSONNEL



PART 21_COMMISSIONED OFFICERS--Table of Contents




                          Subpart A_Definitions

Sec.
21.1 Meaning of terms.

                          Subpart B_Appointment

         Provisions Applicable Both to Regular and Reserve Corps

21.21 Meaning of terms.
21.22 Submission of application and evidence of qualifications.
21.23 False statements as disqualification.
21.24 Physical examinations.
21.25 Eligibility; junior assistant grade.
21.26 Eligibility; assistant grade.
21.27 Eligibility; senior assistant grade.
21.28 Age requirements, Regular Corps, senior assistant grade and below.
21.29 Eligibility; grades above senior assistant grade.
21.30 Determination of creditable years of educational and professional 
          training and experience.
21.31 Eligibility; all grades; academic and professional education and 
          professional training and experience.
21.32 Boards; appointment of; powers and duties.
21.33 General service.
21.34 Certification by candidate; requirement of new physical 
          examination.

               Provisions Applicable Only to Regular Corps

21.41 Professional examinations, holding of; subjects to be included.
21.42 Examinations; junior assistant, assistant, or senior assistant 
          grade.
21.43 Examination; full grade and above.
21.44 Clinical or other practical demonstration.
21.45 Rating values.
21.46 Merit roll.
21.47 Examination; anticipation of meeting qualifications.

               Provisions Applicable Only to Reserve Corps

21.51 Appointment of officers having specialized training or experience 
          in administration and management.
21.52 Waiver of entrance qualifications for original appointment in time 
          of war or national emergency.
21.53 Examination.
21.54 Students.
21.55 Appointment to higher grades; candidates exceptionally qualified 
          in specialized fields.
21.56 Reappointment.
21.57 Examination for reappointment.
21.58 Physical examination for reappointment.

       Subpart C_Involuntary Child and Spousal Support Allotments

21.70 Purpose.
21.71 Applicability and scope.
21.72 Definitions.
21.73 Policy.
21.74 Responsibilities.
21.75 Procedures.



                          Subpart A_Definitions

    Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216.



Sec. 21.1  Meaning of terms.

    As used in this part, the term:
    (a) Act means the Public Health Service Act, 58 Stat. 682, as now or 
hereafter amended.
    (b) Department means the Department of Health and Human Services.
    (c) Secretary means the Secretary of Health and Human Services.
    (d) Service means the Public Health Service.
    (e) Surgeon General means the Surgeon General of the Public Health 
Service.
    (f) Commissioned officer or officer, unless otherwise indicated, 
means either an officer of the Regular Corps or an officer of the 
Reserve Corps.

[21 FR 9806, Dec. 12, 1956]



                          Subpart B_Appointment

    Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216; sec. 
208, 58 Stat. 685, as amended; 42 U.S.C. 209.

    Source: 21 FR 9806, Dec. 12, 1956, unless otherwise noted.

         Provisions Applicable Both to Regular and Reserve Corps



Sec. 21.21  Meaning of terms.

    The terms approved school, approved college, approved postgraduate 
school, or

[[Page 77]]

approved training course means, except as otherwise provided by law:
    (a) A school, college, postgraduate school, or training course which 
has been accredited or approved by a professional body or bodies 
recognized by the Surgeon General for such purpose, or which, in the 
absence of such a body, meets generally accepted professional standards 
as determined by the Surgeon General, or
    (b) In the case of a candidate who is applying for appointment as a 
medical officer, any non-approved medical school provided that the 
candidate has passed examinations given by a professional body or bodies 
recognized by the Surgeon General for such purpose.

[24 FR 1790, Mar. 12, 1959]



Sec. 21.22  Submission of application and evidence of qualifications.

    (a) Application form. Every candidate for examination for 
appointment as an officer shall submit a written application on such 
form as may be prescribed by the Surgeon General.
    (b) Documentary evidence. The application shall be accompanied by 
such documentary evidence as may be required by the Surgeon General.



Sec. 21.23  False statements as disqualification.

    Willfully false statements shall be cause for rejection of the 
application or, as provided in subpart N of this part, for dismissal.



Sec. 21.24  Physical examinations.

    Every candidate for appointment as an officer shall undergo such 
physical examination as the Surgeon General may direct, and no candidate 
who is not found to be physically qualified shall be appointed as an 
officer.



Sec. 21.25  Eligibility; junior assistant grade.

    (a) Requirements; all candidates. Except as provided in Sec. 21.54, 
and as otherwise provided in this section, every candidate for 
examination for appointment in the grade of junior assistant:
    (1) Shall be a citizen of the United States;
    (2) Shall be at least 18 years of age; and
    (3) Shall have been granted an academic or professional degree from 
an approved school, college, or postgraduate school, and, unless the 
required professional training has been otherwise obtained from an 
approved school, college, or postgraduate school, shall have majored in 
the profession in which the examination is being held.
    (b) [Reserved]
    (c) Special requirement; therapists. Every candidate for examination 
for appointment as a therapist shall have received a certificate from an 
approved school of physical therapy or an approved school of 
occupational therapy.

[21 FR 9806, Dec. 12, 1956, as amended at 30 FR 9437, July 29, 1965]



Sec. 21.26  Eligibility; assistant grade.

    (a) Requirements; all candidates. Except as otherwise provided in 
this section every candidate for examination for appointment in the 
grade of assistant:
    (1) Shall meet the requirements for eligibility for examination for 
appointment in the grade of junior assistant;
    (2) Shall be at least 21 years of age; and
    (3) Shall have had at least 7 years of educational and professional 
training or experience subsequent to high school, except that a 
candidate who applies for examination for appointment in the Reserve 
Corps to serve as a medical or dental intern may be examined for such 
appointment upon the completion of 6 years of such education, training, 
or experience.
    (b) Additional requirements; dietitians. Every candidate for 
examination for appointment as a dietitian shall have successfully 
completed an approved training course for dietetic interns.



Sec. 21.27  Eligibility; senior assistant grade.

    Every candidate for examination for appointment in the grade of 
senior assistant shall meet the requirements for eligibility for 
examination for appointment in the grade of assistant and shall have 
completed at least 10 years of educational and professional training or 
experience subsequent to high school.

[[Page 78]]



Sec. 21.28  Age requirements, Regular Corps, senior assistant grade and below.

    No candidate for appointment to the Regular Corps, except in the 
nurse category, shall be appointed (a) after age 31 to the permanent 
junior assistant grade, (b) after age 34 to the permanent assistant 
grade, or (c) after age 37 to the permanent senior assistant grade: 
Provided, That the Surgeon General may waive these age limitations, 
subject to other provisions of law, in the case of any officer of the 
Reserve Corps who is recommended for appointment to the Regular Corps by 
the Chief of the Bureau to which he is assigned and who has been on 
continuous active duty for at least two years immediately preceding the 
date of such recommendation. The age limitations for candidates who have 
had prior active service in the Commissioned Corps of the Public Health 
Service shall be increased by the period of such service.

[27 FR 3886, Apr. 24, 1962]



Sec. 21.29  Eligibility; grades above senior assistant grade.

    Every candidate for examination for appointment in grades above that 
of senior assistant shall meet the requirements for eligibility for 
examination for appointment in the grade of senior assistant. Candidates 
for examination for appointment in the full, senior, or director grade 
shall have completed at least 7, 14, or 15 additional years, 
respectively, of postgraduate professional training for experience. When 
officers of the Service are unavailable for the performance of duties 
requiring highly specialized training and experience in special fields 
related to public health, the Surgeon General may specify that a 
candidate for appointment to the Regular Corps with such highly 
specialized training and experience shall be examined for appointment in 
the full or senior grade upon completion of at least 5 or 12 additional 
years, respectively, of postgraduate professional training or 
experience, except that the total number of such appointments during a 
fiscal year shall not exceed three.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]



Sec. 21.30  Determination of creditable years of educational and professional 

training and experience.

    The level of academic attainment, the number of calendar years and 
the quality of educational and professional training and experience 
shall be considered in determining the number of years of such training 
and experience with which each candidate for appointment may be 
credited.

[25 FR 5184, June 10, 1960]



Sec. 21.31  Eligibility; all grades; academic and professional education and 

professional training and experience.

    The Surgeon General is authorized, subject to the other provisions 
of this subpart to adopt additional standards by which the education, 
training, and experience required under this subpart, and evidence 
thereof, shall be of such specific kind and quality, pertinent to the 
particular profession concerned, as in his judgment are necessary to 
limit the examination to qualified candidates.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]



Sec. 21.32  Boards; appointment of; powers and duties.

    The Surgeon General shall from time to time appoint boards and 
subboards of officers to consider the qualifications of candidates for 
appointment as officers, and shall refer to such boards the applications 
of those candidates who are eligible for examination for appointment. 
Such boards and subboards shall consist of three or more officers, the 
majority of whom, so far as practicable, shall be of the same profession 
as the candidate. The Surgeon General shall prescribe the duties of 
boards and subboards in relation to the examination process not 
otherwise prescribed in this subpart.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]



Sec. 21.33  General service.

    Officers shall be appointed only to general service and shall be 
subject to change of station.

[21 FR 9806, Dec. 12, 1956. Redesignated at 25 FR 5184, June 10, 1960]

[[Page 79]]



Sec. 21.34  Certification by candidate; requirement of new physical 

examination.

    If a candidate for appointment in the Regular Corps or an officer of 
the Reserve Corps on inactive service has passed a physical examination 
within a period of one year from the date on which it is contemplated 
that he will be appointed or called to active duty, he shall, prior to 
being appointed or called to active duty, certify that to the best of 
his knowledge and belief he is free from all disease or injury not noted 
in his record at the time of his examination and that he is willing to 
serve in any climate. If a candidate for appointment in the Regular 
Corps, or an officer of the Reserve Corps on inactive service, has not 
passed a physical examination within a period of one year from the date 
on which it is contemplated that he will be appointed or called to 
active duty, he may, prior to being appointed or called to active duty, 
be required to undergo such physical examination as the Surgeon General 
may direct to determine his physical qualification for appointment or 
call to active duty in accordance with standards prescribed for original 
appointment, or he may be appointed or called to active duty after 
executing the certificate described in this section, but shall be 
physically examined to determine his physical qualification for 
continued active service in accordance with standards prescribed for 
original appointment within a period of 15 days after reporting for duty 
at his first station.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959. 
Redesignated at 25 FR 5184, June 10, 1960]

               Provisions Applicable Only to Regular Corps



Sec. 21.41  Professional examinations, holding of; subjects to be included.

    From time to time the Surgeon General may order examinations to be 
held in such professions or specialties within professions and for such 
grades as he deems necessary for the purpose of providing merit rolls of 
eligible candidates for appointment in the Regular Corps and shall, if a 
professional examination is to be required, prescribe the subjects 
relating to each profession or specialty within such profession in which 
candidates will be examined.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]



Sec. 21.42  Examinations; junior assistant, assistant, or senior assistant 

grade.

    The examination for appointment to the junior assistant, assistant, 
or senior assistant grade in the Regular Corps shall consist of (a) a 
written professional examination relating to the fundamentals of the 
candidate's profession or specialty within his profession and their 
relationship to the activities of the Service, and (b) an examination as 
to the candidate's general fitness, which shall include an oral 
interview, and a review and evaluation of the candidate's academic and 
professional education and professional training and experience, and may 
include other written tests to determine the candidate's fitness for 
appointment as an officer. If an applicant for appointment to any of 
these grades is an officer of the Reserve Corps who has been on active 
duty for not less than one year immediately preceding his application, 
the Surgeon General may direct that the officer be examined as provided 
in Sec. 21.43.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959; 25 
FR 11099, Nov. 23, 1960]



Sec. 21.43  Examination; full grade and above.

    The examination for appointment to the full, senior, or director 
grade in the Regular Corps shall consist of a review and evaluation of 
the candidate's academic and professional education and professional 
training and experience. The Surgeon General may, however, direct that 
the examination of a candidate for appointment to any such grade shall 
also include an oral interview, a written or oral professional 
examination, or both.



Sec. 21.44  Clinical or other practical demonstration.

    In the discretion of the Surgeon General a candidate for appointment 
to any grade up to and including the senior assistant grade in the 
Regular

[[Page 80]]

Corps may be required to perform successfully a clinical or other 
practical demonstration which, if required, shall constitute a part of 
the professional examination.



Sec. 21.45  Rating values.

    The examination of every candidate for appointment to any grade in 
the Regular Corps shall be rated by a board appointed pursuant to Sec. 
21.30 in accordance with such relative values for each part of the 
examination as are prescribed by the Surgeon General. No candidate who 
receives a final rating below 80 shall be appointed in the Regular 
Corps.



Sec. 21.46  Merit roll.

    Each board appointed pursuant to Sec. 21.30 to consider the 
qualifications of candidates for appointment as officers shall assign a 
numerical rating to each candidate for appointment in the Regular Corps 
who passes the examination, and shall submit a report to the Surgeon 
General of the ratings and the relative standing of all such candidates 
for each grade in each profession or specialty within a profession. The 
Surgeon General shall submit each such report with his recommendations 
to the Secretary, and, if approved by the Secretary, the report shall 
constitute a merit roll from which the Secretary shall, in accordance 
with relative standing, recommend available persons to the President for 
nomination as commissioned officers of the Regular Corps. A board may 
consider any newly discovered evidence relating to the physical, 
professional, or personal qualifications of any candidate examined for 
appointment. Upon recommendation of such board after review of such 
evidence, the Surgeon General, with the approval of the Secretary, may 
correct the rating of a candidate or may qualify or disqualify a 
candidate. The placing of a candidate's name on a merit roll shall give 
no assurance of an appointment. A merit roll shall expire when a new 
merit roll in the same profession or specialty within a profession and 
grade has been established, but no merit roll shall continue in effect 
longer than two years after its approval by the Secretary. Every 
candidate who has not been nominated by the President for appointment 
prior to the expiration of a merit roll on which his name appears, 
shall, unless he requests the opportunity to be reexamined, be rated 
with the next group of candidates of the same profession or specialty 
within a profession for appointment in the same grade and shall be given 
the same rating he had on the expired merit roll. If two candidates who 
were examined at the same time receive the same numerical rating the 
elder candidate shall assume relative standing on the merit roll over 
the younger candidate. If a candidate whose name is being transferred 
from an expired to a new merit roll has the same numerical rating as a 
candidate whose name is being placed on the new merit roll for the first 
time, the former shall assume relative standing on the merit roll over 
the latter. The name of a candidate may be removed from a merit roll in 
the event that he refuses an appointment when offered. No candidate's 
eligibility for appointment shall exceed two years unless he again 
becomes eligible as the result of another examination.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]



Sec. 21.47  Examination; anticipation of meeting qualifications.

    A potential candidate for appointment in any grade in the Regular 
Corps may be examined within a period of nine months prior to the date 
upon which it is anticipated that he will qualify for appointment under 
this subpart. Upon successful completion of the examination, his name 
will be entered on a merit roll. In the event that his name, in order of 
relative standing among all candidates, precedes that of fully qualified 
candidates, his name, for purpose of appointment, shall be passed over 
in favor of fully qualified candidates until such time as he becomes 
fully qualified, but in no event shall he otherwise lose his relative 
standing on the merit roll, except as provided in Sec. 21.46. If the 
candidate fails to qualify for appointment at the time that it was 
anticipated that he would qualify, his name shall be removed from the 
merit roll.

[[Page 81]]

               Provisions Applicable Only to Reserve Corps



Sec. 21.51  Appointment of officers having specialized training or experience 

in administration and management.

    The Surgeon General may recommend for original appointment in the 
Reserve Corps candidates who have specialized training or experience in 
administration and management relating to the functions of the Service. 
All such candidates shall be subject to the same eligibility 
requirements for original appointment as are applicable to other 
candidates, except that such a candidate may substitute experience in 
administration or management for the requirement of professional 
training or experience.



Sec. 21.52  Waiver of entrance qualifications for original appointment in time 

of war or national emergency.

    If, in time of war or national emergency proclaimed by the 
President, the Secretary determines that there is need for commissioned 
personnel to meet the needs of the Service, other than persons eligible 
for examination for original appointment under the eligibility 
requirements prescribed in this subpart, he may prescribe standards of 
eligibility for examination for the original appointment of officers in 
the Reserve Corps without regard to such eligibility requirements. Such 
standards shall, however, authorize the examination only of candidates 
with specialized experience in administration or management or 
candidates with training or experience in fields relating to public 
health. The permanent grade of an officer who becomes eligible for 
examination for appointment pursuant to such standards and who becomes 
eligible for appointment after passage of an examination shall be 
limited to the junior assistant or the assistant grade, except that, if 
upon examination a candidate is found to be exceptionally qualified for 
the performance of highly specialized duties with the Service pursuant 
to Sec. 21.55, he may be recommended for appointment to any grade up to 
and including the director grade.

[21 FR 9806, Dec. 12, 1956, as amended at 24 FR 1790, Mar. 12, 1959]



Sec. 21.53  Examination.

    The examination of candidates for original appointment as officers 
to any grade in the Reserve Corps shall consist of a review and 
evaluation of their academic and other education and their training and 
experience. In the discretion of the Surgeon General the examination of 
any such candidate may include an oral interview, a written examination, 
or both.



Sec. 21.54  Students.

    A potential candidate for appointment in the Regular Corps who is 
pursuing a course of instruction which, upon completion, would qualify 
him under Sec. 21.25 or Sec. 21.26 for examination for appointment in 
the junior assistant or assistant grade may be examined for and 
appointed in the Reserve Corps in the junior assistant grade but shall 
not be called to extended active duty until the successful completion of 
such course of instruction, except that: (a) He may be called to active 
duty for purposes of training for periods not to exceed 120 days during 
any fiscal year, and (b) those students who have completed at least 3 
years of collegiate or professional study leading to the qualifying 
degree for appointment may be called to active duty for the purpose of 
completing the requirements of Sec. 21.25(a)(3). An appointment made 
under this subpart shall be terminated upon the officer's failure to 
continue a full-time course of study or failure to meet the requirements 
of Sec. 21.25(a)(3) within 18 months after entering on active duty.

[34 FR 706, Jan. 17, 1969]



Sec. 21.55  Appointment to higher grades; candidates exceptionally qualified 

in specialized fields.

    Any candidate eligible for examination for appointment in the grade 
of assistant pursuant to Sec. 21.26 who, upon examination for such 
purpose, is found

[[Page 82]]

exceptionally qualified for the performance of duties requiring highly 
specialized training or experience may be recommended for appointment in 
the Reserve Corps in any grade up to and including the director grade 
without regard to the additional years of postgraduate training or 
experience prescribed for grades above the assistant grade.



Sec. 21.56  Reappointment.

    An officer of the Reserve Corps, after being examined and found 
qualified for reappointment, may be recommended for reappointment to the 
same grade in the event that his commission expires before he becomes 
eligible for reappointment to a higher grade, or may be recommended for 
reappointment to a higher grade to be effective on or after the date on 
which he meets the qualifications prescribed in this subpart for 
original appointment to such higher grade.



Sec. 21.57  Examination for reappointment.

    The examination of an officer of the Reserve Corps on active duty 
who is being considered for reappointment in such corps shall consist of 
a review and evaluation of his record with the Service. The examination 
of an officer of the Reserve Corps on inactive duty who is being 
considered for reappointment in such corps shall consist of (a) a review 
and evaluation of his record with the Service while on active duty, if 
any, and (b) the record of his training or experience during the period 
of his inactive duty preceding such examination. In the discretion of 
the Surgeon General the examination for reappointment of an officer, 
whether on active or inactive duty, may include an oral interview.



Sec. 21.58  Physical examination for reappointment.

    Every officer of the Reserve Corps being considered for 
reappointment shall undergo such physical examination as the Surgeon 
General may direct. An officer on active duty may be recommended for 
reappointment unless he is found to have a physical disability which is 
determined to render him physically unfit to perform the duties of his 
office under section 402 of the Career Compensation Act of 1949, as 
amended. An officer may be recommended for promotion only if he meets 
the physical qualifications for original appointment. If an officer is 
not available to be physically examined because of circumstances which 
make it impracticable for the Service to require such examination, he 
may, in the discretion of the Surgeon General, be reappointed without 
such examination, but shall be examined as soon thereafter as 
practicable and his physical qualification or disqualification for 
continued or future active service shall be determined on the same basis 
as if the physical examination had been given prior to reappointment.



       Subpart C_Involuntary Child and Spousal Support Allotments

    Authority: 37 U.S.C. 101, 15 U.S.C. 1673, 42 U.S.C. 665.

    Source: 49 FR 7235, Feb. 24, 1984, unless otherwise noted.



Sec. 21.70  Purpose.

    Under references 37 U.S.C. 101, 15 U.S.C. 1673, and 42 U.S.C. 665, 
this subpart provides implementing policies governing involuntary child 
or child and spousal support allotments, assigns responsibilities, and 
prescribes procedures.



Sec. 21.71  Applicability and scope.

    (a) This subpart applies to officers in the Public Health Service 
Commissioned Corps. The term ``Public Health Service,'' hereinafter 
shall be referred to as Service.
    (b) Its provisions pertain to officers of the Service under a call 
or order to active duty for a period of six months or more.



Sec. 21.72  Definitions.

    (a) Child support. Periodic payments for the support and maintenance 
of a child or children, subject to and in accordance with State or local 
law. This includes, but is not limited to payments to provide for health 
care, education, recreation, clothing, or to meet

[[Page 83]]

other specific needs of such a child or children.
    (b) Spousal support. Periodic payments for the support and 
maintenance of a spouse or former spouse in accordance with State or 
local law. It includes, but is not limited to, separate maintenance, 
alimony pendente lite, and maintenance. Spousal support does not include 
any payment for transfer of property or its value by an individual to 
his or her spouse or former spouse in compliance with any community 
property settlement, equitable distribution of property, or other 
division of property between spouse or former spouse.
    (c) Notice. A court order, letter, or similar documentation issued 
by an authorized person, which provides notification that an officer has 
failed to make periodic support payments under a support order.
    (d) Support order. Any order providing for child or child and 
spousal support issued by a court of competent jurisdiction or by 
administrative procedures established under State law that affords 
substantially due process and is subject to judicial review. A court of 
competent jurisdiction includes Indian tribal courts within any State, 
territory, or possession of the United States and the District of 
Columbia.
    (e) Authorized person. (1) Any agent or attorney of any State having 
in effect a plan approved under part D of title IV of the Social 
Security Act (42 U.S.C. 651-665), who has the duty or authority to seek 
recovery of any amounts owed as child or child and spousal support 
(including, when authorized under a State plan, any official of a 
political subdivision); and (2) the court which has authority to issue 
an order against the officer for the support and maintenance of a child, 
or any agent of such court.
    (f) Active duty. Full-time duty in the Service, including full-time 
training duty.
    (g) Legal officer. Shall be an officer of the Service or employee of 
the Department who is a lawyer and who has substantial knowledge of the 
regulations, policies, and procedures relating to the implementation of 
section 172 of Pub. L. 97-248.



Sec. 21.73  Policy.

    (a) It is the policy of the Department of Health and Human Services 
to withhold allotments from pay and allowances of commissioned officers 
on active duty in the Service to make involuntary allotments from pay 
and allowances as payment of child, or child and spousal, support 
payments when the officer has failed to make periodic payments under a 
support order in a total amount equal to the support payable for two 
months or longer. Failure to make such payments shall be established by 
notice from an authorized person to the designated official of the 
Department. Such notice shall specify the name and address of the payee 
to whom the allotment is payable. The amount of the allotment shall be 
the amount necessary to comply with the support order including amounts 
for arrearages as well as for current support. However the amount of the 
allotment, when added to any other amounts withheld from the officer's 
pay pursuant to a support order, shall not exceed the limits for 
involuntary allotments from pay as prescribed in section 303 (b) and (c) 
of the Consumer Credit Protection Act, 15 U.S.C. 1673. An allotment 
under this Subpart shall be adjusted or discontinued upon notice from 
any authorized person.
    (b) Notwithstanding the above, no action shall be taken to withhold 
an allotment from the pay and allowances of any officer until such 
officer has had an opportunity to consult with a legal officer of the 
Department to discuss the legal and other factors involved with respect 
to the officer's support obligation and his or her failure to make 
payments. The Department shall exercise continuing good faith efforts to 
arrange such a consultation, but must begin to withhold allotments on 
the first end-of-month payday after 30 days have elapsed since notice of 
an opportunity to consult was sent to the officer.



Sec. 21.74  Responsibilities.

    (a) The General Counsel, Office of the Secretary, Department of 
Health and Human Services, shall be the Designated Official for the 
Department

[[Page 84]]

and shall provide guidance to the Service regarding administration of 
the provisions of these regulations.
    (b) The Commissioned Personnel Operations Division, Office of 
Personnel Management, Office of Management, Office of the Assistant 
Secretary for Health, shall implement the provisions of these 
regulations.



Sec. 21.75  Procedures.

    (a) Service of notice. (1) An authorized person shall serve on the 
designated official of the Department a signed notice including:
    (i) Full name of the officer;
    (ii) Social security number of the officer;
    (iii) Duty station location of the officer, if known;
    (iv) A statement that support payments are delinquent by an amount 
at least equal to the amount of support payable for two months;
    (v) A photocopy, along with any modifications, of the underlying 
support order;
    (vi) A statement of the amount of arrearages provided for in the 
court order and the amount which is to be applied each month toward 
liquidation of the arrearages, if applicable;
    (vii) The full name and address of the payee to whom the allotment 
will be payable;
    (viii) Any limitations on the duration of the support allotment.
    (2) The service of notice shall be accomplished by certified or 
registered mail, return receipt requested, or by personal service, upon 
the appropriate designated official of the Department. The designated 
official shall note the date and time of receipt on the notice.
    (3) Valid service is not accomplished until the notice is received 
in the office of the designated official.
    (4) If the order of a court or duly authorized administrative agency 
seeks collection of arrearages, the notice must state that the support 
allotment qualifies for the additional 5 percent in excess of the 
maximum percentage limitations found in 15 U.S.C. 1673. Supporting 
evidence must be submitted to the Department establishing that the 
support order is 12 or more weeks in arrears.
    (5) When the information submitted is not sufficient to identify the 
officer the notice shall be returned directly to the authorized person 
with an explanation of the deficiency. However, before returning the 
notice, an attempt should be made to inform the authorized person who 
caused the notice to be served that it will not be honored unless 
adequate information is supplied.
    (6) Upon proper service of notice of delinquent support payments and 
together with all required supplementary documents and information, the 
Service shall identify the officer from whom moneys are due and payable. 
The pay of the officer shall be reduced by the amount necessary to 
comply with the support order and liquidate arrearages if any, if 
provided by order of a court or duly authorized administrative agency. 
The maximum amount to be alloted under the provision together with any 
other moneys withheld from the officer for support pursuant to a court 
order may not exceed:
    (i) 50 percent of the officer's disposable earnings for any month 
when the officer asserts by affidavit or other acceptable evidence that 
he or she is supporting a spouse or dependent child or both, other than 
a party in the support order. When the officer submits evidence, copies 
shall be sent to the authorized person, together with notification that 
the officer's support claim will be honored. If the support claim is 
contested by the authorized person, the authorized person may refer it 
to the appropriate court or other authority for resolution. Pending 
resolution of a contested support claim, the allotment shall be made but 
the amount of such allotment may not exceed 50 percent of the officer's 
disposable earnings;
    (ii) 60 percent of the officer's disposable earnings for any month 
when the officer fails to assert by affidavit or other acceptable 
evidence, that he or she is supporting a spouse or dependent child or 
both;
    (iii) Regardless of the limitations above, an additional five 
percent of the officer's disposable earnings shall be withheld when it 
is stated in the notice that the officer is in arrears in an amount 
equivalent to 12 or more weeks' support.

[[Page 85]]

    (b) Disposable earnings. (1) The following moneys, as defined in the 
U.S. Public Health Service Commissioned Corps Personnel Manual, are 
subject to inclusion in computation of the officer's disposable 
earnings:
    (i) Basic pay;
    (ii) Basic allowances for quarters for officers with dependents and 
officers without dependents;
    (iii) Basic allowance for subsistence;
    (iv) Special pay for physicians, dentists, optometrists, and 
veterinarians;
    (v) Hazardous duty pay;
    (vi) Flying pay; and
    (vii) Family separation allowances (only for officers assigned 
outside the contiguous United States).
    (c) Exclusions. The following moneys are excluded from the 
computation of the officer's disposable earnings. Amounts due from or 
payable by the United States shall be offset by any amounts:
    (1) Owed by the officer to the United States.
    (2) Required by law to be deducted from the remuneration or other 
payment involved including but not limited to:
    (i) Amounts withheld from benefits payable under title II of the 
Social Security Act when the withholding is required by law;
    (ii) FICA.
    (3) Properly withheld for Federal and State income tax purposes if 
the withholding of the amounts is authorized or required by law and if 
amounts withheld are not greater than would be the case if the 
individual claimed all dependents to which he or she were entitled. The 
withholding of additional amounts pursuant to 26 U.S.C. 3402(i) may be 
permitted only when the officer presents evidence of a tax obligation 
which supports the additional withholding.
    (4) Deducted for the Servicemen's Group Life Insurance coverage.
    (5) Advances of pay that may be due and payable by the officer in 
the future.
    (d) Officer Notification. (1) As soon as possible, but not later 
than 30 calendar days after the date of receipt of notice, the 
Commissioned Personnel Operations Division shall send to the officer at 
his or her duty station, written notice:
    (i) That notice has been served, including a copy of the documents 
submitted;
    (ii) Of the maximum limitations set forth, with a request that the 
officer submit supporting affidavits or other documentation necessary 
for determining the applicable percentage limitation;
    (iii) That by submitting supporting affidavits or other necessary 
documentation, the officer consents to the disclosure of such 
information to the party requesting the support allotment;
    (iv) Of the amount of percentage that will be deducted if the 
officer fails to submit the documentation necessary to enable the 
designated official of the Service to respond to the legal process 
within the time limits set forth;
    (v) That a consultation with a legal officer is authorized and will 
be provided by the Department. The name, address, and telephone number 
of the legal officer will be provided;
    (vi) That the officer may waive the personal consultation with a 
legal officer; however if consultation is waived action will be taken to 
initiate the allotment by the first end-of-month payday after 
notification is received that the officer has waived his/her 
consultation;
    (vii) That the allotment will be initiated without the officer 
having received a personal consultation with a legal officer if the 
legal officer provides documentation that consultation could not be 
arranged even though good faith attempts to do so had been made; and
    (viii) Of the date that the allotment is scheduled to begin.
    (2) The Commissioned Personnel Operations Division shall inform the 
appropriate legal officer of the need for consultation with the officer 
and shall provide the legal officer with a copy of the notice and other 
legal documentation served on the designated official.
    (3) If possible, the Commissioned Personnel Operations Division 
shall provide the officer with the following:
    (i) A consultation in person with the appropriate legal officer to 
discuss the legal and other factors involved with

[[Page 86]]

the officer's support obligation and his/her failures to make payment;
    (ii) Copies of any other documents submitted with the notice.
    (4) The legal officer concerned will confirm in writing to the 
Commissioned Personnel Operations Division within 30 days of notice that 
the officer received a consultation concerning the officer's support 
obligation and the consequences of failure to make payments. The legal 
officer concerned must advise the Commissioned Personnel Operations 
Division of the inability to arrange such consultation and the status of 
continuing efforts to contact the officer.
    (e) Lack of money. (1) When notice is served and the identified 
officer is found not to be entitled to any moneys due from or payable by 
the Department of Health and Human Services, the Commissioned Personnel 
Operations Division shall return the notice to the authorized person, 
and advise in writing that no moneys are due from or payable by the 
Department of Health and Human Services to the named individual.
    (2) Where it appears that moneys are only temporarily exhausted or 
otherwise unavailable, the Commissioned Personnel Operations Division 
shall advise the authorized person in writing on a timely basis as to 
why, and for how long, the moneys will be unavailable.
    (3) In instances where the officer separates from active duty, the 
authorized person shall be informed in writing on a timely basis that 
the allotment is discontinued.
    (f) Effective date of allotment. Allotments shall be withheld 
beginning on the first end-of-month payday after the Commissioned 
Personnel Operations Division is notified that the officer has had a 
consultation with a legal officer, has waived his/her right to such 
consultation, or the legal officer has submitted documentation that a 
consultation with the officer could not be arranged after good faith 
attempts to do so were made by the legal officer. The Service shall not 
be required to vary its normal allotment payment cycle to comply with 
the notice.
    (g) Designated official. Department of Health and Human Services, 
General Counsel, Room 5362 North Building, 330 Independence Avenue, SW., 
Washington, DC 20201.

(Approved by the Office of Management and Budget under control number 
0937-0123)



PART 22_PERSONNEL OTHER THAN COMMISSIONED OFFICERS--Table of Contents




   Hansen's Disease Duty by Personnel Other Than Commissioned Officers

Sec.
22.1 Duty at a station of the Service devoted to the care of Hansen's 
          disease patients; additional pay.

                           Special Consultants

22.3 Appointment of special consultants.
22.5 Leave without pay while on detail.

    Authority: Sec. 208(e) of the Public Health Service Act, 42 U.S.C. 
210(e); E.O. 11140, 29 FR 1637.

   Hansen's Disease Duty by Personnel Other Than Commissioned Officers



Sec. 22.1  Duty at a station of the Service devoted to the care of Hansen's 

disease patients; additional pay.

    (a) Non-commissioned officers and other employees of the Service 
shall not receive any additional compensation by reason of being 
assigned to any duty requiring intimate contact with persons with 
Hansen's disease. However, any such officer or employee who was 
entitled, on January 4, 1986, to receive additional pay by reason of 
being assigned to full-time duty, for a period of 30 days or more, at a 
station of the Service devoted to the care of Hansen's disease patients 
and who continues to be assigned to such duty, shall receive special pay 
as long as such assignment continues without a break.
    (b) Such special pay shall, on any future date, be at an annual 
dollar level equal to the lower of the levels that would be paid under 
the following subparagraphs:
    (1) 25% of the lowest level of basic pay that he or she has been 
receiving on any date from January 4, 1986, through that future date;
    (2) The amount by which the level of an employee's basic pay plus 
special pay on January 4, 1986, exceeds the level of that employee's 
basic pay on that on that future date, except that

[[Page 87]]

the special pay under this subparagraph shall not be less that 12 times 
the monthly special pay then paid to Commissioned Officers entitled to 
special pay for duty involving intimate contact with persons who have 
Hansen's disease. (As of October 24, 1985, that monthly rate was $110.)
    (c) An officer or employee may be paid special pay for any pay 
period, under paragraphs (a) and (b) of this section, only to the extent 
that it does not cause his or her aggregate pay for that pay period to 
exceed the biweekly rate of basic pay for Level V of the Executive 
Schedule. As used in this paragraph, ``aggregate pay'' comprises basic 
pay, this special pay, and premiums for overtime, nightwork, irregular 
duty, standby status, and Sunday or holiday work.

[50 FR 43146, Oct. 24, 1985]

                           Special Consultants



Sec. 22.3  Appointment of special consultants.

    (a) When the Public Health Service requires the services of 
consultants who cannot be obtained when needed through regular Civil 
Service appointment or under the compensation provisions of the 
Classification Act of 1949, special consultants to assist and advise in 
the operations of the Service may be appointed, subject to the 
provisions of the following paragraphs and in accordance with such 
instructions as may be issued from time to time by the Secretary of 
Health and Human Services.
    (b) Appointments, pursuant to the provisions of this section, may be 
made by those officials of the Service to whom authority has been 
delegated by the Secretary or his designee.
    (c) The per diem or other rates of compensation shall be fixed by 
the appointing officer in accordance with criteria established by the 
Surgeon General.

(Sec. 208(c), 58 Stat. 686, as amended; 42 U.S.C. 209(e); sec. 207(f), 
58 Stat. 686 as amended by 62 Stat. 40; 42 U.S.C. 209(f))

[21 FR 9821, Dec. 12, 1956, as amended at 31 FR 12939, Oct. 5, 1966]



Sec. 22.5  Leave without pay while on detail.

    The Secretary or his delegate may, pursuant to section 214(d) of the 
Public Health Service Act, 42 U.S.C. 215(d), and with the consent of the 
officer or employee concerned, arrange, through agreements or otherwise, 
for a civilian officer or employee of the Public Health Service to be 
placed on leave without pay for the period of a detail to a State, a 
subdivision thereof, or a private non-profit institution and be paid by 
the non-Federal organization. Such an arrangement may be for a period of 
not to exceed 2 years, but may be extended for additional periods of not 
to exceed 2 years each.

(Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216)

[33 FR 18981, Dec. 20, 1968]



PART 23_NATIONAL HEALTH SERVICE CORPS--Table of Contents




     Subpart A_Assignment of National Health Service Corps Personnel

Sec.
23.1 To what entities does this regulation apply?
23.2 Definitions.
23.3 What entities are eligible to apply for assignment?
23.4 How must an entity apply for assignment?
23.5 What are the criteria for deciding which applications for 
          assignment will be approved?
23.6 What are the criteria for determining the entities to which 
          National Health Service Corps personnel will be assigned?
23.7 What must an entity agree to do before the assignment is made?
23.8 What operational requirements apply to an entity to which National 
          Health Service Corps personnel are assigned?
23.9 What must an entity to which National Health Service Corps 
          personnel are assigned (i.e., a National Health Service Corps 
          site) charge for the provision of health services by assigned 
          personnel?
23.10 Under what circumstances may a National Health Service Corps 
          site's reimbursement obligation to the Federal Government be 
          waived?
23.11 Under what circumstances may the Secretary sell equipment or other 
          property of the United States used by the National Health 
          Service Corps site?
23.12 Who will supervise and control the assigned personnel?

[[Page 88]]

23.13 What nondiscrimination requirements apply to National Health 
          Service Corps sites?

    Subpart B_Private Practice Special Loans for Former Corps Members

23.21 Definitions.
23.22 What is the purpose of a private practice loan?
23.23 Who is eligible to receive a private practice option loan?
23.24 In what amounts are loans made?
23.25 How will interest rates for loans be determined?
23.26 How is the loan repaid?
23.27 What happens if scheduled payments are late?
23.28 What events constitute default?
23.29 What happens in the case of a default?
23.30 May the loan be prepaid?
23.31 May loan payments be postponed or waived?
23.32 What conditions are imposed on the use of the loan funds?
23.33 What security must be given for these loans?
23.34 What other conditions are imposed?
23.35 What criteria are used in making loans?

                     Subpart C_Private Startup Loans

23.41 What conditions are applicable to loans under this subpart?

    Authority: Secs. 333, 338E(c), and 338C(e)(1), Public Health Service 
Act. 90 Stat. 2272, as amended, 95 Stat. 905, 97 Stat. 1345 (42 U.S.C. 
254f et seq.), 95 Stat. 912 (42 U.S.C. 254p(c)), 95 Stat. 910 (42 U.S.C. 
254n(e)(1)).

    Source: 45 FR 12790, Feb. 27, 1980, unless otherwise noted.



     Subpart A_Assignment of National Health Service Corps Personnel



Sec. 23.1  To what entities does this regulation apply?

    This regulation applies to the assignment of National Health Service 
Corps personnel under section 333 et seq. of the Public Health Service 
Act (42 U.S.C. 254f) to provide health services in or to health manpower 
shortage areas as designated under section 332 of the Public Health 
Service Act (42 U.S.C. 254e).



Sec. 23.2  Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended.
    Assigned National Health Service Corps personnel or Corps personnel 
means health personnel of the Regular and Reserve Corps of the Public 
Health Service Commissioned Corps and civilian personnel as designated 
by the Secretary including, but not limited to, physicians, dentists, 
nurses, and other health professions personnel who are assigned under 
section 333 of the Act and this regulation.
    Health manpower shortage area means the geographic area, the 
population group, the public or nonprofit private medical facility or 
any other public facility which has been determined by the Secretary to 
have a shortage of health manpower under section 332 of the Act and its 
implementing regulation (42 CFR part 5).
    National Health Service Corps site means the entity to which 
personnel have been assigned under section 333 of the Act and this 
regulation to provide health services in or to health manpower shortage 
area.
    Nonprofit private entity means as entity which may not lawfully hold 
or use any part of its net earnings to the benefit of any private 
shareholder or individual and which does not hold or use its net 
earnings for that purpose.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of that Department to whom the authority 
involved has been delegated.



Sec. 23.3  What entities are eligible to apply for assignment?

    Any public or nonprofit private entity which is located in a health 
manpower shortage area, or has a demonstrated interest in the shortage 
area, may apply for the assignment of National Health Service Corps 
personnel.



Sec. 23.4  How must an entity apply for assignment?

    (a) An application for the assignment of National Health Service 
Corps personnel must be submitted to the Secretary by an eligibe 
applicant in the form and at the time prescribed by the

[[Page 89]]

Secretary. \1\ The application must be signed by an individual 
authorized to act for the applicant and to assume on behalf of the 
applicant the obligations imposed by law, the Act, this regulation, and 
any additional conditions of assignment imposed under these authorities.
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from Regional 
Offices of the Department of Health and Human Services at the addresses 
set forth at 45 CFR 5.31(b).
---------------------------------------------------------------------------

    (b) In addition to other pertinent information required by the 
Secretary, an application for the assignment of Corps personnel must 
include--
    (1) A description of the applicant's overall organizational 
structure;
    (2) A justification of the request for the assignment of personnel 
based upon the needs of the health manpower shortage area;
    (3) A description of the applicant's financial plan for operating 
the National Health Service Corps site including a proposed budget, 
sources of non-Federal support obtained, and the proposed expenditures 
for obtaining adequate support staff, equipment and supplies;
    (4) A list of the proposed fees and discounted fees to be charged 
for the provision of health services; and
    (5) If an entity wishes to request an interest free loan (not to 
exceed $50,000) under section 335(c) of the Act to assist the applicant 
in establishing the practice of the assigned National Health Service 
Corps personnel, a detailed justification of the amount requested must 
be included.
    (c) An application for assignment must include evidence that the 
applicant has provided a copy of the completed application for review to 
(1) each health systems agency designated under section 1515 of the Act 
for the health service area which includes all or part of the health 
manpower shortage area for which as assignment of National Health 
Service Corps personnel is sought or (2) if no health systems agency has 
been designated for such a health service area, to each State health 
planning and development agency designated under section 1521 of the Act 
for each State which includes all or part of the health manpower 
shortage area for which an assignment of National Health Service Corps 
personnel is sought.
    (d) If an application for assignment is filed by an applicant which 
had previously been assigned National Health Service Corps personnel 
under an agreement entered into under section 329 of the Act as in 
effect before October 1, 1977, or under section 334 of the Act, the 
applicant must provide the information the Secretary considers necessary 
to make the determinations required by section 333(a)(1)(D) of the Act.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec. 23.5  What are the criteria for deciding which applications for 

assignment will be approved?

    (a) In approving or disapproving an application for assignment of 
Corps personnel, the Secretary will consider, among other pertinent 
factors:
    (1) The applicant's ability and plans to meet the operational 
requirements in Sec. 23.8.
    (2) The administrative and managerial capability of the applicant.
    (3) The soundness of the applicant's financial plan for operating 
the National Health Service Corps site.
    (4) The extent to which community resources will be used in 
operating the National Health Service Corps site.
    (5) Comments received from any designated health systems agency or 
any designated State health planning and development agency to which an 
application was submitted for review under Sec. 23.4(c).
    (6) Comments received from health professional societies serving the 
health manpower shortage area.
    (b) Special consideration for the assignment of Corps personnel will 
be given to the entity which is located in a health manpower shortage 
area over an entity which is not located in a health manpower shortage 
area but has a demonstrated interest in it.



Sec. 23.6  What are the criteria for determining the entities to which 

National Health Service Corps personnel will be assigned?

    (a) The Secretary may, upon approving an application for the 
assignment of personnel and after entering into an

[[Page 90]]

agreement with an applicant under Sec. 23.7, assign National Health 
Service Corps personnel to provide health services in or to a health 
manpower shortage area.
    (b) In assigning National Health Service Corps personnel to serve in 
a health manpower shortage area, the Secretary will seek to assign 
personnel who have those characteristics which will increase the 
probability of their remaining to serve in the health manpower shortage 
area upon completion of the period of assignment. In addition, the 
Secretary will apply a weighted-value system in which the first factor 
listed below is assigned the greatest weight and the second, and third 
factors are assigned lesser weights in descending order:
    (1) The need of the health manpower shortage area as determined by 
criteria established under section 332(b) of the Act.
    (2) The willingness of individuals, government agencies, or health 
entities within the health manpower shortage area to cooperate with the 
National Health Service Corps in providing effective health services.
    (3) The comments of health professional societies serving the health 
manpower shortage area.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec. 23.7  What must an entity agree to do before the assignment is made?

    (a) Requirements. To carry out the purposes of section 334 of the 
Act, each National Health Service Corps site must enter into an 
agreement with the Secretary under which the site agrees to:
    (1) Be responsible for charging for health services provided by 
assigned National Health Service Corps personnel;
    (2) Take reasonable action for the collection of the charges for 
those health services;
    (3) Reimburse the United States the sums required under section 334 
of the Act; and
    (4) Prepare and submit an annual report. The agreement will set 
forth the period of assignment (not to exceed 4 years), the number and 
type of Corps personnel to be assigned to the site, and other 
requirements which the Secretary determines necessary to carry out the 
purposes of the Act.
    (b) Termination. An agreement entered into under this section may be 
terminated by either party on 30-days written notice or modified by 
mutual consent consistent with section 333 of the Act.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec. 23.8  What operational requirements apply to an entity to which National 

Health Service Corps personnel are assigned?

    Each National Health Service Corps site must:
    (a) Operate a health care delivery system within a planned or 
existing community structure to assure:
    (1) The provision of high quality comprehensive health care;
    (2) To the extent feasible, full professional health care coverage 
for the health manpower shortage area;
    (3) Continuum of care; and
    (4) The availability and accessibility of secondary and tertiary 
health care (the two more sophisticated levels of health care beyond 
primary care);
    (b) Establish and maintain a patient record system;
    (c) Implement a system for maintaining the confidentiality of 
patient records;
    (d) Meet the requirements of applicable fire and safety codes;
    (e) Develop, to the extent feasible, linkages with other health care 
facilities for the provision of services which supplement or complement 
the services furnished by the assigned Corps personnel;
    (f) Operate a quality assurance system which meets the requirements 
of 42 CFR 51c.303(c) for the establishment and operation of a quality 
assurance system in a community health center; and
    (g) Establish basic data, cost accounting, and management 
information and reporting systems as prescribed by the Secretary.

[[Page 91]]



Sec. 23.9  What must an entity to which National Health Service Corps 

personnel are assigned (i.e., a National Health Service Corps site) charge for 

the provision of health services by assigned personnel?

    (a) Except as provided in paragraph (b) of this section, individuals 
receiving services from assigned National Health Service Corps personnel 
must be charged on a fee-for-service or other basis at a rate which is 
computed to permit recovery of the value of the services and is approved 
by the Secretary.
    (b) In determining whether to approve fees to be charged for health 
services, the Secretary will consider: The costs to the National Health 
Service Corps of providing the health services; the costs to the health 
manpower shortage area for providing the services; and the charges for 
similar services by other practitioners or facilities in or nearby the 
health manpower shortage area. However, if assigned National Health 
Service Corps personnel are providing services within the framework of 
an established health services delivery system, the Secretary may 
approve the fees charged under that system without regard to the 
foregoing factors.
    (c)(1) No charge or a nominal charge will be made for health 
services provided by assigned National Health Service Corps personnel to 
individuals within the health manpower shortage area with annual incomes 
at or below the ``CSA Income Poverty Guidelines'' (45 CFR 1060.2). 
However, no individual will be denied health services based upon 
inability to pay for the services. Any individual who has an annual 
income above the ``CSA Income Poverty Guidelines,'' but whose income 
does not exceed 200 percent of the CSA levels, will receive health 
services at a nominal charge. However, charges will be made for services 
to the extent that payment will be made by a third party which is 
authorized or under legal obligation to pay the charges.
    (2) The provisions of this paragraph also apply with respect to 
services provided by an individual who is fulfilling an NHSC scholarship 
obligation under section 753 or who received a special grant under 
section 755.



Sec. 23.10  Under what circumstances may a National Health Service Corps 

site's reimbursement obligation to the Federal Government be waived?

    (a) The Secretary may waive in whole or in part the reimbursement 
requirements of section 334(a)(3) of the Act if he determines that:
    (1) The National Health Service Corps site is financially unable to 
meet the reimbursement requirements or that compliance with those 
requirements will unreasonably limit the ability of the site to 
adequately support the provision of services by assigned Corps 
personnel. In making these determinations, the Secretary will consider--
    (i) The costs necessary to adequately support the health services 
provided by the assigned National Health Service Corps personnel and the 
income and financial resources available to meet the costs;
    (ii) The ability of the applicant to obtain credit from suppliers, 
lending institutions, private organizations and individuals;
    (iii) The need of the health manpower shortage area for health 
services; and
    (iv) The extent to which the National Health Service Corps site 
utilizes health professions personnel.
    (2) A significant percentage of the individuals who are located in 
the health manpower shortage area and are receiving the health services 
of the assigned National Health Service Corps personnel are elderly, 
living in poverty, or have other characteristics which indicate an 
inability to pay. For purposes of this section, ``elderly'' means 
persons 65 years or older and the ``CSA Income Poverty Guidelines'' will 
be used as the standard for determining whether individuals are living 
in poverty. Other characteristics indicating inability to pay include, 
but are not to be limited to, the ratio of unemployment in the health 
manpower shortage area and the area's cost-of-living index.
    (b) The Secretary may waive in whole or in part the reimbursement 
requirements of section 334(f)(1) of the Act if he or she determines 
that the National Health Service Corps site is a small health center (as 
defined by section 334(f)(5) of the Act) that needs all

[[Page 92]]

or part of the amount otherwise payable to--
    (1) Expand or improve its provision of health services;
    (2) Increase the number of individuals served;
    (3) Renovate or modernize facilities for its provision of health 
services;
    (4) Improve the administration of its health service programs; or
    (5) Establish a financial reserve to assure its ability to continue 
providing health services;
    (c) Where the Secretary determines that a National Health Service 
Corps site is eligible for a waiver under paragraph (a) (1) or (2) of 
this section. the Secretary may waive the application of the 
reimbursement requirements of section 334(a)(3) of the Act and apply the 
reimbursement requirements of section 334(f)(1) of the Act. The 
Secretary may waive in whole or in part the reimbursement requirements 
of section 334(f)(1) for such a site if he or she determines that the 
National Health Service Corps site meets the requirements of paragraph 
(a)(1) of this section. Funds retained by a National Health Service 
Corps site as a result of such waiver must be used for the purposes set 
forth in paragraphs (b) (1) through (5) of this section.
    (d) Requests for a prospective or retrospective waiver must be made 
at the time and in the manner and contain the documentation prescribed 
by the Secretary.

[45 FR 12790, Feb. 27, 1980, as amended at 51 FR 31948, Sept. 8, 1986]



Sec. 23.11  Under what circumstances may the Secretary sell equipment or other 

property of the United States used by the National Health Service Corps site?

    (a) Upon expiration of the assignment of all Corps personnel to a 
health manpower shortage area, the Secretary may sell equipment and 
other property of the United States used by the assigned personnel. The 
equipment may be sold at the fair market value or less than the fair 
market value to any entity providing health services in or to a health 
manpower shortage area if the Secretary determines that an entity is 
unable to pay the fair market value. In determining whether an entity is 
financially unable to purchase equipment or property at fair market 
value, the Secretary will consider (1) the present financial resources 
of the entity available to purchase the equipment or property based upon 
its current liabilities, and (2) the entity's ability to obtain the 
funds necessary to purchase the equipment or property. However, the 
Secretary will not sell the equipment or property for less than fair 
market value to a profitmaking organization unless the organization 
gives reasonable assurance that it will use the equipment or property to 
provide health services in or to the health manpower shortage area.
    (b) The Secretary will give priority to sales to an entity providing 
reasonable assurance that it will use the equipment or property for the 
purpose of retaining within the health manpower shortage area National 
Health Service Corps personnel who have completed their assignments.



Sec. 23.12  Who will supervise and control the assigned personnel?

    Assigned National Health Service Corps personnel will at all times 
remain under the direct supervision and control of the Secretary. 
Observance of institutional rules and regulations by the assigned 
personnel is a mere incident of the performance of their Federal 
functions and does not alter their direct professional and 
administrative responsibility to the Secretary.



Sec. 23.13  What nondiscrimination requirements apply to National Health 

Service Corps sites?

    National Health Service Corps sites are advised that in addition to 
complying with the terms and conditions of this regulation, the 
following laws and regulations are applicable--
    (a) Title VI of the Civil Rights Act of 1964 (43 U.S.C. 2000d et 
seq.) and its implementing regulations, 45 CFR part 80 (prohibiting 
discrimination in federally assisted programs on the grounds of race, 
color, or national origin); and
    (b) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794) 
and its implementing regulations, 45 CFR part 84 (prohibiting 
discrimination in federally assisted programs on the basis of handicap).

[[Page 93]]

    (c) The Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.) and 
its implementing regulations, 45 CFR part 91 (prohibiting 
nondiscrimination on the basis of age in HHS programs or activities 
receiving Federal financial assistance).

[45 FR 12790, Feb. 27, 1980, as amended at 49 FR 38109, Sept. 27, 1984]



    Subpart B_Private Practice Special Loans for Former Corps Members

    Source: 51 FR 31948, Sept. 8, 1986, unless otherwise noted.



Sec. 23.21  Definitions.

    As used in this subpart, terms have the same meanings as those given 
to them in subpart A, Sec. 23.2. In addition:
    National Health Service Corps scholarship recipient means an 
individual receiving a scholarship under the Public Health and National 
Health Service Corps Scholarship Training Program authorized by section 
225 of the Act as in effect on September 30, 1977, and repealed on 
October 1, 1977, or a scholarship under the NHSC Scholarship Program 
authorized by section 338A of the Act, formerly section 751 of the Act.
    Private full-time clinical practice means the provision of 
ambulatory clinical services for a minimum of 40 hours per week for at 
least 45 weeks a year, including the provision of hospital coverage 
services appropriate to meet the needs of patients treated and to assure 
continuity of care. The 40 hours per week must be performed in no less 
than 4 days per week with no more than 12 hours of work being performed 
in any 24-hour period.



Sec. 23.22  What is the purpose of a private practice loan?

    The purpose of the private practice loan is to assist NHSC 
scholarship recipients in establishing private full-time clinical 
practices in designated health manpower shortage areas.



Sec. 23.23  Who is eligible to receive a private practice option loan?

    (a) Eligibility for loans is limited to NHSC scholarship recipients 
who have completed at least 2 years of their service obligations at a 
NHSC site. NHSC scholarship recipients remain eligible for loans under 
this subpart for 1 year after they have completed their service 
obligations at a NHSC site.
    (b) Scholarship recipients who are in arrears 31 days or more on a 
Health Professions Student Loan (42 U.S.C. 294m et seq.), Health 
Education Assistance Loan (42 U.S.C. 294, et seq.), Nursing Student Loan 
(42 U.S.C. 297a et seq.), or any other Federally guaranteed or direct 
student loan are ineligible for this loan program.
    (c) NHSC scholarship recipients who have received loans under either 
this subpart or subpart C of this part are ineligible for loans under 
this subpart.



Sec. 23.24  In what amounts are loans made?

    The Secretary may make loans either in the amount of $12,500, if the 
recipient agrees to practice in accordance with the loan agreement for a 
period of at least 1 year but less than 2 years, or $25,000, if the 
recipient agrees to practice in accordance with the loan agreement for a 
period of at least 2 years.



Sec. 23.25  How will interest rates for loans be determined?

    Interest will be charged at the Treasury Current Value of Funds 
(CVF) rate in effect on April 1 immediately preceding the date on which 
the loan is approved and will accrue from the date the loan funds are 
disbursed to the borrower.



Sec. 23.26  How is the loan repaid?

    Payments shall be made at monthly intervals, beginning 1 month from 
the date of the loan disbursement, in accordance with the repayment 
schedule established by the Secretary and set forth in the loan 
agreement. Only interest payments are required during the first 2 years. 
The repayment schedule may be extended in accordance with Sec. 
23.31(a).



Sec. 23.27  What happens if scheduled payments are late?

    (a) Failure to make full payment of principal and/or interest when 
due will subject the borrower to the assessment of administrative costs 
and penalty

[[Page 94]]

charges, in addition to the regular interest charge, in accordance with 
45 CFR part 30.
    (b) Failure to make full payment of principal and/or interest when 
due may result in the Secretary placing the borrower in default of the 
loan. See Sec. 23.28(a).



Sec. 23.28  What events constitute default?

    The following events will constitute defaults of the loan agreement:
    (a) Failure to make full payment of principal and/or interest when 
due, and continuance of that failure for a period of sixty (60) days, or 
a lesser period of time if the Secretary determines that more immediate 
action is necessary in order to protect the interests of the Government.
    (b) Failure to perform or observe any of the terms and conditions of 
the loan agreement and continuance of that failure for a period of sixty 
(60) days.
    (c) The institution of bankruptcy proceedings, either voluntary or 
involuntary, under any State or Federal statute, which may adversely 
affect the borrower's ability to comply with the terms and conditions of 
the agreement or the promissory note.



Sec. 23.29  What happens in the case of a default?

    (a) In the event of default, the Secretary may declare the entire 
amount owed (including principal, accrued interest and any applicable 
charges) immediately due and payable. Collection of the amount owed will 
be made in accordance with 45 CFR part 30.
    (b) The borrower is not entitled to written notice of any default 
and the failure to deliver written notice of default in no way affects 
the Secretary's right to declare the loan in default and take any 
appropriate action under the loan agreement or the promissory note.
    (c) The failure of the Secretary to exercise any remedy available 
under law or regulation shall in no event be construed as a waiver of 
his or her right to exercise that remedy if any subsequent or continued 
default or breach occurs.



Sec. 23.30  May the loan be prepaid?

    The borrower shall have the option to prepay the balance of any part 
of the loan, together with accrued interest, at any time without 
prepayment penalty.



Sec. 23.31  May loan payments be postponed or waived?

    (a) Whenever health, economic, or other personal problems affect the 
borrower's ability to make scheduled payments on the loan, the Secretary 
may allow the borrower an extension of time or allow the borrower to 
make smaller payments than were previously scheduled; however, interest 
will continue to accrue at the rate specified in the promissory note 
until the loan is repaid in full. The loan must be fully repaid within 
10 years after it was made.
    (b) No waiver, full or partial, of repayment of the loan will be 
granted; except that the obligation of a borrower to repay a loan shall 
be cancelled upon the death or total and permanent disability of the 
borrower, as determined by the Secretary.
    (c) In order to make a determination under paragraph (a) or (b) of 
this section, the Secretary may require supporting medical, financial, 
or other documentation.



Sec. 23.32  What conditions are imposed on the use of the loan funds?

    (a) The borrower must use the total amount of the loan to purchase 
or lease, or both, equipment and supplies, to hire authorized personnel 
to assist in providing health services and/or to renovate facilities for 
use in providing health services in his or her private practice. 
Equipment and supplies purchased and/or leased, personnel hired and 
facilities renovated shall be limited to the items requested in the loan 
application and approved by the Secretary.
    (b) The borrower must expend the loan funds within 6 months from the 
date of the loan or within such other time as the Secretary may approve. 
Documentation of the expenditure of funds must be furnished to the 
Secretary upon request.



Sec. 23.33  What security must be given for these loans?

    The Secretary may require the borrower to pledge to the Secretary a 
security interest in specified collateral.

[[Page 95]]



Sec. 23.34  What other conditions are imposed?

    (a) The borrower must sign a loan agreement describing the loan and 
practice conditions, and a promissory note agreeing to repay the loan 
plus interest.
    (b) The borrower must agree to enter into private full-time clinical 
practice in a HMSA for the time period specified in the loan agreement.
    (c) The borrower must accept assignment, for the time period 
specified in the loan agreement, under section 1842(b)(3)(B)(ii) of the 
Social Security Act as full payment for all services for which payment 
may be made under part B of title XVIII of that Act.
    (d) The borrower must enter into an appropriate agreement, for the 
time period specified in the loan agreement, with the State agency which 
administers the State plan for medical assistance under title XIX of the 
Social Security Act to provide services to individuals entitled to 
medical assistance under the plan.
    (e) During the time period specified in the loan agreement, the 
borrower must provide health services to individuals at the usual and 
customary rate prevailing in the HMSA in which services are provided; 
however, services must be provided at no charge or at a nominal charge 
to those persons unable to pay for these services.
    (f) The borrower must keep and preserve all documents, including 
bills, receipts, checks, and correspondence which affect the operation 
of the private practice and the expenditure of loan funds for the period 
of the practice obligation specified in the loan agreement plus 3 years. 
Accounts will be maintained under one of the accounting principles 
identified by the Secretary in the loan agreement.
    (g) The borrower must provide the Secretary and the Controller 
General of the United States, or their representatives, access during 
normal working hours to accounts, documents, and records for the 
purposes of audit or evaluation; and must permit the Secretary or his or 
her representative to inspect the private practice at reasonable times 
during the period of the practice obligation specified in the loan 
agreement plus 3 years. All information as to personal facts and 
circumstances about recipients of services shall be held confidential, 
and shall not be divulged without the individual's consent except as may 
be required by law or as may be necessary to provide medical service to 
the individual or to provide for medical or fiscal audits by the 
Secretary or his or her designee with appropriate safeguards for 
confidentiality of records.
    (h) For the entire period of loan repayment, the borrower must 
acquire, maintain, and when requested, must provide the Secretary with 
copies of policies of insurance on equipment and supplies in amounts 
adequate to reasonably protect the borrower from risk, including public 
liability, fire, theft, and worker's compensation.
    (i) If the Secretary retains a security interest pursuant to Sec. 
23.33, the borrower must keep and preserve all documents which affect 
that security interest for the period of the loan repayment and allow 
the Secretary or his or her designee access, during normal working 
hours, to those documents.
    (j) The borrower must maintain the loan proceeds in a separate 
account from his or her other transactions and must agree to draw upon 
this account and expend the loan proceeds in accordance with Sec. 
23.32.
    (k) The Secretary may impose other conditions which he or she deems 
appropriate under law or regulation to protect the Government's 
interests.



Sec. 23.35  What criteria are used in making loans?

    Approval of loan applications will be based on the criteria set 
forth below:
    (a) The need in the HMSA for the applicant's health profession as 
determined under section 332 of the Act;
    (b) The applicant's need for the loan funds; and
    (c) The comments from State or local health professional societies 
on the appropriateness of the applicant's intended private practice; and
    (d) The applicant's credit worthiness and projected financial 
ability to repay the loan.

[[Page 96]]



                     Subpart C_Private Startup Loans



Sec. 23.41  What conditions are applicable to loans under this subpart?

    The regulations set out in subpart B of this part are fully 
applicable to loans awarded under section 338C(e)(1) of the Public 
Health Service Act, except as noted below;
    (a) Eligibility. (1) In lieu of Sec. 23.23(a), the following 
applies to loans made under this subpart:
    (i) Eligibility for loans is limited to NHSC scholarship recipients 
who plan to enter private practice and have not begun fulfilling their 
scholarship service obligation or are currently fulfilling their 
scholarship service obligation under section 338B of the Act and have 
completed less than 2 years of this obligation.
    (2) In lieu of Sec. 23.23(c), the following applies to loans made 
under this subpart:
    (i) NHSC scholarship recipients who have received loans under either 
this subpart or subpart B of this part are ineligible for loans under 
this subpart.
    (b) Loan amounts. (1) In lieu of Sec. 23.24, the following applies 
to loans made under this subpart:
    (i) The Secretary may make loans in the amount of $12,500 if the 
recipient agrees to practice in accordance with the loan agreement for a 
period of at least 1 year but less than 2 years or the remaining period 
of the borrower's NHSC scholarship service obligation, whichever is 
shorter.
    (ii) The Secretary may make loans in the amount of $25,000 if the 
recipient agrees to practice in accordance with the loan agreement for a 
period of at least 2 years or the remaining period of the borrower's 
NHSC scholarship service obligation, whichever is shorter.
    (c) Use of funds. (1) In lieu of Sec. 23.32(a), the following 
applies to loans made under this subpart:
    (i) The borrower must use the total amount of the loan only to 
purchase or lease, or both, the equipment and supplies needed for 
providing health services in his or her private practice. Equipment and 
supplies purchased and/or leased shall be limited to the items requested 
in the loan application and approved by the Secretary.

[51 FR 31950, Sept. 8, 1986]



PART 24_SENIOR BIOMEDICAL RESEARCH SERVICE--Table of Contents




Sec.
24.1 Establishment.
24.2 Allocation.
24.3 Policy Board.
24.4 Eligibility.
24.5 Peer review.
24.6 Pay and compensation.
24.7 Performance appraisal system.
24.8 Applicability of provisions of Title 5, U.S. Code.
24.9 Removal from the Service.
24.10 Reporting.

    Authority: Section 228(g) of the Public Health Service Act; 5 U.S.C. 
301.

    Source: 61 FR 6557, Feb. 21, 1996, unless otherwise noted.



Sec. 24.1  Establishment.

    There is established in the Public Health Service (PHS) a Senior 
Biomedical Research Service (SBRS) consisting of members the maximum 
number of which is prescribed by law.



Sec. 24.2  Allocation.

    (a) The Secretary, within the number authorized in the PHS Act, 
shall determine the number of SBRS slots to be allocated to each 
participating Operating Division.
    (b) The SBRS Policy Board may advise the Secretary to make 
adjustments to the allocation at any time.
    (c) The majority of the SBRS allocation is to be reserved for 
recruitment. The remaining SBRS allocation may be used for the retention 
of current employees.
    (d) SBRS slots will be used judiciously, resulting in SBRS 
appointments only where other senior-level appointing authorities are 
not sufficient to recruit or retain scientific talent.
    (e) The Secretary will ensure that SBRS slots are used in support of 
high priority programs authorized by Congress and which directly support 
the research goals and priorities of the Department.



Sec. 24.3  Policy Board.

    The Secretary or his/her designee shall establish an SBRS Policy 
Board to serve in an advisory capacity, recommending SBRS allocations 
among the participating Operating Divisions,

[[Page 97]]

reviewing the operations of the SBRS and ensuring consistent application 
of regulations, policies, and procedural guidelines, and recommending 
changes to the Secretary as necessary. Membership, to the extent 
possible, will include SBRS eligibles nominated by their respective 
Operating Divisions, will be weighted in proportion to Operating 
Divisions' SBRS allocations, and will include representation from the 
Office of the Secretary. The Secretary or his/her designee will select 
the board membership and the Chair.



Sec. 24.4  Eligibility.

    To be eligible for appointment to the Service an individual must 
have a doctoral-level degree in biomedicine or a related field and must 
meet the qualification standards prescribed by the U.S. Office of 
Personnel Management for appointment to a position at GS-15 of the 
General Schedule. In addition, the individual must be outstanding in the 
field of biomedical research or clinical research evaluation. 
Appointment to the Service will be made only to individuals actively 
engaged in either biomedical research or clinical research evaluation.
    (a) Outstanding in the field of biomedical research means an 
individual who is actively engaged in peer-reviewed original biomedical 
research and whose work in this area is considered by his or her peers 
to be outstanding. In order to meet the eligibility criteria, an 
individual must have conducted original peer-reviewed biomedical 
research resulting in major accomplishments reflected by a steady and 
current record of highly cited publications in peer-reviewed journals of 
high stature. In addition, the individual should be the recipient of 
major prizes and awards (such as visiting professorships and named 
lectureships) in recognition of original contributions to research.
    (b) Outstanding in the field of clinical research evaluation means 
that an individual is actively engaged in clinical research evaluation 
and is considered by his or her peers to be outstanding. In order to 
meet the eligibility criteria, an individual, by force of his or her own 
technical expertise, must be in a position to shape the course of drug 
or device evaluation or exert a similar influence on the PHS handling of 
other agents that may affect the public health. The individual would 
normally have dealt with complex, precedent-setting evaluation issues 
that involved significant scientific controversy, had far reaching 
implications for clinical research or resulted in a widespread economic 
effect in the health-care delivery system. In addition, the individual 
should have been involved in the development of scientific or regulatory 
guidelines for clinical research and been the recipient of invitations 
to speak at or to chair major national or international meetings and 
symposia.



Sec. 24.5  Peer review.

    An individual may not be considered for appointment into the SBRS 
unless his/her qualifications have been reviewed by a PHS peer review 
committee and the committee has recommended appointment to the Service.



Sec. 24.6  Pay and compensation.

    The SBRS is an ungraded system, with a single, flexible pay range to 
include all members.
    (a) Pay of the members of the Service shall be determined by the 
Secretary or his/her designee.
    (b) The pay of a member of the Service shall be not less than the 
minimum rate payable for GS-15 of the General Schedule and shall not 
exceed:
    (1) The rate payable for level I of the Executive Schedule unless a 
higher rate of pay is expressly approved on an individual basis by the 
President, pursuant to 5 U.S.C. 5377(d)(2), or
    (2) The rate payable for level II of the Executive Schedule unless a 
higher rate of pay is expressly approved on an individual basis by the 
Secretary.
    (c) While the full pay range will be used, individual pay at the 
higher end of the range will be used only as needed to recognize 
individual scientific value and as necessary to recruit or retain an 
exceptionally well-qualified scientist.
    (d) The following factors will be used in establishing appropriate 
pay rates for individual members:
    (1) Impact of the individual on the scientific field;

[[Page 98]]

    (2) Recognition of the individual by the scientific community;
    (3) Originality of the individual's ideas/work products;
    (4) Specific ``clinical'' or highly technical skills of the 
individual which are of benefit to the agency and which are in addition 
to requirements of the basic scientific assignment;
    (5) The individual's earnings and monetary benefits;
    (6) Salary surveys of similar skills in pertinent labor markets; and
    (7) Other relevant factors.
    (e) Annual adjustments to pay rates may be made effective on the 
first day of the first pay period on or after January 1 of each calendar 
year. The rate of such adjustments will be at the discretion of the 
Secretary or his/her designee, except that the minimum rate payable in 
the SBRS will be increased to the amount of the minimum rate of the GS-
15 of the General Schedule.
    (f) Other pay adjustments will be made on an individual basis by the 
Secretary or his/her designee.
    (g) Except as provided in paragraph (h) of this section, new 
appointees to the Service, who are not covered by the Civil Service 
Retirement System, will be covered by the Federal Employees Retirement 
System.
    (h) Upon the request of a member who performed service in the employ 
of an institution of higher education immediately prior to his 
appointment as a member of the Service, and retains the right to make 
contributions to the retirement system of such institution, the 
Department of Health and Human Services may contribute an amount not to 
exceed ten percent per annum of the member's basic pay to such 
institution's retirement system on behalf of such member. A member who 
participates in this program shall not be covered by any retirement 
system established for employees of the United States under title 5, 
United States Code.



Sec. 24.7  Performance appraisal system.

    The members of the Service shall be subject to a performance 
appraisal system which shall be designed to encourage excellence in 
performance and shall provide for a periodic and systematic appraisal of 
the performance of the members.



Sec. 24.8  Applicability of provisions of Title 5, U.S. Code.

    (a) Appointments to the Service shall be made without regard to the 
provisions of title 5, U.S. Code regarding appointments.
    (b) Members of the Service shall not be covered by the following 
provisions of title 5, U.S. Code:
    (1) Subchapter I of Chapter 35 (relating to retention preference in 
the event of reduction in force);
    (2) Chapter 43, Performance Appraisal (and performance-based 
actions);
    (3) Chapter 51 (relating to classification);
    (4) Subchapter III of Chapter 53, The General Schedule; and
    (5) Chapter 75, Adverse Actions.
    (c) Other provisions of Title 5 will be applied as administratively 
determined by the Secretary or his/her designee.



Sec. 24.9  Removal from the Service.

    (a) A member of the Service may be subject to disciplinary action, 
including removal from the Service, for substandard performance of duty 
as a member of the service, for misconduct, for reasons of national 
security or for other reasons as determined by the Secretary.
    (b) A member for whom disciplinary action is proposed is entitled 
to:
    (1) Written notice of the proposed action and the basis therefor;
    (2) A reasonable opportunity to answer the notice of proposed action 
both orally and in writing;
    (3) The right to be represented by an attorney or other 
representative in making such answer; and
    (4) A written decision on the proposal.
    (c) The decision may be made by an official with delegated authority 
to take such action, but in no case may the official be at a level below 
the head of the Operating Division where the member is assigned.
    (d) A member who is separated from the Service involuntarily and 
without cause and who, immediately prior to his appointment to the 
Service, was a career appointee in the civil service or the Senior 
Executive Service, may be

[[Page 99]]

appointed to a position in the competitive civil service at grade GS-15 
of the General Schedule. Such an appointment may be made by the 
Secretary or his/her designee without regard to the provisions of title 
5, U.S. Code regarding appointments in the civil service.
    (e) A member who is separated from the Service involuntarily and 
without cause and who, immediately prior to appointment to the Service, 
was not a career appointee in the civil service or the Senior Executive 
Service may be appointed to a position in the excepted civil service at 
grade GS-15 of the General Schedule for a period not to exceed two 
years.
    (f) There shall be no right to further review of the final decision 
on a disciplinary action. At his/her discretion, the Secretary may 
review an action taken under this section and may reduce, suspend, or 
overrule the action taken.
    (g) A member of the Service may be removed from the Service for such 
other reasons as may be prescribed by the Secretary.



Sec. 24.10  Reporting.

    For each quarter of the first year of implementation and annually 
thereafter, participating Operating Divisions shall maintain reports on 
the operation of the SBRS. At a minimum, these reports should include 
the number of appointees, the source of those appointees, their earnings 
immediately prior to appointment, and their SBRS pay at appointment.

[[Page 100]]



               SUBCHAPTER C_MEDICAL CARE AND EXAMINATIONS



PART 31_MEDICAL CARE FOR CERTAIN PERSONNEL OF THE COAST GUARD, NATIONAL OCEAN 

SURVEY, PUBLIC HEALTH SERVICE, AND FORMER LIGHTHOUSE SERVICE--Table of 

Contents




                               Definitions

Sec.
31.1 Meaning of terms.

 Provisions Applicable to Coast Guard, National Ocean Survey and Public 
                             Health Service

31.2 Persons entitled to treatment.
31.3 Use of Service facilities.
31.4 Use of other than Service facilities.
31.5 Application for treatment; active duty personnel.
31.6 Personnel absent without leave.
31.7 Continuance of medical relief after loss of status.
31.8 Retired personnel; extent of treatment.
31.9 Dependent members of families; treatment.
31.10 Dependent members of families; use of Service facilities.

     Provisions Applicable to Personnel of Former Lighthouse Service

31.11 Persons entitled to treatment.
31.12 Use of Service facilities.
31.13 Use of other than Service facilities.
31.14 Application for treatment; active duty personnel.
31.15 Continuance of medical relief after loss of status.
31.16 Retired personnel; extent of treatment.

    Source: 21 FR 9821, Dec. 12, 1956, unless otherwise noted.

                               Definitions



Sec. 31.1  Meaning of terms.

    As used in this part, the term:
    (a) Act means the Public Health Service Act, approved July 1, 1944, 
58 Stat. 682, as amended.
    (b) Service means the Public Health Service.
    (c) Surgeon General means the Surgeon General of the Public Health 
Service.
    (d) Medical relief station means a first-, second-, third-, or 
fourth-class station of the Service.
    (e) First-class stations means a hospital operated by the Service.
    (f) Second-class station means a medical relief facility, other than 
a hospital of the Service, under the charge of a commissioned officer.
    (g) Third-class station means a medical relief facility, other than 
a hospital of the Service, under the charge of a medical officer or 
employee of the Service other than a commissioned officer.
    (h) Fourth-class station means a medical relief facility designated 
by the Surgeon General, other than a first-, second-, or third-class 
station.
    (i) Designated physician means a physician holding an appointment to 
act regularly for the Service for a class or classes of specified 
beneficiaries at a place where there is no medical relief station.
    (j) Designated dentist means a dentist holding an appointment to 
perform dental service for the Service for a class or classes of 
specified beneficiaries.
    (k) Active duty means active duty status as distinguished from being 
on inactive status or retired and includes periods of authorized leave 
or liberty.
    (l) Dependent members of families in the case of male personnel 
means the lawful wife, the unmarried children (including stepchildren or 
adopted children) under 21 years of age, and the father or mother if in 
fact dependent upon such son for his or her chief support; and in the 
case of female personnel, the unmarried children (including stepchildren 
or adopted children) under 21 years of age if their father is dead or 
they are in fact dependent on such mother for their chief support, the 
father or mother if in fact dependent upon such daughter for his or her 
chief support, and the husband if in fact dependent upon such wife for 
his chief support: Provided, however, That in the case of members of the 
Women's Reserve of the Coast Guard the husbands of such members shall 
not be considered dependents.

(Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216)

[[Page 101]]

 Provisions Applicable to Coast Guard, National Ocean Survey and Public 
                             Health Service



Sec. 31.2  Persons entitled to treatment.

    To the extent and under the circumstances prescribed in Sec. Sec. 
31.2 to 31.10, the following persons shall be entitled to medical, 
surgical, and dental treatment and hospitalization by the Service:
    (a) Coast Guard. (1) Commissioned officers, chief warrant officers, 
warrant officers, cadets, and enlisted personnel of the Regular Coast 
Guard, including those on shore duty and those on detached duty, whether 
on active duty or retired;
    (2) Regular members of the Coast Guard Reserve when on active duty 
or when retired for disability;
    (3) Temporary members of the Coast Guard Reserve when on active duty 
or in case of physical injury incurred or sickness or disease contracted 
while performing active Coast Guard duty;
    (4) Members of the Women's Reserve of the Coast Guard when on active 
duty or when retired for disability;
    (5) Members of the Coast Guard Auxiliary in case of physical injury 
incurred or sickness or disease contracted while performing active Coast 
Guard duty.
    (b) National Ocean Survey. Commissioned officers, ships' officers, 
and members of the crews of vessels of the National Ocean Survey, 
including those on shore duty and those on detached duty whether on 
active duty or retired.
    (c) Public Health Service. (1) Commissioned officers of the Regular 
Corps of the Service, whether on active duty or retired;
    (2) Commissioned officers of the Reserve Corps of the Service when 
on active duty or when retired for disability.

(Sec. 326, 58 Stat. 697, as amended 42 U.S.C. 253)



Sec. 31.3  Use of Service facilities.

    Except as otherwise provided in Sec. Sec. 31.3 to 31.10, the 
persons specified in Sec. 31.2 shall be entitled to medical, surgical, 
and dental treatment and hospitalization only at medical relief stations 
and by designated physicians and designated dentists, and the cost of 
services procured elsewhere shall not be borne by the Service.

(Sec. 326, 58 Stat. 697, as amended 42 U.S.C. 253)



Sec. 31.4  Use of other than Service facilities.

    (a) When a person specified in Sec. 31.2 who is on active duty 
requires immediate medical, surgical, or dental treatment or 
hospitalization and the urgency of the situation does not permit 
treatment at a medical relief station or by a designated physician or 
designated dentist, an officer of the same service as the patient may 
arrange for treatment or hospitalization at the expense of the Service.
    (b) When the circumstances are such that an officer of the same 
service as the patient is not available to make the necessary 
arrangements, the treatment or hospitalization may be obtained by or on 
behalf of the patient at the expense of the Service.
    (c) In every case of treatment or hospitalization as defined in 
paragraph (b) of this section, the responsible superior officer of the 
patient shall be notified as promptly as possible and a full report 
shall be submitted by such officer to the Surgeon General through 
appropriate official channels. As soon as practicable, unless the 
interests of the patient or the Government require otherwise, treatment 
or hospitalization shall be continued at a medical relief station or by 
a designated physician or designated dentist or at another appropriate 
Federal medical facility.
    (d) When the necessary medical relief cannot be obtained from a 
medical relief station or a designated physician or designated dentist, 
preference shall be given to other Federal medical facilities when 
reasonably available and when conditions permit.
    (e) Vouchers on proper forms covering expenses for treatment or 
hospitalization under the circumstances specified in paragraphs (a) and 
(b) of this section shall be forwarded to the Surgeon General through 
appropriate official channels. Each such voucher shall be accompanied by 
or contain a statement of the facts necessitating the treatment or 
hospitalization. Unreasonable charges for emergency

[[Page 102]]

treatment or hospitalization will not be allowed.
    (f) Expenses for consultants or special services, or for dental 
treatment other than emergency measures to relieve pain, shall not be 
allowed except when authorized in advance by the headquarters of the 
Service or, in extraordinary cases, when subsequently approved by such 
headquarters upon receipt of report and satisfactory explanation as to 
the necessity and urgency therefor.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec. 31.5  Application for treatment; active duty personnel.

    (a) An applicant for medical relief who is on active duty shall 
furnish a certificate identifying him. Such certificate, in the case of 
Coast Guard personnel, shall be signed by an officer of the Coast Guard, 
and in the case of National Ocean Survey personnel, shall be signed by 
an officer of the National Ocean Survey. Commissioned officers of any of 
the services mentioned in Sec. 31.2 and officers in charge of units may 
sign their own certificates. In an emergency, the officer in charge of a 
medical relief station, or a designated physician or designated dentist, 
may accept other evidence of status satisfactory to him.
    (b) A temporary member of the Coast Guard Reserve except when on 
active duty or a member of the Coast Guard Auxiliary shall, when 
applying for medical relief, furnish a statement signed by a responsible 
superior officer setting forth the facts and circumstances giving rise 
to the need for medical relief. In emergencies, such statement shall be 
furnished promptly after the member has received the immediately 
required care and treatment. Such statement shall be presumptive 
evidence of the facts stated, but if investigation indicates that the 
injury, sickness, or disease was not incurred or contracted in the 
manner stated, further treatment may be denied.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec. 31.6  Personnel absent without leave.

    No member of any of the services enumerated in Sec. 31.2 shall be 
entitled when absent without leave to medical relief except at a medical 
relief station or by a designated physician or designated dentist.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec. 31.7  Continuance of medical relief after loss of status.

    If a member is separated from any of the services enumerated in 
Sec. 31.2, except persons specified in Sec. 31.2(a) (3) and (5) who 
shall be entitled to treatment after separation under the conditions set 
forth in such paragraphs, while undergoing treatment by the Service, his 
treatment shall be discontinued immediately unless the physician in 
charge determines that the condition of the patient does not permit 
interruption of treatment, in which case the treatment shall be 
discontinued as soon as practicable and the condition of the patient 
permits. At that time he shall be discharged from treatment and shall 
not thereafter be afforded medical relief by the Service by reason of 
his previous service.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec. 31.8  Retired personnel; extent of treatment.

    (a) A retired member of the Coast Guard, National Ocean Survey, or 
Public Health Service specified in Sec. 31.2 shall be entitled to 
medical, surgical, and dental treatment and hospitalization at medical 
relief stations of the first-, second-, and third-class, upon 
presentation of satisfactory evidence of his status.
    (b) Elective medical or surgical treatment requiring hospitalization 
shall be furnished only at hospitals operated by the Service.
    (c) Dental treatment shall be furnished to the extent of available 
facilities only at medical relief stations where full-time dental 
officers are on duty; at other medical relief stations the dental 
treatment shall be limited

[[Page 103]]

to emergency measures necessary to relieve pain.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec. 31.9  Dependent members of families; treatment.

    To the extent and under the circumstances prescribed in this part, 
the Service shall provide medical advice and outpatient treatment at 
first-, second-, and third-class medical relief stations and 
hospitalization at first-class stations to the dependent members of 
families of the following persons:
    (a) Coast Guard. Commissioned officers, chief warrant officers, 
warrant officers, cadets, and enlisted personnel of the Regular Coast 
Guard, including those on shore duty and those on detached duty, whether 
on active duty or retired; and regular members of the United States 
Coast Guard Reserve and members of the Women's Reserve of the Coast 
Guard, when on active duty or when retired for disability.
    (b) National Ocean Survey. Commissioned officers, ships' officers, 
and members of the crews of vessels of the United States National Ocean 
Survey, including those on shore duty and those on detached duty, 
whether on active duty or retired.
    (c) Public Health Service. Commissioned officers of the Regular 
Corps of the Service, whether on active duty or retired, and 
commissioned officers of the Reserve Corps of the Service when on active 
duty or when retired for disability.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)



Sec. 31.10  Dependent members of families; use of Service facilities.

    (a) A dependent member of the family of any person specified in 
Sec. 31.9 shall, upon presentation of satisfactory evidence of such 
status, be entitled to medical advice and out-patient treatment at 
first-, second-, and third-class medical relief stations and 
hospitalization at first-class stations if suitable accommodations are 
available therein and if the condition of the dependent is such as to 
require hospitalization, both as determined by the medical officer in 
charge.
    (b) Hospitalization at first-class stations shall be at a per diem 
cost to the officer, enlisted person, member of a crew or other person 
concerned. Such cost shall be at such uniform rate as may be prescribed 
from time to time by the President for the hospitalization of dependents 
of naval and Marine Corps personnel at any naval hospital.
    (c) Hospitalization at first-class stations and out-patient 
treatment at first-, second-, and third-class stations may include such 
services and supplies as, in the judgment of the medical officer in 
charge, are necessary for reasonable and adequate treatment.
    (d) Dental treatment shall be furnished to the extent of available 
facilities only at medical relief stations where full-time officers are 
on duty.

(Sec. 326, 58 Stat. 697, as amended; 42 U.S.C. 253)

     Provisions Applicable to Personnel of Former Lighthouse Service



Sec. 31.11  Persons entitled to treatment.

    To the extent and under the circumstances prescribed in this part, 
the following persons shall be entitled to medical, surgical, and dental 
treatment and hospitalization by the Service: Lightkeepers, assistant 
lightkeepers, and officers and crews of vessels of the former Lighthouse 
Service, including any such persons who subsequent to June 30, 1939, 
have involuntarily been assigned to other civilian duty in the Coast 
Guard, who were entitled to medical relief at hospitals and other 
stations of the Service prior to July 1, 1944, and who are now or 
hereafter on active duty or who have been or may hereafter be retired 
under the provisions of section 6 of the act of June 20, 1918, as 
amended (33 U.S.C. 763).

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



Sec. 31.12  Use of Service facilities.

    Except as otherwise provided herein, the persons specified in Sec. 
31.11 shall be entitled to medical, surgical, and dental treatment and 
hospitalization only at medical relief stations and by designated 
physicians and designated dentists, and the cost of services procured

[[Page 104]]

elsewhere shall not be borne by the Service.

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



Sec. 31.13  Use of other than Service facilities.

    (a) When a person specified in Sec. 31.11 who is on active duty 
requires immediate medical, surgical, or dental treatment or 
hospitalization and the urgency of the situation does not permit 
treatment at a medical relief station or by a designated physician or 
designated dentist, an officer or other appropriate supervisory official 
of the Coast Guard may arrange for treatment or hospitalization.
    (b) In every such case of treatment or hospitalization, a full 
report thereof shall be submitted to the Surgeon General through Coast 
Guard headquarters. As soon as practicable, unless the interests of the 
patient or the Government require otherwise, treatment or 
hospitalization shall be continued at a medical relief station or by a 
designated physician or designated dentist or at another appropriate 
Federal medical facility.
    (c) When the necessary medical relief cannot be obtained from a 
medical relief station or a designated physician or designated dentist, 
preference shall be given to other Federal medical facilities when 
reasonably available and when conditions permit.
    (d) Vouchers on proper forms covering expenses for treatment or 
hospitalization under the circumstances specified in paragraph (a) of 
this section shall be forwarded to the Surgeon General through Coast 
Guard headquarters. Each such voucher shall be accompanied by or contain 
a statement of the facts necessitating the treatment or hospitalization. 
Unreasonable charges for emergency treatment or hospitalization will not 
be allowed.
    (e) Expenses for consultants or special services, or for dental 
treatment other than emergency measures to relieve pain, shall not be 
allowed except when authorized in advance by the headquarters of the 
Service or, in extraordinary cases, when subsequently approved by such 
headquarters upon receipt of report and satisfactory explanation as to 
the necessity and urgency therefor.

(Sec. 610(b), 58 Stat. 714 as amended; 33 U.S.C. 763c)



Sec. 31.14  Application for treatment; active duty personnel.

    An applicant for medical relief who is on active duty shall furnish 
a certificate identifying him. Such certificate shall be signed by an 
officer or other appropriate supervisory official of the Coast Guard. In 
an emergency, the officer in charge of a medical relief station, or a 
designated physician or designated dentist, may accept other evidence of 
status satisfactory to him.

(Sec. 610(b), 58 Stat. 714 as amended; 33 U.S.C. 763c)



Sec. 31.15  Continuance of medical relief after loss of status.

    If a person is separated while undergoing treatment by the Service, 
his treatment shall be discontinued immediately unless the physician or 
dentist in charge determines that the condition of the patient does not 
permit interruption of treatment, in which case the treatment shall be 
discontinued as soon as practicable and the condition of the patient 
permits. At that time he shall be discharged from treatment and shall 
not thereafter be afforded medical relief by the Service by reason of 
his previous service.

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



Sec. 31.16  Retired personnel; extent of treatment.

    (a) Any retired person specified in Sec. 31.11 shall be entitled to 
medical, surgical, and dental treatment and hospitalization at medical 
relief stations of the first, second, and third class, upon presentation 
of satisfactory evidence of his status.
    (b) Elective medical or surgical treatment requiring hospitalization 
shall be furnished only at hospitals operated by the Service.
    (c) Dental treatment shall be furnished to the extent of available 
facilities only at medical relief stations where full-time dental 
officers are on duty; at other medical relief stations the dental 
treatment shall be limited

[[Page 105]]

to emergency measures necessary to relieve pain.

(Sec. 610(b), 58 Stat. 714, as amended; 33 U.S.C. 763c)



PART 32_MEDICAL CARE FOR PERSONS WITH HANSEN'S DISEASE AND OTHER PERSONS IN 

EMERGENCIES--Table of Contents




                               Definitions

Sec.
32.1 Meaning of terms.

                              Beneficiaries

32.6 Persons eligible.

                      Persons With Hansen's Disease

32.86 Admissions to Service facilities.
32.87 Confirmation of diagnosis.
32.88 Examinations and treatment.
32.89 Discharge.
32.90 Notification to health authorities regarding discharged patients.
32.91 Purchase of services for Hansen's disease patients.

           Nonbeneficiaries: Temporary Treatment in Emergency

32.111 Conditions and extent of treatment; charges.

    Authority: Secs. 320, 321 and 322(b), Public Health Service Act (42 
U.S.C. 247e, 248 and 249(b)).

    Source: 40 FR 25816, June 19, 1975, unless otherwise noted.

                               Definitions



Sec. 32.1  Meaning of terms.

    All terms not defined herein shall have the same meaning as given 
them in the Act.
    (a) Act means the Public Health Service Act, approved July 1, 1944, 
58 Stat. 682, as amended;
    (b) Service means the Public Health Service;
    (c) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved may have been delegated.
    (d) Authorizing official means Service officers or employees duly 
designated by the Director, Bureau of Health Care Delivery and 
Assistance, to authorize and provide care and treatment to beneficiaries 
at Service expense.

[40 FR 25816, June 19, 1975, as amended at 48 FR 10318, Mar. 11, 1983]

                              Beneficiaries



Sec. 32.6  Persons eligible.

    (a) Under this part the following persons are entitled to care and 
treatment by the Service as hereinafter prescribed:
    (1) Persons afflicted with Hansen's disease; and
    (2) Non-beneficiaries for temporary treatment and care in cases of 
emergency.
    (b) Separate regulations govern: (1) The medical care of certain 
personnel, and their dependents, of the Coast Guard, National Oceanic 
and Atmospheric Administration, and Public Health Service (see part 31 
of this chapter);
    (2) Physical and mental examination of aliens (see part 34 of this 
chapter); and
    (3) Medical care for Native Americans (see part 36 of this chapter).

[48 FR 10318, Mar. 11, 1983]

                      Persons With Hansen's Disease



Sec. 32.86  Admissions to Service facilities.

    Any person with Hansen's disease who presents himself for care or 
treatment or who is referred to the Service by the proper health 
authority of any State, Territory, or the District of Columbia shall be 
received into the Service hospital at Carville, Louisiana, or into any 
other hospital of the Service which has been designated by the Secretary 
as being suitable for the accommodation of persons with Hansen's 
disease.



Sec. 32.87  Confirmation of diagnosis.

    At the earliest practicable date, after the arrival of a patient at 
the Service hospital at Carville, Louisiana, or at another hospital of 
the Service the medical staff shall confirm or disprove the diagnosis of 
Hansen's disease. If the diagnosis of Hansen's disease is confirmed, the 
patient shall be provided appropriate inpatient or outpatient

[[Page 106]]

treatment. If the diagnosis is not confirmed, the patient shall be 
discharged.

[40 FR 25816, June 19, 1975; 40 FR 36774, Aug. 22, 1975]



Sec. 32.88  Examinations and treatment.

    Patients will be provided necessary clinical examinations which may 
be required for the diagnosis of primary or secondary conditions, and 
such treatment as may be prescribed.



Sec. 32.89  Discharge.

    Patients with Hansen's disease will be discharged when, in the 
opinion of the medical staff of the hospital, optimum hospital benefits 
have been received.



Sec. 32.90  Notification to health authorities regarding discharged patients.

    Upon the discharge of a patient the medical officer in charge shall 
give notification of such discharge to the appropriate health officer of 
the State, Territory, or other jurisdiction in which the discharged 
patient is to reside. The notification shall also set forth the clinical 
findings and other essential facts necessary to be known by the health 
officer relative to such discharged patient.



Sec. 32.91  Purchase of services for Hansen's disease patients.

    Hansen's disease patients being treated on either an inpatient or 
outpatient basis at a hospital or clinic facility of the Service, other 
than the National Center for Hansen's Disease (Carville, Louisiana), 
may, at the sole discretion of the Secretary and subject to available 
appropriations, be provided care for the treatment of Hansen's disease 
at the expense of the Service upon closure or transfer of such hospital 
or clinic pursuant to section 987 of the Omnibus Budget Reconciliation 
Act of 1981 (Pub. L. 97-35). Payment will only be made for care arranged 
for by an authorizing official of the Service as defined in Sec. 
32.1(f) of this part.

[46 FR 51918, Oct. 23, 1981]

           Nonbeneficiaries: Temporary Treatment in Emergency



Sec. 32.111  Conditions and extent of treatment; charges.

    (a) Persons not entitled to treatment by the Service may be provided 
temporary care and treatment at medical care facilities of the Service 
in case of emergency as an act of humanity.
    (b) Persons referred to in paragraph (a) of this section who, as 
determined by the officer in charge of the Service facility, are able to 
defray the cost of their care and treatment shall be charged for such 
care and treatment at the following rates (which shall be deemed to 
constitute the entire charge in each instance): In the case of 
hospitalization, at the current interdepartmental reciprocal per diem 
rate; and, in the case of outpatient treatment, at rates established by 
the Secretary.



PART 34_MEDICAL EXAMINATION OF ALIENS--Table of Contents




Sec.
34.1 Applicability.
34.2 Definitions.
34.3 Scope of examinations.
34.4 Medical notifications.
34.5 Postponement of medical examination.
34.6 Applicability of Foreign Quarantine Regulations.
34.7 Medical and other care; death.
34.8 Reexamination; convening of review boards; expert witnesses; 
          reports.

    Authority: 42 U.S.C. 216, 249, 252; 8 U.S.C. 1182, 1224, 1226; sec. 
601 of Pub. L. 101-649.



Sec. 34.1  Applicability.

    The provisions of this part shall apply to the medical examination 
of:
    (a) Aliens applying for a visa at an embassy or consulate of the 
United States;
    (b) Aliens arriving in the United States;
    (c) Aliens required by the INS to have a medical examination in 
connection with determination of their admissibility into the United 
States; and
    (d) Aliens applying for adjustment status.

[56 FR 25001, May 31, 1991]

[[Page 107]]



Sec. 34.2  Definitions.

    As used in this part, terms shall have the following meanings:
    (a) CDC. Centers for Disease Control, Public Health Service, U.S. 
Department of Health and Human Services.
    (b) Communicable disease of public health significance. Any of the 
following diseases:
    (1) Chancroid.
    (2) Gonorrhea.
    (3) Granuloma inguinale.
    (4) Human immunodeficiency virus (HIV) infection.
    (5) Leprosy, infectious.
    (6) Lymphogranuloma venereum.
    (7) Syphilis, infectious stage.
    (8) Tuberculosis, active.
    (c) Civil surgeon. A physician, with not less than 4 years' 
professional experience, selected by the District Director of INS to 
conduct medical examinations of aliens in the United States who are 
applying for adjustment of status to permanent residence or who are 
required by the INS to have a medical examination.
    (d) Class A medical notification. Medical notification of:
    (1) A communicable disease of public health significance;
    (2)(i) A physical or mental disorder and behavior associated with 
the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior; or
    (3) Drug abuse or addiction.
    (e) Class B medical notification. Medical notification of a physical 
or mental abnormality, disease, or disability serious in degree or 
permanent in nature amounting to a substantial departure from normal 
well-being.
    (f) Director. The Director of the Centers for Disease Control.
    (g) Drug abuse. The non-medical use of a substance listed in section 
202 of the Controlled Substances Act, as amended (21 U.S.C. 802) which 
has not necessarily resulted in physical or psychological dependence.
    (h) Drug addiction. The non-medical use of a substance listed in 
section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802) 
which has resulted in physical or psychological dependence.
    (i) INS. Immigration and Naturalization Service, U.S. Department of 
Justice.
    (j) Medical examiner. A panel physician, civil surgeon, or other 
physician designated by the Director to perform medical examinations of 
aliens.
    (k) Medical hold document. A document issued to the INS by a 
quarantine inspector of the Public Health Service at a port of entry 
which defers the inspection for admission until the cause of the medical 
hold is resolved.
    (l) Medical notification. A document issued to a consular authority 
or the INS by a medical examiner, certifying the presence or absence of:
    (1) A communicable disease of public health significance;
    (2)(i) A physical or mental disorder and behavior associated with 
the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (3) Drug abuse or addiction; or
    (4) Any other physical abnormality, disease, or disability serious 
in degree or permanent in nature amounting to a substantial departure 
from normal well-being.
    (m) Medical officer. A physician of the Public Health Service 
Commissioned Corps assigned by the Director to conduct physical and 
mental examinations of aliens.
    (n) Mental disorder. A currently accepted psychiatric diagnosis, as 
defined by the Diagnostic and Statistical Manual of Mental Disorders 
published by the American Psychiatric Association, or by other 
authoritative sources.
    (o) Panel physician. A physician selected by a United States embassy 
or consulate to conduct medical examinations of aliens applying for 
visas.

[[Page 108]]

    (p) Physical disorder. A currently accepted medical diagnosis, as 
defined by the Manual of the International Classification of Diseases, 
Injuries, and Causes of Death published by the World Health 
Organization, or by other authoritative sources.

[21 FR 9829, Dec. 12, 1956, as amended at 52 FR 32543, Aug. 28, 1987; 56 
FR 25001, May 31, 1991]



Sec. 34.3  Scope of examinations.

    (a) General. In performing examinations, medical examiners shall 
consider those matters that relate to:
    (1) A communicable disease of public health significance;
    (2)(i) A physical or mental disorder and behavior associated with 
the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (3) Drug abuse or addiction; and
    (4) Any other physical abnormality, disease, or disability serious 
in degree or permanent in nature amounting to a substantial departure 
from normal well-being.

The scope of the examination shall include any laboratory or additional 
studies that are deemed necessary, either as a result of the physical 
examination or pertinent information elicited from the alien's medical 
history, for the examining physician to reach a conclusion about the 
presence or absence of a physical or mental abnormality, disease, or 
disability.
    (b) Persons subject to requirement for chest X-ray examination and 
serologic testing. (1) Except as provided in paragraph (b)(1)(v) of this 
section, a chest X-ray examination, serologic testing for syphilis and 
serologic testing for HIV of persons 15 years of age and older shall be 
required as part of the examination of:
    (i) Applicants for immigrant visas;
    (ii) Students, exchange visitors, and other applicants for a 
nonimmigrant visa who are required by a consular authority to have a 
medical examination;
    (iii) Aliens outside the United States who apply for refugee status;
    (iv) Applicants in the United States who apply for adjustment of 
status under the immigration statute and regulations;
    (v) Exceptions. Neither a chest X-ray examination nor serologic 
testing for syphilis and HIV shall be required if the alien is under the 
age of 15. Provided, a tuberculin skin test shall be required if there 
is evidence of contact with a person known to have tuberculosis or other 
reason to suspect tuberculosis, and a chest X-ray examination shall be 
required in the event of a positive tuberculin reaction, and serologic 
testing where there is reason to suspect infection with syphilis or HIV. 
Additional exceptions to the requirement for a chest X-ray examination 
may be authorized for good cause upon application approved by the 
Director.
    (2) Tuberculin skin test examination. (i) All aliens 2 years of age 
or older in the United States who apply for adjustment of status to 
permanent residents, under the immigration laws and regulations, or 
other aliens in the United States who are required by the INS to have a 
medical examination in connection with a determination of their 
admissibility, shall be required to have a tuberculin skin test. 
Exceptions to this requirement may be authorized for good cause upon 
application approved by the Director. In the event of a positive 
tuberculin reaction, a chest X-ray examination shall be required. If the 
chest radiograph is consistent with tuberculosis, the alien shall be 
referred to the local health authority for evaluation. Evidence of this 
evaluation shall be provided to the civil surgeon before a medical 
notification may be issued.
    (ii) Aliens less than 2 years old shall be required to have a 
tuberculin skin test if there is evidence of contact with a person known 
to have tuberculosis or other reason to suspect tuberculosis. In the 
event of a positive tuberculin reaction, a chest X-ray examination shall 
be required. If the chest radiograph is consistent with tuberculosis, 
the alien shall be referred to the local health authority for 
evaluation. Evidence of this evaluation shall be provided to the

[[Page 109]]

civil surgeon before a medical notification may be issued.
    (3) Sputum smear examination. All aliens subject to the chest X-ray 
examination requirement and for whom the radiograph shows an abnormality 
consistent with pulmonary tuberculosis shall be required to have a 
sputum smear examination for acid-fast bacilli.
    (4) How and where performed. All chest X-ray films used in medical 
examinations performed under the regulations in this part shall be large 
enough to encompass the entire chest (approximately 14 by 17 inches; 
35.6x43.2 cm.). Serologic testing for HIV shall be a sensitive and 
specific test, confirmed when positive by a test such as the Western 
blot test or an equally reliable test. For aliens examined abroad, the 
serologic testing for HIV must be completed abroad, except that the 
Attorney General after consultation with the Secretary of State and the 
Secretary of Health and Human Services may in emergency circumstances 
permit serologic testing of refugees for HIV to be completed in the 
United States.
    (5) Chest X-ray, laboratory, and treatment reports. The chest X-ray 
reading and serologic test results for syphilis and HIV shall be 
included in the medical notification. When the medical examiner's 
conclusions are based on a study of more than one chest X-ray film, the 
medical notification shall include at least a summary statement of 
findings of the earlier films, followed by a complete reading of the 
last film, and dates and details of any laboratory tests and treatment 
for tuberculosis.
    (c) Procedure for transmitting records. For aliens issued immigrant 
visas, the medical notification and chest X-ray film, if any, shall be 
placed in a separate envelope which shall be sealed and attached to the 
alien's visa in such a manner as to be readily detached at the U.S. port 
of entry. When more than one chest X-ray film is used as a basis for the 
examiner's conclusions, all films shall be included.
    (d) Failure to present records. When a determination of 
admissibility is to be made at the U.S. port of entry, a medical hold 
document shall be issued pending completion of any necessary examination 
procedures. A medical hold document may be issued for aliens who:
    (1) Are not in possession of a valid medical notification, if 
required;
    (2) Have a medical notification which is incomplete;
    (3) Have a medical notification which is not written in English;
    (4) Are suspected to have an excludable medical condition.
    (e) The Attorney General, after consultation with the Secretary of 
State and the Secretary of Health and Human Services, may in emergency 
circumstances permit the medical examination of refugees to be completed 
in the United States.
    (f) All medical examinations shall be carried out in accordance with 
such technical instructions for physicians conducting the medical 
examination of aliens as may be issued by the Director. Copies of such 
technical instructions are available upon request to the Director, 
Division of Quarantine, Mailstop E03, CDC, Atlanta GA 30333.

[56 FR 25002, May 31, 1991]



Sec. 34.4  Medical notifications.

    (a) Medical examiners shall issue medical notifications of their 
findings of the presence or absence of Class A or Class B medical 
conditions. The presence of such condition must have been clearly 
established.
    (b) Class A medical notifications. (1) The medical examiner shall 
report his/her findings to the consular officer or the INS by Class A 
medical notification which lists the specific condition for which the 
alien may be excluded, if an alien is found to have:
    (i) A communicable disease of public health significance;
    (ii)(A) A physical or mental disorder, and behavior associated with 
the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others; or
    (B) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (iii) Drug abuse or addition.

[[Page 110]]


Provided, however, That a Class A medical notification of a physical or 
mental disorder, and behavior associated with that disorder that may 
pose, or has posed, a threat to the property, safety, or welfare of the 
alien or others, shall in no case be issued with respect to an alien 
having only mental shortcomings due to ignorance, or suffering only from 
a condition attributable to remediable physical causes or of a temporary 
nature, caused by a toxin, medically prescribed drug, or disease.
    (2) The medical notification shall state the nature and extent of 
the abnormality; the degree to which the alien is incapable of normal 
physical activity; and the extent to which the condition is remediable. 
The medical examiner shall indicate the likelihood, that because of the 
condition, the applicant will require extensive medical care or 
institutionalization.
    (c) Class B medical notifications. (1) If an alien is found to have 
a physical or mental abnormality, disease, or disability serious in 
degree or permanent in nature amounting to a substantial departure from 
normal well-being, the medical examiner shall report his/her findings to 
the consular or INS officer by Class B medical notification which lists 
the specific conditions found by the medical examiner. Provided, 
however, that a Class B medical notification shall in no case be issued 
with respect to an alien having only mental shortcomings due to 
ignorance, or suffering only from a condition attributable to remediable 
physical causes or of a temporary nature, caused by a toxin, medically 
prescribed drug, or disease.
    (2) The medical notification shall state the nature and extent of 
the abnormality, the degree to which the alien is incapable of normal 
physical activity, and the extent to which the condition is remediable. 
The medical examiner shall indicate the likelihood, that because of the 
condition, the applicant will require extensive medical care or 
institutionalization.
    (d) Other medical notifications. If as a result of the medical 
examination, the medical examiner does not find a Class A or Class B 
condition in an alien, the medical examiner shall so indicate on the 
medical notification form and shall report his findings to the consular 
or INS officer.

[56 FR 25003, May 31, 1991]



Sec. 34.5  Postponement of medical examination.

    Whenever, upon an examination, the medical examiner is unable to 
determine the physical or mental condition of an alien, completion of 
the medical examination shall be postponed for such observation and 
further examination of the alien as may be reasonably necessary to 
determine his/her physical or mental condition. The examination shall be 
postponed for aliens who have an acute infectious disease until the 
condition is resolved. The alien shall be referred for medical care as 
necessary.

[56 FR 25003, May 31, 1991]



Sec. 34.6  Applicability of Foreign Quarantine Regulations.

    Aliens arriving at a port of the United States shall be subject to 
the applicable provisions of 42 CFR part 71, Foreign Quarantine, with 
respect to examination and quarantine measures.

[56 FR 25003, May 31, 1991]



Sec. 34.7  Medical and other care; death.

    (a) An alien detained by or in the custody of the INS may be 
provided medical, surgical, psychiatric, or dental care by the Public 
Health Service through interagency agreements under which the INS shall 
reimburse the Public Health Service. Aliens found to be in need of 
emergency care in the course of medical examination shall be treated to 
the extent deemed practical by the attending physician and if considered 
to be in need of further care, may be referred to the INS along with the 
physician's recommendations concerning such further care.
    (b) In case of the death of an alien, the body shall be delivered to 
the consular or immigration authority concerned. If such death occurs in 
the United States, or in a territory or possession thereof, public 
burial shall be provided upon request of the INS and subject to its 
agreement to pay the

[[Page 111]]

burial expenses. Autopsies shall not be performed unless approved by the 
INS.

[56 FR 25003, May 31, 1991]



Sec. 34.8  Reexamination; convening of review boards; expert witnesses; 

reports.

    (a) The Director shall convene a board of medical officers to 
reexamine an alien:
    (1) Upon the request of the INS for a reexamination by such a board; 
or
    (2) Upon an appeal to the INS by an alien who, having received a 
medical examination in connection with the determination of admissiblity 
to the United States (including examination on arrival and adjustment of 
status as provided in the immigration laws and regulations) has been 
certified for a Class A condition.
    (b) For boards convened to reexamine aliens certified as:
    (1) Having a communicable disease of public health significance, the 
board shall consist of three medical officers, at least one of whom is 
experienced in the diagnosis and treatment of the communicable disease 
for which medical notification has been made, and the decision of the 
majority of the board shall prevail;
    (2)(i) Having a physical or mental disorder and behavior associated 
with the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others; or
    (ii) Having a history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior; or
    (iii) Being a drug abuser or addict;
    (3) In circumstances covered by paragraph (b)(2) of this section, 
the board shall consist of three medical officers, at least one of whom 
shall be a board certified psychiatrist, and the decision of the 
majority of the board shall prevail.
    (c) Reexamination shall include:
    (1) Review of all records submitted by the alien, other witnesses, 
or the board;
    (2) Use of any laboratory or additional studies which are deemed 
clinically necessary as a result of the physical examination or 
pertinent information elicited from the alien's medical history;
    (3) Consideration of statements regarding the alien's physical or 
mental condition made by a physician after his/her examination of the 
alien; and
    (4) An independent physical or psychiatric examination of the alien 
performed by the board, at the board's option.
    (d) An alien who is to be reexamined shall be notified of the time 
and place of his/her reexamination not less than 5 days prior thereto.
    (e) The alien, at his/her own cost and expense, may introduce as 
witnesses before the board such physicians or medical experts as the 
board may in its discretion permit; provided that the alien shall be 
permitted to introduce at least one expert medical witness. If any 
witnesses offered are not permitted by the board to testify, the record 
of the proceedings shall show the reason for the denial of permission.
    (f) Witnesses before the board shall be given a reasonable 
opportunity to examine the medical notification and other records 
involved in the reexamination and to present all relevant and material 
evidence orally or in writing until such time as the proceedings are 
declared by the board to be closed. During the course of the hearing the 
alien's attorney or representative shall be permitted to examine the 
alien and he/she, or the alien, shall be permitted to examine any 
witnesses offered in the alien's behalf and to cross-examine any 
witnesses called by the board. If the alien does not have an attorney or 
representative, the board shall assist the alien in the presentation of 
his/her case to the end that all of the material and relevant facts may 
be considered.
    (g) The findings and conclusions of the board shall be based on its 
medical examination of the alien, if any, and on the evidence presented 
and made a part of the record of its proceedings.
    (h) The board shall report its findings and conclusions to the INS, 
and shall also give prompt notice thereof to the alien if his/her 
reexamination has been based on his/her appeal. The board's report to 
the INS shall specifically affirm, modify, or reject the findings and

[[Page 112]]

conclusions of prior examining medical officers.
    (i) The board shall issue its medical notification in accordance 
with the applicable provisions of this part if it finds that an alien it 
has reexamined has a Class A or Class B condition.
    (j) If the board finds that an alien it has reexamined does not have 
a Class A or Class B condition, it shall issue its medical notification 
in accordance with the applicable provisions of this part.
    (k) After submission of its report, the board shall not be 
reconvened, nor shall a new board be convened, in connection with the 
same application for admission or for adjustment of status, except upon 
the express authorization of the Director.

[56 FR 25004, May 31, 1991]



PART 35_HOSPITAL AND STATION MANAGEMENT--Table of Contents




                            Subpart A_General

Sec.
35.1 Hospital and station rules.
35.2 Compliance with hospital rules.
35.3 Noncompliance; deprivation of privileges.
35.4 Noncompliance; discharge or transfer.
35.5 Entitlement to care after discharge or transfer by reason of 
          noncompliance.
35.6 Admissions; determination of eligibility for care.
35.7 Admissions; designation of person to be notified.
35.8 Safekeeping of money and effects; withdrawals.
35.9 Disposition of money and effects left by other than deceased 
          patients.
35.10 Destruction of effects dangerous to health.
35.11 Clinical records; confidential.
35.12 Solicitation of legal business prohibited.
35.13 Entry for negotiation of release or settlement.
35.14 Solicitation of legal business; negotiation of release or 
          settlement; assistance prohibited.
35.15 Consent to operative procedures.
35.16 Autopsies and other post-mortem operations.
35.17 Fees and charges for copying, certification, search of records and 
          related services.

                     Subpart B_Transfer of Patients

35.21 Authorization of transfer.
35.22 Attendants.

         Subpart C_Disposition of Articles Produced by Patients

35.31 Retention by patients.
35.32 Board of appraisers.
35.33 Sale; prices; deposit of proceeds.
35.34 Resale.
35.35 Unsalable articles.

      Subpart D_Disposal of Money and Effects of Deceased Patients

35.41 Inventory.
35.42 Notice upon death.
35.43 Delivery only upon filing claim; forms; procedure.
35.44 Delivery to legal representative; to other claimants if value is 
          $1,000 or less.
35.45 Disposition of effects; exceptions.
35.46 Conflicting claims.
35.47 Disposition of Government checks.
35.48 Deposit of unclaimed money; sale of unclaimed effects and deposit 
          of proceeds.
35.49 Sale of unclaimed effects; procedures.
35.50 Disposition of unsold effects.
35.51 Manner of delivery; costs, receipts.
35.52 Delivery of possession only; title unaffected.

           Subpart E_Contributions for the Benefit of Patients

35.61 Applicability.
35.62 Acceptance of contributions.
35.63 Report of and accounting for contributions.
35.64 Donors.
35.65 Acceptable personal property.
35.66 Expenditure of cash contributions.

    Authority: Sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216, sec. 
321, 53 Stat. 695, as amended; 42 U.S.C. 248, unless otherwise noted.

    Source: 21 FR 9830, Dec. 12, 1956, unless otherwise noted.



                            Subpart A_General



Sec. 35.1  Hospital and station rules.

    The officer in charge of a station or hospital of the Service is 
authorized to adopt such rules and issue such instructions, not 
inconsistent with the regulations in this part and other provisions of 
law, as he deems necessary for the efficient operation of the station or 
hospital and for the proper and humane care and treatment of all 
patients therein. All general rules governing the conduct and privileges 
of patients, and of members of the public

[[Page 113]]

while on the premises, shall be posted in prominent places.



Sec. 35.2  Compliance with hospital rules.

    All patients and visitors in stations and hospitals of the Service 
are expected to comply with the rules and instructions issued under the 
authority of the officer in charge.



Sec. 35.3  Noncompliance; deprivation of privileges.

    Any patient who wilfully fails or refuses to comply with rules or 
instructions of a hospital or station or with regulations of the 
Service, may, by the direction of the officer in charge, be deprived of 
recreational or other privileges accorded patients. Any visitor who 
wilfully fails or refuses to comply with any such rules, instructions, 
or regulations may, by direction of the officer in charge, be denied 
visiting privileges.



Sec. 35.4  Noncompliance; discharge or transfer.

    (a) If the officer in charge finds, upon investigation, that a 
patient other than a leprosy patient, by willful and persistent failure 
or refusal to comply with such rules, instructions, or regulations is 
seriously impeding the course of his own care and treatment, or that of 
other patients, he may (1) discharge the patient, or (2) if the patient 
is not a voluntary patient, arrange for his transfer to the custody of 
the authority responsible for his admission to the station or hospital. 
No patient shall be discharged or transferred on account of 
noncompliance if to do so would seriously endanger his life or health, 
nor shall any patient be discharged if his failure to comply is due, in 
the opinion of the officer in charge, to a mental disease or disorder.
    (b) If the discharge or transfer of a patient is likely to endanger 
the health of persons other than the patient or officers or employees of 
the station or hospital, the officer in charge shall give advance notice 
to appropriate State, county, or municipal authorities of the discharge 
or transfer.



Sec. 35.5  Entitlement to care after discharge or transfer by reason of 

noncompliance.

    No person otherwise entitled to care, treatment, or hospitalization 
at Service facilities, or in other facilities at the expense of the 
Service, shall be denied such care or treatment by reason of his prior 
discharge or transfer from any such facility under the provisions of 
Sec. 35.4.



Sec. 35.6  Admissions; determination of eligibility for care.

    Except as may otherwise be provided for specific classes of patients 
by the regulations of this chapter, the officer in charge of the station 
or hospital to which application is made is authorized to determine the 
eligibility of applicants, as beneficiaries of the Service, for care and 
for treatment. Such determinations shall be subject to review by the 
chief of the division of the Service responsible for administration of 
the station or hospital concerned upon referral made by the officer in 
charge in doubtful cases or upon appeal made by an applicant who has 
been denied care or treatment.



Sec. 35.7  Admissions; designation of person to be notified.

    Every in-patient, at the time of admission to the hospital or 
station or as soon thereafter as practicable, shall be requested to 
designate a person or persons to be notified in case of emergency.



Sec. 35.8  Safekeeping of money and effects; withdrawals.

    (a) A place for the safekeeping of money and effects of patients 
shall be provided at each station or hospital, and an itemized receipt 
therefor shall be furnished to the patient and to any other person who 
places money or effects therein for the benefit of the patient.
    (b) Money and effects may be withdrawn only by or on behalf of the 
patient, by his legally appointed representative authorized to receive 
or dispose of his property (including the money and effects in the 
custody of the station or hospital), or by a person who is authorized, 
under the law of the State in which the station or hospital

[[Page 114]]

is located, to receive or dispose of the patient's money and effects. In 
any case in which the officer in charge has had actual notice of the 
appointment of a legal representative, withdrawals may be made only by 
such representative or in accordance with his written directions. No 
delivery shall be made under this paragraph unless (1) the person 
receiving the money or effects shall sign an itemized receipt therefor, 
or (2) the delivery is witnessed by two persons. The provisions of this 
paragraph do not prohibit withdrawals made necessary by the provisions 
of this part for the disposition of money and effects left by patients 
on death or on departure from the station or hospital, or by the 
provisions of Sec. 35.10.



Sec. 35.9  Disposition of money and effects left by other than deceased 

patients.

    Money and effects left on the premises by a patient shall be 
forwarded promptly to him. If because his whereabouts are unknown his 
money and effects cannot be delivered to him within 120 days after his 
departure, his money shall be deposited into the Treasury and credited 
to the account entitled ``Money and Effects of Former Patients (PHS (T) 
name of patient),'' and his effects shall be held for him for six months 
and then sold in accordance with Sec. 35.49, and the proceeds deposited 
into the Treasury and credited to the above account.



Sec. 35.10  Destruction of effects dangerous to health.

    The officer in charge shall cause to be destroyed effects brought 
into or received in the station or hospital area by patients which, in 
the judgement of such officer, are dangerous as a source of disease to 
the health or life of patients or personnel of the station or hospital 
or visitors therein and cannot otherwise be safely disposed of or 
rendered harmless by disinfection or other means. The destruction of 
effects shall be witnessed by at least one officer or employee 
designated for that purpose by the officer in charge, and appropriate 
records of the destruction shall be maintained.



Sec. 35.11  Clinical records; confidential.

    A complete clinical record shall be maintained for each patient 
admitted to a station or hospital of the Service. Such records shall be 
confidential and shall not be disclosed except as may be provided 
elsewhere in regulations of the Service.



Sec. 35.12  Solicitation of legal business prohibited.

    The solicitation, directly or indirectly, of legal business or of a 
retainer or agreement authorizing an attorney to render legal services, 
is prohibited in all stations and hospitals of the Service.



Sec. 35.13  Entry for negotiation of release or settlement.

    (a) No person shall be permitted to enter a station or hospital of 
the Service for the purpose of negotiating a settlement or obtaining a 
general or special release or statement from any patient with reference 
to any illness or personal injury for which the patient is receiving 
care or treatment, or for the purpose of conferring with him as an 
attorney or representative of an attorney with reference to such illness 
or injury, unless the patient has signified his willingness to have such 
person enter for such purpose and, in the judgment of the officer in 
charge, the physical or mental condition of the patient will not thereby 
be impaired.
    (b) Any person entering a station or hospital for a purpose 
enumerated in paragraph (a) of this section shall register in the manner 
prescribed by the officer in charge, and shall furnish for the records 
of the station or hospital the name of each patient by whom he has been 
received for such a purpose.



Sec. 35.14  Solicitation of legal business; negotiation of release or 

settlement; assistance prohibited.

    All employees of the Service and all persons attached in any 
capacity to a station or hospital, including patients, are forbidden to 
communicate, directly or indirectly, with any person for the purpose of 
aiding in the solicitation of legal business or in the negotiation of a 
settlement or the obtaining of a general or special release or statement 
from any patient with reference to any

[[Page 115]]

illness or personal injury for which the patient is receiving care or 
treatment therein. No patient is prohibited by this section from 
communicating on his own behalf with an attorney of his choice or with 
other persons.



Sec. 35.15  Consent to operative procedures.

    Except in emergencies when the patient is physically or mentally 
incapable of consenting and the delay required to obtain the consent of 
his natural or legal guardian would seriously endanger the patient's 
health, no operative procedure shall be undertaken unless the patient 
or, in the case of a minor or incompetent, his natural or legal guardian 
gives his consent, nor shall any major operative procedure or the 
administration of a general anaesthetic be undertaken unless such 
consent has been obtained in writing. The consent or refusal of consent 
shall be made a part of the clinical record.



Sec. 35.16  Autopsies and other post-mortem operations.

    Autopsies, or other post-mortem operations, including removal of 
tissue for transplanting, may be performed on the body of a deceased 
patient only by direction of the officer in charge and only if consented 
to in writing by a person authorized under the law of the State in which 
the station or hospital is located to permit an autopsy or such other 
post-mortem operation under the circumstances of the particular death 
involved. Restrictions or limitations imposed by the person consenting 
thereto on the extent of the autopsy or other post-mortem operation 
shall be observed. Documents embodying consent shall be made a part of 
the clinical record.

[25 FR 6331, July 6, 1960]



Sec. 35.17  Fees and charges for copying, certification, search of records and 

related services.

    A prescribed fee, in accordance with the schedule in paragraph (c) 
of this section, shall be collected for each of the listed services.
    (a) Application for services. Any person requesting (1) a copy of a 
clinical record, clinical abstract, or other document containing 
clinical information; or (2) a certification of a clinical record or 
document; or (3) a search of clinical records, shall make written 
application therefor to the Public Health Service facility having 
custody of the subject matter involved. Such application shall state 
specifically the particular record or document requested, and the 
purpose for which such copy or document is desired to be used. The 
application shall be accompanied by a deposit in an amount equal to the 
prescribed charge for the service rendered. Where it is not known if a 
clinical record or other document is in existence, the application shall 
be accompanied by a minimum deposit of $2.50.
    (b) Authorization for disclosure. The furnishing of copies of PHS 
records containing confidential clinical information must comply with 
the requirements of part I, title 42, Code of Federal Regulations, 
governing authorization for the disclosure of such information.
    (c) Schedule of fees.

(1) Photocopy reproduction of a clinical record or other
 document (through use of facility equipment):
  (a) Processing (searching, preparation of record and use of      $3.25
   equipment), first page.......................................
  (b) Each additional page......................................     .25
(2) Certification, per document.................................     .25
(3) Unsuccessful searching, per hour (minimum charge 1 hour)....    2.50
(4) Clinical abstracts, per request.............................    3.00
(5) Arranging commercial duplication of a clinical record, per       \1\
 request........................................................    0.50
(6) If the requested material is to be transmitted by registered
 mail, airmail, or special delivery mail, the postal fees
 therefor shall be added to the other fees provided above,
 unless the applicant has included proper postage or stamped
 return envelopes for this purpose.
 
\1\ The private concern which duplicates records for an applicant will
  make a separate charge therefor and will bill the applicant directly.

    (d) Waiver of fee. The prescribed fee may be waived, in the 
discretion of the medical officer in charge, under the following 
circumstances:
    (1) When the service or document is requested by another agency of 
the Federal Government for use in carrying out official Government 
business.
    (2) When a clinical record is requested for the purpose of providing 
continued medical care to a Service beneficiary by a non-Service 
physician, clinic, or hospital, in which case the record will be 
forwarded only to the physician, clinic, or hospital concerned.

[[Page 116]]

    (3) When the service or document is requested by an attorney in the 
prosecution of a Service beneficiary's personal injury claim against a 
third person, involving the concurrent assertion of a government medical 
care claim under 42 U.S.C. 2651-2653. In such case, the service or 
document requested will be furnished only upon compliance with all 
additional requirements for the release of records in third party 
recovery cases, including the proper execution of form PHS-4686, 
Agreement to Assign Claim Upon Request.
    (4) When the service or document is requested by, and furnished to, 
a Member of Congress for official use.
    (5) When the service or document is requested by, and furnished to, 
a court in lieu of the personal court appearance of an employee of the 
Public Health Service.
    (6) When the service or document is required to be furnished free in 
accordance with a Federal statute or an Executive order.
    (7) When the furnishing of the service or document requested without 
charge would be an appropriate courtesy to a foreign country or 
international organization.

(Sec. 501, 65 Stat. 290; 31 U.S.C. 483(a); sec. 215, 58 Stat. 690, as 
amended; 42 U.S.C. 216)

[32 FR 6842, May 4, 1967]



                     Subpart B_Transfer of Patients



Sec. 35.21  Authorization of transfer.

    Except as otherwise provided by law or regulation with respect to 
certain classes of patients, the officer in charge of a station or 
hospital of the Service may provide, without any cost to the patient, 
for the transfer of the patient either from such station or hospital to 
another station or hospital of the Service or to any non-Service station 
or hospital at which the patient may be received, or from any non-
Service hospital at which he is receiving care or treatment as a patient 
of the Service to a station or hospital of the Service.



Sec. 35.22  Attendants.

    Patients shall be transferred by such means and accompanied by such 
medical, nursing, or other attendants as may be necessary to protect the 
health and safety of the patient and other persons likely to come into 
contact with him, including in the case of a prisoner such guards as may 
be necessary to assure his safekeeping. A female patient requiring the 
services of attendants shall be accompanied by at least one female 
attendant. Medical or nursing attendants shall be qualified to care for 
persons suffering from the type of disease or disorder with which the 
patient is afflicted and shall be provided with equipment and medicines 
necessary for the care of the patient.



         Subpart C_Disposition of Articles Produced by Patients



Sec. 35.31  Retention by patients.

    Subject to the rules of the station or hospital, patients may be 
accorded the privilege of retaining articles produced by them in the 
course of their curative treatment with the aid of materials furnished 
by the Service. Articles not retained by patients shall be disposed of 
as provided in this subpart. The provisions of this subpart do not apply 
to the products of industrial activities established for narcotic 
addicts.



Sec. 35.32  Board of appraisers.

    The officer in charge shall appoint, from the personnel of the 
station or hospital, a board of three persons to serve at his pleasure. 
The board shall provide for the sale of articles having commercial value 
and shall keep appropriate records of such articles and their 
disposition.



Sec. 35.33  Sale; prices; deposit of proceeds.

    The board shall determine and redetermine from time to time the 
prices at which articles are to be sold, and in doing so shall consider 
the cost of materials used, reasonable handling charges, and the fair 
market value of the articles. The sale price shall be indicated on each 
article by tag or other appropriate means, and a list of articles 
offered for sale and their respective sale prices shall be posted from 
time to time in the hospital or station area. In its discretion, the 
board may offer such articles for purchase by

[[Page 117]]

other patients or by charitable organizations before offering them for 
purchase to the general public. No article shall be sold or resold to 
any officer or employee of the Service. Moneys received from the sale of 
articles shall be deposited into the Treasury to the credit of the 
appropriation from which the materials for making such articles were 
purchased.



Sec. 35.34  Resale.

    No article purchased under the provisions of this subpart shall be 
resold in the hospital or station area at a price to exceed the sale 
price fixed by the board for such article.



Sec. 35.35  Unsalable articles.

    Articles having no commercial value shall be stored, destroyed, or 
otherwise disposed of as the officer in charge may direct.



      Subpart D_Disposal of Money and Effects of Deceased Patients



Sec. 35.41  Inventory.

    Promptly after the death of a patient in a station or hospital of 
the Service, an inventory of his money and effects left therein shall be 
made by two or more officers or employees of the Service designated for 
such purpose by the officer in charge.



Sec. 35.42  Notice upon death.

    The officer in charge shall notify in writing all persons known to 
him to whom delivery of the patient's money and effects might be made 
hereunder, and, in the case of an alien patient, a consul of the country 
of his apparent nationality. Each person so notified shall be requested 
to furnish information concerning (a) the existence or whereabouts of 
any persons to whom delivery of the deceased patient's money and effects 
may be made pursuant to these provisions, and (b) the permanent 
residence or home of the deceased.



Sec. 35.43  Delivery only upon filing claim; forms; procedure.

    (a) Delivery of the money and effects of a deceased patient shall be 
made only to a person who has filed a claim therefor on a form 
prescribed by the Surgeon General.
    (b) A claimant shall furnish, in addition to the information on the 
prescribed form, such additional information as the officer in charge 
may consider necessary to establish the identity of the claimant and the 
truth of his statements.
    (c) A person filing a claim as a legal representative shall be 
required to present letters of administration or a certificate of a 
court attesting his qualification or appointment.
    (d) If a claim is made after the money, or proceeds from the sale of 
the effects, of a deceased patient have been deposited in the Treasury, 
the claim shall be referred to the General Accounting Office. If the 
claim is for checks or evidences of indebtedness of the United States 
which have been trasnsmitted to the issuing agency pursuant to 
Sec. Sec. 35.47 and 35.48, the claimant shall be referred to such 
agency.



Sec. 35.44  Delivery to legal representative; to other claimants if value is 

$1,000 or less.

    The money and effects of the deceased patient shall in all cases be 
delivered to the legal representative, if any, of his estate. If the 
value is $1,000 or less, and the officer in charge has neither notice 
nor other knowledge of the appointment or qualification of a legal 
representative, nor reason to believe that a legal representative will 
be appointed or qualified, he shall deliver all the money and effects, 
as soon as practicable after the expiration of 10 days from the sending 
of notices to one of the following in the indicated order of priority:
    (a) A person, if any, designated in writing by the patient to 
receive the same.
    (b) The patient's surviving spouse.
    (c) The patient's child or children in equal parts.
    (d) The patient's parent or parents in equal parts.
    (e) Any other person who would be entitled to receive the money and 
effects under the law of the patient's domicile: Provided, That delivery 
of such money and effects may be made immediately upon application by 
one

[[Page 118]]

of the persons specified above if the officer in charge has neither 
notice nor other knowledge that a person higher in the indicated order 
of priority exists.



Sec. 35.45  Disposition of effects; exceptions.

    Irrespective of the provisions of this subpart, the officer in 
charge may (a) release from among the effects of the deceased patient so 
much of the patient's clothing as may be necessary for use in 
preparation of his body for burial and (b) cause to be destroyed, or 
otherwise disposed of, such used toilet articles of the patient as 
appear to have no commercial or other value.



Sec. 35.46  Conflicting claims.

    In any case in which conflicting claims are filed or the officer in 
charge considers it to be in the interest of persons who may be 
ultimately entitled thereto, delivery may be withheld from all persons 
other than a duly qualified legal representative.



Sec. 35.47  Disposition of Government checks.

    Notwithstanding any other provisions of this subpart, immediately 
upon completion of the inventory, checks drawn on the Treasurer of the 
United States shall be sent by safe means to the department, agency, or 
establishment of the Government of the United States issuing such 
checks. The transmittal shall be accompanied by a statement of the 
reasons therefor and of all available information which may aid the 
issuing unit in the disposition of the check transmitted. Notice of the 
disposition of any checks, with identifying information, shall be given 
to the person or persons, if any, to which money and effects are 
delivered in accordance with Sec. 35.44.



Sec. 35.48  Deposit of unclaimed money; sale of unclaimed effects and deposit 

of proceeds.

    If, within 120 days after sending of notices no claim has been filed 
pursuant to the provisions of Sec. 35.43, the patient's money, 
consisting of all types of United States currency and coin, shall be 
deposited in the Treasury to the credit of the trust-fund account 
entitled ``Money and Effects of Deceased Patients, Public Health 
Service.'' If, within six months after the death of a patient, no claim 
has been filed pursuant to the provisions of Sec. 35.43, his effects 
(including foreign currency and coin but excluding Postal Savings 
Certificates and other evidences of indebtedness of the United States) 
shall be sold at public auction or by sealed bids to the highest bidder 
and the proceeds deposited to the credit of the trust-fund account 
entitled ``Money and Effects of Deceased Patients, Public Health 
Service.'' Postal Savings Certificates and other evidences of 
indebtedness of the United States shall be transmitted to the issuing 
department or agency with a statement of the occasion therefor.



Sec. 35.49  Sale of unclaimed effects; procedures.

    The following provisions shall govern the sale of effects:
    (a) Notice. Reasonable advance notice of proposed sales shall be 
posted at such prominent places in the station or hospital area as the 
officer in charge may designate. In addition, a notice shall be posted 
at the nearest post office, and notices shall be sent by mail to all 
known persons to whom delivery of money and effects of the patient may 
be made under the provisions of this subpart. The officer or employee 
who posts or sends notices of sales shall make an appropriate affidavit 
on a copy of the notice as to his action in that respect, including in 
his affidavit the names of persons to whom copies of the notices were 
mailed and the mailing dates. The copy of the notice on which the 
affidavit appears shall be retained in the files of the station or 
hospital.
    (b) Form and contents of notice. Notice of proposed sales shall be 
given on a form prescribed by the Surgeon General. The notice shall 
include: an inventory of the effects to be offered for sale; the names 
of the patients from whom the effects were received; the precise date, 
time, and place when and where the sale will be held; a statement that 
the articles will be available for inspection immediately prior to sale, 
if sold at public auction, or on a day and during the hours appointed 
for

[[Page 119]]

the inspection of articles if sold by sealed bid; a statement that the 
sale is to be held pursuant to the provisions of the regulations in this 
part, that, if the articles are to be sold by sealed bid, the right to 
reject all bids is reserved, and that, if otherwise authorized, delivery 
will be made of effects or proceeds of sales to persons filing claims 
prior to the sale of effects or prior to the transmittal of proceeds to 
the Surgeon General.
    (c) Time and place of sales. All sales shall be held at reasonable 
hours and at such places within the station or hospital area as the 
officer in charge may designate.
    (d) Who shall conduct sales. All sales shall be conducted by the 
officer in charge or by a responsible officer or employee designated by 
him.
    (e) Sale and delivery. All effects offered for sale shall be sold to 
the highest bidder and delivered to him immediately upon payment of the 
sale price in cash or by postal money order or certified check and 
execution of an appropriate receipt by the person to whom delivery is 
made.



Sec. 35.50  Disposition of unsold effects.

    The officer in charge shall dispose of effects offered for sale but 
remaining unsold in such manner as he considers to be proper, but, if 
practicable, such effects shall be used for the benefit of other 
patients of the Service.



Sec. 35.51  Manner of delivery; costs, receipts.

    (a) If a person entitled under this subpart to receive the money and 
effects of a patient is unable to take possession thereof at the station 
or hospital, they shall be sent to him at the expense of the United 
States in the most economical manner available. The records of the 
station or hospital shall show the names and addresses of persons to 
whom money or effects have been sent, the date of sending, the means 
used, an itemized list of the money or effects sent, and a statement by 
a witnessing officer or employee verifying the foregoing from his own 
observation.
    (b) If not delivered personally by an authorized officer or employee 
of the Service, money, evidences of indebtedness, and other valuable 
papers and documents shall be sent by registered mail (or other safe 
means).
    (c) Persons receiving the money and effects of a patient shall be 
required to execute an itemized receipt therefor.



Sec. 35.52  Delivery of possession only; title unaffected.

    Except for delivery of effects to purchasers at sales held in 
accordance with Sec. 35.49, delivery or deposit under this subpart of 
the money or effects, or the proceeds of a sale of the effects, of a 
deceased patient constitutes only a transfer of possession and is not 
intended to affect in any manner the title to such money, effects, or 
proceeds.



           Subpart E_Contributions for the Benefit of Patients

    Authority: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 
U.S.C. 216); sec. 321, 58 Stat. 695, as amended, 62 Stat. 1017 (42 
U.S.C. 248).

    Source: 42 FR 60742, Nov. 29, 1977, unless otherwise noted.



Sec. 35.61  Applicability.

    This subpart sets forth the policies and procedures governing the 
acceptance and administration of contributions of money or property 
intended solely for the benefit of all patients in a ward or unit or a 
particular hospital or station of the Public Health Service, excluding 
outpatient clinics. Such contributions are distinguishable from (a) 
monies or other valuables belonging to specific patients which are 
accepted and held in custody for the convenience of the patient until 
such time as he or she wishes to withdraw them, and (b) gifts to the 
United States to support Public Health Service functions under section 
501 of the Public Health Service Act or other statutory provisions, 
which may be accepted and administered only in accordance with such 
statutory provisions or other applicable laws.



Sec. 35.62  Acceptance of contributions.

    (a) The officer in charge of a hospital or station or his delegate 
may accept contributions of money or personal property which are donated 
for the

[[Page 120]]

general benefit of all patients within the hospital or station (or a 
ward or unit thereof) without further specification or conditions as to 
use. Contributions tendered subject to conditions by the donor, such as 
expenditure or use only on behalf of certain patients or for specific 
purposes, may not be accepted.
    (b) Contribution of money or property shall be accepted in writing.



Sec. 35.63  Report of and accounting for contributions.

    (a) Contributions of money accepted pursuant to Sec. 35.62 
(hereinafter referred to as ``patient fund'') will be treated 
consistently with Federal deposit rules and as supplemented with 
appropriate procedures of the facility. This regulation is not intended 
to exclude contributions for the benefit of patients from proper 
accountability and control of funds and property.
    (b) Contributions of property accepted pursuant to Sec. 35.62 shall 
be recorded and accounted for in the same manner as other property of a 
similar kind maintained in the hospital or station, but with suitable 
identification so that it can be distinguished from government-owned 
property.



Sec. 35.64  Donors.

    Authorized contributions may be accepted from patients, employees 
and other individuals, and agencies and organizations.



Sec. 35.65  Acceptable personal property.

    Contributions of personal property which may be accepted pursuant to 
Sec. 35.62 include, but are not limited to, recreational equipment, 
furniture, radios and television sets. After its useful life, any cash 
proceeds realized upon disposition of such property shall be deposited 
to the credit of the patient fund and shall be available for expenditure 
pursuant to Sec. 35.66(c).



Sec. 35.66  Expenditure of cash contributions.

    (a) Officials authorized to accept contributions shall not maintain 
control over the actual obligation or expenditure of such monies.
    (b) Only those officers or employees specifically designated in 
writing by the officer in charge for such purpose may obligate and 
expend monies from the patient fund. The names of officials so 
designated shall be provided to the relevant fiscal control office.
    (c) Subject to availability of sufficient funds, monies in the 
patient fund may be expended for materials, services or activities which 
contribute to the well-being or morale of patients, including but not 
limited to provision of reading and entertainment materials, recreation 
activities, and, in appropriate cases, necessary financial support 
(including travel expenses, meals, and lodging) of relatives, guardians, 
or friends of patients to enable such persons to be available for the 
patient's comfort and support.
    (d) Officers in charge may issue such additional instructions, not 
inconsistent with this subpart, as may be necessary to implement its 
provisions.



PART 37_SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF UNDERGROUND COAL MINERS--

Table of Contents




               Subpart_Chest Roentgenographic Examinations

Sec.
37.1 Scope.
37.2 Definitions.
37.3 Chest roentgenograms required for miners.
37.4 Plans for chest roentgenographic examinations.
37.5 Approval of plans.
37.6 Chest roentgenographic examinations conducted by the Secretary.
37.7 Transfer of affected miner to less dusty area.
37.8 Roentgenographic examination at miner's expense.
37.20 Miner identification document.

    Specifications for Performing Chest Roentgenographic Examinations

37.40 General provisions.
37.41 Chest roentgenogram specifications.
37.42 Approval of roentgenographic facilities.
37.43 Protection against radiation emitted by roentgenographic 
          equipment.

  Specifications for Interpretation, Classification, and Submission of 
                          Chest Roentgenograms

37.50 Interpreting and classifying chest roentgenograms.
37.51 Proficiency in the use of systems for classifying the 
          pneumoconioses.

[[Page 121]]

37.52 Method of obtaining definitive interpretations.
37.53 Notification of abnormal roentgenographic findings.
37.60 Submitting required chest roentgenograms and miner identification 
          documents.

                   Review and Availability of Records

37.70 Review of interpretations.
37.80 Availablity of records.

                            Subpart_Autopsies

37.200 Scope.
37.201 Definitions.
37.202 Payment for autopsy.
37.203 Autopsy specifications.
37.204 Procedure for obtaining payment.

    Authority: Sec. 203, 83 Stat. 763; 30 U.S.C. 843, unless otherwise 
noted.

    Source: 43 FR 33715, Aug. 1, 1978, unless otherwise noted.



               Subpart_Chest Roentgenographic Examinations



Sec. 37.1  Scope.

    The provisions of this subpart set forth the specifications for 
giving, interpreting, classifying, and submitting chest roentgenograms 
required by section 203 of the act to be given to underground coal 
miners and new miners.



Sec. 37.2  Definitions.

    Any term defined in the Federal Mine Safety and Health Act of 1977 
and not defined below shall have the meaning given it in the act. As 
used in this subpart:
    (a) Act means the Federal Mine Safety and Health Act of 1977 (30 
U.S.C. 801, et seq.).
    (b) ALOSH means the Appalachian Laboratory for Occupational Safety 
and Health, Box 4258, Morgantown, WV 26505. Although the Division of 
Respiratory Disease Studies, National Institute for Occupational Safety 
and Health, has programmatic responsibility for the chest 
roentgenographic examination program, the Institute's facility in 
Morgantown--ALOSH--is used throughout this subpart in referring to the 
administration of the program.
    (c) Chest roentgenogram means a single posteroanterior 
roentgenographic projection or radiograph of the chest at full 
inspiration recorded on roentgenographic film.
    (d) Convenient time and place with respect to the conduct of any 
examination under this subpart means that the examination must be given 
at a reasonable hour in the locality in which the miner resides or a 
location that is equally accessible to the miner. For example, 
examinations at the mine during, immediately preceding, or immediately 
following work and a ``no appointment'' examination at a medical 
facility in a community easily accessible to the residences of a 
majority of the miners working at the mine, shall be considered of 
equivalent convenience for purposes of this paragraph.
    (e) Institute and NIOSH mean the National Institute for Occupational 
Safety and Health Center for Disease Control, Public Health Service, 
Department of Health and Human Services.
    (f) ILO-U/C Classification means the classification of radiographs 
of the pneumoconioses devised in 1971 by an international committee of 
the International Labor Office and described in ``Medical Radiography 
and Photography,'' volume 48, No. 3, December 1972. ``ILO 
Classification'' means the classification of radiographs of the 
pneumoconioses revised in 1980 by an international committee of the 
International Labor Office and described in ``Medical Radiography and 
Photography'' volume 57, No. 1, 1981, and in ILO publication 22 (revised 
1980) from the ILO Occupational Safety and Health Series.
    (g) Miner means any individual including any coal mine construction 
worker who is working in or at any underground coal mine, but does not 
include any surface worker who does not have direct contact with 
underground coal mining or with coal processing operations.
    (h) Operator means any owner, lessee, or other person who operates, 
controls, or supervises an underground coal mine or any independent 
contractor performing services or construction at such mine.
    (i) Panel of `B' Readers means the U.S. Public Health Service 
Consultant Panel of ``B'' Readers, c/o ALOSH, P.O. Box 4258, Morgantown, 
WV 26505.

[[Page 122]]

    (j) Preemployment physical examination means any medical examination 
which includes a chest roentgenographic examination given in accordance 
with the specifications of this subpart to a person not previously 
employed by the same operator or at the same mine for which that person 
is being considered for employment.
    (k) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved may be delegated.
    (l) MSHA means the Mine Safety and Health Administration, Department 
of Labor.

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7563, Mar. 1, 1984]



Sec. 37.3  Chest roentgenograms required for miners.

    (a) Voluntary examinations. Every operator shall provide to each 
miner who is employed in or at any of its underground coal mines and who 
was employed in underground coal mining prior to December 30, 1969, or 
who has completed the required examinations under Sec. 37.3(b) an 
opportunity for a chest roentgenogram in accordance with this subpart:
    (1) Following August 1, 1978 ALOSH will notify the operator of each 
underground coal mine of a period within which the operator may provide 
examinations to each miner employed at its coal mine. The period shall 
begin no sooner than the effective date of these regulations and end no 
later than a date specified by ALOSH separately for each coal mine. The 
termination date of the period will be approximately 5 years from the 
date of the first examination which was made on a miner employed by the 
operator in its coal mine under the former regulations of this subpart 
adopted July 27, 1973. Within the period specified by ALOSH for each 
mine, the operator may select a 6-month period within which to provide 
examinations in accordance with a plan approved under Sec. 37.5.

    Example: ALOSH finds that between July 27, 1973, and March 31, 1975, 
the first roentgenogram for a miner who was employed at mine Y and who 
was employed in underground coal mining prior to December 30, 1969, was 
made on January 1, 1974. ALOSH will notify the operator of mine Y that 
the operator may select and designate on its plan a 6-month period 
within which to offer its examinations to its miners employed at mine Y. 
The 6-month period shall be scheduled between August 1, 1978 and January 
1, 1979 (5 years after January 1, 1974).

    (2) For all future voluntary examinations, ALOSH will notify the 
operator of each underground coal mine when sufficient time has elapsed 
since the end of the previous 6-month period of examinations. ALOSH will 
specify to the operator of each mine a period within which the operator 
may provide examinations to its miners employed at its coal mine. The 
period shall begin no sooner than 3\1/2\ years and end no later than 
4\1/2\ years subsequent to the ending date of the previous 6-month 
period specified for a coal mine either by the operator on an approved 
plan or by ALOSH if the operator did not submit an approved plan. Within 
the period specified by ALOSH for each mine, the operator may select a 
6-month period within which to provide examinations in accordance with a 
plan approved under Sec. 37.5.

    Example: ALOSH finds that examinations were previously provided to 
miners employed at mine Y in a 6-month period from July 1, 1979, to 
December 31, 1979. ALOSH notifies the operator at least 3 months before 
July 1, 1983 (3\1/2\ years after December 31, 1979) that the operator 
may select and designate on its plan the next 6-month period within 
which to offer examinations to its miners employed at mine Y. The 6-
month period shall be scheduled between July 1, 1983, and July 1, 1984 
(between 3\1/2\ and 4\1/2\ years after December 31, 1979).

    (3) Within either the next or future period(s) specified by ALOSH to 
the operator for each of its coal mines, the operator of the coal mine 
may select a different 6-month period for each of its mines within which 
to offer examinations. In the event the operator does not submit an 
approved plan, ALOSH will specify a 6-month period to the operator 
within which miners shall have the opportunity for examinations.
    (b) Mandatory examinations. Every operator shall provide to each 
miner who begins working in or at a coal mine for the first time after 
December 30, 1969:
    (1) An initial chest roentgenogram as soon as possible, but in no 
event later

[[Page 123]]

than 6 months after commencement of employment. A preemployment physical 
examination which was made within the 6 months prior to the date on 
which the miner started to work will be considered as fulfilling this 
requirement. An initial chest roentgenogram given to a miner according 
to former regulations for this subpart prior to August 1, 1978 will also 
be considered as fulfilling this requirement.
    (2) A second chest roentgenogram, in accordance with this subpart, 3 
years following the initial examination if the miner is still engaged in 
underground coal mining. A second roentgenogram given to a miner 
according to former regulations under this subpart prior to August 1, 
1978 will be considered as fulfilling this requirement.
    (3) A third chest roentgenogram 2 years following the second chest 
roentgenogram if the miner is still engaged in underground coal mining 
and if the second roentgenogram shows evidence of category 1, category 
2, category 3 simple pneumoconioses, or complicated pneumoconioses (ILO 
Classification).
    (c) ALOSH will notify the miner when he or she is due to receive the 
second or third mandatory examination under (b) of this section. 
Similarly, ALOSH will notify the coal mine operator when the miner is to 
be given a second examination. The operator will be notified concerning 
a miner's third examination only with the miner's written consent, and 
the notice to the operator shall not state the medical reason for the 
examination nor that it is the third examination in the series. If the 
miner is notified by ALOSH that the third mandatory examination is due 
and the operator is not so notified, availability of the 
roentgenographic examination under the operator's plan shall constitute 
the operator's compliance with the requirement to provide a third 
mandatory examination even if the miner refuses to take the examination.
    (d) The opportunity for chest roentgenograms to be available by an 
operator for purposes of this subpart shall be provided in accordance 
with a plan which has been submitted and approved in accordance with 
this subpart.
    (e) Any examinations conducted by the Secretary in the National 
Study of Coal Workers' Pneumoconiosis after January 1, 1977, but before 
August 1, 1978 shall satisfy the requirements of this section with 
respect to the specific examination given (see Sec. 37.6(d)).

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978, as amended at 49 
FR 7563, Mar. 1, 1984]



Sec. 37.4  Plans for chest roentgenographic examinations.

    (a) Every plan for chest roentgenographic examinations of miners 
shall be submitted on forms prescribed by the Secretary to ALOSH within 
120 calendar days after August 1, 1978. In the case of a person who 
after August 1, 1978, becomes an operator of a mine for which no plan 
has been approved, that person shall submit a plan within 60 days after 
such event occurs. A separate plan shall be submitted by the operator 
and by each construction contractor for each underground coal mine which 
has a MSHA identification number. The plan shall include:
    (1) The name, address, and telephone number of the operator(s) 
submitting the plan;
    (2) The name, MSHA identification number for respirable dust 
measurements, and address of the mine included in the plan;
    (3) The proposed beginning and ending date of the 6-month period for 
voluntary examinations (see Sec. 37.3(a)) and the estimated number of 
miners to be given or offered examinations during the 6-month period 
under the plan;
    (4) The name and location of the approved X-ray facility or 
facilities, and the approximate date(s) and time(s) of day during which 
the roentgenograms will be given to miners to enable a determination of 
whether the examinations will be conducted at a convenient time and 
place;
    (5) If a mobile facility is proposed, the plan shall provide that 
each miner be given adequate notice of the opportunity to have the 
examination and that no miner shall have to wait for an examination more 
than 1 hour before or after his or her work shift. In addition, the plan 
shall include:
    (i) The number of change houses at the mine.
    (ii) One or more alternate nonmobile approved facilities for the 
reexamination of miners and for the mandatory

[[Page 124]]

examination of miners when necessary (see Sec. 37.3(b)), or an 
assurance that the mobile facility will return to the location(s) 
specified in the plan as frequently as necessary to provide for 
examinations in accordance with these regulations.
    (iii) The name and location of each change house at which 
examinations will be given. For mines with more than one change house, 
the examinations shall be given at each change house or at a change 
house located at a convenient place for each miner.
    (6) The name and address of the ``A'' or ``B'' reader who will 
interpret and classify the chest roentgenograms.
    (7) Assurances that: (i) The operator will not solicit a physician's 
roentgenographic or other findings concerning any miner employed by the 
operator,
    (ii) Instructions have been given to the person(s) giving the 
examinations that duplicate roentgenograms or copies of roentgenograms 
will not be made and that (except as may be necessary for the purpose of 
this subpart) the physician's roentgenographic and other findings, as 
well as the occupational history information obtained from a miner 
unless obtained prior to employment in a preemployment examination, and 
disclosed prior to employment, will not be disclosed in a manner which 
will permit identification of the employee with the information about 
him, and
    (iii) The roentgenographic examinations will be made at no charge to 
the miner.
    (b) Operators may provide for alternate facilities and ``A'' or 
``B'' readers in plans submitted for approval.
    (c) The change of operators of any mine operating under a plan 
approved pursuant to Sec. 37.5 shall not affect the plan of the 
operator which has transferred responsibility for the mine. Every plan 
shall be subject to revision in accordance with paragraph (d) of this 
section.
    (d) The operator shall advise ALOSH of any change in its plan. Each 
change in an approved plan is subject to the same review and approval as 
the originally approved plan.
    (e) The operator shall promptly display in a visible location on the 
bulletin board at the mine its proposed plan or proposed change in plan 
when it is submitted to ALOSH. The proposed plan or change in plan shall 
remain posted in a visible location on the bulletin board until ALOSH 
either grants or denies approval of it at which time the approved plan 
or denial of approval shall be permanently posted. In the case of an 
operator who is a construction contractor and who does not have a 
bulletin board, the construction contractor must otherwise notify its 
employees of the examination arrangements. Upon request, the contractor 
must show ALOSH written evidence that its employees have been notified.
    (f) Upon notification from ALOSH that sufficient time has elapsed 
since the previous period of examinations, the operator will resubmit 
its plan for each of its coal mines to ALOSH for approval for the next 
period of examinations (see Sec. 37.3(a)(2)). The plan shall include 
the proposed beginning and ending dates of the next period of 
examinations and all information required by paragraph (a) of this 
section.

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978]



Sec. 37.5  Approval of plans.

    (a) Approval of plans granted prior to August 1, 1978 is no longer 
effective.
    (b) If, after review of any plan submitted pursuant to this subpart, 
the Secretary determines that the action to be taken under the plan by 
the operator meets the specifications of this subpart and will 
effectively achieve its purpose, the Secretary will approve the plan and 
notify the operator(s) submitting the plan of the approval. Approval may 
be conditioned upon such terms as the Secretary deems necessary to carry 
out the purpose of section 203 of the act.
    (c) Where the Secretary has reason to believe that he will deny 
approval of a plan he will, prior to the denial, give reasonable notice 
in writing to the operator(s) of an opportunity to amend the plan. The 
notice shall specify the ground upon which approval is proposed to be 
denied.
    (d) If a plan is denied approval, the Secretary shall advise the 
operator(s) in writing of the reasons for the denial.

[[Page 125]]



Sec. 37.6  Chest roentgenographic examinations conducted by the Secretary.

    (a) The Secretary will give chest roentgenograms or make 
arrangements with an appropriate person, agency, or institution to give 
the chest roentgenograms and with ``A'' or ``B'' readers to interpret 
the roentgenograms required under this subpart in the locality where the 
miner resides, at the mine, or at a medical facility easily accessible 
to a mining community or mining communities, under the following 
circumstances:
    (1) Where, in the judgment of the Secretary, due to the lack of 
adequate medical or other necessary facilities or personnel at the mine 
or in the locality where the miner resides, the required 
roentgenographic examination cannot be given.
    (2) Where the operator has not submitted an approvable plan.
    (3) Where, after commencement of an operator's program pursuant to 
an approved plan and after notice to the operator of his failure to 
follow the approved plan and, after allowing 15 calendar days to bring 
the program into compliance, the Secretary determines and notifies the 
operator in writing that the operator's program still fails to comply 
with the approved plan.
    (b) The operator of the mine shall reimburse the Secretary or other 
person, agency, or institution as the Secretary may direct, for the cost 
of conducting each examination made in accordance with this section.
    (c) All examinations given or arranged by the Secretary will comply 
with the time requirements of Sec. 37.3. Whenever the Secretary gives 
or arranges for the examinations of miners at a time, a written notice 
of the arrangements will be sent to the operator who shall post the 
notice on the mine bulletin board.
    (d) Operators of mines selected by ALOSH to participate in the 
National Study of Coal Workers' Pneumoconiosis (an epidemiological study 
of respiratory diseases in coal miners) and who agree to cooperate will 
have all their miners afforded the opportunity to have a chest 
roentgenogram required hereunder at no cost to the operator. For future 
examinations and for mandatory examinations each participating operator 
shall submit an approvable plan.



Sec. 37.7  Transfer of affected miner to less dusty area.

    (a) Any miner who, in the judgment of the Secretary based upon the 
interpretation of one or more of the miner's chest roentgenograms, shows 
category 1 (1/0, 1/1, 1/2), category 2 (2/1, 2/2, 2/3), or category 3 
(3/2, 3/3, 3/4) simple pneumoconioses, or complicated pneumoconioses 
(ILO Classification) shall be afforded the option of transferring from 
his or her position to another position in an area of the mine where the 
concentration of respirable dust in the mine atmosphere is not more than 
1.0 mg/m\3\ of air, or if such level is not attainable in the mine, to a 
position in the mine where the concentration of respirable dust is the 
lowest attainable below 2.0 mg/m\3\ of air.
    (b) Any transfer under this section shall be in accordance with the 
procedures specified in part 90 of title 30, Code of Federal 
Regulations.

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978, as amended at 44 
FR 23085, Apr. 18, 1979; 49 FR 7563, Mar. 1, 1984]



Sec. 37.8  Roentgenographic examination at miner's expense.

    Any miner who wishes to obtain an examination at his or her own 
expense at an approved facility and to have submitted to NIOSH for him 
or her a complete examination may do so, provided that the examination 
is made no sooner than 6 months after the most recent examination of the 
miner submitted to ALOSH. ALOSH will provide an interpretation and 
report of the examinations made at the miner's expense in the same 
manner as if it were submitted under an operator's plan. Any change in 
the miner's transfer rights under the act which may result from this 
examination will be subject to the terms of Sec. 37.7.



Sec. 37.20  Miner identification document.

    As part of the roentgenographic examination, a miner identification 
document which includes an occupational history questionnaire shall be 
completed for each miner at the facility where the roentgenogram is made 
at

[[Page 126]]

the same time the chest roentgenogram required by this subpart is given.

    Specifications for Performing Chest Roentgenographic Examinations



Sec. 37.40  General provisions.

    (a) The chest roentgenographic examination shall be given at a 
convenient time and place.
    (b) The chest roentgenographic examination consists of the chest 
roentgenogram, and a complete Roentgenographic Interpretation Form (Form 
CDC/NIOSH (M) 2.8), and miner identification document.
    (c) A roentgenographic examination shall be made in a facility 
approved in accordance with Sec. 37.42 by or under the supervision of a 
physician who regularly makes chest roentgenograms and who has 
demonstrated ability to make chest roentgenograms of a quality to best 
ascertain the presence of pneumoconiosis.



Sec. 37.41  Chest roentgenogram specifications.

    (a) Every chest roentgenogram shall be a single posteroanterior 
projection at full inspiration on a film being no less than 14 by 17 
inches and no greater than 16 by 17 inches. The film and cassette shall 
be capable of being positioned both vertically and horizontally so that 
the chest roentgenogram will include both apices and costophrenic 
angles. If a miner is too large to permit the above requirements, then 
the projection shall include both apices with minimum loss of the 
costophrenic angle.
    (b) Miners shall be disrobed from the waist up at the time the 
roentgenogram is given. The facility shall provide a dressing area and 
for those miners who wish to use one, the facility shall provide a clean 
gown. Facilities shall be heated to a comfortable temperature.
    (c) Roentgenograms shall be made only with a diagnostic X-ray 
machine having a rotating anode tube with a maximum of a 2 mm. source 
(focal spot).
    (d) Except as provided in paragraph (e) of this section, 
roentgenograms shall be made with units having generators which comply 
with the following: (1) The generators of existing roentgenographic 
units acquired by the examining facility prior to July 27, 1973, shall 
have a minimum rating of 200 mA at 100 kVp.; (2) generators of units 
acquired subsequent to that date shall have a minimum rating of 300 mA 
at 125 kVp.

    Note: A generator with a rating of 150 kVp. is recommended.

    (e) Roentgenograms made with battery-powered mobile or portable 
equipment shall be made with units having a minimum rating of 100 mA at 
110 kVp. at 500 Hz, or of 200 mA at 110 kVp. at 60 Hz.
    (f) Capacitor discharge and field emission units may be used if the 
model of such units is approved by ALOSH for quality, performance, and 
safety. ALOSH will consider such units for approval when listed by a 
facility seeking approval under Sec. 37.42 of this subpart.
    (g) Roentgenograms shall be given only with equipment having a beam-
limiting device which does not cause large unexposed boundaries. The 
beam limiting device shall provide rectangular collimation and shall be 
of the type described in part F of the suggested State regulations for 
the control of radiation or (for beam limiting devices manufactured 
after August 1, 1974) of the type specified in 21 CFR 1020.31. The use 
of such a device shall be discernible from an examination of the 
roentgenogram.
    (h) To insure high quality chest roentgenograms:
    (1) The maximum exposure time shall not exceed \1/20\ of a second 
except that with single phase units with a rating less than 300 mA at 
125 kVp. and subjects with chests over 28 cm. posteroanterior, the 
exposure may be increased to not more than \1/10\ of a second;
    (2) The source or focal spot to film distance shall be at least 6 
feet;
    (3) Medium speed film and medium speed intensifying screens are 
recommended. However, any film-screen combination, the rated ``speed'' 
of which is at least 100 and does not exceed 300, which produces 
roentgenograms with spatial resolution, contrast, latitude and quantum 
mottle

[[Page 127]]

similar to those of systems designated as ``medium speed'' may be 
employed;
    (4) Film-screen contact shall be maintained and verified at 6 month 
or shorter intervals;
    (5) Intensifying screens shall be inspected at least once a month 
and cleaned when necessary by the method recommended by the 
manufacturer;
    (6) All intensifying screens in a cassette shall be of the same type 
and made by the same manufacturer;
    (7) When using over 90 kV., a suitable grid or other means of 
reducing scattered radiation shall be used;
    (8) The geometry of the radiographic system shall insure that the 
central axis (ray) of the primary beam is perpendicular to the plane of 
the film surface and impinges on the center of the film;
    (9) A formal quality assurance program shall be established at each 
facility.
    (i) Radiographic processing:
    (1) Either automatic or manual film processing is acceptable. A 
constant time-temperature technique shall be meticulously employed for 
manual processing.
    (2) If mineral or other impurities in the processing water introduce 
difficulty in obtaining a high-quality roentgenogram, a suitable filter 
or purification system shall be used.
    (j) Before the miner is advised that the examination is concluded, 
the roentgenogram shall be processed and inspected and accepted for 
quality by the physician, or if the physician is not available, 
acceptance may be made by the radiologic technologist. In a case of a 
substandard roentgenogram, another shall be immediately made. All 
substandard roentgenograms shall be clearly marked as rejected and 
promptly sent to ALOSH for disposal.
    (k) An electric power supply shall be used which complies with the 
voltage, current, and regulation specified by the manufacturer of the 
machine.
    (l) A densitometric test object may be required on each 
roentgenogram for an objective evaluation of film quality at the 
discretion of ALOSH.
    (m) Each roentgenogram made hereunder shall be permanently and 
legibly marked with the name and address or ALOSH approval number of the 
facility at which it is made, the social security number of the miner, 
and the date of the roentgenogram. No other identifying markings shall 
be recorded on the roentgenogram.

[43 FR 33715, Aug. 1, 1978, as amended at 52 FR 7866, Mar. 13, 1987]



Sec. 37.42  Approval of roentgenographic facilities.

    (a) Approval of roentgenographic facilities given prior to January 
1, 1976, shall terminate upon August 1, 1978 unless each of the 
following conditions have been met:
    (1) The facility must verify that it still meets the requirements 
set forth in the regulations for the second round of roentgenographic 
examinations (38 FR 20076) and it has not changed equipment since it was 
approved by NIOSH.
    (2) From July 27, 1973, to January 1, 1976, the facility submitted 
to ALOSH at least 50 roentgenograms which were interpreted by one or 
more ``B'' readers not employed by the facility who found no more than 5 
percent of all the roentgenograms unreadable.
    (b) Other facilities will be eligible to participate in this program 
when they demonstrate their ability to make high quality diagnostic 
chest roentgenograms by submitting to ALOSH six or more sample chest 
roentgenograms made and processed at the applicant facility and which 
are of acceptable quality to the Panel of ``B'' readers. Applicants 
shall also submit a roentgenogram of a plastic step-wedge object 
(available on loan from ALOSH) which was made and processed at the same 
time with the same technique as the roentgenograms submitted and 
processed at the facility for which approval is sought. At least one 
chest roentgenogram and one test object roentgenogram shall have been 
made with each unit to be used hereunder. All roentgenograms shall have 
been made within 15 calendar days prior to submission and shall be 
marked to identify the facility where each roentgenogram was made, the 
X-ray machine used, and the date each was made. The chest roentgenograms 
will be returned and may be the same roentgenograms submitted pursuant 
to Sec. 37.51.

    Note: The plastic step-wedge object is described in an article by E. 
Dale Trout and

[[Page 128]]

John P. Kelley appearing in ``The American Journal of Roentgenology, 
Radium Therapy and Nuclear Medicine,'' Vol. 117, No. 4, April 1973.

    (c) Each roentgenographic facility submitting chest roentgenograms 
for approval under this section shall complete and include an X-ray 
facility document describing each X-ray unit to be used to make chest 
roentgenograms under the act. The form shall include: (1) The date of 
the last radiation safety inspection by an appropriate licensing agency 
or, if no such agency exists, by a qualified expert as defined in NCRP 
Report No. 33 (see Sec. 37.43); (2) the deficiencies found; (3) a 
statement that all the deficiencies have been corrected; and (4) the 
date of acquisition of the X-ray unit. To be acceptable, the radiation 
safety inspection shall have been made within 1 year preceding the date 
of application.
    (d) Roentgenograms submitted with applications for approval under 
this section will be evaluated by the panel of ``B'' Readers or by a 
qualified radiological physicist or consultant. Applicants will be 
advised of any reasons for denial of approval.
    (e) ALOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved roentgenographic facility at 
any reasonable time to determine if the requirements of this subpart are 
being met.
    (f) ALOSH may require a facility periodically to resubmit 
roentgenograms of a plastic step-wedge object, sample roentgenograms, or 
a Roentgenographic Facility Document for quality control purposes. 
Approvals granted hereunder may be suspended or withdrawn by notice in 
writing when in the opinion of ALOSH the quality of roentgenograms or 
information submitted under this section warrants such action. A copy of 
a notice withdrawing approval will be sent to each operator who has 
listed the facility as its facility for giving chest roentgenograms and 
shall be displayed on the mine bulletin board adjacent to the operator's 
approved plan. The approved plan will be reevaluated by ALOSH in light 
of this change.

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978]



Sec. 37.43  Protection against radiation emitted by roentgenographic 

equipment.

    Except as otherwise specified in Sec. 37.41, roentgenographic 
equipment, its use and the facilities (including mobile facilities) in 
which such equipment is used, shall conform to applicable State and 
Federal regulations (See 21 CFR part 1000). Where no applicable 
regulations exist, roentgenographic equipment, its use and the 
facilities (including mobile facilities) in which such equipment is used 
shall conform to the recommendations of the National Council on 
Radiation Protection and Measurements in NCRP Report No. 33 ``Medical X-
ray and Gamma-Ray Protection for Energies up to 10 MeV--Equipment Design 
and Use'' (issued February 1, 1968), in NCRP Report No. 48, ``Medical 
Radiation Protection for Medical and Allied Health Personnel'' (issued 
August 1, 1976), and in NCRP Report No. 49, ``Structural Shielding 
Design and Evaluation for Medical Use of X-rays and Gamma Rays of up to 
10 MeV'' (issued September 15, 1976). These documents are hereby 
incorporated by reference and made a part of this subpart. These 
documents are available for examination at ALOSH, 944 Chestnut Ridge 
Road, Morgantown, WV 26505, and at the National Institute for 
Occupational Safety and Health, 5600 Fishers Lane, Rockville, MD 20857. 
Copies of NCRP Reports Nos. 33, 48, and 49 may be purchased for $3, 
$4.50, and $3.50 each, respectively, from NCRP Publications, P.O. Box 
30175, Washington, DC 20014.

  Specifications for Interpretation, Classification, and Submission of 
                          Chest Roentgenograms



Sec. 37.50  Interpreting and classifying chest roentgenograms.

    (a) Chest roentgenograms shall be interpreted and classified in 
accordance with the ILO Classification system and recorded on a 
Roentgenographic Interpretation Form (Form CDC/NIOSH (M)2.8).
    (b) Roentgenograms shall be interpreted and classified only by a 
physician who regularly reads chest roentgenograms and who has 
demonstrated proficiency in classifying the

[[Page 129]]

pneumoconioses in accordance with Sec. 37.51.
    (c) All interpreters, whenever interpreting chest roentgenograms 
made under the Act, shall have immediately available for reference a 
complete set of the ILO International Classification of Radiographs for 
Pneumoconioses, 1980.

    Note: This set is available from the International Labor Office, 
1750 New York Avenue, NW., Washington, DC 20006 (Phone: 202/376-2315).

    (d) In all view boxes used for making interpretations:
    (1) Fluorescent lamps shall be simultaneously replaced with new 
lamps at 6-month intervals;
    (2) All the fluorescent lamps in a panel of boxes shall have 
identical manufacturer's ratings as to intensity and color;
    (3) The glass, internal reflective surfaces, and the lamps shall be 
kept clean;
    (4) The unit shall be so situated as to minimize front surface 
glare.

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984]



Sec. 37.51  Proficiency in the use of systems for classifying the 

pneumoconioses.

    (a) First or ``A'' readers:
    (1) Approval as an ``A'' reader shall continue if established prior 
to (insert) effective date of these regulations).
    (2) Physicians who desire to be ``A'' readers must demonstrate their 
proficiency in classifying the pneumoconioses by either:
    (i) Submitting to ALOSH from the physician's files six sample chest 
roentgenograms which are considered properly classified by the Panel of 
``B'' readers. The six roentgenograms shall consist of two without 
pneumoconiosis, two with simple pneumoconiosis, and two with complicated 
pneumoconiosis. The films will be returned to the physician. The 
interpretations shall be on the Roentgenographic Interpretation Form 
(Form CDC/NIOSH (M) 2.8) (These may be the same roentgenograms submitted 
pursuant to Sec. 37.42), or;
    (ii) Satisfactory completion, since June 11, 1970, of a course 
approved by ALOSH on the ILO or ILO-U/C Classification systems or the 
UICC/Cincinnati classification system. As used in this subparagraph, 
``UICC/Cincinnati classification'' means the classification of the 
pneumoconioses devised in 1968 by a Working Committee of the 
International Union Against Cancer.
    (b) Final or ``B'' readers:
    (1) Approval as a ``B'' reader established prior to October 1, 1976, 
shall hereby be terminated.
    (2) Proficiency in evaluating chest roentgenograms for 
roentgenographic quality and in the use of the ILO Classification for 
interpreting chest roentgenograms for pneumoconiosis and other diseases 
shall be demonstrated by those physicians who desire to be ``B'' readers 
by taking and passing a specially designed proficiency examination given 
on behalf of or by ALOSH at a time and place specified by ALOSH. Each 
physician must bring a complete set of the ILO standard reference 
radiographs when taking the examination. Physicians who qualify under 
this provision need not be qualified under paragraph (a) of this 
section.
    (c) Physicians who wish to participate in the program shall make 
application on an Interpreting Physician Certification Document (Form 
CDC/NIOSH (M) 2.12).

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984]



Sec. 37.52  Method of obtaining definitive interpretations.

    (a) All chest roentgenograms which are first interpreted by an ``A'' 
or ``B'' reader will be submitted by ALOSH to a ``B'' reader qualified 
as described in Sec. 37.51. If there is agreement between the two 
interpreters as defined in paragraph (b) of this section the result 
shall be considered final and reported to MSHA for transmittal to the 
miner. When in the opinion of ALOSH substantial agreement is lacking, 
ALOSH shall obtain additional interpretations from the Panel of ``B'' 
readers. If interpretations are obtained from two or more ``B'' readers, 
and if two or more are in agreement then the highest major category 
shall be reported.
    (b) Two interpreters shall be considered to be in agreement when 
they

[[Page 130]]

both find either stage A, B, or C complicated pneumoconiosis, or their 
findings with regard to simple pneumoconiosis are both in the same major 
category, or (with one exception noted below) are within one minor 
category (ILO Classification 12-point scale) of each other. In the last 
situation, the higher of the two interpretations shall be reported. The 
only exception to the one minor category principle is a reading sequence 
of 0/1, 1/0, or 1/0, 0/1. When such a sequence occurs, it shall not be 
considered agreement, and a third (or more) interpretation shall be 
obtained until a consensus involving two or more readings in the same 
major category is obtained.

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984; 52 
FR 7866, Mar. 13, 1987]



Sec. 37.53  Notification of abnormal roentgenographic findings.

    (a) Findings of, or findings suggesting, enlarged heart, 
tuberculosis, lung cancer, or any other significant abnormal findings 
other than pneumoconiosis shall be communicated by the first physician 
to interpret and classify the roentgenogram to the designated physician 
of the miner indicated on the miner's identifcation document. A copy of 
the communication shall be submitted to ALOSH. ALOSH will notify the 
miner to contact his or her physician when any physician who interprets 
and classifies the miner's roentgenogram reports significant abnormal 
findings other than pneumoconiosis.
    (b) In addition, when ALOSH has more than one roentgenogram of a 
miner in its files and the most recent examination was interpreted to 
show enlarged heart, tuberculosis, cancer, complicated pneumoconiosis, 
and any other significant abnormal findings, ALOSH will submit all of 
the miner's roentgenograms in its files with their respective 
interprtations to a ``B'' reader. The ``B'' reader will report any 
significant changes or progression of disease or other comments to ALOSH 
and ALOSH shall submit a copy of the report to the miner's designated 
physician.
    (c) All final findings regarding pneumoconiosis will be sent to the 
miner by MSHA in accordance with section 203 of the act (see 30 CFR part 
90). Positive findings with regard to pneumoconiosis will be reported to 
the miner's designated physician by ALOSH.
    (d) ALOSH will make every reasonable effort to process the findings 
described in paragraph (c) of this section within 60 days of receipt of 
the information described in Sec. 37.60 in a complete and acceptable 
form. The information forwarded to MSHA will be in a form intended to 
facilitate prompt dispatch of the findings to the miner. The results of 
an examination made of a miner will not be processed by ALOSH if the 
examination was made within 6 months of the date of a previous 
acceptable examination.



Sec. 37.60  Submitting required chest roentgenograms and miner identification 

documents.

    (a) Each chest roentgenogram required to be made under this subpart, 
together with the completed roentgenographic interpretation form and the 
completed miner identification document, shall be sumitted together for 
each miner to ALOSH within 14 calendar days after the roentgenographic 
examination is given and become the property of ALOSH.
    (b) If ALOSH deems any part submitted under paragraph (a) of this 
section inadequate, it will notify the operator of the deficiency. The 
operator shall promptly make appropriate arrangements for the necessary 
reexamination.
    (c) Failure to comply with paragraph (a) or (b) of this section 
shall be cause to revoke approval of a plan or any other approval as may 
be appropriate. An approval which has been revoked may be reinstated at 
the discretion of ALOSH after it receives satisfactory assurances and 
evidence that all deficiencies have been corrected and that effective 
controls have been instituted to prevent a recurrence.
    (d) Chest roentgenograms and other required documents shall be 
submitted only for miners. Results of preemployment physical 
examinations of persons who are not hired shall not be submitted.
    (e) If a miner refuses to participate in all phases of the 
examination prescribed in this subpart, no report need

[[Page 131]]

be made. If a miner refuses to participate in any phase of the 
examination prescribed in this subpart, all the forms shall be submitted 
with his or her name and social security account number on each. If any 
of the forms cannot be completed because of the miner's refusal, it 
shall be marked ``Miner Refuses,'' and shall be submitted. No submission 
shall be made, however, without a completed miner identification 
document containing the miner's name, address, social security number 
and place of employment.

                   Review and Availability of Records



Sec. 37.70  Review of interpretations.

    (a) Any miner who believes the interpretation for pneumoconiosis 
reported to him or her by MSHA is in error may file a written request 
with ALOSH that his or her roentgenogram be reevaluated. If the 
interpretation was based on agreement between an ``A'' reader and a 
``B'' reader, ALOSH will obtain one or more additional interpretations 
by ``B'' readers as necessary to obtain agreement in accord with Sec. 
37.52(b), and MSHA shall report the results to the miner together with 
any rights which may accrue to the miner in accordance with Sec. 37.7. 
If the reported interpretation was based on agreement between two (or 
more) ``B'' readers, the reading will be accepted as conclusive and the 
miner shall be so informed by MSHA.
    (b) Any operator who is directed by MSHA to transfer a miner to a 
less dusty atmosphere based on the most recent examination made 
subsequent to August 1, 1978, may file a written request with ALOSH to 
review its findings. The standards set forth in paragraph (a) of this 
section apply and the operator and miner will be notified by MSHA 
whether the miner is entitled to the option to transfer.



Sec. 37.80  Availability of records.

    (a) Medical information and roentgenograms on miners will be 
released by ALOSH only with the written consent from the miner, or if 
the miner is deceased, written consent from the miner's widow, next of 
kin, or legal representative.
    (b) To the extent authorized, roentgenograms will be made available 
for examination only at ALOSH.



                            Subpart_Autopsies

    Authority: Sec. 508, 83 Stat. 803; 30 U.S.C. 957.

    Source: 36 FR 8870, May 14, 1971, unless otherwise noted.



Sec. 37.200  Scope.

    The provisions of this subpart set forth the conditions under which 
the Secretary will pay pathologists to obtain results of autopsies 
performed by them on miners.



Sec. 37.201  Definitions.

    As used in this subpart:
    (a) Secretary means the Secretary of Health and Human Services.
    (b) Miner means any individual who during his life was employed in 
any underground coal mine.
    (c) Pathologist means
    (1) A physician certified in anatomic pathology or pathology by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology,
    (2) A physician who possesses qualifications which are considered 
``Board of eligible'' by the American Board of Pathology or American 
Osteopathic Board of Pathology, or
    (3) An intern, resident, or other physician in a training program in 
pathology who performs the autopsy under the supervision of a 
pathologist as defined in paragraph (c) (1) or (2) of this section.
    (d) ALFORD means the Appalachian Laboratory for Occupational 
Respiratory Diseases, Public Health Service, Department of Health and 
Human Services, Post Office Box 4257, Morgantown, WV 26505.



Sec. 37.202  Payment for autopsy.

    (a) The Secretary will pay up to $200 to any pathologist who, after 
the effective date of the regulations in this part and with legal 
consent:
    (1) Performs an autopsy on a miner in accordance with this subpart; 
and
    (2) Submits the findings and other materials to ALFORD in accordance 
with this subpart within 180 calendar

[[Page 132]]

days after having performed the autopsy; and
    (3) Receives no other specific payment, fee, or reimbursement in 
connection with the autopsy from the miner's widow, his family, his 
estate, or any other Federal agency.
    (b) The Secretary will pay to any pathologist entitled to payment 
under paragraph (a) of this section and additional $10 if the 
pathologist can obtain and submits a good quality copy or original of a 
chest roentgenogram (posteroanterior view) made of the subject of the 
autopsy within 5 years prior to his death together with a copy of any 
interpretation made.

[35 FR 13206, Aug. 19, 1970, as amended at 38 FR 16353, June 22, 1973]



Sec. 37.203  Autopsy specifications.

    (a) Every autopsy for which a claim for payment is submitted 
pursuant to this part:
    (1) Shall be performed consistent with standard autopsy procedures 
such as those, for example, set forth in the ``Autopsy Manual'' prepared 
by the Armed Forces Institute of Pathology, July 1, 1960. (Technical 
Manual No. 8-300. NAVMED P-5065, Air Force Manual No. 160-19.) Copies of 
this document may be borrowed from ALFORD.
    (2) Shall include:
    (i) Gross and microscopic examination of the lungs, pulmonary 
pleura, and tracheobronchial lymph nodes;
    (ii) Weights of the heart and each lung (these and all other 
measurements required under this subparagraph shall be in the metric 
system);
    (iii) Circumference of each cardiac valve when opened;
    (iv) Thickness of right and left ventricles; these measurements 
shall be made perpendicular to the ventricular surface and shall not 
include trabeculations or pericardial fat. The right ventricle shall be 
measured at a point midway between the tricuspid valve and the apex, and 
the left ventricle shall be measured directly above the insertion of the 
anterior papillary muscle;
    (v) Size, number, consistency, location, description and other 
relevant details of all lesions of the lungs;
    (vi) Level of the diaphragm;
    (vii) From each type of suspected pneumoconiotic lesion, 
representative microscopic slides stained with hematoxylin eosin or 
other appropriate stain, and one formalin fixed, paraffin-impregnated 
block of tissue; a minimum of three stained slides and three blocks of 
tissue shall be submitted. When no such lesion is recognized, similar 
material shall be submitted from three separate areas of the lungs 
selected at random; a minimum of three stained slides and three formalin 
fixed, paraffin-impregnated blocks of tissue shall be submitted.
    (b) Needle biopsy techniques shall not be used.



Sec. 37.204  Procedure for obtaining payment.

    Every claim for payment under this subpart shall be submitted to 
ALFORD and shall include:
    (a) An invoice (in duplicate) on the pathologist's letterhead or 
billhead indicating the date of autopsy, the amount of the claim and a 
signed statement that the pathologist is not receiving any other 
specific compensation for the autopsy from the miner's widow, his 
surviving next-of-kin, the estate of the miner, or any other source.
    (b) Completed PHS Consent, Release and History Form (See Fig. 1). 
This form may be completed with the assistance of the pathologist, 
attending physician, family physician, or any other responsible person 
who can provide reliable information.
    (c) Report of autopsy:
    (1) The information, slides, and blocks of tissue required by this 
subpart.
    (2) Clinical abstract of terminal illness and other data that the 
pathologist determines is relevant.
    (3) Final summary, including final anatomical diagnoses, indicating 
presence or absence of simple and complicated pneumoconiosis, and 
correlation with clinical history if indicated.

[[Page 133]]

                                Figure 1

              U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

       Public Health Service--National Coal Workers' Autopsy Study

 Consent, Release, and History Form Federal Coal Mine Health and Safety 
                               Act of 1969

    I, ------------------, (Name) ------------ (Relationship) of ------
------------, (Name of deceased miner) do hereby authorize the 
performance of an autopsy (------------------) (Limitation, if any, on 
autopsy) on said deceased. I understand that the report and certain 
tissues as necessary will be released to the United States Public Health 
Service and to ------------------ (Name of Physician securing autopsy)

I understand that any claims in regard to the deceased for which I may 
sign a general release of medical information will result in the release 
of the information from the Public Health Service. I further understand 
that I shall not make any payment for the autopsy.

                    Occupational and Medical History

    1. Date of Birth of Deceased ------------. (Month, Day, Year)
    2. Social Security Number of Deceased ------------------.
    3. Date and Place of Death ------------, (Month, Day, Year) --------
---------- (City, County, State).
    4. Place of Last Mining Employment:
Name of Mine____________________________________________________________
Name of Mining Company__________________________________________________
Mine Address____________________________________________________________
    5. Last Job Title at Mine of Last Employment
(e.g., Continuous Miner Operator, motorman, foreman, etc.)
    6. Job Title of Principal Mining Occupation (that job to which miner 
devoted the most number of years)
                                                   (e.g., Same as above)
    7. Smoking History of Miner:
    (a) Did he ever smoke cigarettes? Yes
No______________________________________________________________________
    (b) If yes, for how many years?------------
Years.
    (c) If yes, how many cigarettes per day did he smoke on the 
average?----------------
                                                             (Number of)
Cigarettes per day.
    (d) Did he smoke cigarettes up until the time of his death? Yes ----
-- No ------
    (e) If no to (d), for how long before he died had he not been 
smoking cigarettes?
    8. Total Years in Surface and Underground Employment in Coal Mining, 
by State (If known) ------, (Years) ------------ (State).
    9. Total Years in Underground Coal Mining Employment, by State (If 
known) ------, (Years) ------------ (State).
________________________________________________________________________
                                                             (Signature)
________________________________________________________________________
                                                               (Address)
________________________________________________________________________
                                                                  (Date)
Interviewer:____________________________________________________________



PART 38_DISASTER ASSISTANCE FOR CRISIS COUNSELING AND TRAINING--Table of 

Contents




Sec.
38.1 Purpose; coordination.
38.2 Definitions.
38.3 Assistance; procedures, limitations.
38.4 Contracts.
38.5 Grant assistance.
38.6 Nondiscrimination.
38.7 Nonliability.
38.8 Criminal and civil penalties.
38.9 Federal audits.

    Authority: Sec. 413, Pub. L. 93-288. The Disaster Relief Act of 
1974, 88 Stat. 157, 42 U.S.C. 5183, EO 11795, 39 FR 25939, as amended by 
EO 11910, 41 FR 15681.

    Source: 41 FR 52052, Nov. 26, 1976, unless otherwise noted.



Sec. 38.1  Purpose; coordination.

    (a) Purpose. This part establishes standards and procedures for the 
implementation of section 413 of Pub. L. 93-288, the Disaster Relief Act 
of 1974 (42 U.S.C. 5183) which authorizes the provision, either directly 
or through financial assistance to State or local agencies or private 
mental health organizations, of:
    (1) Professional counseling services to victims of a major disaster 
in order to relieve mental health problems caused or aggravated by such 
a major disaster or its aftermath; and
    (2) Training of disaster workers to provide or assist in providing 
those professional counseling services.
    (b) Coordination. The Secretary, acting through the National 
Institute of Mental Health, will, as provided in 24 CFR 2205.51, carry 
out section 413 of the Act and this part in coordination with and under 
the general policy guidance of, the Administrator of the Federal 
Disaster Assistance Administration. Contracts and grants awarded under 
this part are subject to all applicable provisions of the Act and the 
implementing regulations promulgated by the Administrator (24 CFR part 
2205).

[[Page 134]]



Sec. 38.2  Definitions.

    All terms not defined herein shall have the same meaning as given 
them in the Act. As used in this part:
    (a) Act means the Disaster Relief Act of 1974 (42 U.S.C. 5121, et 
seq.).
    (b) Administrator means the Administrator, Federal Disaster 
Assistance Administration (FDAA), Department of Housing and Urban 
Development, and any other person to whom he delegates the authority.
    (c) Contractor means any public agency or private mental health 
organization which, pursuant to this part, contracts with the Secretary 
to provide professional mental health crisis counseling services or to 
provide mental health training for disaster workers.
    (d) Crisis means the existence of any life situation resulting from 
a major disaster or its aftermath which so effects the emotional and 
mental equilibrium of a disaster victim that professional mental health 
counseling services should be provided to help preclude possible 
damaging physical or psychological effects.
    (e) Disaster workers means mental health specialists such as 
psychiatrists, psychologists, psychiatric nurses, social workers, or 
qualified agents thereof.
    (f) Federal Coordinating Officer means the person appointed by the 
Administrator to coordinate Federal assistance in a major disaster.
    (g) Governor means the chief executive of a State.
    (h) Grantee means any public agency or private nonprofit mental 
health organization which, pursuant to this part, is awarded a grant for 
the purpose of providing professional mental health crisis counseling 
services or mental health training for disaster workers.
    (i) Major disaster means any hurricane, tornado, storm, flood, high-
water, wind-driven water, tidal wave, tsunami, earthquake, volcanic 
eruption, landslide, mudslide, snowstorm, drought, fire, explosion, or 
other catastrophe in any part of the United States which, in the 
determination of the President, causes damage of sufficient severity and 
magnitude to warrant major disaster assistance under the Act above and 
beyond emergency services by the Federal Government, to supplement the 
efforts and available resources of the States, local governments, and 
disaster relief organizations, in alleviating the damage, loss, 
hardship, or suffering caused thereby.
    (j) Regional Director means a director of a regional office of the 
Federal Disaster Assistance Administration (FDAA).
    (k) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (l) State means any of the fifty States, the District of Columbia, 
Puerto Rico, the Virgin Islands, Guam, American Samoa, the Canal Zone, 
or the Trust Territory of the Pacific Islands.
    (m) State Coordinating Officer means the person appointed by the 
Governor to act in cooperation with the appointed Federal Coordinating 
Officer.
    (n) Training means the specific instruction which may be required to 
enable disaster workers to provide professional mental health crisis 
counseling to victims of a major disaster or its aftermath.



Sec. 38.3  Assistance; procedures, limitations.

    (a) Application. In order to obtain assistance under this part, the 
Governor or his State Coordinating Officer must, not later than 60 days 
following a major disaster declaration by the President, file with the 
appropriate Regional Director a request which includes:
    (1) An estimate of the number of disaster victims who may need 
professional mental health crisis counseling services and of the number 
of disaster workers who may need training in the provision of such 
services;
    (2) Identification of the geographical areas in which the need 
exists;
    (3) An estimate of the period during which assistance under this 
part will be required and of the total funds which will be required to 
provide such assistance;
    (4) A description of the types of mental health problems caused or 
aggravated by the major disaster or its aftermath; and

[[Page 135]]

    (5) Identification of the State and local agencies and private 
mental health organizations capable of providing professional mental 
health crisis counseling to disaster victims or training of disaster 
workers.
    (b) Review, approval. The Secretary, upon notification by the 
Administrator of a State request for assistance under this part, will 
conduct a review to determine the extent to which such assistance is 
needed to supplement assistance programs provided by State and local 
governments and private organizations and, on the basis of that review, 
prepare and submit a recommendation and report for consideration by the 
Administrator. Upon approval by the Administrator and his advancement of 
funds for carrying out the approved assistance, the Secretary may, 
within the limits of the funds advanced, provide the approved services 
either directly or through a grant or contract.
    (c) Eligibility for services. (1) In order to be eligible for the 
professional mental health crisis counseling services available under 
this part an individual must:
    (i) Have been located within the designated major disaster area or 
have been a resident of such area at the time of the major disaster or 
its aftermath; and
    (ii) Have a mental health problem which was caused or aggravated by 
the major disaster or its aftermath.
    (2) Disaster workers who are available on short notice to provide 
professional mental health crisis counseling services in a major 
disaster area are eligible for training under this part.
    (d) Time limitation. Contracts and grants awarded under this part 
will not continue beyond 180 days after the first day services are 
provided pursuant to such contracts and grants, except that upon the 
recommendation of the Secretary (1) the Regional Director may extend the 
180 day period for up to 30 days or (2) the Administrator may extend the 
180 day period for more than 30 days.



Sec. 38.4  Contracts.

    (a) Eligibility. Public agencies and private mental health 
organizations which are determined by the Secretary to be capable of 
providing the professional mental health crisis counseling services or 
mental health training of disaster workers needed as a result of a major 
disaster are eligible for the award of a contract under this part.
    (b) Use of local agencies. Preference will be given to the extent 
feasible and practicable, to those agencies and organizations which are 
located or do business primarily in the area affected by the major 
disaster.
    (c) General requirements. Contracts under this part shall be entered 
into and carried out in accordance with the provisions of chapters 1 and 
3 of title 41 of the Code of Federal Regulations and all other 
applicable laws and regulations.
    (d) Payments. The Secretary shall from time to time make payments to 
the contractor of all or a portion of the contract award, either by way 
of reimbursement for expenses incurred or in advance for expenses to be 
incurred, to the extent he determines such payments are necessary to 
promote prompt initiation and advancement of the services to be provided 
under the contract. All payments not expended by the contractor within 
the period of the contract shall be returned to the Secretary.
    (e) Reports. Contractors shall submit the following reports to the 
Secretary:
    (1) Progress reports, to be submitted at the end of the first 30 
days of the contract period and every 30 days therafter;
    (2) A final report to be submitted within 60 days of the date upon 
which the contract terminates; and
    (3) Such additional reports as the Secretary may prescribe including 
those which may be required to enable the Federal Coordinating Officer 
to carry out his functions.



Sec. 38.5  Grant assistance.

    (a) Eligibility. Public agencies and private nonprofit mental health 
organizations which are determined by the Secretary to be capable of 
providing the professional mental health crisis counseling services or 
mental health training of disaster workers needed as a result of a major 
disaster are eligible for a grant award under this part.

[[Page 136]]

    (b) Application. The application shall contain:
    (1) A proposed plan for the provision of the services for which 
grant assistance is requested;
    (2) A proposed budget for the expenditure of the requested grant 
funds; and
    (3) Such other pertinent information and assurances as the Secretary 
may require.
    (c) Grant awards. (1) Preference will be given, to the extent 
feasible and practicable, to those public and private nonprofit agencies 
and organizations which are located or do business primarily in the area 
affected by the major disaster.
    (2) Within the limits of the funds advanced by the Administrator, 
the amount of any grant award shall be determined on the basis of the 
Secretary's estimate of the sum necessary to carry out the grant 
purpose.
    (3) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (d) Other HHS regulations that apply. Several other regulations 
apply to grants under this grant. These include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

    (e) Expenditure of grant funds. Any funds granted pursuant to this 
part shall be expended solely for the purposes for which the funds were 
granted in accordance with the approved application and budget, the 
regulations of this part, the terms and the conditions of the award, and 
the applicable cost principles prescribed in subpart Q of 45 CFR part 
74.
    (f) Reports. In exceptional circumstances, a grantee may be required 
to submit special progress reports, in addition to those otherwise 
required, relating to the conduct and results of the approved grant.

[41 FR 52052, Nov. 26, 1976, as amended at 45 FR 57396, Aug. 28, 1980; 
49 FR 38109, Sept. 27, 1984]



Sec. 38.6  Nondiscrimination.

    Attention is called to the requirements of 24 CFR 2205.13 relating 
to nondiscrimination on the grounds of race. religion, sex, color, age, 
economic status, or national origin in the provision of disaster 
assistance.



Sec. 38.7  Nonliability.

    Attention is called to section 308 of the Act (42 U.S.C. 5148) which 
provides that the Federal Government shall not be liable for any claim 
based upon the exercise or performance of or the failure to exercise or 
perform a discretionary function or duty on the part of a Federal agency 
or an employee of the Federal Government in carrying out the provisions 
of the Act.



Sec. 38.8  Criminal and civil penalties.

    Attention is called to section 317 of the Act (42 U.S.C. 5157) which 
provides:

    (a) Any individual who fraudulently or willfully misstates any fact 
in connection with a request for assistance under this Act shall be 
fined not more than $10,000 or imprisoned for not more than one year or 
both for each violation.
    (b) Any individual who knowingly violates any order or regulation 
under this Act shall be subject to a civil penalty of not more than 
$5,000 for each violation.
    (c) Whoever knowingly misapplies the proceeds of a loan or other 
cash benefit obtained under any section of this Act shall be subject to 
a fine in an amount equal to one and one half times the original 
principal amount of the loan or cash benefit.

[[Page 137]]



Sec. 38.9  Federal audits.

    The Secretary, the Administrator, and the Comptroller General of the 
United States, or their duly authorized representatives shall have 
access to any books, documents, papers, and records that pertain to 
Federal funds, equipment, and supplies received under this part for the 
purpose of audit and examination.

[[Page 138]]



                           SUBCHAPTER D_GRANTS



PART 50_POLICIES OF GENERAL APPLICABILITY--Table of Contents




Subpart A [Reserved]

Subpart B_Sterilization of Persons in Federally Assisted Family Planning 
                                Projects

Sec.
50.201 Applicability.
50.202 Definitions.
50.203 Sterilization of a mentally competent individual aged 21 or 
          older.
50.204 Informed consent requirement.
50.205 Consent form requirements.
50.206 Sterilization of a mentally incompetent individual or of an 
          institutionalized individual.
50.207 Sterilization by hysterectomy.
50.208 Program or project requirements.
50.209 Use of Federal financial assistance.
50.210 Review of regulation.

Appendix to Subpart B of Part 50--Required Consent Form

 Subpart C_Abortions and Related Medical Services in Federally Assisted 
                  Programs of the Public Health Service

50.301 Applicability.
50.302 Definitions.
50.303 General rule.
50.304 Life of the mother would be endangered.
50.305 [Reserved]
50.306 Rape and incest.
50.307 Documentation needed by programs or projects.
50.308 Drugs and devices and termination of ectopic pregnancies.
50.309 Recordkeeping requirements.
50.310 Confidentiality.

         Subpart D_Public Health Service Grant Appeals Procedure

50.401 What is the purpose of this subpart?
50.402 To what program do these regulations apply?
50.403 What is the policy basis for these procedures?
50.404 What disputes are covered by these procedures?
50.405 What is the structure of review committees?
50.406 What are the steps in the process?

               Subpart E_Maximum Allowable Cost for Drugs

50.501 Applicability.
50.502 Definitions.
50.503 Policy.
50.504 Allowable cost of drugs.

  Subpart F_Responsibility of Applicants for Promoting Objectivity in 
                Research for Which PHS Funding Is Sought

50.601 Purpose.
50.602 Applicability.
50.603 Definitions.
50.604 Institutional responsibility regarding conflicting interests of 
          investigators
50.605 Management of conflicting interests.
50.606 Remedies.
50.607 Other HHS regulations that apply.

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 
U.S.C. 216); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (42 
U.S.C. 300a-4), unless otherwise noted.

    Source: 43 FR 52165, Nov. 8, 1978, unless otherwise noted.

Subpart A [Reserved]



Subpart B_Sterilization of Persons in Federally Assisted Family Planning 
                                Projects



Sec. 50.201  Applicability.

    The provisions of this subpart are applicable to programs or 
projects for health services which are supported in whole or in part by 
Federal financial assistance, whether by grant or contract, administered 
by the Public Health Service.



Sec. 50.202  Definitions.

    As used in this subpart:
    Arrange for means to make arrangements (other than mere referral of 
an individual to, or the mere making of an appointment for him or her 
with, another health care provider) for the performance of a medical 
procedure on an individual by a health care provider other than the 
program or project.
    Hysterectomy means a medical procedure or operation for the purpose 
of removing the uterus.
    Institutionalized individual means an individual who is (1) 
involuntarily confined or detained, under a civil or criminal statute, 
in a correctional or rehabilitative facility, including a mental 
hospital or other facility for

[[Page 139]]

the care and treatment of mental illness, or (2) confined, under a 
voluntary commitment, in a mental hospital or other facility for the 
care and treatment of mental illness.
    Mentally incompetent individual means an individual who has been 
declared mentally incompetent by a Federal, State, or local court of 
competent jurisdiction for any purpose unless he or she has been 
declared competent for purposes which include the ability to consent to 
sterilization.
    Public Health Service means the Office of the Assistant Secretary 
for Health, Health Resources and Services Administration, National 
Institutes of Health, Centers for Disease Control, Alcohol, Drug Abuse 
and Mental Health Administration and all of their constituent agencies.
    The Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    Sterilization means any medical procedure, treatment, or operation 
for the purpose of rendering an individual permanently incapable of 
reproducing.

[43 FR 52165, Nov. 8, 1978, as amended at 49 FR 38109, Sept. 27, 1984]



Sec. 50.203  Sterilization of a mentally competent individual aged 21 or 

older.

    Programs or projects to which this subpart applies shall perform or 
arrange for the performance of sterilization of an individual only if 
the following requirements have been met:
    (a) The individual is at least 21 years old at the time consent is 
obtained.
    (b) The individual is not a mentally incompetent individual.
    (c) The individual has voluntarily given his or her informed consent 
in accordance with the procedures of Sec. 50.204 of this subpart.
    (d) At least 30 days but not more than 180 days have passed between 
the date of informed consent and the date of the sterilization, except 
in the case of premature delivery or emergency abdominal surgery. An 
individual may consent to be sterilized at the time of premature 
delivery or emergency abdominal surgery, if at least 72 hours have 
passed after he or she gave informed consent to sterilization. In the 
case of premature delivery, the informed consent must have been given at 
least 30 days before the expected date of delivery.



Sec. 50.204  Informed consent requirement.

    Informed consent does not exist unless a consent form is completed 
voluntarily and in accordance with all the requirements of this section 
and Sec. 50.205 of this subpart.
    (a) A person who obtains informed consent for a sterilization 
procedure must offer to answer any questions the individual to be 
sterilized may have concerning the procedure, provide a copy of the 
consent form, and provide orally all of the following information or 
advice to the individual who is to be sterilized:
    (1) Advice that the individual is free to withhold or withdraw 
consent to the procedure any time before the sterilization without 
affecting his or her right to future care or treatment and without loss 
or withdrawal of any federally funded program benefits to which the 
individual might be otherwise entitled:
    (2) A description of available alternative methods of family 
planning and birth control;
    (3) Advice that the sterilization procedure is considered to be 
irreversible;
    (4) A thorough explanation of the specific sterilization procedure 
to be performed;
    (5) A full description of the discomforts and risks that may 
accompany or follow the performing of the procedure, including an 
explanation of the type and possible effects of any anesthetic to be 
used;
    (6) A full description of the benefits or advantages that may be 
expected as a result of the sterilization; and
    (7) Advice that the sterilization will not be performed for at least 
30 days except under the circumstances specified in Sec. 50.203(d) of 
this subpart.
    (b) An interpreter must be provided to assist the individual to be 
sterilized if he or she does not understand the language used on the 
consent form or the language used by the person obtaining the consent.

[[Page 140]]

    (c) Suitable arrangements must be made to insure that the 
information specified in paragraph (a) of this section is effectively 
communicated to any individual to be sterilized who is blind, deaf or 
otherwise handicapped.
    (d) A witness chosen by the individual to be sterilized may be 
present when consent is obtained.
    (e) Informed consent may not be obtained while the individual to be 
sterilized is:
    (1) In labor or childbirth;
    (2) Seeking to obtain or obtaining an abortion; or
    (3) Under the influence of alcohol or other substances that affect 
the individual's state of awareness.
    (f) Any requirement of State and local law for obtaining consent, 
except one of spousal consent, must be followed.



Sec. 50.205  Consent form requirements.

    (a) Required consent form. The consent form appended to this subpart 
or another consent form approved by the Secretary must be used.
    (b) Required signatures. The consent form must be signed and dated 
by:
    (1) The individual to be sterilized; and
    (2) The interpreter, if one is provided; and
    (3) The person who obtains the consent; and
    (4) The physician who will perform the sterilization procedure.
    (c) Required certifications. (1) The person obtaining the consent 
must certify by signing the consent form that:
    (i) Before the individual to be sterilized signed the consent form, 
he or she advised the individual to be sterilized that no Federal 
benefits may be withdrawn because of the decision not to be sterilized,
    (ii) He or she explained orally the requirements for informed 
consent as set forth on the consent form, and
    (iii) To the best of his or her knowledge and belief, the individual 
to be sterilized appeared mentally competent and knowingly and 
voluntarily consented to be sterilized.
    (2) The physician performing the sterilization must certify by 
signing the consent form, that:
    (i) Shortly before the performance of the sterilization, he or she 
advised the individual to be sterilized that no Federal benefits may be 
withdrawn because of the decision not to be sterilized,
    (ii) He or she explained orally the requirements for informed 
consent as set forth on the consent form, and
    (iii) To the best of his or her knowledge and belief, the individual 
to be sterilized appeared mentally competent and knowingly and 
voluntarily consented to be sterilized. Except in the case of premature 
delivery or emergency abdominal surgery, the physician must further 
certify that at least 30 days have passed between the date of the 
individual's signature on the consent form and the date upon which the 
sterilization was performed. If premature delivery occurs or emergency 
abdominal surgery is required within the 30-day period, the physician 
must certify that the sterilization was performed less than 30 days but 
not less than 72 hours after the date of the individual's signature on 
the consent form because of premature delivery or emergency abdominal 
surgery, as applicable. In the case of premature delivery, the physician 
must also state the expected date of delivery. In the case of emergency 
abdominal surgery, the physician must describe the emergency.
    (3) If an interpreter is provided, the interpreter must certify that 
he or she translated the information and advice presented orally, read 
the consent form and explained its contents and to the best of the 
interpreter's knowledge and belief, the individual to be sterilized 
understood what the interpreter told him or her.



Sec. 50.206  Sterilization of a mentally incompetent individual or of an 

institutionalized individual.

    Programs or projects to which this subpart applies shall not perform 
or arrange for the performance of a sterilization of any mentally 
incompetent individual or institutionalized individual.



Sec. 50.207  Sterilization by hysterectomy.

    (a) Programs or projects to which this subpart applies shall not 
perform or arrange for the performance of any

[[Page 141]]

hysterectomy solely for the purpose of rendering an individual 
permanently incapable of reproducing or where, if there is more than one 
purpose to the procedure, the hysterectomy would not be performed but 
for the purpose of rendering the individual permanently incapable of 
reproducing.
    (b) Except as provided in paragraph (c) of this section, programs or 
projects to which this subpart applies may perform or arrange for the 
performance of a hysterectomy not covered by paragraph (a) of this 
section only if:
    (1) The person who secures the authorization to perform the 
hysterectomy has informed the individual and her representative, if any, 
orally and in writing, that the hysterectomy will make her permanently 
incapable of reproducing; and
    (2) The individual or her representative, if any, has signed a 
written acknowledgment of receipt of that information.
    (c)(1) A program or project is not required to follow the procedures 
of paragraph (b) of this section if either of the following 
circumstances exists:
    (i) The individual is already sterile at the time of the 
hysterectomy.
    (ii) The individual requires a hysterectomy because of a life-
threatening emergency in which the physician determines that prior 
acknowledgment is not possible.
    (2) If the procedures of paragraph (b) of this section are not 
followed because one or more of the circumstances of paragraph (c)(1) 
exist, the physician who performs the hysterectomy must certify in 
writing:
    (i) That the woman was already sterile, stating the cause of that 
sterility; or
    (ii) That the hysterectomy was performed under a life-threatening 
emergency situation in which he or she determined prior acknowledgment 
was not possible. He or she must also include a description of the 
nature of the emergency.

[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]



Sec. 50.208  Program or project requirements.

    (a) A program or project must, with respect to any sterilization 
procedure or hysterectomy it performs or arranges, meet all requirements 
of this subpart.
    (b) The program or project shall maintain sufficient records and 
documentation to assure compliance with these regulations, and must 
retain such data for at least 3 years.
    (c) The program or project shall submit other reports as required 
and when requested by the Secretary.



Sec. 50.209  Use of Federal financial assistance.

    (a) Federal financial assistance adminstered by the Public Health 
Service may not be used for expenditures for sterilization procedures 
unless the consent form appended to this section or another form 
approved by the Secretary is used.
    (b) A program or project shall not use Federal financial assistance 
for any sterilization or hysterectomy without first receiving 
documentation showing that the requirements of this subpart have been 
met. Documentation includes consent forms, and as applicable, either 
acknowledgments of receipt of hysterectomy information or certification 
of an exception for hysterectomies.

[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]



Sec. 50.210  Review of regulation.

    The Secretary will request public comment on the operation of the 
provisions of this subpart not later than 3 years after their effective 
date.



      Sec. Appendix to Subpart B of Part 50--Required Consent Form

    Notice: YOUR DECISION AT ANY TIME NOT TO BE STERILIZED WILL NOT 
RESULT IN THE WITHDRAWAL OR WITHHOLDING OF ANY BENEFITS PROVIDED BY 
PROGRAMS OR PROJECTS RECEIVING FEDERAL FUNDS.

                        Consent to Sterilization

    I have asked for and received information about sterilization from 
-------------- (doctor or clinic). When I first asked for the 
information, I was told that the decision to be sterilized is completely 
up to me. I was told that I could decide not to be sterilized. If I 
decide not to be sterilized, my decision will not affect my right to 
future care or treatment. I will not lose any help or benefits

[[Page 142]]

from programs receiving Federal funds, such as A.F.D.C. or medicaid that 
I am now getting or for which I may become eligible.
    I UNDERSTAND THAT THE STERILIZATION MUST BE CONSIDERED PERMANENT AND 
NOT REVERSIBLE. I HAVE DECIDED THAT I DO NOT WANT TO BECOME PREGNANT, 
BEAR CHILDREN OR FATHER CHILDREN.
    I was told about those temporary methods of birth control that are 
available and could be provided to me which will allow me to bear or 
father a child in the future. I have rejected these alternatives and 
chosen to be sterilized.
    I understand that I will be sterilized by an operation known as a --
------------. The discomforts, risks and benefits associated with the 
operation have been explained to me. All my questions have been answered 
to my satisfaction.
    I understand that the operation will not be done until at least 30 
days after I sign this form. I understand that I can change my mind at 
any time and that my decision at any time not to be sterilized will not 
result in the withholding of any benefits or medical services provided 
by federally funded programs.
    I am at least 21 years of age and was born on ---- (day), ---- 
(month), ---- (year).
    I, --------------, hereby consent of my own free will to be 
sterilized by -------------- by a method called --------------. My 
consent expires 180 days from the date of my signature below.
    I also consent to the release of this form and other medical records 
about the operation to:
    Representatives of the Department of Health and Human Services or
    Employees of programs or projects funded by that Department but only 
for determining if Federal laws were observed.
    I have received a copy of this form.

Signature_______________________________________________________________
Date:___________________________________________________________________
(Month, day, year)

    You are requested to supply the following information, but it is not 
required:

                     Ethnicity and Race Designation

    Ethnicity:

[squ] Hispanic or Latino
[squ] Not Hispanic or Latino

    Race (mark one or more):

[squ] American Indian or Alaska Native
[squ] Asian
[squ] Black or African American
[squ] Native Hawaiian or Other Pacific Islander
[squ] White

                         Interpreter's Statement

    If an interpreter is provided to assist the individual to be 
sterilized:
    I have translated the information and advice presented orally to the 
individual to be sterilized by the person obtaining this consent. I have 
also read him/her the consent form in -------------- language and 
explained its contents to him/her. To the best of my knowledge and 
belief he/she understood this explanation.

Interpreter_____________________________________________________________
Date____________________________________________________________________

                    State of Person Obtaining Consent

    Before -------------- (name of individual), signed the consent form, 
I explained to him/her the nature of the sterilization operation ------
--------, the fact that it is intended to be a final and irreversible 
procedure and the discomforts, risks and benefits associated with it.
    I counseled the individual to be sterilized that alternative methods 
of birth control are available which are temporary. I explained that 
sterilization is different because it is permanent.
    I informed the individual to be sterilized that his/her consent can 
be withdrawn at any time and that he/she will not lose any health 
services or any benefits provided by Federal funds.
    To the best of my knowledge and belief the individual to be 
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appears to 
understand the nature and consequence of the procedure.

Signature of person obtaining consent___________________________________
Date____________________________________________________________________
Facility________________________________________________________________
Address_________________________________________________________________

                          Physician's Statement

    Shortly before I performed a sterilization operation upon ----------
---- (name of individual to be sterilized), on ---------- (date of 
sterilization), -------------- (operation), I explained to him/her the 
nature of the sterilization operation -------------- (specify type of 
operation), the fact that it is intended to be a final and irreversible 
procedure and the discomforts, risks and benefits associated with it.
    I counseled the individual to be sterilized that alternative methods 
of birth control are available which are temporary. I explained that 
sterilization is different because it is permanent.
    I informed the individual to be sterilized that his/her consent can 
be withdrawn at any time and that he/she will not lose any health 
services or benefits provided by Federal funds.

[[Page 143]]

    To the best of my knowledge and belief the individual to be 
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appeared to 
understand the nature and consequences of the procedure.
    (Instructions for use of alternative final paragraphs: Use the first 
paragraph below except in the case of premature delivery or emergency 
abdominal surgery where the sterilization is performed less than 30 days 
after the date of the individual's signature on the consent form. In 
those cases, the second paragraph below must be used. Cross out the 
paragraph which is not used.)
    (1) At least 30 days have passed between the date of the 
individual's signature on this consent form and the date the 
sterilization was performed.
    (2) This sterilization was performed less than 30 days but more than 
72 hours after the date of the individual's signature on this consent 
form because of the following circumstances (check applicable box and 
fill in information requested):

[squ] Premature delivery
Individual's expected date of delivery:_________________________________
[squ] Emergency abdominal surgery:
(Describe circumstances):_______________________________________________

Physician_______________________________________________________________
Date____________________________________________________________________

                    Paperwork Reduction Act Statement

    A Federal agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
the currently valid OMB control number. Public reporting burden for this 
collection of information will vary; however, we estimate an average of 
one hour per response, including for reviewing instructions, gathering 
and maintaining the necessary data, and disclosing the information. Send 
any comment regarding the burden estimate or any other aspect of this 
collection of information to the OS Reports Clearance Officer, ASBTF/
Budget Room 503 HHH Building, 200 Independence Avenue, SW., Washington, 
DC 20201.
    Respondents should be informed that the collection of information 
requested on this form is authorized by 42 CFR part 50, subpart B, 
relating to the sterilization of persons in federally assisted public 
health programs. The purpose of requesting this information is to ensure 
that individuals requesting sterilization receive information regarding 
the risks, benefits and consequences, and to assure the voluntary and 
informed consent of all persons undergoing sterilization procedures in 
federally assisted public health programs. Although not required, 
respondents are requested to supply information on their race and 
ethnicity. Failure to provide the other information requested on this 
consent form, and to sign this consent form, may result in an inability 
to receive sterilization procedures funded through federally assisted 
public health programs.
    All information as to personal facts and circumstances obtained 
through this form will be held confidential, and not disclosed without 
the individual's consent, pursuant to any applicable confidentiality 
regulations.

[43 FR 52165, Nov. 8, 1978, as amended at 58 FR 33343, June 17, 1993; 68 
FR 12308, Mar. 14, 2003]



 Subpart C_Abortions and Related Medical Services in Federally Assisted 

                  Programs of the Public Health Service

    Authority: Sec. 118, Pub. L. 96-86, Oct. 12, 1979, unless otherwise 
noted.

    Source: 43 FR 4570, Feb. 2, 1978, unless otherwise noted.



Sec. 50.301  Applicability.

    The provisions of this subpart are applicable to programs or 
projects for health services which are supported in whole or in part by 
Federal financial assistance, whether by grant or contract, appropriated 
to the Department of Health and Human Services and administered by the 
Public Health Service.



Sec. 50.302  Definitions.

    As used in this subpart: (a) Law enforcement agency means an agency, 
or any part thereof, charged under applicable law with enforcement of 
the general penal statutes of the United States, or of any State or 
local jurisdiction.
    (b) Medical procedures performed upon a victim of rape or incest 
means any medical service, including an abortion, performed for the 
purpose of preventing or terminating a pregnancy arising out of an 
incident of rape or incest.
    (c) Physician means a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by the State in which he or 
she practices.
    (d) Public health service means: (1) An agency of the United States 
or of a State or local government, that provides health or medical 
services; and
    (2) A rural health clinic, as defined under section 1(d)(aa)(2) of 
Pub. L. 95-

[[Page 144]]

210, 91 Stat. 1485; except that any agency or facility whose principal 
function is the performance of abortions is specifically excluded from 
this definition.



Sec. 50.303  General rule.

    Federal financial participation is not available for the performance 
of an abortion in programs or projects to which this subpart applies 
except under circumstances described in Sec. 50.304 or Sec. 50.306.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]



Sec. 50.304  Life of the mother would be endangered.

    Federal financial participation is available in expenditures for an 
abortion when a physician has found, and so certified in writing to the 
program or project, that on the basis of his/her professional judgment, 
the life of the mother would be endangered if the fetus were carried to 
term. The certification must contain the name and address of the 
patient.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978]



Sec. 50.305  [Reserved]



Sec. 50.306  Rape and incest.

    Federal financial participation is available in expenditures for 
medical procedures performed upon a victim of rape or incest if the 
program or project has received signed documentation from a law 
enforcement agency or public health service stating:
    (a) That the person upon whom the medical procedure was performed 
was reported to have been the victim of an incident of rape or incest;
    (b) The date on which the incident occurred;
    (c) The date on which the report was made, which must have been 
within 60 days of the date on which the incident occurred;
    (d) The name and address of the victim and the name and address of 
the person making the report (if different from the victim); and
    (e) That the report included the signature of the person who 
reported the incident.

Federal financial participation is also available in expenditures for 
abortions for victims of rape or incest under the circumstances 
described in Sec. 50.304 without regard to the requirements of the 
preceding sentence.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978, as amended at 44 FR 61598, Oct. 26, 1979]



Sec. 50.307  Documentation needed by programs or projects.

    Federal financial participation is unavailable for the performance 
of abortions or other medical procedures otherwise provided for under 
Sec. Sec. 50.304 and 50.306 if the program or project has paid without 
first having received the certifications and documentation specified in 
those sections.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]



Sec. 50.308  Drugs and devices and termination of ectopic pregnancies.

    Federal financial participation is available with respect to the 
cost of drugs or devices to prevent implantation of the fertilized ovum, 
and for medical procedures necessary for the termination of an ectopic 
pregnancy.



Sec. 50.309  Recordkeeping requirements.

    Programs or projects to which this subpart applies must maintain 
copies of the certifications and documentation specified in Sec. Sec. 
50.304 and 50.306 for three years pursuant to the retention and 
custodial requirements for records at 45 CFR 74.20 et seq.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]



Sec. 50.310  Confidentiality.

    Information in the records or in the possession of programs or 
projects which is acquired in connection with the requirements of this 
subpart may not be disclosed in a form which permits the identification 
of an individual without the individual's consent except as may be 
necessary for the health of the individual or as may be necessary for 
the Secretary to monitor the activities of those programs or projects. 
In any event, any disclosure shall be subject to appropriate safeguards

[[Page 145]]

which will minimize the likelihood of disclosures of personal 
information in identifiable form.



         Subpart D_Public Health Service Grant Appeals Procedure

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 
U.S.C. 216); 45 CFR 16.3(c).

    Source: 54 FR 34770, Aug. 22, 1989, unless otherwise noted.



Sec. 50.401  What is the purpose of this subpart?

    This subpart establishes an informal procedure for the resolution of 
certain postaward grant and cooperative agreement disputes within the 
agencies and offices identified in Sec. 50.402.

[63 FR 66062, Dec. 1, 1998]



Sec. 50.402  To what program do these regulations apply?

    This subpart applies to all grant and cooperative agreement 
programs, except block grants, which are administered by the National 
Institutes of Health; The Centers for Disease Control and Prevention; 
the Agency for Toxic Substances and Disease Registry; the Food and Drug 
Administration; and the Office of Public Health and Science. For 
purposes of this subpart, these entities are hereinafter referred to as 
``agencies.''

[70 FR 76175, Dec. 23, 2005]



Sec. 50.403  What is the policy basis for these procedures?

    The Secretary of Health and Human Services has established a 
Departmental Appeals Board for the purpose of providing a fair and 
flexible process for the appeal of written final decisions involving 
certain grant and cooperative agreement programs administered by 
constituent agencies of the Department. The regulatory provision which 
establishes the circumstances under which the Board will accept an 
appeal (45 CFR 16.3) provides, among other things, that the appellant 
must have exhausted any preliminary appeal process required by 
regulation before a formal appeal to the Departmental Board will be 
allowed. This subpart provides such an informal preliminary procedure 
for resolution of disputes in order to preclude submission of cases to 
the Departmental Appeals Board before an agency identified in Sec. 
50.402 has had an opportunity to review decisions of its officials and 
to settle disputes with grantees.

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]



Sec. 50.404  What disputes are covered by these procedures?

    (a) These procedures are applicable to the following adverse 
determinations under discretionary project grants and cooperative 
agreements (both referred to in this subpart as grants) issued by the 
agencies identified at Sec. 50.402;
    (1) Termination, in whole or in part, of a grant for failure of the 
grantee to carry out its approved project in accordance with the 
applicable law and the terms and conditions of such assistance or for 
failure of the grantee otherwise to comply with any law, regulation, 
assurance, term, or condition applicable to the grant.
    (2) A determination that an expenditure not allowable under the 
grant has been charged to the grant or that the grantee has otherwise 
failed to discharge its obligation to account for grant funds.
    (3) A determination that a grant is void.
    (4) A denial of a noncompeting continuation award under the project 
period system of funding where the denial is for failure to comply with 
the terms of a previous award.
    (b) A determination subject to this subpart may not be reviewed by 
the review committee described in Sec. 50.405 unless an officer or 
employee of the agency has notified the grantee in writing of the 
adverse determination. The notification must set forth the reasons for 
the determination in sufficient detail to enable the grantee to respond 
and must inform the grantee of the opportunity for review under this 
subpart.

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]

[[Page 146]]



Sec. 50.405  What is the structure of review committees?

    The head of the agency, or his or her designee, shall appoint review 
committees to review adverse determinations made by officials for 
programs under their jurisdiction. A minimum of three employees shall be 
appointed (one of whom shall be designated as chairperson) either on an 
ad hoc, case-by-case basis, or as regular members of review committees 
for such terms as may be designated. None of the members of the review 
committee reviewing any given appeal may be from the office of the 
responsible official whose adverse determination is being appealed 
(e.g., project officer, grants specialist, program manager, grants 
management officer).

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66062, Dec. 1, 1998]



Sec. 50.406  What are the steps in the process?

    (a) A grantee with respect to whom an adverse determination 
described in Sec. 50.404(a) above has been made and who desires a 
review of that determination must submit a request for such review to 
the head of the appropriate agency or his or her designee no later than 
30 days after the written notification of the determination is received, 
except that if the grantee shows good cause why an extension of time 
should be granted, the head of the appropriate agency or his or her 
designee may grant an extension of time.
    (b) The request for review must include a copy of the adverse 
determination, must identify the issue(s) in dispute, and must contain a 
full statement of the grantee's position with respect to such issue(s) 
and the pertinent facts and reasons in support of the grantee's 
position. In addition to the required written statement, the grantee 
shall provide copies of any documents supporting its claim.
    (c) When a request for review has been filed under this subpart with 
respect to an adverse determination, no action may be taken by the 
awarding agency pursuant to such determination until the request has 
been disposed of, except that the filing of the request shall not affect 
any authority which the agency may have to suspend assistance or 
otherwise to withhold or defer payments under the grant during 
proceedings under this subpart. This paragraph does not require the 
awarding agency to provide continuation funding during the appeal 
process to a grantee whose noncompeting continuation award has been 
denied.
    (d) Upon receipt of a request for review, the head of the agency or 
his or her designee will make a decision as to whether the dispute is 
reviewable under this subpart and will promptly notify the grantee and 
the office responsible for the adverse determination of this decision. 
If the head of the agency or his or her designee determines that the 
dispute is reviewable, he or she will forward the matter to the review 
committee appointed under Sec. 50.405.
    (e) The agency involved will provide the review committee appointed 
under Sec. 50.405 with copies of all relevant background materials 
(including applications(s), award(s), summary statement(s), and 
correspondence) and any additional pertinent information available. 
These materials must be tabbed and organized chronologically and 
accompanied by an indexed list identifying each document.
    (f) The grantee shall be given an opportunity to provide the review 
committee with additional statements and documentation not provided in 
the request for review described in paragraph (b) of this section. This 
additional submission, which must be organized and indexed as indicated 
under paragraph (e) of this section, should provide only material that 
is relevant to the review committee's deliberation of the issues in the 
case.
    (g) The review committee may, at its discretion, invite the grantee 
and/or the agency staff to discuss the pertinent issues with the 
committee and to submit such additional information as the committee 
deems appropriate.
    (h) Based on its review, the review committee will prepare a written 
decision to be signed by the chairperson and each of the other committee 
members. The review committee shall send the written decision with a 
transmittal letter to the grantee and shall send a copy of both to the 
official responsible for the adverse determination. If the

[[Page 147]]

decision is adverse to the grantee's position, the transmittal letter 
must state the grantee's right to appeal to the Departmental Appeals 
Board under 45 CFR part 16.

[54 FR 34770, Aug. 22, 1989, as amended at 63 FR 66063, Dec. 1, 1998]



               Subpart E_Maximum Allowable Cost for Drugs

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 
U.S.C. 216).

    Source: 40 FR 34514, Aug. 15, 1975, unless otherwise noted.



Sec. 50.501  Applicability.

    This subpart is applicable to programs or projects for health 
services which are supported in whole or in part by Federal financial 
assistance, whether by grant or contract, administered by the Public 
Health Service. It applies to Federal funds and to non-Federal funds 
which are required to be expended as a condition to receiving Federal 
funds under such programs or projects.



Sec. 50.502  Definitions.

    As used in this subpart:
    (a) Public Health Service means the Office of the Assistant 
Secretary for Health, Health Resources and Services Administration, 
National Institutes of Health, Centers for Disease Control, Alcohol, 
Drug Abuse and Mental Health Administration, Food and Drug 
Administration, and all of their constituent agencies.
    (b) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (c) Program funds means (1) Federal funds provided through grant or 
contract to support a program or project covered by Sec. 50.501, and 
(2) any non-Federal funds that are required as a condition of such grant 
or contract to be expended to carry out such program or project.
    (d) Provider means one who furnishes medical or pharmaceutical 
services or supplies for which program funds may be expended under any 
of the programs or projects described in Sec. 50.501.
    (e) Acquisition cost means the price generally and currently paid by 
providers for a drug marketed or sold by a particular formulator or 
labeler in the package size of drug most frequently purchased by 
providers, as determined by the Secretary on the basis of drug price 
information furnished by the Department.

[40 FR 34514, Aug. 15, 1975, as amended at 49 FR 38109, Sept. 27, 1984]



Sec. 50.503  Policy.

    It is the policy of the Secretary that program funds which are 
utilized for the acquisition of drugs be expended in the most economical 
manner feasible. In furtherance of this policy, the Secretary has 
established, in 45 CFR part 19, a procedure for determining the Maximum 
Allowable Cost for drugs which are purchased with program funds.



Sec. 50.504  Allowable cost of drugs.

    (a) The maximum amount which may be expended from program funds for 
the acquisition of any drug shall be the lowest of
    (1) The maximum allowable cost (MAC) of the drug, if any, 
established in accordance with 45 CFR part 19, plus a dispensing fee 
determined by the Secretary in accordance with paragraph (b) of this 
section, to be reasonable;
    (2) The acquisition cost of the drug plus a dispensing fee 
determined by the Secretary, in accordance with paragraph (b) of this 
section, to be reasonable; or
    (3) The provider's usual and customary charge to the public for the 
drug; Provided, That the MAC established for any drug shall not apply to 
a brand of that drug prescribed for a patient which the prescriber has 
certified, in accordance with paragraph (c) of this section, is 
medically necessary for that patient; And Provided further, That where 
compensation for drug dispensing is included in other costs allowable 
under the applicable program statute and regulations, the terms and 
conditions of the grant or contract, and the applicable cost principles 
prescribed in 45 CFR part 74, no separate dispensing fee will be 
recognized.

[[Page 148]]

    (b) In determining whether a dispensing fee is reasonable, the 
Secretary will take into account:
    (1) Cost components such as overhead, professional services, and 
profits,
    (2) Payment practices of third-party payment organizations, 
including other Federal programs such as titles XVIII and XIX of the 
Social Security Act; and
    (3) Any surveys by States, universities or others of costs of 
pharmacy operations and the fees charged in the particular area.
    (c) A certification by a prescriber, pursuant to paragraph (a) of 
this section, that a brand of drug is medically necessary for a 
particular patient shall be in the prescriber's own handwriting, in such 
form and manner as the Secretary may prescribe. An example of an 
acceptable certification is the notation ``brand necessary''. A 
procedure for checking a box on a form will not constitute an acceptable 
certification.



  Subpart F_Responsibility of Applicants for Promoting Objectivity in 

                Research for Which PHS Funding Is Sought

    Authority: 42 U.S.C. 216, 289b-1, 299c-3.

    Source: 60 FR 35815, July 11, 1995; 60 FR 39076, July 31, 1995, 
unless otherwise noted.



Sec. 50.601  Purpose.

    This subpart promotes objectivity in research by establishing 
standards to ensure there is no reasonable expectation that the design, 
conduct, or reporting of research funded under PHS grants or cooperative 
agreements will be biased by any conflicting financial interest of an 
Investigator.



Sec. 50.602  Applicability.

    This subpart is applicable to each Institution that applies for PHS 
grants or cooperative agreements for research and, through the 
implementation of this subpart by each Institution, to each Investigator 
participating in such research (see Sec. 50.604(a)); provided, that 
this subpart does not apply to SBIR Program Phase I applications. In 
those few cases where an individual, rather than an institution, is an 
applicant for PHS grants or cooperative agreements for research, PHS 
Awarding Components will make case-by-case determinations on the steps 
to be taken to ensure that the design, conduct, and reporting of the 
research will not be biased by any conflicting financial interest of the 
individual.



Sec. 50.603  Definitions.

    As used in this subpart:
    HHS means the United States Department of Health and Human Services, 
and any components of the Department to which the authority involved may 
be delegated.
    Institution means any domestic or foreign, public or private, entity 
or organization (excluding a Federal agency).
    Investigator means the principal investigator and any other person 
who is responsible for the design, conduct, or reporting of research 
funded by PHS, or proposed for such funding. For purposes of the 
requirements of this subpart relating to financial interests, 
``Investigator'' includes the Investigator's spouse and dependent 
children.
    PHS means the Public Health Service, an operating division of the 
U.S. Department of Health and Human Services, and any components of the 
PHS to which the authority involved may be delegated.
    PHS Awarding Component means the organizational unit of the PHS that 
funds the research that is subject to this subpart.
    Public Health Service Act or PHS Act means the statute codified at 
42 U.S.C. 201 et seq.
    Research means a systematic investigation designed to develop or 
contribute to generalizable knowledge relating broadly to public health, 
including behavioral and social-sciences research. The term encompasses 
basic and applied research and product development. As used in this 
subpart, the term includes any such activity for which research funding 
is available from a PHS Awarding Component through a grant or 
cooperative agreement, whether authorized under the PHS Act or other 
statutory authority.
    Significant Financial Interest means anything of monetary value, 
including but not limited to, salary or other payments for services 
(e.g., consulting fees

[[Page 149]]

or honoraria); equity interests (e.g., stocks, stock options or other 
ownership interests); and intellectual property rights (e.g., patents, 
copyrights and royalties from such rights). The term does not include:
    (1) Salary, royalties, or other remuneration from the applicant 
institution;
    (2) Any ownership interests in the institution, if the institution 
is an applicant under the SBIR Program;
    (3) Income from seminars, lectures, or teaching engagements 
sponsored by public or nonprofit entities;
    (4) Income from service on advisory committees or review panels for 
public or nonprofit entities;
    (5) An equity interest that when aggregated for the Investigator and 
the Investigator's spouse and dependent children, meets both of the 
following tests: Does not exceed $10,000 in value as determined through 
reference to public prices or other reasonable measures of fair market 
value, and does not represent more than a five percent ownership 
interest in any single entity; or
    (6) Salary, royalties or other payments that when aggregated for the 
Investigator and the Investigator's spouse and dependent children over 
the next twelve months, are not expected to exceed $10,000.
    Small Business Innovation Research (SBIR) Program means the 
extramural research program for small business that is established by 
the Awarding Components of the Public Health Service and certain other 
Federal agencies under Pub. L. 97-219, the Small Business Innovation 
Development Act, as amended. For purposes of this subpart, the term SBIR 
Program includes the Small Business Technology Transfer (STTR) Program, 
which was established by Pub. L. 102-564.



Sec. 50.604  Institutional responsibility regarding conflicting interests of 

investigators.

    Each Institution must:
    (a) Maintain an appropriate written, enforced policy on conflict of 
interest that complies with this subpart and inform each Investigator of 
that policy, the Investigator's reporting responsibilities, and of these 
regulations. If the Institution carries out the PHS-funded research 
through subgrantees, contractors, or collaborators, the Institution must 
take reasonable steps to ensure that Investigators working for such 
entities comply with this subpart, either by requiring those 
Investigators to comply with the Institution's policy or by requiring 
the entities to provide assurances to the Institution that will enable 
the Institution to comply with this subpart.
    (b) Designate an institutional official(s) to solicit and review 
financial disclosure statements from each Investigator who is planning 
to participate in PHS-funded research.
    (c)(1) Require that by the time an application is submitted to PHS 
each Investigator who is planning to participate in the PHS-funded 
research has submitted to the designated official(s) a listing of his/
her known Significant Financial Interests (and those of his/her spouse 
and dependent children):
    (i) That would reasonably appear to be affected by the research for 
which PHS funding is sought; and
    (ii) In entities whose financial interests would reasonably appear 
to be affected by the research.
    (2) All financial disclosures must be updated during the period of 
the award, either on an annual basis or as new reportable Significant 
Financial Interests are obtained.
    (d) Provide guidelines consistent with this subpart for the 
designated official(s) to identify conflicting interests and take such 
actions as necessary to ensure that such conflicting interests will be 
managed, reduced, or eliminated.
    (e) Maintain records of all financial disclosures and all actions 
taken by the Institution with respect to each conflicting interest for 
at least three years from the date of submission of the final 
expenditures report or, where applicable, from other dates specified in 
45 CFR 74.53(b) for different situations.
    (f) Establish adequate enforcement mechanisms and provide for 
sanctions where appropriate.
    (g) Certify, in each application for the funding to which this 
subpart applies, that:

[[Page 150]]

    (1) There is an effect at that Institution a written and enforced 
administrative process to identify and manage, reduce or eliminate 
conflicting interests with respect to all research projects for which 
funding is sought from the PHS,
    (2) Prior to the Institution's expenditure of any funds under the 
award, the Institution will report to the PHS Awarding Component the 
existence of a conflicting interest (but not the nature of the interest 
or other details) found by the institution and assure that the interest 
has been managed, reduced or eliminated in accordance with this subpart; 
and, for any interest that the Institution identifies as conflicting 
subsequent to the Institution's initial report under the award, the 
report will be made and the conflicting interest managed, reduced, or 
eliminated, at least on an interim basis, within sixty days of that 
identification;
    (3) The Institution agrees to make information available, upon 
request, to the HHS regarding all conflicting interests identified by 
the Institution and how those interests have been managed, reduced, or 
eliminated to protect the research from bias; and
    (4) The Institution will otherwise comply with this subpart.



Sec. 50.605  Management of conflicting interests.

    (a) The designated official(s) must: Review all financial 
disclosures; and determine whether a conflict of interest exists and, if 
so, determine what actions should be taken by the institution to manage, 
reduce or eliminate such conflict of interest. A conflict of interest 
exists when the designated official(s) reasonably determines that a 
Significant Financial Interest could directly and significantly affect 
the design, conduct, or reporting of the PHS-funded research. Examples 
of conditions or restrictions that might be imposed to manage conflicts 
of interest include, but are not limited to:
    (1) Public disclosure of significant financial interests;
    (2) Monitoring of research by independent reviewers;
    (3) Modification of the research plan;
    (4) Disqualification from participation in all or a portion of the 
research funded by the PHS;
    (5) Divestiture of significant financial interests; or
    (6) Severance of relationships that create actual or potential 
conflicts.
    (b) In addition to the types of conflicting financial interests 
described in this paragraph that must be managed, reduced, or 
eliminated, an Institution may require the management of other 
conflicting financial interests, as the Institution deems appropriate.



Sec. 50.606  Remedies.

    (a) If the failure of an Investigator to comply with the conflict of 
interest policy of the Institution has biased the design, conduct, or 
reporting of the PHS-funded research, the Institution must promptly 
notify the PHS Awarding Component of the corrective action taken or to 
be taken. The PHS Awarding Component will consider the situation and, as 
necessary, take appropriate action, or refer the matter to the 
Institution for further action, which may include directions to the 
Institution on how to maintain appropriate objectivity in the funded 
project.
    (b) The HHS may at any time inquire into the Institutional 
procedures and actions regarding conflicting financial interests in PHS-
funded research, including a requirement for submission of, or review on 
site, all records pertinent to compliance with this subpart. To the 
extent permitted by law, HHS will maintain the confidentiality of all 
records of financial interests. On the basis of its review of records 
and/or other information that may be available, the PHS Awarding 
Component may decide that a particular conflict of interest will bias 
the objectivity of the PHS-funded research to such an extent that 
further corrective action is needed or that the Institution has not 
managed, reduced, or eliminated the conflict of interest in accordance 
with this subpart. The PHS Awarding Component may determine that 
suspension of funding under 45 CFR 74.62 is necessary until the matter 
is resolved.
    (c) In any case in which the HHS determines that a PHS-funded 
project of clinical research whose purpose is to evaluate the safety or 
effectiveness of a drug, medical device, or treatment

[[Page 151]]

has been designed, conducted, or reported by an Investigator with a 
conflicting interest that was not disclosed or managed as required by 
this subpart, the Institution must require the Investigator(s) involved 
to disclose the conflicting interest in each public presentation of the 
results of the research.



Sec. 50.607  Other HHS regulations that apply.

    Several other regulations and policies apply to this subpart.
    They include, but are not necessarily limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Uniform Administrative Requirements for Awards and 
Subawards to Institutions of Higher Education, Hospitals, Other Non-
Profit Organizations, and Commercial Organizations; and Certain Grants 
and Agreements with States, Local Governments and Indian Tribal 
Governments
45 CFR part 76--Government-wide debarment and suspension (non-
procurement)
45 CFR part 79--Program Fraud Civil Remedies
45 CFR part 92--Uniform Administrative Requirements for Grants and 
Cooperative Agreements to State and Local Governments



PART 51_REQUIREMENTS APPLICABLE TO THE PROTECTION AND ADVOCACY FOR INDIVIDUALS 

WITH MENTAL ILLNESS PROGRAM--Table of Contents




Sec.
51.1 Scope.
51.2 Defintitions.

                      Subpart A_Basic Requirements

51.3 Formula for determining allotments.
51.4 Grants administration requirements.
51.5 Eligibility for allotment.
51.6 Use of allotments.
51.7 Eligibility for protection and advocacy services.
51.8 Annual reports.
51.9 [Reserved]
51.10 Remedial actions.
51.11-51.20 [Reserved]

             Subpart B_Program Administration and Priorities

51.21 Contracts for program operations.
51.22 Governing authority.
51.23 Advisory council.
51.24 Program priorities.
51.25 Grievance procedure.
51.26 Conflicts of interest.
51.27 Training.
51.28-51.30 [Reserved]

               Subpart C_Protection and Advocacy Services

51.31 Conduct of protection and advocacy activities.
51.32 Resolving disputes.
51.33-51.40 [Reserved]

         Subpart D_Access to Records, Facilities and Individuals

51.41 Access to records.
51.42 Access to facilities and residents.
51.43 Denial of delay or access.
51.44 [Reserved]
51.45 Confidentiality of protection and advocacy system records.
51.46 Disclosing information obtained from a provider of mental health 
          services.

    Authority: 42 U.S.C. 10801, et seq.

    Source: 63 FR 53564, Oct. 15, 1997, unless otherwise noted.



Sec. 51.1  Scope.

    The provisions of this part apply to recipients of Federal 
assistance under the Protection and Advocacy for Mentally Ill 
Individuals Act of 1986, as amended.



Sec. 51.2  Definitions.

    In addition to the definitions in section 102 of the Act, as 
amended, the following definitions apply:
    Abuse means any act or failure to act by an employee of a facility 
rendering care or treatment which was performed, or which was failed to 
be performed, knowingly, recklessly, or intentionally, and which caused, 
or may have caused, injury or death to an individual with mental 
illness, and includes but is not limited to acts such as: rape or sexual 
assault; striking; the use of excessive force when placing an individual 
with mental illness in bodily restrains; the use of bodily or chemical 
restraints which is not in compliance with Federal and State laws and 
regulations; verbal, nonverbal, mental and emotional harassment; and any 
other practice which is likely to cause immediate physical or 
psychological harm or

[[Page 152]]

result in long-term harm if such practices continue.
    Act means the Protection and Advocacy for Mentally Ill Individuals 
Act of 1986, as amended, also referred to as Protection and Advocacy for 
Individuals with Mental Illness Act.
    ADD means the Administration on Developmental Disabilities within 
the Administration for Children and Families, Department of Health and 
Human Services.
    Care or Treatment means services provided to prevent, identify, 
reduce or stabilize mental illness or emotional impairment such as 
mental health screening, evaluation, counseling, biomedical, behavioral 
and psychotherapies, supportive or other adjunctive therapies, 
medication supervision, special education and rehabilitation, even if 
only ``as needed'' or under a contractual arrangement.
    Center or CMHS means the Center for Mental Health Services, a 
component of the Substance Abuse and Mental Health Services 
Administration.
    Complaint includes, but is not limited to any report or 
communication, whether formal or informal, written or oral, received by 
the P&A system, including media accounts, newspaper articles, telephone 
calls (including anonymous calls) from any source alleging abuse or 
neglect of an individual with mental illness.
    Department or HHS means the U.S. Department of Health and Human 
Services.
    Designated Official is the State official or public or private 
entity empowered by the Governor or State legislature to be accountable 
for the proper use of funds by the P&A system.
    Director means the Director of the Center for Mental Health 
Services, Substance Abuse and Mental Health Services Administration, or 
his or her designee.
    Facility includes any public or private residential setting that 
provides overnight care accompanied by treatment services. Facilities 
include, but are not limited to the following: general and psychiatric 
hospitals, nursing homes, board and care homes, community housing, 
juvenile detention facilities, homeless shelters, and jails and prisons, 
including all general areas as well as special mental health or forensic 
units.
    Fiscal Year or FY means the Federal fiscal year (October 1-September 
30) unless otherwise specified.
    Full Investigation is based upon a complaint or a determination of 
probable cause and means the access to facilities, clients and records 
authorized under this part that is necessary for a P&A system to make a 
determination about whether an allegation of abuse or neglect is taking 
place or has taken place. Full investigations may be conducted 
independently or in cooperation with other agencies authorized to 
conduct similar investigations.
    Governor means the chief executive officer of the State, Territory 
or the District of Columbia, or his or her designee, who has been 
formally designated to act for the Governor in carrying out the 
requirements of the Act and this part.
    Individual with Mental Illness means an individual who has a 
significant mental illness or emotional impairment, as determined by a 
mental health professional qualified under the laws and regulations of 
the State and
    (1) Who is an inpatient or resident in a facility rendering care or 
treatment, even if the whereabouts of such impatient or resident is 
unknown;
    (2) Who is in the process of being admitted to a facility rendering 
care or treatment, including persons being transported to such a 
facility, or
    (3) Who is involuntarily confined in a detention facility, jail or 
prison.
    Legal Guardian, Conservator, and Legal Representative all mean an 
individual whose appointment is made and regularly reviewed by a State 
court or agency empowered under State law to appoint and review such 
officers, and having authority to consent to health/mental health care 
or treatment of an individual with mental illness. It does not include 
persons acting only as a representative payee, persons acting only to 
handle financial payments, attorneys or persons acting on behalf of an 
individual with mental illness only in individual legal matters, or 
officials responsible for the provision of health or mental health 
services to an individual with mental illness, or their designees.

[[Page 153]]

    Neglect means a negligent act or omission by an individual 
responsible for providing services in a facility rendering care or 
treatment which caused or may have caused injury or death to an 
individual with mental illness or which placed an individual with mental 
illness at risk of injury or death, and includes, but is not limited to, 
acts or omissions such as failure to: establish or carry out an 
appropriate individual program or treatment plan (including a discharge 
plan); provide adequate nutrition, clothing, or health care; and the 
failure to provide a safe environment which also includes failure to 
maintain adequate numbers of appropriately trained staff.
    Private Entity means a nonprofit or for-profit corporation, 
partnership or other nongovernmental organization.
    Probable cause means reasonable grounds for belief that an 
individual with mental illness has been, or may be at significant risk 
of being subject to abuse or neglect. The individual making such 
determination may base the decision on reasonable inferences drawn from 
his or her experience or training regarding similar incidents, 
conditions or problems that are usually associated with abuse or 
neglect.
    Program means activities carried out by the P&A system and operating 
as part of a P&A system to meet the requirements of the Act.
    Public Entity means an organizational unit of a State or local 
government or a quasi-governmental entity with one or more governmental 
powers.
    System means the organization or agency designated in a State to 
administer and operate a protection and advocacy program under Part C of 
the Developmental Disabilities Assistance and Bill of Rights Act (42 
U.S.C. 6041, 6042) and thereby eligible to administer a program for 
individuals with mental illness.



                      Subpart A_Basic Requirements



Sec. 51.3  Formula for determining allotments.

    The Secretary shall make allotments to eligible Systems from amounts 
apportioned each year under the Act on the basis of a formula prescribed 
by the Secretary in accordance with the requirements of sections 112 and 
113 of the Act (42 U.S.C. 10822 and 10823).



Sec. 51.4  Grants administration requirements.

    The following parts of titles 42 and 45 CFR apply to grants funded 
under this part.

42 CFR Part 50, Subpart D.
45 CFR Part 16--Procedures of the Departmental Grant Appeal Board.
45 CFR Part 74--Administration of Grants.
45 CFR Part 75--Informal Grant Appeals Procedures.
45 CFR Part 76--Government-wide Debarment and Suspension 
(Nonprocurement) and Government-wide Requirements for Drug-Free 
Workplace.
45 CFR Part 80--Nondiscrimination under Programs Receiving Federal 
Assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964.
45 CFR Part 81--Practice and Procedure for Hearings under Part 80 of 
This Title.
45 CFR Part 84--Nondiscrimination on the Basis of Handicap in Programs 
and Activities Receiving or Benefiting from Federal Financial 
Assistance.
45 CFR Part 86--Nondiscrimination on the Basis of Sex in Education 
Programs and Activities Receiving Federal Financial Assistance.
45 CFR Part 91--Nondiscrimination on the Basis of Age in Education 
Programs and Activities Receiving Federal Financial Assistance from HHS.
45 CFR Part 92--Uniform Administrative Requirements for Grants and 
Cooperative Agreements to State and Local Governments.
45 CFR Part 93--New Restrictions on Lobbying.
45 CFR Part 1386, subpart A.



Sec. 51.5  Eligibility for allotment.

    (a) Federal financial assistance for protection and advocacy 
activities for individuals with mental illness will be given only to a 
System that has been established under Part C of the Developmental 
Disabilities Assistance and Bill of Rights Act (42 U.S.C. 6041, et seq.) 
and designated in accordance with 45 CFR part 1386, subpart B.
    (b) The P&A system must meet the requirements of sections 105 and 
111 of the Act (42 U.S.C. 10805 and 10821) and that P&A system must be 
operational. Each system shall submit an application at the beginning of 
each PAIMI authorization period. This application

[[Page 154]]

shall contain at a minimum the program priorities and budget for the 
first year of the authorization period and the required assurances and 
certifications. Thereafter, the system shall submit yearly updates of 
the budget and program priorities for the upcoming fiscal year through 
its annual report.
    (c) Written assurances of compliance with sections 105 and 111 of 
the Act (42 U.S.C. 10805 and 10821) and other requirements of the Act 
and this part shall be submitted by the P&A system in the format 
designated by the Director. These assurances will remain in effect for 
the period specified in the application for funds unless changes occur 
within the State which affect the functioning of the P&A system, in 
which case an amendment will be required 30 days prior to the effective 
date of the change. The P&A system shall also provide the Department the 
name of the designated official.
    (d) The Governor's written assurance that the allotments made 
available under the Act will be used to supplement and not to supplant 
the level of non-Federal funds available in the State to protect and 
advocate the rights of individuals with mental illness shall be 
submitted by the P&A system. The Governor may provide this assurance 
along with the assurances provided to ADD under 45 CFR part 1386, as 
long as it can reasonably be construed as applying to the PAIMI program. 
Any future ``supplement and not supplant'' assurance shall explicitly 
refer to the PAIMI program.



Sec. 51.6  Use of allotments.

    (a) Allotments must be used to supplement and not to supplant the 
level of non-Federal funds available in the State to protect and 
advocate the rights of individuals with mental illness.
    (b) Allotments may not be used to support lobbying activities to 
influence proposed or pending Federal legislation or appropriations. 
This restriction does not affect the right of any P&A system, 
organization or individual to petition Congress or any other government 
body or official using other resources.
    (c) Allotments may not be used to produce or distribute written, 
audio or visual materials or publicity intended or designed to support 
or defeat any candidate for public office.
    (d) If an eligible P&A system is a public entity, that P&A system 
shall not be required by the State to obligate more than five percent of 
its annual allotment for State oversight administrative expenses under 
this grant such as costs of internal or external evaluations, monitoring 
or auditing. This restriction does not include:
    (1) Salaries, wages and benefits of program staff;
    (2) Costs associated with attending governing board or advisory 
council meetings; or
    (3) Expenses associated with the provision of training or technical 
assistance for staff, contractors, members of the governing board or 
advisory council.
    (e) No more than ten percent of each annual allotment may be used 
for providing technical assistance and training, including travel 
expenses for staff, contractors, or members of the governing board or 
advisory council as defined in Sec. 51.27.
    (f) Allotments may be used to pay the otherwise allowable costs 
incurred by a P&A system in bringing lawsuits in its own right to 
redress incidents of abuse or neglect, discrimination, and other rights 
violations impacting on individuals with mental illness and when it 
appears on behalf of named plaintiffs or a class of plaintiffs for such 
purposes.



Sec. 51.7  Eligibility for protection and advocacy services.

    In accordance with section 105(a)(1)(C) of the Act (42 U.S.C. 
10805(a)(1)(C)) and the priorities established by the P&A system 
governing authority, together with the advisory council, pursuant to 
section 105(c)(2)(B) of the Act (42 U.S.C. 10805(c)(2)(B)), allotments 
may be used:
    (a) To provide protection and advocacy services for:
    (1) Individuals with mental illness as defined in 42 U.S.C. 10802(4) 
and 10805(a), including persons who report matters which occurred while 
they were individuals with mental illness;
    (2) Persons who were individuals with mental illness who are 
residents of the

[[Page 155]]

State, but only with respect to matters which occur within 90 days after 
the date of the discharge of such individuals from a facility providing 
care or treatment; and
    (3) Individuals with mental illness in Federal facilities rendering 
care or treatment who request representation by the eligible P&A system. 
Representation may be requested by an individual with mental illness, or 
by a legal guardian, conservator or legal representative.
    (b) To provide representation of clients in civil commitment 
proceedings if the P&A system is acting on behalf of an eligible 
individual to obtain judicial review of his or her commitment in order 
to appeal or otherwise challenge acts or omissions which have subjected 
the individual to abuse or neglect or otherwise violated his or her 
rights. This restriction does not prevent a P&A system from representing 
clients in commitment or recommitment proceedings using other resources 
so long as this representation does not conflict with responsibilities 
under the Act.



Sec. 51.8  Annual reports.

    By January 1 of each year, a report shall be submitted, pursuant to 
section 105(a)(7) of the Act (42 U.S.C. 10805(a)(7)), to the Secretary 
which is in the format designated by the Secretary.

    Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 51.8 was 
added. This section contains information collection and recordkeeping 
requirements and will not become effective until approval has been given 
by the Office of Management and Budget.



Sec. 51.9  [Reserved]



Sec. 51.10  Remedial actions.

    Failure to submit an annual report in the designated format on time 
or to submit requested information and documentation, corrective action 
plans and ongoing implementation status reports in response to Federal 
review and monitoring activities or to satisfy any other requirement of 
the Act, this part, or other requirements, may be considered a breach of 
the terms and conditions of the grant award and may required remedial 
action, such as the suspension or termination of an active grant, 
withholding of payments or converting to a reimbursement method of 
payment. Any remedial actions shall be taken consistent with 45 CFR Part 
74 and 42 CFR Part 50, as appropriate.

    Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 51.10 was 
added. This section contains information collection and recordkeeping 
requirements and will not become effective until approval has been given 
by the Office of Management and Budget.



Sec. Sec. 51.11-51.20  [Reserved]



             Subpart B_Program Administration and Priorities



Sec. 51.21  Contracts for program operations.

    (a) An eligible P&A system should work cooperatively with existing 
advocacy agencies and groups and, where appropriate, consider entering 
into contracts for protection and advocacy services with organizations 
already working on behalf of individuals with metal illness. Special 
consideration should be given to contracting for the services of groups 
run by individuals who have received or are receiving mental health 
services or by family members of such individuals.
    (b) An eligible P&A system may contract for the operation of all or 
part of its program with another public or private nonprofit 
organization with demonstrated experience in working with individuals 
with mental illness provided that:
    (1) Any organization that will operate the full program meets the 
requirements of section 104(a)(1), 105 and 111 of the Act (42 U.S.C. 
10804(a)(1), 10805 and 10821) and has the capacity to perform protection 
and advocacy activities throughout the State;
    (2) The eligible P&A system institutes oversight and monitoring 
procedures which ensure that this system will be able to meet all 
applicable terms, conditions and obligations of the Federal grant;
    (3) The eligible P&A system and the contractor organization enter 
into a written agreement that includes at least the following:
    (i) A description of the protection and advocacy services to be 
provided;

[[Page 156]]

    (ii) The type of personnel, their qualifications and training;
    (iii) The methods to be used;
    (iv) A timetable for performance;
    (v) A budget;
    (vi) Assurances that the contractor will meet all applicable terms 
and conditions of the grant;
    (vii) Assurances that the contractor has adequate management and 
fiscal systems in place, including insurance coverage, if appropriate:
    (viii) Assurances that the contractor's staff is trained to provide 
advocacy services to and conduct full investigations on behalf of 
individuals with mental illness; and
    (ix) Assurances that the contractor staff is trained to work with 
family members of clients served by the P&A system where the clients 
are:
    (A) Minors;
    (B) Legally competent and choose to involve the family member; or,
    (C) Legally incompetent and the legal guardians, conservators or 
other legal representatives are family members.



Sec. 51.22  Governing authority.

    (a) Each P&A system shall have a governing authority responsible for 
its planning, designing, implementing and functioning. It shall, jointly 
with the advisory council, annually establish program priorities and 
policies.
    (b) If the P&A system is organized with a multi-member governing 
board:
    (1) Each P&A system shall establish policies and procedures for the 
selection of its governing board members and for the board evaluation of 
the P&A system director. The terms of board members shall be staggered 
and for 4 years except that any member appointed to fill a vacancy for 
an unexpired term shall serve for the remainder of such term. A member 
who has been appointed for a term of 4 years may not be reappointed to 
the governing board during the 2-year period beginning on the date on 
which such 4-year term expired.
    (2) The board shall be composed of members who broadly represent or 
are knowledgeable about the needs of the clients served by the P&A 
system and shall include a significant representation of individuals 
with mental illness who are, or have been eligible for services, or have 
received or are receiving mental health services, and family members, 
guardians, advocates, or authorized representatives of such individuals.
    (3) If the governing authority is organized as a private nonprofit 
entity, the chairperson of the advisory council shall be a member of the 
governing board.
    (c) Continuing efforts shall be made to include members of racial 
and ethnic minority groups as board members.
    (d) Any member of the advisory council may also serve on the 
governing board.



Sec. 51.23  Advisory council.

    (a) Each P&A system shall establish an advisory council to:
    (1) Provide independent advice and recommendations to the system.
    (2) Work jointly with the governing authority in the development of 
policies and priorities.
    (3) Submit a section of the system's annual report as required under 
Sec. 51.8.
    (b) Members of the council shall include attorneys, mental health 
professionals, individuals from the public who are knowledgeable about 
mental illness, the advocacy needs of persons with mental illness and 
have demonstrated a substantial commitment to improving mental health 
services, a provider of mental health services, individuals who have 
received or are receiving mental health services and family members of 
such individuals. Continuing efforts shall be made to include members of 
racial and ethnic minority groups on the advisory council.
    (1) At least 60 percent of the membership of the advisory council 
shall be comprised of individuals who have received or are receiving 
mental health services or who are family members of such individuals. At 
least one family member shall be a primary care giver for an individual 
who is currently a minor child or youth who is receiving or has received 
mental health services;
    (2) The council shall be chaired by an individual who has received 
or is receiving mental health services or who is a family member of such 
an individual;

[[Page 157]]

    (3) The advisory council shall meet no less than three times 
annually. The terms of council members shall be staggered and for 4 
years except that any member appointed to fill a vacancy for an 
unexpired term shall serve for the remainder of such term. A member who 
has been appointed for a term of 4 years may not be reappointed to the 
council during the 2-year period beginning on the date on which such 4-
year term expired.
    (c) Each P&A system shall provide its advisory council with reports, 
materials and fiscal data to enable review of existing program policies, 
priorities and performance outcomes. Such submissions shall be made at 
least annually and shall report expenditures for the past two fiscal 
years, as well as projected expenses for the next fiscal year, 
identified by budget category (e.g., salary and wages, contract for 
services, administrative expenses) including the amount allotted for 
training of each the advisory council, governing board and staff.
    (d) Reimbursement of expenses. (1) Allotments may be used to pay for 
all or a part of the expenses incurred by members of the advisory 
council in order to participate in its activities. Expenses may include 
transportation costs, parking, meals, hotel costs, per diem expenses, 
stipends or subsistence allowances, and the cost of day care or child 
care (or its equivalent for the child's travel and subsistence expenses) 
for their dependents with mental illness or developmental disabilities.
    (2) Each P&A system shall establish its own policies and procedures 
for reimbursement of expenses of council members, taking into account 
the needs of individual council members, available resources, and 
applicable restrictions on use of grant funds, including the 
restrictions in Sec. Sec. 51.31(e) and 51.6(e).

    Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 51.23 was 
added. This section contains information collection and recordkeeping 
requirements and will not become effective until approval has been given 
by the Office of Management and Budget.



Sec. 51.24  Program priorities.

    (a) Program priorities and policies shall be established annually by 
the governing authority, jointly with the advisory council. Priorities 
shall specify short-term program goals and objectives, with measurable 
outcomes, to implement the established priorities. In developing 
priorities, consideration shall be given to, at a minimum, case 
selection criteria, the availability of staff and monetary resources, 
and special problems and cultural barriers faced by individuals with 
mental illness who are multiply handicapped or who are members of racial 
or ethnic minorities in obtaining protection of their rights. Systemic 
and legislative activities shall also be addressed in the development 
and implementation of program priorities.
    (b) Members of the public shall be given an opportunity, on an 
annual basis, to comment on the priorities established by, and the 
activities of, the P&A system. Procedures for public comment must 
provide for notice in a format accessible to individuals with mental 
illness, including such individuals who are in residential facilities, 
to family members and representatives of such individuals and to other 
individuals with disabilities. Procedures for public comment must 
provide for receipt of comments in writing or in person.



Sec. 51.25  Grievance procedure.

    (a) The P&A system shall establish procedures to address grievances 
from:
    (1) Clients or prospective clients of the P&A system to assure that 
individuals with mental illness have full access to the services of the 
program; and
    (2) Individuals who have received or are receiving mental health 
services in the State, family members of such individuals, or 
representatives of such individuals or family members to assure that the 
eligible P&A system is operating in compliance with the Act.
    (b) At a minimum, the grievance procedures shall provide for:
    (1) An appeal to the governing authority from any final staff review 
and/or determination; in cases where the governing authority is the 
director of the P&A system, the final review and/or determination shall 
be made by a superior of the governing authority, e.g., a supervisor, or 
by an independent

[[Page 158]]

entity, e.g., an appointed board or committee.
    (2) Reports, at least annually, to the governing authority and the 
advisory council describing the grievances received and processed and 
their resolution;
    (3) Identification of individuals responsible for review;
    (4) A timetable to ensure prompt notification concerning the 
grievance procedure to clients, prospective clients or persons denied 
representation, and to ensure prompt resolution;
    (5) A written response to the grievant; and
    (6) Protection of client confidentiality.

    Effective Date Note: At 62 FR 53564, Oct. 15, 1997, Sec. 51.25 was 
added. This section contains information collection and recordkeeping 
requirements and will not become effective until approval has been given 
by the Office of Management and Budget.



Sec. 51.26  Conflicts of interest.

    The P&A system must develop appropriate policies and procedures to 
avoid actual or apparent conflict of interest involving clients, 
employees, contractors and subcontractors, and members of the governing 
authority and advisory council, particularly with respect to matters 
affecting client services, particular contracts and subcontracts, 
grievance review procedures, reimbursements and expenses, and the 
employment or termination of staff.



Sec. 51.27  Training.

    A P&A system shall provide training for program staff, and may also 
provide training for contractors, governing board and advisory council 
members to enhance the development and implementation of effective 
protection and advocacy services for individuals with mental illness, 
including at a minimum:
    (a)(1) Training of program staff to work with family members of 
clients served by the program where the individual with mental illness 
is:
    (i) A minor,
    (ii) Legally competent and chooses to involve the family member; or
    (iii) Legally incompetent and the legal guardian, conservator or 
other legal representative is a family member.
    (2) This training may be provided by individuals who have received 
or are receiving mental health services and family members of such 
individuals.
    (b) Training to enhance sensitivity to and understanding of 
individuals with mental illness who are members of racial or ethnic 
minorities and to develop strategies for outreach to those populations.
    (c) Training to conduct full investigations of abuse or neglect.



Sec. Sec. 51.28-51.30  [Reserved]



               Subpart C_Protection and Advocacy Services



Sec. 51.31  Conduct of protection and advocacy activities.

    (a) Consistent with State and Federal law and the canons of 
professional ethics, a P&A system may use any appropriate technique and 
pursue administrative, legal or other appropriate remedies to protect 
and advocate on behalf of individuals with mental illness to address 
abuse, neglect or other violations of rights.
    (b) A P&A system shall establish policies and procedures to guide 
and coordinate advocacy activities. The P&A system shall not implement a 
policy or practice restricting the remedies which may be sought on 
behalf of individuals with mental illness or compromising the authority 
of the P&A system to pursue such remedies through litigation, legal 
action or other forms of advocacy. However, this requirement does not 
prevent the P&A system from placing limitations on case or client 
acceptance criteria developed as part of the annual priorities. 
Prospective clients must be informed of any such limitations at the time 
they request service.
    (c) Wherever possible, the program should establish an ongoing 
presence in residential mental health care or treatment facilities, and 
relevant hospital units.
    (d) Program activities should be carried out in a manner which 
allows program staff to:

[[Page 159]]

    (1) Interact regularly with those individuals who are current or 
potential recipients of protection and advocacy services;
    (2) Interact regularly with staff providing care or treatment;
    (3) Obtain information and review records; and
    (4) Communicate with family members, social and community service 
workers and others involved in providing care or treatment.
    (e) A P&A system may support or provide training, including related 
travel expenses, for individuals with mental illness, family members of 
such individuals, and other persons who are not program staff, 
contractors, or board or council members, to increase knowledge about 
protection and advocacy issues, to enhance leadership capabilities, or 
to promote Federal-State and intra-State cooperation on matter related 
to mental health system improvement. Decisions concerning the selection 
of individuals to receive such training shall be made in accordance with 
established policies, procedures and priorities of the P&A system.
    (f) A P&A system may monitor, evaluate and comment on the 
development and implementation of Federal, State and local laws, 
regulations, plans, budgets, levies, projects, policies and hearings 
affecting individuals with mental illness as a part of federally funded 
advocacy activities. A P&A system shall carry out systemic advocacy--
those efforts to implement changes in policies and practices of systems 
that impact persons with mental illness.
    (g) Determination of ``probable cause'' may result from P&A system 
monitoring or other activities, including observation by P&A system 
personnel, and reviews of monitoring and other reports prepared by 
others whether pertaining to individuals with mental illness or to 
general conditions affecting their health or safety.
    (h) A P&A which is a public P&A system shall be free from hiring 
freezes, reductions in force, prohibitions on staff travel, or other 
policies imposed by the State to the extend that such policies would 
impact program staff or activities funded with Federal dollars and would 
prevent the P&A system from carrying out its mandates under the Act.
    (i) A P&A system may exercise its authority under State law where 
the authority exceeds the authority required by the Act. However, State 
law must not diminish the required authority of the Act.



Sec. 51.32  Resolving disputes.

    (a) Each P&A system is encouraged to develop and employ techniques 
such as those involving negotiation, conciliation and mediation to 
resolve disputes early in the protection and advocacy process.
    (b) Disputes should be resolved whenever possible through 
nonadversarial process involving negotiation, mediation and 
conciliation. Consistent with State and Federal laws and canons of 
professional responsibility, family members should be involved in this 
process, as appropriate, where the individual with mental illness is:
    (1) A minor,
    (2) Legally competent and chooses to involve the family member, or
    (3) Legally incompetent and the legal guardian, conservator or other 
legal representative is a family member or the legal guardian, 
conservator or other legal representative chose to involve the family 
member.
    (c) A P&A system must exhaust in a timely manner all administrative 
remedies, where appropriate, prior to initiating legal action in a 
Federal or State court.
    (d) Paragraph (c) of this section does not apply to any legal action 
instituted to prevent or eliminate imminent serious harm to an 
individual with mental illness nor does it apply in circumstances where 
administrative procedures do not exist. If in pursing administrative 
remedies, the P&A system determines that any matter with respect to an 
individual with mental illness with mental illness with not be resolved 
within a reasonable time, the P&A system may pursue alternative 
remedies, including initiating legal action.
    (e) A P&A system shall be held to the standard of exhaustion of 
remedies provided under State and Federal law. The Act imposes no 
additional burden respecting exhaustion of remedies.

[[Page 160]]



Sec. Sec. 51.33-51.40  [Reserved]



         Subpart D_Access to Records, Facilities and Individuals



Sec. 51.41  Access to records.

    (a) Access to records shall be extended promptly to all authorized 
agents of a P&A system.
    (b) A P&A system shall have access to the records of any of the 
following individuals with mental illness:
    (1) An individual who is a client of the P&A system if authorized by 
that individual or the legal guardian, conservator or other legal 
representative.
    (2) An individual, including an individual who has died or whose 
whereabouts is unknown to whom all of the following conditions apply:
    (i) The individual, due to his or her mental or physical condition, 
is unable to authorize the P&A system to have access.
    (ii) The individual does not have a legal guardian, conservator or 
other legal representative, or the individual's guardian is the State or 
one of its political subdivisions; and
    (iii) A complaint or report has been received and the P&A system has 
determined that there is probable cause to believe that the individual 
has been or may be subject to abuse or neglect.
    (3) An individual who has a legal guardian, conservator, or other 
legal representative, with respect to whom a complaint or report has 
been received by the P&A system and with respect to whom the P&A system 
has determined that there is probable cause to believe that the health 
or safety of the individual is in serious and immediate jeopardy, 
whenever all of the following conditions exists:
    (i) The P&A system has made a good faith effort to contact the 
representative upon prompt receipt of the representative's name and 
address;
    (ii) The P&A system has made a good faith effort to offer assistance 
to the representative to resolve the situation; and
    (iii) The representative has failed or refused to act on behalf of 
the individual.

(c) Information and individual records, whether written or in another 
medium, draft or final, including handwritten notes, electronic files, 
photographs or video or audio tape records, which shall be available to 
the P&A system under the Act shall include, but not be limited to:
    (1) Information and individual records, obtained in the course of 
providing intake, assessment, evaluation, supportive and other services, 
including medical records, financial records, and reports prepared or 
received by a member of the staff of a facility or program rendering 
care or treatment. This includes records stored or maintained in 
locations other than the facility or program as long as the system has 
obtained appropriate consent consistent with section 105(a)(4) of the 
Act. The system shall request of facilities that in requesting records 
from service providers or other facilities on residents that they 
indicate in the release form the records may be subject to review by a 
system.
    (2) Reports prepared by an agency charged with investigating abuse 
neglect, or injury occurring at a facility rendering care or treatment, 
or by or for the facility itself, that describe any or all of the 
following:
    (i) Abuse, neglect, or injury occurring at the facility;
    (ii) The steps taken to investigate the incidents;
    (iii) Reports and records, including personnel records, prepared or 
maintained by the facility, in connection with such reports of 
incidents; or
    (iv) Supporting information that was relied upon in creating a 
report, including all information and records used or reviewed in 
preparing reports of abuse, neglect or injury such as records which 
describe persons who were interviewed, physical and documentary evidence 
that was reviewed, and the related investigative findings.
    (3) Discharge planning records.
    (4) Reports prepared by individuals and entities performing 
certification or licensure reviews, or by professional accreditation 
organizations, as well as related assessments prepared for the facility 
by its staff, contractors or related entities, except that nothing in 
this section is intended to preempt State law protecting records 
produced by medical care evaluation or peer review committees.

[[Page 161]]

    (5) Professional, performance, building or other safety standards, 
demographic and statistical information relating to the facility.
    (d) A P&A system shall have reasonable access and authority to 
interview and examine all relevant records of any facility service 
recipient (consistent with the provisions of section 105(a)(4) of the 
Act) or employee.
    (e) A P&A system shall be permitted to inspect and copy records, 
subject to a reasonable charge to offset duplicating costs.



Sec. 51.42  Access to facilities and residents.

    (a) Access to facilities and residents shall be extended to all 
authorized agents of a P&A system.
    (b) A P&A system shall have reasonable unaccompanied access to 
public and private facilities and programs in the State which render 
care or treatment for individuals with mental illness, and to all areas 
of the facility which are used by residents or are accessible to 
residents. The P&A system shall have reasonable unaccompanied access to 
residents at all times necessary to conduct a full investigation of an 
incident of abuse or neglect. This authority shall include the 
opportunity to interview any facility service recipient, employee, or 
other persons, including the person thought to be the victim of such 
abuse, who might be reasonably believed by the system to have knowledge 
of the incident under investigation. Such access shall be afforded, upon 
request, by the P&A system when:
    (1) An incident is reported or a complaint is made to the P&A 
system;
    (2) The P&A system determines there is probable cause to believe 
that an incident has or may have occurred; or
    (3) The P&A system determines that there is or may be imminent 
danger of serious abuse or neglect of an individual with mental illness.
    (c) In addition to access as prescribed in paragraph (b) of this 
section, a P&A system shall have reasonable unaccompanied access to 
facilities including all area which are used by residents, are 
accessible to residents, and to programs and their residents at 
reasonable times, which at a minimum shall include normal working hours 
and visiting hours. Residents include adults or minors who have legal 
guardians or conservators. P&A activities shall be conducted so as to 
minimize interference with facility programs, respect residents' privacy 
interests, and honor a resident's request to terminate an interview. 
This access is for the purpose of:
    (1) Providing information and training on, and referral to programs 
addressing the needs of individuals with mental illness, and information 
and training about individual rights and the protection and advocacy 
services available from the P&A system, including the name, address, and 
telephone number of the P&A system.
    (2) Monitoring compliance with respect to the rights and safety of 
residents; and
    (3) Inspecting, viewing and photographing all areas of the facility 
which are used by residents or are accessible to residents.
    (d) Unaccompanied access to residents shall include the opportunity 
to meet and communicate privately with individuals regularly, both 
formally and informally, by telephone, mail and in person. Residents 
include minors or adults who have legal guardians or conservators.
    (e) The right of access specified in paragraph (c) of this section 
shall apply despite the existence of any State or local laws or 
regulations which restrict informal access to minors and adults with 
legal guardians or conservators. The system shall make very effort to 
ensure that the parents of minors or guardians of individuals in the 
care of a facility are informed that the system will be monitoring 
activities at the facility and may in the course of such monitoring have 
access to the minor or adult with a legal guardian. The system shall 
take no formal action on behalf of individuals with legal guardians or 
conservators, or initiate a formal attorney/client or advocate/client 
relationship without appropriate consent, except in emergency situations 
as described in Sec. 51.41(b)(3).
    (f) A P&A system providing representation to individuals with mental 
illness in Federal facilities shall have all

[[Page 162]]

the rights and authority accorded other representatives of residents of 
such facilities pursuant to State and Federal laws.



Sec. 51.43  Denial or delay of access.

    If a P&A system's access to facilities, programs, residents or 
records covered by the Act or this part is delayed or denied, the P&A 
system shall be provided promptly with a written statement of reasons, 
including, in the case of a denial for alleged lack of authorization, 
the name, address and telephone number of the legal guardian, 
conservator, or other legal representative of an individual with mental 
illness. Access to facilities, records or residents shall not be delayed 
or denied without the prompt provision of written statements of the 
reasons for the denial.



Sec. 51.44  [Reserved]



Sec. 51.45  Confidentiality of protection and advocacy system records.

    (a) Records maintained by the P&A system are the property of the P&A 
system which must protect them from loss, damage, tampering or use by 
unauthorized individuals. The P&A system must:
    (1) Except as provided elsewhere in this section, keep confidential 
all records and information, including information contained in any 
automated electronic database pertaining to:
    (i) Clients to the same extent as is required under Federal or State 
laws for a provider of mental health services;
    (ii) Individuals who have been provided general information or 
technical assistance on a particular matter;
    (iii) Identity of individuals who report incidents of abuse or 
neglect or furnish information that forms the basis for a determination 
that probable cause exists; and
    (iv) Names of individuals who are residents and provide information 
for the record.
    (2) Have written policies governing access to, storage of, 
duplication and release of information from client records; and
    (3) Obtain written consent from the client, if competent, or from 
his or her legal representative, from individuals who have been provided 
general information or technical assistance on a particular matter and 
from individuals who furnish reports or information that forms the basis 
for a determination of probable cause, before releasing information to 
individuals not otherwise authorized to receive it.
    (b) Nothing in this subpart shall prevent the P&A system from. (1) 
Issuing a public report of the results of an investigation which 
maintains the confidentiality of the individuals listed in paragraph 
(a)(1) of this section or,
    (2) Reporting the results of an investigation which maintains the 
confidentiality of individual service recipients to responsible 
investigative or enforcement agencies should an investigation reveal 
information concerning the facility, its staff, or employees warranting 
possible sanctions or corrective action. this information may be 
reported to agencies responsible for facility licensing or 
accreditation, employee discipline, employee licensing or certification, 
or criminal prosecution.
    (c) For purposes of any periodic audit, report, or evaluation of the 
performance of the P&A system, the Secretary shall not require the P&A 
system to disclose the identity, or any other personally identifiable 
information, of any individual requesting assistance under a program. 
This requirement does not restrict access by the Department or other 
authorized Federal or State officials to client records or other records 
of the P&A system when deemed necessary for audit purposes and for 
monitoring P&A system compliance with applicable Federal or State laws 
and regulations. The purpose of obtaining such information is solely to 
determine that P&A systems are spending their grant funds awarded under 
the Act on serving individuals with mental illness. Officials that have 
access to such information must keep it confidential to the maximum 
extent permitted by law and regulations. If photostatic copies of 
materials are provided, then the destruction of such evidence is 
required once such reviews have been completed.
    (d) Subject to the restrictions and procedures set out in this 
section, implementing section 106 (a) and (b) of the Act (42 U.S.C. 
10806 (a) and (b)), this

[[Page 163]]

part does not limit access by a legal guardian, conservator, or other 
legal representative of an individual with mental illness, unless 
prohibited by State or Federal law, court order or the attorney-client 
privilege.



Sec. 51.46  Disclosing information obtained from a provider of mental health 

services.

    (a) Except as provided in paragraph (b) of this section, if a P&A 
system has access to records pursuant to section 105(a)(4) of the Act 
(42 U.S.C. 10805(a)(4)) which, under Federal or State law, are required 
to be maintained in a confidential manner by a provider of mental health 
services, it may not disclose information from such records to the 
individual who is the subject of the information if the mental health 
professional responsible for supervising the provision of mental health 
services to that individual has given the P&A system a written 
determination that disclosure of such information to the individual 
would be detrimental to the individual's health. The provider shall be 
responsible for giving any such written determination to the P&A system 
at the same time as access to the records containing the information is 
granted.
    (b)(1) If the disclosure of information has been denied under 
paragraph (a) of this section to an individual, the following 
individuals or the P&A system may select another mental health 
professional to review the information and to determine if disclosure of 
the information would be detrimental to the individual's health:
    (i) Such individual;
    (ii) The legal guardian, conservator or other legal representative 
of the individual; or
    (iii) An eligible P&A system, acting on behalf of an individual:
    (A) Whose legal guardian is the State; or
    (B) Whose legal guardian, conservator, or other legal representative 
has not, within a reasonable time after the denial of access to 
information under paragraph (a), selected a mental health professional 
to review the information.
    (2) If such mental health professional determines, based on 
professional judgment, that disclosure of the information would not be 
detrimental to the health of the individual, the P&A system may disclose 
such information to the individual.
    (c) The restriction in paragraph (b) of this section does not affect 
the P&A system's access to the records.



PART 51a_PROJECT GRANTS FOR MATERNAL AND CHILD HEALTH--Table of Contents




Sec.
51a.1 To which programs does this regulation apply?
51a.2 Definitions.
51a.3 Who is eligible to apply for Federal funding?
51a.4 How is application made for Federal funding?
51a.5 What criteria will DHHS use to decide which projects to fund?
51a.6 What confidentiality requirements must be met?
51a.7 What other DHHS regulations apply?
51a.8 What other conditions apply to these grants?

    Authority: Sec. 1102 of the Social Security Act, 49 Stat. 647 (42 
U.S.C. 1302); sec. 502(a), 502(b)(1)(A), and 506(a)(3) of the Social 
Security Act, 95 Stat. 819-20 (42 U.S.C. 702(a), 702(b)(1)(A) and 
706(a)(3)).

    Source: 51 FR 7727, Mar. 5, 1986, unless otherwise noted.



Sec. 51a.1  To which programs does this regulation apply?

    The regulation in this part applies to grants, contracts, and other 
arrangements under section 502(a) and 502(b)(1)(A) of the Social 
Security Act, as amended (42 U.S.C. 702(a) and 702(b)(1)(A)), the 
Maternal and Child Health (MCH) Federal Set-Aside project grant 
programs. Section 502(a) authorizes funding for special projects of 
regional and national significance (SPRANS), research and training 
projects with respect to maternal and child health and children with 
special health care needs (including early intervention training and 
services development); genetic disease testing, counseling and 
information programs; comprehensive hemophilia diagnostic and treatment 
centers; projects for screening and follow-up of newborns for sickle 
cell anemia and other genetic disorders; and special maternal and child 
health improvement projects. Section 502(b)(1)(A) authorizes funding

[[Page 164]]

for projects termed community integrated service system (CISS) projects 
for the development and expansion of: maternal and infant health home 
visiting; projects to increase the participation of obstetricians and 
pediatricians in title V and title XIX programs; integrated maternal and 
child health service systems; maternal and child health centers 
operating under the direction of not-for-profit hospitals; rural 
maternal and child health programs; and outpatient and community-based 
services programs for children with special health care needs.

[59 FR 36706, July 19, 1994]



Sec. 51a.2  Definitions.

    Act means the Social Security Act, as amended.
    Genetic diseases means inherited disorders caused by the 
transmission of certain aberrant genes from one generation to another.
    Hemophilia means a genetically transmitted bleeding disorder 
resulting from a deficiency of a plasma clotting factor.
    Institution of higher learning means any college or university 
accredited by a regionalized body or bodies approved for such purpose by 
the Secretary of Education, and any teaching hospital which has higher 
learning among its purposes and functions and which has a formal 
affiliation with an accredited school of medicine and a full-time 
academic medical staff holding faculty status in such school of 
medicine.
    Secretary means the Secretary of Health and Human Services or his or 
her designee.



Sec. 51a.3  Who is eligible to apply for Federal funding?

    (a) With the exception of training and research, as described in 
paragraph (b) of this section, any public or private entity, including 
an Indian tribe or tribal organization (as those terms are defined at 25 
U.S.C. 450b) is eligible to apply for federal funding under this Part.
    (b) Only public or nonprofit private institutions of higher learning 
may apply for training grants. Only public or nonprofit institutions of 
higher learning and public or private nonprofit agencies engaged in 
research or in programs relating to maternal and child health and/or 
services for children with special health care needs may apply for 
grants contracts or cooperative agreements for research in maternal and 
child health services or in services for children with special health 
care needs.

[59 FR 36706, July 19, 1994]



Sec. 51a.4  How is application made for Federal funding?

    An application for funding under the MCH Federal Set-Aside project 
grant programs must be submitted to the Secretary at such time and in 
such manner as the Secretary may prescribe. It must include a budget and 
narrative plan of the manner in which the project will meet each of the 
requirements prescribed by the Secretary. The plan must describe the 
project in sufficient detail to identify clearly the nature, need, and 
specific objectives of, and methodology for carrying out, the project.

(Approved by the Office of Management and Budget under control number 
0915-0050)

[59 FR 36706, July 19, 1994]



Sec. 51a.5  What criteria will DHHS use to decide which projects to fund?

    (a) The Secretary will determine the allocation of funds available 
under sections 502(a) and 502(b)(1)(A) of the Act for each of the 
activities described in Sec. 51a.1.
    (b) Within the limit of funds determined by the Secretary to be 
available for each of the activities described in Sec. 51a.1, the 
Secretary may award Federal funding for projects under this part to 
applicants which will, in his or her judgment, best promote the purpose 
of title V of the Social Security Act and address achievement of Healthy 
Children 2000 objectives, \1\ taking, the following factors into 
account:
---------------------------------------------------------------------------

    \1\ Healthy Children 2000: National Health Promotion and Disease 
Prevention Objectives Related to Mothers, Infants, Children, 
Adolescents, and Youth is a special compendium of health status goals 
and national health objectives affecting mothers, infants, children, 
adolescents, and youth originally published in Healthy People 2000 in 
September 1990. Potential applicants may obtain a copy of Healthy People 
2000 (Full Report: Stock No. 017-001-00474-0 or Healthy People 2000 
(Summary Report; Stock No. 017-001-00473-1) through the Superintendent 
of Documents, Government Printing Office Washington, DC 20402-9325, 
(telephone: 202 512-1800).

---------------------------------------------------------------------------

[[Page 165]]

    (1) The extent to which the project will contribute to the 
advancement of maternal and child health and/or improvement of the 
health of children with special health care needs;
    (2) The extent to which the project is responsive to policy concerns 
applicable to MCH grants and to program objectives, requirements, 
priorities and/or review criteria for specific project categories, as 
published in program announcements or guidance materials.
    (3) The extent to which the estimated cost to the Government of the 
project is reasonable, considering the anticipated results;
    (4) The extent to which the project personnel are well qualified by 
training and/or experience for their roles in the project and the 
applicant organization has adequate facilities and personnel; and
    (5) The extent to which, insofar as practicable, the proposed 
activities, if well executed, are capable of attaining project 
objectives.
    (c) For the following types of CISS projects, preference for funding 
will be given to qualified applicants in areas with a high infant 
mortality rate (relative to the latest average infant mortality rate in 
the United States or in the State in which the area is located):
    (1) Projects for the development and expansion of maternal and 
infant health home visiting;
    (2) Projects to increase the participation of obstetricians and 
pediatricians in title V and title XIX programs;
    (3) Integrated maternal and child health service systems;
    (4) Maternal and child health centers operating under the direction 
of not-for-profit hospitals;
    (5) Rural maternal and child health programs; and
    (6) Outpatient and community based services for children with 
special health care needs.

[59 FR 36706, July 19, 1994]



Sec. 51a.6  What confidentiality requirements must be met?

    All information as to personal facts and circumstances obtained by 
the project's staff about recipients of services shall be held 
confidential, and shall not be disclosed without the individual's 
consent except as may be otherwise required by applicable law or as may 
be necessary to provide for medical audits by the Secretary with 
appropriate safeguards for confidentiality of patient records. 
Otherwise, information may be disclosed only in summary, statistical, or 
other form which does not identify particular individuals.



Sec. 51a.7  What other DHHS regulations apply?

    (a) Several other DHHS regulations apply to awards under this part. 
These include, but are not limited to:

42 CFR part 50--Policies of general applicability:
    subpart B--Sterilization of persons in federally assisted family 
planning projects.
    subpart C--Abortions and related medical services in federally 
assisted programs of the Public Health Service.
    subpart E--Maximum allowable cost for drugs.

45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Service--
Effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under Part 80 of 
this title.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.
45 CFR part 93--New restrictions on lobbying.

    (b) In addition to the above regulations, the following apply to 
projects funded through grants:

42 CFR part 50--Policies of general applicability:

[[Page 166]]

    subpart D--Public Health Service grant appeals procedure.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 74--Administration of grants to nonprofit organizations.
45 CFR part 75--Informal grant appeals procedures.
45 CFR part 92--Administration of grants to State and local governments.

[59 FR 36707, July 19, 1994]



Sec. 51a.8  What other conditions apply to these grants?

    (a) Recipients of project grants will be required to submit such 
additional information to the Secretary on an annual basis as the 
Secretary determines, including:
    (1) the number of individuals served or trained, as appropriate 
under the project;
    (2) a copy of any evaluation conducted by the recipient; and
    (3) a list of Healthy Children 2000 objectives addressed by the 
project and data on how the project contributed toward meeting the 
objectives.
    (b) The Secretary may at the time of award of project grants under 
this Part impose additional conditions, including conditions governing 
the use of information or consent forms, when, in the Secretary's 
judgment, they are necessary to advance the approved program, the 
interest of public health, or the conservation of grant funds.
    (c) Grant recipients of Healthy Tomorrows Partnership for Children 
Program, a Community Integrated Service System-funded initiative, must 
contribute non-Federal matching funds in years 2 through 5 of the 
project period equal to two times the amount of the Federal Grant Award 
or such lesser amount determined by the Secretary for good cause shown. 
Reimbursement for services provided to an individual under a State plan 
under Title XIX will not be deemed ``non-Federal matching funds'' for 
the purposes of this provision.

[59 FR 36707, July 19, 1994, as amended at 72 FR 3080, Jan. 24, 2007]



PART 51b_PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES--Table of Contents




                      Subpart A_General Provisions

Sec.
51b.101 To which programs do these regulations apply?
51b.102 Definitions.
51b.103 What are the general application requirements?
51b.104 Can personnel, supplies, and related items be provided in lieu 
          of cash?
51b.105 Which other HHS regulations apply to these grants?
51b.106 What other conditions apply to these grants?
51b.107 Is participation in preventive health service programs required 
          by these regulations?

          Subpart B_Grants for Childhood Immunization Programs

51b.201 To which programs does this subpart apply?
51b.202 Definitions.
51b.203 Who is eligible for a grant under this subpart?
51b.204 What information is required in the application?
51b.205 How will grant applications be evaluated and the grants awarded?
51b.206 How can grant funds be used?

Subpart C [Reserved]

         Subpart D_Grants for Venereal Disease Control Programs

51b.401 To which programs does this subpart apply?
51b.402 Definitions.
51b.403 Who is eligible for a grant under this subpart?
51b.404 What are the confidentiality requirements?
51b.405 What information is required in the application?
51b.406 How will grant applications be evaluated and the grants awarded?
51b.407 How can grant funds be used?

Subpart E [Reserved]

 Subpart F_Grants for Research, Demonstrations, and Public Information 
    and Education for the Prevention and Control of Venereal Disease

51b.601 To which programs does this subpart apply?
51b.602 Who is eligible for a grant under this subpart?
51b.603 What are the confidentiality requirements?

[[Page 167]]

51b.604 What information is required in the application?
51b.605 How will grant applications be evaluated and the grants awarded?
51b.606 How can grant funds be used?

    Authority: Secs. 317 and 318, Public Health Service Act, 92 Stat. 
3574 and 3582 (42 U.S.C. 247b, 247c); sec. 1743 Pub. L. 97-35, 95 Stat. 
763 (31 U.S.C. 1243 note).



                      Subpart A_General Provisions

    Source: 48 FR 4473, Feb. 1, 1983, unless otherwise noted.



Sec. 51b.101  To which programs do these regulations apply?

    The regulations in this part apply to grants for preventive health 
service programs authorized under section 317 (42 U.S.C. 247b) and for 
venereal disease prevention and control programs authorized under 
section 318 (42 U.S.C. 247c) of the Act.



Sec. 51b.102  Definitions.

    As used in these regulations:
    Act means the Public Health Service Act, as amended.
    Secretary means the Secretary of Health and Human Services (HHS) or 
any other officer or employee of that Department to whom the authority 
involved has been delegated.
    State means one of the 50 States, the District of Columbia, Guam, 
the Commonwealth of Puerto Rico, the Northern Mariana Islands, the 
Virgin Islands, American Samoa, and the Trust Territory of the Pacific 
Islands.



Sec. 51b.103  What are the general application requirements?

    (a) The project application shall contain a full description of the 
program objectives, plans, and activities. With respect to programs 
authorized by section 317 of the Act only, the application shall also 
provide, as the Secretary may require:
    (1) The amount of Federal, State, and other funds obligated by the 
applicant in its latest annual accounting period for the provision of 
such program.
    (2) A description of the services provided by the applicant for this 
accounting period covered under paragraph (a)(1) of this section.
    (3) The amount of Federal funds needed by the applicant to continue 
providing these services.
    (4) A description of any proposed changes in the provision of the 
services, reasons and priorities, and the amount of Federal funds needed 
by the applicant to make the changes.
    (b) The application shall contain evidence satisfactory to the 
Secretary that it has been submitted, as appropriate, for action to the 
planning agency designated by the Secretary under title XV of the Act 
(42 CFR parts 122 and 123). These grants are subject to the 
intergovernmental review of Federal programs of Executive Order 12372.
    (c) The application shall contain assurances that no one will be 
denied services because of inability to pay, and that the services are 
provided in a manner which preserves human dignity and maximizes 
acceptance.



Sec. 51b.104  Can personnel, supplies, and related items be provided in lieu 

of cash?

    The Secretary may reduce a grant by the amount of the fair market 
value of any supplies (including vaccines and other preventive agents) 
or equipment furnished a grant recipient when furnished at the request 
of the recipient. The Secretary also may reduce a grant by the amount of 
the pay, allowances, travel expenses, and any other costs in connection 
with the detail of any officer or employee of the Government to the 
recipient when the detail is at the request of the recipient. The amount 
the grant is reduced shall be available for payment by the Secretary of 
the costs incurred in furnishing the supplies or equipment or in 
detailing personnel and shall be deemed to have been paid to the 
recipient.



Sec. 51b.105  Which other HHS regulations apply to these grants?

    Several other HHS regulations apply to grants under this part. These 
include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants

[[Page 168]]

45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Debarment and suspension from eligibility for financial 
assistance
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[49 FR 38109, Sept. 27, 1984]



Sec. 51b.106  What other conditions apply to these grants?

    (a) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 2 to 
5 years.
    (b) For budgetary and funding purposes, the project period is 
generally divided into 12-month intervals called budget periods. A 
grantee must submit a separate application to have the support continued 
for each subsequent budget period after the initial award. Decisions 
regarding continuation awards and the funding level of such awards will 
be made after consideration of such factors as the grantee's progress 
and management practices and the availability of funds. In all cases, 
continuation awards require a determination by HHS that continued 
funding is in the best interest of the government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (d) Any funds granted pursuant to this subpart shall be expended 
solely for the purposes for which the funds were granted in accordance 
with the approved application and budget, the regulations of this part, 
the terms and conditions of the award, and the applicable cost 
principles prescribed in subpart Q of 45 CFR part 74.
    (e) The Secretary may, at the time of award, impose additional 
conditions, including conditions governing the use of information or 
consent forms, when, in the Secretary's judgment, they are necessary to 
advance the approved program, the interest of the public health, or the 
conservation of grant funds.



Sec. 51b.107  Is participation in preventive health service programs required 

by these regulations?

    Nothing in these regulations shall be construed to require any State 
or political subdivision to have a preventive health service program 
which would require any person who objects to treatment to be treated 
under the program.



          Subpart B_Grants for Childhood Immunization Programs

    Source: 44 FR 40501, July 11, 1979, unless otherwise noted.



Sec. 51b.201  To which programs does this subpart apply?

    The regulations in this subpart apply to the award of grants under 
section 317 of the Act for programs to immunize children against vaccine 
preventable diseases.



Sec. 51b.202  Definitions.

    As used in this subpart:
    Childhood immunization program means a preventive health service 
program to immunize children against vaccine preventable diseases 
including poliomyelitis, measles, mumps, rubella, diphtheria, pertussis, 
and tetanus.



Sec. 51b.203  Who is eligible for a grant under this subpart?

    An applicant must be a State agency or an agency of a political 
subdivision of a State which has legal responsibility for disease 
control under the laws of a State.

[[Page 169]]



Sec. 51b.204  What information is required in the application?

    (a) The initial application must cover the project period, and must 
include a description of the following:
    (1) The need for grant support.
    (2) The immediate (1 year budget period) and long-range (2-5 year 
project period) objectives of the project in specific and measurable 
terms.
    (3) Current immunization programs and the additional or intensified 
activities to be carried out to meet the objectives and priorities.
    (4) The following program elements should be included and described:
    (i) A plan to assure that children begin and complete their 
immunizations on schedule, including the use of a standard immunization 
record card, a provider-based tickler system (public and private) for 
the recall of children, and a hospital-based immunization education 
program for new mothers.
    (ii) Assessment of immunization status of school enterers, children 
attending licensed day-care centers, and children under 2 years of age 
and new enrollees under age 5 served in public clinics.
    (iii) A plan for surveillance of vaccine-preventable diseases that 
includes morbidity and mortality reporting as well as field and 
laboratory investigations.
    (iv) Procedures for prompt review of the data collected from the 
morbidity surveillance system to allow for immediate response to all 
occurrence of suspected diphtheria and polio cases upon notification and 
response to suspected measles cases within 48 hours.
    (v) A system for monitoring vaccine-associated reactions including a 
mechanism for responding to persons with vaccine-related complaints.
    (vi) A plan to systematically immunize susceptible children at 
school entry through vigorous enforcement of school immunization laws.
    (5) The manner in which the applicant intends to evaluate the 
project.
    (b) An application for a continuation grant must be submitted for 
each funding period. This continuation application must include the 
following:
    (1) A budget and justification for the grant funds requested.
    (2) A summary of the progress achieved during the previous budget 
period.
    (3) A description of any changes in the information shown in the 
project application.

[48 FR 4474, Feb. 1, 1983]



Sec. 51b.205  How will grant applications be evaluated and the grants awarded?

    (a) Within the limits of funds available, the Secretary may award a 
grant to assist in meeting part of the cost of a childhood immunization 
program. Grants will be awarded to those applicants whose projects he 
determines will best promote the purposes of section 317 of the Act. 
Before awarding a grant to a local public entity of a State, the 
Secretary will consult with the State health authority.
    (b) Priorities for funding will be based on the following factors:
    (1) The relative extent of the problems which are caused by one or 
more of the vaccine preventable diseases in the area served by the 
applicant.
    (2) The extent to which the proposed program is designed to 
eliminate or reduce the problems.
    (3) The extent to which the proposed program will increase the 
immunization rates in population groups identified as having the lowest 
immunity levels.
    (4) The extent to which the grantee will cooperate with and use 
public and nonprofit private entities and volunteers.
    (5) The extent to which a strong commitment to the objectives of the 
program is reflected in the commitment of grantee resources to the 
program.

[44 FR 40501, July 11, 1979, as amended at 48 FR 4475, Feb. 1, 1983]



Sec. 51b.206  How can grant funds be used?

    Grant funds awarded under this subpart may be used to purchase 
supplies, materials, and equipment for childhood immunization programs. 
Grant funds also may be used to pay for salaries or wages and related 
expenses for personnel directly involved in the planning, organization, 
promotion, epidemiology, surveillance, and other program activities.

[[Page 170]]

Subpart C [Reserved]



         Subpart D_Grants for Venereal Disease Control Programs

    Source: 48 FR 4475, Feb. 1, 1983, unless otherwise noted.



Sec. 51b.401  To which programs does this subpart apply?

    The regulations in this subpart apply to the award of project grants 
under section 318(c) of the Act for venereal disease prevention and 
control programs, and under section 318(b) of the Act with respect to 
public information and education activities which are integral to a 
balanced, comprehensive venereal disease control program.



Sec. 51b.402  Definitions.

    As used in this subpart:
    Venereal disease means gonorrhea, syphilis, or any other disease 
which can be sexually transmitted and which the Secretary determines is 
or may be amenable to control with assistance provided under this 
authority and which is of national significance.
    Venereal disease control program means a program designed to carry 
out activities or to provide services to systematically detect and 
prevent venereal disease as distinguished from those activities or 
services which are designed to diagnose or treat venereal disease 
patients or suspects.



Sec. 51b.403  Who is eligible for a grant under this subpart?

    An applicant must be a State agency or a political subdivision of a 
State which has legal responsibility for disease control under the laws 
of the State.



Sec. 51b.404  What are the confidentiality requirements?

    All information obtained by program personnel in connection with the 
examination, care, and treatment of an individual in this program shall 
be held confidential. It shall not be disclosed without the individual's 
consent except as may be required by the law of a State or political 
subdivision of a State or as may be necessary to provide services to the 
individual. Information may be disclosed in summary, statistical, or 
other form, or for clinical or research purposes, but only if the 
disclosure does not identify particular individuals.



Sec. 51b.405  What information is required in the application?

    (a) The initial application must include a description of the 
following:
    (1) The nature and extent of the venereal disease problem in the 
area.
    (2) The need for project grant support.
    (3) The immediate (1-year budget period) and long-range (2-5 year 
project period) objectives of the project in specific and measurable 
terms.
    (4) The activities to be carried out to meet the objectives. The 
following program elements must be included and described:
    (i) Venereal disease surveillance.
    (ii) Casefinding and case followup.
    (iii) Interstate epidemiologic referral and followup.
    (iv) Public venereal disease information and education.
    (v) Professional (including appropriate allied health personnel) 
venereal disease education, training, and clinical skills improvement 
activities, including efforts to assure high quality clinical services 
in public venereal disease clinics.
    (5) At the option of the applicant, special studies or 
demonstrations to evaluate or test venereal disease prevention and 
control strategies and activities.
    (6) The manner in which the applicant intends to conduct and 
evaluate the project, including a system for analysis of morbidity data 
so that control activities can be efficiently evaluated and targeted.
    (7) The diagnostic and treatment services that will be provided.
    (8) A budget and justification for the grant funds requested. Since 
public information and education activities are authorized separately 
from other control program activities, funds requested for this purpose 
must be itemized and justified separately in the narrative part of the 
application.

[[Page 171]]

    (b) An application for a continuation grant must be submitted for 
each funding period. This continuation application must include the 
following:
    (1) A budget and justification for the grant funds requested.
    (2) A summary of the progress achieved during the previous budget 
period.
    (3) A description of any changes in the information shown in the 
project application.



Sec. 51b.406  How will grant applications be evaluated and the grants awarded?

    (a) Within the limits of funds available, the Secretary may award a 
grant to assist in meeting the cost of a venereal disease control 
program. Before awarding a grant to a political subdivision of a State, 
the Secretary will consult with the State health authority.
    (b) Priorities for funding will be based on the following factors:
    (1) The relative extent of the venereal disease problem in the area 
served by the applicant.
    (2) The design of the venereal disease prevention and control 
program.
    (3) The general quality of the applicant's plan of operation and 
objectives in accordance with the requirements in these regulations. 
Emphasis will be placed on determining the extent to which services are 
coordinated among health care providers in the area served and 
integrated into a cohesive plan for delivery of service to groups having 
the highest incidence of venereal disease.
    (4) The capacity of the applicant to make effective use of Federal 
funds.
    (5) The commitment of the applicant to the control of venereal 
disease as reflected in the commitment of applicant resources to the 
program.



Sec. 51b.407  How can grant funds be used?

    Grant funds awarded under this subpart may be used only for programs 
approved under section 318(c), and with respect to public information 
and education, those programs approved under section 318(b) of the Act. 
Unless specifically approved, grant funds shall not be used for 
performing diagnostic tests (other than gonorrhea screening tests), 
maintaining central registries, purchasing data processing equipment, or 
providing diagnostic and treatment facilities and services. The 
applicant must provide assurances, however, that these services will be 
available as needed as an adjunct to control program activities 
supported with grant funds. To obtain special approval for grant support 
of such activities, the grantee shall justify the exception to the 
satisfaction of the Secretary that funds for this purpose are necessary 
for the proper conduct of the program and are otherwise unavailable. 
Support of these services will generally be approved only in the 
following situations:
    (a) Special studies or demonstrations, (b) the support of 
developmental or start-up activity, or (c) the support of an essential 
service which will result in a savings to a detection or prevention 
activity supported by the grant. Unless otherwise approved, exceptions 
based on paragraphs (b) and (c) of this section are only allowed during 
one funding period. The grantee is expected to support these activities 
in subsequent funding periods.

Subpart E [Reserved]



 Subpart F_Grants for Research, Demonstrations, and Public Information 

    and Education for the Prevention and Control of Venereal Disease

    Source: 48 FR 4476, Feb. 1, 1983, unless otherwise noted.



Sec. 51b.601  To which programs does this subpart apply?

    The regulations in this subpart apply to the award of venereal 
disease control project grants for research, demonstrations, public 
information, and education activities which can be applied to achieve 
improvements in venereal disease prevention and control under section 
318(b) of the Act.



Sec. 51b.602  Who is eligible for a grant under this subpart?

    An applicant must be a State, political subdivision of any State, or 
any other public or nonprofit private entity.

[[Page 172]]



Sec. 51b.603  What are the confidentiality requirements?

    All information obtained by program personnel in connection with the 
examination, care, and treatment of an individual in this program shall 
be held confidential. It shall not be disclosed without the individual's 
consent except as may be required by the law of a State, or political 
subdivision of a State, or as may be necessary to provide services to 
the individual. Information may be disclosed in summary, statistical, or 
other form, or for clinical or research purposes, but only if the 
disclosure does not identify particular individuals.



Sec. 51b.604  What information is required in the application?

    (a) The initial application must include a description of the 
following:
    (1) The setting and circumstances for which project grant support is 
being requested, including:
    (i) The immediate and long-range objectives of the project in 
specific and measurable terms.
    (ii) The activities which will be undertaken to accomplish the 
objectives, including the timing of these activities.
    (iii) The anticipated application of findings to the national 
venereal disease control effort.
    (iv) Any other information which will support the request for grant 
assistance.
    (2) The relationship between the planned activities and the project 
objectives. The application must describe in detail how the applicant 
intends to proceed, particularly if the project is unusually complex and 
several activities are interdependent or unprecedented.
    (3) A comprehensive and realistic plan which the applicant will use 
to evaluate the project. The plan must include periodic assessment of 
any possible impact, both positive and negative, that the proposed 
project might have upon the established venereal disease control program 
in the locality or localities in which the project will be undertaken.
    (b) An application for a continuation grant must be submitted for 
each funding period. This continuation application must include the 
following:
    (1) A budget and justification for the grant funds requested.
    (2) A summary of the progress achieved during the previous budget 
period.
    (3) A description of any changes in the information shown in the 
project application.



Sec. 51b.605  How will grant applications be evaluated and the grants awarded?

    (a) Within the limits of funds available, the Secretary may award a 
grant to assist in meeting the costs of special activities authorized 
under section 318(b) of the Act.
    (b) Grant applications will be reviewed and evaluated according to 
the following criteria:
    (1) Is there adequate evidence that the proposed project is needed 
and that the outcome has potential to directly benefit the national 
venereal disease control effort?
    (2) Are the project objectives specific, measurable, realistic, time 
phased, and related to promoting the purposes of section 318?
    (3) Is the method of operation logical and clearly related to 
project objectives, and does it describe how the applicant intends to 
proceed particularly with activities which are complex, interrelated, or 
unprecedented?
    (4) Does the method of operation include an assessment of any 
possible impact, both positive and negative, that the conduct of the 
proposed initiative might have upon the established venereal disease 
control program in the locality or localities in which the project will 
be undertaken?
    (5) Does the proposal include a comprehensive and realistic plan for 
the evaluation of the project, and specify the measures and instruments 
of measurement to be used?
    (6) Is the budget request reasonable and consistent with the 
intended use of grant funds?
    (7) If the applicant intends only to evaluate an existing disease 
prevention and control approach, are the objectives substantially 
different from those which could be met by routine program evaluation?

[[Page 173]]



Sec. 51b.606  How can grant funds be used?

    (a) Grant funds may be used for the costs associated with planning, 
organizing, and conducting applied research, demonstrations, and public 
information and education programs.
    (b) Grant funds may also be used to reimburse individuals who agree 
to be participants in the applied research projects. This reimbursement, 
however, must be justified as necessary and reasonable. A schedule of 
reimbursements must be submitted with the application and approved as 
part of the program plan.
    (c) Grant funds may not be used to supplant funds supporting 
existing venereal disease control services provided by a State or 
locality.



PART 51c_GRANTS FOR COMMUNITY HEALTH SERVICES--Table of Contents




                      Subpart A_General Provisions

Sec.
51c.101 Applicability.
51c.102 Definitions.
51c.103 Eligibility.
51c.104 Application.
51c.105 Accord with health planning.
51c.106 Amount of grant.
51c.107 Use of project funds.
51c.108 Grant payments.
51c.109 Nondiscrimination.
51c.110 Confidentiality.
51c.111 Publications and copyright.
51c.112 Grantee accountability.
51c.113 Applicability of 45 CFR part 74.

  Subpart B_Grants for Planning and Developing Community Health Centers

51c.201 Applicability.
51c.202 Application.
51c.203 Project elements.
51c.204 Grant evaluation and award.

         Subpart C_Grants for Operating Community Health Centers

51c.301 Applicability.
51c.302 Application.
51c.303 Project elements.
51c.304 Governing board.
51c.305 Grant evaluation and award.

        Subpart D_Grants for Operating Community Health Projects

51c.401 Applicability.
51c.402 Application.
51c.403 Project elements.
51c.404 Grant evaluation and award.

      Subpart E_Acquisition and Modernization of Existing Buildings

51c.501 Applicability.
51c.502 Definitions.
51c.503 Application.
51c.504 Project elements.
51c.505 Determination of cost.
51c.506 Use of grant funds.
51c.507 Facility which has previously received Federal grant.

    Authority: Sec. 330, Public Health Service Act, 89 Stat. 342, (42 
U.S.C. 254c); sec. 215, Public Health Service Act, 58 Stat. 690, (42 
U.S.C. 216).

    Source: 41 FR 53205, Dec. 3, 1976, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 51c.101  Applicability.

    The regulations of this subpart are applicable to all project grants 
authorized by section 330 of the Public Health Service Act (42 U.S.C. 
254c).



Sec. 51c.102  Definitions.

    As used in this part:
    (a) Act means the Public Health Service Act.
    (b) Catchment area means the area served by a project funded under 
section 330 of the Act.
    (c)(1) Community health center or center means an entity which, 
through its staff and supporting resources or through contracts or 
cooperative arrangements with other public or private entities, provides 
for all residents of its catchment area:
    (i) Primary health services;
    (ii) As determined by the Secretary to be appropriate for particular 
centers, supplemental health services necessary for the adequate support 
of primary health services;
    (iii) Referral to providers of supplemental health services and 
payment, as determined by the Secretary to be appropriate and feasible, 
for their provision of such services;
    (iv) Environmental health services, as determined by the Secretary 
to be appropriate for particular centers; and
    (v) Information on the availability and proper use of health 
services.
    (2) For purposes of paragraph (c)(1) of this section, the provision 
of a given

[[Page 174]]

service by a center will be determined by the Secretary to be 
appropriate where:
    (i) There is a need, as determined by the Secretary, for the 
provision of such service in the catchment area; and
    (ii) The provision of such service by the center is feasible, taking 
into consideration the center's projected revenues, other resources, and 
grant support under this part.
    (d) Environmental health services means the detection and 
alleviation of unhealthful conditions of the environment of the 
catchment area, such as problems associated with water supply, sewage 
treatment, solid waste disposal, rodent and parasite infestation, and 
housing conditions. For the purposes of this part, the detection and 
alleviation of unhealthful conditions of the environment includes the 
notification of and making of arrangements with appropriate Federal, 
State, or local authorities responsible for correcting such conditions.
    (e) Medically underserved population means the population of an 
urban or rural area designated by the Secretary as an area with a 
shortage of personal health services or a population group designated by 
the Secretary as having a shortage of such services. Medically 
underserved areas will be designated by the Secretary and a list of 
those designated will be published in the Federal Register from time to 
time, taking into consideration the following factors, among others:
    (1) Available health resources in relation to size of the area and 
its population, including appropriate ratios of primary care physicians 
in general or family practice, internal medicine, pediatrics, or 
obstetrics and gynecology to population;
    (2) Health indices for the population of the area, such as infant 
mortality rate;
    (3) Economic factors affecting the population's access to health 
services, such as percentage of the population with incomes below the 
poverty level; and
    (4) Demographic factors affecting the population's need and demand 
for health services, such as percentage of the population age 65 and 
over.
    (f) Nonprofit, as applied to any private agency, institution, or 
organization, means one which is a corporation or association, or is 
owned and operated by one or more corporations or associations, no part 
of the net earnings of which inures, or may lawfully inure, to the 
benefit of any private shareholder or individual.
    (g) Physician means a licensed doctor of medicine or doctor of 
osteopathy.
    (h) Primary health services means:
    (1) Diagnostic, treatment, consultative, referral, and other 
services rendered by physicians, and, where feasible, by physician's 
extenders, such as physicians' assistants, nurse clinicians, and nurse 
practitioners;
    (2) Diagnostic laboratory services and diagnostic radiologic 
services;
    (3) Preventive health services, including medical social services, 
nutritional assessment and referral, preventive health education, 
children's eye and ear examinations, prenatal and post-partum care, 
prenatal services, well child care (including periodic screening), 
immunizations, and voluntary family planning services;
    (4) Emergency medical services, including provision, through clearly 
defined arrangements, for access of users of the center to health care 
for medical emergencies during and after the center's regularly 
scheduled hours;
    (5) Transportation services as needed for adequate patient care, 
sufficient so that residents of the catchment area served by the center 
with special difficulties of access to services provided by the center 
receive such services; and
    (6) Preventive dental services provided by a licensed dentist or 
other qualified personnel, including (i) oral hygiene instruction; (ii) 
oral prophylaxis, as necessary; and (iii) topical application of 
fluorides, and the prescription of fluorides for systemic use when not 
available in the community water supply.
    (i) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (j) Supplemental health services means health services which are not 
included

[[Page 175]]

as primary health services and which are:
    (1) Inpatient and outpatient hospital services;
    (2) Home health services;
    (3) Extended care facility services;
    (4) Rehabilitative services (including physical and occupational 
therapy) and long-term physical medicine;
    (5) Mental health services, including services of psychiatrists, 
psychologists, and other appropriate mental health professionals;
    (6) Dental services other than those provided as primary health 
services;
    (7) Vision services, including routine eye and vision examinations 
and provision of eyeglasses, as appropriate and feasible;
    (8) Allied health services;
    (9) Pharmaceutical services, including the provision of prescription 
drugs;
    (10) Therapeutic radiologic services;
    (11) Public health services (including nutrition education and 
social services);
    (12) Ambulatory surgical services;
    (13) Health education services; and
    (14) Services, including the services of outreach workers, which 
promote and facilitate optimal use of primary health services and 
services referred to in the preceding subparagraphs of this paragraph 
and, if a substantial number of individuals in the population served by 
the center are of limited English-speaking ability, the services of 
outreach workers and other personnel fluent in the language or languages 
spoken by such individuals.



Sec. 51c.103  Eligibility.

    Any public or nonprofit private entity is eligible to apply for a 
grant under this part.



Sec. 51c.104  Application.

    (a) An application for a grant under this part shall be submitted to 
the Secretary at such time and in such form and manner as the Secretary 
may prescribe.
    (b) The application shall contain a budget and narrative plan of the 
manner in which the applicant intends to conduct the project and carry 
out the requirements of this part. The application must describe how and 
the extent to which the project has met, or plans to meet, each of the 
requirements in subpart B (relating to grants for planning and 
developing community health centers), subpart C (relating to grants for 
the operation of community health centers), or subpart D (relating to 
grants for the operation of community health projects), as applicable. 
In addition, applications must include:
    (1) A statement of specific, measurable objectives and the methods 
to be used to assess the achievement of the objectives in specified time 
periods and at least on an annual basis.
    (2) The precise boundaries of the catchment area to be served by the 
applicant, including an identification of the medically underserved 
population or populations within the catchment area. In addition, the 
application shall include information sufficient to enable the Secretary 
to determine that the applicant's catchment area meets the following 
criteria:
    (i) The size of such area is such that the services to be provided 
by the applicant are available and accessible to the residents of the 
area promptly and as appropriate;
    (ii) The boundaries of such area conform, to the extent practicable, 
to relevant boundaries of political subdivisions, school districts, and 
areas served by Federal and State health and social service programs; 
and
    (iii) The boundaries of such area eliminate, to the extent possible, 
barriers resulting from the area's physical characteristics, its 
residential patterns, its economic and social groupings, and available 
transportation.
    (3) The results of an assessment of the need that the population 
served or proposed to be served has for the services to be provided by 
the project (or in the case of applications for planning and development 
projects, the methods to be used in assessing such need), utilizing, but 
not limited to, the factors set forth in Sec. 51c.102(e)(1)-(4).
    (4) Position descriptions for key personnel who will be utilized in 
carrying out the activities of the project and a statement indicating 
the need for the positions to be supported with grant funds to 
accomplish the objectives of the project.

[[Page 176]]

    (5) Letters and other forms of evidence showing that efforts have 
been made to secure financial and professional assistance and support 
for the project within the proposed catchment area and the continuing 
involvement of the community in the development and operation of the 
project.
    (6) An assurance that an independent certified public accountant, or 
a public accountant licensed before December 31, 1970, will be engaged 
to certify that the system for the management and control of its 
financial assets will be in accord with sound financial management 
practices, including applicable Federal requirements.
    (7) A list of all services proposed to be provided by the project.
    (8) A list of services which are to be provided directly by the 
project through its own staff and resources and a description of any 
contractual or other arrangements (including copies of documents, where 
available) entered into, or planned for the provision of services.
    (9) The schedule of fees and/or payments and schedule of discounts 
for services provided by the project.
    (10) Evidence that all applicable requirements for review and/or 
approval of the application under title XV of the Act have been met.
    (11) An assurance that the project will be conducted in accordance 
with the applicable requirements of this part.
    (c) The application must be executed by an individual authorized to 
act for the applicant and to assume on behalf of the applicant the 
obligations imposed by the statute, the applicable regulations of this 
part, and any additional conditions of the grant.

(Sec. 330, Public Health Service Act, 89 Stat. 342, (42 U.S.C. 254c); 
sec. 215, Public Health Service Act, 58 Stat. 690, 67 Stat. 63 (42 
U.S.C. 216))

[41 FR 53205, Dec. 3, 1976, as amended at 48 FR 29201, June 24, 1983; 48 
FR 45558, Oct. 6, 1983]



Sec. 51c.105  Accord with health planning.

    A grant may be made under this part only if the applicable 
requirements of title XV of the Act relating to review and approval by 
the appropriate health planning agencies have been met.



Sec. 51c.106  Amount of grant.

    (a) The amount of any award under this part will be determined by 
the Secretary on the basis of his estimate of the sum necessary for a 
designated portion of direct project costs plus an additional amount for 
indirect costs, if any, which will be calculated by the Secretary 
either:
    (1) On the basis of the estimate of the actual indirect costs 
reasonably related to the project; or
    (2) On the basis of a percentage of all, or a portion of, the 
estimated direct costs of the project when there are reasonable 
assurances that the use of such percentage will not exceed the 
approximate actual indirect costs. Such award may include an estimated 
provisional amount for indirect costs or for designated direct costs 
(such as fringe benefit rates) subject to upward (within the limits of 
available funds) as well as downward adjustments to actual costs when 
the amount properly expended by the grantee for provisional items has 
been determined by the Secretary: Provided, however, That no grant shall 
be made for an amount in excess of the total cost found necessary by the 
Secretary to carry out the project.
    (i) In determining the percentage of project costs to be borne by 
the grantee, factors which the Secretary will take into consideration 
will include the following:
    (A) The ability of the grantee to finance its share of project costs 
from non-Federal sources;
    (B) The need in the area served by the project for the services to 
be provided; and
    (C) The extent to which the project will provide services in an 
innovative manner which the Secretary desires to stimulate in the 
interest of developing more effective health service delivery systems on 
a regional or national basis.
    (ii) At any time after approval of an application under this part, 
the Secretary may retroactively agree to a percentage of project costs 
to be borne by the grantee lower than that determined pursuant to 
paragraph (a)(2)(i) of this section where he finds that changed 
circumstances justify a smaller contribution.

[[Page 177]]

    (iii) In determining the grantee's share of project costs, costs 
borne by Federal grant funds, or costs used to match other Federal 
grants, may not be included except as otherwise provided by law or 
regulations.
    (b) All grant awards shall be in writing, and shall set forth the 
amount of funds granted and the period for which support is recommended.
    (c) Neither the approval of any project nor any grant award shall 
commit or obligate the United States in any way to make any additional, 
supplemental, continuation, or other award with respect to any approved 
project or portion thereof. For continuation support, grantees must make 
separate application.



Sec. 51c.107  Use of project funds.

    (a) Any funds granted pursuant to this part, as well as other funds 
to be used in performance of the approved project, may be expended 
solely for carrying out the approved project in accordance with section 
330 of the Act, the applicable regulations of this part, the terms and 
conditions of the award, and the applicable cost principles prescribed 
in subpart Q of 45 CFR part 74.
    (b) Project funds awarded under this part may be used for, but need 
not be limited to, the following:
    (1) The costs of acquiring and modernizing existing buildings 
(including the costs of amortizing the principal of, and paying interest 
on, loans), but only in accordance with subpart E of this part and as 
approved in the grant award;
    (2) The costs of obtaining technical assistance to develop and 
improve the management capability of the project, but only as approved 
by the Secretary;
    (3) The reimbursement of members of the grantee's governing board, 
if any, for reasonable expenses actually incurred by reason of their 
participation in board activities;
    (4) The reimbursement of governing board members for wages lost by 
reason of participation in the activities of such board if the member is 
from a family with an annual family income below $10,000 or if the 
member is a single person with an annual income below $7,000;
    (5) The cost of delivering health services, including services 
rendered on a prepaid capitation basis, to residents of the project's 
catchment area within the following limitations: grant funds may be used 
to pay the full cost of project services to individuals and families 
with annual incomes at or below those set forth in the most recent ``CSA 
Income Poverty Guidelines'' (45 CFR 1060.2) issued by the Community 
Services Administration; and to pay the portion of the cost of services 
provided in accordance with the schedule of discounts which, under such 
schedule, is uncompensated; Provided, That (i) charges will be made to 
such individuals and families in accordance with Sec. 51c.303(f) of 
subpart C; (ii) reasonable effort shall be made to collect such charges 
under a billing and collections system; and (iii) the charge to grant 
funds shall exclude any amounts collected pursuant to paragraph 
(b)(5)(ii) of this section;
    (6) The cost of insurance for medical emergency and out-of-area 
coverage;
    (7) The cost of providing to the staff of the project training 
related to the provision of health services provided or to be provided 
by the project, and, to the staff and governing board, if any, training 
related to the management of an ambulatory care facility, consistent 
with the applicable requirements of 45 CFR part 74; and
    (8) The cost of developing and maintaining a reserve fund where 
required by State law for prepaid health care plans.
    (c) Prior approval by the Secretary of revisions of the budget and 
project plan is required whenever there is to be a significant change in 
the scope or nature of project activities.



Sec. 51c.108  Grant payments.

    The Secretary shall from time to time make payments to a grantee of 
all or a portion of any grant award, either in advance or by way of 
reimbursement for expenses incurred or to be incurred, to the extent he 
determines such payments necessary to promote prompt initiation and 
advancement of the approved project.

[[Page 178]]



Sec. 51c.109  Nondiscrimination.

    (a) Attention is called to the requirements of title VI of the Civil 
Rights Act of 1964 (78 Stat. 252, (42 U.S.C. 2000d et seq.)) and in 
particular section 601 of such Act which provides that no person in the 
United States shall on the grounds of race, color, or national origin be 
excluded from participation, in be denied the benefits of, or be 
subjected to discrimination under any program or activity receiving 
Federal Financial assistance. A regulation implementing such title VI, 
which applies to grants made under this part, has been issued by the 
Secretary of Health and Human Services with the approval of the 
President (45 CFR part 80). In addition, no person shall, on the grounds 
of age, sex, creed, or marital status (unless otherwise medically 
indicated), be excluded from participation in, be denied the benefits 
of, or be subjected to discrimination under any program or activity so 
receiving Federal financial assistance.
    (b) Attention is called to the requirements of section 504 of the 
Rehabilitation Act of 1973, as amended, which provides that no otherwise 
qualified handicapped individual in the United States shall, solely by 
reason of his handicap, be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance.



Sec. 51c.110  Confidentiality.

    All information as to personal facts and circumstances obtained by 
the project staff about recipients of services shall be held 
confidential, and shall not be divulged without the individual's consent 
except as may be required by law or as may be necessary to provide 
service to the individual or to provide for medical audits by the 
Secretary or his designee with appropriate safeguards for 
confidentiality of patient records. Otherwise, information may be 
disclosed only in summary, statistical, or other form which does not 
identify particular individuals.



Sec. 51c.111  Publications and copyright.

    Except as may otherwise be provided under the terms and conditions 
of the award, the grantee may copyright without prior approval any 
publications, films, or similar materials developed or resulting from a 
project supported by a grant under this part, subject, however, to a 
royalty-free, nonexclusive, and irrevocable license or right in the 
Government to reproduce, translate, publish, use, disseminate, and 
dispose of such materials and to authorize others to do so.



Sec. 51c.112  Grantee accountability.

    (a) Accounting for grant award payments. All payments made by the 
Secretary shall be recorded by the grantee in accounting records 
separate from the records of all other funds, including funds derived 
from other grant awards. With respect to each approved project, the 
grantee shall account for the sum total of all amounts paid as well as 
other funds and in-kind contributions by presenting or otherwise making 
available evidence satisfactory to the Secretary of expenditure for 
direct and indirect costs meeting the requirements of this part: 
Provided, however, That when the amount awarded for indirect costs was 
based on a predetermined fixed-percentage of estimated direct costs, the 
amount allowed for indirect costs shall be computed on the basis of such 
predetermined fixed-percentage rates applied to the total, or a selected 
element thereof, of the reimbursable direct costs incurred.
    (b) Accounting for interest earned on grant funds. Pursuant to 
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 
4213), a State will not be held accountable for interest earned on grant 
funds, pending their disbursement for grant purposes. A State, as 
defined in section 102 of the Intergovernmental Cooperation Act, means 
any one of the several States, the District of Columbia, Puerto Rico, 
any territory or possession of the United States, or any agency or 
instrumentality of a State, but does not include the government of the 
political subdivisions of the State. All grantees other than a State, as 
defined, must return all interest earned on grant funds to the Federal 
Government.
    (c) Grant closeout--(1) Date of final accounting. A grantee shall 
render, with respect to each approved project, a full

[[Page 179]]

account, as provided herein, as of the date of the termination of grant 
support. The Secretary may require other special and periodic 
accounting.
    (2) Final settlement. There shall be payable to the Federal 
Government as final settlement with respect to each approved project the 
total sum of:
    (i) Any amount not accounted for pursuant to paragraph (a) of this 
section;
    (ii) Any credits for earned interest pursuant to paragraph (b) of 
this section;
    (iii) Any other amounts due pursuant to subparts F, M, and O of 45 
CFR part 74.



Sec. 51c.113  Applicability of 45 CFR part 74.

    The provisions of 45 CFR part 74, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part to State and local governments as those terms are 
defined in subpart A of that part 74. The relevant provisions of the 
following subparts of part 74 shall also apply to grants to all other 
grantee organizations under this part:

                             45 CFR Part 74

Subpart
A General.
B Cash depositories.
C Bonding and insurance.
D Retention and custodial requirements for records.
F Grant-related income.
G Matching and cost sharing.
K Grant payment requirements.
L Budget revision procedures.
M Grant closeout, suspension, and termination.
O Property.
Q Cost principles.



  Subpart B_Grants for Planning and Developing Community Health Centers



Sec. 51c.201  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 330(c) of the Act for projects for planning and developing 
community health centers which will serve medically underserved 
populations.



Sec. 51c.202  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec. 
51c.104 of subpart A, contain information sufficient to enable the 
Secretary to determine that the project for which the grant is sought 
will meet the requirements of Sec. 51c.203.



Sec. 51c.203  Project elements.

    A project for the planning and developing of a community health 
center supported under this subpart must:
    (a) Prepare an assessment of the need of the population proposed to 
be served by the community health center for the services set forth in 
Sec. 51c.102(c)(1) of subpart A, with special attention to the need of 
the medically underserved population for such services. Such assessment 
of need shall, at a minimum, consider the factors listed in Sec. 
51c.102(e)(1)-(4).
    (b) Design a community health center program for such population, 
based on such assessment, which indicates in detail how the proposed 
community health center will fulfill the needs identified in the 
assessment prepared pursuant to paragraph (a) of this section and how it 
will meet the requirements contained in subpart C of this part.
    (c) Develop a plan for the implementation of the program designed 
pursuant to paragraph (b) of this section. Such implementation plan 
shall provide for the time-phased recruitment and training of the 
personnel essential for the operation of a community health center and 
the gradual assumption of operational status of the project so that the 
project will, in the judgment of the Secretary, meet the requirements 
contained in subpart C of this part as of the end of the project period.
    (d) Implement the plan developed pursuant to paragraph (c) of this 
section in accordance with such paragraph.
    (e) Make efforts to secure, within the proposed catchment area of 
such center to the extent possible, financial and professional 
assistance and support for the project.

[[Page 180]]

    (f) Initiate and encourage continuing community involvement in the 
development and operation of the project.
    (g) Establish standards and qualifications for personnel (including 
the project director).
    (h) Utilize, to the maximum extent feasible, other Federal, State, 
local, and private resources available for support of the project, prior 
to use of project funds under this subpart.



Sec. 51c.204  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which will, in his judgment, best promote 
the purposes of section 330(c) of the Act and the applicable regulations 
of this part, taking into account:
    (1) The degree to which the proposed project satisfactorily provides 
for the elements set forth in Sec. 51c.203;
    (2) The relative need of the population to be served for the 
services to be provided;
    (3) The administrative and management capability of the applicant;
    (4) The potential of the project for development of new and 
effective methods for health services delivery and management;
    (5) The soundness of the fiscal plan for assuring effective 
utilization of grant funds and maximizing non-grant revenue;
    (6) The extent to which community resources will be utilized in the 
project;
    (7) The extent to which grants approved under this part will provide 
for an appropriate distribution of resources throughout the country, 
taking into consideration the following factors;
    (i) The urban-rural area to be served;
    (ii) The nature of the organization applying; and
    (iii) The organizational structure for delivery of services;
    (8) Whether the project's catchment area is exclusive of the area 
served by a community health center;
    (9) The degree to which the applicant intends to integrate services 
supported by a grant under this subpart with health services provided 
under other Federally assisted health services or reimbursement programs 
or projects.
    (b) The Secretary may:
    (1) Make no more than two grants under this subpart for the same 
project.
    (2) Make a grant under this subpart to an entity which has been 
awarded one or more grants under section 330(d)(1)(A) and/or section 
330(d)(1)(B) of the Act only if the grant under this subpart is for a 
new project.



         Subpart C_Grants for Operating Community Health Centers



Sec. 51c.301  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A, are applicable to grants awarded pursuant to section 
330(d)(1)(A) of the Act for the costs of operation of community health 
centers which serve medically underserved populations.



Sec. 51c.302  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec. 
51c.104 of subpart A,
    (a) Be submitted by an entity which may be a co-applicant which the 
Secretary determines is a community health center, and
    (b) Contain information sufficient to enable the Secretary to 
determine that the center will meet the requirements of Sec. 51c.103.

[41 FR 53205, Dec. 3, 1976, as amended at 42 FR 60418, Nov. 25, 1977]



Sec. 51c.303  Project elements.

    A community health center supported under this subpart must:
    (a) Provide the health services of the center so that such services 
are available and accessible promptly, as appropriate, and in a manner 
which will assure continuity of service to the residents of the center's 
catchment area.
    (b) Implement a system for maintaining the confidentiality of 
patient records in accordance with the requirements of Sec. 51c.110 of 
subpart A.
    (c) Have an ongoing quality assurance program which provides for the 
following:

[[Page 181]]

    (1) Organizational arrangements, including a focus of 
responsibility, to support the quality assurance program and the 
provision of high quality patient care;
    (2) Periodic assessment of the appropriateness of the utilization of 
services and the quality of services provided or proposed to be provided 
to individuals served by the center. Such assessments shall:
    (i) Be conducted by physicians or by other licensed health 
professionals under the supervision of physicians;
    (ii) Be based on the systematic collection and evaluation of patient 
records; and
    (iii) Identify and document the necessity for change in the 
provision of services by the center and result in the institution of 
such change, where indicated.
    (d) Develop management and control systems which are in accordance 
with sound financial management procedures, including the provision for 
an audit on an annual basis (unless waived for cause by the Secretary) 
by an independent certified public accountant or a public accountant 
licensed prior to December 31, 1970, to determine, at a minimum, the 
fiscal integrity of grant financial transactions and reports, and 
compliance with the regulations of this part and the terms and 
conditions of the grant.
    (e) Where the cost of care and services furnished by or through the 
project is to be reimbursed under title XIX or title XX of the Social 
Security Act, obtain or make every reasonable effort to obtain a written 
agreement with the title XIX or title XX State agency for such 
reimbursement.
    (f) Have prepared a schedule of fees or payments for the provision 
of its services designed to cover its reasonable costs of operation and 
a corresponding schedule of discounts adjusted on the basis of the 
patient's ability to pay. Provided, That such schedule of discounts 
shall provide for a full discount to individuals and families with 
annual incomes at or below those set forth in the most recent CSA 
Proverty Income Guidelines (45 CFR 1060.2) and for no discount to 
individuals and families with annual incomes greater than twice those 
set forth in such Guidelines, except that nominal fees for services may 
be collected from individuals with annual incomes at or below such 
levels where imposition of such fees is consistent with project goals.
    (g) Make every reasonable effort, including the establishment of 
systems for eligibility determination, billing, and collection, to:
    (1) Collect reimbursement for its costs in providing health services 
to persons who are entitled to insurance benefits under title XVIII of 
the Social Security Act, to medical assistance under a State plan 
approved under title XIX of such Act, to social services and family 
planning under title XX of such Act, or to assistance for medical 
expenses under any other public assistance program, grant program, or 
private health insurance or benefit program on the basis of the schedule 
of fees prepared pursuant to paragraph (f) of this section without 
application of any discounts, and
    (2) Secure from patients payments for services in accordance with 
the schedule of fees and discounts required by paragraph (f) of this 
section.
    (h) Have a governing board which meets the requirements of Sec. 
51c.304.
    (i) Have developed an overall plan and budget for the center that:
    (1) Provides for an annual operating budget and a three-year 
financial management plan which include all anticipated income and 
expenses related to items which would, under generally accepted 
accounting principles, be considered income and expense items;
    (2) Provides for a capital expenditures plan for at least a three-
year period (including the year to which the operating budget described 
in paragraph (i)(1) of this section is applicable) which includes and 
identifies in detail the anticipated sources of financing for, and the 
objective of, each anticipated expenditure in excess of $100,000 related 
to the acquisition of land, the improvement of land, buildings, and 
equipment and the replacement, modernization and expansion of buildings 
and equipment which would, under generally accepted accounting 
principles, be considered capital items;
    (3) Provides for plan review and updating at least annually; and

[[Page 182]]

    (4) Is prepared under the direction of the governing board, by a 
committee consisting of representatives of the governing board, and 
administrative staff, and the medical staff, if any, of the center.
    (j) Establish basic statistical data, cost accounting, management 
information, and reporting or monitoring systems which shall enable the 
center to provide such statistics and other information as the Secretary 
may reasonably require relating to the center's costs of operation, 
patterns of utilization of services, and the availability, 
accessibility, and acceptability of its services and to make such 
reports to the Secretary in a timely manner with such frequency as the 
Secretary may reasonably require.
    (k) Review its catchment area annually to insure that the criteria 
set out in Sec. 51c.104(b)(2) of subpart A are met and, where such 
criteria are not met, revise its catchment area, with the approval of 
the Secretary, to conform to such criteria to the extent feasible.
    (l) In the case of a center which serves a population including a 
substantial proportion of individuals of limited English-speaking 
ability, have developed a plan and made arrangements responsive to the 
needs of such populations for providing services to the extent 
practicable in the language and cultural context most appropriate to 
such individuals, and have identified an individual on its staff who is 
fluent in both that language and in English and whose responsibilities 
include providing guidance to such individuals and to appropriate staff 
members with respect to cultural sensitivities and bridging linguistic 
and cultural differences. If more than one non-English language is 
spoken by such group or groups, an individual or individuals fluent in 
those languages and English shall be so identified.
    (m) Be operated in a manner calculated to preserve human dignity and 
to maximize acceptability and effective utilization of services.
    (n) To the extent possible, coordinate and integrate project 
activities with the activities of other Federally funded, as well as 
State and local, health services delivery projects and programs serving 
the same population.
    (o) Establish means for evaluating progress toward the achievement 
of the specific objectives of the project.
    (p) Provide sufficient staff, qualified by training and experience, 
to carry out the activities of the center.
    (q) Assure that facilities utilized in the performance of the 
project meet applicable fire and life safety codes.
    (r) Utilize, to the maximum extent feasible, other Federal, State, 
and local, and private resources available for support of the project, 
prior to use of project funds under this part.
    (s) Provide for community participation through, for example, 
contributions of cash or services, loans of full-or part-time staff, 
equipment, space, materials, or facilities.
    (t) Where the center will provide services through contract or other 
cooperative arrangements with other providers of services, establish 
rates and methods of payment for health care. Such payments must be made 
pursuant to agreements, with a schedule of rates and payment procedures 
maintained by the project. The project must be prepared to substantiate 
that such rates are reasonable and necessary.
    (u) Operate in a manner such that no person shall be denied service 
by reason of his inability to pay therefor: Provided, however, That a 
charge for the provision of services will be made to the extent that a 
third party (including a Government agency) is authorized or is under 
legal obligation to pay such charges.
    (v) In addition to the above, projects which are supported with 
grant funds for the operation of a prepaid health care plan also must 
provide:
    (1) A marketing and enrollment plan, including market analysis, 
marketing strategy, and enrollment growth projections.
    (2) A plan that provides for funding on a capitation basis of such 
portion of the residents of the catchment area of the center, as the 
Secretary shall determine.
    (3) An assurance that services shall be available to all residents 
of the catchment area without regard to method of payment or health 
status.

[[Page 183]]



Sec. 51c.304  Governing board.

    A governing board for the center shall be established by an 
applicant as follows:
    (a) Size. The board shall consist of at least 9 but not more than 25 
members, except that this requirement may be waived by the Secretary for 
good cause shown.
    (b) Composition. (1) A majority of the board members shall be 
individuals who are or will be served by the center and who, as a group, 
represent the individuals being or to be served in terms of demographic 
factors, such as race, ethnicity, sex.
    (2) No more than one-half of the remaining members of the board may 
be individuals who derive more than 10 percent of their annual income 
from the health care industry.
    (3) The remaining members of the board shall be representative of 
the community in which the center's catchment area is located and shall 
be selected for their expertise in community affairs, local government, 
finance and banking, legal affairs, trade unions, and other commercial 
and industrial concerns, or social service agencies within the 
community.
    (4) No member of the board shall be an employee of the center, or 
spouse or child, parent, brother or sister by blood or marriage of such 
an employee. The project director may be a non-voting, ex-officio member 
of the board.
    (c) Selection of members. The method of selection of all governing 
board members shall be prescribed in the by-laws or other internal 
governing rules of the center. Such by-laws or other rules must specify 
a process of selection of individuals on the governing board who 
represent the population served or to be served by the center so that 
such individuals, as a group, are representative of such population. 
Such process of selection in the by-laws or other rules is subject to 
approval by the Secretary.
    (d) Functions and responsibilities. (1) The governing board for the 
center shall have authority for the establishment of policy in the 
conduct of the center.
    (2) The governing board shall hold regularly scheduled meetings, at 
least once each month, for which minutes shall be kept.
    (3) The governing board shall have specific responsibility for:
    (i) Approval for the selection and dismissal of a project director 
or chief executive officer of the center;
    (ii) Establishing personnel policies and procedures, including 
selection and dismissal procedures, salary and benefit scales, employee 
grievance procedures, and equal opportunity practices;
    (iii) Adopting policy for financial management practices, including 
a system to assure accountability for center resources, approval of the 
annual project budget, center priorities, eligibility for services 
including criteria for partial payment schedules, and long-range 
financial planning;
    (iv) Evaluating center activities including services utilization 
patterns, productivity of the center, patient satisfaction, achievement 
of project objectives, and development of a process for hearing and 
resolving patient grievances;
    (v) Assuring that the center is operated in compliance with 
applicable Federal, State, and local laws and regulations; and
    (vi) Adopting health care policies including scope and availability 
of services, location and hours of services, and quality-of-care audit 
procedures.



Sec. 51c.305  Grant evaluation and award.

    Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which will, in his judgment, best promote 
the purposes of section 330(d)(1)(A) of the Act and the applicable 
regulations of this part, taking into consideration;
    (a) The extent to which the project would provide for the elements 
set forth in Sec. 51c.303;
    (b) The relative need of the population to be served for the 
services to be provided;
    (c) The potential of the center for the development of new and 
effective methods for health services delivery and management;
    (d) The soundness of the fiscal plan for assuring effective 
utilization of

[[Page 184]]

grant funds and maximizing non-grant revenue;
    (e) The administrative and management capability of the applicant;
    (f) The extent to which grants approved under this part will provide 
for an appropriate distribution of resources throughout the country, 
taking into consideration the following factors:
    (1) The urban-rural area to be served;
    (2) The nature of the organization applying;
    (3) The organizational structure for delivery of services;
    (g) The number of users of the center and the level of utilization 
of services in previous operational periods, if any;
    (h) Whether the center's catchment area is exclusive of the area 
served by another center;
    (i) The degree to which the applicant intends to integrate services 
supported by a grant under this subpart with health services provided 
under other Federally assisted health services or reimbursement programs 
or projects;
    (j) The extent to which community resources will be utilized by the 
project;
    (k) The extent to which the center will provide preventive health 
services so as to maintain and improve the health status of the 
population served; and
    (l) The extent to which center operations will emphasize direct 
health services, efficiency of operations and sound financial 
management.



        Subpart D_Grants for Operating Community Health Projects



Sec. 51c.401  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A are applicable to grants awarded pursuant to section 
330(d)(1)(B) of the Act for the costs of operation of projects which 
provide health services to medically underserved populations.



Sec. 51c.402  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec. 
51c.104 of subpart A, contain information sufficient to enable the 
Secretary to determine that the project for which the grant is sought 
will meet the requirements of Sec. 51c.403 of this subpart.



Sec. 51c.403  Project elements.

    A project for the operation of a community health project supported 
under this subpart must:
    (a) Meet all of the requirements of Sec. 51c.303 of this part 
except for paragraph (h).
    (b) Provide those services enumerated in Sec. 51c.102(c)(1) of this 
part which the Secretary determines to be feasible and desirable and 
which are specified in the grant award.
    (c) Establish a governing board meeting the requirements of Sec. 
51c.304 by the end of the period of support under section 330(d)(1)(B) 
of the Act and this subpart.



Sec. 51c.404  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which will, in his judgment, best promote 
the purposes of section 330(d)(1)(B) of the Act and the applicable 
regulations of this part,
    (1) Where the project meets the requirements of Sec. 51c.403(a); 
and
    (2) Taking into consideration the following:
    (i) The degree to which the project would provide the services 
enumerated in Sec. 51c.102(c)(1) and the feasibility of its providing 
all of such enumerated services by the end of the period of support 
under section 330(d)(1)(B) of the Act and this subpart;
    (ii) Whether the project will have a governing board meeting the 
requirements of Sec. 51c.304 by the end of the period of support under 
section 330(d)(1)(B) of the Act and this subpart;
    (iii) The degree to which the applicant intends to integrate 
services supported by a grant under this subpart with health services 
provided under other Federally assisted health service or reimbursement 
programs or projects;
    (iv) The need of the population to be served for the services to be 
provided;
    (v) The potential of the project for the development of new and 
effective

[[Page 185]]

methods for health services delivery and management;
    (vi) The soundness of the fiscal plan for assuring effective 
utilization of grant funds and maximizing non-grant revenue;
    (vii) The administrative and management capacity of the applicant; 
and
    (viii) The extent to which community resources will be utilized in 
the project.
    (b) The Secretary may:
    (1) Make no more than two grants for the same entity under section 
330(d)(1)(B) of the Act;
    (2) Not make any grant under section 330(d)(1)(B) to an entity 
which, for the same project, has been awarded more than one grant under 
section 330(c) of the Act;
    (3) Not make a grant under section 330(d)(1)(B) to an entity which 
has been awarded a grant under section 330(d)(1)(A) of the Act.



      Subpart E_Acquisition and Modernization of Existing Buildings



Sec. 51c.501  Applicability.

    The regulations of this subpart, in addition to the regulations of 
the other applicable subparts of this part, are applicable to grants 
under section 330 of the Act for project costs which include the cost of 
acquisition and/or modernization of existing buildings (including the 
cost of amortizing the principal of, and paying the interest on, loans), 
except that, these regulations are not applicable to grants for project 
costs which include the costs of modernization of existing buildings if 
those costs can otherwise be supported under subparts B, C, or D of this 
part.

[43 FR 5352, Feb. 7, 1978]



Sec. 51c.502  Definitions.

    (a) Equipment means nonexpendable personal property as defined in 45 
CFR 74.132.
    (b) Existing building means a completed or substantially completed 
structure, and may include the realty on which it is or is to be 
located.
    (c) Modernization means the alteration, repair, remodeling and/or 
renovation of a building (including the initial equipment thereof and 
improvements to the building's site) which, when completed, will render 
the building suitable for use by the project for which the grant is 
made.

[43 FR 5352, Feb. 7, 1978]



Sec. 51c.503  Application.

    (a) General requirements. An application for a grant under this part 
for a project under subparts B, C, or D which includes the acquisition 
and/or modernization of an existing building must include the following:
    (1) A legal description of the site and a drawing showing the 
location of the building;
    (2) A description of the architectural, structural, and other 
pertinent characteristics of the building sufficient to show that it is 
or that it will be, after alteration and renovation or after 
modernization, suitable for use by the project;
    (3) A detailed estimate of the cost of the proposed acquisition and/
or modernization;
    (4) A description of, and copies of any relevant documents 
concerning, any existing or proposed financing arrangements for the 
acquisition and/or modernization;
    (5) The proposed schedule for acquisition and/or modernization and 
occupancy;
    (6) An assessment of the environmental impact of the proposed 
acquisition and/or modernization as called for by section 102(2)(c) of 
the National Environmental Policy Act of 1969 (42 U.S.C. 4332(c)) and 
such information as may be necessary to comply with the National 
Historic Preservation Act of 1966 (16 U.S.C. 470(f));
    (7) Reasonable assurances that--
    (i) The applicant has or will obtain a fee simple or such other 
estate or interest in the site, including necessary easements and 
rights-of-way, sufficient to assure for a period of not less than 20 
years (in the case of interim facilities, for the period constituting 
the estimated useful life of such facilities) undisturbed use and 
possession for the purpose of the operation of the project;
    (ii) The building will be used for the purposes for which the grant 
is made;

[[Page 186]]

    (iii) The building complies, or after alteration and renovation or 
after modernization will comply, with applicable State and local codes 
and with:
    (A) ``American National Standard Specifications for Making Buildings 
and Facilities Accessible to, and Usable by, the Physically 
Handicapped'' Number ANSI A117.1-1961 (R 1971), as modified by other 
standards prescribed by the Secretary or the Administrator of the 
General Services Administration. The applicant shall be responsible for 
conducting inspections to insure compliance with the specifications;
    (B) The applicable standards set forth in Life Safety Code 1973, 
NFPA No. 101, which is hereby incorporated by reference and made a part 
hereof. Copies of such document are available for examination at the 
Department's and Regional Offices' Information Centers listed in 45 CFR 
5.31 and may also be obtained from the National Fire Protection 
Association, 470 Atlantic Avenue, Boston, MA 02210 for $3.00 per copy.
    (iv) In the case of a public applicant with an approved project 
which involves the displacement of persons or businesses on or after 
January 2, 1971, whose real property has or will be taken, the applicant 
will comply with the provisions of the Uniform Relocation Assistance and 
Real Property Acquisition Policies Act of 1970 (Pub. L. 91-646) and the 
applicable regulations issued thereunder (45 CFR part 15);
    (v) Sufficient funds will be available to meet any portion of the 
cost of acquiring and/or modernizing the building not borne by the grant 
under this part;
    (vi) Sufficient funds will be available after acquisition and/or 
modernization of the building for effective use of the building for the 
purposes of the project;
    (vii) The applicable requirements of the Flood Disaster Protection 
Act of 1973 have been met;
    (8) Such other information as the Secretary may reasonably require.
    (b) Requirement for acquisition grants. Except for a grant solely 
for amortization of principal and payment of interest on an existing 
loan, an application for a grant for a project which includes the 
acquisition of an existing building must include, in addition to the 
requirements of paragraph (a) of this section, evidence satisfactory to 
the Secretary that the applicant has explored other alternatives to the 
proposed acquisition (such as leasing facilities or acquiring other 
facilities in the project's catchment area) and that the proposed 
acquisition constitutes the soundest alternative from a financial and 
program standpoint.
    (c) Requirements for modernization grants. In addition to the 
requirements of paragraph (a) of this section, an application for a 
grant for a project which includes modernization of an existing building 
must include the following:
    (1) Plans and specifications for the proposed modernization which 
conform to the standards specified in Sec. 51c.503(a)(7)(iii);
    (2) Reasonable assurance that any laborer or mechanic employed by 
any contractor or subcontractor in the performance of work on the 
modernization project will be paid wages at rates not less than those 
prevailing on similar work in the locality as determined by the 
Secretary of Labor under the Davis-Bacon Act (40 U.S.C. 276a et seq.) 
and will receive compensation at a rate not less than one and one-half 
times his basic rate of pay for all hours worked in any workweek in 
excess of 8 hours in any calendar day; and
    (3) Copies of any construction and materials contracts already 
entered into for the proposed modernization.

[41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978]



Sec. 51c.504  Project elements.

    (a) General requirements. A grantee which has received a grant under 
section 330 of the Act for a project which includes the acquisition and/
or modernization of an existing building must:
    (1) Assurances. Comply with the assurances provided pursuant to this 
subpart.
    (2) Approval of estimated cost. Not enter into any contract for the 
acquisition and/or modernization funded under this subpart where the 
cost of such acquisition and/or modernization exceeds the estimates in 
the application, without the prior approval of the Secretary.

[[Page 187]]

    (3) Non-default. Make every effort to prevent any default on any 
loan secured by the building and, in the event of a default, promptly 
notify the Secretary of the default and make every effort on a timely 
basis to cure the default.
    (b) Requirements for acquisition grants. In addition to the 
requirements of paragraph (a) of this section, a grantee which has 
received a grant under section 330 of the Act for a project which 
includes the acquisition of an existing building must:
    (1) Bona-fide sale. Acquire or, in the case of a grant solely for 
amortization of principal and payment of interest on an existing loan, 
have acquired the existing building pursuant to a bona-fide sale 
involving an actual cost to the applicant and resulting in additional or 
improved facilities for the purposes of the project.
    (2) Standards of construction and equipment. Except in the case of a 
grant solely for amortization of principal and payment of interest on an 
existing loan, obtain a determination by the Secretary that the facility 
conforms (or upon completion of any necessary alteration and renovation 
or modernization will conform) to the standards set forth in Sec. 
51c.503(a)(7)(iii) of this subpart before entering into a final or 
unconditional contract for the acquisition. Where the Secretary finds 
that exceptions to or modifications of any such standards would be 
consistent with the purposes of the Act and of the program, he may 
authorize such exceptions or modifications.
    (3) Financing. Where the grantee will obtain a loan secured by the 
building in order to acquire the building, obtain such financing at the 
lowest current rate prevailing in the area for comparable loans on 
comparable facilities.
    (c) Requirements for modernization grants. In addition to the 
requirements of paragraph (a) of this section, a grantee which has 
received a grant under section 330 of the Act for a project which 
includes the modernization of an existing building must:
    (1) Costs in excess of approved costs. Finance all costs in excess 
of the estimated costs approved in the application and submit to the 
Secretary for prior approval any changes that substantially alter the 
scope of the function, utilities, or safety of the facility.
    (2) Competitive bids. (i) Obtain the approval of the Secretary 
before the project is advertised or placed on the market for bidding; 
such approval must include a determination by the Secretary that the 
final plans and specifications conform to the standards set forth in 
Sec. 51c.503(a)(7)(iii) of these regulations.
    (ii) Except as otherwise provided by State or local law, contract 
for construction (including the purchase and installation of built-in 
equipment) on a lump sum fixed-price basis, and award contracts on the 
basis of competitive bidding obtained by public advertising with award 
of the contracts to the lowest responsive and responsible bidders. The 
provision for exceptions based on State and local law shall not be 
invoked to give local contractors or suppliers a percentage preference 
over non-local contractors bidding for the same contract. Such practices 
are precluded by this paragraph.
    (3) Construction contracts. (i) Include the following conditions and 
provisions in all construction contracts for the modernization project:
    (A) The provisions set forth in ``DHHS Requirements for Federally 
Assisted Construction Contracts Regarding Labor Standards and Equal 
Employment Opportunities,'' Form DHHS 514 (rev. 7/76) (issued by the 
Office of Grants Administration Policy, U.S. Department of Health and 
Human Services) pertaining to the Davis-Bacon Act, the Contract Work 
Hours Standards Act, and the Copeland Act (Anti-Kickback) Regulations, 
except in the case of contracts in the amount of $2,000 or less; and 
pertaining to Executive Order 11246, 30 FR 12319 (September 24, 1965), 
as amended, relating to nondiscrimination in construction contract 
employment, except in the case of contracts in the amount of $10,000 or 
less;
    (B) That the contractor shall furnish performance and payment bonds 
each of which shall be in the full amount of the contract price, and 
shall maintain, during the life of the contract, adequate fire, 
workmen's compensation, public liability, and property damage insurance: 
Provided, however, That in

[[Page 188]]

the case of a State or local unit of government which enters into a 
construction contract of less than $100,000, State or local provisions 
with respect to performance and payment bonds shall be deemed to meet 
the requirements of this paragraph; and
    (C) That the Secretary shall have access at all reasonable times to 
work wherever it is in preparation or progress, and the contractor shall 
provide proper facilities for such access and inspection.
    (ii) Executive Order 11246. Comply with the applicable requirements 
of Executive Order 11246, 30 FR 12319 (September 24, 1965) as amended, 
relating to nondiscrimination in construction contract employment, and 
the applicable rules, regulations, and procedures prescribed pursuant 
thereto.
    (4) Modernization supervision. Provide and maintain competent and 
adequate architectural or engineering supervision and inspection at the 
modernization site to insure that the completed work conforms with the 
plans and specifications.
    (5) Completion responsibility. Complete the modernization in 
accordance with the grant application and the approved plans and 
specifications.
    (6) Progress reports. Furnish progress reports and such other 
information concerning the modernization as the Secretary may require.
    (d) The Secretary may at any time approve exceptions to the 
provisions of this section where he finds that such exceptions are not 
inconsistent with section 330 of the Act, other requirements of law, or 
the purposes of the program.

[41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978]



Sec. 51c.505  Determination of cost.

    The cost of acquisition and/or modernization of existing buildings 
for which funds may be granted under this part will be determined by the 
Secretary, utilizing such documentation submitted by the applicant as 
the Secretary may prescribe (including the reports of such real estate 
appraisers as the Secretary may approve) and other relevant factors, 
taking into consideration only that portion of the existing building 
necessary for the operation of the approved project.

[41 FR 5700, Dec. 30, 1976]



Sec. 51c.506  Use of grant funds.

    Grant funds may be used to amortize the principal of or pay interest 
on a loan or mortgage on an existing building acquired under this part, 
including a building purchased by a grantee prior to the promulgation of 
this part, but only if the building is being used for the purposes of 
section 330 and complies with the applicable provisions of this subpart 
and only to the extent the Secretary finds such principal amounts and 
interest rates to be reasonable.

[41 FR 5700, Dec. 30, 1976]



Sec. 51c.507  Facility which has previously received Federal grant.

    No grant for the acquisition of a facility which has previously 
received a Federal grant for construction, acquisition, or equipment 
shall serve either to reduce or restrict the liability of the applicant 
or any other transferor or transferee from any obligation of 
accountability imposed by the Federal Government by reason of such prior 
grant.

[41 FR 5700, Dec. 30, 1976]



PART 51d_MENTAL HEALTH AND SUBSTANCE ABUSE EMERGENCY RESPONSE PROCEDURES--

Table of Contents




Sec.
51d.1 To what does this subpart apply?
51d.2 Definitions.
51d.3 Who is eligible for an award under this subpart?
51d.4 What information is required in the application?
51d.5 How is an emergency determined to exist?
51d.6 How will applications be evaluated and awarded?
51d.7 What are the limitations on how award funds may be used?
51d.8 Which other HHS regulations apply to these awards?
51d.9 What other conditions apply to these awards?
51d.10 What are the reporting requirements?

    Authority: 42 U.S.C. 290aa(m).

    Source: 66 FR 51877, Oct. 11, 2001, unless otherwise noted.

[[Page 189]]



Sec. 51d.1  To what does this subpart apply?

    The regulations in this subpart apply to grants that enable public 
entities to respond to needs in local communities created by mental 
health or substance abuse emergencies, as authorized under section 
501(m) of the Public Health Service Act (42 U.S.C. 290aa(m)).



Sec. 51d.2  Definitions.

    As used in this part:
    Federally recognized Indian Tribal government means the governing 
body of any Indian tribe, band, nation, or other organized group or 
community, including any Native village as defined in, or established 
pursuant to, the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et 
seq.), which is recognized as eligible for the special programs and 
services provided by the United States to Indians because of their 
status as Indians;
    Immediate award means a short term award of up to $50,000, or such 
greater amount as determined by the Secretary on a case-by-case basis, 
to address the immediate needs resulting from a mental health or 
substance abuse emergency. Such funding may be provided for a period of 
up to 90 days.
    Intermediate award means an award intended to meet the more ongoing 
needs resulting from a mental health or substance abuse emergency than 
is possible under an Immediate award. Intermediate awards may fund up to 
one year of services, although in some exceptional circumstances, and to 
the extent that funding is available, such funding may be continued for 
an additional period of up to one year.
    Public entity means any State, any political subdivision of a State, 
any Federally recognized Indian tribal government or tribal 
organization.
    Secretary means the Secretary of Health and Human Services (HHS) or 
any other officer or employee of that Department to whom the authority 
involved has been delegated.
    State means one of the 50 States, the District of Columbia, Guam, 
the Commonwealth of Puerto Rico, the Northern Mariana Islands, the 
Virgin Islands, American Samoa, and the Trust Territory of the Pacific 
Islands.
    Tribal organization means the recognized governing body of any 
Indian tribe; any legally established organization of Indians which is 
controlled, sanctioned, or chartered by such governing body or which is 
democratically elected by the adult members of the Indian community to 
be served by such organization and which includes the maximum 
participation of Indians in all phases of its activities.

[66 FR 51877, Oct. 11, 2001, as amended at 67 FR 56931, Sept. 6, 2002]



Sec. 51d.3  Who is eligible for an award under this subpart?

    An applicant must be a public entity as defined by this subpart. 
Applicants are eligible for either or both Immediate and Intermediate 
awards.



Sec. 51d.4  What information is required in the application?

    (a) Application for Immediate awards: The application is to contain 
the following information:
    (1) A certification by the State's chief executive officer, or, for 
the purposes of a Federally recognized Indian tribal government, the 
principal elected official, or such officer's or official's designee, 
that a mental health or substance abuse emergency exists, as well as a 
written statement setting out the basis for the certification;
    (2) A brief program plan describing needs;
    (3) An estimate of the number of people to be served and the 
geographical area to be served;
    (4) A description of the types of services to be provided;
    (5) A budget justifying the amount of the request;
    (6) Required certifications; and
    (7) Such other pertinent information as the Secretary may require.
    (b) Application for Intermediate awards: The application is to be 
submitted on an OMB-approved application form and contain the following:
    (1) If the applicant has not applied previously for an Immediate 
award, a certification by the State's chief executive officer, or, for 
the purposes of a Federally recognized Indian tribal government, the 
principal elected official, or such officer's or official's designee, 
that a mental health or substance

[[Page 190]]

abuse emergency exists, as well as a written statement setting out the 
basis for the certification;
    (2) An application submission date within three months of the date 
of the event that precipitated the mental health or substance abuse 
emergency, as certified in accordance with 51d.4(a)(1) or (b)(1), except 
that upon the request of a State, the Secretary may provide a waiver of 
this application submission deadline if the Secretary determines there 
is good cause to justify the waiver;
    (3) A detailed and comprehensive assessment of need;
    (4) Demographics specific to the estimated number of people to be 
served;
    (5) A description of the services that were provided up to the date 
of the submission of the Intermediate award application;
    (6) The geographical area to be served;
    (7) A detailed implementation program plan and related time line, 
including a description of outreach to special population groups 
affected by the crisis;
    (8) A budget justifying the amount of the request for personnel, 
equipment, supplies, travel, training, data collection and any technical 
assistance required; the budget shall include an identification of the 
resources the applicant is able to commit to the project, if any, 
including any in-kind contributions;
    (9) Any information that has changed since an Immediate application 
was submitted, if one was submitted; and
    (10) such other pertinent information as the Secretary may require.
    (c) Signature on Award Applications. The application must be signed 
by an individual authorized to act for the applicant and to assume on 
behalf of the applicant the obligations imposed by the statute, all 
applicable regulations, and any additional conditions of the grant.



Sec. 51d.5  How is an emergency determined to exist?

    (a) In making a decision as to whether a mental health or substance 
abuse emergency exists for purposes of section 501(m) of the PHS Act, 
the Secretary, using discretion, will consider all relevant factors, but 
at a minimum the following must exist:
    (1) Existing State, Tribal and local systems for mental health and/
or substance abuse services are overwhelmed or unable to meet the 
existing mental health or substance abuse needs of the local community 
at issue; and
    (2) This inability to meet the mental health and/or substance abuse 
service needs of a local community is the direct consequence of a clear 
precipitating event. This precipitating event must:
    (i) Have a sudden, rapid onset and a definite conclusion, such as:
    (A) A natural disaster (including, but not limited to, a hurricane, 
tornado, storm, flood, earthquake, fire, drought, or other natural 
catastrophe); or
    (B) A technological disaster (including, but not limited to, a 
chemical spill, a major industrial accident, or a transportation 
accident); or
    (C) A criminal act with significant casualties (including, but not 
limited to, a domestic act of terrorism, a hostage situation, or an 
incident of mass violence including school shootings and riots); and
    (ii) Result in significant:
    (A) Death,
    (B) Injury,
    (C) Exposure to life-threatening circumstances,
    (D) Hardship,
    (E) Suffering,
    (F) Loss of property, or
    (G) Loss of community infrastructure (e.g., loss of treatment 
facilities, staff, public transportation and/or utilities, or isolation 
from services); and
    (3) No other local, State, Tribal or Federal funding is available to 
adequately address the specific level of need resulting from the 
precipitating event and resulting emergency mental health and/or 
substance abuse service needs of the impacted community.
    (b) In making a determination that a mental health or substance 
abuse emergency exists, the Secretary will consider the certification 
and written statements provided in accordance with Sec. 51d.4(a)(1) or 
(b)(1), and other information independently available to the Secretary.
    (c) Once the Secretary determines that a mental health or substance

[[Page 191]]

abuse emergency exists, the Secretary may exercise discretion to make 
awards to enable public entities to respond to the emergency, within the 
limits of funds available.



Sec. 51d.6  How will applications be evaluated and awarded?

    (a) In assessing applications for funding, the Secretary will 
utilize the following criteria.
    (1) Documentation of Need. Applicant has demonstrated mental health 
and/or substance abuse needs directly resulting from the precipitating 
event. The precipitating event is clearly identified along with 
information regarding its impact. Applicant has identified any high risk 
groups or populations with special concerns that may impact the delivery 
of services (e.g., children, adolescents, older adults, ethnic and 
cultural groups, lower income populations). This documentation of need 
shall include the extent of physical, psychological and social problems 
observed, and a description of how the estimate of the number of people 
to be served was made. Applicant has clearly documented that no other 
local, State, Tribal or Federal funding sources are available to address 
the need.
    (2) Plan of Services. Applicant has a clear plan of services to 
address documented needs within a defined geographic area and in a 
specified time period. The plan of services is appropriate to the type 
of grant requested (e.g., Immediate or Intermediate) and specifically 
addresses the needs of any high risk groups or populations with special 
concerns identified in the assessment of need. The plan of services 
clearly identifies the following:
    (a) The types of services to be provided (e.g., outreach, crisis 
counseling, public education on stress management and crisis mental 
health, public education on substance abuse prevention, information and 
referral services, short term substance abuse or mental health 
prevention and/or treatment services);
    (b) Strategies for targeting those identified as needing services, 
including high risk groups or populations with special concerns 
identified in the needs assessment;
    (c) Appropriate training to be provided to staff to assure that 
services are appropriate to the crisis situation and the plans for 
community recovery;
    (d) Quality control methods in place to assure appropriate services 
to the target population;
    (e) Staff support mechanisms that are available;
    (f) Plans for coordination of services with key local, State, Tribal 
and Federal partners involved in addressing the precipitating event 
(e.g., emergency management agencies, law enforcement, education 
agencies, public health agencies, and other agencies active in crisis 
response); and
    (g) An estimate of the length of time for which said services 
requiring Federal funding will be needed, and the manner in which long-
term cases will be referred for continued assistance after Federal funds 
have ended.
    (3) Organizational Capability. Applicant is a public entity with 
demonstrated organizational capacity to deliver services as described in 
the plan of services. The applicant should also have a demonstrated 
history of service delivery to the target population within the defined 
service area for the program. The budget submitted shall provide 
sufficient justification and demonstrate that it is consistent with the 
documentation of need and plan of services. This shall include a 
description of the facilities to be utilized, including plans for 
securing office space if necessary to the project.
    (b) In determining the appropriateness and necessity of funding, the 
Secretary may consult with other Federal agencies responsible for 
responding to crisis incidents, including the Readiness, Response and 
Recovery Directorate within the Federal Emergency Management Agency 
(FEMA), the Safe and Drug Free Schools Program within the U.S. 
Department of Education, the Office for Victims of Crime (OVC) within 
the U.S. Department of Justice, the National Transportation Safety Board 
(NTSB) within the U.S. Department of Transportation, the Emergency 
Response Program within the Environmental Protection Agency (EPA), the 
Bureau of Indian Affairs (BIA) within the U.S. Department of the 
Interior, the Animal and Plant Health Inspection Service within the U.S. 
Department of Agriculture, the Indian Health

[[Page 192]]

Service (IHS) within the U.S. Department of Health and Human Services, 
and other Federal agencies with jurisdiction over specific types of 
crisis response.



Sec. 51d.7  What are the limitations on how award funds may be used?

    Unallowable Expenses: The following expenses will not be reimbursed 
under section 501(m) of the PHS Act:
    (1) Major construction costs;
    (2) Childcare services, unless provided by the institution or entity 
providing mental health or substance abuse treatment and integral to the 
treatment program;
    (3) Services outside of the geographic area specified in the 
application, except to the extent that the precipitating event requires 
physical relocation of either affected parties or facilities;
    (4) Any mental health or substance abuse services not directly 
related to the mental health or substance abuse emergency;
    (5) Any expenses that supplant ongoing local, State, Tribal or 
Federal expenditures; and
    (6) Any other costs unallowable by Federal law or regulation.



Sec. 51d.8  Which other HHS regulations apply to these awards?

    Several other HHS regulations apply to grants under this part. These 
include, but are not limited to:

45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Debarment and suspension from eligibility for financial 
assistance
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefitting from Federal financial 
assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefitting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to state and local governments

[66 FR 51877, Oct. 11, 2001, as amended at 67 FR 56931, Sept. 6, 2002]



Sec. 51d.9  What other conditions apply to these awards?

    Award funding made under this authority is to be supplemental in 
nature. Consistent with the criteria in Sec. 51d.5 and the 
certification in Sec. 51d.4(a)(1), such funds will only be made 
available if no other local, State, Tribal or Federal source is 
available to adequately address the emergency mental health and/or 
substance abuse service needs of the impacted community.



Sec. 51d.10  What are the reporting requirements?

    (a) For immediate awards:
    (1) A mid-program report only if an Intermediate award application 
is being prepared and submitted. This report shall be included as part 
of the Intermediate award application,
    (2) Quarterly financial status reports of expenditures to date, due 
30 days following the end of the reporting period, as permitted by 45 
CFR 92.41(b),
    (3) A final program report, a financial status report, and a final 
voucher 90 days after the last day of Immediate award services, in 
accordance with 45 CFR 92.50(b).
    (b) For intermediate awards:
    (1) Quarterly progress reports, due 30 days following the end of the 
reporting period, as permitted by 45 CFR 92.40(b),
    (2) Quarterly financial status reports of expenditures to date, due 
30 days following the end of the reporting period, as permitted by 45 
CFR 92.41(b),
    (3) A final program report, to be submitted within 90 days after the 
end of

[[Page 193]]

the program services period, in accordance with 45 CFR 92.50(b),
    (4) A financial status report, to be submitted within 90 days after 
the end of the program services period, in accordance with 45 CFR 
92.50(b),
    (5) Such additional reports as the Secretary may require.
    (c) The following shall be specifically addressed in final program 
reports:
    (1) Description of services provided,
    (2) Number of individuals assisted,
    (3) Amount of funding expended and for what purposes,
    (4) Personnel costs,
    (5) Training costs,
    (6) Technical consultation costs,
    (7) Equipment costs,
    (8) Travel and transportation costs, and
    (9) A narrative describing lessons learned and exemplary practices, 
and a description of the transition plan, for how services will be 
funded or provided when Federal funds have been exhausted.

                        PARTS 51e-51g [RESERVED]



PART 52_GRANTS FOR RESEARCH PROJECTS--Table of Contents




Sec.
52.1 To which programs do these regulations apply?
52.2 Definitions.
52.3 Who is eligible to apply for a grant?
52.4 How to apply for a grant.
52.5 Evaluation and disposition of applications.
52.6 Grant awards.
52.7 Use of funds; changes.
52.8 Other HHS policies and regulations that apply.
52.9 Additional conditions.

    Authority: 42 U.S.C. 216.



Sec. 52.1  To which programs do these regulations apply?

    (a) General. The regulations of this party apply to all health-
related research project grants administered by the PHS or its 
components, except for grants for health services research, 
demonstration, and evaluation projects administered by the Agency for 
Health Care Policy and Research. These regulations do not apply to 
research grants that are not for the support of an identified research 
project (sometimes referred to as general research support grants), 
grants for the construction or operation of research facilities, grants 
for prevention or educational programs, demonstration grants, 
traineeships, training grants, or to the support of research training 
under the National Research Service Awards program.
    (b) Specific programs covered. From time to time the Secretary will 
publish a list of the research project grant programs covered by this 
part. The list is for informational purposes only and is not intended to 
restrict the statement of applicability in paragraph (a) of this 
section. In addition, information on particular research project grant 
programs, including applications and instructions, may be obtained from 
the component of the PHS that administers the program.

[61 FR 55105, Oct. 24, 1996.]



Sec. 52.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Grantee means the institution, organization, individual or other 
person designated in the grant award document as the responsible legal 
entity to whom a grant is awarded under this part. The term shall also 
mean the recipient of a cooperative agreement awarded under this part.
    HHS means the Department of Health and Human Services.
    Principal investigator means a single individual designated by the 
grantee in the grant application and approved by the Secretary, who is 
responsible for the scientific and technical direction of the project.
    Project means the particular activity for which funding is sought 
under this part as described in the application for grant award.
    Public Health Service and PHS means the operating division of the 
Department that consists of the Agency for Health Care Policy and 
Research, the Centers for Disease Control and Prevention, the Food and 
Drug Administration, the Health Resources and Services Administration, 
the Indian Health Service, the National Institutes of Health, the Office 
of the Assistant Secretary for Health, the Substance

[[Page 194]]

Abuse and Mental Health Administration, and the Agency for Toxic 
Substances and Disease Registry.
    Research means a systematic investigation, study or experiment 
designed to contribute to general knowledge relating broadly to public 
health by establishing, discovering, developing, elucidating or 
confirming information about, or the underlying mechanisms relating to, 
the biological functions, diseases, or related matters to be studied.
    Secretary means the Secretary of HHS and any other officer or 
employee of the HHS to whom the authority involved may be delegated.

[61 FR 55105, Oct. 24, 1996]



Sec. 52.3  Who is eligible to apply for a grant?

    (a) Persons eligible. Any individual, corporation, public or private 
institution or agency, or other legal entity shall be eligible for a 
grant award, except:
    (1) An individual or entity which is otherwise ineligible for an 
award under applicable law or regulation;
    (2) Federal agencies or institutions, unless specifically authorized 
by law to receive the grant; or
    (3) Individuals, corporations, institutions, agencies, and other 
entities during the period they are debarred or suspended from 
eligibility for Federal financial assistance (see 45 CFR part 76).
    (b) Permissible activities within research projects. Any project 
found by the Secretary to be a research project within the meaning of 
this part shall be eligible for a grant award. Eligible projects may 
consist of laboratory, clinical, population, field, statistical, basic, 
applied or other types of investigations, studies or experiments, or 
combinations thereof, and may either be limited to one, or a particular 
aspect of a problem or subject, or may consist of two or more related 
problems or subjects for concurrent or consecutive investigation and 
involving multiple disciplines, facilities and resources.
    (c) Preferences. In the award of grants for international research 
relating to the development and evaluation of vaccines and treatments 
for AIDS under section 2315 of the Act, preference shall be given to:
    (1) Activities conducted by, or in cooperation with, the World 
Health Organization, and
    (2) With respect to activities in the Western Hemisphere, activities 
conducted by, or in cooperation with, the Pan American Health 
Organization or the World Health Organization.

[61 FR 55105, Oct. 24, 1996]



Sec. 52.4  How to apply for a grant.

    Each institution interested in applying for a grant under this part 
must submit an application at such time and in such form and manner as 
the Secretary may prescribe.

[61 FR 55105, Oct. 24, 1996]



Sec. 52.5  Evaluation and disposition of applications.

    (a) Evaluation. All applications filed in accordance with Sec. 52.4 
shall be evaluated by the Secretary through such officers and employees 
and such experts or consultants engaged for this purpose as the 
Secretary determines are specially qualified in the areas of research 
involved in the project, including review by an appropriate National 
Advisory Council or other body as may be required by law. The 
Secretary's evaluation shall take into account among other pertinent 
factors the scientific merit and significance of the project, the 
competency of the proposed staff in relation to the type of research 
involved, the feasibility of the project, the likelihood of its 
producing meaningful results, the proposed project period, and the 
adequacy of the applicant's resources available for the project and the 
amount of grant funds necessary for completion, and in the case of 
applications for support of research in emergency medical services, 
special consideration shall be given to applications for grants for 
research relating to the delivery of emergency medical services in rural 
areas.
    (b) Disposition. On the basis of the Secretary's evaluation of an 
application in accordance with paragraph (a) of this section and subject 
to approvals, recommendations or consultations by the appropriate 
National Advisory Council or other body as may be required by law, the 
Secretary will (1) approve, (2) defer because of either lack

[[Page 195]]

of funds or a need for further evaluation, or (3) disapprove support of 
the proposed project in whole or in part. With respect to approved 
projects, the Secretary will determine the project period (subject to 
extension as provided in Sec. 52.7(c)) during which the project may be 
supported. Any deferral and disapproval of an application will not 
preclude its reconsideration or a reapplication.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]



Sec. 52.6  Grant awards.

    (a) Within the limits of funds available for that purpose, the 
Secretary will award a grant to those applicants whose approved projects 
will in the Secretary's judgment best promote the purposes of the 
statute authorizing the grant and the regulations of this part. The date 
specified by the Secretary as the beginning of the project period shall 
be no later than 9 months following the date of any initial or new award 
statement unless the Secretary finds that because of the nature of a 
project or the grantee's particular circumstances earlier assurance of 
grant support is required to initiate the project. Any funds granted 
under this part shall be expended solely for the purposes for which the 
funds were granted in accordance with the approved application and 
budget, the regulations of this part, the terms and conditions of the 
award and the applicable cost principles prescribed in subpart Q of 45 
CFR part 74.
    (b) Evaluation of unapproved drug treatments for AIDS. Grants under 
section 2314 of the Act to support research relating to the evaluation 
of drug treatments for AIDS not approved by the Commissioner of Food and 
Drugs, shall be subject to appropriate scientific and ethical guidelines 
established by the Secretary for each project, pursuant to section 
2314(c) of the Act. In order to receive a grant, the applicant must 
agree to comply with those guidelines.
    (c) Notice of grant award. (1) The notice of grant award specifies 
how long HHS intends to support the project without requiring the 
project to recompete for funds. This period, called the project period, 
will usually be for 1-5 years.
    (2) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit an application at the time and in the form and 
manner as the Secretary may prescribe to have support continued for each 
subsequent year.
    (3) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (d) Multiple or concurrent awards. Whenever a research project 
involves a number of different but related problems, activities or 
disciplines which require evaluation by different groups, or whenever 
support for a project could be more effectively administered by separate 
handling of separate aspects of the project, the Secretary may evaluate, 
approve and make awards pursuant to two or more concurrent applications, 
each dealing with one or more specified aspects of the project.
    (e) Unobligated balances. The Secretary may permit unobligated grant 
funds remaining in the grant account at the close of a budget period to 
be carried forward for obligation during a subsequent budget period, 
provided a continuation award is made for that period and the 
Secretary's written approval is obtained.
    (f) Award for continuation of project under new grantee. The 
Secretary, upon application in accordance with the provisions of Sec. 
52.4 and without further action by a Council or other body, may make a 
grant to any institution or other person eligible under Sec. 52.3 for 
continuation of a currently supported project for which a grant was 
previously made to another institution or person, provided the Secretary 
finds that the change in the conduct of the project is consonant with 
the previous evaluation and approval of the project under Sec. 52.5.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 61 FR 55105, 
Oct. 24, 1996]

[[Page 196]]



Sec. 52.7  Use of funds; changes.

    (a) Delegation of fiscal responsibility. The grantee may not in 
whole or in part delegate or transfer to another person responsibility 
for the use or expenditure of grant funds.
    (b) Changes in project. The permissible changes by the principal 
investigator in the approved project shall be limited to changes in 
methodology, approach or other aspects of the project to expedite 
achievement of the project's research objectives, including changes that 
grow out of the approved project and serve the best scientific strategy. 
If the grantee and the principal investigator are uncertain whether a 
change complies with this provision, the question must be referred to 
the Secretary for a final determination.
    (c) Changes in project period. The project period determined 
pursuant to Sec. 52.5(b) may be extended by the Secretary, with or 
without additional grant support, for such an additional period as the 
Secretary determines may be required to complete, or fulfill the 
purposes of, the approved project.

[45 FR 12240, Feb. 25, 1980]



Sec. 52.8  Other HHS regulations and policies that apply.

    Several other HHS policies and regulations apply to grants under 
this part. These include, but are not necessarily limited to:

37 CFR part 401--Rights to inventions made by nonprofit organizations 
and small business firms under government grants, contracts, and 
cooperative agreements
42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectively in research for which PHS funding is sought
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research.

    Note: This policy is subject to changes, and interested persons 
should contact the Office of Research on Women's Health, NIH, Room 201, 
Building 1, MSC 0161, BETHESDA, MD 20892-0161 (301-402-1770; not a toll-
free number) to obtain references to the current version and any 
amendments.]

59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    Note: This policy is subject to changes, and interested persons 
should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 
6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010 (301-496-
9838; not a toll-free number) to obtain references to the current 
version and any amendments.]

``PHS Grants Policy Statement,'' DHHS Publication No. (OASH) 94-50,000 
(Rev.) April 1, 1994.

    Note: This policy is subject to changes, and interested persons 
should contact the Grants Policy Branch, OASH, Room 17A45, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857 (301-443-1874; not a 
toll-free number) to obtain references to the current version and any 
amendments.]

``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office for Protection from Research Risks, NIH (Revised 
September 1986).

    Note: This policy is subject to changes, and interested persons 
should contact the Office for Protection from Research Risks, NIH, Suite 
3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-
496-

[[Page 197]]

7005; not a toll-free number) to obtain references to the current 
version and any amendments.]

[61 FR 55106 Oct. 24, 1996]



Sec. 52.9  Additional conditions.

    The Secretary may with respect to any grant award or class of awards 
impose additional conditions prior to or at the time of any award when 
in the Secretary's judgment such conditions are necessary to assure or 
protect advancement of the approved project, the interests of the public 
health, or the conservation of grant funds.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]



PART 52a_NATIONAL INSTITUTES OF HEALTH CENTER GRANTS--Table of Contents




Sec.
52a.1 To which programs do these regulations apply?
52a.2 Definitions.
52a.3 Who is eligible to apply?
52a.4 What information must each application contain?
52a.5 How will NIH evaluate applications?
52a.6 Information about grant awards.
52a.7 For what purposes may a grantee spend grant funds?
52a.8 Other HHS regulations and policies that apply.
52a.9 Additional conditions.

    Authority: 42 U.S.C. 216, 284g, 285a-6(c)(1)(E), 285a-7(c)(1)(G), 
285b-4, 285c-5, 285c-8, 285d-6, 285e-2, 285e-3, 285e-10a, 285f-1, 285g-
5, 285g-7, 285g-9, 285m-3, 285o-2, 286a-7(c)(1)(G), 287c-32(c), 300cc-
16.

    Source: 57 FR 61006, Dec. 23, 1992, unless otherwise noted.



Sec. 52a.1  To which programs do these regulations apply?

    (a) The regulations of this part apply to grants by the National 
Institutes of Health and its organizational components to support the 
planning, establishment, expansion, and operation of research and 
demonstration and/or multipurpose centers in health fields described in 
this paragraph. Specifically, these regulations apply to:
    (1) National Institute of Mental Health centers of excellence with 
respect to research on autism, as authorized by section 409C of the Act 
(42 U.S.C. 284g);
    (2) National cancer research and demonstration centers (including 
payments for construction), as authorized by section 414 of the Act (42 
U.S.C. 285a-3);
    (3) National cancer research and demonstration centers with respect 
to breast cancer, as authorized by section 417 of the Act (42 U.S.C. 
285a-6);
    (4) National cancer and demonstration centers with respect to 
prostate cancer, as authorized by section 417A of the Act (42 U.S.C. 
285a-7);
    (5) National research and demonstration centers for heart, blood 
vessel, lung, and blood diseases, sickle cell anemia, blood resources, 
and pediatric cardiovascular diseases (including payments for 
construction), as authorized by section 422 of the Act (42 U.S.C. 485b-
4);
    (6) Research and training centers (including diabetes mellitus, and 
digestive, endocrine, metabolic, kidney and urologic diseases), as 
authorized by section 431 of the Act (42 U.S.C. 285c-5);
    (7) Research and training centers regarding nutritional disorders, 
as authorized by section 434 of the Act (42 U.S.C. 285c-8);
    (8) Multipurpose arthritis and musculoskeletal diseases centers 
(including payments for alteration, but not construction), as authorized 
by section 441 of the Act (42 U.S.C. 285d-6);
    (9) Alzheimer's disease centers, as authorized by section 445 of the 
Act (42 U.S.C. 285e-2);
    (10) Claude D. Peppers Older Americans Independence Centers, as 
authorized by section 445A of the Act (42 U.S.C. 285e-3);
    (11) Centers of excellence in Alzheimer's disease research and 
treatment, as authorized by section 445I of the Act (42 U.S.C. 285e-
10a);
    (12) Research centers regarding chronic fatigue syndrome, as 
authorized by section 447 of the Act (42 U.S.C. 285f-1);
    (13) Research centers with respect to contraception and infertility, 
as authorized by section 452A of the Act (42 U.S.C. 285g-5);
    (14) Child health research centers, as authorized by section 452C of 
the Act (42 U.S.C. 285g-7);
    (15) Fragile X research centers, as authorized by 452E of the Act 
(42 U.S.C. 285g-9);

[[Page 198]]

    (16) Multipurpose deafness and other communication disorders 
centers, as authorized by section 464C of the Act (42 U.S.C. 285m-3);
    (17) National drug abuse research centers, as authorized by section 
464N of the Act (42 U.S.C. 285o-2);
    (18) Centers of excellence in biomedical and behavioral research 
training for individuals who are members of minority health disparity 
populations or other health disparity populations, as authorized by 
section 485F of the Act (42 U.S.C. 287c-32); and
    (19) Centers for acquired immunodeficiency syndrome (AIDS) research, 
as authorized by section 2316 of the Act (42 U.S.C. 300cc-16).
    (b) This part does not apply to:
    (1) Grants for construction (see 42 CFR part 52b), except as noted 
in paragraph (a) of this section;
    (2) Grants covered by 42 CFR part 52 (grants for research projects); 
or
    (3) Grants for general research support under section 301(a)(3) of 
the Act (42 U.S.C. 241(a)(3)).
    (c) This part also applies to cooperative agreements made to support 
the centers specified in paragraph (a) of this section. When a reference 
is made in this part to ``grants,'' the reference shall include 
``cooperative agreements.''

[61 FR 55108, Oct. 24, 1996, as amended at 68 FR 69621, Dec. 15, 2003]



Sec. 52a.2  Definitions.

    As used in this part:
    Act means the Public Health Services Act, as amended (42 U.S.C. 201 
et seq.).
    Center means:
    (a) For purposes of grants authorized by section 409C of the Act, a 
public or nonprofit private entity which provides for planning and 
conducting basic and clinical research into the cause, diagnosis, early 
detection, prevention, control, and treatment of autism, including the 
fields of developmental neurobiology, genetics, and psychopharmacology;
    (b) For purposes of grants authorized by section 414 of the Act, an 
agency or institution which provides for planning and conducting basic 
and clinical research into, training in, and demonstration of advanced 
diagnostic, control, prevention and treatment methods for cancer;
    (c) For purposes of grants authorized by section 417 of the Act, an 
agency or institution which provides for planning and conducting basic, 
clinical, epidemiological, psychological, prevention and treatment 
research and related activities on breast cancer;
    (d) For purposes of grants authorized by section 417A of the Act, an 
agency or institution which provides for planning and conducting basic, 
clinical, and epidemiological, psychosocial, prevention and control, 
treatment, research, and related activities on prostate cancer;
    (e) For purposes of grants authorized by section 422 of the Act, an 
agency or institution which provides for planning and basic and clinical 
research into, training in, and demonstration of, management of blood 
resources and advanced diagnostic, prevention, and treatment methods 
(including emergency services) for heart, blood vessel, lung, or blood 
diseases including sickle cell anemia;
    (f) For purposes of grants authorized by section 431 of the Act, a 
single institution or a consortium of cooperating institutions, which 
conducts research, training, information programs, epidemiological 
studies, data collection activities and development of model programs in 
diabetes mellitus and related endocrine and metabolic diseases;
    (g) For purposes of grants authorized by section 434 of the Act, a 
single institution or a consortium of cooperating institutions which 
conducts basic and clinical research, training, and information programs 
in nutritional disorders, including obesity;
    (h) For purposes of grants authorized by section 441 of the Act, a 
facility which conducts basic and clinical research into arthritis and 
musculosketal diseases; and orthopedic procedures, training, and 
information programs for the health community and the general public;
    (i) For purposes of grants authorized by section 445 of the Act, a 
public or private nonprofit entity (including university medical 
centers) which conducts basic and clinical research (including 
multidisciplinary research) into, training in, and demonstration of

[[Page 199]]

advanced diagnostic, prevention, and treatment methods for Alzheimer's 
disease;
    (j) For purposes of grants authorized by section 445A of the Act, a 
single public or private nonprofit institution or entity or a consortium 
of cooperating institutions or entities which conducts research into the 
aging processes and into the diagnosis and treatment of diseases, 
disorders, and complications related to aging, including menopause, 
which research includes research on such treatments, and on medical 
devices and other medical interventions regarding such diseases, 
disorders, and complications, that can assist individuals in avoiding 
institutionalization and prolonged hospitalization and in otherwise 
increasing the independence of the individuals.
    (k) For the purposes of section 445I of the Act, a single 
institution or consortium of cooperating institutions which conducts 
basic and clinical research on Alzheimer's disease.
    (l) For purposes of grants authorized by section 447 of the Act, a 
single institution or consortium of cooperating institutions which 
conducts basic and clinical research on chronic fatigue syndrome;
    (m) For purposes of grants authorized by section 452A of the Act, a 
single institution or consortium of cooperating institutions which 
conducts clinical and other applied research, training programs, 
continuing education programs, and information programs with respect to 
methods of contraception, and infertility;
    (n) For purposes of grants authorized by section 452C of the Act, an 
agency or institution which conducts research with respect to child 
health, and gives priority to the expeditious transfer of advances from 
basic science to clinical applications and improving the care of infants 
and children;
    (o) For purposes of grants authorized by section 452E of the Act, a 
single institution or a consortium of cooperating institutions which 
conducts research for the purposes of improving the diagnosis and 
treatment of, and finding the cure for, fragile X;
    (p) For purposes of grants authorized by section 464C of the Act, a 
single institution or a consortium of cooperating institutions which 
conducts basic and clinical research into, training in, information and 
continuing education programs for the health community and the general 
public about, and demonstration of, advanced diagnostic, prevention, and 
treatment methods for disorders of hearing and other communication 
processes and complications resulting from these disorders;
    (q) For purposes of grants authorized by section 464N of the Act, 
institutions designated as National Drug Abuse Research Centers for 
interdisciplinary research relating to drug abuse and other biomedical, 
behavioral, and social issues related to drug abuse;
    (r) For purposes of grants authorized by section 485F of the Act, a 
biomedical or behavioral research institution or consortia that:
    (1) Have a significant number of members of minority health 
disparity populations or other health disparity populations enrolled as 
students in the institution (including individuals accepted for 
enrollment in the institution);
    (2) Have been effective in assisting such students of the 
institution to complete the program of education or training and receive 
the degree involved;
    (3) Have made significant efforts to recruit minority students to 
enroll in and graduate from the institution, which may include providing 
means-tested scholarships and other financial assistance as appropriate; 
and
    (4) Have made significant recruitment efforts to increase the number 
of minority or other members of health disparity populations serving in 
faculty or administrative positions at the institution; or
    (s) For the purposes of grants authorized in section 2316 of the 
Act, an entity for basic and clinical research into, and training in, 
advanced diagnostic, prevention, and treatment methods for acquired 
immunodeficiency syndrome (AIDS).
    Director means the Director of NIH or the organizational component 
authorized to award grants to support centers under this part.
    Grant(s) means, unless the context otherwise requires, an award of 
funds

[[Page 200]]

to support a center authorized under Sec. 52a.1. The term includes 
cooperative agreement(s).
    NIH means the National Institutes of Health and its organizational 
components that award grants.
    Nonprofit as applied to any agency or institution means an agency or 
institution which is a corporation or an association, no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    Project period means the period of time, from one to five years, 
specified in the notice of grant award that the NIH or the awarding 
component intends to support a proposed center without requiring the 
center to recompete for funds.

[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55108, Oct. 24, 1996; 
68 FR 69621, Dec. 15, 2003]



Sec. 52a.3  Who is eligible to apply?

    (a) Any public or private nonprofit agency, institution, or 
consortium of agencies is eligible to apply for a grant under sections 
409C, 414, 417, 417A, 422, 445, 445A, 445I, 447, 452A, and 2316 of the 
Act.
    (b) Any public or private nonprofit or for-profit agency, 
institution, or consortium of agencies is eligible to apply for a grant 
under sections 428, 431, 434, 441, 452C, 452E, 464C, 464J, 464N, and 
485F of the Act.
    (c) Any applicant under this part must be located in a State, the 
District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, or the successor States of the Trust Territory of 
the Pacific Islands (the Federated States of Micronesia, the Republic of 
the Marshall Islands, and the Republic of Palau).

[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55109, Oct. 24, 1996; 
68 FR 69622, Dec. 15, 2003]



Sec. 52a.4  What information must each application contain?

    Each application under this part must include detailed information 
as to the following:
    (a) The personnel, facilities, and other resources available to the 
applicant with which to initiate and maintain the proposed center grants 
program;
    (b) Any research, training, demonstration, or information 
dissemination activities in which the applicant is currently engaged; 
the sources of funding for these activities; and the relevance of these 
activities to the proposed center grants program;
    (c) Proposed research, training, demonstration, and information 
dissemination activities;
    (d) The proposed organizational structure of the center and the 
relationship of the proposed center to the applicant organization(s);
    (e) The names and qualifications of the center director and key 
staff members who would be responsible for conducting the proposed 
activities;
    (f) Proposed methods for monitoring and evaluating individual 
activities and the overall center program;
    (g) Proposed methods for coordinating the center's activities, where 
appropriate, with similar efforts by other public and private 
organizations;
    (h) The availability of any community resources necessary to carry 
out proposed activities; and
    (i) Efforts to be made to generate and collect income from sources 
other than NIH to be used to further the purposes of the center program. 
NIH encourages these efforts. Income may include, but is not limited to, 
that generated from the sale or rental of products or services produced 
by grant-supported activities, such as laboratory tests, computer time, 
and payments received from patients or third parties, where appropriate 
(the disposition of grant-related income is governed by 45 CFR 74.40 
through 74.47 and 45 CFR 92.25);
    (j) The proposed budget for the center and a justification for the 
amount of the grant funds requested; and
    (k) Any other information that the Director of the awarding 
institute may request.

(Approved under OMB Control Number 0925-0001)



Sec. 52a.5  How will NIH evaluate applications?

    (a) NIH considers the following in evaluating Center grant 
applications:
    (1) The scientific and technical merit of the proposed program;

[[Page 201]]

    (2) The qualifications and experience of the center director and 
other key personnel;
    (3) The statutory and program purposes to be accomplished;
    (4) The extent to which the various components of the proposed 
program would be coordinated into one multi-disciplinary effort within 
the center;
    (5) The extent to which the center's activities would be coordinated 
with similar efforts by other organizations;
    (6) The administrative and managerial capability of the applicant;
    (7) The reasonableness of the proposed budget in relation to the 
proposed program; and
    (8) Other factors which the awarding institute, center, or division 
considers appropriate in light of its particular statutory mission.
    (b) Where required by statute or NIH policy, applications are 
reviewed by appropriate national advisory councils or boards before 
awards are made. NIH grants may be awarded generally only after approval 
recommendations from both appropriate scientific peer review groups and 
national advisory councils or boards.



Sec. 52a.6  Information about grant awards.

    (a) The notice of grant award specifies how long NIH intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (b) Generally, the grant will initially be for one year, and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by the NIH that continued funding is in the best interest 
of the Federal Government.
    (c) Neither the approval of any application, nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.

[Approved under OMB Control Number 0925-0001]



Sec. 52a.7  For what purposes may a grantee spend grant funds?

    A grantee shall spend funds it receives under this part solely in 
accordance with the approved application and budget, the authorizing 
legislation, the regulations of this part, the terms and conditions of 
the award, and the applicable cost principles prescribed in 45 CFR 
74.27.

[61 FR 55109, Oct. 24, 1996]



Sec. 52a.8  Other HHS regulations and policies that apply.

    Several other regulations and policies apply to this part. These 
include, but are not necessarily limited to:

42 CFR part 50, Subpart A--Responsibilities of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, Subpart D--Public Health Service grant appeals 
procedures
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Uniform administrative requirements for awards and 
subawards to institutions of higher education, hospitals, other 
nonprofit organizations, and commercial organizations; and certain 
grants and agreements with states, local governments and Indian tribal 
governments
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance

[[Page 202]]

45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research.

    [Note: This policy is subject to change, and interested persons 
should contact the Office of Research on Women's Health, NIH, Room 201, 
MSC 0161, BETHESDA, MD 20892-0601 (301-402-1770; not a toll-free number) 
to obtain references to the current version and any amendments.]

59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules.

    [Note: This policy is subject to change, and interested persons 
should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 
6000 Executive Boulevard, MSA 7010, BETHESDA, MD 20892-7010 (301-496-
9838; not a toll-free number) to obtain references to the current 
version and any amendments.]

Public Health Service Policy on Humane Care and Use of Laboratory 
Animals, Office of Laboratory Animal Welfare, Office of Extramural 
Research, NIH (Revised September 1986).

    Note: This policy is subject to change, and interested persons 
should contact the Office of Laboratory Animal Welfare, Office of 
Extramural Research, NIH, Rockledge 1, 6705 Rockledge Drive, Bethesda, 
Maryland 20817, telephone 301-594-2382 (not a toll-free number) to 
obtain references to the current version and any amendments.

[57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55109, Oct. 24, 1996; 
68 FR 69622, Dec. 15, 2003]



Sec. 52a.9  Additional conditions.

    The Director may, with respect to any grant award, impose additional 
conditions prior to or at the time of any award when in the Director's 
judgment the conditions are necessary to assure the carrying out of the 
purposes of the award, the interests of the public health, or the 
conservation of grant funds.

[61 FR 55110, Oct. 24, 1996]



PART 52b_NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS--Table of Contents




Sec.
52b.1 To what programs do these regulations apply?
52b.2 Definitions.
52b.3 Who is eligible to apply?
52b.4 How to apply.
52b.5 How will NIH evaluate applications?
52b.6 What is the rate of federal financial participation?
52b.7 How is the grantee obligated to use the facility?
52b.8 How will NIH monitor the use of facilities constructed with 
          federal funds?
52b.9 What is the right of the United States to recover federal funds 
          when facilities are not used for research or are transferred?
52b.10 What are the terms and conditions of awards?
52b.11 What are the requirements for acquisition and modernization of 
          existing facilities?
52b.12 What are the minimum requirements of construction and equipment?
52b.13 Additional conditions.
52b.14 Other federal laws, regulations, executive orders, and policies 
          that apply.

    Authority: 42 U.S.C. 216, 285a-2, 285a-3, 285b-3, 285b-4, 285d-6, 
285i, 285m-3, 285o-4, 287a-2, 287a-3, 300cc-41.

    Source: 64 FR 63722, Nov. 22, 1999, unless otherwise noted.



Sec. 52b.1  To what programs do these regulations apply?

    (a) General. Except as provided in paragraph (c) of this section, 
this part applies to all grants awarded by NIH and its components for 
construction of new buildings and the alteration, renovation, 
remodeling, improvement, expansion, and repair of existing buildings, 
including the provision of equipment necessary to make the building (or 
applicable part of the building) suitable for the purpose for which it 
was constructed.
    (b) Specific programs covered. From time to time the Director may 
publish a list of the construction grant programs covered by this part. 
The list is for informational purposes only and is not intended to 
restrict the statement of applicability in paragraph (a) of this 
section. In addition, information on

[[Page 203]]

particular construction grant programs, including applications and 
instructions, may be obtained from the component of NIH that administers 
the program.
    (c) Specific programs excluded. The regulations of this part do not 
apply to minor alterations, renovations, or repairs funded under a 
research project grant (see part 52 of this chapter) or alterations or 
renovations funded under an NIH center grant (see part 52a of this 
chapter).



Sec. 52b.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Construction means the construction of new buildings or the 
modernization of, or the completion of shell space in, existing 
buildings (including the installation of fixed equipment), but excluding 
the cost of land acquisition and off-site improvements.
    Construction grant means funds awarded for construction in 
accordance with the applicable provisions of the Act and this part.
    Director means the Director of NIH or the director of an NIH 
national research institute, center, or other component of NIH, 
authorized to award grants for construction under the applicable 
provisions of the Act, and any official to whom the authority involved 
is delegated.
    Federal share with respect to any construction project means the 
proportion, expressed as a percentage, of the cost of a project to be 
paid by a grant award under the Act.
    HHS, DHHS, and Department mean the Department of Health and Human 
Services.
    Institute means any national research institute, center, or other 
agency of the National Institutes of Health.
    Modernization means the alteration, renovation, remodeling, 
improvement, expansion, and/or repair of existing buildings and the 
provision of equipment necessary to make the building suitable for use 
for the purposes of the particular program.
    NIH means the National Institutes of Health and its organizational 
components that award construction grants.
    Nonprofit as applied to any agency or institution means an agency or 
institution which is a corporation or an association, no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    Project means the particular construction activity which is 
supported by a grant under this part.
    Secretary means the Secretary of Health and Human Services and any 
official to whom the authority involved is delegated.



Sec. 52b.3  Who is eligible to apply?

    In order to be eligible for a construction grant under this part, 
the applicant must:
    (a) Be a public or private nonprofit agency or institution;
    (b) Be located in a state, the District of Columbia, Puerto Rico, 
the Virgin Islands, the Canal Zone, Guam, American Samoa, or the 
successor states of the Trust Territory of the Pacific Islands (the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau); and
    (c) Meet any additional eligibility criteria specified in the 
applicable provisions of the Act.



Sec. 52b.4  How to apply.

    Applications for construction grants under this part shall be made 
at the times and in the form and manner as the Secretary may prescribe.



Sec. 52b.5  How will NIH evaluate applications?

    (a) In evaluating and approving applications for construction grants 
under this part, the Director shall take into account, among other 
pertinent factors, the following:
    (1) The priority score assigned to the application by an NIH peer 
review group as described in paragraph (b) of this section;
    (2) The relevance of the project for which construction is proposed 
to the objectives and priorities of the particular program authorized by 
the Act;
    (3) The scientific merit of the research activities that will be 
carried out in the proposed facility;
    (4) The scientific or professional standing or reputation of the 
applicant

[[Page 204]]

and of its existing or proposed officers and research staff;
    (5) The availability, by affiliation or other association, of other 
scientific or health personnel and facilities to the extent necessary to 
carry out effectively the program proposed for the facility, including 
the adequacy of an acceptable biohazard control and containment program 
when warranted;
    (6) The need for the facility and its total effects on similar or 
related facilities in the locale, and the need for appropriate 
geographic distribution of similar facilities; and
    (7) The financial need of the applicant.
    (b) The priority score of the application shall be based, among 
other pertinent factors, on the following criteria:
    (1) The scientific merit of the total program and its component 
parts to be carried out in the facility;
    (2) The administrative and leadership capabilities of the 
applicant's officers and staff;
    (3) The organization of the applicant's research program and its 
relationship with the applicant's overall research programs;
    (4) The anticipated effect of the project on other relevant research 
programs and facilities in the geographic area, and nationwide;
    (5) The need for the project or additional space; and
    (6) The project cost and design.



Sec. 52b.6  What is the rate of federal financial participation?

    (a) Unless otherwise specified by statute, the rate of federal 
financial participation in a construction project supported by a grant 
under this part shall not be more than 50 percent of the necessary 
allowable costs of construction as determined by the Director, except 
that when the Director finds good cause for waiving this limitation, the 
amount of the construction grant may be more than 50 percent of the 
necessary allowable costs of construction.
    (b) Subject to paragraph (a) of this section, the Director shall set 
the actual rate of federal financial participation in the necessary 
allowable costs of construction, taking into consideration the most 
effective use of available federal funds to further the purposes of the 
applicable provisions of the Act.



Sec. 52b.7  How is the grantee obligated to use the facility?

    (a) The grantee shall use the facility (or that portion of the 
facility supported by a grant under this part) for its originally 
authorized purpose so long as needed for that purpose, or other period 
prescribed by statute, unless the grantee obtains advance approval from 
the Director, in the form and manner as the Director may prescribe, to 
use the facility for another purpose. Use for other purposes shall be 
limited as prescribed in Sec. 52b.9(c)(2).
    (b) The Director, in determining whether to approve an alternative 
use of the facility, shall take into consideration the extent to which:
    (1) The facility will be used by the grantee or other owner for a 
purpose described in Sec. 52b.9(c)(2); or
    (2) There are reasonable assurances that alternative facilities not 
previously used for NIH supported research will be utilized to carry out 
the original purpose as prescribed in Sec. 52b.9(c)(1).
    (c) Sale or transfer. In the form and manner as the Director may 
prescribe, the grantee may request the Director's approval to sell the 
facility or transfer title to a third party eligible under Sec. 52b.3 
for continued use of the facility for an authorized purpose in 
accordance with paragraphs (a) and (b) of this section. If approval is 
permissible under the Act or other federal statute and is granted, the 
terms of the transfer shall provide that the transferee shall assume all 
the rights and obligations of the transferor set forth in 45 CFR part 
74, the regulations of this part, and the other terms and conditions of 
the grant.



Sec. 52b.8  How will NIH monitor the use of facilities constructed with 

federal funds?

    NIH may monitor the use of each facility constructed with funds 
awarded under this part to ensure its continued use for the originally 
authorized research purpose, by means of reviewing periodic facility use 
certifications or reports, site visits, and other appropriate means.

[[Page 205]]



Sec. 52b.9  What is the right of the United States to recover Federal funds 

when facilities are not used for research or are transferred?

    (a) If the grantee plans to cease using the facility for the 
particular biomedical research or training purposes for which it was 
constructed as required by Sec. 52b.7 (or alternate use authorized 
under Sec. 52b.7(a) or paragraph (c) of this section), or the grantee 
decides to sell or transfer title to an entity ineligible for a grant 
under Sec. 52b.3, the grantee shall request disposition instructions 
from NIH in the form and manner as the Director may prescribe. Those 
instructions shall provide for one of the following alternatives:
    (1) The facility may be sold and the grantee or transferee shall pay 
to the United States an amount computed by multiplying the federal share 
of the facility times the proceeds from the sale (after deducting the 
actual and reasonable selling and fix-up expenses, if any, from the 
sales proceeds). The sales procedures must provide for competition to 
the extent practicable, and be designed to provide the highest possible 
return;
    (2) The grantee may retain title and shall pay to the United States 
an amount computed by multiplying the current fair market value of the 
facility by the federal share of the facility; or
    (3) The grantee shall transfer the title to either the United States 
or to an eligible non-federal party approved by the Director. The 
grantee shall be entitled to be paid an amount computed by multiplying 
the current fair market value of the facility by the nonfederal share of 
the facility.
    (b) The grantee or transferor of a facility which is sold or 
transferred, or the owner of a facility the use of which has changed, as 
described in paragraph (a) of this section, shall report that action in 
writing to the Director not later than 10 days from the date on which 
the sale, transfer, or change occurs, in the form and manner as the 
Director may prescribe.
    (c) In lieu of disposition of a facility pursuant to the provisions 
of paragraph (a) of this section, the Director may, for good cause, 
supported by assurances provided by the grantee or transferee, approve 
one of the following alternatives:
    (1) Transfer of the remaining usage obligation to facilities of 
substantially comparable or greater value or utility, to carry out the 
biomedical research or training purpose for which the grant was awarded. 
In this event, the remaining usage obligation shall be released from the 
original facility constructed with grant funds and transferred to the 
new facility, and the grantee shall remain subject to all other 
requirements imposed under this part with respect to the new facility; 
or
    (2) Use the facility for as long as needed, in order of priority, 
for one of the following purposes:
    (i) For other health related activities consistent with the purposes 
of one or more of the activities of the awarding institute as authorized 
under title IV or other provisions of the Act;
    (ii) To provide training and instruction in the health fields for 
health professionals or health related information programs for the 
public; or
    (iii) Other health related purposes consistent with one or more of 
the purposes authorized under the Act.
    (d) The right of recovery of the United States set forth in 
paragraph (a) of this section shall not, prior to judgment, constitute a 
lien on any facility supported in whole or in part by a federal grant, 
including a construction grant under this part.
    (e) Any amount required to be paid to the United States under this 
section will be paid to the awarding institute for disposition as 
required by law.

(Approved by the Office of Management and Budget under Control Number 
0925-0424; expires November 30, 2001)



Sec. 52b.10  What are the terms and conditions of awards?

    In addition to any other requirement imposed by law or determined by 
the Director to be reasonably necessary to fulfill the purposes of the 
grant, each construction grant shall be subject to the terms and 
conditions and the grantee assurances required by this section, 
supported by such documentation as the Director may reasonably require. 
The Director may, by general policy or for good cause shown by an 
applicant, approve exceptions to these

[[Page 206]]

terms and conditions or assurances where the Director finds that the 
exceptions are consistent with the applicable provisions of the Act and 
the purposes of the particular program:
    (a) Title. The applicant must have a fee simple or other estate or 
interest in the site, including necessary easements and rights-of-way, 
sufficient to assure for the estimated useful life of the facility, as 
determined by the Director, undisturbed use and possession for the 
purpose of the construction and operation of the facility.
    (b) Plans and specifications. Approval by the Director of the final 
working drawings, specifications, and cost estimates must be obtained 
before the project is advertised or placed on the market for bidding. 
The approval must include a determination by the Director that the final 
plans and specifications conform to the minimum standards of 
construction and equipment as set forth in Sec. 52b.12.
    (c) Relocation assistance. An applicant with an approved project 
which involves the displacement of persons or businesses shall comply 
with the provisions of the Uniform Relocation Assistance and Real 
Property Acquisition Policies Act of 1970, as amended (42 U.S.C. 4601 et 
seq.) and the applicable regulations issued under that Act (45 CFR part 
15; 49 CFR part 24).
    (d) Approval of changes in estimated cost. Unless approved by the 
Director, the applicant shall not enter into any construction contracts 
for the project or a part of the project, the cost of which exceeds the 
estimated cost approved in the terms of an award for that portion of the 
work covered by the plans and specifications. Exceptions shall be 
requested in the form and manner as the Director may prescribe.
    (e) Completion responsibility. The applicant must construct the 
project, or cause it to be constructed, to final completion in 
accordance with the grant application, the terms and conditions of the 
award, and the approved plans and specifications.
    (f) Construction schedule inspection. Prior to the start of 
construction, the grantee shall submit an approved copy of the 
construction schedule (critical path method) to the Director in the form 
and manner as the Director may prescribe.
    (g) Construction management. The applicant must provide and maintain 
competent and adequate construction management services for inspection 
at the construction site to ensure that the completed work conforms with 
the approved plans and specifications. Construction management services 
shall include daily construction logs and monthly status reports which 
shall be maintained at the job site and shall be submitted to the 
Director at the times and in the form and manner as the Director may 
prescribe.
    (h) Nonfederal share. Sufficient funds must be available to meet the 
nonfederal share of the costs of constructing the facility.
    (i) Funds for operation. Sufficient funds must be available when 
construction is completed for effective use of the facility for the 
purposes for which it is being constructed.
    (j) Inspection. The Director and the Director's representatives 
shall have access at all reasonable times to all work areas and 
documents during any stage of construction and the contractor shall 
provide proper facilities for this access and inspection.
    (k) Accessibility to handicapped persons. The facility must be 
designed to comply with the Uniform Federal Accessibility Standards (41 
CFR part 101-19, subpart 101-19.6, Appendix A), as modified by other 
standards prescribed by the Director or the Administrator of General 
Services. The applicant shall conduct inspections to ensure compliance 
with these specifications by the contractor.
    (l) Notice of Federal Interest. The grantee shall record a Notice of 
Federal Interest in the appropriate official land records of the 
jurisdiction in which the property is located.
    (m) Title insurance. The grantee shall purchase a title insurance 
policy unless a legal opinion has been provided which certifies that the 
grantee institution has fee simple title to the site free and clear of 
all liens, easements, rights-of-way, and any other adverse interests 
which would encumber the project. The Director may waive this 
requirement upon a request from the grantee adequately documenting self-
insurance

[[Page 207]]

against the risks involved and containing such other information as the 
Director may prescribe.
    (n) Physical destruction insurance. At the time construction is 
completed or at the time of beneficial occupancy, whichever comes first, 
the grantee shall purchase an insurance policy which insures the 
facility for the full appraised value of the property using state 
certified appraisers. The insurance policy must protect the property 
from total and partial physical destruction. The insurance policy must 
be maintained throughout the period of federal interest. The Director 
may waive this requirement upon a written request from the grantee 
adequately documenting self-insurance against the risks involved and 
containing such other information as the Director may prescribe.

(Approved by the Office of Management and Budget under Control Number 
0925-0424; expires November 30, 2001)



Sec. 52b.11  What are the requirements for acquisition and modernization of 

existing facilities?

    Grant awards for the acquisition and modernization of existing 
facilities are permitted if authorized by the statutes authorizing the 
construction grant program and shall be subject to the requirements of 
this section.
    (a) Minimum standards of construction and equipment. A determination 
by the Director that the facility conforms (or upon completion of any 
necessary construction will conform) to the minimum standards of 
construction and equipment as set forth in Sec. 52b.12 shall be 
obtained before entering into a final or unconditional contract for the 
acquisition and/or modernization of facilities. Where the Director finds 
that exceptions to or modifications of these minimum standards would be 
consistent with the purposes of the applicable section of the Act under 
which the acquisition or modernization is supported, the Director may 
authorize the exceptions or modifications.
    (b) Estimated cost of acquisition and remodeling: suitability of 
facility. Each application for a project involving the acquisition of 
existing facilities shall include in the detailed estimates of the costs 
of the project, the cost of acquiring the facilities, and any cost of 
remodeling, renovating or altering the facilities to serve the purposes 
for which they are acquired. The application shall demonstrate to the 
satisfaction of the Director that the architectural, mechanical, 
electrical, plumbing, structural, and other pertinent features of the 
facility, as modified by any proposed expansion, remodeling, renovation, 
or alteration, will be suitable for the purposes of the applicable 
sections of the Act.
    (c) Bona fide sale. Grant awards for the acquisition of existing 
facilities shall be subject to the condition that the acquisition 
constitutes a bona fide sale involving an actual cost to the applicant 
and will result in additional or improved facilities for purposes of the 
applicable provisions of the Act.
    (d) Facility previously funded by a federal grant. No grant for the 
acquisition or modernization of a facility which has previously been 
funded in whole or in part by a federal grant for construction, 
acquisition, or equipment shall serve either to reduce or restrict the 
liability of the applicant or any other transferor or transferee from 
any obligation of accountability imposed by the Federal Government by 
reason of the prior grant.

(Approved by the Office of Management and Budget under Control Number 
0925-0424; expires November 30, 2001)



Sec. 52b.12  What are the minimum requirements of construction and equipment?

    (a) General. In addition to being subject to other laws, 
regulations, executive orders, and policies referred to in Sec. 52b.14, 
the standards set forth in this section have been determined by the 
Director to constitute minimum requirements of construction and 
equipment, including the expansion, remodeling, renovation, or 
alteration of existing buildings, and these standards, as may be 
amended, or any revisions or successors of these standards, shall apply 
to all projects for which federal assistance is requested under this 
part. The publications referenced in this section are hereby 
incorporated by reference and made a part of the regulations in this 
part.

[[Page 208]]

    (b) Incorporation by reference. The Director of the Federal Register 
approves the incorporations by reference in paragraph (c) of this 
section in accordance with 5 U.S.C. 552(a)(1) and 1 CFR part 51. Copies 
may also be obtained from the organizations at the addresses listed in 
paragraph (c) of this section. Copies may be inspected at the National 
Cancer Institute, Executive Plaza North, Room 539, 6130 Executive 
Boulevard, Rockville, MD 20852 (telephone 301-496-8534; not a toll-free 
number); the National Center for Research Services, Building 31, Room 
3B11, 9000 Rockville Pike, Bethesda, MD 20892 (telephone 301-496-5793); 
not a toll-free number); and at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. 
The Director may for good cause shown, approve plans and specifications 
which contain deviations from the requirements prescribed in paragraph 
(c) of this section, if the Director is satisfied that the purposes of 
the requirements have been fulfilled. In addition to these requirements, 
each project shall meet the requirements of the applicable state and 
local codes and ordinances relating to construction.
    (c) Design and construction standards. The facility shall comply 
with the following mandatory design and construction standards:
    (1) ``Guidelines for Design and Construction of Hospital and Health 
Care Facilities'' (1996-97). American Institute of Architects Academy of 
Architecture for Health (AIA); available from AIA Rizzoli Catalogue 
Sales, 117 Post Street, San Francisco, CA 94108 (telephone 1-800-522-
6657, fax 415-984-0024).
    (2) 1995 ASHRAE Handbook: Heating, Ventilating, and Air Conditioning 
Applications (1995), Chapter 13, ``Laboratory Systems.'' American 
Society of Heating, Refrigerating and Air Conditioning Engineers, Inc., 
1791 Tullie Circle, NE, Atlanta, GA 30329 (telephone 404-636-8400).
    (3) ICBO ``Uniform Building Code,'' Volumes 1-3 (1997). 
International Conference of Building Officials (ICBO), 5360 South 
Workman Mill Road, Whittier, CA 90601-2298 (telephone 562-699-0541 or 
800-284-4406).
    (4) BOCA National Building Code (1996) 1998 Supplement, Building 
Officials and Code Administrators International, Inc. (BOCA), 4051 West 
Fossmoor Road, Country Club Hills, IL 60478-5795 (telephone 708-799-
4981; fax 708-799-4981).
    (5) ``Recommended Lateral Force Requirements and Commentary'' 
(1996). Structural Engineers Association of California; available from 
International Conference of Building Officials, 5360 South Workman Mill 
Road, Whittier, CA 90601-2298 (telephone 562-699-0541).
    (6) ``Prudent Practices in the Laboratory: Handling and Disposal of 
Chemicals'' (1995). National Research Council; available from National 
Academy Press, 8700 Spectrum Drive, Landover, MD 20785 (telephone 1-800-
624-6242).
    (7) The following material is available for purchase from the 
National Fire Protection Association (NFPA), 11 Tracy Drive, Avon, MA 
02322-9908 (telephone 617-770-3000 or 1-800-735-0100):
    (i) NFPA 45, ``Standard on Protection for Laboratories Using 
Chemicals'' (1996).
    (ii) NFPA 70, ``National Electric Code'' (1996).
    (iii) NFPA 99, Chapter 4, ``Gas and Vacuum Systems'' (1996).
    (iv) NFPA 101, ``Life Safety Code'' (1997).
    (v) NFPA ``Health Care Facilities Handbook'' (1996).
    (8) NSF Standard No. 49 for Class II (Laminar Flow) Biohazard 
Cabinetry (1992). National Sanitation Foundation (NSF), 3475 Plymouth 
Road, Box 1468, Ann Arbor, MI 48106 (telephone 734-769-9010).
    (9) ACGIH ``Industrial Ventilation: A Manual of Recommended 
Practice'' (1998). American Conference of Governmental Industrial 
Hygienists (ACGIH), 1330 Kemper Meadow Drive, Cincinnati, OH 45240-1634 
(telephone 513-742-2020).
    (10) AIHA ``Laboratory Ventilation Workbook'' (1994). American 
Industrial Hygiene Association (AIHA), 2700 Prosperity Avenue, Suite 
250, Fairfax, VA 22031 (telephone 703-849-8888).

[[Page 209]]

    (11) The following material is available for purchase from the 
Southern Building Code Congress (SBCC), 900 Montclair Road, Birmingham, 
AL 35213-1206 (telephone 205-591-1853; fax 202-591-0075:
    (i) SBCC ``International Standard Plumbing Code'' (1997).
    (ii) SBCC ``Standard Building Code'' (1997).

[64 FR 63722, Nov. 22, 1999, as amended at 69 FR 18803, Apr. 9, 2004]



Sec. 52b.13  Additional conditions.

    The Director may with respect to any grant award impose additional 
conditions consistent with the regulations of this part prior to or at 
the time of any award when in the Director's judgment the conditions are 
necessary to assure or protect advancement of the approved project, the 
purposes of the applicable provisions of the Act, or the conservation of 
grant funds.



Sec. 52b.14  Other federal laws, regulations, executive orders, and policies 

that apply.

    Other federal laws, regulations, executive orders, and policies 
apply to grants under this part. These include, but are not necessarily 
limited to:
    (a) Laws.
    An Act to Provide for the Preservation of Historical and 
Archeological Data (and other purposes), as amended (16 U.S.C. 469 et 
seq.).

Architectural Barriers Act of 1968, as amended (42 U.S.C. 4151 et seq.).
Earthquake Hazards Reduction Act of 1977, as amended (42 U.S.C. 7701 et 
seq.).
Flood Disaster Protection Act of 1973, section 202, as amended (42 
U.S.C. 4106).
National Historic Preservation Act, section 106, as amended (16 U.S.C. 
470f).
Safe Drinking Water Act, as amended (42 U.S.C. 300f et seq.).

    (b) Regulations.

9 CFR part 3--Standards (Animal Welfare).
29 CFR 1910.1450--Occupational exposure to hazardous chemicals in 
laboratories.
36 CFR part 1190--Minimum guidelines and requirements for accessible 
design.
41 CFR part 101-19, subpart 101-19.6--Accommodations for the physically 
handicapped.
41 CFR part 101-19, subpart 101-19.6, Appendix A--Uniform Federal 
accessibility standards.
42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science.
42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure.
45 CFR part 15--Uniform relocation assistance and real property 
acquisition for Federal and federally assisted programs.
45 CFR part 16--Procedures of the Departmental Grant Appeals Board.
45 CFR part 46--Protection of human subjects.
45 CFR part 74--Uniform administrative requirements for awards and 
subawards to institutions of higher education, hospitals, other 
nonprofit organizations, and commercial organizations; and certain 
grants and agreements with states, local governments and Indian tribal 
governments.
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants).
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
effectuation of title VI of the Civil Rights Act of 1964.
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this chapter.
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance.
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefitting from Federal financial 
assistance.
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to State and local governments.
45 CFR part 93--New restrictions on lobbying.
49 CFR part 24--Uniform relocation assistance and real property 
acquisition for Federal and federally assisted programs.

    (c) Executive orders.

Executive Order 11988, Floodplain Management (May 24, 1977)(3 CFR, 1977 
Comp., p. 117).
Executive Order 11990, Protection of Wetlands (May 24, 1977)(3 CFR, 1977 
Comp., p. 121).
Executive Order 12699, Seismic Safety of Federal and Federally Assisted 
or Regulated New Building Construction (January 5, 1990)(3 CFR, 1990 
Comp., p. 269).

    (d) Policies. (1) Design Policy and Guidelines (1996). Division of 
Engineering Services, National Institutes of Health (Note: To obtain 
copies of the

[[Page 210]]

policy, interested persons should contact the Division of Engineering 
Services, 9000 Rockville Pike, Building 13, Room 2E43, Bethesda, MD 
20892 (telephone 301-496-6186; not a toll-free number) or visit the 
following site on the World Wide Web (http://des.od.nih/gov/
nihpol.html).).
    (2) NIH Guidelines on the Inclusion of Women and Minorities as 
Subjects in Clinical Research (1994) (Note: To obtain copies of the 
policy, interested persons should contact the Office of Research on 
Women's Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD 20892-
0161 (telephone 301-402-1770; not a toll-free number).).
    (3) NIH Guidelines for Research Involving Recombinant DNA Molecules 
(1994) (Note: To obtain copies of the policy, interested persons should 
contact the Office of Recombinant DNA Activities, NIH, 6000 Executive 
Boulevard, Suite 323, MSC 7010, Bethesda, MD 20892-7010 (telephone 301-
496-9838; not a toll-free number).).
    (4) ``NIH Grants Policy Statement.'' NIH Pub. No. 99-80 (Oct. 1998) 
(Note: To obtain copies of the policy, interested persons should contact 
the Extramural Outreach and Information Resources Office (EOIRO), Office 
of Extramural Research, NIH, 6701 Rockledge Drive, Room 6208, MSC 7910, 
Bethesda, MD 20892-7910 (telephone 301-435-0714; not a toll-free 
number). Information may also be obtained by contacting the EOIRO via 
its e-mail address (asknih@odrockml.od.nih.gov) and by browsing the NIH 
Home Page site on the World Wide Web (http://www.nih.gov).).
    (5) ``Guide for the Care and Use of Laboratory Animals (1996). 
Institute of Laboratory Animal Resources, Commission on Life Sciences, 
National Research Council (Note: To obtain copies of the policy, 
interested persons should contact the Office for Protection from 
Research Risks, NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507, 
Rockville, MD 20852-7507 (telephone 301-496-7005; not a toll-free 
number).).
    (6) ``Public Health Service Policy on Humane Care and Use of 
Laboratory Animals.'' (Rev. Sept. 1986). Office for Protection from 
Research Risks, NIH (Note: To obtain copies of the policy, interested 
persons should contact the Office for Protection from Research Risks, 
NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, MD 
20852-7507 (telephone 301-496-7005; not a toll-free number).).
    (7) ``Biosafety in Microbiological and Biomedical Laboratories.'' 
DHHS Publication No. (CDC) 88-8395 (1993). Centers for Disease Control 
and Prevention (CDC) (Note: To obtain copies of the policy, interested 
persons should contact the Division of Safety, Occupational Safety and 
Health Branch, NIH, 13 South Drive, Room 3K04, MSC 5760, Bethesda, MD 
20892-5760 (telephone 301-496-2960; not a toll-free number).).
    (8) ``NIH Guidelines for the Laboratory Use of Chemical 
Carcinogens,'' DHHS Publication No. (NIH) 81-2385 (May 1981) (Note: To 
obtain copies of the policy, interested persons should contact the 
Division of Safety, Occupational Safety and Health Branch, NIH, 13 South 
Drive, Room 3K04, MSC 5760, Bethesda, MD 20892-5760 (telephone 301-496-
2960; not a toll-free number).).
    (9) ``NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects (March 6, 1998).'' NIH 
Guide for Grants and Contracts (Note: To obtain copies of the policy, 
interested persons should contact the Office of Extramural Research, 
NIH, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, MD 20817-7910 
(telephone 301-435-0714; not a toll-free number). Information may also 
be obtained by browsing the NIH Home Page site on the World Wide Web 
(http://www.nih.gov).).



PART 52c_MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM--Table of Contents




Sec.
52c.1 Applicability.
52c.2 Definitions.
52c.3 Eligibility.
52c.4 Application.
52c.5 Grant awards.
52c.6 Expenditure of grant funds.
52c.7 Other HHS regulations that apply.
52c.8 Additional conditions.

    Authority: 42 U.S.C. 216, 241(a)(3).

    Source: 45 FR 12246, Feb. 25, 1980, unless otherwise noted.

[[Page 211]]



Sec. 52c.1  Applicability.

    The regulations in this part apply to grants (under the Minority 
Biomedical Research Support Program) awarded in accordance with section 
301(a)(3) of the Public Health Service (PHS) Act (42 U.S.C. 241(a)(3)) 
to increase the numbers of ethnic minority faculty, students, and 
investigators engaged in biomedical research, and to broaden the 
opportunities for participation in biomedical research of ethnic 
minority faculty, students, and investigators, by providing general 
support for biomedical research programs at eligible institutions.

[58 FR 61030, Nov. 19, 1993]



Sec. 52c.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Ethnic minorities includes but is not limited to such groups as 
Black Americans, Hispanic Americans, Asian/Pacific Islanders, and 
American Indians/Native Alaskans (Native Americans).
    HHS means the Department of Health and Human Services.
    Nonprofit as applied to any institution means an institution which 
is a corporation or association no part of the net earnings of which 
inures or may lawfully inure to the benefit of any private shareholder 
or individual.
    Program director means a single individual, designated in the grant 
application, who is scientifically trained and has research experience 
and who is responsible for the overall execution of the program 
supported under this part at the grantee institution.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.

[58 FR 61030, Nov. 19, 1993]



Sec. 52c.3  Eligibility.

    To be eligible for a grant under this Program, an applicant must be:
    (a) One of the following:
    (1) A public or private nonprofit university, four year college, or 
other institution offering undergraduate, graduate, or health 
professional degrees, with a traditionally high (more than 50 percent) 
minority student enrollment;
    (2) A public or private nonprofit two year college with a 
traditionally high (more than 50 percent) minority student enrollment;
    (3) A public or private nonprofit university, four year college, or 
other institution offering undergraduate, graduate, or health 
professional degrees, with a student enrollment a significant proportion 
(but not necessarily more than 50 percent) of which is derived from 
ethnic minorities, provided the Secretary determines that said 
institution has a demonstrated commitment to the special encouragement 
of and assistance to ethnic minority faculty, students, and 
investigators; or
    (4) An Indian tribe which has a recognized governing body which 
performs substantial governmental functions, or an Alaska Regional 
Corporation as defined in the Alaska Native Claims Settlement Act (43 
U.S.C. 1601 et seq.), and
    (b) Located in a State, the District of Columbia, Puerto Rico, the 
Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor 
States of the Trust Territory of the Pacific Islands (the Federated 
States of Micronesia, the Republic of the Marshall Islands, and the 
Republic of Palau).

[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 58 FR 61030, 
Nov. 19, 1993]



Sec. 52c.4  Application.

    An institution interested in applying for a grant under this part 
must submit an application at the time and in the form and manner that 
the Secretary may prescribe.

[58 FR 61030, Nov. 19, 1993]



Sec. 52c.5  Grant awards.

    (a) Within the limits of funds available, and upon such 
recommendation as may be required by law, the Secretary shall award 
grants to those applications with proposed biomedical research programs 
which will, in the Secretary's judgment, best promote the purposes of 
this part, taking into consideration among other pertinent factors:

[[Page 212]]

    (1) The benefits that can be expected to accrue to the national 
effort in biomedical research and in increasing the pool of biomedical 
researchers;
    (2) The institution's capability, from a scientific and technical 
standpoint, to engage in biomedical research;
    (3) The benefits that can be expected to accrue to the institution 
and its students;
    (4) The administrative and managerial capability and competence of 
the applicant;
    (5) The availability of the facilities and resources (including 
where necessary collaborative arrangements with other institutions) to 
engage in biomedical research;
    (6) The applicant's relative need for funding; and
    (7) The overall significance of the proposal in terms of numbers of 
ethnic minority persons benefited thereby.
    (b) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (c) Generally the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by HHS that continued funding is in the best interest of 
the government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.

[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 58 FR 61030, 
Nov. 19, 1993]



Sec. 52c.6  Expenditure of grant funds.

    (a) Any funds granted pursuant to this part shall be expended solely 
for the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the terms 
and conditions of the award, and the applicable cost principles 
prescribed by subpart Q of 45 CFR part 74.
    (b) The Secretary may permit unobligated grant funds remaining in 
the grant account at the close of a budget period to be carried forward 
for obligation during a subsequent budget period, provided a 
continuation award is made for that period and the Secretary's written 
approval is obtained. The amount of any subsequent award will take into 
consideration unobligated grant funds remaining in the grant account.

[45 FR 12246, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980; 45 FR 68392, 
Oct. 15, 1980]



Sec. 52c.7  Other HHS regulations that apply.

    Several other regulations and policies apply to grants under this 
part. These include, but are not necessarily limited to:

37 CFR part 401--Rights to inventions made by nonprofit organizations 
and small business firms under government grants, contracts, and 
cooperative agreements
42 CFR part 50, subpart A--Responsibilities of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals 
procedures
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving Federal financial assistance

[[Page 213]]

45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs 
and activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
51 FR 16958, or successor--NIH Guidelines for Research Involving 
Recombinant DNA Molecules
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office for Protection from Research Risks, NIH (Revised 
September 1986), or successor

[58 FR 61030, Nov. 19, 1993]



Sec. 52c.8  Additional conditions.

    The Secretary may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in the Secretary's 
judgment those conditions are necessary to assure or protect advancement 
of the approved program, the interests of the public health, or the 
conservation of grant funds.



PART 52d_NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM--Table of 

Contents




Sec.
52d.1 Applicability.
52d.2 Definitions.
52d.3 Eligibility.
52d.4 Application.
52d.5 Program requirements.
52d.6 Grant awards.
52d.7 Expenditure of grant funds.
52d.8 Other HHS regulations that apply.
52d.9 Additional conditions.

    Authority: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 
U.S.C. 216); sec. 404(a)(4), 92 Stat. 3426 (42 U.S.C. 285).

    Source: 45 FR 12247, Feb. 25, 1980, unless otherwise noted.



Sec. 52d.1  Applicability.

    The regulations in this part apply to grants under the Clinical 
Cancer Education Program authorized by section 404(a)(4) of the Public 
Health Service Act, to encourage planning and development of 
multidisciplinary educational programs aimed at achieving optimal care 
of cancer patients and to enable students in the health professions to 
acquire basic knowledge of neoplastic disease and the preventive 
measures and diagnostic and therapeutic skills necessary to the 
provision of such care.



Sec. 52d.2  Definitions.

    (a) Act means the Public Health Service Act, as amended.
    (b) Director, NCI, means the Director of the National Cancer 
Institute and any other officer or employee of said Institute to whom 
the authority involved has been delegated.
    (c) [Reserved]
    (d) Board means the National Cancer Advisory Board established by 
section 407 of the Act (42 U.S.C. 286b).
    (e) Affiliated teaching hospital means a hospital which, although 
not owned by such school, has a written agreement with a school of 
medicine, osteopathy, dentistry, or public health eligible for 
assistance under this part, providing for effective control by the 
school of the teaching in the hospital.
    (f) Specialized cancer institute means an institution which has as 
its primary mission the diagnosis, prevention, or treatment of cancer.

[45 FR 12247, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980, as amended at 
47 FR 53012, Nov. 24, 1982]



Sec. 52d.3  Eligibility.

    To be eligible for a grant under this part, an applicant must be:
    (a) A public or private school of medicine, osteopathy, dentistry, 
or public health, affiliated teaching hospital, or specialized cancer 
institute; and
    (b) Located in a State, the District of Columbia, Puerto Rico, the 
Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust 
Territory of the Pacific Islands.

[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]



Sec. 52d.4  Application.

    (a) Application for a grant under this subpart shall be made on an 
authorized

[[Page 214]]

form. \1\ Applicants shall submit completed forms, on or before the 
dates the Director, NCI, may prescribe.
---------------------------------------------------------------------------

    \1\ Applications and instructions are available from the Division of 
Cancer Research Resources and Centers, Education Branch, Westwood 
Building, 5333 Westbard Avenue, Bethesda, MD 20205.
---------------------------------------------------------------------------

    (b) [Reserved]
    (c) In addition to any other pertinent information that the 
Director, NCI, may require, each application shall set forth in detail:
    (1) A program plan defining the objectives of the proposed program 
and the means by which these objectives would be achieved, including 
descriptions of:
    (i) The general educational level (e.g., pre-doctoral, post-
doctoral) of the students to be involved in the program;
    (ii) The proposed course of study and its relation to the diagnosis, 
prevention, control, and treatment of cancer;
    (iii) The clinical experiences to be provided to the students;
    (iv) Multidisciplinary aspects of the program;
    (v) The particular schools or branches within the institution which 
would have responsibility for individual aspects of the program; and
    (vi) The teaching mechanisms to be employed, including specific 
discussion of those techniques which would be innovative.
    (2) The availability of personnel, facilities, and resources needed 
to carry out the program;
    (3) The names, qualifications, and proposed duties of the program 
director and any staff members who would be responsible for the program, 
including a description of those duties which would actually be carried 
out by the program director and those which would be shared with or 
assigned to others;
    (4) The names and qualifications of proposed members of a cancer 
education committee which would be established by the applicant to 
advise it on the planning, organization, operation and evaluation of the 
program and the specific duties which would be assigned to said 
committee;
    (5) Insofar as necessary, cooperative arrangements with other 
schools, hospitals, and institutions which would participate in the 
program;
    (6) The proposed project period, a detailed budget for the first 
budget period including a list of other anticipated sources of support 
and anticipated total needs for each of the succeeding budget periods of 
the requested project period, and a justification for the amount of 
grant funds requested;
    (7) Proposed methods for monitoring and evaluating the program; and
    (8) A description of how the education and training effort will be 
sustained upon expiration of the award.

[45 FR 12247, Feb. 25, 1980, as amended at 47 FR 53012, Nov. 24, 1982]



Sec. 52d.5  Program requirements.

    (a) If the program is to be offered at the graduate level, it must 
be multidisciplinary in scope involving at least two or more clinical or 
preclinical sciences relating to cancer;
    (b) The cancer education committee provided for in the approved 
application must meet at least four times per year, and must be chaired 
by the program director.



Sec. 52d.6  Grant awards.

    (a) Within the limits of funds available, after consultation with 
the Board, the Director, NCI, may award grants to applicants with 
proposed programs which in the NCI Director's judgment best promote the 
purposes of this part, taking into consideration among other pertinent 
factors:
    (1) The relevance of the proposed program to the objectives of this 
part;
    (2) The extent to which the program would involve innovative 
teaching techniques;
    (3) The availability of adequate staff, facilities, and resources 
(including where necessary cooperative arrangements with other 
institutions or hospitals) to carry out the program;
    (4) The qualifications and experience of the program director;
    (5) The authority of the program director to ensure that the program 
is planned with multidisciplinary input and that multidisciplinary 
aspects of the program are carried out;
    (6) The extent to which the cancer education committee is broadly 
representative of the disciplines concerned

[[Page 215]]

with cancer care and teaching and is allowed to participate in the 
planning, organization, operation, and evaluation of the program;
    (7) If the program is to be offered at the pre-doctoral level, the 
extent to which its objectives are designed to aid students:
    (i) To acquire a basic understanding of fundamental principles of 
cancer biology, epidemiology, detection, diagnosis, prevention, 
treatment and control;
    (ii) To interest students in learning more about cancer; and
    (iii) To develop an appreciation of the need for a comprehensive 
multidisciplinary approach to the care of cancer patients;
    (8) The administrative and managerial capability of the applicant;
    (9) The reasonableness of the proposed budget in relation to the 
proposed program;
    (10) The adequacy of the methods for monitoring and evaluating the 
program on a continuing basis; and
    (11) The degree to which the application adequately provides for the 
requirements set forth in Sec. 52d.5.
    (b) The notice of grant award specifies how long HHS intends to 
support the program without requiring the program to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (c) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by HHS that continued funding is in the best interest of 
the government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.



Sec. 52d.7  Expenditure of grant funds.

    (a) Any funds granted pursuant to this part shall be expended solely 
for the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the terms 
and conditions of the awards, and the applicable cost principles 
prescribed by subpart Q of 45 CFR part 74, except that grant funds may 
not be used for costs incurred in connection with activities which, 
prior to the grant, were part of the grantee's standard curriculum.
    (b) The Director, NCI, may permit unobligated grant funds remaining 
in the grant account at the close of a budget period to be carried 
forward for obligation during a subsequent budget period, provided a 
continuation award is made for that period and the NCI Director's 
written approval is obtained. The amount of any subsequent award will 
take into consideration unobligated grant funds remaining in the grant 
account.



Sec. 52d.8  Other HHS regulations that apply.

    Several other regulations apply to grants under this subpart. These 
include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[49 FR 38111, Sept. 27, 1984]

[[Page 216]]



Sec. 52d.9  Additional conditions.

    The Director, NCI, may with respect to any grant award impose 
additional conditions prior to or at the time of any award when in the 
NCI Director's judgment those conditions are necessary to assure or 
protect advancement of the approved program, the interests of the public 
health, or the conservation of grant funds.



PART 52e_NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION AND 

CONTROL PROJECTS--Table of Contents




Sec.
52e.1 To what programs do these regulations apply?
52e.2 Definitions.
52e.3 Who is eligible to apply?
52e.4 How to apply.
52e.5 What are the project requirements?
52e.6 How will NIH evaluate applications?
52e.7 What are the terms and conditions of awards?
52e.8 Other HHS regulations and policies that apply.
52e.9 Additional conditions.

    Authority: 42 U.S.C. 216, 285b-1.

    Source: 45 FR 12249, Feb. 25, 1980, unless otherwise noted.



Sec. 52e.1  To what programs do these regulations apply?

    (a) This part applies to grants under section 419 of the Act (42 
U.S.C. 285b-1) for projects to:
    (1) Demonstrate and evaluate the effectiveness of new techniques or 
procedures for the prevention and control of heart, blood vessel, lung, 
and blood diseases, with special consideration given to the prevention 
and control of these diseases in children, and in populations that are 
at increased risk with respect to such diseases;
    (2) Develop and evaluate methods of educating health practitioners 
concerning the prevention and control of these diseases; and
    (3) Develop and evaluate methods of educating the public concerning 
the prevention and control of these diseases.
    (b) For purposes of this part, prevention and control projects shall 
include community-based and population-based programs carried out in 
cooperation with other Federal agencies, with public health agencies of 
State or local governments, with nonprofit private entities that are 
community-based health agencies, or with other appropriate public or 
nonprofit private entities.

[45 FR 12249, Feb. 25, 1980; 45 FR 20097, Mar. 27, 1980, as amended at 
58 FR 54298, Oct. 21, 1993; 59 FR 59372, Nov. 17, 1994]



Sec. 52e.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Council means the National Heart, Lung, and Blood Advisory Council, 
established under section 406 of the Act (42 U.S.C. 284a).
    Director means the Director of the National Heart, Lung, and Blood 
Institute and any official to whom the authority involved may be 
delegated.
    Emergency medical services means the services utilized in responding 
to the perceived individual need for immediate medical care in order to 
prevent loss of life or aggravation of physiological or psychological 
illness or injury.
    HHS means the Department of Health and Human Services.
    National program means the National Heart, Blood Vessel, Lung, and 
Blood Diseases and Blood Resources Program referred to in section 421 of 
the Act (42 U.S.C. 285b-3).
    Nonprofit as applied to any agency or institution means an agency or 
institution which is a corporation or an association, no part of the net 
earnings of which inures or may lawfully inure to the benefit of any 
private shareholder or individual.
    PHS means the Public Health Service.

[58 FR 54298, Oct. 21, 1993]



Sec. 52e.3  Who is eligible to apply?

    To be eligible for a grant under this part, an applicant must be a 
public or nonprofit private agency or institution.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]

[[Page 217]]



Sec. 52e.4  How to apply.

    (a) Application for a grant under this subpart shall be made on an 
authorized form. \2\ Applicants shall submit completed forms on or 
before the dates the Director may prescribe.
---------------------------------------------------------------------------

    \2\ Applications and instructions are available from the Division of 
Extramural Affairs, National Heart, Lung, and Blood Institute, National 
Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20205.
---------------------------------------------------------------------------

    (b) Each private institution which does not already have on file 
with the National Institutes of Health evidence of nonprofit status, 
must submit with its application acceptable proof of such status.
    (c) In addition to any other pertinent information that the Director 
may require each application shall set forth in detail:
    (1) The nature and purpose of the proposed project and the methods 
to be employed in carrying it out;
    (2) The relevance of the proposed project to the National Program;
    (3) The defined population to participate in the proposed project 
and the rationale for its selection;
    (4) With respect to applications relating to projects covered by 
Sec. 52e.1(a)(1), prior research findings on which the proposed project 
is based;
    (5) The personnel, facilities, and other resources, including 
community resources, available to carry out the proposed project;
    (6) Current activities of the applicant involving prevention or 
control of heart, blood vessel, lung, and blood diseases, the sources of 
funding for such activities, and the anticipated relationship of these 
activities to the proposed project;
    (7) The names and qualifications of the project director and key 
staff members who would be responsible for conducting the proposed 
project;
    (8) Proposed methods for monitoring and evaluating the project; and
    (9) The proposed project period; a detailed budget for the first 
budget period, including a list of other anticipated sources of support 
and anticipated total needs for each of the succeeding budget periods of 
the requested project period; and a justification for the amount of 
grant funds requested.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]



Sec. 52e.5  What are the project requirements?

    (a) An approvable application must demonstrate to the satisfaction 
of the Director that:
    (1) With respect to applications relating to projects covered by 
Sec. 52e.1(a)(1), the techniques or procedures to be demonstrated and 
evaluated have been found safe and effective in the research setting 
and, based upon research findings, appear to have the potential for 
general applicability to the prevention, diagnosis, or treatment of 
heart, blood vessel, lung, or blood diseases;
    (2) With respect to applications relating to projects covered by 
Sec. 52e.1(a)(2) and Sec. 52e.1(a)(3), the project will include 
development and evaluation of one or more methods for educating health 
practitioners or the public concerning advances in the prevention, 
diagnosis, or treatment of such diseases; and
    (3) The nature of the project is such that its completion may be 
anticipated within the project period, or such other period as may be 
specified in the application.
    (b) The project must, in the judgment of the Director, be necessary 
for cooperation by the National Heart, Lung, and Blood Institute with 
one or more other Federal Health agencies, State, local or regional 
public health agencies, or nonprofit private health agencies in the 
diagnosis, prevention, or treatment of heart, blood vessel, lung or 
blood diseases.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298 and 54299, Oct. 
21, 1993]



Sec. 52e.6  How will NIH evaluate applications?

    (a) Within the limits of funds available, after consultation with 
the Council, the Director may award grants to applicants with proposed 
projects which in the Director's judgment will best promote the purposes 
of section 419 of the Act, taking into consideration among other 
pertinent factors:
    (1) The scientific and technical merit of the proposed project;

[[Page 218]]

    (2) The significance of the project in relation to the goals of the 
National Program;
    (3) Whether the project appropriately emphasizes the prevention, 
diagnosis, or treatment of heart, blood vessel, lung, or blood diseases 
of children;
    (4) The qualifications and experience of the project director and 
other key personnel;
    (5) The administrative and managerial capability and fiscal 
responsibility of the applicant;
    (6) The reasonableness of the proposed budget in relation to the 
proposed project;
    (7) The adequacy of the methods proposed for monitoring and 
evaluating the proposed project; and
    (8) The degree to which the application adequately provides for the 
requirements set forth in Sec. Sec. 52e.5(a) and 52e.5(b).
    (b) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (c) Generally, the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
grantee must submit a separate application to have the support continued 
for each subsequent year. Decisions regarding continuation awards and 
the funding level of such awards will be made after consideration of 
such factors as the grantee's progress and management practices, and the 
availability of funds. In all cases, continuation awards require a 
determination by HHS that continued funding is in the best interest of 
the government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.
    (e) Any funds granted under this part shall be expended solely for 
the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the 
terms, and conditions of the award, and the applicable cost principles 
prescribed in subpart Q of 45 CFR part 74.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]



Sec. 52e.7  What are the terms and conditions of awards?

    (a) Any funds granted pursuant to this part shall be expended solely 
for the purposes for which the funds were granted in accordance with the 
approved application and budget, the regulations of this part, the terms 
and conditions of the award, and the applicable cost principles 
prescribed by subpart Q of 45 CFR part 74.
    (b) The Director may permit unobligated grant funds remaining in the 
grant account at the close of a budget period to be carried forward for 
obligation during a subsequent budget period, provided a continuation 
award is made for that period and the NHLBI Director's written approval 
is obtained. The amount of any subsequent award will take into 
consideration unobligated grant funds remaining in the grant account.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298 and 54299, Oct. 
21, 1993]



Sec. 52e.8  Other HHS regulations and policies that apply.

    Several other regulations apply to grants under this part. These 
include but are not necessarily limited to:

42 CFR part 50, subpart A--Responsibility of PHS awardee and applicant 
institutions for dealing with and reporting possible misconduct in 
science
42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 76--Governmentwide debarment and suspension (nonprocurement) 
and governmentwide requirements for drug-free workplace (grants)
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services--
Effectuation of Title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearings under part 80 of 
this title

[[Page 219]]

45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in education 
programs and activities receiving or benefiting from Federal financial 
assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to State and local governments
45 CFR part 93--New restrictions on lobbying
51 FR 16958 or successor--NIH Guidelines for Research Involving 
Recombinant DNA Molecules
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office for Protection from Research Risks, NIH (Revised 
September 1986), or successor
59 FR 14508 (as republished March 28, 1994), as may be amended, or its 
successor--NIH Guidelines on the Inclusion of Women and Minorities as 
Subjects in Clinical Research.

[58 FR 54298, Oct. 21, 1993, as amended at 59 FR 59372, Nov. 17, 1994]



Sec. 52e.9  Additional conditions.

    The Director, may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in the Director's 
judgment those conditions are necessary to assure or protect advancement 
of the approved project, the interests of the public health, or the 
conservation of grant funds.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54299, Oct. 21, 1993]



PART 52h_SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH 

AND DEVELOPMENT CONTRACT PROJECTS--Table of Contents




Sec.
52h.1 Applicability.
52h.2 Definitions.
52h.3 Establishment and operation of peer review groups.
52h.4 Composition of peer review groups.
52h.5 Conflict of interest.
52h.6 Availability of information.
52h.7 What matters must be reviewed for grants?
52h.8 What are the review criteria for grants?
52h.9 What matters must be reviewed for unsolicited contract proposals?
52h.10 What matters must be reviewed for solicited contract proposals?
52h.11 What are the review criteria for contract projects and proposals?
52h.12 Other regulations that apply.

    Authority: 42 U.S.C. 216; 42 U.S.C. 282 (b)(6); 42 U.S.C. 284 
(c)(3); 42 U.S.C. 289a.

    Source: 69 FR 275, Jan. 5, 2004, unless otherwise noted.



Sec. 52h.1  Applicability.

    (a) This part applies to:
    (1) Applications of the National Institutes of Health for grants or 
cooperative agreements (a reference in this part to grants includes 
cooperative agreements) for biomedical and behavioral research; and
    (2) Biomedical and behavioral research and development contract 
project concepts and proposals for contract projects administered by the 
National Institutes of Health.
    (b) This part does not apply to applications for:
    (1) Continuation funding for budget periods within an approved 
project period;
    (2) Supplemental funding to meet increased administrative costs 
within a project period; or
    (3) Construction grants.



Sec. 52h.2  Definitions.

    As used in this part:
    (a) Act means the Public Health Service Act, as amended (42 U.S.C. 
201 et seq.).
    (b) Appearance of a conflict of interest means that a reviewer or 
close relative or professional associate of the reviewer has a financial 
or other interest in an application or proposal that is known to the 
reviewer or the government official managing the review and would cause 
a reasonable person to question the reviewer's impartiality if he or she 
were to participate in the review; the government official managing the 
review (the Scientific Review Administrator or equivalent) will evaluate 
the appearance of a conflict of interest and determine, in accordance 
with this subpart, whether or not the interest would likely bias the 
reviewer's evaluation of the application or proposal.

[[Page 220]]

    (c) Awarding official means the Secretary of Health and Human 
Services and any other officer or employee of the Department of Health 
and Human Services to whom the authority involved has been delegated; 
except that, where the Act specifically authorizes another official to 
make awards in connection with a particular program, the awarding 
official shall mean that official and any other officer or employee of 
the Department of Health and Human Services to whom the authority 
involved has been delegated.
    (d) Budget period means the interval of time (usually 12 months) 
into which the project period is divided for budgetary and reporting 
purposes.
    (e) Close relative means a parent, spouse, domestic partner, or son 
or daughter.
    (f) Contract proposal means a written offer to enter into a contract 
that is submitted to the appropriate agency official by an individual or 
nonfederal organization which includes, at a minimum, a description of 
the nature, purpose, duration, and cost of the project, and the methods, 
personnel, and facilities to be utilized in carrying it out. A contract 
proposal may be unsolicited by the federal government or submitted in 
response to a request for proposals.
    (g) Development means the systematic use of knowledge gained from 
research to create useful materials, devices, systems, or methods.
    (h) DHHS means the Department of Health and Human Services.
    (i) Director means the Director of the National Institutes of Health 
and any other official or employee of the National Institutes of Health 
to whom the authority involved has been delegated.
    (j) Grant as used in this part, includes cooperative agreements.
    (k) Peer review group means a group of primarily nongovernment 
experts qualified by training and experience in particular scientific or 
technical fields, or as authorities knowledgeable in the various 
disciplines and fields related to the scientific areas under review, to 
give expert advice on the scientific and technical merit of grant 
applications or contract proposals, or the concept of contract projects, 
in accordance with this part.
    (l) Principal investigator has the same meaning as in 42 CFR part 
52.
    (m) Professional associate means any colleague, scientific mentor, 
or student with whom the peer reviewer is currently conducting research 
or other significant professional activities or with whom the member has 
conducted such activities within three years of the date of the review.
    (n) Project approach means the methodology to be followed and the 
resources needed in carrying out the project.
    (o) Project concept means the basic purpose, scope, and objectives 
of the project.
    (p) Project period has the same meaning as in 42 CFR part 52.
    (q) Real conflict of interest means a reviewer or a close relative 
or professional associate of the reviewer has a financial or other 
interest in an application or proposal that is known to the reviewer and 
is likely to bias the reviewer's evaluation of that application or 
proposal as determined by the government official managing the review 
(the Scientific Review Administrator, or equivalent), as acknowledged by 
the reviewer, or as prescribed by this part. A reviewer shall have a 
real conflict of interest if he/she or a close relative or professional 
associate of the reviewer:
    (1) Has received or could receive a direct financial benefit of any 
amount deriving from an application or proposal under review;
    (2) Apart from any direct financial benefit deriving from an 
application or proposal under review, has received or could receive a 
financial benefit from the applicant institution, offeror or principal 
investigator that in the aggregate exceeds $10,000 per year; this amount 
includes honoraria, fees, stock or other financial benefit, and 
additionally includes the current value of the reviewer's already 
existing stock holdings. The Director, NIH, may amend the dollar 
threshold periodically, as appropriate, after public notice and comment; 
or
    (3) Has any other interest in the application or proposal that is 
likely to bias the reviewer's evaluation of that application or 
proposal. Regardless of the level of financial involvement or

[[Page 221]]

other interest, if the reviewer feels unable to provide objective 
advice, he/she must recuse him/herself from the review of the 
application or proposal at issue. The peer review system relies on the 
professionalism of each reviewer to identify to the designated 
government official any real or apparent conflicts of interest that are 
likely to bias the reviewer's evaluation of an application or proposal.
    (r) Request for proposals means a Government solicitation to 
prospective offerors, under procedures for negotiated contracts, to 
submit a proposal to fulfill specific agency requirements based on terms 
and conditions defined in the request for proposals. The request for 
proposals contains information sufficient to enable all offerors to 
prepare proposals, and is as complete as possible with respect to: 
nature of work to be performed; descriptions and specifications of items 
to be delivered; performance schedule; special requirements clauses, or 
other circumstances affecting the contract; format for cost proposals; 
and evaluation criteria by which the proposals will be evaluated.
    (s) Research has the same meaning as in 42 CFR part 52.
    (t) Research and development contract project means an identified, 
circumscribed activity, involving a single contract or two or more 
similar, related, or interdependent contracts, intended and designed to 
acquire new or fuller knowledge and understanding in the areas of 
biomedical or behavioral research and/or to use such knowledge and 
understanding to develop useful materials, devices, systems, or methods.
    (u) Scientific review group has the same meaning as peer review 
group, which is defined in paragraph (k) of this section.
    (v) Solicited contract proposal has the same meaning as the 
definition of offer in 48 CFR 2.101.
    (w) Unsolicited contract proposal has the same meaning as 
unsolicited proposal in 48 CFR 15.601.



Sec. 52h.3  Establishment and operation of peer review groups.

    (a) To the extent applicable, the Federal Advisory Committee Act, as 
amended (5 U.S.C. appendix 2) and chapter 9 of the DHHS General 
Administration Manual \1\ shall govern the establishment and operation 
of peer review groups.
---------------------------------------------------------------------------

    \1\ The DHHS General Administration Manual is available for public 
inspection and copying at the Department's information centers listed in 
45 CFR 5.31 and may be purchased from the Superintendent of Documents, 
U.S. Government Printing Office, Washington, DC 20402.
---------------------------------------------------------------------------

    (b) Subject to Sec. 52h.5 and paragraph (a) of this section, the 
Director will adopt procedures for the conduct of reviews and the 
formulation of recommendations under Sec. Sec. 52h.7, 52h.9, and 
52h.10.



Sec. 52h.4  Composition of peer review groups.

    (a) To the extent applicable, the selection and appointment of 
members of peer review groups and their terms of service shall be 
governed by chapter 9 of the DHHS General Administration Manual.
    (b) Subject to paragraph (a) of this section, members will be 
selected based upon their training and experience in relevant scientific 
or technical fields, or upon their qualifications as authorities 
knowledgeable in the various disciplines and fields related to the 
scientific areas under review, taking into account, among other factors:
    (1) The level of formal scientific or technical education completed 
or experience acquired by the individual;
    (2) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of the research;
    (3) Recognition as reflected by awards and other honors received 
from scientific and professional organizations; and
    (4) The need for the group to have included within its membership 
experts from various areas of specialization within relevant scientific 
or technical fields, or authorities knowledgeable in the various 
disciplines and fields related to the scientific areas under review.
    (c) Except as otherwise provided by law, not more than one-fourth of 
the members of any peer review group to

[[Page 222]]

which this part applies may be officers or employees of the United 
States. Being a member of a scientific peer review group does not make 
an individual an officer or employee of the United States.



Sec. 52h.5  Conflict of interest.

    (a) This section applies only to conflicts of interest involving 
members of peer review groups. This section does not cover individuals 
serving on National Advisory Councils or Boards, Boards of Scientific 
Counselors, or Program Advisory Committees who, if not already officers 
or employees of the United States, are special Government employees and 
covered by title 18 of the United States Code, the Office of Government 
Ethics Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635), and Executive Order 11222, as amended. For 
those federal employees serving on peer review groups, in accordance 
with Sec. 52h.4, the requirements of title 18 of the United States 
Code, 5 CFR part 2635 and Executive Order 12674, as modified by 
Executive Order 12731, apply.
    (b) A reviewer with a real conflict of interest must recuse him/
herself from the review of the application or proposal, except as 
otherwise provided in this section.
    (1) A reviewer who is a salaried employee, whether full-time or 
part-time, of the applicant institution, offeror, or principal 
investigator, or is negotiating for employment, shall be considered to 
have a real conflict of interest with regard to an application/proposal 
from that organization or principal investigator, except that the 
Director may determine there is no real conflict of interest or an 
appearance of a conflict of interest where the components of a large or 
multicomponent organization are sufficiently independent to constitute, 
in effect, separate organizations, provided that the reviewer has no 
responsibilities at the institution that would significantly affect the 
other component.
    (2) Where a reviewer's real conflict of interest is based upon the 
financial or other interest of a close relative or professional 
associate of the reviewer, that reviewer must recuse him/herself, unless 
the Director provides a waiver in accordance with paragraph (b)(4) of 
this section.
    (3) For contract proposal reviews, an individual with a real 
conflict of interest in a particular proposal(s) is generally not 
permitted to participate in the review of any proposals responding to 
the same request for proposals. However, if there is no other qualified 
reviewer available having that individual's expertise and that expertise 
is essential to ensure a competent and fair review, a waiver may be 
granted by the Director to permit that individual to serve as a reviewer 
of those proposals with which the reviewer has no conflict, while 
recusing him/herself from the review of any particular proposal(s) in 
which there is a conflict of interest.
    (4) The Director may waive any of the requirements in paragraph (b) 
of this section relating to a real conflict of interest if the Director 
determines that there are no other practical means for securing 
appropriate expert advice on a particular grant or cooperative agreement 
application, contract project, or contract proposal, and that the real 
conflict of interest is not so substantial as to be likely to affect the 
integrity of the advice to be provided by the reviewer.
    (c) Any appearance of a conflict of interest will result in recusal 
of the reviewer, unless the Director provides a waiver, determining that 
it would be difficult or impractical to carry out the review otherwise, 
and the integrity of the review process would not be impaired by the 
reviewer's participation.
    (d) When a peer review group meets regularly it is assumed that a 
relationship among individual reviewers in the group exists and that the 
group as a whole may not be objective about evaluating the work of one 
of its members. In such a case, a member's application or proposal shall 
be reviewed by another qualified review group to ensure that a competent 
and objective review is obtained.
    (e) When a member of a peer review group participates in or is 
present during the concept review of a contract proposal that occurs 
after release of the solicitation, as described under Sec. 52h.10(b), 
but before receipt of proposals, the member is not considered to

[[Page 223]]

have a real conflict of interest as described in paragraph (b) of this 
section, but is subject to paragraph (c) of this section concerning 
appearance of conflict of interest if the member is planning to respond 
to the solicitation. When the concept review occurs after receipt of 
proposals, paragraph (b) applies.
    (f) No member of a peer review group may participate in any review 
of a specific grant application or contract project for which the member 
has had or is expected to have any other responsibility or involvement 
(whether pre-award or post-award) as an officer or employee of the 
United States.
    (g) The Director may periodically issue guidance to the government 
officials responsible for managing reviews and reviewers on what 
interests would constitute a real conflict of interest or an appearance 
of a conflict of interest.



Sec. 52h.6  Availability of information.

    (a) Transcripts, minutes, and other documents made available to or 
prepared for or by a peer review group will be available for public 
inspection and copying to the extent provided by the Freedom of 
Information Act, as amended (5 U.S.C. 552), the Federal Advisory 
Committee Act, as amended (5 U.S.C. appendix 2), the Privacy Act of 
1974, as amended (5 U.S.C. 552a), and implementing DHHS regulations (45 
CFR parts 5, 5b).
    (b) Meetings of peer review groups reviewing grant applications or 
contract proposals are closed to the public in accordance with sections 
552b(c)(4) and 552b(c)(6) of the Government in the Sunshine Act, as 
amended (5 U.S.C. 552b(c)(4) and 552b(c)(6)) and section 10(d) of the 
Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2). 
Documents made available to, or prepared for or by peer review groups 
that contain trade secrets or commercial or financial information 
obtained from a person that is privileged or confidential, and personal 
information concerning individuals associated with applications or 
proposals, the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy, are exempt from disclosure in 
accordance with the Freedom of Information Act, as amended (5 U.S.C. 
552(b)(4) and 552(b)(6)).
    (c) Meetings of peer review groups reviewing contract project 
concepts are open to the public in accordance with the provisions of the 
Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2) and the 
Government in the Sunshine Act, as amended (5 U.S.C. 552b).



Sec. 52h.7  What matters must be reviewed for grants?

    (a) Except as otherwise provided by law, no awarding official shall 
award a grant based upon an application covered by this part unless the 
application has been reviewed by a peer review group in accordance with 
the provisions of this part and the group has made recommendations 
concerning the scientific merit of that application. In addition, where 
under applicable law an awarding official is required to secure the 
approval or advice of a national council or board concerning an 
application, the application may not be considered by the council or 
board unless it has been reviewed by the appropriate peer review group, 
in accordance with the provisions of this part, and the group has made 
recommendations concerning the scientific merit of the application, 
except where the council or board is the peer review group.
    (b) Except to the extent otherwise provided by law, recommendations 
by peer review groups are advisory only and not binding on the awarding 
official or the national advisory council or board.



Sec. 52h.8  What are the review criteria for grants?

    In carrying out its review under Sec. 52h.7, the scientific peer 
review group shall assess the overall impact that the project could have 
on the research field involved, taking into account, among other 
pertinent factors:
    (a) The significance of the goals of the proposed research, from a 
scientific or technical standpoint;
    (b) The adequacy of the approach and methodology proposed to carry 
out the research;
    (c) The innovativeness and originality of the proposed research;

[[Page 224]]

    (d) The qualifications and experience of the principal investigator 
and proposed staff;
    (e) The scientific environment and reasonable availability of 
resources necessary to the research;
    (f) The adequacy of plans to include both genders, minorities, 
children and special populations as appropriate for the scientific goals 
of the research;
    (g) The reasonableness of the proposed budget and duration in 
relation to the proposed research; and
    (h) The adequacy of the proposed protection for humans, animals, and 
the environment, to the extent they may be adversely affected by the 
project proposed in the application.



Sec. 52h.9  What matters must be reviewed for unsolicited contract proposals?

    (a) Except as otherwise provided by law, no awarding official shall 
award a contract based upon an unsolicited contract proposal covered by 
this part unless the proposal has been reviewed by a peer review group 
in accordance with the provisions of this part and the group has made 
recommendations concerning the scientific merit of that proposal.
    (b) Except to the extent otherwise provided by law, peer review 
group recommendations are advisory only and not binding on the awarding 
official.



Sec. 52h.10  What matters must be reviewed for solicited contract proposals?

    (a) Subject to paragraphs (b) and (c) of this section, no awarding 
official shall issue a request for contract proposals with respect to a 
contract project involving solicited contract proposals, unless the 
project concept has been reviewed by a peer review group or advisory 
council in accordance with this part and the group has made 
recommendations concerning the scientific merit of the concept.
    (b) The awarding official may delay carrying out the requirements 
for peer review of paragraph (a) of this section until after issuing a 
request for proposals if the official determines that the accomplishment 
of essential program objectives would otherwise be placed in jeopardy 
and any further delay clearly would not be in the best interest of the 
Government. The awarding official shall specify in writing the grounds 
on which this determination is based. Under these circumstances, the 
awarding official will not award a contract until peer review of the 
project concept and the proposals has been completed. The request for 
proposals shall state that the project concept will be reviewed by a 
peer review group and that no award will be made until the review is 
conducted and recommendations made based on that review.
    (c) The awarding official may determine that peer review of the 
project concept for behavioral or biomedical research and development 
contracts is not needed if one of the following circumstances applies: 
the solicitation is to re-compete or extend a project that is within the 
scope of a current project that has been peer reviewed, or there is a 
Congressional authorization or mandate to conduct specific contract 
projects. If a substantial amount of time has passed since the concept 
review, the awarding official shall determine whether peer review is 
required to ensure the continued scientific merit of the concept.
    (d) Except to the extent otherwise provided by law, the 
recommendations referred to in this section are advisory only and not 
binding on the awarding official.



Sec. 52h.11  What are the review criteria for contract projects and proposals?

    (a) In carrying out its review of a project concept under Sec. 
52h.10(a) or Sec. 52h.10(b), the peer review group shall take into 
account, among other pertinent factors:
    (1) The significance from a scientific or technical standpoint of 
the goals of the proposed research or development activity;
    (2) The availability of the technology and other resources necessary 
to achieve those goals;
    (3) The extent to which there are identified, practical uses for the 
anticipated results of the activity; and
    (4) Where the review includes the project approach, the adequacy of 
the methodology to be utilized in carrying out the activity.

[[Page 225]]

    (b) In carrying out its review of unsolicited contract proposals 
under Sec. 52h.9, the peer review group shall take into account, among 
other pertinent factors, the criteria in Sec. 52h.8 which are relevant 
to the particular proposals.
    (c) In carrying out its review of solicited proposals under Sec. 
52h.10(a) or (b), the peer review group shall evaluate each proposal in 
accordance with the criteria set forth in the request for proposals.



Sec. 52h.12  Other regulations that apply.

    The regulations in this part are in addition to, and do not 
supersede other regulations concerning grant applications, contract 
projects, or contract proposals set forth elsewhere in this title, title 
45, or title 48 of the Code of Federal Regulations.



PART 53_GRANTS, LOANS AND LOAN GUARANTEES FOR CONSTRUCTION AND MODERNIZATION 

OF HOSPITALS AND MEDICAL FACILITIES--Table of Contents




Subparts A-K [Reserved]

    Subpart L_Services for Persons Unable To Pay; Community Service; 
                            Nondiscrimination

Sec.
53.111 Services for persons unable to pay.
53.112 Nondiscrimination.
53.113 Community service.

Subpart M [Reserved]

               Subpart N_Loan Guarantees and Direct Loans

53.154 Waiver of right of recovery.
53.155 Modification of loans.
53.156 Fees for modification requests.

    Authority: Secs. 215, 603, 609, 621, 623, Public Health Service Act 
as amended, 58 Stat. 690, 78 Stat. 451 and 456, 84 Stat. 344 and 346 (42 
U.S.C. 216, 291c, 291i, 291j-1 and 291j-3; 31 U.S.C. 9701).

Subparts A-K [Reserved]



    Subpart L_Services for Persons Unable To Pay; Community Service; 

                           Nondiscrimination.



Sec. 53.111  Services for persons unable to pay.

    (a) Applicability. The provisions of this section apply to every 
applicant which heretofore has given or hereafter will give an assurance 
that it will make available a reasonable volume of services to persons 
unable to pay therefor but shall not apply to an applicant (1) for more 
than 20 years after the completion of construction of any facility with 
respect to which funds have been paid under section 606 of the Act or 
(2) beyond the period during which any amount of a direct loan made 
under sections 610 or 623 of the Act, or any amount of a loan with 
respect to which a loan guarantee and interest subsidy has been provided 
under sections 623 and 624 of the Act remains unpaid.
    (b) Definitions. As used in this section:
    (1) The term facility includes hospitals, facilities for long-term 
care, outpatient facilities, rehabilitation facilities, and public 
health centers;
    (2) The term applicant means an applicant for, or recipient of, a 
grant, a loan guarantee or a loan under the Act;
    (3) Fiscal year means the fiscal year of the applicant;
    (4) The term operating costs means the actual operating costs of the 
applicant for a fiscal year as determined in accordance with cost 
determination principles and requirements under title XVIII of the 
Social Security Act (42 U.S.C. 1395): Provided, That such ``operating 
costs'' shall be determined for the applicant's entire facility and for 
all patients regardless of the source of payment for such care: And 
provided further, That in determining such operating costs there shall 
be deducted the amount of all actual or estimated reimbursements, as 
applicable, for services received or to be received pursuant to title 
XVIII and XIX of the Social Security Act (42 U.S.C. 1395 and 1936);
    (5) The term reasonable cost means the cost of providing services to 
a specific patient determined in accordance with the cost determination 
principles and requirements under title XVIII of

[[Page 226]]

the Social Security Act (42 U.S.C. 1395) and subpart D of the 
regulations thereunder (20 CFR part 405, \1\ part 401 et seq.);
---------------------------------------------------------------------------

    \1\ Redesignated as 42 CFR part 405 at 42 FR 52826, Sept. 30, 1977.
---------------------------------------------------------------------------

    (6) The term uncompensated services means services which are made 
available to persons unable to pay therefor without charge or at a 
charge which is less than the reasonable cost of such services. The 
level of such services is measured by the difference between the amount 
charged such persons for such services and the reasonable cost thereof;
    (7) Reasonable volume of services to persons unable to pay therefor 
means a level of uncompensated services which meets a need for such 
services in the area served by an applicant and which is within the 
financial ability of such applicant to provide.
    (c) Assurance. (1) Before an application under this part is 
recommended by a State agency to the Secretary for approval, the State 
agency shall obtain an assurance from the applicant that there will be 
made available in the facility or portion thereof to be constructed or 
modernized a reasonable volume of services to persons unable to pay 
therefor. The requirement of an assurance from an applicant shall be 
waived if the applicant demonstrates to the satisfaction of the State 
agency, subject to subsequent approval by the Secretary, that such a 
requirement is not feasible from a financial viewpoint.
    (2) Prior to recommending that such requirement be waived, the State 
agency shall publish in a newspaper of general circulation in the area 
served by the applicant a notice of the request for such waiver and 
invite public comment thereon, allowing not less than 30 days therefor. 
All comments received shall be available for public inspection, and 
shall be considered by the State agency in arriving at its 
recommendation. Notice of the determination on the request for waiver 
shall be given to all interested persons and to the public before the 
approval of the Secretary is sought.
    (d) Presumptive compliance guideline. An applicant which, for a 
fiscal year, (1) budgets for the support of, and makes available on 
request, uncompensated services at a level not less than the lesser of 3 
percent of operating costs or 10 percent of all Federal assistance 
provided to or on behalf of the applicant under the Act, or (2) 
certifies that it will not exclude any person from admission on the 
ground that such person is unable to pay for needed services and that it 
will make available to each person so admitted services provided by the 
facility without charge or at a charge below reasonable cost which does 
not exceed any such person's ability to pay therefor as determined in 
accordance with criteria established pursuant to paragraph (g), shall be 
deemed in presumptive compliance with its assurance. In the case of a 
loan guarantee with interest subsidy or a direct loan guarantee be sold 
by the Secretary with an interest subsidy, the amount of Federal 
assistance shall include the total amount of the interest subsidy which 
the Secretary is, or will be, obligated to pay over the full life of the 
loan, as well as any other payments which the Secretary makes on behalf 
of the applicant in connection with the loan guarantee or the direct 
loan which has been sold.
    (e) Compliance reports. (1) Each applicant shall, not later than 120 
days after the end of a fiscal year, unless a longer period is approved 
by the State agency for good cause shown, file with the State agency a 
copy of its annual statement for such year as required by section 646 of 
the Act and Sec. 53.128(q), which shall set forth its operating costs.
    (2) With respect to each fiscal year for which a level of 
uncompensated services has been established in accordance with this 
section, the annual statement shall also set forth the amount of 
uncompensated services provided in such year.
    (i) The provision of a level of uncompensated services in such year 
which equals or exceeds the level established pursuant to paragraph (h) 
of this section for such year shall constitute compliance with the 
assurance.
    (ii) If the level of services provided was less than the level of 
uncompensated services established pursuant to paragraph (h) of this 
section, the applicant shall submit with such statement:

[[Page 227]]

A justification therefor, showing that the provision of such lower level 
of uncompensated services was reasonable under the circumstances; and a 
description of the steps it proposes to take to assure the availability 
and utilization of the level of uncompensated services to be established 
for the current fiscal year, which shall include an affirmative action 
plan, utilizing press releases or other appropriate means as the 
facility may desire to bring to the attention of the public the 
availability of such uncompensated services and the conditions of 
eligibility therefor.
    (3) Each applicant shall file with its annual statement a copy of 
that portion of its adopted budget for the current fiscal year relating 
to the support of uncompensated services in such year. Such budget for 
uncompensated services shall be based on the operating costs of the 
applicant for the preceding fiscal year and shall give due cognizance to 
probable increases in operating costs. Except in the case of a 
certification pursuant to paragraph (d)(2) of this section, if the 
budget statement does not conform to the presumptive compliance 
guideline, the applicant shall submit with its statement.
    (i) A justification therefor, showing that such lower level of 
uncompensated services is reasonable under the circumstances, and
    (ii) A plan to increase such uncompensated services to meet the 
presumptive compliance guideline or such other level of uncompensated 
services as may have been established or as it requests the State agency 
to establish in accordance with paragraph (h) of this section.
    (4) The applicant shall also submit such additional reports related 
to compliance with its assurance as the State agency may reasonably 
require.
    (5) Pending the establishment of a level of uncompensated services 
for any fiscal year pursuant to paragraph (h) of this section, the 
applicant shall, in such fiscal year, provide a level of services which 
is the higher of
    (i) The level established for the preceding fiscal year (or if no 
such level has been established for such prior year, the level of 
services provided in such year) or
    (ii) The level proposed in its adopted budget for the current fiscal 
year.
    (f) Qualifying services. (1) In determining the amount of 
uncompensated services provided by an applicant, there shall be included 
only those services provided to an individual with respect to whom the 
applicant has made a written determination prior to the provision of 
such services that such individual is unable to pay therefor under the 
criteria established pursuant to 42 CFR 53.111(g), except that:
    (i) Such determination may be made after the provision of such 
services in the case of services provided on an emergency basis: 
Provided, That when billing is made for such service, such billing must 
be accompanied by substantially the information required in the posted 
notice under paragraph (i) of this section; and
    (ii) Such determination may be made after the provision of such 
services in the case of a change in circumstances as a result of the 
illness or injury occasioning such services (e.g., the patient's 
financial condition has changed due to a loss of wages resulting from 
the illness) or in case of insurance coverage or other resources being 
less than anticipated or the costs of services being greater than 
anticipated. Further, in all cases where such determination was not made 
prior to the provision of services, such services may not be included as 
uncompensated services if any collection effort has been made other than 
the rendering of bills permissible in the above exceptions: Provided, 
That such a determination may be made at any time if the determination 
was hindered or delayed by reason of erroneous or incomplete information 
furnished by or in behalf of the patient.
    (2) There shall be excluded from the computation of uncompensated 
services:
    (i) Any amount which the applicant has received, or is entitled to 
receive, from a third party insurer or under a governmental program; and
    (ii) The reasonable cost of any services for which payment in whole 
or in part would be available under a governmental program (e.g., 
Medicare and

[[Page 228]]

Medicaid) in which the applicant, although eligible to do so, does not 
participate, but only to the extent of such otherwise available payment.
    (g) Persons unable to pay for services. (1) The State agency shall 
set forth in its State plan, subject to approval by the Secretary, 
criteria for identifying persons unable to pay for services, which shall 
include persons who are otherwise self-supporting but unable to pay the 
full charge for needed services. Such criteria shall be based on the 
following or similar factors:
    (i) The health and medical care insurance coverage, personal or 
family income, the size of the patient's family, and other financial 
obligations and resources of the patient or the family in relation to 
the reasonable cost of the services;
    (ii) Generally recognized standards of need such as:
    (a) The State standard for the medically needy as determined for the 
purposes of the Aid for Families with Dependent Children program;
    (b) The current Social Security Administration poverty income level;
    (c) The current Office of Economic Opportunity Income Poverty 
Guidelines applicable in the area; or
    (iii) Any other equivalent measures which are found by the Secretary 
to provide a reasonable basis for determining an individual's ability to 
pay for medical and hospital services.
    (2) A copy of such criteria shall be provided by the applicant, upon 
request, to any patient or former patient of the applicant and to any 
person seeking services from the applicant.
    (3) The State agency shall provide a copy of such criteria to any 
person requesting it.
    (h) Level of uncompensated services. (1) The State agency shall set 
forth in its State plan procedures for the determination for each 
applicant of the level of uncompensated services which constitutes a 
reasonable volume of services to persons unable to pay therefor provided 
that in no event shall the level of uncompensated services established 
under this section exceed the presumptive compliance guideline.
    (2) The State agency shall for the purpose of making such 
determination, review, and evaluate the annual statement, the budget and 
the related documents submitted by each applicant pursuant to paragraph 
(e) of this section, by applying the following criteria:
    (i) The financial status of the applicant, taking account of income 
from all sources, and its financial ability to provide uncompensated 
services;
    (ii) The nature and quantity of services provided by the applicant;
    (iii) The need within the area served by the applicant for the 
provision, without charge or at charge which is less than reasonable 
cost, for services of the nature provided or to be provided by the 
applicant; and
    (iv) The extent and nature of joint or cooperative programs with 
other facilities for the provision of uncompensated services, and the 
extent and nature of outreach services directed to the needs of 
underserved areas.
    (3) In accordance with its findings made after such review and 
evaluation, the State agency shall, within 60 days after receipt of the 
annual statement and related documents required by paragraph (e) of this 
section, for each fiscal year of an applicant which begins following the 
expiration of 90 days after the effective date of this regulation:
    (i) Establish a level of uncompensated services for each applicant 
which may be equal to or less than the presumptive compliance guideline: 
Provided, That if the State agency determines, in accordance with 
paragraph (h)(2) of this section, that (a) there is a need in the area 
served by an applicant for a level of uncompensated services greater 
than the level proposed in the applicant's budget statement, and (b) the 
applicant is financially able to provide such greater level of 
uncompensated services, the State agency shall establish such greater 
level as the level applicable to the applicant; and
    (ii) Accept or modify a plan submitted pursuant to paragraph (e) of 
this section.
    (4) The State agency shall notify the applicant in writing of the 
level of uncompensated services which it has established for the 
applicant for the fiscal year. At the time of notifying the applicant, 
the State agency shall also

[[Page 229]]

publish as a public notice in a newspaper of general circulation within 
the community served by the applicant the rate that has been established 
and a statement that the documents upon which the agency based its 
determination are available for public inspection at a location and time 
prescribed. In the case of the establishment by the State agency of a 
rate which is less than the presumptive compliance guideline, such 
notice shall also include a statement that persons wishing to object to 
the rate established may do so by writing to the State agency within 20 
days after publication of the notice: Provided, That the applicant may 
object to any level established which is greater than the level proposed 
in the applicant's budget statement.
    (5) In accordance with the provisions of paragraph (h)(4) of this 
section, the applicant or any person or persons residing or located 
within the area served by the applicant, or any organization on behalf 
of such person or persons, may submit to the State agency within 20 days 
of the publication and sending of the notice objections to the rate 
established by the State agency for the applicant. Such objections may 
be supported in writing by factual information and argument. The State 
agency shall give public notice of receipt of the objections and shall 
make the objections and their supporting documents available for public 
inspection and comment. It may, if it believes that determination of the 
objections will be assisted by oral evidence or by oral argument, set a 
public hearing on the objections and shall give notice of such hearing 
to all interested parties and to the public. The State agency shall 
within 60 days of the expiration of the period within which objections 
may be filed, rule upon the objections in writing, stating its reason 
for sustaining or overruling them, in whole or in part, and establishing 
finally the rate of uncompensated services either the same as, above, or 
below the rate previously established, as may best accord with all of 
the evidence on file with or heard by the State agency. Notice of the 
final determination shall be mailed to all parties who filed objections 
or who participated in the proceedings leading to the redetermination.
    (6) Within 20 days of receipt of written notice of the final 
determination of a State agency after ruling on objections to the rate 
established by the State agency, the applicant or any other interested 
person or organization may submit to the Secretary a written request for 
review of the State agency determination. Such review shall be made upon 
the record of the State agency determination which shall be sustained if 
supported by substantial evidence and is not otherwise arbitrary or 
capricious. If the Secretary or his designee determines that the rate 
established by the State agency is unsupported by the evidence in the 
record or is otherwise arbitrary or capricious, the Secretary or his 
designee shall, upon the basis of the record or upon other evidence or 
information which is before him or which he may obtain, establish a 
level of uncompensated services which he determines, in accordance with 
the criteria set out in paragraph (h)(2) of this section, is 
appropriate.
    (7) The level of uncompensated services established for an applicant 
under this section for any fiscal year shall constitute a reasonable 
volume of services to persons unable to pay therefor with respect to 
such applicant for such fiscal year.
    (i) Posted notice. The applicant shall post notice (which shall be 
multilingual where the applicant serves a multilingual community), in 
substantially the following form, in appropriate areas within the 
facility (admissions, office, emergency department and business office) 
for the purpose of informing patients or potential patients that 
criteria for eligibility and applications are available upon request:

                    Notice of Hill-Burton Obligation

    This hospital (or other facility) is required by law to give a 
reasonable amount of service at no cost or less than full cost to people 
who cannot pay. If you think that you are eligible for these services, 
please contact our business office (give office location) and ask for 
assistance. If you are not satisfied with the results, you may contact 
(the State Hill-Burton agency with address).

[[Page 230]]

    Provided, That an applicant which has selected a presumptive 
compliance guideline under paragraph (d)(1) of this section may, at its 
option, either (1) add to such notice language stating that the 
facility's obligation is limited to a specified dollar volume of 
uncompensated services and that if the facility has, during a specified 
period (e.g., year, quarter, month), already provided a volume of 
uncompensated services sufficient to satisfy such obligation, any person 
inquiring about such services will be given a written statement to that 
effect which shall also state when additional uncompensated services 
will be available; or (2) post an additional notice stating that the 
facility's obligation has been satisfied for the current period and 
stating when additional uncompensated services will be available.

    (j) Evaluation and enforcement. The State plan shall provide for 
evaluation and enforcement of the assurance in accordance with the 
following requirements:
    (1) The State agency shall,
    (i) At least annually, perform evaluations of the amount of the 
various services provided in each facility with respect to which Federal 
assistance has been provided under the Act, to determine whether such 
assurance is being complied with; and
    (ii) Establish procedures for the investigation of complaints that 
such assurance is not being complied with.
    (2) Evaluation pursuant to paragraph (j)(1) of this section shall be 
based on the annual budget of each facility for uncompensated services 
and on financial statements of such facilities filed pursuant to section 
646 of the Act and Sec. 53.128(q), and on such other information, 
including reports of investigations and hearing decisions, as the State 
agency deems relevant and material.
    (3) The State plan shall provide for adequate methods of enforcement 
of the assurance, including effective sanctions to be applied against 
any facility which fails to comply with such assurance. Such sanctions 
may include, but need not be limited to, license revocation, termination 
of State assistance, and court action.
    (k) Reports. (1) The State agency shall, not less often than 
annually, report in writing to the Secretary its evaluation of each 
facility's compliance with the assurance, the disposition of each 
complaint received by the State agency, proposed remedial action with 
respect to each facility found by the State agency to be not in 
compliance with the assurance, and the status of such remedial action.
    (2) In addition, the State agency shall promptly report to the 
Regional Attorney and Regional Health Director of the Department of 
Health and Human Services the institution of any legal action against a 
facility or the State agency involving compliance with the assurance.

[37 FR 14721, July 22, 1972, as amended at 38 FR 16354, June 22, 1973; 
40 FR 46203, Oct. 6, 1975]



Sec. 53.112  Nondiscrimination.

    (a) Before an application is recommended by a State agency to the 
Secretary for approval, the State agency shall obtain an assurance from 
the applicant that all portions and services of the entire facility for 
the construction or modernization of which, or in connection with which, 
aid under the Act is sought will be made available without 
discrimination on account of creed and no professionally qualified 
person will be discriminated against on account of creed with respect to 
the privilege of professional practice in the facility.
    (b) Each construction contract is subject to the condition that the 
applicant shall comply with the requirements of Executive Order 11246, 
September 24, 1965 (30 FR 12319), relating to nondiscrimination in 
construction contract employment, and the applicable rules, regulations, 
and procedures prescribed pursuant thereto.
    (c) Attention is called to the requirement of title VI of the Civil 
Rights Act of 1964 (42 U.S.C. 2000d; 78 Stat. 252) which provides that 
no person in the United States shall, on the ground of race, color, or 
national origin be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance. A regulation 
implementing such title VI, applicable to assistance under this part for 
construction and modernization of hospitals and medical facilities, has 
been issued by the Secretary of Health and Human Services

[[Page 231]]

with the approval of the President (45 CFR part 80).

[37 FR 182, Jan. 6, 1972, as amended at 39 FR 31767, Aug. 30, 1974]



Sec. 53.113  Community service.

    (a) Applicability. The provisions of this section apply to every 
applicant which heretofore has given or hereafter will give a community 
service assurance.
    (b) Definitions. As used in this section:
    (1) The term community service assurance means an assurance required 
by regulations promulgated pursuant to section 603(e)(1) of the Act or 
the predecessor of that section (section 622(f), Public Health Service 
Act, enacted by Pub. L. 79-725, 60 Stat. 1041).
    (2) The term facility has the same meaning as is given it in Sec. 
53.111(b)(1).
    (3) The term applicant has the same meaning as is given it in Sec. 
53.111(b)(2).
    (4) The term fiscal year has the same meaning as is given it in 
Sec. 53.111(b)(3).
    (c) Assurance. Before an application under this part is recommended 
by a State agency to the Secretary for approval, the State agency shall 
obtain an assurance from the applicant that the facility will furnish a 
community service.
    (d) Compliance. In order to comply with its community service 
assurance an applicant must:
    (1)(i) Make the services it furnishes available to the general 
public, or
    (ii) Limit the availability of such services only on the basis of 
age, medical indigency, or type or kind of medical or mental disability, 
or
    (iii) If the facility constitutes a medical or nursing care unit of 
a home or other institution, make such home or other institution 
available in accordance with paragraph (d)(1) (i) or (ii) of this 
section; and
    (2)(i) Make arrangements, if eligible to do so, for reimbursement 
for services with:
    (A) Those principal State and local governmental third-party payors 
which provide reimbursement for services that is not less than the 
actual cost of such services as determined in accordance with accepted 
cost accounting principles; and
    (B) Those Federal governmental third-party programs, such as 
Medicare and Medicaid, to the extent that the applicant is entitled to 
reimbursement at reasonable cost under a formula established in 
accordance with applicable Federal law.
    (ii) Take such additional steps as may be necessary to ensure that 
admission to and services of the facility will be available to 
beneficiaries of the governmental programs specified in paragraph 
(d)(2)(i) of this section without discrimination (or preference) on 
account of their being such beneficiaries.
    (e) Reports. The annual statement required by section 646 of the Act 
and Sec. 53.128(q), a copy of which must be submitted to the State 
agency in accordance with the requirements of Sec. 53.111(e)(1), shall 
set forth the amount of the reimbursement received pursuant to each 
arrangement with a principal governmental third-party payor.
    (f) Evaluation and enforcement. The State plan shall provide for 
evaluation and enforcement of the community service assurance in 
accordance with the following requirements:
    (1) The State agency shall,
    (i) At least annually, evaluate the compliance of facilities with 
such assurance; and
    (ii) Establish procedures for the investigation of complaints that 
such assurance is not being complied with.
    (2) The State plan shall provide for adequate methods of enforcement 
of the assurance, including effective sanctions to be applied against 
any facility which fails to comply with such assurance. Such sanctions 
may include, but need not be limited to, license revocation, termination 
of State assistance and court action.
    (g) Reports. (1) The State agency shall, not less often than 
annually, report in writing to the Secretary its general evaluation of 
facilities' compliance with the assurance, the disposition of each 
complaint received by the State agency, proposed remedial action with 
respect to each facility found by the State agency to be not in 
compliance with the assurance, and the status of such remedial action.
    (2) In addition, the State agency shall promptly report to the 
Regional Attorney and Regional Health Director

[[Page 232]]

of the Department of Health and Human Services the institution of any 
legal action against a facility or the State agency involving compliance 
with the assurance.

[39 FR 31767, Aug. 30, 1974, as amended at 42 FR 16780, Mar. 30, 1977]

Subpart M [Reserved]



               Subpart N_Loan Guarantees and Direct Loans



Sec. 53.154  Waiver of right of recovery.

    In determining whether there is good cause for waiver of any right 
of recovery which he may have against a nonprofit private agency by 
reason of any payments made pursuant to a loan guarantee, or against a 
public agency by reason of the failure of such agency to make payments 
of principal and interest on a direct loan to such agency, the Secretary 
shall take into consideration the extent to which:
    (a) The facility with respect to which the loan guarantee or direct 
loan was made will continue to be devoted by the applicant or other 
owner to use for the purpose for which it was constructed or another 
public or nonprofit purpose which will promote the purposes of the Act;
    (b) There are reasonable assurances that for the remainder of the 
repayment period of the loan other public or non-profit facilities not 
previously utilized for the purpose for which the facility was 
constructed will be so utilized and are substantially equivalent in 
nature and extent for such purposes; and
    (c) Such recovery would seriously curtail the provision of medical 
services to persons in need of such services in the area.

[37 FR 182, Jan. 6, 1972]



Sec. 53.155  Modification of loans.

    No official of the Department of Health and Human Services will 
approve any proposal to modify the terms of a loan guaranteed under 
title VI of the Public Health Service Act (42 U.S.C. 291 et seq.) and 
this subpart which would permit the use of the guaranteed loan (or the 
guarantee) as collateral for an issue of tax-exempt securities.

[48 FR 42984, Sept. 21, 1983]



Sec. 53.156  Fees for modification requests.

    (a) Fees will be charged for the processing of requests for parity, 
and for major and minor modifications of the terms of documents 
evidencing and securing direct and guaranteed loans. In accordance with 
the requirements of the User Charge Statute, 31 U.S.C. 9701(b), the 
Secretary determines the amount of the application fee that must be 
submitted with each type of modification.
    (1) As used in this section, a request for parity allows new debt to 
share lien position (i.e. collateral) with an existing Hill-Burton loan.
    (2) As used in this section, a major modification is any 
modification involving the release of $100,000 or more of collateral; a 
corporate restructuring that involves a transfer of assets; master 
indenture requests; modifications to a sinking fund; defeasance requests 
and requests for additional secured indebtedness; and any, other 
modification that involves a comparably significant use of Department 
resources.
    (3) As used in this section, a minor modification is any 
modification involving the release of less than $100,000 of collateral; 
an easement; and any other modification that involves a comparable use 
of Department resources.
    (b) A request for modification is to be accompanied by a certified 
check or money order in the amount of the appropriate fee, payable to 
the U.S. Treasury. The fees for modification requests submitted on or 
after October 28, 1986 are as follows:
    (1) $1,500 for a minor modification,
    (2) $4,500 for a major modification, and
    (3) $5,500 for a request for parity.
    (c) A submitter may withdraw its request for modification within 10 
business days following its receipt and receive a refund of the fee.
    (d) If the Secretary determines that a change in the amount of a fee 
is appropriate, the Department will issue a notice of proposed 
rulemaking in the

[[Page 233]]

Federal Register to announce the proposed amount.

[51 FR 39376, Oct. 28, 1986]



  PART 54_CHARITABLE CHOICE REGULATIONS APPLICABLE TO STATES RECEIVING 

SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANTS AND/OR PROJECTS FOR 

ASSISTANCE IN TRANSITION FROM HOMELESSNESS GRANTS--Table of Contents




Sec.
54.1 Scope.
54.2 Definitions.
54.3 Nondiscrimination against religious organizations.
54.4 Religious activities.
54.5 Religious character and independence.
54.6 Employment practices.
54.7 Nondiscrimination requirement.
54.8 Right to services from an alternative provider.
54.9 Assurances and State oversight of the Charitable Choice 
          requirements.
54.10 Fiscal accountability.
54.11 Effects on State and local funds.
54.12 Treatment of intermediate organizations.
54.13 Educational requirements for personnel in drug treatment programs.

    Authority: 42 U.S.C. 300x-65, et seq., 42 U.S.C. 290kk, et seq., 42 
U.S.C. 300x-21, et seq., 42 U.S.C. 290cc-21, et seq., and 42 U.S.C. 
2000bb, et seq.

    Source: 68 FR 56444, Sept. 30, 2003, unless otherwise noted.



Sec. 54.1  Scope.

    These provisions apply only to funds provided directly to pay for 
substance abuse prevention and treatment services under 42 U.S.C. 300x-
21 et seq., and 42 U.S.C. 290cc-21 to 290cc-35. This part does not apply 
to direct funding under any such authorities for activities that do not 
involve the provision of substance abuse services, such as for 
infrastructure activities authorized under Section 1971 of the PHS Act, 
42 U.S.C. 300y, and for technical assistance activities. This part 
implements the SAMHSA Charitable Choice provisions, 42 U.S.C. 300x-65 
and 42 U.S.C. 290kk, et seq.



Sec. 54.2  Definitions.

    (a) Applicable program means the programs authorized under:
    (1) The Substance Abuse Prevention and Treatment (SAPT) Block Grant, 
42 U.S.C. 300x to 300x-66, and
    (2) The Projects for Assistance in Transition from Homelessness 
(PATH) Formula Grants, 42 U.S.C. 290cc-21 to 290cc-35 insofar as they 
fund substance abuse prevention and/or treatment services.
    (b) Religious organization means a nonprofit religious organization.
    (c) Program beneficiary means an individual who receives substance 
abuse services under a program funded in whole or in part by applicable 
programs.
    (d) Program participant means a public or private entity that has 
received financial assistance, under an applicable program.
    (e) SAMHSA means the U.S. Substance Abuse and Mental Health Services 
Administration.
    (f) SAMHSA Charitable Choice provisions means the provisions of 42 
U.S.C. 300x-65 and 42 U.S.C. 290kk, et seq.
    (g) Direct funding or Funds provided directly means funding that is 
provided to an organization directly by a governmental entity or 
intermediate organization that has the same duties under this part as a 
governmental entity, as opposed to funding that an organization receives 
as the result of the genuine and independent private choice of a 
beneficiary through a voucher, certificate, coupon, or other similar 
mechanism.



Sec. 54.3  Nondiscrimination against religious organizations.

    (a) Religious organizations are eligible, on the same basis as any 
other organization, to participate in applicable programs, as long as 
their services are provided consistent with the Establishment Clause and 
the Free Exercise Clause of the First Amendment to the United States 
Constitution. Except as provided herein or in the SAMHSA Charitable 
Choice provisions, nothing in these regulations shall restrict the 
ability of the Federal government, or a State or local government, from 
applying to religious organizations the same

[[Page 234]]

eligibility conditions in applicable programs as are applied to any 
other nonprofit private organization.
    (b) Neither the Federal government nor a State or local government 
receiving funds under these programs shall discriminate against an 
organization that is, or applies to be, a program participant on the 
basis of religion or the organization's religious character or 
affiliation.



Sec. 54.4  Religious activities.

    No funds provided directly from SAMHSA or the relevant State or 
local government to organizations participating in applicable programs 
may be expended for inherently religious activities, such as worship, 
religious instruction, or proselytization. If an organization conducts 
such activities, it must offer them separately, in time or location, 
from the programs or services for which it receives funds directly from 
SAMHSA or the relevant State or local government under any applicable 
program, and participation must be voluntary for the program 
beneficiaries.



Sec. 54.5  Religious character and independence.

    A religious organization that participates in an applicable program 
will retain its independence from Federal, State, and local governments 
and may continue to carry out its mission, including the definition, 
practice and expression of its religious beliefs. The organization may 
not expend funds that it receives directly from SAMHSA or the relevant 
State or local government to support any inherently religious 
activities, such as worship, religious instruction, or proselytization. 
Among other things, faith-based organizations may use space in their 
facilities to provide services supported by applicable programs, without 
removing religious art, icons, scriptures, or other symbols. In 
addition, a SAMHSA-funded religious organization retains the authority 
over its internal governance, and it may retain religious terms in its 
organization's name, select its board members on a religious basis, and 
include religious references in its organization's mission statements 
and other governing documents.



Sec. 54.6  Employment practices.

    (a) The participation of a religious organization in, or its receipt 
of funds from, an applicable program does not affect that organization's 
exemption provided under 42 U.S.C. 2000e-1 regarding employment 
practices.
    (b) To the extent that 42 U.S.C. 300x-57(a)(2) or 42 U.S.C. 290cc-
33(a)(2) precludes a program participant from employing individuals of a 
particular religion to perform work connected with the carrying on of 
its activities, those provisions do not apply if such program 
participant is a religious corporation, association, educational 
institution, or society and can demonstrate that its religious exercise 
would be substantially burdened by application of these religious 
nondiscrimination requirements to its employment practices in the 
program or activity at issue. In order to make this demonstration, the 
program participant must certify: that it sincerely believes that 
employing individuals of a particular religion is important to the 
definition and maintenance of its religious identity, autonomy, and/or 
communal religious exercise; that it makes employment decisions on a 
religious basis in analogous programs; that the grant would materially 
affect its ability to provide the type of services in question; and that 
providing the services in question is expressive of its values or 
mission. The organization must maintain documentation to support these 
determinations and must make such documentation available to SAMHSA upon 
request.
    (c) Nothing in this section shall be construed to modify or affect 
any State law or regulation that relates to discrimination in 
employment.
    (d) The phrases ``with respect to the employment,'' ``individuals of 
a particular religion,'' and ``religious corporation, association, 
educational institution, or society'' shall have the same meaning as 
those terms have under section 702 of the Civil Rights Act of 1964, 42 
U.S.C. 2000e-1(a).



Sec. 54.7  Nondiscrimination requirement.

    A religious organization that is a program participant shall not, in 
providing program services or engaging in outreach activities under 
applicable

[[Page 235]]

programs, discriminate against a program beneficiary or prospective 
program beneficiary on the basis of religion, a religious belief, a 
refusal to hold a religious belief, or a refusal to actively participate 
in a religious practice.



Sec. 54.8  Right to services from an alternative provider.

    (a) General requirements. If an otherwise eligible program 
beneficiary or prospective program beneficiary objects to the religious 
character of a program participant, within a reasonable period of time 
after the date of such objection, such program beneficiary shall have 
rights to notice, referral, and alternative services, as outlined in 
paragraphs (b) through (d) of this section.
    (b) Notice. Program participants that refer an individual to 
alternative service providers, and the State government that administers 
the applicable programs, shall ensure that notice of the individual's 
right to services from an alternative provider is provided to all 
program beneficiaries or prospective beneficiaries. The notice must 
clearly articulate the program beneficiary's right to a referral and to 
services that reasonably meet the requirements of timeliness, capacity, 
accessibility, and equivalency as discussed in this section. A model 
notice is set out in appendix A to part 54a.
    (c) Referral to an alternative provider. If a program beneficiary or 
prospective program beneficiary objects to the religious character of a 
program participant that is a religious organization, that participating 
religious organization shall, within a reasonable time after the date of 
such objection, refer such individual to an alternative provider. The 
State shall have a system in place to ensure that referrals are made to 
an alternative provider. That system shall ensure that the following 
occurs:
    (1) The religious organization that is a program participant shall, 
within a reasonable time after the date of such objection, refer the 
beneficiary to an alternative provider;
    (2) In making such referral, the program participant shall consider 
any list that the State or local government makes available to entities 
in the geographic area that provide program services, which may include 
utilizing any treatment locator system developed by SAMHSA;
    (3) All referrals shall be made in a manner consistent with all 
applicable confidentiality laws, including, but not limited to, 42 CFR 
Part 2 (``Confidentiality of Alcohol and Drug Abuse Patient Records'');
    (4) Upon referring a program beneficiary to an alternative provider, 
the program participant shall notify the State or responsible unit of 
government of such referral; and
    (5) The program participant shall ensure that the program 
beneficiary makes contact with the alternative provider to which he or 
she is referred.
    (d) Provision and funding of alternative services. If an otherwise 
eligible applicant or recipient objects to the religious character of a 
SAMHSA-funded service provider, the recipient is entitled to receive 
services from an alternative provider. In such cases, the State or local 
agency must provide the individual with alternative services within a 
reasonable period of time, as defined by the State agency. That 
alternative provider must be reasonably accessible and have the capacity 
to provide comparable services to the individual. Such services shall 
have a value that is not less than the value of the services that the 
individual would have received from the program participant to which the 
individual had such objection, as defined by the State agency. The 
alternative provider need not be a secular organization. It must simply 
be a provider to which the recipient has no religious objection. States 
may define and apply the terms ``reasonably accessible,'' ``a reasonable 
period of time,'' ``comparable,'' ``capacity,'' and ``value that is not 
less than.'' The appropriate State or local governments that administer 
SAMHSA-funded programs shall ensure that notice of their right to 
alternative services is provided to applicants or recipients. The notice 
must clearly articulate the recipient's right to a referral and to 
services that reasonably meet the timeliness, capacity, accessibility, 
and equivalency requirements discussed above.

[[Page 236]]

    (e) PATH annual report. As part of the annual report to SAMHSA, PATH 
grantees shall include a description of the activities the grantee has 
taken to comply with 42 CFR part 54.



Sec. 54.9  Assurances and State oversight of the Charitable Choice 

requirements.

    In order to ensure that States receiving grant funding under the 
SAPT block grant and PATH formula grant programs comply with the SAMHSA 
Charitable Choice provisions and provide oversight of religious 
organizations that provide substance abuse services under such programs, 
States are required as part of their applications for funding to certify 
that they will comply with all of the requirements of such provisions 
and the implementing regulations under this part, and that they will 
provide such oversight of religious organizations.



Sec. 54.10  Fiscal accountability.

    (a) Religious organizations that receive applicable program funds 
for substance abuse services are subject to the same regulations as 
other nongovernmental organizations to account, in accordance with 
generally accepted auditing and accounting principles, for the use of 
such funds.
    (b) Religious organizations shall segregate Federal funds they 
receive under an applicable program into a separate account from non-
Federal funds. Only the Federal funds shall be subject to audit by 
government under the SAMHSA program.



Sec. 54.11  Effects on State and local funds.

    If a State or local government contributes its own funds to 
supplement activities carried out under the applicable programs, the 
State or local government has the option to separate out the Federal 
funds or commingle them. If the funds are commingled, the provisions of 
this part shall apply to all of the commingled funds in the same manner, 
and to the same extent, as the provisions apply to the Federal funds.



Sec. 54.12  Treatment of intermediate organizations.

    If a nongovernmental organization (referred to here as an 
``intermediate organization''), acting under a contract or other 
agreement with the Federal Government or a State or local government, is 
given the authority under the contract or agreement to select 
nongovernmental organizations to provide services under any applicable 
program, the intermediate organization shall have the same duties under 
this part as the government. The intermediate organization retains all 
other rights of a nongovernmental organization under this part and the 
SAMHSA Charitable Choice provisions.



Sec. 54.13  Educational requirements for personnel in drug treatment programs.

    In determining whether personnel of a program participant that has a 
record of successful drug treatment for the preceding three years have 
satisfied State or local requirements for education and training, a 
State or local government shall not discriminate against education and 
training provided to such personnel by a religious organization, so long 
as such education and training is comparable to that provided by 
nonreligious organizations, or is comparable to education and training 
that the State or local government would otherwise credit for purposes 
of determining whether the relevant requirements have been satisfied.



PART 54a_CHARITABLE CHOICE REGULATIONS APPLICABLE TO STATES, LOCAL GOVERNMENTS 

AND RELIGIOUS ORGANIZATIONS RECEIVING DISCRETIONARY FUNDING UNDER TITLE V OF 

THE PUBLIC HEALTH SERVICE ACT, 42 U.S.C. 290aa, ET SEQ., FOR SUBSTANCE ABUSE 

PREVENTION AND TREATMENT SERVICES--Table of Contents




Sec.
54a.1 Scope.
54a.2 Definitions.
54a.3 Nondiscrimination against religious organizations.
54a.4 Religious activities.

[[Page 237]]

54a.5 Religious character and independence.
54a.6 Employment practices.
54a.7 Nondiscrimination requirement.
54a.8 Right to services from an alternative provider.
54a.9 Oversight of the Charitable Choice requirements.
54a.10 Fiscal accountability.
54a.11 Effect on State and local funds.
54a.12 Treatment of intermediate organizations.
54a.13 Educational requirements for personnel in drug treatment 
          programs.
54a.14 Determination of nonprofit status.

Appendix to Part 54a--Model Notice to Individuals Receiving Substance 
          Abuse Services.

    Authority: 42 U.S.C. 300x-65, and 42 U.S.C. 290kk, et seq., 42 
U.S.C. 290aa, et seq.

    Source: 68 FR 56446, Sept. 30, 2003, unless otherwise noted.



Sec. 54a.1  Scope.

    These provisions apply only to funds provided directly to pay for 
substance abuse prevention and treatment services under Title V of the 
Public Health Service Act, 42 U.S.C. 290aa, et seq., which are 
administered by the Substance Abuse and Mental Health Services 
Administration. This part does not apply to direct funding under any 
such authorities for only mental health services or for certain 
infrastructure and technical assistance activities, such as cooperative 
agreements for technical assistance centers, that do not provide 
substance abuse services to clients. This part implements the provisions 
of 42 U.S.C. 300x-65 and 42 U.S.C. 290kk, et seq.



Sec. 54a.2  Definitions.

    (a) Applicable program means the programs authorized under Title V 
of the PHS Act, 42 U.S.C. 290aa, et seq., for the provision of substance 
abuse prevention and or treatment services.
    (b) Religious organization means a nonprofit religious organization.
    (c) Program beneficiary means an individual who receives substance 
abuse services under a program funded in whole or in part by applicable 
programs.
    (d) Program participant means a public or private entity that has 
received financial assistance under an applicable program.
    (e) SAMHSA means the Substance Abuse and Mental Health Services 
Administration.
    (f) SAMHSA Charitable Choice provisions means the provisions of 42 
U.S.C. 300x-65 and 42 U.S.C. 290kk, et seq.
    (g) Direct funding or Funds provided directly means funding that is 
provided to an organization directly by a governmental entity or 
intermediate organization that has the same duties under this part as a 
governmental entity, as opposed to funding that an organization receives 
as the result of the genuine and independent private choice of a 
beneficiary through a voucher, certificate, coupon, or other similar 
mechanism.



Sec. 54a.3  Nondiscrimination against religious organizations.

    (a) Religious organizations are eligible, on the same basis as any 
other organization, to participate in applicable programs as long as 
their services are provided consistent with the Establishment Clause and 
the Free Exercise Clause of the First Amendment to the United States 
Constitution. Except as provided herein or in the SAMHSA Charitable 
Choice provisions, nothing in these regulations shall restrict the 
ability of the Federal government, or a State or local government, from 
applying to religious organizations the same eligibility conditions in 
applicable programs as are applied to any other nonprofit private 
organization.
    (b) Neither the Federal government nor a State or local government 
receiving funds under these programs shall discriminate against an 
organization that is, or applies to be, a program participant on the 
basis of the organization's religious character or affiliation.



Sec. 54a.4  Religious activities.

    No funds provided directly from SAMHSA or the relevant State or 
local government to organizations participating in applicable programs 
may be expended for inherently religious activities, such as worship, 
religious instruction, or proselytization. If an organization conducts 
such activities, it must offer them separately, in time or location, 
from the programs or services for which it receives funds directly from 
SAMHSA or the relevant State or

[[Page 238]]

local government under any applicable program, and participation must be 
voluntary for the program beneficiaries.



Sec. 54a.5  Religious character and independence.

    A religious organization that participates in an applicable program 
will retain its independence from Federal, State, and local governments 
and may continue to carry out its mission, including the definition, 
practice and expression of its religious beliefs. The organization may 
not expend funds that it receives directly from SAMHSA or the relevant 
State or local government to support any inherently religious 
activities, such as worship, religious instruction, or proselytization. 
Among other things, faith-based organizations may use space in their 
facilities to provide services supported by applicable programs, without 
removing religious art, icons, scriptures, or other symbols. In 
addition, a SAMHSA-funded religious organization retains the authority 
over its internal governance, and it may retain religious terms in its 
organization's name, select its board members on a religious basis, and 
include religious references in its organization's mission statements 
and other governing documents.



Sec. 54a.6  Employment practices.

    (a) The participation of a religious organization in or its receipt 
of funds from an applicable program does not affect that organization's 
exemption provided under 42 U.S.C. 2000e-1 regarding employment 
practices.
    (b) Nothing in this section shall be construed to modify or affect 
any State law or regulation that relates to discrimination in 
employment.



Sec. 54a.7  Nondiscrimination requirement.

    A religious organization that is a program participant shall not, in 
providing program services or engaging in outreach activities under 
applicable programs, discriminate against a program beneficiary or 
prospective program on the basis of religion, a religious belief, a 
refusal to hold a religious belief, or a refusal to actively participate 
in a religious practice.



Sec. 54a.8  Right to services from an alternative provider.

    (a) General requirements. If an otherwise eligible program 
beneficiary or prospective program beneficiary objects to the religious 
character of a program participant, within a reasonable period of time 
after the date of such objection, such program beneficiary shall have 
rights to notice, referral, and alternative services, as outlined in 
paragraphs (b) through (d) of this section. With respect to SAMHSA 
discretionary programs, for purposes of determining what is the 
appropriate Federal, State, or local government, the following principle 
shall apply: When SAMHSA provides funding directly to another unit of 
government, such as a State or local government, that unit of government 
is responsible for providing the alternative services. When SAMHSA 
provides discretionary grant funding directly to a nongovernmental 
organization, SAMHSA is the responsible unit of government.
    (b) Notice. Program participants that refer an individual to 
alternative providers, and the appropriate Federal, State, or local 
governments that administer the applicable programs, shall ensure that 
notice of the individual's rights to services from an alternative 
provider is provided to all program beneficiaries or prospective 
beneficiaries. The notice must clearly articulate the program 
beneficiary's right to a referral and to services that reasonably meet 
the requirements of timeliness, capacity, accessibility, and equivalency 
as discussed in this section. A model notice is set out in appendix A to 
this part.
    (c) Referral to services from an alternative provider. If a program 
beneficiary or a prospective program beneficiary objects to the 
religious character of a program participant that is a religious 
organization, that participating religious organization shall, within a 
reasonable time after the date of such objection, refer such individual 
to an alternative provider.
    (1) When the State or local government is the responsible unit of 
government, the State shall have a system in place to ensure that such 
referrals are made. That system shall ensure that the following occurs:

[[Page 239]]

    (i) The religious organization that is a program participant shall, 
within a reasonable time after the date of such objection, refer the 
beneficiary to an alternative provider;
    (ii) In making such referral, the religious organization shall 
consider any list that the State or local government makes available to 
entities in the geographic area that provide program services, which may 
include utilizing any treatment locator system developed by SAMHSA;
    (iii) All referrals are to be made in a manner consistent with all 
applicable confidentiality laws, including, but not limited to, 42 CFR 
part 2 (``Confidentiality of Alcohol and Drug Abuse Patient Records'');
    (iv) Upon referring a program beneficiary to an alternative 
provider, the religious organization shall notify the responsible unit 
of government of such referral; and
    (v) The religious organization shall ensure that the program 
beneficiary makes contact with the alternative provider to which he or 
she is referred.
    (2) When SAMHSA is the responsible unit of government, the referral 
process is as follows:
    (i) When a program beneficiary requests alternative services, the 
religious organization will seek to make such a referral.
    (ii) If the religious organization cannot locate an appropriate 
provider of alternative services, the religious organization will 
contact SAMHSA. They will work together to identify additional 
alternative providers, utilizing the SAMHSA Treatment Locator system, if 
appropriate.
    (iii) The religious organization will contact these alternative 
providers and seek to make the referral, in a manner consistent with all 
applicable confidentiality laws, including, but not limited to, 42 CFR 
part 2 (``Confidentiality of Alcohol and Drug Abuse Patient Records'').
    (iv) In the event the religious organization is still unable to 
locate an alternative provider, it may again contact SAMHSA for 
assistance.
    (d) Referral reporting procedures. The program participant shall 
notify the appropriate Federal, State or local government agency that 
administers the program of such referral. If a State or local government 
is the responsible unit of government, it may determine its own 
reporting procedures. When SAMHSA is the responsible unit of government, 
this notification will occur during the course of the regular reports 
that may be required under the terms of the funding award.
    (e) Provision and funding of alternative services. The responsible 
unit of government, as defined in paragraph (a) of this section, shall 
provide to an otherwise eligible program beneficiary or prospective 
program beneficiary who objects to the religious character of a program 
participant, services and fund services from an alternative provider 
that is reasonably accessible to, and has the capacity to provide such 
services to the individual. Such services shall have a value that is not 
less than the value of the services that the individual would have 
received from the program participant to which the individual had such 
objection. The appropriate State or local governments that administer 
SAMHSA-funded programs shall ensure that notice of their right to 
alternative services is provided to applicants or recipients. The 
alternative provider need not be a secular organization. It must simply 
be a provider to which the program beneficiary has no religious 
objection.
    (1) When the State receives a discretionary grant from SAMHSA, it 
shall utilize its own implementation procedures for these provisions and 
shall use funds from the SAMHSA discretionary grant to finance such 
alternative services, as needed;
    (2) When the local government receives a discretionary grant from 
SAMHSA, it shall utilize State implementation procedures for these 
provisions and shall use funds from the SAMHSA discretionary grant to 
finance such alternative services, as needed;
    (3) When a religious organization receives a discretionary grant 
from SAMHSA, if a publicly funded alternative provider is available that 
is reasonably accessible and can provide equivalent services, the 
religious organization shall refer the beneficiary to

[[Page 240]]

that provider. However, if such a provider is not available, the 
religious organization shall contract with an alternative provider to 
provide such services and may finance such services with funds from the 
SAMHSA discretionary grant.



Sec. 54a.9  Oversight of the Charitable Choice requirements.

    In order to ensure that program funds are used in compliance with 
the SAMHSA Charitable Choice provisions, applicants for funds under 
applicable programs are required, as part of their applications for 
funding, to certify that they will comply with all of the requirements 
of the SAMHSA Charitable Choice provisions and the implementing 
regulations under this part.



Sec. 54a.10  Fiscal accountability.

    (a) Religious organizations that receive applicable program funds 
for substance abuse services are subject to the same regulations as 
other nongovernmental organizations to account, in accordance with 
generally accepted auditing and accounting principles, for the use of 
such funds.
    (b) Religious organizations shall segregate Federal funds they 
receive under applicable programs into a separate account from non-
Federal funds. Only the Federal funds shall be subject to audit by the 
government under the SAMHSA program.



Sec. 54a.11  Effect on State and local funds.

    If a State or local government contributes its own funds to 
supplement activities carried out under the applicable programs, the 
State or local government has the option to separate out the Federal 
funds or commingle them. If the funds are commingled, the provisions of 
this part shall apply to all of the commingled funds, in the same 
manner, and to the same extent, as the provisions apply to the Federal 
funds.



Sec. 54a.12  Treatment of intermediate organizations.

    If a nongovernmental organization (referred to here as an 
``intermediate organization''), acting under a contract or other 
agreement with the Federal Government or a State or local government, is 
given the authority under the contract or agreement to select 
nongovernmental organizations to provide services under any applicable 
program, the intermediate organization shall have the same duties under 
this part as the government. The intermediate organization retains all 
other rights of a nongovernmental organization under this part and the 
SAMHSA Charitable Choice provisions.



Sec. 54a.13  Educational requirements for personnel in drug treatment 

programs.

    In determining whether personnel of a program participant that has a 
record of successful drug treatment for the preceding three years have 
satisfied State or local requirements for education and training, a 
State or local government shall not discriminate against education and 
training provided to such personnel by a religious organization, so long 
as such education and training is comparable to that provided by 
nonreligious organizations, or is comparable to education and training 
that the State or local government would otherwise credit for purposes 
of determining whether the relevant requirements have been satisfied.



Sec. 54a.14  Determination of nonprofit status.

    The nonprofit status of any SAMHSA applicant can be determined by 
any of the following:
    (a) Reference to the organization's listing in the Internal Revenue 
Service's (IRS) most recent list of tax-exempt organizations described 
in section 501(c)(3) of the IRS code.
    (b) A copy of a currently valid IRS Tax exemption certificate.
    (c) A statement from a State taxing body, State Attorney General, or 
other appropriate State official certifying that the applicant 
organization has a nonprofit status and that none of its net earnings 
accrue to any private shareholder or individuals.
    (d) A certified copy of the organization's certificate of 
incorporation or similar document if it clearly establishes the 
nonprofit status of the organization.
    (e) Any of the above proof for a State or national parent 
organization and a

[[Page 241]]

statement signed by the parent organization that the applicant 
organization is a local nonprofit affiliate.



    Sec. Appendix to Part 54a--Model Notice of Individuals Receiving 
                        Substance Abuse Services

     Model Notice to Individuals Receiving Substance Abuse Services

    No provider of substance abuse services receiving Federal funds from 
the U.S. Substance Abuse and Mental Health Services Administration, 
including this organization, may discriminate against you on the basis 
of religion, a religious belief, a refusal to hold a religious belief, 
or a refusal to actively participate in a religious practice.
    If you object to the religious character of this organization, 
Federal law gives you the right to a referral to another provider of 
substance abuse services. The referral, and your receipt of alternative 
services, must occur within a reasonable period of time after you 
request them. The alternative provider must be accessible to you and 
have the capacity to provide substance abuse services. The services 
provided to you by the alternative provider must be of a value not less 
than the value of the services you would have received from this 
organization.



PART 55a_PROGRAM GRANTS FOR BLACK LUNG CLINICS--Table of Contents




                      Subpart A_General Provisions

Sec.
55a.101 Definitions.
55a.102 Who is eligible to apply for a Black Lung clinics grant?
55a.103 What criteria has HHS established for deciding which grant 
          application to fund?
55a.104 What confidentiality requirements must be met?
55a.105 How must grantees carry out their projects?
55a.106 Provision for waiver by the Secretary.
55a.107 What other regulations apply?

                       Subpart B_Grants to States

55a.201 What is required for a State application?

             Subpart C_Grants to Entities Other Than States

55a.301 What is required for an application from an entity other than a 
          State?

    Authority: Sec. 427(a), Federal Mine Safety and Health Act of 1977, 
92 Stat. 100 (30 U.S.C. 937(a)).

    Source: 50 FR 7913, Feb. 27, 1985, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 55a.101  Definitions.

    Act, as used in this part, means the Federal Mine Safety and Health 
Act of 1977, as amended (30 U.S.C. 801 et seq.).
    Secretary means the Secretary of Health and Human Services and any 
other officer or empolyee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    Miner or coal miner means any individual who works or has worked in 
or around a coal mine or coal preparation facility in the extraction or 
preparation of coal. The term also includes an individual who works or 
has worked in coal mine construction or transportation in or around a 
coal mine, to the extent that the individual was exposed to coal dust as 
a result of employment.



Sec. 55a.102  Who is eligible to apply for a Black Lung clinics grant?

    Any State or public or private entity may apply for a grant under 
this part.



Sec. 55a.103  What criteria has HHS established for deciding which grant 

application to fund?

    (a) The Secretary will give preference to a State, which meets the 
requirements of this part and applies for a grant under this part, over 
other applicants in that State.
    (b) Within the limits of funds available for these purposes the 
Secretary may award grants to assist in the carrying out of those 
programs which will in the Secretary's judgment best promote the 
purposes of section 427(a) of the Act, taking into account;
    (1) The number of miners to be served and their needs; and
    (2) The quality and breadth of services to be provided.



Sec. 55a.104  What confidentiality requirements must be met?

    All information as to personal facts and circumstances obtained by 
the grantee's staff about recipients of services shall be held 
confidential and shall not be disclosed without the individual's consent 
except as may be required

[[Page 242]]

by law or as may be necessary to provide service to the individual or to 
provide for audits with appropriate safeguards for confidentiality of 
patient records. Otherwise, information may be disclosed only in 
summary, statistical, or other form which does not identify particular 
individuals.



Sec. 55a.105  How must grantees carrry out their projects?

    Grantees must carry out their projects in accordance with their 
applications and the provisions of this part.



Sec. 55a.106  Provision for waiver by the Secretary.

    The Secretary may, for good cause shown, waive provisions of these 
regulations.



Sec. 55a.107  What other regulations apply?

    Other regulations which apply to the Black Lung Clinics Program 
include, but are not limited to, the following:

42 CFR part 50, subpart D--Public Health Service grant appeals 
procedure;
42 CFR part 50, subpart E--Maximum allowable cost for drugs;
45 CFR part 16--Procedures of the Departmental Grant Appeals Board;
45 CFR part 19--Limitations on payment or reimbursement for drugs;
45 CFR part 74--Administration of grants;
45 CFR part 75--Informal grant appeals procedures;
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964;
45 CFR part 81--Practice and procedure for hearings under part 80;
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial 
assistance; and
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance.



                       Subpart B_Grants to States



Sec. 55a.201  What is required for a State application?

    An approvable State application must contain assurances that the 
State will:
    (a) Provide the following services for active and inactive miners in 
the State:
    (1) Primary care;
    (2) Patient and family education and counseling;
    (3) Outreach;
    (4) Patient care coordination, including individual patient care 
plans for all patients;
    (5) Antismoking advice; and
    (6) Other symptomatic treatments.
    (b) Provide medical services in consultation with a physician with 
special training or experience in the diagnosis and treatment of 
respiratory diseases.
    (c) Meet all criteria for approval and designation by the Department 
of Labor under 20 CFR part 725 to perform disability examination and 
provide treatment under the Act.
    (d) Use grant funds under this part to supplement and not supplant 
existing services of the State.
    (e) Provide the services described above for those miners previously 
served by a Black Lung Clinic in the State for which grant support 
expires during the funding period of the State's grant.
    (f) Provide services described above regardless of a person's 
ability to pay.
    (g) Audit its expenditures from amounts received under this part in 
accordance with the provisions of Attachment P, Audit Requirements, of 
Office of Management and Budget Circular A-102, Uniform Requirements for 
Assistance to State and Local Governments, as adopted for the Department 
of Health and Human Services by 45 CFR part 74.

(Approved by the Office of Management and Budget under control number 
0915-0081)

[50 FR 7913, Feb. 27, 1985, as amended at 50 FR 53156, Dec. 30, 1985]



             Subpart C_Grants to Entities Other Than States



Sec. 55a.301  What is required for an application from an entity other than a 

State?

    An approvable application must contain the following:
    (a) A plan for the provision of the services required by Sec. 
55a.201(a), consistent with the requirements of Sec. 55a.201 (b) and 
(c). The plan must also

[[Page 243]]

contain at least the following elements:
    (1) A description of the target population to whom services are to 
be provided, including a statement of the need for services;
    (2) An assurance that charges shall be made for services rendered as 
follows:
    (i) A schedule shall be maintained listing fees or payments for the 
provision of services, designed to cover reasonable costs of operations;
    (ii) A schedule of discounts adjusted on the basis of a patient's 
ability to pay shall be maintained. The schedule of discounts must 
provide for a full discount to individuals and families with annual 
incomes at or below the poverty line established in accordance with 
section 673(2) of the Community Services Block Grant Act (42 U.S.C. 
9902(2)), (except that nominal fees for service may be requested, but 
not required, from individuals and families with annual incomes at or 
below the poverty line). No discounts shall be provided to individuals 
and families with annual incomes greater than twice the poverty line; 
and
    (iii) Where third-party payors (including Government Agencies) are 
authorized or under a legal obligation to pay all or a portion of such 
charges, all services covered by that reimbursement plan will be billed 
and every reasonable effort will be made to obtain payment.
    (b) An assurance that no person will be denied services because of 
inability to pay.
    (c) An assurance that grant funds received under this part will be 
used to supplement and not supplant existing services of the grantee.

(Approved by the Office of Management and Budget under control number 
0915-0081)

[50 FR 7913, Feb. 27, 1985, as amended at 50 FR 53156, Dec. 30, 1985]



PART 56_GRANTS FOR MIGRANT HEALTH SERVICES--Table of Contents




                      Subpart A_General Provisions

Sec.
56.101 Applicability.
56.102 Definitions.
56.103 Eligibility.
56.104 Application.
56.105 Accord with health planning.
56.106 Amount of grant.
56.107 Priorities for grants.
56.108 Use of grant funds.
56.109 Grant payments.
56.110 Nondiscrimination.
56.111 Confidentiality.
56.112 Publications and copyright.
56.113 Grantee accountability.
56.114 Applicability of 45 CFR part 74.

   Subpart B_Grants for Planning and Developing Migrant Health Centers

56.201 Applicability.
56.202 Application.
56.203 Project elements.
56.204 Grant evaluation and award.

          Subpart C_Grants for Operating Migrant Health Centers

56.301 Applicability.
56.302 Application.
56.303 Project elements.
56.304 Governing board.
56.305 Grant evaluation and award.

         Subpart D_Grants for Operating Migrant Health Entities

56.401 Applicability.
56.402 Application.
56.403 Project elements.
56.404 Grant evaluation and award.

  Subpart E_Grants for Planning and Developing Migrant Health Programs

56.501 Applicability.
56.502 Application.
56.503 Project elements.
56.504 Grant evaluation and award.

         Subpart F_Grants for Operating Migrant Health Programs

56.601 Applicability.
56.602 Application.
56.603 Project elements.
56.604 Grant evaluation and award.

                Subpart G_Grants for Technical Assistance

56.701 Applicability.
56.702 Application.
56.703 Project elements.
56.704 Grant evaluation and award.

      Subpart H_Acquisition and Modernization of Existing Buildings

56.801 Applicability of 42 CFR part 51c, subpart E.


[[Page 244]]


    Authority: Secs. 215, 319, Public Health Service Act (42 U.S.C. 216, 
247d).

    Source: 42 FR 60406, Nov. 25, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 56.101  Applicability.

    The regulations of this subpart are applicable to all grants 
authorized by section 319 of the Public Health Service Act (42 U.S.C. 
247d).



Sec. 56.102  Definitions.

    As used in this part:
    (a) Act means the Public Health Service Act (42 U.S.C. 201 et seq.), 
as amended.
    (b)(1) Agriculture means farming in all its branches, including--
    (i) Cultivation and tillage of the soil;
    (ii) The production, cultivation, growing, and harvesting of any 
commodity grown on, in, or as an adjunct to or part of a commodity grown 
in, or on, the land; and
    (iii) Any practice (including preparation and processing for market 
and delivery to storage or to market or to carriers for transportation 
to market) performed by a farmer or on a farm incident to or in 
conjunction with an activity described in subsection (ii).
    (c) Catchment area means the geographic area served by a project 
funded under section 319 of the Act.
    (d) Environmental health services means the detection and 
alleviation of unhealthful conditions of the environment of the persons 
served by the project, such as problems associated with water supply, 
sewage treatment, solid waste disposal, rodent and parasite infestation, 
field sanitation, and housing conditions and the treatment of medical 
conditions arising therefrom. For the purposes of this part, the 
detection and alleviation of unhealthful conditions of the environment 
includes the notification of appropriate Federal, State, or local 
authorities responsible for correcting such conditions and the making of 
arrangements therefor with such authorities.
    (e) Health professionals means professionals (such as physicians, 
dentists, nurses, podiatrists, optometrists, and physicians' extenders) 
who are engaged in the delivery of health services and who meet all 
applicable Federal or State requirements to provide their professional 
services.
    (f) High impact area means a catchment area which has not less than 
6,000 migratory agricultural workers, seasonal agricultural workers, and 
members of the families of such workers residing within its boundaries 
for more than two months in the most recent calendar year for which 
statistical data acceptable to the Secretary is available.
    (g)(1) Migrant health center means an entity which either through 
its staff and supporting resources or through contracts or cooperative 
arrangements with other public or private entities provides for 
migratory agricultural workers, seasonal agricultural workers, and the 
members of the families of such workers, within its catchment area:
    (i) Primary health services;
    (ii) As determined by the Secretary to be appropriate for particular 
centers, supplemental health services necessary for the adequate support 
of primary health services;
    (iii) Referral to providers of supplemental health services and 
payment, as determined by the Secretary to be appropriate and feasible, 
for the provision of such services;
    (iv) Environmental health services, as determined by the Secretary 
to be appropriate for particular centers;
    (v) As determined by the Secretary to be appropriate for particular 
centers, infectious and parasitic disease screening and control 
services;
    (vi) As determined by the Secretary to be appropriate for particular 
centers, accident prevention programs, including prevention of excessive 
exposure to pesticides through, but not limited to, notification of 
appropriate Federal, State or local authorities of hazardous conditions 
due to pesticide use; and
    (vii) Information on the availability and proper use of health 
services.
    (2) For purposes of paragraph (g)(1) of this section, the provision 
of a given service by a center will be determined by the Secretary to be 
appropriate where

[[Page 245]]

    (i) There is a need, as determined by the Secretary, for the 
provision of such service to individuals described in paragraph (g)(1) 
of this section in the catchment area; and
    (ii) The provision of such service by the center is feasible, taking 
into consideration the center's projected revenues, other resources, and 
grant support under this part.
    (h) Migratory agricultural worker means an individual whose 
principal employment is in agriculture on a seasonal basis, who has been 
so employed within the last 24 months, and who establishes for the 
purpose of such employment a temporary place of abode;
    (i) Nonprofit, as applied to any private agency, institution, or 
organization, means one which is a corporation or association, or is 
owned and operated by one or more corporations or associations, no part 
of the net earnings of which inures, or may lawfully inure, to the 
benefit of any private shareholder or individual.
    (j) Physician means a licensed doctor of medicine or doctor of 
osteopathy.
    (k) Primary care means preventive, diagnostic, treatment, 
consultant, referral, and other services rendered by physicians 
(including, as appropriate, physicians' extenders), routine associated 
laboratory services and diagnostic radiologic services, and emergency 
health services.
    (l) Primary health services means:
    (1) Diagnostic, treatment, consultative referral, and other services 
rendered by physicians and, where feasible, by physicians' extenders, 
such as physicians' assistants, nurse clinicians, and nurse 
practitioners;
    (2) Diagnostic laboratory services and diagnostic radiologic 
services;
    (3) Preventive health services, including children's eye and ear 
examinations, prenatal and post-partum care, perinatal services, well 
child care (including periodic screening), immunizations, and voluntary 
family planning services;
    (4) Emergency medical services, including provision, through clearly 
defined arrangements, for access of users of the center to health care 
for medical and dental emergencies during and after the center's 
regularly scheduled hours;
    (5) Transportation services as needed for adequate patient care, 
sufficient so that residents of the catchment area served by the center 
with special difficulties of access to services provided by the center 
receive such services; and
    (6) Preventive dental services provided by a licensed dentist or 
other qualified personnel, including--
    (i) Oral hygiene instruction;
    (ii) Oral prophylaxis, as necessary; and
    (iii) Topical application of fluorides, and the prescription of 
fluorides for systemic use when not available in the community water 
supply.
    (m) Seasonal agricultural worker means an individual whose principal 
employment is in agriculture on a seasonal basis and who is not a 
migratory agricultural worker.
    (n) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (o) Supplemental health services means health services which are not 
included as primary health services and which are:
    (1) Inpatient and outpatient hospital services;
    (2) Home health services;
    (3) Extended care facility services;
    (4) Rehabilitative services (including physical and occupational 
therapy) and long-term physical medicine;
    (5) Mental health services, including services of psychiatrists, 
psychologists, and other appropriate mental health professionals;
    (6) Dental services other than those provided as primary health 
services;
    (7) Vision services, including routine eye and vision examinations 
and provision of eyeglasses, as appropriate and feasible;
    (8) Allied health services;
    (9) Pharmaceutical services, including the provision of prescription 
drugs;
    (10) Therapeutic radiologic services;
    (11) Ambulatory surgical services;
    (12) Public health services (including nutrition education and 
social services);
    (13) Health education services; and
    (14) Services including the services of outreach workers, which 
promote and

[[Page 246]]

facilitate optimal use of primary health services and services referred 
to in the preceding subparagraphs of this paragraph and, if a 
substantial number of individuals in the population served by the center 
are of limited English-speaking ability, the services of outreach 
workers and other personnel fluent in the language or languages spoken 
by such individuals.



Sec. 56.103  Eligibility.

    Any public or nonprofit private entity is eligible to apply for a 
grant under this part.



Sec. 56.104  Application.

    (a) An application for a grant under this part shall be submitted to 
the Secretary at such time and in such form and manner as the Secretary 
may prescribe.
    (b) The application shall contain a budget and narrative plan of the 
manner in which the applicant intends to conduct the project and carry 
out the requirements of this part. The application must describe how and 
the extent to which the project has met, or plans to meet, each of the 
requirements in subpart B (relating to grants for planning and 
development of migrant health centers), subpart C (relating to grants 
for the operation of migrant health centers), subpart D (relating to 
grants for the operation of migrant health entities), subpart E 
(relating to grants for planning and developing migrant health 
programs), subpart F (relating to grants for the operation of migrant 
health programs), or subpart G (relating to grants for technical 
assistance), as applicable. In addition, applications must include:
    (1) A statement of specific, measurable objectives and the methods 
to be used to assess the achievement of the objectives in specified time 
periods and at least on an annual basis.
    (2) The precise boundaries of the catchment area to be served by the 
applicant. In addition, the application shall include information 
sufficient to enable the Secretary to determine that the applicant's 
catchment area meets the following criteria:
    (i) The size of such area is such that the services to be provided 
by the applicant are available and accessible to the residents of the 
area promptly and as appropriate;
    (ii) The boundaries of such area conform, to the extent practicable, 
to relevant boundaries of political subdivisions, school districts, and 
areas served by Federal and State health and social service programs; 
and
    (iii) The boundaries of such area eliminate, to the extent possible, 
barriers resulting from the area's physical characteristics, its 
residential patterns, its economic and social groupings, and available 
transportation.
    (3)(i) The number of migratory agricultural workers and members of 
their families, and seasonal agricultural workers and members of their 
families which resided in the project's catchment area in the most 
recent calendar year for which statistical data acceptable to the 
Secretary is available; and
    (ii) The approximate period or periods of residence of all groups of 
migratory agricultural workers and their families counted under 
paragraph (b)(3)(i) of this section.
    (4) The results of an assessment of the need that the population to 
be served has for the services to be provided by the project (or in the 
case of applications for planning and development projects, the methods 
to be used in assessing such need), taking into consideration the 
following factors:
    (i) Available health resources in relation to size of the catchment 
area and population of migratory and seasonal agricultural workers and 
their families in such area, including appropriate ratios of primary 
care physicians in general or family practice, internal medicine, 
pediatrics, or obstetrics and gynecology, to such population;
    (ii) Health indices for such population, such as infant mortality 
rate;
    (iii) Economic factors affecting such population's use of health 
services, such as percentage of such population with incomes below the 
poverty level;
    (iv) Demographic factors affecting such population's need and demand 
for health services, such as percentage of such population age 65 and 
over; and
    (v) Special factors of access resulting from the conditions of 
employment of

[[Page 247]]

such workers (including working hours, housing, and sanitation).
    (5) Position descriptions for personnel who will be utilized in 
carrying out the activities of the project and a statement indicating 
the need for the positions to be supported with grant funds to 
accomplish the objectives of the project.
    (6) Letters and other forms of evidence showing that efforts have 
been made to secure financial and professional assistance and support 
for the project within the proposed catchment area and the continuing 
involvement of the community in the development and operation of the 
project.
    (7) An assurance that an independent certified public accountant 
will be engaged to certify that the project's system for the management 
and control of its finances will be in accord with sound financial 
management practices, including applicable Federal requirements.
    (8) A list of all services proposed to be provided by the project.
    (9) A list of services which are to be provided directly by the 
project through its own staff and resources and a description of any 
contractual or other arrangements (including copies of documents, where 
available) entered into, or planned for the provision of services.
    (10) The schedule of fees and/or payments and schedule of discounts 
for services provided by the project.
    (11) If the applicant provides services to populations other than 
migratory and seasonal agricultural workers and their families, 
identification of such populations.

    Note: Funds granted under this part and non-Federal funds required 
to be expended by the project as a condition of any such grant may not 
be used to provide services to individuals who are not migratory or 
seasonal agricultural workers or members of the families of such 
workers.

    (12) Evidence that all applicable requirements for review and/or 
approval of the application under title XV of the Act have been met.
    (13) An assurance that the project will be conducted in accordance 
with the applicable requirements of this part.
    (c) The application must be executed by an individual authorized to 
act for the applicant and to assume on behalf of the applicant the 
obligations imposed by the statute, the applicable regulations of this 
part, and any additional conditions of the grant.

(Sec. 215, Public Health Service Act, 58 Stat. 690, 67 Stat. 631 (42 
U.S.C. 216); sec. 329, Public Health Service Act, 95 Stat. 569 (42 
U.S.C. 254b)).

[42 FR 60406, Nov. 25, 1977, as amended at 48 FR 29202, June 24, 1983; 
48 FR 45559, Oct. 6, 1983]



Sec. 56.105  Accord with health planning.

    A grant may be made under this part only if the applicable 
requirements of title XV of the Act relating to review and approval by 
the appropriate health planning agencies have been met.



Sec. 56.106  Amount of grant.

    (a) The amount of any award under this part will be determined by 
the Secretary on the basis of his estimate of the sum necessary for a 
designated portion of direct project costs plus an additional amount for 
indirect costs, if any, which will be calculated by the Secretary 
either:
    (1) On the basis of the estimate of the actual indirect costs 
reasonably related to the project; or
    (2) On the basis of a percentage of all, or a portion of, the 
estimated direct costs of the project when there are reasonable 
assurances that the use of such percentage will not exceed the 
approximate actual indirect costs. Such award may include an estimated 
provisional amount for indirect costs or for designated direct costs 
(such as fringe benefit rates) subject to upward (within the limits of 
available funds) as well as downward adjustments to actual costs when 
the amount properly expended by the grantee for provisional items has 
been determined by the Secretary: Provided, however, That no grant shall 
be made for an amount in excess of the total costs found necessary by 
the Secretary to carry out the project.
    (i) In determining the percentage of project costs to be borne by 
the grantee, factors which the Secretary will take into consideration 
will include the following:

[[Page 248]]

    (A) The ability of the grantee to finance its share of project costs 
from non-Federal sources;
    (B) The need in the area served by the project for the services to 
be provided; and
    (C) The extent to which the project will provide services in an 
innovative manner which the Secretary desires to stimulate in the 
interest of developing more effective health service delivery systems on 
a regional or national basis.
    (ii) At any time after approval of an application under this part, 
the Secretary may retroactively agree to a percentage of project costs 
to be borne by the grantee lower than that determined pursuant to 
paragraph (a)(2)(i) of this section where he finds that changed 
circumstances justify a smaller contribution.
    (iii) In determining the grantee's share of project costs, costs 
borne by Federal grant funds, or costs used to match other Federal 
grants, may not be included except as otherwise provided by law or 
regulations.
    (b) All grant awards shall be in writing, and shall set forth the 
amount of funds granted and the period for which support is recommended.
    (c) Neither the approval of any project nor any grant award, shall 
commit or obligate the United States in any way to make any additional, 
supplemental, continuation, or other award with respect to any approved 
project or portion thereof. For continuation support, grantees must make 
separate application.



Sec. 56.107  Priorities for grants.

    (a) Grants under sections 319(c) (1)(A), 319(d)(1)(A), 319(d)(1)(B) 
of the Act and subparts B, C, and D of this part shall be made in 
accordance with the following priorities:
    (1) Highest priority will be given to approvable applications which 
propose to serve catchment areas in which 6,000 or more migratory 
agricultural workers and members of their families reside for more than 
two months in the calendar year.
    (2) Second priority will be given to approvable applications which 
propose to serve catchment areas in which fewer than 6,000 but more than 
1,000 migratory agricultural workers and members of their families 
reside for more than two months in the applicable calendar year.
    (3) Third priority will be given to approvable applications which 
propose to serve catchment areas in which migratory agricultural workers 
and members of their families reside but in which fewer than 1,000 such 
persons reside for more than two months in the applicable calendar year.
    (4) Fourth priority will be given to approvable applications which 
propose to serve catchment areas in which migratory agricultural workers 
and members of their families reside in the applicable calendar year but 
in which no such persons reside for more than two months in such year.
    (5) Fifth priority will be given to approvable applications which 
propose to serve catchment areas in which no migratory agricultural 
workers or members of their families reside for any period in the 
applicable calendar year but in which 6,000 or more seasonal 
agricultural workers and the members of their families reside.
    (6) Lowest priority will be given to approvable applications which 
propose to serve catchment areas in which no migratory agricultural 
workers or members of their families reside for any period in the 
applicable calendar year and in which fewer than 6,000 seasonal 
agricultural workers and the members of their families reside.
    (b) Grants under sections 319(c) (1)(B) and 319(d)(1)(C) of the Act 
and subparts E and F of this part will be made in accordance with 
priorities set forth in paragraphs (a)(2) through (a)(6) of this 
section, in the order set forth.
    (c) For the purposes of this section, the applicable calendar year 
will be the calendar year for which data is provided in accordance with 
Sec. 56.104(b)(3) of this subpart.



Sec. 56.108  Use of grant funds.

    (a) Any funds granted pursuant to this part, as well as other funds 
to be used in performance of the approved project, may be expended 
solely for carrying out the approved project in accordance with section 
319 of the Act, the applicable regulations of this part, the terms and 
conditions of the award,

[[Page 249]]

and the applicable cost principles prescribed in subpart Q of 45 CFR 
part 74.
    (b) Project funds awarded under this part may be used for, but need 
not be limited to, the following:
    (1) The costs of acquiring and modernizing existing buildings 
(including the costs of amortizing the principal of, and paying interest 
on, loans), but only in accordance with subpart H of this part and as 
approved in the grant award;
    (2) The costs of obtaining technical assistance to develop and 
improve the management or service capability of the project but only as 
approved by the Secretary;
    (3) To reimburse members of the grantee's governing board 
established pursuant to Sec. 56.304 of subpart C, or advisory council 
established pursuant to Sec. 56.603(q) of subpart F, if any, for 
reasonable expenses actually incurred by reason of their participation 
in the activities of such board or council;
    (4) To reimburse such governing board or advisory council members 
who are individuals eligible to be served by the project for wages lost 
by reason of participation in the activities of such board or council;
    (5) The cost of delivering health services to migratory agricultural 
workers, seasonal agricultural workers and the members of their families 
within the project's catchment area, within the following limitations: 
grant funds may be used to pay the full cost of project services to such 
individuals and families with annual incomes at or below those set forth 
in the most recent ``CSA Income Poverty Guidelines'' (45 CFR 1060.2) 
issued by the Community Services Administration, and to pay the portion 
of the cost of services provided in accordance with the schedule of 
discounts which, under such schedule, is uncompensated; Provided, That
    (i) Charges will be made to such individuals and families in 
accordance with Sec. 56.303(f) of subpart C or Sec. 56.603(e) of 
subpart F, as applicable;
    (ii) Reasonable effort shall be made to collect such charges under a 
billing and collections system; and
    (iii) The charge to grant funds shall exclude any amounts collected 
pursuant to paragraph (b)(5)(ii) of this section;
    (6) The cost of insurance for medical emergency and out-of-area 
coverage; and
    (7) The cost of providing to the staff and governing board, if any, 
of the project training related to the management of an ambulatory care 
facility, and to the staff of a project funded under subpart C, D, or F 
of this part, training related to the provision of primary, supplemental 
and environmental health services provided or to be provided by the 
project, consistent with the applicable requirements of 45 CFR part 74.
    (c) Prior approval by the Secretary of revisions of the budget and 
project plan is required whenever there is to be a significant change in 
the scope or nature of project activities.



Sec. 56.109  Grant payments.

    The Secretary shall from time to time make payments to a grantee of 
all or a portion of any grant award, either in advance or by way of 
reimbursement for expenses incurred or to be incurred, to the extent he 
determines such payments necessary to promote prompt initiation and 
advancement of the approved project.



Sec. 56.110  Nondiscrimination.

    (a) Attention is called to the requirements of title VI of the Civil 
Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in 
particular section 601 of such Act which provides that no person in the 
United States shall on the grounds of race, color, or national origin be 
excluded from participation in, be denied the benefits of, or be 
subjected to discrimination under any program or activity receiving 
Federal financial assistance. A regulation implementing such title VI, 
which applies to grants made under this part, has been issued by the 
Secretary of Health and Human Services with the approval of the 
President (45 CFR part 80). In addition, no person shall, on the grounds 
of age, sex, creed, or marital status (unless otherwise medically 
indicated), be excluded from participation in, be denied the benefits 
of, or be subjected to discrimination under any program or activity so 
receiving Federal financial assistance.

[[Page 250]]

    (b) Attention is called to the requirements of section 504 of the 
Rehabilitation Act of 1973, as amended, which provides that no otherwise 
qualified handicapped individual in the United States shall, solely by 
reason of his handicap, be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance.



Sec. 56.111  Confidentiality.

    All information as to personal facts and circumstances obtained by 
the project staff about recipients of services shall be held 
confidential and shall not be divulged without the individual's consent 
except as may be required by law or as may be necessary to provide 
service to the individual or to provide for medical audits by the 
Secretary or his designee with appropriate safeguards for 
confidentiality of patient records. Otherwise, information may be 
disclosed only in summary, statistical, or other form which does not 
identify particular individuals.



Sec. 56.112  Publications and copyright.

    Except as may otherwise be provided under the terms and conditions 
of the award, the grantee may copyright without prior approval any 
publications, films, or similar materials developed or resulting from a 
project supported by a grant under this part, subject, however, to a 
royalty-free, non-exclusive, and irrevocable license or right in the 
Government to reproduce, translate, publish, use, disseminate, and 
dispose of such materials and to authorize others to do so.



Sec. 56.113  Grantee accountability.

    (a) Accounting for grant award payments. All payments made by the 
Secretary shall be recorded by the grantee in accounting records 
separate from the records of all other funds, including funds derived 
from other grant awards. With respect to each approved project, the 
grantee shall account for the sum total of all amounts paid as well as 
other funds and in-kind contributions by presenting or otherwise making 
available evidence satisfactory to the Secretary of expenditures for 
direct and indirect costs meeting the requirements of this part: 
Provided, however, That when the amount awarded for indirect costs was 
based on a predetermined fixed-percentage of estimated direct costs, the 
amount allowed for indirect costs shall be computed on the basis of such 
predetermined fixed-percentage rates applied to the total, or a selected 
element thereof, of the reimbursable direct costs incurred.
    (b) Accounting for interest earned on grant funds. Pursuant to 
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 
4213), a State will not be held accountable for interest earned on grant 
funds, pending their disbursement for grant purposes. A State, as 
defined in section 102 of the Intergovernmental Cooperation Act, means 
any one of the several States, the District of Columbia, Puerto Rico, 
any territory or possession of the United States, or any agency or 
instrumentality of a State, but does not include the government of the 
political subdivisions of the State. All grantees other than a State, as 
so defined, must return all interest earned on grant funds to the 
Federal Government.
    (c) Grant closeout--(1) Date of final accounting. A grantee shall 
render, with respect to each approved project, a full account, as 
provided herein, as of the date of the termination of grant support. The 
Secretary may require other special and periodic accounting.
    (2) Final settlement. There shall be payable to the Federal 
Government as final settlement with respect to each approved project, 
the sum of:
    (i) Any amount not accounted for pursuant to paragraph (a) of this 
section;
    (ii) Any credits for earned interest pursuant to paragraph (b) of 
this section;
    (iii) Any other amounts due pursuant to subparts F, M, and O of 45 
CFR part 74.

Such total sum shall constitute a debt owed by the grantee to the 
Federal Government and shall be recovered from the grantee or its 
successors or assignees by setoff or other action as provided by law.

[[Page 251]]



Sec. 56.114  Applicability of 45 CFR part 74.

    The provisions of 45 CFR part 74, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part to States and local governments as those terms 
are defined in subpart A of that part 74. The relevant provisions of the 
following subparts of part 74 shall also apply to grants to all other 
grantee organizations under this part:

                             45 CFR Part 74

Subpart
A General.
B Cash depositories.
C Bonding and insurance.
D Retention and custodial requirements for records.
F Grant-related income.
G Matching and cost sharing.
K Grant payment requirements.
L Budget revision procedures.
M Grant closeout, suspension, and termination.
O Property.
Q Cost principles.



   Subpart B_Grants for Planning and Developing Migrant Health Centers



Sec. 56.201  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 319(c)(1)(A) of the Act for projects for planning and developing 
migrant health centers in high impact areas.



Sec. 56.202  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec. 
56.104 of subpart A of this part, contain information sufficient to 
enable the Secretary to determine that the project for which the grant 
is sought will meet the requirements of this part.



Sec. 56.203  Project elements.

    A project for planning and developing a migrant health center 
supported under this subpart must:
    (a) Determine (by survey or other appropriate means) the approximate 
number of (1) migratory agricultural workers and the members of their 
families, and (2) seasonal agricultural workers and the members of their 
families, within the proposed catchment area in the calendar year in 
which the grant is made and the period of time these workers and their 
families reside in the catchment area during such year.
    (b) Prepare an assessment of the need of the population proposed to 
be served by the migrant health center for the services set forth in 
Sec. 56.102(g)(1) of subpart A of this part. This assessment of need 
must, at a minimum, include the factors listed in Sec. 56.104(b)(3) 
(i)-(iv).
    (c) Design a migrant health center program for such population, 
based on the assessment prepared pursuant to paragraph (b) of this 
section which indicates in detail how the proposed center will fulfill 
the needs identified in that assessment and meet the requirements of 
subpart C of this part.
    (d) Develop a plan for the implementation of the program designed 
pursuant to paragraph (c) of this section. This implementation plan must 
provide for the time-phased recruitment and training of the personnel 
essential for the operation of a migrant health center and the gradual 
assumption of operational status of the project so that the project 
will, in the judgment of the Secretary, meet the requirements contained 
in subpart C of this part by the end of the project period.
    (e) Implement the plan developed pursuant to paragraph (d) of this 
section in accordance with such paragraph.
    (f) Make efforts to secure within the proposed catchment area of 
such center, to the extent possible, financial and professional 
assistance and support for the project.
    (g) Initiate and encourage continuing community involvement in the 
development and operation of the project through, for example, 
contributions or loans of cash, services, equipment, full-or part-time 
staff, space, materials, or facilities.
    (h) Provide for sufficient staff, qualified by training and 
experience, to carry out the project and establish standards and 
qualifications for personnel (including the project director).

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    (i) Utilize, to the maximum extent feasible, other Federal, State, 
local, and private resources available for support of the project, prior 
to use of project funds under this subpart.
    (j) Provide the means for evaluating the project's progress in 
achievement of its specific objectives, and submit such progress reports 
on the project as the Secretary may from time to time request.



Sec. 56.204  Grant evaluation and award.

    (a) Within the limits of funds determined by the Secretary to be 
available for such purpose, the Secretary may award grants under this 
subpart to applicants therefor which, in his judgment, will provide 
needed health services in a catchment area which will not be served by 
another project funded under this part and meet the applicable 
requirements of section 319(c)(1)(A) of the Act and this part, in 
accordance with priorities established pursuant to section 319(b) of the 
Act and Sec. 56.107 of subpart A of this part; Provided, That in the 
case of applicants which propose to serve substantially the same 
catchment areas or where available funds are insufficient to fund all 
approvable applications within a priority category specified in Sec. 
56.107,
    (1) Priority shall be given to applications submitted by community-
based organizations which are representative of the population to be 
served by the project. For purposes of this paragraph, an applicant 
shall be deemed to be such an organization if it provides a formal 
mechanism (such as membership on the organization's governing body or 
membership on an advisory body) which gives migratory seasonal 
agricultural workers and their families significant involvement in the 
formulation of the organization's policies; and
    (2) Where all such applicants are community-based organizations 
representative of the population to be served by the project, the 
Secretary shall award the grant to the applicants which will, in his 
judgment, best promote the purposes of section 319(c)(1)(A) of the Act 
and the applicable regulations of this part, taking into account with 
respect to each application:
    (i) The degree to which the proposed project satisfactorily provides 
for the elements set forth in Sec. 56.203;
    (ii) The administrative and management capability of the applicant;
    (iii) The extent to which community resources will be utilized in 
the project; and
    (iv) The degree to which the applicant intends to integrate services 
supported by a grant under this part with health services provided under 
other federally assisted health services or reimbursement programs or 
projects.
    (b) The Secretary shall award no more than two grants under this 
subpart for the same project.



          Subpart C_Grants for Operating Migrant Health Centers



Sec. 56.301  Applicability.

    The regulations of this subpart, in addition to the regulations of 
subpart A of this part, are applicable to grants awarded pursuant to 
section 319(d)(1)(A) of the Act for the costs of operation of migrant 
health centers in high impact areas.



Sec. 56.302  Application.

    To be approved by the Secretary under this subpart, an application 
for a grant must, in addition to meeting the requirements of Sec. 
56.104 of subpart A of this part,
    (a) Be submitted by an entity (which may be a co-applicant) which 
the Secretary determines is a migrant health center, and
    (b) Contain information sufficient to enable the Secretary to 
determine that the center will meet the requirements of this part.



Sec. 56.303  Project elements.

    A migrant health center supported under this subpart must:
    (a) Provide the health services of the center so that such services 
are available and accessible promptly, as appropriate, and in a manner 
which will assure continuity of service to the migratory and seasonal 
agricultural workers and their families within the center's catchment 
area.
    (b) Implement a system for maintaining the confidentiality of 
patient

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records in accordance with the requirements of Sec. 56.111 of subpart A 
of this part.
    (c) Have an ongoing quality assurance program which provides for the 
following:
    (1) Organizational arrangements, including a focus of 
responsibility, to support the quality assurance program and the 
provision of high quality patient care;
    (2) Periodic assessment of the appropriateness of the utilization of 
services and the quality of services provided or proposed to be provided 
by the center, and by other providers through contract or other 
cooperative arrangement with the center. Such assessments must:
    (i) Be conducted by physicians or by other appropriate health 
professionals under the supervision of physicians or, as appropriate, by 
health professionals who are peers of the health professionals who 
provided the services;
    (ii) Be based on the systematic collection and evaluation of patient 
records; and
    (iii) Identify and document the necessity for change in the 
provision of services by the center and result in the institution of 
such change, where indicated.
    (d) Develop management and control systems which are in accordance 
with sound financial management procedures, including the provision for 
an audit (1) conducted in accordance with the ``Guide for Audits of 
Migrant Health Grants'' of the DHHS Audit Agency, and (2) conducted with 
reasonable frequency, usually annually but not less frequently than 
every two years (unless waived for cause by the Secretary), to be made 
by qualified individuals who are sufficiently independent of those who 
authorize the expenditure of Federal funds to produce unbiased opinions, 
conclusions, or judgments, and to determine, at a minimum, the fiscal 
integrity of grant financial transactions and reports, and compliance 
with the applicable regulations of this part and the terms and 
conditions of the grant.
    (e) Where the cost of care and services furnished by or through the 
center is to be reimbursed under title XIX or title XX of the Social 
Security Act, obtain or make every reasonable effort to obtain a written 
agreement with the title XIX or title XX State agency for such 
reimbursement.
    (f) Have prepared a schedule of fees or payments for the provision 
of its services designed to cover its reasonable costs of operation and 
a corresponding schedule of discounts adjusted on the basis of the 
patient's ability to pay. The schedule of discounts must provide for a 
full discount to individuals and families with annual incomes at or 
below those set forth in the most recent CSA Poverty Income Guidelines 
(42 CFR 1060.2) (except that nominal fees for service may be collected 
from such individuals and families) and for no discount to individuals 
and families with annual incomes greater than twice those set forth in 
such Guidelines.
    (g) Make every reasonable effort, including the establishment of 
systems for eligibility determination, billing, and collection, to
    (1) Collect reimbursement for its costs in providing health services 
to persons who are entitled to insurance benefits under title XVIII of 
the Social Security Act, to medical assistance under a State plan 
approved under title XIX of such Act, to social services and family 
planning under title XX of such Act, or to assistance for medical 
expenses under any other public assistance program, grant program, or 
private health insurance or benefit program on the basis of the schedule 
of fees prepared pursuant to paragraph (f) of this section without 
application of any discounts, and
    (2) Secure from patients payments for services in accordance with 
the schedule of fees and discounts required by paragraph (f) of this 
section.
    (h) Have a governing board which meets the requirements of Sec. 
56.304.
    (i) Have developed an overall plan and budget for the center that:
    (1) Provides for an annual operating budget and a three-year 
financial management plan which includes all anticipated income and 
expenses related to items which would, under generally accepted 
accounting principles, be considered income and expense items;
    (2) Provides for a capital expenditure plan for at least a three-
year period

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(including the year to which the operating budget described in paragraph 
(h)(i)(1) is applicable) which includes and identifies in detail the 
anticipated sources of financing for, and the objective of, each 
anticipated expenditure in excess of $100,000 related to the acquisition 
of land, the improvement of land, buildings, and equipment and the 
replacement, modernization and expansion of buildings and equipment 
which would, under generally accepted accounting principles, be 
considered capital items;
    (3) Provides for plan review and updating at least annually; and
    (4) Is prepared under the direction of the governing board by a 
committee consisting of representatives of the governing board, the 
administrative staff, and the medical staff, if any, of the center.
    (j) Establish basic statistical data, cost accounting, management 
information, and reporting or monitoring systems which will enable the 
center to provide such statistics and other information as the Secretary 
may reasonably require relating to the center's costs of operation, 
patterns of utilization of services, and the availability, 
accessibility, and acceptability of its services, and to make such 
reports to the Secretary in a timely manner with such frequency as the 
Secretary may reasonably require.
    (k) Review its catchment area annually to insure that the criteria 
set out in Sec. 56.104(b)(2) are met and, if criteria are not met, 
revise its catchment area, with the approval of the Secretary, to 
conform with such criteria to the extent feasible.
    (l) In the case of a center which serves a population including a 
substantial proportion of individuals of limited English-speaking 
ability, have developed a plan and made arrangements responsive to the 
needs of such populations for providing services to the extent 
practicable in the language and cultural context most appropriate to 
such individuals, and have identified an individual on its staff who is 
fluent in both that language and in English and whose responsibilities 
include providing guidance to such individuals and to appropriate staff 
members with respect to cultural sensitivities and bridging linguistic 
and cultural differences. If more than one non-English language is 
spoken by such group or groups, an individual or individuals fluent in 
those languages and English must be so identified.
    (m) Be operated in a manner calculated to preserve human dignity and 
to maximize acceptability and effective utilization of services.
    (n) To the extent possible, coordinate and integrate project 
activities with the activities of other federally funded, as well as 
State and local, health services delivery projects and programs serving 
the same population.
    (o) Establish means for evaluating progress toward the achievement 
of the specific objectives of the project.
    (p) Provide sufficient staff, qualified by training and experience, 
to carry out the activities of the center.
    (q) Assure that facilities utilized in the performance of the 
project meet applicable fire and life safety codes.
    (r) Utilize, to the maximum extent feasible, other Federal, State 
and local, and private resources available for support of the project, 
prior to use of project funds under this part.
    (s) Provide for community participation through, for example, 
contributions of cash or services, loans of full- or part-time staff, 
equipment, space, materials, or facilities.
    (t) Where the center will provide services through contract or other 
cooperative arrangements with other providers of services, the center 
must:
    (1) Enter into the contract or arrangement only if the provider of 
services will provide the services in a timely manner and make the 
services accessible and acceptable to the population to be served;
    (2) Make payment for services so provided only pursuant to 
agreements with the providers in accordance with a schedule of rates and 
payment procedures established and maintained by the center. The center 
must be prepared to substantiate that such rates are reasonable and 
necessary;
    (3) Directly provide at least primary care unless the center has 
made arrangements for the provision of primary care which include 
transfer of all medical and financial information relating to such care 
to the center; and

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    (4) Enter into contracts or arrangements for the provision of 
primary health services only if alternative resources are reasonably 
available to provide these services in the event of termination of such 
arrangements.
    (u) Operate in a manner such that no migratory or seasonal 
agricultural worker or member of their family will be denied service by 
reason of his or her inability to pay therefor. Provided, however, That 
a charge for the provision of services will be made to the extent that a 
third party (including a Government agency) is authorized or is under 
legal obligation to pay such charges.



Sec. 56.304  Governing board.

    The governing board of the center must meet the following 
requirements:
    (a) Size. The board must consist of at least 9 but not more than 25 
members except that this provision may be waived by the Secretary for 
good cause shown.
    (b) Composition. (1) A majority of the board members must be 
migratory and seasonal agricultural workers and members of their 
families who are or will be served by the center and who, as a group, 
represent the individuals being or to be served in terms of demographic 
factors, such as race, ethnicity, and sex.
    (2) No more than two-thirds of the remaining members of the board 
may be individuals who derive more than 10 percent of their annual 
income from the health care industry.
    (3) The remaining members of the board must be representatives of 
the community in which the center's catchment area is located and shall 
be selected for their expertise in relevant subject areas, such as 
community affairs, local government, finance and b