[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2011 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          Title 42

Public Health


________________________

Parts 1 to 399

                         Revised as of October 1, 2011

          Containing a codification of documents of general 
          applicability and future effect

          As of October 1, 2011
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register.

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 42:
          Chapter I--Public Health Service, Department of 
          Health and Human Services                                  3
          Chapters II-III [Reserved]
  Finding Aids:
      Table of CFR Titles and Chapters........................     911
      Alphabetical List of Agencies Appearing in the CFR......     931
      List of CFR Sections Affected...........................     941

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                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 42 CFR 2.1 refers to 
                       title 42, part 2, section 
                       1.

                     ----------------------------

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                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, October 1, 2011), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
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instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
April 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in eleven separate 
volumes. For the period beginning April 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
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This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed as 
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CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
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alphabetical list of agencies publishing in the CFR are also included in 
this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.

[[Page vii]]

    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
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the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

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in the Code of Federal Regulations.

INQUIRIES

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or write to the Director, Office of the Federal Register, National 
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    Raymond A. Mosley,
    Director,
    Office of the Federal Register.
    October 1, 2011.







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                               THIS TITLE

    Title 42--Public Health is composed of five volumes. The parts in 
these volumes are arranged in the following order: Parts 1-399, parts 
400-413, parts 414-429, parts 430 to 481, and part 482 to end. The first 
volume (parts 1-399) contains current regulations issued under chapter 
I--Public Health Service (HHS). The second, third, and fourth volumes 
(parts 400-413, parts 414-429, and parts 430 to 481) include regulations 
issued under chapter IV--Centers for Medicare & Medicaid Services (HHS) 
and the fifth volume (part 482 to end) contains the remaining 
regulations in chapter IV and the regulations issued under chapter V by 
the Office of Inspector General-Health Care (HHS). The contents of these 
volumes represent all current regulations codified under this title of 
the CFR as of October 1, 2011.

    The OMB control numbers for the Centers for Medicare & Medicaid 
Services appear in Sec.  400.310 of chapter IV. For the convenience of 
the user, subpart C consisting of Sec. Sec.  400.300-400.310 is 
reprinted in the Finding Aids section of the third, fourth and fifth 
volumes.

    For this volume, Michele Bugenhagen was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Michael L. White, assisted by Ann Worley.

[[Page 1]]



                         TITLE 42--PUBLIC HEALTH




                   (This book contains parts 1 to 399)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Public Health Service, Department of Health and 
  Human Services............................................           2
chapters ii-iii [Reserved]

[[Page 3]]



    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES




  --------------------------------------------------------------------


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

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

2               Confidentiality of alcohol and drug abuse 
                    patient records.........................           9
2a              Protection of identity--research subjects...          28
3               Patient safety organizations and patient 
                    safety work product.....................          33
4               National Library of Medicine................          65
5               Designation of health professional(s) 
                    shortage areas..........................          67
5a               Rural physician training grant program.....          85
6               Federal tort claims act coverage of certain 
                    grantees and individuals................          85
7               Distribution of reference biological 
                    standards and biological preparations...          87
8               Certification of opioid treatment programs..          88
9               Standards of care for chimpanzees held in 
                    the federally supported sanctuary system         109
                         SUBCHAPTER B--PERSONNEL
21              Commissioned officers.......................         123
22              Personnel other than commissioned officers..         133
23              National Health Service Corps...............         134
24              Senior Biomedical Research Service..........         143
               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......................         147

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32              Medical care for persons with Hansen's 
                    disease and other persons in emergencies         152
34              Medical examination of aliens...............         153
35              Hospital and station management.............         160
37              Specifications for medical examinations of 
                    underground coal miners.................         169
38              Disaster assistance for crisis counseling 
                    and training............................         181
                          SUBCHAPTER D--GRANTS
50              Policies of general applicability...........         186
51              Requirements applicable to the protection 
                    and advocacy for individuals with mental 
                    illness program.........................         205
51a             Project grants for maternal and child health         217
51b             Project grants for preventive health 
                    services................................         220
51c             Grants for community health services........         227
51d             Mental health and substance abuse emergency 
                    response procedures.....................         242
51e-51g         [Reserved]

52              Grants for research projects................         247
52a             National Institutes of Health center grants.         251
52b             National Institutes of Health construction 
                    grants..................................         256
52c             Minority Biomedical Research Support Program         265
52d             National Cancer Institute Clinical Cancer 
                    Education Program.......................         267
52e             National Heart, Lung, and Blood Institute 
                    grants for prevention and control 
                    projects................................         270
52h             Scientific peer review of research grant 
                    applications and research and 
                    development contract projects...........         273
53              Grants, loans and loan guarantees for 
                    construction and modernization of 
                    hospitals and medical facilities........         279
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.....         287
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......................         290
55a             Program grants for Black Lung clinics.......         295
56              Grants for migrant health services..........         297

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57              Grants for construction of teaching 
                    facilities, educational improvements, 
                    scholarships and student loans..........         317
58              Grants for training of public health and 
                    allied health personnel.................         359
59              Grants for family planning services.........         359
59a             National Library of Medicine grants.........         368
60              Health Education Assistance Loan Program....         372
            SUBCHAPTER E--FELLOWSHIPS, INTERNSHIPS, TRAINING
61              Fellowships.................................         404
62              National Health Service Corps Scholarship 
                    and Loan Repayment Programs.............         409
63              Traineeships................................         427
63a             National Institutes of Health training 
                    grants..................................         430
64              National Library of Medicine training grants         434
64a             Obligated service for mental health 
                    traineeships............................         436
65              National Institute of Environmental Health 
                    Sciences hazardous waste worker training         440
65a             National Institute of Environmental Health 
                    Sciences hazardous substances basic 
                    research and training grants............         443
66              National Research Service Awards............         447
67              Agency for Health Care Policy and Research 
                    grants and contracts....................         454
68a             National Institutes of Health (NIH) Clinical 
                    Research Loan Repayment Program for 
                    Individuals from Disadvantaged 
                    Backgrounds (CR-LRP)....................         464
68c             National Institute of Child Health and Human 
                    Development Contraception and 
                    Infertility Research Loan Repayment 
                    Program.................................         469
             SUBCHAPTER F--QUARANTINE, INSPECTION, LICENSING
70              Interstate quarantine.......................         475
71              Foreign quarantine..........................         477
72              [Reserved]

73              Select agents and toxins....................         488
75              Standards for the accreditation of 
                    educational programs for and the 
                    credentialing of radiologic personnel...         503
   SUBCHAPTER G--OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED 
                               ACTIVITIES
80              Administrative functions, practices, and 
                    procedures..............................         517

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81              Guidelines for determining probability of 
                    causation under the energy employees 
                    occupational illness compensation 
                    program act of 2000.....................         518
82              Methods for conducting dose reconstruction 
                    under the Energy Employees Occupational 
                    Illness Compensation Program Act of 2000         525
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........         536
84              Approval of respiratory protective devices..         548
85              Requests for health hazard evaluations......         612
85a             Occupational safety and health 
                    investigations of places of employment..         617
86              Grants for education programs in 
                    occupational safety and health..........         622
87              National Institute for Occupational Safety 
                    and Health Research and demonstration 
                    grants..................................         630
88              World Trade Center Health Program...........         632
SUBCHAPTER H--HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS 
                   SUBSTANCES RELEASES AND FACILITIES
90              Administrative functions, practices, and 
                    procedures..............................         644
93              Public health service policies on research 
                    misconduct..............................         648
                         SUBCHAPTER I [RESERVED]
                         SUBCHAPTER J--VACCINES
100             Vaccine injury compensation.................         677
102             Smallpox compensation program...............         682
110             Countermeasures injury compensation program.         709
               SUBCHAPTER K--HEALTH RESOURCES DEVELOPMENT
121             Organ Procurement and Transplantation 
                    Network.................................         734
124             Medical facility construction and 
                    modernization...........................         745
125-129         [Reserved]

                  SUBCHAPTER L--COMPASSIONATE PAYMENTS
130             Ricky Ray Hemophilia Relief Fund Program....         781
131-135         [Reserved]

  SUBCHAPTER M--INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
136             Indian health...............................         814
136a            Indian health...............................         848

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137             Tribal self-governance......................         856
138-199         [Reserved]

[[Page 9]]



                     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 10]]

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 11]]

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 12]]



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 13]]

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 14]]

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 15]]

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 16]]

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 17]]

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 18]]

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 19]]

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 20]]

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 21]]


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 22]]

    (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 23]]

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 24]]

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 25]]

    (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 26]]

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 27]]

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 28]]

    (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 29]]

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 30]]

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 31]]

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 32]]

    (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 33]]

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_PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT--
Table of Contents



                      Subpart A_General Provisions

Sec.
3.10 Purpose.
3.20 Definitions.

            Subpart B_PSO Requirements and Agency Procedures

3.102 Process and requirements for initial and continued listing of 
          PSOs.
3.104 Secretarial actions.
3.106 Security requirements.
3.108 Correction of deficiencies, revocation, and voluntary 
          relinquishment.
3.110 Assessment of PSO compliance.
3.112 Submissions and forms.

 Subpart C_Confidentiality and Privilege Protections of Patient Safety 
                              Work Product

3.204 Privilege of patient safety work product.
3.206 Confidentiality of patient safety work product.
3.208 Continued protection of patient safety work product.

[[Page 34]]

3.210 Required disclosure of patient safety work product to the 
          Secretary.
3.212 Nonidentification of patient safety work product.

                      Subpart D_Enforcement Program

3.304 Principles for achieving compliance.
3.306 Complaints to the Secretary.
3.308 Compliance reviews.
3.310 Responsibilities of respondents.
3.312 Secretarial action regarding complaints and compliance reviews.
3.314 Investigational subpoenas and inquiries.
3.402 Basis for a civil money penalty.
3.404 Amount of a civil money penalty.
3.408 Factors considered in determining the amount of a civil money 
          penalty.
3.414 Limitations.
3.416 Authority to settle.
3.418 Exclusivity of penalty.
3.420 Notice of proposed determination.
3.422 Failure to request a hearing.
3.424 Collection of penalty.
3.426 Notification of the public and other agencies.
3.504 Hearings before an ALJ.
3.506 Rights of the parties.
3.508 Authority of the ALJ.
3.510 Ex parte contacts.
3.512 Prehearing conferences.
3.514 Authority to settle.
3.516 Discovery.
3.518 Exchange of witness lists, witness statements, and exhibits.
3.520 Subpoenas for attendance at hearing.
3.522 Fees.
3.524 Form, filing, and service of papers.
3.526 Computation of time.
3.528 Motions.
3.530 Sanctions.
3.532 Collateral estoppel.
3.534 The hearing.
3.538 Witnesses.
3.540 Evidence.
3.542 The record.
3.544 Post hearing briefs.
3.546 ALJ's decision.
3.548 Appeal of the ALJ's decision.
3.550 Stay of the Secretary's decision.
3.552 Harmless error.

    Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6.

    Source: 73 FR 70796, Nov. 21, 2008, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 3.10  Purpose.

    The purpose of this part is to implement the Patient Safety and 
Quality Improvement Act of 2005 (Pub. L. 109-41), which amended Title IX 
of the Public Health Service Act (42 U.S.C. 299 et seq.) by adding 
sections 921 through 926, 42 U.S.C. 299b-21 through 299b-26.



Sec. 3.20  Definitions.

    As used in this part, the terms listed alphabetically below have the 
meanings set forth as follows:
    Affiliated provider means, with respect to a provider, a legally 
separate provider that is the parent organization of the provider, is 
under common ownership, management, or control with the provider, or is 
owned, managed, or controlled by the provider.
    AHRQ stands for the Agency for Healthcare Research and Quality in 
HHS.
    ALJ stands for an Administrative Law Judge of HHS.
    Board means the members of the HHS Departmental Appeals Board, in 
the Office of the Secretary, which issues decisions in panels of three.
    Bona fide contract means:
    (1) A written contract between a provider and a PSO that is executed 
in good faith by officials authorized to execute such contract; or
    (2) A written agreement (such as a memorandum of understanding or 
equivalent recording of mutual commitments) between a Federal, State, 
local, or Tribal provider and a Federal, State, local, or Tribal PSO 
that is executed in good faith by officials authorized to execute such 
agreement.
    Complainant means a person who files a complaint with the Secretary 
pursuant to Sec. 3.306.
    Component organization means an entity that:
    (1) Is a unit or division of a legal entity (including a 
corporation, partnership, or a Federal, State, local or Tribal agency or 
organization); or
    (2) Is owned, managed, or controlled by one or more legally separate 
parent organizations.
    Component PSO means a PSO listed by the Secretary that is a 
component organization.
    Confidentiality provisions means for purposes of subparts C and D, 
any requirement or prohibition concerning confidentiality established by 
sections 921 and 922(b)-(d), (g) and (i) of the Public Health Service 
Act, 42 U.S.C. 299b-21, 299b-22(b)-(d), (g) and (i) and the

[[Page 35]]

provisions, at Sec. Sec. 3.206 and 3.208, that implement the statutory 
prohibition on disclosure of identifiable patient safety work product.
    Disclosure means the release, transfer, provision of access to, or 
divulging in any other manner of patient safety work product by:
    (1) An entity or natural person holding the patient safety work 
product to another legally separate entity or natural person, other than 
a workforce member of, or a health care provider holding privileges 
with, the entity holding the patient safety work product; or
    (2) A component PSO to another entity or natural person outside the 
component PSO and within the legal entity of which the component PSO is 
a part.
    Entity means any organization or organizational unit, regardless of 
whether the organization is public, private, for-profit, or not-for-
profit.
    Group health plan means an employee welfare benefit plan (as defined 
in section 3(1) of the Employee Retirement Income Security Act of 1974 
(ERISA)) to the extent that the plan provides medical care (as defined 
in paragraph (2) of section 2791(a) of the Public Health Service Act, 
including items and services paid for as medical care) to employees or 
their dependents (as defined under the terms of the plan) directly or 
through insurance, reimbursement, or otherwise.
    Health insurance issuer means an insurance company, insurance 
service, or insurance organization (including a health maintenance 
organization, as defined in 42 U.S.C. 300gg-91(b)(3)) which is licensed 
to engage in the business of insurance in a State and which is subject 
to State law which regulates insurance (within the meaning of 29 U.S.C. 
1144(b)(2)). This term does not include a group health plan.
    Health maintenance organization means:
    (1) A Federally qualified health maintenance organization (HMO) (as 
defined in 42 U.S.C. 300e(a));
    (2) An organization recognized under State law as a health 
maintenance organization; or
    (3) A similar organization regulated under State law for solvency in 
the same manner and to the same extent as such a health maintenance 
organization.
    HHS stands for the United States Department of Health and Human 
Services.
    HIPAA Privacy Rule means the regulations promulgated under section 
264(c) of the Health Insurance Portability and Accountability Act of 
1996 (HIPAA), at 45 CFR part 160 and subparts A and E of part 164.
    Identifiable patient safety work product means patient safety work 
product that:
    (1) Is presented in a form and manner that allows the identification 
of any provider that is a subject of the work product, or any providers 
that participate in, or are responsible for, activities that are a 
subject of the work product;
    (2) Constitutes individually identifiable health information as that 
term is defined in the HIPAA Privacy Rule at 45 CFR 160.103; or
    (3) Is presented in a form and manner that allows the identification 
of an individual who in good faith reported information directly to a 
PSO or to a provider with the intention of having the information 
reported to a PSO (``reporter'').
    Nonidentifiable patient safety work product means patient safety 
work product that is not identifiable patient safety work product in 
accordance with the nonidentification standards set forth at Sec. 
3.212.
    OCR stands for the Office for Civil Rights in HHS.
    Parent organization means an organization that: owns a controlling 
interest or a majority interest in a component organization; has the 
authority to control or manage agenda setting, project management, or 
day-to-day operations; or the authority to review and override decisions 
of a component organization. The component organization may be a 
provider.
    Patient Safety Act means the Patient Safety and Quality Improvement 
Act of 2005 (Pub. L. 109-41), which amended Title IX of the Public 
Health Service Act (42 U.S.C. 299 et seq.) by inserting a new Part C, 
sections 921 through 926, which are codified at 42 U.S.C. 299b-21 
through 299b-26.

[[Page 36]]

    Patient safety activities means the following activities carried out 
by or on behalf of a PSO or a provider:
    (1) Efforts to improve patient safety and the quality of health care 
delivery;
    (2) The collection and analysis of patient safety work product;
    (3) The development and dissemination of information with respect to 
improving patient safety, such as recommendations, protocols, or 
information regarding best practices;
    (4) The utilization of patient safety work product for the purposes 
of encouraging a culture of safety and of providing feedback and 
assistance to effectively minimize patient risk;
    (5) The maintenance of procedures to preserve confidentiality with 
respect to patient safety work product;
    (6) The provision of appropriate security measures with respect to 
patient safety work product;
    (7) The utilization of qualified staff; and
    (8) Activities related to the operation of a patient safety 
evaluation system and to the provision of feedback to participants in a 
patient safety evaluation system.
    Patient safety evaluation system means the collection, management, 
or analysis of information for reporting to or by a PSO.
    Patient safety organization (PSO) means a private or public entity 
or component thereof that is listed as a PSO by the Secretary in 
accordance with subpart B. A health insurance issuer or a component 
organization of a health insurance issuer may not be a PSO. See also the 
exclusions in Sec. 3.102 of this part.
    Patient safety work product:
    (1) Except as provided in paragraph (2) of this definition, patient 
safety work product means any data, reports, records, memoranda, 
analyses (such as root cause analyses), or written or oral statements 
(or copies of any of this material)
    (i) Which could improve patient safety, health care quality, or 
health care outcomes; and
    (A) Which are assembled or developed by a provider for reporting to 
a PSO and are reported to a PSO, which includes information that is 
documented as within a patient safety evaluation system for reporting to 
a PSO, and such documentation includes the date the information entered 
the patient safety evaluation system; or
    (B) Are developed by a PSO for the conduct of patient safety 
activities; or
    (ii) Which identify or constitute the deliberations or analysis of, 
or identify the fact of reporting pursuant to, a patient safety 
evaluation system.
    (2)(i) Patient safety work product does not include a patient's 
medical record, billing and discharge information, or any other original 
patient or provider information; nor does it include information that is 
collected, maintained, or developed separately, or exists separately, 
from a patient safety evaluation system. Such separate information or a 
copy thereof reported to a PSO shall not by reason of its reporting be 
considered patient safety work product.
    (ii) Patient safety work product assembled or developed by a 
provider for reporting to a PSO may be removed from a patient safety 
evaluation system and no longer considered patient safety work product 
if:
    (A) The information has not yet been reported to a PSO; and
    (B) The provider documents the act and date of removal of such 
information from the patient safety evaluation system.
    (iii) Nothing in this part shall be construed to limit information 
that is not patient safety work product from being:
    (A) Discovered or admitted in a criminal, civil or administrative 
proceeding;
    (B) Reported to a Federal, State, local or Tribal governmental 
agency for public health or health oversight purposes; or
    (C) Maintained as part of a provider's recordkeeping obligation 
under Federal, State, local or Tribal law.
    Person means a natural person, trust or estate, partnership, 
corporation, professional association or corporation, or other entity, 
public or private.
    Provider means:
    (1) An individual or entity licensed or otherwise authorized under 
State law to provide health care services, including--

[[Page 37]]

    (i) A hospital, nursing facility, comprehensive outpatient 
rehabilitation facility, home health agency, hospice program, renal 
dialysis facility, ambulatory surgical center, pharmacy, physician or 
health care practitioner's office (includes a group practice), long term 
care facility, behavior health residential treatment facility, clinical 
laboratory, or health center; or
    (ii) A physician, physician assistant, registered nurse, nurse 
practitioner, clinical nurse specialist, certified registered nurse 
anesthetist, certified nurse midwife, psychologist, certified social 
worker, registered dietitian or nutrition professional, physical or 
occupational therapist, pharmacist, or other individual health care 
practitioner;
    (2) Agencies, organizations, and individuals within Federal, State, 
local, or Tribal governments that deliver health care, organizations 
engaged as contractors by the Federal, State, local, or Tribal 
governments to deliver health care, and individual health care 
practitioners employed or engaged as contractors by the Federal State, 
local, or Tribal governments to deliver health care; or
    (3) A parent organization of one or more entities described in 
paragraph (1)(i) of this definition or a Federal, State, local, or 
Tribal government unit that manages or controls one or more entities 
described in paragraphs (1)(i) or (2) of this definition.
    Research has the same meaning as the term is defined in the HIPAA 
Privacy Rule at 45 CFR 164.501.
    Respondent means a provider, PSO, or responsible person who is the 
subject of a complaint or a compliance review.
    Responsible person means a person, other than a provider or a PSO, 
who has possession or custody of identifiable patient safety work 
product and is subject to the confidentiality provisions.
    Workforce means employees, volunteers, trainees, contractors, or 
other persons whose conduct, in the performance of work for a provider, 
PSO or responsible person, is under the direct control of such provider, 
PSO or responsible person, whether or not they are paid by the provider, 
PSO or responsible person.



            Subpart B_PSO Requirements and Agency Procedures



Sec. 3.102  Process and requirements for initial and continued listing 
of PSOs.

    (a) Eligibility and process for initial and continued listing--(1) 
Submission of certification. Any entity, except as specified in 
paragraph (a)(2) of this section, may request from the Secretary an 
initial or continued listing as a PSO by submitting a completed 
certification form that meets the requirements of this section, in 
accordance with Sec. 3.112. An individual with authority to make 
commitments on behalf of the entity seeking listing will be required to 
submit contact information for the entity and:
    (i) Attest that the entity is not subject to any exclusion in 
paragraph (a)(2) of this section;
    (ii) Provide certifications that the entity meets each requirement 
for PSOs in paragraph (b) of this section;
    (iii) If the entity is a component of another organization, provide 
the additional certifications that the entity meets the requirements of 
paragraph (c)(1)(i) of this section;
    (iv) If the entity is a component of an excluded entity described in 
paragraph (a)(2)(ii), provide the additional certifications and 
information required by paragraph (c)(1)(ii) of this section;
    (v) Attest that the entity has disclosed if the Secretary has ever 
delisted this entity (under its current name or any other) or refused to 
list the entity or whether any of its officials or senior managers held 
comparable positions of responsibility in an entity that was denied 
listing or delisted and, if any of these circumstances apply, submit 
with its certifications and related disclosures, the name of the entity 
or entities that the Secretary declined to list or delisted;
    (vi) Attest that the PSO will promptly notify the Secretary during 
its period of listing if it can no longer comply with any of its 
attestations and the applicable requirements in Sec. Sec. 3.102(b) and 
3.102(c) or if there have been any changes in the accuracy of the 
information submitted for listing, along with the pertinent changes; and

[[Page 38]]

    (vii) Provide other information that the Secretary determines to be 
necessary to make the requested listing determination.
    (2) Exclusion of certain entities. The following types of entities 
may not seek listing as a PSO:
    (i) A health insurance issuer; a unit or division of a health 
insurance issuer; or an entity that is owned, managed, or controlled by 
a health insurance issuer;
    (ii)(A) An entity that accredits or licenses health care providers;
    (B) An entity that oversees or enforces statutory or regulatory 
requirements governing the delivery of health care services;
    (C) An agent of an entity that oversees or enforces statutory or 
regulatory requirements governing the delivery of health care services; 
or
    (D) An entity that operates a Federal, state, local or Tribal 
patient safety reporting system to which health care providers (other 
than members of the entity's workforce or health care providers holding 
privileges with the entity) are required to report information by law or 
regulation.
    (iii) A component of an entity listed in paragraph (a)(2)(ii) may 
seek listing as a component PSO subject to the requirements and 
restrictions of paragraph (c)(1)(ii) of this section.
    (3) Submission of certification for continued listing. To facilitate 
a timely Secretarial determination regarding acceptance of its 
certification for continued listing, a PSO must submit the required 
certification no later than 75 days before the expiration of a PSO's 
three-year period of listing.
    (b) Fifteen general PSO certification requirements. The 
certifications submitted to the Secretary in accordance with paragraph 
(a)(1)(ii) of this section must conform to the following 15 
requirements:
    (1) Required certification regarding eight patient safety 
activities--(i) Initial listing. An entity seeking initial listing as a 
PSO must certify that it has written policies and procedures in place to 
perform each of the eight patient safety activities, defined in Sec. 
3.20. With respect to paragraphs (5) and (6) in the definition of 
patient safety activities regarding confidentiality and security, the 
policies and procedures must include and provide for:
    (A) Compliance with the confidentiality provisions of subpart C of 
this part and with appropriate security measures as required by Sec. 
3.106 of this subpart.
    (B) Notification of each provider that submitted patient safety work 
product or data as described in Sec. 3.108(b)(2) to the entity if the 
submitted work product or data was subject to an unauthorized disclosure 
or its security was breached.
    (ii) Continued Listing. A PSO seeking continued listing must certify 
that it is performing, and will continue to perform, each of the patient 
safety activities defined in Sec. 3.20, and is and will continue to 
comply with the requirements of paragraphs (b)(1)(i)(A) and (B) of this 
section.
    (2) Required certification regarding seven PSO criteria--(i) Initial 
Listing. In its initial certification submission, an entity must also 
certify that, if listed as a PSO, it will comply with the seven 
requirements in paragraphs (b)(2)(i)(A) through (G) of this section.
    (A) The mission and primary activity of the PSO must be to conduct 
activities that are to improve patient safety and the quality of health 
care delivery.
    (B) The PSO must have appropriately qualified workforce members, 
including licensed or certified medical professionals.
    (C) The PSO, within the 24-month period that begins on the date of 
its initial listing as a PSO, and within each sequential 24-month period 
thereafter, must have 2 bona fide contracts, each of a reasonable period 
of time, each with a different provider for the purpose of receiving and 
reviewing patient safety work product.
    (D) The PSO is not a health insurance issuer, and is not a component 
of a health insurance issuer.
    (E) The PSO must make disclosures to the Secretary as required under 
Sec. 3.102(d), in accordance with Sec. 3.112 of this subpart.
    (F) To the extent practical and appropriate, the PSO must collect 
patient safety work product from providers in a standardized manner that 
permits valid comparisons of similar cases among similar providers.

[[Page 39]]

    (G) The PSO must utilize patient safety work product for the purpose 
of providing direct feedback and assistance to providers to effectively 
minimize patient risk.
    (ii) Continued Listing. A PSO seeking continued listing must certify 
that it is complying with, and will continue to comply with, the 
requirements of paragraphs (b)(2)(i)(A) through (G) of this section.
    (iii) Compliance with the criterion for collecting patient safety 
work product in a standardized manner to the extent practical and 
appropriate. With respect to paragraph (b)(2)(i)(F) of this section, the 
Secretary will assess compliance by a PSO in the following manner.
    (A) A PSO seeking continued listing must:
    (1) Certify that the PSO is using the Secretary's published guidance 
for common formats and definitions in its collection of patient safety 
work product (option (I));
    (2) Certify that the PSO is using an alternative system of formats 
and definitions that permits valid comparisons of similar cases among 
similar providers (option (II)); or
    (3) Provide a clear explanation for why it is not practical or 
appropriate for the PSO to comply with options (I) or (II) at this time.
    (B) The Secretary will consider a PSO to be in compliance if the 
entity complies with option (I), satisfactorily demonstrates that option 
(II) permits valid comparisons of similar cases among similar providers, 
or satisfactorily demonstrates that it is not practical or appropriate 
for the PSO to comply with options (I) or (II) at this time.
    (c) Additional certifications required of component organizations--
(1) Requirements when seeking listing--(i) Requirements that all 
component organizations must meet. In addition to meeting the 15 general 
PSO certification requirements of paragraph (b) of this section, an 
entity seeking initial listing that is a component of another 
organization must certify that it will comply with the requirements of 
paragraph (c)(2) of this section. A component PSO seeking continued 
listing must certify that it is complying with, and will continue to 
comply with, the requirements of this same paragraph (c)(2). At initial 
and continued listing, a component entity must attach to its 
certifications for listing contact information for its parent 
organization(s).
    (ii) Additional requirements and limitations applicable to 
components of entities that are excluded from listing. In addition to 
the requirements under paragraph (c)(1)(i) of this section, a component 
of an organization excluded from listing under paragraph (a)(2)(ii) of 
this section must submit the additional certifications and specified 
information for initial and continued listing and comply with paragraph 
(c)(4) of this section.
    (2) Required component certifications--(i) Separation of patient 
safety work product. A component PSO must maintain patient safety work 
product separately from the rest of the parent organization(s) of which 
it is a part, and establish appropriate security measures to maintain 
the confidentiality of patient safety work product. The information 
system in which the component PSO maintains patient safety work product 
must not permit unauthorized access by one or more individuals in, or by 
units of, the rest of the parent organization(s) of which it is a part.
    (ii) Nondisclosure of patient safety work product. A component PSO 
must require that members of its workforce and any other contractor 
staff not make unauthorized disclosures of patient safety work product 
to the rest of the parent organization(s) of which it is a part.
    (iii) No conflict of interest. The pursuit of the mission of a 
component PSO must not create a conflict of interest with the rest of 
the parent organization(s) of which it is a part.
    (3) Written agreements for assisting a component PSO in the conduct 
of patient safety activities. Notwithstanding the requirements of 
paragraph (c)(2) of this section, a component PSO may provide access to 
identifiable patient safety work product to one or more individuals in, 
or to one or more units of, the rest of the parent organization(s) of 
which it is a part, if the component PSO enters into a written agreement 
with such individuals or units which requires that:

[[Page 40]]

    (i) The component PSO will only provide access to identifiable 
patient safety work product to enable such individuals or units to 
assist the component PSO in its conduct of patient safety activities, 
and
    (ii) Such individuals or units that receive access to identifiable 
patient safety work product pursuant to such written agreement will only 
use or disclose such information as specified by the component PSO to 
assist the component PSO in its conduct of patient safety activities, 
will take appropriate security measures to prevent unauthorized 
disclosures and will comply with the other certifications the component 
has made pursuant to paragraph (c)(2) of this section regarding 
unauthorized disclosures and conducting the mission of the PSO without 
creating conflicts of interest.
    (4) Required attestations, information and operational limitations 
for components of entities excluded from listing. A component 
organization of an entity that is subject to the restrictions of 
paragraph (a)(2)(ii) of this section must:
    (i) Submit the following information with its certifications for 
listing:
    (A) A statement describing its parent organization's role, and the 
scope of the parent organization's authority, with respect to any of the 
following that apply: Accreditation or licensure of health care 
providers, oversight or enforcement of statutory or regulatory 
requirements governing the delivery of health care services, serving as 
an agent of such a regulatory oversight or enforcement authority, or 
administering a public mandatory patient safety reporting system;
    (B) An attestation that the parent organization has no policies or 
procedures that would require or induce providers to report patient 
safety work product to their component organization once listed as a PSO 
and that the component PSO will notify the Secretary within 5 calendar 
days of the date on which the component organization has knowledge of 
the adoption by the parent organization of such policies or procedures, 
and an acknowledgment that the adoption of such policies or procedures 
by the parent organization during the component PSO's period of listing 
will result in the Secretary initiating an expedited revocation process 
in accordance with Sec. 3.108(e); and
    (C) An attestation that the component organization will prominently 
post notification on its Web site and publish in any promotional 
materials for dissemination to providers, a summary of the information 
that is required by paragraph (c)(4)(i)(A) of this section.
    (ii) Comply with the following requirements during its period of 
listing:
    (A) The component organization may not share staff with its parent 
organization(s).
    (B) The component organization may enter into a written agreement 
pursuant to paragraph (c)(3) but such agreements are limited to units or 
individuals of the parent organization(s) whose responsibilities do not 
involve the activities specified in the restrictions in paragraph 
(a)(2)(ii) of this section.
    (d) Required notifications. Upon listing, PSOs must meet the 
following notification requirements:
    (1) Notification regarding PSO compliance with the minimum contract 
requirement. No later than 45 calendar days prior to the last day of the 
pertinent 24-month assessment period, specified in paragraph 
(b)(2)(iii)(C) of this section, the Secretary must receive from a PSO a 
certification that states whether it has met the requirement of that 
paragraph regarding two bona fide contracts, submitted in accordance 
with Sec. 3.112 of this subpart.
    (2) Notification regarding a PSO's relationships with its 
contracting providers--(i) Requirement. A PSO must file a disclosure 
statement regarding a provider with which it has a contract that 
provides the confidentiality and privilege protections of the Patient 
Safety Act (hereinafter referred to as a Patient Safety Act contract) if 
the PSO has any other relationships with this provider that are 
described in paragraphs (d)(2)(i)(A) through (D) of this section. The 
PSO must disclose all such relationships. A disclosure statement is not 
required if all of its other relationships with the provider are limited 
to Patient Safety Act contracts.
    (A) The provider and PSO have current contractual relationships, 
other

[[Page 41]]

than those arising from any Patient Safety Act contracts, including 
formal contracts or agreements that impose obligations on the PSO.
    (B) The provider and PSO have current financial relationships other 
than those arising from any Patient Safety Act contracts. A financial 
relationship may include any direct or indirect ownership or investment 
relationship between the PSO and the contracting provider, shared or 
common financial interests or direct or indirect compensation 
arrangements whether in cash or in-kind.
    (C) The PSO and provider have current reporting relationships other 
than those arising from any Patient Safety Act contracts, by which the 
provider has access to information regarding the work and operation of 
the PSO that is not available to other contracting providers.
    (D) Taking into account all relationships that the PSO has with the 
provider, the PSO is not independently managed or controlled, or the PSO 
does not operate independently from, the contracting provider.
    (ii) Content. A PSO must submit to the Secretary the required 
attestation form for disclosures with the information specified below in 
accordance with Sec. 3.112 and this section. The substantive 
information that must be included with each submission has two required 
parts:
    (A) The Required Disclosures. The first part of the substantive 
information must provide a succinct list of obligations between the PSO 
and the contracting provider apart from their Patient Safety Act 
contract(s) that create, or contain, any of the types of relationships 
that must be disclosed based upon the requirements of paragraphs 
(d)(2)(i)(A) through (D) of this section. Each reportable obligation or 
discrete set of obligations that the PSO has with this contracting 
provider should be listed only once; noting the specific aspects of the 
obligation(s) that reflect contractual or financial relationships, 
involve access to information that is not available to other providers, 
or affect the independence of PSO operations, management, or control.
    (B) An Explanatory Narrative. The second required part of the 
substantive information must provide a brief explanatory narrative 
succinctly describing: The policies and procedures that the PSO has in 
place to ensure adherence to objectivity and professionally recognized 
analytic standards in the assessments it undertakes; and any other 
policies or procedures, or agreements with this provider, that the PSO 
has in place to ensure that it can fairly and accurately perform patient 
safety activities.
    (iii) Deadlines for submission. The Secretary must receive a 
disclosure statement within 45 days of the date on which a PSO enters a 
contract with a provider if the circumstances described in any of the 
paragraphs (d)(2)(i)(A) through (D) of this section are met on the date 
the contract is entered. During the contract period, if these 
circumstances subsequently arise, the Secretary must receive a 
disclosure statement from the PSO within 45 days of the date that any 
disclosure requirement in paragraph (d)(2)(i) of this section first 
applies.



Sec. 3.104  Secretarial actions.

    (a) Actions in response to certification submissions for initial and 
continued listing as a PSO. (1) In response to an initial or continued 
certification submission by an entity, pursuant to the requirements of 
Sec. 3.102 of this subpart, the Secretary may--
    (i) Accept the certification submission and list the entity as a 
PSO, or maintain the listing of a PSO, if the Secretary determines that 
the entity meets the applicable requirements of the Patient Safety Act 
and this subpart;
    (ii) Deny acceptance of a certification submission and, in the case 
of a currently listed PSO, remove the entity from the list if the entity 
does not meet the applicable requirements of the Patient Safety Act and 
this subpart; or
    (iii) Condition the listing of an entity or the continued listing of 
a PSO, following a determination made pursuant to paragraph (c) of this 
section or a determination after review of the pertinent history of an 
entity that has been

[[Page 42]]

delisted or refused listing and its officials and senior managers.
    (2) Basis for determination. In making a determination regarding 
listing, the Secretary will consider the certification submission; any 
prior actions by the Secretary regarding the entity or PSO including 
delisting; any history of or current non-compliance by the entity or the 
PSO or its officials or senior managers with statutory or regulatory 
requirements or requests from the Secretary; the relationships of the 
entity or PSO with providers; and any findings made by the Secretary in 
accordance with paragraph (c) of this section.
    (3) Notification. The Secretary will notify in writing each entity 
of action taken on its certification submission for initial or continued 
listing. The Secretary will provide reasons when an entity's 
certification is conditionally accepted and the entity is conditionally 
listed, when an entity's certification is not accepted and the entity is 
not listed, or when acceptance of its certification is revoked and the 
entity is delisted.
    (b) Actions regarding PSO compliance with the minimum contract 
requirement. After the date on which the Secretary, under Sec. 
3.102(d)(1) of this subpart, must receive notification regarding 
compliance of a PSO with the minimum contract requirement--
    (1) If the PSO has met the minimum contract requirement, the 
Secretary will acknowledge in writing receipt of the notification and 
add information to the list established pursuant to paragraph (d) of 
this section stating that the PSO has certified that it has met the 
requirement.
    (2) If the PSO states that it has not yet met the minimum contract 
requirement by the date specified in Sec. 3.102(d)(1), or if notice is 
not received by that date, the Secretary will issue to the PSO a notice 
of a preliminary finding of deficiency as specified in Sec. 3.108(a)(2) 
and establish a period for correction that extends until midnight of the 
last day of the PSO's applicable 24-month period of assessment. 
Thereafter, if the requirement has not been met, the Secretary will 
provide the PSO a written notice of proposed revocation and delisting in 
accordance with Sec. 3.108(a)(3).
    (c) Actions regarding required disclosures by PSOs of relationships 
with contracting providers. The Secretary will review and make findings 
regarding each disclosure statement submitted by a PSO, pursuant to 
Sec. 3.102(d)(2), regarding its relationships with contracting 
provider(s), determine whether such findings warrant action regarding 
the listing of the PSO in accordance with paragraph (c)(2) of this 
section, and make the findings public.
    (1) Basis of findings regarding PSO disclosure statements. In 
reviewing disclosure statements, submitted pursuant to Sec. 3.102(d)(2) 
of this subpart, the Secretary will consider the disclosed 
relationship(s) between the PSO and the contracting provider and the 
statements and material submitted by the PSO describing the policies and 
procedures that the PSO has in place to determine whether the PSO can 
fairly and accurately perform the required patient safety activities.
    (2) Determination by the Secretary. Based on the Secretary's review 
and findings, he may choose to take any of the following actions:
    (i) For an entity seeking an initial or continued listing, the 
Secretary may list or continue the listing of an entity without 
conditions, list the entity subject to conditions, or deny the entity's 
certification for initial or continued listing; or
    (ii) For a listed PSO, the Secretary may determine that the entity 
will remain listed without conditions, continue the entity's listing 
subject to conditions, or remove the entity from the list of PSOs.
    (3) Release of disclosure statements and Secretarial findings. (i) 
Subject to paragraph (c)(3)(ii) of this section, the Secretary will make 
disclosure statements available to the public along with related 
findings that are made available in accordance with paragraph (c) of 
this section.
    (ii) The Secretary may withhold information that is exempt from 
public disclosure under the Freedom of Information Act, e.g., trade 
secrets or confidential commercial information that are subject to the 
restrictions of 18 U.S.C. 1905.
    (d) Maintaining a list of PSOs. The Secretary will compile and 
maintain a

[[Page 43]]

publicly available list of entities whose certifications as PSOs have 
been accepted. The list will include contact information for each 
entity, a copy of all certification forms and disclosure statements 
submitted by each entity in accordance with paragraph (c)(3)(ii) of this 
section, the effective date of the PSO's listing, and information on 
whether a PSO has certified that it has met the two contract 
requirement. The list also will include a copy of the Secretary's 
findings regarding each disclosure statement submitted by an entity, 
information describing any related conditions that have been placed by 
the Secretary on the listing of an entity as a PSO, and other 
information that this Subpart states may be made public. AHRQ may 
maintain a PSO website (or a comparable future form of public notice) 
and may post the list on this website.
    (e) Three-year period of listing. (1) The three-year period of 
listing of a PSO will automatically expire at midnight of the last day 
of this period, unless the listing had been revoked or relinquished 
earlier in accordance with Sec. 3.108 of this subpart, or if, prior to 
this automatic expiration, the PSO seeks a new three-year listing, in 
accordance with Sec. 3.102, and the Secretary accepts the PSO's 
certification for a new three-year listing, in accordance with Sec. 
3.104(a).
    (2) The Secretary plans to send a written notice of imminent 
expiration to a PSO at least 60 calendar days prior to the date on which 
its three-year period of listing expires if the Secretary has not yet 
received a certification for continued listing. The Secretary plans to 
indicate, on the AHRQ PSO website, the PSOs from whom certifications for 
continued listing have not been timely received.
    (f) Effective dates of Secretarial actions. Unless otherwise stated, 
the effective date of each action by the Secretary pursuant to this 
subpart will be specified in the written notice of such action that is 
sent to the entity. When the Secretary sends a notice that addresses 
acceptance or revocation of an entity's certifications or voluntary 
relinquishment by an entity of its status as a PSO, the notice will 
specify the effective date and time of listing or delisting.



Sec. 3.106  Security requirements.

    (a) Application. A PSO must secure patient safety work product in 
conformance with the security requirements of paragraph (b) of this 
section. These requirements must be met at all times and at any location 
at which the PSO, its workforce members, or its contractors receive, 
access, or handle patient safety work product. Handling patient safety 
work product includes its processing, development, use, maintenance, 
storage, removal, disclosure, transmission and destruction.
    (b) Security framework. A PSO must have written policies and 
procedures that address each of the considerations specified in this 
subsection. In addressing the framework that follows, the PSO may 
develop appropriate and scalable security standards, policies, and 
procedures that are suitable for the size and complexity of its 
organization.
    (1) Security management. A PSO must address:
    (i) Maintenance and effective implementation of written policies and 
procedures that conform to the requirements of this section to protect 
the confidentiality, integrity, and availability of the patient safety 
work product that is received, accessed, or handled; and to monitor and 
improve the effectiveness of such policies and procedures, and
    (ii) Training of the PSO workforce and PSO contractors who receive, 
access, or handle patient safety work product regarding the requirements 
of the Patient Safety Act, this Part, and the PSO's policies and 
procedures regarding the confidentiality and security of patient safety 
work product.
    (2) Distinguishing patient safety work product. A PSO must address:
    (i) Maintenance of the security of patient safety work product, 
whether in electronic or other media, through either physical separation 
from non-patient safety work product, or if co-located with non-patient 
safety work product, by making patient safety work product 
distinguishable so that the appropriate form and level of security can 
be applied and maintained;

[[Page 44]]

    (ii) Protection of the media, whether in electronic, paper, or other 
media or format, that contain patient safety work product, limiting 
access to authorized users, and sanitizing and destroying such media 
before their disposal or release for reuse; and
    (iii) Physical and environmental protection, to control and limit 
physical and virtual access to places and equipment where patient safety 
work product is received, accessed, or handled.
    (3) Security control and monitoring. A PSO must address:
    (i) Identification of those authorized to receive, access, or handle 
patient safety work product and an audit capacity to detect unlawful, 
unauthorized, or inappropriate receipt, access, or handling of patient 
safety work product, and
    (ii) Methods to prevent unauthorized receipt, access, or handling of 
patient safety work product.
    (4) Security assessment. A PSO must address:
    (i) Periodic assessments of security risks and controls to establish 
if its controls are effective, to correct any deficiency identified, and 
to reduce or eliminate any vulnerabilities.
    (ii) System and communications protection, to monitor, control, and 
protect PSO receipt, access, or handling of patient safety work product 
with particular attention to the transmission of patient safety work 
product to and from providers, other PSOs, contractors or any other 
responsible persons.



Sec. 3.108  Correction of deficiencies, revocation, and voluntary 
relinquishment.

    (a) Process for correction of a deficiency and revocation--(1) 
Circumstances leading to revocation. The Secretary may revoke his 
acceptance of an entity's certification (``revocation'') and delist the 
entity as a PSO if he determines--
    (i) The PSO is not fulfilling the certifications made to the 
Secretary as required by Sec. 3.102;
    (ii) The PSO has not met the two contract requirement, as required 
by Sec. 3.102(d)(1);
    (iii) Based on a PSO's disclosures made pursuant to Sec. 
3.102(d)(2) , that the entity cannot fairly and accurately perform the 
patient safety activities of a PSO with a public finding to that effect; 
or
    (iv) The PSO is not in compliance with any other provision of the 
Patient Safety Act or this part.
    (2) Notice of preliminary finding of deficiency and establishment of 
an opportunity for correction of a deficiency. (i) Except as provided by 
paragraph (e) of this section, if the Secretary determines that a PSO is 
not in compliance with its obligations under the Patient Safety Act or 
this subpart, the Secretary must send a PSO written notice of the 
preliminary finding of deficiency. The notice must state the actions or 
inactions that encompass the deficiency finding, outline the evidence 
that the deficiency exists, specify the possible and/or required 
corrective actions that must be taken, and establish a date by which the 
deficiency must be corrected. The Secretary may specify in the notice 
the form of documentation required to demonstrate that the deficiency 
has been corrected.
    (ii) The notice of a preliminary finding of deficiency is presumed 
received five days after it is sent, absent evidence of the actual 
receipt date. If a PSO does not submit evidence to the Secretary within 
14 calendar days of actual or constructive receipt of such notice, 
whichever is longer, which demonstrates that the preliminary finding is 
factually incorrect, the preliminary finding will be the basis for a 
finding of deficiency.
    (3) Determination of correction of a deficiency. (i) Unless the 
Secretary specifies another date, the Secretary must receive 
documentation to demonstrate that the PSO has corrected any deficiency 
cited in the preliminary finding of deficiency no later than five 
calendar days following the last day of the correction period that is 
specified by the Secretary in such notice.
    (ii) In making a determination regarding the correction of any 
deficiency, the Secretary will consider the documentation submitted by 
the PSO, any assessments under Sec. 3.110, recommendations of program 
staff, and any other information available regarding the PSO that the 
Secretary deems appropriate and relevant to the PSO's implementation of 
the terms of its certification.

[[Page 45]]

    (iii) After completing his review, the Secretary may make one of the 
following determinations:
    (A) The action(s) taken by the PSO have corrected any deficiency, in 
which case the Secretary will withdraw the notice of deficiency and so 
notify the PSO;
    (B) The PSO has acted in good faith to correct the deficiency, but 
the Secretary finds an additional period of time is necessary to achieve 
full compliance and/or the required corrective action specified in the 
notice of a preliminary finding of deficiency needs to be modified in 
light of the experience of the PSO in attempting to implement the 
corrective action, in which case the Secretary will extend the period 
for correction and/or modify the specific corrective action required; or
    (C) The PSO has not completed the corrective action because it has 
not acted with reasonable diligence or speed to ensure that the 
corrective action was completed within the allotted time, in which case 
the Secretary will issue to the PSO a notice of proposed revocation and 
delisting.
    (iv) When the Secretary issues a written notice of proposed 
revocation and delisting, the notice will specify the deficiencies that 
have not been timely corrected and will detail the manner in which the 
PSO may exercise its opportunity to be heard in writing to respond to 
the deficiencies specified in the notice.
    (4) Opportunity to be heard in writing following a notice of 
proposed revocation and delisting. The Secretary will afford a PSO an 
opportunity to be heard in writing, as specified in paragraph (a)(4)(i) 
of this section, to provide a substantive response to the deficiency 
finding(s) set forth in the notice of proposed revocation and delisting.
    (i) The notice of proposed revocation and delisting is presumed 
received five days after it is sent, absent evidence of actual receipt. 
The Secretary will provide a PSO with a period of time, beginning with 
the date of receipt of the notice of proposed revocation and delisting 
of which there is evidence, or the presumed date of receipt if there is 
no evidence of earlier receipt, and ending at midnight 30 calendar days 
thereafter, during which the PSO may submit a substantive response to 
the deficiency findings in writing.
    (ii) The Secretary will provide to the PSO any rules of procedure 
governing the form or transmission of the written response to the notice 
of proposed revocation and delisting. Such rules may also be posted on 
the AHRQ PSO Web site or published in the Federal Register.
    (iii) If a PSO does not submit a written response to the deficiency 
finding(s) within 30 calendar days of receipt of the notice of proposed 
revocation and delisting, the notice of proposed revocation becomes 
final as a matter of law and the basis for Secretarial action under 
paragraph (b)(1) of this section.
    (5) The Secretary's decision regarding revocation. The Secretary 
will review the entire administrative record pertaining to a notice of 
proposed revocation and delisting and any written materials submitted by 
the PSO under paragraph (a)(4) of this section. The Secretary may 
affirm, reverse, or modify the notice of proposed revocation and 
delisting and will make a determination with respect to the continued 
listing of the PSO.
    (b) Revocation of the Secretary's acceptance of a PSO's 
certifications--(1) Establishing the date and time of revocation and 
delisting. When the Secretary concludes, in accordance with a decision 
made under paragraphs (a)(5), (e)(3)(iii) or (e)(3)(iv)(C) of this 
section, that revocation of the acceptance of a PSO's certification is 
warranted for its failure to comply with requirements of the Patient 
Safety Act or of this Part, the Secretary will establish the effective 
time and date for such prompt revocation and removal of the entity from 
the list of PSOs, so notify the PSO in writing, and provide the relevant 
public notice required by Sec. 3.108(d) of this subpart.
    (2) Required notification of providers and status of data. (i) Upon 
being notified of the Secretary's action pursuant to paragraph (b)(1) of 
this section, the former PSO will take all reasonable actions to notify 
each provider, whose patient safety work product it collected

[[Page 46]]

or analyzed, of the Secretary's action(s) and the following statutory 
information: Confidentiality and privilege protections that applied to 
patient safety work product while the former PSO was listed continue to 
apply after the entity is removed from listing. Data submitted by 
providers to the former PSO for 30 calendar days following the date and 
time on which the entity was removed from the list of PSOs pursuant to 
paragraph (b)(1) of this section will have the same status as data 
submitted while the entity was still listed.
    (ii) Within 15 days of being notified of the Secretary's action 
pursuant to paragraph (b)(1) of this section, the former PSO shall 
submit to the Secretary confirmation that it has taken the actions in 
paragraph (b)(2)(i) of this section.
    (3) Disposition of patient safety work product and data. Within 90 
days following the effective date of revocation and delisting pursuant 
to paragraph (b)(1) of this section, the former PSO will take one or 
more of the following measures in regard to patient safety work product 
and data described in paragraph (b)(2)(i) of this section:
    (i) Transfer such patient safety work product or data, with the 
approval of the source from which it was received, to a PSO that has 
agreed to receive such patient safety work product or data;
    (ii) Return such work product or data to the source from which it 
was submitted; or
    (iii) If returning such patient safety work product or data to its 
source is not practicable, destroy such patient safety work product or 
data.
    (c) Voluntary relinquishment--(1) Circumstances constituting 
voluntary relinquishment. A PSO will be considered to have voluntarily 
relinquished its status as a PSO if the Secretary accepts a notification 
from a PSO that it wishes to relinquish voluntarily its listing as a 
PSO.
    (2) Notification of voluntary relinquishment. A PSO's notification 
of voluntary relinquishment to the Secretary must include the following:
    (i) An attestation that all reasonable efforts have been made, or 
will have been made by a PSO within 15 calendar days of this statement, 
to notify the sources from which it received patient safety work product 
of the PSO's intention to cease PSO operations and activities, to 
relinquish voluntarily its status as a PSO, to request that these other 
entities cease reporting or submitting any further information to the 
PSO as soon as possible, and inform them that any information reported 
after the effective date and time of delisting that the Secretary sets 
pursuant to paragraph (c)(3) of this section will not be protected as 
patient safety work product under the Patient Safety Act.
    (ii) An attestation that the entity has established a plan, or 
within 15 calendar days of this statement, will have made all reasonable 
efforts to establish a plan, in consultation with the sources from which 
it received patient safety work product, that provides for the 
disposition of the patient safety work product held by the PSO 
consistent with, to the extent practicable, the statutory options for 
disposition of patient safety work product as set out in paragraph 
(b)(3) of this section; and
    (iii) Appropriate contact information for further communications 
from the Secretary.
    (3) Response to notification of voluntary relinquishment. (i) After 
a PSO provides the notification required by paragraph (c)(2) of this 
section, the Secretary will respond in writing to the entity indicating 
whether the proposed voluntary relinquishment of its PSO status is 
accepted. If the voluntary relinquishment is accepted, the Secretary's 
response will indicate an effective date and time for the entity's 
removal from the list of PSOs and will provide public notice of the 
voluntary relinquishment and the effective date and time of the 
delisting, in accordance with Sec. 3.108(d) of this subpart.
    (ii) If the Secretary receives a notification of voluntary 
relinquishment during or immediately after revocation proceedings for 
cause under paragraphs (a)(4) and (a)(5) of this section, the Secretary, 
as a matter of discretion, may accept voluntary relinquishment in 
accordance with the preceding paragraph or decide not to accept the 
entity's proposed voluntary relinquishment and proceed with the 
revocation for cause

[[Page 47]]

and delisting pursuant to paragraph (b)(1) of this section.
    (4) Non-applicability of certain procedures and requirements. (i) A 
decision by the Secretary to accept a request by a PSO to relinquish 
voluntarily its status as a PSO pursuant to paragraph (c)(2) of this 
section does not constitute a determination of a deficiency in PSO 
compliance with the Patient Safety Act or with this Subpart.
    (ii) The procedures and requirements of Sec. 3.108(a) of this 
subpart regarding deficiencies including the opportunity to correct 
deficiencies and to be heard in writing, and the procedures and 
requirements of Sec. 3.108(b) are not applicable to determinations of 
the Secretary made pursuant to this subsection.
    (d) Public notice of delisting regarding removal from listing. If 
the Secretary removes an entity from the list of PSOs following 
revocation of acceptance of the entity's certification pursuant to Sec. 
3.108(b)(1), voluntary relinquishment pursuant to Sec. 3.108(c)(3), or 
expiration of an entity's period of listing pursuant to Sec. 
3.104(e)(1), the Secretary will promptly publish in the Federal Register 
and on the AHRQ PSO website, or in a comparable future form of public 
notice, a notice of the actions taken and the effective dates.
    (e) Expedited revocation and delisting--(1) Basis for expedited 
revocation. Notwithstanding any other provision of this section, the 
Secretary may use the expedited revocation process described in 
paragraph (e)(3) of this section if he determines--
    (i) The PSO is not in compliance with this part because it is or is 
about to become an entity described in Sec. 3.102(a)(2).
    (ii) The parent organization of the PSO is an entity described in 
Sec. 3.102(a)(2) and requires or induces health care providers to 
report patient safety work product to its component PSO; or
    (iii) The circumstances for revocation in paragraph (a)(1) of this 
section exist, and the Secretary has determined that there would be 
serious adverse consequences if the PSO were to remain listed.
    (2) Applicable provisions. If the Secretary uses the expedited 
revocation process described in paragraph (e)(3) of this section, the 
procedures in paragraphs (a)(2) through (5) of this section shall not 
apply and paragraph (a)(1) and paragraphs (b) and (d) of this section 
shall apply.
    (3) Expedited revocation process. (i) The Secretary must send the 
PSO a written notice of deficiency that:
    (A) Identifies the evidence that the circumstances for revocation 
and delisting under paragraph (a)(1) of this section exist, and any 
corrective action that the PSO must take if the Secretary determines 
that corrective action may resolve the matter so that the entity would 
not be delisted; and
    (B) Provides an opportunity for the PSO to respond in writing to 
correct the facts or the legal bases for delisting found in the notice, 
and to offer any other grounds for its not being delisted.
    (ii) The notice of deficiency will be presumed to be received five 
days after it is sent, absent evidence of the actual receipt date.
    (iii) If the PSO does not submit a written response to the Secretary 
within 14 calendar days of actual or constructive receipt of such 
notice, whichever is longer, the Secretary may revoke his acceptance of 
the PSO's certifications and remove the entity from the list of PSOs.
    (iv) If the PSO responds in writing within the required 14-day time 
period, the Secretary may take any of the following actions:
    (A) Withdraw the notice of deficiency;
    (B) Provide the PSO with more time to resolve the matter to the 
Secretary's satisfaction; or
    (C) Revoke his acceptance of the PSO's certifications and remove the 
entity from the list of PSOs.



Sec. 3.110  Assessment of PSO compliance.

    The Secretary may request information or conduct announced or 
unannounced reviews of, or site visits to, PSOs, to assess or verify PSO 
compliance with the requirements of this subpart and for these purposes 
will be allowed to inspect the physical or virtual sites maintained or 
controlled by the PSO. The Secretary will be allowed to inspect and/or 
be given or sent copies of any PSO records deemed necessary

[[Page 48]]

and requested by the Secretary to implement the provisions of this 
subpart. Such PSO records may include patient safety work product in 
accordance with Sec. 3.206(d) of this part.



Sec. 3.112  Submissions and forms.

    (a) Forms referred to in this subpart may be obtained on the PSO Web 
site (http://www.pso.ahrq.gov) maintained for the Secretary by AHRQ or a 
successor agency or on successor publication technology or by requesting 
them in writing by e-mail at [email protected], or by mail from the 
Agency for Healthcare Research and Quality, CQuIPS, PSO Liaison, 540 
Gaither Road, Rockville, MD 20850. A form (including any required 
attachments) must be submitted in accordance with the accompanying 
instructions.
    (b) Information submitted to AHRQ in writing, but not required to be 
on or attached to a form, and requests for information from AHRQ, may be 
submitted by mail or other delivery to the Agency for Healthcare 
Research and Quality, CQuIPS, PSO Liaison, 540 Gaither Road, Rockville, 
MD 20850, by facsimile at (301) 427-1341, or by e-mail at 
[email protected]gov.
    (c) If a submission to the Secretary is incomplete or additional 
information is needed to allow a determination to be made under this 
subpart, the submitter will be notified if any additional information is 
required.



 Subpart C_Confidentiality and Privilege Protections of Patient Safety 
                              Work Product



Sec. 3.204  Privilege of patient safety work product.

    (a) Privilege. Notwithstanding any other provision of Federal, 
State, local, or Tribal law and subject to paragraph (b) of this section 
and Sec. 3.208 of this subpart, patient safety work product shall be 
privileged and shall not be:
    (1) Subject to a Federal, State, local, or Tribal civil, criminal, 
or administrative subpoena or order, including in a Federal, State, 
local, or Tribal civil or administrative disciplinary proceeding against 
a provider;
    (2) Subject to discovery in connection with a Federal, State, local, 
or Tribal civil, criminal, or administrative proceeding, including in a 
Federal, State, local, or Tribal civil or administrative disciplinary 
proceeding against a provider;
    (3) Subject to disclosure pursuant to section 552 of Title 5, United 
States Code (commonly known as the Freedom of Information Act) or any 
other similar Federal, State, local, or Tribal law;
    (4) Admitted as evidence in any Federal, State, local, or Tribal 
governmental civil proceeding, criminal proceeding, administrative 
rulemaking proceeding, or administrative adjudicatory proceeding, 
including any such proceeding against a provider; or
    (5) Admitted in a professional disciplinary proceeding of a 
professional disciplinary body established or specifically authorized 
under State law.
    (b) Exceptions to privilege. Privilege shall not apply to (and shall 
not be construed to prohibit) one or more of the following disclosures:
    (1) Disclosure of relevant patient safety work product for use in a 
criminal proceeding, subject to the conditions at Sec. 3.206(b)(1) of 
this subpart.
    (2) Disclosure to the extent required to permit equitable relief 
subject to the conditions at Sec. 3.206(b)(2) of this subpart.
    (3) Disclosure pursuant to provider authorizations subject to the 
conditions at Sec. 3.206(b)(3) of this subpart.
    (4) Disclosure of non-identifiable patient safety work product 
subject to the conditions at Sec. 3.206(b)(5) of this subpart.
    (c) Implementation and enforcement by the Secretary. Privilege shall 
not apply to (and shall not be construed to prohibit) disclosures of 
relevant patient safety work product to or by the Secretary if such 
patient safety work product is needed to investigate or determine 
compliance, or to seek or impose civil money penalties, with respect to 
this part or the HIPAA Privacy Rule, or to make or support decisions 
with respect to listing of a PSO.



Sec. 3.206  Confidentiality of patient safety work product.

    (a) Confidentiality. Subject to paragraphs (b) through (e) of this 
section,

[[Page 49]]

and Sec. Sec. 3.208 and 3.210 of this subpart, patient safety work 
product shall be confidential and shall not be disclosed.
    (b) Exceptions to confidentiality. The confidentiality provisions 
shall not apply to (and shall not be construed to prohibit) one or more 
of the following disclosures:
    (1) Disclosure in criminal proceedings. Disclosure of relevant 
patient safety work product for use in a criminal proceeding, but only 
after a court makes an in-camera determination that:
    (i) Such patient safety work product contains evidence of a criminal 
act;
    (ii) Such patient safety work product is material to the proceeding; 
and
    (iii) Such patient safety work product is not reasonably available 
from any other source.
    (2) Disclosure to permit equitable relief for reporters. Disclosure 
of patient safety work product to the extent required to permit 
equitable relief under section 922 (f)(4)(A) of the Public Health 
Service Act, provided the court or administrative tribunal has issued a 
protective order to protect the confidentiality of the patient safety 
work product in the course of the proceeding.
    (3) Disclosure authorized by identified providers. (i) Disclosure of 
identifiable patient safety work product consistent with a valid 
authorization if such authorization is obtained from each provider 
identified in such work product prior to disclosure. A valid 
authorization must:
    (A) Be in writing and signed by the provider from whom authorization 
is sought; and
    (B) Contain sufficient detail to fairly inform the provider of the 
nature and scope of the disclosures being authorized;
    (ii) A valid authorization must be retained by the disclosing entity 
for six years from the date of the last disclosure made in reliance on 
the authorization and made available to the Secretary upon request.
    (4) Disclosure for patient safety activities--(i) Disclosure between 
a provider and a PSO. Disclosure of patient safety work product for 
patient safety activities by a provider to a PSO or by a PSO to that 
disclosing provider.
    (ii) Disclosure to a contractor of a provider or a PSO. A provider 
or a PSO may disclose patient safety work product for patient safety 
activities to an entity with which it has contracted to undertake 
patient safety activities on its behalf. A contractor receiving patient 
safety work product for patient safety activities may not further 
disclose patient safety work product, except to the provider or PSO with 
which it is contracted.
    (iii) Disclosure among affiliated providers. Disclosure of patient 
safety work product for patient safety activities by a provider to an 
affiliated provider.
    (iv) Disclosure to another PSO or provider. Disclosure of patient 
safety work product for patient safety activities by a PSO to another 
PSO or to another provider that has reported to the PSO, or, except as 
otherwise permitted in paragraph (b)(4)(iii) of this section, by a 
provider to another provider, provided:
    (A) The following direct identifiers of any providers and of 
affiliated organizations, corporate parents, subsidiaries, practice 
partners, employers, members of the workforce, or household members of 
such providers are removed:
    (1) Names;
    (2) Postal address information, other than town or city, State and 
zip code;
    (3) Telephone numbers;
    (4) Fax numbers;
    (5) Electronic mail addresses;
    (6) Social security numbers or taxpayer identification numbers;
    (7) Provider or practitioner credentialing or DEA numbers;
    (8) National provider identification number;
    (9) Certificate/license numbers;
    (10) Web Universal Resource Locators (URLs);
    (11) Internet Protocol (IP) address numbers;
    (12) Biometric identifiers, including finger and voice prints; and
    (13) Full face photographic images and any comparable images; and
    (B) With respect to any individually identifiable health information 
in such patient safety work product, the direct identifiers listed at 45 
CFR 164.514(e)(2) have been removed.

[[Page 50]]

    (5) Disclosure of nonidentifiable patient safety work product. 
Disclosure of nonidentifiable patient safety work product when patient 
safety work product meets the standard for nonidentification in 
accordance with Sec. 3.212 of this subpart.
    (6) Disclosure for research. (i) Disclosure of patient safety work 
product to persons carrying out research, evaluation or demonstration 
projects authorized, funded, certified, or otherwise sanctioned by rule 
or other means by the Secretary, for the purpose of conducting research.
    (ii) If the patient safety work product disclosed pursuant to 
paragraph (b)(6)(i) of this section is by a HIPAA covered entity as 
defined at 45 CFR 160.103 and contains protected health information as 
defined by the HIPAA Privacy Rule at 45 CFR 160.103, such patient safety 
work product may only be disclosed under this exception in the same 
manner as would be permitted under the HIPAA Privacy Rule.
    (7) Disclosure to the Food and Drug Administration (FDA) and 
entities required to report to FDA. (i) Disclosure by a provider of 
patient safety work product concerning an FDA-regulated product or 
activity to the FDA, an entity required to report to the FDA concerning 
the quality, safety, or effectiveness of an FDA-regulated product or 
activity, or a contractor acting on behalf of FDA or such entity for 
these purposes.
    (ii) Any person permitted to receive patient safety work product 
pursuant to paragraph (b)(7)(i) of this section may only further 
disclose such patient safety work product for the purpose of evaluating 
the quality, safety, or effectiveness of that product or activity to 
another such person or the disclosing provider.
    (8) Voluntary disclosure to an accrediting body. (i) Voluntary 
disclosure by a provider of patient safety work product to an 
accrediting body that accredits that provider, provided, with respect to 
any identified provider other than the provider making the disclosure:
    (A) The provider agrees to the disclosure; or
    (B) The identifiers at Sec. 3.206(b)(4)(iv)(A) are removed.
    (ii) An accrediting body may not further disclose patient safety 
work product it receives pursuant to paragraph (b)(8)(i) of this 
section.
    (iii) An accrediting body may not take an accrediting action against 
a provider based on a good faith participation of the provider in the 
collection, development, reporting, or maintenance of patient safety 
work product in accordance with this Part. An accrediting body may not 
require a provider to reveal its communications with any PSO.
    (9) Disclosure for business operations. (i) Disclosure of patient 
safety work product by a provider or a PSO for business operations to 
attorneys, accountants, and other professionals. Such contractors may 
not further disclose patient safety work product, except to the entity 
from which they received the information.
    (ii) Disclosure of patient safety work product for such other 
business operations that the Secretary may prescribe by regulation as 
consistent with the goals of this part.
    (10) Disclosure to law enforcement. (i) Disclosure of patient safety 
work product to an appropriate law enforcement authority relating to an 
event that either constitutes the commission of a crime, or for which 
the disclosing person reasonably believes constitutes the commission of 
a crime, provided that the disclosing person believes, reasonably under 
the circumstances, that the patient safety work product that is 
disclosed is necessary for criminal law enforcement purposes.
    (ii) Law enforcement personnel receiving patient safety work product 
pursuant to paragraph (b)(10)(i) of this section only may disclose that 
patient safety work product to other law enforcement authorities as 
needed for law enforcement activities related to the event that gave 
rise to the disclosure under paragraph (b)(10)(i) of this section.
    (c) Safe harbor. A provider or responsible person, but not a PSO, is 
not considered to have violated the requirements of this subpart if a 
member of its workforce discloses patient safety work product, provided 
that the disclosure does not include materials, including oral 
statements, that:
    (1) Assess the quality of care of an identifiable provider; or

[[Page 51]]

    (2) Describe or pertain to one or more actions or failures to act by 
an identifiable provider.
    (d) Implementation and enforcement by the Secretary. The 
confidentiality provisions shall not apply to (and shall not be 
construed to prohibit) disclosures of relevant patient safety work 
product to or by the Secretary if such patient safety work product is 
needed to investigate or determine compliance or to seek or impose civil 
money penalties, with respect to this part or the HIPAA Privacy Rule, or 
to make or support decisions with respect to listing of a PSO.
    (e) No limitation on authority to limit or delegate disclosure or 
use. Nothing in subpart C of this part shall be construed to limit the 
authority of any person to enter into a contract requiring greater 
confidentiality or delegating authority to make a disclosure or use in 
accordance with this subpart.



Sec. 3.208  Continued protection of patient safety work product.

    (a) Except as provided in paragraph (b) of this section, patient 
safety work product disclosed in accordance with this subpart, or 
disclosed impermissibly, shall continue to be privileged and 
confidential.
    (b)(1) Patient safety work product disclosed for use in a criminal 
proceeding pursuant to section 922(c)(1)(A) of the Public Health Service 
Act, 42 U.S.C. 299b-22(c)(1)(A), and/or pursuant to Sec. 3.206(b)(1) of 
this subpart continues to be privileged, but is no longer confidential.
    (2) Non-identifiable patient safety work product that is disclosed 
is no longer privileged or confidential and not subject to the 
regulations under this part.
    (3) Paragraph (b) of this section applies only to the specific 
patient safety work product disclosed.



Sec. 3.210  Required disclosure of patient safety work product to the
Secretary.

    Notwithstanding any other provision in this part, providers, PSOs, 
and responsible persons must disclose patient safety work product upon 
request by the Secretary when the Secretary determines such patient 
safety work product is needed to investigate or determine compliance or 
to seek or impose civil money penalties, with respect to this part or 
the HIPAA Privacy Rule, or to make or support decisions with respect to 
listing of a PSO.



Sec. 3.212  Nonidentification of patient safety work product.

    (a) Patient safety work product is nonidentifiable with respect to a 
particular identified provider or a particular identified reporter if:
    (1) A person with appropriate knowledge of and experience with 
generally accepted statistical and scientific principles and methods for 
rendering information not individually identifiable:
    (i) Applying such principles and methods, determines that the risk 
is very small that the information could be used, alone or in 
combination with other reasonably available information, by an 
anticipated recipient to identify an identified provider or reporter; 
and
    (ii) Documents the methods and results of the analysis that justify 
such determination; or
    (2)(i) The following identifiers of such provider or reporter and of 
affiliated organizations, corporate parents, subsidiaries, practice 
partners, employers, members of the workforce, or household members of 
such providers or reporters are removed:
    (A) The direct identifiers listed at Sec. 3.206(b)(4)(iv)(A)(1) 
through (13) of this subpart;
    (B) Geographic subdivisions smaller than a State, including street 
address, city, county, precinct, zip code and equivalent geocodes, 
except for the initial three digits of a zip code if, according to the 
current publicly available data from the Bureau of the Census, the 
geographic unit formed by combining all zip codes with the same three 
initial digits contains more than 20,000 people;
    (C) All elements of dates (except year) for dates directly related 
to a patient safety incident or event; and
    (D) Any other unique identifying number, characteristic, or code 
except as permitted for re-identification; and
    (ii) The provider, PSO or responsible person making the disclosure 
does not

[[Page 52]]

have actual knowledge that the information could be used, alone or in 
combination with other information that is reasonably available to the 
intended recipient, to identify the particular provider or reporter.
    (3) Re-identification. A provider, PSO, or responsible person may 
assign a code or other means of record identification to allow 
information made nonidentifiable under this section to be re-identified 
by such provider, PSO, or responsible person, provided that:
    (i) The code or other means of record identification is not derived 
from or related to information about the provider or reporter and is not 
otherwise capable of being translated so as to identify the provider or 
reporter; and
    (ii) The provider, PSO, or responsible person does not use or 
disclose the code or other means of record identification for any other 
purpose, and does not disclose the mechanism for re-identification.
    (b) Patient safety work product is non-identifiable with respect to 
a particular patient only if the individually identifiable health 
information regarding that patient is de-identified in accordance with 
the HIPAA Privacy Rule standard and implementation specifications for 
the de-identification at 45 CFR 164.514(a) through (c).



                      Subpart D_Enforcement Program



Sec. 3.304  Principles for achieving compliance.

    (a) Cooperation. The Secretary will, to the extent practicable, seek 
the cooperation of providers, PSOs, and responsible persons in obtaining 
compliance with the applicable confidentiality provisions.
    (b) Assistance. The Secretary may provide technical assistance to 
providers, PSOs, and responsible persons to help them comply voluntarily 
with the applicable confidentiality provisions.



Sec. 3.306  Complaints to the Secretary.

    (a) Right to file a complaint. A person who believes that patient 
safety work product has been disclosed in violation of the 
confidentiality provisions may file a complaint with the Secretary.
    (b) Requirements for filing complaints. Complaints under this 
section must meet the following requirements:
    (1) A complaint must be filed in writing, either on paper or 
electronically.
    (2) A complaint must name the person that is the subject of the 
complaint and describe the act(s) believed to be in violation of the 
applicable confidentiality provision(s).
    (3) A complaint must be filed within 180 days of when the 
complainant knew or should have known that the act complained of 
occurred, unless this time limit is waived by the Secretary for good 
cause shown.
    (4) The Secretary may prescribe additional procedures for the filing 
of complaints, as well as the place and manner of filing, by notice in 
the Federal Register.
    (c) Investigation. The Secretary may investigate complaints filed 
under this section. Such investigation may include a review of the 
pertinent policies, procedures, or practices of the respondent and of 
the circumstances regarding any alleged violation. At the time of 
initial written communication with the respondent about the complaint, 
the Secretary will describe the act(s) that are the basis of the 
complaint.



Sec. 3.308  Compliance reviews.

    The Secretary may conduct compliance reviews to determine whether a 
respondent is complying with the applicable confidentiality provisions.



Sec. 3.310  Responsibilities of respondents.

    (a) Provide records and compliance reports. A respondent must keep 
such records and submit such compliance reports, in such time and manner 
and containing such information, as the Secretary may determine to be 
necessary to enable the Secretary to ascertain whether the respondent 
has complied or is complying with the applicable confidentiality 
provisions.
    (b) Cooperate with complaint investigations and compliance reviews. 
A respondent must cooperate with the Secretary, if the Secretary 
undertakes an investigation or compliance review of the policies, 
procedures, or practices of the respondent to determine whether it is 
complying with the applicable confidentiality provisions.

[[Page 53]]

    (c) Permit access to information. (1) A respondent must permit 
access by the Secretary during normal business hours to its facilities, 
books, records, accounts, and other sources of information, including 
patient safety work product, that are pertinent to ascertaining 
compliance with the applicable confidentiality provisions. If the 
Secretary determines that exigent circumstances exist, such as when 
documents may be hidden or destroyed, a respondent must permit access by 
the Secretary at any time and without notice.
    (2) If any information required of a respondent under this section 
is in the exclusive possession of any other agency, institution, or 
person, and the other agency, institution, or person fails or refuses to 
furnish the information, the respondent must so certify and set forth 
what efforts it has made to obtain the information.



Sec. 3.312  Secretarial action regarding complaints and compliance
reviews.

    (a) Resolution when noncompliance is indicated. (1) If an 
investigation of a complaint pursuant to Sec. 3.306 of this subpart or 
a compliance review pursuant to Sec. 3.308 of this subpart indicates 
noncompliance, the Secretary may attempt to reach a resolution of the 
matter satisfactory to the Secretary by informal means. Informal means 
may include demonstrated compliance or a completed corrective action 
plan or other agreement.
    (2) If the matter is resolved by informal means, the Secretary will 
so inform the respondent and, if the matter arose from a complaint, the 
complainant, in writing.
    (3) If the matter is not resolved by informal means, the Secretary 
will--
    (i) So inform the respondent and provide the respondent an 
opportunity to submit written evidence of any mitigating factors. The 
respondent must submit any evidence to the Secretary within 30 days 
(computed in the same manner as prescribed under Sec. 3.526 of this 
subpart) of receipt of such notification; and
    (ii) If, following action pursuant to paragraph (a)(3)(i) of this 
section, the Secretary decides that a civil money penalty should be 
imposed, inform the respondent of such finding in a notice of proposed 
determination in accordance with Sec. 3.420 of this subpart.
    (b) Resolution when no violation is found. If, after an 
investigation pursuant to Sec. 3.306 of this subpart or a compliance 
review pursuant to Sec. 3.308 of this subpart, the Secretary determines 
that further action is not warranted, the Secretary will so inform the 
respondent and, if the matter arose from a complaint, the complainant, 
in writing.
    (c) Uses and disclosures of information obtained. (1) Identifiable 
patient safety work product obtained by the Secretary in connection with 
an investigation or compliance review under this subpart will not be 
disclosed by the Secretary, except in accordance with Sec. 3.206(d) of 
this subpart, or if otherwise permitted by this part or the Patient 
Safety Act.
    (2) Except as provided for in paragraph (c)(1) of this section, 
information, including testimony and other evidence, obtained by the 
Secretary in connection with an investigation or compliance review under 
this subpart may be used by HHS in any of its activities and may be used 
or offered into evidence in any administrative or judicial proceeding.



Sec. 3.314  Investigational subpoenas and inquiries.

    (a) The Secretary may issue subpoenas in accordance with 42 U.S.C. 
405(d) and (e), and 1320a-7a(j), to require the attendance and testimony 
of witnesses and the production of any other evidence including patient 
safety work product during an investigation or compliance review 
pursuant to this part.
    (1) A subpoena issued under this paragraph must--
    (i) State the name of the person (including the entity, if 
applicable) to whom the subpoena is addressed;
    (ii) State the statutory authority for the subpoena;
    (iii) Indicate the date, time, and place that the testimony will 
take place;
    (iv) Include a reasonably specific description of any documents or 
items required to be produced; and

[[Page 54]]

    (v) If the subpoena is addressed to an entity, describe with 
reasonable particularity the subject matter on which testimony is 
required. In that event, the entity must designate one or more natural 
persons who will testify on its behalf, and must state as to each such 
person that person's name and address and the matters on which he or she 
will testify. The designated person must testify as to matters known or 
reasonably available to the entity.
    (2) A subpoena under this section must be served by--
    (i) Delivering a copy to the natural person named in the subpoena or 
to the entity named in the subpoena at its last principal place of 
business; or
    (ii) Registered or certified mail addressed to the natural person at 
his or her last known dwelling place or to the entity at its last known 
principal place of business.
    (3) A verified return by the natural person serving the subpoena 
setting forth the manner of service or, in the case of service by 
registered or certified mail, the signed return post office receipt, 
constitutes proof of service.
    (4) Witnesses are entitled to the same fees and mileage as witnesses 
in the district courts of the United States (28 U.S.C. 1821 and 1825). 
Fees need not be paid at the time the subpoena is served.
    (5) A subpoena under this section is enforceable through the 
district court of the United States for the district where the 
subpoenaed natural person resides or is found or where the entity 
transacts business.
    (b) Investigational inquiries are non-public investigational 
proceedings conducted by the Secretary.
    (1) Testimony at investigational inquiries will be taken under oath 
or affirmation.
    (2) Attendance of non-witnesses is discretionary with the Secretary, 
except that a witness is entitled to be accompanied, represented, and 
advised by an attorney.
    (3) Representatives of the Secretary are entitled to attend and ask 
questions.
    (4) A witness will have the opportunity to clarify his or her 
answers on the record following questioning by the Secretary.
    (5) Any claim of privilege must be asserted by the witness on the 
record.
    (6) Objections must be asserted on the record. Errors of any kind 
that might be corrected if promptly presented will be deemed to be 
waived unless reasonable objection is made at the investigational 
inquiry. Except where the objection is on the grounds of privilege, the 
question will be answered on the record, subject to objection.
    (7) If a witness refuses to answer any question not privileged or to 
produce requested documents or items, or engages in conduct likely to 
delay or obstruct the investigational inquiry, the Secretary may seek 
enforcement of the subpoena under paragraph (a)(5) of this section.
    (8) The proceedings will be recorded and transcribed. The witness is 
entitled to a copy of the transcript, upon payment of prescribed costs, 
except that, for good cause, the witness may be limited to inspection of 
the official transcript of his or her testimony.
    (9)(i) The transcript will be submitted to the witness for 
signature.
    (A) Where the witness will be provided a copy of the transcript, the 
transcript will be submitted to the witness for signature. The witness 
may submit to the Secretary written proposed corrections to the 
transcript, with such corrections attached to the transcript. If the 
witness does not return a signed copy of the transcript or proposed 
corrections within 30 days (computed in the same manner as prescribed 
under Sec. 3.526 of this part) of its being submitted to him or her for 
signature, the witness will be deemed to have agreed that the transcript 
is true and accurate.
    (B) Where, as provided in paragraph (b)(8) of this section, the 
witness is limited to inspecting the transcript, the witness will have 
the opportunity at the time of inspection to propose corrections to the 
transcript, with corrections attached to the transcript. The witness 
will also have the opportunity to sign the transcript. If the witness 
does not sign the transcript or offer corrections within 30 days 
(computed in the same manner as prescribed

[[Page 55]]

under Sec. 3.526 of this part) of receipt of notice of the opportunity 
to inspect the transcript, the witness will be deemed to have agreed 
that the transcript is true and accurate.
    (ii) The Secretary's proposed corrections to the record of 
transcript will be attached to the transcript.



Sec. 3.402  Basis for a civil money penalty.

    (a) General rule. A person who discloses identifiable patient safety 
work product in knowing or reckless violation of the confidentiality 
provisions shall be subject to a civil money penalty for each act 
constituting such violation.
    (b) Violation attributed to a principal. A principal is 
independently liable, in accordance with the federal common law of 
agency, for a civil money penalty based on the act of the principal's 
agent, including a workforce member, acting within the scope of the 
agency if such act could give rise to a civil money penalty in 
accordance with Sec. 3.402(a) of this subpart.



Sec. 3.404  Amount of a civil money penalty.

    (a) The amount of a civil money penalty will be determined in 
accordance with paragraph (b) of this section and Sec. 3.408 of this 
subpart.
    (b) The Secretary may impose a civil money penalty in the amount of 
not more than $11,000.

[73 FR 70796, Nov. 21, 2008, as amended at 74 FR 42779, Aug. 25, 2009]



Sec. 3.408  Factors considered in determining the amount of a civil
money penalty.

    In determining the amount of any civil money penalty, the Secretary 
may consider as aggravating or mitigating factors, as appropriate, any 
of the following:
    (a) The nature of the violation.
    (b) The circumstances, including the consequences, of the violation, 
including:
    (1) The time period during which the violation(s) occurred; and
    (2) Whether the violation caused physical or financial harm or 
reputational damage;
    (c) The degree of culpability of the respondent, including:
    (1) Whether the violation was intentional; and
    (2) Whether the violation was beyond the direct control of the 
respondent.
    (d) Any history of prior compliance with the Patient Safety Act, 
including violations, by the respondent, including:
    (1) Whether the current violation is the same or similar to prior 
violation(s);
    (2) Whether and to what extent the respondent has attempted to 
correct previous violations;
    (3) How the respondent has responded to technical assistance from 
the Secretary provided in the context of a compliance effort; and
    (4) How the respondent has responded to prior complaints.
    (e) The financial condition of the respondent, including:
    (1) Whether the respondent had financial difficulties that affected 
its ability to comply;
    (2) Whether the imposition of a civil money penalty would jeopardize 
the ability of the respondent to continue to provide health care or 
patient safety activities; and
    (3) The size of the respondent.
    (f) Such other matters as justice may require.



Sec. 3.414  Limitations.

    No action under this subpart may be entertained unless commenced by 
the Secretary, in accordance with Sec. 3.420 of this subpart, within 6 
years from the date of the occurrence of the violation.



Sec. 3.416  Authority to settle.

    Nothing in this subpart limits the authority of the Secretary to 
settle any issue or case or to compromise any penalty.



Sec. 3.418  Exclusivity of penalty.

    (a) Except as otherwise provided by paragraph (b) of this section, a 
penalty imposed under this part is in addition to any other penalty 
prescribed by law.
    (b) Civil money penalties shall not be imposed both under this part 
and under the HIPAA Privacy Rule (45 CFR parts 160 and 164).

[[Page 56]]



Sec. 3.420  Notice of proposed determination.

    (a) If a penalty is proposed in accordance with this part, the 
Secretary must deliver, or send by certified mail with return receipt 
requested, to the respondent, written notice of the Secretary's intent 
to impose a penalty. This notice of proposed determination must include:
    (1) Reference to the statutory basis for the penalty;
    (2) A description of the findings of fact regarding the violations 
with respect to which the penalty is proposed;
    (3) The reason(s) why the violation(s) subject(s) the respondent to 
a penalty;
    (4) The amount of the proposed penalty;
    (5) Any factors described in Sec. 3.408 of this subpart that were 
considered in determining the amount of the proposed penalty; and
    (6) Instructions for responding to the notice, including a statement 
of the respondent's right to a hearing, a statement that failure to 
request a hearing within 60 days permits the imposition of the proposed 
penalty without the right to a hearing under Sec. 3.504 of this subpart 
or a right of appeal under Sec. 3.548 of this subpart, and the address 
to which the hearing request must be sent.
    (b) The respondent may request a hearing before an ALJ on the 
proposed penalty by filing a request in accordance with Sec. 3.504 of 
this subpart.



Sec. 3.422  Failure to request a hearing.

    If the respondent does not request a hearing within the time 
prescribed by Sec. 3.504 of this subpart and the matter is not settled 
pursuant to Sec. 3.416 of this subpart, the Secretary may impose the 
proposed penalty or any lesser penalty permitted by sections 921 through 
926 of the Public Health Service Act, 42 U.S.C. 299b-21 through 299b-26. 
The Secretary will notify the respondent by certified mail, return 
receipt requested, of any penalty that has been imposed and of the means 
by which the respondent may satisfy the penalty, and the penalty is 
final on receipt of the notice. The respondent has no right to appeal a 
penalty under Sec. 3.548 of this subpart with respect to which the 
respondent has not timely requested a hearing.



Sec. 3.424  Collection of penalty.

    (a) Once a determination of the Secretary to impose a penalty has 
become final, the penalty will be collected by the Secretary, subject to 
the first sentence of 42 U.S.C. 1320a-7a(f).
    (b) The penalty may be recovered in a civil action brought in the 
United States district court for the district where the respondent 
resides, is found, or is located.
    (c) The amount of a penalty, when finally determined, or the amount 
agreed upon in compromise, may be deducted from any sum then or later 
owing by the United States, or by a State agency, to the respondent.
    (d) Matters that were raised or that could have been raised in a 
hearing before an ALJ, or in an appeal under 42 U.S.C. 1320a-7a(e), may 
not be raised as a defense in a civil action by the United States to 
collect a penalty under this part.



Sec. 3.426  Notification of the public and other agencies.

    Whenever a proposed penalty becomes final, the Secretary will 
notify, in such manner as the Secretary deems appropriate, the public 
and the following organizations and entities thereof and the reason it 
was imposed: The appropriate State or local medical or professional 
organization, the appropriate State agency or agencies administering or 
supervising the administration of State health care programs (as defined 
in 42 U.S.C. 1320a-7(h)), the appropriate utilization and quality 
control peer review organization, and the appropriate State or local 
licensing agency or organization (including the agency specified in 42 
U.S.C. 1395aa(a), 1396a(a)(33)).



Sec. 3.504  Hearings before an ALJ.

    (a) A respondent may request a hearing before an ALJ. The parties to 
the hearing proceeding consist of--
    (1) The respondent; and
    (2) The officer(s) or employee(s) of HHS to whom the enforcement 
authority involved has been delegated.

[[Page 57]]

    (b) The request for a hearing must be made in writing signed by the 
respondent or by the respondent's attorney and sent by certified mail, 
return receipt requested, to the address specified in the notice of 
proposed determination. The request for a hearing must be mailed within 
60 days after notice of the proposed determination is received by the 
respondent. For purposes of this section, the respondent's date of 
receipt of the notice of proposed determination is presumed to be 5 days 
after the date of the notice unless the respondent makes a reasonable 
showing to the contrary to the ALJ.
    (c) The request for a hearing must clearly and directly admit, deny, 
or explain each of the findings of fact contained in the notice of 
proposed determination with regard to which the respondent has any 
knowledge. If the respondent has no knowledge of a particular finding of 
fact and so states, the finding shall be deemed denied. The request for 
a hearing must also state the circumstances or arguments that the 
respondent alleges constitute the grounds for any defense and the 
factual and legal basis for opposing the penalty.
    (d) The ALJ must dismiss a hearing request where--
    (1) On motion of the Secretary, the ALJ determines that the 
respondent's hearing request is not timely filed as required by 
paragraph (b) or does not meet the requirements of paragraph (c) of this 
section;
    (2) The respondent withdraws the request for a hearing;
    (3) The respondent abandons the request for a hearing; or
    (4) The respondent's hearing request fails to raise any issue that 
may properly be addressed in a hearing.



Sec. 3.506  Rights of the parties.

    (a) Except as otherwise limited by this subpart, each party may--
    (1) Be accompanied, represented, and advised by an attorney;
    (2) Participate in any conference held by the ALJ;
    (3) Conduct discovery of documents as permitted by this subpart;
    (4) Agree to stipulations of fact or law that will be made part of 
the record;
    (5) Present evidence relevant to the issues at the hearing;
    (6) Present and cross-examine witnesses;
    (7) Present oral arguments at the hearing as permitted by the ALJ; 
and
    (8) Submit written briefs and proposed findings of fact and 
conclusions of law after the hearing.
    (b) A party may appear in person or by a representative. Natural 
persons who appear as an attorney or other representative must conform 
to the standards of conduct and ethics required of practitioners before 
the courts of the United States.
    (c) Fees for any services performed on behalf of a party by an 
attorney are not subject to the provisions of 42 U.S.C. 406, which 
authorizes the Secretary to specify or limit their fees.



Sec. 3.508  Authority of the ALJ.

    (a) The ALJ must conduct a fair and impartial hearing, avoid delay, 
maintain order, and ensure that a record of the proceeding is made.
    (b) The ALJ may--
    (1) Set and change the date, time and place of the hearing upon 
reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences to identify or simplify the issues, or to 
consider other matters that may aid in the expeditious disposition of 
the proceeding;
    (4) Administer oaths and affirmations;
    (5) Issue subpoenas requiring the attendance of witnesses at 
hearings and the production of documents at or in relation to hearings;
    (6) Rule on motions and other procedural matters;
    (7) Regulate the scope and timing of documentary discovery as 
permitted by this subpart;
    (8) Regulate the course of the hearing and the conduct of 
representatives, parties, and witnesses;
    (9) Examine witnesses;
    (10) Receive, rule on, exclude, or limit evidence;
    (11) Upon motion of a party, take official notice of facts;
    (12) Conduct any conference, argument or hearing in person or, upon

[[Page 58]]

agreement of the parties, by telephone; and
    (13) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact. A 
summary judgment decision constitutes a hearing on the record for the 
purposes of this subpart.
    (c) The ALJ--
    (1) May not find invalid or refuse to follow Federal statutes, 
regulations, or Secretarial delegations of authority and must give 
deference to published guidance to the extent not inconsistent with 
statute or regulation;
    (2) May not enter an order in the nature of a directed verdict;
    (3) May not compel settlement negotiations; or
    (4) May not enjoin any act of the Secretary.



Sec. 3.510  Ex parte contacts.

    No party or person (except employees of the ALJ's office) may 
communicate in any way with the ALJ on any matter at issue in a case, 
unless on notice and opportunity for both parties to participate. This 
provision does not prohibit a party or person from inquiring about the 
status of a case or asking routine questions concerning administrative 
functions or procedures.



Sec. 3.512  Prehearing conferences.

    (a) The ALJ must schedule at least one prehearing conference, and 
may schedule additional prehearing conferences as appropriate, upon 
reasonable notice, which may not be less than 14 business days, to the 
parties.
    (b) The ALJ may use prehearing conferences to discuss the 
following--
    (1) Simplification of the issues;
    (2) The necessity or desirability of amendments to the pleadings, 
including the need for a more definite statement;
    (3) Stipulations and admissions of fact or as to the contents and 
authenticity of documents;
    (4) Whether the parties can agree to submission of the case on a 
stipulated record;
    (5) Whether a party chooses to waive appearance at an oral hearing 
and to submit only documentary evidence (subject to the objection of the 
other party) and written argument;
    (6) Limitation of the number of witnesses;
    (7) Scheduling dates for the exchange of witness lists and of 
proposed exhibits;
    (8) Discovery of documents as permitted by this subpart;
    (9) The time and place for the hearing;
    (10) The potential for the settlement of the case by the parties; 
and
    (11) Other matters as may tend to encourage the fair, just and 
expeditious disposition of the proceedings, including the protection of 
confidentiality of identifiable patient safety work product that may be 
submitted into evidence or otherwise used in the proceeding, if 
appropriate.
    (c) The ALJ must issue an order containing the matters agreed upon 
by the parties or ordered by the ALJ at a prehearing conference.



Sec. 3.514  Authority to settle.

    The Secretary has exclusive authority to settle any issue or case 
without the consent of the ALJ.



Sec. 3.516  Discovery.

    (a) A party may make a request to another party for production of 
documents for inspection and copying that are relevant and material to 
the issues before the ALJ.
    (b) For the purpose of this section, the term ``documents'' includes 
information, reports, answers, records, accounts, papers and other data 
and documentary evidence. Nothing contained in this section may be 
interpreted to require the creation of a document, except that requested 
data stored in an electronic data storage system must be produced in a 
form accessible to the requesting party.
    (c) Requests for documents, requests for admissions, written 
interrogatories, depositions and any forms of discovery, other than 
those permitted under paragraph (a) of this section, are not authorized.
    (d) This section may not be construed to require the disclosure of 
interview reports or statements obtained by any party, or on behalf of 
any party, of persons who will not be called as witnesses

[[Page 59]]

by that party, or analyses and summaries prepared in conjunction with 
the investigation or litigation of the case, or any otherwise privileged 
documents.
    (e)(1) When a request for production of documents has been received, 
within 30 days the party receiving that request must either fully 
respond to the request, or state that the request is being objected to 
and the reasons for that objection. If objection is made to part of an 
item or category, the part must be specified. Upon receiving any 
objections, the party seeking production may then, within 30 days or any 
other time frame set by the ALJ, file a motion for an order compelling 
discovery. The party receiving a request for production may also file a 
motion for protective order any time before the date the production is 
due.
    (2) The ALJ may grant a motion for protective order or deny a motion 
for an order compelling discovery if the ALJ finds that the discovery 
sought--
    (i) Is irrelevant;
    (ii) Is unduly costly or burdensome;
    (iii) Will unduly delay the proceeding; or
    (iv) Seeks privileged information.
    (3) The ALJ may extend any of the time frames set forth in paragraph 
(e)(1) of this section.
    (4) The burden of showing that discovery should be allowed is on the 
party seeking discovery.



Sec. 3.518  Exchange of witness lists, witness statements, and exhibits.

    (a) The parties must exchange witness lists, copies of prior written 
statements of proposed witnesses, and copies of proposed hearing 
exhibits, including copies of any written statements that the party 
intends to offer in lieu of live testimony in accordance with Sec. 
3.538, not more than 60, and not less than 15, days before the scheduled 
hearing.
    (b)(1) If, at any time, a party objects to the proposed admission of 
evidence not exchanged in accordance with paragraph (a) of this section, 
the ALJ must determine whether the failure to comply with paragraph (a) 
of this section should result in the exclusion of that evidence.
    (2) Unless the ALJ finds that extraordinary circumstances justified 
the failure timely to exchange the information listed under paragraph 
(a) of this section, the ALJ must exclude from the party's case-in-
chief--
    (i) The testimony of any witness whose name does not appear on the 
witness list; and
    (ii) Any exhibit not provided to the opposing party as specified in 
paragraph (a) of this section.
    (3) If the ALJ finds that extraordinary circumstances existed, the 
ALJ must then determine whether the admission of that evidence would 
cause substantial prejudice to the objecting party.
    (i) If the ALJ finds that there is no substantial prejudice, the 
evidence may be admitted.
    (ii) If the ALJ finds that there is substantial prejudice, the ALJ 
may exclude the evidence, or, if he or she does not exclude the 
evidence, must postpone the hearing for such time as is necessary for 
the objecting party to prepare and respond to the evidence, unless the 
objecting party waives postponement.
    (c) Unless the other party objects within a reasonable period of 
time before the hearing, documents exchanged in accordance with 
paragraph (a) of this section will be deemed to be authentic for the 
purpose of admissibility at the hearing.



Sec. 3.520  Subpoenas for attendance at hearing.

    (a) A party wishing to procure the appearance and testimony of any 
person at the hearing may make a motion requesting the ALJ to issue a 
subpoena if the appearance and testimony are reasonably necessary for 
the presentation of a party's case.
    (b) A subpoena requiring the attendance of a person in accordance 
with paragraph (a) of this section may also require the person (whether 
or not the person is a party) to produce relevant and material evidence 
at or before the hearing.
    (c) When a subpoena is served by a respondent on a particular 
employee or official or particular office of HHS, the Secretary may 
comply by designating

[[Page 60]]

any knowledgeable HHS representative to appear and testify.
    (d) A party seeking a subpoena must file a written motion not less 
than 30 days before the date fixed for the hearing, unless otherwise 
allowed by the ALJ for good cause shown. That motion must--
    (1) Specify any evidence to be produced;
    (2) Designate the witnesses; and
    (3) Describe the address and location with sufficient particularity 
to permit those witnesses to be found.
    (e) The subpoena must specify the time and place at which the 
witness is to appear and any evidence the witness is to produce.
    (f) Within 15 days after the written motion requesting issuance of a 
subpoena is served, any party may file an opposition or other response.
    (g) If the motion requesting issuance of a subpoena is granted, the 
party seeking the subpoena must serve it by delivery to the person 
named, or by certified mail addressed to that person at the person's 
last dwelling place or principal place of business.
    (h) The person to whom the subpoena is directed may file with the 
ALJ a motion to quash the subpoena within 10 days after service.
    (i) The exclusive remedy for contumacy by, or refusal to obey a 
subpoena duly served upon, any person is specified in 42 U.S.C. 405(e).



Sec. 3.522  Fees.

    The party requesting a subpoena must pay the cost of the fees and 
mileage of any witness subpoenaed in the amounts that would be payable 
to a witness in a proceeding in United States District Court. A check 
for witness fees and mileage must accompany the subpoena when served, 
except that, when a subpoena is issued on behalf of the Secretary, a 
check for witness fees and mileage need not accompany the subpoena.



Sec. 3.524  Form, filing, and service of papers.

    (a) Forms. (1) Unless the ALJ directs the parties to do otherwise, 
documents filed with the ALJ must include an original and two copies.
    (2) Every pleading and paper filed in the proceeding must contain a 
caption setting forth the title of the action, the case number, and a 
designation of the paper, such as motion to quash subpoena.
    (3) Every pleading and paper must be signed by and must contain the 
address and telephone number of the party or the person on whose behalf 
the paper was filed, or his or her representative.
    (4) Papers are considered filed when they are mailed.
    (b) Service. A party filing a document with the ALJ or the Board 
must, at the time of filing, serve a copy of the document on the other 
party. Service upon any party of any document must be made by delivering 
a copy, or placing a copy of the document in the United States mail, 
postage prepaid and addressed, or with a private delivery service, to 
the party's last known address. When a party is represented by an 
attorney, service must be made upon the attorney in lieu of the party.
    (c) Proof of service. A certificate of the natural person serving 
the document by personal delivery or by mail, setting forth the manner 
of service, constitutes proof of service.



Sec. 3.526  Computation of time.

    (a) In computing any period of time under this subpart or in an 
order issued thereunder, the time begins with the day following the act, 
event or default, and includes the last day of the period unless it is a 
Saturday, Sunday, or legal holiday observed by the Federal Government, 
in which event it includes the next business day.
    (b) When the period of time allowed is less than 7 days, 
intermediate Saturdays, Sundays, and legal holidays observed by the 
Federal Government must be excluded from the computation.
    (c) Where a document has been served or issued by placing it in the 
mail, an additional 5 days must be added to the time permitted for any 
response. This paragraph does not apply to requests for hearing under 
Sec. 3.504.



Sec. 3.528  Motions.

    (a) An application to the ALJ for an order or ruling must be by 
motion. Motions must state the relief sought, the

[[Page 61]]

authority relied upon and the facts alleged, and must be filed with the 
ALJ and served on all other parties.
    (b) Except for motions made during a prehearing conference or at the 
hearing, all motions must be in writing. The ALJ may require that oral 
motions be reduced to writing.
    (c) Within 10 days after a written motion is served, or such other 
time as may be fixed by the ALJ, any party may file a response to the 
motion.
    (d) The ALJ may not grant a written motion before the time for 
filing responses has expired, except upon consent of the parties or 
following a hearing on the motion, but may overrule or deny the motion 
without awaiting a response.
    (e) The ALJ must make a reasonable effort to dispose of all 
outstanding motions before the beginning of the hearing.



Sec. 3.530  Sanctions.

    The ALJ may sanction a person, including any party or attorney, for 
failing to comply with an order or procedure, for failing to defend an 
action or for other misconduct that interferes with the speedy, orderly 
or fair conduct of the hearing. The sanctions must reasonably relate to 
the severity and nature of the failure or misconduct. The sanctions may 
include--
    (a) In the case of refusal to provide or permit discovery under the 
terms of this part, drawing negative factual inferences or treating the 
refusal as an admission by deeming the matter, or certain facts, to be 
established;
    (b) Prohibiting a party from introducing certain evidence or 
otherwise supporting a particular claim or defense;
    (c) Striking pleadings, in whole or in part;
    (d) Staying the proceedings;
    (e) Dismissal of the action;
    (f) Entering a decision by default;
    (g) Ordering the party or attorney to pay the attorney's fees and 
other costs caused by the failure or misconduct; and
    (h) Refusing to consider any motion or other action that is not 
filed in a timely manner.



Sec. 3.532  Collateral estoppel.

    When a final determination that the respondent violated a 
confidentiality provision has been rendered in any proceeding in which 
the respondent was a party and had an opportunity to be heard, the 
respondent is bound by that determination in any proceeding under this 
part.



Sec. 3.534  The hearing.

    (a) The ALJ must conduct a hearing on the record in order to 
determine whether the respondent should be found liable under this part.
    (b)(1) The respondent has the burden of going forward and the burden 
of persuasion with respect to any challenge to the amount of a proposed 
penalty pursuant to Sec. Sec. 3.404 and 3.408, including any factors 
raised as mitigating factors.
    (2) The Secretary has the burden of going forward and the burden of 
persuasion with respect to all other issues, including issues of 
liability and the existence of any factors considered as aggravating 
factors in determining the amount of the proposed penalty.
    (3) The burden of persuasion will be judged by a preponderance of 
the evidence.
    (c) The hearing must be open to the public unless otherwise ordered 
by the ALJ for good cause shown, which may be that identifiable patient 
safety work product has been introduced into evidence or is expected to 
be introduced into evidence.
    (d)(1) Subject to the 15-day rule under Sec. 3.518(a) and the 
admissibility of evidence under Sec. 3.540, either party may introduce, 
during its case in chief, items or information that arose or became 
known after the date of the issuance of the notice of proposed 
determination or the request for hearing, as applicable. Such items and 
information may not be admitted into evidence, if introduced--
    (i) By the Secretary, unless they are material and relevant to the 
acts or omissions with respect to which the penalty is proposed in the 
notice of proposed determination pursuant to Sec. 3.420 of this part, 
including circumstances that may increase penalties; or

[[Page 62]]

    (ii) By the respondent, unless they are material and relevant to an 
admission, denial or explanation of a finding of fact in the notice of 
proposed determination under Sec. 3.420 of this part, or to a specific 
circumstance or argument expressly stated in the request for hearing 
under Sec. 3.504, including circumstances that may reduce penalties.
    (2) After both parties have presented their cases, evidence may be 
admitted in rebuttal even if not previously exchanged in accordance with 
Sec. 3.518.



Sec. 3.538  Witnesses.

    (a) Except as provided in paragraph (b) of this section, testimony 
at the hearing must be given orally by witnesses under oath or 
affirmation.
    (b) At the discretion of the ALJ, testimony of witnesses other than 
the testimony of expert witnesses may be admitted in the form of a 
written statement. The ALJ may, at his or her discretion, admit prior 
sworn testimony of experts that has been subject to adverse examination, 
such as a deposition or trial testimony. Any such written statement must 
be provided to the other party, along with the last known address of the 
witness, in a manner that allows sufficient time for the other party to 
subpoena the witness for cross-examination at the hearing. Prior written 
statements of witnesses proposed to testify at the hearing must be 
exchanged as provided in Sec. 3.518.
    (c) The ALJ must exercise reasonable control over the mode and order 
of interrogating witnesses and presenting evidence so as to:
    (1) Make the interrogation and presentation effective for the 
ascertainment of the truth;
    (2) Avoid repetition or needless consumption of time; and
    (3) Protect witnesses from harassment or undue embarrassment.
    (d) The ALJ must permit the parties to conduct cross-examination of 
witnesses as may be required for a full and true disclosure of the 
facts.
    (e) The ALJ may order witnesses excluded so that they cannot hear 
the testimony of other witnesses, except that the ALJ may not order to 
be excluded--
    (1) A party who is a natural person;
    (2) In the case of a party that is not a natural person, the officer 
or employee of the party appearing for the entity pro se or designated 
as the party's representative; or
    (3) A natural person whose presence is shown by a party to be 
essential to the presentation of its case, including a person engaged in 
assisting the attorney for the Secretary.



Sec. 3.540  Evidence.

    (a) The ALJ must determine the admissibility of evidence.
    (b) Except as provided in this subpart, the ALJ is not bound by the 
Federal Rules of Evidence. However, the ALJ may apply the Federal Rules 
of Evidence where appropriate, for example, to exclude unreliable 
evidence.
    (c) The ALJ must exclude irrelevant or immaterial evidence.
    (d) Although relevant, evidence may be excluded if its probative 
value is substantially outweighed by the danger of unfair prejudice, 
confusion of the issues, or by considerations of undue delay or needless 
presentation of cumulative evidence.
    (e) Although relevant, evidence must be excluded if it is privileged 
under Federal law.
    (f) Evidence concerning offers of compromise or settlement is 
inadmissible to the extent provided in Rule 408 of the Federal Rules of 
Evidence.
    (g) Evidence of crimes, wrongs, or acts other than those at issue in 
the instant case is admissible in order to show motive, opportunity, 
intent, knowledge, preparation, identity, lack of mistake, or existence 
of a scheme. This evidence is admissible regardless of whether the 
crimes, wrongs, or acts occurred during the statute of limitations 
period applicable to the acts or omissions that constitute the basis for 
liability in the case and regardless of whether they were referenced in 
the Secretary's notice of proposed determination under Sec. 3.420.
    (h) The ALJ must permit the parties to introduce rebuttal witnesses 
and evidence.
    (i) All documents and other evidence offered or taken for the record 
must be open to examination by both parties, unless otherwise ordered by 
the ALJ for good cause shown.

[[Page 63]]



Sec. 3.542  The record.

    (a) The hearing must be recorded and transcribed. Transcripts may be 
obtained following the hearing from the ALJ. A party that requests a 
transcript of hearing proceedings must pay the cost of preparing the 
transcript unless, for good cause shown by the party, the payment is 
waived by the ALJ or the Board, as appropriate.
    (b) The transcript of the testimony, exhibits, and other evidence 
admitted at the hearing, and all papers and requests filed in the 
proceeding constitute the record for decision by the ALJ and the 
Secretary.
    (c) The record may be inspected and copied (upon payment of a 
reasonable fee) by any person, unless otherwise ordered by the ALJ for 
good cause shown, which may include the presence in the record of 
identifiable patient safety work product.
    (d) For good cause, which may include the presence in the record of 
identifiable patient safety work product, the ALJ may order appropriate 
redactions made to the record.



Sec. 3.544  Post hearing briefs.

    The ALJ may require the parties to file post-hearing briefs. In any 
event, any party may file a post-hearing brief. The ALJ must fix the 
time for filing the briefs. The time for filing may not exceed 60 days 
from the date the parties receive the transcript of the hearing or, if 
applicable, the stipulated record. The briefs may be accompanied by 
proposed findings of fact and conclusions of law. The ALJ may permit the 
parties to file reply briefs.



Sec. 3.546  ALJ's decision.

    (a) The ALJ must issue a decision, based only on the record, which 
must contain findings of fact and conclusions of law.
    (b) The ALJ may affirm, increase, or reduce the penalties imposed by 
the Secretary.
    (c) The ALJ must issue the decision to both parties within 60 days 
after the time for submission of post-hearing briefs and reply briefs, 
if permitted, has expired. If the ALJ fails to meet the deadline 
contained in this paragraph, he or she must notify the parties of the 
reason for the delay and set a new deadline.
    (d) Unless the decision of the ALJ is timely appealed as provided 
for in Sec. 3.548, the decision of the ALJ will be final and binding on 
the parties 60 days from the date of service of the ALJ's decision.



Sec. 3.548  Appeal of the ALJ's decision.

    (a) Any party may appeal the decision of the ALJ to the Board by 
filing a notice of appeal with the Board within 30 days of the date of 
service of the ALJ decision. The Board may extend the initial 30 day 
period for a period of time not to exceed 30 days if a party files with 
the Board a request for an extension within the initial 30 day period 
and shows good cause.
    (b) If a party files a timely notice of appeal with the Board, the 
ALJ must forward the record of the proceeding to the Board.
    (c) A notice of appeal must be accompanied by a written brief 
specifying exceptions to the initial decision and reasons supporting the 
exceptions. Any party may file a brief in opposition to the exceptions, 
which may raise any relevant issue not addressed in the exceptions, 
within 30 days of receiving the notice of appeal and the accompanying 
brief. The Board may permit the parties to file reply briefs.
    (d) There is no right to appear personally before the Board or to 
appeal to the Board any interlocutory ruling by the ALJ.
    (e) The Board may not consider any issue not raised in the parties' 
briefs, nor any issue in the briefs that could have been raised before 
the ALJ but was not.
    (f) If any party demonstrates to the satisfaction of the Board that 
additional evidence not presented at such hearing is relevant and 
material and that there were reasonable grounds for the failure to 
adduce such evidence at the hearing, the Board may remand the matter to 
the ALJ for consideration of such additional evidence.
    (g) The Board may decline to review the case, or may affirm, 
increase, reduce, reverse or remand any penalty determined by the ALJ.

[[Page 64]]

    (h) The standard of review on a disputed issue of fact is whether 
the initial decision of the ALJ is supported by substantial evidence on 
the whole record. The standard of review on a disputed issue of law is 
whether the decision is erroneous.
    (i) Within 60 days after the time for submission of briefs and reply 
briefs, if permitted, has expired, the Board must serve on each party to 
the appeal a copy of the Board's decision and a statement describing the 
right of any respondent who is penalized to seek judicial review.
    (j)(1) The Board's decision under paragraph (i) of this section, 
including a decision to decline review of the initial decision, becomes 
the final decision of the Secretary 60 days after the date of service of 
the Board's decision, except with respect to a decision to remand to the 
ALJ or if reconsideration is requested under this paragraph.
    (2) The Board will reconsider its decision only if it determines 
that the decision contains a clear error of fact or error of law. New 
evidence will not be a basis for reconsideration unless the party 
demonstrates that the evidence is newly discovered and was not 
previously available.
    (3) A party may file a motion for reconsideration with the Board 
before the date the decision becomes final under paragraph (j)(1) of 
this section. A motion for reconsideration must be accompanied by a 
written brief specifying any alleged error of fact or law and, if the 
party is relying on additional evidence, explaining why the evidence was 
not previously available. Any party may file a brief in opposition 
within 15 days of receiving the motion for reconsideration and the 
accompanying brief unless this time limit is extended by the Board for 
good cause shown. Reply briefs are not permitted.
    (4) The Board must rule on the motion for reconsideration not later 
than 30 days from the date the opposition brief is due. If the Board 
denies the motion, the decision issued under paragraph (i) of this 
section becomes the final decision of the Secretary on the date of 
service of the ruling. If the Board grants the motion, the Board will 
issue a reconsidered decision, after such procedures as the Board 
determines necessary to address the effect of any error. The Board's 
decision on reconsideration becomes the final decision of the Secretary 
on the date of service of the decision, except with respect to a 
decision to remand to the ALJ.
    (5) If service of a ruling or decision issued under this section is 
by mail, the date of service will be deemed to be 5 days from the date 
of mailing.
    (k)(1) A respondent's petition for judicial review must be filed 
within 60 days of the date on which the decision of the Board becomes 
the final decision of the Secretary under paragraph (j) of this section.
    (2) In compliance with 28 U.S.C. 2112(a), a copy of any petition for 
judicial review filed in any U.S. Court of Appeals challenging the final 
decision of the Secretary must be sent by certified mail, return receipt 
requested, to the General Counsel of HHS. The petition copy must be a 
copy showing that it has been time-stamped by the clerk of the court 
when the original was filed with the court.
    (3) If the General Counsel of HHS received two or more petitions 
within 10 days after the final decision of the Secretary, the General 
Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation 
of any petitions that were received within the 10 day period.



Sec. 3.550  Stay of the Secretary's decision.

    (a) Pending judicial review, the respondent may file a request for 
stay of the effective date of any penalty with the ALJ. The request must 
be accompanied by a copy of the notice of appeal filed with the Federal 
court. The filing of the request automatically stays the effective date 
of the penalty until such time as the ALJ rules upon the request.
    (b) The ALJ may not grant a respondent's request for stay of any 
penalty unless the respondent posts a bond or provides other adequate 
security.
    (c) The ALJ must rule upon a respondent's request for stay within 10 
days of receipt.



Sec. 3.552  Harmless error.

    No error in either the admission or the exclusion of evidence, and 
no error or defect in any ruling or order or in

[[Page 65]]

any act done or omitted by the ALJ or by any of the parties is ground 
for vacating, modifying or otherwise disturbing an otherwise appropriate 
ruling or order or act, unless refusal to take such action appears to 
the ALJ or the Board inconsistent with substantial justice. The ALJ and 
the Board at every stage of the proceeding must disregard any error or 
defect in the proceeding that does not affect the substantial rights of 
the parties.



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 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).

[[Page 66]]



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 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.

[[Page 67]]

    (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 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.

[[Page 68]]



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 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

[[Page 69]]

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:
    (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.

[[Page 70]]

    (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 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

[[Page 71]]

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. 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.

[[Page 72]]

    (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 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.

[[Page 73]]

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 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.

[[Page 74]]

    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:
    (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

[[Page 75]]

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 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.

[[Page 76]]

    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:

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:

[[Page 77]]

    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 
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

[[Page 78]]

    (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 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-

[[Page 79]]

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
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.

[[Page 80]]

    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 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.

[[Page 81]]

    (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.

----------------------------------------------------------------------------------------------------------------
                                              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.

[[Page 82]]

    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:
    (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:


[[Page 83]]


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.
    (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:

[[Page 84]]

    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:
    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./

[[Page 85]]

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.
    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 5a_RURAL PHYSICIAN TRAINING GRANT PROGRAM--Table of Contents



Sec.
5a.1 Statutory basis and purpose.
5a.2 Applicability.
5a.3 Definition of Underserved Rural Community.

    Authority: Sec. 749B of the Public Health Service Act (42 U.S.C. 
293k) as amended.

    Source: 75 FR 29451, May 26, 2010, unless otherwise noted.



Sec. 5a.1  Statutory basis and purpose.

    This part implements section 749B(f) of the Public Health Service 
Act. These provisions define ``underserved rural community'' for 
purposes of the Rural Physician Training Grant Program.



Sec. 5a.2  Applicability.

    This part applies to grants made under section 749B of the Public 
Health Service Act.



Sec. 5a.3  Definition of Underserved Rural Community.

    Underserved Rural Community means a community:
    (a) Located in:
    (1) A non-Metropolitan County or Micropolitan county; or
    (2) If it is within a Metropolitan county, all Census Tracts that 
are assigned a Rural-Urban Commuting Area (RUCAs) codes of 4-10; or
    (3) Census Tracts within a Metropolitan Area with RUCA codes 2 and 3 
that are larger than 400 square miles and have population density of 
less than 30 people per square mile; and
    (b) Located in a current:
    (1) Federally-designated Primary Health Care Geographic Health 
Professions Shortage Area, (under section 332(a)(1)(A) of the Public 
Health Service Act) or
    (2) Federally-designated Medically Underserved Area (under section 
330(b)(3) of the Public Health Service Act).



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

[[Page 86]]

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 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

[[Page 87]]

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.



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,

[[Page 88]]

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.
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 noted.



                         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

[[Page 89]]

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 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.

[[Page 90]]

    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 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.

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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, 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.

[[Page 92]]

    (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.
    (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

[[Page 93]]

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 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.

[[Page 94]]

    (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.
    (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.

[[Page 95]]



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 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.

[[Page 96]]



             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
    (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

[[Page 97]]

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 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

[[Page 98]]

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.
    (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]

[[Page 99]]



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 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

[[Page 100]]

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.
    (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

[[Page 101]]

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 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

[[Page 102]]

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 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).

[[Page 103]]

    (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.



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

[[Page 104]]

    (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.



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.

[[Page 105]]



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 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

[[Page 106]]

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.
    (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

[[Page 107]]

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
    (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.

[[Page 108]]



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 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.

[[Page 109]]



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.



PART 9_STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY 
SUPPORTED SANCTUARY SYSTEM--Table of Contents



Sec.
9.1 Applicability and purpose.
9.2 Definitions.
9.3 Sanctuary policies and responsibilities.
9.4 Physical facility policies and design.
9.5 Chimpanzee ownership, fees, and studies.
9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia.
9.7 Reproduction.
9.8 Animal records.
9.9 Facility staffing.
9.10 Occupational Health and Safety Program (OHSP) and biosafety 
          requirements.
9.11 Animal transport.
9.12 Compliance with the Standards of Care, USDA and PHS policies and 
          regulations.
9.13 Other federal laws, regulations, and statutes that apply to this 
          part.

    Authority: 42 U.S.C. 216, 287a-3a.

    Source: 73 FR 60423, Oct. 10, 2008, unless otherwise noted.



Sec. 9.1  Applicability and purpose.

    (a) General. The standards of care set forth in this part apply to 
the chimpanzee sanctuaries that are contracted (or subcontracted) to the 
Federal Government to operate the federally supported chimpanzee 
sanctuary system authorized by section 481C of the Public Health Service 
(PHS) Act, as amended (42 U.S.C. 287a-3a).
    (b) What is the purpose of the federally supported chimpanzee 
sanctuary system and the authority for establishing these standards of 
care regulation? The Chimpanzee Health Improvement, Maintenance, and 
Protection Act (Pub. L. 106-551, referred to as the ``CHIMP Act'' or 
``Chimpanzee Retirement Act'') was enacted by Congress to provide for 
the establishment and operation of a sanctuary system to provide 
lifetime care for chimpanzees that have been used, or were bred or 
purchased for use, in research conducted or supported by the agencies of 
the Federal Government, and that are determined to be no longer needed 
for such research. The CHIMP Act also mandates that standards of care 
for chimpanzees in the sanctuary shall be developed to ensure the well-
being of chimpanzees and the health and safety of the chimpanzees.
    (c) To what chimpanzee sanctuaries do the standards of care in this 
part apply? The standards of care set forth in this part apply to only 
those sanctuaries that are contracted or subcontracted to the Federal 
Government to operate the federally supported chimpanzee sanctuary 
system.



Sec. 9.2  Definitions.

    As used in this part:
    Adequate veterinary care means a program directed by a veterinarian 
qualified through training and/or experience to provide professional 
medical care to the chimpanzees within the Sanctuary and with the 
appropriate authority to provide this care. The program also provides 
guidance to all caregivers on all matters relating to the health and 
well-being of the chimpanzees.
    American Zoo and Aquarium Association (AZA) means the professional 
society composed of individuals with various backgrounds and interests 
that are devoted to advancing the knowledge and understanding of zoo 
animals and the management of zoos in the United States.
    American Zoo and Aquarium Association (AZA) Accreditation Standards 
are those standards developed by the AZA that are used to review, 
evaluate, and accredit zoos or zoological gardens. These standards cover 
a variety of areas including facilities, policies and procedures, 
training, staff qualifications, medical and animal care, husbandry and 
well-being procedures, and conservation, along with other specific 
areas.
    Animal Care and Use Committee means the Institutional Animal Care 
and Use Committee established under section 13(b) of the Animal Welfare 
Act of 1985

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and the Health Research Extension Act of 1985. For the purpose of these 
Standards of Care, it shall consist of at least five (5) members 
including the Chairperson, a Doctor of Veterinary Medicine (D.V.M. or 
V.M.D.) knowledgeable in nonhuman primate care and diseases and with 
delegated program responsibility, a member not affiliated with the 
Sanctuary, a scientist, and a member of the animal protection community. 
The requirement that a member of the ACUC must be from an animal 
protection organization is unique to this part and is not required under 
the Animal Welfare Regulations or the Public Health Service Policy on 
the Humane Care and Use of Laboratory Animals. This Committee must be 
established if research as defined by the Animal Welfare Act Regulations 
and the Public Health Service Policy (research, teaching, testing, 
exhibition) is to be conducted at the sanctuary.
    Animal protection organization means a nonprofit organization whose 
primary mission is protection of animals through positive advocacy and 
action.
    Animal Resource Manager (or Animal Resource Supervisor) means the 
individual employee responsible for managing the nonprofessional staff 
providing care for the chimpanzees at the sanctuary. This individual may 
perform other duties as assigned by the Sanctuary Contractor.
    Animal Welfare Act/Regulations means the Act of August 24, 1966 
(Pub. L. 89-544, commonly known as the Laboratory Animal Welfare Act), 
as amended by the Act of December 24, 1970 (Pub. L. 91-579, the Animal 
Welfare Act of 1970), the Act of April 22, 1976 (Pub. L. 94-279, the 
Animal Welfare Act of 1976), and the Act of December 23, 1985 (Pub. L. 
99-198, the Food Security Act of 1985), and as may be subsequently 
amended, and the United States Department of Agriculture (USDA) 
regulations implementing the Animal Welfare Act in title 9, chapter 1, 
subchapter A of the CFR.
    Animal Welfare Assurance means the documentation from an institution 
assuring compliance with the PHS Policy on Humane Care and Use of 
Laboratory Animals. This policy is administered by the Office of 
Laboratory Animal Welfare (OLAW), National Institutes of Health.
    Association for Assessment and Accreditation of Laboratory Animal 
Care, International (AAALAC) means the nonprofit organization that is 
recognized in the United States and abroad as being the body responsible 
for the accreditation of laboratory animal programs.
    Behaviorist means a person hired by the sanctuary to administer or 
oversee the enrichment and behavioral program for the chimpanzees at the 
sanctuary. This individual must be qualified through training or 
experience.
    Biosafety Officer means the individual responsible for establishing 
and monitoring workplace safety procedures designed to minimize or 
prevent injury or loss due to biohazards in accordance with policies 
established by the sanctuary administration.
    Board of Directors (BOD) means the individuals selected by the 
Contractor to govern the nonprofit institution responsible for operating 
the federally supported chimpanzee Sanctuary system. The board members 
must meet the qualifications and criteria stated in the CHIMP Act.
    Chair of the Board of Directors means the individual chosen by the 
BOD or other legally empowered entity to carry out such action, who is 
responsible for chairing meetings and acting on behalf of the board. 
This individual reports directly to the Board.
    Chief Executive Officer (CEO) means the principal person responsible 
for overall accomplishment of the mission of the chimpanzee sanctuary.
    CHIMP Act means the Chimpanzee Health Improvement, Maintenance, and 
Protection Act of December 20, 2000 (Pub. L. 106-551) commonly known as 
the ``CHIMP Act'' or ``Chimpanzee Retirement Act,'' and any future 
amendments.
    Chimpanzee means a member of Pan troglodytes. It excludes the pygmy 
chimpanzee (Pan paniscus or bonobo).
    Chimpanzee caregivers (caregivers) mean all sanctuary technical and 
husbandry staff providing long-term care and services for the 
chimpanzees.
    Contractor/Primary Contractor/Sanctuary Contractor means the 
nonprofit

[[Page 111]]

entity awarded a contract by the Federal Government to establish and 
operate the chimpanzee sanctuary system.
    Euthanasia means the humane death of a chimpanzee accomplished by a 
method that produces rapid unconsciousness and subsequent death without 
evidence of pain or distress. The method must be consistent with the 
recommendations of the American Veterinary Medical Association Panel on 
Euthanasia.
    Exhibition means exhibiting chimpanzees to the public for 
compensation. This definition excludes limited viewing for educational 
purposes that are not disruptive to the chimpanzees.
    Facility director means the individual responsible for directing the 
overall activities at the Sanctuary site.
    Facility Veterinarian means a person who has graduated from a 
veterinary school accredited by the American Veterinary Medical 
Association (AVMA) Council on Education, or who has a certificate issued 
by the AVMA's Education Commission for Foreign Veterinary Graduates; has 
training and/or experience in the care and management of nonhuman 
primates; and has direct or delegated authority for activities involving 
chimpanzees at the federally funded chimpanzee sanctuary.
    Federal Acquisition Regulations (FAR) means the codified rules 
applicable to contracts, specifically those sections of the FAR (48 CFR 
chapter 1, part 52) that are applicable to contracts between the Federal 
Government and a contractor (in this case a private, nonprofit entity 
under contract to operate the chimpanzee sanctuary system).
    Federal agency means an executive agency as such term is defined in 
section 105 of title 5, United States Code, and refers to the agency 
from which the research facility receives a Federal award for projects 
involving animals.
    Federally owned chimpanzees mean chimpanzees that have been 
purchased by, bred by, or donated to a federal agency for use in 
biomedical/behavioral research. Chimpanzees whose ownership was 
subsequently transferred from Federal ownership via written transfer 
agreements are no longer federally owned.
    Guide means The Guide for the Care and Use of Laboratory Animals, 
published by the National Academy of Sciences, Institute for Laboratory 
Animal Research of the National Research Council, 1996, International 
Standard Book Number 0-309-05377-3.
    Housing facility means any land, premises, shed, barn, building, 
trailer, or other structure or area housing intended to house 
chimpanzees.
    Indoor housing facility refers to any structure or enclosure (for 
example, cages, pens, rooms) for maintaining animals in a controlled 
environment that provides for normal physiological and behavioral needs.
    Interstate air transport live animals (IATA) regulations means those 
regulations and standards covering the air transportation of nonhuman 
primates developed and implemented by the International Air 
Transportation Association.
    Invasive research (studies) utilizes those procedures that cause 
more than momentary pain, distress, fear, discomfort, injury, or other 
negative modalities to a chimpanzee. Any procedure that enters or 
exposes a body cavity is considered to be invasive. Sanctuary 
chimpanzees may not be used in invasive research. This definition 
excludes any invasive procedure that is a part of veterinary, medical, 
or surgical care that is performed by or under the direction of the 
Sanctuary Veterinarian using acceptable veterinary practices. Some 
examples of invasive studies are:
    (1) Experimental exposure to a substance that may be detrimental to 
a chimpanzee's health (e.g., infectious disease, radiation). This does 
not include accidental exposures to infectious diseases transmitted from 
cage mates or from radiation or other exposures at the time of regularly 
scheduled or necessary veterinary examinations and treatments;
    (2) Any invasion of a body cavity;
    (3) Surgery and surgical implantation of devices that are not a part 
of a veterinary medical treatment or colony management purposes.
    (4) Behavioral studies that cause distress or discomfort, such as 
induction of a fear response;
    (5) Testing of any drug;
    (6) Purposeful manipulation of social groups or the removal from 
their social

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group or addition of individuals in order to conduct behavioral research 
(for example, on aggression). Creation and refinement of social groups 
will be necessary when the animals arrive at the Sanctuary and this 
should take place only when necessary in regards to colony management 
and should not be driven by independently initiated research studies;
    (7) Restraint unless it is in conjunction with the annual exam or 
clinical care; and
    (8) Darting or anesthesia induction other than at annual exam or in 
the case of an emergency in which the chimpanzee's well-being is at 
stake.
    National Primate Research Center (NPRC) means those centers 
supported by the National Center for Research Resources, National 
Institutes of Health, Department of Health and Human Services, as 
national resources for providing high-quality nonhuman primate research 
resources and facilities. As of June 2007, there were eight such 
centers.
    National Research Council means the component of the National 
Academy of Sciences that advises the Federal Government on matters 
related to science, research, and research resources.
    Nonfederally owned chimpanzees mean chimpanzees that have not been 
purchased by, bred by, or donated to the Federal Government for use in 
federally supported research projects. In accordance with the CHIMP Act, 
chimpanzees owned on the date of passage of the CHIMP Act by a National 
Primate Research Center may enter the sanctuary system without requiring 
the NPRC to pay a fee. Offspring born in the sanctuary is owned by the 
Sanctuary Contractor.
    Noninvasive research (studies) means the use of procedures that 
depend upon close observation of chimpanzee behavior or on medical 
information collected during the course of normal veterinary care. These 
procedures do not require removal of the chimpanzees from their social 
group or environment, or require a separate anesthetic or sedation event 
to collect data or record observations. Some examples of noninvasive 
studies are:
    (1) Visual observation;
    (2) Behavioral studies designed to improve the establishment and 
maintenance of social groups. These activities may cause stress as a 
result of novel interactions between chimpanzees and caregivers, but 
they are not considered invasive as long as they are intended to 
maximize the well-being of the chimpanzees;
    (3) Medical examinations as deemed necessary to oversee the health 
of the chimpanzees, in the least invasive manner possible. Collection of 
samples routinely obtained during a physical examination for processing 
during this time is also considered noninvasive since a separate event 
is not required;
    (4) Administration and evaluation of environmental enrichment used 
to promote the psychological well-being of the chimpanzees; and
    (5) Actions taken to provide essential medical treatment to an 
individual chimpanzee exhibiting symptoms of illness. This applies only 
to serious illness that cannot be treated while the chimpanzee remains 
within the colony.
    Outdoor housing facility (area) means corrals, Primadomes (a 
prefabricated outdoor housing unit), fenced open areas, or similar 
structures or areas for maintaining chimpanzees with access to adequate 
protection from the extremes of environmental elements and harsh weather 
conditions.
    Outdoor ranging area means an area that allows chimpanzees greater 
ranging space than corrals or other outdoor housing area and includes a 
variety of vegetation, shrubbery, grasses and trees, thereby providing 
for a fairly unrestricted natural setting for the chimpanzees to engage 
in species-appropriate activities. The area is secured by an outer 
perimeter barrier.
    Project Officer means the individual designated by the Federal 
Government to represent the contracting officer and interests of the 
federal agency, within defined areas, in monitoring and overseeing the 
chimpanzee sanctuary system contract.
    Sanctuary Chimpanzee Care Committee (SCCC) or similar designated 
committee means the group of individuals designated by the CEO of the 
sanctuary that reviews and monitors adherence to the policies, 
procedures, and regulations at the sanctuary.

[[Page 113]]

    Sanctuary Contractor means the nonprofit, private entities selected 
by NCRR/NIH to develop and operate the chimpanzee sanctuary system. This 
contractor is also known as the ``primary contractor'' for the sanctuary 
system.
    Sanctuary Director means the individual who provides day-to-day 
direction and oversight to the employees responsible for performing the 
daily tasks at the facility.
    Sanctuary or federally supported chimpanzee sanctuary system means 
the sanctuary or sanctuary system established by the Federal Government 
through contracting with a private, nonprofit entity, for the purpose of 
carrying out the provisions of the CHIMP Act of 2000. The system 
includes a primary Contractor and may include additional subcontractors 
as required. This sanctuary system is supported primarily from funds 
allocated by NCRR/NIH/HHS with some matching funds from the nonprofit 
contractor.
    Secretary means the Secretary of Health and Human Services or his/
her designee.
    Subcontractor means a private, nonprofit entity selected by the 
primary contractor to provide additional sanctuary services.
    Surplus chimpanzees means chimpanzees that are no longer needed in 
research and that were used, or were bred or purchased for use, in 
research conducted or supported by the Federal Government.
    USDA licensed intermediate handler/carrier means any person, 
including a department, agency, or instrumentality of the United States 
or of any State or local government, who is engaged in any business in 
which it receives custody of animals in connection with their 
transportation in commerce and who is licensed by the USDA.
    Zoonotic disease(s) means diseases that are transmissible from 
chimpanzees to humans.



Sec. 9.3  Sanctuary policies and responsibilities.

    (a) What are the policies and responsibilities governing the 
sanctuary system? It will be the policies and responsibilities of the 
sanctuary system to:
    (1) Appoint a Board of Directors (BOD) responsible for the overall 
governance and direction of the Sanctuary. The BOD shall designate the 
Chief Executive Officer (CEO), who is responsible for the management and 
oversight of the daily operations of the sanctuary and the performance 
of other delegated tasks. Subcontractors, if applicable, shall be 
governed by the policies that are developed by the Board of Directors of 
the primary contractor.
    (2) Direct the BOD to:
    (i) Ensure that chimpanzees accepted into the sanctuary are not 
discharged;
    (ii) Develop guidelines for accepting chimpanzees not owned by the 
Federal Government into the sanctuary if the conditions are met as 
outlined in 42 U.S.C. 287;
    (iii) Ensure that the Board of Directors of the primary contractor 
consists of no more than thirteen (13) individuals, and that the 
conditions governing the terms of the Board members are in compliance 
with the CHIMP Act;
    (iv) Include individuals with the following expertise and experience 
as set forth in the CHIMP Act;
    (A) At least one veterinarian who is qualified in veterinary care of 
nonhuman primates. These qualifications may be met through postdoctoral 
training, experience, or both;
    (B) Individual(s) with expertise and experience in zoological 
science and with knowledge in behavioral primatology;
    (C) Individual(s) with experience in the animal protection field;
    (D) Individual(s) with experience and expertise in the field of 
business and management of nonprofit organizations;
    (E) Individual(s) knowledgeable and experienced in accrediting 
programs of animal care;
    (F) Individual(s) with experience and expertise in containing 
biohazards;
    (v) Ensure that a member of the Board of Directors serves as the 
Chair of the Board of Directors, who may be elected or appointed by the 
Board from among the individuals identified in paragraphs (a) (1) (iv) 
(A) through (F) of this section;
    (vi) Ensure that no member of the board shall have been fined for, 
or

[[Page 114]]

signed a consent decree for, any violation of the Animal Welfare Act;
    (vii) Create a safe and species-appropriate physical and social 
environment for the lifetime care of chimpanzees;
    (viii) Comply with all applicable provisions of the animal welfare 
regulations and other federal, state and local laws, regulations, and 
policies;
    (ix) Achieve accreditations from appropriate accrediting bodies 
within a reasonable time frame mutually agreed upon by the Contractor 
and NCRR;
    (x) Prohibit any invasive research on the resident chimpanzees, but 
permit noninvasive studies (Definitions for the terms invasive and non-
invasive are set forth in Sec. 9.2 of this part.);
    (xi) Prohibit exhibition of chimpanzees in the sanctuary (This 
policy does not prohibit educational activities that may involve limited 
viewing of chimpanzees in their environment and that are designed to 
promote an understanding of chimpanzee behavior, well-being, or 
importance to the ecological system that does not adversely affect the 
chimpanzees' routine.);
    (xii) Staff the organization with people with appropriate 
experience; and
    (xiii) Authorize the establishment of a Sanctuary Chimpanzee Care 
Committee (SCCC) that is appointed by and reports to the CEO or 
President of the company or corporationThe SCCC is responsible for 
overseeing the chimpanzee care program and operations to ensure the 
health and well-being of the chimpanzees and the occupational safety of 
the staff are being addressed. The Committee must consist of no fewer 
than five people who must include:
    (A) A chair (person) knowledgeable of the needs of chimpanzees;
    (B) A veterinarian with chimpanzee care experience;
    (C) A behaviorist with experience in chimpanzee behavior;
    (D) A member of the chimpanzee care staff; and
    (E) Member or members from the community, including at least one 
with affiliation or employment with an animal protection organization as 
defined in Sec. 9.2 of this part.
    (F) The SCCC will:
    (1) Oversee and evaluate the chimpanzee care and socialization 
program;
    (2) Review and approve proposed education programs. No program 
should be approved that might interfere with the chimpanzees' well-being 
or routine activities;
    (3) Conduct a formal review of the program on a semiannual basis and 
submit reports to the Sanctuary Director. The reports must be available 
for review by the USDA and NIH representatives during site visits;
    (4) Establish a mechanism for receipt and review of concerns 
involving the care of chimpanzees and resolving such concerns;
    (5) Review all noninvasive study proposals. The SCCC membership may 
require additional qualified individuals to perform the functions of an 
Animal Care and Use Committee (ACUC) if and when the need arises. The 
contractor may establish a separate ACUC. The ACUC must be established 
in accordance with the applicable provisions of the Animal Welfare Act 
regulations, the Public Health Service Policy on Humane Care and Use of 
Laboratory Animals, and these standards of care;
    (6) Review all euthanasia events. Euthanasia events performed for 
medical or humane reasons must be based upon sound professional 
veterinary judgment that conforms to current veterinary medical 
practices and must be in the best interest of the chimpanzee. Euthanasia 
performed for emergency reasons without advance review by the SCCC shall 
be reviewed by the SCCC as soon as possible after the event to ensure 
compliance with established policy;
    (7) Establish procedures to prevent any reproduction in the colony 
through appropriate permanent birth control, preferably by vasectomy of 
all sexually mature male chimpanzees in the sanctuary; and
    (8) Develop procedures for maintaining chimpanzees that are 
seropositive for or harboring infectious agents or previously have been 
exposed to infectious agents (whether experimentally induced or 
naturally occurring) that will allow them to be accepted by the 
sanctuary and properly housed. The procedures must be submitted to NCRR/
NIH for approval.

[[Page 115]]

    (b) Who is responsible for developing or revising sanctuary 
policies? (1) The Sanctuary Contractor is responsible for developing, 
revising, and implementing policies affecting the sanctuary.
    (2) The federal agency (NCRR/NIH) designated by the Secretary must 
concur with any changes that substantially change existing policies. The 
Secretary, or designee, will determine if a policy change will have a 
substantial impact upon current policy after consultation with the 
Sanctuary Contractor.



Sec. 9.4  Physical facility policies and design.

    (a) What standards apply to the facility design and physical plant? 
The chimpanzee sanctuary facility must be designed to provide sufficient 
space and variety of natural or artificial objects to accommodate 
natural activities of chimpanzees while restricting their movement and 
range to the defined area. Daily observation of chimpanzees within the 
enclosures is required and shall be accomplished with minimal 
disturbance to the chimpanzees. The facility design and physical plant 
should be in accordance with the recommendation of The Guide for the 
Care and Use of Laboratory Animals (Guide), where applicable. The Guide 
is published by the National Research Council, 1996, International 
Standard Book Number 0-309-05377-3. The Guide is incorporated by 
reference in this section. The Director of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain a copy of the publication from the National 
Academy Press, 2101 Constitution Avenue, NW., Lockbox 285, Washington, 
DC 20055; or you may order it electronically via the Internet at http://
www.nap.edu; or view it online at http://oacu.od.nih.gov/regs/guide/
guidex.htm. You may inspect a copy at NIH, NCRR, 1 Democracy Plaza, 6701 
Democracy Boulevard, Bethesda, MD 20817-4874, or 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.
    (1) The facility design and physical plant consist of the following 
components: Indoor design features; outdoor design features; 
construction and construction materials; physical barriers; shelter; 
service support space, including storage areas for food, supplies, and 
equipment; personnel and administrative support space; quarantine and 
isolation facilities; treatment area; heating, ventilation, and air 
conditioning (HVAC); food preparation area; and animal waste treatment.
    (2) A housing system shall include indoor and outdoor enclosures 
that must be kept in good repair to prevent escape and injury to the 
chimpanzees, promote physical comfort, facilitate sanitation and 
servicing, and address the psychological well-being and social needs of 
the chimpanzees. Chimpanzees must be able to retreat from areas where 
they feel threatened or agitated by close human encounters or encounters 
with other chimpanzees.
    (3) Indoor areas shall have special areas for social introductions 
and medical treatment. Quarantine and isolation facilities are required 
for the sanctuary. These facilities must be designed to prevent the 
spread of undesirable agents from quarantine and isolation rooms to 
other parts of the facility.
    (4) Outdoor areas must provide sufficient ranging space and either 
natural or artificial structures that chimpanzees can use for shelter or 
nesting areas to sleep, rest, or seek refuge from rain, direct sun, 
wind, and extreme temperatures.
    (5) Animal waste from the Sanctuary must be properly treated to 
remove known hazardous agents before discharging it into the environment 
in accordance with currently acceptable and effective waste treatment 
procedures, including current industry standards and Federal laws, 
regulations or guidelines, as applicable.
    (6) An area for treatment of and performing veterinary clinical 
procedures on chimpanzees must be provided at each Sanctuary site. This 
area must be constructed and provisioned to perform emergency 
procedures, including minor surgery and emergency surgical procedures, 
complete physical examinations,

[[Page 116]]

and facilities for extended care of medical conditions as needed.
    (b) What security measures are required for the sanctuary? The 
sanctuary must provide adequate security against unauthorized entry, 
sabotage, malicious damage, and theft of chimpanzees and property and 
must minimize any chance of escape by a chimpanzee. The security staff 
must have training and/or experience in methods and equipment designed 
to detect possible security breaches and the ability to respond to 
security events in a timely and effective manner. Perimeter containment 
shall be used to protect the compound housing the chimpanzees consistent 
with the recommendations of the Guide (incorporated by reference, see 
paragraph (a) of this section).
    (c) Is the sanctuary required to develop disaster and escaped animal 
contingency plans? The sanctuary facility must prepare disaster and 
escaped animal contingency plans outlining simple and easy to follow 
plans for dealing with natural and man-made disasters and steps to be 
taken in case a chimpanzee escapes from the compound. The Sanctuary also 
must provide adequate security against unauthorized entry, sabotage, 
malicious damage, and theft of chimpanzees and property and must 
minimize any chance of escape by a chimpanzee. Primary barriers must be 
constructed to prevent escape of chimpanzees and secondary or perimeter 
barriers must prevent entry of unauthorized persons into the facility, 
consistent with the recommendations of the Guide (incorporated by 
reference, see paragraph (a) of this section).



Sec. 9.5  Chimpanzee ownership, fees, and studies.

    (a) Who owns the chimpanzees in the federally supported sanctuary? 
The Federal Government retains ownership of chimpanzees owned by the 
Federal Government at the time they enter the sanctuary system. Non-
federally owned or supported chimpanzees will be owned by the sanctuary. 
The chimpanzees shall continue to be maintained in the sanctuary 
throughout their lifetime and shall not be discharged from the sanctuary 
except as specifically indicated in the CHIMP Act.
    (b) Is there a charge for placing chimpanzees in the sanctuary? No 
fees shall be charged by the Sanctuary Contractor for federally owned or 
supported chimpanzees entering the sanctuary. Chimpanzees that were 
owned by a NPRC when the CHIMP Act became effective are also admitted 
without payment of fees. Fees for maintenance of the chimpanzees alluded 
to above are provided for in the contract between the Federal Government 
and the Sanctuary Contractor.
    (c) May the sanctuary agree to accept chimpanzees that are not owned 
by the Federal Government? The sanctuary may accept chimpanzees that are 
not owned by the Federal Government subject to the following conditions:
    (1) Ownership of the chimpanzee must be transferred to the 
sanctuary;
    (2) Fees for these chimpanzees may be levied based on a range of 
considerations that include most importantly, the well-being of the 
chimpanzee and, secondarily, factors that include (but are not limited 
to) the resources available to support the chimpanzee; the health, age, 
and social history of the chimpanzee; and other relevant factors 
affecting the cost of caring for the chimpanzee. While chimpanzees not 
owned or supported by the Federal Government may be admitted to the 
sanctuary, federal funds may not be used for their support unless 
authorized by the Secretary or an authorized designee;
    (3) Available space exists in the sanctuary; and
    (4) An agreement exists between the sanctuary system and the NCRR/
NIH documenting that the chimpanzee may be brought into the sanctuary.
    (d) What additional conditions apply when nongovernmental owned 
chimpanzees transfer to the chimpanzee sanctuary? The following 
additional conditions apply when nongovernmental owned chimpanzees 
transfer to the chimpanzee sanctuary:
    (1) Chimpanzees transferred to the sanctuary sites must be 
permanently incapable of reproduction, for example, by vasectomy, tubal 
ligation, or another reliable procedure;
    (2) Complete histories must accompany each chimpanzee. Any 
chimpanzee missing documentation for any

[[Page 117]]

period of research or other use may not be transferred to the Sanctuary 
without the concurrent authorization of the Sanctuary Contractor's Board 
of Directors and the NCRR; the records may be created and retained in 
electronic form; and
    (3) Appropriate screening of each chimpanzee must be performed to 
assess the likelihood of the chimpanzee being a health or safety threat 
to the care staff and/or other chimpanzees.
    (e) What are the criteria for acceptance and the fees for admission 
into the sanctuary for nongovernmental owned chimpanzees? The chimpanzee 
Sanctuary Contractor, in conjunction with NCRR, must establish criteria 
and a fee system for acceptance of nongovernmental owned chimpanzees. 
Funds collected for this purpose must be accounted for and used to help 
defray the expenses incurred in operating the sanctuary.
    (f) Under what circumstances might a chimpanzee from the sanctuary 
be returned to research at a United States research facility? In 
December 2007, the CHIMP Act was amended by the ``Chimp Haven is Home 
Act,'' which terminated the authority for the removal of chimpanzees 
from the sanctuary system for research purposes.



Sec. 9.6  Animal care, well-being, husbandry, veterinary care, 
and euthanasia.

    (a) What are the requirements for promoting the well-being of 
sanctuary chimpanzees? The goal of chimpanzee housing and management in 
the sanctuary is to promote the chimpanzees' well-being.
    (b) What are the provisions for daily chimpanzee husbandry and care? 
Adequate and proper care for chimpanzees in the sanctuary must be 
provided with respect to physical environment, housing and husbandry, 
behavioral management, and population management and control. Specific 
requirements include the following:
    (1) Chimpanzees must have access to food, water, and bedding at all 
times, unless medical or behavioral conditions dictate otherwise. 
Husbandry procedures shall represent current policies and practices and 
conform to standards set by a nationally recognized accrediting 
association in accordance with the Guide (incorporated by reference, see 
paragraph (a) of Sec. 9.4).
    (2) Indoor primary enclosures must be cleaned as often as required 
to maintain a clean and healthy environment, with a minimum of once 
daily. Outdoor enclosures must be monitored daily and cleaned on a 
routine basis. Outdoor ranging areas will not require a routine cleaning 
schedule but must be monitored for excessive accumulation of waste or 
other unhealthy conditions. Housing areas shall provide sufficient space 
for chimpanzees to perform species-typical behavior and expression. 
Examples of such activities include but are not limited to natural 
movements, climbing, swinging, resting, running, group interactions, 
sleeping, etc. Feeding and watering implements must be sanitized at 
intervals required to maintain them in a sanitary condition, in 
accordance with the Guide (incorporated by reference, see paragraph (a) 
of Sec. 9.4).
    (3) The federally supported chimpanzee sanctuary must employ a 
behavioral scientist knowledgeable in primate behavior and socialization 
requirements. This individual shall provide primary leadership in 
developing, implementing, and monitoring the chimpanzee behavioral 
guidelines for the sanctuary. Enrichment techniques used shall be 
currently accepted practices. The sanctuary must provide for the 
expertise to plan, administer, and evaluate the effectiveness of the 
well-being program.
    (4) Many chimpanzees can be trained through positive reinforcement 
to cooperate with a variety of veterinary and chimpanzee care 
procedures. Efforts must be made to develop or maintain this capability 
for chimpanzees housed in the sanctuary to the extent possible. Trainers 
must use currently acceptable practices that do not include physical 
punishment.
    (c) What are the requirements for an adequate veterinary care and 
animal health program? The sanctuary staff must provide sufficient 
resources of personnel, equipment, supplies, and facilities to enable 
the provision of adequate veterinary care as set forth in the Guide 
(incorporated by reference,

[[Page 118]]

see paragraph (b) of Sec. 9.4). For additional guidance see the 
American College of Laboratory Animal Medicine document, ``The Provision 
of Adequate Veterinary Care,'' available on the Internet at http://
www.aclam.org.
    (1) If the sanctuary houses chimpanzees with infectious diseases, it 
must have a veterinarian knowledgeable in the infectious diseases and 
care of chimpanzees. The Facility Veterinarian is responsible for 
establishing and implementing a health monitoring system specifically 
designed to meet the health requirements of chimpanzees in the 
sanctuary. Routine observation and the prevention of disease, metabolic 
conditions, abnormal behavior and injury must be a priority focus of the 
Facility Veterinarian and staff.
    (2) Newly received chimpanzees must be quarantined for a period for 
physiological, psychological, and nutritional stabilization before their 
introduction to the rest of the group. The stabilization period must be 
lengthened appropriately if the chimpanzee has a significant medical 
problem or if abnormal medical findings are detected during the 
quarantine period. If the chimpanzee has not been given a complete 
physical examination within six months, an examination must be conducted 
during the stabilization period.
    (3) The sanctuary must implement appropriate methods for disease 
surveillance and diagnosis of diseases, which may include the following:
    (4) Tuberculin (TB) tests must be negative for two (2) consecutive 
tests before the chimpanzee is released from quarantine. Any chimpanzee 
that is suspected of harboring the TB organism, or that is diagnosed 
with TB will be isolated and treated until determined by the Facility 
Veterinarian to be of no health risk to other chimpanzees or humans. The 
Facility Veterinarian may recommend euthanasia in those cases that do 
not respond to therapy and in which the chimpanzee consequently 
experiences undue pain and suffering that cannot be alleviated. The 
procedures noted under Sec. 9.6 (d) must be observed if euthanasia is 
necessary.
    (5) Fecal samples must be checked for parasites and parasitic ova.
    (6) A complete blood count and serum chemical panel must be 
obtained.
    (7) Additional serum for banking and/or testing shall be obtained as 
appropriate by the Facility Veterinarian and is considered beneficial 
for chimpanzee health.
    (8) If the donating facility did not test for the appropriate 
viruses, the sanctuary must perform a viral panel and serology for the 
various chronic hepatitis viruses and HIV.
    (9) Additional tests or procedures that are deemed beneficial to the 
chimpanzees' health may be required by the Facility Veterinarian.
    (10) Chimpanzees are susceptible to many of the vaccine preventable 
diseases of human childhood. Appropriate vaccines must be considered and 
administered if deemed necessary, at the discretion of the Facility 
Veterinarian, to protect the chimpanzees in the sanctuary. Methods of 
disease prevention, diagnosis, and therapy must comply with those 
currently accepted in veterinary medical practice. Arrangements with 
diagnostic laboratories must be established before chimpanzees arrive at 
the sanctuary.
    (11) The sanctuary must minimize the use of physical and chemical 
restraint. Chimpanzees in the sanctuary shall be trained to permit 
certain procedures with minimal or no restraint. Such procedures may 
include injections, dosing or other treatments, and cage-side health 
observations. However, chemical sedation sometimes may be appropriate 
for certain necessary medical interventions or for the safety of the 
chimpanzee and caregivers. If physical restraint measures are necessary, 
due consideration must be given to the temporary or permanent effects 
upon the chimpanzee and human and animal safety concerns.
    (12) Methods used to relieve pain must be documented in the 
chimpanzee medical or surgical records. These records will be available 
for review by USDA and NIH representatives. The Facility Veterinarian 
must ensure that pain management is current and in accordance with 
acceptable veterinary medical practices.
    (13) Chimpanzees must be cared for by qualified personnel on a daily 
basis, including weekends and holidays, to

[[Page 119]]

safeguard their well-being. Emergency veterinary care must also be 
available during these times. Notification procedures must be documented 
in the form of operating procedures.
    (d) Under what circumstances is euthanasia permitted? As stated in 
section 481C(d)(2)(I) of the Public Health Service Act, as added by 
section 2 of the CHIMP Act, none of the chimpanzees may be subjected to 
euthanasia except when it is in the best interest of the chimpanzee 
involved as determined by the SCCC and the Facility Veterinarian. 
Therefore, euthanasia for medical or humane reasons is permitted. 
Euthanasia may be permitted for reasons of health or quality of life of 
the individual chimpanzee, including for disease, in connection with 
trauma, complications of aging, or for other humane reasons. The 
sanctuary must establish a policy on euthanasia that will provide 
conditions that must be met before euthanasia is permitted and guidance 
for performing euthanasia.
    (1) Methods of euthanasia will be consistent with the most recent 
report of the American Veterinary Medical Association Panel on 
Euthanasia (2002), unless more reliable data becomes available. When 
euthanasia is performed, the veterinarian will determine the appropriate 
agent, and it will be administered only by properly trained personnel 
under the direction of the Facility Veterinarian. The decision to 
perform euthanasia will be made by the veterinarian in consultation with 
the Facility Director or Deputy Director.
    (2) The SCCC will participate in the decision in nonmedical 
emergencies. All euthanasia decisions must be reviewed by the SCCC, 
preferably prior to euthanasia. In emergencies, where euthanasia has to 
be performed immediately by the Facility Veterinarian, the circumstances 
and the decision by the Facility Veterinarian will be presented at the 
next scheduled or special meeting of the SCCC. The NCRR Project Officer 
must be notified of the euthanasia event within 72 hours by electronic 
or telephonic means. Euthanasia of individual chimpanzees may negatively 
affect the care staff and appropriate counseling and psychological 
support shall be considered.



Sec. 9.7  Reproduction.

    Chimpanzee reproduction is prohibited in the sanctuary. Therefore, 
all males must be sterilized by vasectomy before acceptance into the 
system, or, as a temporary measure, housed apart from females until they 
are sterilized. Vasectomies are advisable because they are minimally 
invasive and because effectiveness of the vasectomy may be validated 
through laboratory testing for semen. Seminal collection techniques must 
be carefully evaluated to avoid painful stimuli. Other proven methods of 
birth control may be used under special conditions deemed appropriate by 
the Facility Veterinarian and SCCC. The Facility Veterinarian must 
determine the appropriate test(s) to use to validate sterility. A 
veterinarian experienced in performing vasectomies in chimpanzees should 
perform the operation. Documentation must accompany each male accepted 
to the sanctuary system attesting to the fact that the male has been 
vasectomized and laboratory tests confirm that a segment of the Vas 
Deferens has been removed, or that the test used is reliable and is 
negative for sperm. The sanctuary must have a contingency plan for 
handling accidental births that includes the length of time the 
offspring is expected to remain with the mother.



Sec. 9.8  Animal records.

    (a) What records must be maintained for chimpanzees in the sanctuary 
and how are they managed? (1) Contractors and Subcontractors operating 
the federal chimpanzee sanctuary system must maintain appropriate 
records to allow for accountability and disposition of chimpanzees under 
their care as required by the USDA Animal Welfare Regulations (9 CFR 
2.35). The records may be created and retained in electronic form.
    (2) The animal records currently required by the USDA Animal Welfare 
Regulations are also required for these standards. Chimpanzees must be 
individually and permanently identifiable.
    (3) Retrievable records must be maintained for a minimum of three 
years beyond the disposition or death of each chimpanzee in accordance 
with the Animal Welfare Regulations section 2.35(f) (9 CFR 2.35(f)). 
Original records

[[Page 120]]

or a copy must be transferred if the chimpanzee moves to a different 
facility. The records must include standard information, including 
permanent individual identification, research use(s), reproductive 
status (past and present), a summary or copy of the medical and 
behavioral history, the sire's identification number (if available), the 
dam's identification number, birth date, sex, and date acquired by the 
sanctuary. The disposition date must also be noted, if applicable, 
including whether the chimpanzee died or was transferred to another site 
in the federal sanctuary system. The records may be created and retained 
in electronic form.
    (4) The contractor and any subcontractor(s) operating the federally 
supported chimpanzee sanctuary must provide special, quarterly, and 
annual progress reports to the designated Federal officials as 
identified in the contract. The annual report must also contain a 
statement that certifies the sanctuary is in full compliance with these 
standards of care regulation.
    (b) What are the rules governing the disposition of necropsy 
records? The CHIMP Act requires that necropsy records from chimpanzees 
previously used in federally funded research projects be made available 
on a reasonable basis to investigators engaged in biomedical or 
behavioral research. In order to comply with this provision, the 
contractor for the sanctuary system must devise a plan that will allow 
interested parties to contact the sanctuary and receive necropsy records 
when they become available. Records may be provided free of charge but 
requesters may be required to pay for packaging and shipping costs. The 
records may be created and retained in electronic form.



Sec. 9.9  Facility staffing.

    How many personnel are required to staff the chimpanzee sanctuary 
and what qualifications and training must the staff possess? (a) The 
professional, managerial, and support staff must be sufficient to 
support the scope and diversity of the activities and chimpanzee 
population of the sanctuary. The level of staffing shall be adequate to 
ensure that the chimpanzees receive appropriate health care, are well 
cared for, and the administrative and fiscal operations are sound and in 
keeping with current practices required by NCRR/NIH;
    (b) There must be a sufficient number of appropriately trained 
animal care and technical personnel to provide appropriate care to the 
chimpanzees at all times, including evenings, weekends, and holidays. 
The number of animal care staff to chimpanzee ratio shall be adjusted as 
experience is gained during the operation of the sanctuary. Sufficiently 
trained staff also must be available to maintain adequate behavioral 
enrichment;
    (c) The Facility Director must be a person with experience in 
chimpanzee care and socialization techniques. In addition, the Director 
must have management and administrative experience;
    (d) The Biosafety Officer must have experience in developing and 
monitoring biohazards and dealing with biosafety issues related to 
captive nonhuman primates. Experience in these areas dealing 
specifically with chimpanzees is desirable;
    (e) The remaining staff, which may include part-time, full-time, or 
contractor Facility Veterinarian(s) and Behaviorist(s), must possess the 
skills, knowledge, and/or experience required to perform their duties, 
as elaborated within the regulation.



Sec. 9.10  Occupational Health and Safety Program (OHSP) and biosafety
requirements.

    (a) How are employee Occupational Health and Safety Program risks 
and concerns addressed? The sanctuary shall assure that an Occupational 
Health and Safety Program (OHSP) is developed and implemented in 
accordance with current veterinary medical practices and the guidelines 
and standards found in the Guide (incorporated by reference, see 
paragraph (a) of section 9.4);
    (b) How are biosafety concerns addressed? The sanctuary shall 
institute and administer an effective biosafety program that addresses 
the biosafety hazards at that particular site. The

[[Page 121]]

program shall include identifying biohazards, outlining practices and 
procedures to be followed, providing personal safety equipment or 
protective clothing and equipment, and establishing a description of the 
facility requirements for working with hazardous agents or materials. 
Policies and procedures must be implemented to avoid exposure to 
environmental and animal hazards. Biosafety must be included in the 
training program for all Sanctuary employees. In establishing a program, 
the Sanctuary must use current accepted practices and publications 
prepared by the CDC, NIH, and professional societies specializing in 
biosafety. The input and guidance of personnel trained or experienced in 
biosafety are essential. Complete records of both clinical and 
experimental agent exposure must accompany each chimpanzee sent to the 
sanctuary. The donating facility must also provide recent testing (for 
example, serology, virus culture, histology) so that the sanctuary staff 
is fully aware of the health condition of the arriving chimpanzee. The 
records may be created and retained in electronic form.



Sec. 9.11  Animal transport.

    The transportation of chimpanzees by surface or air must be in 
accordance with the requirements set forth in the Animal Welfare Act and 
Regulations and the International Air Transport Association (IATA) Live 
Animal Regulations and guidelines, as applicable.



Sec. 9.12  Compliance with the Standards of Care, and USDA and PHS 
policies and regulations.

    (a) How will compliance with the standards set forth in this part be 
monitored and what are the consequences of noncompliance with the 
standards? The federally supported chimpanzee sanctuary must comply with 
the standards of care set forth in this part and include a statement in 
the Annual Progress Report certifying compliance with these standards of 
care in accordance with the terms of the current contract between NCRR 
and the Sanctuary Contractor. A designated representative of the 
Secretary will monitor compliance. The responsibility to monitor 
compliance with the standards is delegated to NCRR/NIH/HHS. The NIH/NCRR 
Project Officer for this contract will conduct scheduled site visits at 
least one time annually (or more often if necessary) and review monthly 
and quarterly reports submitted to the Project and Contract Officer. 
Subcontractors are subjected to the same provisions. Failure to comply 
with the standards set forth in this part, or to correct deficiencies 
noted within the allowable time period, could result in termination of 
the contract by the Federal Government (HHS/NIH), or allow the Secretary 
to correct the deficiencies according to the terms and conditions 
outlined in the contract. The Secretary may impose additional sanctions 
on the contractor up to, and including, authorizing assumption or 
reassignment of the management of the sanctuary contract.
    (b) To what type of outside review or inspection will the federally 
supported sanctuary be subjected? As noted in paragraph (a) of this 
section, the contractor for the sanctuary will be monitored on a 
regularly scheduled basis by representatives of NCRR/NIH/HHS. The NCRR 
representative will use facility site visits, reports, personal contact, 
and any other means as appropriate to ensure compliance with these 
standards. The contractor and subcontractors are required to obtain and 
maintain an Animal Welfare Assurance from NIH's Office of Laboratory 
Animal Welfare (OLAW) when chimpanzees are used for noninvasive studies 
as authorized in the CHIMP Act. In addition, the sanctuary must achieve 
accreditation by a nationally recognized animal program accrediting body 
(such as the AAALAC, the AZA, or similar recognized body) within a time 
frame to be determined by NCRR/NIH. The federally supported sanctuary 
must comply with the requirements set forth in the Animal Welfare 
Regulations (9 CFR parts 1 through 3).



Sec. 9.13  Other federal laws, regulations, and statutes that apply
to the sanctuary.

    (a) Animal Welfare Act (7 U.S.C. 2131-2159).
    (b) Animal Welfare Regulations, 9 CFR, subchapter A, parts 1 and 2; 
part

[[Page 122]]

3, subpart D--Specifications for the Humane Handling, Care, Treatment, 
and Transport of Nonhuman Primates.

[[Page 123]]



                         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 124]]

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 125]]



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 126]]



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 127]]

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 128]]

               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 129]]

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 130]]

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 131]]

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 132]]

    (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 133]]

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 134]]

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 135]]

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 136]]

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 137]]

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 138]]



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 139]]

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 140]]

    (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 141]]

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 142]]



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 143]]



                     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 144]]

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 145]]

    (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 146]]

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 147]]



               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 148]]

 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 149]]

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 150]]

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 151]]

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 152]]

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 153]]

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. 252; 8 U.S.C. 1182 and 1222.



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 154]]



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) Communicable diseases as listed in a Presidential Executive 
Order, as provided under Section 361(b) of the Public Health Service 
Act. The current revised list of quarantinable communicable diseases is 
available at http://www.cdc.gov and http://www.archives.gov/federal-
register.
    (3) Communicable diseases that may pose a public health emergency of 
international concern if it meets one or more of the factors listed in 
Sec. 34.3(d) and for which the CDC Director has determined (A) a threat 
exists for importation into the United States, and (B) such disease may 
potentially affect the health of the American public. The determination 
will be made consistent with criteria established in Annex 2 of the 
revised International Health Regulations (http://www.who.int/csr/ihr/en/
), as adopted by the Fifty-Eighth World Health Assembly in 2005, and as 
entered into effect in the United States in July, 2007, subject to the 
U.S. Government's reservation and understandings:
    (i) Any of the communicable diseases for which a single case 
requires notification to the World Health Organization (WHO) as an event 
that may constitute a public health emergency of international concern, 
or
    (ii) Any other communicable disease the occurrence of which requires 
notification to the WHO as an event that may constitute a public health 
emergency of international concern.HHS/CDC's determinations will be 
announced by notice in the Federal Register.
    (4) Gonorrhea.
    (5) Granuloma inguinale.
    (6) Leprosy, infectious.
    (7) Lymphogranuloma venereum.
    (8) Syphilis, infectious stage.
    (9) 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

[[Page 155]]

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.
    (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; 73 FR 58056, Oct. 6, 2008; 74 FR 56562, Nov. 2, 
2009]



Sec. 34.3  Scope of examinations.

    (a) General. In performing examinations, medical examiners shall 
consider those matters that relate to the following:
    (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.
    (b) Scope of all medical examinations. (1) All medical examinations 
will include the following:
    (i) A general physical examination and medical history, evaluation 
for tuberculosis, and serologic testing for syphilis.
    (ii) A physical examination and medical history for diseases 
specified in Sec. Sec. 34.2(b)(1), and 34.2(b)(4) through 34.2(b)(10).
    (2) 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.
    (c) Additional medical screening and testing for examinations 
performed outside the United States. (1) HHS/CDC may require additional 
medical screening and testing for medical examinations performed outside 
the United States for diseases specified in Sec. Sec. 34.2(b)(2) and 
34.2(b)(3) by applying the risk-based medical and epidemiologic factors 
in paragraph (d)(2) of this section.
    (2) Such examinations shall be conducted in a defined population in 
a geographic region or area outside the United States as determined by 
HHS/CDC.
    (3) Additional medical screening and testing shall include a medical 
interview, physical examination, laboratory testing, radiologic exam, or 
other diagnostic procedure, as determined by HHS/CDC.
    (4) Additional medical screening and testing will continue until 
HHS/CDC

[[Page 156]]

determines such screening and testing is no longer warranted based on 
factors such as the following: Results of disease outbreak 
investigations and response efforts; effectiveness of containment and 
control measures; and the status of an applicable determination of 
public health emergency of international concern declared by the 
Director General of the WHO.
    (5) HHS/CDC will directly provide medical examiners information 
pertaining to all applicable additional requirements for medical 
screening and testing, and will post these at the following Internet 
addresses: http://www.cdc.gov/ncidod/dq/technica.htm and http://
www.globalhealth.gov.
    (d) Risk-based approach. (1) HHS/CDC will use the medical and 
epidemiological factors listed in paragraph (d)(2) of this section to 
determine the following:
    (i) Whether a disease as specified in Sec. 34.2(b)(3)(ii) is a 
communicable disease of public health significance.
    (ii) Which diseases in Sec. Sec. 34.2(b)(2) and (b)(3) merit 
additional screening and testing, and the geographic area in which HHS/
CDC will require this screening.
    (2) Medical and epidemiological factors include the following:
    (i) The seriousness of the disease's public health impact;
    (ii) Whether the emergence of the disease was unusual or unexpected;
    (iii) The risk of the spread of the disease in the United States;
    (iv) The transmissibility and virulence of the disease;
    (v) The impact of the disease at the geographic location of medical 
screening; and
    (vi) Other specific pathogenic factors that would bear on a 
disease's ability to threaten the health security of the United States.
    (e) Persons subject to requirement for chest X-ray examination and 
serologic testing. (1) As provided in paragraph (e)(2) of this section, 
a chest x-ray examination and serologic testing for syphilis shall be 
required as part of the examination of the following:
    (i) Applicants for immigrant visas;
    (ii) Students, exchange visitors, and other applicants for non-
immigrant visas required by a U.S. consular authority to have a medical 
examination;
    (iii) Applicants outside the United States who apply for refugee 
status;
    (iv) Applicants in the United States who apply for adjustment of 
their status under the immigration statute and regulations.
    (2) Chest X-ray examination and serologic testing. Except as 
provided in paragraph (e)(2)(iv) of this section, applicants described 
in paragraph (e)(1) of this section shall be required to have the 
following:
    (i) For applicants 15 years of age and older, a chest x-ray 
examination;
    (ii) For applicants under 15 years of age, a chest x-ray examination 
if the applicant has symptoms of tuberculosis, a history of 
tuberculosis, or evidence of possible exposure to a transmissible 
tuberculosis case in a household or other enclosed environment for a 
prolonged period;
    (iii) For applicants 15 years of age and older, serologic testing 
for syphilis and HIV.
    (iv) Exceptions. Serologic testing for syphilis shall not be 
required if the alien is under the age of 15, unless there is reason to 
suspect infection with syphilis. An alien, regardless of age, in the 
United States, who applies for adjustment of status to lawful permanent 
resident shall not be required to have a chest x-ray examination unless 
their tuberculin skin test, or an equivalent test for showing an immune 
response to Mycobacterium tuberculosis antigens, is positive. HHS/CDC 
may authorize exceptions to the requirement for a tuberculin skin test, 
an equivalent test for showing an immune response to M. tuberculosis 
antigens, or chest x-ray examination for good cause, upon application 
approved by the Director.
    (3) Immune response to Mycobacterium tuberculosis antigens. (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 U.S. Department of Homeland Security to have a medical 
examination in connection with a determination of their admissibility, 
shall be required to have a tuberculin skin test or an equivalent test 
for showing an immune response to

[[Page 157]]

Mycobacterium tuberculosis antigens. 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, or an equivalent, appropriate test to show an 
immune response to Mycobacterium tuberculosis antigens, 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 civil surgeon before a medical 
notification may be issued.
    (iii) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to Mycobacterium 
tuberculosis antigens, and, if indicated, a chest radiograph.
    (iv) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to Mycobacterium 
tuberculosis antigens, and a chest radiograph, regardless of age, if 
they have symptoms of tuberculosis, a history of tuberculosis, or 
evidence of possible exposure to a transmissible tuberculosis case in a 
household or other enclosed environment for a prolonged period.
    (4) Additional testing requirements. All applicants subject to the 
chest radiograph requirement, and for whom the radiograph shows an 
abnormality suggestive of tuberculosis disease, shall be required to 
undergo additional testing for tuberculosis.
    (5) How and where performed. All chest x-ray images used in medical 
examinations performed under the regulations to this part shall be large 
enough to encompass the entire chest (approximately 14 x 17 inches; 35.6 
x 32.2 cm).
    (6) Chest x-ray, laboratory, and treatment reports. The chest 
radiograph reading and serologic test results for syphilis 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 image, the 
medical notification shall include at least a summary statement of 
findings of the earlier images, followed by a complete reading of the 
last image, and dates and details of any laboratory tests and treatment 
for tuberculosis.
    (f) Procedure for transmitting records. For aliens issued immigrant 
visas, the medical notification and chest X-ray images, if any, shall be 
placed in a separate envelope which shall be sealed. When more than one 
chest X-ray image is used as a basis for the examiner's conclusions, all 
images shall be included.
    (g) 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.
    (h) The Secretary of Homeland Security, 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.
    (i) All medical examinations shall be carried out in accordance with 
such technical instructions for physicians conducting the medical 
examination of

[[Page 158]]

aliens as may be issued by the Director. Copies of such technical 
instructions are available upon request to the Director, Division of 
Global Migration and Quarantine, Mailstop E03, HHS/CDC, Atlanta GA 
30333.

[73 FR 58056, Oct. 6, 2008, as amended at 73 FR 62211, Oct. 20, 2008; 74 
FR 56562, Nov. 2, 2009]



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.

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

[[Page 159]]

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 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

[[Page 160]]

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 
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.

[[Page 161]]

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 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

[[Page 162]]

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 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

[[Page 163]]

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 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.

[[Page 164]]



(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.
    (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

[[Page 165]]

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 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.

[[Page 166]]



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 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

[[Page 167]]

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 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).

[[Page 168]]


    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 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.

[[Page 169]]



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.
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.

[[Page 170]]

    (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.
    (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

[[Page 171]]

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 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.

[[Page 172]]

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 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,

[[Page 173]]

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.



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

[[Page 174]]

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 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

[[Page 175]]

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 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

[[Page 176]]

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 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

[[Page 177]]

``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 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

[[Page 178]]

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 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

[[Page 179]]

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 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

[[Page 180]]

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 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.

[[Page 181]]

    (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.

                                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.


[[Page 182]]


    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).



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

[[Page 183]]

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
    (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.

[[Page 184]]

    (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.
    (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]

[[Page 185]]



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.



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 186]]



                           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_Promoting Objectivity in Research

50.601 Purpose.
50.602 Applicability.
50.603 Definitions.
50.604 Responsibilities of Institutions regarding Investigator financial 
          conflicts of interest.
50.605 Management and reporting of financial conflicts of interest.
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 187]]

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 188]]

    (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 189]]

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 190]]

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 191]]

    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 192]]

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 193]]

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 194]]



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 195]]

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 196]]

    (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_Promoting Objectivity in Research

    Authority: 42 U.S.C. 216, 289b-1, 299c-4; Sec. 219, Tit. II, Div. D, 
Pub. L. 111-117, 123 Stat. 3034.

    Source: 76 FR 53283, August 25, 2011, unless otherwise noted.



Sec. 50.601  Purpose.

    This subpart promotes objectivity in research by establishing 
standards that provide a reasonable expectation that the design, 
conduct, and reporting of research funded under Public Health Service 
(PHS) grants or cooperative agreements will be free from bias resulting 
from Investigator financial conflicts of interest.



Sec. 50.602  Applicability.

    This subpart is applicable to each Institution that is applying for, 
or that receives, PHS research funding by means of a grant or 
cooperative agreement and, through the implementation of this subpart by 
the Institution, to each Investigator who is planning to participate in, 
or is participating in, such research; provided, however, that this 
subpart does not apply to SBIR Program Phase I applications. In those 
few cases where an individual, rather than an Institution, is applying 
for, or receives, PHS research funding, PHS Awarding Components will 
make case-by-case determinations on the steps to be taken, consistent 
with this subpart, to provide a reasonable expectation that the design, 
conduct, and reporting of the research will be free from bias resulting 
from a financial conflict of interest of the individual.



Sec. 50.603  Definitions.

    As used in this subpart:
    Disclosure of significant financial interests means an 
Investigator's disclosure of significant financial interests to an 
Institution.
    Financial conflict of interest (FCOI) means a significant financial 
interest that could directly and significantly affect the design, 
conduct, or reporting of PHS-funded research.
    FCOI report means an Institution's report of a financial conflict of 
interest to a PHS Awarding Component.
    Financial interest means anything of monetary value, whether or not 
the value is readily ascertainable.
    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) that is applying for, or 
that receives, PHS research funding.
    Institutional responsibilities means an Investigator's professional 
responsibilities on behalf of the Institution, and as defined by the 
Institution in its policy on financial conflicts of interest, which may 
include for example: activities such as research, research consultation, 
teaching, professional practice, institutional committee memberships, 
and service on panels such as Institutional Review Boards or Data and 
Safety Monitoring Boards.
    Investigator means the project director or principal Investigator 
and any other person, regardless of title or position, who is 
responsible for the design, conduct, or reporting of research funded by 
the PHS, or proposed for such funding, which may include, for example, 
collaborators or consultants.

[[Page 197]]

    Manage means taking action to address a financial conflict of 
interest, which can include reducing or eliminating the financial 
conflict of interest, to ensure, to the extent possible, that the 
design, conduct, and reporting of research will be free from bias.
    PD/PI means a project director or principal Investigator of a PHS-
funded research project; the PD/PI is included in the definitions of 
senior/key personnel and Investigator under this subpart.
    PHS means the Public Health Service of the U.S. Department of Health 
and Human Services, and any components of the PHS to which the authority 
involved may be delegated, including the National Institutes of Health 
(NIH).
    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, study or experiment 
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 (e.g., a 
published article, book or book chapter) and product development (e.g., 
a diagnostic test or drug). 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, such as a 
research grant, career development award, center grant, individual 
fellowship award, infrastructure award, institutional training grant, 
program project, or research resources award.
    Senior/key personnel means the PD/PI and any other person identified 
as senior/key personnel by the Institution in the grant application, 
progress report, or any other report submitted to the PHS by the 
Institution under this subpart.
    Significant financial interest means:
    (1) A financial interest consisting of one or more of the following 
interests of the Investigator (and those of the Investigator's spouse 
and dependent children) that reasonably appears to be related to the 
Investigator's institutional responsibilities:
    (i) With regard to any publicly traded entity, a significant 
financial interest exists if the value of any remuneration received from 
the entity in the twelve months preceding the disclosure and the value 
of any equity interest in the entity as of the date of disclosure, when 
aggregated, exceeds $5,000. For purposes of this definition, 
remuneration includes salary and any payment for services not otherwise 
identified as salary (e.g., consulting fees, honoraria, paid 
authorship); equity interest includes any stock, stock option, or other 
ownership interest, as determined through reference to public prices or 
other reasonable measures of fair market value;
    (ii) With regard to any non-publicly traded entity, a significant 
financial interest exists if the value of any remuneration received from 
the entity in the twelve months preceding the disclosure, when 
aggregated, exceeds $5,000, or when the Investigator (or the 
Investigator's spouse or dependent children) holds any equity interest 
(e.g., stock, stock option, or other ownership interest); or
    (iii) Intellectual property rights and interests (e.g., patents, 
copyrights), upon receipt of income related to such rights and 
interests.
    (2) Investigators also must disclose the occurrence of any 
reimbursed or sponsored travel (i.e., that which is paid on behalf of 
the Investigator and not reimbursed to the Investigator so that the 
exact monetary value may not be readily available), related to their 
institutional responsibilities; provided, however, that this disclosure 
requirement does not apply to travel that is reimbursed or sponsored by 
a Federal, state, or local government agency, an Institution of higher 
education as defined at 20 U.S.C. 1001(a), an academic teaching 
hospital, a medical center, or a research institute that is affiliated 
with an Institution of higher education. The Institution's FCOI policy

[[Page 198]]

will specify the details of this disclosure, which will include, at a 
minimum, the purpose of the trip, the identity of the sponsor/organizer, 
the destination, and the duration. In accordance with the Institution's 
FCOI policy, the institutional official(s) will determine if further 
information is needed, including a determination or disclosure of 
monetary value, in order to determine whether the travel constitutes an 
FCOI with the PHS-funded research.
    (3) The term significant financial interest does not include the 
following types of financial interests: salary, royalties, or other 
remuneration paid by the Institution to the Investigator if the 
Investigator is currently employed or otherwise appointed by the 
Institution, including intellectual property rights assigned to the 
Institution and agreements to share in royalties related to such rights; 
any ownership interest in the Institution held by the Investigator, if 
the Institution is a commercial or for-profit organization; income from 
investment vehicles, such as mutual funds and retirement accounts, as 
long as the Investigator does not directly control the investment 
decisions made in these vehicles; income from seminars, lectures, or 
teaching engagements sponsored by a Federal, state, or local government 
agency, an Institution of higher education as defined at 20 U.S.C. 
1001(a), an academic teaching hospital, a medical center, or a research 
institute that is affiliated with an Institution of higher education; or 
income from service on advisory committees or review panels for a 
Federal, state, or local government agency, an Institution of higher 
education as defined at 20 U.S.C. 1001(a), an academic teaching 
hospital, a medical center, or a research institute that is affiliated 
with an Institution of higher education.
    Small Business Innovation Research (SBIR) Program means the 
extramural research program for small businesses that is established by 
the Awarding Components of the Public Health Service and certain other 
Federal agencies under Public Law 97-219, the Small Business Innovation 
Development Act, as amended. For purposes of this subpart, the term SBIR 
Program also includes the Small Business Technology Transfer (STTR) 
Program, which was established by Public Law 102-564.



Sec. 50.604  Responsibilities of Institutions regarding Investigator 
financial conflicts of interest.

    Each Institution shall:
    (a) Maintain an up-to-date, written, enforced policy on financial 
conflicts of interest that complies with this subpart, and make such 
policy available via a publicly accessible Web site. If the Institution 
does not have any current presence on a publicly accessible Web site 
(and only in those cases), the Institution shall make its written policy 
available to any requestor within five business days of a request. If, 
however, the Institution acquires a presence on a publicly accessible 
Web site during the time of the PHS award, the requirement to post the 
information on that Web site will apply within 30 calendar days. If an 
Institution maintains a policy on financial conflicts of interest that 
includes standards that are more stringent than this subpart (e.g., that 
require a more extensive disclosure of financial interests), the 
Institution shall adhere to its policy and shall provide FCOI reports 
regarding identified financial conflicts of interest to the PHS Awarding 
Component in accordance with the Institution's own standards and within 
the timeframe prescribed by this subpart.
    (b) Inform each Investigator of the Institution's policy on 
financial conflicts of interest, the Investigator's responsibilities 
regarding disclosure of significant financial interests, and of these 
regulations, and require each Investigator to complete training 
regarding the same prior to engaging in research related to any PHS-
funded grant and at least every four years, and immediately when any of 
the following circumstances apply:
    (1) The Institution revises its financial conflict of interest 
policies or procedures in any manner that affects the requirements of 
Investigators;
    (2) An Investigator is new to an Institution; or
    (3) An Institution finds that an Investigator is not in compliance 
with the Institution's financial conflict of interest policy or 
management plan.

[[Page 199]]

    (c) If the Institution carries out the PHS-funded research through a 
subrecipient (e.g., subcontractors or consortium members), the 
Institution (awardee Institution) must take reasonable steps to ensure 
that any subrecipient Investigator complies with this subpart by:
    (1) Incorporating as part of a written agreement with the 
subrecipient terms that establish whether the financial conflicts of 
interest policy of the awardee Institution or that of the subrecipient 
will apply to the subrecipient's Investigators.
    (i) If the subrecipient's Investigators must comply with the 
subrecipient's financial conflicts of interest policy, the subrecipient 
shall certify as part of the agreement referenced above that its policy 
complies with this subpart. If the subrecipient cannot provide such 
certification, the agreement shall state that subrecipient Investigators 
are subject to the financial conflicts of interest policy of the awardee 
Institution for disclosing significant financial interests that are 
directly related to the subrecipient's work for the awardee Institution;
    (ii) Additionally, if the subrecipient's Investigators must comply 
with the subrecipient's financial conflicts of interest policy, the 
agreement referenced above shall specify time period(s) for the 
subrecipient to report all identified financial conflicts of interest to 
the awardee Institution. Such time period(s) shall be sufficient to 
enable the awardee Institution to provide timely FCOI reports, as 
necessary, to the PHS as required by this subpart;
    (iii) Alternatively, if the subrecipient's Investigators must comply 
with the awardee Institution's financial conflicts of interest policy, 
the agreement referenced above shall specify time period(s) for the 
subrecipient to submit all Investigator disclosures of significant 
financial interests to the awardee Institution. Such time period(s) 
shall be sufficient to enable the awardee Institution to comply timely 
with its review, management, and reporting obligations under this 
subpart.
    (2) Providing FCOI reports to the PHS Awarding Component regarding 
all financial conflicts of interest of all subrecipient Investigators 
consistent with this subpart, i.e., prior to the expenditure of funds 
and within 60 days of any subsequently identified FCOI.
    (d) Designate an institutional official(s) to solicit and review 
disclosures of significant financial interests from each Investigator 
who is planning to participate in, or is participating in, the PHS-
funded research.
    (e)(1) Require that each Investigator who is planning to participate 
in the PHS-funded research disclose to the Institution's designated 
official(s) the Investigator's significant financial interests (and 
those of the Investigator's spouse and dependent children) no later than 
the time of application for PHS-funded research.
    (2) Require each Investigator who is participating in the PHS-funded 
research to submit an updated disclosure of significant financial 
interests at least annually, in accordance with the specific time period 
prescribed by the Institution, during the period of the award. Such 
disclosure shall include any information that was not disclosed 
initially to the Institution pursuant to paragraph (e)(1) of this 
section, or in a subsequent disclosure of significant financial 
interests (e.g., any financial conflict of interest identified on a PHS-
funded project that was transferred from another Institution), and shall 
include updated information regarding any previously disclosed 
significant financial interest (e.g., the updated value of a previously 
disclosed equity interest).
    (3) Require each Investigator who is participating in the PHS-funded 
research to submit an updated disclosure of significant financial 
interests within thirty days of discovering or acquiring (e.g., through 
purchase, marriage, or inheritance) a new significant financial 
interest.
    (f) Provide guidelines consistent with this subpart for the 
designated institutional official(s) to determine whether an 
Investigator's significant financial interest is related to PHS-funded 
research and, if so related, whether the significant financial interest 
is a financial conflict of interest. An Investigator's significant 
financial interest is related to PHS-funded research when the 
Institution, through its designated official(s), reasonably determines 
that

[[Page 200]]

the significant financial interest: could be affected by the PHS-funded 
research; or is in an entity whose financial interest could be affected 
by the research. The Institution may involve the Investigator in the 
designated official(s)'s determination of whether a significant 
financial interest is related to the PHS-funded research. A financial 
conflict of interest exists when the Institution, through its designated 
official(s), reasonably determines that the significant financial 
interest could directly and significantly affect the design, conduct, or 
reporting of the PHS-funded research.
    (g) Take such actions as necessary to manage financial conflicts of 
interest, including any financial conflicts of a subrecipient 
Investigator pursuant to paragraph (c) of this section. Management of an 
identified financial conflict of interest requires development and 
implementation of a management plan and, if necessary, a retrospective 
review and a mitigation report pursuant to Sec. 50.605(a).
    (h) Provide initial and ongoing FCOI reports to the PHS as required 
pursuant to Sec. 50.605(b).
    (i) Maintain records relating to all Investigator disclosures of 
financial interests and the Institution's review of, and response to, 
such disclosures (whether or not a disclosure resulted in the 
Institution's determination of a financial conflict of interest) and all 
actions under the Institution's policy or retrospective review, if 
applicable, for at least three years from the date the final 
expenditures report is submitted to the PHS or, where applicable, from 
other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different 
situations.
    (j) Establish adequate enforcement mechanisms and provide for 
employee sanctions or other administrative actions to ensure 
Investigator compliance as appropriate.
    (k) Certify, in each application for funding to which this subpart 
applies, that the Institution:
    (1) Has in effect at that Institution an up-to-date, written, and 
enforced administrative process to identify and manage financial 
conflicts of interest with respect to all research projects for which 
funding is sought or received from the PHS;
    (2) Shall promote and enforce Investigator compliance with this 
subpart's requirements including those pertaining to disclosure of 
significant financial interests;
    (3) Shall manage financial conflicts of interest and provide initial 
and ongoing FCOI reports to the PHS Awarding Component consistent with 
this subpart;
    (4) Agrees to make information available, promptly upon request, to 
the HHS relating to any Investigator disclosure of financial interests 
and the Institution's review of, and response to, such disclosure, 
whether or not the disclosure resulted in the Institution's 
determination of a financial conflict of interest; and
    (5) Shall fully comply with the requirements of this subpart.



Sec. 50.605  Management and reporting of financial conflicts of interest.

    (a) Management of financial conflicts of interest.
    (1) Prior to the Institution's expenditure of any funds under a PHS-
funded research project, the designated official(s) of an Institution 
shall, consistent with Sec. 50.604(f): review all Investigator 
disclosures of significant financial interests; determine whether any 
significant financial interests relate to PHS-funded research; determine 
whether a financial conflict of interest exists; and, if so, develop and 
implement a management plan that shall specify the actions that have 
been, and shall be, taken to manage such financial conflict of interest. 
Examples of conditions or restrictions that might be imposed to manage a 
financial conflict of interest include, but are not limited to:
    (i) Public disclosure of financial conflicts of interest (e.g., when 
presenting or publishing the research);
    (ii) For research projects involving human subjects research, 
disclosure of financial conflicts of interest directly to participants;
    (iii) Appointment of an independent monitor capable of taking 
measures to protect the design, conduct, and reporting of the research 
against bias resulting from the financial conflict of interest;

[[Page 201]]

    (iv) Modification of the research plan;
    (v) Change of personnel or personnel responsibilities, or 
disqualification of personnel from participation in all or a portion of 
the research;
    (vi) Reduction or elimination of the financial interest (e.g., sale 
of an equity interest); or
    (vii) Severance of relationships that create financial conflicts.
    (2) Whenever, in the course of an ongoing PHS-funded research 
project, an Investigator who is new to participating in the research 
project discloses a significant financial interest or an existing 
Investigator discloses a new significant financial interest to the 
Institution, the designated official(s) of the Institution shall, within 
sixty days: review the disclosure of the significant financial interest; 
determine whether it is related to PHS-funded research; determine 
whether a financial conflict of interest exists; and, if so, implement, 
on at least an interim basis, a management plan that shall specify the 
actions that have been, and will be, taken to manage such financial 
conflict of interest. Depending on the nature of the significant 
financial interest, an Institution may determine that additional interim 
measures are necessary with regard to the Investigator's participation 
in the PHS-funded research project between the date of disclosure and 
the completion of the Institution's review.
    (3) Whenever an Institution identifies a significant financial 
interest that was not disclosed timely by an Investigator or, for 
whatever reason, was not previously reviewed by the Institution during 
an ongoing PHS-funded research project (e.g., was not timely reviewed or 
reported by a subrecipient), the designated official(s) shall, within 
sixty days: review the significant financial interest; determine whether 
it is related to PHS-funded research; determine whether a financial 
conflict of interest exists; and, if so:
    (i) Implement, on at least an interim basis, a management plan that 
shall specify the actions that have been, and will be, taken to manage 
such financial conflict of interest going forward;
    (ii)(A) In addition, whenever a financial conflict of interest is 
not identified or managed in a timely manner including failure by the 
Investigator to disclose a significant financial interest that is 
determined by the Institution to constitute a financial conflict of 
interest; failure by the Institution to review or manage such a 
financial conflict of interest; or failure by the Investigator to comply 
with a financial conflict of interest management plan, the Institution 
shall, within 120 days of the Institution's determination of 
noncompliance, complete a retrospective review of the Investigator's 
activities and the PHS-funded research project to determine whether any 
PHS-funded research, or portion thereof, conducted during the time 
period of the noncompliance, was biased in the design, conduct, or 
reporting of such research.
    (B) The Institution is required to document the retrospective 
review; such documentation shall include, but not necessarily be limited 
to, all of the following key elements:
    (1) Project number;
    (2) Project title;
    (3) PD/PI or contact PD/PI if a multiple PD/PI model is used;
    (4) Name of the Investigator with the FCOI;
    (5) Name of the entity with which the Investigator has a financial 
conflict of interest;
    (6) Reason(s) for the retrospective review;
    (7) Detailed methodology used for the retrospective review (e.g., 
methodology of the review process, composition of the review panel, 
documents reviewed);
    (8) Findings of the review; and
    (9) Conclusions of the review.
    (iii) Based on the results of the retrospective review, if 
appropriate, the Institution shall update the previously submitted FCOI 
report, specifying the actions that will be taken to manage the 
financial conflict of interest going forward. If bias is found, the 
Institution is required to notify the PHS Awarding Component promptly 
and submit a mitigation report to the PHS Awarding Component. The 
mitigation report must include, at a minimum, the key elements 
documented in the retrospective review above and a description of the 
impact of the bias on the research project and the Institution's plan of 
action or actions taken

[[Page 202]]

to eliminate or mitigate the effect of the bias (e.g., impact on the 
research project; extent of harm done, including any qualitative and 
quantitative data to support any actual or future harm; analysis of 
whether the research project is salvageable). Thereafter, the 
Institution will submit FCOI reports annually, as specified elsewhere in 
this subpart. Depending on the nature of the financial conflict of 
interest, an Institution may determine that additional interim measures 
are necessary with regard to the Investigator's participation in the 
PHS-funded research project between the date that the financial conflict 
of interest or the Investigator's noncompliance is determined and the 
completion of the Institution's retrospective review.
    (4) Whenever an Institution implements a management plan pursuant to 
this subpart, the Institution shall monitor Investigator compliance with 
the management plan on an ongoing basis until the completion of the PHS-
funded research project.
    (5)(i) Prior to the Institution's expenditure of any funds under a 
PHS-funded research project, the Institution shall ensure public 
accessibility, via a publicly accessible Web site or written response to 
any requestor within five business days of a request, of information 
concerning any significant financial interest disclosed to the 
Institution that meets the following three criteria:
    (A) The significant financial interest was disclosed and is still 
held by the senior/key personnel as defined by this subpart;
    (B) The Institution determines that the significant financial 
interest is related to the PHS-funded research; and
    (C) The Institution determines that the significant financial 
interest is a financial conflict of interest.
    (ii) The information that the Institution makes available via a 
publicly accessible Web site or written response to any requestor within 
five business days of a request, shall include, at a minimum, the 
following: the Investigator's name; the Investigator's title and role 
with respect to the research project; the name of the entity in which 
the significant financial interest is held; the nature of the 
significant financial interest; and the approximate dollar value of the 
significant financial interest (dollar ranges are permissible: $0-
$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 
by increments of $20,000; amounts above $100,000 by increments of 
$50,000), or a statement that the interest is one whose value cannot be 
readily determined through reference to public prices or other 
reasonable measures of fair market value.
    (iii) If the Institution uses a publicly accessible Web site for the 
purposes of this subsection, the information that the Institution posts 
shall be updated at least annually. In addition, the Institution shall 
update the Web site within sixty days of the Institution's receipt or 
identification of information concerning any additional significant 
financial interest of the senior/key personnel for the PHS-funded 
research project that was not previously disclosed, or upon the 
disclosure of a significant financial interest of senior/key personnel 
new to the PHS-funded research project, if the Institution determines 
that the significant financial interest is related to the PHS-funded 
research and is a financial conflict of interest. The Web site shall 
note that the information provided is current as of the date listed and 
is subject to updates, on at least an annual basis and within 60 days of 
the Institution's identification of a new financial conflict of 
interest. If the Institution responds to written requests for the 
purposes of this subsection, the Institution will note in its written 
response that the information provided is current as of the date of the 
correspondence and is subject to updates, on at least an annual basis 
and within 60 days of the Institution's identification of a new 
financial conflict of interest, which should be requested subsequently 
by the requestor.
    (iv) Information concerning the significant financial interests of 
an individual subject to paragraph (a)(5) of this section shall remain 
available, for responses to written requests or for posting via the 
Institution's publicly accessible Web site for at least three years from 
the date that the information was most recently updated.

[[Page 203]]

    (6) In addition to the types of financial conflicts of interest as 
defined in this subpart that must be managed pursuant to this section, 
an Institution may require the management of other financial conflicts 
of interest in its policy on financial conflicts of interest, as the 
Institution deems appropriate.
    (b) Reporting of financial conflicts of interest.
    (1) Prior to the Institution's expenditure of any funds under a PHS-
funded research project, the Institution shall provide to the PHS 
Awarding Component an FCOI report regarding any Investigator's 
significant financial interest found by the Institution to be 
conflicting and ensure that the Institution has implemented a management 
plan in accordance with this subpart. In cases in which the Institution 
identifies a financial conflict of interest and eliminates it prior to 
the expenditure of PHS-awarded funds, the Institution shall not submit 
an FCOI report to the PHS Awarding Component.
    (2) For any significant financial interest that the Institution 
identifies as conflicting subsequent to the Institution's initial FCOI 
report during an ongoing PHS-funded research project (e.g., upon the 
participation of an Investigator who is new to the research project), 
the Institution shall provide to the PHS Awarding Component, within 
sixty days, an FCOI report regarding the financial conflict of interest 
and ensure that the Institution has implemented a management plan in 
accordance with this subpart. Pursuant to paragraph (a)(3)(ii) of this 
section, where such FCOI report involves a significant financial 
interest that was not disclosed timely by an Investigator or, for 
whatever reason, was not previously reviewed or managed by the 
Institution (e.g., was not timely reviewed or reported by a 
subrecipient), the Institution also is required to complete a 
retrospective review to determine whether any PHS-funded research, or 
portion thereof, conducted prior to the identification and management of 
the financial conflict of interest was biased in the design, conduct, or 
reporting of such research. Additionally, pursuant to paragraph 
(a)(3)(iii) of this section, if bias is found, the Institution is 
required to notify the PHS Awarding Component promptly and submit a 
mitigation report to the PHS Awarding Component.
    (3) Any FCOI report required under paragraphs (b)(1) or (b)(2) of 
this section shall include sufficient information to enable the PHS 
Awarding Component to understand the nature and extent of the financial 
conflict, and to assess the appropriateness of the Institution's 
management plan. Elements of the FCOI report shall include, but are not 
necessarily limited to the following:
    (i) Project number;
    (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used;
    (iii) Name of the Investigator with the financial conflict of 
interest;
    (iv) Name of the entity with which the Investigator has a financial 
conflict of interest;
    (v) Nature of the financial interest (e.g., equity, consulting fee, 
travel reimbursement, honorarium);
    (vi) Value of the financial interest (dollar ranges are permissible: 
$0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-
$100,000 by increments of $20,000; amounts above $100,000 by increments 
of $50,000), or a statement that the interest is one whose value cannot 
be readily determined through reference to public prices or other 
reasonable measures of fair market value;
    (vii) A description of how the financial interest relates to the 
PHS-funded research and the basis for the Institution's determination 
that the financial interest conflicts with such research; and
    (viii) A description of the key elements of the Institution's 
management plan, including:
    (A) Role and principal duties of the conflicted Investigator in the 
research project;
    (B) Conditions of the management plan;
    (C) How the management plan is designed to safeguard objectivity in 
the research project;
    (D) Confirmation of the Investigator's agreement to the management 
plan;
    (E) How the management plan will be monitored to ensure Investigator 
compliance; and

[[Page 204]]

    (F) Other information as needed.
    (4) For any financial conflict of interest previously reported by 
the Institution with regard to an ongoing PHS-funded research project, 
the Institution shall provide to the PHS Awarding Component an annual 
FCOI report that addresses the status of the financial conflict of 
interest and any changes to the management plan for the duration of the 
PHS-funded research project. The annual FCOI report shall specify 
whether the financial conflict is still being managed or explain why the 
financial conflict of interest no longer exists. The Institution shall 
provide annual FCOI reports to the PHS Awarding Component for the 
duration of the project period (including extensions with or without 
funds) in the time and manner specified by the PHS Awarding Component.
    (5) In addition to the types of financial conflicts of interest as 
defined in this subpart that must be reported pursuant to this section, 
an Institution may require the reporting of other financial conflicts of 
interest in its policy on financial conflicts of interest, as the 
Institution deems appropriate.



Sec. 50.606  Remedies.

    (a) If the failure of an Investigator to comply with an 
Institution's financial conflicts of interest policy or a financial 
conflict of interest management plan appears to have biased the design, 
conduct, or reporting of the PHS-funded research, the Institution shall 
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 PHS-funded research project. PHS may, for example, require 
Institutions employing such an Investigator to enforce any applicable 
corrective actions prior to a PHS award or when the transfer of a PHS 
grant(s) involves such an Investigator.
    (b) The PHS Awarding Component and/or HHS may inquire at any time 
before, during, or after award into any Investigator disclosure of 
financial interests and the Institution's review (including any 
retrospective review) of, and response to, such disclosure, regardless 
of whether the disclosure resulted in the Institution's determination of 
a financial conflict of interest. An Institution is required to submit, 
or permit on site review of, 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 or other information that may be available, the 
PHS Awarding Component may decide that a particular financial 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 the financial conflict of interest in 
accordance with this subpart. The PHS Awarding Component may determine 
that imposition of special award conditions under 45 CFR 74.14 and 
92.12, or suspension of funding or other enforcement action under 45 CFR 
74.62 and 92.43, 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 has been designed, 
conducted, or reported by an Investigator with a financial conflict of 
interest that was not managed or reported by the Institution as required 
by this subpart, the Institution shall require the Investigator involved 
to disclose the financial conflict of interest in each public 
presentation of the results of the research and to request an addendum 
to previously published presentations.



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:

2 CFR part 376--Nonprocurement debarment and suspension (HHS)
42 CFR part 50, subpart D--Public Health Service grant appeals procedure

[[Page 205]]

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 
nonprofit organizations, and commercial organizations
45 CFR part 79--Program fraud civil remedies
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements to State, local, and tribal 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: 62 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 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

[[Page 206]]

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.
    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.

[[Page 207]]

    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 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

[[Page 208]]

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 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

[[Page 209]]

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;
    (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:

[[Page 210]]

    (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;
    (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.

[[Page 211]]

    (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 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

[[Page 212]]

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:
    (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

[[Page 213]]

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.



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:

[[Page 214]]

    (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.
    (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

[[Page 215]]

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 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

[[Page 216]]

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 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.

[[Page 217]]



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 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

[[Page 218]]

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 219]]

    (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:
    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.

[[Page 220]]

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?
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).

[[Page 221]]



                      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
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

[[Page 222]]

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.



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.

[[Page 223]]

    (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.

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

[[Page 224]]

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.
    (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.

[[Page 225]]



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.



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,

[[Page 226]]

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?



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

[[Page 227]]

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 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

[[Page 228]]

    (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 as primary health services and which are:
    (1) Inpatient and outpatient hospital services;
    (2) Home health services;
    (3) Extended care facility services;

[[Page 229]]

    (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.
    (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

[[Page 230]]

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.
    (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

[[Page 231]]

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.



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

[[Page 232]]

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 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

[[Page 233]]

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.
    (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).

[[Page 234]]

    (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:
    (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

[[Page 235]]

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
    (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.

[[Page 236]]

    (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.



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

[[Page 237]]

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 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

[[Page 238]]

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 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

[[Page 239]]

    (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;
    (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

[[Page 240]]

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.
    (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

[[Page 241]]

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 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

[[Page 242]]

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.



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)).

[[Page 243]]



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 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

[[Page 244]]

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 
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.

[[Page 245]]



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 Service (IHS) within the 
U.S. Department of Health and Human Services, and other Federal agencies 
with jurisdiction over specific types of crisis response.

[[Page 246]]



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 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

[[Page 247]]

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 the individual(s) judged by the 
applicant organization to have the appropriate level of authority and 
responsibility to direct the project or program supported by the grant 
and who is or are 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 248]]

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, as amended at 74 FR 57921, Nov. 10, 2009]



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

[[Page 249]]

Council or other body as may be required by law, the Secretary will (1) 
approve, (2) defer because of either lack 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 one or more awards pursuant to one or more 
applications. When making more than one award in response to a single 
application, the Secretary shall consult with the applicant 
organization(s), as appropriate.
    (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

[[Page 250]]

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; 74 FR 57921, Nov. 10, 2009]



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).


[[Page 251]]


    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-
496-7005; 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);

[[Page 252]]

    (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);
    (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;

[[Page 253]]

    (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 
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, an