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


42PUBLIC HEALTH12008-10-012008-10-01falseGENERAL PROVISIONSASUBCHAPTER APUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
                     SUBCHAPTER A_GENERAL PROVISIONS



                            PART 1 [RESERVED]



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

Contents




                         Subpart A_Introduction

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

                      Subpart B_General Provisions

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

              Subpart C_Disclosures With Patient's Consent

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

              Subpart D_Disclosures Without Patient Consent

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

          Subpart E_Court Orders Authorizing Disclosure and Use

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

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

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



                         Subpart A_Introduction



Sec. 2.1  Statutory authority for confidentiality of drug abuse patient 

records.

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

[[Page 8]]

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

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

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

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



Sec. 2.2  Statutory authority for confidentiality of alcohol abuse patient 

records.

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

[[Page 9]]

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

            Sec. 290dd-3. Confidentiality of patient records

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

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

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

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

[[Page 10]]



Sec. 2.3  Purpose and effect.

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



Sec. 2.4  Criminal penalty for violation.

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



Sec. 2.5  Reports of violations.

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



                      Subpart B_General Provisions



Sec. 2.11  Definitions.

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

[[Page 11]]

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

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



Sec. 2.12  Applicability.

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

[[Page 12]]

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

[[Page 13]]

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

[[Page 14]]

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

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



Sec. 2.13  Confidentiality restrictions.

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

[[Page 15]]

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



Sec. 2.14  Minor patients.

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



Sec. 2.15  Incompetent and deceased patients.

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

[[Page 16]]

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



Sec. 2.16  Security for written records.

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



Sec. 2.17  Undercover agents and informants.

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

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



Sec. 2.18  Restrictions on the use of identification cards.

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



Sec. 2.19  Disposition of records by discontinued programs.

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

[[Page 17]]

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



Sec. 2.20  Relationship to State laws.

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



Sec. 2.21  Relationship to Federal statutes protecting research subjects 

against compulsory disclosure of their identity.

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



Sec. 2.22  Notice to patients of Federal confidentiality requirements.

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

[[Page 18]]

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

        Confidentiality of Alcohol and Drug Abuse Patient Records

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

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

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



Sec. 2.23  Patient access and restrictions on use.

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



              Subpart C_Disclosures With Patient's Consent



Sec. 2.31  Form of written consent.

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


[[Page 19]]


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

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

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



Sec. 2.32  Prohibition on redisclosure.

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

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

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



Sec. 2.33  Disclosures permitted with written consent.

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



Sec. 2.34  Disclosures to prevent multiple enrollments in detoxification and 

maintenance treatment programs.

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

[[Page 20]]

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



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

referred patients.

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

[[Page 21]]

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



              Subpart D_Disclosures Without Patient Consent



Sec. 2.51  Medical emergencies.

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

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



Sec. 2.52  Research activities.

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

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



Sec. 2.53  Audit and evaluation activities.

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

[[Page 22]]

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



          Subpart E_Court Orders Authorizing Disclosure and Use



Sec. 2.61  Legal effect of order.

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

[[Page 23]]

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

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



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

researchers, auditors and evaluators.

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



Sec. 2.63  Confidential communications.

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



Sec. 2.64  Procedures and criteria for orders authorizing disclosures for 

noncriminal purposes.

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

[[Page 24]]

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



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

of records to criminally investigate or prosecute patients.

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

[[Page 25]]

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

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



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

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

records.

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



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

criminally investigate employees or agents of a program.

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

[[Page 26]]

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



PART 2a_PROTECTION OF IDENTITY_RESEARCH SUBJECTS--Table of Contents




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

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

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



Sec. 2a.1  Applicability.

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

[[Page 27]]

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



Sec. 2a.2  Definitions.

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



Sec. 2a.3  Application; coordination.

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

[[Page 28]]

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



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

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

[[Page 29]]

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



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

administered.

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



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

limitation.

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

[[Page 30]]

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



Sec. 2a.7  Effect of Confidentiality Certificate.

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

[[Page 31]]

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



Sec. 2a.8  Termination.

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

                            PART 3 [RESERVED]



PART 4_NATIONAL LIBRARY OF MEDICINE--Table of Contents




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

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

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



Sec. 4.1  Programs to which these regulations apply.

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

[[Page 32]]

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



Sec. 4.2  Definitions.

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



Sec. 4.3  Purpose of the Library.

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



Sec. 4.4  Use of Library facilities.

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

[[Page 33]]

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



Sec. 4.5  Use of materials from the collections.

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

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



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

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

[[Page 34]]

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



Sec. 4.7  Fees.

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



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

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



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




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

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

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

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



Sec. 5.1  Purpose.

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



Sec. 5.2  Definitions.

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

[[Page 35]]

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



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

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



Sec. 5.4  Notification and publication of designations and withdrawals.

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

[[Page 36]]

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



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

            Shortages of Primary Medical Care Professional(s)

                        Part I--Geographic Areas

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

[[Page 37]]

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

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

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

[[Page 38]]

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

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

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

                       Part II--Population Groups

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

[[Page 39]]

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

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

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

                          Part III--Facilities

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

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

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

[[Page 40]]

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

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



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

                        Part I--Geographic Areas

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

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

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

[[Page 41]]

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

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

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

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

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

[[Page 42]]

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

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

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

                       Part II--Population Groups

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

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

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

                          Part III--Facilities

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


[[Page 43]]


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

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

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



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

                Shortages of Mental Health Professionals

                        Part I--Geographic Areas

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

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

[[Page 44]]

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

[[Page 45]]

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

                        High Needs Not Indicated

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

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

                          High Needs Indicated

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

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

[[Page 46]]

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

    (2) For areas with unusually high need:

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

                       Part II--Population Groups

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

                          Part III--Facilities

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

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

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

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

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

[[Page 47]]

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

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



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

                Shortages of Vision Care Professional(s)

                        Part I--Geographic Areas

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

[[Page 48]]



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

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

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

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

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

                       Part II--Population Groups

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



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

                 Shortages of Podiatric Professional(s)

                        Part I--Geographic Areas

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

[[Page 49]]

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

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

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

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

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

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

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

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

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

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



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

                  Shortages of Pharmacy Professional(s)

                        Part I--Geographic Areas

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

[[Page 50]]

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

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

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

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

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

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

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

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



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

                 Shortages of Veterinary Professional(s)

                        Part I--Geographic Areas

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

[[Page 51]]

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

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

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

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

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

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

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

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

[[Page 52]]

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



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

Table of Contents




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

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

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



Sec. 6.1  Applicability.

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



Sec. 6.2  Definitions.

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



Sec. 6.3  Eligible entities.

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



Sec. 6.4  Covered individuals.

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



Sec. 6.5  Deeming process for eligible entities.

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

[[Page 53]]

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



Sec. 6.6  Covered acts and omissions.

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

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



PART 7_DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL 

PREPARATIONS--Table of Contents




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

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

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

[[Page 54]]



Sec. 7.1  Applicability.

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



Sec. 7.2  Establishment of a user charge.

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



Sec. 7.3  Definitions.

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



Sec. 7.4  Schedule of charges.

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



Sec. 7.5  Payment procedures.

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



Sec. 7.6  Exemptions.

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



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




                         Subpart A_Accreditation

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

             Subpart B_Certification and Treatment Standards

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

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

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

[[Page 55]]

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

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

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



                         Subpart A_Accreditation



Sec. 8.1  Scope.

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



Sec. 8.2  Definitions.

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

[[Page 56]]

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

[[Page 57]]

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



Sec. 8.3  Application for approval as an accreditation body.

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

[[Page 58]]

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

[[Page 59]]

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



Sec. 8.4  Accreditation body responsibilities.

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

[[Page 60]]

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

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



Sec. 8.5  Periodic evaluation of accreditation bodies.

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



Sec. 8.6  Withdrawal of approval of accreditation bodies.

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

[[Page 62]]

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



             Subpart B_Certification and Treatment Standards



Sec. 8.11  Opioid treatment program certification.

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

[[Page 63]]

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

[[Page 64]]

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

[[Page 65]]

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

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



Sec. 8.12  Federal opioid treatment standards.

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

[[Page 66]]

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

[[Page 67]]

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

[[Page 68]]

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

[[Page 69]]

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

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



Sec. 8.13  Revocation of accreditation and accreditation body approval.

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

[[Page 70]]



Sec. 8.14  Suspension or revocation of certification.

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



Sec. 8.15  Forms.

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

[[Page 71]]



Subpart C_Procedures for Review of Suspension or Proposed Revocation of 

    OTP Certification, and of Adverse Action Regarding Withdrawal of 

                    Approval of an Accreditation Body



Sec. 8.21  Applicability.

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



Sec. 8.22  Definitions.

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



Sec. 8.23  Limitation on issues subject to review.

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



Sec. 8.24  Specifying who represents the parties.

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



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

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



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

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

[[Page 72]]

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



Sec. 8.27  Opportunity for oral presentation.

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

[[Page 73]]

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



Sec. 8.28  Expedited procedures for review of immediate suspension.

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

[[Page 74]]

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



Sec. 8.29  Ex parte communications.

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



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

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



Sec. 8.31  Authority and responsibilities of the reviewing official.

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



Sec. 8.32  Administrative record.

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



Sec. 8.33  Written decision.

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

[[Page 75]]

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



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

administrative remedies.

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

[[Page 76]]