[Title 42 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2017 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 42

Public Health


________________________

Parts 1 to 399

                         Revised as of October 1, 2017

          Containing a codification of documents of general 
          applicability and future effect

          As of October 1, 2017
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register.

[[Page ii]]

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                            Table of Contents



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

  Title 42:
          Chapter I--Public Health Service, Department of 
          Health and Human Services                                  3
          Chapters II-III [Reserved]
  Finding Aids:
      Table of CFR Titles and Chapters........................    1013
      Alphabetical List of Agencies Appearing in the CFR......    1033
      List of CFR Sections Affected...........................    1043

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

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

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

[[Page v]]



                               EXPLANATION

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

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

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

LEGAL STATUS

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

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, October 1, 2017), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

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

OMB CONTROL NUMBERS

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

[[Page vi]]

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

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
in the past by using the appropriate List of CFR Sections Affected 
(LSA). For the convenience of the reader, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

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

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed as 
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or call 202-741-6010.

CFR INDEXES AND TABULAR GUIDES

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separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
and Rules. A list of CFR titles, chapters, subchapters, and parts and an 
alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
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    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
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the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, 8601 Adelphi Road, College Park, MD 
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    The e-CFR is a regularly updated, unofficial editorial compilation 
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of the Federal Register and the Government Publishing Office. It is 
available at www.ecfr.gov.

    Oliver A. Potts,
    Director,
    Office of the Federal Register.
    October 1, 2017.

                                
                                      
                            

  

[[Page ix]]



                               THIS TITLE

    Title 42--Public Health is composed of five volumes. The parts in 
these volumes are arranged in the following order: Parts 1-399, parts 
400-413, parts 414-429, parts 430-481, and part 482 to end. The first 
volume (parts 1-399) contains current regulations issued under chapter 
I--Public Health Service (HHS). The second, third, and fourth volumes 
(parts 400-413, parts 414-429, and parts 430-481) include regulations 
issued under chapter IV--Centers for Medicare & Medicaid Services (HHS) 
and the fifth volume (part 482 to end) contains the remaining 
regulations in chapter IV and the regulations issued under chapter V by 
the Office of Inspector General-Health Care (HHS). The contents of these 
volumes represent all current regulations codified under this title of 
the CFR as of October 1, 2017.

    For this volume, Michele Bugenhagen was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                         TITLE 42--PUBLIC HEALTH




                   (This book contains parts 1 to 399)

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

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

[[Page 3]]



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




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


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

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

2               Confidentiality of substance use disorder 
                    patient records.........................           9
2a              Protection of identity--research subjects...          29
3               Patient safety organizations and patient 
                    safety work product.....................          35
4               National Library of Medicine................          66
5               Designation of health professional(s) 
                    shortage areas..........................          69
5a              Rural physician training grant program......          86
6               Federal tort claims act coverage of certain 
                    grantees and individuals................          87
7               Distribution of reference biological 
                    standards and biological preparations...          89
8               Medication assisted treatment for opioid use 
                    disorders...............................          90
9               Standards of care for chimpanzees held in 
                    the federally supported sanctuary system         116
10              340B Drug Pricing Program...................         129
11              Clinical trials registration and results 
                    information submission..................         133
                         SUBCHAPTER B--PERSONNEL
21              Commissioned officers.......................         166
22              Personnel other than commissioned officers..         176
23              National Health Service Corps...............         177

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24              Senior Biomedical Research Service..........         186
               SUBCHAPTER C--MEDICAL CARE AND EXAMINATIONS
31              Medical care for certain personnel of the 
                    Coast Guard, National Ocean Survey, 
                    Public Health Service, and former 
                    Lighthouse Service......................         190
32              Medical care for persons with Hansen's 
                    disease and other persons in emergencies         195
34              Medical examination of aliens...............         196
35              Hospital and station management.............         205
37              Specifications for medical examinations of 
                    coal miners.............................         213
38              Disaster assistance for crisis counseling 
                    and training............................         239
                          SUBCHAPTER D--GRANTS
50              Policies of general applicability...........         244
51              Requirements applicable to the protection 
                    and advocacy for individuals with mental 
                    illness program.........................         263
51a             Project grants for maternal and child health         275
51b             Project grants for preventive health 
                    services................................         278
51c             Grants for community health services........         285
51d             Mental health and substance abuse emergency 
                    response procedures.....................         300
51e-51g         [Reserved]

52              Grants for research projects................         305
52a             National Institutes of Health center grants.         309
52b             National Institutes of Health construction 
                    grants..................................         314
52c             Minority Biomedical Research Support Program         322
52d             National Cancer Institute Clinical Cancer 
                    Education Program.......................         325
52e             National Heart, Lung, and Blood Institute 
                    grants for prevention and control 
                    projects................................         327
52h             Scientific peer review of research grant 
                    applications and research and 
                    development contract projects...........         331
52i             National Institute on Minority Health and 
                    Health Disparities Research Endowment 
                    Programs................................         337
53              Grants, loans and loan guarantees for 
                    construction and modernization of 
                    hospitals and medical facilities........         342
54              Charitable Choice regulations applicable to 
                    States receiving Substance Abuse 
                    Prevention and Treatment block grants 
                    and/or Projects for Assistance in 
                    Transition from Homelessness grants.....         350

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54a             Charitable Choice regulations applicable to 
                    States, local governments and religious 
                    organizations receiving discretionary 
                    funding under Title V of the Public 
                    Health Service Act, 42 U.S.C. 290aa, et 
                    seq., for substance abuse prevention and 
                    treatment services......................         353
55a             Program grants for Black Lung clinics.......         358
56              Grants for migrant health services..........         360
57              Grants for construction of teaching 
                    facilities, educational improvements, 
                    scholarships and student loans..........         380
58              Grants for training of public health and 
                    allied health personnel.................         422
59              Grants for family planning services.........         422
59a             National Library of Medicine grants.........         431
60              Health Education Assistance Loan Program....         435
            SUBCHAPTER E--FELLOWSHIPS, INTERNSHIPS, TRAINING
61              Fellowships.................................         467
62              National Health Service Corps Scholarship 
                    and Loan Repayment Programs.............         472
63              Traineeships................................         490
63a             National Institutes of Health training 
                    grants..................................         493
64              National Library of Medicine training grants         497
64a             Obligated service for mental health 
                    traineeships............................         499
65              National Institute of Environmental Health 
                    Sciences hazardous waste worker training         503
65a             National Institute of Environmental Health 
                    Sciences hazardous substances basic 
                    research and training grants............         506
66              National Research Service Awards............         510
67              Agency for Health Care Policy and Research 
                    grants and contracts....................         517
68              National Institutes of Health (NIH) Loan 
                    Repayment Programs (LRPs)...............         527
68b             National Institutes of Health (NIH) 
                    Undergraduate Scholarship Program 
                    Regarding Professions Needed by National 
                    Research Institutes (UGSP)..............         535
             SUBCHAPTER F--QUARANTINE, INSPECTION, LICENSING
70              Interstate quarantine.......................         540
71              Foreign quarantine..........................         550
72              [Reserved]

73              Select agents and toxins....................         582

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75              Standards for the accreditation of 
                    educational programs for and the 
                    credentialing of radiologic personnel...         606
   SUBCHAPTER G--OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED 
                               ACTIVITIES
80              [Reserved]

81              Guidelines for determining probability of 
                    causation under the energy employees 
                    occupational illness compensation 
                    program act of 2000.....................         619
82              Methods for conducting dose reconstruction 
                    under the Energy Employees Occupational 
                    Illness Compensation Program Act of 2000         626
83              Procedures for designating classes of 
                    employees as members of the special 
                    exposure cohort under the Energy 
                    Employees Occupational Illness 
                    Compensation Program Act of 2000........         637
84              Approval of respiratory protective devices..         649
85              Requests for health hazard evaluations......         728
85a             Occupational safety and health 
                    investigations of places of employment..         733
86              Grants for education programs in 
                    occupational safety and health..........         738
87              National Institute for Occupational Safety 
                    and Health Research and demonstration 
                    grants..................................         746
88              World Trade Center Health Program...........         748
SUBCHAPTER H--HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS 
                   SUBSTANCES RELEASES AND FACILITIES
90              Administrative functions, practices, and 
                    procedures..............................         765
93              Public health service policies on research 
                    misconduct..............................         769
                         SUBCHAPTER I [RESERVED]
                         SUBCHAPTER J--VACCINES
100             Vaccine injury compensation.................         798
110             Countermeasures injury compensation program.         807
               SUBCHAPTER K--HEALTH RESOURCES DEVELOPMENT
121             Organ Procurement and Transplantation 
                    Network.................................         835
124             Medical facility construction and 
                    modernization...........................         846
125-129         [Reserved]

                  SUBCHAPTER L--COMPASSIONATE PAYMENTS
130             Ricky Ray Hemophilia Relief Fund Program....         882

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131-135         [Reserved]

  SUBCHAPTER M--INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
136             Indian health...............................         915
136a            Indian health...............................         952
137             Tribal self-governance......................         959
138-199         [Reserved]

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                     SUBCHAPTER A_GENERAL PROVISIONS



                            PART 1 [RESERVED]



PART 2_CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS
--Table of Contents



                         Subpart A_Introduction

Sec.
2.1  Statutory authority for confidentiality of substance use disorder 
          patient records.
2.2  Purpose and effect.
2.3  Criminal penalty for violation.
2.4  Reports of violations.

                      Subpart B_General Provisions

2.11  Definitions.
2.12  Applicability.
2.13  Confidentiality restrictions and safeguards.
2.14  Minor patients.
2.15  Incompetent and deceased patients.
2.16  Security for 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 Consent

2.31  Consent requirements.
2.32  Prohibition on re-disclosure.
2.33  Disclosures permitted with written consent.
2.34  Disclosures to prevent multiple enrollments.
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.
2.53  Audit and evaluation.

          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 part 2 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 part 2 
          program.

    Authority: 42 U.S.C. 290dd-2.

    Source: 82 FR 6115, Jan. 18, 2017, unless otherwise noted.



                         Subpart A_Introduction



Sec. 2.1  Statutory authority for confidentiality of substance 
use disorder patient records.

    Title 42, United States Code, Section 290dd-2(g) authorizes the 
Secretary to prescribe regulations. Such regulations may contain such 
definitions, and may provide for such safeguards and procedures, 
including procedures and criteria for the issuance and scope of orders, 
as in the judgment of the Secretary are necessary or proper to 
effectuate the purposes of this statute, to prevent circumvention or 
evasion thereof, or to facilitate compliance therewith.



Sec. 2.2  Purpose and effect.

    (a) Purpose. Pursuant to 42 U.S.C. 290dd-2(g), the regulations in 
this part impose restrictions upon the disclosure and use of substance 
use disorder patient records which are maintained in connection with the 
performance of any part 2 program. The regulations in this part include 
the following subparts:
    (1) Subpart B of this part: General Provisions, including 
definitions, applicability, and general restrictions;

[[Page 10]]

    (2) Subpart C of this part: Disclosures with Patient Consent, 
including disclosures which require patient consent and the consent form 
requirements;
    (3) Subpart D of this part: Disclosures without Patient Consent, 
including disclosures which do not require patient consent or an 
authorizing court order; and
    (4) Subpart E of this part: Court Orders Authorizing Disclosure and 
Use, including 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.
    (b) Effect. (1) The regulations in this part prohibit the disclosure 
and use of patient records unless certain circumstances exist. If any 
circumstance 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) The regulations in this part are not intended to direct the 
manner in which substantive functions such as research, treatment, and 
evaluation are carried out. They are intended to ensure that a patient 
receiving treatment for a substance use disorder in a part 2 program is 
not made more vulnerable by reason of the availability of their patient 
record than an individual with a substance use disorder who does not 
seek treatment.
    (3) Because there is a criminal penalty 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. 2.3  Criminal penalty for violation.

    Under 42 U.S.C. 290dd-2(f), any person who violates any provision of 
this section or any regulation issued pursuant to this section shall be 
fined in accordance with Title 18 of the U.S. Code.



Sec. 2.4  Reports of violations.

    (a) The report of any violation of the regulations in this part may 
be directed to the United States Attorney for the judicial district in 
which the violation occurs.
    (b) The report of any violation of the regulations in this part by 
an opioid treatment program may be directed to the United States 
Attorney for the judicial district in which the violation occurs as well 
as to the Substance Abuse and Mental Health Services Administration 
(SAMHSA) office responsible for opioid treatment program oversight.



                      Subpart B_General Provisions



Sec. 2.11  Definitions.

    For purposes of the regulations in this part:
    Central registry means an organization which obtains from two or 
more member programs patient identifying information about individuals 
applying for withdrawal management or maintenance treatment for the 
purpose of avoiding an individual's concurrent enrollment in more than 
one treatment program.
    Diagnosis means any reference to an individual's substance use 
disorder or to a condition which is identified as having been caused by 
that substance use disorder which is made for the purpose of treatment 
or referral for treatment.
    Disclose means to communicate any information identifying a patient 
as being or having been diagnosed with a substance use disorder, having 
or having had a substance use disorder, or being or having been referred 
for treatment of a substance use disorder either directly, by reference 
to publicly available information, or through verification of such 
identification by another person.
    Federally assisted--see Sec. 2.12(b).
    Informant means an individual:
    (1) Who is a patient or employee of a part 2 program or who becomes 
a patient or employee of a part 2 program at the request of a law 
enforcement agency or official; and
    (2) Who at the request of a law enforcement agency or official 
observes one or more patients or employees of the part 2 program for the 
purpose of reporting the information obtained to the law enforcement 
agency or official.
    Maintenance treatment means long-term pharmacotherapy for 
individuals

[[Page 11]]

with substance use disorders that reduces the pathological pursuit of 
reward and/or relief and supports remission of substance use disorder-
related symptoms.
    Member program means a withdrawal management 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 in a state that participates in data sharing with the central 
registry of the program in question.
    Minor, as used in the regulations in this part, means an individual 
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 18 years.
    Part 2 program means a federally assisted program (federally 
assisted as defined in Sec. 2.12(b) and program as defined in this 
section). See Sec. 2.12(e)(1) for examples.
    Part 2 program director means:
    (1) In the case of a part 2 program that is an individual, that 
individual.
    (2) In the case of a part 2 program that is an entity, the 
individual designated as director or managing director, or individual 
otherwise vested with authority to act as chief executive officer of the 
part 2 program.
    Patient means any individual who has applied for or been given 
diagnosis, treatment, or referral for treatment for a substance use 
disorder at a part 2 program. Patient includes any individual who, after 
arrest on a criminal charge, is identified as an individual with a 
substance use disorder in order to determine that individual's 
eligibility to participate in a part 2 program. This definition includes 
both current and former patients.
    Patient identifying information means the name, address, social 
security number, fingerprints, photograph, or similar information by 
which the identity of a patient, as defined in this section, can be 
determined with reasonable accuracy either directly or by reference to 
other information. The term does not include a number assigned to a 
patient by a part 2 program, for internal use only by the part 2 
program, if that number does not consist of or contain numbers (such as 
a social security, or driver's license number) that could be used to 
identify a patient with reasonable accuracy from sources external to the 
part 2 program.
    Person means an individual, partnership, corporation, federal, state 
or local government agency, or any other legal entity, (also referred to 
as ``individual or entity'').
    Program means:
    (1) An individual or entity (other than a general medical facility) 
who holds itself out as providing, and provides, substance use disorder 
diagnosis, treatment, or referral for treatment; or
    (2) An identified unit within a general medical facility that holds 
itself out as providing, and provides, substance use disorder diagnosis, 
treatment, or referral for treatment; or
    (3) Medical personnel or other staff in a general medical facility 
whose primary function is the provision of substance use disorder 
diagnosis, treatment, or referral for treatment and who are identified 
as such providers.
    Qualified service organization means an individual or entity who:
    (1) Provides services to a part 2 program, such as data processing, 
bill collecting, dosage preparation, laboratory analyses, or legal, 
accounting, population health management, medical staffing, 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
    (2) Has entered into a written agreement with a part 2 program under 
which that individual or entity:
    (i) Acknowledges that in receiving, storing, processing, or 
otherwise dealing with any patient records from the part 2 program, it 
is fully bound by the regulations in this part; and
    (ii) If necessary, will resist in judicial proceedings any efforts 
to obtain access to patient identifying information related to substance 
use disorder diagnosis, treatment, or referral for treatment except as 
permitted by the regulations in this part.
    Records means any information, whether recorded or not, created by, 
received, or acquired by a part 2 program relating to a patient (e.g., 
diagnosis, treatment and referral for treatment information, billing 
information,

[[Page 12]]

emails, voice mails, and texts). For the purpose of the regulations in 
this part, records include both paper and electronic records.
    Substance use disorder means a cluster of cognitive, behavioral, and 
physiological symptoms indicating that the individual continues using 
the substance despite significant substance-related problems such as 
impaired control, social impairment, risky use, and pharmacological 
tolerance and withdrawal. For the purposes of the regulations in this 
part, this definition does not include tobacco or caffeine use.
    Third-party payer means an individual or entity who pays and/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 the 
patient's family or on the basis of the patient's eligibility for 
federal, state, or local governmental benefits.
    Treating provider relationship means that, regardless of whether 
there has been an actual in-person encounter:
    (1) A patient is, agrees to, or is legally required to be diagnosed, 
evaluated, and/or treated, or agrees to accept consultation, for any 
condition by an individual or entity, and;
    (2) The individual or entity undertakes or agrees to undertake 
diagnosis, evaluation, and/or treatment of the patient, or consultation 
with the patient, for any condition.
    Treatment means the care of a patient suffering from a substance use 
disorder, a condition which is identified as having been caused by the 
substance use disorder, or both, in order to reduce or eliminate the 
adverse effects upon the patient.
    Undercover agent means any federal, state, or local law enforcement 
agency or official who enrolls in or becomes an employee of a part 2 
program for the purpose of investigating a suspected violation of law or 
who pursues that purpose after enrolling or becoming employed for other 
purposes.
    Withdrawal management means the use of pharmacotherapies to treat or 
attenuate the problematic signs and symptoms arising when heavy and/or 
prolonged substance use is reduced or discontinued.



Sec. 2.12  Applicability.

    (a) General--(1) Restrictions on disclosure. The restrictions on 
disclosure in the regulations in this part apply to any information, 
whether or not recorded, which:
    (i) Would identify a patient as having or having had a substance use 
disorder either directly, by reference to publicly available 
information, or through verification of such identification by another 
person; and
    (ii) Is drug abuse information obtained by a federally assisted drug 
abuse program after March 20, 1972 (part 2 program), or is alcohol abuse 
information obtained by a federally assisted alcohol abuse program after 
May 13, 1974 (part 2 program); or if obtained before the pertinent date, 
is maintained by a part 2 program after that date as part of an ongoing 
treatment episode which extends past that date; for the purpose of 
treating a substance use disorder, 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. 290dd-2(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 (part 2 program), or is alcohol abuse information 
obtained by a federally assisted alcohol abuse program after May 13, 
1974 (part 2 program); or if obtained before the pertinent date, is 
maintained by a part 2 program after that date as part of an ongoing 
treatment episode which extends past that date; for the purpose of 
treating a substance use disorder, making a diagnosis for the treatment, 
or making a referral for the treatment.
    (b) Federal assistance. A 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 (2) of this section relating to the 
Department of Veterans Affairs and the Armed Forces);
    (2) It is being carried out under a license, certification, 
registration, or

[[Page 13]]

other authorization granted by any department or agency of the United 
States including but not limited to:
    (i) Participating provider in the Medicare program;
    (ii) Authorization to conduct maintenance treatment or withdrawal 
management; or
    (iii) Registration to dispense a substance under the Controlled 
Substances Act to the extent the controlled substance is used in the 
treatment of substance use disorders;
    (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 
substance use disorder diagnosis, treatment, or referral for treatment; 
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 substance use disorder 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) Department of Veterans Affairs. These 
regulations do not apply to information on substance use disorder 
patients maintained in connection with the Department of Veterans 
Affairs' provision of hospital care, nursing home care, domiciliary 
care, and medical services under Title 38, U.S.C. Those records are 
governed by 38 U.S.C. 7332 and regulations issued under that authority 
by the Secretary of Veterans Affairs.
    (2) Armed Forces. The regulations in this part 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 those components of the Department of Veterans Affairs furnishing 
health care to veterans.
    (3) Communication within a part 2 program or between a part 2 
program and an entity having direct administrative control over that 
part 2 program. The restrictions on disclosure in the regulations in 
this part 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 patients with substance use disorders if the 
communications are:
    (i) Within a part 2 program; or
    (ii) Between a part 2 program and an entity that has direct 
administrative control over the program.
    (4) Qualified service organizations. The restrictions on disclosure 
in the regulations in this part do not apply to communications between a 
part 2 program and a qualified service organization of information 
needed by the qualified service organization to provide services to the 
program.
    (5) Crimes on part 2 program premises or against part 2 program 
personnel. The restrictions on disclosure and use in the regulations in 
this part do not apply to communications from part 2 program personnel 
to law enforcement agencies or officials which:
    (i) Are directly related to a patient's commission of a crime on the 
premises of the part 2 program or against part 2 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 the regulations in this part 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 substance use disorder 
patient records maintained by the part 2 program including their 
disclosure

[[Page 14]]

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 the regulations in this part 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 part 2 program, regardless of the status of the 
person obtaining the information or whether the information was obtained 
in accordance with the regulations in this part. 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--(i) Third-party payers, 
administrative entities, and others. The restrictions on disclosure in 
the regulations in this part apply to:
    (A) Third-party payers with regard to records disclosed to them by 
part 2 programs or under Sec. 2.31(a)(4)(iii)(A);
    (B) Entities having direct administrative control over part 2 
programs with regard to information that is subject to the regulations 
in this part communicated to them by the part 2 program under paragraph 
(c)(3) of this section; and
    (C) Individuals or entities who receive patient records directly 
from a part 2 program or other lawful holder of patient identifying 
information and who are notified of the prohibition on re-disclosure in 
accordance with Sec. 2.32.
    (ii) [Reserved]
    (e) Explanation of applicability--(1) Coverage. These regulations 
cover any information (including information on referral and intake) 
about patients receiving diagnosis, treatment, or referral for treatment 
for a substance use disorder created by a part 2 program. 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 providing, and provide substance use disorder 
diagnosis, treatment, or referral for treatment. However, the 
regulations in this part 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 substance use disorder diagnosis, treatment, or referral for 
treatment 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 substance 
use disorder diagnosis, treatment, or referral for treatment is not 
provided by a part 2 program, that patient's record is not covered by 
the regulations in this part. 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 paragraph (b) of this 
section. 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 the 
regulations in this part unless the program itself received federal 
assistance as defined by paragraph (b) of this section.
    (3) Information to which restrictions are applicable. Whether a 
restriction applies to use or disclosure affects the type of information 
which may be disclosed. The restrictions on disclosure apply to any 
information which would identify a patient as having or having had a 
substance use disorder. The restriction on use of information to bring 
criminal charges against a patient for a crime applies to any 
information obtained by the part 2 program for the purpose of diagnosis, 
treatment, or referral for treatment of patients with substance use 
disorders. (Note that restrictions on use and disclosure apply to 
recipients of information under paragraph (d) of this section.)

[[Page 15]]

    (4) How type of diagnosis affects coverage. These regulations cover 
any record of a diagnosis identifying a patient as having or having had 
a substance use disorder which is initially prepared by a part 2 
provider in connection with the treatment or referral for treatment of a 
patient with a substance use disorder. A diagnosis prepared for the 
purpose of treatment or referral for treatment but which is not so used 
is covered by the regulations in this part. The following are not 
covered by the regulations in this part:
    (i) Diagnosis which is made solely for the purpose of providing 
evidence for use by law enforcement agencies or officials; or
    (ii) A diagnosis of drug overdose or alcohol intoxication which 
clearly shows that the individual involved does not have a substance use 
disorder (e.g., involuntary ingestion of alcohol or drugs or reaction to 
a prescribed dosage of one or more drugs).



Sec. 2.13  Confidentiality restrictions and safeguards.

    (a) General. The patient records subject to the regulations in this 
part may be disclosed or used only as permitted by the regulations in 
this part 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 the 
regulations in this part 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 the regulations in this part apply whether or not 
the part 2 program or other lawful holder of the patient identifying 
information believes that the person seeking the information already has 
it, has other means of obtaining it, is a law enforcement agency or 
official or other government official, has obtained a subpoena, or 
asserts any other justification for a disclosure or use which is not 
permitted by the regulations in this part.
    (c) Acknowledging the presence of patients: Responding to requests. 
(1) The presence of an identified patient in a health care facility or 
component of a health care facility which is publicly identified as a 
place where only substance use disorder diagnosis, treatment, or 
referral for treatment is provided may be acknowledged only if the 
patient's written consent is obtained in accordance with subpart C of 
this part or if an authorizing court order is entered in accordance with 
subpart E of this part. The regulations permit acknowledgement of the 
presence of an identified patient in a health care facility or part of a 
health care facility if the health care facility is not publicly 
identified as only a substance use disorder diagnosis, treatment, or 
referral for treatment facility, and if the acknowledgement does not 
reveal that the patient has a substance use disorder.
    (2) Any answer to a request for a disclosure of patient records 
which is not permissible under the regulations in this part must be made 
in a way that will not affirmatively reveal that an identified 
individual has been, or is being, diagnosed or treated for a substance 
use disorder. An inquiring party may be provided a copy of the 
regulations in this part and advised that they restrict the disclosure 
of substance use disorder patient records, but may not be told 
affirmatively that the regulations restrict the disclosure of the 
records of an identified patient.
    (d) List of disclosures. Upon request, patients who have consented 
to disclose their patient identifying information using a general 
designation pursuant to Sec. 2.31(a)(4)(iii)(B)(3) must be provided a 
list of entities to which their information has been disclosed pursuant 
to the general designation.
    (1) Under this paragraph (d), patient requests:
    (i) Must be made in writing; and
    (ii) Are limited to disclosures made within the past two years;
    (2) Under this paragraph (d), the entity named on the consent form 
that discloses information pursuant to a patient's general designation 
(the entity that serves as an intermediary, as described in 
Sec. 2.31(a)(4)(iii)(B)) must:
    (i) Respond in 30 or fewer days of receipt of the written request; 
and
    (ii) Provide, for each disclosure, the name(s) of the entity(-ies) 
to which the disclosure was made, the date of the disclosure, and a 
brief description of

[[Page 16]]

the patient identifying information disclosed.
    (3) The part 2 program is not responsible for compliance with this 
paragraph (d); the entity that serves as an intermediary, as described 
in Sec. 2.31(a)(4)(iii)(B), is responsible for compliance with the list 
of disclosures requirement.



Sec. 2.14  Minor patients.

    (a) 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 substance use disorder treatment, any 
written consent for disclosure authorized under subpart C of this part 
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 part 2 
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.
    (b) State law requiring parental consent to treatment. (1) Where 
state law requires consent of a parent, guardian, or other individual 
for a minor to obtain treatment for a substance use disorder, any 
written consent for disclosure authorized under subpart C of this part 
must be given by both the minor and their parent, guardian, or other 
individual 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 individual 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 this part; or
    (ii) The minor lacks the capacity to make a rational choice 
regarding such consent as judged by the part 2 program director under 
paragraph (c) of this section.
    (c) Minor applicant for services lacks capacity for rational choice. 
Facts relevant to reducing a substantial threat to the life or physical 
well-being of the minor applicant or any other individual may be 
disclosed to the parent, guardian, or other individual authorized under 
state law to act in the minor's behalf if the part 2 program director 
judges that:
    (1) A minor applicant for services lacks capacity because of extreme 
youthor mental or physical condition to make a rational decision on 
whether to consent to a disclosure under subpart C of this part to their 
parent, guardian, or other individual authorized under state law to act 
in the minor's behalf; and
    (2) The minor applicant's situation poses a substantial threat to 
the life or physical well-being of the minor applicant or any other 
individual which may be reduced by communicating relevant facts to the 
minor's parent, guardian, or other individual 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 
their own affairs, any consent which is required under the regulations 
in this part may be given by the guardian or other individual authorized 
under state law to act in the patient's behalf.
    (2) No adjudication of incompetency. In the case of a patient, other 
than a minor or one who has been adjudicated incompetent, that for any 
period suffers from a medical condition that prevents knowing or 
effective action on their own behalf, the part 2 program director may 
exercise the right of the patient to consent to a disclosure under 
subpart C of this part 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

[[Page 17]]

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 having a substance use 
disorder is subject to the regulations in this part. 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 applicable state law 
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 records.

    (a) The part 2 program or other lawful holder of patient identifying 
information must have in place formal policies and procedures to 
reasonably protect against unauthorized uses and disclosures of patient 
identifying information and to protect against reasonably anticipated 
threats or hazards to the security of patient identifying information. 
These formal policies and procedures must address:
    (1) Paper records, including:
    (i) Transferring and removing such records;
    (ii) Destroying such records, including sanitizing the hard copy 
media associated with the paper printouts, to render the patient 
identifying information non-retrievable;
    (iii) Maintaining such records in a secure room, locked file 
cabinet, safe, or other similar container, or storage facility when not 
in use;
    (iv) Using and accessing workstations, secure rooms, locked file 
cabinets, safes, or other similar containers, and storage facilities 
that use or store such information; and
    (v) Rendering patient identifying information non-identifiable in a 
manner that creates a very low risk of re-identification (e.g., removing 
direct identifiers).
    (2) Electronic records, including:
    (i) Creating, receiving, maintaining, and transmitting such records;
    (ii) Destroying such records, including sanitizing the electronic 
media on which such records are stored, to render the patient 
identifying information non-retrievable;
    (iii) Using and accessing electronic records or other electronic 
media containing patient identifying information; and
    (iv) Rendering the patient identifying information non-identifiable 
in a manner that creates a very low risk of re-identification (e.g., 
removing direct identifiers).
    (b) [Reserved]



Sec. 2.17  Undercover agents and informants.

    (a) Restrictions on placement. Except as specifically authorized by 
a court order granted under Sec. 2.67, no part 2 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 part 2 program pursuant to an authorizing court 
order, may be used to criminally investigate or prosecute any patient.



Sec. 2.18  Restrictions on the use of identification cards.

    No person may require any patient to carry in their immediate 
possession while away from the part 2 program premises any card or other 
object which would identify the patient as having a substance use 
disorder. This section does not prohibit a person from requiring 
patients to use or carry cards or other identification objects on the 
premises of a part 2 program.



Sec. 2.19  Disposition of records by discontinued programs.

    (a) General. If a part 2 program discontinues operations or is taken 
over or acquired by another program, it must remove patient identifying 
information from its records or destroy its records, including 
sanitizing any associated hard copy or electronic media, to render the 
patient identifying information non-retrievable in a manner consistent 
with the policies and procedures established under Sec. 2.16, unless:

[[Page 18]]

    (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 part 2 program.
    (b) Special procedure where retention period required by law. If 
paragraph (a)(2) of this section applies:
    (1) Records, which are paper, must be:
    (i) 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]'';
    (A) All hard copy media from which the paper records were produced, 
such as printer and facsimile ribbons, drums, etc., must be sanitized to 
render the data non-retrievable; and
    (B) [Reserved]
    (ii) Held under the restrictions of the regulations in this part by 
a responsible person who must, as soon as practicable after the end of 
the required retention period specified on the label, destroy the 
records and sanitize any associated hard copy media to render the 
patient identifying information non-retrievable in a manner consistent 
with the discontinued program's or acquiring program's policies and 
procedures established under Sec. 2.16.
    (2) Records, which are electronic, must be:
    (i) Transferred to a portable electronic device with implemented 
encryption to encrypt the data at rest so that there is a low 
probability of assigning meaning without the use of a confidential 
process or key and implemented access controls for the confidential 
process or key; or
    (ii) Transferred, along with a backup copy, to separate electronic 
media, so that both the records and the backup copy have implemented 
encryption to encrypt the data at rest so that there is a low 
probability of assigning meaning without the use of a confidential 
process or key and implemented access controls for the confidential 
process or key; and
    (iii) Within one year of the discontinuation or acquisition of the 
program, all electronic media on which the patient records or patient 
identifying information resided prior to being transferred to the device 
specified in (i) above or the original and backup electronic media 
specified in (ii) above, including email and other electronic 
communications, must be sanitized to render the patient identifying 
information non-retrievable in a manner consistent with the discontinued 
program's or acquiring program's policies and procedures established 
under Sec. 2.16; and
    (iv) The portable electronic device or the original and backup 
electronic media must be:
    (A) Sealed in a container along with any equipment needed to read or 
access the information, and 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
    (B) Held under the restrictions of the regulations in this part by a 
responsible person who must store the container in a manner that will 
protect the information (e.g., climate controlled environment); and
    (v) The responsible person must be included on the access control 
list and be provided a means for decrypting the data. The responsible 
person must store the decryption tools on a device or at a location 
separate from the data they are used to encrypt or decrypt; and
    (vi) As soon as practicable after the end of the required retention 
period specified on the label, the portable electronic device or the 
original and backup electronic media must be sanitized to render the 
patient identifying information non-retrievable consistent with the 
policies established under Sec. 2.16.

[[Page 19]]



Sec. 2.20  Relationship to state laws.

    The statute authorizing the regulations in this part (42 U.S.C. 
290dd-2) does not preempt the field of law which they cover to the 
exclusion of all state laws in that field. If a disclosure permitted 
under the regulations in this part is prohibited under state law, 
neither the regulations in this part nor the authorizing statute may be 
construed to authorize any violation of that state law. However, no 
state law may either authorize or compel any disclosure prohibited by 
the regulations in this part.



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 the regulations in this part and 
by administrative action taken under section 502(c) of the Controlled 
Substances Act (21 U.S.C. 872(c) and the implementing regulations at 21 
CFR part 1316); or section 301(d) of the Public Health Service Act (42 
U.S.C. 241(d) and the implementing regulations at 42 CFR part 2a). 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 
this part of a court order authorizing a disclosure of information about 
a patient does not affect an exercise of authority under these research 
privilege statutes.



Sec. 2.22  Notice to patients of federal confidentiality requirements.

    (a) Notice required. At the time of admission to a part 2 program 
or, in the case that a patient does not have capacity upon admission to 
understand his or her medical status, as soon thereafter as the patient 
attains such capacity, each part 2 program shall:
    (1) Communicate to the patient that federal law and regulations 
protect the confidentiality of substance use disorder 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 
part 2 program may acknowledge that an individual is present or disclose 
outside the part 2 program information identifying a patient as having 
or having had a substance use disorder;
    (2) A statement that violation of the federal law and regulations by 
a part 2 program is a crime and that suspected violations may be 
reported to appropriate authorities consistent with Sec. 2.4, along with 
contact information;
    (3) A statement that information related to a patient's commission 
of a crime on the premises of the part 2 program or against personnel of 
the part 2 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; and
    (5) A citation to the federal law and regulations.
    (c) Program options. The part 2 program must devise a notice to 
comply with the requirement to provide the patient with a summary in 
writing of the federal law and regulations. In this written summary, the 
part 2 program also may include information concerning state law and any 
of the part 2 program's policies that are not inconsistent with state 
and federal law on the subject of confidentiality of substance use 
disorder patient records.

[[Page 20]]



Sec. 2.23  Patient access and restrictions on use.

    (a) Patient access not prohibited. These regulations do not prohibit 
a part 2 program from giving a patient access to their own records, 
including the opportunity to inspect and copy any records that the part 
2 program maintains about the patient. The part 2 program is not 
required to obtain a patient's written consent or other authorization 
under the regulations in this part 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 this 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 Consent



Sec. 2.31  Consent requirements.

    (a) Required elements for written consent. A written consent to a 
disclosure under the regulations in this part may be paper or electronic 
and must include:
    (1) The name of the patient.
    (2) The specific name(s) or general designation(s) of the part 2 
program(s), entity(ies), or individual(s) permitted to make the 
disclosure.
    (3) How much and what kind of information is to be disclosed, 
including an explicit description of the substance use disorder 
information that may be disclosed.
    (4)(i) The name(s) of the individual(s) to whom a disclosure is to 
be made; or
    (ii) Entities with a treating provider relationship with the 
patient. If the recipient entity has a treating provider relationship 
with the patient whose information is being disclosed, such as a 
hospital, a health care clinic, or a private practice, the name of that 
entity; or
    (iii) Entities without a treating provider relationship with the 
patient.
    (A) If the recipient entity does not have a treating provider 
relationship with the patient whose information is being disclosed and 
is a third-party payer, the name of the entity; or
    (B) If the recipient entity does not have a treating provider 
relationship with the patient whose information is being disclosed and 
is not covered by paragraph (a)(4)(iii)(A) of this section, such as an 
entity that facilitates the exchange of health information or a research 
institution, the name(s) of the entity(-ies); and
    (1) The name(s) of an individual participant(s); or
    (2) The name(s) of an entity participant(s) that has a treating 
provider relationship with the patient whose information is being 
disclosed; or
    (3) A general designation of an individual or entity participant(s) 
or class of participants that must be limited to a participant(s) who 
has a treating provider relationship with the patient whose information 
is being disclosed.
    (i) When using a general designation, a statement must be included 
on the consent form that the patient (or other individual authorized to 
sign in lieu of the patient), confirms their understanding that, upon 
their request and consistent with this part, they must be provided a 
list of entities to which their information has been disclosed pursuant 
to the general designation (see Sec. 2.13(d)).
    (ii) [Reserved]
    (5) The purpose of the disclosure. In accordance with Sec. 2.13(a), 
the disclosure must be limited to that information which is necessary to 
carry out the stated purpose.
    (6) A statement that the consent is subject to revocation at any 
time except to the extent that the part 2 program or other lawful holder 
of patient identifying information that is permitted 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
    (7) The date, event, or condition upon which the consent will expire 
if not revoked before. This date, event, or condition must ensure that 
the consent will last no longer than reasonably necessary to serve the 
purpose for which it is provided.

[[Page 21]]

    (8) The signature of the patient and, when required for a patient 
who is a minor, the signature of an individual authorized to give 
consent under Sec. 2.14; or, when required for a patient who is 
incompetent or deceased, the signature of an individual authorized to 
sign under Sec. 2.15. Electronic signatures are permitted to the extent 
that they are not prohibited by any applicable law.
    (9) The date on which the consent is signed.
    (b) 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 reasonable diligence could be known, by the 
individual or entity holding the records to be materially false.



Sec. 2.32  Prohibition on re-disclosure.

    (a) 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 information in 
this record that identifies a patient as having or having had a 
substance use disorder either directly, by reference to publicly 
available information, or through verification of such identification by 
another person unless further disclosure is expressly permitted by the 
written consent of the individual whose information is being disclosed 
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 (see Sec. 2.31). The federal rules restrict any use of the 
information to investigate or prosecute with regard to a crime any 
patient with a substance use disorder, except as provided at 
Secs. 2.12(c)(5) and 2.65.
    (b) [Reserved]



Sec. 2.33  Disclosures permitted with written consent.

    If a patient consents to a disclosure of their records under 
Sec. 2.31, a program may disclose those records in accordance with that 
consent to any person identified in the consent, except that disclosures 
to central registries and in connection with criminal justice referrals 
must meet the requirements of Secs. 2.34 and 2.35, respectively.



Sec. 2.34  Disclosures to prevent multiple enrollments.

    (a) Restrictions on disclosure. A part 2 program, as defined in 
Sec. 2.11, may disclose patient records to a central registry or to any 
withdrawal management or maintenance treatment program not more than 200 
miles away for the purpose of preventing the multiple enrollment of a 
patient only if:
    (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 withdrawal management or maintenance treatment 
program to which a disclosure will be made; and
    (ii) The consent may authorize a disclosure to any withdrawal 
management or maintenance treatment program established within 200 miles 
of the program, but does not need to individually name all programs.
    (b) Use of information limited to prevention of multiple 
enrollments. A central registry and any withdrawal management or 
maintenance treatment program to which information is disclosed to 
prevent multiple enrollments may not re-disclose or use patient 
identifying information for any purpose other than the prevention of 
multiple enrollments unless authorized by a

[[Page 22]]

court order under subpart E of this part.
    (c) 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 
enrollments.
    (d) Permitted disclosure by a withdrawal management or maintenance 
treatment program to prevent a multiple enrollment. A withdrawal 
management 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 enrollments.



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

    (a) A part 2 program may disclose information about a patient to 
those individuals within the criminal justice system who have made 
participation in the part 2 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 post-trial 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 part 2 program, the patient, and the 
individual(s) within the criminal justice system 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, 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 re-disclosure and use. An individual within the 
criminal justice system who receives patient information under this 
section may re-disclose and use it only to carry out that individual'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 to the extent necessary to meet a bona fide medical 
emergency in which the patient's prior informed consent cannot be 
obtained.
    (b) Special rule. Patient identifying information may be disclosed 
to medical personnel of the Food and Drug

[[Page 23]]

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 part 2 program 
shall document, in writing, the disclosure in the patient's records, 
including:
    (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).



Sec. 2.52  Research.

    (a) Notwithstanding other provisions of this part, including 
paragraph (b)(2) of this section, patient identifying information may be 
disclosed by the part 2 program or other lawful holder of part 2 data, 
for the purpose of conducting scientific research if the individual 
designated as director or managing director, or individual otherwise 
vested with authority to act as chief executive officer or their 
designee makes a determination that the recipient of the patient 
identifying information:
    (1) If a HIPAA-covered entity or business associate, has obtained 
and documented authorization from the patient, or a waiver or alteration 
of authorization, consistent with the HIPAA Privacy Rule at 45 CFR 
164.508 or 164.512(i), as applicable; or
    (2) If subject to the HHS regulations regarding the protection of 
human subjects (45 CFR part 46), either provides documentation that the 
researcher is in compliance with the requirements of the HHS 
regulations, including the requirements related to informed consent or a 
waiver of consent (45 CFR 46.111 and 46.116) or that the research 
qualifies for exemption under the HHS regulations (45 CFR 46.101(b) and 
any successor regulations; or
    (3) If both a HIPAA covered entity or business associate and subject 
to the HHS regulations regarding the protection of human subjects, has 
met the requirements of paragraphs (a)(1) and (2) of this section; and
    (4) If neither a HIPAA covered entity or business associate or 
subject to the HHS regulations regarding the protection of human 
subjects, this section does not apply.
    (b) Any individual or entity conducting scientific research using 
patient identifying information obtained under paragraph (a) of this 
section:
    (1) Is fully bound by the regulations in this part and, if 
necessary, will resist in judicial proceedings any efforts to obtain 
access to patient records except as permitted by the regulations in this 
part.
    (2) Must not re-disclose patient identifying information except back 
to the individual or entity from whom that patient identifying 
information was obtained or as permitted under paragraph (c) of this 
section.
    (3) May include part 2 data in research reports only in aggregate 
form in which patient identifying information has been rendered non-
identifiable such that the information cannot be re-identified and serve 
as an unauthorized means to identify a patient, directly or indirectly, 
as having or having had a substance use disorder.
    (4) Must maintain and destroy patient identifying information in 
accordance with the security policies and procedures established under 
Sec. 2.16.
    (5) Must retain records in compliance with applicable federal, 
state, and local record retention laws.
    (c) Data linkages--(1) Researchers. Any individual or entity 
conducting scientific research using patient identifying information 
obtained under paragraph (a) of this section that requests linkages to 
data sets from a data repository(-ies) holding patient identifying 
information must:
    (i) Have the request reviewed and approved by an Institutional 
Review Board (IRB) registered with the Department of Health and Human 
Services, Office for Human Research Protections in accordance with 45 
CFR part 46 to ensure that patient privacy

[[Page 24]]

is considered and the need for identifiable data is justified. Upon 
request, the researcher may be required to provide evidence of the IRB 
approval of the research project that contains the data linkage 
component.
    (ii) Ensure that patient identifying information obtained under 
paragraph (a) of this section is not provided to law enforcement 
agencies or officials.
    (2) Data repositories. For purposes of this section, a data 
repository is fully bound by the provisions of part 2 upon receipt of 
the patient identifying data and must:
    (i) After providing the researcher with the linked data, destroy or 
delete the linked data from its records, including sanitizing any 
associated hard copy or electronic media, to render the patient 
identifying information non-retrievable in a manner consistent with the 
policies and procedures established under Sec. 2.16 Security for 
records.
    (ii) Ensure that patient identifying information obtained under 
paragraph (a) of this section is not provided to law enforcement 
agencies or officials.
    (2) Except as provided in paragraph (c) of this section, a 
researcher may not redisclose patient identifying information for data 
linkages purposes.



Sec. 2.53  Audit and evaluation.

    (a) Records not copied or removed. If patient records are not 
downloaded, copied or removed from the part 2 program premises or 
forwarded electronically to another electronic system or device, patient 
identifying information, as defined in Sec. 2.11, may be disclosed in 
the course of a review of records on the part 2 program premises to any 
individual or entity who agrees in writing to comply with the 
limitations on re-disclosure and use in paragraph (d) of this section 
and who:
    (1) Performs the audit or evaluation on behalf of:
    (i) Any federal, state, or local government agency which provides 
financial assistance to the part 2 program or is authorized by law to 
regulate its activities; or
    (ii) Any individual or entity who provides financial assistance to 
the part 2 program, which is a third-party payer covering patients in 
the part 2 program, or which is a quality improvement organization 
performing a utilization or quality control review; or
    (2) Is determined by the part 2 program to be qualified to conduct 
an audit or evaluation of the part 2 program.
    (b) Copying, removing, downloading, or forwarding patient records. 
Records containing patient identifying information, as defined in 
Sec. 2.11, may be copied or removed from a part 2 program premises or 
downloaded or forwarded to another electronic system or device from the 
part 2 program's electronic records by any individual or entity who:
    (1) Agrees in writing to:
    (i) Maintain and destroy the patient identifying information in a 
manner consistent with the policies and procedures established under 
Sec. 2.16;
    (ii) Retain records in compliance with applicable federal, state, 
and local record retention laws; and
    (iii) Comply with the limitations on disclosure and use in paragraph 
(d) of this section; and
    (2) Performs the audit or evaluation on behalf of:
    (i) Any federal, state, or local government agency which provides 
financial assistance to the part 2 program or is authorized by law to 
regulate its activities; or
    (ii) Any individual or entity who provides financial assistance to 
the part 2 program, which is a third-party payer covering patients in 
the part 2 program, or which is a quality improvement organization 
performing a utilization or quality control review.
    (c) Medicare, Medicaid, Children's Health Insurance Program (CHIP), 
or related audit or evaluation. (1) Patient identifying information, as 
defined in Sec. 2.11, may be disclosed under paragraph (c) of this 
section to any individual or entity for the purpose of conducting a 
Medicare, Medicaid, or CHIP audit or evaluation, including an audit or 
evaluation necessary to meet the requirements for a Centers for Medicare 
& Medicaid Services (CMS)-regulated accountable care organization (CMS-
regulated ACO) or similar CMS-regulated organization (including a CMS-
regulated Qualified Entity (QE)), if the individual or entity agrees in 
writing to comply with the following:

[[Page 25]]

    (i) Maintain and destroy the patient identifying information in a 
manner consistent with the policies and procedures established under 
Sec. 2.16;
    (ii) Retain records in compliance with applicable federal, state, 
and local record retention laws; and
    (iii) Comply with the limitations on disclosure and use in paragraph 
(d) of this section.
    (2) A Medicare, Medicaid, or CHIP audit or evaluation under this 
section includes a civil or administrative investigation of a part 2 
program by any federal, state, or local government agency with oversight 
responsibilities for Medicare, Medicaid, or CHIP and includes 
administrative enforcement, against the part 2 program by the government 
agency, of any remedy authorized by law to be imposed as a result of the 
findings of the investigation.
    (3) An audit or evaluation necessary to meet the requirements for a 
CMS-regulated ACO or similar CMS-regulated organization (including a 
CMS-regulated QE) must be conducted in accordance with the following:
    (i) A CMS-regulated ACO or similar CMS-regulated organization 
(including a CMS-regulated QE) must:
    (A) Have in place administrative and/or clinical systems; and
    (B) Have in place a leadership and management structure, including a 
governing body and chief executive officer with responsibility for 
oversight of the organization's management and for ensuring compliance 
with and adherence to the terms and conditions of the Participation 
Agreement or similar documentation with CMS; and
    (ii) A CMS-regulated ACO or similar CMS-regulated organization 
(including a CMS-regulated QE) must have a signed Participation 
Agreement or similar documentation with CMS, which provides that the 
CMS-regulated ACO or similar CMS-regulated organization (including a 
CMS-regulated QE):
    (A) Is subject to periodic evaluations by CMS or its agents, or is 
required by CMS to evaluate participants in the CMS-regulated ACO or 
similar CMS-regulated organization (including a CMS-regulated QE) 
relative to CMS-defined or approved quality and/or cost measures;
    (B) Must designate an executive who has the authority to legally 
bind the organization to ensure compliance with 42 U.S.C. 290dd-2 and 
this part and the terms and conditions of the Participation Agreement in 
order to receive patient identifying information from CMS or its agents;
    (C) Agrees to comply with all applicable provisions of 42 U.S.C. 
290dd-2 and this part;
    (D) Must ensure that any audit or evaluation involving patient 
identifying information occurs in a confidential and controlled setting 
approved by the designated executive;
    (E) Must ensure that any communications or reports or other 
documents resulting from an audit or evaluation under this section do 
not allow for the direct or indirect identification (e.g., through the 
use of codes) of a patient as having or having had a substance use 
disorder; and
    (F) Must establish policies and procedures to protect the 
confidentiality of the patient identifying information consistent with 
this part, the terms and conditions of the Participation Agreement, and 
the requirements set forth in paragraph (c)(1) of this section.
    (4) Program, as defined in Sec. 2.11, 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)(2) of this section.
    (5) If a disclosure to an individual or entity is authorized under 
this section for a Medicare, Medicaid, or CHIP audit or evaluation, 
including a civil investigation or administrative remedy, as those terms 
are used in paragraph (c)(2) of this section, then a quality improvement 
organization which obtains the information under paragraph (a) or (b) of 
this section may disclose the information to that individual or entity 
but only for the purpose of conducting a Medicare, Medicaid, or CHIP 
audit or evaluation.
    (6) The provisions of this paragraph do not authorize the part 2 
program, the federal, state, or local government agency, or any other 
individual or entity to disclose or use patient identifying information 
obtained during the audit

[[Page 26]]

or evaluation for any purposes other than those necessary to complete 
the audit or evaluation as specified in paragraph (c) of this section.
    (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.



          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. 290dd-2 and the regulations in this 
part. 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 the regulations in this part.
    (b) Examples. (1) A person holding records subject to the 
regulations in this part receives a subpoena for those records. The 
person may not disclose the records in response to the subpoena unless a 
court of competent jurisdiction enters an authorizing order under the 
regulations in this part.
    (2) An authorizing court order is entered under the regulations in 
this part, but the person holding the records 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 holding the records must disclose, 
unless there is a valid legal defense to the process other than the 
confidentiality restrictions of the regulations in this part.



Sec. 2.62  Order not applicable to records disclosed without consent
to researchers, auditors and evaluators.

    A court order under the regulations in this part 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 the regulations in this part may authorize 
disclosure of confidential communications made by a patient to a part 2 
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 allegedly committed by the 
patient, 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 the applicant asserts

[[Page 27]]

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 written 
consent (meeting the requirements of the regulations in this part) to 
disclosure or the court has ordered the record of the proceeding sealed 
from public scrutiny.
    (b) Notice. The patient and the person holding the records from whom 
disclosure is sought must be provided:
    (1) Adequate notice in a manner which does 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 as described in Sec. 2.64(d).
    (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 manner which meets the written 
consent requirements of the regulations in this part. 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 investigate or prosecute a patient in connection with 
a criminal proceeding may be applied for by the person holding the 
records or by any law enforcement or prosecutorial officials who are 
responsible for 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 in 
addition to an order under this section, the person holding the records 
must be provided:
    (1) Adequate notice (in a manner which will not disclose patient 
identifying information to other persons) of an application by a law 
enforcement agency or official;
    (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 as described in Sec. 2.65(d); and
    (3) An opportunity to be represented by counsel independent of 
counsel for an applicant who is a law enforcement agency or official.
    (c) Review of evidence: Conduct of hearings. Any oral argument, 
review of

[[Page 28]]

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 part 2 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 law enforcement agency or official, that:
    (i) The person holding the records has been afforded the opportunity 
to be 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 the 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.



Sec. 2.66  Procedures and criteria for orders authorizing disclosure
and use of records to investigate or prosecute a part 2 program or 
the person holding the records.
          

    (a) Application. (1) An order authorizing the disclosure or use of 
patient records to investigate or prosecute a part 2 program or the 
person holding the records (or employees or agents of that part 2 
program or person holding the records) in connection with a criminal or 
administrative matter 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 part 2 program or the person holding 
the records (or agents or employees of the part 2 program or person 
holding the records) in which the applicant asserts 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 provided written consent (meeting the 
requirements of Sec. 2.31) 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 part 2 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 in accordance with 
Sec. 2.66(c).

[[Page 29]]

    (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.
    (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 in connection with 
a criminal matter, or be used as the basis for an application for an 
order under Sec. 2.65.



Sec. 2.67  Orders authorizing the use of undercover agents and
informants to investigate employees or agents of a part 2 program
in connection with a criminal matter.

    (a) Application. A court order authorizing the placement of an 
undercover agent or informant in a part 2 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 part 
2 program are engaged in criminal misconduct.
    (b) Notice. The part 2 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 in accordance 
with Sec. 2.67(c)), unless the application asserts that:
    (1) The part 2 program director is involved in the suspected 
criminal activities to be investigated by the undercover agent or 
informant; or
    (2) The part 2 program director will intentionally or 
unintentionally disclose the proposed placement of an undercover agent 
or informant to the employees or agents of the program 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 all of the following:
    (1) There is reason to believe that an employee or agent of the part 
2 program is engaged in criminal activity;
    (2) Other ways of obtaining evidence of the suspected 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 part 2 program outweigh the potential injury 
to patients of the part 2 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 part 2 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 investigate or prosecute employees or agents of the part 2 
program in connection with the suspected criminal activity; and
    (4) Include any other measures which are appropriate to limit any 
potential disruption of the part 2 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 in a part 2 program under this 
section may be used to investigate or prosecute any patient in 
connection with a criminal matter or as the basis for an application for 
an order under Sec. 2.65.



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.

[[Page 30]]

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-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.

[[Page 31]]

    (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 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 Secs. 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.

[[Page 32]]

    (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 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:

[[Page 33]]

    (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:
    (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

[[Page 34]]

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 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

[[Page 35]]

the names and other identifying characteristics of individuals who begin 
their participation as research subjects after the effective date of 
such termination. (See Sec. 2a.4(k) requiring researchers to notify 
subjects who enter the project after the termination of the 
Confidentiality Certificate of termination of the Certificate). The 
protection afforded by a Confidentiality Certificate is permanent with 
respect to subjects who participated in research during any time the 
authorization was in effect.



PART 3_PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT
--Table of Contents



                      Subpart A_General Provisions

Sec.
3.10  Purpose.
3.20  Definitions.

            Subpart B_PSO Requirements and Agency Procedures

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

 Subpart C_Confidentiality and Privilege Protections of Patient Safety 
                              Work Product

3.204  Privilege of patient safety work product.
3.206  Confidentiality of patient safety work product.
3.208  Continued protection of patient safety work product.
3.210  Required disclosure of patient safety work product to the 
          Secretary.
3.212  Nonidentification of patient safety work product.

                      Subpart D_Enforcement Program

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

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

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



                      Subpart A_General Provisions



Sec. 3.10  Purpose.

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



Sec. 3.20  Definitions.

    As used in this part, the terms listed alphabetically below have the 
meanings set forth as follows:
    Affiliated provider means, with respect to a provider, a legally 
separate provider that is the parent organization of the provider, is 
under common ownership, management, or control with the provider, or is 
owned, managed, or controlled by the provider.

[[Page 36]]

    AHRQ stands for the Agency for Healthcare Research and Quality in 
HHS.
    ALJ stands for an Administrative Law Judge of HHS.
    Board means the members of the HHS Departmental Appeals Board, in 
the Office of the Secretary, which issues decisions in panels of three.
    Bona fide contract means:
    (1) A written contract between a provider and a PSO that is executed 
in good faith by officials authorized to execute such contract; or
    (2) A written agreement (such as a memorandum of understanding or 
equivalent recording of mutual commitments) between a Federal, State, 
local, or Tribal provider and a Federal, State, local, or Tribal PSO 
that is executed in good faith by officials authorized to execute such 
agreement.
    Complainant means a person who files a complaint with the Secretary 
pursuant to Sec. 3.306.
    Component organization means an entity that:
    (1) Is a unit or division of a legal entity (including a 
corporation, partnership, or a Federal, State, local or Tribal agency or 
organization); or
    (2) Is owned, managed, or controlled by one or more legally separate 
parent organizations.
    Component PSO means a PSO listed by the Secretary that is a 
component organization.
    Confidentiality provisions means for purposes of subparts C and D, 
any requirement or prohibition concerning confidentiality established by 
sections 921 and 922(b)-(d), (g) and (i) of the Public Health Service 
Act, 42 U.S.C. 299b-21, 299b-22(b)-(d), (g) and (i) and the provisions, 
at Secs. 3.206 and 3.208, that implement the statutory prohibition on 
disclosure of identifiable patient safety work product.
    Disclosure means the release, transfer, provision of access to, or 
divulging in any other manner of patient safety work product by:
    (1) An entity or natural person holding the patient safety work 
product to another legally separate entity or natural person, other than 
a workforce member of, or a health care provider holding privileges 
with, the entity holding the patient safety work product; or
    (2) A component PSO to another entity or natural person outside the 
component PSO and within the legal entity of which the component PSO is 
a part.
    Entity means any organization or organizational unit, regardless of 
whether the organization is public, private, for-profit, or not-for-
profit.
    Group health plan means an employee welfare benefit plan (as defined 
in section 3(1) of the Employee Retirement Income Security Act of 1974 
(ERISA)) to the extent that the plan provides medical care (as defined 
in paragraph (2) of section 2791(a) of the Public Health Service Act, 
including items and services paid for as medical care) to employees or 
their dependents (as defined under the terms of the plan) directly or 
through insurance, reimbursement, or otherwise.
    Health insurance issuer means an insurance company, insurance 
service, or insurance organization (including a health maintenance 
organization, as defined in 42 U.S.C. 300gg-91(b)(3)) which is licensed 
to engage in the business of insurance in a State and which is subject 
to State law which regulates insurance (within the meaning of 29 U.S.C. 
1144(b)(2)). This term does not include a group health plan.
    Health maintenance organization means:
    (1) A Federally qualified health maintenance organization (HMO) (as 
defined in 42 U.S.C. 300e(a));
    (2) An organization recognized under State law as a health 
maintenance organization; or
    (3) A similar organization regulated under State law for solvency in 
the same manner and to the same extent as such a health maintenance 
organization.
    HHS stands for the United States Department of Health and Human 
Services.
    HIPAA Privacy Rule means the regulations promulgated under section 
264(c) of the Health Insurance Portability and Accountability Act of 
1996 (HIPAA), at 45 CFR part 160 and subparts A and E of part 164.
    Identifiable patient safety work product means patient safety work 
product that:

[[Page 37]]

    (1) Is presented in a form and manner that allows the identification 
of any provider that is a subject of the work product, or any providers 
that participate in, or are responsible for, activities that are a 
subject of the work product;
    (2) Constitutes individually identifiable health information as that 
term is defined in the HIPAA Privacy Rule at 45 CFR 160.103; or
    (3) Is presented in a form and manner that allows the identification 
of an individual who in good faith reported information directly to a 
PSO or to a provider with the intention of having the information 
reported to a PSO (``reporter'').
    Nonidentifiable patient safety work product means patient safety 
work product that is not identifiable patient safety work product in 
accordance with the nonidentification standards set forth at Sec. 3.212.
    OCR stands for the Office for Civil Rights in HHS.
    Parent organization means an organization that: owns a controlling 
interest or a majority interest in a component organization; has the 
authority to control or manage agenda setting, project management, or 
day-to-day operations; or the authority to review and override decisions 
of a component organization. The component organization may be a 
provider.
    Patient Safety Act means the Patient Safety and Quality Improvement 
Act of 2005 (Pub. L. 109-41), which amended Title IX of the Public 
Health Service Act (42 U.S.C. 299 et seq.) by inserting a new Part C, 
sections 921 through 926, which are codified at 42 U.S.C. 299b-21 
through 299b-26.
    Patient safety activities means the following activities carried out 
by or on behalf of a PSO or a provider:
    (1) Efforts to improve patient safety and the quality of health care 
delivery;
    (2) The collection and analysis of patient safety work product;
    (3) The development and dissemination of information with respect to 
improving patient safety, such as recommendations, protocols, or 
information regarding best practices;
    (4) The utilization of patient safety work product for the purposes 
of encouraging a culture of safety and of providing feedback and 
assistance to effectively minimize patient risk;
    (5) The maintenance of procedures to preserve confidentiality with 
respect to patient safety work product;
    (6) The provision of appropriate security measures with respect to 
patient safety work product;
    (7) The utilization of qualified staff; and
    (8) Activities related to the operation of a patient safety 
evaluation system and to the provision of feedback to participants in a 
patient safety evaluation system.
    Patient safety evaluation system means the collection, management, 
or analysis of information for reporting to or by a PSO.
    Patient safety organization (PSO) means a private or public entity 
or component thereof that is listed as a PSO by the Secretary in 
accordance with subpart B. A health insurance issuer or a component 
organization of a health insurance issuer may not be a PSO. See also the 
exclusions in Sec. 3.102 of this part.
    Patient safety work product:
    (1) Except as provided in paragraph (2) of this definition, patient 
safety work product means any data, reports, records, memoranda, 
analyses (such as root cause analyses), or written or oral statements 
(or copies of any of this material)
    (i) Which could improve patient safety, health care quality, or 
health care outcomes; and
    (A) Which are assembled or developed by a provider for reporting to 
a PSO and are reported to a PSO, which includes information that is 
documented as within a patient safety evaluation system for reporting to 
a PSO, and such documentation includes the date the information entered 
the patient safety evaluation system; or
    (B) Are developed by a PSO for the conduct of patient safety 
activities; or
    (ii) Which identify or constitute the deliberations or analysis of, 
or identify the fact of reporting pursuant to, a patient safety 
evaluation system.
    (2)(i) Patient safety work product does not include a patient's 
medical record, billing and discharge information, or any other original 
patient or

[[Page 38]]

provider information; nor does it include information that is collected, 
maintained, or developed separately, or exists separately, from a 
patient safety evaluation system. Such separate information or a copy 
thereof reported to a PSO shall not by reason of its reporting be 
considered patient safety work product.
    (ii) Patient safety work product assembled or developed by a 
provider for reporting to a PSO may be removed from a patient safety 
evaluation system and no longer considered patient safety work product 
if:
    (A) The information has not yet been reported to a PSO; and
    (B) The provider documents the act and date of removal of such 
information from the patient safety evaluation system.
    (iii) Nothing in this part shall be construed to limit information 
that is not patient safety work product from being:
    (A) Discovered or admitted in a criminal, civil or administrative 
proceeding;
    (B) Reported to a Federal, State, local or Tribal governmental 
agency for public health or health oversight purposes; or
    (C) Maintained as part of a provider's recordkeeping obligation 
under Federal, State, local or Tribal law.
    Person means a natural person, trust or estate, partnership, 
corporation, professional association or corporation, or other entity, 
public or private.
    Provider means:
    (1) An individual or entity licensed or otherwise authorized under 
State law to provide health care services, including--
    (i) A hospital, nursing facility, comprehensive outpatient 
rehabilitation facility, home health agency, hospice program, renal 
dialysis facility, ambulatory surgical center, pharmacy, physician or 
health care practitioner's office (includes a group practice), long term 
care facility, behavior health residential treatment facility, clinical 
laboratory, or health center; or
    (ii) A physician, physician assistant, registered nurse, nurse 
practitioner, clinical nurse specialist, certified registered nurse 
anesthetist, certified nurse midwife, psychologist, certified social 
worker, registered dietitian or nutrition professional, physical or 
occupational therapist, pharmacist, or other individual health care 
practitioner;
    (2) Agencies, organizations, and individuals within Federal, State, 
local, or Tribal governments that deliver health care, organizations 
engaged as contractors by the Federal, State, local, or Tribal 
governments to deliver health care, and individual health care 
practitioners employed or engaged as contractors by the Federal State, 
local, or Tribal governments to deliver health care; or
    (3) A parent organization of one or more entities described in 
paragraph (1)(i) of this definition or a Federal, State, local, or 
Tribal government unit that manages or controls one or more entities 
described in paragraphs (1)(i) or (2) of this definition.
    Research has the same meaning as the term is defined in the HIPAA 
Privacy Rule at 45 CFR 164.501.
    Respondent means a provider, PSO, or responsible person who is the 
subject of a complaint or a compliance review.
    Responsible person means a person, other than a provider or a PSO, 
who has possession or custody of identifiable patient safety work 
product and is subject to the confidentiality provisions.
    Workforce means employees, volunteers, trainees, contractors, or 
other persons whose conduct, in the performance of work for a provider, 
PSO or responsible person, is under the direct control of such provider, 
PSO or responsible person, whether or not they are paid by the provider, 
PSO or responsible person.



            Subpart B_PSO Requirements and Agency Procedures



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

    (a) Eligibility and process for initial and continued listing--(1) 
Submission of certification. Any entity, except as specified in 
paragraph (a)(2) of this section, may request from the Secretary an 
initial or continued listing as a PSO by submitting a completed 
certification form that meets the requirements of

[[Page 39]]

this section, in accordance with Sec. 3.112. An individual with 
authority to make commitments on behalf of the entity seeking listing 
will be required to submit contact information for the entity and:
    (i) Attest that the entity is not subject to any exclusion in 
paragraph (a)(2) of this section;
    (ii) Provide certifications that the entity meets each requirement 
for PSOs in paragraph (b) of this section;
    (iii) If the entity is a component of another organization, provide 
the additional certifications that the entity meets the requirements of 
paragraph (c)(1)(i) of this section;
    (iv) If the entity is a component of an excluded entity described in 
paragraph (a)(2)(ii), provide the additional certifications and 
information required by paragraph (c)(1)(ii) of this section;
    (v) Attest that the entity has disclosed if the Secretary has ever 
delisted this entity (under its current name or any other) or refused to 
list the entity or whether any of its officials or senior managers held 
comparable positions of responsibility in an entity that was denied 
listing or delisted and, if any of these circumstances apply, submit 
with its certifications and related disclosures, the name of the entity 
or entities that the Secretary declined to list or delisted;
    (vi) Attest that the PSO will promptly notify the Secretary during 
its period of listing if it can no longer comply with any of its 
attestations and the applicable requirements in Secs. 3.102(b) and 
3.102(c) or if there have been any changes in the accuracy of the 
information submitted for listing, along with the pertinent changes; and
    (vii) Provide other information that the Secretary determines to be 
necessary to make the requested listing determination.
    (2) Exclusion of certain entities. The following types of entities 
may not seek listing as a PSO:
    (i) A health insurance issuer; a unit or division of a health 
insurance issuer; or an entity that is owned, managed, or controlled by 
a health insurance issuer;
    (ii)(A) An entity that accredits or licenses health care providers;
    (B) An entity that oversees or enforces statutory or regulatory 
requirements governing the delivery of health care services;
    (C) An agent of an entity that oversees or enforces statutory or 
regulatory requirements governing the delivery of health care services; 
or
    (D) An entity that operates a Federal, state, local or Tribal 
patient safety reporting system to which health care providers (other 
than members of the entity's workforce or health care providers holding 
privileges with the entity) are required to report information by law or 
regulation.
    (iii) A component of an entity listed in paragraph (a)(2)(ii) may 
seek listing as a component PSO subject to the requirements and 
restrictions of paragraph (c)(1)(ii) of this section.
    (3) Submission of certification for continued listing. To facilitate 
a timely Secretarial determination regarding acceptance of its 
certification for continued listing, a PSO must submit the required 
certification no later than 75 days before the expiration of a PSO's 
three-year period of listing.
    (b) Fifteen general PSO certification requirements. The 
certifications submitted to the Secretary in accordance with paragraph 
(a)(1)(ii) of this section must conform to the following 15 
requirements:
    (1) Required certification regarding eight patient safety 
activities--(i) Initial listing. An entity seeking initial listing as a 
PSO must certify that it has written policies and procedures in place to 
perform each of the eight patient safety activities, defined in 
Sec. 3.20. With respect to paragraphs (5) and (6) in the definition of 
patient safety activities regarding confidentiality and security, the 
policies and procedures must include and provide for:
    (A) Compliance with the confidentiality provisions of subpart C of 
this part and with appropriate security measures as required by 
Sec. 3.106 of this subpart.
    (B) Notification of each provider that submitted patient safety work 
product or data as described in Sec. 3.108(b)(2) to the entity if the 
submitted work product or data was subject to an unauthorized disclosure 
or its security was breached.
    (ii) Continued Listing. A PSO seeking continued listing must certify 
that it

[[Page 40]]

is performing, and will continue to perform, each of the patient safety 
activities defined in Sec. 3.20, and is and will continue to comply with 
the requirements of paragraphs (b)(1)(i)(A) and (B) of this section.
    (2) Required certification regarding seven PSO criteria--(i) Initial 
Listing. In its initial certification submission, an entity must also 
certify that, if listed as a PSO, it will comply with the seven 
requirements in paragraphs (b)(2)(i)(A) through (G) of this section.
    (A) The mission and primary activity of the PSO must be to conduct 
activities that are to improve patient safety and the quality of health 
care delivery.
    (B) The PSO must have appropriately qualified workforce members, 
including licensed or certified medical professionals.
    (C) The PSO, within the 24-month period that begins on the date of 
its initial listing as a PSO, and within each sequential 24-month period 
thereafter, must have 2 bona fide contracts, each of a reasonable period 
of time, each with a different provider for the purpose of receiving and 
reviewing patient safety work product.
    (D) The PSO is not a health insurance issuer, and is not a component 
of a health insurance issuer.
    (E) The PSO must make disclosures to the Secretary as required under 
Sec. 3.102(d), in accordance with Sec. 3.112 of this subpart.
    (F) To the extent practical and appropriate, the PSO must collect 
patient safety work product from providers in a standardized manner that 
permits valid comparisons of similar cases among similar providers.
    (G) The PSO must utilize patient safety work product for the purpose 
of providing direct feedback and assistance to providers to effectively 
minimize patient risk.
    (ii) Continued Listing. A PSO seeking continued listing must certify 
that it is complying with, and will continue to comply with, the 
requirements of paragraphs (b)(2)(i)(A) through (G) of this section.
    (iii) Compliance with the criterion for collecting patient safety 
work product in a standardized manner to the extent practical and 
appropriate. With respect to paragraph (b)(2)(i)(F) of this section, the 
Secretary will assess compliance by a PSO in the following manner.
    (A) A PSO seeking continued listing must:
    (1) Certify that the PSO is using the Secretary's published guidance 
for common formats and definitions in its collection of patient safety 
work product (option (I));
    (2) Certify that the PSO is using an alternative system of formats 
and definitions that permits valid comparisons of similar cases among 
similar providers (option (II)); or
    (3) Provide a clear explanation for why it is not practical or 
appropriate for the PSO to comply with options (I) or (II) at this time.
    (B) The Secretary will consider a PSO to be in compliance if the 
entity complies with option (I), satisfactorily demonstrates that option 
(II) permits valid comparisons of similar cases among similar providers, 
or satisfactorily demonstrates that it is not practical or appropriate 
for the PSO to comply with options (I) or (II) at this time.
    (c) Additional certifications required of component organizations--
(1) Requirements when seeking listing--(i) Requirements that all 
component organizations must meet. In addition to meeting the 15 general 
PSO certification requirements of paragraph (b) of this section, an 
entity seeking initial listing that is a component of another 
organization must certify that it will comply with the requirements of 
paragraph (c)(2) of this section. A component PSO seeking continued 
listing must certify that it is complying with, and will continue to 
comply with, the requirements of this same paragraph (c)(2). At initial 
and continued listing, a component entity must attach to its 
certifications for listing contact information for its parent 
organization(s).
    (ii) Additional requirements and limitations applicable to 
components of entities that are excluded from listing. In addition to 
the requirements under paragraph (c)(1)(i) of this section, a component 
of an organization excluded from listing under paragraph (a)(2)(ii) of 
this section must submit the additional certifications and specified 
information for initial and continued listing and

[[Page 41]]

comply with paragraph (c)(4) of this section.
    (2) Required component certifications--(i) Separation of patient 
safety work product. A component PSO must maintain patient safety work 
product separately from the rest of the parent organization(s) of which 
it is a part, and establish appropriate security measures to maintain 
the confidentiality of patient safety work product. The information 
system in which the component PSO maintains patient safety work product 
must not permit unauthorized access by one or more individuals in, or by 
units of, the rest of the parent organization(s) of which it is a part.
    (ii) Nondisclosure of patient safety work product. A component PSO 
must require that members of its workforce and any other contractor 
staff not make unauthorized disclosures of patient safety work product 
to the rest of the parent organization(s) of which it is a part.
    (iii) No conflict of interest. The pursuit of the mission of a 
component PSO must not create a conflict of interest with the rest of 
the parent organization(s) of which it is a part.
    (3) Written agreements for assisting a component PSO in the conduct 
of patient safety activities. Notwithstanding the requirements of 
paragraph (c)(2) of this section, a component PSO may provide access to 
identifiable patient safety work product to one or more individuals in, 
or to one or more units of, the rest of the parent organization(s) of 
which it is a part, if the component PSO enters into a written agreement 
with such individuals or units which requires that:
    (i) The component PSO will only provide access to identifiable 
patient safety work product to enable such individuals or units to 
assist the component PSO in its conduct of patient safety activities, 
and
    (ii) Such individuals or units that receive access to identifiable 
patient safety work product pursuant to such written agreement will only 
use or disclose such information as specified by the component PSO to 
assist the component PSO in its conduct of patient safety activities, 
will take appropriate security measures to prevent unauthorized 
disclosures and will comply with the other certifications the component 
has made pursuant to paragraph (c)(2) of this section regarding 
unauthorized disclosures and conducting the mission of the PSO without 
creating conflicts of interest.
    (4) Required attestations, information and operational limitations 
for components of entities excluded from listing. A component 
organization of an entity that is subject to the restrictions of 
paragraph (a)(2)(ii) of this section must:
    (i) Submit the following information with its certifications for 
listing:
    (A) A statement describing its parent organization's role, and the 
scope of the parent organization's authority, with respect to any of the 
following that apply: Accreditation or licensure of health care 
providers, oversight or enforcement of statutory or regulatory 
requirements governing the delivery of health care services, serving as 
an agent of such a regulatory oversight or enforcement authority, or 
administering a public mandatory patient safety reporting system;
    (B) An attestation that the parent organization has no policies or 
procedures that would require or induce providers to report patient 
safety work product to their component organization once listed as a PSO 
and that the component PSO will notify the Secretary within 5 calendar 
days of the date on which the component organization has knowledge of 
the adoption by the parent organization of such policies or procedures, 
and an acknowledgment that the adoption of such policies or procedures 
by the parent organization during the component PSO's period of listing 
will result in the Secretary initiating an expedited revocation process 
in accordance with Sec. 3.108(e); and
    (C) An attestation that the component organization will prominently 
post notification on its Web site and publish in any promotional 
materials for dissemination to providers, a summary of the information 
that is required by paragraph (c)(4)(i)(A) of this section.
    (ii) Comply with the following requirements during its period of 
listing:
    (A) The component organization may not share staff with its parent 
organization(s).

[[Page 42]]

    (B) The component organization may enter into a written agreement 
pursuant to paragraph (c)(3) but such agreements are limited to units or 
individuals of the parent organization(s) whose responsibilities do not 
involve the activities specified in the restrictions in paragraph 
(a)(2)(ii) of this section.
    (d) Required notifications. Upon listing, PSOs must meet the 
following notification requirements:
    (1) Notification regarding PSO compliance with the minimum contract 
requirement. No later than 45 calendar days prior to the last day of the 
pertinent 24-month assessment period, specified in paragraph 
(b)(2)(iii)(C) of this section, the Secretary must receive from a PSO a 
certification that states whether it has met the requirement of that 
paragraph regarding two bona fide contracts, submitted in accordance 
with Sec. 3.112 of this subpart.
    (2) Notification regarding a PSO's relationships with its 
contracting providers--(i) Requirement. A PSO must file a disclosure 
statement regarding a provider with which it has a contract that 
provides the confidentiality and privilege protections of the Patient 
Safety Act (hereinafter referred to as a Patient Safety Act contract) if 
the PSO has any other relationships with this provider that are 
described in paragraphs (d)(2)(i)(A) through (D) of this section. The 
PSO must disclose all such relationships. A disclosure statement is not 
required if all of its other relationships with the provider are limited 
to Patient Safety Act contracts.
    (A) The provider and PSO have current contractual relationships, 
other than those arising from any Patient Safety Act contracts, 
including formal contracts or agreements that impose obligations on the 
PSO.
    (B) The provider and PSO have current financial relationships other 
than those arising from any Patient Safety Act contracts. A financial 
relationship may include any direct or indirect ownership or investment 
relationship between the PSO and the contracting provider, shared or 
common financial interests or direct or indirect compensation 
arrangements whether in cash or in-kind.
    (C) The PSO and provider have current reporting relationships other 
than those arising from any Patient Safety Act contracts, by which the 
provider has access to information regarding the work and operation of 
the PSO that is not available to other contracting providers.
    (D) Taking into account all relationships that the PSO has with the 
provider, the PSO is not independently managed or controlled, or the PSO 
does not operate independently from, the contracting provider.
    (ii) Content. A PSO must submit to the Secretary the required 
attestation form for disclosures with the information specified below in 
accordance with Sec. 3.112 and this section. The substantive information 
that must be included with each submission has two required parts:
    (A) The Required Disclosures. The first part of the substantive 
information must provide a succinct list of obligations between the PSO 
and the contracting provider apart from their Patient Safety Act 
contract(s) that create, or contain, any of the types of relationships 
that must be disclosed based upon the requirements of paragraphs 
(d)(2)(i)(A) through (D) of this section. Each reportable obligation or 
discrete set of obligations that the PSO has with this contracting 
provider should be listed only once; noting the specific aspects of the 
obligation(s) that reflect contractual or financial relationships, 
involve access to information that is not available to other providers, 
or affect the independence of PSO operations, management, or control.
    (B) An Explanatory Narrative. The second required part of the 
substantive information must provide a brief explanatory narrative 
succinctly describing: The policies and procedures that the PSO has in 
place to ensure adherence to objectivity and professionally recognized 
analytic standards in the assessments it undertakes; and any other 
policies or procedures, or agreements with this provider, that the PSO 
has in place to ensure that it can fairly and accurately perform patient 
safety activities.

[[Page 43]]

    (iii) Deadlines for submission. The Secretary must receive a 
disclosure statement within 45 days of the date on which a PSO enters a 
contract with a provider if the circumstances described in any of the 
paragraphs (d)(2)(i)(A) through (D) of this section are met on the date 
the contract is entered. During the contract period, if these 
circumstances subsequently arise, the Secretary must receive a 
disclosure statement from the PSO within 45 days of the date that any 
disclosure requirement in paragraph (d)(2)(i) of this section first 
applies.



Sec. 3.104  Secretarial actions.

    (a) Actions in response to certification submissions for initial and 
continued listing as a PSO. (1) In response to an initial or continued 
certification submission by an entity, pursuant to the requirements of 
Sec. 3.102 of this subpart, the Secretary may--
    (i) Accept the certification submission and list the entity as a 
PSO, or maintain the listing of a PSO, if the Secretary determines that 
the entity meets the applicable requirements of the Patient Safety Act 
and this subpart;
    (ii) Deny acceptance of a certification submission and, in the case 
of a currently listed PSO, remove the entity from the list if the entity 
does not meet the applicable requirements of the Patient Safety Act and 
this subpart; or
    (iii) Condition the listing of an entity or the continued listing of 
a PSO, following a determination made pursuant to paragraph (c) of this 
section or a determination after review of the pertinent history of an 
entity that has been delisted or refused listing and its officials and 
senior managers.
    (2) Basis for determination. In making a determination regarding 
listing, the Secretary will consider the certification submission; any 
prior actions by the Secretary regarding the entity or PSO including 
delisting; any history of or current non-compliance by the entity or the 
PSO or its officials or senior managers with statutory or regulatory 
requirements or requests from the Secretary; the relationships of the 
entity or PSO with providers; and any findings made by the Secretary in 
accordance with paragraph (c) of this section.
    (3) Notification. The Secretary will notify in writing each entity 
of action taken on its certification submission for initial or continued 
listing. The Secretary will provide reasons when an entity's 
certification is conditionally accepted and the entity is conditionally 
listed, when an entity's certification is not accepted and the entity is 
not listed, or when acceptance of its certification is revoked and the 
entity is delisted.
    (b) Actions regarding PSO compliance with the minimum contract 
requirement. After the date on which the Secretary, under 
Sec. 3.102(d)(1) of this subpart, must receive notification regarding 
compliance of a PSO with the minimum contract requirement--
    (1) If the PSO has met the minimum contract requirement, the 
Secretary will acknowledge in writing receipt of the notification and 
add information to the list established pursuant to paragraph (d) of 
this section stating that the PSO has certified that it has met the 
requirement.
    (2) If the PSO states that it has not yet met the minimum contract 
requirement by the date specified in Sec. 3.102(d)(1), or if notice is 
not received by that date, the Secretary will issue to the PSO a notice 
of a preliminary finding of deficiency as specified in Sec. 3.108(a)(2) 
and establish a period for correction that extends until midnight of the 
last day of the PSO's applicable 24-month period of assessment. 
Thereafter, if the requirement has not been met, the Secretary will 
provide the PSO a written notice of proposed revocation and delisting in 
accordance with Sec. 3.108(a)(3).
    (c) Actions regarding required disclosures by PSOs of relationships 
with contracting providers. The Secretary will review and make findings 
regarding each disclosure statement submitted by a PSO, pursuant to 
Sec. 3.102(d)(2), regarding its relationships with contracting 
provider(s), determine whether such findings warrant action regarding 
the listing of the PSO in accordance with paragraph (c)(2) of this 
section, and make the findings public.

[[Page 44]]

    (1) Basis of findings regarding PSO disclosure statements. In 
reviewing disclosure statements, submitted pursuant to Sec. 3.102(d)(2) 
of this subpart, the Secretary will consider the disclosed 
relationship(s) between the PSO and the contracting provider and the 
statements and material submitted by the PSO describing the policies and 
procedures that the PSO has in place to determine whether the PSO can 
fairly and accurately perform the required patient safety activities.
    (2) Determination by the Secretary. Based on the Secretary's review 
and findings, he may choose to take any of the following actions:
    (i) For an entity seeking an initial or continued listing, the 
Secretary may list or continue the listing of an entity without 
conditions, list the entity subject to conditions, or deny the entity's 
certification for initial or continued listing; or
    (ii) For a listed PSO, the Secretary may determine that the entity 
will remain listed without conditions, continue the entity's listing 
subject to conditions, or remove the entity from the list of PSOs.
    (3) Release of disclosure statements and Secretarial findings. (i) 
Subject to paragraph (c)(3)(ii) of this section, the Secretary will make 
disclosure statements available to the public along with related 
findings that are made available in accordance with paragraph (c) of 
this section.
    (ii) The Secretary may withhold information that is exempt from 
public disclosure under the Freedom of Information Act, e.g., trade 
secrets or confidential commercial information that are subject to the 
restrictions of 18 U.S.C. 1905.
    (d) Maintaining a list of PSOs. The Secretary will compile and 
maintain a publicly available list of entities whose certifications as 
PSOs have been accepted. The list will include contact information for 
each entity, a copy of all certification forms and disclosure statements 
submitted by each entity in accordance with paragraph (c)(3)(ii) of this 
section, the effective date of the PSO's listing, and information on 
whether a PSO has certified that it has met the two contract 
requirement. The list also will include a copy of the Secretary's 
findings regarding each disclosure statement submitted by an entity, 
information describing any related conditions that have been placed by 
the Secretary on the listing of an entity as a PSO, and other 
information that this Subpart states may be made public. AHRQ may 
maintain a PSO website (or a comparable future form of public notice) 
and may post the list on this website.
    (e) Three-year period of listing. (1) The three-year period of 
listing of a PSO will automatically expire at midnight of the last day 
of this period, unless the listing had been revoked or relinquished 
earlier in accordance with Sec. 3.108 of this subpart, or if, prior to 
this automatic expiration, the PSO seeks a new three-year listing, in 
accordance with Sec. 3.102, and the Secretary accepts the PSO's 
certification for a new three-year listing, in accordance with 
Sec. 3.104(a).
    (2) The Secretary plans to send a written notice of imminent 
expiration to a PSO at least 60 calendar days prior to the date on which 
its three-year period of listing expires if the Secretary has not yet 
received a certification for continued listing. The Secretary plans to 
indicate, on the AHRQ PSO website, the PSOs from whom certifications for 
continued listing have not been timely received.
    (f) Effective dates of Secretarial actions. Unless otherwise stated, 
the effective date of each action by the Secretary pursuant to this 
subpart will be specified in the written notice of such action that is 
sent to the entity. When the Secretary sends a notice that addresses 
acceptance or revocation of an entity's certifications or voluntary 
relinquishment by an entity of its status as a PSO, the notice will 
specify the effective date and time of listing or delisting.



Sec. 3.106  Security requirements.

    (a) Application. A PSO must secure patient safety work product in 
conformance with the security requirements of paragraph (b) of this 
section. These requirements must be met at all times and at any location 
at which the PSO, its workforce members, or its contractors receive, 
access, or handle patient safety work product. Handling

[[Page 45]]

patient safety work product includes its processing, development, use, 
maintenance, storage, removal, disclosure, transmission and destruction.
    (b) Security framework. A PSO must have written policies and 
procedures that address each of the considerations specified in this 
subsection. In addressing the framework that follows, the PSO may 
develop appropriate and scalable security standards, policies, and 
procedures that are suitable for the size and complexity of its 
organization.
    (1) Security management. A PSO must address:
    (i) Maintenance and effective implementation of written policies and 
procedures that conform to the requirements of this section to protect 
the confidentiality, integrity, and availability of the patient safety 
work product that is received, accessed, or handled; and to monitor and 
improve the effectiveness of such policies and procedures, and
    (ii) Training of the PSO workforce and PSO contractors who receive, 
access, or handle patient safety work product regarding the requirements 
of the Patient Safety Act, this Part, and the PSO's policies and 
procedures regarding the confidentiality and security of patient safety 
work product.
    (2) Distinguishing patient safety work product. A PSO must address:
    (i) Maintenance of the security of patient safety work product, 
whether in electronic or other media, through either physical separation 
from non-patient safety work product, or if co-located with non-patient 
safety work product, by making patient safety work product 
distinguishable so that the appropriate form and level of security can 
be applied and maintained;
    (ii) Protection of the media, whether in electronic, paper, or other 
media or format, that contain patient safety work product, limiting 
access to authorized users, and sanitizing and destroying such media 
before their disposal or release for reuse; and
    (iii) Physical and environmental protection, to control and limit 
physical and virtual access to places and equipment where patient safety 
work product is received, accessed, or handled.
    (3) Security control and monitoring. A PSO must address:
    (i) Identification of those authorized to receive, access, or handle 
patient safety work product and an audit capacity to detect unlawful, 
unauthorized, or inappropriate receipt, access, or handling of patient 
safety work product, and
    (ii) Methods to prevent unauthorized receipt, access, or handling of 
patient safety work product.
    (4) Security assessment. A PSO must address:
    (i) Periodic assessments of security risks and controls to establish 
if its controls are effective, to correct any deficiency identified, and 
to reduce or eliminate any vulnerabilities.
    (ii) System and communications protection, to monitor, control, and 
protect PSO receipt, access, or handling of patient safety work product 
with particular attention to the transmission of patient safety work 
product to and from providers, other PSOs, contractors or any other 
responsible persons.



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

    (a) Process for correction of a deficiency and revocation--(1) 
Circumstances leading to revocation. The Secretary may revoke his 
acceptance of an entity's certification (``revocation'') and delist the 
entity as a PSO if he determines--
    (i) The PSO is not fulfilling the certifications made to the 
Secretary as required by Sec. 3.102;
    (ii) The PSO has not met the two contract requirement, as required 
by Sec. 3.102(d)(1);
    (iii) Based on a PSO's disclosures made pursuant to Sec. 3.102(d)(2) 
, that the entity cannot fairly and accurately perform the patient 
safety activities of a PSO with a public finding to that effect; or
    (iv) The PSO is not in compliance with any other provision of the 
Patient Safety Act or this part.
    (2) Notice of preliminary finding of deficiency and establishment of 
an opportunity for correction of a deficiency. (i) Except as provided by 
paragraph (e) of this section, if the Secretary determines that a PSO is 
not in compliance with its obligations under the Patient Safety Act or 
this subpart, the Secretary must send a PSO written notice

[[Page 46]]

of the preliminary finding of deficiency. The notice must state the 
actions or inactions that encompass the deficiency finding, outline the 
evidence that the deficiency exists, specify the possible and/or 
required corrective actions that must be taken, and establish a date by 
which the deficiency must be corrected. The Secretary may specify in the 
notice the form of documentation required to demonstrate that the 
deficiency has been corrected.
    (ii) The notice of a preliminary finding of deficiency is presumed 
received five days after it is sent, absent evidence of the actual 
receipt date. If a PSO does not submit evidence to the Secretary within 
14 calendar days of actual or constructive receipt of such notice, 
whichever is longer, which demonstrates that the preliminary finding is 
factually incorrect, the preliminary finding will be the basis for a 
finding of deficiency.
    (3) Determination of correction of a deficiency. (i) Unless the 
Secretary specifies another date, the Secretary must receive 
documentation to demonstrate that the PSO has corrected any deficiency 
cited in the preliminary finding of deficiency no later than five 
calendar days following the last day of the correction period that is 
specified by the Secretary in such notice.
    (ii) In making a determination regarding the correction of any 
deficiency, the Secretary will consider the documentation submitted by 
the PSO, any assessments under Sec. 3.110, recommendations of program 
staff, and any other information available regarding the PSO that the 
Secretary deems appropriate and relevant to the PSO's implementation of 
the terms of its certification.
    (iii) After completing his review, the Secretary may make one of the 
following determinations:
    (A) The action(s) taken by the PSO have corrected any deficiency, in 
which case the Secretary will withdraw the notice of deficiency and so 
notify the PSO;
    (B) The PSO has acted in good faith to correct the deficiency, but 
the Secretary finds an additional period of time is necessary to achieve 
full compliance and/or the required corrective action specified in the 
notice of a preliminary finding of deficiency needs to be modified in 
light of the experience of the PSO in attempting to implement the 
corrective action, in which case the Secretary will extend the period 
for correction and/or modify the specific corrective action required; or
    (C) The PSO has not completed the corrective action because it has 
not acted with reasonable diligence or speed to ensure that the 
corrective action was completed within the allotted time, in which case 
the Secretary will issue to the PSO a notice of proposed revocation and 
delisting.
    (iv) When the Secretary issues a written notice of proposed 
revocation and delisting, the notice will specify the deficiencies that 
have not been timely corrected and will detail the manner in which the 
PSO may exercise its opportunity to be heard in writing to respond to 
the deficiencies specified in the notice.
    (4) Opportunity to be heard in writing following a notice of 
proposed revocation and delisting. The Secretary will afford a PSO an 
opportunity to be heard in writing, as specified in paragraph (a)(4)(i) 
of this section, to provide a substantive response to the deficiency 
finding(s) set forth in the notice of proposed revocation and delisting.
    (i) The notice of proposed revocation and delisting is presumed 
received five days after it is sent, absent evidence of actual receipt. 
The Secretary will provide a PSO with a period of time, beginning with 
the date of receipt of the notice of proposed revocation and delisting 
of which there is evidence, or the presumed date of receipt if there is 
no evidence of earlier receipt, and ending at midnight 30 calendar days 
thereafter, during which the PSO may submit a substantive response to 
the deficiency findings in writing.
    (ii) The Secretary will provide to the PSO any rules of procedure 
governing the form or transmission of the written response to the notice 
of proposed revocation and delisting. Such rules may also be posted on 
the AHRQ PSO Web site or published in the Federal Register.

[[Page 47]]

    (iii) If a PSO does not submit a written response to the deficiency 
finding(s) within 30 calendar days of receipt of the notice of proposed 
revocation and delisting, the notice of proposed revocation becomes 
final as a matter of law and the basis for Secretarial action under 
paragraph (b)(1) of this section.
    (5) The Secretary's decision regarding revocation. The Secretary 
will review the entire administrative record pertaining to a notice of 
proposed revocation and delisting and any written materials submitted by 
the PSO under paragraph (a)(4) of this section. The Secretary may 
affirm, reverse, or modify the notice of proposed revocation and 
delisting and will make a determination with respect to the continued 
listing of the PSO.
    (b) Revocation of the Secretary's acceptance of a PSO's 
certifications--(1) Establishing the date and time of revocation and 
delisting. When the Secretary concludes, in accordance with a decision 
made under paragraphs (a)(5), (e)(3)(iii) or (e)(3)(iv)(C) of this 
section, that revocation of the acceptance of a PSO's certification is 
warranted for its failure to comply with requirements of the Patient 
Safety Act or of this Part, the Secretary will establish the effective 
time and date for such prompt revocation and removal of the entity from 
the list of PSOs, so notify the PSO in writing, and provide the relevant 
public notice required by Sec. 3.108(d) of this subpart.
    (2) Required notification of providers and status of data. (i) Upon 
being notified of the Secretary's action pursuant to paragraph (b)(1) of 
this section, the former PSO will take all reasonable actions to notify 
each provider, whose patient safety work product it collected or 
analyzed, of the Secretary's action(s) and the following statutory 
information: Confidentiality and privilege protections that applied to 
patient safety work product while the former PSO was listed continue to 
apply after the entity is removed from listing. Data submitted by 
providers to the former PSO for 30 calendar days following the date and 
time on which the entity was removed from the list of PSOs pursuant to 
paragraph (b)(1) of this section will have the same status as data 
submitted while the entity was still listed.
    (ii) Within 15 days of being notified of the Secretary's action 
pursuant to paragraph (b)(1) of this section, the former PSO shall 
submit to the Secretary confirmation that it has taken the actions in 
paragraph (b)(2)(i) of this section.
    (3) Disposition of patient safety work product and data. Within 90 
days following the effective date of revocation and delisting pursuant 
to paragraph (b)(1) of this section, the former PSO will take one or 
more of the following measures in regard to patient safety work product 
and data described in paragraph (b)(2)(i) of this section:
    (i) Transfer such patient safety work product or data, with the 
approval of the source from which it was received, to a PSO that has 
agreed to receive such patient safety work product or data;
    (ii) Return such work product or data to the source from which it 
was submitted; or
    (iii) If returning such patient safety work product or data to its 
source is not practicable, destroy such patient safety work product or 
data.
    (c) Voluntary relinquishment--(1) Circumstances constituting 
voluntary relinquishment. A PSO will be considered to have voluntarily 
relinquished its status as a PSO if the Secretary accepts a notification 
from a PSO that it wishes to relinquish voluntarily its listing as a 
PSO.
    (2) Notification of voluntary relinquishment. A PSO's notification 
of voluntary relinquishment to the Secretary must include the following:
    (i) An attestation that all reasonable efforts have been made, or 
will have been made by a PSO within 15 calendar days of this statement, 
to notify the sources from which it received patient safety work product 
of the PSO's intention to cease PSO operations and activities, to 
relinquish voluntarily its status as a PSO, to request that these other 
entities cease reporting or submitting any further information to the 
PSO as soon as possible, and inform them that any information reported 
after the effective date and time of delisting that the Secretary sets 
pursuant to paragraph (c)(3) of this section

[[Page 48]]

will not be protected as patient safety work product under the Patient 
Safety Act.
    (ii) An attestation that the entity has established a plan, or 
within 15 calendar days of this statement, will have made all reasonable 
efforts to establish a plan, in consultation with the sources from which 
it received patient safety work product, that provides for the 
disposition of the patient safety work product held by the PSO 
consistent with, to the extent practicable, the statutory options for 
disposition of patient safety work product as set out in paragraph 
(b)(3) of this section; and
    (iii) Appropriate contact information for further communications 
from the Secretary.
    (3) Response to notification of voluntary relinquishment. (i) After 
a PSO provides the notification required by paragraph (c)(2) of this 
section, the Secretary will respond in writing to the entity indicating 
whether the proposed voluntary relinquishment of its PSO status is 
accepted. If the voluntary relinquishment is accepted, the Secretary's 
response will indicate an effective date and time for the entity's 
removal from the list of PSOs and will provide public notice of the 
voluntary relinquishment and the effective date and time of the 
delisting, in accordance with Sec. 3.108(d) of this subpart.
    (ii) If the Secretary receives a notification of voluntary 
relinquishment during or immediately after revocation proceedings for 
cause under paragraphs (a)(4) and (a)(5) of this section, the Secretary, 
as a matter of discretion, may accept voluntary relinquishment in 
accordance with the preceding paragraph or decide not to accept the 
entity's proposed voluntary relinquishment and proceed with the 
revocation for cause and delisting pursuant to paragraph (b)(1) of this 
section.
    (4) Non-applicability of certain procedures and requirements. (i) A 
decision by the Secretary to accept a request by a PSO to relinquish 
voluntarily its status as a PSO pursuant to paragraph (c)(2) of this 
section does not constitute a determination of a deficiency in PSO 
compliance with the Patient Safety Act or with this Subpart.
    (ii) The procedures and requirements of Sec. 3.108(a) of this 
subpart regarding deficiencies including the opportunity to correct 
deficiencies and to be heard in writing, and the procedures and 
requirements of Sec. 3.108(b) are not applicable to determinations of 
the Secretary made pursuant to this subsection.
    (d) Public notice of delisting regarding removal from listing. If 
the Secretary removes an entity from the list of PSOs following 
revocation of acceptance of the entity's certification pursuant to 
Sec. 3.108(b)(1), voluntary relinquishment pursuant to Sec. 3.108(c)(3), 
or expiration of an entity's period of listing pursuant to 
Sec. 3.104(e)(1), the Secretary will promptly publish in the Federal 
Register and on the AHRQ PSO website, or in a comparable future form of 
public notice, a notice of the actions taken and the effective dates.
    (e) Expedited revocation and delisting--(1) Basis for expedited 
revocation. Notwithstanding any other provision of this section, the 
Secretary may use the expedited revocation process described in 
paragraph (e)(3) of this section if he determines--
    (i) The PSO is not in compliance with this part because it is or is 
about to become an entity described in Sec. 3.102(a)(2).
    (ii) The parent organization of the PSO is an entity described in 
Sec. 3.102(a)(2) and requires or induces health care providers to report 
patient safety work product to its component PSO; or
    (iii) The circumstances for revocation in paragraph (a)(1) of this 
section exist, and the Secretary has determined that there would be 
serious adverse consequences if the PSO were to remain listed.
    (2) Applicable provisions. If the Secretary uses the expedited 
revocation process described in paragraph (e)(3) of this section, the 
procedures in paragraphs (a)(2) through (5) of this section shall not 
apply and paragraph (a)(1) and paragraphs (b) and (d) of this section 
shall apply.
    (3) Expedited revocation process. (i) The Secretary must send the 
PSO a written notice of deficiency that:
    (A) Identifies the evidence that the circumstances for revocation 
and delisting under paragraph (a)(1) of this section exist, and any 
corrective action

[[Page 49]]

that the PSO must take if the Secretary determines that corrective 
action may resolve the matter so that the entity would not be delisted; 
and
    (B) Provides an opportunity for the PSO to respond in writing to 
correct the facts or the legal bases for delisting found in the notice, 
and to offer any other grounds for its not being delisted.
    (ii) The notice of deficiency will be presumed to be received five 
days after it is sent, absent evidence of the actual receipt date.
    (iii) If the PSO does not submit a written response to the Secretary 
within 14 calendar days of actual or constructive receipt of such 
notice, whichever is longer, the Secretary may revoke his acceptance of 
the PSO's certifications and remove the entity from the list of PSOs.
    (iv) If the PSO responds in writing within the required 14-day time 
period, the Secretary may take any of the following actions:
    (A) Withdraw the notice of deficiency;
    (B) Provide the PSO with more time to resolve the matter to the 
Secretary's satisfaction; or
    (C) Revoke his acceptance of the PSO's certifications and remove the 
entity from the list of PSOs.



Sec. 3.110  Assessment of PSO compliance.

    The Secretary may request information or conduct announced or 
unannounced reviews of, or site visits to, PSOs, to assess or verify PSO 
compliance with the requirements of this subpart and for these purposes 
will be allowed to inspect the physical or virtual sites maintained or 
controlled by the PSO. The Secretary will be allowed to inspect and/or 
be given or sent copies of any PSO records deemed necessary and 
requested by the Secretary to implement the provisions of this subpart. 
Such PSO records may include patient safety work product in accordance 
with Sec. 3.206(d) of this part.



Sec. 3.112  Submissions and forms.

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



 Subpart C_Confidentiality and Privilege Protections of Patient Safety 
                              Work Product



Sec. 3.204  Privilege of patient safety work product.

    (a) Privilege. Notwithstanding any other provision of Federal, 
State, local, or Tribal law and subject to paragraph (b) of this section 
and Sec. 3.208 of this subpart, patient safety work product shall be 
privileged and shall not be:
    (1) Subject to a Federal, State, local, or Tribal civil, criminal, 
or administrative subpoena or order, including in a Federal, State, 
local, or Tribal civil or administrative disciplinary proceeding against 
a provider;
    (2) Subject to discovery in connection with a Federal, State, local, 
or Tribal civil, criminal, or administrative proceeding, including in a 
Federal, State, local, or Tribal civil or administrative disciplinary 
proceeding against a provider;
    (3) Subject to disclosure pursuant to section 552 of Title 5, United 
States Code (commonly known as the Freedom of Information Act) or any 
other similar Federal, State, local, or Tribal law;

[[Page 50]]

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



Sec. 3.206  Confidentiality of patient safety work product.

    (a) Confidentiality. Subject to paragraphs (b) through (e) of this 
section, and Secs. 3.208 and 3.210 of this subpart, patient safety work 
product shall be confidential and shall not be disclosed.
    (b) Exceptions to confidentiality. The confidentiality provisions 
shall not apply to (and shall not be construed to prohibit) one or more 
of the following disclosures:
    (1) Disclosure in criminal proceedings. Disclosure of relevant 
patient safety work product for use in a criminal proceeding, but only 
after a court makes an in-camera determination that:
    (i) Such patient safety work product contains evidence of a criminal 
act;
    (ii) Such patient safety work product is material to the proceeding; 
and
    (iii) Such patient safety work product is not reasonably available 
from any other source.
    (2) Disclosure to permit equitable relief for reporters. Disclosure 
of patient safety work product to the extent required to permit 
equitable relief under section 922 (f)(4)(A) of the Public Health 
Service Act, provided the court or administrative tribunal has issued a 
protective order to protect the confidentiality of the patient safety 
work product in the course of the proceeding.
    (3) Disclosure authorized by identified providers. (i) Disclosure of 
identifiable patient safety work product consistent with a valid 
authorization if such authorization is obtained from each provider 
identified in such work product prior to disclosure. A valid 
authorization must:
    (A) Be in writing and signed by the provider from whom authorization 
is sought; and
    (B) Contain sufficient detail to fairly inform the provider of the 
nature and scope of the disclosures being authorized;
    (ii) A valid authorization must be retained by the disclosing entity 
for six years from the date of the last disclosure made in reliance on 
the authorization and made available to the Secretary upon request.
    (4) Disclosure for patient safety activities--(i) Disclosure between 
a provider and a PSO. Disclosure of patient safety work product for 
patient safety activities by a provider to a PSO or by a PSO to that 
disclosing provider.
    (ii) Disclosure to a contractor of a provider or a PSO. A provider 
or a PSO may disclose patient safety work product for patient safety 
activities to an entity with which it has contracted to undertake 
patient safety activities on its behalf. A contractor receiving patient 
safety work product for patient safety activities may not further 
disclose patient safety work product, except to the provider or PSO with 
which it is contracted.

[[Page 51]]

    (iii) Disclosure among affiliated providers. Disclosure of patient 
safety work product for patient safety activities by a provider to an 
affiliated provider.
    (iv) Disclosure to another PSO or provider. Disclosure of patient 
safety work product for patient safety activities by a PSO to another 
PSO or to another provider that has reported to the PSO, or, except as 
otherwise permitted in paragraph (b)(4)(iii) of this section, by a 
provider to another provider, provided:
    (A) The following direct identifiers of any providers and of 
affiliated organizations, corporate parents, subsidiaries, practice 
partners, employers, members of the workforce, or household members of 
such providers are removed:
    (1) Names;
    (2) Postal address information, other than town or city, State and 
zip code;
    (3) Telephone numbers;
    (4) Fax numbers;
    (5) Electronic mail addresses;
    (6) Social security numbers or taxpayer identification numbers;
    (7) Provider or practitioner credentialing or DEA numbers;
    (8) National provider identification number;
    (9) Certificate/license numbers;
    (10) Web Universal Resource Locators (URLs);
    (11) Internet Protocol (IP) address numbers;
    (12) Biometric identifiers, including finger and voice prints; and
    (13) Full face photographic images and any comparable images; and
    (B) With respect to any individually identifiable health information 
in such patient safety work product, the direct identifiers listed at 45 
CFR 164.514(e)(2) have been removed.
    (5) Disclosure of nonidentifiable patient safety work product. 
Disclosure of nonidentifiable patient safety work product when patient 
safety work product meets the standard for nonidentification in 
accordance with Sec. 3.212 of this subpart.
    (6) Disclosure for research. (i) Disclosure of patient safety work 
product to persons carrying out research, evaluation or demonstration 
projects authorized, funded, certified, or otherwise sanctioned by rule 
or other means by the Secretary, for the purpose of conducting research.
    (ii) If the patient safety work product disclosed pursuant to 
paragraph (b)(6)(i) of this section is by a HIPAA covered entity as 
defined at 45 CFR 160.103 and contains protected health information as 
defined by the HIPAA Privacy Rule at 45 CFR 160.103, such patient safety 
work product may only be disclosed under this exception in the same 
manner as would be permitted under the HIPAA Privacy Rule.
    (7) Disclosure to the Food and Drug Administration (FDA) and 
entities required to report to FDA. (i) Disclosure by a provider of 
patient safety work product concerning an FDA-regulated product or 
activity to the FDA, an entity required to report to the FDA concerning 
the quality, safety, or effectiveness of an FDA-regulated product or 
activity, or a contractor acting on behalf of FDA or such entity for 
these purposes.
    (ii) Any person permitted to receive patient safety work product 
pursuant to paragraph (b)(7)(i) of this section may only further 
disclose such patient safety work product for the purpose of evaluating 
the quality, safety, or effectiveness of that product or activity to 
another such person or the disclosing provider.
    (8) Voluntary disclosure to an accrediting body. (i) Voluntary 
disclosure by a provider of patient safety work product to an 
accrediting body that accredits that provider, provided, with respect to 
any identified provider other than the provider making the disclosure:
    (A) The provider agrees to the disclosure; or
    (B) The identifiers at Sec. 3.206(b)(4)(iv)(A) are removed.
    (ii) An accrediting body may not further disclose patient safety 
work product it receives pursuant to paragraph (b)(8)(i) of this 
section.
    (iii) An accrediting body may not take an accrediting action against 
a provider based on a good faith participation of the provider in the 
collection, development, reporting, or maintenance of patient safety 
work product in accordance with this Part. An accrediting body may not 
require a provider to reveal its communications with any PSO.

[[Page 52]]

    (9) Disclosure for business operations. (i) Disclosure of patient 
safety work product by a provider or a PSO for business operations to 
attorneys, accountants, and other professionals. Such contractors may 
not further disclose patient safety work product, except to the entity 
from which they received the information.
    (ii) Disclosure of patient safety work product for such other 
business operations that the Secretary may prescribe by regulation as 
consistent with the goals of this part.
    (10) Disclosure to law enforcement. (i) Disclosure of patient safety 
work product to an appropriate law enforcement authority relating to an 
event that either constitutes the commission of a crime, or for which 
the disclosing person reasonably believes constitutes the commission of 
a crime, provided that the disclosing person believes, reasonably under 
the circumstances, that the patient safety work product that is 
disclosed is necessary for criminal law enforcement purposes.
    (ii) Law enforcement personnel receiving patient safety work product 
pursuant to paragraph (b)(10)(i) of this section only may disclose that 
patient safety work product to other law enforcement authorities as 
needed for law enforcement activities related to the event that gave 
rise to the disclosure under paragraph (b)(10)(i) of this section.
    (c) Safe harbor. A provider or responsible person, but not a PSO, is 
not considered to have violated the requirements of this subpart if a 
member of its workforce discloses patient safety work product, provided 
that the disclosure does not include materials, including oral 
statements, that:
    (1) Assess the quality of care of an identifiable provider; or
    (2) Describe or pertain to one or more actions or failures to act by 
an identifiable provider.
    (d) Implementation and enforcement by the Secretary. The 
confidentiality provisions shall not apply to (and shall not be 
construed to prohibit) disclosures of relevant patient safety work 
product to or by the Secretary if such patient safety work product is 
needed to investigate or determine compliance or to seek or impose civil 
money penalties, with respect to this part or the HIPAA Privacy Rule, or 
to make or support decisions with respect to listing of a PSO.
    (e) No limitation on authority to limit or delegate disclosure or 
use. Nothing in subpart C of this part shall be construed to limit the 
authority of any person to enter into a contract requiring greater 
confidentiality or delegating authority to make a disclosure or use in 
accordance with this subpart.



Sec. 3.208  Continued protection of patient safety work product.

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



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

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

[[Page 53]]



Sec. 3.212  Nonidentification of patient safety work product.

    (a) Patient safety work product is nonidentifiable with respect to a 
particular identified provider or a particular identified reporter if:
    (1) A person with appropriate knowledge of and experience with 
generally accepted statistical and scientific principles and methods for 
rendering information not individually identifiable:
    (i) Applying such principles and methods, determines that the risk 
is very small that the information could be used, alone or in 
combination with other reasonably available information, by an 
anticipated recipient to identify an identified provider or reporter; 
and
    (ii) Documents the methods and results of the analysis that justify 
such determination; or
    (2)(i) The following identifiers of such provider or reporter and of 
affiliated organizations, corporate parents, subsidiaries, practice 
partners, employers, members of the workforce, or household members of 
such providers or reporters are removed:
    (A) The direct identifiers listed at Sec. 3.206(b)(4)(iv)(A)(1) 
through (13) of this subpart;
    (B) Geographic subdivisions smaller than a State, including street 
address, city, county, precinct, zip code and equivalent geocodes, 
except for the initial three digits of a zip code if, according to the 
current publicly available data from the Bureau of the Census, the 
geographic unit formed by combining all zip codes with the same three 
initial digits contains more than 20,000 people;
    (C) All elements of dates (except year) for dates directly related 
to a patient safety incident or event; and
    (D) Any other unique identifying number, characteristic, or code 
except as permitted for re-identification; and
    (ii) The provider, PSO or responsible person making the disclosure 
does not have actual knowledge that the information could be used, alone 
or in combination with other information that is reasonably available to 
the intended recipient, to identify the particular provider or reporter.
    (3) Re-identification. A provider, PSO, or responsible person may 
assign a code or other means of record identification to allow 
information made nonidentifiable under this section to be re-identified 
by such provider, PSO, or responsible person, provided that:
    (i) The code or other means of record identification is not derived 
from or related to information about the provider or reporter and is not 
otherwise capable of being translated so as to identify the provider or 
reporter; and
    (ii) The provider, PSO, or responsible person does not use or 
disclose the code or other means of record identification for any other 
purpose, and does not disclose the mechanism for re-identification.
    (b) Patient safety work product is non-identifiable with respect to 
a particular patient only if the individually identifiable health 
information regarding that patient is de-identified in accordance with 
the HIPAA Privacy Rule standard and implementation specifications for 
the de-identification at 45 CFR 164.514(a) through (c).



                      Subpart D_Enforcement Program



Sec. 3.304  Principles for achieving compliance.

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



Sec. 3.306  Complaints to the Secretary.

    (a) Right to file a complaint. A person who believes that patient 
safety work product has been disclosed in violation of the 
confidentiality provisions may file a complaint with the Secretary.
    (b) Requirements for filing complaints. Complaints under this 
section must meet the following requirements:
    (1) A complaint must be filed in writing, either on paper or 
electronically.
    (2) A complaint must name the person that is the subject of the 
complaint and describe the act(s) believed to be in

[[Page 54]]

violation of the applicable confidentiality provision(s).
    (3) A complaint must be filed within 180 days of when the 
complainant knew or should have known that the act complained of 
occurred, unless this time limit is waived by the Secretary for good 
cause shown.
    (4) The Secretary may prescribe additional procedures for the filing 
of complaints, as well as the place and manner of filing, by notice in 
the Federal Register.
    (c) Investigation. The Secretary may investigate complaints filed 
under this section. Such investigation may include a review of the 
pertinent policies, procedures, or practices of the respondent and of 
the circumstances regarding any alleged violation. At the time of 
initial written communication with the respondent about the complaint, 
the Secretary will describe the act(s) that are the basis of the 
complaint.



Sec. 3.308  Compliance reviews.

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



Sec. 3.310  Responsibilities of respondents.

    (a) Provide records and compliance reports. A respondent must keep 
such records and submit such compliance reports, in such time and manner 
and containing such information, as the Secretary may determine to be 
necessary to enable the Secretary to ascertain whether the respondent 
has complied or is complying with the applicable confidentiality 
provisions.
    (b) Cooperate with complaint investigations and compliance reviews. 
A respondent must cooperate with the Secretary, if the Secretary 
undertakes an investigation or compliance review of the policies, 
procedures, or practices of the respondent to determine whether it is 
complying with the applicable confidentiality provisions.
    (c) Permit access to information. (1) A respondent must permit 
access by the Secretary during normal business hours to its facilities, 
books, records, accounts, and other sources of information, including 
patient safety work product, that are pertinent to ascertaining 
compliance with the applicable confidentiality provisions. If the 
Secretary determines that exigent circumstances exist, such as when 
documents may be hidden or destroyed, a respondent must permit access by 
the Secretary at any time and without notice.
    (2) If any information required of a respondent under this section 
is in the exclusive possession of any other agency, institution, or 
person, and the other agency, institution, or person fails or refuses to 
furnish the information, the respondent must so certify and set forth 
what efforts it has made to obtain the information.



Sec. 3.312  Secretarial action regarding complaints and compliance
reviews.

    (a) Resolution when noncompliance is indicated. (1) If an 
investigation of a complaint pursuant to Sec. 3.306 of this subpart or a 
compliance review pursuant to Sec. 3.308 of this subpart indicates 
noncompliance, the Secretary may attempt to reach a resolution of the 
matter satisfactory to the Secretary by informal means. Informal means 
may include demonstrated compliance or a completed corrective action 
plan or other agreement.
    (2) If the matter is resolved by informal means, the Secretary will 
so inform the respondent and, if the matter arose from a complaint, the 
complainant, in writing.
    (3) If the matter is not resolved by informal means, the Secretary 
will--
    (i) So inform the respondent and provide the respondent an 
opportunity to submit written evidence of any mitigating factors. The 
respondent must submit any evidence to the Secretary within 30 days 
(computed in the same manner as prescribed under Sec. 3.526 of this 
subpart) of receipt of such notification; and
    (ii) If, following action pursuant to paragraph (a)(3)(i) of this 
section, the Secretary decides that a civil money penalty should be 
imposed, inform the respondent of such finding in a notice of proposed 
determination in accordance with Sec. 3.420 of this subpart.
    (b) Resolution when no violation is found. If, after an 
investigation pursuant to Sec. 3.306 of this subpart or a compliance 
review pursuant to Sec. 3.308 of this subpart, the Secretary determines

[[Page 55]]

that further action is not warranted, the Secretary will so inform the 
respondent and, if the matter arose from a complaint, the complainant, 
in writing.
    (c) Uses and disclosures of information obtained. (1) Identifiable 
patient safety work product obtained by the Secretary in connection with 
an investigation or compliance review under this subpart will not be 
disclosed by the Secretary, except in accordance with Sec. 3.206(d) of 
this subpart, or if otherwise permitted by this part or the Patient 
Safety Act.
    (2) Except as provided for in paragraph (c)(1) of this section, 
information, including testimony and other evidence, obtained by the 
Secretary in connection with an investigation or compliance review under 
this subpart may be used by HHS in any of its activities and may be used 
or offered into evidence in any administrative or judicial proceeding.



Sec. 3.314  Investigational subpoenas and inquiries.

    (a) The Secretary may issue subpoenas in accordance with 42 U.S.C. 
405(d) and (e), and 1320a-7a(j), to require the attendance and testimony 
of witnesses and the production of any other evidence including patient 
safety work product during an investigation or compliance review 
pursuant to this part.
    (1) A subpoena issued under this paragraph must--
    (i) State the name of the person (including the entity, if 
applicable) to whom the subpoena is addressed;
    (ii) State the statutory authority for the subpoena;
    (iii) Indicate the date, time, and place that the testimony will 
take place;
    (iv) Include a reasonably specific description of any documents or 
items required to be produced; and
    (v) If the subpoena is addressed to an entity, describe with 
reasonable particularity the subject matter on which testimony is 
required. In that event, the entity must designate one or more natural 
persons who will testify on its behalf, and must state as to each such 
person that person's name and address and the matters on which he or she 
will testify. The designated person must testify as to matters known or 
reasonably available to the entity.
    (2) A subpoena under this section must be served by--
    (i) Delivering a copy to the natural person named in the subpoena or 
to the entity named in the subpoena at its last principal place of 
business; or
    (ii) Registered or certified mail addressed to the natural person at 
his or her last known dwelling place or to the entity at its last known 
principal place of business.
    (3) A verified return by the natural person serving the subpoena 
setting forth the manner of service or, in the case of service by 
registered or certified mail, the signed return post office receipt, 
constitutes proof of service.
    (4) Witnesses are entitled to the same fees and mileage as witnesses 
in the district courts of the United States (28 U.S.C. 1821 and 1825). 
Fees need not be paid at the time the subpoena is served.
    (5) A subpoena under this section is enforceable through the 
district court of the United States for the district where the 
subpoenaed natural person resides or is found or where the entity 
transacts business.
    (b) Investigational inquiries are non-public investigational 
proceedings conducted by the Secretary.
    (1) Testimony at investigational inquiries will be taken under oath 
or affirmation.
    (2) Attendance of non-witnesses is discretionary with the Secretary, 
except that a witness is entitled to be accompanied, represented, and 
advised by an attorney.
    (3) Representatives of the Secretary are entitled to attend and ask 
questions.
    (4) A witness will have the opportunity to clarify his or her 
answers on the record following questioning by the Secretary.
    (5) Any claim of privilege must be asserted by the witness on the 
record.
    (6) Objections must be asserted on the record. Errors of any kind 
that might be corrected if promptly presented will be deemed to be 
waived unless reasonable objection is made at the investigational 
inquiry. Except

[[Page 56]]

where the objection is on the grounds of privilege, the question will be 
answered on the record, subject to objection.
    (7) If a witness refuses to answer any question not privileged or to 
produce requested documents or items, or engages in conduct likely to 
delay or obstruct the investigational inquiry, the Secretary may seek 
enforcement of the subpoena under paragraph (a)(5) of this section.
    (8) The proceedings will be recorded and transcribed. The witness is 
entitled to a copy of the transcript, upon payment of prescribed costs, 
except that, for good cause, the witness may be limited to inspection of 
the official transcript of his or her testimony.
    (9)(i) The transcript will be submitted to the witness for 
signature.
    (A) Where the witness will be provided a copy of the transcript, the 
transcript will be submitted to the witness for signature. The witness 
may submit to the Secretary written proposed corrections to the 
transcript, with such corrections attached to the transcript. If the 
witness does not return a signed copy of the transcript or proposed 
corrections within 30 days (computed in the same manner as prescribed 
under Sec. 3.526 of this part) of its being submitted to him or her for 
signature, the witness will be deemed to have agreed that the transcript 
is true and accurate.
    (B) Where, as provided in paragraph (b)(8) of this section, the 
witness is limited to inspecting the transcript, the witness will have 
the opportunity at the time of inspection to propose corrections to the 
transcript, with corrections attached to the transcript. The witness 
will also have the opportunity to sign the transcript. If the witness 
does not sign the transcript or offer corrections within 30 days 
(computed in the same manner as prescribed under Sec. 3.526 of this 
part) of receipt of notice of the opportunity to inspect the transcript, 
the witness will be deemed to have agreed that the transcript is true 
and accurate.
    (ii) The Secretary's proposed corrections to the record of 
transcript will be attached to the transcript.



Sec. 3.402  Basis for a civil money penalty.

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



Sec. 3.404  Amount of a civil money penalty.

    (a) The amount of a civil money penalty will be determined in 
accordance with paragraph (b) of this section and Sec. 3.408.
    (b) The Secretary may impose a civil monetary penalty in the amount 
of not more than $11,000. This amount has been updated and will be 
updated annually, in accordance with the Federal Civil Monetary penalty 
Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the 
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 
2015 (section 701 of Pub. L. 114-74). The amount, as updated, is 
published at 45 CFR part 102.

[81 FR 61560, Sept. 6, 2016]



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

    In determining the amount of any civil money penalty, the Secretary 
may consider as aggravating or mitigating factors, as appropriate, any 
of the following:
    (a) The nature of the violation.
    (b) The circumstances, including the consequences, of the violation, 
including:
    (1) The time period during which the violation(s) occurred; and
    (2) Whether the violation caused physical or financial harm or 
reputational damage;
    (c) The degree of culpability of the respondent, including:

[[Page 57]]

    (1) Whether the violation was intentional; and
    (2) Whether the violation was beyond the direct control of the 
respondent.
    (d) Any history of prior compliance with the Patient Safety Act, 
including violations, by the respondent, including:
    (1) Whether the current violation is the same or similar to prior 
violation(s);
    (2) Whether and to what extent the respondent has attempted to 
correct previous violations;
    (3) How the respondent has responded to technical assistance from 
the Secretary provided in the context of a compliance effort; and
    (4) How the respondent has responded to prior complaints.
    (e) The financial condition of the respondent, including:
    (1) Whether the respondent had financial difficulties that affected 
its ability to comply;
    (2) Whether the imposition of a civil money penalty would jeopardize 
the ability of the respondent to continue to provide health care or 
patient safety activities; and
    (3) The size of the respondent.
    (f) Such other matters as justice may require.



Sec. 3.414  Limitations.

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



Sec. 3.416  Authority to settle.

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



Sec. 3.418  Exclusivity of penalty.

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



Sec. 3.420  Notice of proposed determination.

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



Sec. 3.422  Failure to request a hearing.

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

[[Page 58]]

subpart with respect to which the respondent has not timely requested a 
hearing.



Sec. 3.424  Collection of penalty.

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



Sec. 3.426  Notification of the public and other agencies.

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



Sec. 3.504  Hearings before an ALJ.

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



Sec. 3.506  Rights of the parties.

    (a) Except as otherwise limited by this subpart, each party may--
    (1) Be accompanied, represented, and advised by an attorney;
    (2) Participate in any conference held by the ALJ;
    (3) Conduct discovery of documents as permitted by this subpart;
    (4) Agree to stipulations of fact or law that will be made part of 
the record;

[[Page 59]]

    (5) Present evidence relevant to the issues at the hearing;
    (6) Present and cross-examine witnesses;
    (7) Present oral arguments at the hearing as permitted by the ALJ; 
and
    (8) Submit written briefs and proposed findings of fact and 
conclusions of law after the hearing.
    (b) A party may appear in person or by a representative. Natural 
persons who appear as an attorney or other representative must conform 
to the standards of conduct and ethics required of practitioners before 
the courts of the United States.
    (c) Fees for any services performed on behalf of a party by an 
attorney are not subject to the provisions of 42 U.S.C. 406, which 
authorizes the Secretary to specify or limit their fees.



Sec. 3.508  Authority of the ALJ.

    (a) The ALJ must conduct a fair and impartial hearing, avoid delay, 
maintain order, and ensure that a record of the proceeding is made.
    (b) The ALJ may--
    (1) Set and change the date, time and place of the hearing upon 
reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences to identify or simplify the issues, or to 
consider other matters that may aid in the expeditious disposition of 
the proceeding;
    (4) Administer oaths and affirmations;
    (5) Issue subpoenas requiring the attendance of witnesses at 
hearings and the production of documents at or in relation to hearings;
    (6) Rule on motions and other procedural matters;
    (7) Regulate the scope and timing of documentary discovery as 
permitted by this subpart;
    (8) Regulate the course of the hearing and the conduct of 
representatives, parties, and witnesses;
    (9) Examine witnesses;
    (10) Receive, rule on, exclude, or limit evidence;
    (11) Upon motion of a party, take official notice of facts;
    (12) Conduct any conference, argument or hearing in person or, upon 
agreement of the parties, by telephone; and
    (13) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact. A 
summary judgment decision constitutes a hearing on the record for the 
purposes of this subpart.
    (c) The ALJ--
    (1) May not find invalid or refuse to follow Federal statutes, 
regulations, or Secretarial delegations of authority and must give 
deference to published guidance to the extent not inconsistent with 
statute or regulation;
    (2) May not enter an order in the nature of a directed verdict;
    (3) May not compel settlement negotiations; or
    (4) May not enjoin any act of the Secretary.



Sec. 3.510  Ex parte contacts.

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



Sec. 3.512  Prehearing conferences.

    (a) The ALJ must schedule at least one prehearing conference, and 
may schedule additional prehearing conferences as appropriate, upon 
reasonable notice, which may not be less than 14 business days, to the 
parties.
    (b) The ALJ may use prehearing conferences to discuss the 
following--
    (1) Simplification of the issues;
    (2) The necessity or desirability of amendments to the pleadings, 
including the need for a more definite statement;
    (3) Stipulations and admissions of fact or as to the contents and 
authenticity of documents;
    (4) Whether the parties can agree to submission of the case on a 
stipulated record;
    (5) Whether a party chooses to waive appearance at an oral hearing 
and to submit only documentary evidence

[[Page 60]]

(subject to the objection of the other party) and written argument;
    (6) Limitation of the number of witnesses;
    (7) Scheduling dates for the exchange of witness lists and of 
proposed exhibits;
    (8) Discovery of documents as permitted by this subpart;
    (9) The time and place for the hearing;
    (10) The potential for the settlement of the case by the parties; 
and
    (11) Other matters as may tend to encourage the fair, just and 
expeditious disposition of the proceedings, including the protection of 
confidentiality of identifiable patient safety work product that may be 
submitted into evidence or otherwise used in the proceeding, if 
appropriate.
    (c) The ALJ must issue an order containing the matters agreed upon 
by the parties or ordered by the ALJ at a prehearing conference.



Sec. 3.514  Authority to settle.

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



Sec. 3.516  Discovery.

    (a) A party may make a request to another party for production of 
documents for inspection and copying that are relevant and material to 
the issues before the ALJ.
    (b) For the purpose of this section, the term ``documents'' includes 
information, reports, answers, records, accounts, papers and other data 
and documentary evidence. Nothing contained in this section may be 
interpreted to require the creation of a document, except that requested 
data stored in an electronic data storage system must be produced in a 
form accessible to the requesting party.
    (c) Requests for documents, requests for admissions, written 
interrogatories, depositions and any forms of discovery, other than 
those permitted under paragraph (a) of this section, are not authorized.
    (d) This section may not be construed to require the disclosure of 
interview reports or statements obtained by any party, or on behalf of 
any party, of persons who will not be called as witnesses by that party, 
or analyses and summaries prepared in conjunction with the investigation 
or litigation of the case, or any otherwise privileged documents.
    (e)(1) When a request for production of documents has been received, 
within 30 days the party receiving that request must either fully 
respond to the request, or state that the request is being objected to 
and the reasons for that objection. If objection is made to part of an 
item or category, the part must be specified. Upon receiving any 
objections, the party seeking production may then, within 30 days or any 
other time frame set by the ALJ, file a motion for an order compelling 
discovery. The party receiving a request for production may also file a 
motion for protective order any time before the date the production is 
due.
    (2) The ALJ may grant a motion for protective order or deny a motion 
for an order compelling discovery if the ALJ finds that the discovery 
sought--
    (i) Is irrelevant;
    (ii) Is unduly costly or burdensome;
    (iii) Will unduly delay the proceeding; or
    (iv) Seeks privileged information.
    (3) The ALJ may extend any of the time frames set forth in paragraph 
(e)(1) of this section.
    (4) The burden of showing that discovery should be allowed is on the 
party seeking discovery.



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

    (a) The parties must exchange witness lists, copies of prior written 
statements of proposed witnesses, and copies of proposed hearing 
exhibits, including copies of any written statements that the party 
intends to offer in lieu of live testimony in accordance with 
Sec. 3.538, not more than 60, and not less than 15, days before the 
scheduled hearing.
    (b)(1) If, at any time, a party objects to the proposed admission of 
evidence not exchanged in accordance with paragraph (a) of this section, 
the ALJ must determine whether the failure to comply with paragraph (a) 
of this section should result in the exclusion of that evidence.

[[Page 61]]

    (2) Unless the ALJ finds that extraordinary circumstances justified 
the failure timely to exchange the information listed under paragraph 
(a) of this section, the ALJ must exclude from the party's case-in-
chief--
    (i) The testimony of any witness whose name does not appear on the 
witness list; and
    (ii) Any exhibit not provided to the opposing party as specified in 
paragraph (a) of this section.
    (3) If the ALJ finds that extraordinary circumstances existed, the 
ALJ must then determine whether the admission of that evidence would 
cause substantial prejudice to the objecting party.
    (i) If the ALJ finds that there is no substantial prejudice, the 
evidence may be admitted.
    (ii) If the ALJ finds that there is substantial prejudice, the ALJ 
may exclude the evidence, or, if he or she does not exclude the 
evidence, must postpone the hearing for such time as is necessary for 
the objecting party to prepare and respond to the evidence, unless the 
objecting party waives postponement.
    (c) Unless the other party objects within a reasonable period of 
time before the hearing, documents exchanged in accordance with 
paragraph (a) of this section will be deemed to be authentic for the 
purpose of admissibility at the hearing.



Sec. 3.520  Subpoenas for attendance at hearing.

    (a) A party wishing to procure the appearance and testimony of any 
person at the hearing may make a motion requesting the ALJ to issue a 
subpoena if the appearance and testimony are reasonably necessary for 
the presentation of a party's case.
    (b) A subpoena requiring the attendance of a person in accordance 
with paragraph (a) of this section may also require the person (whether 
or not the person is a party) to produce relevant and material evidence 
at or before the hearing.
    (c) When a subpoena is served by a respondent on a particular 
employee or official or particular office of HHS, the Secretary may 
comply by designating any knowledgeable HHS representative to appear and 
testify.
    (d) A party seeking a subpoena must file a written motion not less 
than 30 days before the date fixed for the hearing, unless otherwise 
allowed by the ALJ for good cause shown. That motion must--
    (1) Specify any evidence to be produced;
    (2) Designate the witnesses; and
    (3) Describe the address and location with sufficient particularity 
to permit those witnesses to be found.
    (e) The subpoena must specify the time and place at which the 
witness is to appear and any evidence the witness is to produce.
    (f) Within 15 days after the written motion requesting issuance of a 
subpoena is served, any party may file an opposition or other response.
    (g) If the motion requesting issuance of a subpoena is granted, the 
party seeking the subpoena must serve it by delivery to the person 
named, or by certified mail addressed to that person at the person's 
last dwelling place or principal place of business.
    (h) The person to whom the subpoena is directed may file with the 
ALJ a motion to quash the subpoena within 10 days after service.
    (i) The exclusive remedy for contumacy by, or refusal to obey a 
subpoena duly served upon, any person is specified in 42 U.S.C. 405(e).



Sec. 3.522  Fees.

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



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

    (a) Forms. (1) Unless the ALJ directs the parties to do otherwise, 
documents filed with the ALJ must include an original and two copies.

[[Page 62]]

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



Sec. 3.526  Computation of time.

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



Sec. 3.528  Motions.

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



Sec. 3.530  Sanctions.

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

[[Page 63]]



Sec. 3.532  Collateral estoppel.

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



Sec. 3.534  The hearing.

    (a) The ALJ must conduct a hearing on the record in order to 
determine whether the respondent should be found liable under this part.
    (b)(1) The respondent has the burden of going forward and the burden 
of persuasion with respect to any challenge to the amount of a proposed 
penalty pursuant to Secs. 3.404 and 3.408, including any factors raised 
as mitigating factors.
    (2) The Secretary has the burden of going forward and the burden of 
persuasion with respect to all other issues, including issues of 
liability and the existence of any factors considered as aggravating 
factors in determining the amount of the proposed penalty.
    (3) The burden of persuasion will be judged by a preponderance of 
the evidence.
    (c) The hearing must be open to the public unless otherwise ordered 
by the ALJ for good cause shown, which may be that identifiable patient 
safety work product has been introduced into evidence or is expected to 
be introduced into evidence.
    (d)(1) Subject to the 15-day rule under Sec. 3.518(a) and the 
admissibility of evidence under Sec. 3.540, either party may introduce, 
during its case in chief, items or information that arose or became 
known after the date of the issuance of the notice of proposed 
determination or the request for hearing, as applicable. Such items and 
information may not be admitted into evidence, if introduced--
    (i) By the Secretary, unless they are material and relevant to the 
acts or omissions with respect to which the penalty is proposed in the 
notice of proposed determination pursuant to Sec. 3.420 of this part, 
including circumstances that may increase penalties; or
    (ii) By the respondent, unless they are material and relevant to an 
admission, denial or explanation of a finding of fact in the notice of 
proposed determination under Sec. 3.420 of this part, or to a specific 
circumstance or argument expressly stated in the request for hearing 
under Sec. 3.504, including circumstances that may reduce penalties.
    (2) After both parties have presented their cases, evidence may be 
admitted in rebuttal even if not previously exchanged in accordance with 
Sec. 3.518.



Sec. 3.538  Witnesses.

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

[[Page 64]]

    (2) In the case of a party that is not a natural person, the officer 
or employee of the party appearing for the entity pro se or designated 
as the party's representative; or
    (3) A natural person whose presence is shown by a party to be 
essential to the presentation of its case, including a person engaged in 
assisting the attorney for the Secretary.



Sec. 3.540  Evidence.

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



Sec. 3.542  The record.

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



Sec. 3.544  Post hearing briefs.

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



Sec. 3.546  ALJ's decision.

    (a) The ALJ must issue a decision, based only on the record, which 
must contain findings of fact and conclusions of law.
    (b) The ALJ may affirm, increase, or reduce the penalties imposed by 
the Secretary.
    (c) The ALJ must issue the decision to both parties within 60 days 
after the time for submission of post-hearing briefs and reply briefs, 
if permitted, has expired. If the ALJ fails to meet

[[Page 65]]

the deadline contained in this paragraph, he or she must notify the 
parties of the reason for the delay and set a new deadline.
    (d) Unless the decision of the ALJ is timely appealed as provided 
for in Sec. 3.548, the decision of the ALJ will be final and binding on 
the parties 60 days from the date of service of the ALJ's decision.



Sec. 3.548  Appeal of the ALJ's decision.

    (a) Any party may appeal the decision of the ALJ to the Board by 
filing a notice of appeal with the Board within 30 days of the date of 
service of the ALJ decision. The Board may extend the initial 30 day 
period for a period of time not to exceed 30 days if a party files with 
the Board a request for an extension within the initial 30 day period 
and shows good cause.
    (b) If a party files a timely notice of appeal with the Board, the 
ALJ must forward the record of the proceeding to the Board.
    (c) A notice of appeal must be accompanied by a written brief 
specifying exceptions to the initial decision and reasons supporting the 
exceptions. Any party may file a brief in opposition to the exceptions, 
which may raise any relevant issue not addressed in the exceptions, 
within 30 days of receiving the notice of appeal and the accompanying 
brief. The Board may permit the parties to file reply briefs.
    (d) There is no right to appear personally before the Board or to 
appeal to the Board any interlocutory ruling by the ALJ.
    (e) The Board may not consider any issue not raised in the parties' 
briefs, nor any issue in the briefs that could have been raised before 
the ALJ but was not.
    (f) If any party demonstrates to the satisfaction of the Board that 
additional evidence not presented at such hearing is relevant and 
material and that there were reasonable grounds for the failure to 
adduce such evidence at the hearing, the Board may remand the matter to 
the ALJ for consideration of such additional evidence.
    (g) The Board may decline to review the case, or may affirm, 
increase, reduce, reverse or remand any penalty determined by the ALJ.
    (h) The standard of review on a disputed issue of fact is whether 
the initial decision of the ALJ is supported by substantial evidence on 
the whole record. The standard of review on a disputed issue of law is 
whether the decision is erroneous.
    (i) Within 60 days after the time for submission of briefs and reply 
briefs, if permitted, has expired, the Board must serve on each party to 
the appeal a copy of the Board's decision and a statement describing the 
right of any respondent who is penalized to seek judicial review.
    (j)(1) The Board's decision under paragraph (i) of this section, 
including a decision to decline review of the initial decision, becomes 
the final decision of the Secretary 60 days after the date of service of 
the Board's decision, except with respect to a decision to remand to the 
ALJ or if reconsideration is requested under this paragraph.
    (2) The Board will reconsider its decision only if it determines 
that the decision contains a clear error of fact or error of law. New 
evidence will not be a basis for reconsideration unless the party 
demonstrates that the evidence is newly discovered and was not 
previously available.
    (3) A party may file a motion for reconsideration with the Board 
before the date the decision becomes final under paragraph (j)(1) of 
this section. A motion for reconsideration must be accompanied by a 
written brief specifying any alleged error of fact or law and, if the 
party is relying on additional evidence, explaining why the evidence was 
not previously available. Any party may file a brief in opposition 
within 15 days of receiving the motion for reconsideration and the 
accompanying brief unless this time limit is extended by the Board for 
good cause shown. Reply briefs are not permitted.
    (4) The Board must rule on the motion for reconsideration not later 
than 30 days from the date the opposition brief is due. If the Board 
denies the motion, the decision issued under paragraph (i) of this 
section becomes the final decision of the Secretary on the date of 
service of the ruling. If the Board grants the motion, the Board will 
issue a reconsidered decision, after

[[Page 66]]

such procedures as the Board determines necessary to address the effect 
of any error. The Board's decision on reconsideration becomes the final 
decision of the Secretary on the date of service of the decision, except 
with respect to a decision to remand to the ALJ.
    (5) If service of a ruling or decision issued under this section is 
by mail, the date of service will be deemed to be 5 days from the date 
of mailing.
    (k)(1) A respondent's petition for judicial review must be filed 
within 60 days of the date on which the decision of the Board becomes 
the final decision of the Secretary under paragraph (j) of this section.
    (2) In compliance with 28 U.S.C. 2112(a), a copy of any petition for 
judicial review filed in any U.S. Court of Appeals challenging the final 
decision of the Secretary must be sent by certified mail, return receipt 
requested, to the General Counsel of HHS. The petition copy must be a 
copy showing that it has been time-stamped by the clerk of the court 
when the original was filed with the court.
    (3) If the General Counsel of HHS received two or more petitions 
within 10 days after the final decision of the Secretary, the General 
Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation 
of any petitions that were received within the 10 day period.



Sec. 3.550  Stay of the Secretary's decision.

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



Sec. 3.552  Harmless error.

    No error in either the admission or the exclusion of evidence, and 
no error or defect in any ruling or order or in any act done or omitted 
by the ALJ or by any of the parties is ground for vacating, modifying or 
otherwise disturbing an otherwise appropriate ruling or order or act, 
unless refusal to take such action appears to the ALJ or the Board 
inconsistent with substantial justice. The ALJ and the Board at every 
stage of the proceeding must disregard any error or defect in the 
proceeding that does not affect the substantial rights of the parties.



PART 4_NATIONAL LIBRARY OF MEDICINE--Table of Contents



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

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

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



Sec. 4.1  Programs to which these regulations apply.

    (a) The regulations of this part govern access to the National 
Library of Medicine's facilities and library collections and the 
availability of its bibliographic, reproduction, reference, and related 
services. These functions are performed by the Library directly for the 
benefit of the general public and health-sciences professionals as 
required by sections 465(b) (3)-(6) of the Act (42 U.S.C. 286(b) (3)-
(6)).
    (b) The regulations of this part do not apply to:
    (1) The Library's internal functions relating to the acquisition and 
preservation of materials and the organization of these materials as 
required by sections 465(b) (1) and (2) of the Act (42 U.S.C. 286(b) (1) 
and (2)).
    (2) The availability of ``records'' under the Freedom of Information 
Act or the Privacy Act of 1974 (5 U.S.C. 552, 552a). These matters are 
covered in 45 CFR parts 5 and 5b.

[[Page 67]]

    (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 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.

[[Page 68]]



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 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

[[Page 69]]

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 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

[[Page 70]]

(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:
    (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

[[Page 71]]

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. Criteria

    A geographic area will be designated as having a shortage of primary 
medical care manpower if the following three criteria are met:
    1. The area is a rational area for the delivery of primary medical 
care services.
    2. One of the following conditions prevails within the area:
    (a) The area has population to full-time-equivalent primary care 
physician ratio of at least 3,500:1.
    (b) The area has a population to full-time-equivalent primary care 
physician ratio of less than 3,500:1 but greater than 3,000:1 and has 
usually high needs for primary care services or insufficient capacity of 
existing primary care providers.
    3. Primary medical care manpower 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 Primary Medical Care Services.
    (a) The following areas will be considered rational areas for the 
delivery of primary medical care services:
    (i) A county, or a group of contiguous counties whose population 
centers are within 30 minutes travel time of each other.
    (ii) A portion of a county, or an area made up of portions of more 
than one county, whose population, because of topography, market or 
transportation patterns, distinctive population characteristics or other 
factors, has limited access to contiguous area resources, as measured 
generally by a travel time greater than 30 minutes to such resources.
    (iii) Established neighborhoods and communities within metropolitan 
areas which display a strong self-identity (as indicated by a 
homogeneous socioeconomic or demographic structure and/or a tradition of 
interaction or interdependency), have limited interaction with 
contiguous areas, and which, in general, have a minimum population of 
20,000.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 30 minutes travel time:
    (i) Under normal conditions with primary roads available: 20 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 15 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
25 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 30 minutes travel time.
    2. Population Count.
    The population count used will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, with 
the following adjustments, where appropriate:
    (a) Adjustments to the population for the differing health service 
requirements of various age-sex population groups will be computed using 
the table below of visit rates for 12 age-sex population cohorts. The 
total expected visit rate will first be obtained by multiplying each of 
the 12 visit rates in the table by the size of the area population 
within that particular age-sex cohort and adding the resultant 12 visit 
figures together. This total expected visit rate will then be divided by 
the U.S. average per capita visit rate of 5.1, to obtain the adjusted 
population for the area.

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


[[Page 72]]

    (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 = 0.25  x  (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. 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.

[[Page 73]]

    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$5,000
Group 2.........................  R$5,000...........  5,000>R$4,000
Group 3.........................  5,000>R$4,000.....  4,000>R$3,500
Group 4.........................  4,000>R$3,500.....  3,500>R$3,000
------------------------------------------------------------------------

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

                       Part II--Population Groups

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

Group 1--No physicians or R>5,000.
Group 2--5,000>R$4,000.
Group 3--4,000>R$3,500.
Group 4--3,500>R$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

[[Page 74]]

                          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 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)  x  number 
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) 
 x  number 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. Public or Non-Profit Medical Facilities.
    1. Criteria.
    Public or non-profit private medical facilities will be designated 
as having a shortage of primary medical care professional(s) if:
    (a) the facility is providing primary medical care services to an 
area or population group designated as having a primary care 
professional(s) shortage; and
    (b) the facility has insufficient capacity to meet the primary care 
needs of that area or population group.
    2. Methodology
    In determining whether public or nonprofit private medical 
facilities meet the criteria established by paragraph B.1 of this Part, 
the following methodology will be used:
    (a) Provision of Services to a Designated Area or Population Group.
    A facility will be considered to be providing services to a 
designated area or population group if either:
    (i) A majority of the facility's primary care services are being 
provided to residents of designated primary care professional(s) 
shortage areas or to population groups designated as having a shortage 
of primary care professional(s); or
    (ii) The population within a designated primary care shortage area 
or population group has reasonable access to primary care services 
provided at the facility. Reasonable access will be assumed if the area 
within which the population resides lies within 30 minutes travel time 
of the facility and non-physical barriers (relating to demographic and 
socioeconomic characteristics of the population) do not prevent the 
population from receiving care at the facility.
    Migrant health centers (as defined in section 319(a)(1) of the Act) 
which are located in areas with designated migrant population groups and 
Indian Health Service facilities are assumed to be meeting this 
requirement.
    (b) Insufficient capacity to meet primary care needs.
    A facility will be considered to have insufficient capacity to meet 
the primary care needs of the area or population it serves if at least 
two of the following conditions exist at the facility:
    (i) There are more than 8,000 outpatient visits per year per FTE 
primary care physician on the staff of the facility. (Here the number of 
FTE primary care physicians is computed as in Part I, Section B, 
paragraph 3 above.)
    (ii) There is excessive usage of emergency room facilities for 
routine primary care.
    (iii) Waiting time for appointments is more than 7 days for 
established patients or more than 14 days for new patients, for routine 
health services.
    (iv) Waiting time at the facility is longer than 1 hour where 
patients have appointments or 2 hours where patients are treated on a 
first-come, first-served basis.
    3. Determination of Degree of Shortage.
    Each designated medical facility will be assigned to the same 
degree-of-shortage group as the designated area or population group 
which it serves.

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

[[Page 75]]



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

                        Part I--Geographic Areas

                               A. Criteria

    A geographic area will be designated as having a dental manpower 
shortage if the following three criteria are met:
    1. The area is a rational area for the delivery of dental services.
    2. One of the following conditions prevails in the area:
    (a) The area has a population to full-time-equivalent dentist ratio 
of less than 5,000:1 or
    (b) The area has a population to full-time-equivalent dentist ratio 
of less than 5,000:1 but greater than 4,000:1 and has unusually high 
needs for dental services or insufficient capacity of existing dental 
providers.
    3. Dental manpower in contiguous areas are over utilized, 
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 Area for the Delivery of Dental Services.
    (a) The following areas will be considered rational areas for the 
delivery of dental health services:
    (i) A county, or a group of several contiguous counties whose 
population centers are within 40 minutes travel time of each other.
    (ii) A portion of a county (or an area made up of portions of more 
than one county) whose population, because of topography, market or 
transportation patterns, distinctive population characteristics, or 
other factors, has limited access to contiguous area resources, as 
measured generally by a travel time of greater than 40 minutes to such 
resources.
    (iii) Established neighborhoods and communities within metropolitan 
areas which display a strong self-identity (as indicated by a homogenous 
socioeconomic or demographic structure and/or a traditional of 
interaction or intradependency), have limited interaction with 
contiguous areas, and which, in general, have a minimum population of 
20,000.
    (b) The following distances will be used as guidelines in 
determining distances corresponding to 40 minutes travel time:
    (i) Under normal conditions with primary roads available: 25 miles.
    (ii) In mountainous terrain or in areas with only secondary roads 
available: 20 miles.
    (iii) In flat terrain or in areas connected by interstate highways: 
30 miles.
    Within inner portions of metropolitan areas, information on the 
public transportation system will be used to determine the distance 
corresponding to 40 minutes travel time.
    2. Population Count.
    The population count use will be the total permanent resident 
civilian population of the area, excluding inmates of institutions, with 
the following adjustments:
    (a) Seasonal residents, i.e., those who maintain a residence in the 
area but inhabit it for only 2 to 8 months per year, may be included but 
must be weighted in proportion to the fraction of the year they are 
present in the area.
    (b) Migratory workers and their families may be included in an 
area's population using the following formula: Effective migrant 
contribution to population = (fraction of year migrants are present in 
area)  x  (average daily number of migrants during portion of year that 
migrants are present).
    3. Counting of Dental Practitioners.
    (a) All non-Federal dentists providing patient care will be counted, 
except in those areas where it is shown that specialists (those dentists 
not in general practice or pedodontics) are serving a larger area and 
are not addressing the general dental care needs of the area under 
consideration.
    (b) Full-time equivalent (FTE) figures will be used to reflect 
productivity differences among dental practices based on the age of the 
dentists, the number of auxiliaries employed, and the number of hours 
worked per week. In general, the number of FTE dentists will be computed 
using weights obtained from the matrix in Table 1, which is based on the 
productivity of dentists at various ages, with different numbers of 
auxiliaries, as compared with the average productivity of all dentists. 
For the purposes of these determinations, an auxiliary is defined as any 
non-dentist staff employed by the dentist to assist in operation of the 
practice.

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

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

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


[[Page 76]]

    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 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$8,000.
Group 2.........................  R$8,000...........  8,000>R$6,000.
Group 3.........................  8,000>R$6,000.....  6,000>R$5,000.
Group 4.........................  6,000>R$5,000.....  5,000>R$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

[[Page 77]]

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--8,000>R$6,000.
Group 3--6,000>R$5,000.
Group 4--5,000>R$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 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 + 2 
 x  ALOS)  x  number 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. 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

[[Page 78]]

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 
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,

[[Page 79]]

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 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

[[Page 80]]

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
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

[[Page 81]]

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 and youth detention facilities will be designated as having 
a shortage of psychiatric manpower 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 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 psychiatric 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 the intake psychiatric examinations are routinely performed upon 
entry, then--
    Number 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 psychiatric examinations are routinely performed upon 
entry, then--
    Number of internees=average number of inmates+\1/
3\ x [1+(2 x ALOS)] x number of new inmates per year
    where ALOS=average length-of-stay (in fraction of year) (The number 
of FTE psychiatrists 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 ration (R) of 
internees to FTE psychiatrists, as follows:
    Group 1--Institutions with 500 or more inmates and no psychiatrist.
    Group 2--Other institutions with no psychiatrists and institutions 
with R greater than (or equal to) 3,000:1.
    Group 3--Institutions with R greater than (or equal to) 2,000:1 but 
less than 3,000:1.

    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 R>1,800.
    Group 2--1,800>R>1,200.
    Group 3--1,200>R>600.
    Group 4--600>R>300.

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

[[Page 82]]

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.

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

[[Page 83]]

    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:
    (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

[[Page 84]]

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.
    (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.

[[Page 85]]

    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:
    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

[[Page 86]]

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)
 + .2  x  (number of other cattle and calves)
 + .05  x  (number of hogs and pigs)
 + .05  x  (number of sheep)
 + .002  x  (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)
 + .75  x  (mixed practice veterinarians with greater than 50% of 
practice in large animal care)
 + .5  x  (mixed practice veterinarians with approximately 50% of 
practice in large animal care)
 + .25  x  (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)
 + .75  x  (mixed practice veterinarians with greater than 50% of 
practice in small animal care)
 + .5  x  (mixed practice veterinarians with approximately 50% of 
practice in small animal care)
 + .25  x  (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.
    Group 2--Areas (not included above) with a food animal veterinarian 
shortage and no food animal veterinarians.
    Group 3--All other food animal veterinarian shortage areas.
    Group 4--All companion animal shortage areas (not included above) 
having no veterinarians.
    Group 5--All other companion animal shortage areas.



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



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

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

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



Sec. 5a.1  Statutory basis and purpose.

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

[[Page 87]]



Sec. 5a.2  Applicability.

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



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

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



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



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

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

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



Sec. 6.1  Applicability.

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



Sec. 6.2  Definitions.

    Act means the Public Health Service Act, as amended.
    Attorney General means the Attorney General of the United States and 
any 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.

[[Page 88]]

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



Sec. 6.5  Deeming process for eligible entities.

    Eligible entities will be covered by this part only on and after the 
effective date of a determination by the Secretary that they meet the 
requirements of section 224(h) of the Act. In making such determination, 
the Secretary will receive such assurances and conduct such 
investigations as he or she deems necessary.



Sec. 6.6  Covered acts and omissions.

    (a) Only acts and omissions occurring on and after the effective 
date of the Secretary's determination under Sec. 6.5 and before the 
later date specified in section 224(g)(3) of the Act are covered by this 
part.
    (b) Only claims for damage for personal injury, including death, 
resulting from the performance of medical, surgical, dental, or related 
functions are covered by this part.
    (c) With respect to covered individuals, only acts and omissions 
within the scope of their employment (or contract for services) are 
covered. If a covered individual is providing services which are not on 
behalf of the covered entity, such as on a volunteer basis or on behalf 
of a third-party (except as described in paragraph (d) of this section), 
whether for pay or otherwise, acts and omissions which are related to 
such services are not covered.
    (d) Only acts and omissions related to the grant-supported activity 
of entities are covered. Acts and omissions related to services provided 
to individuals who are not patients of a covered entity will be covered 
only if the Secretary determines that:
    (1) The provision of the services to such individuals benefits 
patients of the entity and general populations that could be served by 
the entity through 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.

[[Page 89]]

    (4) For the specific activities described in this paragraph (e)(4), 
when carried out by an entity (and its eligible personnel) that has been 
covered under paragraph (c) of this section, the Department has 
determined that coverage is provided under paragraph (d) of this 
section, without the need for specific application for an additional 
coverage determination under paragraph (d) of this section, if the 
activity or arrangement in question fits squarely within these 
descriptions; otherwise, the health center should seek a particularized 
determination of coverage.
    (i) Community-Wide Interventions. (A) School-Based Clinics: Health 
center staff provide primary and preventive health care services at a 
facility located in a school or on school grounds. The health center has 
a written affiliation agreement with the school.
    (B) School-Linked Clinics: Health center staff provide primary and 
preventive health care services, at a site not located on school 
grounds, to students of one or more schools. The health center has a 
written affiliation agreement with each school.
    (C) Health Fairs: On behalf of the health center, health center 
staff conduct or participate in an event to attract community members 
for purposes of performing health assessments. Such events may be held 
in the health center, outside on its grounds, or elsewhere in the 
community.
    (D) Immunization Campaigns: On behalf of the health center, health 
center staff conduct or participate in an event to immunize individuals 
against infectious illnesses. The event may be held at the health 
center, schools, or elsewhere in the community.
    (E) Migrant Camp Outreach: Health center staff travel to a migrant 
farmworker residence camp to conduct intake screening to determine those 
in need of clinic services (which may mean health care is provided at 
the time of such intake activity or during subsequent clinic staff 
visits to the camp).
    (F) Homeless Outreach: Health center staff travel to a shelter for 
homeless persons, or a street location where homeless persons 
congregate, to conduct intake screening to determine those in need of 
clinic services (which may mean health care is provided at the time of 
such intake activity or during subsequent clinic staff visits to that 
location).
    (ii) Hospital-Related Activities. Periodic hospital call or hospital 
emergency room coverage is required by the hospital as a condition for 
obtaining hospital admitting privileges. There must also be 
documentation for the particular health care provider that this coverage 
is a condition of employment at the health center.
    (iii) Coverage-Related Activities. As part of a health center's 
arrangement with local community providers for after-hours coverage of 
its patients, the health center's providers are required by their 
employment contract to provide periodic or occasional cross-coverage for 
patients of these providers.
    (iv) Coverage in Certain Individual Emergencies. A health center 
provider is providing or undertaking to provide covered services to a 
health center patient within the approved scope of project of the 
center, or to an individual who is not a patient of the health center 
under the conditions set forth in this rule, when the provider is then 
asked, called upon, or undertakes, at or near that location and as the 
result of a non-health center patient's emergency situation, to 
temporarily treat or assist in treating that non-health center patient. 
In addition to any other documentation required for the original 
services, the health center must have documentation (such as employee 
manual provisions, health center bylaws, or an employee contract) that 
the provision of individual emergency treatment, when the practitioner 
is already providing or undertaking to provide covered services, is a 
condition of employment at the health center.

[60 FR 22532, May 8, 1995; 60 FR 36073, July 13, 1995; 78 FR 58204, 
Sept. 23, 2013]



PART 7_DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL
PREPARATIONS--Table of Contents



Sec.
7.1  Applicability.
7.2  Establishment of a user charge.

[[Page 90]]

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 Appropriations Act of 1952 (31 U.S.C. 
9701); and secs. 301(a) and 352 of the Public Health Service Act, as 
amended (42 U.S.C. 241(a) and 263).

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



Sec. 7.1  Applicability.

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

[78 FR 43820, July 22, 2013]



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 changes 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 cost 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 Division of Scientific Resources, Centers for Disease Control, 
1600 Clifton Road NE., MS C-17, Atlanta, Georgia, 30333 or 404-639-3466.

[78 FR 43820, July 22, 2013]



Sec. 7.5  Payment procedures.

    An up-to-date fee schedule and instructions for terms of payment are 
available from the Division of Scientific Resources, Centers for Disease 
Control and Prevention, 1600 Clifton Road, MS C-17, Atlanta, Georgia 
30333 or 404-639-3466. Any changes in the fee schedule will be published 
in the Federal Register. The fee must be paid in U.S. dollars at the 
time that the requester requests the biological reference standard or 
biological preparation.

[78 FR 43820, July 22, 2013]



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_MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS--
Table of Contents



                      Subpart A_General Provisions

Sec.
8.1  Scope.
8.2  Definitions.

          Subpart B_Accreditation of Opioid Treatment Programs

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.

[[Page 91]]

  Subpart C_Certification and Treatment Standards for Opioid Treatment 
                                Programs

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

8.21  Applicability.
8.22  Definitions.
8.23  Limitation on issues subject to review.
8.24  Specifying who represents the parties.
8.25  Informal review and the reviewing official's response.
8.26  Preparation of the review file and written arguments.
8.27  Opportunity for oral presentation.
8.28  Expedited procedures for review of immediate suspension.
8.29  Ex parte communications.
8.30  Transmission of written communications by reviewing official and 
          calculation of deadlines.
8.31  Authority and responsibilities of the reviewing official.
8.32  Administrative record.
8.33  Written decision.
8.34  Court review of final administrative action; exhaustion of 
          administrative remedies.

Subpart E [Reserved]

    Subpart F_Authorization To Increase Patient Limit to 275 Patients

8.610  Which practitioners are eligible for a patient limit of 275?
8.615  What constitutes a qualified practice setting?
8.620  What is the process to request a patient limit of 275?
8.625  How will a Request for Patient Limit Increase be processed?
8.630  What must practitioners do in order to maintain their approval to 
          treat up to 275 patients?
8.635  What are the reporting requirements for practitioners whose 
          Request for Patient Limit Increase is approved?
8.640  What is the process for renewing a practitioner's Request for 
          Patient Limit Increase approval?
8.645  What are the responsibilities of practitioners who do not submit 
          a renewal Request for Patient Limit Increase, or whose renewal 
          request is denied?
8.650  Can SAMHSA's approval of a practitioner's Request for Patient 
          Limit Increase be suspended or revoked?
8.655  Can a practitioner request to temporarily treat up to 275 
          patients in emergency situations?

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

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

    Editorial Note: Nomenclature changes to part appear at 81 FR 44736, 
July 8, 2016.



                      Subpart A_General Provisions



Sec. 8.1  Scope.

    (a) Subparts A through C of 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 (CSA) (21 U.S.C. 823(g)) to dispense 
opioid drugs in the treatment of opioid use disorders. The 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 use disorder 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 
treatment of opioid use disorder with an opioid agonist treatment 
medication.
    (b) The regulations in subpart F of this part establish the 
procedures and requirements that practitioners who

[[Page 92]]

are authorized to treat up to 100 patients pursuant to a waiver obtained 
under section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy 
in order to treat up to 275 patients with medications covered under 
section 303(g)(2)(C) of the CSA.

[81 FR 44736, July 8, 2016]



Sec. 8.2  Definitions.

    The following definitions apply to this part:
    Accreditation body means a body that has been approved by SAMHSA in 
this part 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.
    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).
    Additional Credentialing means board certification in addiction 
medicine or addiction psychiatry by the American Board of Addiction 
Medicine, the American Board of Medical Specialties, or the American 
Osteopathic Association or certification by the American Board of 
Addiction Medicine, or the American Society of Addiction Medicine.
    Approval term means the 3 year period in which a practitioner is 
approved to treat up to 275 patients that commences when a 
practitioner's Request for Patient Limit Increase is approved in 
accordance with Sec. 8.625.
    Behavioral health services means any non-pharmacological 
intervention carried out in a therapeutic context at an individual, 
family, or group level. Interventions may include structured, 
professionally administered interventions (e.g., cognitive behavior 
therapy or insight oriented psychotherapy) delivered in person, 
interventions delivered remotely via telemedicine shown in clinical 
trials to facilitate medication-assisted treatment (MAT) outcomes, or 
non-professional interventions.
    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.
    Covered medications means the drugs or combinations of drugs that 
are covered under 21 U.S.C. 823(g)(2)(C).
    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.
    Dispense means to deliver a controlled substance to an ultimate user 
by, or pursuant to, the lawful order of, a practitioner, including the 
prescribing and administering of a controlled substance.
    Diversion control plan means a set of documented procedures that 
reduce the possibility that controlled substances will be transferred or 
used illicitly.
    Emergency situation means that an existing State, tribal, or local 
system for substance use disorder services is overwhelmed or unable to 
meet the existing

[[Page 93]]

need for medication-assisted treatment as a direct consequence of a 
clear precipitating event. This precipitating event must have an abrupt 
onset, such as practitioner incapacity; natural or human-caused 
disaster; an outbreak associated with drug use; and result in 
significant death, injury, exposure to life-threatening circumstances, 
hardship, suffering, loss of property, or loss of community 
infrastructure.
    Federal opioid treatment standards means the standards established 
by the Secretary in Sec. 8.12 that are used to determine whether an 
opioid treatment program is qualified to engage in e 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 an opioid treatment program 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 use disorder.
    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-Assisted Treatment (MAT) means the use of medication in 
combination with behavioral health services to provide an individualized 
approach to the treatment of substance use disorder, including opioid 
use disorder.
    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.
    Nationally recognized evidence-based guidelines means a document 
produced by a national or international medical professional 
association, public health agency, such as the World Health 
Organization, or governmental body with the aim of assuring the 
appropriate use of evidence to guide individual diagnostic and 
therapeutic clinical decisions.
    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 opioid use disorder.
    Opioid dependence means repeated self-administration that usually 
results in opioid tolerance, withdrawal symptoms, and compulsive drug-
taking. Dependence may occur with or without the physiological symptoms 
of tolerance and withdrawal.
    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 program or ``OTP'' means a program or practitioner 
engaged in opioid treatment of individuals with an opioid agonist 
treatment

[[Page 94]]

medication registered under 21 U.S.C. 823(g)(1).
    Opioid treatment program 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 
described in Sec. 8.12.
    Opioid use disorder means a cluster of cognitive, behavioral, and 
physiological symptoms in which the individual continues use of opioids 
despite significant opioid-induced problems.
    Opioid use disorder 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 an opioid use disorder. This term includes a range 
of services including detoxification treatment, short-term 
detoxification treatment, long-term detoxification treatment, 
maintenance treatment, comprehensive maintenance treatment, and interim 
maintenance treatment.
    Patient for purposes of subparts B through E of this part, means any 
individual who receives maintenance or detoxification treatment in an 
opioid treatment program. For purposes of subpart F of this part, 
patient means any individual who is dispensed or prescribed covered 
medications by a practitioner.
    Patient limit means the maximum number of individual patients that a 
practitioner may dispense or prescribe covered medications to at any one 
time.
    Practitioner means a physician who is appropriately licensed by the 
State to dispense covered medications and who possesses a waiver under 
21 U.S.C. 823(g)(2).
    Practitioner incapacity means the inability of a practitioner as a 
result of an involuntary event to physically or mentally perform the 
tasks and duties required to provide medication-assisted treatment in 
accordance with nationally recognized evidence-based guidelines.
    Program sponsor means the person named in the application for 
certification described in Sec. 8.11(b) as responsible for the operation 
of the opioid treatment program and who assumes responsibility for all 
its employees, including any practitioners, agents, or other persons 
providing medical, rehabilitative, or counseling services at the program 
or any of its medication units. The program sponsor need not be a 
licensed physician but shall employ a licensed physician for the 
position of medical director.
    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 opioid use disorder 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.

[66 FR 4090, Jan. 17, 2001, as amended at 81 FR 44736, July 8, 2016; 81 
FR 62404, Sept. 9, 2016]



          Subpart B_Accreditation of Opioid Treatment Programs

    Source: 81 FR 44738, July 8, 2016, unless otherwise noted.



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. Electronic copies of an 
accreditation body application form [SMA-167] shall be submitted to: 
http://buprenorphine.samhsa.gov/pls/bwns/waiver. 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

[[Page 95]]

body. The application shall be signed by the responsible official;
    (2) Evidence of the nonprofit status of the applicant (i.e., of 
fulfilling Internal Revenue Service requirements as a nonprofit 
organization) if the applicant is not a State governmental entity or 
political subdivision;
    (3) A set of the accreditation elements or standards and a detailed 
discussion showing how the proposed accreditation elements or standards 
will ensure that each OTP surveyed by the applicant is qualified to meet 
or is meeting each of the Federal opioid treatment standards set forth 
in Sec. 8.12;
    (4) A detailed description of the applicant's decisionmaking 
process, including:
    (i) Procedures for initiating and performing onsite accreditation 
surveys of OTPs;
    (ii) Procedures for assessing OTP personnel qualifications;
    (iii) Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTPs during 
the accreditation process, including a request for a complete history of 
prior accreditation activities and a statement that all information and 
data submitted in the application for accreditation is true and 
accurate, and that no material fact has been omitted;
    (iv) Policies and procedures for notifying OTPs and SAMHSA of 
deficiencies and for monitoring corrections of deficiencies by OTPs;
    (v) Policies and procedures for suspending or revoking an OTP's 
accreditation;
    (vi) Policies and procedures that will ensure processing of 
applications for accreditation and applications for renewal of 
accreditation within a timeframe approved by SAMHSA; and
    (vii) A description of the applicant's appeals process to allow OTPs 
to contest adverse accreditation decisions.
    (5) Policies and procedures established by the accreditation body to 
avoid conflicts of interest, or the appearance of conflicts of interest, 
by the applicant's board members, commissioners, professional personnel, 
consultants, administrative personnel, and other representatives;
    (6) A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership, and the identification of at least one licensed 
physician on the applicant's staff;
    (7) A description of the applicant's training policies;
    (8) Fee schedules, with supporting cost data;
    (9) Satisfactory assurances that the body will comply with the 
requirements of Sec. 8.4, including a contingency plan for investigating 
complaints under Sec. 8.4(e);
    (10) Policies and procedures established to protect confidential 
information the applicant will collect or receive in its role as an 
accreditation body; and
    (11) Any other information SAMHSA may require.
    (c) Application for renewal of approval. An accreditation body that 
intends to continue to serve as an accreditation body beyond its current 
term shall apply to SAMHSA for renewal, or notify SAMHSA of its 
intention not to apply for renewal, in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of an 
accreditation body's term of approval, the body shall inform SAMHSA in 
writing of its intent to seek renewal.
    (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

[[Page 96]]

renewal of approval if it determines the applicant substantially meets 
the accreditation body requirements of this subpart.
    (2) If SAMHSA determines that the applicant does not substantially 
meet the requirements set forth in this subpart. SAMHSA will notify the 
applicant of the deficiencies in the application and request that the 
applicant resolve such deficiencies within 90 days of receipt of the 
notice. If the deficiencies are resolved to the satisfaction of SAMHSA 
within the 90-day time period, the body will be approved as an 
accreditation body. If the deficiencies have not been resolved to the 
satisfaction of SAMHSA within the 90-day time period, the application 
for approval as an accreditation body will be denied.
    (3) If SAMHSA does not reach a final decision on a renewal 
application before the expiration of an accreditation body's term of 
approval, the approval will be deemed extended until SAMHSA reaches a 
final decision, unless an accreditation body does not rectify 
deficiencies in the application within the specified time period, as 
required in paragraph (d)(2) of this section.
    (e) Relinquishment of approval. An accreditation body that intends 
to relinquish its accreditation approval before expiration of the body's 
term of approval shall submit a letter of such intent to SAMHSA, at the 
address in paragraph (b) of this section, at least 9 months before 
relinquishing such approval.
    (f) Notification. An accreditation body that does not apply for 
renewal of approval, or is denied such approval by SAMHSA, relinquishes 
its accreditation approval before expiration of its term of approval, or 
has its approval withdrawn, shall:
    (1) Transfer copies of records and other related information as 
required by SAMHSA to a location, including another accreditation body, 
and according to a schedule approved by SAMHSA; and
    (2) Notify, in a manner and time period approved by SAMHSA, all OTPs 
accredited or seeking accreditation by the body that the body will no 
longer have approval to provide accreditation services.
    (g) Term of approval. An accreditation body's term of approval is 
for a period not to exceed 5 years.
    (h) State accreditation bodies. State governmental entities, 
including political subdivisions thereof, may establish organizational 
units that may act as accreditation bodies, provided such units meet the 
requirements of this section, are approved by SAMHSA under this section, 
and have taken appropriate measures to prevent actual or apparent 
conflicts of interest, including cases in which State or Federal funds 
are used to support opioid treatment services.

[66 FR 4090, Jan. 17, 2001, as amended at 81 FR 44737, July 8, 2016]



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

[[Page 97]]

in an OTP that may pose a serious risk to public health or safety or 
patient care.
    (iii) If an accreditation body determines that an OTP is 
substantially meeting the Federal opioid treatment standards, but is not 
meeting one or more accreditation elements, the accreditation body shall 
determine the necessary corrective measures to be taken by the OTP, 
establish a schedule for implementation of such measures, and notify the 
OTP in writing that it must implement such measures within the specified 
schedule in order to ensure continued accreditation. The accreditation 
body shall verify that the necessary steps are taken by the OTP within 
the schedule specified and that all accreditation elements are being 
substantially met or will be substantially met.
    (2) Nothing in this part shall prevent accreditation bodies from 
granting accreditation, contingent on promised programmatic or 
performance changes, to OTPs with less substantial violations. Such 
accreditation shall not exceed 12 months. OTPs that have been granted 
such accreditation must have their accreditation revoked if they fail to 
make changes to receive unconditional accreditation upon resurvey or 
reinspection.
    (c) Recordkeeping. (1) Accreditation bodies shall maintain records 
of their accreditation activities for at least 5 years from the creation 
of the record. Such records must contain sufficient detail to support 
each accreditation decision made by the accreditation body.
    (2) Accreditation bodies shall establish procedures to protect 
confidential information collected or received in their role as 
accreditation bodies that are consistent with, and that are designed to 
ensure compliance with, all Federal and State laws, including 42 CFR 
part 2.
    (i) Information collected or received for the purpose of carrying 
out accreditation body responsibilities shall not be used for any other 
purpose or disclosed, other than to SAMHSA or its duly designated 
representatives, unless otherwise required by law or with the consent of 
the OTP.
    (ii) Nonpublic information that SAMHSA shares with the accreditation 
body concerning an OTP shall not be further disclosed except with the 
written permission of SAMHSA.
    (d) Reporting. (1) Accreditation bodies shall provide to SAMHSA any 
documents and information requested by SAMHSA within 5 days of receipt 
of the request.
    (2) Accreditation bodies shall make a summary of the results of each 
accreditation survey available to SAMHSA upon request. Such summaries 
shall contain sufficient detail to justify the accreditation action 
taken.
    (3) Accreditation bodies shall provide SAMHSA upon request a list of 
each OTP surveyed and the identity of all individuals involved in the 
conduct and reporting of survey results.
    (4) Accreditation bodies shall submit to SAMHSA the name of each OTP 
for which the accreditation body accredits conditionally, denies, 
suspends, or revokes accreditation, and the basis for the action, within 
48 hours of the action.
    (5) Notwithstanding any reports made to SAMHSA under paragraphs 
(d)(1) through (d)(4) of this section, each accreditation body shall 
submit to SAMHSA semiannually, on January 15 and July 15 of each 
calendar year, a report consisting of a summary of the results of each 
accreditation survey conducted in the past year. The summary shall 
contain sufficient detail to justify each accreditation action taken.
    (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

[[Page 98]]

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 use 
disorder;
    (iii) Psychosocial counseling of individuals undergoing opioid 
treatment; and
    (iv) Organizational and administrative issues associated with opioid 
treatment programs.
    (2) Members of the accreditation team must be able to recuse 
themselves at any time from any survey in which either they or the OTP 
believes there is an actual conflict of interest or the appearance of a 
conflict of interest.
    (i) Accreditation fees. Fees charged to OTPs for accreditation shall 
be reasonable. SAMHSA generally will find fees to be reasonable if the 
fees are limited to recovering costs to the accreditation body, 
including overhead incurred. Accreditation body activities that are not 
related to accreditation functions are not recoverable through fees 
established for accreditation.
    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different OTPs.
    (2) At SAMHSA's request, accreditation bodies shall provide to 
SAMHSA financial records or other materials, in a manner specified by 
SAMHSA, to assist in assessing the reasonableness of accreditation body 
fees.



Sec. 8.5  Periodic evaluation of accreditation bodies.

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



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.

[[Page 99]]

    (2) An accreditation body that has lost its approval shall notify 
each OTP that has been accredited or is seeking accreditation that the 
accreditation body's approval has been withdrawn. Such notification 
shall be made within a time period and in a manner approved by SAMHSA.
    (b) Minor deficiencies. If SAMHSA determines that the accreditation 
body has minor deficiencies in the performance of an accreditation 
function, that are less serious or more limited than the types of 
deficiencies described in paragraph (a) of this section, SAMHSA will 
notify the body that it has 90 days to submit to SAMHSA a plan of 
corrective action. The plan must include a summary of corrective actions 
and a schedule for their implementation. SAMHSA may place the body on 
probationary status for a period of time determined by SAMHSA, or may 
withdraw approval of the body if corrective action is not taken.
    (1) If SAMHSA places an accreditation body on probationary status, 
the body shall notify all OTPs that have been accredited, or that are 
seeking accreditation, of the accreditation body's probationary status 
within a time period and in a manner approved by SAMHSA.
    (2) Probationary status will remain in effect until such time as the 
body can demonstrate to the satisfaction of SAMHSA that it has 
successfully implemented or is implementing the corrective action plan 
within the established schedule, and the corrective actions taken have 
substantially eliminated all identified problems.
    (3) If SAMHSA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, SAMHSA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all OTPs that have been accredited, or are seeking accreditation, of the 
accreditation body's loss of SAMHSA approval within a time period and in 
a manner approved by SAMHSA.
    (c) Reapplication. (1) An accreditation body that has had its 
approval withdrawn may submit a new application for approval if the body 
can provide information to SAMHSA to establish that the problems that 
were grounds for withdrawal of approval have been resolved.
    (2) If SAMHSA determines that the new application demonstrates that 
the body satisfactorily has addressed the causes of its previous 
unacceptable performance, SAMHSA may reinstate approval of the 
accreditation body.
    (3) SAMHSA may request additional information or establish 
additional conditions that must be met before SAMHSA approves the 
reapplication.
    (4) SAMHSA may refuse to accept an application from a former 
accreditation body whose approval was withdrawn because of fraud, 
material false statement, or willful disregard of public health.
    (d) Hearings. An opportunity to challenge an adverse action taken 
regarding withdrawal of approval of an accreditation body shall be 
addressed through the relevant procedures set forth in subpart C of this 
part, except that the procedures in Sec. 8.28 for expedited review of an 
immediate suspension would not apply to an accreditation body that has 
been notified under paragraph (a) or (b) of this section of the 
withdrawal of its approval.



  Subpart C_Certification and Treatment Standards for Opioid Treatment 
                                Programs

    Source: Redesignated at 81 FR 44737, July 8, 2016, unless otherwise 
noted.



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 use 
disorder. 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 use disorder.

[[Page 100]]

    (2) To obtain certification from SAMHSA, an OTP must meet the 
Federal opioid treatment standards in Sec. 8.12, must be the subject of 
a current, valid accreditation by an accreditation body or other entity 
designated by SAMHSA, and must comply with any other conditions for 
certification established by SAMHSA.
    (3) Certification shall be granted for a term not to exceed 3 years, 
except that certification may be extended during the third year if an 
application for accreditation is pending.
    (b) Application for certification. Three copies of an application 
for certification must be submitted by the OTP to the address identified 
in Sec. 8.3(b). SAMHSA will consider and accept the electronic 
submission of these materials when electronic submission systems are 
developed and available. The application for certification shall 
include:
    (1) A description of the current accreditation status of the OTP;
    (2) A description of the organizational structure of the OTP;
    (3) The names of the persons responsible for the OTP;
    (4) The addresses of the OTP and of each medication unit or other 
facility under the control of the OTP;
    (5) The sources of funding for the OTP and the name and address of 
each governmental entity that provides such funding; and
    (6) A statement that the OTP will comply with the conditions of 
certification set forth in paragraph (f) of this section.
    (7) The application shall be signed by the program sponsor who shall 
certify that the information submitted in the application is truthful 
and accurate.
    (c) Action on application. (1) Following SAMHSA's receipt of an 
application for certification of an OTP, and after consultation with the 
appropriate State authority regarding the qualifications of the 
applicant, SAMHSA may grant the application for certification, or renew 
an existing certification, if SAMHSA determines that the OTP has 
satisfied the requirements for certification or renewal of 
certification.
    (2) SAMHSA may deny the application if SAMHSA determines that:
    (i) The application for certification is deficient in any respect;
    (ii) The OTP will not be operated in accordance with the Federal 
opioid treatment standards established under Sec. 8.12;
    (iii) The OTP will not permit an inspection or a survey to proceed, 
or will not permit in a timely manner access to relevant records or 
information; or
    (iv) The OTP has made misrepresentations in obtaining accreditation 
or in applying for certification.
    (3) Within 5 days after it reaches a final determination that an OTP 
meets the requirements for certification, SAMHSA will notify the Drug 
Enforcement Administration (DEA) that the OTP has been determined to be 
qualified to provide opioid treatment under section 303(g)(1) of the 
Controlled Substances Act.
    (d) Transitional certification. OTPs that before May 18, 2001 were 
the subject of a current, valid approval by FDA under 21 CFR, part 291 
(contained in the 21 CFR parts 200 to 299 edition, revised as of July 1, 
2000), are deemed to be the subject of a current valid certification for 
purposes of paragraph (a)(11) of this section. Such ``transitional 
certification'' will expire on August 17, 2001 unless the OTP submits 
the information required by paragraph (b) of this section to SAMHSA on 
or before August 17, 2001. In addition to this application, OTPs must 
certify with a 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

[[Page 101]]

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 
use disorder. The provisions of this section requiring compliance with 
requirements imposed by State law, or the submission of applications or 
reports required by the State authority, do not apply to OTPs operated 
directly by the Department of Veterans Affairs, the Indian Health 
Service, or any other department or agency of the United States. Federal 
agencies operating OTPs have agreed to cooperate voluntarily with State 
agencies by granting permission on an informal basis for designated 
State representatives to visit Federal OTPs and by furnishing a copy of 
Federal reports to the State authority, including the reports required 
under this section.
    (2) OTPs shall allow, in accordance with Federal controlled 
substances laws and Federal confidentiality laws, inspections and 
surveys by duly authorized employees of SAMHSA, by accreditation bodies, 
by the DEA, and by authorized employees of any relevant State or Federal 
governmental authority.
    (3) Disclosure of patient records maintained by an OTP is governed 
by the provisions of 42 CFR part 2, and every program must comply with 
that part. Records on the receipt, storage, and distribution of opioid 
agonist treatment medications are also subject to inspection under 
Federal controlled substances laws and under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.). Federally-sponsored treatment 
programs are subject to applicable Federal confidentiality statutes.
    (4) A treatment program or medication unit or any part thereof, 
including any facility or any individual, shall permit a duly authorized 
employee of SAMHSA to have access to and to copy all records on the use 
of opioid drugs in accordance with the provisions of 42 CFR part 2.
    (5) OTPs shall notify SAMHSA within 3 weeks of any replacement or 
other change in the status of the program sponsor or medical director.
    (6) OTPs shall comply with all regulations enforced by the DEA under 
21 CFR chapter II, and must be registered by the DEA before 
administering or 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:

[[Page 102]]

    (i) Such officer does not object to the providing of interim 
maintenance treatment in the State;
    (ii) The OTP seeking to provide such treatment is unable to place 
patients in a public or nonprofit private comprehensive treatment 
program within a reasonable geographic area within 14 days of the time 
patients seek admission to such programs;
    (iii) The authorization of the OTP to provide interim maintenance 
treatment will not otherwise reduce the capacity of comprehensive 
maintenance treatment programs in the State to admit individuals 
(relative to the date on which such officer so certifies); and
    (iv) The State certifies that each individual enrolled in interim 
maintenance treatment will be transferred to a comprehensive maintenance 
treatment program no later than 120 days from the date on which each 
individual first requested treatment, as provided in section 1923 of the 
Public Health Service Act (21 U.S.C. 300x-23).
    (3) SAMHSA will provide notice to the OTP denying or approving the 
request to provide interim maintenance treatment. The OTP shall not 
provide such treatment until it has received such notice from SAMHSA.
    (h) Exemptions. An OTP may, at the time of application for 
certification or any time thereafter, request from SAMHSA exemption from 
the regulatory requirements set forth under this section and Sec. 8.12. 
An example of a case in which an exemption might be granted would be for 
a private practitioner who wishes to treat a limited number of patients 
in a non-metropolitan area with few physicians and no rehabilitative 
services geographically accessible and requests exemption from some of 
the staffing and service standards. The OTP shall support the rationale 
for the exemption with thorough documentation, to be supplied in an 
appendix to the initial application for certification or in a separate 
submission. SAMHSA will approve or deny such exemptions at the time of 
application, or any time thereafter, if appropriate. SAMHSA shall 
consult with the appropriate State authority prior to taking action on 
an exemption request.
    (i) Medication units, long-term care facilities and hospitals. (1) 
Certified OTPs may establish medication units that are authorized to 
dispense opioid agonist treatment medications for observed ingestion. 
Before establishing a medication unit, a certified OTP must notify 
SAMHSA by submitting form SMA-162. The OTP must also comply with the 
provisions of 21 CFR part 1300 before establishing a medication unit. 
Medication units shall comply with all pertinent state laws and 
regulations.
    (2) Certification as an OTP under this part will not be required for 
the maintenance or detoxification treatment of a patient who is admitted 
to a hospital or long-term care facility for the treatment of medical 
conditions other than opioid use disorder 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 
use disorder

[[Page 103]]

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 use disorder must have sufficient education, training, and 
experience, or any combination thereof, to enable that person to perform 
the assigned functions. All physicians, nurses, and other licensed 
professional care providers, including addiction counselors, must comply 
with the credentialing requirements of their respective professions.
    (e) Patient admission criteria--(1) Maintenance treatment. An OTP 
shall maintain current procedures designed to ensure that patients are 
admitted to maintenance treatment by qualified personnel who have 
determined, using accepted medical criteria such as those listed in the 
Diagnostic and Statistical Manual for Mental Disorders (DSM-IV), that 
the person is currently addicted to an opioid drug, and that the person 
became addicted at least 1 year before admission for treatment. In 
addition, a program physician shall ensure that each patient voluntarily 
chooses maintenance treatment and that all relevant facts concerning the 
use of the opioid drug are clearly and adequately explained to the 
patient, and that each patient provides informed written consent to 
treatment.
    (2) Maintenance treatment for persons under age 18. A person under 
18 years of age is required to have had two documented unsuccessful 
attempts at short-term detoxification or drug-free treatment within a 
12-month period to be eligible for maintenance treatment. No person 
under 18 years of age may be admitted to maintenance treatment unless a 
parent, legal guardian, or responsible adult designated by the relevant 
State authority consents in writing to such treatment.
    (3) Maintenance treatment admission exceptions. If clinically 
appropriate, the program physician may waive the requirement of a 1-year 
history of addiction under paragraph (e)(1) of this section, for 
patients released from penal institutions (within 6 months after 
release), for pregnant patients (program physician must certify 
pregnancy), and for previously treated patients (up to 2 years after 
discharge).
    (4) Detoxification treatment. An OTP shall maintain current 
procedures that are designed to ensure that patients are admitted to 
short- or long-term detoxification treatment by qualified personnel, 
such as a program physician, who determines that such treatment is 
appropriate for the specific patient by applying established diagnostic 
criteria. Patients with two or more unsuccessful detoxification episodes 
within a 12-month period must be 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.

[[Page 104]]

    (2) Initial medical examination services. OTPs shall require each 
patient to undergo a complete, fully documented physical evaluation by a 
program physician or a primary care physician, or an authorized 
healthcare professional under the supervision of a program physician, 
before admission to the OTP. The full medical examination, including the 
results of serology and other tests, must be completed within 14 days 
following admission.
    (3) Special services for pregnant patients. OTPs must maintain 
current policies and procedures that reflect the special needs of 
patients who are pregnant. Prenatal care and other gender specific 
services or pregnant patients must be provided either by the OTP or by 
referral to appropriate healthcare providers.
    (4) Initial and periodic assessment services. Each patient accepted 
for treatment at an OTP shall be assessed initially and periodically by 
qualified personnel to determine the most appropriate combination of 
services and treatment. The initial assessment must include preparation 
of a treatment plan that includes the patient's short-term goals and the 
tasks the patient must perform to complete the short-term goals; the 
patient's requirements for education, vocational rehabilitation, and 
employment; and the medical, psychosocial, economic, legal, or other 
supportive services that a patient needs. The treatment plan also must 
identify the frequency with which these services are to be provided. The 
plan must be reviewed and updated to reflect that patient's personal 
history, his or her current needs for medical, social, and psychological 
services, and his or her current needs for education, vocational 
rehabilitation, and employment services.
    (5) Counseling services. (i) OTPs must provide adequate substance 
abuse counseling to each patient as clinically necessary. This 
counseling shall be provided by a program counselor, qualified by 
education, training, or experience to assess the psychological and 
sociological background of patients, to contribute to the appropriate 
treatment plan for the patient and to monitor patient progress.
    (ii) OTPs must provide counseling on preventing exposure to, and the 
transmission of, human immunodeficiency virus (HIV) disease for each 
patient admitted or readmitted to maintenance or detoxification 
treatment.
    (iii) OTPs must provide directly, or through referral to adequate 
and reasonably accessible community resources, vocational 
rehabilitation, education, and employment services for patients who 
either request such services or who have been determined by the program 
staff to be in need of such services.
    (6) Drug abuse testing services. OTPs must provide adequate testing 
or analysis for drugs of abuse, including at least eight random drug 
abuse tests per year, per patient in maintenance treatment, in 
accordance with generally accepted clinical practice. For patients in 
short-term detoxification treatment, the OTP shall perform at least one 
initial drug abuse test. For patients receiving long-term detoxification 
treatment, the program shall perform initial and monthly random tests on 
each patient.
    (g) Recordkeeping and patient confidentiality. (1) OTPs shall 
establish and maintain a recordkeeping system that is adequate to 
document and monitor patient care. This system is required to comply 
with all Federal and State reporting requirements relevant to opioid 
drugs approved for use in treatment of opioid use disorder. 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

[[Page 105]]

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 use disorder. 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 use disorder. 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 use disorder:
    (i) Methadone;
    (ii) Levomethadyl acetate (LAAM); and
    (iii) Buprenorphine and buprenorphine combination products that have 
been approved for use in the treatment of opioid use disorder.
    (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 
opioid abstinence symptoms.
    (4) OTPs shall maintain current procedures adequate to ensure that 
each opioid agonist treatment medication used by the program is 
administered and dispensed in accordance with its approved product 
labeling. Dosing and administration decisions shall be made by a program 
physician familiar with the most up-to-date product labeling. These 
procedures must ensure that any significant deviations from the approved 
labeling, including deviations with regard to dose, frequency, or the 
conditions of use described in the approved labeling, are specifically 
documented in the patient's record.
    (i) Unsupervised or ``take-home'' use. To limit the potential for 
diversion of opioid agonist treatment medications to the illicit market, 
opioid agonist treatment medications dispensed to patients for 
unsupervised use shall be subject to the following requirements.
    (1) Any patient in comprehensive maintenance treatment may receive a 
single take-home dose for a day that the clinic is closed for business, 
including Sundays and State and Federal holidays.
    (2) Treatment program decisions on dispensing opioid treatment 
medications to patients for unsupervised use 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;

[[Page 106]]

    (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 
dispensing restrictions set forth in paragraphs (i)(3)(i) through (vi) 
of this section apply. The dispensing restrictions set forth in 
paragraphs (i)(3)(i) through (vi) of this section do not apply to 
buprenorphine and buprenorphine products listed under paragraph 
(h)(2)(iii) of this section.
    (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) are 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) are three doses per 
week.
    (iv) In the remaining months of the first year, a patient may be 
given a maximum 6-day supply of take-home medication.
    (v) After 1 year of continuous treatment, a patient may be given a 
maximum 2-week supply of take-home medication.
    (vi) After 2 years of continuous treatment, a patient may be given a 
maximum one-month supply of take-home medication, but must make monthly 
visits.
    (4) No medications shall be dispensed to patients in short-term 
detoxification treatment or interim maintenance treatment for 
unsupervised or take-home use.
    (5) OTPs must maintain current procedures adequate to identify the 
theft or diversion of take-home medications, including labeling 
containers with the OTP's name, address, and telephone number. Programs 
also must ensure that take-home supplies are packaged in a manner that 
is designed to reduce the risk of accidental ingestion, including child-
proof containers (see Poison Prevention Packaging Act, Public Law 91-601 
(15 U.S.C. 1471 et seq.)).
    (j) Interim maintenance treatment. (1) The program sponsor of a 
public or nonprofit private OTP may place an individual, who is eligible 
for admission to comprehensive maintenance treatment, in interim 
maintenance treatment if the individual cannot be placed in a public or 
nonprofit private comprehensive program within a reasonable geographic 
area and within 14 days of the individual's application for admission to 
comprehensive maintenance treatment. An initial and at least two other 
urine screens shall be taken from interim patients during the maximum of 
120 days permitted for such treatment. A program shall establish and 
follow reasonable criteria for establishing priorities for transferring 
patients from interim maintenance to comprehensive maintenance 
treatment. These transfer criteria shall be in writing and shall 
include, at a minimum, a preference for pregnant women in admitting 
patients to interim maintenance and in transferring patients from 
interim maintenance to comprehensive maintenance treatment. Interim 
maintenance shall be provided in a manner consistent with all applicable 
Federal and State laws, including sections 1923, 1927(a), and 1976 of 
the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-
11).
    (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,

[[Page 107]]

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; 77 
FR 72761, Dec. 6, 2012; 80 FR 34838, June 18, 2015]



Sec. 8.13  Revocation of accreditation and accreditation body approval.

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



Sec. 8.14  Suspension or revocation of certification.

    (a) Revocation. Except as provided in paragraph (b) of this section, 
SAMHSA may revoke the certification of an OTP if SAMHSA finds, after 
providing the program sponsor with notice and an opportunity for a 
hearing in accordance with subpart C of this part, that the program 
sponsor, or any employee of the OTP:
    (1) Has been found guilty of misrepresentation in obtaining the 
certification;
    (2) Has failed to comply with the Federal opioid treatment standards 
in any respect;
    (3) Has failed to comply with reasonable requests from SAMHSA or 
from an accreditation body for records, information, reports, or 
materials that are necessary to determine the continued eligibility of 
the OTP for certification or continued compliance with the Federal 
opioid treatment standards; or
    (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

[[Page 108]]

health or safety, SAMHSA may immediately suspend the certification of an 
OTP before holding a hearing under subpart C of this part. SAMHSA may 
immediately suspend as well as propose revocation of the certification 
of an OTP before holding a hearing under subpart C of this part if 
SAMHSA makes a finding described in paragraph (a) of this section and 
also determines that:
    (1) The failure to comply with the Federal opioid treatment 
standards presents an imminent danger to the public health or safety;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the failure to comply with the 
Federal opioid treatment standards was intentional or was associated 
with fraud.
    (c) Written notification. In the event that SAMHSA suspends the 
certification of an OTP in accordance with paragraph (b) of this section 
or proposes to revoke the certification of an OTP in accordance with 
paragraph (a) of this section, SAMHSA shall promptly provide the sponsor 
of the OTP with written notice of the suspension or proposed revocation 
by facsimile transmission, personal service, commercial overnight 
delivery service, or certified mail, return receipt requested. Such 
notice shall state the reasons for the action and shall state that the 
OTP may seek review of the action in accordance with the procedures in 
subpart C of this part.
    (d)(1) If SAMHSA suspends certification in accordance with paragraph 
(b) of this section:
    (i) SAMHSA will immediately notify DEA that the OTP's registration 
should be suspended under 21 U.S.C. 824(d); and
    (ii) SAMHSA will provide an opportunity for a hearing under subpart 
C of this part.
    (2) Suspension of certification under paragraph (b) of this section 
shall remain in effect until the agency determines that:
    (i) The basis for the suspension cannot be substantiated;
    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The OTP's certification shall be revoked.



Sec. 8.15  Forms.

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



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

    Source: Redesignated at 81 FR 44737, July 8, 2016, unless otherwise 
noted.



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

[[Page 109]]

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



Sec. 8.23  Limitation on issues subject to review.

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



Sec. 8.24  Specifying who represents the parties.

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



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

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



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

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. The 
procedures for development of the review file and submission of written 
argument are:
    (a) Appellant's documents and brief. Within 30 days after receiving 
the acknowledgment of the request for review, the appellant shall submit 
to the reviewing official the following (with a copy to the respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation of 
appellant's certification or to take adverse action regarding withdrawal 
of approval of the accreditation body is incorrect (appellant's brief).
    (b) Respondent's documents and brief. Within 30 days after receiving 
a copy of the acknowledgment of the request for review, the respondent 
shall submit to the reviewing official the following (with a copy to the 
appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification, or approval as 
an accreditation body, tabbed and organized chronologically, and 
accompanied by an index identifying each document. Only 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).

[[Page 110]]

    (c) Reply briefs. Within 10 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive documentation. The reviewing official may take any 
appropriate steps to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.
    (f) Discovery. The use of interrogatories, depositions, and other 
forms of discovery shall not be allowed.



Sec. 8.27  Opportunity for oral presentation.

    (a) Electing oral presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decisionmaking process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide for 
an oral presentation at the official's own initiative or at the request 
of the respondent.
    (b) Presiding official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral presentation.
    (c) Preliminary conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues; stipulations 
and admissions; limitations on evidence and witnesses that will be 
presented at the hearing; time allotted for each witness and the hearing 
altogether; scheduling the hearing; and any other matter that will 
assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding official 
may, at the presiding official's discretion, produce a written document 
summarizing the conference or transcribe the conference, either of which 
will be made a part of the record.
    (d) Time and place of oral presentation. The presiding official will 
attempt to schedule the oral presentation within 45 days of the date 
appellant's request for review is received or within 15 days of 
submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the oral presentation--(1) General. The presiding 
official is responsible for conducting the oral presentation. The 
presiding official may be assisted by one or more HHS officers or 
employees or consultants in conducting the oral presentation and 
reviewing the evidence. While the oral presentation will be kept as 
informal as possible, the presiding official may take all necessary 
steps to ensure an orderly proceeding.
    (2) Burden of proof/standard of proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend, propose revocation, or take adverse action is 
appropriate. The appellant, however, has a responsibility to respond to 
the respondent's allegations with evidence and argument to show that the 
respondent is incorrect.
    (3) Admission of evidence. The rules of evidence do not apply and 
the presiding official will generally admit all testimonial evidence 
unless it is clearly irrelevant, immaterial, or unduly repetitious. Each 
party may make an opening and closing statement, may present witnesses 
as agreed upon in the pre-hearing conference or otherwise, and may 
question the opposing party's witnesses. Since the parties have ample 
opportunity to prepare the review file, a party may introduce additional 
documentation during the oral presentation only with the permission of 
the presiding official. The presiding official may question witnesses 
directly and take such other steps necessary to ensure an effective and 
efficient consideration of the evidence, including setting time 
limitations on direct and cross-examinations.

[[Page 111]]

    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing the 
motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of justice or making of false statements. 
Obstruction of justice or the making of false statements by a witness or 
any other person may be the basis for a criminal prosecution under 18 
U.S.C. 1001 or 1505.
    (g) Post-hearing procedures. At the presiding official's discretion, 
the presiding official may require or permit the parties to submit post-
hearing briefs or proposed findings and conclusions. Each party may 
submit comments on any major prejudicial errors in the transcript.



Sec. 8.28  Expedited procedures for review of immediate suspension.

    (a) Applicability. When the Secretary notifies a treatment program 
in writing that its certification has been immediately suspended, the 
appellant may request an expedited review of the suspension and any 
proposed revocation. The appellant must submit this request in writing 
to the reviewing official within 10 days of the date the OTP received 
notice of the suspension. The request for review must include a copy of 
the suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is incorrect, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing official's response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review file and briefs. Within 10 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official in accordance 
with Sec. 8.27(a), the presiding official will attempt to schedule the 
oral presentation within 20 to 30 days of the date of appellant's 
request for review at a time and place determined by the presiding 
official following consultation with the parties. The presiding official 
may hold a pre-hearing conference in accordance with Sec. 8.27(c) and 
will conduct the oral presentation in accordance with the procedures of 
Secs. 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

[[Page 112]]

not communicate with the reviewing or presiding official without notice 
to the other party.



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

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



Sec. 8.31  Authority and responsibilities of the reviewing official.

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



Sec. 8.32  Administrative record.

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



Sec. 8.33  Written decision.

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

[[Page 113]]



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.

Subpart E [Reserved]



    Subpart F_Authorization To Increase Patient Limit to 275 Patients

    Source: 81 FR 44738, July 8, 2016, unless otherwise noted.



Sec. 8.610  Which practitioners are eligible for a patient limit of 275?

    The total number of patients that a practitioner may dispense or 
prescribe covered medications to at any one time for purposes of 21 
U.S.C. 823(g)(2)(B)(iii) is 275 if:
    (a) The practitioner possesses a current waiver to treat up to 100 
patients under section 303(g)(2) of the Controlled Substances Act (21 
U.S.C. 823(g)(2)) and has maintained the waiver in accordance with 
applicable statutory requirements without interruption for at least one 
year since the practitioner's notification of intent (NOI) under section 
303(g)(2)(B) to treat up to 100 patients was approved;
    (b) The practitioner:
    (1) Holds additional credentialing as defined in Sec. 8.2; or
    (2) Provides medication-assisted treatment (MAT) utilizing covered 
medications in a qualified practice setting as defined in Sec. 8.615;
    (c) The practitioner has not had his or her enrollment and billing 
privileges in the Medicare program revoked under Sec. 424.535 of this 
title; and
    (d) The practitioner has not been found to have violated the 
Controlled Substances Act pursuant to 21 U.S.C. 824(a).



Sec. 8.615  What constitutes a qualified practice setting?

    A qualified practice setting is a practice setting that:
    (a) Provides professional coverage for patient medical emergencies 
during hours when the practitioner's practice is closed;
    (b) Provides access to case-management services for patients 
including referral and follow-up services for programs that provide, or 
financially support, the provision of services such as medical, 
behavioral, social, housing, employment, educational, or other related 
services;
    (c) Uses health information technology (health IT) systems such as 
electronic health records, if otherwise required to use these systems in 
the practice setting. Health IT means the electronic systems that health 
care professionals and patients use to store, share, and analyze health 
information;
    (d) Is registered for their State prescription drug monitoring 
program (PDMP) where operational and in accordance with Federal and 
State law. PDMP means a statewide electronic database that collects 
designated data on substances dispensed in the State. For practitioners 
providing care in their capacity as employees or contractors of a 
Federal government agency, participation in a PDMP is required only when 
such participation is not restricted based on their State of licensure 
and is in accordance with Federal statutes and regulations;
    (e) Accepts third-party payment for costs in providing health 
services, including written billing, credit, and collection policies and 
procedures, or Federal health benefits.



Sec. 8.620  What is the process to request a patient limit of 275?

    In order for a practitioner to receive approval for a patient limit 
of 275, a practitioner must meet all of the requirements specified in 
Sec. 8.610 and submit a Request for Patient Limit Increase to SAMHSA 
that includes all of the following:
    (a) Completed Request for Patient Limit Increase form;
    (b) Statement certifying that the practitioner:

[[Page 114]]

    (1) Will adhere to nationally recognized evidence-based guidelines 
for the treatment of patients with opioid use disorders;
    (2) Will provide patients with necessary behavioral health services 
as defined in Sec. 8.2 or through an established formal agreement with 
another entity to provide behavioral health services;
    (3) Will provide appropriate releases of information, in accordance 
with Federal and State laws and regulations, including the Health 
Information Portability and Accountability Act Privacy Rule (45 CFR part 
160 and 45 CFR part 164, subparts A and E) and 42 CFR part 2, if 
applicable, to permit the coordination of care with behavioral health, 
medical, and other service practitioners;
    (4) Will use patient data to inform the improvement of outcomes;
    (5) Will adhere to a diversion control plan to manage the covered 
medications and reduce the possibility of diversion of covered 
medications from legitimate treatment use;
    (6) Has considered how to assure continuous access to care in the 
event of practitioner incapacity or an emergency situation that would 
impact a patient's access to care as defined in Sec. 8.2; and
    (7) Will notify all patients above the 100 patient level, in the 
event that the request for the higher patient limit is not renewed or 
the renewal request is denied, that the practitioner will no longer be 
able to provide MAT services using buprenorphine to them and make every 
effort to transfer patients to other addiction treatment;
    (c) Any additional documentation to demonstrate compliance with 
Sec. 8.610 as requested by SAMHSA.



Sec. 8.625  How will a Request for Patient Limit Increase be 
processed?

    (a) Not later than 45 days after the date on which SAMHSA receives a 
practitioner's Request for Patient Limit Increase as described in 
Sec. 8.620, or renewal Request for Patient Limit Increase as described 
in Sec. 8.640, SAMHSA shall approve or deny the request.
    (1) A practitioner's Request for Patient Limit Increase will be 
approved if the practitioner satisfies all applicable requirements under 
Secs. 8.610 and 8.620. SAMHSA will thereafter notify the practitioner 
who requested the patient limit increase, and the Drug Enforcement 
Administration (DEA), that the practitioner has been approved to treat 
up to 275 patients using covered medications. A practitioner's approval 
to treat up to 275 patients under this section will extend for a term 
not to exceed 3 years.
    (2) SAMHSA may deny a practitioner's Request for Patient Limit 
Increase if SAMHSA determines that:
    (i) The Request for Patient Limit Increase is deficient in any 
respect; or
    (ii) The practitioner has knowingly submitted false statements or 
made misrepresentations of fact in the practitioner's Request for 
Patient Limit Increase.
    (b) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal), SAMHSA shall notify the practitioner of the 
reasons for the denial.
    (c) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal) based solely on deficiencies that can be resolved, 
and the deficiencies are resolved to the satisfaction of SAMHSA in a 
manner and time period approved by SAMHSA, the practitioner's Request 
for Patient Limit Increase will be approved. If the deficiencies have 
not been resolved to the satisfaction of SAMHSA within the designated 
time period, the Request for Patient Limit Increase may be denied.



Sec. 8.630  What must practitioners do in order to maintain their
approval to treat up to 275 patients?

    (a) A practitioner whose Request for Patient Limit Increase is 
approved in accordance with Sec. 8.625 shall maintain all eligibility 
requirements specified in Sec. 8.610, and all attestations made in 
accordance with Sec. 8.620(b), during the practitioner's 3-year approval 
term. Failure to do so may result in SAMHSA withdrawing its approval of 
a practitioner's Request for Patient Limit Increase.

[[Page 115]]

    (b) All practitioners whose Request for Patient Limit Increase has 
been approved under Sec. 8.625 must provide reports to SAMHSA as 
specified in Sec. 8.635.

[66 FR 4090, Jan. 17, 2001, as amended at 81 FR 66196, Sept. 27, 2016]



Sec. 8.635  What are the reporting requirements for practitioners
whose Request for Patient Limit Increase is approved?

    (a) General. All practitioners whose Request for Patient Limit 
Increase is approved under Sec. 8.625 must submit to SAMHSA annually a 
report along with documentation and data, as requested by SAMHSA, to 
demonstrate compliance with applicable provisions in Secs. 8.610, 8.620, 
and 8.630.
    (b) Schedule. The report must be submitted within 30 days following 
the anniversary date of a practitioner's Request for Patient Limit 
Increase approval under Sec. 8.625, and during this period on an annual 
basis thereafter or on another annual schedule as determined by SAMHSA.
    (c) Content of the Annual Report. The report shall include 
information concerning the following, as further detailed in report form 
instructions issued by the Secretary:
    (1) The annual caseload of patients by month.
    (2) Numbers of patients provided behavioral health services and 
referred to behavioral health services.
    (3) Features of the practitioner's diversion control plan.
    (d) Discrepancies. SAMHSA may check reports from practitioners 
prescribing under the higher patient limit against other data sources to 
the extent allowable under applicable law. If discrepancies between 
reported information and other data are identified, SAMHSA may require 
additional documentation from the practitioner.
    (e) Noncompliance. Failure to submit reports under this section, or 
deficient reports, may be deemed a failure to satisfy the requirements 
for a patient limit increase, and may result in the withdrawal of 
SAMHSA's approval of the practitioner's Request for Patient Limit 
Increase.

[81 FR 66196, Sept. 27, 2016]



Sec. 8.640  What is the process for renewing a practitioner's Request
for Patient Limit Increase approval?

    (a) Practitioners who intend to continue to treat up to 275 patients 
beyond their current 3 year approval term must submit a renewal Request 
for Patient Limit Increase in accordance with the procedures outlined 
under Sec. 8.620 at least 90 days before the expiration of their 
approval term.
    (b) If SAMHSA does not reach a final decision on a renewal Request 
for Patient Limit Increase before the expiration of a practitioner's 
approval term, the practitioner's existing approval term will be deemed 
extended until SAMHSA reaches a final decision.



Sec. 8.645  What are the responsibilities of practitioners who do 
not submit a renewal Request for Patient Limit Increase, or whose 
renewal request is denied?

    Practitioners who are approved to treat up to 275 patients in 
accordance with Sec. 8.625, but who do not renew their Request for 
Patient Limit Increase, or whose renewal request is denied, shall 
notify, under Sec. 8.620(b)(7) in a time period specified by SAMHSA, all 
patients affected above the 100 patient limit, that the practitioner 
will no longer be able to provide MAT services using covered medications 
and make every effort to transfer patients to other addiction treatment.



Sec. 8.650  Can SAMHSA's approval of a practitioner's Request for
Patient Limit Increase be suspended or revoked?

    (a) SAMHSA, at any time during a practitioner's 3 year approval 
term, may suspend or revoke its approval of a practitioner's Request for 
Patient Limit Increase under Sec. 8.625 if it is determined that:
    (1) Immediate action is necessary to protect public health or 
safety;
    (2) The practitioner made misrepresentations in the practitioner's 
Request for Patient Limit Increase;
    (3) The practitioner no longer satisfies the requirements of this 
subpart; or
    (4) The practitioner has been found to have violated the CSA 
pursuant to 21 U.S.C. 824(a).
    (b) [Reserved]

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Sec. 8.655  Can a practitioner request to temporarily treat up 
to 275 patients in emergency situations?

    (a) Practitioners with a current waiver to prescribe up to 100 
patients and who are not otherwise eligible to treat up to 275 patients 
under Sec. 8.610 may request a temporary increase to treat up to 275 
patients in order to address emergency situations as defined in Sec. 8.2 
if the practitioner provides information and documentation that:
    (1) Describes the emergency situation in sufficient detail so as to 
allow a determination to be made regarding whether the situation 
qualifies as an emergency situation as defined in Sec. 8.2, and that 
provides a justification for an immediate increase in that 
practitioner's patient limit;
    (2) Identifies a period of time, not longer than 6 months, in which 
the higher patient limit should apply, and provides a rationale for the 
period of time requested; and
    (3) Describes an explicit and feasible plan to meet the public and 
individual health needs of the impacted persons once the practitioner's 
approval to treat up to 275 patients expires.
    (b) Prior to taking action on a practitioner's request under this 
section, SAMHSA shall consult, to the extent practicable, with the 
appropriate governmental authorities in order to determine whether the 
emergency situation that a practitioner describes justifies an immediate 
increase in the higher patient limit.
    (c) If SAMHSA determines that a practitioner's request under this 
section should be granted, SAMHSA will notify the practitioner that his 
or her request has been approved. The period of such approval shall not 
exceed six months.
    (d) If a practitioner wishes to receive an extension of the approval 
period granted under this section, he or she must submit a request to 
SAMHSA at least 30 days before the expiration of the six month period, 
and certify that the emergency situation as defined in Sec. 8.2 
necessitating an increased patient limit continues. Prior to taking 
action on a practitioner's extension request under this section, SAMHSA 
shall consult, to the extent practicable, with the appropriate 
governmental authorities in order to determine whether the emergency 
situation that a practitioner describes justifies an extension of an 
increase in the higher patient limit.
    (e) Except as provided in this section and Sec. 8.650, requirements 
in other sections under subpart F of this part do not apply to 
practitioners receiving waivers in this section.



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



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

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

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



Sec. 9.1  Applicability and purpose.

    (a) General. The standards of care set forth in this part apply to 
the chimpanzee sanctuaries that are contracted (or subcontracted) to the 
Federal Government to operate the federally supported chimpanzee 
sanctuary system authorized by section 481C of the Public Health Service 
(PHS) Act, as amended (42 U.S.C. 287a-3a).
    (b) What is the purpose of the federally supported chimpanzee 
sanctuary system and the authority for establishing these standards of 
care regulation? The Chimpanzee Health Improvement, Maintenance, and 
Protection Act (Pub. L. 106-551, referred to as the ``CHIMP Act'' or 
``Chimpanzee Retirement Act'') was enacted by Congress to provide for 
the establishment and operation of a sanctuary system to provide 
lifetime care

[[Page 117]]

for chimpanzees that have been used, or were bred or purchased for use, 
in research conducted or supported by the agencies of the Federal 
Government, and that are determined to be no longer needed for such 
research. The CHIMP Act also mandates that standards of care for 
chimpanzees in the sanctuary shall be developed to ensure the well-being 
of chimpanzees and the health and safety of the chimpanzees.
    (c) To what chimpanzee sanctuaries do the standards of care in this 
part apply? The standards of care set forth in this part apply to only 
those sanctuaries that are contracted or subcontracted to the Federal 
Government to operate the federally supported chimpanzee sanctuary 
system.



Sec. 9.2  Definitions.

    As used in this part:
    Adequate veterinary care means a program directed by a veterinarian 
qualified through training and/or experience to provide professional 
medical care to the chimpanzees within the Sanctuary and with the 
appropriate authority to provide this care. The program also provides 
guidance to all caregivers on all matters relating to the health and 
well-being of the chimpanzees.
    American Zoo and Aquarium Association (AZA) means the professional 
society composed of individuals with various backgrounds and interests 
that are devoted to advancing the knowledge and understanding of zoo 
animals and the management of zoos in the United States.
    American Zoo and Aquarium Association (AZA) Accreditation Standards 
are those standards developed by the AZA that are used to review, 
evaluate, and accredit zoos or zoological gardens. These standards cover 
a variety of areas including facilities, policies and procedures, 
training, staff qualifications, medical and animal care, husbandry and 
well-being procedures, and conservation, along with other specific 
areas.
    Animal Care and Use Committee means the Institutional Animal Care 
and Use Committee established under section 13(b) of the Animal Welfare 
Act of 1985 and the Health Research Extension Act of 1985. For the 
purpose of these Standards of Care, it shall consist of at least five 
(5) members including the Chairperson, a Doctor of Veterinary Medicine 
(D.V.M. or V.M.D.) knowledgeable in nonhuman primate care and diseases 
and with delegated program responsibility, a member not affiliated with 
the Sanctuary, a scientist, and a member of the animal protection 
community. The requirement that a member of the ACUC must be from an 
animal protection organization is unique to this part and is not 
required under the Animal Welfare Regulations or the Public Health 
Service Policy on the Humane Care and Use of Laboratory Animals. This 
Committee must be established if research as defined by the Animal 
Welfare Act Regulations and the Public Health Service Policy (research, 
teaching, testing, exhibition) is to be conducted at the sanctuary.
    Animal protection organization means a nonprofit organization whose 
primary mission is protection of animals through positive advocacy and 
action.
    Animal Resource Manager (or Animal Resource Supervisor) means the 
individual employee responsible for managing the nonprofessional staff 
providing care for the chimpanzees at the sanctuary. This individual may 
perform other duties as assigned by the Sanctuary Contractor.
    Animal Welfare Act/Regulations means the Act of August 24, 1966 
(Pub. L. 89-544, commonly known as the Laboratory Animal Welfare Act), 
as amended by the Act of December 24, 1970 (Pub. L. 91-579, the Animal 
Welfare Act of 1970), the Act of April 22, 1976 (Pub. L. 94-279, the 
Animal Welfare Act of 1976), and the Act of December 23, 1985 (Pub. L. 
99-198, the Food Security Act of 1985), and as may be subsequently 
amended, and the United States Department of Agriculture (USDA) 
regulations implementing the Animal Welfare Act in title 9, chapter 1, 
subchapter A of the CFR.
    Animal Welfare Assurance means the documentation from an institution 
assuring compliance with the PHS Policy on Humane Care and Use of 
Laboratory Animals. This policy is administered by the Office of 
Laboratory Animal Welfare (OLAW), National Institutes of Health.

[[Page 118]]

    Association for Assessment and Accreditation of Laboratory Animal 
Care, International (AAALAC) means the nonprofit organization that is 
recognized in the United States and abroad as being the body responsible 
for the accreditation of laboratory animal programs.
    Behaviorist means a person hired by the sanctuary to administer or 
oversee the enrichment and behavioral program for the chimpanzees at the 
sanctuary. This individual must be qualified through training or 
experience.
    Biosafety Officer means the individual responsible for establishing 
and monitoring workplace safety procedures designed to minimize or 
prevent injury or loss due to biohazards in accordance with policies 
established by the sanctuary administration.
    Board of Directors (BOD) means the individuals selected by the 
Contractor to govern the nonprofit institution responsible for operating 
the federally supported chimpanzee Sanctuary system. The board members 
must meet the qualifications and criteria stated in the CHIMP Act.
    Chair of the Board of Directors means the individual chosen by the 
BOD or other legally empowered entity to carry out such action, who is 
responsible for chairing meetings and acting on behalf of the board. 
This individual reports directly to the Board.
    Chief Executive Officer (CEO) means the principal person responsible 
for overall accomplishment of the mission of the chimpanzee sanctuary.
    CHIMP Act means the Chimpanzee Health Improvement, Maintenance, and 
Protection Act of December 20, 2000 (Pub. L. 106-551) commonly known as 
the ``CHIMP Act'' or ``Chimpanzee Retirement Act,'' and any future 
amendments.
    Chimpanzee means a member of Pan troglodytes. It excludes the pygmy 
chimpanzee (Pan paniscus or bonobo).
    Chimpanzee caregivers (caregivers) mean all sanctuary technical and 
husbandry staff providing long-term care and services for the 
chimpanzees.
    Contractor/Primary Contractor/Sanctuary Contractor means the 
nonprofit entity awarded a contract by the Federal Government to 
establish and operate the chimpanzee sanctuary system.
    Euthanasia means the humane death of a chimpanzee accomplished by a 
method that produces rapid unconsciousness and subsequent death without 
evidence of pain or distress. The method must be consistent with the 
recommendations of the American Veterinary Medical Association Panel on 
Euthanasia.
    Exhibition means exhibiting chimpanzees to the public for 
compensation. This definition excludes limited viewing for educational 
purposes that are not disruptive to the chimpanzees.
    Facility director means the individual responsible for directing the 
overall activities at the Sanctuary site.
    Facility Veterinarian means a person who has graduated from a 
veterinary school accredited by the American Veterinary Medical 
Association (AVMA) Council on Education, or who has a certificate issued 
by the AVMA's Education Commission for Foreign Veterinary Graduates; has 
training and/or experience in the care and management of nonhuman 
primates; and has direct or delegated authority for activities involving 
chimpanzees at the federally funded chimpanzee sanctuary.
    Federal Acquisition Regulations (FAR) means the codified rules 
applicable to contracts, specifically those sections of the FAR (48 CFR 
chapter 1, part 52) that are applicable to contracts between the Federal 
Government and a contractor (in this case a private, nonprofit entity 
under contract to operate the chimpanzee sanctuary system).
    Federal agency means an executive agency as such term is defined in 
section 105 of title 5, United States Code, and refers to the agency 
from which the research facility receives a Federal award for projects 
involving animals.
    Federally owned chimpanzees mean chimpanzees that have been 
purchased by, bred by, or donated to a federal agency for use in 
biomedical/behavioral research. Chimpanzees whose ownership was 
subsequently transferred from Federal ownership via written transfer 
agreements are no longer federally owned.
    Guide means The Guide for the Care and Use of Laboratory Animals, 
published by the National Academy of Sciences, Institute for Laboratory 
Animal Research of the National Research

[[Page 119]]

Council, 1996, International Standard Book Number 0-309-05377-3.
    Housing facility means any land, premises, shed, barn, building, 
trailer, or other structure or area housing intended to house 
chimpanzees.
    Indoor housing facility refers to any structure or enclosure (for 
example, cages, pens, rooms) for maintaining animals in a controlled 
environment that provides for normal physiological and behavioral needs.
    Interstate air transport live animals (IATA) regulations means those 
regulations and standards covering the air transportation of nonhuman 
primates developed and implemented by the International Air 
Transportation Association.
    Invasive research (studies) utilizes those procedures that cause 
more than momentary pain, distress, fear, discomfort, injury, or other 
negative modalities to a chimpanzee. Any procedure that enters or 
exposes a body cavity is considered to be invasive. Sanctuary 
chimpanzees may not be used in invasive research. This definition 
excludes any invasive procedure that is a part of veterinary, medical, 
or surgical care that is performed by or under the direction of the 
Sanctuary Veterinarian using acceptable veterinary practices. Some 
examples of invasive studies are:
    (1) Experimental exposure to a substance that may be detrimental to 
a chimpanzee's health (e.g., infectious disease, radiation). This does 
not include accidental exposures to infectious diseases transmitted from 
cage mates or from radiation or other exposures at the time of regularly 
scheduled or necessary veterinary examinations and treatments;
    (2) Any invasion of a body cavity;
    (3) Surgery and surgical implantation of devices that are not a part 
of a veterinary medical treatment or colony management purposes.
    (4) Behavioral studies that cause distress or discomfort, such as 
induction of a fear response;
    (5) Testing of any drug;
    (6) Purposeful manipulation of social groups or the removal from 
their social group or addition of individuals in order to conduct 
behavioral research (for example, on aggression). Creation and 
refinement of social groups will be necessary when the animals arrive at 
the Sanctuary and this should take place only when necessary in regards 
to colony management and should not be driven by independently initiated 
research studies;
    (7) Restraint unless it is in conjunction with the annual exam or 
clinical care; and
    (8) Darting or anesthesia induction other than at annual exam or in 
the case of an emergency in which the chimpanzee's well-being is at 
stake.
    National Primate Research Center (NPRC) means those centers 
supported by the National Center for Research Resources, National 
Institutes of Health, Department of Health and Human Services, as 
national resources for providing high-quality nonhuman primate research 
resources and facilities. As of June 2007, there were eight such 
centers.
    National Research Council means the component of the National 
Academy of Sciences that advises the Federal Government on matters 
related to science, research, and research resources.
    Nonfederally owned chimpanzees mean chimpanzees that have not been 
purchased by, bred by, or donated to the Federal Government for use in 
federally supported research projects. In accordance with the CHIMP Act, 
chimpanzees owned on the date of passage of the CHIMP Act by a National 
Primate Research Center may enter the sanctuary system without requiring 
the NPRC to pay a fee. Offspring born in the sanctuary is owned by the 
Sanctuary Contractor.
    Noninvasive research (studies) means the use of procedures that 
depend upon close observation of chimpanzee behavior or on medical 
information collected during the course of normal veterinary care. These 
procedures do not require removal of the chimpanzees from their social 
group or environment, or require a separate anesthetic or sedation event 
to collect data or record observations. Some examples of noninvasive 
studies are:
    (1) Visual observation;
    (2) Behavioral studies designed to improve the establishment and 
maintenance of social groups. These activities may cause stress as a 
result of novel

[[Page 120]]

interactions between chimpanzees and caregivers, but they are not 
considered invasive as long as they are intended to maximize the well-
being of the chimpanzees;
    (3) Medical examinations as deemed necessary to oversee the health 
of the chimpanzees, in the least invasive manner possible. Collection of 
samples routinely obtained during a physical examination for processing 
during this time is also considered noninvasive since a separate event 
is not required;
    (4) Administration and evaluation of environmental enrichment used 
to promote the psychological well-being of the chimpanzees; and
    (5) Actions taken to provide essential medical treatment to an 
individual chimpanzee exhibiting symptoms of illness. This applies only 
to serious illness that cannot be treated while the chimpanzee remains 
within the colony.
    Outdoor housing facility (area) means corrals, Primadomes (a 
prefabricated outdoor housing unit), fenced open areas, or similar 
structures or areas for maintaining chimpanzees with access to adequate 
protection from the extremes of environmental elements and harsh weather 
conditions.
    Outdoor ranging area means an area that allows chimpanzees greater 
ranging space than corrals or other outdoor housing area and includes a 
variety of vegetation, shrubbery, grasses and trees, thereby providing 
for a fairly unrestricted natural setting for the chimpanzees to engage 
in species-appropriate activities. The area is secured by an outer 
perimeter barrier.
    Project Officer means the individual designated by the Federal 
Government to represent the contracting officer and interests of the 
federal agency, within defined areas, in monitoring and overseeing the 
chimpanzee sanctuary system contract.
    Sanctuary Chimpanzee Care Committee (SCCC) or similar designated 
committee means the group of individuals designated by the CEO of the 
sanctuary that reviews and monitors adherence to the policies, 
procedures, and regulations at the sanctuary.
    Sanctuary Contractor means the nonprofit, private entities selected 
by NCRR/NIH to develop and operate the chimpanzee sanctuary system. This 
contractor is also known as the ``primary contractor'' for the sanctuary 
system.
    Sanctuary Director means the individual who provides day-to-day 
direction and oversight to the employees responsible for performing the 
daily tasks at the facility.
    Sanctuary or federally supported chimpanzee sanctuary system means 
the sanctuary or sanctuary system established by the Federal Government 
through contracting with a private, nonprofit entity, for the purpose of 
carrying out the provisions of the CHIMP Act of 2000. The system 
includes a primary Contractor and may include additional subcontractors 
as required. This sanctuary system is supported primarily from funds 
allocated by NCRR/NIH/HHS with some matching funds from the nonprofit 
contractor.
    Secretary means the Secretary of Health and Human Services or his/
her designee.
    Subcontractor means a private, nonprofit entity selected by the 
primary contractor to provide additional sanctuary services.
    Surplus chimpanzees means chimpanzees that are no longer needed in 
research and that were used, or were bred or purchased for use, in 
research conducted or supported by the Federal Government.
    USDA licensed intermediate handler/carrier means any person, 
including a department, agency, or instrumentality of the United States 
or of any State or local government, who is engaged in any business in 
which it receives custody of animals in connection with their 
transportation in commerce and who is licensed by the USDA.
    Zoonotic disease(s) means diseases that are transmissible from 
chimpanzees to humans.



Sec. 9.3  Sanctuary policies and responsibilities.

    (a) What are the policies and responsibilities governing the 
sanctuary system? It will be the policies and responsibilities of the 
sanctuary system to:
    (1) Appoint a Board of Directors (BOD) responsible for the overall 
governance and direction of the Sanctuary. The BOD shall designate the

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Chief Executive Officer (CEO), who is responsible for the management and 
oversight of the daily operations of the sanctuary and the performance 
of other delegated tasks. Subcontractors, if applicable, shall be 
governed by the policies that are developed by the Board of Directors of 
the primary contractor.
    (2) Direct the BOD to:
    (i) Ensure that chimpanzees accepted into the sanctuary are not 
discharged;
    (ii) Develop guidelines for accepting chimpanzees not owned by the 
Federal Government into the sanctuary if the conditions are met as 
outlined in 42 U.S.C. 287;
    (iii) Ensure that the Board of Directors of the primary contractor 
consists of no more than thirteen (13) individuals, and that the 
conditions governing the terms of the Board members are in compliance 
with the CHIMP Act;
    (iv) Include individuals with the following expertise and experience 
as set forth in the CHIMP Act;
    (A) At least one veterinarian who is qualified in veterinary care of 
nonhuman primates. These qualifications may be met through postdoctoral 
training, experience, or both;
    (B) Individual(s) with expertise and experience in zoological 
science and with knowledge in behavioral primatology;
    (C) Individual(s) with experience in the animal protection field;
    (D) Individual(s) with experience and expertise in the field of 
business and management of nonprofit organizations;
    (E) Individual(s) knowledgeable and experienced in accrediting 
programs of animal care;
    (F) Individual(s) with experience and expertise in containing 
biohazards;
    (v) Ensure that a member of the Board of Directors serves as the 
Chair of the Board of Directors, who may be elected or appointed by the 
Board from among the individuals identified in paragraphs (a) (1) (iv) 
(A) through (F) of this section;
    (vi) Ensure that no member of the board shall have been fined for, 
or signed a consent decree for, any violation of the Animal Welfare Act;
    (vii) Create a safe and species-appropriate physical and social 
environment for the lifetime care of chimpanzees;
    (viii) Comply with all applicable provisions of the animal welfare 
regulations and other federal, state and local laws, regulations, and 
policies;
    (ix) Achieve accreditations from appropriate accrediting bodies 
within a reasonable time frame mutually agreed upon by the Contractor 
and NCRR;
    (x) Prohibit any invasive research on the resident chimpanzees, but 
permit noninvasive studies (Definitions for the terms invasive and non-
invasive are set forth in Sec. 9.2 of this part.);
    (xi) Prohibit exhibition of chimpanzees in the sanctuary (This 
policy does not prohibit educational activities that may involve limited 
viewing of chimpanzees in their environment and that are designed to 
promote an understanding of chimpanzee behavior, well-being, or 
importance to the ecological system that does not adversely affect the 
chimpanzees' routine.);
    (xii) Staff the organization with people with appropriate 
experience; and
    (xiii) Authorize the establishment of a Sanctuary Chimpanzee Care 
Committee (SCCC) that is appointed by and reports to the CEO or 
President of the company or corporationThe SCCC is responsible for 
overseeing the chimpanzee care program and operations to ensure the 
health and well-being of the chimpanzees and the occupational safety of 
the staff are being addressed. The Committee must consist of no fewer 
than five people who must include:
    (A) A chair (person) knowledgeable of the needs of chimpanzees;
    (B) A veterinarian with chimpanzee care experience;
    (C) A behaviorist with experience in chimpanzee behavior;
    (D) A member of the chimpanzee care staff; and
    (E) Member or members from the community, including at least one 
with affiliation or employment with an animal protection organization as 
defined in Sec. 9.2 of this part.
    (F) The SCCC will:
    (1) Oversee and evaluate the chimpanzee care and socialization 
program;
    (2) Review and approve proposed education programs. No program 
should be approved that might interfere with the

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chimpanzees' well-being or routine activities;
    (3) Conduct a formal review of the program on a semiannual basis and 
submit reports to the Sanctuary Director. The reports must be available 
for review by the USDA and NIH representatives during site visits;
    (4) Establish a mechanism for receipt and review of concerns 
involving the care of chimpanzees and resolving such concerns;
    (5) Review all noninvasive study proposals. The SCCC membership may 
require additional qualified individuals to perform the functions of an 
Animal Care and Use Committee (ACUC) if and when the need arises. The 
contractor may establish a separate ACUC. The ACUC must be established 
in accordance with the applicable provisions of the Animal Welfare Act 
regulations, the Public Health Service Policy on Humane Care and Use of 
Laboratory Animals, and these standards of care;
    (6) Review all euthanasia events. Euthanasia events performed for 
medical or humane reasons must be based upon sound professional 
veterinary judgment that conforms to current veterinary medical 
practices and must be in the best interest of the chimpanzee. Euthanasia 
performed for emergency reasons without advance review by the SCCC shall 
be reviewed by the SCCC as soon as possible after the event to ensure 
compliance with established policy;
    (7) Establish procedures to prevent any reproduction in the colony 
through appropriate permanent birth control, preferably by vasectomy of 
all sexually mature male chimpanzees in the sanctuary; and
    (8) Develop procedures for maintaining chimpanzees that are 
seropositive for or harboring infectious agents or previously have been 
exposed to infectious agents (whether experimentally induced or 
naturally occurring) that will allow them to be accepted by the 
sanctuary and properly housed. The procedures must be submitted to NCRR/
NIH for approval.
    (b) Who is responsible for developing or revising sanctuary 
policies? (1) The Sanctuary Contractor is responsible for developing, 
revising, and implementing policies affecting the sanctuary.
    (2) The federal agency (NCRR/NIH) designated by the Secretary must 
concur with any changes that substantially change existing policies. The 
Secretary, or designee, will determine if a policy change will have a 
substantial impact upon current policy after consultation with the 
Sanctuary Contractor.



Sec. 9.4  Physical facility policies and design.

    (a) What standards apply to the facility design and physical plant? 
The chimpanzee sanctuary facility must be designed to provide sufficient 
space and variety of natural or artificial objects to accommodate 
natural activities of chimpanzees while restricting their movement and 
range to the defined area. Daily observation of chimpanzees within the 
enclosures is required and shall be accomplished with minimal 
disturbance to the chimpanzees. The facility design and physical plant 
should be in accordance with the recommendation of The Guide for the 
Care and Use of Laboratory Animals (Guide), where applicable. The Guide 
is published by the National Research Council, 1996, International 
Standard Book Number 0-309-05377-3. The Guide is incorporated by 
reference in this section. The Director of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain a copy of the publication from the National 
Academy Press, 2101 Constitution Avenue, NW., Lockbox 285, Washington, 
DC 20055; or you may order it electronically via the Internet at http://
www.nap.edu; or view it online at http://oacu.od.nih.gov/regs/guide/
guidex.htm. You may inspect a copy at NIH, NCRR, 1 Democracy Plaza, 6701 
Democracy Boulevard, Bethesda, MD 20817-4874, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (1) The facility design and physical plant consist of the following 
components: Indoor design features; outdoor design features; 
construction and construction materials; physical barriers;

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shelter; service support space, including storage areas for food, 
supplies, and equipment; personnel and administrative support space; 
quarantine and isolation facilities; treatment area; heating, 
ventilation, and air conditioning (HVAC); food preparation area; and 
animal waste treatment.
    (2) A housing system shall include indoor and outdoor enclosures 
that must be kept in good repair to prevent escape and injury to the 
chimpanzees, promote physical comfort, facilitate sanitation and 
servicing, and address the psychological well-being and social needs of 
the chimpanzees. Chimpanzees must be able to retreat from areas where 
they feel threatened or agitated by close human encounters or encounters 
with other chimpanzees.
    (3) Indoor areas shall have special areas for social introductions 
and medical treatment. Quarantine and isolation facilities are required 
for the sanctuary. These facilities must be designed to prevent the 
spread of undesirable agents from quarantine and isolation rooms to 
other parts of the facility.
    (4) Outdoor areas must provide sufficient ranging space and either 
natural or artificial structures that chimpanzees can use for shelter or 
nesting areas to sleep, rest, or seek refuge from rain, direct sun, 
wind, and extreme temperatures.
    (5) Animal waste from the Sanctuary must be properly treated to 
remove known hazardous agents before discharging it into the environment 
in accordance with currently acceptable and effective waste treatment 
procedures, including current industry standards and Federal laws, 
regulations or guidelines, as applicable.
    (6) An area for treatment of and performing veterinary clinical 
procedures on chimpanzees must be provided at each Sanctuary site. This 
area must be constructed and provisioned to perform emergency 
procedures, including minor surgery and emergency surgical procedures, 
complete physical examinations, and facilities for extended care of 
medical conditions as needed.
    (b) What security measures are required for the sanctuary? The 
sanctuary must provide adequate security against unauthorized entry, 
sabotage, malicious damage, and theft of chimpanzees and property and 
must minimize any chance of escape by a chimpanzee. The security staff 
must have training and/or experience in methods and equipment designed 
to detect possible security breaches and the ability to respond to 
security events in a timely and effective manner. Perimeter containment 
shall be used to protect the compound housing the chimpanzees consistent 
with the recommendations of the Guide (incorporated by reference, see 
paragraph (a) of this section).
    (c) Is the sanctuary required to develop disaster and escaped animal 
contingency plans? The sanctuary facility must prepare disaster and 
escaped animal contingency plans outlining simple and easy to follow 
plans for dealing with natural and man-made disasters and steps to be 
taken in case a chimpanzee escapes from the compound. The Sanctuary also 
must provide adequate security against unauthorized entry, sabotage, 
malicious damage, and theft of chimpanzees and property and must 
minimize any chance of escape by a chimpanzee. Primary barriers must be 
constructed to prevent escape of chimpanzees and secondary or perimeter 
barriers must prevent entry of unauthorized persons into the facility, 
consistent with the recommendations of the Guide (incorporated by 
reference, see paragraph (a) of this section).



Sec. 9.5  Chimpanzee ownership, fees, and studies.

    (a) Who owns the chimpanzees in the federally supported sanctuary? 
The Federal Government retains ownership of chimpanzees owned by the 
Federal Government at the time they enter the sanctuary system. Non-
federally owned or supported chimpanzees will be owned by the sanctuary. 
The chimpanzees shall continue to be maintained in the sanctuary 
throughout their lifetime and shall not be discharged from the sanctuary 
except as specifically indicated in the CHIMP Act.
    (b) Is there a charge for placing chimpanzees in the sanctuary? No 
fees shall be charged by the Sanctuary Contractor for federally owned or 
supported chimpanzees entering the sanctuary. Chimpanzees that were 
owned

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by a NPRC when the CHIMP Act became effective are also admitted without 
payment of fees. Fees for maintenance of the chimpanzees alluded to 
above are provided for in the contract between the Federal Government 
and the Sanctuary Contractor.
    (c) May the sanctuary agree to accept chimpanzees that are not owned 
by the Federal Government? The sanctuary may accept chimpanzees that are 
not owned by the Federal Government subject to the following conditions:
    (1) Ownership of the chimpanzee must be transferred to the 
sanctuary;
    (2) Fees for these chimpanzees may be levied based on a range of 
considerations that include most importantly, the well-being of the 
chimpanzee and, secondarily, factors that include (but are not limited 
to) the resources available to support the chimpanzee; the health, age, 
and social history of the chimpanzee; and other relevant factors 
affecting the cost of caring for the chimpanzee. While chimpanzees not 
owned or supported by the Federal Government may be admitted to the 
sanctuary, federal funds may not be used for their support unless 
authorized by the Secretary or an authorized designee;
    (3) Available space exists in the sanctuary; and
    (4) An agreement exists between the sanctuary system and the NCRR/
NIH documenting that the chimpanzee may be brought into the sanctuary.
    (d) What additional conditions apply when nongovernmental owned 
chimpanzees transfer to the chimpanzee sanctuary? The following 
additional conditions apply when nongovernmental owned chimpanzees 
transfer to the chimpanzee sanctuary:
    (1) Chimpanzees transferred to the sanctuary sites must be 
permanently incapable of reproduction, for example, by vasectomy, tubal 
ligation, or another reliable procedure;
    (2) Complete histories must accompany each chimpanzee. Any 
chimpanzee missing documentation for any period of research or other use 
may not be transferred to the Sanctuary without the concurrent 
authorization of the Sanctuary Contractor's Board of Directors and the 
NCRR; the records may be created and retained in electronic form; and
    (3) Appropriate screening of each chimpanzee must be performed to 
assess the likelihood of the chimpanzee being a health or safety threat 
to the care staff and/or other chimpanzees.
    (e) What are the criteria for acceptance and the fees for admission 
into the sanctuary for nongovernmental owned chimpanzees? The chimpanzee 
Sanctuary Contractor, in conjunction with NCRR, must establish criteria 
and a fee system for acceptance of nongovernmental owned chimpanzees. 
Funds collected for this purpose must be accounted for and used to help 
defray the expenses incurred in operating the sanctuary.
    (f) Under what circumstances might a chimpanzee from the sanctuary 
be returned to research at a United States research facility? In 
December 2007, the CHIMP Act was amended by the ``Chimp Haven is Home 
Act,'' which terminated the authority for the removal of chimpanzees 
from the sanctuary system for research purposes.



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

    (a) What are the requirements for promoting the well-being of 
sanctuary chimpanzees? The goal of chimpanzee housing and management in 
the sanctuary is to promote the chimpanzees' well-being.
    (b) What are the provisions for daily chimpanzee husbandry and care? 
Adequate and proper care for chimpanzees in the sanctuary must be 
provided with respect to physical environment, housing and husbandry, 
behavioral management, and population management and control. Specific 
requirements include the following:
    (1) Chimpanzees must have access to food, water, and bedding at all 
times, unless medical or behavioral conditions dictate otherwise. 
Husbandry procedures shall represent current policies and practices and 
conform to standards set by a nationally recognized accrediting 
association in accordance with the Guide (incorporated by reference, see 
paragraph (a) of Sec. 9.4).
    (2) Indoor primary enclosures must be cleaned as often as required 
to

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maintain a clean and healthy environment, with a minimum of once daily. 
Outdoor enclosures must be monitored daily and cleaned on a routine 
basis. Outdoor ranging areas will not require a routine cleaning 
schedule but must be monitored for excessive accumulation of waste or 
other unhealthy conditions. Housing areas shall provide sufficient space 
for chimpanzees to perform species-typical behavior and expression. 
Examples of such activities include but are not limited to natural 
movements, climbing, swinging, resting, running, group interactions, 
sleeping, etc. Feeding and watering implements must be sanitized at 
intervals required to maintain them in a sanitary condition, in 
accordance with the Guide (incorporated by reference, see paragraph (a) 
of Sec. 9.4).
    (3) The federally supported chimpanzee sanctuary must employ a 
behavioral scientist knowledgeable in primate behavior and socialization 
requirements. This individual shall provide primary leadership in 
developing, implementing, and monitoring the chimpanzee behavioral 
guidelines for the sanctuary. Enrichment techniques used shall be 
currently accepted practices. The sanctuary must provide for the 
expertise to plan, administer, and evaluate the effectiveness of the 
well-being program.
    (4) Many chimpanzees can be trained through positive reinforcement 
to cooperate with a variety of veterinary and chimpanzee care 
procedures. Efforts must be made to develop or maintain this capability 
for chimpanzees housed in the sanctuary to the extent possible. Trainers 
must use currently acceptable practices that do not include physical 
punishment.
    (c) What are the requirements for an adequate veterinary care and 
animal health program? The sanctuary staff must provide sufficient 
resources of personnel, equipment, supplies, and facilities to enable 
the provision of adequate veterinary care as set forth in the Guide 
(incorporated by reference, see paragraph (b) of Sec. 9.4). For 
additional guidance see the American College of Laboratory Animal 
Medicine document, ``The Provision of Adequate Veterinary Care,'' 
available on the Internet at http://www.aclam.org.
    (1) If the sanctuary houses chimpanzees with infectious diseases, it 
must have a veterinarian knowledgeable in the infectious diseases and 
care of chimpanzees. The Facility Veterinarian is responsible for 
establishing and implementing a health monitoring system specifically 
designed to meet the health requirements of chimpanzees in the 
sanctuary. Routine observation and the prevention of disease, metabolic 
conditions, abnormal behavior and injury must be a priority focus of the 
Facility Veterinarian and staff.
    (2) Newly received chimpanzees must be quarantined for a period for 
physiological, psychological, and nutritional stabilization before their 
introduction to the rest of the group. The stabilization period must be 
lengthened appropriately if the chimpanzee has a significant medical 
problem or if abnormal medical findings are detected during the 
quarantine period. If the chimpanzee has not been given a complete 
physical examination within six months, an examination must be conducted 
during the stabilization period.
    (3) The sanctuary must implement appropriate methods for disease 
surveillance and diagnosis of diseases, which may include the following:
    (4) Tuberculin (TB) tests must be negative for two (2) consecutive 
tests before the chimpanzee is released from quarantine. Any chimpanzee 
that is suspected of harboring the TB organism, or that is diagnosed 
with TB will be isolated and treated until determined by the Facility 
Veterinarian to be of no health risk to other chimpanzees or humans. The 
Facility Veterinarian may recommend euthanasia in those cases that do 
not respond to therapy and in which the chimpanzee consequently 
experiences undue pain and suffering that cannot be alleviated. The 
procedures noted under Sec. 9.6 (d) must be observed if euthanasia is 
necessary.
    (5) Fecal samples must be checked for parasites and parasitic ova.
    (6) A complete blood count and serum chemical panel must be 
obtained.
    (7) Additional serum for banking and/or testing shall be obtained as 
appropriate by the Facility Veterinarian and

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is considered beneficial for chimpanzee health.
    (8) If the donating facility did not test for the appropriate 
viruses, the sanctuary must perform a viral panel and serology for the 
various chronic hepatitis viruses and HIV.
    (9) Additional tests or procedures that are deemed beneficial to the 
chimpanzees' health may be required by the Facility Veterinarian.
    (10) Chimpanzees are susceptible to many of the vaccine preventable 
diseases of human childhood. Appropriate vaccines must be considered and 
administered if deemed necessary, at the discretion of the Facility 
Veterinarian, to protect the chimpanzees in the sanctuary. Methods of 
disease prevention, diagnosis, and therapy must comply with those 
currently accepted in veterinary medical practice. Arrangements with 
diagnostic laboratories must be established before chimpanzees arrive at 
the sanctuary.
    (11) The sanctuary must minimize the use of physical and chemical 
restraint. Chimpanzees in the sanctuary shall be trained to permit 
certain procedures with minimal or no restraint. Such procedures may 
include injections, dosing or other treatments, and cage-side health 
observations. However, chemical sedation sometimes may be appropriate 
for certain necessary medical interventions or for the safety of the 
chimpanzee and caregivers. If physical restraint measures are necessary, 
due consideration must be given to the temporary or permanent effects 
upon the chimpanzee and human and animal safety concerns.
    (12) Methods used to relieve pain must be documented in the 
chimpanzee medical or surgical records. These records will be available 
for review by USDA and NIH representatives. The Facility Veterinarian 
must ensure that pain management is current and in accordance with 
acceptable veterinary medical practices.
    (13) Chimpanzees must be cared for by qualified personnel on a daily 
basis, including weekends and holidays, to safeguard their well-being. 
Emergency veterinary care must also be available during these times. 
Notification procedures must be documented in the form of operating 
procedures.
    (d) Under what circumstances is euthanasia permitted? As stated in 
section 481C(d)(2)(I) of the Public Health Service Act, as added by 
section 2 of the CHIMP Act, none of the chimpanzees may be subjected to 
euthanasia except when it is in the best interest of the chimpanzee 
involved as determined by the SCCC and the Facility Veterinarian. 
Therefore, euthanasia for medical or humane reasons is permitted. 
Euthanasia may be permitted for reasons of health or quality of life of 
the individual chimpanzee, including for disease, in connection with 
trauma, complications of aging, or for other humane reasons. The 
sanctuary must establish a policy on euthanasia that will provide 
conditions that must be met before euthanasia is permitted and guidance 
for performing euthanasia.
    (1) Methods of euthanasia will be consistent with the most recent 
report of the American Veterinary Medical Association Panel on 
Euthanasia (2002), unless more reliable data becomes available. When 
euthanasia is performed, the veterinarian will determine the appropriate 
agent, and it will be administered only by properly trained personnel 
under the direction of the Facility Veterinarian. The decision to 
perform euthanasia will be made by the veterinarian in consultation with 
the Facility Director or Deputy Director.
    (2) The SCCC will participate in the decision in nonmedical 
emergencies. All euthanasia decisions must be reviewed by the SCCC, 
preferably prior to euthanasia. In emergencies, where euthanasia has to 
be performed immediately by the Facility Veterinarian, the circumstances 
and the decision by the Facility Veterinarian will be presented at the 
next scheduled or special meeting of the SCCC. The NCRR Project Officer 
must be notified of the euthanasia event within 72 hours by electronic 
or telephonic means. Euthanasia of individual chimpanzees may negatively 
affect the care staff and appropriate counseling and psychological 
support shall be considered.



Sec. 9.7  Reproduction.

    Chimpanzee reproduction is prohibited in the sanctuary. Therefore, 
all males must be sterilized by vasectomy before acceptance into the 
system, or,

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



Sec. 9.8  Animal records.

    (a) What records must be maintained for chimpanzees in the sanctuary 
and how are they managed? (1) Contractors and Subcontractors operating 
the federal chimpanzee sanctuary system must maintain appropriate 
records to allow for accountability and disposition of chimpanzees under 
their care as required by the USDA Animal Welfare Regulations (9 CFR 
2.35). The records may be created and retained in electronic form.
    (2) The animal records currently required by the USDA Animal Welfare 
Regulations are also required for these standards. Chimpanzees must be 
individually and permanently identifiable.
    (3) Retrievable records must be maintained for a minimum of three 
years beyond the disposition or death of each chimpanzee in accordance 
with the Animal Welfare Regulations section 2.35(f) (9 CFR 2.35(f)). 
Original records or a copy must be transferred if the chimpanzee moves 
to a different facility. The records must include standard information, 
including permanent individual identification, research use(s), 
reproductive status (past and present), a summary or copy of the medical 
and behavioral history, the sire's identification number (if available), 
the dam's identification number, birth date, sex, and date acquired by 
the sanctuary. The disposition date must also be noted, if applicable, 
including whether the chimpanzee died or was transferred to another site 
in the federal sanctuary system. The records may be created and retained 
in electronic form.
    (4) The contractor and any subcontractor(s) operating the federally 
supported chimpanzee sanctuary must provide special, quarterly, and 
annual progress reports to the designated Federal officials as 
identified in the contract. The annual report must also contain a 
statement that certifies the sanctuary is in full compliance with these 
standards of care regulation.
    (b) What are the rules governing the disposition of necropsy 
records? The CHIMP Act requires that necropsy records from chimpanzees 
previously used in federally funded research projects be made available 
on a reasonable basis to investigators engaged in biomedical or 
behavioral research. In order to comply with this provision, the 
contractor for the sanctuary system must devise a plan that will allow 
interested parties to contact the sanctuary and receive necropsy records 
when they become available. Records may be provided free of charge but 
requesters may be required to pay for packaging and shipping costs. The 
records may be created and retained in electronic form.



Sec. 9.9  Facility staffing.

    How many personnel are required to staff the chimpanzee sanctuary 
and what qualifications and training must the staff possess? (a) The 
professional, managerial, and support staff must be sufficient to 
support the scope and diversity of the activities and chimpanzee 
population of the sanctuary. The level of staffing shall be adequate to 
ensure that the chimpanzees receive appropriate health care, are well 
cared for, and the administrative and fiscal operations are sound and in 
keeping with current practices required by NCRR/NIH;

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    (b) There must be a sufficient number of appropriately trained 
animal care and technical personnel to provide appropriate care to the 
chimpanzees at all times, including evenings, weekends, and holidays. 
The number of animal care staff to chimpanzee ratio shall be adjusted as 
experience is gained during the operation of the sanctuary. Sufficiently 
trained staff also must be available to maintain adequate behavioral 
enrichment;
    (c) The Facility Director must be a person with experience in 
chimpanzee care and socialization techniques. In addition, the Director 
must have management and administrative experience;
    (d) The Biosafety Officer must have experience in developing and 
monitoring biohazards and dealing with biosafety issues related to 
captive nonhuman primates. Experience in these areas dealing 
specifically with chimpanzees is desirable;
    (e) The remaining staff, which may include part-time, full-time, or 
contractor Facility Veterinarian(s) and Behaviorist(s), must possess the 
skills, knowledge, and/or experience required to perform their duties, 
as elaborated within the regulation.



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

    (a) How are employee Occupational Health and Safety Program risks 
and concerns addressed? The sanctuary shall assure that an Occupational 
Health and Safety Program (OHSP) is developed and implemented in 
accordance with current veterinary medical practices and the guidelines 
and standards found in the Guide (incorporated by reference, see 
paragraph (a) of section 9.4);
    (b) How are biosafety concerns addressed? The sanctuary shall 
institute and administer an effective biosafety program that addresses 
the biosafety hazards at that particular site. The program shall include 
identifying biohazards, outlining practices and procedures to be 
followed, providing personal safety equipment or protective clothing and 
equipment, and establishing a description of the facility requirements 
for working with hazardous agents or materials. Policies and procedures 
must be implemented to avoid exposure to environmental and animal 
hazards. Biosafety must be included in the training program for all 
Sanctuary employees. In establishing a program, the Sanctuary must use 
current accepted practices and publications prepared by the CDC, NIH, 
and professional societies specializing in biosafety. The input and 
guidance of personnel trained or experienced in biosafety are essential. 
Complete records of both clinical and experimental agent exposure must 
accompany each chimpanzee sent to the sanctuary. The donating facility 
must also provide recent testing (for example, serology, virus culture, 
histology) so that the sanctuary staff is fully aware of the health 
condition of the arriving chimpanzee. The records may be created and 
retained in electronic form.



Sec. 9.11  Animal transport.

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



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

    (a) How will compliance with the standards set forth in this part be 
monitored and what are the consequences of noncompliance with the 
standards? The federally supported chimpanzee sanctuary must comply with 
the standards of care set forth in this part and include a statement in 
the Annual Progress Report certifying compliance with these standards of 
care in accordance with the terms of the current contract between NCRR 
and the Sanctuary Contractor. A designated representative of the 
Secretary will monitor compliance. The responsibility to monitor 
compliance with the standards is delegated to NCRR/NIH/HHS. The NIH/NCRR 
Project Officer for this contract will conduct scheduled site visits at 
least one time annually (or more often if necessary) and review monthly 
and quarterly reports submitted to the Project and Contract Officer. 
Subcontractors are subjected to the same

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provisions. Failure to comply with the standards set forth in this part, 
or to correct deficiencies noted within the allowable time period, could 
result in termination of the contract by the Federal Government (HHS/
NIH), or allow the Secretary to correct the deficiencies according to 
the terms and conditions outlined in the contract. The Secretary may 
impose additional sanctions on the contractor up to, and including, 
authorizing assumption or reassignment of the management of the 
sanctuary contract.
    (b) To what type of outside review or inspection will the federally 
supported sanctuary be subjected? As noted in paragraph (a) of this 
section, the contractor for the sanctuary will be monitored on a 
regularly scheduled basis by representatives of NCRR/NIH/HHS. The NCRR 
representative will use facility site visits, reports, personal contact, 
and any other means as appropriate to ensure compliance with these 
standards. The contractor and subcontractors are required to obtain and 
maintain an Animal Welfare Assurance from NIH's Office of Laboratory 
Animal Welfare (OLAW) when chimpanzees are used for noninvasive studies 
as authorized in the CHIMP Act. In addition, the sanctuary must achieve 
accreditation by a nationally recognized animal program accrediting body 
(such as the AAALAC, the AZA, or similar recognized body) within a time 
frame to be determined by NCRR/NIH. The federally supported sanctuary 
must comply with the requirements set forth in the Animal Welfare 
Regulations (9 CFR parts 1 through 3).



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

    (a) Animal Welfare Act (7 U.S.C. 2131-2159).
    (b) Animal Welfare Regulations, 9 CFR, subchapter A, parts 1 and 2; 
part 3, subpart D--Specifications for the Humane Handling, Care, 
Treatment, and Transport of Nonhuman Primates.



PART 10_340B DRUG PRICING PROGRAM--Table of Contents



    Effective Date Note: At 82 FR 1229, Jan. 5, 2017, part 10 was 
revised, effective July 1, 2018. The new part appears after the text of 
this part
Sec.

                      Subpart A_General Provisions

10.1  Purpose.
10.2  Summary of 340B Drug Pricing Program.
10.3  Definitions.

              Subpart B_Eligibility To Purchase 340B Drugs

10.10  Entities eligible to participate in the 340B Drug Pricing 
          Program.

            Subpart C_Drugs Eligible for Purchase under 340B

10.20  Drugs eligible for purchase Under 340B.
10.21  Exclusion of orphan drugs for certain covered entities.

    Authority: Sec. 340B of the Public Health Service Act (42 U.S.C. 
256b), as amended; Sec. 215 of the Public Health Service Act (42 U.S.C. 
216), as amended; Sec. 526 of the Federal Food, Drug, and Cosmetic Act, 
as amended (21 U.S.C. 360bb); Sec. 701(a) of the Federal Food, Drug, and 
Cosmetic Act, as amended (21 U.S.C. 371(a)); Sec. 1927 of the Social 
Security Act, as amended (42 U.S.C. 1396r-8).

    Source: 78 FR 44027, July 23, 2013, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 10.1  Purpose.

    This part implements section 340B of the Public Health Service Act 
(PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.''



Sec. 10.2  Summary of 340B Drug Pricing Program.

    Section 340B of the PHSA instructs the Secretary of Health and Human 
Services to enter into agreements with manufacturers of covered drugs 
under which the amount required to be paid to these manufacturers by 
certain statutorily-defined entities does not exceed the average 
manufacturer price for the drug under title XIX of the Social Security 
Act (SSA) reduced by a rebate percentage which is calculated as 
indicated in 340B(a)(1) and 340B(a)(2)(A). Manufacturers participating 
in the 340B Drug Pricing Program (340B Program) are required to

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provide these discounts on all covered outpatient drugs sold to 
participating 340B covered entities.



Sec. 10.3  Definitions.

    Ceiling price means the maximum statutory price established under 
section 340B(a)(1) of the PHSA.
    Covered entity means an entity that meets the requirements under 
section 340B(a)(5) of the PHSA and is listed in section 340B(a)(4) of 
the PHSA.
    Covered outpatient drug has the meaning set forth in section 1927(k) 
of the SSA.
    Group purchasing organization (GPO) is an entity that contracts with 
purchasers, such as hospitals, nursing homes, and home health agencies, 
to aggregate purchasing volume and negotiate final prices with 
manufacturers, distributors, and other vendors.
    Manufacturer has the same meaning as set forth in section 1927(k)(5) 
of the SSA.
    Orphan drug means a drug designated by the Secretary under section 
526 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
    Participating drug manufacturer means a manufacturer that has 
entered into a Pharmaceutical Pricing Agreement with the Secretary.
    Pharmaceutical Pricing Agreement (PPA) means an agreement described 
in section 340B(a)(1) of the PHSA.
    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.
    Section 340B means section 340B of the PHSA.



              Subpart B_Eligibility To Purchase 340B Drugs



Sec. 10.10  Entities eligible to participate in the 340B Drug Pricing
Program.

    Only organizations meeting the definition of a covered entity and 
listed on the 340B database are eligible to purchase covered outpatient 
drugs under the 340B Program. A covered entity remains responsible for 
complying with all other 340B requirements and applicable Federal, 
state, and local laws.



            Subpart C_Drugs Eligible for Purchase Under 340B



Sec. 10.20  Drugs eligible for purchase under 340B.

    The definition of a covered outpatient drug has the meaning given to 
such term in section 1927(k)(2) of the SSA except as provided in 
Sec. 10.21 of this part.



Sec. 10.21  Exclusion of orphan drugs for certain covered entities.

    (a) General. For the covered entities described in paragraph (b) of 
this section, a covered outpatient drug does not include orphan drugs 
that are transferred, prescribed, sold, or otherwise used for the rare 
condition or disease for which that orphan drug was designated under 
section 526 of the FFDCA. A covered outpatient drug includes drugs that 
are designated under section 526 of the FFDCA when they are transferred, 
prescribed, sold, or otherwise used for any medically-accepted 
indication other than treating the rare disease or condition for which 
the drug was designated under section 526 of the FFDCA.
    (b) Covered entities to which the orphan drug exclusion applies. (1) 
The exclusion of orphan drugs when used to treat the rare disease or 
condition for which the drug was designated under section 526 of the 
FFDCA from the definition of covered outpatient drugs described in 
paragraph (a) of this section shall only apply to the following covered 
entities: free-standing cancer hospitals qualifying under section 
340B(a)(4)(M) of the PHSA, critical access hospitals qualifying under 
section 340B(a)(4)(N) of the PHSA, and rural referral centers and sole 
community hospitals qualifying under section 340B(a)(4)(O) of the PHSA. 
The exclusion does not apply to the remaining covered entities that meet 
the 340B Program eligibility requirements.
    (2) When an entity described in this paragraph (b) meets more than 
one eligibility criterion as a covered entity, the entity shall select 
its eligibility type and notify the Secretary. These eligible entities 
are limited to participating in the 340B Program under only one covered 
entity hospital type and

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shall abide by all applicable restrictions and requirements for that 
entity type. A covered entity subject to this provision may only change 
its participation type to another hospital entity type on a quarterly 
basis upon express written confirmation from the Secretary.
    (c) Covered entity responsibility to maintain records of compliance. 
(1) A covered entity listed in paragraph (b) of this section is 
responsible for ensuring that any orphan drugs purchased through the 
340B Program are not transferred, prescribed, sold, or otherwise used 
for the rare condition or disease for which the orphan drugs are 
designated under section 526 of the FFDCA. A covered entity listed in 
paragraph (b) of this section that purchases orphan drugs under the 340B 
Program is required to maintain and provide auditable records on request 
which document the covered entity's compliance with this requirement 
available for audit by the Federal Government or, with Federal 
Government approval, by the manufacturer.
    (2) A covered entity may develop an alternative system by which it 
can prove compliance. Any alternate system must be approved by the 
Secretary prior to implementation. Each alternate system of compliance 
will be reviewed on a case-by-case basis.
    (3) A covered entity listed in paragraph (b) of this section that 
cannot or does not wish to maintain auditable records sufficient to 
demonstrate compliance with this rule, must notify HRSA and purchase all 
orphan drugs outside of the 340B Program regardless of the indication 
for which the drug is used. Once a hospital is enrolled in 340B, it may 
change its decision to purchase all orphan drugs outside of the 340B 
Program on a quarterly basis by notifying HRSA.
    This documentation will be made public. This information will also 
be verified during the annual recertification process.
    (d) Use of group purchasing organizations by a free-standing cancer 
hospital. (1) A free-standing cancer hospital enrolled under section 
340B(a)(4)(M) must also comply with the prohibition against using a GPO 
under section 340B(a)(4)(L)(iii) of the PHSA for the purchase of any 
covered outpatient drug.
    (2) A covered entity that is a free-standing cancer hospital cannot 
use a GPO to purchase orphan drugs when they are transferred, 
prescribed, sold, or otherwise used for an indication other than the 
rare condition or disease for which that orphan drug was designated 
under section 526 of the FFDCA.
    (3) A covered entity that is a free-standing cancer hospital may use 
a GPO for purchasing orphan drugs when orphan drugs are transferred, 
prescribed, sold, or otherwise used for the rare disease or condition 
for which it was designated under section 526 of the FFDCA.
    (4) If a covered entity that is a free-standing cancer hospital 
chooses to use a GPO for purchasing an orphan drug used for a rare 
disease or condition for which it is designated, it is required to 
maintain auditable records that demonstrate full compliance with the 
orphan drug purchasing requirements and limitations. A free-standing 
cancer hospital covered entity that cannot or does not wish to maintain 
auditable records sufficient to demonstrate compliance, must notify HRSA 
and purchase all orphan drugs outside of the 340B Program, regardless of 
indication for which the drug is used, and is not permitted to use a GPO 
to purchase those drugs. Once a free-standing cancer hospital is 
enrolled in 340B, it may change its decision to purchase all orphan 
drugs outside of the 340B Program on a quarterly basis by notifying 
HRSA. This documentation will be made public. This information will also 
be verified during the annual recertification process.
    (e) Identification of orphan drugs. Designations under section 526 
of the FFDCA are the responsibility of and administered by the FDA. Only 
covered outpatient drugs that match the listing and sponsor of the 
orphan designation are considered orphan drugs for purposes of this 
section. HRSA will publish on its public Web site FDA's section 526 list 
of drugs that will govern the next quarter's purchases.

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    (f) Failure to comply. Failure to comply with this section shall be 
considered a violation of sections 340B(a)(5) and 340B(e) of the PHSA, 
as applicable.

    Effective Date Note: At 82 FR 1229, Jan. 5, 2017, part 10 was 
revised, effective July 1, 2018. For the convenience of the user, 
revised text is set forth as follows:



PART 10_340B DRUG PRICING PROGRAM



                      Subpart A_General Provisions



Sec. 10.1  Purpose.

    This part implements section 340B of the Public Health Service Act 
(PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.''



Sec. 10.2  Summary of 340B Drug Pricing Program.

    Section 340B of the PHSA instructs the Secretary of Health and Human 
Services to enter into agreements with manufacturers of covered 
outpatient drugs under which the amount to be paid to manufacturers by 
certain statutorily-defined covered entities does not exceed the 340B 
ceiling price.



Sec. 10.3  Definitions.

    For the purposes of this part, the following definitions apply:
    Average Manufacturer Price (AMP) has the meaning set forth in 
section 1927(k)(1) of the Social Security Act, as implemented in 42 CFR 
447.504.
    Ceiling price means the maximum statutory price established under 
section 340B(a)(1) of the PHSA and this section.
    CMS is the Centers for Medicare & Medicaid Services.
    Covered entity means an entity that is listed within section 
340B(a)(4) of the PHSA, meets the requirements under section 340B(a)(5) 
of the PHSA, and is registered and listed in the 340B database.
    Covered outpatient drug has the meaning set forth in section 1927(k) 
of the Social Security Act.
    Manufacturer has the meaning set forth in section 1927(k) of the 
Social Security Act, as implemented in 42 CFR 447.502.
    National Drug Code (NDC) has the meaning set forth in 42 CFR 
447.502.
    Pharmaceutical Pricing Agreement (PPA) means an agreement described 
in section 340B(a)(1) of the PHSA.
    Quarter refers to a calendar quarter unless otherwise specified.
    Secretary means the Secretary of the Department of Health and Human 
Services and any other officer of employee of the Department of Health 
and Human Services to whom the authority involved has been delegated.



                      Subpart B_340B Ceiling Price



Sec. 10.10  Ceiling price for a covered outpatient drug.

    A manufacturer is required to calculate the 340B ceiling price for 
each covered outpatient drug, by National Drug Code (NDC) on a quarterly 
basis.
    (a) Calculation of 340B ceiling price. The 340B ceiling price for a 
covered outpatient drug is equal to the Average Manufacturer Price (AMP) 
from the preceding calendar quarter for the smallest unit of measure 
minus the Unit Rebate Amount (URA) and will be calculated using six 
decimal places. HRSA will publish the 340B ceiling price rounded to two 
decimal places.
    (b) Exception. When the ceiling price calculation in paragraph (a) 
of this section results in an amount less than $0.01 the ceiling price 
will be $0.01.
    (c) New drug price estimation. A manufacturer must estimate the 340B 
ceiling price for a new covered outpatient drug as of the date the drug 
is first available for sale. That estimation should be calculated as 
wholesale acquisition cost minus the appropriate rebate percentage until 
an AMP is available, which should occur no later than the 4th quarter 
that the drug is available for sale. Manufacturers are required to 
calculate the actual 340B ceiling price as described in paragraph (a) of 
this section and offer to refund or credit the covered entity the 
difference between the estimated 340B ceiling price and the actual 340B 
ceiling price within 120 days of the determination by the manufacturer 
that an overcharge occurred.



Sec. 10.11  Manufacturer civil monetary penalties.

    (a) General. Any manufacturer with a pharmaceutical pricing 
agreement that knowingly and intentionally charges a covered entity more 
than the ceiling price, as defined in Sec. 10.10, for a covered 
outpatient drug, may be subject to a civil monetary penalty not to 
exceed $5,000 for each instance of overcharging, as defined in paragraph 
(b) of this section. This penalty will be imposed pursuant to the 
applicable procedures at 42 CFR part 1003. Any civil monetary penalty 
assessed will be in addition to repayment for an instance of 
overcharging as required by section 340B(d)(1)(B)(ii) of the PHSA.
    (b) Instance of overcharging. An instance of overcharging is any 
order for a covered outpatient drug, by NDC, which results in a covered 
entity paying more than the ceiling price, as defined in Sec. 10.10, for 
that covered outpatient drug.
    (1) Each order for an NDC will constitute a single instance, 
regardless of the number of units of each NDC ordered. This includes any 
order placed directly with a manufacturer or through a wholesaler, 
authorized distributor, or agent.

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    (2) Manufacturers have an obligation to ensure that the 340B 
discount is provided through distribution arrangements made by the 
manufacturer.
    (3) An instance of overcharging is considered at the NDC level and 
may not be offset by other discounts provided on any other NDC or 
discounts provided on the same NDC on other transactions, orders, or 
purchases.
    (4) An instance of overcharging may occur at the time of initial 
purchase or when subsequent ceiling price recalculations due to pricing 
data submitted to CMS or new drug price estimations as defined in 
Sec. 10.10(c) result in a covered entity paying more than the ceiling 
price due to failure or refusal to refund or credit a covered entity.



PART 11_CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION
SUBMISSION--Table of Contents



                      Subpart A_General Provisions

Sec.
11.2  What is the purpose of this part?
11.4  To whom does this part apply?
11.6  What are the requirements for the submission of truthful 
          information?
11.8  In what format must clinical trial information be submitted?
11.10  What definitions apply to this part?

                         Subpart B_Registration

11.20  Who must submit clinical trial registration information?
11.22  Which applicable clinical trials must be registered?
11.24  When must clinical trial registration information be submitted?
11.28  What constitutes clinical trial registration information?
11.35  By when will the NIH Director post clinical trial registration 
          information submitted under Sec. 11.28?

                Subpart C_Results Information Submission

11.40  Who must submit clinical trial results information?
11.42  For which applicable clinical trials must clinical trial results 
          information be submitted?
11.44  When must clinical trial results information be submitted for 
          applicable clinical trials subject to Sec. 11.42?
11.48  What constitutes clinical trial results information?
11.52  By when will the NIH Director post submitted clinical trial 
          results information?
11.54  What are the procedures for requesting a waiver of the 
          requirements for clinical trial results information 
          submission?

      Subpart D_Additional Submission of Clinical Trial Information

11.60  What requirements apply to the voluntary submission of clinical 
          trial information for clinical trials of FDA-regulated drug 
          products (including biological products) and device products?
11.62  What requirements apply to applicable clinical trials for which 
          submission of clinical trial information has been determined 
          by the Director to be necessary to protect the public health?
11.64  When must clinical trial information submitted to 
          ClinicalTrials.gov be updated or corrected?

        Subpart E_Potential Legal Consequences of Non-Compliance

11.66  What are potential legal consequences of not complying with the 
          requirements of this part?

    Authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 
U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b).

    Source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 11.2  What is the purpose of this part?

    This part implements section 402(j) of the Public Health Service Act 
(42 U.S.C. 282(j)) by providing requirements and procedures for the 
submission of clinical trial information for certain applicable clinical 
trials and other clinical trials to the Director of the National 
Institutes of Health (NIH) to be made publicly available via 
ClinicalTrials.gov, the Internet-accessible clinical trial registry and 
results data bank established by the National Library of Medicine (NLM) 
at https://clinicaltrials.gov.



Sec. 11.4  To whom does this part apply?

    (a) This part applies to the responsible party for an applicable 
clinical trial that is required to be registered under Sec. 11.22, a 
clinical trial for which clinical trial registration information or 
clinical trial results information is submitted voluntarily in 
accordance with Sec. 11.60, or an applicable clinical trial that is 
required by the Director to have clinical trial information submitted to 
protect the public health under Sec. 11.62.

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    (b) The responsible party must communicate the identity and contact 
information of the responsible party to the Director by submitting the 
Responsible Party, by Official Title and Responsible Party Contact 
Information data elements under Sec. 11.28(a)(2)(iii)(B) and 
(a)(2)(iv)(F) as part of the clinical trial information submitted at the 
time of registration. Changes must be communicated to the Director by 
updating information in accordance with Sec. 11.64(a).
    (c) Determination of responsible party. For purposes of this part, 
each applicable clinical trial or other clinical trial must have one 
responsible party. With respect to a clinical trial, the sponsor of the 
clinical trial will be considered the responsible party unless and until 
a principal investigator has been designated the responsible party, in 
accordance with paragraph (c)(2) of this section. With respect to a 
pediatric postmarket surveillance of a device product that is not a 
clinical trial, the responsible party is the entity that the U.S. Food 
and Drug Adminstration (FDA), under section 522 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 3601), orders to conduct the pediatric 
postmarket surveillance of a device product.
    (1) Determination of sponsor. For purposes of this part, each 
applicable clinical trial or other clinical trial must have one sponsor.
    (i) When an applicable clinical trial or other clinical trial is 
conducted under an investigational new drug application (IND) or 
investigational device exemption (IDE), the IND or IDE holder will be 
considered the sponsor.
    (ii) When an applicable clinical trial or other clinical trial is 
not conducted under an IND or IDE, the single person or entity who 
initiates the trial, by preparing and/or planning the trial, and who has 
authority and control over the trial, will be considered the sponsor.
    (2) Designation of a principal investigator as the responsible 
party.
    (i) The sponsor may designate a principal investigator as the 
responsible party if such principal investigator meets all of the 
following requirements:
    (A) Is responsible for conducting the trial;
    (B) Has access to and control over the data from the trial;
    (C) Has the right to publish the results of the trial; and
    (D) Has the ability to meet all of the requirements for submitting 
and updating clinical trial information as specified in this part.
    (ii) With regard to an applicable clinical trial or other clinical 
trial, a designation by the sponsor under paragraph (c)(2)(i) of this 
section shall consist of the sponsor obtaining from the principal 
investigator an acknowledgment of the principal investigator's 
responsibilities under this part as responsible party, and the principal 
investigator acknowledging the designation as responsible party to the 
Director in the format specified at https://prsinfo.clinicaltrials.gov.
    (3) Withdrawal of the designation of a principal investigator as the 
responsible party.
    In the event that a principal investigator who has been designated 
the responsible party no longer meets or is no longer able to meet all 
the requirements for being so designated under paragraph (c)(2)(i) of 
this section, the sponsor must withdraw the designation in the format 
specified at https://prsinfo.clinicaltrials.gov, at which time the 
sponsor will be considered the responsible party unless and until the 
sponsor makes a new designation in accordance with paragraph (c)(2) of 
this section.



Sec. 11.6  What are the requirements for the submission of truthful 
information?

    The clinical trial information submitted by a responsible party 
under this part shall not be false or misleading in any particular. A 
responsible party who submits false and/or misleading information is 
subject to civil monetary penalties and/or other civil or criminal 
remedies available under U.S. law.



Sec. 11.8  In what format must clinical trial information be 
submitted?

    Information submitted under this part must be submitted 
electronically to ClinicalTrials.gov, in the format

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specified at https://prsinfo.clinicaltrials.gov.



Sec. 11.10  What definitions apply to this part?

    (a) The following definitions apply to terms used in this part:
    Adverse event means any untoward or unfavorable medical occurrence 
in a human subject, including any abnormal sign (for example, abnormal 
physical exam or laboratory finding), symptom, or disease, temporally 
associated with the subject's participation in the research, whether or 
not considered related to the subject's participation in the research. 
See also the definition of ``serious adverse event.''
    Applicable clinical trial means an applicable device clinical trial 
or an applicable drug clinical trial. Expanded access use under section 
561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) is 
not an applicable clinical trial.
    Applicable device clinical trial means:
    (1) A prospective clinical study of health outcomes comparing an 
intervention with a device product subject to section 510(k), 515, or 
520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 
U.S.C. 360e, 21 U.S.C. 360j(m)) against a control in human subjects 
(other than a small clinical trial to determine the feasibility of a 
device product, or a clinical trial to test prototype device products 
where the primary outcome measure relates to feasibility and not to 
health outcomes);
    (2) A pediatric postmarket surveillance of a device product as 
required under section 522 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 3601); or
    (3) A clinical trial of a combination product with a device primary 
mode of action under 21 CFR part 3, provided that it meets all other 
criteria of the definition under this part.
    Applicable drug clinical trial means a controlled clinical 
investigation, other than a phase 1 clinical investigation, of a drug 
product subject to section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) or a biological product subject to section 351 of 
the Public Health Service Act (42 U.S.C. 262), where ``clinical 
investigation'' has the meaning given in 21 CFR 312.3 and ``phase 1'' 
has the meaning given in 21 CFR 312.21. A clinical trial of a 
combination product with a drug primary mode of action under 21 CFR part 
3 is also an applicable drug clinical trial, provided that it meets all 
other criteria of the definition under this part.
    Approved drug means a drug product that is approved for any use 
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) or a biological product licensed for any use under section 351 of 
the Public Health Service Act (42 U.S.C. 262).
    Approved or cleared device means a device product that is cleared 
for any use under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C 360(k)) or approved for any use under sections 515 or 
520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e, 
360j(m)).
    Arm means a pre-specified group or subgroup of human subject(s) in a 
clinical trial assigned to receive specific intervention(s) (or no 
intervention) according to a protocol.
    Clinical study means research according to a protocol involving one 
or more human subjects to evaluate biomedical or health-related 
outcomes, including interventional studies and observational studies.
    Clinical trial means a clinical investigation or a clinical study in 
which human subject(s) are prospectively assigned, according to a 
protocol, to one or more interventions (or no intervention) to evaluate 
the effect(s) of the intervention(s) on biomedical or health-related 
outcomes.
    Clinical trial information means the data elements, including 
clinical trial registration information and clinical trial results 
information, that the responsible party is required to submit to 
ClinicalTrials.gov, as specified in section 402(j) of the Public Health 
Service Act (42 U.S.C. 282(j)) and this part.
    Clinical trial registration information means the data elements that 
the responsible party is required to submit to ClinicalTrials.gov, as 
specified in section 402(j)(2)(A)(ii) of the Public Health Service Act 
(42 U.S.C. 282(j)(2)(A)(ii)) or Sec. 11.28, as applicable.
    Clinical trial results information means the data elements that the 
responsible

[[Page 136]]

party is required to submit to ClinicalTrials.gov, as specified in 
sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act 
(42 U.S.C. 282(j)(3)(C) and (I)) or Sec. 11.48, as applicable. If a 
responsible party submits clinical trial results information voluntarily 
for a clinical trial, clinical trial results information also means 
Sec. 11.60(b)(2)(i)(B) or Sec. 11.60(c)(2)(i)(B), as applicable.
    Comparison group means a grouping of human subjects in a clinical 
trial that is or may be used in analyzing the results data collected 
during the clinical trial.
    Completion date means, for a clinical trial, including an applicable 
clinical trial, the date that the final subject was examined or received 
an intervention for the purposes of final collection of data for the 
primary outcome, whether the clinical trial concluded according to the 
pre-specified protocol or was terminated. In the case of clinical trials 
with more than one primary outcome measure with different completion 
dates, this term refers to the date on which data collection is 
completed for all of the primary outcomes. For a pediatric postmarket 
surveillance of a device product that is not a clinical trial, 
completion date means the date on which the final report of the 
pediatric postmarket surveillance of the device product is submitted to 
FDA. For purposes of this part, completion date is referred to as 
``primary completion date.''
    Control or controlled means, with respect to a clinical trial, that 
data collected on human subjects in the clinical trial will be compared 
to concurrently collected data or to non-concurrently collected data 
(e.g., historical controls, including a human subject's own baseline 
data), as reflected in the pre-specified primary or secondary outcome 
measures. For purposes of this part, all clinical trials with one or 
more arms and pre-specified outcome measure(s) are controlled.
    Device means a device as defined in section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
    Director means the NIH Director or any official of NIH to whom the 
NIH Director delegates authorities granted in section 402(j) of the 
Public Health Service Act (42 U.S.C. 282(j)).
    Drug means a drug as defined in section 201(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(g)) or a biological product as 
defined in section 351 of the Public Health Service Act (42 U.S.C. 262).
    Enroll or enrolled means a human subject's, or their legally 
authorized representative's, agreement to participate in a clinical 
trial following completion of the informed consent process, as required 
in 21 CFR part 50 and/or 45 CFR part 46, as applicable. For the purposes 
of this part, potential subjects who are screened for the purpose of 
determining eligibility for a trial, but do not participate in the 
trial, are not considered enrolled, unless otherwise specified by the 
protocol.
    Human subjects protection review board means an institutional review 
board (IRB) as defined in 21 CFR 50.3 or 45 CFR 46.102, as applicable, 
that is responsible for assuring the protection of the rights, safety, 
and well-being of human subjects involved in a clinical trial and is 
adequately constituted to provide assurance of that protection. An IRB 
may also be known as an ``independent ethics committee.''
    Interventional means, with respect to a clinical study or a clinical 
investigation, that participants are assigned prospectively to an 
intervention or interventions according to a protocol to evaluate the 
effect of the intervention(s) on biomedical or other health-related 
outcomes.
    Investigational Device Exemption (IDE) has the meaning given in 21 
CFR part 812.
    Investigational New Drug Application (IND) has the meaning given in 
21 CFR 312.3.
    NCT number means the unique identification code assigned to each 
record in ClinicalTrials.gov, including a record for an applicable 
clinical trial, a clinical trial, or an expanded access program.
    Ongoing means, with respect to a clinical trial of a drug product 
(including a biological product) or a device product and to a date, that 
one or more human subjects is enrolled in the clinical trial, and the 
date is before the primary completion date of the clinical trial. With 
respect to a pediatric

[[Page 137]]

postmarket surveillance of a device product, ongoing means a date 
between the date on which FDA approves the plan for conducting the 
surveillance and the date on which the final report is submitted to FDA.
    Outcome measure means a pre-specified measurement that will be used 
to determine the effect of an experimental variable on the human 
subject(s) in a clinical trial. See also the definitions of ``primary 
outcome measure'' and ``secondary outcome measure.''
    Pediatric postmarket surveillance of a device product means the 
active, systematic, scientifically valid collection, analysis, and 
interpretation of data or other information conducted under section 522 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) about a 
marketed device product that is expected to have significant use in 
patients who are 21 years of age or younger at the time of diagnosis or 
treatment. A pediatric postmarket surveillance of a device product may 
be, but is not always, a clinical trial.
    Primary completion date means, for purposes of this part, 
``completion date.'' See the definition of ``completion date.''
    Primary outcome measure means the outcome measure(s) of greatest 
importance specified in the protocol, usually the one(s) used in the 
power calculation. Most clinical trials have one primary outcome 
measure, but a clinical trial may have more than one. For purposes of 
this part, ``primary outcome'' has the same meaning as primary outcome 
measure.
    Principal investigator means the individual who is responsible for 
the overall scientific and technical direction of the study.
    Protocol means the written description of the clinical trial, 
including objective(s), design, and methods. It may also include 
relevant scientific background and statistical considerations.
    Responsible party means, with respect to a clinical trial, the 
sponsor of the clinical trial, as defined in 21 CFR 50.3; or the 
principal investigator of such clinical trial if so designated by a 
sponsor, grantee, contractor, or awardee, so long as the principal 
investigator is responsible for conducting the trial, has access to and 
control over the data from the clinical trial, has the right to publish 
the results of the trial, and has the ability to meet all of the 
requirements under this part for the submission of clinical trial 
information. For a pediatric postmarket surveillance of a device product 
that is not a clinical trial, the responsible party is the entity who 
FDA orders to conduct the pediatric postmarket surveillance of the 
device product.
    Secondary outcome measure means an outcome measure that is of lesser 
importance than a primary outcome measure, but is part of a pre-
specified analysis plan for evaluating the effects of the intervention 
or interventions under investigation in a clinical trial and is not 
specified as an exploratory or other measure. A clinical trial may have 
more than one secondary outcome measure. For purposes of this part, 
``secondary outcome'' has the same meaning as secondary outcome measure.
    Secretary means the Secretary of Health and Human Services or any 
other official(s) to whom the Secretary delegates the authority 
contained in section 402(j) of the Public Health Service Act (42 U.S.C. 
282(j)).
    Serious adverse event means an adverse event that results in any of 
the following outcomes: Death, a life-threatening adverse event as 
defined in 21 CFR 312.32, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions, 
or a congenital anomaly/birth defect. Important medical events that may 
not result in death, be life-threatening, or require hospitalization may 
be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the human subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of a substance use disorder.

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    Sponsor means either a ``sponsor'' or ``sponsor-investigator,'' as 
each is defined in 21 CFR 50.3.
    Study completion date means, for a clinical trial, the date the 
final subject was examined or received an intervention for purposes of 
final collection of data for the primary and secondary outcome measures 
and adverse events (e.g., last subject's last visit), whether the 
clinical trial concluded according to the pre-specified protocol or was 
terminated.
    U.S. FDA-regulated device product means, for purposes of this part, 
a device product subject to section 510(k), 515, 520(m), or 522 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 
21 U.S.C. 360j(m), 21 U.S.C. 360l).
    U.S. FDA-regulated drug product means, for purposes of this part, a 
drug product subject to section 505 of the Federal Food, Drug, and 
Cosmetic Act or a biological product subject to section 351 of the 
Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
    (b) The following definitions apply to data elements of clinical 
trial information referenced in this part, unless otherwise specified:
    (1) Brief Title means a short title of the clinical trial written in 
language intended for the lay public, including any acronym or 
abbreviation used publicly to identify the clinical trial.
    (2) Official Title means the title of the clinical trial, 
corresponding to the title of the protocol.
    (3) Brief Summary means a short description of the clinical trial, 
including a brief statement of the clinical trial's hypothesis, written 
in language intended for the lay public.
    (4) Primary Purpose means the main objective of the intervention(s) 
being evaluated by the clinical trial.
    (5) Study Design means a description of the manner in which the 
clinical trial will be conducted, including the following information:
    (i) Interventional Study Model. The strategy for assigning 
interventions to human subjects.
    (ii) Number of Arms. The number of arms in the clinical trial. For a 
trial with multiple periods or phases that have different numbers of 
arms, it means the maximum number of arms during all periods or phases.
    (iii) Arm Information. A description of each arm of the clinical 
trial that indicates its role in the clinical trial, provides an 
informative title, and, if necessary, additional descriptive information 
(including which interventions are administered in each arm) to 
differentiate each arm from other arms in the clinical trial.
    (iv) Allocation. The method by which human subjects are assigned to 
arms in a clinical trial.
    (v) Masking. The party or parties, if any, involved in the clinical 
trial who are prevented from having knowledge of the interventions 
assigned to individual human subjects.
    (6) Study Phase means, for a clinical trial of a drug product 
(including a biological product), the numerical phase of such clinical 
trial, consistent with terminology in 21 CFR 312.21, such as phase 2 or 
phase 3, and in 21 CFR 312.85 for phase 4 studies.
    (7) Study Type means the nature of the investigation or 
investigational use for which clinical trial information is being 
submitted, e.g., interventional, observational.
    (8) Pediatric Postmarket Surveillance of a Device Product means a 
clinical trial or study that includes a U.S. FDA-regulated device 
product as an intervention and is a pediatric postmarket surveillance of 
a device product ordered under section 522 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 369l).
    (9) Primary Disease or Condition Being Studied in the Trial, or the 
Focus of the Study means the name(s) of the disease(s) or condition(s) 
studied in the clinical trial, or the focus of the clinical trial. Use, 
if available, appropriate descriptors from NLM's Medical Subject 
Headings (MeSH)-controlled vocabulary thesaurus or terms from another 
vocabulary, such as the Systematized Nomenclature of Medicine--Clinical 
Terms (SNOMED CT), that has been mapped to MeSH within the Unified 
Medical Language System (UMLS) Metathesaurus.
    (10) Intervention Name(s) means a brief descriptive name used to 
refer to the intervention(s) studied in each arm of the clinical trial. 
A non-proprietary name of the intervention must be used,

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if available. If a non-proprietary name is not available, a brief 
descriptive name or identifier must be used.
    (11) Other Intervention Name(s) means other current and former 
name(s) or alias(es), if any, different from the Intervention Name(s), 
that the sponsor has used publicly to identify the intervention(s), 
including, but not limited to, past or present names such as brand 
name(s), or serial numbers.
    (12) Intervention Description means details that can be made public 
about the intervention, other than the Intervention Name(s) and Other 
Intervention Name(s), sufficient to distinguish the intervention from 
other, similar interventions studied in the same or another clinical 
trial. For example, interventions involving drugs may include dosage 
form, dosage, frequency, and duration.
    (13) Intervention Type means, for each intervention studied in the 
clinical trial, the general type of intervention, e.g., drug, 
biological/vaccine, or, device.
    (14) Device Product Not Approved or Cleared by U.S. FDA means that 
at least one device product studied in the clinical trial has not been 
previously approved or cleared by FDA for one or more uses.
    (15) Product Manufactured in and Exported from the U.S. means that 
any drug product (including a biological product) or device product 
studied in the clinical trial is manufactured in the United States or 
one of its territories and exported for study in a clinical trial in 
another country.
    (16) Study Start Date means the estimated date on which the clinical 
trial will be open for recruitment of human subjects, or the actual date 
on which the first human subject was enrolled.
    (17) Primary Completion Date means the estimated or actual primary 
completion date. If an estimated primary completion date is used, the 
responsible party must update the Primary Completion Date data element 
once the clinical trial has reached the primary completion date to 
reflect the actual primary completion date.
    (18) Enrollment means the estimated total number of human subjects 
to be enrolled (target number) or the actual total number of human 
subjects that are enrolled in the clinical trial. Once the trial has 
reached the primary completion date, the responsible party must update 
the Enrollment data element to reflect the actual number of human 
subjects enrolled in the clinical trial.
    (19) Primary Outcome Measure Information means a description of each 
primary outcome measure, to include the following information:
    (i) Name of the specific primary outcome measure;
    (ii) Description of the metric used to characterize the specific 
primary outcome measure; and
    (iii) Time point(s) at which the measurement is assessed for the 
specific metric used.
    (20) Secondary Outcome Measure Information means a description of 
each secondary outcome measure, to include the following information:
    (i) Name of the specific secondary outcome measure;
    (ii) Description of the metric used to characterize the specific 
secondary outcome measure; and
    (iii) Time point(s) at which the measurement is assessed for the 
specific metric used.
    (21) Eligibility Criteria means a limited list of criteria for 
selection of human subjects to participate in the clinical trial, 
provided in terms of inclusion and exclusion criteria and suitable for 
assisting potential human subjects in identifying clinical trials of 
interest.
    (22) Sex/Gender means the sex and, if applicable, gender of the 
human subjects who may participate in the clinical trial.
    (23) Age Limits means the minimum and maximum age of human subjects 
who may participate in the clinical trial, provided in relevant units of 
time.
    (24) Accepts Healthy Volunteers means that human subjects who do not 
have a disease or condition, or related conditions or symptoms, under 
study in the clinical trial are permitted to participate in the clinical 
trial.
    (25) Overall Recruitment Status means the recruitment status for the 
clinical trial as a whole, based on the status of the individual sites. 
If at least one facility in a multi-site clinical trial has

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an individual site status of ``recruiting,'' then the overall 
recruitment status for the trial must be ``recruiting.''
    (26) Why Study Stopped means, for a clinical trial that is suspended 
or terminated or withdrawn prior to its planned completion as 
anticipated by the protocol, a brief explanation of the reason(s) why 
the clinical trial was stopped.
    (27) Individual Site Status means the recruitment status of each 
participating facility in a clinical trial.
    (28) Availability of Expanded Access means, for an applicable drug 
clinical trial of a drug product (including a biological product) that 
is not an approved drug product (including a biological product), and 
for which the responsible party is both the manufacturer of the drug 
product (including a biological product) and the sponsor of the 
applicable clinical trial:
    (i) An indication of whether there is expanded access to the 
investigational drug product (including a biological product) under 
section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb) for those individuals who do not qualify for enrollment in the 
applicable clinical trial, under one or more of the following types of 
expanded access programs: for individual patients, including for 
emergency use, as specified in 21 CFR 312.310; for intermediate-size 
patient populations, as specified in 21 CFR 312.315; or under a 
treatment IND or treatment protocol, as specified in 21 CFR 312.320; and
    (ii) If expanded access is available under section 561 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb), the NCT number 
of the expanded access record.
    (29) Name of the Sponsor means the name of the entity or individual 
who is the sponsor of the clinical trial, as defined in this part.
    (30) Responsible Party, by Official Title means an:
    (i) Indication of whether the responsible party is the sponsor of 
the clinical trial, as that term is defined in 21 CFR 50.3; the sponsor-
investigator, as that term is defined in 21 CFR 50.3; or a principal 
investigator designated pursuant to this part; and
    (ii) Either:
    (A) The official name of the entity, if the responsible party is an 
entity; or
    (B) The official title and primary organizational affiliation of the 
individual, if the responsible party is an individual.
    (31) Facility Information means, for each participating facility in 
a clinical trial, the following information:
    (i) Facility Name, meaning the full name of the organization where 
the clinical trial is being conducted;
    (ii) Facility Location, including city, state, country and zip code 
for U.S. locations (including territories of the United States) and city 
and country for locations in other countries; and
    (iii) Either:
    (A) For each facility participating in a clinical trial, Facility 
Contact, including the name or title, telephone number, and email 
address of a person to whom questions concerning the trial and 
enrollment at that site can be addressed; or
    (B) Central Contact Person, including the name or title, toll-free 
telephone number, and email address of a person to whom questions 
concerning enrollment at any location of the trial can be addressed.
    (32) Unique Protocol Identification Number means any unique 
identifier assigned to the protocol by the sponsor.
    (33) Secondary ID means:
    (i) Any identifier(s) other than the organization's unique protocol 
identifier or NCT number that is assigned to the clinical trial, 
including any unique clinical trial identifiers assigned by other 
publicly available clinical trial registries. If the clinical trial is 
funded in whole or in part by a U.S. Federal Government agency, the 
complete grant or contract number must be submitted as a Secondary ID.
    (ii) A description of the type of Secondary ID.
    (34) U.S. Food and Drug Administration IND or IDE Number means an 
indication of whether there is an IND or IDE for the clinical trial and, 
if so, each of the following elements:
    (i) Name or abbreviation of the FDA center with whom the IND or IDE 
is filed;
    (ii) IND or IDE number assigned by the FDA center; and

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    (iii) For an IND, the IND serial number, as defined in 21 CFR 
312.23(e), if any, assigned to the clinical trial.
    (35) Human Subjects Protection Review Board Status means information 
to indicate whether a clinical trial has been reviewed and approved by a 
human subjects protection review board or whether such review is not 
required per applicable law (e.g., 21 CFR part 56, 45 CFR part 46, or 
other applicable regulation). Human Subjects Protection Review Board 
Status must be listed as ``approved'' if at least one human subjects 
protection review board has approved the clinical trial.
    (36) Record Verification Date means the date on which the 
responsible party last verified the clinical trial information in the 
entire ClinicalTrials.gov record for the clinical trial, even if no 
additional or updated information was submitted at that time.
    (37) Responsible Party Contact Information means administrative 
information to identify and allow communication with the responsible 
party by telephone, email, and regular mail or delivery service. 
Responsible Party Contact Information includes the name, official title, 
organizational affiliation, physical address, mailing address, phone 
number, and email address of the individual who is the responsible party 
or of a designated employee of the organization that is the responsible 
party.
    (38) Studies a U.S. FDA-regulated Device Product means that a 
clinical trial studies a device product subject to section 510(k), 515, 
or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 
21 U.S.C. 360e, 21 U.S.C. 360j(m)).
    (39) Studies a U.S. FDA-regulated Drug Product means a clinical 
trial studies a drug product (including a biological product) subject to 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
or section 351 of the Public Health Service Act (42 U.S.C. 262).
    (40) Post Prior to U.S. FDA Approval or Clearance means, for an 
applicable device clinical trial of a device product that has not been 
previously approved or cleared, the responsible party indicates to the 
Director that it is authorizing the Director, in accordance with 
Sec. 11.35(b)(2)(ii), to publicly post its clinical trial registration 
information, which would otherwise be subject to delayed posting, as 
specified in Sec. 11.35(b)(2)(i), prior to the date of FDA approval or 
clearance of its device product.
    (41) Study Completion Date means the estimated or actual study 
completion date. Once the clinical trial has reached the study 
completion date, the responsible party must update the Study Completion 
Date data element to reflect the actual study completion date in 
accordance with Sec. 11.64(a)(1)(ii)(J) .



                         Subpart B_Registration



Sec. 11.20  Who must submit clinical trial registration information?

    The responsible party for an applicable clinical trial specified in 
Sec. 11.22 must submit clinical trial registration information for that 
clinical trial.



Sec. 11.22  Which applicable clinical trials must be registered?

    (a) General specification. (1) Any applicable clinical trial that is 
initiated after September 27, 2007, must be registered.
    (2) Any applicable clinical trial that is initiated on or before 
September 27, 2007, and is ongoing on December 26, 2007, must be 
registered.
    (3) Determining the date of initiation for an applicable clinical 
trial. An applicable clinical trial, other than a pediatric postmarket 
surveillance of a device product that is not a clinical trial, is 
considered to be initiated on the date on which the first human subject 
is enrolled. A pediatric postmarket surveillance of a device product 
that is not a clinical trial is considered to be initiated on the date 
on which FDA approves the plan for conducting the surveillance.
    (b) Determination of applicable clinical trial for a clinical trial 
or study initiated on or after January 18, 2017. A clinical trial or 
study that, at any point in time, meets the conditions listed in 
paragraph (b)(1) or (2) of this section will be considered to meet the 
definition of an applicable clinical trial.
    (1) Applicable device clinical trial. A clinical trial or study that 
meets the conditions listed in either paragraph

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(b)(1)(i) or (ii) of this section is an applicable device clinical 
trial:
    (i) The study is a pediatric postmarket surveillance of a device 
product as required by FDA under section 522 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 3601).
    (ii) The study is a clinical trial with one or more arms that meets 
all of the following criteria:
    (A) Study Type is interventional;
    (B) Primary Purpose of the clinical trial is other than a 
feasibility study;
    (C) The clinical trial Studies a U.S. FDA-regulated Device Product; 
and
    (D) One or more of the following applies:
    (1) At least one Facility Location is within the United States or 
one of its territories,
    (2) A device product under investigation is a Product Manufactured 
in and Exported from the U.S. or one of its territories for study in 
another country, or
    (3) The clinical trial has a U.S. Food and Drug Administration IDE 
Number.
    (2) Applicable drug clinical trial. A clinical trial with one or 
more arms that meets the following conditions is an applicable drug 
clinical trial:
    (i) Study Type is interventional;
    (ii) Study Phase is other than phase 1;
    (iii) The clinical trial Studies a U.S. FDA-regulated Drug Product; 
and
    (iv) One or more of the following applies:
    (A) At least one Facility Location for the clinical trial is within 
the United States or one of its territories,
    (B) A drug product (including a biological product) under 
investigation is a Product Manufactured in and Exported from the U.S. or 
one of its territories for study in another country, or
    (C) The clinical trial has a U.S. Food and Drug Administration IND 
Number.



Sec. 11.24  When must clinical trial registration information be
submitted?

    (a) General. Except as provided in paragraph (b) of this section, 
the responsible party for an applicable clinical trial for which 
submission of clinical trial registration information is required must 
submit the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) or Sec. 11.28(a), as applicable, not later than 
December 26, 2007, or 21 calendar days after the first human subject is 
enrolled, whichever date is later.
    (b) Exceptions:. (1) The responsible party for an applicable 
clinical trial that is a clinical trial and for which the submission of 
clinical trial registration information is required and that is not for 
a serious or life-threatening disease or condition must submit clinical 
trial registration information as specified in section 402(j)(2)(A)(ii) 
of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or 
Sec. 11.28(a), as applicable, not later than September 27, 2008, or 21 
calendar days after the first human subject is enrolled, whichever date 
is later.
    (2) The responsible party for an applicable device clinical trial 
that is a pediatric postmarket surveillance of a device product and is 
not a clinical trial must submit clinical trial registration 
information, as specified in section 402(j)(2)(A)(ii) of the Public 
Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or Sec. 11.28(b), not 
later than December 26, 2007, or 21 calendar days after FDA approves the 
postmarket surveillance plan, whichever date is later.



Sec. 11.28  What constitutes clinical trial registration information?

    (a) For each applicable clinical trial that must be registered with 
ClinicalTrials.gov, other than a pediatric postmarket surveillance of a 
device product that is not a clinical trial, the responsible party must 
submit the following information:
    (1) For such applicable clinical trials that were initiated before 
January 18, 2017, the responsible party must submit the information 
specified in section 402(j)(2)(A)(ii) of the Public Health Service Act 
(42 U.S.C. 282(j)(2)(A)(ii)).
    (2) For such applicable clinical trials that are initiated on or 
after January 18, 2017, the responsible party must submit the data 
elements listed below:
    (i) Descriptive information:
    (A) Brief Title;
    (B) Official Title;
    (C) Brief Summary;
    (D) Primary Purpose;

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    (E) Study Design;
    (F) Study Phase, for an applicable drug clinical trial;
    (G) Study Type;
    (H) Pediatric Postmarket Surveillance of a Device Product, for an 
applicable device clinical trial that is a Pediatric Postmarket 
Surveillance of a Device Product;
    (I) Primary Disease or Condition Being Studied in the Trial, or the 
Focus of the Study;
    (J) Intervention Name(s), for each intervention studied;
    (K) Other Intervention Name(s), for each intervention studied;
    (L) Intervention Description, for each intervention studied;
    (M) Intervention Type, for each intervention studied;
    (N) Studies a U.S. FDA-regulated Device Product;
    (O) Studies a U.S. FDA-regulated Drug Product;
    (P) Device Product Not Approved or Cleared by U.S. FDA, if any 
studied intervention is a device product;
    (Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable 
device clinical trial that studies at least one device product not 
previously approved or cleared by the U.S. FDA;
    (R) Product Manufactured in and Exported from the U.S., if the entry 
for U.S. Food and Drug Administration IND or IDE Number in 
Sec. 11.28(a)(2)(iv)(C) indicates that there is no IND or IDE for the 
clinical trial, and the entry(ies) for Facility Information in 
Sec. 11.28(a)(2)(iii)(C) include no facility locations in the United 
States or its territories;
    (S) Study Start Date;
    (T) Primary Completion Date;
    (U) Study Completion Date;
    (V) Enrollment;
    (W) Primary Outcome Measure Information, for each primary outcome 
measure; and
    (X) Secondary Outcome Measure Information, for each secondary 
outcome measure.
    (ii) Recruitment information:
    (A) Eligibility Criteria;
    (B) Sex/Gender;
    (C) Age Limits;
    (D) Accepts Healthy Volunteers;
    (E) Overall Recruitment Status;
    (F) Why Study Stopped;
    (G) Individual Site Status; and
    (H) Availability of Expanded Access. If expanded access is available 
for an investigational drug product (including a biological product), an 
expanded access record must be submitted in accordance with 
Sec. 11.28(c), unless an expanded access record was submitted previously 
in accordance with that provision.
    (iii) Location and contact information:
    (A) Name of the Sponsor;
    (B) Responsible Party, by Official Title; and
    (C) Facility Information.
    (iv) Administrative data:
    (A) Unique Protocol Identification Number;
    (B) Secondary ID;
    (C) U.S. Food and Drug Administration IND or IDE Number;
    (D) Human Subjects Protection Review Board Status;
    (E) Record Verification Date; and
    (F) Responsible Party Contact Information.
    (b) Pediatric postmarket surveillance of a device product that is 
not a clinical trial. For each pediatric postmarket surveillance of a 
device product that is not a clinical trial, the responsible party must 
submit the following information:
    (1) For such applicable device clinical trials that were initiated 
before January 18, 2017, the responsible party must submit the 
information specified in section 402(j)(2)(A)(ii) of the Public Health 
Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
    (2) For such applicable device clinical trials that are initiated on 
or after January 18, 2017, the responsible party must submit the data 
elements listed below:
    (i) Descriptive information:
    (A) Brief Title. A short title of the pediatric postmarket 
surveillance of a device product in language intended for the lay 
public. If an acronym or abbreviation is used to publicly identify the 
surveillance, it must be provided.
    (B) Official Title. The title of the pediatric postmarket 
surveillance of a device product, corresponding to the title of the 
protocol or the FDA-approved plan for conducting the surveillance

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    (C) Brief Summary. A short description of the pediatric postmarket 
surveillance of a device product, including a brief statement of the 
hypothesis or objective, written in language intended for the lay 
public, and a general description of the surveillance design, including 
relevant population information
    (D) Study Type. The type of study being registered. In the case of a 
pediatric postmarket surveillance of a device product that is not a 
clinical trial, a study type of ``observational'' is required.
    (E) Pediatric Postmarket Surveillance of a Device Product. For a 
study that includes an FDA-regulated device product as an intervention 
and is a pediatric postmarket surveillance of a device product
    (F) Primary Disease or Condition Being Studied, or the Focus of the 
Study. The name(s) of the disease(s) or condition(s) being studied in 
the pediatric postmarket surveillance of a device product, or the focus 
of the surveillance study. Use, if available, appropriate descriptors 
fromNLM's MeSH-controlled vocabulary thesaurus or terms from another 
vocabulary, such as the SNOMED CT, that has been mapped to MeSH within 
the UMLS Metathesaurus.
    (G) Intervention Name(s). A brief descriptive name used to refer to 
each intervention studied in the pediatric postmarket surveillance of a 
device product. A non-proprietary name of the intervention must be used, 
if available. If a non-proprietary name is not available, a brief 
descriptive name or identifier must be used.
    (H) Other Intervention Name(s). Any other current and former name(s) 
or alias(es), different from the Intervention Name(s), that the sponsor 
has used publicly to identify the intervention(s), including, but not 
limited to, past or present names such as brand name(s), or serial 
numbers
    (I) Intervention Description. Details that can be made public about 
each intervention, other than the Intervention Name(s) and Other 
Intervention Name(s), sufficient to distinguish the intervention from 
other, similar interventions studied in the same or another clinical 
trial or pediatric postmarket surveillance of a device product that is 
not a clinical trial
    (J) Intervention Type. For each intervention studied in the 
pediatric postmarket surveillance of a device product, the general type 
of intervention
    (K) Study Start Date. The date on which FDA approves the pediatric 
postmarket surveillance plan, as specified in 21 CFR 822.19(a).
    (L) Primary Completion Date. The estimated or actual date on which 
the final report of the pediatric postmarket surveillance of a device 
product is expected to be submitted to FDA. Once the final report has 
been submitted, this is the actual date on which the final report is 
submitted to FDA.
    (ii) Location and contact information:
    (A) Name of the Sponsor.
    (B) Responsible Party, by Official Title:
    (1) If the responsible party is an entity, the official name of the 
entity; or
    (2) If the responsible party is an individual, the official title 
and primary organizational affiliation of the individual.
    (C) Contact Information. The name or official title, toll-free 
telephone number, and email address of a person to whom questions 
concerning the pediatric postmarket surveillance of a device product can 
be addressed.
    (iii) Administrative data:
    (A) Unique Protocol Identification Number. The unique identifier 
assigned to the pediatric postmarket surveillance of a device product by 
the sponsor, if any.
    (B) Secondary ID: (1) Identifier(s) other than the organization's 
unique protocol identifier or NCT number that is assigned to the 
pediatric postmarket surveillance of a device product, if any, including 
any unique identifiers assigned by other publicly available clinical 
study registries. If the pediatric postmarket surveillance of a device 
product is funded in whole or in part by a U.S. Federal Government 
agency, the complete grant or contract number must be submitted as a 
Secondary ID.
    (2) For each secondary ID listed, a description of the type of 
secondary ID.
    (C) Human Subjects Protection Review Board Status. Information to 
indicate

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whether a pediatric postmarket surveillance of a device product has been 
reviewed and approved by a human subjects protection review board or 
whether such review is not required per applicable law (e.g., 21 CFR 
part 56, 45 CFR part 46, or other applicable regulation). Human Subjects 
Protection Review Board Status must be listed as ``approved'' if at 
least one human subjects protection review board has approved the 
pediatric postmarket surveillance.
    (D) Record Verification Date. The date on which the responsible 
party last verified the clinical trial information in the entire 
ClinicalTrials.gov record for the pediatric postmarket surveillance of a 
device product, even if no additional or updated information was 
submitted at that time
    (E) Responsible Party Contact Information. Administrative 
information sufficient to identify and allow communication with the 
responsible party by telephone, email, and regular mail or delivery 
service. Responsible Party Contact Information includes the name, 
official title, organizational affiliation, physical address, mailing 
address, phone number, and email address of the individual who is the 
responsible party or of a designated employee of the organization that 
is the responsible party.
    (c) Expanded access record. If expanded access is available, as 
specified in 21 CFR 312.315 (for an intermediate-size patient 
population) or 21 CFR 312.320 (under a treatment IND or treatment 
protocol), for an investigational drug product (including a biological 
product) studied in an applicable drug clinical trial, and the data 
elements set forth in paragraphs (c)(1) through (4) of this section have 
not been submitted in an expanded access record for that investigational 
product, the responsible party, if both the manufacturer of the 
investigational product and the sponsor of the applicable clinical 
trial, must submit the clinical trial information specified in 
paragraphs (c)(1) through (4) of this section to ClinicalTrials.gov in 
the form of an expanded access record. If expanded access is available 
only as specified in 21 CFR 312.310 (for individual patients, including 
for emergency use) for an investigational drug product (including a 
biological product) studied in an applicable drug clinical trial, and 
the data elements set forth in paragraphs (c)(1)(i), (iii), (iv), (vi), 
(ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv), and (v) of this 
section have not been submitted in an expanded access record for that 
investigational product, the responsible party, if both the manufacturer 
of the investigational product and the sponsor of the applicable 
clinical trial, must submit the clinical trial information specified in 
those paragraphs to ClinicalTrials.gov in the form of an expanded access 
record.
    (1) Descriptive information:
    (i) Brief Title. A short title identifying the expanded access, 
written in language intended for the lay public. If an acronym or 
abbreviation is used publicly to identify the expanded access, it must 
be provided.
    (ii) Official Title. The title, if any, of the expanded access 
program corresponding to the title that has been submitted to FDA for 
that program
    (iii) Brief Summary. A short description of the availability of 
expanded access, including the procedure for requesting the 
investigational drug product (including a biological product).
    (iv) Study Type. The nature of the investigation or investigational 
use for which clinical trial information is being submitted, i.e., 
``expanded access''.
    (v) Primary Disease or Condition. The name(s) of the disease(s) or 
condition(s) for which expanded access to the investigational drug 
product (including a biological product) is available. Use, if 
available, appropriate descriptors from NLM's MeSH-controlled vocabulary 
thesaurus, or terms from another vocabulary, such as the SNOMED CT, that 
has been mapped to MeSH within the UMLS Metathesaurus.
    (vi) Intervention Name(s). A brief descriptive name used to refer to 
the investigational drug product (including a biological product) that 
is available through expanded access. A non-proprietary name of the 
intervention must be used, if available. If a non-proprietary name is 
not available, a brief descriptive name or identifier must be used.

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    (vii) Other Intervention Name(s). Any other current and former 
name(s) or alias(es), different from the Intervention Name(s), that the 
sponsor has used publicly to identify the intervention, including, but 
not limited to, past or present names such as brand name(s), or serial 
numbers.
    (viii) Intervention Description. Details that can be made public 
about each intervention, other than the Intervention Name(s) or Other 
Intervention Name(s), sufficient to distinguish the intervention from 
other, similar interventions that are available through expanded access 
or in clinical trials.
    (ix) Intervention Type. For each investigational drug product 
(including a biological product) for which expanded access is available, 
the general type of intervention, e.g., drug.
    (x) Expanded Access Type. The type(s) of expanded access for which 
the investigational drug product (including a biological product) is 
available, as specified in Sec. 11.10(b)(28).
    (2) Recruitment information:
    (i) Eligibility Criteria. A limited list of criteria for determining 
who is eligible to receive the investigational drug product (including a 
biological product) through expanded access, provided in terms of 
inclusion and exclusion criteria and suitable for assisting potential 
patients in identifying investigational drug products (including 
biological products) of interest for which expanded access is available.
    (ii) Sex/Gender. The sex and gender (if applicable) of the patients 
for whom expanded access is available.
    (iii) Age Limits. The minimum and maximum age of patients for whom 
expanded access is available, provided in relevant units of time.
    (iv) Expanded Access Status. The status of availability of the 
investigational drug product (including a biological product) through 
expanded access.
    (3) Contact information:
    (i) Name of the Sponsor.
    (ii) Responsible Party, by Official Title. The official name of the 
entity.
    (iii) Contact Information. The name or official title, toll-free 
telephone number, and email address of a person to whom questions 
concerning expanded access can be addressed.
    (4) Administrative data:
    (i) Unique Protocol Identification Number. Any unique identifier 
assigned by the sponsor to refer to the availability of its 
investigational drug product (including a biological product) for 
expanded access use or to identify the expanded access record.
    (ii) Secondary ID: (A) Any identifier(s) other than the Unique 
Protocol Identification Number or the NCT number that is assigned to the 
expanded access record, including any unique identifiers assigned by 
other publicly available clinical trial or expanded access registries.
    (B) For each Secondary ID listed, a description of the type of 
Secondary ID.
    (iii) U.S. Food and Drug Administration IND Number. An indication of 
whether there is an IND and, if so, each of the following elements:
    (A) Name or abbreviation of the FDA center with whom the IND is 
filed (i.e., CDER or CBER), if applicable;
    (B) IND number (assigned by the FDA center) under which the 
investigational drug product (including a biological product) is being 
made available for expanded access, if applicable; and
    (C) IND serial number. as defined in 21 CFR 312.23(e), if any, 
assigned to the expanded access.
    (iv) Record Verification Date. The date on which the responsible 
party last verified the information in the expanded access record, even 
if no additional or updated information was submitted at that time.
    (v) Responsible Party Contact Information. Administrative 
information sufficient to identify and allow communication with the 
responsible party entering the clinical trial information into the 
expanded access record by telephone, email, and regular mail or delivery 
service. Responsible Party Contact Information includes the name, 
official title, organizational affiliation, physical address, mailing 
address, phone number, and email address of the individual who is the 
responsible party or of a designated employee of the organization that 
is the responsible party.

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Sec. 11.35  By when will the NIH Director post clinical trial
registration information submitted under Sec. 11.28?

    (a) Applicable drug clinical trial. The Director will post publicly 
on ClinicalTrials.gov the clinical trial registration information, 
except for certain administrative data, for an applicable drug clinical 
trial not later than 30 calendar days after the responsible party has 
submitted such information, as specified in Sec. 11.24.
    (b) Applicable device clinical trial. (1) For an applicable device 
clinical trial of a device product that was previously approved or 
cleared, the Director will post publicly on ClinicalTrials.gov the 
clinical trial registration information, except for certain 
administrative data, as soon as practicable, but not later than 30 
calendar days after clinical trial results information is required to be 
posted, as specified in Sec. 11.52.
    (2) For an applicable device clinical trial of a device product that 
has not been previously approved or cleared:
    (i) The Director will post publicly on ClinicalTrials.gov the 
clinical trial registration information, except for certain 
administrative data, not earlier than the date of FDA approval or 
clearance of the device product and not later than 30 calendar days 
after the date of such approval or clearance, except as otherwise 
provided in paragraph (b)(2)(ii) of this section.
    (ii) If, prior to the date of approval or clearance of the device 
product, the responsible party for an applicable clinical trial that is 
initiated on or after January 18, 2017, indicates to the Director, by 
submitting the Post Prior to U.S. FDA Approval or Clearance data element 
under Sec. 11.28(a)(2)(i)(Q), that it is authorizing the Director to 
publicly post its clinical trial registration information, which would 
otherwise be subject to delayed posting as specified in paragraph 
(b)(2)(i) of this section, prior to the date of FDA approval or 
clearance of its device product, the Director will publicly post the 
registration information, except for certain administrative data, as 
soon as practicable.



                Subpart C_Results Information Submission



Sec. 11.40  Who must submit clinical trial results information?

    The responsible party for an applicable clinical trial specified in 
Sec. 11.42 must submit clinical trial results information for that 
clinical trial.



Sec. 11.42  For which applicable clinical trials must clinical trial
results information be submitted?

    (a) Applicable clinical trials for which the studied product is 
approved, licensed, or cleared by FDA. Unless a waiver of the 
requirement to submit clinical trial results information is granted in 
accordance with Sec. 11.54, clinical trial results information must be 
submitted for any applicable clinical trial for which the studied 
product is approved, licensed, or cleared by FDA for which submission of 
clinical trial registration information is required in accordance with 
the following:
    (1) If the primary completion date is before January 18, 2017, the 
responsible party must submit the clinical trial results information 
specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health 
Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)); or
    (2) If the primary completion date is on or after January 18, 2017, 
the responsible party must submit the clinical trial results information 
specified in Sec. 11.48.
    (b) Applicable clinical trials for which the studied product is not 
approved, licensed, or cleared by FDA. Unless a waiver of the 
requirement to submit clinical trial results information is granted in 
accordance with Sec. 11.54, clinical trial results information specified 
in Sec. 11.48 must be submitted for any applicable clinical trial with a 
primary completion date on or after January 18, 2017 for which clinical 
trial registration information is required to be submitted and for which 
the studied product is not approved, licensed, or cleared by FDA.

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Sec. 11.44  When must clinical trial results information be submitted
for applicable clinical trials subject to Sec. 11.42?

    (a) Standard submission deadline. In general, for applicable 
clinical trials subject to Sec. 11.42, clinical trial results 
information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the 
Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 
282(j)(3)(I)) or in Sec. 11.48, as applicable, must be submitted no 
later than 1 year after the primary completion date of the applicable 
clinical trial.
    (b) Delayed submission of results information with certification if 
seeking approval, licensure, or clearance of a new use--(1) General 
requirements. If, prior to the results information submission deadline 
specified under paragraph (a) of this section, the responsible party 
submits a certification that an applicable clinical trial involves an 
FDA-regulated drug product (including a biological product) or device 
product that previously has been approved, licensed, or cleared, for 
which the manufacturer is the sponsor of the applicable clinical trial 
and for which an application or premarket notification seeking approval, 
licensure, or clearance of the use being studied (which is not included 
in the labeling of the approved, licensed, or cleared drug product 
(including a biological product) or device product) has been filed or 
will be filed within 1 year with FDA, the deadline for submitting 
clinical trial results information, as specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or Sec. 11.48, as 
applicable, will be 30 calendar days after the earliest of the following 
events:
    (i) FDA approves, licenses, or clears the drug product (including a 
biological product) or device product for the use studied in the 
applicable clinical trial;
    (ii) FDA issues a letter that ends the regulatory review cycle for 
the application or submission but does not approve, license, or clear 
the drug product (including a biological product) or device product for 
the use studied in the applicable clinical trial; or
    (iii) The application or premarket notification seeking approval, 
licensure, or clearance of the new use is withdrawn without resubmission 
for not less than 210 calendar days.
    (2) Two-year limitation. Notwithstanding the deadlines specified in 
paragraph (b)(1) of this section, the responsible party must submit 
clinical trial results information specified in paragraph (b)(1) of this 
section not later than the date that is 2 years after the date that the 
certification was submitted, except to the extent that paragraph (d) of 
this section applies.
    (3) Additional requirements. If a responsible party who is both the 
manufacturer of the drug product (including a biological product) or 
device product studied in an applicable clinical trial and the sponsor 
of the applicable clinical trial submits a certification in accordance 
with paragraph (b)(1) of this section, that responsible party must 
submit such a certification for each applicable clinical trial that 
meets the following criteria:
    (i) The applicable clinical trial is required to be submitted in an 
application or premarket notification seeking approval, licensure, or 
clearance of a new use; and
    (ii) The applicable clinical trial studies the same drug product 
(including a biological product) or device product for the same use as 
studied in the applicable clinical trial for which the initial 
certification was submitted.
    (c) Delayed submission of results with certification if seeking 
initial approval, licensure, or clearance.--(1) General requirements. 
If, prior to the submission deadline specified under paragraph (a) of 
this section, a responsible party submits a certification that an 
applicable clinical trial studies an FDA-regulated drug product 
(including a biological product) or device product that was not 
approved, licensed, or cleared by FDA for any use before the primary 
completion date of the trial, and that the sponsor intends to continue 
with product development and is either seeking, or may at a future date 
seek, FDA approval, licensure, or clearance of the drug product 
(including a biological product) or device product under study, the 
deadline for submitting clinical trial results information, as specified

[[Page 149]]

in Sec. 11.48, will be 30 calendar days after the earlier of the date on 
which:
    (i) FDA approves, licenses, or clears the drug product (including a 
biological product) or device product for any use that is studied in the 
applicable clinical trial; or
    (ii) The marketing application or premarket notification is 
withdrawn without resubmission for not less than 210 calendar days.
    (2) Two-year limitation. Notwithstanding the deadlines established 
in paragraph (c)(1) of this section, the responsible party must submit 
clinical trial results information specified in paragraph (c)(1) of this 
section not later than 2 years after the date on which the certification 
was submitted, except to the extent that paragraph (d) of this section 
applies.
    (d) Submitting partial results information. (1) If clinical trial 
results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) 
of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 
282(j)(3)(I)) or Sec. 11.48, as applicable, has not been collected for a 
secondary outcome measure(s) or additional adverse event information by 
the primary completion date, the responsible party must submit the 
remaining required clinical trial results information for secondary 
outcome measure(s) or additional adverse event information for that 
clinical trial by the following deadlines:
    (i) For secondary outcome measure(s), by the later of:
    (A) One year after the date on which the final subject is examined 
or receives an intervention for the purposes of final collection of data 
for that secondary outcome measure, whether the clinical trial was 
concluded according to the pre-specified protocol or was terminated; or
    (B) If a certification to delay results information submission has 
been submitted under paragraph (b) or (c) of this section, the date on 
which results information for the primary outcome measures is due 
pursuant to paragraph (b) or (c) of this section.
    (ii) For additional adverse event information, by the later of:
    (A) One year after the date of data collection for additional 
adverse event information, whether the clinical trial was concluded 
according to the pre-specified protocol or was terminated; or
    (B) If a certification to delay results information submission has 
been submitted under paragraph (b) or (c) of this section, the date on 
which results information for the primary outcome measures is due 
pursuant to paragraph (b) or (c) of this section.
    (2) Except, if clinical trial results information was submitted for 
the primary outcome measure(s) prior to the effective date of these 
regulations but data collection for all of the secondary outcome 
measure(s) or additional adverse event information is not completed 
until on or after January 18, 2017, clinical trial results information 
for all primary and secondary outcome measures and adverse event 
information for the clinical trial must be submitted as specified in 
sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act 
(42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
    (3) For each submission of partial results information for a 
clinical trial, as specified in paragraph (d)(1) of this section:
    (i) If any amendments were made to the protocol and/or statistical 
analysis plan as described in Sec. 11.48(a)(5) since the previous 
submission of partial results information, the responsible party must 
submit a copy of the revised protocol and/or statistical analysis plan; 
and
    (ii) If information about certain agreements as described in 
Sec. 11.48(a)(6)(ii) has changed since the previous submission of 
partial results information, the responsible party must submit 
information to reflect the new status of certain agreements between the 
principal investigator and the sponsor.
    (e) Extensions for good cause. (1) A responsible party may request 
an extension of the deadline for submitting clinical trial results 
information subject to paragraphs (e)(1)(i) and (ii) of this section or 
section 402(j)(3)(E)(vi) of the Public Health Service Act (42 U.S.C. 
282(j)(3)(E)(vi)), as applicable, and may request more than one 
extension for the same applicable clinical trial.

[[Page 150]]

    (i) The responsible party must submit a request for an extension to 
ClinicalTrials.gov prior to the date on which clinical trial results 
information would otherwise be due in accordance with paragraph (a), 
(b), (c), (d), (e), or (f) of this section.
    (ii) A request for an extension must contain the following:
    (A) Description of the reason(s) why clinical trial results 
information cannot be provided according to the deadline, with 
sufficient detail to allow for the evaluation of the request; and
    (B) Estimate of the date on which the clinical trial results 
information will be submitted.
    (2) Decision and submission deadline. The Director will provide a 
response electronically to the responsible party indicating whether the 
requested extension demonstrates good cause and has been granted.
    (i) If the extension request is granted, the responsible party must 
submit clinical trial results information not later than the date of the 
deadline specified in the electronic response.
    (ii) If the extension request is denied, the responsible party must 
either appeal in accordance with paragraph (e)(3) of this section or 
submit clinical trial results information specified in Sec. 11.48 by the 
later of the submission deadline specified in paragraph (a), (b), (c), 
(d), (e), or (f) of this section, as applicable, or 30 calendar days 
after the date on which the electronic notice of the denial is sent to 
the responsible party.
    (3) Appealing a denied extension request. (i) A responsible party 
who seeks to appeal a denied extension request or the deadline specified 
in a granted extension must submit an appeal to the Director in the 
format specified at https://prsinfo.clinicaltrials.gov/ not later than 
30 calendar days after the date on which the electronic notification of 
the granting or denial of the request is sent to the responsible party.
    (ii) An appeal must contain an explanation of the reason(s) why the 
initial decision to deny the extension request or to grant the extension 
request with a shorter deadline than requested should be overturned or 
revised, with sufficient detail to allow for the evaluation of the 
appeal.
    (iii) The Director will provide an electronic notification to the 
responsible party indicating whether the requested extension has been 
granted upon appeal.
    (iv) If the Director grants the extension request upon appeal, the 
responsible party must submit clinical trial results information not 
later than the deadline specified in the electronic notification 
specified in paragraph (e)(3)(iii) of this section.
    (v) If the Director denies the appeal of a denied extension request, 
the responsible party must submit clinical trial results information by 
the later of the deadline specified in paragraph (a), (b), (c), (d), 
(e), or (f) of this section, or 30 calendar days after the electronic 
notification of the denial of the appeal, specified in paragraph 
(e)(3)(iii) of this section, is sent to the responsible party.
    (vi) If the Director denies an appeal of a denied deadline specified 
in a granted extension request, the responsible party must submit 
clinical trial results information by the later of the deadline 
specified in the notification granting the extension request, specified 
in paragraph (e)(2)(i) of this section, or 30 calendar days after the 
electronic notification denying the appeal, specified in paragraph 
(e)(3)(iii) of this section, is sent to the responsible party.
    (f) Pediatric postmarket surveillance of a device product that is 
not a clinical trial. For each pediatric postmarket surveillance of a 
device product that is not a clinical trial as defined in this part, the 
responsible party must submit clinical trial results information as 
specified in Sec. 11.48(b) or section 402(j)(C)(3) of the Public Health 
Service Act (42 U.S.C. 282(j)(C)(3)), as applicable, not later than 30 
calendar days after the date on which the final report of the approved 
pediatric postmarket surveillance of a device product, as specified in 
21 CFR 822.38, is submitted to FDA.



Sec. 11.48  What constitutes clinical trial results information?

    (a) For each applicable clinical trial, other than a pediatric 
postmarket surveillance of a device product that is not a clinical 
trial, for which clinical

[[Page 151]]

trial results information must be submitted under Sec. 11.42, the 
responsible party must provide the following:
    (1) Participant flow. Information for completing a table documenting 
the progress of human subjects through a clinical trial, by arm, 
including the number who started and completed the clinical trial. This 
information must include the following elements:
    (i) Participant Flow Arm Information. A brief description of each 
arm used for describing the flow of human subjects through the clinical 
trial, including a descriptive title used to identify each arm;
    (ii) Pre-assignment Information. A description of significant events 
in the clinical trial that occur after enrollment and prior to 
assignment of human subjects to an arm, if any; and
    (iii) Participant Data. The number of human subjects that started 
and completed the clinical trial, by arm. If assignment is based on a 
unit other than participants, also include a description of the unit of 
assignment and the number of units that started and completed the 
clinical trial, by arm.
    (2) Demographic and baseline characteristics. Information for 
completing a table of demographic and baseline measures and data 
collected by arm or comparison group and for the entire population of 
human subjects who participated in the clinical trial. This information 
must include the following elements:
    (i) Baseline Characteristics Arm/Group Information. A brief 
description of each arm or comparison group used for describing the 
demographic and baseline characteristics of the human subjects in the 
clinical trial, including a descriptive title used to identify each arm 
or comparison group.
    (ii) Baseline Analysis Population Information--(A) Overall Number of 
Baseline Participants. The total number of human subjects for whom 
baseline characteristics were measured, by arm or comparison group and 
overall.
    (B) Overall Number of Units Analyzed. If the analysis is based on a 
unit other than participants, a description of the unit of analysis and 
the number of units for which baseline measures were measured and 
analyzed, by arm or comparison group and overall.
    (C) Analysis Population Description. If the Overall Number of 
Baseline Participants (or units) differs from the number of human 
subjects (or units) assigned to the arm or comparison group and overall, 
a brief description of the reason(s) for the difference.
    (iii) Baseline Measure Information. A description of each baseline 
or demographic characteristic measured in the clinical trial, including 
age, sex/gender, race, ethnicity (if collected under the protocol), and 
any other measure(s) that were assessed at baseline and are used in the 
analysis of the primary outcome measure(s) in accordance with 
Sec. 11.48(a)(3). The description of each measure must include the 
following elements:
    (A) Name and description of the measure, including any categories 
that are used to submit Baseline Measure Data.
    (B) Measure Type and Measure of Dispersion: For each baseline 
measure submitted, an indication of the type of data to be submitted and 
the associated measure of dispersion.
    (C) Unit of Measure. For each baseline measure for which data are 
collected, the unit of measure.
    (iv) Baseline Measure Data. The value(s) for each submitted baseline 
measure, by arm or comparison group and for the entire population of 
human subjects for whom baseline characteristics were measured.
    (v) Number of baseline participants (and units), by arm or 
comparison group and overall, if different from the Overall Number of 
Baseline Participants or Overall Number of Units Analyzed in 
Sec. 11.48(a)(2)(ii)(A) and (B), respectively.
    (3) Outcomes and statistical analyses. Information for completing a 
table of data for each primary and secondary outcome measure by arm or 
comparison group, including the result(s) of scientifically appropriate 
statistical analyses that were performed on the outcome measure data, if 
any. This information must include the following elements:
    (i) Outcome Measure Arm/Group Information. A brief description of 
each arm or comparison group used for submitting an outcome measure for 
the clinical trial, including a descriptive title

[[Page 152]]

to identify each arm or comparison group.
    (ii) Analysis Population Information--(A) Number of Participants 
Analyzed. The number of human subjects for whom an outcome was measured 
and analyzed, by arm or comparison group.
    (B) Number of Units Analyzed. If the analysis is based on a unit 
other than participants, a description of the unit of analysis and the 
number of units for which an outcome was measured and analyzed, by arm 
or comparison group.
    (C) Analysis Population Description. If the Number of Participants 
Analyzed or Number of Units Analyzed differs from the number of human 
subjects or units assigned to the arm or comparison group, a brief 
description of the reason(s) for the difference.
    (iii) Outcome Measure Information. A description of each outcome 
measure, to include the following elements:
    (A) Name of the specific outcome measure, including the titles of 
any categories in which Outcome Measure Data in Sec. 11.48(a)(3)(iv) are 
aggregated.
    (B) Description of the metric used to characterize the specific 
outcome measure.
    (C) Time point(s) at which the measurement was assessed for the 
specific metric.
    (D) Outcome Measure Type. The type of outcome measure, whether 
primary, secondary, other pre-specified, or post-hoc.
    (E) Measure Type and Measure of Dispersion or Precision. For each 
outcome measure for which data are collected, the type of data submitted 
and the measure of dispersion or precision.
    (F) Unit of Measure. For each outcome measure for which data are 
collected, the unit of measure.
    (iv) Outcome Measure Data. The measurement value(s) for each outcome 
measure for which data are collected, by arm or comparison group and by 
category (if specified).
    (v) Statistical Analyses. Result(s) of scientifically appropriate 
tests of the statistical significance of the primary and secondary 
outcome measures, if any.
    (A) A statistical analysis is required to be submitted if it is:
    (1) Pre-specified in the protocol and/or statistical analysis plan 
and was performed on the outcome measure data,
    (2) Made public by the sponsor or responsible party prior to the 
date on which clinical trial results information is submitted for the 
primary outcome measures(s) studied in the clinical trial to which the 
statistical analysis applies, or
    (3) Conducted on a primary outcome measure in response to a request 
made by FDA prior to the date on which clinical trial results 
information is submitted for the primary outcome measure(s) studied in 
the clinical trial to which the statistical analysis applies.
    (B) Information for each statistical analysis specified in paragraph 
(a)(3)(v)(A) of this section must include the following elements:
    (1) Statistical Analysis Overview: Identification of the arms or 
comparison groups compared in the statistical analysis; the type of 
statistical test conducted; and, for a non-inferiority or equivalence 
test, a description of the analysis that includes, at minimum, the power 
calculation and non-inferiority or equivalence margin.
    (2) One of the following, as applicable:
    (i) Statistical Test of Hypothesis: The p-value and the procedure 
used for the statistical analysis; or
    (ii) Method of Estimation: The estimation parameter, estimated 
value, and confidence interval (if calculated).
    (4) Adverse event information. (i) Information to describe the 
methods for collecting adverse events during an applicable clinical 
trial:
    (A) Time Frame. The specific period of time over which adverse event 
information was collected and for which information is submitted in 
paragraph (a)(4)(iii) of this section.
    (B) Adverse Event Reporting Description. If the adverse event 
information collected in the clinical trial is collected based on a 
different definition of adverse event and/or serious adverse event than 
defined in this part, a brief description of how those definitions 
differ.
    (C) Collection Approach. The type of approach taken to collect 
adverse event information, whether systematic or non-systematic.

[[Page 153]]

    (ii) Information for completing three tables summarizing anticipated 
and unanticipated adverse events collected during an applicable clinical 
trial:
    (A) Table of all serious adverse events grouped by organ system, 
with the number and frequency of each event by arm or comparison group;
    (B) Table of all adverse events, other than serious adverse events, 
that exceed a frequency of 5 percent within any arm of the clinical 
trial, grouped by organ system, with the number and frequency of each 
event by arm or comparison group; and
    (C) Table of all-cause mortality, with the number and frequency of 
deaths due to any cause by arm or comparison group.
    (iii) Information for each table specified in paragraph (a)(4)(ii) 
of this section must include the following elements, unless otherwise 
specified:
    (A) Adverse Event Arm/Group Information. A brief description of each 
arm or comparison group used for submitting adverse event information 
from the clinical trial, including a descriptive title used to identify 
each arm or comparison group.
    (B) Total Number Affected. The overall number of human subjects 
affected, by arm or comparison group, by:
    (1) Serious adverse event(s);
    (2) Adverse event(s) other than serious adverse events that exceed a 
frequency of 5 percent within any arm of the clinical trial; and
    (3) Deaths due to any cause.
    (C) Total Number at Risk. The overall number of human subjects 
included in the assessment, by arm or comparison group, for:
    (1) Serious adverse events;
    (2) Adverse event(s) other than serious adverse events that exceed a 
frequency of 5 percent within any arm of the clinical trial; or
    (3) Deaths due to any cause.
    (D) Adverse Event Information. For the two tables described in 
paragraphs (a)(4)(ii)(A) and (B) of this section, a description of each 
type of serious adverse event and other adverse event that is not a 
serious adverse event and exceeds a frequency of 5 percent within any 
arm of the clinical trial, consisting of the following attributes:
    (1) Descriptive term for the adverse event; and
    (2) Organ system associated with the adverse event.
    (E) Adverse Event Data. For the two tables described in paragraphs 
(a)(4)(ii)(A) and (B) of this section and for each adverse event listed 
in accordance with paragraph (a)(4)(iii)(D) of this section:
    (1) Number of human subjects affected by such adverse event.
    (2) Number of human subjects at risk for such adverse event.
    (5) Protocol and statistical analysis plan. A copy of the protocol 
and the statistical analysis plan (if not included in the protocol), 
including all amendments that have been approved by a human subjects 
protection review board (if applicable) before the time of submission 
under this subsection and that apply to all clinical trial Facility 
Locations. The responsible party must include the Official Title (as 
defined in Sec. 11.10(b)(2)), NCT number (as defined in Sec. 11.10(a)) 
(if available), and date of the protocol and the statistical analysis 
plan on the cover page of each document. The responsible party may 
redact names, addresses, and other personally identifiable information, 
as well as any trade secret and/or confidential commercial information 
(as those terms are defined in the Freedom of Information Act (5 U.S.C. 
552) and the Trade Secrets Act (18 U.S.C. 1905)) contained in the 
protocol or statistical analysis plan prior to submission, unless such 
information is otherwise required to be submitted under this part. The 
protocol and statistical analysis plan must be submitted in a common 
electronic document format specified at https://
prsinfo.clinicaltrials.gov.
    (6) Administrative information--(i) Results Point of Contact. Point 
of contact for scientific information about the clinical trial results 
information, including the following:
    (A) Name or official title of the point of contact
    (B) Name of the affiliated organization, and
    (C) Telephone number and email address of the point of contact.
    (ii) Certain Agreements. An indication of whether the principal 
investigator is an employee of the sponsor and, if not,

[[Page 154]]

whether there exists any agreement (other than an agreement solely to 
comply with applicable provisions of law protecting the privacy of human 
subjects participating in the clinical trial) between the sponsor or its 
agent and the principal investigator that restricts in any manner the 
ability of the principal investigator, after the primary completion date 
of the clinical trial, to discuss the results of the clinical trial at a 
scientific meeting or any other public or private forum or to publish in 
a scientific or academic journal information concerning the results of 
the clinical trial
    (7) Additional clinical trial results information for applicable 
device clinical trials of unapproved or uncleared device products. (i) 
For an applicable device clinical trial of an unapproved or uncleared 
device product and for which clinical trial registration information has 
not been posted publicly on Clinical Trials.gov by the Director in 
accordance with Sec. 11.35(b)(2)(i), the responsible party must provide 
the following data elements, as the data elements are defined in 
Sec. 11.10(b): Brief Title; Official Title; Brief Summary; Primary 
Purpose; Study Design; Study Type; Primary Disease or Condition Being 
Studied in the Trial, or the Focus of the Study; Intervention Name(s); 
Other Intervention Name(s); Intervention Description; Intervention Type; 
Device Product Not Approved or Cleared by U.S. FDA, if any studied 
intervention is a device product; Study Start Date; Primary Completion 
Date; Study Completion Date, Enrollment; Primary Outcome Measure 
Information; Secondary Outcome Measure Information; Eligibility 
Criteria; Sex/Gender; Age Limits; Accepts Healthy Volunteers; Overall 
Recruitment Status; Why Study Stopped; Name of the Sponsor; Responsible 
Party, by Official Title; Facility Name and Facility Location, for each 
participating facility in a clinical trial; Unique Protocol 
Identification Number; Secondary ID; Human Subjects Protection Review 
Board Status; and Record Verification Date.
    (ii) The responsible party shall submit all the results information 
specified in paragraph (a)(7)(i) and must submit an affirmation that any 
information previously submitted to ClinicalTrials.gov for the data 
elements listed in paragraph (a)(7)(i) of this section have been updated 
in accordance with Sec. 11.64(a) and are to be included as clinical 
trial results information.
    (b) Pediatric postmarket surveillance of a device product that is 
not a clinical trial. For each pediatric postmarket surveillance of a 
device product that is not a clinical trial, the responsible party must 
submit a copy of any final report that is submitted to FDA as specified 
in 21 CFR 822.38. The responsible party may redact names, addresses, and 
other personally identifiable information or commercial confidential 
information contained in the final report prior to submission to NIH, 
unless such information is otherwise required to be submitted under this 
part. The final report must be in a common electronic document format 
specified at https://prsinfo.clinicaltrials.gov.



Sec. 11.52  By when will the NIH Director post submitted clinical
trial results information?

    Except for clinical trial results information submitted under 
section 402(j)(4)(A) of the PHS Act and Sec. 11.60, the Director will 
post publicly clinical trial results information on ClinicalTrials.gov 
not later than 30 calendar days after the date of submission.



Sec. 11.54  What are the procedures for requesting and obtaining 
a waiver of the requirements for clinical trial results information 
submission?

    (a) Waiver request. (1) A responsible party for an applicable 
clinical trial with a primary completion date on or after January 18, 
2017 may request a waiver from any applicable requirement(s) of this 
subpart C by submitting a waiver request in the format specified at 
https://prsinfo.clinicaltrials.gov/ to the Secretary or delegate prior 
to the deadline specified in Sec. 11.44(a) for submitting clinical trial 
results information.
    (2) The waiver request must contain:
    (i) The NCT number, Brief Title, and Name of the Sponsor of the 
applicable clinical trial for which the waiver is requested;
    (ii) The specific requirement(s) of this subpart C for which the 
waiver is requested; and

[[Page 155]]

    (iii) A description of the extraordinary circumstances that the 
responsible party believes justify the waiver and an explanation of why 
granting the request would be consistent with the protection of public 
health or in the interest of national security.
    (3) The responsible party will not be required to comply with the 
specified requirements of this subpart for which a waiver is granted.
    (4) The responsible party must comply with any requirements of this 
subpart for which a waiver is not granted or must submit an appeal as 
set forth in paragraph (b) of this section. The deadline for submitting 
any required clinical trial results information will be the later of the 
original submission deadline or 30 calendar days after the notification 
of the denial is sent to the responsible party.
    (b) Appealing a denied waiver request. (1) A responsible party for 
an applicable clinical trial with a primary completion date on or after 
January 18, 2017 may appeal a denied waiver request by submitting an 
appeal to the Secretary or delegate in the format specified at https://
prsinfo.clinicaltrials.gov/ not later than 30 calendar days after the 
date on which the electronic notification of the denial in paragraph 
(a)(4) of this section denying the request is sent to the responsible 
party.
    (2) The responsible party is not required to comply with any 
requirements of this subpart for which a waiver is granted upon appeal.
    (3) The responsible party must submit clinical trial results 
information to comply with any requirements of this subpart that are not 
waived upon appeal by the later of the original submission deadline or 
30 calendar days after the notice of the denial upon appeal is sent to 
the responsible party.
    (c) If a waiver is granted under paragraph (a) or (b) of this 
section:
    (1) The Director will include a notation in the clinical trial 
record that specified elements of the requirements of this part have 
been waived.
    (2) The Secretary will notify, in writing, the appropriate 
committees of Congress and provide an explanation for why the waiver was 
granted, not later than 30 calendar days after any waiver is granted.
    (d) A responsible party for an applicable clinical trial with a 
primary completion date before January 18, 2017 may request a waiver 
from any applicable requirement(s) for clinical trial results 
information submission by submitting a waiver request, as specified in 
section 402(j)(3)(H) of the Public Health Service Act (42 U.S.C. 
282(j)(3)(H)).



      Subpart D_Additional Submission of Clinical Trial Information



Sec. 11.60  What requirements apply to the voluntary submission 
of clinical trial information for clinical trials of FDA-regulated 
drug products (including biological products) and device products?

    (a) If a responsible party voluntarily submits clinical trial 
information for a clinical trial described in paragraph (a)(1) of this 
section, the responsible party must meet the conditions specified in 
paragraph (a)(2) of this section.
    (1) The requirements of paragraph (a) of this section apply to a 
clinical trial that was initiated before January 18, 2017 and has a 
primary completion date before January 18, 2017, and that is either:
    (i) A clinical trial of an FDA-regulated drug product (including a 
biological product) or device product that is not an applicable clinical 
trial, or
    (ii) An applicable clinical trial that is not otherwise required to 
submit clinical trial registration information.
    (2) If the responsible party for a clinical trial described in 
paragraph (a)(1) of this section voluntarily submits clinical trial 
registration information and/or clinical trial results information, the 
responsible party must comply with the following requirements:
    (i) The responsible party must submit the information in paragraphs 
(b)(2)(i)(A), (B), or (C) of this section for the clinical trial being 
submitted voluntarily.
    (A) If the responsible party voluntarily registers a clinical trial, 
the responsible party must submit clinical trial registration 
information specified in section 402(j)(2)(A)(ii) of the Public

[[Page 156]]

Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
    (B) If the responsible party voluntarily submits clinical trial 
results information for a clinical trial for which the clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) has not been 
submitted, the responsible party must submit the clinical trial results 
information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the 
Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 
282(j)(3)(I)).
    (C) If the responsible party both voluntarily submits clinical trial 
registration information and voluntarily submits clinical trial results 
information, the responsible party must submit both clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and clinical 
trial results information specified in sections 402(j)(3)(C) and 
402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) 
and 42 U.S.C. 282(j)(3)(I)).
    (ii) If, on or after September 27, 2007, a manufacturer submits an 
application or premarket notification to FDA for approval, licensure, or 
clearance of a drug product (including a biological product) or device 
product under sections 505, 510(k), 515, or 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C 355, 360(k), 360e, 360j(m)) or section 
351 of the Public Health Service Act (42 U.S.C. 262) for the use studied 
in the clinical trial submitted under paragraph (a)(1) of this section, 
the responsible party specified in paragraph (a)(1) of this section must 
also submit the information specified in paragraph (a)(2)(iii) of this 
section by the deadline specified in paragraph (a)(2)(iv)(B) of this 
section for any applicable clinical trial that has not been submitted to 
ClinicalTrials.gov and that meets the following criteria:
    (A) The applicable clinical trial is required to be submitted to FDA 
under sections 505, 510(k), 515, or 520(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 
of the Public Health Service Act (42 U.S.C. 262) in an application or 
premarket notification for approval, licensure, or clearance to market 
the drug product (including a biological product) or device product for 
the use studied in the clinical trial specified in paragraph (a)(1) of 
this section; and
    (B) The manufacturer of the drug product (including a biological 
product) or device product studied in the applicable clinical trial is 
also the responsible party for the clinical trial specified in paragraph 
(a)(1) of this section.
    (iii) Information to be submitted for clinical trials described in 
paragraph (a)(2)(ii) of this section:
    (A) If the clinical trial information voluntarily submitted for a 
clinical trial described in paragraph (a)(1) of this section consists 
only of the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)), the information to be submitted in accordance with 
paragraph (a)(2)(ii) of this section must consist, at minimum, of the 
clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)).
    (B) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (a)(1) of this section consists of 
the clinical trial results information specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information to be 
submitted in accordance with paragraph (a)(2)(ii) of this section must 
consist of the clinical trial results information specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)).
    (C) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (a)(1) of this section consists of 
both the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) and the clinical trial results information specified 
in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service 
Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information 
to be submitted in accordance with paragraph

[[Page 157]]

(a)(2)(ii) of this section must consist of both the clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical 
trial results information specified in sections 402(j)(3)(C) and 
402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) 
and 42 U.S.C. 282(j)(3)(I)).
    (iv) Submission deadlines:
    (A) Secondary outcome measure(s) and adverse event information for 
voluntarily submitted clinical trials, under paragraph (a) of this 
section:
    (1) If data collection for secondary outcome measure(s) for a 
voluntarily submitted clinical trial under paragraph (a) of this section 
is not completed by the primary completion date of the voluntarily 
submitted clinical trial, clinical trial results information for the 
secondary outcome measure(s) required in section 402(j)(3)(C) of the 
Public Health Service Act (42 U.S.C. 282(j)(3)(C)) must be submitted by 
the later of the date that the clinical trial results information is 
voluntarily submitted for the primary outcome measure(s) or 1 year after 
the date on which the final subject was examined or received an 
intervention for the purposes of final collection of data for the 
secondary outcome(s), whether the clinical trial was concluded according 
to the pre-specified protocol or was terminated.
    (2) If data collection for adverse event information continues after 
the primary completion date of the voluntarily submitted clinical trial, 
any adverse event information collected after the primary completion 
date and subject to the submission requirements in section 402(j)(3)(I) 
of the Public Health Service Act (42 U.S.C. 282(j)(3)(I)) must be 
submitted by the later of the date that the clinical trial results 
information is voluntarily submitted for the primary outcome measure(s) 
or 1 year after the date of final collection of data for adverse event 
information, whether the clinical trial was concluded according to the 
pre-specified protocol or was terminated.
    (B) The clinical trial information specified in paragraph 
(a)(2)(iii) of this section must be submitted not later than the later 
of the date on which the application or premarket notification to FDA 
for approval, licensure, or clearance to market a drug product 
(including a biological product) or device product under section 351 of 
the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial 
specified under paragraph (a)(1) of this section is submitted to FDA or 
the date on which the clinical trial information specified in paragraph 
(a)(2)(i) of this section for the clinical trial specified under 
paragraph (a)(1) of this section is submitted to ClinicalTrials.gov.
    (b) If a responsible party voluntarily submits clinical trial 
information for a clinical trial described in paragraph (b)(1) of this 
section, the responsible party must meet the conditions specified in 
paragraph (b)(2) of this section.
    (1) The requirements of paragraph (b) of this section apply to a 
clinical trial that was initiated before January 18, 2017 and has a 
primary completion date on or after January 18, 2017, and that is 
either:
    (i) A clinical trial of an FDA-regulated drug product (including a 
biological product) or device product that is not an applicable clinical 
trial; or
    (ii) An applicable clinical trial that is not otherwise required to 
submit clinical trial registration information.
    (2) If the responsible party for a clinical trial described in 
paragraph (b)(1) of this section voluntarily submits clinical trial 
registration information and/or clinical trial results information, the 
responsible party must comply with the following requirements:
    (i) The responsible party must submit the information in paragraph 
(b)(2)(i)(A), (B), or (C) of this section for the clinical trial being 
submitted voluntarily.
    (A) If the responsible party voluntarily registers a clinical trial, 
the responsible party must submit clinical trial registration 
information specified in section 402(j)(2)(A)(ii) of the Public Health 
Service Act (42 U.S.C. 282(j)(2)(A)(ii)).
    (B) If the responsible party voluntarily submits clinical trial 
results information for a clinical trial for which

[[Page 158]]

the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) has not been submitted, the responsible party must 
submit the data elements specified in Sec. 11.48, as well as the data 
elements listed below, as those data elements are defined in 
Sec. 11.10(b) and apply to the clinical trial and the intervention(s) 
studied: Brief Title; Official Title; Brief Summary; Primary Purpose; 
Study Design; Study Phase, for a clinical trial of a drug product 
(including a biological product); Study Type; Pediatric Postmarket 
Surveillance of a Device Product; Primary Disease or Condition Being 
Studied in the Trial, or the Focus of the Study; Intervention Name(s), 
for each intervention studied; Other Intervention Name(s), for each 
intervention studied; Intervention Description, for each intervention 
studied; Intervention Type, for each intervention studied; Device 
Product Not Approved or Cleared by U.S. FDA, if any studied intervention 
is a device product; Product Manufactured in and Exported from the U.S.; 
Studies a U.S. FDA-regulated Device Product; Studies a U.S. FDA-
regulated Drug Product; Study Start Date; Primary Completion Date; Study 
Completion Date; Enrollment; Eligibility Criteria; Sex/Gender; Age 
Limits; Accepts Healthy Volunteers; Overall Recruitment Status; Why 
Study Stopped; Availability of Expanded Access, if any studied 
intervention is an investigational drug product (including a biological 
product); Name of the Sponsor; Responsible Party, by Official Title; 
Facility Information, for each participating facility; Unique Protocol 
Identification Number; Secondary ID; U.S. Food and Drug Administration 
IND or IDE Number; Human Subjects Protection Review Board Status; Record 
Verification Date; and Responsible Party Contact Information.
    (C) If the responsible party both voluntarily submits clinical trial 
registration information and voluntarily submits clinical trial results 
information, the responsible party must submit both the clinical trial 
registration information specified in section 402(j)(2)(A)(ii) of the 
Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical 
trial results information specified in Sec. 11.48.
    (ii) If, on or after September 27, 2007, a manufacturer submits an 
application or premarket notification to FDA for approval, licensure, or 
clearance of a drug product (including a biological product) or device 
product under section 505, 510(k), 515, or 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 
351 of the Public Health Service Act (42 U.S.C. 262) for the use studied 
in the clinical trial submitted under paragraph (b)(1) of this section, 
the responsible party specified in paragraph (b)(1) of this section must 
also submit the information specified in paragraph (b)(2)(iii) of this 
section by the deadline specified in paragraph (b)(2)(iv)(B) of this 
section for any applicable clinical trial that has not been submitted to 
ClinicalTrials.gov and that meets the following criteria:
    (A) The applicable clinical trial is required to be submitted to FDA 
under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of 
the Public Health Service Act (42 U.S.C. 262) in an application or 
premarket notification for approval, licensure, or clearance to market 
the drug product (including a biological product) or device product for 
the use studied in the clinical trial specified in paragraph (b)(1) of 
this section; and
    (B) The manufacturer of the drug product (including a biological 
product) or device product studied in the applicable clinical trial is 
also the responsible party for the clinical trial specified in paragraph 
(b)(1) of this section.
    (iii) Information to be submitted for clinical trials described in 
paragraph (b)(2)(ii) of this section:
    (A) If the clinical trial information voluntarily submitted for a 
clinical trial described in paragraph (b)(1) of this section consists 
only of the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)), the information to be submitted in accordance with 
paragraph (b)(2)(ii) of this section must consist, at minimum, of the 
clinical trial registration information specified

[[Page 159]]

in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)).
    (B) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (b)(1) of this section consists of 
the clinical trial results information specified in 
Sec. 11.60(b)(2)(i)(B), the information to be submitted in accordance 
with paragraph (b)(2)(ii) of this section must consist of the clinical 
trial results information specified in Sec. 11.60(b)(2)(i)(B).
    (C) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (b)(1) of this section consists of 
both the clinical trial registration information specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) and the clinical trial results information specified 
in Sec. 11.48, the information to be submitted in accordance with 
paragraph (b)(2)(ii) of this section must consist of both the clinical 
trial registration information specified in section 402(j)(2)(A)(ii) of 
the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the 
clinical trial results information specified in Sec. 11.48.
    (iv) Submission deadlines:
    (A) Secondary outcome measure(s) and adverse event information for 
voluntarily submitted clinical trials, under paragraph (b) of this 
section:
    (1) If data collection for secondary outcome measure(s) for a 
voluntarily submitted clinical trial under paragraph (b) of this section 
is not completed by the primary completion date of the voluntarily 
submitted clinical trial, clinical trial results information for the 
secondary outcome measure(s) required in Sec. 11.48(a)(3) must be 
submitted by the later of the date that the clinical trial results 
information is voluntarily submitted for the primary outcome measure(s) 
or 1 year after the date on which the final subject was examined or 
received an intervention for the purposes of final collection of data 
for the secondary outcome(s), whether the clinical trial was concluded 
according to the pre-specified protocol or was terminated.
    (2) If data collection for adverse event information continues after 
the primary completion date of the voluntarily submitted clinical trial, 
any adverse event information collected after the primary completion 
date and subject to the submission requirements in Sec. 11.48(a)(4) must 
be submitted by the later of the date that the clinical trial results 
information is voluntarily submitted for the primary outcome measure(s) 
or 1 year after the date of final collection of data for adverse event 
information, whether the clinical trial was concluded according to the 
pre-specified protocol or was terminated.
    (B) The clinical trial information specified in paragraph 
(b)(2)(iii) of this section must be submitted not later than the later 
of the date on which the application or premarket notification to FDA 
for approval, licensure, or clearance to market a drug product 
(including a biological product) or device product under section 351 of 
the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial 
specified under paragraph (b)(1) of this section is submitted to FDA or 
the date on which the clinical trial information specified in paragraph 
(b)(2)(i) of this section for the clinical trial specified under 
paragraph (b)(1) of this section is submitted to ClinicalTrials.gov.
    (c) If a responsible party voluntarily submits clinical trial 
information for a clinical trial described in paragraph (c)(1) of this 
section, the responsible party must meet the conditions specified in 
paragraph (c)(2) of this section.
    (1) The requirements of paragraph (c) of this section apply to a 
clinical trial that was initiated on or after January 18, 2017 and has a 
primary completion date on or after January 18, 2017, and that is 
either:
    (i) A clinical trial of an FDA-regulated drug product (including a 
biological product) or device product that is not an applicable clinical 
trial; or
    (ii) An applicable clinical trial that is not otherwise required to 
submit clinical trial registration information.
    (2) If the responsible party for a clinical trial described in 
paragraph (c)(1) of this section voluntarily submits clinical trial 
registration information

[[Page 160]]

and/or clinical trial results information, the responsible party must 
comply with the following requirements:
    (i) The responsible party must submit the information in paragraph 
(c)(2)(i)(A), (B), or (C) of this section for the clinical trial being 
submitted voluntarily.
    (A) If the responsible party voluntarily registers a clinical trial, 
the responsible party must submit the clinical trial registration 
information specified in Sec. 11.28(a).
    (B) If the responsible party voluntarily submits clinical trial 
results information for a clinical trial for which the clinical trial 
registration information specified in Sec. 11.28(a) has not been 
submitted, the responsible party must submit the data elements specified 
in paragraph (b)(2)(i)(B) of this section.
    (C) If the responsible party both voluntarily submits clinical trial 
registration information and voluntarily submits clinical trial results 
information, the responsible party must submit both the clinical trial 
registration information specified in Sec. 11.28(a) and the clinical 
trial results information specified in Sec. 11.48.
    (ii) If, on or after September 27, 2007, a manufacturer submits an 
application or premarket notification to FDA for approval, licensure, or 
clearance of a drug product (including a biological product) or device 
product under section 505, 510(k), 515, or 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 
351 of the Public Health Service Act (42 U.S.C. 262) for the use studied 
in the clinical trial submitted under paragraph (c)(1) of this section, 
the responsible party specified in paragraph (c)(1) of this section must 
also submit the information specified in paragraph (c)(2)(iii) of this 
section by the deadline specified in paragraph (c)(2)(iv)(B) of this 
section for any applicable clinical trial that has not been submitted to 
ClinicalTrials.gov and that meets the following criteria:
    (A) The applicable clinical trial is required to be submitted to FDA 
under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of 
the Public Health Service Act (42 U.S.C. 262) in an application or 
premarket notification for approval, licensure, or clearance to market 
the drug product (including a biological product) or device product for 
the use studied in the clinical trial specified in paragraph (c)(1) of 
this section; and
    (B) The manufacturer of the drug product (including a biological 
product) or device product studied in the applicable clinical trial is 
also the responsible party for the clinical trial specified in paragraph 
(c)(1) of this section.
    (iii) Information to be submitted for clinical trials described in 
paragraph (c)(2)(ii) of this section:
    (A) If the clinical trial information voluntarily submitted for a 
clinical trial described in paragraph (c)(1) of this section consists 
only of the clinical trial registration information specified in 
Sec. 11.28(a), the information to be submitted in accordance with 
paragraph (c)(2)(ii) of this section must consist, at minimum, of the 
clinical trial registration information specified in Sec. 11.28(a).
    (B) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (c)(1) of this section consists of 
the clinical trial results information specified in 
Sec. 11.60(c)(2)(i)(B), the information to be submitted in accordance 
with paragraph (c)(2)(ii) of this section must consist of the clinical 
trial results information specified in Sec. 11.60(c)(2)(i)(B).
    (C) If the clinical trial information voluntarily submitted for a 
clinical trial described by paragraph (c)(1) of this section consists of 
both the clinical trial registration information specified in 
Sec. 11.28(a) and the clinical trial results information specified in 
Sec. 11.48, the information to be submitted in accordance with paragraph 
(c)(2)(ii) of this section must consist of both the clinical trial 
registration information specified in Sec. 11.28(a) and the clinical 
trial results information specified in Sec. 11.48.
    (iv) Submission deadlines:
    (A) Secondary outcome measure(s) and adverse event information for 
voluntarily-submitted clinical trials, under paragraph (c) of this 
section:
    (1) If data collection for secondary outcome measure(s) for a 
voluntarily

[[Page 161]]

submitted clinical trial under paragraph (c) of this section is not 
completed by the primary completion date of the voluntarily submitted 
clinical trial, clinical trial results information for the secondary 
outcome measure(s) required in Sec. 11.48(a)(3) must be submitted by the 
later of the date that the clinical trial results information is 
voluntarily submitted for the primary outcome measure(s) or 1 year after 
the date on which the final subject was examined or received an 
intervention for the purposes of final collection of data for the 
secondary outcome(s), whether the clinical trial was concluded according 
to the pre-specified protocol or was terminated.
    (2) If data collection for adverse event information continues after 
the primary completion date of the voluntarily submitted clinical trial, 
any adverse event information collected after the primary completion 
date and subject to the submission requirements in Sec. 11.48(a)(4) must 
be submitted by the later of the date that the clinical trial results 
information is voluntarily submitted for the primary outcome measure(s) 
or 1 year after the date of final collection of data for adverse events 
information, whether the clinical trial was concluded according to the 
pre-specified protocol or was terminated.
    (B) The clinical trial information specified in paragraph 
(c)(2)(iii) of this section must be submitted not later than the later 
of the date on which the application or premarket notification to FDA 
for approval, licensure, or clearance to market a drug product 
(including a biological product) or device product under section 351 of 
the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial 
specified under paragraph (c)(1) of this section is submitted to FDA or 
the date on which the clinical trial information specified in paragraph 
(c)(2)(i) of this section for the clinical trial specified under 
paragraph (c)(1) of this section is submitted to ClinicalTrials.gov.
    (v) All submissions of clinical trial information under paragraph 
(c) of this section are subject to the applicable update and corrections 
requirements specified in Sec. 11.64.
    (d) Statement to accompany applicable clinical trials submitted 
under paragraphs (a), (b), and (c) of this section. Each applicable 
clinical trial for which clinical trial information is submitted under 
paragraphs (a), (b), and (c) of this section and posted on 
ClinicalTrials.gov will include the statement ``This clinical trial 
information was submitted voluntarily under the applicable law and, 
therefore, certain submission deadlines may not apply. (That is, 
clinical trial information for this applicable clinical trial was 
submitted under section 402(j)(4)(A) of the Public Health Service Act 
and 42 CFR 11.60 and is not subject to the deadlines established by 
sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 
11.24 and 11.44.)''



Sec. 11.62  What requirements apply to applicable clinical trials
for which submission of clinical trial information has been
determined by the Director to be necessary to protect the public
health?

    (a) A responsible party who receives notification that the Director 
has determined that posting of clinical trial information for an 
applicable clinical trial described in paragraph (b) of this section is 
necessary to protect the public health must submit clinical trial 
information as specified in paragraph (c) of this section.
    (b) An applicable clinical trial subject to this section must be 
either:
    (1) An applicable clinical trial of an approved, licensed, or 
cleared drug product (including a biological product) or device product 
that has a primary completion date on or after September 27, 1997; or
    (2) An applicable clinical trial that is subject to registration 
under Sec. 11.22(a) and studies a drug product (including a biological 
product) or device product that is unapproved, unlicensed, or uncleared, 
regardless of whether approval, licensure, or clearance was, is, or will 
be sought, and that is not otherwise subject to results information 
submission in accordance with the regulation.
    (c) Deadline for submission of clinical trial information:

[[Page 162]]

    (1) General. Except as provided in paragraphs (c)(2) and (c)(3) of 
this section, a responsible party for an applicable clinical trial that 
is subject to this section must submit the clinical trial registration 
information specified in Sec. 11.28(a) and the clinical trial results 
information specified in Sec. 11.48(a) not later than 30 calendar days 
after the submission date specified in the notification described in 
paragraph (a) of this section.
    (2) Exception. If a responsible party submits a certification 
consistent with Sec. 11.44(b) or (c) not later than 30 calendar days 
after the submission date specified in the notification described in 
paragraph (a) of this section, the responsible party must submit the 
clinical trial results information specified in Sec. 11.48(a) not later 
than the deadline specified in Sec. 11.44(b) or (c), as applicable.
    (3) If a responsible party submitted clinical trial registration 
information describing the applicable clinical trial specified in the 
notification described in paragraph (a) of this section prior to the 
date on which the notification is sent to the responsible party, the 
responsible party must update such clinical trial information to reflect 
changes, if any, in the applicable clinical trial not later than 30 
calendar days after the submission date specified in the notification 
described in paragraph (a) of this section, irrespective of the deadline 
for updates specified in Sec. 11.64.



Sec. 11.64  When must clinical trial information submitted to 
ClinicalTrials.gov be updated or corrected?

    (a) Updates. (1) Clinical trial registration information:
    (i) The responsible party for an applicable clinical trial for which 
clinical trial registration information was required to be submitted if 
the clinical trial was initiated before January 18, 2017, must submit 
updates in accordance with the following:
    (A) In general, changes to the clinical trial registration 
information specified in section 402(j)(2)(A)(ii) of the Public Health 
Service Act (42 U.S.C. 282(j)(2)(A)(ii)) that was required at the time 
of submission must be updated not less than once every 12 months.
    (B) Overall Recruitment Status must be updated not later than 30 
calendar days after any change in overall recruitment status.
    (C) Primary Completion Date must be updated not later than 30 
calendar days after the clinical trial reaches its actual primary 
completion date.
    (ii) The responsible party for an applicable clinical trial, or for 
another clinical trial for which registration information was 
voluntarily submitted pursuant to Sec. 11.60(c), if the clinical trial 
was initiated on or after January 18, 2017, must submit updates in 
accordance with the following:
    (A) In general, changes to clinical trial registration information 
specified in Sec. 11.28 must be updated not less than once every 12 
months.
    (B) If the first human subject was not enrolled in the clinical 
trial at the time of registration, the Study Start Date data element 
must be updated not later than 30 calendar days after the first human 
subject is enrolled.
    (C) Intervention Name(s) must be updated to a non-proprietary name 
not later than 30 calendar days after a non-proprietary name is 
established for any intervention included in the Intervention Name(s) 
data element.
    (D) Availability of expanded access:
    (1) If expanded access to an investigational drug product (including 
a biological product) becomes available after an applicable clinical 
trial of that product has been registered, the responsible party, if 
both the manufacturer of the investigational drug product (including a 
biological product) and the sponsor of the applicable clinical trial, 
must, not later than 30 calendar days after expanded access becomes 
available, update the Availability of Expanded Access data element for 
that applicable clinical trial and, unless an expanded access record has 
already been created as required by Sec. 11.28(a)(2)(ii)(H), submit the 
data elements in accordance with Sec. 11.28(c) to create an expanded 
access record.
    (2) No later than 30 calendar days after the date on which the 
responsible party receives an NCT number for an

[[Page 163]]

expanded access record created as required by Sec. 11.28(a)(2)(ii)(H), 
the responsible party must update the Availability of Expanded Access 
data element by entering the NCT number in the clinical trial record for 
the applicable clinical trial.
    (E) Expanded access record:
    (1) Expanded Access Status, under Sec. 11.28(c)(2)(iv), must be 
updated not later than 30 calendar days after a change in the 
availability of expanded access to an investigational drug product 
(including a biological product) under section 561 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb).
    (2) Expanded Access Type, under Sec. 11.28(c)(1)(x), must be updated 
not later than 30 calendar days after a change in the type(s) of 
expanded access available for an investigational drug product (including 
a biological product) under section 561 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb).
    (F) Overall Recruitment Status must be updated not later than 30 
calendar days after any change in overall recruitment status. If, at any 
time, Overall Recruitment Status is changed to ``suspended,'' 
``terminated,'' or ``withdrawn,'' the responsible party must also submit 
the Why Study Stopped data element.
    (G) Individual Site Status must be updated not later than 30 
calendar days after a change in status for any individual site.
    (H) Human Subjects Protection Review Board Status must be updated 
not later than 30 calendar days after a change in status.
    (I) Primary Completion Date must be updated not later than 30 
calendar days after the clinical trial reaches its actual primary 
completion date. At the time, the date is changed to ``actual,'' and the 
Enrollment data element specifying the actual number of participants 
enrolled must be submitted.
    (J) Study Completion Date must be updated not later than 30 calendar 
days after the clinical trial reaches its actual study completion date.
    (K) Responsible Party, by Official Title must be updated not later 
than 30 calendar days after a change in the responsible party or the 
official title of the responsible party.
    (L) Responsible Party Contact Information must be updated not later 
than 30 calendar days after a change in the responsible party or the 
contact information for the responsible party.
    (M) Device Product Not Approved or Cleared by U.S. FDA must be 
updated not later than 15 calendar days after a change in approval or 
clearance status has occurred.
    (N) Record Verification Date must be updated any time the 
responsible party reviews the complete set of submitted clinical trial 
information for accuracy and not less than every 12 months, even if no 
other updated information is submitted at that time.
    (O) If a protocol is amended in such a manner that changes are 
communicated to human subjects in the clinical trial, updates to any 
relevant clinical trial registration information data elements must be 
submitted not later than 30 calendar days after the protocol amendment 
is approved by a human subjects protection review board.
    (iii) In addition to the update requirements established in 
paragraphs (a)(1)(i) and (a)(1)(ii) of this section, clinical trial 
registration information must be updated at the time that clinical trial 
results information for that clinical trial is initially submitted.
    (A) If the clinical trial was initiated before January 18, 2017, a 
responsible party must submit updates to the clinical trial registration 
information described in Sec. 11.64(a)(1)(i).
    (B) If the clinical trial was initiated on or after January 18, 
2017, the responsible party must submit updates to the clinical trial 
registration information in accordance with Sec. 11.64(a)(1)(ii).
    (2) Clinical trial results information. The responsible party for an 
applicable clinical trial, or for another clinical trial for which 
results information was voluntarily submitted pursuant to Sec. 11.60(b) 
or (c), where the clinical trial has a Primary Completion Date on or 
after January 18, 2017, must submit updates in accordance with the 
following:
    (i) In general, changes to required clinical trial results 
information, other than the protocol and statistical analysis plan 
specified in Sec. 11.48(a)(5) and

[[Page 164]]

certain agreements specified in Sec. 11.48(a)(6)(ii),must be updated not 
less than once every 12 months.
    (ii) For applicable device clinical trials of unapproved or 
uncleared device products, the responsible party must update the 
following data elements, as defined in Sec. 11.10(b), in accordance with 
the following:
    (A) Intervention Name(s) must be updated to a non-proprietary name 
not later than 30 calendar days after a non-proprietary name is 
established for any intervention included in the Intervention Name(s) 
data element.
    (B) Primary Completion Date must be updated not later than 30 
calendar days after the clinical trial reaches its actual primary 
completion date. At the time the date is changed to ``actual,'' the 
Enrollment data element specifying the actual number of participants 
enrolled must be submitted.
    (C) Study Completion Date must be updated not later than 30 calendar 
days after the clinical trial reaches its actual study completion date.
    (D) Overall Recruitment Status must be updated not later than 30 
calendar days after any change in overall recruitment status. If, at any 
time, Overall Recruitment Status is changed to ``suspended,'' 
``terminated,'' or ``withdrawn,'' the responsible party must also submit 
the Why Study Stopped data element.
    (E) Record Verification Date must be updated any time the 
responsible party reviews the complete set of submitted clinical trial 
information for accuracy and not less than every 12 months, even if no 
other updated information is submitted at that time.
    (3) A responsible party's obligation to submit updates as specified 
in this section ends on the date on which all required clinical trial 
results information has been submitted as specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C)) and 42 U.S.C. 282(j)(3)(I)) or as specified in 
Sec. 11.48, as applicable, and corrections have been made or addressed 
in response to any electronic notice received under Sec. 11.64(b)(1). If 
no clinical trial results information is required to be submitted, a 
responsible party's obligation to submit updates to clinical trial 
registration information ends on the date on which all required clinical 
trial registration information has been submitted as specified in 
section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii) or Sec. 11.28, as applicable, and corrections have been 
made or addressed in response to any electronic notice received under 
Sec. 11.64(b)(1).
    (4) Public availability of updates. (i) Updates to clinical trial 
registration information and clinical trial results information will be 
posted in accordance with Sec. 11.35 and Sec. 11.52, respectively.
    (ii) The Director will retain prior clinical trial registration 
information and clinical trial results information and make it publicly 
available in accordance with Sec. 11.35 and Sec. 11.52, respectively, 
through ClinicalTrials.gov so that updates do not result in the removal 
of any information from the original submission or any preceding update.
    (b) Corrections--(1) Quality control. After clinical trial 
registration information has been submitted as specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) or Sec. 11.28, as applicable, or clinical trial 
results information has been submitted as specified in sections 
402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 
U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or Sec. 11.48, as 
applicable, including the updates specified in paragraph (a) of this 
section, the Director may provide electronic notification to the 
responsible party of apparent errors, deficiencies, and/or 
inconsistencies in the submitted information identified during 
procedures for quality control review established by the Director, as 
specified at https://prsinfo.clinicaltrials.gov. The responsible party 
must correct or address all apparent errors, deficiencies, and/or 
inconsistencies identified in the notification not later than 15 
calendar days for clinical trial registration information, or 25 
calendar days for clinical trial results information, after the date of 
the electronic notification sent to the responsible party.
    (2) Other corrections. (i) A responsible party who becomes aware of 
errors, other than those specified in paragraph

[[Page 165]]

(b)(1) of this section, in any clinical trial information submitted 
under this part shall have not more than 15 calendar days for clinical 
trial registration information, or 25 calendar days for clinical trial 
results information, to correct or address such errors.
    (ii) A responsible party's obligation to correct or address errors 
as specified in paragraph (b)(2) of this section ends on the date on 
which all required clinical trial results information has been submitted 
as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public 
Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) 
or Sec. 11.48, as applicable, and corrections have been made or 
addressed in response to any electronic notice received under 
Sec. 11.64(b)(1). If no clinical trial results information is required 
to be submitted, a responsible party's obligation to correct or address 
errors ends on the date on which all required clinical trial 
registration information has been submitted as specified in section 
402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(A)(ii)) or Sec. 11.28, as applicable, and corrections have 
been made or addressed in response to any electronic notice received 
under Sec. 11.64(b)(1).
    (3) Compliance with the quality control review process, including 
the requirements of this section, does not constitute a legal defense to 
enforcement pursuant to section 301(jj) of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 331(jj)), section 303(f)(3) of the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 333(f)(3)), or any other Federal law.



        Subpart E_Potential Legal Consequences of Non-Compliance



Sec. 11.66  What are potential legal consequences of not complying 
with the requirements of this part?

    (a) Civil or criminal judicial actions. Failure to comply with the 
requirements of this part, issued under section 402(j) of the Public 
Health Service Act (42 U.S.C. 282(j)), is a prohibited act under one or 
more provisions of section 301(jj) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(jj)):
    (1) Failure to submit the certification required by section 
402(j)(5)(B) of the Public Health Service (42 U.S.C. 282(j)(5)(B)) that 
all applicable requirements of section 402(j) have been met, or 
knowingly submitting a false certification under section 402(j)(5)(B), 
is a prohibited act under section 301(jj)(1) of the Federal Food, Drug, 
and Cosmetic Act.
    (2) Failure to submit clinical trial information required under 
section 402(j) of the Public Health Service Act is a prohibited act 
under section 301(jj)(2) of the Federal Food, Drug, and Cosmetic Act.
    (3) Submission of clinical trial information under section 402(j) 
that is false or misleading in any particular is a prohibited act under 
section 301(jj)(3) of the Federal Food, Drug, and Cosmetic Act.
    (b) Civil monetary penalty actions. Any person who violates section 
301(jj) of the Federal Food, Drug, and Cosmetic Act is subject to civil 
monetary penalties under section 303(f)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333(f)(3)).
    (c) Grant funding actions. Under section 402(j)(5)(A) of the Public 
Health Service Act (42 U.S.C. 282(j)(5)(A)), if an applicable clinical 
trial is funded in whole or part by the Department of Health and Human 
Services, any required grant or progress report forms must include a 
certification that the responsible party has made all required 
registration and results submissions. If it is not verified that the 
required registration and results clinical trial information for each 
applicable clinical trial for which a grantee is the responsible party 
has been submitted, any remaining funding for a grant or funding for a 
future grant to such grantee will not be released. If the head of an HHS 
agency verifies that a grantee has not submitted such required clinical 
trial information, the agency head will provide notice to the grantee of 
the non-compliance and allow the grantee 30 days to correct the non-
compliance and submit the required clinical trial information.

[[Page 166]]



                         SUBCHAPTER B_PERSONNEL





PART 21_COMMISSIONED OFFICERS--Table of Contents



                          Subpart A_Definitions

Sec.
21.1  Meaning of terms.

                          Subpart B_Appointment

         Provisions Applicable Both to Regular and Reserve Corps

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

               Provisions Applicable Only to Regular Corps

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

               Provisions Applicable Only to Reserve Corps

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

       Subpart C_Involuntary Child and Spousal Support Allotments

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



                          Subpart A_Definitions

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



Sec. 21.1  Meaning of terms.

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

[21 FR 9806, Dec. 12, 1956]



                          Subpart B_Appointment

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

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

         Provisions Applicable Both to Regular and Reserve Corps



Sec. 21.21  Meaning of terms.

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

[[Page 167]]

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

[24 FR 1790, Mar. 12, 1959]



Sec. 21.22  Submission of application and evidence of qualifications.

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



Sec. 21.23  False statements as disqualification.

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



Sec. 21.24  Physical examinations.

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



Sec. 21.25  Eligibility; junior assistant grade.

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

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



Sec. 21.26  Eligibility; assistant grade.

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



Sec. 21.27  Eligibility; senior assistant grade.

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

[[Page 168]]



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

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

[27 FR 3886, Apr. 24, 1962]



Sec. 21.29  Eligibility; grades above senior assistant grade.

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

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



Sec. 21.30  Determination of creditable years of educational and 
professional training and experience.

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

[25 FR 5184, June 10, 1960]



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

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

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



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

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

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



Sec. 21.33  General service.

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

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

[[Page 169]]



Sec. 21.34  Certification by candidate; requirement of new physical
examination.

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

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

               Provisions Applicable Only to Regular Corps



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

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

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



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

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

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



Sec. 21.43  Examination; full grade and above.

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



Sec. 21.44  Clinical or other practical demonstration.

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

[[Page 170]]

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



Sec. 21.45  Rating values.

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



Sec. 21.46  Merit roll.

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

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



Sec. 21.47  Examination; anticipation of meeting qualifications.

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

[[Page 171]]

               Provisions Applicable Only to Reserve Corps



Sec. 21.51  Appointment of officers having specialized training
or experience in administration and management.

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



Sec. 21.52  Waiver of entrance qualifications for original appointment
in time of war or national emergency.

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

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



Sec. 21.53  Examination.

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



Sec. 21.54  Students.

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

[34 FR 706, Jan. 17, 1969]



Sec. 21.55  Appointment to higher grades; candidates exceptionally
qualified in specialized fields.

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

[[Page 172]]

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



Sec. 21.56  Reappointment.

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



Sec. 21.57  Examination for reappointment.

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



Sec. 21.58  Physical examination for reappointment.

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



       Subpart C_Involuntary Child and Spousal Support Allotments

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

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



Sec. 21.70  Purpose.

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



Sec. 21.71  Applicability and scope.

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



Sec. 21.72  Definitions.

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

[[Page 173]]

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



Sec. 21.73  Policy.

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



Sec. 21.74  Responsibilities.

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

[[Page 174]]

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



Sec. 21.75  Procedures.

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

[[Page 175]]

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

[[Page 176]]

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

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



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



   Hansen's Disease Duty by Personnel Other Than Commissioned Officers

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

                           Special Consultants

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

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

   Hansen's Disease Duty by Personnel Other Than Commissioned Officers



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

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

[[Page 177]]

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

[50 FR 43146, Oct. 24, 1985]

                           Special Consultants



Sec. 22.3  Appointment of special consultants.

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

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

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



Sec. 22.5  Leave without pay while on detail.

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

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

[33 FR 18981, Dec. 20, 1968]



PART 23_NATIONAL HEALTH SERVICE CORPS--Table of Contents



     Subpart A_Assignment of National Health Service Corps Personnel

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

[[Page 178]]

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

    Subpart B_Private Practice Special Loans for Former Corps Members

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

                     Subpart C_Private Startup Loans

23.41  What conditions are applicable to loans under this subpart?

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

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



     Subpart A_Assignment of National Health Service Corps Personnel



Sec. 23.1  To what entities does this regulation apply?

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



Sec. 23.2  Definitions.

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



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

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



Sec. 23.4  How must an entity apply for assignment?

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

[[Page 179]]

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

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

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

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



Sec. 23.5  What are the criteria for deciding which applications
for assignment will be approved?

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



Sec. 23.6  What are the criteria for determining the entities 
to which National Health Service Corps personnel will be assigned?

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

[[Page 180]]

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

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



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

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

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



Sec. 23.8  What operational requirements apply to an entity to which
National Health Service Corps personnel are assigned?

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

[[Page 181]]



Sec. 23.9  What must an entity to which National Health Service Corps 
personnel are assigned (i.e., a National Health Service Corps site) 
charge for the provision of health services by assigned personnel?
          

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



Sec. 23.10  Under what circumstances may a National Health Service
Corps site's reimbursement obligation to the Federal Government
be waived?

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

[[Page 182]]

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

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



Sec. 23.11  Under what circumstances may the Secretary sell equipment
or other property of the United States used by the National Health 
Service Corps site?

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



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

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



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

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

[[Page 183]]

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

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



    Subpart B_Private Practice Special Loans for Former Corps Members

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



Sec. 23.21  Definitions.

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



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

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



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

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



Sec. 23.24  In what amounts are loans made?

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



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

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



Sec. 23.26  How is the loan repaid?

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



Sec. 23.27  What happens if scheduled payments are late?

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

[[Page 184]]

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



Sec. 23.28  What events constitute default?

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



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

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



Sec. 23.30  May the loan be prepaid?

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



Sec. 23.31  May loan payments be postponed or waived?

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



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

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



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

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

[[Page 185]]



Sec. 23.34  What other conditions are imposed?

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



Sec. 23.35  What criteria are used in making loans?

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

[[Page 186]]



                     Subpart C_Private Startup Loans



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

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

[51 FR 31950, Sept. 8, 1986]



PART 24_SENIOR BIOMEDICAL RESEARCH SERVICE--Table of Contents



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

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

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



Sec. 24.1  Establishment.

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



Sec. 24.2  Allocation.

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



Sec. 24.3  Policy Board.

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

[[Page 187]]

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



Sec. 24.4  Eligibility.

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



Sec. 24.5  Peer review.

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



Sec. 24.6  Pay and compensation.

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

[[Page 188]]

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



Sec. 24.7  Performance appraisal system.

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



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

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



Sec. 24.9  Removal from the Service.

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

[[Page 189]]

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



Sec. 24.10  Reporting.

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

[[Page 190]]



               SUBCHAPTER C_MEDICAL CARE AND EXAMINATIONS





PART 31_MEDICAL CARE FOR CERTAIN PERSONNEL OF THE COAST GUARD, 
NATIONAL OCEAN SURVEY, PUBLIC HEALTH SERVICE, AND FORMER LIGHTHOUSE
SERVICE--Table of Contents



                               Definitions

Sec.
31.1  Meaning of terms.

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

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

     Provisions Applicable to Personnel of Former Lighthouse Service

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

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

                               Definitions



Sec. 31.1  Meaning of terms.

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

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

[[Page 191]]

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



Sec. 31.2  Persons entitled to treatment.

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

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



Sec. 31.3  Use of Service facilities.

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

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



Sec. 31.4  Use of other than Service facilities.

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

[[Page 192]]

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

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



Sec. 31.5  Application for treatment; active duty personnel.

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

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



Sec. 31.6  Personnel absent without leave.

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

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



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

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

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



Sec. 31.8  Retired personnel; extent of treatment.

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

[[Page 193]]

to emergency measures necessary to relieve pain.

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



Sec. 31.9  Dependent members of families; treatment.

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

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



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

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

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

     Provisions Applicable to Personnel of Former Lighthouse Service



Sec. 31.11  Persons entitled to treatment.

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

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



Sec. 31.12  Use of Service facilities.

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

[[Page 194]]

elsewhere shall not be borne by the Service.

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



Sec. 31.13  Use of other than Service facilities.

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

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



Sec. 31.14  Application for treatment; active duty personnel.

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

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



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

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

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



Sec. 31.16  Retired personnel; extent of treatment.

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

[[Page 195]]

to emergency measures necessary to relieve pain.

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



PART 32_MEDICAL CARE FOR PERSONS WITH HANSEN'S DISEASE AND OTHER
PERSONS IN EMERGENCIES--Table of Contents



                               Definitions

Sec.
32.1  Meaning of terms.

                              Beneficiaries

32.6  Persons eligible.

                      Persons With Hansen's Disease

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

           Nonbeneficiaries: Temporary Treatment in Emergency

32.111  Conditions and extent of treatment; charges.

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

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

                               Definitions



Sec. 32.1  Meaning of terms.

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

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

                              Beneficiaries



Sec. 32.6  Persons eligible.

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

[48 FR 10318, Mar. 11, 1983]

                      Persons With Hansen's Disease



Sec. 32.86  Admissions to Service facilities.

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



Sec. 32.87  Confirmation of diagnosis.

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

[[Page 196]]

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

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



Sec. 32.88  Examinations and treatment.

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



Sec. 32.89  Discharge.

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



Sec. 32.90  Notification to health authorities regarding discharged
patients.

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



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

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

[46 FR 51918, Oct. 23, 1981]

           Nonbeneficiaries: Temporary Treatment in Emergency



Sec. 32.111  Conditions and extent of treatment; charges.

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



PART 34_MEDICAL EXAMINATION OF ALIENS--Table of Contents



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

    Authority: 42 U.S.C. 252; 8 U.S.C. 1182 and 1222.

    Source: 81 FR 4201, Jan. 26, 2016, unless otherwise noted.



Sec. 34.1  Applicability.

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

[[Page 197]]



Sec. 34.2  Definitions.

    As used in this part, terms shall have the following meanings:
    (a) CDC. Centers for Disease Control and Prevention, Department of 
Health and Human Services, or an authorized representative acting on its 
behalf.
    (b) Communicable disease of public health significance. Any of the 
following diseases:
    (1) Communicable diseases as listed in a Presidential Executive 
Order, as provided under Section 361(b) of the Public Health Service 
Act. The current revised list of quarantinable communicable diseases is 
available at http://www.cdc.gov and http://www.archives.gov/federal-
register.
    (2) Communicable diseases that may pose a public health emergency of 
international concern if it meets one or more of the factors listed in 
Sec. 34.3(d) and for which the Director has determined a threat exists 
for importation into the United States, and such disease may potentially 
affect the health of the American public. The determination will be made 
consistent with criteria established in Annex 2 of the International 
Health Regulations (http://www.who.int/csr/ihr/en/), as adopted by the 
Fifty-Eighth World Health Assembly in 2005, and as entered into effect 
in the United States in July 2007, subject to the U.S. Government's 
reservation and understandings:
    (i) Any of the communicable diseases for which a single case 
requires notification to the World Health Organization (WHO) as an event 
that may constitute a public health emergency of international concern, 
or
    (ii) Any other communicable disease the occurrence of which requires 
notification to the WHO as an event that may constitute a public health 
emergency of international concern. HHS/CDC's determinations will be 
announced by notice in the Federal Register.
    (3) Gonorrhea.
    (4) Hansen's disease, infectious.
    (5) Syphilis, infectious.
    (6) Tuberculosis, active.
    (c) Civil surgeon. A physician designated by DHS to conduct medical 
examinations of aliens in the United States who are applying for 
adjustment of status to permanent residence or who are required by DHS 
to have a medical examination.
    (d) Class A medical notification. Medical notification of:
    (1) A communicable disease of public health significance;
    (2) A failure to present documentation of having received 
vaccination against ``vaccine-preventable diseases'' for an alien who 
seeks admission as an immigrant, or who seeks adjustment of status to 
one lawfully admitted for permanent residence, which shall include at 
least the following diseases: Mumps, measles, rubella, polio, tetanus 
and diphtheria toxoids, pertussis, Haemophilus influenza type B and 
hepatitis B, and any other vaccinations recommended by the Advisory 
Committee for Immunization Practices (ACIP) for which HHS/CDC 
determines, by applying criteria published in the Federal Register, 
there is a public health need at the time of immigration or adjustment 
of status. Provided, however, that in no case shall a Class A medical 
notification be issued for an adopted child who is 10 years of age or 
younger if, prior to the admission of the child, an adoptive parent or 
prospective adoptive parent of the child, who has sponsored the child 
for admission as an immediate relative, has executed an affidavit 
stating that the parent is aware of the vaccination requirement and will 
ensure that, within 30 days of the child's admission, or at the earliest 
time that is medically appropriate, the child will receive the 
vaccinations identified in the requirement.
    (3)(i) A current physical or mental disorder and behavior associated 
with the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior; or
    (4) Drug abuse or addiction.
    (e) Class B medical notification. Medical notification of a physical 
or mental health condition, disease, or disability serious in degree or 
permanent in nature.

[[Page 198]]

    (f) DHS. U.S. Department of Homeland Security.
    (g) Director. The Director of the Centers for Disease Control and 
Prevention or a designee as approved by the Director or Secretary of 
Health and Human Services.
    (h) Drug abuse. ``Current substance use disorder or substance-
induced disorder, mild'' as defined in the most recent edition of the 
Diagnostic and Statistical Manual for Mental Disorders (DSM) as 
published by the American Psychiatric Association, or by another 
authoritative source as determined by the Director, of a substance 
listed in Section 202 of the Controlled Substances Act, as amended (21 
U.S.C. 802).
    (i) Drug addiction. ``Current substance use disorder or substance-
induced disorder, moderate or severe'' as defined in the most recent 
edition of the Diagnostic and Statistical Manual for Mental Disorders 
(DSM), as published by the American Psychiatric Association, or by 
another authoritative source as determined by the Director, of a 
substance listed in Section 202 of the Controlled Substances Act, as 
amended (21 U.S.C. 802).
    (j) Medical examiner. A panel physician, civil surgeon, or other 
physician designated by the Director to perform medical examinations of 
aliens.
    (k) Medical hold document. A document issued to DHS by a quarantine 
officer of HHS at a port of entry which defers the inspection for 
admission until the cause of the medical hold is resolved.
    (l) Medical notification. A medical examination document issued to a 
U.S. consular authority or DHS by a medical examiner, certifying the 
presence or absence of:
    (1) A communicable disease of public health significance;
    (2) Documentation of having received vaccination against ``vaccine-
preventable diseases'' for an alien who seeks admission as an immigrant, 
or who seeks adjustment of status to one lawfully admitted for permanent 
residence, which shall include at least the following diseases: Mumps, 
measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, 
Haemophilus influenza type B and hepatitis B, and any other vaccinations 
recommended by the Advisory Committee for Immunization Practices (ACIP) 
for which HHS/CDC determines, based upon criteria published in the 
Federal Register, there is a public health need at the time of 
immigration or adjustment of status. Provided, however, that in no case 
shall a Class A medical notification be issued for an adopted child who 
is 10 years of age or younger if, prior to the admission of the child, 
an adoptive parent or prospective adoptive parent of the child, who has 
sponsored the child for admission as an immediate relative, has executed 
an affidavit stating that the parent is aware of the vaccination 
requirement and will ensure that, within 30 days of the child's 
admission, or at the earliest time that is medically appropriate, the 
child will receive the vaccinations identified in the requirement;
    (3)(i) A current physical or mental disorder and behavior associated 
with the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (4) Drug abuse or addiction; or
    (5) Any other physical or mental condition, disease, or disability 
serious in degree or permanent in nature.
    (m) Medical officer. A physician or other medical professional 
assigned by the Director to conduct physical and mental examinations of 
aliens on behalf of HHS/CDC.
    (n) Mental disorder. A currently accepted psychiatric diagnosis, as 
defined by the current edition of the Diagnostic and Statistical Manual 
of Mental Disorders published by the American Psychiatric Association or 
by another authoritative source as determined by the Director.
    (o) Panel physician. A physician selected by a United States embassy 
or consulate to conduct medical examinations of aliens applying for 
visas.
    (p) Physical disorder. A currently accepted medical diagnosis, as 
defined by the current edition of the Manual of

[[Page 199]]

the International Classification of Diseases, Injuries, and Causes of 
Death published by the World Health Organization or by another 
authoritative source as determined by the Director.



Sec. 34.3  Scope of examinations.

    (a) General. In performing examinations, medical examiners shall 
consider those matters that relate to the following:
    (1) Communicable disease of public health significance;
    (2) Documentation of having received vaccination against ``vaccine-
preventable diseases'' for an alien who seeks admission as an immigrant, 
or who seeks adjustment of status to one lawfully admitted for permanent 
residence, which shall include at least the following diseases: Mumps, 
measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, 
Haemophilus influenza type B and hepatitis B, and any other vaccinations 
recommended by the Advisory Committee for Immunization Practices (ACIP) 
for which HHS/CDC determines there is a public health need at the time 
of immigration or adjustment of status.
    Provided, however, that in no case shall a Class A medical 
notification be issued for an adopted child who is 10 years of age or 
younger if, prior to the admission of the child, an adoptive parent or 
prospective adoptive parent of the child, who has sponsored the child 
for admission as an immediate relative, has executed an affidavit 
stating that the parent is aware of the vaccination requirement and will 
ensure that, within 30 days of the child's admission, or at the earliest 
time that is medically appropriate, the child will receive the 
vaccinations identified in the requirement;
    (3)(i) A current physical or mental disorder and behavior associated 
with the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (4) Drug abuse or drug addiction; and
    (5) Any other physical or mental health condition, disease, or 
disability serious in degree or permanent in nature.
    (b) Scope of all medical examinations. (1) All medical examinations 
will include the following:
    (i) A general physical examination and medical history, evaluation 
for tuberculosis, and serologic testing for syphilis.
    (ii) A physical examination and medical history for diseases 
specified in Secs. 34.2(b)(1), and 34.2(b)(4) through 34.2(b)(10).
    (2) For the examining physician to reach a determination and 
conclusion about the presence or absence of a physical or mental 
abnormality, disease, or disability, the scope of the examination shall 
include any laboratory or additional studies that are deemed necessary, 
either as a result of the physical examination or pertinent information 
elicited from the alien's medical history or other relevant records.
    (c) Additional medical screening and testing for examinations 
performed outside the United States.
    (1) HHS/CDC may require additional medical screening and testing for 
medical examinations performed outside the United States for diseases 
specified in Secs. 34.2(b)(2) and 34.2(b)(3) by applying the risk-based 
medical and epidemiologic factors in paragraph (d)(2) of this section.
    (2) Such examinations shall be conducted in a defined population in 
a geographic region or area outside the United States as determined by 
HHS/CDC.
    (3) Additional medical screening and testing shall include a medical 
interview, physical examination, laboratory testing, radiologic exam, or 
other diagnostic procedure, as determined by HHS/CDC.
    (4) Additional medical screening and testing will continue until 
HHS/CDC determines such screening and testing is no longer warranted 
based on factors such as the following: Results of disease outbreak 
investigations and response efforts; effectiveness of containment and 
control measures; and the status of an applicable determination

[[Page 200]]

of public health emergency of international concern declared by the 
Director General of the WHO.
    (5) HHS/CDC will directly provide medical examiners information 
pertaining to all applicable additional requirements for medical 
screening and testing, and will post these at the following Internet 
addresses: http://www.cdc.gov/ncidod/dq/technica.htm and http://
www.globalhealth.gov.
    (d) Risk-based approach. (1) HHS/CDC will use the medical and 
epidemiological factors listed in paragraph (d)(2) of this section to 
determine the following:
    (i) Whether a disease as specified in Sec. 34.2(b)(3)(ii) is a 
communicable disease of public health significance;
    (ii) Which diseases in Sec. 34.2(b)(2) and (3) merit additional 
screening and testing, and the geographic area in which HHS/CDC will 
require this screening.
    (2) Medical and epidemiological factors include the following: (i) 
The seriousness of the disease's public health impact;
    (ii) Whether the emergence of the disease was unusual or unexpected;
    (iii) The risk of the spread of the disease in the United States;
    (iv) The transmissibility and virulence of the disease;
    (v) The impact of the disease at the geographic location of medical 
screening; and
    (vi) Other specific pathogenic factors that would bear on a 
disease's ability to threaten the health security of the United States.
    (e) Persons subject to requirement for chest radiograph examination 
and serologic testing. (1) As provided in paragraph (e)(2) of this 
section, a chest radiograph examination and serologic testing for 
syphilis shall be required as part of the examination of the following:
    (i) Applicants for immigrant visas;
    (ii) Students, exchange visitors, and other applicants for non-
immigrant visas required by a U.S. consular authority to have a medical 
examination;
    (iii) Applicants outside the United States who apply for refugee 
status;
    (iv) Applicants in the United States who apply for adjustment of 
their status under the immigration statute and regulations.
    (v) Applicants required by DHS to have a medical examination in 
connection with determination of their admissibility into the United 
States.
    (2) Chest radiograph examination and serologic testing. Except as 
provided in paragraph (e)(2)(iv) of this section, applicants described 
in paragraph (e)(1) of this section shall be required to have the 
following:
    (i) For applicants 15 years of age and older, a chest radiograph 
examination;
    (ii) For applicants under 15 years of age, a chest radiograph 
examination if the applicant has symptoms of tuberculosis, a history of 
tuberculosis, or evidence of possible exposure to a transmissible 
tuberculosis case in a household or other enclosed environment for a 
prolonged period;
    (iii) For applicants 15 years of age and older, serologic testing 
for syphilis and other communicable diseases of public health 
significance as determined by the Director through technical 
instructions.
    (iv) Exceptions. Serologic testing for syphilis shall not be 
required if the alien is under the age of 15, unless there is reason to 
suspect infection with syphilis. An alien, regardless of age, in the 
United States, who applies for adjustment of status to lawful permanent 
resident, shall not be required to have a chest radiograph examination 
unless their tuberculin skin test, or an equivalent test for showing an 
immune response to Mycobacterium tuberculosis antigens, is positive. 
HHS/CDC may authorize exceptions to the requirement for a tuberculin 
skin test, an equivalent test for showing an immune response to 
Mycobacterium tuberculosis antigens, or chest radiograph examination for 
good cause, upon application approved by the Director.
    (3) Immune response to Mycobacterium tuberculosis antigens. (i) All 
aliens 2 years of age or older in the United States who apply for 
adjustment of status to permanent residents, under the immigration laws 
and regulations, or other aliens in the United States who are required 
by DHS to have a medical examination in connection with a determination 
of their admissibility, shall be required to have a tuberculin skin test 
or an equivalent test for showing an immune response to

[[Page 201]]

Mycobacterium tuberculosis antigens. Exceptions to this requirement may 
be authorized for good cause upon application approved by the Director. 
In the event of a positive test of immune response, a chest radiograph 
examination shall be required. If the chest radiograph is consistent 
with tuberculosis, the alien shall be referred to the local health 
authority for evaluation. Evidence of this evaluation shall be provided 
to the civil surgeon before a medical notification may be issued.
    (ii) Aliens in the United States less than 2 years of age shall be 
required to have a tuberculin skin test, or an equivalent, appropriate 
test to show an immune response to Mycobacterium tuberculosis antigens, 
if there is evidence of contact with a person known to have tuberculosis 
or other reason to suspect tuberculosis. In the event of a positive test 
of immune response, a chest radiograph examination shall be required. If 
the chest radiograph is consistent with tuberculosis, the alien shall be 
referred to the local health authority for evaluation. Evidence of this 
evaluation shall be provided to the civil surgeon before a medical 
notification may be issued.
    (iii) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to Mycobacterium 
tuberculosis antigens, and, if indicated, a chest radiograph.
    (iv) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to Mycobacterium 
tuberculosis antigens, and a chest radiograph, regardless of age, if he/
she has symptoms of tuberculosis, a history of tuberculosis, or evidence 
of possible exposure to a transmissible tuberculosis case in a household 
or other enclosed environment for a prolonged period, as determined by 
the Director.
    (4) Additional testing requirements. All applicants may be required 
to undergo additional testing for tuberculosis based on the medical 
evaluation.
    (5) How and where performed. All chest radiograph images used in 
medical examinations performed under the regulations to this part shall 
be large enough to encompass the entire chest.
    (6) Chest x-ray, laboratory, and treatment reports. The chest 
radiograph reading and serologic test results for syphilis shall be 
included in the medical notification. When the medical examiner's 
conclusions are based on a study of more than one chest x-ray image, the 
medical notification shall include at least a summary statement of 
findings of the earlier images, followed by a complete reading of the 
last image, and dates and details of any laboratory tests and treatment 
for tuberculosis.
    (f) Procedure for transmitting records. For aliens issued immigrant 
visas, the medical notification and chest radiograph images, if any, 
shall be placed in a separate envelope, which shall be sealed. When more 
than one chest radiograph image is used as a basis for the examiner's 
conclusions, all images shall be included. Records may be transmitted by 
other means, as approved by the Director.
    (g) Failure to present records. When a determination of 
admissibility is to be made at the U.S. port of entry, a medical hold 
document shall be issued pending completion of any necessary examination 
procedures. A medical hold document may be issued for aliens who:
    (1) Are not in possession of a valid medical notification, if 
required;
    (2) Have a medical notification which is incomplete;
    (3) Have a medical notification which is not written in English;
    (4) Are suspected to have an inadmissible medical condition.
    (h) The Secretary of Homeland Security, after consultation with the 
Secretary of State and the Secretary of Health and Human Services, may 
in emergency circumstances permit the medical examination of refugees to 
be completed in the United States.
    (i) All medical examinations shall be carried out in accordance with 
such technical instructions for physicians conducting the medical 
examination of aliens as may be issued by the Director. Copies of such 
technical instructions are available upon request to the Director, 
Division of Global Migration

[[Page 202]]

and Quarantine, Mailstop E03, HHS/CDC, Atlanta GA 30333.



Sec. 34.4  Medical notifications.

    (a) Medical examiners shall issue medical notifications of their 
findings of the presence or absence of Class A or Class B medical 
conditions. The presence of such condition must have been clearly 
established.
    (b) Class A medical notifications. (1) The medical examiner shall 
report his/her findings to the consular officer or DHS by Class A 
medical notification which lists the specific condition for which the 
alien may be inadmissible, if an alien is found to have:
    (i) A communicable disease of public health significance;
    (ii) A lack of documentation, or no waiver, for an alien who seeks 
admission as an immigrant, or who seeks adjustment of status to one 
lawfully admitted for permanent residence, of having received 
vaccination against vaccine-preventable diseases which shall include at 
least the following diseases: Mumps, measles, rubella, polio, tetanus 
and diphtheria toxoids, pertussis, Haemophilus influenza type B and 
hepatitis B, and any other vaccinations recommended by the Advisory 
Committee for Immunization Practices (ACIP) for which HHS/CDC 
determines, by applying criteria published in the Federal Register, 
there is a public health need at the time of immigration or adjustment 
of status. Provided however, that a Class A medical notification shall 
in no case be issued for an adopted child who is 10 years of age or 
younger if, prior to the admission of the child, an adoptive parent or 
prospective adoptive parent of the child, who has sponsored the child 
for admission as an immediate relative, has executed an affidavit 
stating that the parent is aware of the vaccination requirement and will 
ensure that, within 30 days of the child's admission, or at the earliest 
time that is medically appropriate, the child will receive the 
vaccinations identified in the requirement;
    (iii)(A) A current physical or mental disorder, and behavior 
associated with the disorder that may pose, or has posed, a threat to 
the property, safety, or welfare of the alien or others; or
    (B) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (iv) Drug abuse or drug addiction. Provided, however, that a Class A 
medical notification of a physical or mental disorder, and behavior 
associated with that disorder that may pose, or has posed, a threat to 
the property, safety, or welfare of the alien or others, shall in no 
case be issued with respect to an alien having only mental shortcomings 
due to ignorance, or suffering only from a condition attributable to 
remediable physical causes or of a temporary nature, caused by a toxin, 
medically prescribed drug, or disease.
    (2) The medical notification shall state the nature and extent of 
the abnormality; the degree to which the alien is incapable of normal 
physical activity; and the extent to which the condition is remediable. 
The medical examiner shall indicate the likelihood, that because of the 
condition, the applicant will require extensive medical care or 
institutionalization.
    (c) Class B medical notifications. (1) If an alien is found to have 
a physical or mental abnormality, disease, or disability serious in 
degree or permanent in nature amounting to a substantial departure from 
normal well-being, the medical examiner shall report his/her findings to 
the consular or DHS officer by Class B medical notification which lists 
the specific conditions found by the medical examiner. Provided, 
however, that a Class B medical notification shall in no case be issued 
with respect to an alien having only mental shortcomings due to 
ignorance, or suffering only from a condition attributable to remediable 
physical causes or of a temporary nature, caused by a toxin, medically 
prescribed drug, or disease.
    (2) The medical notification shall state the nature and extent of 
the abnormality, the degree to which the alien is incapable of normal 
physical activity, and the extent to which the condition is remediable. 
The medical examiner shall indicate the likelihood,

[[Page 203]]

that because of the condition, the applicant will require extensive 
medical care or institutionalization.
    (d) Other medical notifications. If as a result of the medical 
examination, the medical examiner does not find a Class A or Class B 
condition in an alien, the medical examiner shall so indicate on the 
medical notification form and shall report his findings to the consular 
or DHS officer.



Sec. 34.5  Postponement of medical examination.

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



Sec. 34.6  Applicability of foreign quarantine regulations.

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



Sec. 34.7  Medical and other care; death.

    (a) An alien detained by or in the custody of DHS may be provided 
medical, surgical, psychiatric, or dental care by HHS through 
interagency agreements under which DHS shall reimburse HHS. Aliens found 
to be in need of emergency care in the course of medical examination 
shall be treated to the extent deemed practical by the attending 
physician and if considered to be in need of further care, may be 
referred to DHS along with the physician's recommendations concerning 
such further care.
    (b) In case of the death of an alien, the body shall be delivered to 
the consular or immigration authority concerned. If such death occurs in 
the United States, or in a territory or possession thereof, public 
burial shall be provided upon request of DHS and subject to its 
agreement to pay the burial expenses. Autopsies shall not be performed 
unless approved by DHS.



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

    (a) The Director shall convene a board of medical officers to 
reexamine an alien:
    (1) Upon the request of DHS for a reexamination by such a board; or
    (2) Upon an appeal to DHS by an alien who, having received a medical 
examination in connection with the determination of admissibility to the 
United States (including examination on arrival and adjustment of status 
as provided in the immigration laws and regulations) has been certified 
for a Class A condition.
    (b) The board shall reexamine an alien certified as:
    (1) Having a communicable disease of public health significance;
    (2) Lacking documentation of having received vaccination against 
``vaccine-preventable diseases'' for an alien who seeks admission as an 
immigrant, or who seeks adjustment of status to one lawfully admitted 
for permanent residence, which shall include at least the following 
diseases: Mumps, measles, rubella, polio, tetanus and diphtheria 
toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and 
any other vaccinations recommended by the Advisory Committee for 
Immunization Practices (ACIP) for which HHS/CDC determines, by applying 
criteria published in the Federal Register, there is a public health 
need at the time of immigration or adjustment of status. Provided, 
however, that in no case shall a Class A medical notification be issued 
for an adopted child who is 10 years of age or younger if, prior to the 
admission of the child, an adoptive or prospective adoptive parent, who 
has sponsored the child for admission as an immediate relative, has 
executed an affidavit stating that the parent is aware of the 
vaccination requirement and will ensure that the child will be 
vaccinated within 30 days of the child's admission, or at the earliest 
time that is medically appropriate.

[[Page 204]]

    (3)(i) Having a current physical or mental disorder and behavior 
associated with the disorder that may pose, or has posed, a threat to 
the property, safety, or welfare of the alien or others; or
    (ii) Having a history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior; or
    (iii) Having drug abuse or drug addiction;
    (c) The board shall consist of the following:
    (1) In circumstances covered by paragraph (b)(1) of this section, 
the board shall consist of at least one medical officer who is 
experienced in the diagnosis and treatment of the communicable disease 
for which the medical notification has been made;
    (2) In circumstances covered by paragraph (b)(2) of this section, 
the board shall consist of at least one medical officer who is 
experienced in the diagnosis and treatment of the vaccine-preventable 
disease for which the medical notification has been made;
    (3) In circumstances covered by paragraph (b)(3) of this section, 
the board shall consist of at least one medical officer who is 
experienced in the diagnosis and treatment of the physical or mental 
disorder, or substance-related disorder for which medical notification 
has been made.
    (d) The decision of the majority of the board shall prevail, 
provided that at least two medical officers concur in the judgment of 
the board.
    (e) Reexamination shall include:
    (1) Review of all records submitted by the alien, other witnesses, 
or the board;
    (2) Use of any laboratory or additional studies which are deemed 
clinically necessary as a result of the physical examination or 
pertinent information elicited from the alien's medical history;
    (3) Consideration of statements regarding the alien's physical or 
mental condition made by a physician after his/her examination of the 
alien; and
    (4) A physical or psychiatric examination of the alien performed by 
the board, at the board's discretion;
    (f) An alien who is to be reexamined shall be notified of the 
reexamination not less than 5 days prior thereto.
    (g) The alien, at his/her own cost and expense, may introduce as 
witnesses before the board such physicians or medical experts as the 
board may in its discretion permit; provided that the alien shall be 
permitted to introduce at least one expert medical witness. If any 
witnesses offered are not permitted by the board to testify (either 
orally or through written testimony), the record of the proceedings 
shall show the reason for the denial of permission.
    (h) Witnesses before the board shall be given a reasonable 
opportunity to review the medical notification and other records 
involved in the reexamination and to present all relevant and material 
evidence orally or in writing until such time as the reexamination is 
declared by the board to be closed. During the course of the 
reexamination the alien's attorney or representative shall be permitted 
to question the alien and he/she, or the alien, shall be permitted to 
question any witnesses offered in the alien's behalf or any witnesses 
called by the board. If the alien does not have an attorney or 
representative, the board shall assist the alien in the presentation of 
his/her case to the end that all of the material and relevant facts may 
be considered.
    (i) Any proceedings under this section may, at the board's 
discretion, be conducted based on the written record, including through 
written questions and testimony.
    (j) The findings and conclusions of the board shall be based on its 
medical examination of the alien, if any, and on the evidence presented 
and made a part of the record of its proceedings.
    (k) The board shall report its findings and conclusions to DHS, and 
shall also give prompt notice thereof to the alien if his/her 
reexamination has been based on his/her appeal. The board's report to 
DHS shall specifically affirm, modify, or reject the findings and 
conclusions of prior examining medical officers.
    (l) The board shall issue its medical notification in accordance 
with the applicable provisions of this part if it

[[Page 205]]

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



PART 35_HOSPITAL AND STATION MANAGEMENT--Table of Contents



                            Subpart A_General

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

                     Subpart B_Transfer of Patients

35.21  Authorization of transfer.
35.22  Attendants.

         Subpart C_Disposition of Articles Produced by Patients

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

      Subpart D_Disposal of Money and Effects of Deceased Patients

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

           Subpart E_Contributions for the Benefit of Patients

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

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

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



                            Subpart A_General



Sec. 35.1  Hospital and station rules.

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

[[Page 206]]



Sec. 35.2  Compliance with hospital rules.

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



Sec. 35.3  Noncompliance; deprivation of privileges.

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



Sec. 35.4  Noncompliance; discharge or transfer.

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



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

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



Sec. 35.6  Admissions; determination of eligibility for care.

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



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

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



Sec. 35.8  Safekeeping of money and effects; withdrawals.

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

[[Page 207]]

may be made only by such representative or in accordance with his 
written directions. No delivery shall be made under this paragraph 
unless (1) the person receiving the money or effects shall sign an 
itemized receipt therefor, or (2) the delivery is witnessed by two 
persons. The provisions of this paragraph do not prohibit withdrawals 
made necessary by the provisions of this part for the disposition of 
money and effects left by patients on death or on departure from the 
station or hospital, or by the provisions of Sec. 35.10.



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

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



Sec. 35.10  Destruction of effects dangerous to health.

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



Sec. 35.11  Clinical records; confidential.

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



Sec. 35.12  Solicitation of legal business prohibited.

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



Sec. 35.13  Entry for negotiation of release or settlement.

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



Sec. 35.14  Solicitation of legal business; negotiation of release
or settlement; assistance prohibited.

    All employees of the Service and all persons attached in any 
capacity to a station or hospital, including patients, are forbidden to 
communicate, directly or indirectly, with any person for the purpose of 
aiding in the solicitation of legal business or in the negotiation of a 
settlement or the obtaining of a general or special release or statement 
from any patient with reference to any illness or personal injury for 
which the patient is receiving care or treatment therein. No patient is 
prohibited by this section from communicating on his own behalf with an 
attorney of his choice or with other persons.

[[Page 208]]



Sec. 35.15  Consent to operative procedures.

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



Sec. 35.16  Autopsies and other post-mortem operations.

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

[25 FR 6331, July 6, 1960]



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

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

(1) Photocopy reproduction of a clinical record or other
 document (through use of facility equipment):
  (a) Processing (searching, preparation of record and use of      $3.25
   equipment), first page.......................................
  (b) Each additional page......................................     .25
(2) Certification, per document.................................     .25
(3) Unsuccessful searching, per hour (minimum charge 1 hour)....    2.50
(4) Clinical abstracts, per request.............................    3.00
(5) Arranging commercial duplication of a clinical record, per    \1\ 0.
 request........................................................      50
(6) If the requested material is to be transmitted by registered
 mail, airmail, or special delivery mail, the postal fees
 therefor shall be added to the other fees provided above,
 unless the applicant has included proper postage or stamped
 return envelopes for this purpose.
 
\1\ The private concern which duplicates records for an applicant will
  make a separate charge therefor and will bill the applicant directly.

    (d) Waiver of fee. The prescribed fee may be waived, in the 
discretion of the medical officer in charge, under the following 
circumstances:
    (1) When the service or document is requested by another agency of 
the Federal Government for use in carrying out official Government 
business.
    (2) When a clinical record is requested for the purpose of providing 
continued medical care to a Service beneficiary by a non-Service 
physician, clinic, or hospital, in which case the record will be 
forwarded only to the physician, clinic, or hospital concerned.
    (3) When the service or document is requested by an attorney in the 
prosecution of a Service beneficiary's personal injury claim against a 
third person, involving the concurrent assertion of a government medical 
care claim under 42 U.S.C. 2651-2653. In such case, the service or 
document requested will

[[Page 209]]

be furnished only upon compliance with all additional requirements for 
the release of records in third party recovery cases, including the 
proper execution of form PHS-4686, Agreement to Assign Claim Upon 
Request.
    (4) When the service or document is requested by, and furnished to, 
a Member of Congress for official use.
    (5) When the service or document is requested by, and furnished to, 
a court in lieu of the personal court appearance of an employee of the 
Public Health Service.
    (6) When the service or document is required to be furnished free in 
accordance with a Federal statute or an Executive order.
    (7) When the furnishing of the service or document requested without 
charge would be an appropriate courtesy to a foreign country or 
international organization.

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

[32 FR 6842, May 4, 1967]



                     Subpart B_Transfer of Patients



Sec. 35.21  Authorization of transfer.

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



Sec. 35.22  Attendants.

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



         Subpart C_Disposition of Articles Produced by Patients



Sec. 35.31  Retention by patients.

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



Sec. 35.32  Board of appraisers.

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



Sec. 35.33  Sale; prices; deposit of proceeds.

    The board shall determine and redetermine from time to time the 
prices at which articles are to be sold, and in doing so shall consider 
the cost of materials used, reasonable handling charges, and the fair 
market value of the articles. The sale price shall be indicated on each 
article by tag or other appropriate means, and a list of articles 
offered for sale and their respective sale prices shall be posted from 
time to time in the hospital or station area. In its discretion, the 
board may offer such articles for purchase by other patients or by 
charitable organizations before offering them for purchase to the 
general public. No article shall be sold or resold to any officer or 
employee of the Service. Moneys received from the sale of articles shall 
be deposited into the Treasury to the credit of the appropriation from 
which

[[Page 210]]

the materials for making such articles were purchased.



Sec. 35.34  Resale.

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



Sec. 35.35  Unsalable articles.

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



      Subpart D_Disposal of Money and Effects of Deceased Patients



Sec. 35.41  Inventory.

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



Sec. 35.42  Notice upon death.

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



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

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



Sec. 35.44  Delivery to legal representative; to other claimants
if value is $1,000 or less.

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

[[Page 211]]



Sec. 35.45  Disposition of effects; exceptions.

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



Sec. 35.46  Conflicting claims.

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



Sec. 35.47  Disposition of Government checks.

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



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

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



Sec. 35.49  Sale of unclaimed effects; procedures.

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

[[Page 212]]

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



Sec. 35.50  Disposition of unsold effects.

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



Sec. 35.51  Manner of delivery; costs, receipts.

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



Sec. 35.52  Delivery of possession only; title unaffected.

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



           Subpart E_Contributions for the Benefit of Patients

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

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



Sec. 35.61  Applicability.

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



Sec. 35.62  Acceptance of contributions.

    (a) The officer in charge of a hospital or station or his delegate 
may accept contributions of money or personal property which are donated 
for the general benefit of all patients within the hospital or station 
(or a ward or unit thereof) without further specification or conditions 
as to use. Contributions tendered subject to conditions by the donor, 
such as expenditure or use

[[Page 213]]

only on behalf of certain patients or for specific purposes, may not be 
accepted.
    (b) Contribution of money or property shall be accepted in writing.



Sec. 35.63  Report of and accounting for contributions.

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



Sec. 35.64  Donors.

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



Sec. 35.65  Acceptable personal property.

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



Sec. 35.66  Expenditure of cash contributions.

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



PART 37_SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF COAL MINERS--
Table of Contents



                 Subpart_Chest Radiographic Examinations

Sec.
37.1  Scope.
37.2  Definitions.
37.3  Chest radiographs required for miners.
37.4  Chest radiographic examinations conducted by the Secretary.
37.10  Standards incorporated by reference.
37.20  Miner identification document.

      Specifications for Performing Chest Radiographic Examinations

37.40  General provisions.
37.41  Chest radiograph specifications--film.
37.42  Chest radiograph specifications--digital radiography systems.
37.43  Approval of radiographic facilities that use film radiography 
          systems..
37.44  Approval of radiographic facilities that use digital radiography 
          systems.
37.45  Protection against radiation emitted by radiographic equipment.

  Specifications for Interpretation, Classification, and Submission of 
                            Chest Radiographs

37.50  Interpreting and classifying chest radiographs--film radiography 
          systems.
37.51  Interpreting and classifying chest radiographs--digital 
          radiography systems.
37.52  Proficiency in the use of systems for classifying the 
          pneumoconioses.
37.53  Method of obtaining definitive chest radiograph classifications.
37.54  Notification of abnormal radiographic findings.
37.60  Submitting required chest radiograph classification and miner 
          identification documents.

[[Page 214]]

                   Review and Availability of Records

37.70  Review of classifications.
37.80  Availability of records for radiographs.

                       Subpart_Spirometry Testing

37.90  Scope.
37.91  Definitions.
37.92  Spirometry testing required for miners.
37.93  Approval of spirometry facilities.
37.94  Respiratory assessment form.
37.95  Specifications for performing spirometry tests.
37.96  Spirometry interpretations, reports, and submission.
37.97  Notification of spirometry results.
37.98  Standards incorporated by reference.

                      Subpart_General Requirements

37.100  Coal mine operator plan for medical examinations.
37.101  Approval of plans.
37.102  Transfer of affected miner to less dusty area.
37.103  Medical examination at miner's expense.

                            Subpart_Autopsies

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

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

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



                 Subpart_Chest Radiographic Examinations



Sec. 37.1  Scope.

    Under this subpart, coal mine operators are required to provide 
radiographic examinations to each current and new coal miner, using 
medical facilities approved by NIOSH in accordance with standards 
established in this subpart.

[79 FR 45118, Aug. 4, 2014]



Sec. 37.2  Definitions.

    Any term defined in the Federal Mine Safety and Health Act of 1977 
(30 U.S.C. 801 et seq., Pub. L. 95-164, as amended) and not defined 
below will have the meaning given it in the Act. As used in this 
subpart:
    Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 
801, et seq., Pub. L. 95-164, as amended).
    B Reader means a physician certified by NIOSH as able to classify 
chest radiographs using the ILO Classification system, pursuant to 
Sec. 37.52(b).
    Chest radiograph means a single posteroanterior radiographic 
projection or radiograph of the chest at full inspiration recorded on 
either film or digital radiography systems.
    Convenient time and place means that an examination conducted 
pursuant to this part must be given at a reasonable hour in the locality 
in which the miner resides or a location that is equally accessible to 
the miner. For example, examinations at the mine during, immediately 
preceding, or immediately following work and a ``no appointment'' 
examination at a medical facility in a community easily accessible to 
the residences of a majority of the miners working at the mine will be 
considered of equivalent convenience for purposes of this definition.
    Digital radiography systems, as used in this context, include both 
Digital Radiography (DR) and Computed Radiography (CR) systems.
    (1) Computed radiography (CR) is the term for digital radiographic 
image acquisition systems that detect radiographic signals using a 
cassette-based photostimulable storage phosphor. Subsequently, the 
cassette is processed using a stimulating laser beam to convert the 
latent radiographic image to electronic signals which are then processed 
and stored so they can be displayed.
    (2) Digital radiography (DR) is the term used for digital 
radiographic image acquisition systems in which the radiographic signals 
received by the image detector are converted nearly instantaneously to 
electronic signals without movable cassettes.
    Facility means a facility or organization licensed to provide health 
care by the State or Territory in which services are provided, such as a 
hospital, a clinic, or other provider that performs medical 
examinations.
    ILO Classification means the classification of radiographs using the 
International Classification of Radiographs of Pneumoconioses, a system 
devised

[[Page 215]]

by an international committee of the International Labour Office (ILO), 
including a complete set of standard film radiographs or digital chest 
image files available from the ILO or other set of chest image files 
approved by NIOSH as equivalent. The ILO Classification is incorporated 
by reference into Secs. 37.50(a) and (c) and 37.51(b).
    MSHA means the Mine Safety and Health Administration, Department of 
Labor.
    Miner means any individual working in a coal or other mine.
    NIOSH means the National Institute for Occupational Safety and 
Health (NIOSH), located within the Centers for Disease Control and 
Prevention (CDC). Within NIOSH, the Respiratory Health Division (RHD), 
1095 Willowdale Road, Morgantown, WV 26505, is the organizational unit 
that has programmatic responsibility for the Coal Workers' Health 
Surveillance Program.
    NIOSH representative means employees of CDC/NIOSH and employees of 
CDC contractors.
    Operator means any owner, lessee, or other person who operates, 
controls, or supervises a coal or other mine or any independent 
contractor performing services or construction at such mine.
    Panel of B Readers means the group of physicians that are currently 
certified by NIOSH as B Readers and who classify or otherwise evaluate 
radiographs for the Coal Workers' Health Surveillance Program.
    Pre-placement physical examination means any medical examination 
that includes a chest radiographic examination given in accordance with 
the specifications of this Part to a person not previously employed by 
the same operator. Such examinations should be conducted consistent with 
applicable law, including the Americans with Disabilities Act of 1990, 
which provides that pre-placement examinations take place only after an 
offer of employment has been made and subject to certain restrictions 
(42 U.S.C. 12112(d)).
    Qualified medical physicist means an individual who is trained in 
evaluating the performance of radiographic equipment including radiation 
controls and facility quality assurance programs, and has the relevant 
current certification by a competent U.S. national board, or 
unrestricted license or approval from a U.S. State or territory.
    Radiographic technique chart means a table that specifies the types 
of cassette, intensifying screen, film or digital detector, grid, 
filter, and lists X-ray machine settings (timing, kVp, mA) that enables 
the radiographer to select the correct settings based on the body 
habitus or the thickness of the chest tissue.
    Radiologic technologist means an individual who has met the 
requirements for privileges to perform general radiographic procedures 
and for competence in using the equipment and software employed by the 
examining facility to obtain chest radiographs as specified by the State 
or Territory and examining facility in which such services are provided. 
Optimally, such an individual will have completed a formal training 
program in radiography leading to a certificate, an associate degree, or 
a bachelor's degree and participated in the voluntary initial 
certification and annual renewal of registration for radiologic 
technologists offered by the American Registry of Radiologic 
Technologists.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved may be delegated.
    Soft copy means the image of a coal miner's chest radiograph 
acquired using a digital radiography system, viewed at the full 
resolution of the image acquisition system using an electronic medical 
image display device.

[77 FR 56726, Sept. 13, 2012, as amended at 79 FR 45118, Aug. 4, 2014; 
81 FR 73279, Oct. 24, 2016]



Sec. 37.3  Chest radiographs required for miners.

    (a) Voluntary examinations. Every operator must provide to each 
miner who is employed in or at any of its coal mines and who was 
employed in coal mining prior to December 30, 1969, or who has completed 
the required examinations under paragraph (b) of this section an 
opportunity for a chest radiograph at no cost to the miner in accordance 
with this subpart:

[[Page 216]]

    (1) NIOSH will notify the operator of each coal mine of a period 
within which the operator may provide examinations to each miner 
employed at its coal mine. The period must begin no sooner than 3.5 
years and end no later than 4.5 years subsequent to the ending date of 
the previous 6-month period specified for a coal mine either by the 
operator on an approved plan or by NIOSH if the operator did not submit 
an approved plan. Within the period specified for each mine, the 
operator may select a 6-month period within which to provide 
examinations in accordance with a plan approved under Sec. 37.101.
    (2) Within either the next or future period(s) specified to the 
operator for each of its coal mines, the operator of the coal mine may 
select a different 6-month period for each of its mines within which to 
offer examinations. In the event the operator does not submit an 
approved plan, NIOSH will specify a 6-month period to the operator 
within which miners must have the opportunity for examinations.
    (b) Mandatory examinations. Every operator must provide to each 
miner who begins working in or at an underground coal mine for the first 
time after December 30, 1969 or in or at a surface coal mine for the 
first time after August 1, 2014:
    (1) An initial chest radiograph, as soon as possible, but in no 
event later than 30 days after commencement of employment or within 30 
days of approval of a plan to provide chest radiographs. An initial 
chest radiograph given to a miner according to former regulations for 
this subpart prior to August 1, 2014 will also be considered as 
fulfilling this requirement.
    (2) A second chest radiograph, in accordance with this subpart, 3 
years following the initial examination if the miner is still engaged in 
coal mining. A second radiograph given to a miner according to former 
regulations under this subpart prior to August 1, 2014 will be 
considered as fulfilling this requirement.
    (3) A third chest radiograph 2 years following the second chest 
radiograph if the miner is still engaged in coal mining and if the 
second radiograph shows evidence of category 1 (1/0, 1/1, 1/2), category 
2 (2/1, 2/2, 2/3), category 3 (3/2, 3/3, 3/+) simple pneumoconiosis, or 
complicated pneumoconiosis (ILO Classification) or if the second 
spirometry examination specified in Sec. 37.92(b)(2) shows evidence of 
decreased lung function to the extent specified in Sec. 37.92(b)(3).
    (c) Notification. NIOSH will notify the miner when he or she is due 
to receive the second or third mandatory examination under paragraph (b) 
of this section. NIOSH will notify the coal mine operator when the miner 
is to be given a second examination.
    (1) The operator will be notified of a miner's third examination 
only with the miner's written consent. The notice to the operator will 
not state the medical reason for the examination or that it is the third 
examination in the series.
    (2) If the miner is notified by NIOSH that the third mandatory 
examination is due and the operator is not so notified, availability of 
the radiographic examination under the NIOSH-approved operator's plan 
will constitute the operator's compliance with the requirement to 
provide a third mandatory examination even if the miner refuses to take 
the examination.
    (d) Availability of chest radiographs. The opportunity for chest 
radiographs to be made available by an operator for purposes of this 
subpart must be provided in accordance with a plan that has been 
submitted and approved in accordance with this part.

[81 FR 73280, Oct. 24, 2016]



Sec. 37.4  Chest radiographic examinations conducted by the Secretary.

    (a) The Secretary will give chest radiographs or make arrangements 
with an appropriate person, agency, or institution to give the chest 
radiographs and with A or B Readers to interpret the radiographs 
required under this subpart in the locality where the miner resides, at 
the mine, or at a medical facility easily accessible to a mining 
community or mining communities, under the following circumstances:
    (1) Where, in the judgment of the Secretary, due to the lack of 
adequate medical or other necessary facilities or personnel at the mine 
or in the locality

[[Page 217]]

where the miner resides, the required radiographic examination cannot be 
given.
    (2) Where the operator has not submitted an approvable plan.
    (3) Where, after commencement of an operator's program pursuant to 
an approved plan and after notice to the operator of his failure to 
follow the approved plan and, after allowing 15 calendar days to bring 
the program into compliance, the Secretary determines and notifies the 
operator in writing that the operator's program still fails to comply 
with the approved plan.
    (b) The operator of the mine must reimburse the Secretary or other 
person, agency, or institution as the Secretary may direct, for the cost 
of conducting each examination made in accordance with this section.
    (c) All examinations given or arranged by the Secretary will comply 
with the time requirements of Sec. 37.3. Whenever the Secretary gives or 
arranges for the examinations of miners at a time, a written notice of 
the arrangements will be sent to the operator who must post the notice 
on the mine bulletin board.

[81 FR 73281, Oct. 24, 2016]



Sec. 37.10  Standards incorporated by reference.

    (a) Certain material is incorporated by reference into this subpart, 
Subpart--Chest Radiographic Examinations, with the approval of the 
Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 
51. To enforce any edition other than that specified in this section, 
NIOSH must publish notice of change in the Federal Register and the 
material must be available to the public. All approved material is 
available for inspection at NIOSH, Respiratory Health Division, 1095 
Willowdale Road, Morgantown, WV 26505. To arrange for an inspection at 
NIOSH, call 304-285-5749. Copies are also available for inspection at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030 or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (b) American Association of Physicists in Medicine, Order 
Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI 
53705, http://www.aapm.org/pubs/reports:
    (1) AAPM On-Line Report No. 03, Assessment of Display Performance 
for Medical Imaging Systems, April 2005, into Sec. 37.51(d) and (e).
    (2) AAPM Report No. 14, Performance Specifications and Acceptance 
Testing for X-Ray Generators and Automatic Exposure Control Devices, 
Report of the Diagnostic X-Ray Imaging Committee Task Group on 
Performance Specifications and Acceptance Testing for X-Ray Generators 
and Automatic Exposure Control Devices, published by the American 
Institute of Physics for AAPM, January 1985, into Secs. 37.42(h) and 
37.44(g).
    (3) AAPM Report No. 31, Standardized Methods for Measuring 
Diagnostic X-Ray Exposures, Report of Task Group 8, Diagnostic X-Ray 
Imaging Committee, published by the American Institute of Physics, July 
1990, into Sec. 37.44(g).
    (4) AAPM Report No. 74, Quality Control in Diagnostic Radiology, 
Report of Task Group 12, Diagnostic X-Ray Imaging Committee, published 
by Medical Physics Publishing for AAPM, July 2002, into Secs. 37.42(h), 
37.43(f), and 37.44(g).
    (5) AAPM Report No. 93, Acceptance Testing and Quality Control of 
Photostimulable Storage Phosphor Imaging Systems, October 2006, into 
Secs. 37.42(i) and 37.44(g).
    (6) AAPM Report No. 116, An Exposure Indicator for Digital 
Radiography, Report of AAPM Task Group 116, published by AAPM, July 
2009, into Sec. 37.44(g).
    (c) American College of Radiology, 1891 Preston White Dr., Reston, 
VA 20191, http://www.acr.org:
    (1) ACR Practice Guideline for Diagnostic Reference Levels in 
Medical X-Ray Imaging, Revised 2008 (Resolution 3), into Secs. 37.42(i) 
and 37.44(g).
    (2) [Reserved]
    (d) International Labour Office, CH-1211 Geneva 22, Switzerland, 
http://www.ilo.org/publns:
    (1) Guidelines for the Use of the ILO International Classification 
of

[[Page 218]]

Radiographs of Pneumoconioses, Revised Edition 2011, into 
Secs. 37.50(a), 37.50(c), and 37.51(b).
    (2) [Reserved]
    (e) National Council on Radiation Protection and Measurements, NCRP 
Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095, 
Telephone (800) 229-2652, http://www.ncrppublications.org:
    (1) NCRP Report No. 102, Medical X-ray, Electron Beam, and Gamma-Ray 
Protection for Energies Up to 50 MeV (Equipment Design, Performance, and 
Use), issued June 30, 1989, into Sec. 37.45.
    (2) NCRP Report No. 105, Radiation Protection for Medical and Allied 
Health Personnel, issued October 30, 1989, into Sec. 37.45.
    (3) NCRP Report No. 147, Structural Shielding Design for Medical X-
Ray Imaging Facilities, revised March 18, 2005, into Sec. 37.45.
    (f) National Electrical Manufacturers Association, 1300 N. 17th 
Street, Rosslyn, VA 22209, http://medical.nema.org:
    (1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 3: Information Object Definitions, 
copyright 2011, into Sec. 37.42(i).
    (2) DICOM Standard PS3.4-2011, Digital Imaging and Communications in 
Medicine (DICOM) standard, Part 4: Service Class Specifications, 
copyright 2011, into Sec. 37.42(i).
    (3) DICOM Standard PS 3.10-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 10: Media Storage and File Format for 
Media Interchange, copyright 2011, into Sec. 37.42(i).
    (4) DICOM Standard PS 3.11-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 11: Media Storage Application 
Profiles, copyright 2011, into Sec. 37.42(i).
    (5) DICOM Standard PS 3.12-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 12: Media Formats and Physical Media 
for Media Interchange, copyright 2011, into Secs. 37.42(i) and 37.44(a).
    (6) DICOM Standard PS 3.14-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 14: Grayscale Standard Display 
Function, copyright 2011, into Secs. 37.42(i)(5) and 37.51(d).
    (7) DICOM Standard PS 3.16-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 16: Content Mapping Resource, 
copyright 2011, into Sec. 37.42(i).

[81 FR 73281, Oct. 24, 2016]



Sec. 37.20  Miner identification document.

    As part of the examination, a Miner Identification Document (CDC/
NIOSH (M)2.9) which includes an occupational history questionnaire must 
be completed for each miner at the facility where the examination is 
made (this document is required for both radiographic and spirometry 
examinations conducted pursuant to this part).

[81 FR 73282, Oct. 24, 2016]

      Specifications for Performing Chest Radiographic Examinations



Sec. 37.40  General provisions.

    (a) The chest radiographic examination must be given at a convenient 
time and place.
    (b) The chest radiographic examination consists of the chest 
radiograph, a completed Chest Radiograph Classification Form (CDC/NIOSH 
2.8), and a completed Miner Identification Document (CDC/NIOSH 2.9).
    (c) A radiographic examination must be made in a facility approved 
in accordance with Sec. 37.43 or Sec. 37.44. Chest radiographs of miners 
under this section must be performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec. 37.2.

[81 FR 73282, Oct. 24, 2016]



Sec. 37.41  Chest radiograph specifications--film.

    (a) Miners must be disrobed from the waist up at the time the 
radiograph is given. The facility must provide a dressing area and for 
those miners who

[[Page 219]]

wish to use one, the facility will provide a clean gown. Facilities must 
be heated to a comfortable temperature.
    (b) Every chest radiograph must be a single posteroanterior 
projection at full inspiration on a film being no less than 14 by 17 
inches and no greater than 16 by 17 inches. The film and cassette must 
be capable of being positioned both vertically and horizontally so that 
the chest radiograph will include both apices and costophrenic angles. 
If a miner is too large to permit the above requirements, then the 
projection must include both apices with minimum loss of the 
costophrenic angle.
    (c) Chest radiographs of miners under this section must be 
performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec. 37.2.
    (d) Radiographs must be made with a diagnostic X-ray machine with a 
maximum actual (not nominal) source (focal spot) of 2 mm, as measured in 
two orthogonal directions.
    (e) Except as provided in this paragraph (e), radiographs must be 
made with units having generators that comply with the following:
    (1) The generators of existing radiographic units acquired by the 
examining facility prior to July 27, 1973, must have a minimum rating of 
200 mA at 100 kVp;
    (2) Generators of units acquired subsequent to that date must have a 
minimum rating of 300 mA at 125 kVp.
    (f) Radiographs made with battery-powered mobile or portable 
equipment must be made with units having a minimum rating of 100 mA at 
110 kVp at 500 Hz, or of 200 mA at 110 kVp at 60 Hz.
    (g) Capacitor discharge and field emission units may be used if the 
model of such units is approved by NIOSH for quality, performance, and 
safety. NIOSH will consider such units for approval when listed by a 
facility seeking approval under Secs. 37.43 or 37.44.
    (h) Radiographs must be given only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The beam 
limiting device must provide rectangular collimation and must be of the 
type described in 21 CFR 1020.31(d), (e), (f), and (g). The use of such 
a device must be discernible from an examination of the radiograph.
    (i) To ensure high quality chest radiographs:
    (1) The maximum exposure time must not exceed 50 milliseconds except 
that with single phase units with a rating less than 300 mA at 125 kVp 
and subjects with chests over 28 cm posteroanterior, the exposure may be 
increased to not more than 100 milliseconds;
    (2) The source or focal spot to film distance must be at least 6 
feet;
    (3) Medium speed film and medium speed intensifying screens are 
recommended. However, any film-screen combination, the rated ``speed'' 
of which is at least 100 and does not exceed 300, that produces 
radiographs with spatial resolution, contrast, latitude and quantum 
mottle similar to those of systems designated as ``medium speed'' may be 
employed;
    (4) Film-screen contact shall be maintained and verified at 6 month 
or shorter intervals;
    (5) Intensifying screens shall be inspected at least once a month 
and cleaned when necessary by the method recommended by the 
manufacturer;
    (6) All intensifying screens in a cassette shall be of the same type 
and made by the same manufacturer;
    (7) A suitable grid or other means of reducing scattered radiation 
must be used;
    (8) The geometry of the radiographic system shall insure that the 
central axis (ray) of the primary beam is perpendicular to the plane of 
the film surface and impinges on the center of the film;
    (9) A formal quality assurance program shall be established at each 
facility.
    (j) Radiographic processing:
    (1) Either automatic or manual film processing is acceptable. A 
constant time-temperature technique shall be meticulously employed for 
manual processing.

[[Page 220]]

    (2) If mineral or other impurities in the processing water introduce 
difficulty in obtaining a high-quality radiograph, a suitable filter or 
purification system must be used.
    (k) Before the miner is advised that the examination is concluded, 
the radiograph must be processed and inspected and accepted for quality 
by the physician, or if the physician is not available, acceptance may 
be made by the radiologic technologist. In a case of a substandard 
radiograph, another must be immediately made. All substandard 
radiographs must be clearly marked as rejected and promptly sent to 
NIOSH for disposal.
    (l) An electric power supply shall be used which complies with the 
voltage, current, and regulation specified by the manufacturer of the 
machine.
    (m) A test object may be required on each radiograph for an 
objective evaluation of film quality at the discretion of NIOSH.
    (n)(1) Each radiograph made hereunder must be permanently and 
legibly marked with:
    (i) The name and address or NIOSH approval number of the facility at 
which it is made;
    (ii) The miner's Social Security number;
    (iii) The miner's date of birth; and
    (iv) The date of the radiograph.
    (2) No other identifying markings may be recorded on the radiograph.

[43 FR 33715, Aug. 1, 1978, as amended at 52 FR 7866, Mar. 13, 1987; 77 
FR 56729, Sept. 13, 2012]



Sec. 37.42  Chest radiograph specifications--digital radiography
systems.

    (a) Miners must be disrobed from the waist up at the time the 
radiograph is given. The facility must provide a private dressing area 
and for those miners who wish to use one, the facility must provide a 
clean gown. Facilities must be heated to a comfortable temperature.
    (b) Every digital chest radiograph taken as required under this 
section must be a single posteroanterior projection at full inspiration 
on a digital detector with sensor area being no less than 1505 cm square 
centimeters with a minimum width of 35cm. The imaging plate must have a 
maximum pixel pitch of 200mm, with a minimum bit depth of 10. Spatial 
resolution must be at least 2.5 line pairs per millimeter. The storage 
phosphor cassette or digital image detector must be positioned either 
vertically or horizontally so that the image includes the apices and 
costophrenic angles of both right and left lungs. If the detector cannot 
include the apices and costophrenic angles of both lungs as described, 
then two side-by-side images can be obtained that together include the 
apices and the costophrenic angles of both right and left lungs.
    (c) Chest radiographs of miners under this section must be 
performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec. 37.2.
    (d) Radiographs must be made with a diagnostic X-ray machine with a 
maximum actual (not nominal) source (focal spot) of 2 mm, as measured in 
two orthogonal directions.
    (e) Radiographs must be made with units having generators which have 
a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage must be at 
least the minimum as recommended by the manufacturer for chest 
radiography.
    (f) An electric power supply must be used that complies with the 
voltage, current, and regulation specified by the manufacturer of the 
machine. If the manufacturer or installer of the radiographic equipment 
recommends equipment for control of electrical power fluctuations, such 
equipment must be used as recommended.
    (g) Radiographs must be obtained only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The beam 
limiting device must provide rectangular collimation. Electronic post-
image acquisition ``shutters'' available on some CR and DR systems that 
limit the size of the final image and that simulate collimator limits 
must not be used. The use and effect of the beam limiting device must be 
discernible on the resulting image.

[[Page 221]]

    (h) Radiographic technique charts must be used that are developed 
specifically for the X-ray system and detector combinations used, 
indicating exposure parameters by anatomic measurements.
    (1) If automated exposure control devices are used, performance must 
be documented by a medical physicist utilizing the image capture systems 
and exposure parameters used at the facility for chest imaging, using 
methods recommended in AAPM Report No. 74, pages 17-18, and in AAPM 
Report No. 14, pages 61-62 (incorporated by reference, see Sec. 37.10).
    (2) Exposure parameters achieved during the evaluation of the 
automated exposure system must be recorded by the medical physicist in a 
written report or electronic file that is stored at the facility and 
available for inspection by NIOSH for a minimum of 5 years after the 
miner's examination.
    (i) To ensure high quality digital chest radiographs:
    (1) The maximum exposure time must not exceed 50 milliseconds except 
for subjects with chests over 28 centimeters posteroanterior, for whom 
the exposure time must not exceed 100 milliseconds;
    (2) The distance from source or focal spot to detector must be at 
least 70 inches (or 180 centimeters if measured in centimeters);
    (3) The exposure setting for chest images must be within the range 
of 100-300 equivalent exposure speeds and must comply with ACR Practice 
Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging, 
Section V--Diagnostic Reference Levels For Imaging With Ionizing 
Radiation and Section VII--Radiation Safety in Imaging (incorporated by 
reference, see Sec. 37.10). Radiation exposures should be periodically 
measured and patient radiation doses estimated by the medical physicist 
to assure doses are as low as reasonably achievable.
    (4) Digital radiography system performance, including resolution, 
modulation transfer function (MTF), image signal-to-noise and detective 
quantum efficiency must be evaluated and judged acceptable by a 
qualified medical physicist using the specifications in AAPM Report No. 
93, pages 1-68 (incorporated by reference, see Sec. 37.10). Image 
management software and settings for routine chest imaging must be used, 
including routine amplification of digital detector signal as well as 
standard image post-processing functions. Image or edge enhancement 
software functions must not be employed unless they are integral to the 
digital radiography system (not elective); in such cases, only the 
minimum image enhancement permitted by the system may be employed.
    (5)(i) The image object, transmission and associated data storage, 
file format, and transmission of associated information must conform to 
the following components of the Digital Imaging and Communications in 
Medicine (DICOM) standard (incorporated by reference, see Sec. 37.10):
    (A) DICOM Standard PS 3.3-2011, Annex A--Composite Information 
Object Definitions, sections: Computed Radiography Image Information 
Object Definition; Digital X-Ray Image Information Object Definition; X-
Ray Radiation Dose SR Information Object Definition; and Grayscale 
Softcopy Presentation State Information Object Definition.
    (B) DICOM Standard PS3.4-2011, Annex B--Storage Service Class; Annex 
N--Softcopy Presentation State Storage SOP Classes; Annex O--Structured 
Reporting Storage SOP Classes.
    (C) DICOM Standard PS 3.10-2011.
    (D) DICOM Standard PS 3.11-2011
    (E) DICOM Standard PS 3.12-2011.
    (F) DICOM Standard PS 3.14-2011.
    (G) DICOM Standard PS 3.16-2011.
    (ii) Identification of each miner, chest image, facility, date and 
time of the examination must be encoded within the image information 
object, according to DICOM Standard PS 3.3-2011, Information Object 
Definitions, for the DICOM ``DX'' object. If data compression is 
performed, it must be lossless. Exposure parameters (kVp, mA, time, beam 
filtration, scatter reduction, radiation exposure) must be stored in the 
DX information object.
    (iii) Exposure parameters as defined in the DICOM Standard PS 3.16-
2011 must additionally be provided, when such parameters are available 
from the facility digital image acquisition system or recorded in a 
written report or

[[Page 222]]

electronic file and either transmitted to NIOSH or stored at the 
facility and available for inspection by NIOSH for 5 years after the 
examination.
    (6) A specific test object may be required on each radiograph for an 
objective evaluation of image quality at the discretion of NIOSH.
    (7) CR imaging plates must be inspected at least once a month and 
cleaned when necessary by the method recommended by the manufacturer;
    (8) A grid or air gap for reducing scattered radiation must be used; 
grids must not be used that cause Moire interference patterns in either 
horizontal or vertical images.
    (9) The geometry of the radiographic system must ensure that the 
central axis (ray) of the primary beam is perpendicular to the plane of 
the CR imaging plate, or DR detector and is correctly aligned to the 
grid;
    (10) Radiographs must not be made when the environmental 
temperatures and humidity in the facility are outside the manufacturer's 
recommended range of the CR and DR equipment to be used.
    (11) Before the miner is advised that the examination is concluded, 
the radiograph must be processed and inspected and accepted for quality 
by the physician, or if the physician is not available, acceptance may 
be made by the radiologic technologist. In a case of a substandard 
radiograph, another must be made immediately. Unacceptable digital image 
files must be fully deleted immediately or rendered permanently 
inaccessible in the event that permanent deletion is not technologically 
feasible.
    (j) The following are not authorized for use under this section:
    (1) Digital images derived from film screen chest radiographs (e.g., 
by scanning or digital photography); or
    (2) Images that were acquired using digital systems and then printed 
on transparencies for back-lighted display (e.g., using tradition view 
boxes).

[77 FR 56730, Sept. 13, 2012]



Sec. 37.43  Approval of radiographic facilities that use film
radiography systems.

    (a) Facilities become eligible to participate in this program by 
demonstrating their ability to make high quality diagnostic chest 
radiographs by submitting to NIOSH six or more sample chest radiographs 
made and processed at the applicant facility and which are of acceptable 
quality to one or more individuals selected by NIOSH from the panel of B 
Readers. Applicants must also submit a radiograph of a plastic step-
wedge object \1\ or other test object (available on loan from NIOSH) 
that was made and processed at the same time with the same technique as 
the radiographs submitted and processed at the facility for which 
approval is sought.
---------------------------------------------------------------------------

    \1\ The plastic step-wedge object is described in E. Dale Trout, 
John P. Kelley, A Phantom for the Evaluation of Techniques and Equipment 
Used for Roentgenography of the Chest, Amer J Roentgenol 
1973;117(4):771-776.
---------------------------------------------------------------------------

    (1) At least one chest radiograph and one test object radiograph 
must have been made with each unit to be used hereunder.
    (2) All radiographs must have been made within 15 calendar days 
prior to submission and must be marked to identify the facility where 
each radiograph was made, the X-ray machine used, and the date each was 
made.
    (3) The chest radiographs will be returned and may be the same 
radiographs submitted pursuant to Sec. 37.52(a)(2)(i).
    (b) Each radiographic facility submitting chest radiographs for 
approval under this section must complete and include a Radiographic 
Facility Certification Document (CDC 2.11) describing each unit to be 
used to make chest radiographs under the Act. The form must include:
    (1) The date of the last radiation safety inspection by an 
appropriate licensing agency or, if no such agency exists, by a 
qualified expert as defined in NCRP Report No. 102 (incorporated by 
reference, see Sec. 37.10);
    (2) The deficiencies found;
    (3) A statement that all the deficiencies have been corrected; and
    (4) The date of acquisition of the unit. To be acceptable, the 
radiation safety inspection must have been made within 1 year preceding 
the date of application.

[[Page 223]]

    (c) Radiographs submitted with applications for approval under this 
section will be evaluated by one or more individuals selected by NIOSH 
from the panel of B Readers or by a qualified medical physicist or 
consultant. Applicants will be advised of any reasons for denial of 
approval.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may require a facility periodically to resubmit 
radiographs of a test object, sample radiographs, or a Radiographic 
Facility Certification Document for quality control purposes.
    (1) Approvals granted hereunder may be suspended or withdrawn by 
notice in writing when in the opinion of NIOSH the quality of 
radiographs or information submitted under this section warrants such 
action.
    (2) A copy of a notice withdrawing approval will be sent to each 
operator who has listed the facility as its facility for giving chest 
radiographs and must be displayed on the mine bulletin board adjacent to 
the operator's approved plan. The approved plan will be reevaluated by 
NIOSH in light of this change.
    (f) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and must conform to the standards in AAPM Report No. 
74, pages 1-19, 47-53, and 56 (incorporated by reference, see 
Sec. 37.10).
    (g) In conducting medical examinations pursuant to this part, 
physicians and radiographic facilities must maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, classifications, and images) 
consistent with applicable statutes and regulations governing the 
handling and protection of individually identifiable health information, 
including, as applicable, the HIPAA Privacy and Security Rules (45 CFR 
part 160 and 45 CFR part 164, subparts A, C, and E).

[81 FR 73282, Oct. 24, 2016]



Sec. 37.44  Approval of radiographic facilities that use digital
radiography systems.

    (a) Facilities seeking approval must demonstrate the ability to make 
high quality digital chest radiographs by submitting to NIOSH digital 
radiographic image files of a test object (e.g., a plastic step-wedge or 
chest phantom which will be provided on loan from NIOSH) as well as 
digital radiographic image files from six or more sample chest 
radiographs that are of acceptable quality to one or more individuals 
selected by NIOSH from the panel of B Readers and a qualified medical 
physicist or consultant, both designated by NIOSH.
    (1) Image files must be submitted on standard portable media 
(compact or digital video disc) and formatted to meet specifications of 
the Digital Imaging and Communications in Medicine (DICOM) standard PS 
3.12-2011 (incorporated by reference, see Sec. 37.10). Applicants will 
be advised of any reasons for denial of approval.
    (2) All submitted images must be made within 60 days prior to the 
date of application using the same technique, equipment, and software as 
will be used by the facility under the requested approval. At least six 
chest radiographs and one test object radiograph must have been made 
with each digital radiographic unit to be used by the facility under the 
requested approval. The corresponding radiographic image files must be 
submitted on standard portable media (compact or digital video disc) and 
formatted to meet specifications of the current DICOM Standard PS 3.12-
2011.
    (3) Documentation must include the following: the identity of the 
facility where each radiograph was made; the X-ray machine used; and the 
model, version, and production date of each image acquisition software 
program and hardware component.
    (4) The submitted sample digital chest image files must include at 
least two taken with the detector in the vertical position and two in 
the horizontal position where the imaging system permits these 
positions, and at least two chest images must be from persons within the 
highest quartile of chest diameters (28 cm or greater).

[[Page 224]]

    (b) Each radiographic facility submitting chest radiographic image 
files for approval under this section must complete and include an 
Radiographic Facility Certification Document (CDC 2.11) describing each 
system component, and the models and versions of image acquisition 
hardware and software to be used to make digital chest radiographs under 
the Act. The form must include:
    (1) A copy of a dated report signed by a qualified medical 
physicist, documenting the evaluation of radiation safety and 
performance characteristics specified in this section for each digital 
radiography system;
    (2) A copy of the report of the most recent radiation safety 
inspection by a licensing agency, if such agency exists;
    (3) A listing of all deficiencies noted in either of the reports;
    (4) A statement that all the listed deficiencies have been 
corrected; and
    (5) The names and relevant training and experience of facility 
personnel described in paragraphs (c), (e), and (f) of this section. To 
be acceptable, the report by the medical physicist and radiation safety 
inspection specified in this paragraph (b) must have been made within 1 
year prior to the date of submission of the application.
    (c) Facilities must maintain ongoing licensure and certification 
under relevant local, State, and Federal laws and regulations for all 
digital equipment and related processes covered under this part.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may periodically require a facility to resubmit 
radiographic image files of the NIOSH-supplied test object (e.g., step-
wedge or chest phantom), sample radiographs, or a Radiographic Facility 
Certification Document. Approvals granted to facilities under this 
section may be suspended or withdrawn by notice in writing when, in the 
opinion of NIOSH, deficiencies in the quality of radiographs or 
information submitted under this section warrant such action. A copy of 
a notice suspending or withdrawing approval will be sent to each 
operator that has listed the facility for its use under this part and 
must be displayed on the mine bulletin board adjacent to the operator's 
approved plan. The operator's approved plan may be reevaluated by NIOSH 
in response to such suspension or withdrawal.
    (f) A qualified medical physicist who is familiar with the facility 
hardware and software systems for image acquisition, manipulation, 
display, and storage, must be on site or available as a consultant. The 
physicist must be trained in evaluating the performance of radiographic 
equipment and facility quality assurance programs, and must be licensed/
approved by a State or Territory of the United States or certified by a 
competent U.S. national board.
    (g) Facilities must document that testing performed by a qualified 
medical physicist has verified that performance of each image 
acquisition system for which approval is sought met initial 
specifications and standards of the equipment manufacturer and 
performance testing as required under paragraphs (c), (f), and (h) of 
this section.
    (h) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and must conform to the standards in AAPM Report No. 
74, pages 1-19, 47-53, and 56, and AAPM Report No. 116, sections VIII, 
IX, and X (incorporated by reference, see Sec. 37.10).
    (1) Applications for facility approval must include a comprehensive 
assessment by a qualified medical physicist within 12 months prior to 
application addressing the performance of X-ray generators, automatic 
exposure controls, and image capture systems. The assessment must comply 
with the following guidelines: AAPM Report No. 93, pages 1-68; AAPM 
Report No. 74, pages 6-11; and AAPM Report No. 14, pages 1-96 
(incorporated by reference, see Sec. 37.10).
    (2) Radiographic technique charts must be used that are developed 
specifically for the radiography system

[[Page 225]]

and detector combinations used, indicating exposure parameters by 
anatomic measurements. If automated exposure control devices are used, 
calibration for chest imaging must be documented using the actual 
voltages and image capture systems.
    (i) Radiological exposures resulting from at least ten (randomly 
selected) digital chest images obtained at the facility must be 
monitored at least quarterly to detect and correct potential dose creep, 
using methods specified in AAPM Report No. 31 (incorporated by 
reference, see Sec. 37.10). Radiation exposures must be compared to a 
professionally accepted reference level published in the American 
College of Radiology (ACR) Practice Guideline for Diagnostic Reference 
Levels in Medical X-Ray Imaging, pages 1-6 (incorporated by reference, 
see Sec. 37.10).
    (ii) The medical physicist must conduct an annual assessment of 
measured or estimated radiation exposures, with specific recommended 
actions to minimize exposures during examinations performed under this 
part.
    (3) For each digital radiography device and system, performance must 
be monitored annually in accordance with the recommendations of AAPM 
Report No. 93 (incorporated by reference, see Sec. 37.10), except for 
the testing specifically excluded below. Documentation must be 
maintained on the completion of quality assurance testing, including the 
reproducibility of X-ray output, linearity and reproducibility of mA 
settings, accuracy and reproducibility of timer and kVp settings, 
accuracy of source-to-detector distance, and X-ray field focal spot 
size, selection, beam quality, congruence and collimation. For DR 
systems, the following tests listed in AAPM Report No. 93 are not 
required under this part:
    (i) Section 8.4.5: Laser beam function.
    (ii) Section 8.4.9: Erasure Thoroughness.
    (iii) Section 8.4.11: Imaging Plate (IP) Throughput.
    (4) Facilities must maintain documentation, available for inspection 
by NIOSH for 5 years, of the ongoing implementation of policies and 
procedures for monitoring and evaluating the effective management, 
safety, and proper performance of chest image acquisition, digitization, 
processing, compression, transmission, display, archiving, and retrieval 
functions of digital radiography devices and systems.
    (i) In conducting medical examinations pursuant to this part, 
physicians and radiographic facilities must maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, interpretations, and images) 
consistent with applicable statutes and regulations governing the 
handling and protection of individually identifiable health information, 
including, as applicable, the HIPAA Privacy and Security Rules (45 CFR 
part 160 and 45 CFR part 164, subparts A, C, and E).

[81 FR 73282, Oct. 24, 2016]



Sec. 37.45  Protection against radiation emitted by radiographic
equipment.

    Except as otherwise specified in Sec. 37.41 and Sec. 37.42, 
radiographic equipment, its use and the facilities (including mobile 
facilities) in which such equipment is used, must conform to applicable 
State or Territorial and Federal regulations. Where no applicable 
regulations exist, radiographic equipment, its use and the facilities 
(including mobile facilities) in which such equipment is used must 
conform to the recommendations in NCRP Report No. 102, NCRP Report No. 
105, and NCRP Report No. 147 (incorporated by reference, see 
Sec. 37.10).

[77 FR 56733, Sept. 13, 2012]

  Specifications for Interpretation, Classification, and Submission of 
                            Chest Radiographs



Sec. 37.50  Interpreting and classifying chest radiographs--film 
radiography systems.

    (a) Chest radiographs must be interpreted and classified in 
accordance with the Guidelines for the Use of the ILO International 
Classification of Radiographs of Pneumoconioses (incorporated by 
reference, see Sec. 37.10). Chest radiograph interpretations and 
classifications must be recorded on a paper or electronic Chest 
Radiograph Classification Form (CDC/NIOSH 2.8).

[[Page 226]]

    (b) Radiographs must be interpreted and classified only by a 
physician who reads chest radiographs in the normal course of practice 
and who has demonstrated proficiency in classifying the pneumoconioses 
in accordance with Sec. 37.52.
    (1) Initial clinical interpretations and notification of findings 
other than pneumoconiosis under paragraph (a) of this section must be 
provided by a qualified physician who provides these services for the 
examining facility. This physician must have all required licensure and 
privileges, and must interpret chest radiographs in the normal course of 
practice.
    (2) [Reserved]
    (c) All interpreters, whenever interpreting chest radiographs made 
under the Act, must have immediately available for reference a complete 
set of the standard radiographs for use with the Guidelines for the Use 
of the ILO International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec. 37.10).
    (d) View boxes used for making interpretations must comply with the 
following:
    (1) Fluorescent lamps must be simultaneously replaced with new lamps 
at 6-month intervals;
    (2) All the fluorescent lamps in a panel of boxes must have 
identical manufacturer's ratings as to intensity and color;
    (3) The glass, internal reflective surfaces, and the lamps must be 
kept clean;
    (4) The unit must be so situated as to minimize front surface glare.

[81 FR 73284, Oct. 24, 2016]



Sec. 37.51  Interpreting and classifying chest radiographs--digital
radiography systems.

    (a) For each chest radiograph obtained at an approved facility using 
a digital radiography system, a qualified and licensed physician who 
reads chest radiographs in the normal course of practice must provide an 
initial clinical interpretation and notification, as specified in 
Sec. 37.54, of any significant abnormal findings other than 
pneumoconiosis.
    (b) Chest radiographs must be classified for pneumoconiosis by 
physician readers (B Readers) who have demonstrated ongoing proficiency, 
as specified in Sec. 37.52(b), in classifying the pneumoconioses in a 
manner consistent with the Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec. 37.10). Chest radiograph 
classifications must be recorded on a paper or electronic Chest 
Radiograph Classification Form (CDC/NIOSH 2.8).
    (c) All B Readers, whenever classifying digitally-acquired chest 
radiographs made under the Act, must have immediately available for 
reference a complete set of NIOSH-approved standard digital chest 
radiographic images, including electronic images such as scanned images, 
provided for use with the Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec. 37.10).
    (1) Only NIOSH-approved standard digital (electronic) images may be 
used for classifying digital chest images for pneumoconiosis.
    (2) Modification of the appearance of the standard images using 
software tools is not permitted.
    (d) Viewing systems should enable readers to display the coal 
miner's chest image at the full resolution of the image acquisition 
system, side-by-side with the selected NIOSH-approved standard images 
for comparison.
    (1)(i) Image display devices must be flat panel monitors displaying 
at least 3 MP at 10 bit depth. Image displays and associated graphics 
cards must meet the calibration and other specifications of the Digital 
Imaging and Communications in Medicine (DICOM) standard PS 3.14-2011 
(incorporated by reference, see Sec. 37.10).
    (ii) Image displays and associated graphics cards must not deviate 
by more than 10 percent from the grayscale standard display function 
(GSDF) when assessed according to the AAPM On-Line Report No. 03, pages 
1-146 (incorporated by reference, see Sec. 37.10).
    (2) Display system luminance (maximum and ratio), relative noise, 
linearity, modulation transfer function (MTF), frequency, and glare 
should

[[Page 227]]

meet or exceed recommendations listed in AAPM On-Line Report No. 03, 
pages 1-146 (incorporated by reference, see Sec. 37.10). Viewing 
displays must have a maximum luminance of at least 171 cd/m2, a ratio of 
maximum luminance to minimum luminance of at least 250, and a glare 
ratio greater than 400. The contribution of ambient light reflected from 
the display surface, after light sources have been minimized, must be 
included in luminance measurements.
    (3) Displays must be situated so as to minimize front surface glare. 
Readers must minimize reflected light from ambient sources during the 
performance of classifications.
    (4) Measurements of the width and length of pleural shadows and the 
diameter of opacities must be taken using calibrated software measuring 
tools. If permitted by the viewing software, a record must be made of 
the presentation state(s), including any noise reduction and edge 
enhancement or restoration functions that were used in performing the 
classification, including any annotations and measurements.
    (e) Quality control procedures for devices used to display chest 
images for classification must comply with the recommendations of the 
American Association of Physicists in Medicine AAPM On-Line Report No. 
03, pages 1-146 (incorporated by reference, see Sec. 37.10).
    (1) If automatic quality assurance systems are used, visual 
inspection must be performed using one or more test patterns recommended 
by the medical physicist every 6 months, or more frequently, to check 
for defects that automatic systems may not detect.
    (2) [Reserved]
    (f) Classification of CR and DR digitally-acquired chest radiographs 
under this part must be performed based on the viewing of images 
displayed as soft copies using the viewing workstations specified in 
this section. Classification of radiographs must not be based on the 
viewing of hard copy printed transparencies of images that were 
digitally-acquired.
    (g) The classification of chest radiographs based on digitized 
copies of chest radiographs that were originally acquired using film-
screen techniques is not permissible under this part.

[81 FR 73284, Oct. 24, 2016]



Sec. 37.52  Proficiency in the use of systems for classifying
the pneumoconioses.

    (a) First or A Readers:
    (1) Approval of a physician as an A Reader continues indefinitely if 
established prior to October 15, 2012.
    (2) Physicians who desire to become A Readers must demonstrate their 
proficiency in classifying the pneumoconioses by either:
    (i) Submitting to NIOSH from the physician's files six sample chest 
radiographs which are considered properly classified by one or more 
individuals selected by NIOSH from the panel of B Readers. The six 
radiographs must consist of two without pneumoconiosis, two with simple 
pneumoconiosis, and two with complicated pneumoconiosis (these may be 
the same radiographs submitted for facility approval pursuant to 
Secs. 37.43 and 37.44). The films will be returned to the physician. The 
classifications must be on the Chest Radiograph Classification Form 
(CDC/NIOSH 2.8); or
    (ii) Satisfactory completion, since June 11, 1970, of a course 
approved by NIOSH on the ILO International Classification of Radiographs 
of Pneumoconioses.
    (b) Final or B Readers:
    (1) Approval as a B Reader established prior to October 1, 1976, is 
hereby terminated.
    (2) Proficiency in evaluating chest radiographs for radiographic 
quality and in the use of the ILO Classification for interpreting chest 
radiographs for pneumoconiosis and other diseases must be demonstrated 
by those physicians who desire to be B Readers by taking and passing a 
specially-designed proficiency examination given on behalf of or by 
NIOSH at a time and place specified by NIOSH.
    (i) Each physician who desires to take the digital version of the 
examination will be provided a complete set of the current NIOSH-
approved standard reference digital radiographs.
    (ii) Physicians who qualify under this provision need not be 
qualified under paragraph (a) of this section.

[[Page 228]]

    (c) Physicians who wish to participate in the program must 
familiarize themselves with the necessary components for attainment of 
reliable classification of chest radiographs for the pneumoconioses\2\ 
and apply using a Physician Application for Certification Form (CDC 
2.12(E)).
---------------------------------------------------------------------------

    \2\ NIOSH Safety and Health Topic, Chest Radiography: Radiographic 
Classification, http://www.cdc.gov/niosh/topics/chestradiography/
radiographic-classification.html.

[81 FR 73284, Oct. 24, 2016]



Sec. 37.53  Method of obtaining definitive chest radiograph
classifications.

    (a) All chest radiographs which are first classified by an A or B 
Reader will be submitted by NIOSH to a B Reader qualified pursuant to 
Sec. 37.52.
    (1) If there is agreement between the two classifications, as 
described in paragraph (b) of this section, the result will be 
considered final and reported to MSHA for transmittal to the miner.
    (2) When agreement is lacking, NIOSH must obtain a third 
classification from the panel of B Readers.
    (i) If any two of the three classifications demonstrate agreement, 
the result must be considered the final determination.
    (ii) If agreement is lacking among the three classifications, NIOSH 
will obtain independent classifications from two additional B Readers 
selected from the panel, and the final determination will be the median 
category derived from the total of five classifications.
    (b) Two classifications are considered to be in agreement when:
    (1) They are derived from complete classifications recorded using 
approved paper or electronic versions of the Chest Radiograph 
Classification Form (CDC/NIOSH 2.8) and received by NIOSH; and
    (2) Both find either stage A, B, or C complicated pneumoconiosis; 
or,
    (3) For simple pneumoconiosis, are both in the same major category 
or are within one minor category (ILO Classification 12-point scale) of 
each other (subject to the exception in paragraph (b)(3)(ii) of this 
section).
    (i) The higher of the two classifications must be reported.
    (ii) The only exception to the one minor category principle is a 
reading sequence of 0/1, 1/0 or 1/0, 0/1, which are not considered 
agreement.

[81 FR 73285, Oct. 24, 2016]



Sec. 37.54  Notification of abnormal radiographic findings.

    (a) Significant abnormal findings other than pneumoconiosis. The 
first physician to interpret the radiograph must communicate findings 
of, or findings suggesting, abnormality of cardiac shape or size, 
tuberculosis, lung cancer, or any other significant abnormal findings 
other than pneumoconiosis to the miner indicated on the Miner 
Identification Document or to the miner's designated physician. A notice 
of the communication must be submitted to NIOSH. When significant 
abnormal findings are reported, NIOSH will also notify the miner to 
contact his or her physician.
    (b) Significant changes or progression of disease. When NIOSH has 
more than one radiograph of a miner in its files and the most recent 
examination was found by the first physician to interpret the radiograph 
or subsequently by NIOSH B Readers to show an abnormality of cardiac 
shape or size, tuberculosis, cancer, complicated pneumoconiosis, and any 
other significant abnormal findings, NIOSH will arrange for a licensed 
physician to compare the most recent image to older images and NIOSH 
will inform the miner of any significant changes or progression of 
disease or other findings.
    (c) Notice of eligibility for part 90 transfer option. All final 
determinations of radiographic classifications providing evidence for 
development of pneumoconiosis will be reported to the miner or to the 
miner's designated physician by NIOSH. In addition, NIOSH will 
coordinate with MSHA to assure that such miners are notified of 
eligibility to transfer to a less dusty area, in accordance with section 
203 of the Act (see 30 CFR part 90 and Sec. 37.102).
    (d) Prompt dispatch of findings. NIOSH will make every reasonable 
effort to process the findings described in paragraph (c) of this 
section within 60 days of receipt of the information described in 
Sec. 37.60 in a complete and acceptable form.

[[Page 229]]

    (1) NIOSH will coordinate with MSHA to provide notice of eligibility 
for the part 90 transfer option within the same time frame.
    (2) The results of an examination may not be processed by NIOSH if 
the examination was made within 6 months of the date of a previous 
acceptable examination.

[81 FR 73285, Oct. 24, 2016]



Sec. 37.60  Submitting required chest radiograph classification
and miner identification documents.

    (a) Each chest radiograph required to be made under this subpart, 
together with the completed Chest Radiograph Classification Form and the 
completed Miner Identification Document, must be submitted together for 
each miner to NIOSH within 14 calendar days after the radiographic 
examination is given. All submitted items become the property of NIOSH.
    (1) When the radiograph is digital, the image file for each 
radiograph, together with either hard copy or electronic versions of the 
completed Chest Radiograph Classification Form and the completed Miner 
Identification Document, must be submitted to NIOSH using the software 
and format specified by NIOSH either using portable electronic media, or 
a secure electronic file transfer.
    (2) NIOSH will notify the submitting facility when it has received 
the image files and forms from the examination. After this notification, 
the facility will permanently delete, or if this is not technologically 
feasible for the imaging system used, render permanently inaccessible 
all files and forms from its electronic and physical files.
    (b) If NIOSH deems any submission under paragraph (a) of this 
section inadequate, the operator will be notified of the deficiency. The 
operator must promptly make appropriate arrangements for the necessary 
reexamination at no expense to the miner.
    (c) Failure to comply with paragraph (a) or (b) of this section will 
be cause to revoke approval of a plan or any other approval as may be 
appropriate. An approval that has been revoked may be reinstated at the 
discretion of NIOSH after it receives satisfactory assurances and 
evidence that all deficiencies have been corrected and that effective 
controls have been instituted to prevent a recurrence.
    (d) Chest radiographs and other required documents must be submitted 
only for miners.
    (e) If a miner refuses to participate in all phases of the 
examination prescribed in this subpart, no report need be made. If a 
miner refuses to participate in any phase of the examination prescribed 
in this subpart, all forms must be submitted with his or her name and 
the last four digits of the Social Security number on each. If any form 
cannot be completed because of the miner's refusal, it must be marked 
``Miner Refuses,'' and submitted to NIOSH. No submission will be made, 
however, without a completed Miner Identification Document (CDC/NIOSH 
2.9) containing the miner's name, address, last four digits of the 
Social Security number and place of employment.

[81 FR 73285, Oct. 24, 2016]

                   Review and Availability of Records



Sec. 37.70  Review of classifications.

    (a) Any miner who believes the classification for pneumoconiosis 
reported to him or her by MSHA is in error may file a written request 
with NIOSH that his or her radiograph be reevaluated.
    (1) If the classification was based on agreement between an A Reader 
and a B Reader, NIOSH will obtain one or more additional classifications 
by B Readers as necessary to obtain agreement in accordance with 
Sec. 37.53, and MSHA must report the results to the miner together with 
notification from MSHA of any rights which may accrue to the miner in 
accordance with Sec. 37.102.
    (2) If the reported classification was based on agreement between 
two (or more) B Readers, the reading will be accepted as conclusive and 
the miner must be so informed by MSHA.
    (b) Any operator who is directed by MSHA to transfer a miner to a 
less dusty atmosphere based on the most recent examination may file a 
written request with NIOSH to review its findings. The standards set 
forth in paragraph (a) of this section apply and the operator and miner 
will be notified by

[[Page 230]]

MSHA whether the miner is entitled to the option to transfer.

[81 FR 73286, Oct. 24, 2016]



Sec. 37.80  Availability of records for radiographs.

    (a) Medical information and radiographs on miners will be released 
by NIOSH only with the written consent from the miner, or if the miner 
is deceased, written consent from the miner's widow or widower, next of 
kin, or legal representative.
    (b) To the extent authorized, original film radiographs will be made 
available for examination only at the NIOSH facility in Morgantown, WV.

[81 FR 73286, Oct. 24, 2016]



                       Subpart_Spirometry Testing

    Source: 79 FR 45119, Aug. 4, 2014, unless otherwise noted.



Sec. 37.90  Scope.

    Under this subpart, coal mine operators are required to provide 
spirometry testing to both current and newly employed coal miners, using 
medical facilities approved by NIOSH in accordance with standards 
established in this subpart.

[81 FR 73286, Oct. 24, 2016]



Sec. 37.91  Definitions.

    Definitions provided in Sec. 37.2 will have the same meaning in this 
subpart. Any term defined in the Federal Mine Safety and Health Act of 
1977 (Pub. L. 95-164, as amended) and not defined in Sec. 37.2 or this 
section will have the meaning given it in the Act. As used in this 
subpart:
    ATS means American Thoracic Society.
    ERS means European Respiratory Society.
    FET means forced expiratory time, which is the time from the 
beginning of a forced exhalation (the back-extrapolated ``time zero'') 
maneuver to the end of expiration.
    FEV1 means forced expiratory volume in one second, which is the 
greatest volume of air that can be forcibly blown out within the first 
second, after full inspiration.
    FEV1/FVC means the ratio between the largest acceptable FEV1 and the 
largest acceptable FVC following the forced vital capacity maneuver. It 
is usually reported as a percentage.
    FEV6 means forced expiratory volume in six seconds, which is the 
greatest volume of air that can forcibly be blown out in six seconds, 
after full inspiration.
    FVC means forced vital capacity, which is the greatest volume of air 
that can forcibly be blown out after full inspiration.
    PEF means peak expiratory flow, which is the maximal airflow 
generated during a forced vital capacity maneuver.
    Spirometry test means a pulmonary function test that measures 
expiratory volume and airflow rates and may determine the presence and 
severity of lung function impairments, if such are present.

[81 FR 73286, Oct. 24, 2016]



Sec. 37.92  Spirometry testing required for miners.

    (a) Voluntary tests. Each operator must provide to all miners who 
are employed in or at any of its coal mines the opportunity to have a 
spirometry test and a respiratory assessment at no cost to the miner at 
least once every 5 years in accordance with this subpart. The tests will 
be available during a 6-month period that begins no less than 3.5 years 
and not more than 4.5 years from the end of the last 6-month period.
    (b) Mandatory tests. Every operator must provide to each miner who 
begins work in or at a coal mine for the first time on or after August 
1, 2014, spirometry testing and respiratory assessment at no cost to the 
miner in accordance with this subpart.
    (1) Initial spirometry testing and respiratory assessment will be 
provided to all miners who begin work in or at a coal mine for the first 
time on or after August 1, 2014 within the first 30 days of their 
employment or within 30 days of approval of a plan to provide spirometry 
testing.
    (2) A follow-up second spirometry test and respiratory assessment 
will be provided to the miner no later than 3

[[Page 231]]

years after the initial spirometry if the miner is still engaged in coal 
mining.
    (3) A third spirometry test and respiratory assessment will be 
provided no later than 2 years after the tests in paragraphs 
Sec. 37.3(b)(2) and paragraph (b)(2) of this section if the chest 
radiograph shows evidence of pneumoconiosis as defined in 
Sec. 37.3(b)(3) or if the second spirometry test results demonstrate a 
15 percent or greater decline in the percent predicted FEV1 value since 
the initial (i.e., baseline) test.
    (i) Percent predicted FEV1 will be calculated according to 
prediction equations published in Spirometric Reference Values from a 
Sample of the General U.S. Population, American Journal of Respiratory 
and Critical Care Medicine, 159(1):179-187, January 1999 (incorporated 
by reference, see Sec. 37.98).
    (ii) A correction factor to Caucasian reference values will be 
applied when testing individuals of Asian descent as specified in the 
ATS Technical Standards: Spirometry in the Occupational Setting, p. 987 
(incorporated by reference, see Sec. 37.98).
    (c) Notification. NIOSH will notify the miner when he or she is due 
to receive the second or third mandatory test under paragraph (b) of 
this section. NIOSH will notify the coal mine operator when the miner is 
to perform a second spirometry test.
    (1) The operator will be notified of a miner's eligibility for a 
third test only with the miner's written consent. The notice to the 
operator will not state the medical reason for the test or that it is 
the third test in the series.
    (2) If the miner is notified by NIOSH that the third mandatory test 
is due and the operator is not so notified, availability of spirometry 
testing under the NIOSH-approved operator's plan will constitute the 
operator's compliance with the requirement to provide a third spirometry 
test even if the miner does not take the test.
    (d) Availability of spirometry testing. The opportunity for 
spirometry to be available for purposes of this subpart must be 
indicated in an operator's plan that has been submitted and approved in 
accordance with this subpart.

[81 FR 73286, Oct. 24, 2016]



Sec. 37.93  Approval of spirometry facilities.

    (a) Application for facility approval. Facilities seeking approval 
to provide the spirometry testing specified under this subpart must have 
the ability to provide spirometry of high technical quality. Thus, 
NIOSH-approved facilities must meet the requirements specified in this 
subpart for the following activities: Training of technicians who 
perform the tests; conducting spirometry tests using equipment and 
procedures that meet required specifications; collecting the respiratory 
assessment form; transmitting data to NIOSH; and communicating with 
miners as required for scheduling, testing, and notification of results. 
Facilities seeking approval may apply to NIOSH using the Spirometry 
Facility Certification document (CDC/NIOSH 2.14).
    (b) Spirometry quality assurance. A spirometry quality assurance 
program must be in place to minimize the rate of invalid test results. 
This program must include all of the following components:
    (1) Instrument calibration checks. Testing personnel must fully 
comply with the 2005 ATS/ERS Standardisation of Spirometry guidelines 
for instrument calibration check procedures, pp. 322-323, including 
Table 3 (incorporated by reference, see Sec. 37.98).
    (i) For volume spirometers, calibration check procedures must 
include daily (day of testing) leak and volume accuracy checks. In 
addition, volume linearity checks must be performed according to the 
frequency established by the 2005 ATS/ERS guidelines.
    (ii) For flow-type spirometers, calibration must be checked daily by 
injecting 3 liters of air from a calibration syringe at 3 different 
speeds (fast, medium, slow). Flow linearity must be checked weekly as 
established by the 2005 ATS/ERS guidelines.
    (iii) Instrument calibration check records must be maintained by the 
facility and available for inspection by NIOSH, as deemed necessary.
    (2) Automated maneuver and test session quality checks. The 
spirometer software must automatically perform quality assurance checks 
on expiratory maneuvers during each spirometry testing

[[Page 232]]

session. Screen displayed error messages must alert the technician to 
maneuver acceptability and test session non-repeatability. Each 
spirometry test session must have the goal of obtaining 3 acceptable 
with 2 repeatable forced vital capacity maneuvers, as defined by the 
2005 ATS/ERS Standardisation of Spirometry, p. 325 (incorporated by 
reference, see Sec. 37.98).
    (3) Ongoing monitoring of test quality. Facilities must submit 
spirometry results to NIOSH within 14 calendar days of testing as 
specified in Sec. 37.96(c) to permit NIOSH to monitor test quality and 
provide a results report to each miner. NIOSH may provide quality 
performance feedback to the appropriate technician(s) along with 
suggestions for improvement.
    (4) Quality assurance audits. NIOSH may periodically conduct audits 
to review tests submitted by approved facilities and assess the quality 
of spirometry provided. Such audits may include a review of all 
spirometry data obtained during a specified time period or review of 
spirometry test data collected over time on selected miners.
    (c) Noncompliance. If NIOSH determines that a facility is not 
compliant with the policies and procedures specified in this subpart, or 
determines as the result of a quality assurance audit as specified in 
this section that a facility is not performing spirometry of adequate 
quality, the facility will be notified of the deficiency. The facility 
must promptly make appropriate arrangements for the deficiency to be 
rectified.
    (d) Revocation of approval. If a facility fails to rectify 
deficiencies within 60 days of notification, NIOSH approval of the 
facility may be revoked. An approval which has been revoked may be 
reinstated at the discretion of NIOSH after it receives satisfactory 
assurances and evidence that all deficiencies have been corrected and 
that effective controls have been instituted by the facility to prevent 
a recurrence.
    (e) Maintenance of records. When conducting spirometry tests 
pursuant to this subpart, physicians and facilities must maintain the 
results and analyses of these tests (including any hard copies or 
digital files containing individual data, such as interpretations) in a 
manner consistent with applicable statutes and regulations governing the 
handling and protection of individually identifiable health information, 
including, as applicable, the HIPAA Privacy and Security Rules (45 CFR 
part 160 and 45 CFR part 164, subparts A, C, and E).

[81 FR 73287, Oct. 24, 2016]



Sec. 37.94  Respiratory assessment form.

    As part of the spirometry testing and concurrent with it, personnel 
at the facility must complete a Respiratory Assessment Form (CDC/NIOSH 
2.13).

[81 FR 73287, Oct. 24, 2016]



Sec. 37.95  Specifications for performing spirometry tests.

    (a) Persons administering spirometry tests. Each person 
administering spirometry tests for the Coal Workers' Health Surveillance 
Program must successfully complete a NIOSH-approved spirometry training 
course and maintain a valid certificate by periodically completing 
NIOSH-approved spirometry refresher training courses, identified on the 
NIOSH Web site at http://www.cdc.gov/niosh/. A copy of the certificate 
of completion from a NIOSH-approved spirometry training or refresher 
course, with validation dates printed on the document, must be available 
for inspection. NIOSH will assign each person administering spirometry 
tests a unique identification number, which must be entered into the 
spirometry system computer whenever instrument quality assurance or 
miner testing is done or on the Spirometry Results Notification Form 
(CDC/NIOSH 2.15).
    (b) Spirometer specifications. Spirometry testing equipment must 
meet the 2005 ATS/ERS Standardisation of Spirometry specifications for 
spirometer accuracy and precision and real-time display size and 
content, pp. 331-333, including Table 2 on p. 322 and Table 6 on p. 332 
(incorporated by reference, see Sec. 37.98). Facilities must make 
available for inspection written verification from a third-party testing 
laboratory (not the manufacturer or distributor) that the model of 
spirometer being used has successfully passed its validation

[[Page 233]]

checks as required by the Standardization of Spirometry; 1994 Update 
protocol, Appendix B pp. 1126-1134, including Table C1 (incorporated by 
reference, see Sec. 37.98). Facilities may request such documentation 
from spirometer manufacturers. For each forced expiratory maneuver 
submitted for a miner under this part, the spirometry data file must 
retain a record of the parameters defined in the 2005 ATS/ERS 
Standardisation of Spirometry, p. 335 including Table 8 (incorporated by 
reference, see Sec. 37.98). Spirometers that provide electronic transfer 
of spirometry data results files must use the format, content, and data 
structure specified by the 2005 ATS/ERS Standardisation of Spirometry, 
p. 335, or a procedure for data transfer that is approved by NIOSH.
    (c) Spirometry procedures. Administration of spirometry must include 
the following:
    (1) Miner Identification Document. The Miner Identification Document 
(CDC/NIOSH (M)2.9), described in Sec. 37.20, must be completed for each 
miner at the facility where spirometry is performed.
    (2) Pre-test checklist. The Spirometry Pre-Test Checklist portion of 
the Spirometry Results Notification Form (CDC/NIOSH 2.15) must be 
completed prior to each spirometry session to identify possible 
contraindications to testing, or factors that might affect results.
    (3) Respiratory Assessment Form. A standardized Respiratory 
Assessment Form (CDC/NIOSH 2.13) must be completed at the initial 
spirometry and repeated at each spirometry testing procedure.
    (4) Collection of anthropometric and demographic information. The 
miner's standing height must be measured in stocking feet using a 
stadiometer (or equivalent device) each time the miner performs 
spirometry. The miner's weight must also be measured (in stocking feet). 
The miner's birth date, race, and ethnicity must also be recorded. These 
data will be entered into the spirometry system computer and transmitted 
with the spirometry data file or, if required under the facility's 
approval, on the Spirometry Results Notification Form (CDC/NIOSH 2.15).
    (5) Test procedures. Spirometry will be conducted in accordance with 
test procedures defined in the 2005 ATS/ERS Standardisation of 
Spirometry, pp. 323-326, and the Standardisation of Lung Function 
Testing, Replies to Readers, pp. 1496-1498 (both incorporated by 
reference, see Sec. 37.98).
    (i) The technician must be able to view real-time testing display 
screens as specified in the 2005 ATS/ERS Standardisation of Spirometry, 
p. 322 (incorporated by reference, see Sec. 37.98).
    (ii) A miner will be tested in the standing position, but may be 
seated if he or she experiences lightheadedness or other signs or 
symptoms that raise a safety concern relating to the standing position 
during the spirometry test.
    (d) Records retention. On-site records of the results will include 
spirometry test reports and retention of all spirometry sessions, pre-
test checklists, and standardized respiratory assessment results in 
electronic or printed format until notification to delete or render the 
information inaccessible, as described in Sec. 37.100(b)(6)(ii), is 
received from NIOSH.

[81 FR 73287, Oct. 24, 2016]



Sec. 37.96  Spirometry interpretations, reports, and submission.

    (a) Interpretation of spirometry tests. Interpretations will be 
carried out by physicians or other qualified health care professionals 
with expertise in spirometry who have all required licensure and 
privileges to provide this service in their State or Territory. 
Interpretations must be carried out using procedures and criteria 
consistent with recommendations in the ATS Technical Standards: 
Spirometry in the Occupational Setting, pp. 987-990, and the ATS/ERS 
Interpretative Strategies for Lung Function Tests, p. 950, p. 956 
including Table 5, and p. 957 including Table 6 (both incorporated by 
reference, see Sec. 37.98).
    (b) Spirometry reports at NIOSH-approved spirometry facilities. (1) 
Spirometry test reports must contain the following:
    (i) The miner's age, height, gender, race, and weight;
    (ii) Numerical values (FVC, FEV6, FEV1, FEV1/FVC, FEV1/FEV6, FET, 
and PEF) and volume-time and flow-

[[Page 234]]

volume spirograms for all recorded expiratory maneuvers; normal 
reference value set used; and the predicted, percent predicted, and 
lower limit of normal threshold values;
    (iii) Miner position during testing (standing or sitting);
    (iv) Dates of test and last calibration check;
    (v) Ambient temperature and barometric pressure (volume 
spirometers); and
    (vi) The technician's unique identification number.
    (2) NIOSH will notify the submitting facility when to permanently 
delete or, if this is not technologically feasible for the spirometry 
system used, render permanently inaccessible all files and forms 
associated with a miner's spirometry test from its electronic and 
physical files.
    (c) Submission of spirometry results. Facilities must submit results 
of spirometry tests electronically with content as specified in 
Sec. 37.96(b), completed pre-test screening checklists (found in 
Spirometry Results Notification Form CDC/NIOSH 2.15), and completed 
Respiratory Assessment Form (CDC/NIOSH 2.13) within 14 calendar days of 
testing a miner.
    (1) Electronic spirometry test results. Submission of spirometry 
test results in the form of an electronic data file in a format approved 
by NIOSH is preferred. Facilities must utilize a secure internet data 
transfer site specified by NIOSH. Data submission must be performed as 
specified in the facility's approval. The transmitted spirometry data 
files must include a variable length record providing all parameters in 
the format, content, and data structure described by the 2005 ATS/ERS 
Standardisation of Spirometry, p. 335 including Table 8 (incorporated by 
reference, see Sec. 37.98), or an alternate data file that is approved 
by NIOSH.
    (2) Spirometry test results submitted using the Spirometry Results 
Notification form. If specified under a facility's approval, spirometry 
results may be provided using the Spirometry Results Notification Form 
(CDC/NIOSH 2.15). The form must be completed and submitted 
electronically, accompanied by image files in a format approved by NIOSH 
that documents the flow-volume and volume-time curves for each trial 
reported on the form. The method of electronic submission must be 
approved by NIOSH and carried out securely as specified for electronic 
data files in Sec. 37.96(c)(1).
    (d) Confidentiality of spirometry results. Individual medical 
information and spirometry results are considered protected health 
information under HIPAA and may only be released as specified by HIPAA 
or to NIOSH, as discussed in paragraph (d)(1) of this section, and 
maintained by the spirometry facility as specified in Sec. 37.93(e).
    (1) Personally identifiable information in the possession of NIOSH 
will be released only with the written consent of the miner or, if the 
miner is deceased, the written consent of the miner's next of kin or 
legal representative.
    (2) To provide on-site back-up and assure complete data transfer, 
facilities must retain the forms and results (in electronic or paper 
format) from a miner's test until instruction has been received from 
NIOSH to delete the associated files and forms or, if this is not 
technologically feasible, render the data permanently inaccessible.

[81 FR 73288, Oct. 24, 2016]



Sec. 37.97  Notification of spirometry results.

    (a) Findings must be communicated to the miner or, if requested by 
the miner, to the miner's designated physician. The health care 
professional at the NIOSH-approved facility must inform the miner if the 
spirometry shows abnormal results or if the respiratory assessment 
suggests he or she may benefit from the medical follow-up or a smoking 
cessation intervention.
    (b) NIOSH will notify the miner of his or her spirometry test 
results, a comparison between current and previously submitted 
spirometry tests (if available), and will advise the miner to contact a 
health care professional as appropriate based on the results.

[81 FR 73289, Oct. 24, 2016]

[[Page 235]]



Sec. 37.98  Standards incorporated by reference.

    (a) Certain material is incorporated by reference into this subpart, 
Subpart--Spirometry Testing, with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any 
edition other than that specified in this section, NIOSH must publish 
notice of change in the Federal Register and the material must be 
available to the public. All approved material is available for 
inspection at NIOSH, Respiratory Health Division, 1095 Willowdale Road, 
Morgantown, WV 26505. To arrange for an inspection at NIOSH, call 304-
285-5749. Copies are also available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030 or go to http:/
/www.archives.gov/federal_register/code_of_federal_regulations/
ibv_locations.html.
    (b) American Journal of Respiratory and Critical Care Medicine, 
American Thoracic Society (ATS), 25 Broadway, 18th Floor, New York, NY 
10004. Phone: (800) 635-7181, extension 8065. Email: 
[email protected] http://www.atsjournals.org/action/showHome:
    (1) Standardization of Spirometry; 1994 Update. Official Statement 
of the ATS, adopted November 11, 1994. American Journal of Respiratory 
and Critical Care Medicine 152(3):1107-1136, September 1995, into 
Sec. 37.95(b). This ATS Official Statement is also available at http://
www.atsjournals.org/doi/pdf/10.1164/ajrccm.152.3.7663792.
    (2) Official American Thoracic Society Technical Standards: 
Spirometry in the Occupational Setting (``ATS Technical Standards: 
Spirometry in the Occupational Setting''). Redlich CA, Tarlo SM, 
Hankinson JL, Townsend MC, Eschenbacher WL, Von Essen SG, Sigsgaard T, 
and Weissman DN. American Journal of Respiratory and Critical Care 
Medicine 189(8):983-994, April 15, 2014, into Secs. 37.92(b) and 
37.96(a).
    (3) Spirometric Reference Values from a Sample of the General U.S. 
Population. Hankinson JL, Odencrantz JR, Fedan KB. American Journal of 
Respiratory and Critical Care Medicine, 159(1):179-187, January 1999, 
into Sec. 37.92(b).
    (c) European Respiratory Journal, 442 Glossop Road, Sheffield, S10 
2PX, UK. Phone: 44 114 267 28 60; Fax: 44 114 266 50 64. Email: 
[email protected] http://erj.ersjournals.com/.
    (1) Standardisation of Spirometry (``2005 ATS/ERS Standardisation of 
Spirometry''). ATS/ERS Task Force: Standardization of Lung Function 
Testing. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, 
Coates A, Crapo R, Enright P, van der Grinten CPM, Gustafsson P, Jensen 
R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino 
R, Viegi G, and Wanger J. European Respiratory Journal 26(2):319-338, 
August 2005, into Secs. 37.93(b); 37.95(b) and (c); and 37.96(c). The 
ATS/ERS Standardisation of Spirometry is also available on the ATS Web 
site at https://www.thoracic.org/statements/resources/pfet/PFT2.pdf.
    (2) Interpretative Strategies for Lung Function Tests (``ATS/ERS 
Interpretative Strategies for Lung Function Tests''). ATS/ERS Task 
Force: Standardisation of Lung Function Testing. Pellegrino R, Viegi G, 
Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten 
CPM, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay 
R, Miller MR, Navajas D, Pedersen OF, and Wanger J. European Respiratory 
Journal 26(5):948-968, November 2005, into Sec. 37.96(a). The ATS/ERS 
Standardisation of Lung Function Testing is also available on the ATS 
Web site at http://www.thoracic.org/statements/resources/pft/pft5.pdf.
    (3) Standardisation of Lung Function Testing, the Authors' Replies 
to Readers' Comments (``Standardisation of Lung Function Testing, 
Replies to Readers''). Miller MR, Hankinson J, Brusasco V, Burgos F, 
Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P, Jensen 
R, MacIntyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G, and Wanger 
J. European Respiratory Journal 36(6):1496-1498, December 2010, into 
Sec. 37.95(c). The Standardisation of Lung Function Testing, Replies to 
Readers is also available on the ATS Web site at http://

[[Page 236]]

www.thoracic.org/statements/resources/pft/clarification-12-2010.pdf.

[81 FR 73289, Oct. 24, 2016]



                      Subpart_General Requirements

    Source: 79 FR 45123, Aug. 4, 2014, unless otherwise noted.



Sec. 37.100  Coal mine operator plan for medical examinations.

    (a) Each coal mine operator must submit and receive NIOSH approval 
of a plan for the provision of chest radiographs, occupational 
histories, spirometry tests, and respiratory assessments of miners, 
using the appropriate forms provided by NIOSH.
    (1) During the transition from August 1, 2014 until the time when 
spirometry facilities are approved by NIOSH, any person becoming a coal 
mine operator on or after August 1, 2014, or any coal mine operator 
without an approved plan as of that date must submit a plan within 60 
days that provides for chest radiographs and occupational histories 
only.
    (2) Coal mine operators with previously approved plans for only 
chest radiographs and occupational histories, or with plans developed 
pursuant to paragraph (a)(1) of this section, will be notified by MSHA 
when the plans must be amended to include spirometry testing and 
respiratory assessments. Amendments must be submitted to NIOSH within 60 
days of MSHA's notification.
    (b) The coal mine operator's plan must include:
    (1) The name, address, and telephone number of the operator(s) 
submitting the plan;
    (2) The name, MSHA identification number for respirable dust 
measurements, and address of the mine included in the plan;
    (3) The proposed beginning and ending date of the 6-month period(s) 
for voluntary radiography exams and spirometry tests (see Secs. 37.3(a) 
and 37.92(a)), the estimated number of miners to be given or offered 
examinations during the 6-month period under the plan, and a roster 
specifying the names and current home mailing addresses of each miner 
covered by the plan;
    (4) The name and location of the approved radiograph and spirometry 
facility or facilities, and the approximate date(s) and time(s) of day 
during which the radiograph examination and spirometry will be given to 
miners to enable a determination of whether the examinations will be 
conducted at a convenient time and place;
    (5) If a mobile medical examination facility is proposed to provide 
some or all of the surveillance tests specified in paragraph (a) of this 
section, the plan must provide that each miner be given adequate notice 
of the opportunity to have the examination and that no miner will have 
to wait for an examination more than 1 hour before or after his or her 
work shift. The plan must include:
    (i) The number of change houses at the mine.
    (ii) One or more alternate non-mobile approved medical examination 
facilities for the reexamination of miners and for the mandatory 
examination of miners when necessary (see Secs. 37.3(b) and 37.92(b)), 
or an assurance that the mobile facility will return to the location(s) 
specified in the plan as frequently as necessary to provide for medical 
surveillance examinations in accordance with these regulations.
    (iii) The name and location of each change house at which 
examinations will be given. For mines with more than one change house, 
the examinations must be given at each change house or at a change house 
located at a convenient place for each miner.
    (6) Assurances that:
    (i) The operator will not solicit a physician's spirometric, 
radiographic or other findings concerning any miner employed by the 
operator;
    (ii) Instructions have been given to the person(s) giving the 
examinations that duplicate spirograms or copies of spirograms 
(including copies of electronic files) and radiographs or copies of 
radiographs (including, for digital radiographs, copies of electronic 
files) will not be made, and to the extent that it is technically 
feasible all related electronic files must be permanently deleted from 
the facility records or rendered permanently inaccessible following the 
confirmed transfer of such data to NIOSH, and that (except

[[Page 237]]

as may be necessary for the purpose of this part) the physician's 
spirometric, radiographic and other findings, as well as the 
occupational history and respiratory assessment information obtained 
from a miner will not be disclosed in a manner that would permit 
identification of the individual miner with his or her information; and
    (iii) The spirometry and radiographic examinations will be made at 
no charge to the miner.
    (c) Operators may provide for alternate spirometry or radiography 
facilities in plans submitted to NIOSH for approval.
    (d) The change of operators of any mine operating under a plan 
approved pursuant to Sec. 37.101(a) must not affect the plan of the 
operator which has transferred responsibility for the mine. Every plan 
is subject to revision in accordance with paragraph (e) of this section.
    (e) The operator must advise NIOSH of any change in its plan. Each 
change in an approved plan is subject to the same review and approval as 
the originally approved plan.
    (f) The operator must promptly display in a visible location on the 
bulletin board at the mine its proposed plan or proposed change in a 
NIOSH-approved plan when it is submitted to NIOSH. The proposed plan or 
change in a NIOSH-approved plan must remain posted in a visible location 
on the bulletin board until NIOSH either grants or denies approval at 
which time the approved plan or denial of approval must be permanently 
posted. In the case of an operator who does not have a bulletin board, 
such as an operator that is a contractor, the operator must otherwise 
notify its employees of the examination arrangements. Upon request, the 
contractor must show NIOSH written evidence that its employees have been 
notified.
    (g) Upon notification from NIOSH that sufficient time has elapsed 
since the previous period of examinations, the operator must resubmit a 
plan for each of its coal mines to NIOSH for approval for the next 
period of examinations (see Secs. 37.3(a)(2) and 37.92(a)). The plan 
must include the proposed beginning and ending dates of the next period 
of examinations and all information required by paragraph (b) of this 
section.

[81 FR 73289, Oct. 24, 2016]



Sec. 37.101  Approval of plans.

    (a) If, after review of any plan submitted pursuant to this subpart, 
NIOSH determines that the action to be taken under the plan by the 
operator meets the specifications of this subpart and will effectively 
achieve its purpose, NIOSH will approve the plan and notify the operator 
submitting the plan of the approval. Approval may be conditioned upon 
such terms as the Secretary deems necessary to carry out the purpose of 
section 203 of the Act.
    (b) Where NIOSH has reason to believe that it will deny approval of 
a plan NIOSH will, prior to the denial, give notice in writing to the 
operator(s) of an opportunity to amend the plan. The notice must specify 
the ground(s) upon which approval is proposed to be denied.
    (c) If a plan is denied approval, NIOSH will advise the operator(s) 
in writing of the reasons for the denial and inform MSHA that the plan 
was denied.

[81 FR 73290, Oct. 24, 2016]



Sec. 37.102  Transfer of affected miner to less dusty area.

    (a) Any miner who, in the judgment of NIOSH, has evidence of the 
development of pneumoconiosis, must be afforded the option of 
transferring from his or her position to another position in an area of 
the mine where the concentration of respirable dust in the mine 
atmosphere is in compliance with the MSHA requirements in 30 CFR part 
90. A classification of one or more of the miner's chest radiographs as 
showing category 1 (\1/0\, \1/1\, \1/2\), category 2 (\2/1\, \2/2\, \2/
3\), or category 3 (\3/2\, \3/3\, 3/+) simple pneumoconiosis, or 
complicated pneumoconiosis (ILO Classification) will be accepted as such 
evidence. NIOSH will, at its discretion, also accept other medical 
examinations provided to NIOSH for review, such as computed tomography 
scans of the chest or lung biopsies, as evidence of the development of 
pneumoconiosis.

[[Page 238]]

    (b) Any transfer under this section shall be in accordance with the 
procedures specified in 30 CFR part 90.

[81 FR 73290, Oct. 24, 2016]



Sec. 37.103  Medical examination at miner's expense.

    Any miner who wishes to obtain a medical examination at the miner's 
own expense at an approved spirometry or radiography facility and to 
have the complete examination submitted to NIOSH may do so, provided 
that the examination is made no sooner than 6 months after the most 
recent examination of the miner submitted to NIOSH. NIOSH will provide 
radiographic classification, evaluation of spirometry test results, and 
reporting of the results of examinations made at the miner's expense in 
the same manner as if they were submitted under an operator's plan. Any 
change in the miner's transfer rights under the Act that may result from 
this examination will be subject to the terms of Sec. 37.102.

[81 FR 73290, Oct. 24, 2016]



                            Subpart_Autopsies

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

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



Sec. 37.200  Scope.

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



Sec. 37.201  Definitions.

    As used in this subpart:
    (a) Secretary means the Secretary of Health and Human Services.
    (b) Miner means any individual who during his life was employed in 
any underground coal mine.
    (c) Pathologist means
    (1) A physician certified in anatomic pathology or pathology by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology,
    (2) A physician who possesses qualifications which are considered 
``Board of eligible'' by the American Board of Pathology or American 
Osteopathic Board of Pathology, or
    (3) An intern, resident, or other physician in a training program in 
pathology who performs the autopsy under the supervision of a 
pathologist as defined in paragraph (c) (1) or (2) of this section.
    (d) NIOSH means the National Institute for Occupational Safety and 
Health, United States Public Health Service, Department of Health and 
Human Services, Post Office Box 4258, Morgantown, WV 26504.

[43 FR 33715, Aug. 1, 1978, as amended at 77 FR 56735, Sept. 13, 2012]



Sec. 37.202  Payment for autopsy.

    (a) The Secretary will pay up to $200 to any pathologist who, after 
the effective date of the regulations in this part and with legal 
consent:
    (1) Performs an autopsy on a miner in accordance with this subpart; 
and
    (2) Submits the findings and other materials to NIOSH in accordance 
with this subpart within 180 calendar days after having performed the 
autopsy; and
    (3) Receives no other specific payment, fee, or reimbursement in 
connection with the autopsy from the miner's widow, his family, his 
estate, or any other Federal agency.
    (b) The Secretary will pay to any pathologist entitled to payment 
under paragraph (a) of this section and additional $10 if the 
pathologist can obtain and submits a good quality copy or original of a 
chest radiograph (posteroanterior view) made of the subject of the 
autopsy within 5 years prior to his death together with a copy of any 
interpretation made.

[35 FR 13206, Aug. 19, 1970, as amended at 38 FR 16353, June 22, 1973; 
77 FR 56735, Sept. 13, 2012]



Sec. 37.203  Autopsy specifications.

    (a) Every autopsy for which a claim for payment is submitted 
pursuant to this part:
    (1) Shall be performed consistent with standard autopsy procedures 
such as those, for example, set forth in the ``Autopsy Manual'' prepared 
by the Armed Forces Institute of Pathology, July 1, 1960. (Technical 
Manual No. 8-

[[Page 239]]

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



Sec. 37.204  Procedure for obtaining payment.

    Every claim for payment under this subpart must be submitted to 
NIOSH and must include:
    (a) An invoice (in duplicate) on the pathologist's letterhead or 
billhead indicating the date of autopsy, the amount of the claim and a 
signed statement that the pathologist is not receiving any other 
specific compensation for the autopsy from the miner's widow, his 
surviving next-of-kin, the estate of the miner, or any other source.
    (b) Completed PHS Consent, Release and History form (Form CDC/NIOSH 
(M)2.6). This form may be completed with the assistance of the 
pathologist, attending physician, family physician, or any other 
responsible person who can provide reliable information.
    (c) Report of autopsy:
    (1) The information, slides, and blocks of tissue required by this 
subpart.
    (2) Clinical abstract of terminal illness and other data that the 
pathologist determines is relevant.
    (3) Final summary, including final anatomical diagnoses, indicating 
presence or absence of simple and complicated pneumoconiosis, and 
correlation with clinical history if indicated.

[43 FR 33715, Aug. 1, 1978, as amended at 77 FR 56735, Sept. 13, 2012]



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



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

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

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



Sec. 38.1  Purpose; coordination.

    (a) Purpose. This part establishes standards and procedures for the 
implementation of section 413 of Pub. L. 93-288, the Disaster Relief Act 
of 1974 (42 U.S.C. 5183) which authorizes the provision, either directly 
or through financial assistance to State or local agencies or private 
mental health organizations, of:
    (1) Professional counseling services to victims of a major disaster 
in order to relieve mental health problems

[[Page 240]]

caused or aggravated by such a major disaster or its aftermath; and
    (2) Training of disaster workers to provide or assist in providing 
those professional counseling services.
    (b) Coordination. The Secretary, acting through the National 
Institute of Mental Health, will, as provided in 24 CFR 2205.51, carry 
out section 413 of the Act and this part in coordination with and under 
the general policy guidance of, the Administrator of the Federal 
Disaster Assistance Administration. Contracts and grants awarded under 
this part are subject to all applicable provisions of the Act and the 
implementing regulations promulgated by the Administrator (24 CFR part 
2205).



Sec. 38.2  Definitions.

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



Sec. 38.3  Assistance; procedures, limitations.

    (a) Application. In order to obtain assistance under this part, the 
Governor or his State Coordinating Officer must, not later than 60 days 
following a major disaster declaration by the

[[Page 241]]

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



Sec. 38.4  Contracts.

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

[[Page 242]]

contract period and every 30 days therafter;
    (2) A final report to be submitted within 60 days of the date upon 
which the contract terminates; and
    (3) Such additional reports as the Secretary may prescribe including 
those which may be required to enable the Federal Coordinating Officer 
to carry out his functions.



Sec. 38.5  Grant assistance.

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

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

    (e) Expenditure of grant funds. Any funds granted pursuant to this 
part shall be expended solely for the purposes for which the funds were 
granted in accordance with the approved application and budget, the 
regulations of this part, the terms and the conditions of the award, and 
the applicable cost principles prescribed in 45 CFR part 75, subpart E.
    (f) Reports. In exceptional circumstances, a grantee may be required 
to submit special progress reports, in addition to those otherwise 
required, relating to the conduct and results of the approved grant.

[41 FR 52052, Nov. 26, 1976, as amended at 45 FR 57396, Aug. 28, 1980; 
49 FR 38109, Sept. 27, 1984; 81 FR 3006, Jan. 20, 2016]



Sec. 38.6  Nondiscrimination.

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



Sec. 38.7  Nonliability.

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

[[Page 243]]

Federal Government in carrying out the provisions of the Act.



Sec. 38.8  Criminal and civil penalties.

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

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



Sec. 38.9  Federal audits.

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

[[Page 244]]



                           SUBCHAPTER D_GRANTS





PART 50_POLICIES OF GENERAL APPLICABILITY--Table of Contents



Subpart A [Reserved]

Subpart B_Sterilization of Persons in Federally Assisted Family Planning 
                                Projects

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

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

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

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

         Subpart D_Public Health Service Grant Appeals Procedure

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

               Subpart E_Maximum Allowable Cost for Drugs

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

               Subpart F_Promoting Objectivity in Research

50.601  Purpose.
50.602  Applicability.
50.603  Definitions.
50.604  Responsibilities of Institutions regarding Investigator 
          financial conflicts of interest.
50.605  Management and reporting of financial conflicts of interest.
50.606  Remedies.
50.607  Other HHS regulations that apply.

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

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

Subpart A [Reserved]



Subpart B_Sterilization of Persons in Federally Assisted Family Planning 
                                Projects



Sec. 50.201  Applicability.

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



Sec. 50.202  Definitions.

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

[[Page 245]]

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

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



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

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



Sec. 50.204  Informed consent requirement.

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

[[Page 246]]

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



Sec. 50.205  Consent form requirements.

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



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

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



Sec. 50.207  Sterilization by hysterectomy.

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

[[Page 247]]

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

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



Sec. 50.208  Program or project requirements.

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



Sec. 50.209  Use of Federal financial assistance.

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

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



Sec. 50.210  Review of regulation.

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



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

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

                        Consent to Sterilization

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

[[Page 248]]

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

Signature_______________________________________________________________
Date:___________________________________________________________________
(Month, day, year)

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

                     Ethnicity and Race Designation

    Ethnicity:

v Hispanic or Latino
v Not Hispanic or Latino

    Race (mark one or more):

v American Indian or Alaska Native
v Asian
v Black or African American
v Native Hawaiian or Other Pacific Islander
v White

                         Interpreter's Statement

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

Interpreter_____________________________________________________________
Date____________________________________________________________________

                    State of Person Obtaining Consent

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

Signature of person obtaining consent___________________________________
Date____________________________________________________________________
Facility________________________________________________________________
Address_________________________________________________________________

                          Physician's Statement

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

[[Page 249]]

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

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

Physician_______________________________________________________________
Date____________________________________________________________________

                    Paperwork Reduction Act Statement

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

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



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

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

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



Sec. 50.301  Applicability.

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



Sec. 50.302  Definitions.

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

[[Page 250]]

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



Sec. 50.303  General rule.

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

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



Sec. 50.304  Life of the mother would be endangered.

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

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

[43 FR 13868, July 21, 1978]



Sec. 50.305  [Reserved]



Sec. 50.306  Rape and incest.

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

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

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

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



Sec. 50.307  Documentation needed by programs or projects.

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

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



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

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



Sec. 50.309  Recordkeeping requirements.

    Programs or projects to which this subpart applies must maintain 
copies of the certifications and documentation specified in Secs. 50.304 
and 50.306 for three years pursuant to the retention and custodial 
requirements for records at 45 CFR 75.361 et seq.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979; 81 
FR 3006, Jan. 20, 2016]



Sec. 50.310  Confidentiality.

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

[[Page 251]]

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



         Subpart D_Public Health Service Grant Appeals Procedure

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

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



Sec. 50.401  What is the purpose of this subpart?

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

[63 FR 66062, Dec. 1, 1998]



Sec. 50.402  To what program do these regulations apply?

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

[70 FR 76175, Dec. 23, 2005]



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

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

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