[Title 45 CFR ]
[Code of Federal Regulations (annual edition) - October 1, 2000 Edition]
[From the U.S. Government Printing Office]
Parts 1 to 199
Revised as of October 1, 2000
Containing a Codification of documents of general
applicability and future effect
As of October 1, 2000
Office of the Federal Register
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Table of Contents
Subtitle A--Department of Health and Human Services 3
Material Approved for Incorporation by Reference........ 669
Table of CFR Titles and Chapters........................ 671
Alphabetical List of Agencies Appearing in the CFR...... 689
Redesignation Table..................................... 699
List of CFR Sections Affected........................... 701
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Office of the Federal Register.
October 1, 2000.
Title 45--Public Welfare is composed of four volumes. The parts in
these volumes are arranged in the following order: Parts 1-199, 200-499,
500-1199, and 1200 to end. Volume one (parts 1-199) contains all current
regulations issued under subtitle A--Department of Health and Human
Services. Volume two (parts 200-499) contains all current regulations
issued under subtitle B--Regulations Relating to Public Welfare, chapter
II--Office of Family Assistance (Assistance Programs), Administration
for Children and Families, Department of Health and Human Services,
chapter III--Office of Child Support Enforcement (Child Support
Enforcement Program), Administration for Children and Families,
Department of Health and Human Services, and chapter IV--Office of
Refugee Resettlement, Administration for Children and Families,
Department of Health and Human Services. Volume three (parts 500-1199)
contains all current regulations issued under chapter V--Foreign Claims
Settlement Commission of the United States, Department of Justice,
chapter VI--National Science Foundation, chapter VII--Commission on
Civil Rights, chapter VIII--Office of Personnel Management, chapter X--
Office of Community Services, Administration for Children and Families,
Department of Health and Human Services, and chapter XI--National
Foundation on the Arts and the Humanities. Volume four (part 1200 to
end) contains all current regulations issued under chapter XII--
Corporation for National and Community Service, chapter XIII--Office of
Human Development Services, Department of Health and Human Services,
chapter XVI--Legal Services Corporation, chapter XVII--National
Commission on Libraries and Information Science, chapter XVIII--Harry S
Truman Scholarship Foundation, chapter XXI--Commission of Fine Arts,
chapter XXIII--Artic Research Commission, chapter XXIV--James Madison
Memorial Fellowship Foundation, and chapter XXV--Corporation for
National and Community Service. The contents of these volumes represent
all of the current regulations codified under this title of the CFR as
of October 1, 2000.
A subject index to 45 CFR parts 680-684 appears at the end of
chapter VI in the volume containing parts 500-1199. Those amendments to
part 801--Voting Rights Program, Appendixes A, B, and D, which apply to
Texas also appear in Spanish following Appendix D.
Redesignation tables appear in the Finding Aids section of volumes
one and four.
For this volume, Ruth Reedy Green was Chief Editor. The Code of
Federal Regulations publication program is under the direction of
Frances D. McDonald, assisted by Alomha S. Morris.
TITLE 45--PUBLIC WELFARE
(This book contains parts 1 to 199)
SUBTITLE A--Department of Health And Human Services......... 1
SUBTITLE A--DEPARTMENT OF HEALTH
AND HUMAN SERVICES
SUBCHAPTER A--GENERAL ADMINISTRATION
1 HHS's regulations........................... 7
2 Testimony by employees and production of
documents in proceedings where the
United States is not a party............ 7
3 Conduct of persons and traffic on the
National Institutes of Health Federal
4 Service of process.......................... 17
5 Freedom of Information Regulations.......... 18
5b Privacy Act regulations..................... 32
7 Employee inventions......................... 45
9 Use of HHS research facilities by academic
scientists, engineers, and students..... 47
12 Disposal and utilization of surplus real
property for public health purposes..... 48
12a Use of Federal real property to assist the
13 Implementation of the Equal Access to
Justice Act in agency proceedings....... 65
15 Uniform relocation assistance and real
property acquisition for Federal and
federally assisted programs............. 74
16 Procedures of the Departmental Grant Appeals
17 Release of adverse information to news media 82
30 Claims collection........................... 83
31 Referral of debt to IRS for tax refund
35 Tort Claims against the government.......... 102
36 Indemnification of HHS Employees............ 105
46 Protection of human subjects................ 106
50 U.S. Exchange Visitor Program--request for
waiver of the two-year foreign residence
51 Criteria for evaluating comprehensive plan
to reduce reliance on alien physicians.. 127
57 Volunteer services.......................... 129
60 National Practitioner Data Bank for adverse
information on physicians and other
health care practitioners............... 130
61 Healthcare integrity and protection data
bank for final adverse information on
health care providers, suppliers and
63 Grant programs administered by the Office of
the Assistant Secretary for Planning and
73 Standards of conduct........................ 156
73a Standards of conduct: Food and Drug
Administration supplement............... 189
73b Debarment or suspension of former employees. 194
74 Uniform administrative requirements for
awards and subawards to institutions of
higher education, hospitals, other
nonprofit organizations, and commercial
organizations; and certain grants and
agreements with States, local
governments and Indian tribal
76 Governmentwide debarment and suspension
(nonprocurement) and governmentwide
requirements for drug-free workplace
77 Remedial actions applicable to letter of
credit administration................... 263
78 Conditions for waiver of denial of Federal
79 Program fraud civil remedies................ 266
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...................... 282
81 Practice and procedure for hearings under
Part 80 of this title................... 307
83 Regulation for the administration and
enforcement of sections 799A and 845 of
the Public Health Service Act........... 317
84 Nondiscrimination on the basis of handicap
in programs and activities receiving
Federal financial assistance............ 323
85 Enforcement of nondiscrimination on the
basis of handicap in programs or
activities conducted by the Department
of Health and Human Services............ 363
86 Nondiscrimination on the basis of sex in
education programs and activities
receiving or benefiting from Federal
financial assistance.................... 380
90 Nondiscrimination on the basis of age in
programs or activities receiving Federal
financial assistance.................... 398
91 Nondiscrimination on the basis of age in HHS
programs or activities receiving Federal
financial assistance.................... 405
92 Uniform administrative requirements for
grants and cooperative agreements to
State and local governments............. 412
93 New restrictions on lobbying................ 439
94 Responsible prospective contractors......... 451
95 General administration--grant programs
(public assistance, medical assistance
and state children's health insurance
96 Block grants................................ 473
97 Consolidation of grants to the insular areas 530
98 Child care and development fund............. 531
99 Procedure for hearings for the child care
and development fund.................... 561
100 Intergovernmental review of Department of
Health and Human Services programs and
SUBCHAPTER B--REQUIREMENTS RELATING TO HEALTH CARE ACCESS
144 Requirements relating to health insurance
146 Requirements for the group health insurace
148 Requirements for the individual health
insurance market........................ 616
150 HCFA enforcement in group and individual
insurance markets....................... 633
SUBCHAPTER C--ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS
160 General administrative requirements......... 654
162 Administrative requirements................. 657
SUBCHAPTER A--GENERAL ADMINISTRATION
PART 1--HHS'S REGULATIONS--Table of Contents
1.1 Location of HHS regulations.
1.2 Subject matter of Office of the Secretary regulations in parts 1-
Sec. 1.1 Location of HHS regulations.
Regulations for HHS's programs and activities are located in several
different titles of the Code of Federal Regulations:
Regulations having HHS-wide application or which the Office
of the Secretary administers are located in Parts 1-99 of Title 45.
Health regulations are located at Parts 1-399 of Title 42.
Health care financing regulations are located at Parts 400-
499 of Title 42. These include regulations for Medicare and Medicaid.
Human development services regulations are located at Parts
200-299 and 1300-1399 of Title 45. These include regulations for Head
Start, social services, social and nutrition services for older persons,
rehabilitative services, developmental disabilities services, Native
American programs, and various programs relating to families and
Social Security regulations are located at Parts 400-499 of
Food and Drug regulations are located at Parts 1-1299 of
Procurement (contract) regulations are located at Chapter 3
of Title 41.
Each volume of the Code contains an index of its parts.
(5 U.S.C. 301)
[44 FR 61598, Oct. 26, 1979, as amended at 48 FR 35099, Aug. 3, 1983]
Sec. 1.2 Subject matter of Office of the Secretary regulations in parts 1-99.
This subject matter of the regulations in Parts 1-99 of this title
Civil rights/nondiscrimination: Parts 80, 81, 83, 84, 86,
Protection of human subjects: Part 46.
Day care requirements: Part 71.
Information, privacy, advisory committees: Parts 5, 5a, 5b,
11, 17, 99.
Personnel: Parts 50, 57, 73, 73a.
Grants and letter of credit administration, property,
hearing rights: Parts 10, 12, 15, 16, 74, 75, 77, 95.
Claims: Parts 30, 35.
Inventions and patents: Parts 6, 7, 8.
Miscellaneous: Parts 3, 4, 9, 67.
(5 U.S.C. 301)
[50 FR 781, Jan. 7, 1985, as amended at 52 FR 28658, July 31, 1987]
PART 2--TESTIMONY BY EMPLOYEES AND PRODUCTION OF DOCUMENTS IN PROCEEDINGS WHERE THE UNITED STATES IS NOT A PARTY--Table of Contents
2.1 Scope, purpose, and applicability.
2.3 Policy on presentation of testimony and production of documents.
2.4 Procedures when voluntary testimony is requested or when an
employee is subpoenaed.
2.5 Subpoenas duces tecum.
2.6 Certification and authentication of records.
Authority: 5 U.S.C. 301, 5 U.S.C. 552.
Source: 52 FR 37146, Oct. 5, 1987, unless otherwise noted.
Sec. 2.1 Scope, purpose, and applicability.
(a) This part sets forth rules to be followed when a Department of
Health and Human Services employee, other than an employee of the Food
and Drug Administration, is requested or subpoenaed to provide
testimony, in a deposition, trial, or other similar proceeding,
concerning information acquired in the course of performing official
duties or because of the employee's official capacity. This part also
sets forth procedures for the handling of subpoenas duces tecum and
other requests for any document in the possession of the Department of
Health and Human Services other than the Food and Drug Administration,
and to requests for certification of copies of documents. Separate
regulations, 21 CFR part 20 and 20 CFR part 401, govern the Food and
Drug Administration and requests for certain information maintained by
the Social Security Administration, and those regulations are not
affected by this part.
(b) It is the policy of the Department of Health and Human Services
to provide information, data, and records to
non-federal litigants to the same extent and in the same manner that
they are available to the general public. The availability of Department
of Health and Human Services' employees to testify in litigation not
involving Federal parties is governed by the Department of Health and
Human Services' policy on maintaining strict impartiality with respect
to private litigants and to minimize the disruption of official duties.
(c) This part applies to state and local court, administrative, and
legislative proceedings and Federal court and administrative
(d) This part does not apply to:
(1) Any civil or criminal proceedings where the United States, the
Department of Health and Human Services, and any agency thereof, or any
other Federal agency is a party.
(2) Congressional requests or subpoenas for testimony or documents.
(3) Consultative services and technical assistance provided by the
Department of Health and Human Services, or any agency thereof, in
carrying out its normal program activities.
(4) Employees serving as expert witnesses in connection with
professional and consultative services as approved outside activities in
accordance with 45 CFR 73.735-704 and 73.735-708. (In cases where
employees are providing such outside services, they must state for the
record that the testimony represents their own views and does not
necessarily represent the official position of the Department of Health
and Human Services.)
(5) Employees making appearances in their private capacity in legal
or administrative proceedings that do not relate to the Department of
Health and Human Services (such as cases arising out of traffic
accidents, crimes, domestic relations, etc.) and not involving
professional and consultative services.
(6) Any matters covered in 21 CFR part 20, involving the Food and
Drug Administration, and 20 CFR part 401, involving the Social Security
(7) Any civil or criminal proceedings in State court brought on
behalf of the Department of Health and Human Services.
[52 FR 37146, Oct. 5, 1987, as amended at 55 FR 4611, Feb. 9, 1990]
Sec. 2.2 Definitions.
Agency Head refers to the head of the relevant operating division or
other major component of the Deparment of Health and Human Services, or
his or her delegatees. For each component of the Department, the Agency
Head for the purposes of this part is as follows:
(1) Office of the Secretary--Assistant Secretary for Management and
(2) Office of Human Development Services--Assistant Secretary for
Human Development Services;
(3) Public Health Service--Assistant Secretary for Health;
(4) Health Care Financing Administration--Administrator;
(5) Family Support Administration--Assistant Secretary for Family
(6) Social Security Administration--Commissioner; and
(7) Office of the Inspector General--Inspector General.
Employee includes commissioned officers in the Public Health Service
Commissioned Corps, as well as regular and special Department of Health
and Human Services employees (except employees of the Food and Drug
Administration), and any employees of health insurance intermediaries
and carriers performing functions under agreements entered into pursuant
to sections 1816 and 1842 of the Social Security Act, 42 U.S.C. 1395h,
Testify and testimony includes both in-person, oral statements
before a court, legislative or administrative body and statements made
pursuant to depositions, interrogatories, declarations, affidavits, or
other formal participation.
[52 FR 37146, Oct. 5, 1987, as amended at 55 FR 4611, Feb. 9, 1990]
Sec. 2.3 Policy on presentation of testimony and production of documents.
(a) No Department of Health and Human Services employee may provide
testimony or produce documents in any proceedings to which this part
applies concerning information acquired
in the course of performing official duties or because of the employee's
official relationship with the Department of Health and Human Services
unless authorized by the Agency head pursuant to this part based on a
determination by the Agency head, after consultation with the Office of
the General Counsel, that compliance with the request would promote the
objectives of the Department of Health and Human Services.
(b) The Office of the General Counsel will request the assistance of
the Department of Justice where necessary to represent the interests of
the Department of Health and Human Services and its employees under this
Sec. 2.4 Procedures when voluntary testimony is requested or when an employee is subpoenaed.
(a) All requests for testimony by a Department of Health and Human
Services employee in his or her official capacity and not subject to the
exceptions set forth in Sec. 2.1(d), of this part, must be in writing
and must state the nature of the requested testimony, why the
information sought is unavailable by any other means, and the reasons
why the testimony would be in the interests of the Department of Health
and Human Services or the Federal Government.
(b) If the Agency head denies approval to comply with a subpoena for
testimony, or if the Agency head has not acted by the return date, the
employee will appear at the stated time and place, unless advised by the
Office of the General Counsel that responding to the subpoena would be
inappropriate (in such circumstances as, for example, an instance where
the subpoena was not validly issued or served, where the subpoena has
been withdrawn, or where discovery has been stayed), produce a copy of
these regulations, and respectfully decline to testify or produce any
documents on the basis of these regulations.
Sec. 2.5 Subpoenas duces tecum.
(a) Subpoenas duces tecum for records of the Department of Health
and Human Services shall be deemed a request for records under the
Freedom of Information Act and shall be handled pursuant to the rules
governing public disclosure established in 45 CFR Part 5.
(b) Whenever a subpoena duces tecum, in appropriate form, has been
lawfully served upon a Department of Health and Human Services' employee
commanding the production of any record, such employee, after
consultation with the Office of the General Counsel, shall appear in
response thereto, respectfully decline to produce the record(s) on the
ground that it is prohibited by this section, and state that the
production of the record(s) involved will be handled by the procedures
and disclosure rules established in 45 CFR Part 5.
Sec. 2.6 Certification and authentication of records.
Upon request, Department of Health and Human Services' agencies will
certify the authenticity of copies of records that are to be disclosed
pursuant to 45 CFR Part 5 and will authenticate copies of records
previously disclosed. Fees for such certification are set forth in 45
[52 FR 37146, Oct. 5, 1987, as amended at 55 FR 4611, Feb. 9, 1990]
PART 3--CONDUCT OF PERSONS AND TRAFFIC ON THE NATIONAL INSTITUTES OF HEALTH FEDERAL ENCLAVE--Table of Contents
3.4 False reports and reports of injury or damage.
3.5 Lost and found, and abandoned property.
Subpart B--Traffic Regulations
3.21 Emergency vehicles.
3.22 Request for identification.
3.24 Parking permits.
3.25 Servicing of vehicles.
3.26 Speed limit.
Subpart C--Facilities and Grounds
3.41 Admission to facilities or grounds.
3.42 Restricted activities.
3.43 Removal of property.
Authority: 40 U.S.C. 318-318d. 486; Delegation of Authority, 33 FR
Source: 55 FR 2068, Jan. 22, 1990, unless otherwise noted.
Sec. 3.1 Definitions.
Director means the Director or Acting Director of the National
Institutes of Health (NIH), or other officer or employee of NIH to whom
the authority involved has been delegated.
Enclave means, unless the context requires a different meaning, the
area, containing about 318 acres, acquired by the United States in
several parcels in the years 1935 through 1983, and any further future
acquisitions, comprising the National Institutes of Health located in
Montgomery County, Maryland, over which the United States acquired
exclusive jurisdiction under the Act of March 31, 1953, Chapter 158
(1953 Maryland Laws 311).
Police officer means a uniformed or non-uniformed police officer
appointed under a delegation of authority to the Director under Title 40
United States Code section 318 or 318d; any other Federal law
enforcement officer; and any other person whose law enforcement services
are secured by contract, or upon request or deputation from a State or
local law enforcement agency.
Sec. 3.2 Applicability.
(a) The regulations in this part apply to all areas in the enclave
and to all persons on or within the enclave, except as otherwise
(b) The regulations in this part do not apply to occupants, their
visitors, and other authorized persons in areas used as living quarters:
(1) When specifically made inapplicable, and
(2) In the case of the following provisions: Sec. 3.24 Parking
permits; Sec. 3.25 Servicing of vehicles; Sec. 3.42 Hobbies and sports;
and Sec. 3.42(f) Smoking.
(c) All regulations in this part are in addition to the provisions
in the United States Code, including title 18 relating to crimes and
criminal procedure, and title 21 relating to food and drugs, which
(1) Without regard to the place of the offense, or
(2) To areas (such as the enclave) subject to the ``special maritime
and territorial jurisdiction of the United States,'' as defined in Title
18 United States Code section 7.
(d) In accordance with the Assimilative Crimes Act (18 U.S.C. 13),
whoever is found guilty of an offense which, although not made
punishable by any act of Congress, nor any provision of these
regulations, would be punishable if committed within the State of
Maryland, shall be guilty of a like offense and subject to a like
punishment. In the event of an irreconcilable conflict between a
provision of this part and a Maryland statute governing the identical
subject matter, this part shall control.
(e) Federal criminal statutes which apply. The following Federal
criminal statutes in the United States Code apply to Federal enclaves
and elsewhere without regard to the place of the offense. This listing
is provided solely for the information of the public and is not all-
inclusive. The omission of other Federal statutes does not mean that
such other statutes do not apply. In any given situation, the cited
statutory provisions and any amendments in effect when the alleged
offense occurred shall determine the specifics of the offense,
applicability, and penalty.
Subject U.S. Code Provides generally Maximum penalty
1. By force or threat of force, 18 U.S.C. 245........ Prohibits................. Not involving death or
willful injury, intimidation or bodily injury:
interference with, or attempts to Imprisonment one year
injure, intimidate or interfere and/or $1,000 fine.
with, a person from participating
in or enjoying any benefit,
service, privilege, program,
facility, or activity, provided
by or administered by the U.S.,
and engaging in certain other
Federal protected activities.
2. Malicious destruction or 18 U.S.C. 844(f)..... Prohibits................. First offense not
damage, by an explosive, to a involving death or
building or other property owned, personal injury:
possessed, used, or leased by the Imprisonment 10 years
U.S., U.S. agency, or any and/or $10,000 fine and
organization receiving Federal seizure and forfeiture
financial assistance. of explosive materials.
3. Possession of explosive in 18 U.S.C. 844(g)..... Prohibits, except with Imprisonment one year and/
buildings owned, possessed, used, written consent of the or $1,000 fine and
or leased by U.S. or U.S. agency. agency. seizure and forfeiture
of explosive materials.
4. Use of or carrying an explosive 18 U.S.C. 844(h)..... Prohibits................. First offense:
to commit, or during commission Imprisonment 10 years
of, a felony prosecutable in a and seizure and
U.S. court. forfeiture of explosive
5. Use of or carrying a firearm 18 U.S.C. 924(c)..... Prohibits................. First offense:
during and in relation to any Imprisonment 5 years and
crime of violence prosecutable in $5,000 fine and seizure
a U.S. court. and forfeiture of
firearm and ammunition.
6. Manufacture, distribution, 21 U.S.C. 841, 842, Prohibits, except as First offense:
dispensing, or possession with 843, 845. authorized by the Imprisonment 20 years
intent to do these acts, of Controlled Substances Act and/or $250,000 fine
narcotics and other controlled (generally 21 U.S.C. 801- depending on the amount
substances and counterfeit 904). and kind of substance
substances. (twice the above
distribution by a person
at least 18 years of age
to one under age 21).
7. Simple possession of narcotics 21 U.S.C. 844........ Prohibits, unless First offense:
or other controlled substances. substance obtained Imprisonment 1 year and/
directly, or pursuant to or $5,000 fine.
prescription or order,
from a practitioner,
acting in the course of
professional practice, or
as otherwise authorized
under the Controlled
(f) Maryland criminal statutes that apply. The matters described in
this paragraph are governed, in whole or in part, by the current version
of the cited Maryland criminal statutory provisions, which are made
Federal criminal offenses under the Assimilative Crimes Act (18 U.S.C.
13). This listing sets forth areas of conduct particularly relevant to
the enclave and is provided solely for the information of the public.
The list is not all-inclusive and omission of other Maryland criminal
statutes does not mean that such other statutes are not assimilated as
Federal offenses under the Act. Generally, other Maryland criminal
statutes will apply on the enclave, by force of the Act, unless
superseded by Federal Law or a given provision of this part. In any
given situation, the cited statutory provisions and any amendments in
effect when the alleged offense occured shall determine the specifics of
the offense, applicability, and penalty.
Subject annotated Provides generally Maximum penalty
1. Pedestrian right-of-way........ Transportation, Sec. Pedestrians have the right- Imprisonment 2 months and/
21-502. of-way in crosswalks and or $500 fine.
certain other areas.
Subject to certain
Sec. 21-511.......... Blind, partially blind, or $500 fine.
pedestrians have the
right-of-way at any
crossing or intersection.
Subject to certain
2. Drivers to exercise due care... Transportation, Sec. Drivers shall exercise due $500 fine.
21-504. care to avoid colliding
3. Driving while intoxicated, Transportation, Sec. Prohibits................. Sec. 21-902(a) (driving
under the influence of alcohol 21-902. while intoxicated, first
and/or a drug or controlled offense): Imprisonment 1
substance. year and/or $1,000 fine.
Sec. 21-902 (b), (c), (d)
(driving under the
2 months and/or $500
4. Unattended motor vehicles...... Transportation, Sec. Prohibits leaving motor $500 fine.
21-1101. vehicles unattended
precautions are taken.
5. Carrying or wearing certain Article 27, Sec. 36.. Prohibits, except for law Imprisonment 3 years or
concealed weapons (other than enforcement personnel or $1,000 fine.
handguns) or openly with intent as a reasonable
to injure. precaution against
6. Unlawful wearing, carrying, or Article 27, Sec. 36B. Prohibits except by law First offense and no
transporting a handgun, whether enforcement personnel or prior related offense:
concealed or openly. with permit. Imprisonment 3 years and/
or $2,500 fine.
7. Use of handgun or concealable Article 27, Sec. 36B. Prohibits................. Imprisonment 20 years.
antique firearm in commission of
felony or crime of violence.
8. Disturbance of the peace....... Article 27, Sec. 122. Prohibits acting in a Imprisonment 30 days and/
disorderly manner in or $500 fine.
9. Gambling....................... Article 27, Secs. Prohibits betting, Sec. 240: Imprisonment
240, 245. wagering and gambling, one year and/or $1,000
and certain games of fine. Sec. 245:
chance (does not apply to Imprisonment 2 years and/
vending or purchasing or $100 fine.
authorized under State
law in accordance with
Sec. 3.3 Compliance.
A person must comply with the regulations in this part; with all
official signs; and with the lawful directions or orders of a police
officer or other authorized person, including traffic and parking
Sec. 3.4 False reports and reports of injury or damage.
A person may not knowingly give any false or fictitious report
concerning an accident or violation of the regulations of this part or
any applicable Federal or Maryland statute to any person properly
investigating an accident or alleged violation. All incidents resulting
in injury to persons or willful damage to property in excess of $100.00
(one hundred dollars) in value must be reported by the persons involved
to the Police Office as soon as possible. The Police Office's main
location and telephone number is: Building 31, Room B3BN10; (301) 496-
Sec. 3.5 Lost and found, and abandoned property.
Lost articles which are found on the enclave, including money and
other personal property, together with any identifying information, must
be deposited at the Police Office or with an office (such as the place
where found) which may likely have some knowledge of ownership. If the
article is deposited with an office other than the Police Office and the
owner does not claim it within 30 days, it shall be deposited at the
Police Office for further disposition in accordance with General
Services Administration regulations (41 CFR part 101-48). Abandoned, or
other unclaimed property and, in the absence of specific direction by a
court, forfeited property, may be so identified by the Police Office and
sold and the proceeds deposited in accordance with 41 CFR 101-45.304 and
[57 FR 1874, Jan. 16, 1992]
Sec. 3.6 Nondiscrimination.
A person may not discriminate by segregation or otherwise against
another person because of age, color, creed, handicap, national origin,
race or sex, in furnishing or by refusing to furnish to that person the
use of any facility of a public nature, including all services,
privileges, accommodations, and activities provided within the enclave.
(Title 18 United States Code section 245 prohibits, by use of force or
threat of force, willful injury, intimidation, or interference with, a
person from participating in or enjoying any benefit, service,
privilege, program, facility, or activity provided by or administered by
the United States, attempts to do these acts, and engaging in certain
Subpart B--Traffic Regulations
Sec. 3.21 Emergency vehicles.
A person must yield the right of way to an emergency vehicle
operating its siren or flashing lights.
Sec. 3.22 Request for identification.
Upon request by a police officer, a person involved in any of the
following situations must provide identification, for example, by
exhibiting satisfactory credentials (such as an employment
identification card or driver's license):
(a) A traffic accident within the enclave;
(b) The police officer reasonably believes that the individual is
engaged in, or has engaged in, criminal conduct or a violation of the
regulations of this part; or
(c) The enclave or a portion of the enclave is not open to the
public (see Sec. 3.41).
A driver of a motor vehicle involved in an accident within the
enclave shall also exhibit, upon the request of a police officer, the
owner's registration card or other satisfactory proof of ownership.
Sec. 3.23 Parking.
(a) A person may not stand (vehicle stopped, with or without, an
occupant), or park a motor vehicle or other vehicle:
(1) In a lane, space, or area not designated by a sign for parking,
(2) On a sidewalk;
(3) Within an intersection or crosswalk;
(4) Within 10 feet of a fire hydrant, 5 feet of a driveway, or 20
feet of a stop
sign, crosswalk, or traffic control signal;
(5) In a double-parked position;
(6) At a curb painted yellow;
(7) On the side of a street facing oncoming traffic;
(8) In a position that would obstruct traffic;
(9) For a period in excess of 24 hours, except at living quarters,
or with the approval of the Police Office.
(b) A person must park bicycles, motorbikes, and similar vehicles
only in designated areas, and may not bring these vehicles inside
(c) A visitor must park in an area identified for that purpose by
posted signs or similar instructions, such as ``visitor parking'' and
``reserved for visitors''.
(d) A person may not drive or park an unauthorized motor vehicle on
a grassy, or any other unpaved, area without the approval of the Police
Sec. 3.24 Parking permits.
Except for visitor parking, a person may not park a motor vehicle
without displaying a parking permit, currently valid for that location.
The Director may revoke or refuse to issue or renew any parking permit
for violation of this section, or any provision of this part.
Sec. 3.25 Servicing of vehicles.
A person may not wash, polish, change oil, lubricate, or make
nonemergency repairs on a privately owned vehicle.
Sec. 3.26 Speed limit.
The speed limit is 25 miles per hour, unless otherwise posted. A
driver of a vehicle may not exceed the speed limit.
Sec. 3.27 Bicycles.
A person may not operate a bicycle, motorbike, or similar vehicle
without a horn or other warning device, and, if the vehicle is operated
between dusk and dawn, it must be equipped with an operating headlight,
and taillight or reflector.
Subpart C--Facilities and Grounds
Sec. 3.41 Admission to facilities or grounds.
The enclave is officially open to the public during normal working
and visiting hours and for approved public events. The enclave is closed
to the public at all other times, and the Director may also officially
close all or part of the enclave, or any building, in emergency
situations and at other times the Director deems necessary to ensure the
orderly conduct of Government business. When all or part of the enclave
is closed to the public, admission is restricted to employees and other
authorized persons who may be required to display Government credentials
or other identification when requested by a police officer and may be
required to sign a register. The living quarters and adjacent areas are
not open to the public but are open at all times to occupants and their
visitors and business invitees, unless otherwise closed by the Director.
Sec. 3.42 Restricted activities.
(a) Hobbies and sports. A person may undertake hobbies and sports
only in designated areas or as approved by the Director.
(b) Pets and other animals. A person may not bring on the enclave
any cat, dog, or other animal except for authorized purposes. This
prohibition does not apply to domestic pets at living quarters or to the
exercise of these pets under leash or other appropriate restraints. The
use of a dog by a handicapped person to assist that person is
(c) Photography. A person may take photographs, films or
audiovisuals, for personal or news purposes on the grounds of the
enclave or in entrances, lobbies, foyers, corridors, and auditoriums in
use for public meetings, except when contrary to security regulations or
Department of Health and Human Services policies, or where prohibited by
appropriate signs. Photographs and similar activities for advertising or
commercial purposes may be taken only with the advance written approval
of the Director. A person may take photographs of a patient only
with the informed consent of the patient (or the natural or legal
guardian) and of the Director of the Warren Grant Magnuson Clinical
Center or delegate.
(d) Intoxicating beverages, narcotics, and other controlled
substances. A person may not possess, sell, consume, or use alcohol or
other intoxicating beverages, except in connection with official duties,
as part of authorized research, or as otherwise authorized by the
Director, or, in the case of possession, consumption or use only, in
living quarters. (The sale, consumption, use, or possession of narcotics
and other controlled substances is prohibited and shall be governed by
the Controlled Substances Act (21 U.S.C. 841-845); driving under the
influence of an alcoholic beverage, drug or controlled substance is
prohibited and shall be governed by the Maryland Transportation Code
Annotated section 21-902.)
(e) Nuisances and disturbances. The following acts by a person are
prohibited: Unwarranted loitering, disorderly conduct (acting in a
disorderly manner to the disturbance of the public peace is prohibited
and shall be governed by Maryland Code Annotated, Article 27, section
122); littering or disposal of rubbish in an unauthorized manner, the
creation of any hazard to persons or property; the throwing of articles
of any kind from or at a building; the climbing upon any part of a
building for other than an authorized purpose; the loud playing of
radios or other similar devices; and rollerskating, skateboarding,
sledding or similar activities, except in officially designated areas.
(f) Smoking. Except as part of an approved medical research
protocol, a person may not smoke in any building on the enclave.
(g) Firearms, explosive, and other weapons. No person other than a
specifically authorized police officer shall possess firearms,
explosives, or other dangerous or deadly weapons or dangerous materials
intended to be used as weapons either openly or concealed. Upon written
request, the Director may permit possession in living quarters of
antique firearms held for collection purposes, if the Director finds
that the collection does not present any risk of harm.
[55 FR 2068, Jan. 22, 1990, as amended at 57 FR 1874, Jan. 16, 1992]
Sec. 3.43 Removal of property.
A person may not remove Federal property from the enclave or any
building on the enclave without a property pass, signed by an authorized
property custodian, which specifically describes the items to be
removed. In an emergency, or when the property custodian is not
available, a police officer may approve removal of Federal property if,
after consulting with the administrative officer or other appropriate
official, the police officer is authorized by the official to do so.
Privately-owned property, other than that ordinarily carried on one's
person, may be removed only under this property pass procedure, or upon
properly establishing ownership of the property to a police officer.
Packages, briefcases, or other containers brought within the enclave
are subject to inspection while on, or being removed from, the enclave.
Sec. 3.44 Solicitation.
It shall be unlawful for a person (other than an employee using
authorized bulletin boards), without prior written approval of the
Director, to offer or display any article or service for sale within the
enclave buildings or grounds; or to display any sign, placard, or other
form of advertisement; or to collect private debts; or to solicit
business, alms, subscriptions or contributions, except in connection
with approved national or local campaigns for funds for welfare, health
and other public interest purposes, or solicitation of labor
organization membership or dues as authorized under the Civil Service
Reform Act of 1978 (Pub. L. 95-454).
This provision shall not apply to authorized lessees and their
agents and employees with regard to space leased for commercial,
cultural, educational, or recreational purposes, under the Public
Buildings Cooperative Use Act of 1976 (40 U.S.C. 490(A)(16)).
Sec. 3.61 Penalties.
(a) A person found guilty of violating any provision of the
regulations in this part is subject to a fine of not more than $50 or
imprisonment of not more than thirty days or both, for each violation
(40 U.S.C. 318c).
(b) Penalties for violation of offenses proscribed by Federal
statutes (generally codified in title 18 of the United States Code) and
Maryland criminal statutes which are made Federal offenses under the
Assimilative Crimes Act and are prescribed in the applicable provisions
of those statutes.
PART 4--SERVICE OF PROCESS--Table of Contents
4.1 Suits against the Department and its employees in their official
4.2 Other process directed to the Department or Secretary.
4.3 Process against Department officials in their individual
4.4 Acknowledgment of mailed process.
4.5 Effect of regulations.
4.6 Materials related to petitions under the National Vaccine Injury
Authority: 5 U.S.C. 301, 42 U.S.C. 300aa-11.
Source: 48 FR 24079, May 31, 1983, unless otherwise noted.
Sec. 4.1 Suits against the Department and its employees in their official capacities.
Summonses and complaints to be served by mail on the Department of
Health and Human Services, the Secretary of Health and Human Services,
or other employees of the Department in their official capacities should
be sent to the General Counsel, Department of Health and Human Services,
200 Independence Avenue, S.W., Washington, DC 20201.
Sec. 4.2 Other process directed to the Department or Secretary.
Subpoenas and other process (other than summonses and complaints)
that are required to be served on the Department of Health and Human
Services or the Secretary of Health and Human Services in his official
capacity should be served as follows:
(a) If authorized by law to be served by mail, any mailed process
should be sent to the General Counsel, Department of Health and Human
Services, 200 Independence, S.W., Washington, DC 20201.
(b) If served by an individual, the process should be delivered to
the staff of the correspondence control unit in the Office of the
General Counsel, Room 711-E, 200 Independence Avenue, S.W., Washington,
DC, or, in the absence of that staff, to any Deputy General Counsel or
secretary to any Deputy General Counsel of the Department.
Sec. 4.3 Process against Department officials in their individual capacities.
Process to be served on Department officials in their individual
capacities must be served in compliance with the requirements for
service of process on individuals who are not governmental officials.
The Office of the General Counsel is authorized but not required to
accept process to be served on Departmental officials in their
individual capacities if the suit relates to an employee's official
Sec. 4.4 Acknowledgement of mailed process.
The Department will not provide a receipt or other acknowledgement
of process received, except for a return receipt associated with
certified mail and, where required, the acknowledgement specified by
Rule 4(c)(2)(C) of the Federal Rules of Civil Procedure.
Sec. 4.5 Effect of regulations.
The regulations in this part are intended solely to identify
Department officials who are authorized to accept service of process.
Litigants must comply with all requirements pertaining to service of
process that are established by statute and court rule even though they
are not repeated in these regulations.
Sec. 4.6 Materials related to petitions under the National Vaccine Injury Compensation Program.
Notwithstanding the provisions of Secs. 4.1, 4.2, and 4.3, service
of the Secretary's copies of petitions for compensation under the
Injury Compensation Program and of related filings, whether by mail or
in person, shall be upon the Director, Bureau of Health Professions,
5600 Fishers Lane, Suite 8-05, Rockville, Maryland 20857.
[53 FR 49552, Dec. 8, 1988]
PART 5--FREEDOM OF INFORMATION REGULATIONS--Table of Contents
Subpart A--Basic Policy
5.4 Relationship between the FOIA and the Privacy Act of 1974.
Subpart B--Obtaining a Record
5.21 How to request records.
5.22 Requests not handled under the FOIA.
5.23 Referral of requests outside the Department.
5.24 Responding to your request.
Subpart C--Release and Denial of Records
5.31 Designation of authorized officials.
5.32 Release of records.
5.33 Denial of requests.
5.34 Appeal of denials.
5.35 Time limits.
5.41 Fees to be charged--categories of requests.
5.42 Fees to be charged--general provisions.
5.43 Fee schedule.
5.44 Procedures for assessing and collecting fees.
5.45 Waiver or reduction of fees.
Subpart E--Records Available for Public Inspection
5.51 Records available.
5.52 Indexes of records.
Subpart F--Reasons for Withholding Some Records
5.62 Exemption one: National defense and foreign policy.
5.63 Exemption two: Internal personnel rules and practices.
5.64 Exemption three: Records exempted by other statutes.
5.65 Exemption four: Trade secrets and confidential commercial or
5.66 Exemption five: Internal memoranda.
5.67 Exemption six: Clearly unwarranted invasion of personal privacy.
5.68 Exemption seven: Law enforcement.
5.69 Exemptions 8 and 9: Records on financial institutions; records on
Authority: 5 U.S.C. 552, 18 U.S.C. 1905, 31 U.S.C. 9701, 42 U.S.C.
1306(c), E.O. 12600.
Source: 53 FR 47700, Nov. 25, 1988, unless otherwise noted.
Subpart A--Basic Policy
Sec. 5.1 Purpose.
This part contains the rules that the Department of Health and Human
Services (HHS) follows in handling requests for records under the
Freedom of Information Act (FOIA). It describes how to make a FOIA
request; who can release records and who can decide not to release; how
much time it should take to make a determination regarding release; what
fees may be charged; what records are available for public inspection;
why some records are not released; and your right to appeal and then go
to court if we refuse to release records.
Sec. 5.2 Policy.
As a general policy, HHS follows a balanced approach in
administering FOIA. We not only recognize the right of public access to
information in the possession of the Department, but also protect the
integrity of internal processes. In addition, we recognize the
legitimate interests of organizations or persons who have submitted
records to the Department or who would otherwise be affected by release
of records. For example, we have no discretion to release certain
records, such as trade secrets and confidential commercial information,
prohibited from release by law. This policy calls for the fullest
responsible disclosure consistent with those requirements of
administrative necessity and confidentiality which are recognized in the
Freedom of Information Act.
Sec. 5.3 Scope.
These rules apply to all components of the Department. Some units
may establish additional rules because of unique program requirements,
but such rules must be consistent with these
rules and must have the concurrence of the Assistant Secretary for
Public Affairs. Existing implementing rules remain in effect to the
extent that they are consistent with the new Departmental regulation. If
additional rules are issued, they will be published in the Federal
Register, and you may get copies from our Freedom of information
Sec. 5.4 Relationship between the FOIA and the Privacy Act of 1974.
(a) Coverage. The FOIA and this rule apply to all HHS records. The
Privacy Act, 5 U.S.C. 552a, applies to records that are about
individuals, but only if the records are in a system of records.
``Individuals'' and ``system of records'' are defined in the Privacy Act
and in our Privacy Act regulation, part 5b of this title.
(b) Requesting your own records. If you are an individual and
request records, then to the extent you are requesting your own records
in a system of records, we will handle your request under the Privacy
Act and part 5b. If there is any record that we need not release to you
under those provisions, we will also consider your request under the
FOIA and this rule, and we will release the record to you if the FOIA
(c) Requesting another individual's record. Whether or not you are
an individual, if you request records that are about an individual
(other than yourself) and that are in a system of records, we will
handle your request under the FOIA and this rule. (However, if our
disclosure in response to your request would be permitted by the Privacy
Act's disclosure provision, 5 U.S.C. 552a(b), for reasons other than the
requirements of the FOIA, and if we decide to make the disclosure, then
we will not handle your request under the FOIA and this rule. For
example, when we make routine use disclosures pursuant to requests, we
do not handle them under the FOIA and this rule. ``Routine use'' is
defined in the Privacy Act and in Part 5b). If we handle your request
under the FOIA and this rule and the FOIA does not require releasing the
record to you, then the Privacy Act may prohibit the release and remove
our discretion to release.
Sec. 5.5 Definitions.
As used in this part,
Agency means any executive department, military department,
government corporation, government controlled corporation, or other
establishment in the executive branch of the Federal Government, or any
independent regulatory agency. Thus, HHS is an agency. A private
organization is not an agency even if it is performing work under
contract with the Government or is receiving Federal financial
assistance. Grantee and contractor records are not subject to the FOIA
unless they are in the possession or under the control of HHS or its
agents, such as Medicare health insurance carriers and intermediaries.
Commercial use means, when referring to a request, that the request
is from or on behalf of one who seeks information for a use or purpose
that furthers the commercial, trade, or profit interests of the
requester or of a person on whose behalf the request is made. Whether a
request is for a commercial use depends on the purpose of the request
and the use to which the records will be put; the identity of the
requester (individual, non-profit corporation, for-profit corporation),
on the nature of the records, while in some cases indicative of that
purpose or use, is not necessarily determinative. When a request is from
a representative of the news media, a purpose or use supporting the
requester's news dissemination function is not a commercial use.
Department or HHS means the Department of Health and Human Services.
It includes Medicare health insurance carriers and intermediaries to the
extent they are performing functions under agreements entered into under
sections 1816 and 1842 of the Social Security Act, 42 U.S.C. 1395h,
Duplication means the process of making a copy of a record and
sending it to the requester, to the extent necessary to respond to the
request. Such copies include paper copy, microform, audio-visual
materials, and magnetic tapes, cards, and discs.
Educational institution means a preschool, elementary or secondary
school, institution of undergraduate or
graduate higher education, or institution of professional or vocational
education, which operates a program of scholarly research.
Freedom of Information Act or FOIA means section 552 of Title 5,
United States Code, as amended.
Freedom of Information Officer means an HHS official who has been
delegated the authority to release or withhold records and assess,
waive, or reduce fees in response to FOIA requests.
Non-commercial scientific institution means an institution that is
not operated substantially for purposes of furthering its own or someone
else's business, trade, or profit interests, and that is operated for
purposes of conducting scientific research whose results are not
intended to promote any particular product or industry.
Records means any handwritten, typed, or printed documents (such as
memoranda, books, brochures, studies, writings, drafts, letters,
transcripts, and minutes) and documentary material in other forms (such
as punchcards; magnetic tapes, cards, or discs; paper tapes; audio or
video recordings; maps; photographs; slides; microfilm; and motion
pictures). It does not include objects or articles such as exhibits,
models, equipment, and duplication machines or audiovisual processing
materials. Nor does it include books, magazines, pamphlets, or other
reference material in formally organized and officially designated HHS
libraries, where such materials are available under the rules of the
Representative of the news media means a person actively gathering
information for an entity organized and operated to publish or broadcast
news to the public. News media entities include television and radio
broadcasters, publishers of periodicals who distribute their products to
the general public or who make their products available for purchase or
subscription by the general public, and entities that may disseminate
news through other media (e.g., electronic dissemination of text). We
will treat freelance journalists as representatives of a new media
entity if they can show a likelihood of publication through such an
entity. A publication contract is such a basis, and the requester's past
publication record may show such a basis.
Request means asking for records, whether or not you refer
specifically to the Freedom of Information Act. Requests from Federal
agencies and court orders for documents are not included within this
definition. Subpoenas are requests only to the extent provided by Part 2
of this title.
Review means, when used in connection with processing records for a
commercial use request, examining the records to determine what
portions, if any, may be withheld, and any other processing that is
necessary to prepare the records for release. It includes only the
examining and processing that are done the first time we analyze whether
a specific exemption applies to a particular record or portion of a
record. It does not include examination done in the appeal stage with
respect to an exemption that was applied at the initial request stage.
However, if we initially withhold a record under one exemption, and on
appeal we determine that that exemption does not apply, then examining
the record in the appeal stage for the purpose of determining whether a
different exemption applies is included in review. It does not include
the process of researching or resolving general legal or policy issues
Search means looking for records or portions of records responsive
to a request. It includes reading and interpreting a request, and also
page-by-page and line-by-line examination to identify responsive
portions of a document. However, it does not include line-by-line
examination where merely duplicating the entire page would be a less
expensive and quicker way to comply with the request.
Subpart B--Obtaining a Record
Sec. 5.21 How to request records.
(a) General. Our policy is to answer all requests, both oral and
written, for records. However, in order to have the rights given you by
the FOIA and by this regulation (for example, the right to appeal if we
deny your request and the right to have our decisions reviewed in
court), you must either make your request in writing or make it
orally to a Freedom of Information Officer. Freedom of Information
Officers and their staffs may put in writing any oral requests they
(b) Addressing requests. It will help us to handle your request
sooner if you address it to the Freedom of Information Officer in the
HHS unit that is most likely to have the records you want. (See
Sec. 5.31 of this Part for a list of Freedom of Information Officers.)
If you cannot determine this, send the request to: HHS Freedom of
Information Officer, 645-F, Hubert H. Humphrey Building, Department of
Health and Human Services, 200 Independence Avenue SW., Washington, DC
20201. Write the words ``Freedom of Information Act Request'' on the
envelope and letter.
(c) Details in the letter. You should provide details that will help
us identify and find the records you are requesting. If there is
insufficient information, we will ask you for more. Include your
telephone number(s) to help us reach you if we have questions. If you
are not sure how to write your request or what details to include,
communicate with a Freedom of Information Officer.
Sec. 5.22 Requests not handled under the FOIA.
(a) We will not handle your request under the FOIA and this
regulation to the extent it asks for records that are currently
available, either from HHS or from another part of the Federal
Government, under a statute that provides for charging fees for those
records. For example, we will not handle your request under the FOIA and
this regulation to the extent it asks for detailed earnings statements
under the Social Security program, or records currently available from
the Government Printing Office of the National Technical Information
(b) We will not handle your request under the FOIA and this
regulation to the extent it asks for records that are distributed by an
HHS program office as part of its regular program activity, for example,
health education brochures distributed by the Public Health Service or
public information leaflets distributed by the Social Security
Sec. 5.23 Referral of requests outside the Department.
If you request records that were created by, or provided to us by,
another Federal agency, and if that agency asserts control over the
records, we may refer the records and your request to that agency. We
may likewise refer requests for classified records to the agency that
classified them. In these cases, the other agency will process and
respond to your request, to the extent it concerns those records, under
that agency's regulation, and you need not make a separate request to
that agency. We will notify you when we refer your request to another
Sec. 5.24 Responding to your request.
(a) Retrieving records. The Department is required to furnish copies
of records only when they are in our possession or we can retrieve them
from storage. If we have stored the records you want in the National
Archives or another storage center, we will retrieve and review them for
possible disclosure. However, the Federal Government destroys many old
records, so sometimes it is impossible to fill requests. Various laws,
regulations, and manuals give the time periods for keeping records
before they may be destroyed. For example, there is information about
retention of records in the Records Disposal Act of 1944, 44 U.S.C. 3301
through 3314; the Federal Property Management Regulations, 41 CFR 101-
11.4; the General Records Schedules of the National Archives and Records
Administration; and in the HHS Handbook: Files Maintenance and Records
(b) Furnishing records. The requirement is that we furnish copies
only of records that we have or can retrieve. We are not compelled to
create new records. For example, we are not required to write a new
program so that a computer will print information in the format you
prefer. However, if the requested information is maintained in
computerized form, but we can, with minimal computer instructions,
produce the information on paper, we will do this if it is the only way
to respond to a request. Nor are we required to perform research for
you. On the other hand, we may decide to conserve
government resources and at the same time supply the records you need by
consolidating information from various records rather than copying them
all. Moreover, we are required to furnish only one copy of a record and
usually impose that limit. If information exists in different forms, we
will provide the record in the form that best conserves government
resources. For example, if it requires less time and expense to provide
a computer record as a paper printout rather than in an electronic
medium, we will provide the printout.
Subpart C--Release and Denial of Records
Sec. 5.31 Designation of authorized officials.
(a) Freedom of Information Officers. To provide coordination and
consistency in responding to FOIA requests, only Freedom of Information
Officers have the authority to release or deny records. These same
officials determine fees.
(1) HHS Freedom of Information Officer. Only the HHS Freedom of
Information Officer may determine whether to release or deny records in
any of the following situations:
(i) The records you seek include records addressed to or sent from
an official or office of the Office of the Secretary, including its
staff offices, or of any Regional Director's Office;
(ii) The records you seek include any records of the Office of Human
Development Services, the Family Support Administration, or any
organizational unit of HHS not specifically indentified below; or
(iii) The records include records of more than one of the major
units identified below (PHS, HCFA, and SSA) either at headquarters or in
a Regional Office.
(2) PHS Freedom of Information Officer. If the records you seek are
exclusively records of the Public Health Service or if the records you
seek involve more than one health agency of the Public Health Service,
including its records in the regions, only the Deputy Assistant
Secretary for Health (Communications), who also is the PHS Freedom of
Information Officer, may determine whether to release or deny the
records, except as follows:
(i) CDC and ATSDR Freedom of Information Officer. If the records you
seek are exclusively records of the Centers for Disease Control and/or
the Agency for Toxic Substances and Disease Registry, only the Director,
Office of Public Affairs, CDC, who also is the CDC and ATSDR Freedom of
Information Officer, may determine whether to release or deny the
(ii) FDA Freedom of Information Officer. If the records you seek are
exclusively records of the Food and Drug Administration, only the
Associate Commissioner for Public Affairs, FDA, who also is the FDA
Freedom of Information Officer, may determine whether to release or deny
(iii) NIH Freedom of Information Officer. If the records you seek
are exclusively records of the National Institutes of Health, only the
Associate Director of Communications, HIH, who also is the NIH Freedom
of Information Officer, may determine whether to release or deny the
(iv) HRSA Freedom of Information Officer. If the records you seek
are exclusively records of the Health Resources and Services
Administration, only the Associate Administrator for Communications,
HRSA, who also is the HRSA Freedom of Information Officer, may determine
whether to release or deny the records.
(v) ADAMHA Freedom of Information Officer. If the records you seek
are exclusively records of the Alcohol, Drug Abuse and Mental Health
Administration, only the Associate Administrator for Communications and
Public Affairs, ADAMHA, who is also the ADAMHA Freedom of Information
Officer, may determine whether to release or deny the records.
(vi) IHS Freedom of Information Officer. If the records you seek are
exclusively records of the Indian Health Service, only the Director of
Communications, IHS, who also is the IHS Freedom of Information Officer,
may determine whether to release or deny the records.
(3) SSA Freedom of Information Officer. If the records you seek are
records of the Social Security Administration, including its records in
the regions, only the Director, Office of Public Inquiries, SSA, who
also is the SSA Freedom of Information Officer, may determine whether to
release or deny the records.
(4) HCFA Freedom of Information Officer. If the records you seek are
exclusively records of the Health Care Financing Administration,
including its records in the regions, only the Director, Office of
Public Affairs, HCFA, who also is the HCFA Freedom of Information
Officer, may determine whether to release or deny the records.
(b) Delegations. Any of the above Freedom of Information Officers
may delegate his or her authority to release or deny records and to
determine fees. Any such delegation requires the concurrence of the
Assistant Secretary for Public Affairs.
(c) Addresses and telephone numbers. The addresses and telephone
numbers of the Freedom of Information Officers are listed below.
Freedom of Information Officers
HHS Freedom of Information Officer, Room 645-F, Hubert H. Humphrey
Building, 200 Independence Avenue SW., Washington, DC 20201, Tel: (202)
SSA Freedom of Information Officer, Room 4-H-8, Annex Building, 6401
Security Boulevard, Baltimore, Maryland 21235, Tel: (301) 965-3962
HCFA Freedom of Information Officer, Room 100, Professional Building,
Office of Public Affairs, 6660 Security Boulevard, Baltimore, Maryland
21207, Tel: (301) 966-5352
PHS Freedom of Information Officer, Room 13-C-24, Parklawn Building,
5600 Fishers Lane, Rockville, Maryland 20857, Tel: (301) 443-5252
FDA Freedom of Information Officer, HFW-35, Room 12A16, Parklawn
Building, 5600 Fishers Land, Rockville, Maryland 20857, Tel: (301) 443-
NIH Freedom of Information Officer, National Institutes of Health,
Building 31, Room 2B39, 9000 Rockville Pike, Bethesda, Maryland 20892,
Tel: (301) 496-5633
CDC Freedom of Information Officer, Centers for Disease Control, 1600
Clifton Road, NE., Atlanta, Georgia 30333, Tel: (404) 329-3286
HRSA Freedom of Information Officer, Room 14-43, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland 20857, Tel: (301) 443-2086
ADAMHA Freedom of Information Officer, Room 12-C-15, Parklawn Building,
5600 Fishers Lane, Rockville, Maryland 20857, Tel: (301) 443-3783
IHS Freedom of Information Officer, Room 5-A-39, Parklawn Building, 5600
Fishers Land, Rockville, Maryland 20857, Tel: (301) 443-1397.
Sec. 5.32 Release of records.
(a) Records previously released. If we have released a record, or a
part of a record, to others in the past, we will ordinarily release it
to you also. However, we will not release it to you if a statute forbids
this disclosure, and we will not necessarily release it to you if an
exemption applies in your situation and did not apply, or applied
differently, in the previous situations.
(b) Unauthorized disclosure. The principle stated in paragraph (a)
of this section, does not apply if the previous release was
(c) Poor copy. If we cannot make a legible copy of a record to be
released, we do not attempt to reconstruct it. Instead, we furnish the
best copy possible and note its poor quality in our reply.
Sec. 5.33 Denial of requests.
(a) Information furnished. All denials are in writing and describe
in general terms the material withheld; state the reasons for the
denial, including, as applicable, a reference to the specific exemption
of the FOIA authorizing the withholding or deletion; explain your right
to appeal the decision and identify the official to whom you should send
the appeal; and are signed by the person who made the decision to deny
all or part of the request.
(b) Unproductive searches. We make a diligent search for records to
satisfy your request. Nevertheless, we may not be able always to find
the records you want using the information you provided, or they may not
exist. If we advise you that we have been unable to find the records
despite a diligent search, this does not constitute a denial of your
Sec. 5.34 Appeal of denials.
(a) Right of appeal. You have the right to appeal a partial or full
denial of your FOIA request. To do so, you must put your appeal in
writing and send it to the review official identified in the denial
letter. You must send
your appeal within 30 days from the date you receive that letter or from
the date you receive the records released as a partial grant of your
request, whichever is later.
(b) Letter of appeal. The appeal letter should state reasons why you
believe that the FOIA exemption(s) we cited do not apply to the records
that you requested, or give reasons why they should be released
regardless of whether the exemption(s) apply. Because we have some
discretionary authority in deciding whether to release or withhold
records, you may strengthen your request by explaining your reasons for
wanting the records. However, you are not required to give any
(c) Review process. Before making a decision on an appeal of a
denial, the designated review official will consult with the General
Counsel to ensure that the rights and interests of all parties affected
by the request are protected. Also, the concurrence of the Assistant
Secretary for Public Affairs is required in all appeal decisions,
including those on fees. When the review official responds to an appeal,
that constitutes the Department's final action on the request. If the
review official grants your appeal, we will send the records to you
promptly or let you inspect them, or else we will explain the reason for
any delay and the approximate date you will receive copies or be allowed
to inspect the records. If the decision is to deny your appeal, the
official will state the reasons for the decision in writing and inform
you of the FOIA provision for judicial review.
Sec. 5.35 Time limits.
(a) General. FOIA sets certain time limits for us to decide whether
to disclose the records you requested, and to decide appeals. If we fail
to meet the deadlines, you may proceed as if we had denied your request
or your appeal. We will try diligently to comply with the time limits,
but if it appears that processing your request may take longer than we
would wish, we will acknowledge your request and tell you its status.
Since requests may be misaddressed or misrouted, you should call or
write to confirm that we have the request and to learn its status if you
have not heard from us in a reasonable time.
(b) Time allowed. (1) We will decide whether to release records
within 10 working days after your request reaches the appropriate FOI
office, as identified in Sec. 5.31 of this part. When we decide to
release records, we will actually provide the records, or let you
inspect them, as soon as possible after that decision.
(2) We will decide an appeal within 20 working days after the appeal
reaches the appropriate review official
(c) Extension of time limits. FOI Officers of review officials may
extend the time limits in unusual circumstances. Extension at the
request stage and at the appeal stage may total up to 10 working days.
We will notify you in writing of any extension. ``Unusual
circumstances'' include situations when we:
(1) Search for and collect records from field facilites, archives,
or locations other than the office processing the request.
(2) Search for, collect, or examine a great many records in response
to a single request.
(3) Consult with another office or agency that has substantial
interest in the determination of the request.
(4) Conduct negotiations with submitters and requesters of
information to determine the nature and extent of non-disclosable
Sec. 5.41 Fees to be charged--categories of requests.
The paragraphs below state, for each category of request, the type
of fees that we will generally charge. However, for each of these
categories, the fees may be limited, waived, or reduced for the reasons
given in Secs. 5.42 through 5.45 or for other reasons.
(a) Commercial use request. If your request is for a commercial use,
HHS will charge you the costs of search, review, and duplication.
(b) Educational and scientific institutions and news media. If you
are an educational institution or a non-commercial scientific
institution, operated primarily for scholarly or scientific research, or
a representative of the news
media, and your request is not for a commercial use, HHS will charge you
only for the duplication of documents. Also, HHS will not charge you the
copying costs for the first 100 pages of duplication.
(c) Other requesters. If your request is not the kind described by
paragraph (a) or (b) of this section, then HHS will charge you only for
the search and the duplication. Also, we will not charge you for the
first two hours of search time or for the copying costs of the first 100
pages of duplication.
Sec. 5.42 Fees to be charged--general provisions.
(a) We may charge search fees even if the records we find are exempt
from disclosure, or even if we do not find any records at all.
(b) If we are not charging you for the first two hours of search
time, under Sec. 5.41(c), and those two hours are spent on a computer
search, then the two free hours are the first two hours of the
operator's own operation. If the operator spends less than two hours on
the search, we well reduce the total search fees by the average hourly
rate for the operator's time, multipled by two.
(c) If we are not charging you for the first 100 pages of
duplication, under Sec. 5.41 (b) or (c), then those 100 pages are the
first 100 pages of photocopies of standard size pages, or the first 100
pages of computer printout. If we cannot use this method to calculate
the fee reduction, then we will reduce your total duplication fee by the
normal charge for photocopying a standard size page, multiplied by 100.
(d) We will not charge you any fee at all if the costs of routine
collection and processing of the fee are likely to equal or exceed the
amount of the fee. As of May 1987, such costs among the units HHS ranged
between $6.00 and $12.50.
(e) If we determine that you (acting either alone or together with
others) are breaking down a single request into a series of requests in
order to avoid (or reduce) the fees charged, we may aggregate all these
requests for purposes of calculating the fees charged.
(f) We will charge interest on unpaid bills beginning on the 31st
day following the day the bill was sent. We will use the provisions of
Part 30 of this Title in assessing interest, administrative costs, and
penalties and in taking actions to encourage payment.
(g) This subpart does not apply to requests for Social Security
program records on Social Security number holders, wage earners,
employers, and claimants, where the requests are governed by section
1106 of the Social Security Act, 42 U.S.C. 1306(c), and by 20 CFR
Sec. 5.43 Fee schedule.
HHS charges the following fees:
(a) Manual searching for or reviewing of records--when the search or
review is performed by employees at grade GS-1 through GS-8, an hourly
rate based on the salary of a GS-5, step 7, employee; when done by a GS-
9 through GS-14, an hourly rate based on the salary of a GS-12, step 4,
employee; and when done by a GS-15 or above, an hourly rate based on the
salary of a GS-15, step 7, employee. In each case, the hourly rate will
be computed by taking the current hourly rate for the specified grade
and step, adding 16% of that rate to cover benefits, and rounding to the
nearest whole dollar. As of November 25, 1988, these rates were $10,
$20, and $37 respectively. When a search involves employees at more than
one of these levels, we will charge the rate appropriate for each.
(b) Computer searching and printing--the actual cost of operating
the computer plus charges for the time spent by the operator, at the
rates given in paragraph (a) of this section.
(c) Photocopying standard size pages--$0.10 per page. FOI Officers
may charge lower fees for particular documents where--
(1) The document has already been printed in large numbers,
(2) The program office determines that using existing stock to
answer this request, and any other anticipated FOI requests, will not
interfere with program requirements, and
(3) The FOI Officer determines that the lower fee is adequate to
recover the prorated share of the original printing costs.
(d) Photocopying odd-size documents (such as punchcards or
blueprints), or reproducing other records (such as tapes)--the actual
costs of operating
the machine, plus the actual cost of the materials used, plus charges
for the time spent by the operator, at the rates given in paragraph (a)
of this section.
(e) Certifying that records are true copies. This service is not
required by the FOIA. If we agree to provide it, we will charge $10 per
(f) Sending records by express mail, certified mail, or other
special methods. This service is not required by the FOIA. If we agree
to provide it, we will charge our actual costs.
(g) Performing any other special service that you request and we
agree to--actual costs of operating any machinery, plus actual cost of
any materials used, plus charges for the time of our employees, at the
rates given in paragraph (a) of this section.
Sec. 5.44 Procedures for assessing and collecting fees.
(a) Agreement to pay. We generally assume that when you request
records you are willing to pay the fees we charge for services
associated with your request. You may specify a limit on the amount you
are willing to spend. We will notify you if it appears that the fees
will exceed the limit and ask whether you nevertheless want us to
proceed with the search.
(b) Advance payment. If you have failed to pay previous bills in a
timely fashion, or if our initial review of your request indicates that
we will charge you fees exceeding $250, we will require you to pay your
past due fees and/or the estimated fees, or a deposit, before we start
searching for the records you want. If so, we will let you know promptly
upon receiving your request. In such cases, the administrative time
limits prescribed in Sec. 5.35 of the part (i.e., ten working days from
receipt of initial requests and 20 working days from receipt of appeals
from initial denials, plus permissible extensions of these time limits)
will begin only after we come to an agreement with you over payment of
fees, or decide that fee waiver or reduction is appropriate.
(c) Billing and payment. We will normally require you to pay all
fees before we furnish the records to you. We may, at our discretion,
send you a bill along with or following the furnishing of the records.
For example, we may do this if you have a history of prompt payment. We
may also, at our discretion, aggregate the charges for certain time
periods in order to avoid sending numerous small bills to frequent
requesters, or to businesses or agents representing requesters. For
example, we might send a bill to such a requester once a month. Fees
should be paid in accordance with the instructions furnished by the
person who responds to your requests.
Sec. 5.45 Waiver or reduction of fees.
(a) Standard. We will waive or reduce the fees we would otherwise
charge if disclosure of the information meets both of the following
(1) It is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of
the government, and
(2) It is not primarily in the commercial interest of the requester.
These two tests are explained in paragraphs (b) and (c) of this
(b) Public interest. The disclosure passes the first test only if it
furthers the specific public interest of being likely to contribute
significantly to public understanding of government operations or
activities, regardless of any other public interest it may further. In
analyzing this question, we will consider the following factors.
(1) How, if at all, do the records to be disclosed pertain to the
operations or activities of the Federal Government?
(2) Would disclosure of the records reveal any meaningful
information about government operations or activities? Can one learn
from these records anything about such operations that is not already
(3) Will the disclosure advance the understanding of the general
public as distinguished from a narrow segment of interested persons?
Under this factor we may consider whether the requester is in a position
to contribute to public understanding. For example, we may consider
whether the requester has such knowledge or expertise as may be
necessary to understand the information, and whether the requester's
intended use of the information would be likely to disseminate the
information among the public. An unsupported
claim to be doing research for a book or article does not demonstrate
that likelihood, while such a claim by a representative of the news
media is better evidence.
(4) Will the contribution to public understanding be a significant
one? Will the public's understanding of the government's operations be
substantially greater as a result of the disclosure?
(c) Not primarily in the requester's commercial interest. If the
disclosure passes the test of furthering the specific public interest
described in paragraph (b) of this section, we will determine whether it
also furthers the requester's commercial interest and, if so, whether
this effect outweighs the advancement of that public interest. In
applying this second test, we will consider the following factors:
(1) Would the disclosure further a commercial interest of the
requester, or of someone on whose behalf the requester is acting?
``Commercial interests'' include interests relating to business, trade,
and profit. Not only profit-making corporations have commercial
interests--so do nonprofit corporations, individuals, unions, and other
associations. The interest of a representative of the news media in
using the information for news dissemination purposes will not be
considered a commercial interest.
(2) If disclosure would further a commercial interest of the
requester, would that effect outweigh the advancement of the public
interest defined in paragraph (b) of this section? Which effect is
(d) Deciding between waiver and reduction. If the disclosure passes
both tests, we will normally waive fees. However, in some cases we may
decide only to reduce the fees. For example, we may do this when
disclosure of some but not all of the requested records passes the
(e) Procedure for requesting a waiver or reduction. You must make
your request for a waiver or reduction at the same time you make your
request for records. You should explain why you believe a waiver or
reduction is proper under the analysis in paragraphs (a) through (d) of
this section. Only FOI Officers may make the decision whether to waive,
or reduce, the fees. If we do not completely grant your request for a
waiver or reduction, the denial letter will designate a review official.
You may appeal the denial to that official. In your appeal letter, you
should discuss whatever reasons are given in our denial letter. The
process prescribed in Sec. 5.34(c) of this part will also apply to these
Subpart E--Records Available for Public Inspection
Sec. 5.51 Records available.
(a) Records of general interest. We will make the following records
of general interest available for your inspection and copying. Before
releasing them, however, we may delete the names of people, or
information that would identify them, if release would invade their
personal privacy to a clearly unwarranted degree. (See Sec. 5.67 of this
(1) Orders and final opinions, including concurring and dissenting
opinions in adjudications, such as Letters of Finding issued by the
Office for Civil Rights in civil rights complaints, and Social Security
Rulings. (See Sec. 5.66 of this part for availability of internal
memoranda, including attorney opinions and advice.)
(2) Statements of policy and interpretations that we have adopted
but have not published in the Federal Register.
(3) Administrative staff manuals and instructions to staff that
affect the public. (We will not make available, however, manuals or
instructions that reveal investigative or audit procedures as described
in Secs. 5.63 and 5.68 of this part.)
(b) Other records. In addition to such records as those described in
paragraph (a) of this section, we will make available to any person a
copy of all other agency records, unless we determine that such records
should be withheld from disclosure under subsection (b) of the Act and
Subpart F of this regulation.
Sec. 5.52 Indexes of records.
(a) Inspection and copying. We will maintain and provide for your
inspection and copying current indexes of the records described in
Sec. 5.51(a). We will also publish and distribute copies of
the indexes unless we announce in the Federal Register that it is
unnecessary or impracticable to do so. For assistance in locating
indexes maintained in the Department, you may contact the HHS Freedom of
Information Officer at the address and telephone number in Sec. 5.31(c).
(b) Record citation as precedent. We will not use or cite any record
described in Sec. 5.51(a) as a precedent for an action against a person
unless we have indexed the record and published it or made it available,
or unless the person has timely notice of the record.
Subpart F--Reasons for Withholding Some Records
Sec. 5.61 General.
Section 552(b) of the Freedom of Information Act contains nine
exemptions to the mandatory disclosure of records. We describe these
exemptions below and explain how this Department applies them to
disclosure determinations. (In some cases more than one exemption may
apply to the same document.) Information obtained by the Department from
any individual or organization, furnished in reliance on a provision for
confidentiality authorized by applicable statute or regulation, will not
be disclosed, to the extent it can be withheld under one of these
exemptions. This section does not itself authorize the giving of any
pledge of confidentiality by any officer or employee of the Department.
Sec. 5.62 Exemption one: National defense and foreign policy.
We are not required to release records that, as provided by FOIA,
are ``(a) specifically authorized under criteria established by an
Executive Order to be kept secret in the interest of national defense or
foreign policy and (b) are in fact properly classified pursuant to such
Executive Order.'' Executive Order No. 12356 (1982) provides for such
classification. When the release of certain records may adversely affect
U.S. relations with foreign countries, we usually consult with officials
of those countries or officials of the Department of State. Also, we may
on occasion have in our possession records classified by some other
agency. We may refer your request for such records to the agency that
classified them and notify you that we have done so, as explained in
Sec. 5.63 Exemption two: Internal personnel rules and practices.
We are not required to release records that are ``related solely to
the internal personnel rules and practices of an agency.'' Under this
exemption, we may withhold routine internal agency practices and
procedures. For example, we may withhold guard schedules and rules
governing parking facilities or lunch periods. Also under this
exemption, we may withhold internal records whose release would help
some persons circumvent the law or agency regulations. For example, we
ordinarily do not disclose manuals that instruct our investigators or
auditors how to investigate possible violations of law, to the extent
that this release would help some persons circumvent the law.
Sec. 5.64 Exemption three: Records exempted by other statutes.
We are not required to release records if another statute
specifically allows us to withhold them. We may use another statute to
justify withholding only if it absolutely prohibits disclosure or if it
sets forth criteria to guide our decision on releasing or identifies
particular types of material to be withheld.
Sec. 5.65 Exemption four: Trade secrets and confidential commercial or financial information.
We will withhold trade secrets and commercial or financial
information that is obtained from a person and is privileged or
(a) Trade secrets. A trade secret is a secret, commercially valuable
plan, formula, process, or device that is used for the making,
preparing, compounding, or processing of trade commodities and that can
be said to be the end product of either innovation or substantial
effort. There must be a direct relationship between the trade secret and
the productive process.
(b) Commercial or financial information. We will not disclose
information is ``commercial or financial,'' is obtained from a person,
and is ``privileged or confidential.''
(1) Information is ``commercial or financial'' if it relates to
businesses, commerce, trade, employment, profits, or finances (including
personal finances). We interpret this category broadly.
(2) Information is ``obtained from a person'' if HHS or another
agency has obtained it from someone outside the Federal Government or
from someone within the Government who has a commercial or financial
interest in the information. ``Person'' includes an individual,
partnership, corporation, association, state or foreign government, or
other organization. Information is not ``obtained from a person'' if it
is generated by HHS or another federal agency. However, information is
``obtained from a person'' if it is provided by someone, including but
not limited to an agency employee, who retains a commercial or financial
interest in the information.
(3) Information is ``privileged'' if it would ordinarily be
protected from disclosure in civil discovery by a recognized evidentiary
privilege, such as the attorney-client privilege or the work product
privilege. Information may be privileged for this purpose under a
privilege belonging to a person outside the government, unless the
providing of the information to the government rendered the information
no longer protectable in civil discovery.
(4) Information is ``confidential'' if it meets one of the following
(i) Disclosure may impair the government's ability to obtain
necessary information in the future;
(ii) Disclosure would substantially harm the competitive position of
the person who submitted the information;
(iii) Disclosure would impair other government interests, such as
program effectiveness and compliance; or
(iv) Disclosure would impair other private interests, such as an
interest in controlling availability of intrinsically valuable records,
which are sold in the market by their owner.
The following questions may be relevant in analyzing whether a record
meets one or more of the above tests: Is the information of a type
customarily held in strict confidence and not disclosed to the public by
the person to whom it belongs? What is the general custom or usage with
respect to such information in the relevant occupation or business? How
many, and what types of, individuals have access to the information?
What kind and degree of financial injury can be expected if the
information is disclosed?
(c) Designation of certain confidential information. A person who
submits records to the government may designate part or all of the
information in such records as exempt from disclosure under Exemption 4
of the FOIA. The person may make this designation either at the time the
records are submitted to the government or within a reasonable time
thereafter. The designation must be in writing. Where a legend is
required by a request for proposals or request for quotations, pursuant
to 48 CFR 352.215-12, then that legend is necessary for this purpose.
Any such designation will expire ten years after the records were
submitted to the government.
(d) Predisclosure notification. The procedures in this paragraph
apply to records on which the submitter has designated information as
provided in paragraph (c) of this section. They also apply to records
that were submitted to the government where we have substantial reason
to believe that information in the records could reasonably be
considered exempt under Exemption 4. Certain exceptions to these
procedures are stated in paragraph (e) of this section.
(1) When we receive a request for such records, and we determine
that we may be required to disclose them, we will make reasonable
efforts to notify the submitter about these facts. The notice will
include a copy of the request, and it will inform the submitter about
the procedures and time limits for submission and consideration of
objections to disclosure. If we must notify a large number of
submitters, we may do this by posting or publishing a notice in a place
where the submitters are reasonably likely to become aware of it.
(2) The submitter has five working days from receipt of the notice
to object to disclosure of any part of the
records and to state all bases for its objections.
(3) We will give consideration to all bases that have been timely
stated by the submitter. If we decide to disclose the records, we will
notify the submitter in writing. This notice will briefly explain why we
did not sustain its objections. We will include with the notice a copy
of the records about which the submitter objected, as we propose to
disclose them. The notice will state that we intend to disclose the
records five working days after the submitter receives the notice unless
we are ordered by a United States District Court not to release them.
(4) When a requester files suit under the FOIA to obtain records
covered by this paragraph, we will promptly notify the submitter.
(5) Whenever we send a notice to a submitter under paragraph (d)(1)
of this section, we will notify the requester that we are giving the
submitter a notice and an opportunity to object. Whenever we send a
notice to a submitter under paragraph (d)(3) of this section, we will
notify the requester of this fact.
(e) Exceptions to predisclosure notification. The notice
requirements in paragraph (d) of this section do not apply in the
(1) We decided not to disclose the records;
(2) The information has previously been published or made generally
(3) Disclosure is required by a regulation, issued after notice and
opportunity for public comment, that specifies narrow categories of
records that are to be disclosed under the FOIA, but in this case a
submitter may still designate records as described in paragraph (c) of
this section, and in exceptional cases, we may, at our discretion,
follow the notice procedures in paragraph (d) of this section; or
(4) The designation appears to be obviously frivolous, but in this
case we will still give the submitter the written notice required by
paragraph (d)(3) of this section (although this notice need not explain
our decision or include a copy of the records), and we will notify the
requester as described in paragraph (d)(5) of this section.
Sec. 5.66 Exemption five: Internal memoranda.
This exemption covers internal government communications and notes
that fall within a generally recognized evidentiary privilege. Internal
government communications include an agency's communications with an
outside consultant or other outside person, with a court, or with
Congress, when those communications are for a purpose similar to the
purpose of privileged intra-agency communications. Some of the most-
commonly applicable privileges are described in the following
(a) Deliberative process privilege. This privilege protects
predecisional deliberative communications. A communication is protected
under this privilege if it was made before a final decision was reached
on some question of policy and if it expressed recommendations or
opinions on that question. The purpose of the privilege is to prevent
injury to the quality of the agency decisionmaking process by
encouraging open and frank internal policy discussions, by avoiding
premature disclosure of policies not yet adopted, and by avoiding the
public confusion that might result from disclosing reasons that were not
in fact the ultimate grounds for an agency's decision. Purely factual
material in a deliberative document is within this privilege only if it
is inextricably intertwined with the deliberative portions so that it
cannot reasonably be segregated, if it would reveal the nature of the
deliberative portions, or if its disclosure would in some other way make
possible an intrusion into the decisionmaking process. We will release
purely factual material in a deliberative document unless that material
is otherwise exempt. The privilege continues to protect predecisional
documents even after a decision is made.
(b) Attorney work product privilege. This privilege protects
documents prepared by or for an agency, or by or for its representative
(typically, HHS attorneys) in anticipation of litigation or for trial.
It includes documents prepared for purposes of administrative
adjudications as well as court litigation. It includes documents
by program offices as well as by attorneys. It includes factual material
in such documents as well as material revealing opinions and tactics.
Finally, the privilege continues to protect the documents even after the
litigation is closed.
(c) Attorney-client communication privilege. This privilege protects
confidential communications between a lawyer and an employee or agent of
the government where there is an attorney-client relationship between
them (typically, where the lawyer is acting as attorney for the agency
and the employee is communicating on behalf of the agency) and where the
employee has communicated information to the attorney in confidence in
order to obtain legal advice or assistance.
Sec. 5.67 Exemption six: Clearly unwarranted invasion of personal privacy.
(a) Documents affected. We may withhold records about individuals if
disclosure would constitute a clearly unwarranted invasion of their
(b) Balancing test. In deciding whether to release records to you
that contain personal or private information about someone else, we
weigh the foreseeable harm of invading that person's privacy against the
public benefit that would result from the release. If you were seeking
information for a purely commercial venture, for example, we might not
think that disclosure would primarily benefit the public and we would
deny your request. On the other hand, we would be more inclined to
release information if you were working on a research project that gave
promise of providing valuable information to a wide audience. However,
in our evaluation of requests for records we attempt to guard against
the release of information that might involve a violation of personal
privacy because of a requester being able to ``read between the lines''
or piece together items that would constitute information that normally
would be exempt from mandatory disclosure under Exemption Six.
(c) Examples. Some of the information that we frequently withhold
under Exemption Six is: Home addresses, ages, and minority group status
of our employees or former employees; social security numbers; medical
information about individuals participating in clinical research
studies; names and addresses of individual beneficiaries of our
programs, or benefits such individuals receive; earning records, claim
files, and other personal information maintained by the Social Security
Administration, the Public Health Service, and the Health Care Financing
Sec. 5.68 Exemption seven: Law enforcement.
We are not required to disclose information or records that the
government has compiled for law enforcement purposes. The records may
apply to actual or potential violations of either criminal or civil laws
or regulations. We can withhold these records only to the extent that
releasing them would cause harm in at least one of the following
(a) Enforcement proceedings. We may withhold information whose
release could reasonably be expected to interfere with prospective or
ongoing law enforcement proceedings. Investigations of fraud and
mismanagement, employee misconduct, and civil rights violations may fall
into this category. In certain cases--such as when a fraud investigation
is likely--we may refuse to confirm or deny the existence of records
that relate to the violations in order not to disclose that an
investigation is in progress, or may be conducted.
(b) Fair trial or impartial adjudication. We may withhold records
whose release would deprive a person of a fair trial or an impartial
adjudication because of prejudicial publicity.
(c) Personal privacy. We are careful not to disclose information
that could reasonably be expected to constitute an unwarranted invasion
of personal privacy. When a name surfaces in an investigation, that
person is likely to be vulnerable to innuendo, rumor, harassment, and
(d) Confidential sources and information. We may withhold records
whose release could reasonably be expected to disclose the identity of a
confidential source of information. A confidential source may be an
individual; a state, local, or foreign government agency; or
any private organization. The exemption applies whether the source
provides information under an express promise of confidentiality or
under circumstances from which such an assurance could be reasonably
inferred. Also, where the record, or information in it, has been
compiled by a criminal law enforcement authority conducting a criminal
investigation, or by an agency conducting a lawful national security
investigation, the exemption also protects all information supplied by a
confidential source. Also protected from mandatory disclosure is any
information which, if disclosed, could reasonably be expected to
jeopardize the system of confidentiality that assures a flow of
information from sources to investigatory agencies.
(e) Techniques and procedures. We may withhold records reflecting
special techniques or procedures of investigation or prosecution, not
otherwise generally known to the public. In some cases, it is not
possible to describe even in general terms those techniques without
disclosing the very material to be withheld. We may also withhold
records whose release would disclose guidelines for law enforcement
investigations or prosecutions if this disclosure could reasonably be
expected to create a risk that someone could circumvent requirements of
law or of regulation.
(f) Life and physical safety. We may withhold records whose
disclosure could reasonably be expected to endanger the life or physical
safety of any individual. This protection extends to threats and
harassment as well as to physical violence.
Sec. 5.69 Exemptions 8 and 9: Records on financial institutions; records on wells.
Exemption eight permits us to withhold records about regulation or
supervision of financial institutions. Exemption nine permits the
withholding of geological and geophysical information and data,
including maps, concerning wells.
PART 5a [RESERVED]
PART 5b--PRIVACY ACT REGULATIONS--Table of Contents
5b.2 Purpose and scope.
5b.4 Maintenance of records.
5b.5 Notification of or access to records.
5b.6 Special procedures for notification of or access to medical
5b.7 Procedures for correction or amendment of records.
5b.8 Appeals of refusals to correct or amend records.
5b.9 Disclosure of records.
5b.10 Parents and guardians.
5b.11 Exempt systems.
Appendix A to Part 5b--Employee Standards of Conduct
Appendix B to Part 5b--Routine Uses Applicable to More Than One System
of Records Maintained by HHS
Appendix C to Part 5b--Delegations of Authority [Reserved]
Authority: 5 U.S.C. 301, 5 U.S.C. 552a.
Source: 40 FR 47409, Oct. 8, 1975, unless otherwise noted.
Sec. 5b.1 Definitions.
As used in this part:
(a) Access means availability of a record to a subject individual.
(b) Agency means the Department of Health and Human Services.
(c) Department means the Department of Health and Human Services.
(d) Disclosure means the availability or release of a record to
anyone other than the subject individual.
(e) Individual means a living person who is a citizen of the United
States or an alien lawfully admitted for permanent residence. It does
not include persons such as sole proprietorships, partnerships, or
corporations. A business firm which is identified by the name of one or
more persons is not an individual within the meaning of this part.
(f) Maintain means to maintain, collect, use, or disseminate when
used in connection with the term ``record''; and, to have control over
or responsibility for a system of records when used in connection with
the term ``system of records.''
(g) Notification means communication to an individual whether he is
a subject individual.
(h) Record means any item, collection, or grouping of information
about an individual that is maintained by the Department, including but
not limited to the individual's education, financial transactions,
medical history, and criminal or employment history and that contains
his name, or an identifying number, symbol, or other identifying
particular assigned to the individual, such as a finger or voice print
or a photograph. When used in this part, record means only a record
which is in a system of records.
(i) Responsible Department official means that officer who is listed
in a notice of a system of records as the system manager for a given
system of records or another individual listed in the notice of a system
of records to whom requests may be made, or the designee of either such
officer or individual.
(j) Routine use means the disclosure of a record outside the
Department, without the consent of the subject individual, for a purpose
which is compatible with the purpose for which the record was collected.
It includes disclosures required to be made by statute other than the
Freedom of Information Act, 5 U.S.C. 552. It does not include
disclosures which are permitted to be made without the consent of the
subject individual which are not compatible with the purpose for which
it was collected such as disclosures to the Bureau of the Census, the
General Accounting Office, or to Congress.
(k) Secretary means the Secretary of Health and Human Services, or
(l) Statistical record means a record maintained for statistical
research or reporting purposes only and not maintained to make
determinations about a particular subject individual.
(m) Subject individual means that individual to whom a record
(n) System of records means any group of records under the control
of the Department from which a record is retrieved by personal
identifier such as the name of the individual, number, symbol or other
unique retriever assigned to the individual. Single records or groups of
records which are not retrieved by a personal identifier are not part of
a system of records. Papers maintained by individual employees of the
Department which are prepared, maintained, or discarded at the
discretion of the employee and which are not subject to the Federal
Records Act, 44 U.S.C. 2901, are not part of a system of records;
Provided, That such personal papers are not used by the employee or the
Department to determine any rights, benefits, or privileges of
Sec. 5b.2 Purpose and scope.
(a) This part implements section 3 of the Privacy Act of 1974, 5
U.S.C. 552a (hereinafter referred to as the Act), by establishing agency
policies and procedures for the maintenance of records. This part also
establishes agency policies and procedures under which a subject
individual may be given notification of or access to a record pertaining
to him and policies and procedures under which a subject individual may
have his record corrected or amended if he believes that his record is
not accurate, timely, complete, or relevant or necessary to accomplish a
(b) All components of the Department are governed by the provisions
of this part. Also governed by the provisions of this part are:
(1) Certain non-Federal entities which operate as agents of the
Department for purposes of carrying out Federal functions, such as
intermediaries and carriers performing functions under contracts and
agreements entered into pursuant to sections 1816 and 1842 of the Social
Security Act, 42 U.S.C. 1395h and 1395u.
(2) Advisory committees and councils within the meaning of the
Federal Advisory Committee Act which provide advice to (i) any official
or component of the Department or (ii) the President and for which the
Department has been delegated responsibility for providing services.
(c) Employees of the Department governed by this part include all
regular and special government employees of the Department; members of
the Public Health Service Commissioned Corps; experts and consultants
whose temporary (not in excess of 1 year) or intermittent services have
been procured by the Department by contract
pursuant to 3109 of Title 5, United States Code; volunteers where
acceptance of their services are authorized by law; those individuals
performing gratuitous services as permitted under conditions prescribed
by the Civil Service Commission; and, participants in work-study or
(d) Where other statutes mandate procedures which are inconsistent
with the procedures set forth in this part, components of the Department
may issue supplementary regulations containing procedures necessary to
comply with such statutes. In addition, components of the Department may
supplement by regulation the policies and procedures set forth in this
part to meet particular needs of the programs administered by such
(e) This part does not:
(1) Make available to a subject individual records which are not
retrieved by that individual's name or other personal identifier.
(2) Make available to the general public records which are retrieved
by a subject individual's name or other personal identifier or make
available to the general public records which would otherwise not be
available to the general public under the Freedom of Information Act, 5
U.S.C. 552, and Part 5 of this title.
(3) Govern the maintenance or disclosure of, notification of or
access to, records in the possession of the Department which are subject
to regulations of another agency, such as personnel records subject to
the regulations of the Civil Service Commission.
(4) Apply to grantees, including State and local governments or
subdivisions thereof, administering federally funded programs.
(5) Make available records compiled by the Department in reasonable
anticipation of court litigation or formal administrative proceedings.
The availability of such records to the general public or to any subject
individual or party to such litigation or proceedings shall be governed
by applicable constitutional principles, rules of discovery, and
applicable regulations of the Department and any of its components.
Sec. 5b.3 Policy.
It is the policy of the Department to protect the privacy of
individuals to the fullest extent possible while nonetheless permitting
the exchange of records required to fulfill the administrative and
program responsibilities of the Department, and responsibilities of the
Department for disclosing records which the general public is entitled
to have under the Freedom of Information Act, 5 U.S.C. 552, and Part 5
of this title.
Sec. 5b.4 Maintenance of records.
(a) No record will be maintained by the Department unless:
(1) It is relevant and necessary to accomplish a Department function
required to be accomplished by statute or Executive Order;
(2) It is acquired to the greatest extent practicable from the
subject individual when maintenance of the record may result in a
determination about the subject individual's rights, benefits or
privileges under Federal programs;
(3) The individual providing the record is informed of the authority
for providing the record (including whether the providing of the record
is mandatory or voluntary, the principal purpose for maintaining the
record, the routine uses for the record, what effect his refusal to
provide the record may have on him), and if the record is not required
by statute or Executive Order to be provided by the individual, he
agrees to provide the record.
(b) No record will be maintained by the Department which describes
how an individual exercises rights guaranteed by the First Amendment
unless expressly authorized (1) by statute, or (2) by the subject
individual, or (3) unless pertinent to and within the scope of an
authorized law enforcement activity.
Sec. 5b.5 Notification of or access to records.
(a) Times, places, and manner of requesting notification of or
access to a record. (1) Subject to the provisions governing medical
records in Sec. 5b.6 of this part, any individual may request
notification of a record. He may at the same time request access to any
record pertaining to him. An individual may
be accompanied by another individual of his choice when he requests
access to a record in person; Provided, That he affirmatively authorizes
the presence of such other individual during any discussion of a record
to which access is requested.
(2) An individual making a request for notification of or access to
a record shall address his request to the responsible Department
official and shall verify his identity when required in accordance with
paragraph (b)(2) of this section. At the time the request is made, the
individual shall specify which systems of records he wishes to have
searched and the records to which he wishes to have access. He may also
request that copies be made of all or any such records. An individual
shall also provide the responsible Department official with sufficient
particulars to enable such official to distinguish between records on
subject individuals with the same name. The necessary particulars are
set forth in the notices of systems of records.
(3) An individual who makes a request in person may leave with any
responsible Department official a request for notification of or access
to a record under the control of another responsible Department
official; Provided, That the request is addressed in writing to the
appropriate responsible Department official.
(b) Verification of identity--(1) When required. Unless an
individual, who is making a request for notification of or access to a
record in person, is personally known to the responsible Department
official, he shall be required to verify his identity in accordance with
paragraph (b)(2) of this section if:
(i) He makes a request for notification of a record and the
responsible Department official determines that the mere disclosure of
the existence of the record would be a clearly unwarranted invasion of
privacy if disclosed to someone other than the subject individual; or,
(ii) He makes a request for access to a record which is not required
to be disclosed to the general public under the Freedom of Information
Act, 5 U.S.C. 552, and Part 5 of this title.
(2) Manner of verifying identity. (i) An individual who makes a
request in person shall provide to the responsible Department official
at least one piece of tangible identification such as a driver's
license, passport, alien or voter registration card, or union card to
verify his identity. If an individual does not have identification
papers to verify his identity, he shall certify in writing that he is
the individual who he claims to be and that he understands that the
knowing and willful request for or acquisition of a record pertaining to
an individual under false pretenses is a criminal offense under the Act
subject to a $5,000 fine.
(ii) Except as provided in paragraph (b)(2)(v) of this section, an
individual who does not make a request in person shall submit a
notarized request to the responsible Department official to verify his
identity or shall certify in his request that he is the individual who
he claims to be and that he understands that the knowing and willful
request for or acquisition of a record pertaining to an individual under
false pretenses is a criminal offense under the Act subject to a $5,000
(iii) An individual who makes a request on behalf of a minor or
legal incompetent as authorized under Sec. 5b.10 of this part shall
verify his relationship to the minor or legal incompetent, in addition
to verifying his own identity, by providing a copy of the minor's birth
certificate, a court order, or other competent evidence of guardianship
to the responsible Department official; except that, an individual is
not required to verify his relationship to the minor or legal
incompetent when he is not required to verify his own identity or when
evidence of his relationship to the minor or legal incompetent has been
previously given to the responsible Department official.
(iv) An individual shall further verify his identity if he is
requesting notification of or access to sensitive records such as
medical records. Any further verification shall parallel the record to
which notification or access is being sought. Such further verification
may include such particulars as the individual's years of attendance at
a particular educational institution, rank attained in the uniformed
services, date or place of birth, names of parents, an occupation or the
times the individual received medical treatment.
(v) An individual who makes a request by telephone shall verify his
identity by providing to the responsible Department official identifying
particulars which parallel the record to which notification or access is
being sought. If the responsible Department official determines that the
particulars provided by telephone are insufficient, the requester will
be required to submit the request in writing or in person. Telephone
requests will not be accepted where an individual is requesting
notification of or access to sensitive records such as medical records.
(c) Granting notification of or access to a record. (1) Subject to
the provisions governing medical records in Sec. 5b.6 of this part and
the provisions governing exempt systems in Sec. 5b.11 of this part, a
responsible Department official, who receives a request for notification
of or access to a record and, if required, verification of an
individual's identity, will review the request and grant notification or
access to a record, if the individual requesting access to the record is
the subject individual.
(2) If the responsible Department official determines that there
will be a delay in responding to a request because of the number of
requests being processed, a breakdown of equipment, shortage of
personnel, storage of records in other locations, etc., he will so
inform the individual and indicate when notification or access will be
(3) Prior to granting notification of or access to a record, the
responsible Department official may at his discretion require an
individual making a request in person to reduce his request to writing
if the individual has not already done so at the time the request is
Sec. 5b.6 Special procedures for notification of or access to medical records.
(a) General. An individual in general has a right to notification of
or access to his medical records, including psychological records, as
well as to other records pertaining to him maintained by the Department.
This section sets forth special procedures as permitted by the Act for
notification of or access to medical records, including a special
procedure for notification of or access to medical records of minors.
The special procedures set forth in paragraph (b) of this section may
not be suitable for use by every component of the Department. Therefore,
components may follow the paragraph (b) procedure for notification of or
access to medical records, or may issue regulations establishing special
procedures for such purposes. The special procedure set forth in
paragraph (c) of this section relating to medical records of minors is
(b) Medical records procedures--(1) Notification of or access to
medical records. (i) Any individual may request notification of or
access to a medical record pertaining to him. Unless the individual is a
parent or guardian requesting notification of or access to a minor's
medical record, an individual shall make a request for a medical record
in accordance with this section and the procedures in Sec. 5b.5 of this
(ii) An individual who requests notification of or access to a
medical record shall, at the time the request is made, designate a
representative in writing. The representative may be a physician, other
health professional, or other responsible individual, who would be
willing to review the record and inform the subject individual of its
contents at the representative's discretion.
(2) Utilization of the designated representative. A subject
individual will be granted direct access to a medical record if the
responsible official determines that direct access is not likely to have
an adverse effect on the subject individual. If the responsible
Department official believes that he is not qualified to determine, or
if he does determine, that direct access to the subject individual is
likely to have an adverse effect on the subject individual, the record
will be sent to the designated representative. The subject individual
will be informed in writing that the record has been sent.
(c) Medical records of minors--(1) Requests by minors; notification
of or access to medical records to minors. A minor may request
notification of or access to a medical record pertaining to him in
accordance with paragraph (b) of this section.
(2) Requests on a minor's behalf; notification of or access to
medical records to an individual on a minor's behalf. (i) In order to
protect the privacy of a minor, a parent or guardian, authorized to act
on a minor's behalf as provided in Sec. 5b.10 of this part, who makes a
request for notification of or access to a minor's medical record will
not be given direct notification of or access to such record.
(ii) A parent or guardian shall make all requests for notification
of or access to a minor's medical record in accordance with this
paragraph and the procedures in Sec. 5b.5 of this part. A parent or
guardian shall at the time he makes a request designate a family
physician or other health professional (other than a family member) to
whom the record, if any, will be sent.
(iii) Where a medical record on the minor exists, it will be sent to
the physician or health professional designated by the parent or
guardian in all cases. If disclosure of the record would constitute an
invasion of the minor's privacy, that fact will be brought to the
attention of the physician or health professional to whom the record is
sent. The physician or health professional will be asked to consider the
effect that disclosure of the record to the parent or guardian would
have on the minor in determining whether the minor's medical record
should be made available to the parent or guardian. Response to the
parent or guardian making the request will be made in substantially the
We have completed processing your request for notification of or access
(Name of minor)
medical records. Please be informed that if any medical record were
found pertaining to that individual, they have not been sent to your
designated physician or health professional.
In each case where a minor's medical record is sent to a physician or
health professional, reasonable efforts will be made to so inform the
Sec. 5b.7 Procedures for correction or amendment of records.
(a) Any subject individual may request that his record be corrected
or amended if he believes that the record is not accurate, timely,
complete, or relevant or necessary to accomplish a Department function.
A subject individual making a request to amend or correct his record
shall address his request to the responsible Department official in
writing; except that, the request need not be in writing if the subject
individual makes his request in person and the responsible Department
official corrects or amends the record at that time. The subject
individual shall specify in each request:
(1) The system of records from which the record is retrieved;
(2) The particular record which he is seeking to correct or amend;
(3) Whether he is seeking an addition to or a deletion or
substitution of the record; and,
(4) His reasons for requesting correction or amendment of the
(b) A request for correction or amendment of a record will be
acknowledged within 10 working days of its receipt unless the request
can be processed and the subject individual informed of the responsible
Department official's decision on the request within that 10 day period.
(c) If the responsible Department official agrees that the record is
not accurate, timely, or complete based on a preponderance of the
evidence, the record will be corrected or amended. The record will be
deleted without regard to its accuracy, if the record is not relevant or
necessary to accomplish the Department function for which the record was
provided or is maintained. In either case, the subject individual will
be informed in writing of the correction, amendment, or deletion and, if
accounting was made of prior disclosures of the record, all previous
recipients of the record will be informed of the corrective action
(d) If the responsible Department official does not agree that the
record should be corrected or amended, the subject individual will be
informed in writing of the refusal to correct or amend the record. He
will also be informed that he may appeal the refusal to correct or amend
his record to the appropriate appeal authority listed in
Sec. 5b.8 of this part. The appropriate appeal authority will be
identified to the subject individual by name, title, and business
(e) Requests to correct or amend a record governed by the regulation
of another government agency, e.g., Civil Service Commission, Federal
Bureau of Investigation, will be forwarded to such government agency for
processing and the subject individual will be informed in writing of the
Sec. 5b.8 Appeals of refusals to correct or amend records.
(a) Processing the appeal. (1) A subject individual who disagrees
with a refusal to correct or amend his record may appeal the refusal in
writing. All appeals shall be made to the following appeal authorities,
or their designees, or successors in function:
(i) Assistant Secretary for Administration and Management for
records of the Office of the Secretary, or where the initial refusal to
correct or amend was made by another appeal authority. The appeal
authority for an initial refusal by the Assistant Secretary for
Administration and Management is the Under Secretary.
(ii) Assistant Secretary for Health for records of the Public Health
Service including Office of Assistant Secretary for Health; Health
Resources Administration; Health Services Administration; Alcohol, Drug
Abuse, and Mental Health Administration; Center for Disease Control;
National Institutes of Health; and Food and Drug Administration.
(iii) Assistant Secretary for Education for records of the Office of
the Assistant Secretary for Education, National Center for Education
Statistics, National Institute of Education, and Office of Education.
(iv) Assistant Secretary for Human Development for records of the
Office of Human Development.
(v) Commissioner of Social Security for records of the Social
(vi) Administrator, Social and Rehabilitation Service for the
records of the Social and Rehabilitation Service.
(2) An appeal will be completed within 30 working days from its
receipt by the appeal authority; except that, the appeal authority may
for good cause extend this period for an additional 30 days. Should the
appeal period be extended, the subject individual appealing the refusal
to correct or amend the record will be informed in writing of the
extension and the circumstances of the delay. The subject individual's
request to amend or correct the record, the responsible Department
official's refusal to correct or amend, and any other pertinent material
relating to the appeal will be reviewed. No hearing will be held.
(3) If the appeal authority agrees that the record subject to the
appeal should be corrected or amended, the record will be amended and
the subject individual will be informed in writing of the correction or
amendment. Where an accounting was made of prior disclosures of the
record, all previous recipients of the record will be informed of the
corrective action taken.
(4) If the appeal is denied, the subject individual will be informed
(i) Of the denial and the reasons for the denial;
(ii) That he has a right to seek judicial review of the denial; and,
(iii) That he may submit to the responsible Department official a
concise statement of disagreement to be associated with the disputed
record and disclosed whenever the record is disclosed.
(b) Notation and disclosure of disputed records. Whenever a subject
individual submits a statement of disagreement to the responsible
Department official in accordance with paragraph (a)(4)(iii) of this
section, the record will be noted to indicate that it is disputed. In
any subsequent disclosure, a copy of the subject individual's statement
of disagreement will be disclosed with the record. If the responsible
Department official deems it appropriate, a concise statement of the
appeal authority's reasons for denying the subject individual's appeal
may also be disclosed with the record. While the subject individual will
have access to this statement of reasons, such statement will not be
subject to correction or amendment. Where an accounting was made of
prior disclosures of the record, all previous recipients of the record
will be provided a copy of the subject individual's statement of
well as the statement, if any, of the appeal authority's reasons for
denying the subject individual's appeal.
Sec. 5b.9 Disclosure of records.
(a) Consent to disclosure by a subject individual. (1) Except as
provided in paragraph (b) of this section authorizing disclosures of
records without consent, no disclosure of a record will be made without
the consent of the subject individual. In each case the consent, whether
obtained from the subject individual at the request of the Department or
whether provided to the Department by the subject individual on his own
initiative, shall be in writing. The consent shall specify the
individual, organizational unit or class of individuals or
organizational units to whom the record may be disclosed, which record
may be disclosed and, where applicable, during which time frame the
record may be disclosed (e.g., during the school year, while the subject
individual is out of the country, whenever the subject individual is
receiving specific services). A blanket consent to disclose all of a
subject individual's records to unspecified individuals or
organizational units will not be honored. The subject individual's
identity and, where applicable (e.g., where a subject individual gives
consent to disclosure of a record to a specific individual), the
identity of the individual to whom the record is to be disclosed shall
(2) A parent or guardian of any minor is not authorized to give
consent to a disclosure of the minor's medical record.
(b) Disclosures without the consent of the subject individual. The
disclosures listed in this paragraph may be made without the consent of
the subject individual. Such disclosures are:
(1) To those officers and employees of the Department who have a
need for the record in the performance of their duties. The responsible
Department official may upon request of any officer or employee, or on
his own initiative, determine what constitutes legitimate need.
(2) Required to be disclosed under the Freedom of Information Act, 5
U.S.C. 552, and Part 5 of this title.
(3) For a routine use as defined in paragraph (j) of Sec. 5b.1 of
this part. Routine uses will be listed in any notice of a system of
records. Routine uses published in Appendix B are applicable to more
than one system of records. Where applicable, notices of systems of
records may contain references to the routine uses listed in Appendix B.
Appendix B will be published with any compendium of notices of systems
(4) To the Bureau of the Census for purposes of planning or carrying
out a census or survey or related activity pursuant to the provisions of
Title 13 U.S.C.
(5) To a recipient who has provided the agency with advance written
assurance that the record will be used solely as a statistical research
or reporting record; Provided, That, the record is transferred in a form
that does not identify the subject individual.
(6) To the National Archives of the United States as a record which
has sufficient historical or other value to warrant its continued
preservation by the United States Government, or for evaluation by the
Administrator of General Services or his designee to determine whether
the record has such value.
(7) To another government agency or to an instrumentality of any
governmental jurisdiction within or under the control of the United
States for a civil or criminal law enforcement activity if the activity
is authorized by law, and if the head of such government agency or
instrumentality has submitted a written request to the Department
specifying the record desired and the law enforcement activity for which
the record is sought.
(8) To an individual pursuant to a showing of compelling
circumstances affecting the health or safety of any individual if a
notice of the disclosure is transmitted to the last known address of the
(9) To either House of Congress, or to the extent of matter within
its jurisdiction, any committee or subcommittee thereof, any joint
committee of Congress or subcommittee of any such joint committee.
(10) To the Comptroller General, or any of his authorized
in the course of the performance of the duties of the General Accounting
(11) Pursuant to the order of a court of competent jurisdiction.
(c) Accounting of disclosures. (1) An accounting of all disclosures
of a record will be made and maintained by the Department for 5 years or
for the life of the record, whichever is longer; except that, such an
accounting will not be made:
(i) For disclosures under paragraphs (b) (1) and (2) of this
(ii) For disclosures made with the written consent of the subject
(2) The accounting will include:
(i) The date, nature, and purpose of each disclosure; and
(ii) The name and address of the person or entity to whom the
disclosure is made.
(3) Any subject individual may request access to an accounting of
disclosures of a record. The subject individual shall make a request for
access to an accounting in accordance with the procedures in Sec. 5b.5
of this part. A subject individual will be granted access to an
accounting of the disclosures of a record in accordance with the
procedures of this part which govern access to the related record.
Access to an accounting of a disclosure of a record made under paragraph
(b)(7) of this section may be granted at the discretion of the
responsible Department official.
Sec. 5b.10 Parents and guardians.
For the purpose of this part, a parent or guardian of any minor or
the legal guardian or any individual who has been declared incompetent
due to physical or mental incapacity or age by a court of competent
jurisdiction is authorized to act on behalf of an individual or a
subject individual. Except as provided in paragraph (b)(2) of Sec. 5b.5,
of this part governing procedures for verifying an individual's
identity, and paragraph (c) (2) of Sec. 5b.6 of this part governing
special procedures for notification of or access to a minor's medical
records, an individual authorized to act on behalf of a minor or legal
incompetent will be viewed as if he were the individual or subject
Sec. 5b.11 Exempt systems.
(a) General policy. The Act permits certain types of specific
systems of records to be exempt from some of its requirements. It is the
policy of the Department to exercise authority to exempt systems of
records only in compelling cases.
(b) Specific systems of records exempted. (1) Those systems of
records listed in paragraph (b)(2) of this section are exempt from the
following provisions of the Act and this part:
(i) 5 U.S.C. 552a(c)(3) and paragraph (c)(2) of Sec. 5b.9 of this
part which require a subject individual to be granted access to an
accounting of disclosures of a record.
(ii) 5 U.S.C. 552a(d) (1) through (4) and (f) and Secs. 5b.6, 5b.7,
and 5b.8 of this part relating to notification of or access to records
and correction or amendment of records.
(iii) 5 U.S.C. 552a(e)(4) (G) and (H) which require inclusion of
information about Department procedures for notification, access, and
correction or amendment of records in the notice for the systems of
(iv) 5 U.S.C. 552(e)(3) and paragraph (a)(3) of Sec. 5b.4 of this
part which require that an individual asked to provide a record to the
Department be informed of the authority for providing the record
(including whether the providing of the record is mandatory or
voluntary, the principal purposes for maintaining the record, the
routine uses for the record, and what effect his refusal to provide the
record may have on him), and if the record is not required by statute or
Executive Order to be provided by the individual, he agrees to provide
the record. This exemption applies only to an investigatory record
compiled by the Department for criminal law enforcement purposes in a
system of records exempt under subsection (j)(2) of the Act to the
extent that these requirements would prejudice the conduct of the
(2) The following systems of records are exempt from those
provisions of the Act and this part listed in paragraph (b) (1) of this
(i) Pursuant to subsection (j)(2) of the Act:
(A) The Saint Elizabeths Hospital's Court-Ordered Forensic
Investigatory Materials Files; and
(B) The Investigatory Material Compiled for Law Enforcement Purposes
(ii) Pursuant to subsection (k)(2) of the Act:
(A) The General Criminal Investigation Files, HHS/SSA;
(B) The Criminal Investigations File, HHS/SSA; and,
(C) The Program Integrity Case Files, HHS/SSA.
(D) Civil and Administrative Investigative Files of the Inspector
(E) Complaint Files and Log. HHS/OS/OCR.
(F) Investigative materials compiled for law enforcement purposes
for the Healthcare Integrity and Protection Data Bank (HIPDB), of the
Office of Inspector General. (See Sec. 61.15 of this title for access
and correction rights under the HIPDB by subjects of the Data Bank.)
(iii) Pursuant to subsection (k)(4) of the Act:
(A) The Health and Demographic Surveys Conduct in Random Samples of
the U.S. Population;
(B) The Health Manpower Inventories and Surveys;
(C) The Vital Statistics for Births, Deaths, Fetal Deaths, Marriages
and Divorces Occurring in the U.S. during Each Year; and,
(D) The Maryland Psychiatric Case Register.
(E) The Health Resources Utilization Statistics, DHHS/OASH/NCHS.
(F) National Medical Expenditure Survey Records. HHS/OASH/NCHSR.
(iv) Pursuant to subsection (k)(5) of the Act:
(A) The Investigatory Material Compiled for Security and Suitability
Purposes System, HHS; and,
(B) The Suitability for Employment Records, HHS.
(v) Pursuant to subsections (j)(2), (k)(2), and (k)(5) of the Act:
(A) The Clinical Investigatory Records, HHS/FDA;
(B) The Regulated Industry Employee Enforcement Records, HHS/FDA;
(C) The Employee Conduct Investigative Records, HHS/FDA; and,
(D) The Service Contractor Employee Investigative Records, HHS/FDA.
(vi) Pursuant to subsection (k)(6) of the Act:
(A) The Personnel Research and Merit Promotion Test Records, HHS/
(vii) Pursuant to subsections (k)(2) and (k)(5) of the Act:
(A) Public Health Service Records Related to Investigations of
Scientific Misconduct, HHS/OASH/ORI.
(B) Administration: Investigative Records, HHS/NIH/OM/OA/OMA.
(c) Notification of or access to records in exempt systems of
records. (1) Where a system of records is exempt as provided in
paragraph (b) of this section, any individual may nonetheless request
notification of or access to a record in that system. An individual
shall make requests for notification of or access to a record in an
exempt system of records in accordance with the procedures of Secs. 5b.5
and 5b.6 of this part.
(2) An individual will be granted notification of or access to a
record in an exempt system but only to the extent such notification or
access would not reveal the identity of a source who furnished the
record to the Department under an express promise, and prior to
September 27, 1975 an implied promise, that his identity would be held
in confidence, if:
(i) The record is in a system of records which is exempt under
subsection (k)(2) of the Act and the individual has been, as a result of
the maintenance of the record, denied a right, privilege, or benefit to
which he would otherwise be eligible; or,
(ii) The record is in a system of records which is exempt under
subsection (k)(5) of the Act.
(3) If an individual is not granted notification of or access to a
record in a system of records exempt under subsections (k) (2) and (5)
of the Act in accordance with this paragraph, he will be informed that
the identity of a confidential source would be revealed if notification
of or access to the record were granted to him.
(d) Discretionary actions by the responsible Department official.
Unless disclosure of a record to the general public is
otherwise prohibited by law, the responsible Department official may in
his discretion grant notification of or access to a record in a system
of records which is exempt under paragraph (b) of this section.
Discretionary notification of or access to a record in accordance with
this paragraph will not be a precedent for discretionary notification of
or access to a similar or related record and will not obligate the
responsible Department official to exercise his discretion to grant
notification of or access to any other record in a system of records
which is exempt under paragraph (b) of this section.
[40 FR 47409, Oct. 8, 1975, as amended at 43 FR 40229, Sept. 11, 1978;
47 FR 57040, Dec. 22, 1982; 49 FR 14108, Apr. 10, 1984; 51 FR 41352,
Nov. 14, 1986; 59 FR 36717, July 19, 1994; 65 FR 34988, June 1, 2000; 65
FR 37289, June 14, 2000]
Sec. 5b.12 Contractors.
(a) All contracts entered into on or after September 27, 1975 which
require a contractor to maintain or on behalf of the Department to
maintain, a system of records to accomplish a Department function must
contain a provision requiring the contractor to comply with the Act and
(b) All unexpired contracts entered into prior to September 27, 1975
which require the contractor to maintain or on behalf of the Department
to maintain, a system of records to accomplish a Department function
will be amended as soon as practicable to include a provision requiring
the contractor to comply with the Act and this part. All such contracts
must be so amended by July 1, 1976 unless for good cause the appeal
authority identified in Sec. 5b.8 of this part authorizes the
continuation of the contract without amendment beyond that date.
(c) A contractor and any employee of such contractor shall be
considered employees of the Department only for the purposes of the
criminal penalties of the Act, 5 U.S.C. 552a(i), and the employee
standards of conduct listed in Appendix A of this part where the
contract contains a provision requiring the contractor to comply with
the Act and this part.
(d) This section does not apply to systems of records maintained by
a contractor as a result of his management discretion, e.g., the
contractor's personnel records.
Sec. 5b.13 Fees.
(a) Policy. Where applicable, fees for copying records will be
charged in accordance with the schedule set forth in this section. Fees
may only be charged where an individual requests that a copy be made of
the record to which he is granted access. No fee may be charged for
making a search of the system of records whether the search is manual,
mechanical, or electronic. Where a copy of the record must be made in
order to provide access to the record (e.g., computer printout where no
screen reading is available), the copy will be made available to the
individual without cost. Where a medical record is made available to a
representative designated by the individual or to a physician or health
professional designated by a parent or guardian under Sec. 5b.6 of this
part, no fee will be charged.
(b) Fee schedule. The fee schedule for the Department is as follows:
(1) Copying of records susceptible to photocopying--$.10 per page.
(2) Copying records not susceptible to photocopying (e.g., punch
cards or magnetic tapes)--at actual cost to be determined on a case-by-
(3) No charge will be made if the total amount of copying does not
Appendix A to Part 5b--Employee Standards of Conduct
(a) General. All employees are required to be aware of their
responsibilities under the Privacy Act of 1974, 5 U.S.C. 552a.
Regulations implementing the Act are set forth in 45 CFR 5b. Instruction
on the requirements of the Act and regulation shall be provided to all
new employees of the Department. In addition, supervisors shall be
responsible for assuring that employees who are working with systems of
records or who undertake new duties which require the use of systems of
records are informed of their responsibilities. Supervisors shall also
be responsible for assuring that all employees who work with such
systems of records are periodically reminded of the requirements of the
Act and are advised of any new provisions or interpretations of the Act.
(b) Penalties. (1) All employees must guard against improper
disclosure f records which
are governed by the Act. Because of the serious consequences of improper
invasions of personal privacy, employees may be subject to disciplinary
action and criminal prosecution for knowing and willful violations of
the Act and regulation. In addition, employees may also be subject to
disciplinary action for unknowing or unwillful violations, where the
employee had notice of the provisions of the Act and regulations and
failed to inform himself sufficiently or to conduct himself in
accordance with the requirements to avoid violations.
(2) The Department may be subjected to civil liability for the
following actions undertaken by its employees:
(a) Making a determination under the Act and Secs. 5b.7 and 5b.8 of
the regulation not to amend an individual's record in accordance with
his request, or failing to make such review in conformity with those
(b) Refusing to comply with an individual's request for notification
of or access to a record pertaining to hiem;
(c) Failing to maintain any record pertaining to any individual with
such accuracy, relevance, timeliness, and completeness as is necessary
to assure fairness in any determination relating to the qualifications,
character, rights, or opportunities of, or benefits to the individual
that may be made on the basis of such a record, and consequently a
determination is made which is adverse to the individual; or
(d) Failing to comply with any other provision of the Act or any
rule promulgated thereunder, in such a way as to have an adverse effect
on an individual.
(3) An employee may be personally subject to criminal liability as
set forth below and in 5 U.S.C. 552a (i):
(a) Any officer or employee of an agency, who by virtue of his
employment or official position, has possession of, or access to, agency
records which contain individually identifiable information the
disclosure of which is prohibited by the Act or by rules or regulations
established thereunder, and who, knowing that disclosure of the specific
material is so prohibited, willfully discloses the material in any
manner to any person or agency not entitled to receive it, shall be
guilty of a misdemeanor and fined not more than $5,000.
(b) Any officer or employee of any agency who willfully maintains a
system of records without meeting the notice requirements [of the Act]
shall be guilty of a misdemeanor and fined not more than $5,000.
(c) Rules Governing Employees Not Working With Systems of Records.
Employees whose duties do not involve working with systems of records
will not generally disclose to any one, without specific authorization
from their supervisors, records pertaining to employees or other
individuals which by reason of their official duties are available to
them. Notwithstanding the above, the following records concerning
Federal employees are a matter of public record and no further
authorization is necessary for disclosure:
(1) Name and title of individual.
(2) Grade classification or equivalent and annual rate of salary.
(3) Position description.
(4) Location of duty station, including room number and telephone
In addition, employees shall disclose records which are listed in
the Department's Freedom of Information Regulation as being available to
the public. Requests for other records will be referred to the
responsible Department official. This does not preclude employees from
discussing matters which are known to them personally, and without
resort to a record, to official investigators of Federal agencies for
official purposes such as suitability checks, Equal Employment
Opportunity investigations, adverse action proceedings, grievance
(d) Rules governing employees whose duties require use or reference
to systems of records. Employees whose official duties require that they
refer to, maintain, service, or otherwise deal with systems of records
(hereinafter referred to as ``Systems Employees'') are governed by the
general provisions. In addition, extra precautions are required and
systems employees are held to higher standards of conduct.
(1) Systems Employees shall:
(a) Be informed with respect to their responsibilities under the
(b) Be alert to possible misuses of the system and report to their
supervisors any potential or actual use of the system which they believe
is not in compliance with the Act and regulation;
(c) Make a disclosure of records within the Department only to an
employee who has a legitimate need to know the record in the course of
his official duties;
(d) Maintain records as accurately as practicable.
(e) Consult with a supervisor prior to taking any action where they
are in doubt whether such action is in conformance with the Act and
(2) Systems Employees shall not:
(a) Disclose in any form records from a system of records except (1)
with the consent or at the request of the subject individual; or (2)
where its disclosure is permitted under Sec. 5b.9 of the regulation.
(b) Permit unauthorized individuals to be present in controlled
areas. Any unauthorized individuals observed in controlled areas shall
be reported to a supervisor or to the guard force.
(c) Knowingly or willfully take action which might subject the
Department to civil liability.
(d) Make any arrangements for the design development, or operation
of any system of
records without making reasonable effort to provide that the system can
be maintained in accordance with the Act and regulation.
(e) Contracting officers. In addition to any applicable provisions
set forth above, those employees whose official duties involve entering
into contracts on behalf of the Department shall also be governed by the
(1) Contracts for design, or development of systems and equipment.
No contract for the design or development of a system of records, or for
equipment to store, service or maintain a system of records shall be
entered into unless the contracting officer has made reasonable effort
to ensure that the product to be purchased is capable of being used
without violation of the Act or regulation. Special attention shall be
given to provision of physical safeguards.
(2) Contracts for the operation of systems of records. A review by
the Contracting Officer, in conjunction with other officials whom he
feels appropriate, of all proposed contracts providing for the operation
of systems of records shall be made prior to execution of the contracts
to determine whether operation of the system of records is for the
purpose of accomplishing a Department function. If a determination is
made that the operation of the system is to accomplish a Department
function, the contracting officer shall be responsible for including in
the contract appropriate provisions to apply the provisions of the Act
and regulation to the system, including prohibitions against improper
release by the contractor, his employees, agents, or subcontractors.
(3) Other service contracts. Contracting officers entering into
general service contracts shall be responsible for determining the
appropriateness of including provisions in the contract to prevent
potential misuse (inadvertent or otherwise) by employees, agents, or
subcontractors of the contractor.
(f) Rules Governing Responsible Department Officials. In addition to
the requirements for Systems Employees, responsible Department officials
(1) Respond to all requests for notification of or access,
disclosure, or amendment of records in a timely fashion in accordance
with the Act and regulation;
(2) Make any amendment of records accurately and in a timely
(3) Inform all persons whom the accounting records show have
received copies of the record prior to the amendments of the correction;
(4) Associate any statement of disagreement with the disputed
(a) Transmit a copy of the statement to all persons whom the
accounting records show have received a copy of the disputed record, and
(b) Transmit that statement with any future disclosure.
Appendix B to Part 5b--Routine Uses Applicable to More Than One System
of Records Maintained by HHS
(1) In the event that a system of records maintained by this agency
or carry out its functions indicates a violation or potential violation
of law, whether civil, criminal or regulatory in nature, and whether
arising by general statute or particular program statute, or by
regulation, rule or order issued pursuant thereto, the relevant records
in the system of records may be referred, as a routine use, to the
appropriate agency, whether federal, or foreign, charged with the
responsibility of investigating or prosecuting such violation or charged
with enforcing or implementing the statute, or rule, regulation or order
issued pursuant thereto.
(2) Referrals may be made of assignments of research investigators
and project monitors to specific research projects to the Smithsonian
Institution to contribute to the Smithsonian Science Information
(3) In the event the Department deems it desirable or necessary, in
determining whether particular records are required to be disclosed
under the Freedom of Information Act, disclosure may be made to the
Department of Justice for the purpose of obtaining its advice.
(4) A record from this system of records may be disclosed as a
``routine use'' to a federal, state or local agency maintaining civil,
criminal or other relevant enforcement records or other pertinent
records, such as current licenses, if necessary to obtain a record
relevant to an agency decision concerning the hiring or retention of an
employee, the issuance of a security clearance, the letting of a
contract, or the issuance of a license, grant or other benefit.
A record from this system of records may be disclosed to a Federal
agency, in response to its request, in connection with the hiring or
retention of an employee, the issuance of a security clearance, the
reporting of an investigation of an employee, the letting of a contract,
or the issuance of a license, grant, or other benefit by the requesting
agency, to the extent that the record is relevant and necessary to the
requesting agency's decision on the matter.
(5) In the event that a system of records maintained by this agency
to carry out its function indicates a violation or potential violation
of law, whether civil, criminal or regulatory in nature, and whether
arising by general statute or particular program statute, or by
regulation, rule or order issued pursuant thereto, the relevant records
in the system of records may be referred, as a routine use, to the
appropriate agency, whether state or local charged with the
of investigating or prosecuting such violation or charged with enforcing
or implementing the statute, or rule, regulation or order issued
(6) Where Federal agencies having the power to subpoena other
Federal agencies' records, such as the Internal Revenue Service or the
Civil Rights Commission, issue a subpoena to the Department for records
in this system of records, the Department will make such records
(7) Where a contract between a component of the Department and a
labor organization recognized under E.O. 11491 provides that the agency
will disclose personal records relevant to the organization's mission,
records in this system of records may be disclosed to such organization.
(8) Where the appropriate official of the Department, pursuant to
the Department's Freedom of Information Regulation determines that it is
in the public interest to disclose a record which is otherwise exempt
from mandatory disclosure, disclosure may be made from this system of
(9) The Department contemplates that it will contract with a private
firm for the purpose of collating, analyzing, aggregating or otherwise
refining records in this system. Relevant records will be disclosed to
such a contractor. The contractor shall be required to maintain Privacy
Act safeguards with respect to such records.
(100) To the Department of Justice or other appropriate Federal
agencies in defending claims against the United States when the claim is
based upon an individual's mental or physical condition and is alleged
to have arisen because of activities of the Public Health Service in
connection with such individual.
(101) To individuals and organizations, deemed qualified by the
Secretary to carry out specific research solely for the purpose of
carrying out such research.
(102) To organizations deemed qualified by the Secretary to carry
out quality assessment, medical audits or utilization review.
(103) Disclosures in the course of employee discipline or competence
Appendix C to Part 5b--Delegations of Authority [Reserved]
PART 6 [RESERVED]
PART 7--EMPLOYEE INVENTIONS--Table of Contents
7.0 Who are employees.
7.1 Duty of employee to report inventions.
7.3 Determination as to domestic rights.
7.4 Option to acquire foreign rights.
7.7 Notice to employee of determination.
7.8 Employee's right of appeal.
Authority: Reorg. Plan No. 1 of 1953, 18 FR 2053; 3 CFR 1953 Supp.
E.O. 10096, 15 FR 391; 3 CFR. 1950 Supp. and E.O. 10930, 26 FR 2583; 3
CFR 1961 Supp.
Sec. 7.0 Who are employees.
As used in this part, the term Government employee means any officer
or employee, civilian or military, except such part-time employees or
part-time consultants as may be excluded therefrom by a determination
made in writing by the head of the employee's office or constituent
organization, pursuant to an exemption approved by the Commissioner of
Patents that to include him or them would be impracticable or
inequitable, given the reasons therefor. A person shall not be
considered to be a part-time employee or part-time consultant for this
purpose unless the terms of his employment contemplate that he shall
work for less than the minimum number of hours per day, or less than a
minimum number of days per week, or less than the minimum number of
weeks per year, regularly required of full-time employees of his class.
[27 FR 7986, Aug. 10, 1962]
Sec. 7.1 Duty of employee to report inventions.
Every Department employee is required to report to the Assistant
Secretary (Health and Scientific Affairs) in accordance with the
procedures established therefor, every invention made by him (whether or
not jointly with others) which bears any relation to his official duties
or which was made in whole or in any part during working hours, or with
any contribution of Government facilities, equipment, material, funds,
or information, or of time or services of other Government employees on
[31 FR 12842, Oct. 1, 1966]
Sec. 7.3 Determination as to domestic rights.
The determination of the ownership of the domestic right, title, and
interest in and to an invention which is or
may be patentable, made by a Government employee while under the
administrative jurisdiction of the Department, shall be made in writing
by the Assistant Secretary (Health and Scientific Affairs), in
accordance with the provisions of Executive Order 10096 and Government-
wide regulations issued thereunder by the Commissioner of Patents as
(a) The Government as represented by the Assistant Secretary (Health
and Scientific Affairs) shall obtain the entire domestic right, title
and interest in and to all inventions made by any Government employee
(1) during working hours, or (2) with a contribution by the Government
of facilities, equipment, materials, funds, or information, or of time
or services of other Government employees on official duty, or (3) which
bear a direct relation to or are made in consequence of the official
duties of the inventor.
(b) In any case where the contribution of the Government, as
measured by any one or more of the criteria set forth in paragraph (a)
of this section, to the invention is insufficient equitably to justify a
requirement of assignment to the Government of the entire domestic
right, title and interest in and to such invention, or in any case where
the Government has insufficient interest in an invention to obtain the
entire domestic right, title, and interest therein (although the
Government could obtain same under paragraph (a) of this section), the
Department, subject to the approval of the Commissioner, shall leave
title to such invention in the employee, subject, however, to the
reservation to the Government of a nonexclusive, irrevocable, royalty-
free license in the invention with power to grant licenses for all
governmental purposes, such reservation to appear, where practicable, in
any patent, domestic or foreign, which may issue on such invention.
(c) In applying the provisions of paragraphs (a) and (b) of this
section, to the facts and circumstances relating to the making of any
particular invention, it shall be presumed that an invention made by an
employee who is employed or assigned (1) to invent or improve or perfect
any art, machine, manufacture, or composition of matter, (2) to conduct
or perform research, development work, or both, (3) to supervise,
direct, coordinate, or review Government financed or conducted research,
development work, or both, or (4) to act in a liaison capacity among
governmental or nongovernmental agencies or individuals engaged in such
work, falls within the provisions of paragraph (a) of this section, and
it shall be presumed that any invention made by any other employee falls
within the provisions of paragraph (b) of this section. Either
presumption may be rebutted by a showing of the facts and circumstances
and shall not preclude a determination that these facts and
circumstances justify leaving the entire right, title and interest in
and to the invention in the Government employee, subject to law.
(d) In any case wherein the Government neither (1) obtains the
entire domestic right, title and interest in and to an invention
pursuant to the provisions of paragraph (a) of this section, nor (2)
reserves a nonexclusive, irrevocable, royalty-free license in the
invention, with power to grant licenses for all governmental purposes,
pursuant to the provisions of paragraph (b) of this section, the
Government shall leave the entire right, title and interest in and to
the invention in the Government employee, subject to law.
[27 FR 7986, Aug. 10, 1962, as amended at 31 FR 12842, Nov. 1, 1966]
Sec. 7.4 Option to acquire foreign rights.
In any case where it is determined that all domestic rights should
be assigned to the Government, it shall further be determined, pursuant
to Executive Order 9865 and Government-wide regulations issued
thereunder, that the Government shall reserve an option to require the
assignment of such rights in all or in any specified foreign countries.
In case where the inventor is not required to assign the patent rights
in any foreign country or countries to the Government or the Government
fails to exercise its option within such period of time as may be
provided by regulations issued by the Commissioner of Patents, any
application for a patent which may be filed in such country or countries
by the inventor or his assignee shall nevertheless be subject to a
nonexclusive, irrevocable, royalty-
free license to the Government for all governmental purposes, including
the power to issue sublicenses for use in behalf of the Government and/
or in furtherance of the foreign policies of the Government.
[27 FR 7987, Aug. 10, 1962]
Sec. 7.7 Notice to employee of determination.
The employee-inventor shall be notified in writing of the
Department's determination of the rights to his invention and of his
right of appeal, if any. Notice need not be given if the employee stated
in writing that he would agree to the determination of ownership which
was in fact made.
[31 FR 12842, Oct. 1, 1966]
Sec. 7.8 Employee's right of appeal.
An employee who is aggrieved by a determination of the Department
may appeal to the Commissioner of Patents, pursuant to section 4(d) of
Executive Order 10096, as amended by Executive Order 10930, and
regulations issued thereunder, by filing a written appeal with the
Commissioner, in duplicate, and a copy of the appeal with the Assistant
Secretary (Health and Scientific Affairs), within 30 days (or such
longer period as the Commissioner may, for good cause, fix in any case)
after receiving written notice of such determination.
[27 FR 7986, Aug. 10, 1962, as amended at 31 FR 12842, Oct. 1, 1966]
PART 8 [RESERVED]
PART 9--USE OF HHS RESEARCH FACILITIES BY ACADEMIC SCIENTISTS, ENGINEERS, AND STUDENTS--Table of Contents
9.3 Delegations of authority.
Authority: 27 Stat. 395, as amended; 20 U.S.C. 91.
Source: 34 FR 18938, Nov. 27, 1969, unless otherwise noted.
Sec. 9.1 Purpose.
To enhance the availability of DHHS scientific research and study
facilities to academic scientists, engineers, and qualified students.
Sec. 9.2 Policy.
It is the policy of the Department of Health and Human Services in
accordance with the policy of the President announced on February 21,
1969, to make research and study facilities of the Department readily
available to the scientific community, especially qualified academic
scientists and engineers. Unique, unusual, and expensive-to-duplicate
facilities at laboratories and other study and research facilities of
the Department will be made available to the national scientific
community, to the maximum extent practical without serious detriment to
the missions of those facilities. It is also the policy of the
Department to permit qualified students and graduates of institutions of
learning in the several States, and territories, as well as the District
of Columbia, to use study and research facilities of the Department.
When such facilities are used by academic scientists, engineers, and
students, the costs incurred for the operation of the unique or unusual
research facilities, as well as of the other facilities, should be
funded by the operating agency responsible for the operation of that
facility, except for any significant incremental costs incurred in
support of research not directly related to an HHS mission.
Sec. 9.3 Delegations of authority.
(a) The heads of operating agencies are delegated authority for
negotiations and decisions as to the use of Department facilities by
qualified academic scientists, engineers, and students.
(b) The heads of operating agencies may (and are encouraged to)
redelegate to the heads of their respective component organizations,
with the power to further redelegate to laboratory directors, the
authority for negotiations and decisions as to the use of departmental
facilities. Appropriate use shall be made of advisory groups in
formulating their decisions.
Sec. 9.4 Criteria.
(a) The official permitting use of Department facilities must
determine that it would be consistent with the programs of his activity
to participate. Facilities may be made available provided the use of
such facilities will be of direct benefit to the objectives of the
academic scientist, or engineer, or student, with the prospect of
fruitful interchange of ideas and information between Department
personnel and the academic scientist, or engineer, or student, and such
use will not interfere with the Department program.
(b) The official permitting use of Department facilities will
furnish the non-Government user with safety requirements or operating
procedures to be followed. Such requirements or procedures are to
include the requirement to report to the permitting official any
accident involving the non-Government user.
(c) The official delegated authority for approving the use of
Department facilities will not permit the use of laboratory facilities
unless he determines:
(1) That facilities are available for the period desired; and
(2) That the proposed research will not interfere with regular
Department functions or needs, nor require the subsequent acquisition of
additional equipment by the Department.
Sec. 9.5 Restrictions.
(a) Each individual authorized to use Department facilities will be
expected to use the facilities and equipment with customary care and
otherwise conduct himself in such manner as to complete his research or
study within any time limits prescribed.
(b) Each individual authorized to use HHS facilities may not be
authorized to sign requisitions for supplies and equipment.
(c) Any official approving the use of HHS facilities should seek an
agreement, executed by non-Government users, absolving the Federal
agency of liability in case of personal injury, death, and failure or
damage to the non-Government user's experiments or equipment. The
agreement must also contain a statement that the non-Government user
will comply with all safety regulations and procedures while using such
PART 12--DISPOSAL AND UTILIZATION OF SURPLUS REAL PROPERTY FOR PUBLIC HEALTH PURPOSES--Table of Contents
12.3 General policies.
12.6 Notice of available property.
12.7 Applications for surplus real property.
12.8 Assignment of surplus real property.
12.9 General disposal terms and conditions.
12.10 Compliance with the National Environmental Policy Act of 1969 and
other related Acts (environmental impact).
12.11 Special terms and conditions.
12.13 Form of conveyance.
12.14 Compliance inspections and reports.
12.15 Reports to Congress.
Exhibit A--Public Benefit Allowance for Transfer of Real Property for
Authority: Sec. 203, 63 Stat. 385, as amended; 40 U.S.C. 484; sec.
501 of Pub. L. 100-77, 101 Stat. 509-10, 42 U.S.C. 11411.
Source: 45 FR 72173, Oct. 31, 1980, unless otherwise noted.
Sec. 12.1 Definitions.
(a) Act means the Federal Property and Administrative Services Act
of 1949, 63 Stat. 377 (40 U.S.C. 471 et seq.). Terms defined in the Act
and not defined in this section have the meanings given to them in the
(b) Accredited means having the approval of a recognized
accreditation board or association on a regional, State, or national
level, such as a State Board of Health. Approval as used above describes
the formal process carried out by State Agencies and institutions in
determining that health organizations or programs meet minimum
(c) Administrator means the Administrator of General Services.
(d) Assigned property means real and related personal property
which, in the discretion of the Administrator or his designee, has been
made available to the Department for transfer for public health
(e) Department means the U.S. Department of Health and Human
(f) Disposal agency means the executive agency of the Government
which has authority to assign property to the Department for transfer
for public health purposes.
(g) Excess means any property under the control of any Federal
agency which is not required for its needs and the discharge of its
responsibilities, as determined by the head thereof.
(h) Fair market value means the highest price which the property
will bring by sale in the open market by a willing seller to a willing
(i) Holding agency means the Federal agency which has control over
and accountability for the property involved.
(j) Nonprofit institution means any institution, organization, or
association, whether incorporated or unincorporated, no part of the net
earnings of which inures or may lawfully inure to the benefit of any
private shareholder or individual, and (except for institutions which
lease property to assist the homeless under Title V of Pub. L. 100-77)
which has been held to be tax-exempt under section 501(c)(3) of the
Internal Revenue Code of 1954.
(k) Off-site property means surplus buildings, utilities and all
other removable improvements, including related personal property, to be
transferred by the Department for removal and use away from the site for
public health purposes.
(l) On-site means surplus real property, including related personal
property, to be transferred by the Department for use in place for
public health purposes.
(m) Public benefit allowance means a discount on the sale or lease
price of real property transferred for public health purposes,
representing any benefit determined by the Secretary which has accrued
or may accrue to the United States thereby.
(n) Related personal property means any personal property: (1) Which
is located on and is (i) an integral part of, or (ii) useful in the
operation of real property; or (2) which is determined by the
Administrator to be otherwise related to the real property.
(o) Secretary means the Secretary of Health and Human Services.
(p) State means a State of the United States, and includes the
District of Columbia, the Commonwealth of Puerto Rico, and the
Territories and possessions of the United States.
(q) Surplus when used with respect to real property means any excess
real property not required for the needs and the discharge of the
responsibilities of all Federal agencies as determined by the
[45 FR 72173, Oct. 31, 1980, as amended at 53 FR 7745, Mar. 10, 1988]
Sec. 12.2 Scope.
This part is applicable to surplus real property located within any
State which is appropriate for assignment to, or which has been assigned
to, the Department for transfer for public health purposes, as provided
for in section 203(k) of the Act.
Sec. 12.3 General policies.
(a) It is the policy of the Department to foster and assure maximum
utilization of surplus real property for public health purposes,
(b) Transfers may be made only to States, their political
subdivisions and instrumentalities, tax-supported public health
institutions, and nonprofit public health institutions which (except for
institutions which lease property to assist the homeless under Title V
of Pub. L. 100-77) have been held tax-exempt under section 501(c)(3) of
the Internal Revenue Code of 1954.
(c) Real property will be requested for assignment only when the
Department has determined that the property is suitable and needed for
public health purposes. The amount of real and related personal property
to be transferred shall not exceed normal operating requirements of the
applicant. Such property will not be requested for assignment unless it
is needed at the time of application for public health purposes or will
be so needed within the immediate or foreseeable future. Where
construction or major renovation is not required or proposed, the
property must be placed into use within twelve (12) months from the date
of transfer. When construction or major renovation is contemplated at
of transfer, the property must be placed in use within 36 months from
the date of transfer. If the applicable time limitation is not met, the
transferee shall either commence payments in cash to the Department for
each month thereafter during which the proposed use has not been
implemented or take such other action as set forth in Sec. 12.12 as is
deemed appropriate by the Department. Such monthly payments shall be
computed on the basis of the current fair market value of the property
at the time of the first payment by subtracting therefrom any portion of
the purchase price paid in cash at the time of transfer, and by dividing
the balance by the total number of months in the period of restriction.
If the facility has not been placed into use within eight (8) years of
the date of the deed, title to the property will be revested in the
United States, or, at the discretion of the Department, the restrictions
and conditions may be abrogated in accordance with Sec. 12.9.
(d) Transfers will be made only after the applicant has certified
that the proposed program is not in conflict with State or local zoning
restrictions, building codes, or similar limitations.
(e) Organizations which may be eligible include those which provide
care and training for the physically and mentally ill, including medical
care of the aged and infirm; clinical services; services (including
shelter) to homeless individuals; other public health services
(including water and sewer); or similar services devoted primarily to
the promotion and protection of public health. In addition,
organizations which provide assistance to homeless individuals may be
eligible for leases under title V of Public Law 100-77. Except for the
provision of services (including shelter) to homeless individuals,
organizations which have as their principal purpose the providing of
custodial or domiciliary care are not eligible. The eligible
organization must be authorized to carry out the activity for which it
requests the property.
(f) An applicant's plan of operation will not be approved unless it
provides that the applicant will not discriminate because of race,
color, sex, handicap, or national origin in the use of the property.
[45 FR 72173, Oct. 31, 1980, as amended at 53 FR 7745, Mar. 10, 1988; 55
FR 32252, Aug. 8, 1990]
Sec. 12.4 Limitations.
(a) Surplus property transferred pursuant to this part will be
disposed of on an ``as is, where is,'' basis without warranty of any
(b) Unless excepted by the General Services Administrator in his
assignment, mineral rights will be conveyed together with the surface
Sec. 12.5 Awards.
Where there is more than one applicant for the same property, it
will be awarded to the applicant having a program of utilization which
provides, in the opinion of the Department, the greatest public benefit.
Where the property will serve more than one program, it will be
apportioned to fit the needs of as many programs as is practicable.
Sec. 12.6 Notice of available property.
Reasonable publicity will be given to the availability of surplus
real property which is suitable for assignment to the Department for
transfer for public health uses. The Department will establish
procedures reasonably calculated to afford all eligible users having a
legitimate interest in acquiring the property for such uses an
opportunity to make an application therefor. However, publicity need not
be given to the availability of surplus real property which is occupied
and being used for eligible public health purposes at the time the
property is declared surplus, the occupant expresses interest in the
property, and the Department determines that it has a continuing need
Sec. 12.7 Applications for surplus real property.
Applications for surplus real property for public health purposes
shall be made to the Department through the office specified in the
notice of availability.
[55 FR 32252, Aug. 8, 1990]
Sec. 12.8 Assignment of surplus real property.
(a) Notice of interest in a specific property for public health
purposes will be furnished the General Services Administrator by the
Department at the earliest possible date.
(b) Requests to the Administrator for assignment of surplus real
property to the Department for transfer for public health purposes will
be based on the following conditions:
(1) The Department has an acceptable application for the property.
(2) The applicant is willing, authorized, and in a position to
assume immediate care, custody, and maintenance of the property.
(3) The applicant is able, willing and authorized to pay the
administrative expenses incident to the transfer.
(4) The applicant has the necessary funds, or the ability to obtain
such funds, to carry out the approved program of use of the property.
Sec. 12.9 General disposal terms and conditions.
(a) Surplus real property transfers under this part will be limited
to public health purposes. Transferees shall be entitled to a public
benefit allowance in terms of a percentage which will be applied against
the value of the property to be conveyed. Such an allowance will be
computed on the basis of benefits to the United States from the use of
such property for public health purposes. The computation of such public
benefit allowances will be in accordance with Exhibit A attached hereto
and made a part hereof.
(b) A transfer of surplus real property for public health purposes
is subject to the disapproval of the Administrator within 30 days after
notice is given to him of the proposed transfer.
(c) Transfers will be on the following terms and conditions:
(1) The transferee will be obligated to utilize the property
continuously in accordance with an approved plan of operation.
(2) The transferee will not be permitted to sell, lease or sublease,
rent, mortgage, encumber, or otherwise dispose of the property, or any
part thereof, without the prior written authorization of the Department.
(3) The transferee will file with the Department such reports
covering the utilization of the property as may be required.
(4) In the event the property is sold, leased or subleased,
encumbered, disposed of, or is used for purposes other than those set
forth in the approved plan without the consent of the Department, all
revenues or the reasonable value of other benefits received by the
transferee directly or indirectly from such use, as determined by the
Department, will be considered to have been received and held in trust
by the transferee for the account of the United States and will be
subject to the direction and control of the Department. The provisions
of this paragraph shall not impair or affect the rights reserved to the
United States in paragraph (c)(6) of this section, or the right of the
Department to impose conditions to its consent.
(5) Lessees will be required to carry all perils and liability
insurance to protect the Government and the Government's residual
interest in the property. Transferees will be required to carry such
flood insurance as may be required by the Department pursuant to Pub. L.
93-234. Where the transferee elects to carry insurance against damages
to or loss of on-site property due to fire or other hazards, and where
loss or damage to transferred Federal surplus real property occurs, all
proceeds from insurance shall be promptly used by the transferee for the
purpose of repairing and restoring the property to its former condition,
or replacing it with equivalent or more suitable facilities. If not so
used, there shall be paid to the United States that part of the
insurance proceeds that is attributable to the Government's residual
interest in the property lost, damaged, or destroyed in the case of
leases, attributable to the fair market value of the leased facilities.
(6) With respect to on-site property, in the event of noncompliance
with any of the conditions of the transfer as determined by the
Department, title to the property transferred and the right to immediate
possession shall, at the option of the Department, revert to the
Government. In the event title is reverted to the United States for
noncompliance or voluntarily reconveyed, the transferee shall, at the
option of the Department, be required to reimburse the Government for
the decrease in value of the property not due to reasonable wear and
tear or acts of God or attributable to alterations completed by the
transferee to adapt the property to the public health use for which the
property was transferred. With respect to leased property, in the event
of noncompliance with any of the conditions of the lease, as determined
by the Department, the right of occupancy and possession shall, at the
option of the Department, be terminated. In the event a leasehold is
terminated by the United States for noncompliance or is voluntarily
surrendered, the lessee shall be required at the option of the
Department to reimburse the Government for the decrease in value of the
property not due to reasonable wear and tear or acts of God or
attributable to alterations completed by the lessee to adapt the
property to the public health use for which the property was leased.
With respect to any reverter of title or termination of leasehold
resulting from noncompliance, the Government shall, in addition thereto,
be reimbursed for such costs as may be incurred in recovering title to
or possession of the property.
Any payments of cash made by the transferee against the purchase price
of property transferred shall, upon a forfeiture of title to the
property for breach of condition, be forfeited.
(7) With respect to off-site property, in the event of noncompliance
with any of the terms and conditions of the transfer, the unearned
public benefit allowance shall, at the option of the Department, become
immediately due and payable or, if the property or any portion thereof
is sold, leased, or otherwise disposed of without authorization from the
Department, such sale, lease or sublease, or other disposal shall be for
the benefit and account of the United States and the United States shall
be entitled to the proceeds. In the event the transferee fails to remove
the property or any portion thereof within the time specified, then in
addition to the rights reserved above, at the option of the Department,
all right, title, and interest in and to such unremoved property shall
be retransferred to other eligible applicants or shall be forfeited to
the United States.
(8) With respect only to on-site property which has been declared
excess by the Department of Defense, such declaration having included a
statement indicating the property has a known potential for use during a
national emergency, the Department shall reserve the right during any
period of emergency declared by the President of the United States or by
the Congress of the United States to the full and unrestricted use by
the Government of the surplus real property, or of any portion thereof,
disposed of in accordance with the provisions of this part. Such use may
be either exclusive or nonexclusive. Prior to the expiration or
termination of the period of restricted use by the transferee, the
Government will not be obligated to pay rent or any other fees or
charges during the period of emergency, except that the Government will:
(i) Bear the entire cost of maintenance of such portion of the
property used by it exclusively or over which it may have exclusive
possession or control;
(ii) Pay the fair share, commensurate with the use of the cost of
maintenance of such surplus real property as it may use nonexclusively
or over which it may have nonexclusive possession or control;
(iii) Pay a fair rental for the use of improvements or additions to
the surplus real property made by the purchaser or lessee without
Government aid; and
(iv) Be responsible for any damage to the surplus real property
caused by its use, reasonable wear and tear, the common enemy and acts
of God excepted. Subsequent to the expiration or termination of the
period of restricted use, the obligations of the Government will be as
set forth in the preceding sentence and, in addition, the Government
shall be obligated to pay a fair rental for all or any portion of the
conveyed premises which it uses.
(9) The restrictions set forth in paragraphs (c) (1) through (7) of
will extend for thirty (30) years for land with or without improvements;
and for facilities being acquired separately from land whether they are
for use on-site or off-site, the period of limitations on the use of the
structures will be equal to their estimated economic life. The
restrictions set forth in paragraphs (c) (1) through (7) of this section
will extend for the entire initial lease period and for any renewal
periods for property leased from the Department.
(d) Transferees, by obtaining the consent of the Department, may
abrogate the restrictions set forth in paragraph (c) of this section for
all or any portion of the property upon payment in cash to the
Department of an amount equal to the then current fair market value of
the property to be released, multiplied by the public benefit allowance
granted at the time of conveyance, divided by the total number of months
of the period of restriction set forth in the conveyance document and
multiplied by the number of months that remain in the period of
restriction as determined by the Department. For purposes of abrogation
payment computation, the current fair market value shall not include the
value of any improvements placed on the property by the transferee.
(e) Related personal property will be transferred or leased as a
part of the realty and in accordance with real property procedures. It
will be subject to the same public benefit allowance granted for the
real property. Where related personal property is involved in an on-site
transfer, the related personal property may be transferred by a bill of
sale imposing restrictions for a period not to exceed five years from
the date of transfer, other terms and conditions to be the same as, and
made a part of, the real property transaction.
Sec. 12.10 Compliance with the National Environmental Policy Act of 1969 and other related Acts (environmental impact).
(a) The Department will, prior to making a final decision to convey
or lease, or to amend, reform, or grant an approval or release with
respect to a previous conveyance or lease of, surplus real property for
public health purposes, complete an environmental assessment of the
proposed transaction in keeping with applicable provisions of the
National Environmental Policy Act of 1969, the National Historic
Preservation Act of 1966, the National Archeological Data Preservation
Act, and other related acts. No permit to use surplus real property
shall allow the permittee to make, or cause to be made, any irreversible
change in the condition of said property, and no use permit shall be
employed for the purpose of delaying or avoiding compliance with the
requirements of these Acts.
(b) Applicants shall be required to provide such information as the
Department deems necessary to make an assessment of the impact of the
proposed Federal action on the human environment. Materials contained in
the applicant's official request, responses to a standard questionnaire
prescribed by the Public Health Service, as well as other relevant
information, will be used by the Department in making said assessment.
(c) If the assessment reveals (1) That the proposed Federal action
involves properties of historical significance which are listed, or
eligible for listing, in the National Register of Historic Places, or
(2) that a more than insignificant impact on the human environment is
reasonably foreseeable as a result of the proposed action, or (3) that
the proposed Federal action could result in irreparable loss or
destruction of archeologically significant items or data, the Department
will, except as provided for in paragraph (d) of this section, prepare
and distribute, or cause to be prepared or distributed, such notices and
statements and obtain such approvals as are required by the above cited
(d) If a proposed action involves other Federal agencies in a
sequence of actions, or a group of actions, directly related to each
other because of their functional interdependence, the Department may
enter into and support a lead agency agreement to designate a single
lead agency which will assume primary responsibility for coordinating
the assessment of environmental effects of proposed Federal actions,
preparing and distributing such notices and statements, or obtaining
such approvals, as are required by the above cited Acts. The procedures
of the designated lead agency will be utilized in conducting the
environmental assessment. In the event of disagreement between the
Department and another Federal agency, the Department will reserve the
right to abrogate its lead agency agreement with the other Federal
[45 FR 72173, Oct. 31, 1980, as amended at 55 FR 32252, Aug. 8, 1990]
Sec. 12.11 Special terms and conditions.
(a) Applicants will be required to pay all external administrative
costs which will include, but not be limited to, taxes, surveys,
appraisals, inventory costs, legal fees, title search, certificate or
abstract expenses, decontamination costs, moving costs, closing fees in
connection with the transaction and service charges, if any, made by
State Agencies for Federal Property Assistance under the terms of a
cooperative agreement with the Department.
(b) In the case of off-site property, applicants will be required to
post performance bonds, make performance guarantee deposits, or give
such other assurances as may be required by the Department or the
holding agency to insure adequate site clearance and to pay service
charges, if any, made by State Agencies for Federal Property Assistance
under the terms of a cooperative agreement with the Department.
(c) Whenever negotiations are undertaken for disposal to private
nonprofit public health organizations of any surplus real property which
cost the Government $1 million or more, the Department will give notice
to the Attorney General of the United States of the proposed disposal
and the terms and conditions thereof. The applicant shall furnish to the
Department such information and documents as the Attorney General may
determine to be appropriate or necessary to enable him to give the
advice as provided for by section 207 of the Act.
(d) Where an applicant proposes to acquire or lease and use in place
improvements located on land which the Government does not own, he shall
be required, before the transfer is consummated, to obtain a right to
use the land commensurate with the duration of the restrictions
applicable to the improvements, or the term of the lease. The applicant
will be required to assume, or obtain release of, the Government's
obligations respecting the land including but not limited to obligations
relating to restoration, waste, and rent. At the option of the
Department, the applicant may be required to post a bond to indemnify
the Government against such obligations.
(e) The Department may require the inclusion in the transfer or
lease document of any other provision deemed desirable or necessary.
(f) Where an eligible applicant for an on-site transfer proposes to
construct new, or rehabilitate old, facilities, the financing of which
must be accomplished through issuance of revenue bonds having terms
inconsistent with the terms and conditions of transfer prescribed in
Sec. 12.9 (c), (d), and (e) of this chapter, the Department may, in its
discretion, impose such alternate terms and conditions of transfer in
lieu thereof as may be appropriate to assure utilization of the property
for public health purposes.
Sec. 12.12 Utilization.
(a) Where property or any portion thereof is not being used for the
purposes for which transferred, the transferee will be required at the
direction of the Department:
(1) To place the property into immediate use for an approved
(2) To retransfer such property to such other public health user as
the Department may direct;
(3) To sell such property for the benefit and account of the United
(4) To return title to such property to the United States or to
relinquish any leasehold interest therein;
(5) To abrogate the conditions and restrictions of the transfer, as
set forth in Sec. 12.9(d) of this chapter, except that, where property
has never been placed in use for the purposes for which transferred,
abrogation will not be permitted except under extenuating circumstances;
(6) To make payments as provided for in Sec. 12.3(c) of this
(b) Where the transferee or lessee desires to place the property in
temporary use for a purpose other than that for which the property was
transferred or leased, approval from the Department must be obtained,
and will be conditioned upon such terms as the Department may impose.
Sec. 12.13 Form of conveyance.
(a) Transfers or leases of surplus real property will be on forms
approved by the Office of General Counsel of the Department and will
include such of the disposal or lease terms and conditions set forth in
this part and such other terms and conditions as the Office of General
Counsel may deem appropriate or necessary.
(b) Transfers of on-site property will normally be by quitclaim deed
without warranty of title.
Sec. 12.14 Compliance inspections and reports.
The Department will make or have made such compliance inspections as
are necessary and will require of the transferee or lessee such
compliance reports and actions as are deemed necessary.
Sec. 12.15 Reports to Congress.
The Secretary will make such reports of real property disposal
activities as are required by section 203 of the Act and such other
reports as may be required by law.
Exhibit A--Public Benefit Allowance for Transfer of Real Property for Health Purposes \1\
Organization allowances Utilization allowances
Classification Basic Unmet needs public
public Tax ------------------------------------ Integrated Outpatient Public Training benefit
benefit support Accreditation Hardship research services services program allowance
allowance 10 to 25% 26 to 50% 51 to 100% program
Hospitals.................................... 50 20 20 10 10 20 30 10 10 10 10 100
Clinics...................................... 50 20 20 10 10 20 30 .......... .......... .......... .......... 100
Nursing Homes................................ 50 20 20 10 10 20 30 .......... .......... .......... 10 100
Public Health Administration................. \2\ 100 .......... ............. .......... .......... .......... .......... .......... .......... .......... .......... \2\ 100
Public Refuse Disposal and Water Systems..... \2\ 100 .......... ............. .......... .......... .......... .......... .......... .......... .......... .......... \2\ 100
Research..................................... \2\ 100 .......... ............. .......... .......... .......... .......... .......... .......... .......... .......... \2\ 100
Rehabilitation Facility...................... 50 20 20 10 10 20 30 10 10 10 10 100
Special Services............................. 50 20 20 10 10 20 30 .......... .......... 10 .......... 100
Assistance to the Homeless................... \2\ 100 .......... ............. .......... .......... .......... .......... .......... .......... .......... .......... \2\ 100
\1\ This public benefit allowance applies only to surplus real property being sold for on-site use. When surplus real property is to be moved from the site, a basic public benefit allowance of
100% will be granted.
\2\ Applicable when this is the primary use to be made of the property. The public benefit allowance for the overall health program is applicable when such facilities are conveyed as a minor
component of other facilities.
[45 FR 72173, Oct. 31, 1980, as amended at 53 FR 7745, Mar. 10, 1988]
PART 12a--USE OF FEDERAL REAL PROPERTY TO ASSIST THE HOMELESS--Table of Contents
12a.3 Collecting the information.
12a.4 Suitability determination.
12a.5 Real property reported excess to GSA.
12a.6 Suitability criteria.
12a.7 Determination of availability.
12a.8 Public notice of determination.
12a.9 Application process.
12a.10 Action on approved applications.
12a.11 Unsuitable properties.
12a.12 No applications approved.
Authority: 42 U.S.C. 11411; 40 U.S.C. 484(k); 42 U.S.C. 3535(d).
Source: 56 FR 23794, 23795, May 24, 1991, unless otherwise noted.
Effective Date Note: At 56 FR 23794, 23795, May 24, 1991, part 12a
was added, effective May 24, 1991, except for Sec. 12a.3, which will not
become effective until approved by the District Court for the District
of Columbia, pending further proceedings.
Sec. 12a.1 Definitions.
Applicant means any representative of the homeless which has
submitted an application to the Department of Health and Human Services
to obtain use of a particular suitable property to assist the homeless.
Checklist or property checklist means the form developed by HUD for
use by landholding agencies to report the information to be used by HUD
in making determinations of suitability.
Classification means a property's designation as unutilized,
underutilized, excess, or surplus.
Day means one calendar day including weekends and holidays.
Eligible organization means a State, unit of local government or a
private non-profit organization which provides assistance to the
homeless, and which is authorized by its charter or by State law to
enter into an agreement with the Federal government for use of real
property for the purposes of this subpart. Representatives of the
homeless interested in receiving a deed for a particular piece of
surplus Federal property must be section 501(c)(3) tax exempt.
Excess property means any property under the control of any Federal
executive agency that is not required for the agency's needs or the
discharge of its responsibilities, as determined by the head of the
agency pursuant to 40 U.S.C. 483.
GSA means the General Services Administration.
HHS means the Department of Health and Human Services.
(1) An individual or family that lacks a fixed, regular, and
adequate nighttime residence; and
(2) An individual or family that has a primary nighttime residence
(i) A supervised publicly or privately operated shelter designed to
provide temporary living accommodations (including welfare hotels,
congregate shelters, and transitional housing for the mentally ill);
(ii) An institution that provides a temporary residence for
individuals intended to be institutionalized; or
(iii) A public or private place not designed for, or ordinarily used
as, a regular sleeping accommodation for human beings. This term does
not include any individual imprisoned or otherwise detained under an Act
of the Congress or a State law.
HUD means the Department of Housing and Urban Development.
ICH means the Interagency Council on the Homeless.
Landholding agency means a Federal department or agency with
statutory authority to control real property.
Lease means an agreement between either the Department of Health and
Human Services for surplus property, or landholding agencies in the case
of non-excess properties or properties subject to the Base Closure and
Realignment Act (Public Law 100-526; 10 U.S.C. 2687), and the applicant,
giving rise to the relationship of lessor and lessee for the use of
Federal real property for a term of at least one year under the
conditions set forth in the lease document.
Non-profit organization means an organization no part of the net
earnings of which inures to the benefit of any member, founder,
contributor, or individual; that has a voluntary board; that has an
accounting system or has designated an entity that will maintain a
functioning accounting system
for the organization in accordance with generally accepted accounting
procedures; and that practices nondiscrimination in the provision of
Permit means a license granted by a landholding agency to use
unutilized or underutilized property for a specific amount of time under
terms and conditions determined by the landholding agency.
Property means real property consisting of vacant land or buildings,
or a portion thereof, that is excess, surplus, or designated as
unutilized or underutilized in surveys by the heads of landholding
agencies conducted pursuant to section 202(b)(2) of the Federal Property
and Administrative Services Act of 1949 (40 U.S.C. 483(b)(2).)
Regional Homeless Coordinator means a regional coordinator of the
Interagency Council on the Homeless.
Representative of the Homeless means a State or local government
agency, or private nonprofit organization which provides, or proposes to
provide, services to the homeless.
Screen means the process by which GSA surveys Federal agencies, or
State, local and non-profit entities, to determine if any such entity
has an interest in using excess Federal property to carry out a
particular agency mission or a specific public use.
State Homeless Coordinator means a state contact person designated
by a state to receive and disseminate information and communications
received from the Interagency Council on the Homeless in accordance with
section 210(a) of the Stewart B. McKinney Act of 1987, as amended.
Suitable property means that HUD has determined that a particular
property satisfies the criteria listed in Sec. 12a.6.
Surplus property means any excess real property not required by any
Federal landholding agency for its needs or the discharge of its
responsibilities, as determined by the Administrator of GSA.
Underutilized means an entire property or portion thereof, with or
without improvements which is used only at irregular periods or
intermittently by the accountable landholding agency for current program
purposes of that agency, or which is used for current program purposes
that can be satisfied with only a portion of the property.
Unsuitable property means that HUD has determined that a particular
property does not satisfy the criteria in Sec. 12a.6.
Unutilized property means an entire property or portion thereof,
with or without improvements, not occupied for current program purposes
for the accountable executive agency or occupied in caretaker status
Sec. 12a.2 Applicability.
(a) This part applies to Federal real property which has been
designated by Federal landholding agencies as unutilized, underutilized,
excess or surplus and is therefore subject to the provisions of title V
of the McKinney Act (42 U.S.C. 11411).
(b) The following categories of properties are not subject to this
subpart (regardless of whether they may be unutilized or underutilized).
(1) Machinery and equipment.
(2) Government-owned, contractor-operated machinery, equipment,
land, and other facilities reported excess for sale only to the using
contractor and subject to a continuing military requirement.
(3) Properties subject to special legislation directing a particular
(4) Properties subject to a Court Order.
(5) Property not subject to survey requirements of Executive Order
12512 (April 29, 1985).
(6) Mineral rights interests.
(7) Air Space interests.
(8) Indian Reservation land subject to section 202(a)(2) of the
Federal Property and Administrative Service Act of 1949, as amended.
(9) Property interests subject to reversion.
(11) Property purchased in whole or in part with Federal funds if
title to the property is not held by a Federal landholding agency as
defined in this Part.
Sec. 12a.3 Collecting the information.
(a) Canvass of landholding agencies. On a quarterly basis, HUD will
landholding agencies to collect information about property described as
unutilized, underutilized, excess, or surplus, in surveys conducted by
the agencies under section 202 of the Federal Property and
Administrative Services Act (40 U.S.C. 483), Executive Order 12512, and
41 CFR part 101-47.800. Each canvass will collect information on
properties not previously reported and about property reported
previously the status or classification of which has changed or for
which any of the information reported on the property checklist has
(1) HUD will request descriptive information on properties
sufficient to make a reasonable determination, under the criteria
described below, of the suitability of a property for use as a facility
to assist the homeless.
(2) HUD will direct landholding agencies to respond to requests for
information within 25 days of receipt of such requests.
(b) Agency Annual Report. By December 31 of each year, each
landholding agency must notify HUD regarding the current availability
status and classification of each property controlled by the agency
(1) Was included in a list of suitable properties published that
year by HUD, and
(2) Remains available for application for use to assist the
homeless, or has become available for application during that year.
(c) GSA Inventory. HUD will collect information, in the same manner
as described in paragraph (a) of this section, from GSA regarding
property that is in GSA's current inventory of excess or surplus
(d) Change in Status. If the information provided on the property
checklist changes subsequent to HUD's determination of suitability, and
the property remains unutilized, underutilized, excess or surplus, the
landholding agency shall submit a revised property checklist in response
to the next quarterly canvass. HUD will make a new determination of
suitability and, if it differs from the previous determination,
republish the property information in the Federal Register. For example,
property determined unsuitable for national security concerns may no
longer be subject to security restrictions, or property determined
suitable may subsequently be found to be contaminated.
Sec. 12a.4 Suitability determination.
(a) Suitability determination. Within 30 days after the receipt of
information from landholding agencies regarding properties which were
reported pursuant to the canvass described in Sec. 12a.3(a), HUD will
determine, under criteria set forth in Sec. 12a.6, which properties are
suitable for use as facilities to assist the homeless and report its
determination to the landholding agency. Properties that are under
lease, contract, license, or agreement by which a Federal agency retains
a real property interest or which are scheduled to become unutilized or
underutilized will be reviewed for suitability no earlier than six
months prior to the expected date when the property will become
unutilized or underutilized, except that properties subject to the Base
Closure and Realignment Act may be reviewed up to eighteen months prior
to the expected date when the property will become unutilized or
(b) Scope of suitability. HUD will determine the suitability of a
property for use as a facility to assist the homeless without regard to
any particular use.
(c) Environmental information. HUD will evaluate the environmental
information contained in property checklists forwarded to HUD by the
landholding agencies solely for the purpose of determining suitability
of properties under the criteria in Sec. 12a.6.
(d) Written record of suitability determination. HUD will assign an
identification number to each property reviewed for suitability. HUD
will maintain a written public record of the following:
(1) The suitability determination for a particular piece of
property, and the reasons for that determination; and
(2) The landholding agency's response to the determination pursuant
to the requirements of Sec. 12a.7(a).
(e) Property determined unsuitable. Property that is reviewed by HUD
under this section and that is determined unsuitable for use to assist
the homeless may not be made available
for any other purpose for 20 days after publication in the Federal
Register of a Notice of unsuitability to allow for review of the
determination at the request of a representative of the homeless.
(f) Procedures for appealing unsuitability determinations. (1) To
request review of a determination of unsuitability, a representative of
the homeless must contact HUD within 20 days of publication of notice in
the Federal Register that a property is unsuitable. Requests may be
submitted to HUD in writing or by calling 1-800-927-7588 (Toll Free).
Written requests must be received no later than 20 days after notice of
unsuitability is published in the Federal Register.
(2) Requests for review of a determination of unsuitability may be
made only by representatives of the homeless, as defined in Sec. 12a.1.
(3) The request for review must specify the grounds on which it is
based, i.e., that HUD has improperly applied the criteria or that HUD
has relied on incorrect or incomplete information in making the
determination (e.g., that property is in a floodplain but not in a
(4) Upon receipt of a request to review a determination of
unsuitability, HUD will notify the landholding agency that such a
request has been made, request that the agency respond with any
information pertinent to the review, and advise the agency that it
should refrain from initiating disposal procedures until HUD has
completed its reconsideration regarding unsuitability.
(i) HUD will act on all requests for review within 30 days of
receipt of the landholding agency's response and will notify the
representative of the homeless and the landholding agency in writing of
(ii) If a property is determined suitable as a result of the review,
HUD will request the landholding agency's determination of availability
pursuant to Sec. 12a.7(a), upon receipt of which HUD will promptly
publish the determination in the Federal Register. If the determination
of unsuitability stands, HUD will inform the representative of the
homeless of its decision.
Sec. 12a.5 Real property reported excess to GSA.
(a) Each landholding agency must submit a report to GSA of
properties it determines excess. Each landholding agency must also
provide a copy of HUD's suitability determination, if any, including
HUD's identification number for the property.
(b) If a landholding agency reports a property to GSA which has been
reviewed by HUD for homeless assistance suitability and HUD determined
the property suitable, GSA will screen the property pursuant to
Sec. 12a.5(g) and will advise HUD of the availability of the property
for use by the homeless as provided in Sec. 12a.5(e). In lieu of the
above, GSA may submit a new checklist to HUD and follow the procedures
in Sec. 12a.5(c) through Sec. 12a.5(g).
(c) If a landholding agency reports a property to GSA which has not
been reviewed by HUD for homeless assistance suitability, GSA will
complete a property checklist, based on information provided by the
landholding agency, and will forward this checklist to HUD for a
suitability determination. This checklist will reflect any change in
classification, i.e., from unutilized or underutilized to excess.
(d) Within 30 days after GSA's submission, HUD will advise GSA of
the suitability determination.
(e) When GSA receives a letter from HUD listing suitable excess
properties in GSA's inventory, GSA will transmit to HUD within 45 days a
response which includes the following for each identified property:
(1) A statement that there is no other compelling Federal need for
the property, and therefore, the property will be determined surplus; or
(2) A statement that there is further and compelling Federal need
for the property (including a full explanation of such need) and that,
therefore, the property is not presently available for use to assist the
(f) When an excess property is determined suitable and available and
notice is published in the Federal Register, GSA will concurrently
notify HHS, HUD, State and local government units, known homeless
assistance providers that have expressed interest in
the particular property, and other organizations, as appropriate,
concerning suitable properties.
(g) Upon submission of a Report of Excess to GSA, GSA may screen the
property for Federal use. In addition, GSA may screen State and local
governmental units and eligible nonprofit organizations to determine
interest in the property in accordance with current regulations. (See 41
CFR 101-47.203-5, 101-47.204-1 and 101-47.303-2.)
(h) The landholding agency will retain custody and accountability
and will protect and maintain any property which is reported excess to
GSA as provided in 41 CFR 101-47.402.
Sec. 12a.6 Suitability criteria.
(a) All properties, buildings and land will be determined suitable
unless a property's characteristics include one or more of the following
(1) National security concerns. A property located in an area to
which the general public is denied access in the interest of national
security (e.g., where a special pass or security clearance is a
condition of entry to the property) will be determined unsuitable. Where
alternative access can be provided for the public without compromising
national security, the property will not be determined unsuitable on
(2) Property containing flammable or explosive materials. A property
located within 2000 feet of an industrial, commercial or Federal
facility handling flammable or explosive material (excluding underground
storage) will be determined unsuitable. Above ground containers with a
capacity of 100 gallons or less, or larger containers which provide the
heating or power source for the property, and which meet local safety,
operation, and permitting standards, will not affect whether a
particular property is determined suitable or unsuitable. Underground
storage, gasoline stations and tank trucks are not included in this
category and their presence will not be the basis of an unsuitability
determination unless there is evidence of a threat to personal safety as
provided in paragraph (a)(5) of this section.
(3) Runway clear zone and military airfield clear zone. A property
located within an airport runway clear zone or military airfield clear
zone will be determined unsuitable.
(4) Floodway. A property located in the floodway of a 100 year
floodplain will be determined unsuitable. If the floodway has been
contained or corrected, or if only an incidental portion of the property
not affecting the use of the remainder of the property is in the
floodway, the property will not be determined unsuitable.
(5) Documented deficiencies. A property with a documented and
extensive condition(s) that represents a clear threat to personal
physical safety will be determined unsuitable. Such conditions may
include, but are not limited to, contamination, structural damage or
extensive deterioration, friable asbestos, PCB's, or natural hazardous
substances such as radon, periodic flooding, sinkholes or earth slides.
(6) Inaccessible. A property that is inaccessible will be determined
unsuitable. An inaccessible property is one that is not accessible by
road (including property on small off-shore islands) or is land locked
(e.g., can be reached only by crossing private property and there is no
established right or means of entry).
Sec. 12a.7 Determination of availability.
(a) Within 45 days after receipt of a letter from HUD pursuant to
Sec. 12a.4(a), each landholding agency must transmit to HUD a statement
of one of the following:
(1) In the case of unutilized or underutilized property:
(i) An intention to declare the property excess,
(ii) An intention to make the property available for use to assist
the homeless, or
(iii) The reasons why the property cannot be declared excess or made
available for use to assist the homeless. The reasons given must be
different than those listed as suitability criteria in Sec. 12a.6.
(2) In the case of excess property which had previously been
reported to GSA:
(i) A statement that there is no compelling Federal need for the
property, and that, therefore, the property will be determined surplus;
(ii) A statement that there is a further and compelling Federal need
for the property (including a full explanation of such need) and that,
therefore, the property is not presently available for use to assist the
Sec. 12a.8 Public notice of determination.
(a) No later than 15 days after the last 45 day period has elapsed
for receiving responses from the landholding agencies regarding
availability, HUD will publish in the Federal Register a list of all
properties reviewed, including a description of the property, its
address, and classification. The following designations will be made:
(1) Properties that are suitable and available.
(2) Properties that are suitable and unavailable.
(3) Properties that are suitable and to be declared excess.
(4) Properties that are unsuitable.
(b) Information about specific properties can be obtained by
contacting HUD at the following toll free number, 1-800-927-7588.
(c) HUD will transmit to the ICH a copy of the list of all
properties published in the Federal Register. The ICH will immediately
distribute to all state and regional homeless coordinators area-relevant
portions of the list. The ICH will encourage the state and regional
homeless coordinators to disseminate this information widely.
(d) No later than February 15 of each year, HUD shall publish in the
Federal Register a list of all properties reported pursuant to
(e) HUD shall publish an annual list of properties determined
suitable but which agencies reported unavailable including the reasons
such properties are not available.
(f) Copies of the lists published in the Federal Register will be
available for review by the public in the HUD headquarters building
library (room 8141); area-relevant portions of the lists will be
available in the HUD regional offices and in major field offices.
Sec. 12a.9 Application process.
(a) Holding period. (1) Properties published as available for
application for use to assist the homeless shall not be available for
any other purpose for a period of 60 days beginning on the date of
publication. Any representative of the homeless interested in any
underutilized, unutilized, excess or surplus Federal property for use as
a facility to assist the homeless must send to HHS a written expression
of interest in that property within 60 days after the property has been
published in the Federal Register.
(2) If a written expression of interest to apply for suitable
property for use to assist the homeless is received by HHS within the 60
day holding period, such property may not be made available for any
other purpose until the date HHS or the appropriate landholding agency
has completed action on the application submitted pursuant to that
expression of interest.
(3) The expression of interest should identify the specific
property, briefly describe the proposed use, include the name of the
organization, and indicate whether it is a public body or a private non-
profit organization. The expression of interest must be sent to the
Division of Health Facilities Planning (DHFP) of the Department of
Health and Human Services at the following address:
Director, Division of Health Facilities Planning, Public Health Service,
Room 17A-10, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland
HHS will notify the landholding agency (for unutilized and underutilized
properties) or GSA (for excess and surplus properties) when an
expression of interest has been received for a particular property.
(4) An expression of interest may be sent to HHS any time after the
60 day holding period has expired. In such a case, an application
submitted pursuant to this expression of interest may be approved for
use by the homeless if:
(i) No application or written expression of interest has been made
under any law for use of the property for any purpose; and
(ii) In the case of excess or surplus property, GSA has not received
a bona fide offer to purchase that property or advertised for the sale
of the property by public auction.
(b) Application Requirements. Upon receipt of an expression of
interest, DHFP will send an application packet to the interested entity.
The application packet requires the applicant to provide certain
information, including the following--
(1) Description of the applicant organization. The applicant must
document that it satisfies the definition of a ``representative of the
homeless,'' as specified in Sec. 12a.1 of this subpart. The applicant
must document its authority to hold real property. Private non-profit
organizations applying for deeds must document that they are section
(2) Description of the property desired. The applicant must describe
the property desired and indicate that any modifications made to the
property will conform to local use restrictions except for local zoning
(3) Description of the proposed program. The applicant must fully
describe the proposed program and demonstrate how the program will
address the needs of the homeless population to be assisted. The
applicant must fully describe what modifications will be made to the
property before the program becomes operational.
(4) Ability to finance and operate the proposed program. The
applicant must specifically describe all anticipated costs and sources
of funding for the proposed program. The applicant must indicate that it
can assume care, custody, and maintenance of the property and that it
has the necessary funds or the ability to obtain such funds to carry out
the approved program of use for the property.
(5) Compliance with non-discrimination requirements. Each applicant
and lessee under this part must certify in writing that it will comply
with the requirements of the Fair Housing Act (42 U.S.C. 3601-3619) and
implementing regulations; and as applicable, Executive Order 11063
(Equal Opportunity in Housing) and implementing regulations; title VI of
the Civil Rights Act of 1964 (42 U.S.C. 2000d to d-4) (Nondiscrimination
in Federally Assisted Programs) and implementing regulations; the
prohibitions against discrimination on the basis of age under the Age
Discrimination Act of 1975 (42 U.S.C. 6101-6107) and implementing
regulations; and the prohibitions against otherwise qualified
individuals with handicaps under section 504 of the Rehabilitation Act
of 1973 (29 U.S.C. 794) and implementing regulations. The applicant must
state that it will not discriminate on the basis of race, color,
national origin, religion, sex, age, familial status, or handicap in the
use of the property, and will maintain the required records to
demonstrate compliance with Federal laws.
(6) Insurance. The applicant must certify that it will insure the
property against loss, damage, or destruction in accordance with the
requirements of 45 CFR 12.9.
(7) Historic preservation. Where applicable, the applicant must
provide information that will enable HHS to comply with Federal historic
(8) Environmental information. The applicant must provide sufficient
information to allow HHS to analyze the potential impact of the
applicant's proposal on the environment, in accordance with the
instructions provided with the application packet. HHS will assist
applicants in obtaining any pertinent environmental information in the
possession of HUD, GSA, or the landholding agency.
(9) Local government notification. The applicant must indicate that
it has informed the applicable unit of general local government
responsible for providing sewer, water, police, and fire services, in
writing of its proposed program.
(10) Zoning and Local Use Restrictions. The applicant must indicate
that it will comply with all local use restrictions, including local
building code requirements. Any applicant which applies for a lease or
permit for a particular property is not required to comply with local
zoning requirements. Any applicant applying for a deed of a particular
property, pursuant to Sec. 12a. 9(b)(3), must comply with local zoning
requirements, as specified in 45 CFR part 12.
(c) Scope of evaluations. Due to the short time frame imposed for
evaluating applications, HHS' evaluation will, generally, be limited to
the information contained in the application.
(d) Deadline. Completed applications must be received by DHFP, at
the above address, within 90 days after an expression of interest is
received from a particular applicant for that property. Upon written
request from the applicant, HHS may grant extensions, provided that the
appropriate landholding agency concurs with the extension. Because each
applicant will have a different deadline based on the date the applicant
submitted an expression of interest, applicants should contact the
individual landholding agency to confirm that a particular property
remains available prior to submitting an application.
(e) Evaluations. (1) Upon receipt of an application, HHS will review
it for completeness, and, if incomplete, may return it or ask the
applicant to furnish any missing or additional required information
prior to final evaluation of the application.
(2) HHS will evaluate each completed application within 25 days of
receipt and will promptly advise the applicant of its decision.
Applications are evaluated on a first-come, first-serve basis. HHS will
notify all organizations which have submitted expressions of interest
for a particular property regarding whether the first application
received for that property has been approved or disapproved. All
applications will be reviewed on the basis of the following elements,
which are listed in descending order of priority, except that paragraphs
(e)(2)(iv) and (e)(2)(v) of this section are of equal importance.
(i) Services offered. The extent and range of proposed services,
such as meals, shelter, job training, and counseling.
(ii) Need. The demand for the program and the degree to which the
available property will be fully utilized.
(iii) Implementation Time. The amount of time necessary for the
proposed program to become operational.
(iv) Experience. Demonstrated prior success in operating similar
programs and recommendations attesting to that fact by Federal, State,
and local authorities.
(v) Financial Ability. The adequacy of funding that will likely be
available to run the program fully and properly and to operate the
(3) Additional evaluation factors may be added as deemed necessary
by HHS. If additional factors are added, the application packet will be
revised to include a description of these additional factors.
(4) If HHS receives one or more competing applications for a
property within 5 days of the first application HHS will evaluate all
completed applications simultaneously. HHS will rank approved
applications based on the elements listed in Sec. 12a.8(e)(2), and
notify the landholding agency, or GSA, as appropriate, of the relative
(Approved by the Office of Management and Budget under control number
Sec. 12a.10 Action on approved applica-tions.
(a) Unutilized and underutilized properties.
(1) When HHS approves an application, it will so notify the
applicant and forward a copy of the application to the landholding
agency. The landholding agency will execute the lease, or permit
document, as appropriate, in consultation with the applicant.
(2) The landholding agency maintains the discretion to decide the
(i) The length of time the property will be available. (Leases and
permits will be for a period of at least one year unless the applicant
requests a shorter term.)
(ii) Whether to grant use of the property via a lease or permit;
(iii) The terms and conditions of the lease or permit document.
(b) Excess and surplus properties. (1) When HHS approves an
application, it will so notify the applicant and request that GSA assign
the property to HHS for leasing. Upon receipt of the assignment, HHS
will execute a lease in accordance with the procedures and requirements
set out in 45 CFR part 12. In accordance with 41 CFR 101-47.402, custody
and accountability of the property will remain throughout the lease term
with the agency which initially reported the property as excess.
(2) Prior to assignment to HHS, GSA may consider other Federal uses
other important national needs; however, in deciding the disposition of
surplus real property, GSA will generally give priority of consideration
to uses to assist the homeless. GSA may consider any competing request
for the property made under section 203(k) of the Federal Property and
Administrative Services Act of 1949 (40 U.S.C. 484(k)) that is so
meritorious and compelling that it outweighs the needs of the homeless,
and HHS may likewise consider any competing request made under
subsection 203(k)(1) of that law.
(3) Whenever GSA or HHS decides in favor of a competing request over
a request for property for homeless assistance use as provided in
paragraph (b)(2) of this section, the agency making the decision will
transmit to the appropriate committees of the Congress an explanatory
statement which details the need satisfied by conveyance of the surplus
property, and the reasons for determining that such need was so
meritorious and compelling as to outweigh the needs of the homeless.
(4) Deeds. Surplus property may be conveyed to representatives of
the homeless pursuant to section 203(k) of the Federal Property and
Administrative Services Act of 1949 (40 U.S.C. 484(k)(1), and section
501(f) of the McKinney Act as amended, 42 U.S.C. 11411. Representatives
of the homeless must complete the application packet pursuant to the
requirements of Sec. 12a.9 of this part and in accordance with the
requirements of 45 CFR part 12.
(c) Completion of Lease Term and Reversion of Title. Lessees and
grantees will be responsible for the protection and maintenance of the
property during the time that they possess the property. Upon
termination of the lease term or reversion of title to the Federal
government, the lessee or grantee will be responsible for removing any
improvements made to the property and will be responsible for
restoration of the property. If such improvements are not removed, they
will become the property of the Federal government. GSA or the
landholding agency, as appropriate, will assume responsibility for
protection and maintenance of a property when the lease terminates or
Sec. 12a.11 Unsuitable properties.
The landholding agency will defer, for 20 days after the date that
notice of a property is published in the Federal Register, action to
dispose of properties determined unsuitable for homeless assistance. HUD
will inform landholding agencies or GSA if appeal of an unsuitability
determination is filed by a representative of the homeless pursuant to
Sec. 12a.4(f)(4). HUD will advise the agency that it should refrain from
initiating disposal procedures until HUD has completed its
reconsideration process regarding unsuitability. Thereafter, or if no
appeal has been filed after 20 days, GSA or the appropriate landholding
agency may proceed with disposal action in accordance with applicable
Sec. 12a.12 No applications approved.
(a) At the end of the 60 day holding period described in
Sec. 12a.9(a), HHS will notify GSA, or the landholding agency, as
appropriate, if an expression of interest has been received for a
particular property. Where there is no expression of interest, GSA or
the landholding agency, as appropriate, will proceed with disposal in
accordance with applicable law.
(b) Upon advice from HHS that all applications have been
disapproved, or if no completed applications or requests for extensions
have been received by HHS within 90 days from the date of the last
expression of interest, disposal may proceed in accordance with
PART 13--IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY PROCEEDINGS--Table of Contents
Subpart A--General Provisions
13.1 Purpose of these rules.
13.2 When these rules apply.
13.3 Proceedings covered.
13.4 Eligibility of applicants.
13.5 Standards for awards.
13.6 Allowable fees and expenses.
13.7 Studies, exhibits, analyses, engineering reports, tests and
Subpart B--Information Required from Applicants
13.10 Contents of application.
13.11 Net worth exhibits.
13.12 Documentation of fees and expenses.
Subpart C--Procedures for Considering Applications
13.21 Filing and service of pleadings.
13.22 When an application may be filed.
13.23 Responsive pleadings.
13.25 Further proceedings.
13.27 Agency review.
13.28 Judicial review.
13.29 Payment of award.
13.30 Designation of adjudicative officer.
Appendix A to Part 13
Authority: Sec. 203(a)(1), Pub. L. 96-481, 94 Stat. 2325 (5 U.S.C.
Source: 48 FR 45252, Oct. 4, 1983, unless otherwise noted.
Subpart A--General Provisions
Sec. 13.1 Purpose of these rules.
These rules implement section 203 of the Equal Access to Justice
Act, 5 U.S.C. 504 and 504 note, for the Department of Health and Human
Services. They describe the circumstances under which the Department may
award attorney fees and certain other expenses to eligible individuals
and entities who prevail over the Department in certain administrative
proceedings (called ``adversary adjudications''). The Department may
reimburse parties for expenses incurred in adversary adjudications if
the party prevails in the proceeding and if the Department's position in
the proceeding was not substantially justified. These rules explain how
to apply for an award. They also describe what proceedings constitute
adversary adjudications covered by the Act, what types of persons and
entities may be eligible for an award, and what procedures and standards
the Department will use to make a determination as to whether a party
may receive an award.
Sec. 13.2 When these rules apply.
These rules apply to adversary adjudications pending before the
Department between October 1, 1981 and September 30, 1984.
Sec. 13.3 Proceedings covered.
(a) These rules apply only to adversary adjudications. For the
purpose of these rules, only an adjudication required to be under 5
U.S.C. 554, in which the position of the Department or one of its
components is represented by an attorney or other representative (``the
agency's litigating party'') who enters an appearance and participates
in the proceeding, constitutes an adversary adjudication. These rules do
not apply to proceedings for the purpose of establishing or fixing a
rate or for the purpose of granting, denying, or renewing a license.
Department proceedings covered by these rules, if the agency's
litigating party enters an appearance and participates, are listed in
(b) If a proceeding is covered by these rules, but also involves
issues excluded under paragraph (a) of this section from the coverage of
these rules, reimbursement is available only for fees and expenses
resulting from covered issues.
Sec. 13.4 Eligibility of applicants.
(a) To be eligible for an award of attorney fees and other expenses
under these regulations, the applicant must be a party, as defined in 5
U.S.C. 551(3), to the adversary adjudication for which it seeks an
award. An applicant must show that it meets all conditions of
eligibility set out in this subpart and in Subpart B.
(b) The categories of eligible applicants are as follows:
(1) Individuals with a net worth of not more than $1 million;
(2) Sole owners of unincorporated businesses if the owner has a net
worth of not more than $5 million, including both personal and business
interests, and not more than 500 employees;
(3) Charitable or other tax-exempt organizations described in
section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3))
with not more than 500 employees;
(4) Cooperative associations as defined in section 15(a) of the
Agricultural Marketing Act (12 U.S.C. 1141j(a)) with not more than 500
(5) All other partnerships, corporations, associations or public or
private organizations with a net worth of not
more than $5 million and with not more than 500 employees.
(c) For the purpose of determining eligibility, the net worth and
number of employees of an applicant is calculated as of the date the
proceeding was initiated. The net worth of an applicant is determined by
generally accepted accounting principles.
(d) Whether an applicant who owns an unincorporated business will be
considered as an ``individual'' or a ``sole owner of an unincorporated
business'' will be determined by whether the applicant's participation
in the proceeding is related primarily to individual interests or to
(e) The employees of an applicant include all those persons
regularly providing services for remuneration for the applicant, under
the applicant's direction and control. Part-time employees shall be
included on a proportional basis.
(f) The net worth and number of employees of the applicant and all
of its affiliates shall be aggregated to determine eligibility. Any
individual, corporation or other entity that directly or indirectly
controls or owns a majority of the voting shares or other interest of
the applicant, or any corporation or other entity of which the applicant
directly or indirectly owns or controls a majority of the voting shares
or other interest, will be considered an affiliate for purposes of this
part, unless the adjudicative officer determines that such treatment
would be unjust and contrary to the purposes of the Act in light of the
actual relationship between the affiliated entities. In addition, the
adjudicative officer may determine that financial relationships of the
applicant other than those described in this paragraph constitute
special circumstances that would make an award unjust.
(g) An applicant is not eligible if it appears from the facts and
circumstances that it has participated in the proceedings only or
primarily on behalf of other persons or entities that are ineligible.
Sec. 13.5 Standards for awards.
(a) Awards will not be made for fees and expenses where the
Department's position in the proceeding was substantially justified at
the time the proceeding was initiated. The fact that a party has
prevailed in a proceeding does not create a presumption that the
Department's position was not substantially justified. The burden of
proof that an award should not be made to an eligible prevailing
applicant is on the agency's litigating party, which may avoid an award
by showing that its position was reasonable in law and fact.
(b) When two or more matters are joined together for one hearing,
each of which could have been heard separately (without regard to laws
or rules fixing a jurisdictional minimum amount for claims), and an
applicant has prevailed with respect to one or several of the matters,
an eligible applicant may receive an award for expenses associated only
with the matters on which it prevailed if the Department's position on
those matters was not substantially justified.
(c) Awards for fees and expenses incurred before the date on which a
proceeding was initiated will be made only if the applicant can
demonstrate that they were reasonably incurred in preparation for the
(d) Awards will be reduced or denied if the applicant has unduly or
unreasonably protracted the proceeding or if other special circumstances
make an award unjust.
Sec. 13.6 Allowable fees and expenses.
(a) Awards will be limited to the rates customarily charged by
persons engaged in the business of acting as attorneys, agents and
expert witnesses. Awards will not be made for more than the applicant's
actual expenses. If a party has already received, or is eligible to
receive, reimbursement for any expenses under another statutory
provision or another program allowing reimbursement, its award under
these rules must be reduced by the amount the prevailing party has
already received, or is eligible to receive, from the Federal
(b) An award for the fees of an attorney or agent may not exceed
$75.00 per hour, regardless of the actual rate charged by the attorney
or agent. An award for the fees of an expert witness
may not exceed the highest rate at which the Department pays expert
witnesses, which is $24.09 per hour, regardless of the actual rates
charged by the witness. These limits apply only to fees; an award may
include the reasonable expenses of the attorney, agent, or witness as a
separate item, if the attorney, agent or witness ordinarily charges
separately for such expenses.
(c) In determining the reasonableness of the fees sought for
attorneys, agents or expert witnesses, the adjudicative officer must
consider factors bearing on the request, which include, but are not
(1) If the attorney, agent or witness is in private practice, his or
her customary fee for like services; if the attorney, agent or witness
is an employee of the applicant, the fully allocated cost of service;
(2) The prevailing rate for similar services in the community in
which the attorney, agent or witness ordinarily performs services;
(3) The time actually spent in the representation of the applicant;
(4) The time reasonably spent in light of the difficulty or
complexity of the issues in the proceeding; and
(5) Such other factors as may bear on the value of the services
Sec. 13.7 Studies, exhibits, analyses, engineering reports, tests and projects.
The reasonable cost (or the reasonable portion of the cost) for any
study, exhibit, analysis, engineering report, test, project or similar
matter prepared on behalf of a party may be awarded to the extent that:
(a) The charge for the service does not exceed the prevailing rate
payable for similar services,
(b) The study or other matter was necessary to the preparation for
the administrative proceeding, and
(c) The study or other matter was prepared for use in connection
with the administrative proceeding. No award will be made for a study or
other matter which was necessary to satisfy statutory or regulatory
requirements, or which would ordinarily be conducted as part of the
party's business irrespective of the administrative proceeding.
Subpart B--Information Required from Applicants
Sec. 13.10 Contents of application.
(a) Applications for an award of fees and expenses must include:
(1) The name of the applicant and the identification of the
(2) A declaration that the applicant believes it has prevailed, and
an identification of the position of the Department that the applicant
alleges was not substantially justified at the time of the initiation of
(3) Unless the applicant is an individual, a statement of the number
of its employees on the date on which the proceeding was initiated, and
a brief description of the type and purpose of its organization or
(4) A description of any affiliated individuals or entities, as the
term ``affiliate'' is defined in Sec. 13.4(f), or a statement that none
(5) A statement that the applicant's net worth as of the date on
which the proceeding was initiated did not exceed $1 million (if an
individual) or $5 million (for all other applicants, including their
affiliates). However, an applicant may omit this statement if:
(i) It attaches a copy of a ruling by the Internal Revenue Service
that it qualifies as an organization described in section 501(c)(3) of
the Internal Revenue Code (26 U.S.C. 501(c)(3)) or, in the case of a
tax-exempt organization not required to obtain a ruling from the
Internal Revenue Service on its exempt status, a statement that
describes the basis for the applicant's belief that it qualified under
such section; or
(ii) It states that it is a cooperative association as defined in
section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a));
(6) A statement of the amount of fees and expenses for which an
award is sought;
(7) A declaration that the applicant has not received, has not
applied for, and does not intend to apply for reimbursement of the cost
of items listed in the Statement of Fees and Expenses under any other
program or statute; or if the applicant has received or applied for or
will receive or apply for reimbursement of those expenses under another
program or statute, a statement
of the amount of reimbursement received or applied for or intended to be
applied for; and
(8) Any other matters the applicant wishes the Department to
consider in determining whether and in what amount an award should be
(b) All applications must be signed by the applicant or by an
authorized officer or attorney of the applicant. It shall also contain
or be accompanied by a written verification under oath or under penalty
of perjury that the information provided in the application is true and
(Approved by the Office of Management and Budget under control number
Sec. 13.11 Net worth exhibits.
(a) Each applicant except a qualified tax-exempt organization or
cooperative association must provide with its application a detailed
exhibit showing the net worth of the applicant and any affiliates (as
defined in Sec. 13.4(f) of this part) when the proceeding was initiated.
If any individual, corporation, or other entity directly or indirectly
controls or owns a majority of the voting shares or other interest of
the applicant, or if the applicant directly or indirectly owns or
controls a majority of the voting shares or other interest of any
corporation or other entity, the exhibit must include a showing of the
net worth of all such affiliates or of the applicant including the
affiliates. The exhibit may be in any form convenient to the applicant
that provides full disclosure of the applicant's and its affiliates'
assets and liabilities and is sufficient to determine whether the
applicant qualifies under the standards in this part. The adjudicative
officer may require an applicant to file additional information to
determine its eligibility for an award.
(b) The net worth exhibit shall describe any transfers of assets
from, or obligations incurred by, the applicant or any affiliate,
occurring in the one year period prior to the date on which the
proceeding was initiated, that reduced the net worth of the applicant
and its affiliates below the applicable net worth ceiling. If there were
no such transactions, the applicant shall so state.
(c) Ordinarily, the net worth exhibit will be included in the public
record of the proceeding. However, an applicant that objects to public
disclosure of information in any portion of the exhibit and believes
there are legal grounds for withholding it from disclosure may submit
that portion of the exhibit directly to the adjudicative officer in a
sealed envelope labeled ``Confidential Financial Information,''
accompanied by a motion to withhold the information from public
disclosure. The motion shall describe the information sought to be
withheld and explain, in detail, why it falls within one or more of the
specific exemptions from mandatory disclosure under the Freedom of
Information Act, 5 U.S.C. 552(b)(1)-(9), why public disclosure of the
information would adversely affect the applicant, and why disclosure is
not required in the public interest. The material in question shall be
served on counsel representing the agency against which the applicant
seeks an award, but need not be served on any other party to the
proceeding. If the adjudicative officer finds that the information
should not be withheld from disclosure, it shall be placed in the public
record of the proceeding. Otherwise, the officer will omit the material
from the public record. In that case, any decision regarding disclosure
of the material (whether in response to a request from an agency or
person outside the Department or on the Department's own initiative)
will be made in accordance with applicable statutes and Department rules
and procedures for commercial and financial records which the submitter
claims are confidential or privileged. In particular, this regulation is
not a basis for a promise or obligation of confidentiality.
(Approved by the Office of Management and Budget under control number
Sec. 13.12 Documentation of fees and expenses.
(a) All applicants must be accompanied by full documentation of the
fees and expenses, including the cost of any study, exhibit, analysis,
report, test or other similar item, for which the applicant seeks
(b) The documentation shall include an affidavit from each attorney,
agent, or expert witness representing or appearing in behalf of the
party, stating the actual time expended, the rate at which fees and
other expenses were computed, a description of the specific services
performed, the total amount claimed, and the total amount paid or
payable by the applicant or by any other person or entity for the
services provided. Where the adversary adjudication includes covered
proceedings (as described in Sec. 13.3) as well as excluded proceedings,
or two or more matters, each of which could have been heard separately,
the fees and expenses shall be shown separately for each proceeding or
matter, and the basis for allocating expenses among the proceedings or
matters shall be indicated.
(1) The affidavit shall itemize in detail the services performed by
the date, number of hours per date and the services performed during
those hours. In order to establish the hourly rate, the affidavit shall
state the hourly rate which is billed and paid by the majority of
clients during the relevant time periods.
(2) If no hourly rate is paid by the majority of clients because,
for instance, the attorney or agent represents most clients on a
contingency basis, the attorney or agent shall provide affidavits from
two attorneys or agents with similar experience, who perform similar
work, stating the hourly rate which they bill and are paid by the
majority of their clients during a comparable time period.
(c) If the applicant seeks reimbursement of any expenses not covered
by the affidavit described in paragraph (b), the documentation must also
include an affidavit describing all such expenses and stating the
amounts paid or payable by the applicant or by any other person or
entity for the services provided.
(d) The adjudicative officer may require the applicant to provide
vouchers, receipts, or other substantiation for any expenses claimed.
(Approved by the Office of Management and Budget under control number
Subpart C--Procedures for Considering Applications
Sec. 13.21 Filing and service of pleadings.
All pleadings, including applications for an award of fees, answers,
comments, and other pleadings related to the applications, shall be
filed in the same manner as other pleadings in the proceeding and served
on all other parties and participants, except as provided in
Sec. 13.11(b) of this part concerning confidential financial
Sec. 13.22 When an application may be filed.
(a) The applicant must file and serve its application no later than
30 calendar days after the Department's final disposition of the
proceeding which makes the applicant a prevailing party.
(b) For purposes of this rule, final disposition means the later of
(1) the date on which an initial decision or other recommended
disposition of the merits of the proceeding by an adjudicative officer
or intermediate review board becomes administratively final; (2)
issuance of an order disposing of any petitions for reconsideration of
the Department's final order in the proceeding; (3) if no petition for
reconsideration is filed, the last date on which such a petition could
have been filed; or (4) issuance of a final order or any other final
resolution of a proceeding, such as a settlement or voluntary dismissal,
which is not subject to a petition for reconsideration.
(c) For purposes of this rule, an applicant has prevailed when the
agency has made a final disposition favorable to the applicant with
respect to any matter which could have been heard as a separate
proceeding, regardless of whether it was joined with other matters for
(d) If review or reconsideration is sought or taken of a decision as
to which an applicant believes it has prevailed, proceedings for the
award of fees shall be stayed pending final disposition of the
Sec. 13.23 Responsive pleadings.
(a) Within 30 calendar days after service of the application, the
litigating party shall file an answer either consenting to the award or
explaining in detail any objections to the award requested, and
identifying the facts relied on in support of its position. The
adjudicative officer may for good cause grant an extension of time for
filing an answer.
(b) Within 15 calendar days after service of an answer, the
applicant may file a reply. If the reply is based on any alleged facts
not already in the record of the proceeding, the applicant shall include
with the reply either supporting affidavits or a request for further
proceedings under Sec. 13.25.
(c) Any party to or participant in a proceeding may file comments on
an application within 30 calendar days, or on an answer within 15
calendar days after service of the application or answer.
Sec. 13.24 Settlements.
The applicant and the agency's litigating party may agree on a
proposed settlement of the award at any time prior to final action on
the application. If the parties agree on a proposed settlement of an
award before an application has been filed, the application shall be
filed with the proposed settlement. All settlements must be approved by
the adjudicative officer and the head of the agency or office or his or
her designee before becoming final.
Sec. 13.25 Further proceedings.
(a) Ordinarily, a decision on an application will be made on the
basis of the hearing record and pleadings related to the application.
However, at the request of either the applicant or the agency's
litigating party, or on his or her own initiative, the adjudicative
officer may order further proceedings, including an informal conference,
oral argument, additional written submissions, or an evidentiary
hearing. Such further proceedings shall be held only when necessary for
full and fair resolution of the issues arising from the application, and
shall be conducted as promptly as possible.
(b) A request that the adjudicative officer order additional written
submissions or oral testimony shall identify the information sought and
shall explain why the information is necessary to decide the issues.
(c) The adjudicative officer may impose sanctions on any party for
failure to comply with his or her order to file pleadings, produce
documents, or present witnesses for oral examination. These sanctions
may include but are not limited to granting the application partly or
completely, dismissing the application, and diminishing the award
Sec. 13.26 Decisions.
The adjudicative officer shall issue an initial decision on the
application as promptly as possible after the filing of the last
document or conclusion of the hearing. The decision must include written
findings and conclusions on the applicant's eligibility and status as a
prevailing party, including a finding on the net worth of the applicant.
Where the adjudicative officer has determined under Sec. 13.11(b) that
the applicant's net worth information is exempted from disclosure under
the Freedom of Information Act, the finding on net worth shall be kept
confidential. The decision shall also include, if at issue, findings on
whether the agency's position was substantially justified, whether the
applicant unduly protracted the proceedings, an explanation of any
difference between the amount requested and the amount awarded, and
whether any special circumstances make the award unjust.
Sec. 13.27 Agency review.
(a) The head of the agency or office, or his or her designee, shall
review any award granted under this part whether or not the parties
request such review, and issue a final decision. No award shall be made
under this subpart without approval of the head of the agency or office
or his or her designee.
(b) If either the applicant or the agency's litigating party seeks
review of the adjudicative officer's decision on the fee application, it
shall file and serve exceptions within 30 days after issuance of the
initial decision. The head of the agency or office or his or her
designee shall issue a final decision on the application as soon as
possible or remand the application to the adjudicative officer for
Any party that does not file and serve exceptions within the stated time
limit loses the opportunity to do so.
Sec. 13.28 Judicial review.
Judicial review of final agency decisions on awards may be obtained
as provided in 5 U.S.C. 504(c)(2).
Sec. 13.29 Payment of award.
The notification to an applicant of a final decision that an award
will be made shall contain the name and address of the appropriate
Departmental finance office that will pay the award. An applicant
seeking payment of an award shall submit to that finance officer a copy
of the final decision granting the award, accompanied by a statement
that the applicant will not seek review of the decision in the United
States courts. The Department will pay the amount awarded to the
applicant within 60 days, unless judicial review of the award or of the
underlying decision of the adversary adjudication has been sought by the
applicant or any other party to the proceedings.
Sec. 13.30 Designation of adjudicative officer.
Upon the filing of an application pursuant to Sec. 13.11(a), the
officer who presided over the taking of evidence in the proceeding which
gave rise to the application will, if available, be automatically
designated as the adjudicative officer for the handling of the
Proceedings covered Statutory authority Applicable regulations
Office of the Inspector General
Proceeding to impose civil monetary penalties or 42 U.S.C. 1320a-7a.............................. ................................................
assessments for fraudulent claims under Medicare,
Medicaid, and Title V.
Health Care Financing Administration
Proceedings to suspend or revoke licenses of 42 U.S.C. 263a(e), (g).......................... ................................................
Proceedings provided to a fiscal intermediary before 42 U.S.C. 1395h................................. ................................................
assigning or reassigning Medicare providers to a
different fiscal intermediary.
Proceedings before the Provider Reimbursement Review 42 U.S.C. 1395oo................................ 42 CFR Part 405, Subpart R.
Board when HCFA acts as fiscal intermediary.
Food and Drug Administration
Proceedings to withdraw approval of new drug 21 U.S.C. 355(d), (e)........................... 21 CFR Part 12, 21 CFR 314.200.
Proceedings to withdraw approval of new animal drug 21 U.S.C. 360b(d), (e), (m)..................... 21 CFR Part 12, 21 CFR Part 514, Subpart B.
applications and medicated feed applications.
Proceedings to withdraw approval of medical device 21 U.S.C. 306e(d), (e), (g)..................... 21 CFR Part 12.
premarket approval applications.
Office of Civil Rights
Proceedings to enforce Title VI of the Civil Rights 42 U.S.C. 200d-1................................ 45 CFR 80.9.
Act of 1964, which prohibits descrimination on the
basis of race, color or national origin by
recipients of Federal financial assistance.
Proceedings to enforce Section 504 of the 29 U.S.C. 794................................... 45 CFR 84.61.
Rehabilitation Act of 1973, which prohibits
discrimination on the basis of handicap by
recipients of Federal financial assistance.
Proceedings to enforce the Age Discrimination Act of 42 U.S.C. 6101, 6104(a)......................... 45 CFR 90.47.
1975, which prohibits discrimination on the basis
of age by recipients of Federal financial
Proceedings to enforce Title IX of the Education 20 U.S.C. 1681, 1682............................ 45 CFR 86.71.
Amendments of 1972, which prohibits discrimination
on the basis of sex in certain education programs
by recipients of Federal financial assistance.
PART 15--UNIFORM RELOCATION ASSISTANCE AND REAL PROPERTY ACQUISITION FOR FEDERAL AND FEDERALLY ASSISTED PROGRAMS--Table of Contents
Authority: Sec. 213, Uniform Relocation Assistance and Real Property
Acquisition Policies Act of 1970, Pub. L. 91-646, 84 Stat. 1894 (42
U.S.C. 4633) as amended by the Surface Transportation and Uniform
Relocation Assistance Act of 1987, Title IV of Pub. L. 100-17, 101 Stat.
246-256 (42 U.S.C. 4601 note).
Sec. 15.1 Uniform relocation assistance and real property acquisition.
Regulations and procedures for complying with the Uniform Relocation
Assistance and Real Property Acquisition Policies Act of 1970 (Pub. L.
91-646, 84 Stat. 1894, 42 U.S.C. 4601 et seq.), as amended by the
Surface Transportation and Uniform Relocation Assistance Act of 1987
(Title IV of Pub. L. 100-17, 101 Stat. 246-256, 42 U.S.C. 4601 note) are
set forth in 49 CFR Part 24.
[52 FR 48026, Dec. 17, 1987 and 54 FR 8912, Mar. 2, 1989]
PART 16--PROCEDURES OF THE DEPARTMENTAL GRANT APPEALS BOARD--Table of Contents
16.1 What this part does.
16.3 When these procedures become available.
16.4 Summary of procedures below.
16.5 How the Board operates.
16.6 Who represents the parties.
16.7 The first steps in the appeal process: The notice of appeal and
the Board's response.
16.8 The next step in the appeal process: Preparation of an appeal file
and written argument.
16.9 How the Board will promote development of the record.
16.10 Using a conference.
16.12 The expedited process.
16.13 Powers and responsibilities.
16.14 How Board review is limited.
16.15 Failure to meet deadlines and other requirements.
16.16 Parties to the appeal.
16.17 Ex parte communications (communications outside the record).
16.19 How to calculate deadlines.
16.20 How to submit material to the Board.
16.21 Record and decisions.
16.22 The effect of an appeal.
16.23 How long an appeal takes.
Appendix A to Part 16--What Disputes the Board Reviews
Authority: 5 U.S.C. 301 and secs. 1, 5, 6, and 7 of Reorganization
Plan No. 1 of 1953, 18 FR 2053, 67 Stat. 631 and authorities cited in
Source: 46 FR 43817, Aug. 31, 1981, unless otherwise noted.
Sec. 16.1 What this part does.
This part contains requirements and procedures applicable to certain
disputes arising under the HHS programs described in Appendix A. This
part is designed to provide a fair, impartial, quick and flexible
process for appeal from written final decisions. This part supplements
the provisions in Part 74 of this title.
Sec. 16.2 Definitions.
(a) Board means the Departmental Grant Appeals Board of the
Department of Health and Human Services. Reference below to an action of
the Board means an action of the Chair, another Board member, or Board
staff acting at the direction of a Board member. In certain instances,
the provisions restrict action to particular Board personnel, such as
the Chair or a Board member assigned to a case.
(b) Other terms shall have the meaning set forth in Part 74 of this
title, unless the context below otherwise requires.
Sec. 16.3 When these procedures become available.
Before the Board will take an appeal, three circumstances must be
(a) The dispute must arise under a program which uses the Board for
dispute resolution, and must meet any special conditions established for
that program. An explanation is contained in Appendix A.
(b) The appellant must have received a final written decision, and
must appeal that decision within 30 days after receiving it. Details of
how final decisions are developed and issued, and what must be in them,
are contained in 45 CFR 74.304.
(c) The appellant must have exhausted any preliminary appeal process
required by regulation. For example, see 42 CFR part 50 (subpart D) for
Public Health Service programs. In such cases, the final written
decision required for the Board's review is the decision resulting from
the preliminary review or appeal process. Appendix A contains further
[46 FR 43817, Aug. 31, 1981, as amended at 62 FR 38218, July 17, 1997]
Sec. 16.4 Summary of procedures below.
The Board's basic process is review of a written record (which both
parties are given ample opportunity to develop), consisting of relevant
documents and statements submitted by both parties (see Sec. 16.8). In
addition, the Board may hold an informal conference (see Sec. 16.10).
The informal conference primarily involves questioning of the
participants by a presiding Board member. Conferences may be conducted
by telephone conference call. The written record review also may be
supplemented by a hearing involving an opportunity for examining
evidence and witnesses, cross-examination, and oral argument (see
Sec. 16.11). A hearing is more expensive and time-consuming than a
determination on the written record alone or with an informal
conference. Generally, therefore, the Board will schedule a hearing only
if the Board determines that there are complex issues or material facts
in dispute, or that the Board's review would otherwise be significantly
enhanced by a hearing. Where the amount in dispute is $25,000 or less,
there are special expedited procedures (see Sec. 16.12 of this part). In
all cases, the Board has the flexibility to modify procedures to ensure
fairness, to avoid delay, and to accommodate the peculiar needs of a
given case. The Board makes maximum feasible use of preliminary informal
steps to refine issues and to encourage resolution by the parties. The
Board also has the capability to provide mediation services (see
Sec. 16.5 How the Board operates.
(a) The Board's professional staff consists of a Chair (who is also
a Board member) and full- and part-time Board members, all appointed by
the Secretary; and a staff of employees and consultants who are
attorneys or persons from other relevant disciplines, such as
(b) The Chair will assign a Board member to have lead responsibility
for each case (the ``presiding Board member''). The presiding Board
member will conduct the conference or hearing, if one is held. Each
decision of the Board is issued by the presiding Board member and two
other Board members.
(c) The Board staff assists the presiding Board member, and may
request information from the parties; conduct telephone conference calls
to request information, to clarify issues, or to schedule events; and
assist in developing decisions and other documents in a case.
(d) The Chair will assure that no Board or staff member will
participate in a case where his or her impartiality could reasonably be
(e) The Board's powers and responsibilities are set forth in
Sec. 16.6 Who represents the parties.
The appellant's notice of appeal, or the first subsequent submission
to the Board, should specify the name, address and telephone number of
the appellant's representative. In its first submission to the Board and
the appellant, the respondent (i.e., the federal party to the appeal)
should specify the name, address and telephone number of the
Sec. 16.7 The first steps in the appeal process: The notice of appeal and the Board's response.
(a) As explained in 45 CFR 74.304, a prospective appellant must
submit a notice of appeal to the Board within 30 days after receiving
the final decision. The notice of appeal must include a copy of the
final decision, a statement of the amount in dispute in the appeal, and
a brief statement of why the decision is wrong.
(b) Within ten days after receiving the notice of appeal, the Board
will send an acknowledgment, enclose a copy of these procedures, and
advise the appellant of the next steps. The Board will also send a copy
of the notice of appeal, its attachments, and the
Board's acknowledgment to the respondent. If the Board Chair has
determined that the appeal does not meet the conditions of Sec. 16.3 or
if further information is needed to make this determination, the Board
will notify the parties at this point.
Sec. 16.8 The next step in the appeal process: Preparation of an appeal file and written argument.
Except in expedited cases (generally those of $25,000 or less; see
Sec. 16.12 for details), the appellant and the respondent each
participate in developing an appeal file for the Board to review. Each
also submits written argument in support of its position. The
responsibilities of each are as follows:
(a) The appellant's responsibility. Within 30 days after receiving
the acknowledgment of the appeal, the appellant shall submit the
following to the Board (with a copy to the respondent):
(1) An appeal file containing the documents supporting the claim,
tabbed and organized chronologically and accompanied by an indexed list
identifying each document. The appellant should include only those
documents which are important to the Board's decision on the issues in
(2) A written statement of the appellant's argument concerning why
the respondent's final decision is wrong (appellant's brief).
(b) The respondent's responsibility. Within 30 days after receiving
the appellant's submission under paragraph (a) of this section, the
respondent shall submit the following to the Board (with a copy to the
(1) A supplement to the appeal file containing any additional
documents supporting the respondent's position, organized and indexed as
indicated under paragraph (a) of this section. The respondent should
avoid submitting duplicates of documents submitted by the appellant.
(2) A written statement (respondent's brief) responding to the
(c) The appellant's reply. Within 15 days after receiving the
respondent's submission, the appellant may submit a short reply. The
appellant should avoid repeating arguments already made.
(d) Cooperative efforts. Whenever possible, the parties should try
to develop a joint appeal file, agree to preparation of the file by one
of them, agree to facts to eliminate the need for some documents, or
agree that one party will submit documents identified by the other.
(e) Voluminous documentation. Where submission of all relevant
documents would lead to a voluminous appeal file (for example where
review of a disputed audit finding of inadequate documentation might
involve thousands of receipts), the Board will consult with the parties
about how to reduce the size of the file.
Sec. 16.9 How the Board will promote development of the record.
The Board may, at the time it acknowledges an appeal or at any
appropriate later point, request additional documents or information;
request briefing on issues in the case; issue orders to show cause why a
proposed finding or decision of the Board should not become final; hold
preliminary conferences (generally by telephone) to establish schedules
and refine issues; and take such other steps as the Board determines
appropriate to develop a prompt, sound decision.
Sec. 16.10 Using a conference.
(a) Once the Board has reviewed the appeal file, the Board may, on
its own or in response to a party's request, schedule an informal
conference. The conference will be conducted by the presiding Board
member. The purposes of the conference are to give the parties an
opportunity to make an oral presentation and the Board an opportunity to
clarify issues and question both parties about matters which the Board
may not yet fully understand from the record.
(b) If the Board has decided to hold a conference, the Board will
consult or correspond with the parties to schedule the conference,
identify issues, and discuss procedures. The Board will identify the
persons who will be allowed to participate, along with the parties'
representatives, in the conference. The parties can submit with their
briefs under Sec. 16.8 a list of persons who might participate with
them, indicating how
each person is involved in the matter. If the parties wish, they may
also suggest questions or areas of inquiry which the Board may wish to
pursue with each participant.
(c) Unless the parties and the Board otherwise agree, the following
(1) Conferences will be recorded at Department expense. On request,
a party will be sent one copy of the transcript. The presiding Board
member will insure an orderly transcript by controlling the sequence and
identification of speakers.
(2) Only in exceptional circumstances will documents be received at
a conference. Inquiry will focus on material in the appeal file. If a
party finds that further documents should be in the record for the
conference, the party should supplement the appeal file, submitting a
supplementary index and copies of the documents to the Board and the
other party not less than ten days prior to the conference.
(3) Each party's representative may make an oral presentation.
Generally, the only oral communications of other participants will
consist of statements requested by the Board or responses to the Board's
questions. The Board will allow reply comment, and may allow short
closing statements. On request, the Board may allow the participants to
question each other.
(4) There will be no post-conference submissions, unless the Board
determines they would be helpful to resolve the case. The Board may
require or allow the parties to submit proposed findings and
Sec. 16.11 Hearing.
(a) Electing a hearing. If the appellant believes a hearing is
appropriate, the appellant should specifically request one at the
earliest possible time (in the notice of appeal or with the appeal
file). The Board will approve a request (and may schedule a hearing on
its own or in response to a later request) if it finds there are complex
issues or material facts in dispute the resolution of which would be
significantly aided by a hearing, or if the Board determines that its
decisionmaking otherwise would be enhanced by oral presentations and
arguments in an adversary, evidentiary hearing. The Board will also
provide a hearing if otherwise required by law or regulation.
(b) Preliminary conference before the hearing. The Board generally
will hold a prehearing conference (which may be conducted by telephone
conference call) to consider any of the following: the possibility of
settlement; simplifying and clarifying issues; stipulations and
admissions; limitations on evidence and witnesses that will be presented
at the hearing; scheduling the hearing; and any other matter that may
aid in resolving the appeal. Normally, this conference will be conducted
informally and off the record; however, the Board, after consulting with
the parties, may reduce results of the conference to writing in a
document which will be made part of the record, or may transcribe
proceedings and make the transcript part of the record.
(c) Where hearings are held. Hearings generally are held in
Washington, DC. In exceptional circumstances, the Board may hold the
hearing at an HHS Regional Office or other convenient facility near the
(d) Conduct of the hearing. (1) The presiding Board member will
conduct the hearing. Hearings will be as informal as reasonably
possible, keeping in mind the need to establish an orderly record. The
presiding Board member generally will admit evidence unless it is
determined to be clearly irrelevant, immaterial or unduly repetitious,
so the parties should avoid frequent objections to questions and
documents. Both sides may make opening and closing statements, may
present witnesses as agreed upon in the prehearing conference, and may
cross-examine. Since the parties have ample opportunity to develop a
complete appeal file, a party may introduce an exhibit at the hearing
only after explaining to the satisfaction of the presiding Board member
why the exhibit was not submitted earlier (for example, because the
information was not available).
(2) The Board may request the parties to submit written statements
of witnesses to the Board and each other prior to the hearing so that
the hearing will primarily be concerned with cross-examination and
(3) False statements of a witness may be the basis for criminal
prosecution under sections 287 and 1001 of Title 18 of the United States
(4) The hearing will be recorded at Department expense.
(e) Procedures after the hearing. The Board will send one copy of
the transcript to each party as soon as it is received by the Board. At
the discretion of the Board, the parties may be required or allowed to
submit post-hearing briefs or proposed findings and conclusions (the
parties will be informed at the hearing). A party should note any major
prejudicial transcript errors in an addendum to its post-hearing brief
(or if no brief will be submitted, in a letter submitted within a time
limit set by the Board).
Sec. 16.12 The expedited process.
(a) Applicability. Where the amount in dispute is $25,000 or less,
the Board will use these expedited procedures, unless the Board Chair
determines otherwise under paragraph (b) of this section. If the Board
and the parties agree, the Board may use these procedures in cases of
more than $25,000.
(b) Exceptions. If there are unique or unusually complex issues
involved, or other exceptional circumstances, the Board may use
(c) Regular expedited procedures. (1) Within 30 days after receiving
the Board's acknowledgment of the appeal (see Sec. 16.7), each party
shall submit to the Board and the other party any relevant background
documents (organized as required under Sec. 16.8), with a cover letter
(generally not to exceed ten pages) containing any arguments the party
wishes to make.
(2) Promptly after receiving the parties' submissions, the presiding
Board member will arrange a telephone conference call to receive the
parties' oral comments in response to each other's submissions. After
notice to the parties, the Board will record the call. The Board member
will advise the parties whether any opportunities for further briefing,
submissions or oral presentations will be established. Cooperative
efforts will be encouraged (see Sec. 16.8(d)).
(3) The Board may require the parties to submit proposed findings
(d) Special expedited procedures where there has already been
review. Some HHS components (for example, the Public Health Service) use
a board or other relatively independent reviewing authority to conduct a
formal preliminary review process which results in a written decision
based on a record including documents or statements presented after
reasonable notice and opportunity to present such material. In such
cases, the following rules apply to appeals of $25,000 or less instead
of those under paragraph (c) of this section:
(1) Generally, the Board's review will be restricted to whether the
decision of the preliminary review authority was clearly erroneous. But
if the Board determines that the record is inadequate, or that the
procedures under which the record was developed in a given instance were
unfair, the Board will not be restricted this way.
(2) Within 30 days after receiving the Board's acknowledgment of
appeal (see Sec. 16.7), the parties shall submit the following:
(i) The appellant shall submit to the Board and the respondent a
statement why the decision was clearly erroneous. Unless allowed by the
Board after consultation with the respondent, the appellant shall not
submit further documents.
(ii) The respondent shall submit to the Board the record in the
case. If the respondent has reason to believe that all materials in the
record already are in the possession of the appellant, the respondent
need only send the appellant a list of the materials submitted to the
(iii) The respondent may, if it wishes, submit a statement why the
decision was not clearly erroneous.
(3) The Board, in its discretion, may allow or require the parties
to present further arguments or information.
Sec. 16.13 Powers and responsibilities.
In addition to powers specified elsewhere in these procedures, Board
members have the power to issue orders (including ``show cause''
orders); to examine witnesses; to take all steps necessary for the
conduct of an orderly hearing; to rule on requests and motions,
including motions to dismiss; to
grant extensions of time for good reasons; to dismiss for failure to
meet deadlines and other requirements; to close or suspend cases which
are not ready for review; to order or assist the parties to submit
relevant information; to remand a case for further action by the
respondent; to waive or modify these procedures in a specific case with
notice to the parties; to reconsider a Board decision 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 these procedures.
Sec. 16.14 How Board review is limited.
The Board shall be bound by all applicable laws and regulations.
Sec. 16.15 Failure to meet deadlines and other requirements.
(a) Since one of the objectives of administrative dispute resolution
is to provide a decision as fast as possible consistent with fairness,
the Board will not allow parties to delay the process unduly. The Board
may grant extensions of time, but only if the party gives a good reason
for the delay.
(b) If the appellant fails to meet any filing or procedural
deadlines, appeal file or brief submission requirements, or other
requirements established by the Board, the Board may dismiss the appeal,
may issue an order requiring the party to show cause why the appeal
should not be dismissed, or may take other action the Board considers
(c) If the respondent fails to meet any such requirements, the Board
may issue a decision based on the record submitted to that point or take
such other measures as the Board considers appropriate.
Sec. 16.16 Parties to the appeal.
(a) The only parties to the appeal are the appellant and the
respondent. If the Board determines that a third person is a real party
in interest (for example, where the major impact of an audit
disallowance would be on the grantee's contractor, not on the grantee),
the Board may allow the third person to present the case on appeal for
the appellant or to appear with a party in the case, after consultation
with the parties and if the appellant does not object.
(b) The Board may also allow other participation, in the manner and
by the deadlines established by the Board, where the Board decides that
the intervenor has a clearly identifiable and substantial interest in
the outcome of the dispute, that participation would sharpen issues or
otherwise be helpful in resolution of the dispute, and that
participation would not result in substantial delay.
Sec. 16.17 Ex parte communications (communications outside the record).
(a) A party shall not communicate with a Board or staff member about
matters involved in an appeal without notice to the other party. If such
communication occurs, the Board will disclose it to the other party and
make it part of the record after the other party has an opportunity to
comment. Board members and staff shall not consider any information
outside the record (see Sec. 16.21 for what the record consists of)
about matters involved in an appeal.
(b) The above does not apply to the following: Communications among
Board members and staff; communications concerning the Board's
administrative functions or procedures; requests from the Board to a
party for a document (although the material submitted in response also
must be given to the other party); and material which the Board includes
in the record after notice and an opportunity to comment.
Sec. 16.18 Mediation.
(a) In cases pending before the Board. If the Board decides that
mediation would be useful to resolve a dispute, the Board, in
consultation with the parties, may suggest use of mediation techniques
and will provide or assist in selecting a mediator. The mediator may
take any steps agreed upon by the parties to resolve the dispute or
clarify issues. The results of mediation are not binding on the parties
unless the parties so agree in writing. The Board will internally
insulate the mediator from any Board or staff members assigned to handle
(b) In other cases. In any other grants dispute, the Board may,
limitations of its resources, offer persons trained in mediation skills
to aid in resolving the dispute. Mediation services will only be offered
at the request, or with the concurrence, of a responsible federal
program official in the program under which the dispute arises. The
Board will insulate the mediator if any appeal subsequently arises from
Sec. 16.19 How to calculate deadlines.
In counting days, include Saturdays, Sundays, and holidays; but if a
due date would fall on a Saturday, Sunday or Federal holiday, then the
due date is the next Federal working day.
Sec. 16.20 How to submit material to the Board.
(a) All submissions should be addressed as follows: Departmental
Grant Appeals Board, Room 2004, Switzer Building, 330 C Street SW.,
Washington, DC 20201.
(b) All submissions after the notice of appeal should identify the
Board's docket number (the Board's acknowledgement under Sec. 16.7 will
specify the docket number).
(c) Unless the Board otherwise specifies, parties shall submit to
the Board an original and two copies of all materials. Each submission
other than the notice of appeal, must include a statement that one copy
of the materials has been sent to the other party, identifying when and
to whom the copy was sent.
(d) Unless hand delivered, all materials should be sent to the Board
and the other party by certified or registered mail, return receipt
(e) The Board considers material to be submitted on the date when it
is postmarked or hand delivered to the Board.
Sec. 16.21 Record and decisions.
(a) Each decision is issued by three Board members (see
Sec. 16.5(b)), who base their decision on a record consisting of the
appeal file; other submissions of the parties; transcripts or other
records of any meetings, conferences or hearings conducted by the Board;
written statements resulting from conferences; evidence submitted at
hearings; and orders and other documents issued by the Board. In
addition, the Board may include other materials (such as evidence
submitted in another appeal) after the parties are given notice and an
opportunity to comment.
(b) The Board will promptly notify the parties in writing of any
disposition of a case and the basis for the disposition.
Sec. 16.22 The effect of an appeal.
(a) General. Until the Board disposes of an appeal, the respondent
shall take no action to implement the final decision appealed.
(b) Exceptions. The respondent may--
(1) Suspend funding (see Sec. 74.114 of this title);
(2) Defer or disallow other claims questioned for reasons also
disputed in the pending appeal;
(3) In programs listed in Appendix A, B.(a)(1), implement a decision
to disallow Federal financial participation claimed in expenditures
reported on a statement of expenditures, by recovering, withholding or
offsetting payments, if the decision is issued before the reported
expenditures are included in the calculation of a subsequent grant; or
(4) Take other action to recover, withhold, or offset funds if
specifically authorized by statute or regulation.
Sec. 16.23 How long an appeal takes.
The Board has established general goals for its consideration of
cases, as follows (measured from the point when the Board receives the
first submission after the notice of appeal):
--For regular review based on a written record under Sec. 16.8, 6
months. When a conference under Sec. 16.10 is held, the goal remains
at 6 months, unless a requirement for post-conference briefing in a
particular case renders the goal unrealistic.
--For cases involving a hearing under Sec. 16.11, 9 months.
--For the expedited process under Sec. 16.12, 3 months.
These are goals, not rigid requirements. The paramount concern of
the Board is to take the time needed to review a record fairly and
adequately in order to produce a sound decision. Furthermore, many
factors are beyond the
Board's direct control, such as unforeseen delays due to the parties'
negotiations or requests for extensions, how many cases are filed, and
Board resources. On the other hand, the parties may agree to steps which
may shorten review by the Board; for example, by waiving the right to
submit a brief, by agreeing to shorten submission schedules, or by
electing the expedited process.
Appendix A to Part 16--What Disputes the Board Reviews
A. What this Appendix covers.
This appendix describes programs which use the Board for dispute
resolution, the types of disputes covered, and any conditions for Board
review of final written decisions resulting from those disputes.
Disputes under programs not specified in this appendix may be covered in
a program regulation or in a memorandum of understanding between the
Board and the head of the appropriate HHS operating component or other
agency responsible for administering the program. If in doubt, call the
Board. Even though a dispute may be covered here, the Board still may
not be able to review it if the limits in paragraph F apply.
B. Mandatory grant programs.
(a) The Board reviews the following types of final written decisions
in disputes arising in HHS programs authorizing the award of mandatory
(1) Disallowances under Titles I, IV, VI, X, XIV, XVI(AABD), XIX,
and XX of the Social Security Act, including penalty disallowances such
as those under sections 403(g) and 1903(g) of the Act and fiscal
disallowances based on quality control samples.
(2) Disallowances in mandatory grant programs administered by the
Public Health Service, including Title V of the Social Security Act.
(3) Disallowances in the programs under sections 113 and 132 of the
Developmental Disabilities Act.
(4) Disallowances under Title III of the Older American Act.
(5) Decisions relating to repayment and withholding under block
grant programs as provided in 45 CFR 96.52.
(6) Decisions relating to repayment and withholding under State
Legalization Impact Assistance Grants as provided in 45 CFR 402.24 and
(b) In some of these disputes, there is an option for review by the
head of the granting agency prior to appeal to the Board. Where an
appellant has requested review by the agency head first, the ``final
written decision'' required by Sec. 16.3 for purposes of Board review
will generally be the agency head's decision affirming the disallowance.
If the agency head declines to review the disallowance or if the
appellant withdraws its request for review by the agency head, the
original disallowance decision is the ``final written decision.'' In the
latter cases, the 30-day period for submitting a notice of appeal begins
with the date of receipt of the notice declining review or with the date
of the withdrawal letter.
C. Direct, discretionary project programs.
(a) The Board reviews the following types of final written decisions
in disputes arising in any HHS program authorizing the award of direct,
discretionary project grants or cooperative agreements:
(1) A disallowance or other determination denying payment of an
amount claimed under an award, or requiring return or set-off of funds
already received. This does not apply to determinations of award amount
or disposition of unobligated balances, or selection in the award
document of an option for disposition of program-related income.
(2) A termination for failure to comply with the terms of an award.
(3) A denial of a noncompeting continuation award under the project
period system of funding where the denial is for failure to comply with
the terms of a previous award.
(4) A voiding (a decision that an award is invalid because it was
not authorized by statute or regulation or because it was fraudulently
(b) Where an HHS component uses a preliminary appeal process (for
example, the Public Health Service), the ``final written decision'' for
purposes of Board review is the decision issued as a result of that
D. Cost allocation and rate disputes.
The Board reviews final written decisions in disputes which may
affect a number of HHS programs because they involve cost allocation
plans or rate determinations. These include decisions related to cost
allocation plans negotiated with State or local governments and
negotiated rates such as indirect cost rates, fringe benefit rates,
computer rates, research patient care rates, and other special rates.
E. SSI agreement disputes.
The Board reviews disputes in the Supplemental Security Income (SSI)
program arising under agreements for Federal administration of State
supplementary payments under section 1616 of the Social Security Act or
mandatory minimum supplements under section 212 of Pub. L. 93-66. In
these cases, the Board provides an opportunity to be heard and offer
evidence at the Secretarial level of review as set out in the applicable
agreements. Thus, the ``final written decision'' for purposes of Board
review is that determination appealable to the Secretary under the
F. Where Board review is not available.
The Board will not review a decision if a hearing under 5 U.S.C. 554
is required by statute, if the basis of the decision is a violation of
applicable civil rights or nondiscrimination laws or regulations (for
example, Title VI of the Civil Rights Act), or if some other hearing
process is established pursuant to statute.
G. How the Board determines whether it will review a case.
Under Sec. 16.7, the Board Chair determines whether an appeal meets
the requirements of this Appendix. If the Chair finds that there is some
question about this, the Board will request the written opinion of the
HHS component which issued the decision. Unless the Chair determines
that the opinion is clearly erroneous, the Board will be bound by the
opinion. If the HHS component does not respond within a time set by the
Chair, or cannot determine whether the Board clearly does or does not
have jurisdiction, the Board will take the appeal.
[46 FR 43817, Aug. 31, 1981, as amended at 47 FR 29492, July 6, 1982; 53
FR 7864, Mar. 10, 1988; 62 FR 38218, July 17, 1997]
PART 17--RELEASE OF ADVERSE INFORMATION TO NEWS MEDIA--Table of Contents
17.2 Basic policy.
17.3 Precautions to be taken.
17.4 Regulatory investigations and trial-type proceedings.
17.5 Context to be reflected.
17.6 Advance notice.
17.7 Retractions or corrections.
Authority: 5 U.S.C. 301.
Source: 41 FR 3, Jan. 2, 1976, unless otherwise noted.
Sec. 17.1 Definition.
Adverse information released by an agency means any statement or
release by the Department or any principal operating component made to
the news media inviting public attention to an action or a finding by
the Department or principal operating component of the Department which
may adversely affect persons or organizations identified therein. This
part does not apply to nor is it affected by any disclosure of records
to the public in response to requests made under the Freedom of
Information Act (Pub. L. 90-23). The criteria for such disclosures are
set forth in the Department's Public Information Regulation (45 CFR Part
Sec. 17.2 Basic policy.
All adverse information release to news media shall be factual in
content and accurate in description. Disparaging terminology not
essential to the content and purpose of the publicity shall be avoided.
Sec. 17.3 Precautions to be taken.
The issuing organization shall take reasonable precautions to assure
that information released is accurate and that its release fulfills an
Sec. 17.4 Regulatory investigations and trial-type proceedings.
Adverse information relating to regulatory investigations of
specifically identified persons or organizations or to pending agency
trial-type proceedings shall be released only in limited circumstances
in accordance with the criteria outlined below:
(a) Where the Department or a principal operating component
determines that there is a significant risk that the public health or
safety may be impaired or substantial economic harm may occur unless the
public is notified immediately, it may release information to news media
as one of the means of notifying the affected public speedily and
accurately. However, where the Department or principal operating
component determines that public harm can be avoided by immediate
discontinuance of an offending practice, a respondent shall be allowed
an opportunity, where feasible, to cease the practice (pending a legal
test) in lieu of release of adverse information by the agency.
(b) Where it is required in order to bring notice of pending agency
adjudication to persons likely to desire to participate therein or
likely to be affected by that or a related adjudication, the Department
or principal operating component shall rely on the news media to the
extent necessary to provide such notice even though it may be adverse to
Sec. 17.5 Context to be reflected.
The authority for and the character of the information shall be made
where appropriate, the release shall explain the nature of any studies
performed, the sources of relevant data, the areas in which
administrative findings of fact were made, and whether the information
is based on allegations subject to subsequent adjudication.
Sec. 17.6 Advance notice.
Any respondent or prospective respondent in an agency proceeding
shall, if practicable and consistent with the nature of the proceeding,
be given advance notice of information to be released about the
proceeding and a reasonable opportunity to prepare in advance a response
to the information released.
Sec. 17.7 Retractions or corrections.
Where the Assistant Secretary for Public Affairs finds that
information released by the Department was misleading or a misstatement
of fact and any person named therein requests a retraction or
correction, the Department shall issue a retraction or correction in the
same manner to all of the media outlets that received the original
information (or as many of them as is feasible). Where information shown
to be misleading or misstatement of fact has been released by a
principal operating component of the Department and any person named
therein requests a retraction or correction, the agency head shall issue
a retraction or correction in the same manner to all of the media
outlets that received the original information (or as many of them as is
PART 30--CLAIMS COLLECTION--Table of Contents
30.1 Purpose and scope.
30.3 Interagency claims.
30.4 Other administrative proceedings.
30.5 Other remedies.
30.6 Property claims.
30.7 Claims involving criminal activity or misconduct.
30.8 Claims arising from GAO exceptions.
30.9 Subdivision of claims.
30.10 Omissions not a defense.
Subpart B--Collection of Claims
30.11 Collection rule.
30.12 Notices to debtor.
30.13 Interest, administrative costs and late payment penalties.
30.14 Interest and charges pending waiver or review.
30.15 Administrative offset.
30.16 Use of credit reporting agencies.
30.17 Contracting for collection services.
30.18 Liquidation of collateral.
30.19 Installment payments.
30.20 Taxpayer information.
30.21 Army hold-up list.
Subpart C--Compromise of Claims
30.22 Compromise rule.
30.24 Inability to collect the full amount.
30.25 Litigative probabilities.
30.26 Cost of collecting claim.
30.27 Enforcement policy.
30.28 Joint and several liability.
30.29 Further review of compromise offers.
Subpart D--Termination or Suspension of Collection Action
30.31 Termination rule.
Subpart E--Referrals to the Department of Justice or GAO
30.34 Claims over $20,000.
30.35 GAO exceptions.
Authority: Subchapter II of Chapter 37 of Title 31, United States
Code, 5 U.S.C. 5514 and 5 U.S.C. 552a as amended by Pub. L. 97-365, 96
Source: 52 FR 264, Jan. 5, 1987, unless otherwise noted.
Sec. 30.1 Purpose and scope.
(a) This regulation prescribes standards and procedures for the
officers and employees of the Department, including officers and
employees of the various Operating Divisions and regional offices of the
Department, charged with collection and disposition of debts owed to the
(b) These standards and procedures will be applied where a statute,
regulation or contract does not prescribe different standards or
procedures. The authority for the regulation lies in the Federal Claims
Collection Act of 1966,
as amended, 31 U.S.C. 3711 and 3716-3718; the Federal Claims Collection
Standards, at 4 CFR Parts 101-105; related statutes (5 U.S.C. 5512 and
5514, 5 U.S.C. 552a) and regulations (5 CFR Part 550); and the common
law. The covered activities include collecting claims in any amount;
compromising claims, or suspending or terminating collection of claims
that do not exceed $20,000, exclusive of interest and charges; and
referring debts that cannot be disposed of by the Department to the
Department of Justice or to the General Accounting Office for further
administrative action or litigation. Further guidance may be found in
the Departmental General Administration Manual, Personnel Manual,
Accounting Manual and Grants Administration Manual, and any other
manuals which may be issued by each Operating Division, office, or
Sec. 30.2 Definitions.
In this part, unless the context otherwise requires--
Amounts payable under the Social Security Act means payments by the
Department to beneficiaries, providers, intermediaries, physicians,
suppliers, carriers, States, or other contractors or grantees under a
Social Security Act program, including: Title I (Grants to States for
Old-Age Assistance and Medical Assistance for the Aged); Title II
(Federal Old-Age Survivors, and Disability Insurance Benefits); Title
III (Grants to States for Unemployment Compensation Administration);
Title IV (Grants to States for Aid and Services to Needy Families with
Children and for Child-Welfare Services); Title V (Maternal and Child
Health and Crippled Children's Services); Title IX (Unemployment
Compensation Program); Title X (Grants to States for Aid to the Blind);
Title XI, Part B (Peer Review of the Utilization and Quality of Health
Care Services); Title XII (Advances to State Unemployment Funds); Title
XIV (Grants to States for Aid to Permanently and Totally Disabled);
Title XVI (Supplemental Security Income for the Aged, Blind, and
Disabled); Title XVII (Grants to States to Fight Mental Retardation);
Title XVIII (Medicare); Title XIX (Medicaid); and Title XX (Block Grants
to States for Social Services). Federal employee salaries and other
payments made by the Department in the course of administering the
provisions of the Social Security Act are not deemed to be ``payable
under'' the Social Security Act for purposes of this regulation.
Claim or Debt means an amount of money or other property owed to the
United States. Debts include, but are not limited to amounts owed on
account of loans made, insured or guaranteed by the United States;
salary overpayments to employees; overpayments to program beneficiaries;
overpayments to contractors and grantees, including overpayments arising
from audit disallowances; excessive cash advances to employees, grantees
and contractors; civil penalties and assessments; theft or loss of money
or property; and damages.
Debtor means an individual, organization, association, partnership,
corporation, or a State or local government or subdivision indebted to
the Department; or the person or entity with legal responsibility for
assuming the debtor's obligation.
Debts arising under the Social Security Act are overpayments to, or
contributions, penalties or assessments owed by, beneficiaries,
providers, intermediaries, physicians, suppliers, carriers, States or
other contractors or grantees under Titles I, II, III, IV, V, IX, X, XI
(Part B), XII, XIV, XVI, XVII, XVIII, XIX and XX of the Social Security
Act. Salary overpayments and other debts that result from the
administration of the provisions of the Social Security Act are not
deemed to ``arise under'' the Social Security Act for purposes of this
Department means the United States Department of Health and Human
Services and each of its Operating Divisions and regional offices.
Liquidated or certain in amount refers to a debt of an amount
already fixed and determined by the Secretary, or which may be readily
fixed and determined from the information available in the debt file,
irrespective of any dispute by the debtor.
Local government means a political subdivision, instrumentality, or
authority of any State; the District of
Columbia; the Commonwealth of Puerto Rico; a territory or possession of
the United States; or an Indian tribe, band or nation.
Operating Division means each separate component within the
Department of Health and Human Services, and includes the Office of the
Secretary, the Office of Human Development Services, the Family Support
Administration, the Health Care Financing Administration, the Public
Health Service and the Social Security Administration.
Overdue refers to a debt not paid by the payment due date specified
in the notice of the debt to the debtor (see Sec. 30.13(a)) and not the
subject of a repayment agreement approved by the Secretary. Also, a debt
subject to repayment agreement is considered overdue if the debtor fails
to satisfy his or her obligations under that agreement. ``Overdue'' and
``delinquent'' have the same meaning. See 4 CFR 101.2(b).
Secretary means the Secretary of Health and Human Services or the
Secretary's designee within any Operating Division or Regional Office.
Sec. 30.3 Interagency claims.
This regulation does not apply to debts owed by other Federal
agencies. These debts will be resolved by negotiation or referral to the
General Accounting Office.
Sec. 30.4 Other administrative proceedings.
This regulation does not supersede or require omission or
duplication of administrative proceedings required under contract,
statute, regulation or other agency procedures. Examples: Resolution of
audit findings under grants or contracts, Chapter 1-105, Grants
Administration Manual (GAM); informal grant appeals, 45 CFR Part 75
(Departmental), 42 CFR 50.401 et seq. (Public Health Service); formal
appeals to the Departmental Grant Appeals Board, 45 CFR Part 16; and
review under a procurement contract Disputes Clause and the Contract
Disputes Act of 1978 (41 U.S.C. 601 et seq.), 48 CFR Part 33.
Sec. 30.5 Other remedies.
The remedies and sanctions available to the Department under this
regulation when collecting debts are not intended to be exclusive. The
Secretary may impose other appropriate sanctions upon a debtor for
inexcusable, prolonged or repeated failure to pay a debt. For example,
the Secretary may stop doing business with a grantee, contractor,
borrower or lender; convert the method of payment under a grant from an
advance to a reimbursement method; or revoke a grantee's letter-of-
Sec. 30.6 Property claims.
Any person who converts, or negligently loses or destroys personal
property belonging, entrusted or loaned to the Department is liable for
the return of the property or payment of its fair market value. A person
who damages such property is liable for the cost of repairs or its fair
market value, whichever is less. Collection of these debts means the
recovery of the property, its fair market value, or the cost of repairs.
Demand for payment of these claims means a demand for the return of the
property or for payment of its fair market value or the cost of repairs.
Sec. 30.7 Claims involving criminal activity or misconduct.
(a) A debtor whose indebtedness involves criminal activity is
subject to punishment by fine or imprisonment as well as to a civil
claim by the United States for compensation for the misappropriated
funds or property. Examples of such activity are fraud, embezzlement and
theft or misuse of Government money or property. See 18 U.S.C. 641, 643.
The Secretary will refer cases of suspected criminal activity or
misconduct to the Office of Inspector General. That office will
investigate such cases, refer them to the Department of Justice for
criminal prosecution and/or return them to the Secretary for collection,
application of administrative sanctions or other disposition.
(b) Debts involving anti-trust violations, fraud, false claims or
(1) Shall be referred by the Secretary to the Office of Inspector
General for review. The Office of Inspector General
shall refer the claim back to the Secretary for collection or other
disposition to the extent authorized by the Department of Justice.
(2) Shall not be compromised, terminated, suspended or otherwise
disposed of by the Secretary under these regulations. Only the
Department of Justice is authorized to compromise, terminate, suspend or
otherwise dispose of such debts.
Sec. 30.8 Claims arising from GAO exceptions.
The Secretary may not compromise but will collect, suspend or
terminate collection of debts due on account of illegal, improper or
incorrect payments shown in General Accounting Office notices of
exception issued to certifying or disbursing officers. Only the General
Accounting Office has the authority to compromise such debts.
Sec. 30.9 Subdivision of claims.
Debts may not be subdivided to avoid the monetary ceilings imposed
by 31 U.S.C. 3711(a) (2) and (3) on the Secretary's authority to
compromise, suspend or terminate collection of debts. A debtor's
liability arising from a particular incident or transaction will be
considered a single debt in determining whether the claim exceeds
$20,000 for purposes of compromising, suspending or terminating
Sec. 30.10 Omissions not a defense.
Failure by the Secretary to comply with any provision of this
regulation may not serve as a defense to any debtor.
Subpart B--Collection of Claims
Sec. 30.11 Collection rule.
(a) Aggressive agency action. The Secretary will take aggressive
action to collect debts and reduce delinquencies. Collection efforts
shall, at a minimum, normally include sending to the debtor's last known
address a total of three progressively stronger written demands for
payment at not more than 30-day intervals unless amounts are available
for offset under section 30.15, or a response to the first or second
demand indicates that further demand would be futile and the debtor's
response does not require rebuttal.
(b) Immediate action. When necessary to protect the Government's
interest, written demand may be preceded by other appropriate action,
such as withholding of amounts payable to the debtor or immediate
referral of the debt for litigation or filing of a claim in bankruptcy
court or against a decedent's estate.
(c) Finding debtors. The Secretary will exhaust every reasonable
effort to locate debtors, using such sources as telephone directories,
city directories, postmasters, driving license records, automobile title
and license records in State and local government agencies, the Internal
Revenue Service, credit reporting agencies and skip locator services.
Referral of a confess-judgment note to the appropriate United States
Attorney's Office for entry of judgment will not be delayed because the
debtor cannot be located.
(d) Joint and several liability. Collection of the full amount of
the debt will be pursued from each debtor jointly and severally liable.
(e) Debtor disputes. A debtor who disputes a debt must promptly
provide available supporting evidence.
(f) Debt files. The Secretary will maintain an administrative file
for each debt or debtor, documenting the debt(s), all administrative
collection action, including communications to and from the debtor, and
disposition of the debt(s). Information from a debt file relating to an
individual may be disclosed only for purposes consistent with this
regulation, the Privacy Act of 1974 (5 U.S.C. 552a), and any other
Sec. 30.12 Notices to debtor.
(a) Required notice. The first written demand for payment must
inform the debtor of--
(1) The amount and nature of the debt;
(2) The date payment is due, which will generally be 30 days from
the date the notice was mailed; and
(3) The assessment under Sec. 30.13 of interest from the date the
notice was mailed, and full administrative costs if payment is not
received within the 30 days.
(b) Other notice. Where applicable, the Secretary must inform the
debtor in writing of--(1) His or her right to dispute the debt or
request a waiver of the debt, citing the applicable review or waiver
authority, the conditions for review or waiver, and the effect of the
review or waiver request on collection of the debt, interest, charges
and late payment penalties (see Sec. 30.14);
(2) The office, address and telephone number that the debtor should
contact to discuss repayment, reconsideration or waiver of the debt;
(3) The proposed sanctions if the debt is overdue, including
assessment of late payment penalties under 30.13 (if the debt is more
than 90 days overdue) or referral of the debt to a credit reporting
agency under Sec. 30.17, or to a collection agency under Sec. 30.18.
(See also Sec. 30.5).
(c) Exception. This section does not require duplication of any
notice already contained in a written agreement, letter or other
document signed by, or provided to the debtor.
Sec. 30.13 Interest, administrative costs and late payment penalties.
(a) Interest. (1) Interest will accrue on all debts from the date
notice of the debt and the interest requirement is first mailed to the
last known address or hand-delivered to the debtor if the debt is not
paid within 30 days from the date of mailing of the notice. Except as
provided in paragraph (a)(2) of this section, or unless the Secretary
determines a higher rate is necessary to protect the Government's
interests, the Secretary shall charge an annual rate of interest as
fixed by the Secretary of the Treasury after taking into consideration
private consumer rates of interest prevailing on the date that the
Department becomes entitled to recovery. This rate may be revised
quarterly by the Secretary of the Treasury and shall be published by the
HHS Assistant Secretary for Management and Budget quarterly in the
Federal Register. Debtors who were not paying interest, or were paying
interest at a different rate prior to October 25, 1982, may be charged
interest at the above-stated rate in effect on the date that notice of
the new interest requirement is mailed after 1982. The Secretary may use
the advance billing procedure and include the interest notification
prior to the debt being owed. Bills sent before a debt is due will
include notification of the interest requirement. In these cases,
interest will begin to accrue on the day after the due date.
(2) The interest rate established in paragraph (a) of this section
shall be no lower than the current value of funds rate, as set by the
Secretary of the Treasury pursuant to 31 U.S.C. 3717, except that in the
case of installment payment agreements under Sec. 30.19, such rate shall
be no lower than the applicable rate determined from the U.S. Treasury
``Schedule of Certified Interest Rates with Range of Maturities.''
(3) The Secretary may, at his or her discretion, extend the 30 day
interest-free period an additional 30 days if the Secretary determines
that such action is in the best interests of the Government, or
otherwise warranted by equity and good conscience.
(4) The rate of interest, as initially assessed, will remain fixed
for the duration of the indebtedness; except that if a debtor defaults
on a repayment agreement, interest may be set at the Treasury rate in
effect on the date a new agreement is executed.
(5) Interest will not be charged on interest, administrative costs
or late payment penalties required by this section. However, if the
debtor defaults on a previous repayment agreement, unpaid accrued
interest, charges and late payment penalties under the defaulted
agreement may be added to the principal to be paid under a new repayment
(b) Administrative costs of collecting overdue debts. Delinquent
debtors will be assessed the administrative costs incurred by the
Department as a result of handling and collecting the overdue debts,
based on either actual or average costs incurred. These costs will
include direct (personnel, supplies, etc.) and indirect costs of
collecting inhouse and contracting with collection agencies and may
include the costs of providing hearings or any other form of review
requested by debtors. See Sec. 30.14. These charges will be assessed
monthly, or per payment period, throughout the period that the debt is
overdue. Such costs may also be additive to
other administrative costs if collection is being made for another
Federal agency or unit.
(c) Late payment penalties. A penalty charge of 6 percent a year
will be assessed on a debt, a payment, or any portion thereof that is
more than 90 days overdue. Late payment penalty charges will accrue from
the date the debt, or portion thereof, became overdue until the overdue
amount is paid. These charges will be assessed monthly, or per payment
period. See also Sec. 30.14.
(d) Social Security Act debts. (1) Unless specifically authorized by
statute, regulations or written agreement, or unless the debts arise
from, or involve, fraud or criminal activity, the Secretary will not
charge interest on debts arising from payments to beneficiaries under
Titles II, XVI and XVIII of Social Security Act. The charging of
interest is appropriate on debts arising from section 1862(b) of the Act
for Medicare payments for which a beneficiary has been reimbursed by a
liable third party, in which case the charging of interest would be
(2) The Secretary will charge administrative costs or late payment
penalties on debts arising under the Social Security Act where
authorized by statute, regulations, or written agreement.
(e) Other debts not covered by 31 U.S.C. 3717. The Secretary will
charge administrative costs or late payment penalties on debts arising
under a contract executed prior to, and in effect on October 25, 1982,
or debts owed by State or local governments where authorized by statute,
regulation, or written agreement.
(f) Allocation of payments. Partial or installment payments will be
applied first to outstanding administrative cost charges and late
payment penalties, second to accrued interest and third to outstanding
(g) Inactive claims. Interest, but not administrative cost charges
or late payment penalties, will continue to accrue when collection of a
debt is suspended under Sec. 30.33(a).
(h) Waivers. The Secretary may waive collecting all or part of
interest, administrative costs or late payment penalties, if--
(1) The debt or the charges resulted from the agency's error, action
or inaction (other than normal processing delays), and without fault on
the part of the debtors; or
(2) Collection in any manner authorized under this regulation would
defeat the overall objectives of a Departmental program.
Sec. 30.14 Interest and charges pending waiver or review.
(a) Rule. A debtor may either pay the debt, or be liable for
interest on the uncollected debt, while a waiver determination, a bona
fide dispute or a formal or informal review of the debt is pending. If a
final determination is to the effect that any amount was properly a debt
to HHS and the debtor chose to retain the amount in dispute, the
Secretary shall collect or offset from any future payments to the
debtor, an amount equal to the amount of the debt plus interest (as
calculated under Sec. 30.13(a)) on such debt amount starting from the
date the debtor was first made aware of the debt and ending when such
debt is repaid. The debtor will also be assessed administrative cost
charges and late payment penalties on the upaid debt for this period if
the reviewing or hearing officer determines in writing that the request
for a waiver, a hearing or other form of review was spurious.
(b) Exception. Interest, late payment penalties and administrative
cost charges will not be assessed pending consideration of waiver or
review under a statute which prohibits collection of the debt during
this period, unless the reviewing or hearing officer determines in
writing that the request for a waiver, a hearing or other form of review
Sec. 30.15 Administrative offset.
(a) Rule. The Secretary will collect debts owed to the Department by
administrative offset if--
(1) The debt is liquidated or certain in amount;
(2) Offset is not expressly or implicitly prohibited by statute or
(3) Offset is cost-effective or has significant deterrent value;
(4) Offset does not substantially impair or defeat program
(5) Overall, offset is best suited to further and protect the
The Secretary may consider financial impact of the proposed offset on
the debtor in determining the method and amount of the offset.
(b) Definitions. (1) ``Administrative Offset'' means satisfying a
debt by withholding money payable by the Department to, or held by the
Department for a debtor. Amounts available for offset include, for
example, benefit payments to a program beneficiary overpaid under the
same or a different program, amounts due a defaulting or overpaid
contractor or grantee under the same or a different agreement, salaries
of Federal employees, Federal income tax refunds and judgments held by
the debtor against the United States. (Offset against judgments will be
effected through the Comptroller General pursuant to 31 U.S.C. 3728.)
(2) ``Hearing'' means either a review of the record or an oral
hearing. A review of the record means a review of the documentary
evidence by a designated hearing officer. An oral hearing means an
informal conference before a designated hearing officer.
(3) ``Hearing officer'' is an individual appointed by the Secretary
to review and issue a final decision on an employee's dispute of a debt.
In the case of an employee debt subject to 5 U.S.C. 5514, the hearing
officer may not be an individual under the supervision of the Secretary;
will normally be an independent contractor of the Department or an
employee of another Federal agency, see 4 CFR 102.1 and 5 CFR 550.1107;
and may be an administrative law judge if appointment of an independent
contractor or an employee of another Federal agency is not feasible.
(4) ``Pay'' means basic pay, special pay, incentive pay, retired
pay, retainer pay, or, in case of an employee not entitled to basic pay,
other authorized pay.
(5) ``Disposable pay'' means the amount that remains from an
employee's Federal pay after withholding of all deductions listed in 5
CFR 581.105(b) and any other deductions required by law (including, but
not limited to, Federal, State, and local income taxes; Social Security
taxes, including Medicare taxes; and Federal retirement programs).
(c) Scope. This section satisfies the standards in 4 CFR 102.3 and
102.4 and 5 CFR Part 550, for offset under the common law, 31 U.S.C.
3716, 5 U.S.C. 5514 and any other statute under which standards and
procedures for offset have not otherwise been promulgated, including:
(1) Offset of debts owed or to amounts payable, under a grant or
contract; except that paragraphs (j)-(p) of this section do not apply.
See Sec. 30.4.
(2) Offset of debts owed by former employees from final salary and
lump sum payments; and from the Civil Service Retirement and Disability
Fund (which also requires compliance with 5 CFR Part 831, Subpart R);
(3) Offset of salary overpayments and other debts under statutes
such as 5 U.S.C. 5514 (or 31 U.S.C. 3716 in the case of commissioned
officers), travel advances under 5 U.S.C. 5705, training expenses under
5 U.S.C. 4108, debts of employees removed for cause under 5 U.S.C. 5511
and amounts owed by accountable officers under 5 U.S.C. 5512, from the
current pay of Federal employees, including employees of the Social
Security Administration and other offices administering a Social
Security Act program;
(4) Offset of debts owed by state or local governments;
(5) Offset of debts arising, or from amounts payable, under the
Social Security Act, except that unless specifically authorized by
statute, regulation, or written agreement, or unless the debts arise
from, or involve, fraud or criminal activity, administrative offset will
not be applied to recover debts arising from, or to withhold, payments
to beneficiaries under Titles II, XVI, and XVIII of the Social Security
Act with the exception of debts arising from section 1862(b) of the Act
for Medicare payments for which a beneficiary has been reimbursed by a
liable third party.
(d) Exceptions. (1) So long as the conditions listed in paragraphs
(a) (2)-(5) and (e) are met, offset may be effected
with the debtor's consent without regard to the other provisions in this
(2) This section does not apply to debts reduced to judgment, debts
already subject to a written repayment or settlement agreement, or debts
with respect to which the specified procedures have already been
otherwise afforded. Debts reduced to judgment may be offset from the
current pay of a Federal employee under Federal Personnel Manual
(3) This section does not apply to any adjustment to a Federal
employee's pay arising out of the employee's request for, or change in,
coverage under a Federal benefits program such as health or life
insurance, which requires periodic deductions from pay, if the amount to
be recovered was accumulated over four pay periods or less. Employees
consent to deductions from pay whenever they elect or change coverage.
Affected employees will receive a notice informing them of these
retroactive adjustments to pay and the office to contact if the employee
disputes the amount of the adjustment.
(e) Advance payments. Under many programs, the Department advances
funds to pay for a recipient's anticipated costs. Before offsetting such
an advance payment in order to collect a debt, the Secretary may request
an assurance that the recipient will incur additional allowable costs
whose Federal share is at least equal to the amount of the offset plus
the amount of funds actually advanced. If the Secretary believes that
the recipient will not incur sufficient costs, the advance will not be
offset. In such case, the Secretary may request cash payment or convert
the method of paying the recipient from an advance to a reimbursement
basis and collect the debt by offsetting payments for costs already
(f) Multiple debts. Amounts available for offset will be applied to
multiple debts in accordance with the best interests of the Department
and the Government as determined on a case-by-case basis. Other factors
being equal, recovery will be equally apportioned, except that debts
owed to the Department will be satisfied before debts owed to other
(g) Statutory bar to offset. (1) Administrative offset will not be
initiated more than 10 years after the Government's right to collect the
debt first accrued, unless facts material to the Government's right to
collect the debt were not known and could not reasonably have been known
by the officer responsible for discovering or collecting the debt. For
this purpose, a debt accrues when it is administratively determined to
exist, when it is affirmed by an administrative appeals board or a court
having jurisdiction, or when a debtor defaults on a repayment agreement,
whichever is later. Offset is initiated when the notice of the proposed
offset is mailed to the debtor under paragraph (i) of this section or
under other agency procedures, when money payable to the debtor is first
withheld, or when the Department requests offset from money held by
another agency, whichever is first.
(2) The 10 year statutory bar does not apply to offset of a debt
arising out of the Social Security Act. However, offset against such
debts will generally not be initiated more than 10 years after the debt
accrued unless the Secretary did not previously have the necessary
information or the means by which to collect the debt by administrative
(h) Offset against assigned claims. The Assignment of Claims Act of
1940, 31 U.S.C. 3727, 41 U.S.C. 15, strictly limits the conditions under
which a contractor or any other person or entity entitled to receive
payments from the United States may assign his or her rights to the
payments to a third party. The Federal Acquisition Regulations implement
at 48 CFR Part 32, Subpart 32.8, the statutory conditions to assignment
of a contractor's right to be paid by the United States for performance
under a Federal procurement contract. A contractor may assign his or her
right to payment by the United States only to a bank, trust company, or
other financing institution, as security for a loan to the contrator.
(1) The Secretary normally may not collect a debt owed by a
contractor by offset from payments due the contractor if the contractor
has properly assigned his or her rights to such payments to a financing
assigned payments are due under a contract with a ``no setoff''
(i) The contractor's debt to the United States arose independently
of the contract; or
(ii) The debt arose under the contract because of renegotiation,
fines, penalties (other than penalties for noncompliance with the terms
of the contract), taxes or social security contributions, or withholding
or nonwithholding of taxes or social security contributions.
Notwithstanding the satisfaction of all the conditions of this
paragraph, offset may be appropriate under certain circumstances, for
example: If the financing institution has made neither a loan nor a firm
commitment to make a loan under the assignment; or to the extent that
the amount due on the contract exceeds the amount of any loans made or
expected to be made under a firm commitment.
(2) The Secretary may not offset a debt from payments due any debtor
if the debtor has properly assigned his or her right to such payments
and the debt arose after the effective date of the assignment.
(3) The Secretary may not attempt to satisfy the assignor's
indebtedness by recovering payments already made to the assignee.
(i) Amount of offset. Whenever feasible debts will be offset in one
lump sum, except that deductions from an employee's current pay pursuant
to 5 U.S.C. 5514 may not exceed 15 percent of the employee's disposable
pay for any pay period, unless the employee agrees in writing to a
larger deduction. However, if the employee retires, resigns, or is
discharged, or if his or her employment or active duty otherwise ends,
an amount necessary to satisfy the debt may be offset immediately from
payments of any nature due the individual.
(j) Pre-offset requirements. Before effecting offset, the Secretary
will send the debtor written notice of the following--
(1) The nature and amount of the debt;
(2) The agency intention to collect the debt by offsetting the lump
sum or installments (stating the amount, frequency, proposed beginning
date and duration of the installments) unless the debtor pays the debt
or responds within 30 days from the date the notice was mailed to the
(3) The interest, administrative cost charges and penalties that
will or may be assessed under Secs. 30.13 and 30.14 if the debt is not
paid, or the debtor has not consented to a lump sum offset, within 30
days from the date the notice was mailed to the debtor;
(4) The debtor's right, if a previous opportunity was not provided,
to request within 15 days (unless otherwise provided by statute or
regulation) from the date of mailing of the notice--
(i) Copies of agency records pertaining to the debt;
(ii) An alternative repayment schedule; or
(iii) A hearing if the debtor contends no debt is owed, the debt is
for a different amount, or the proposed offset does not comply with this
(5) The debtor's right, if any, to request waiver of the debt,
interest or changes, citing the applicable statutory authority, request
procedures and waiver conditions and the effect of the waiver request on
collection of the debt, interest and charges by offset;
(6) The office, address and telephone number of whom the debtor
should address any inquiries or requests;
(7) The requirement that the hearing officer issue a decision at the
earliest practical date; except that under 5 U.S.C. 5514, the decision
may be issued no later than 60 days after the request for the hearing
was filed unless the employee requested and was granted an extension;
(8) That any knowingly false or frivolous statements,
representations or evidence may subject the debtor to criminal or civil
penalties under 18 U.S.C. 286, 287, 1001 and 1002 or 31 U.S.C. 3729-
3731; or also disciplinary action under 5 CFR Part 752 or any other
applicable authority if the debtor is an employee;
(9) Any other rights and remedies available to the debtor under the
statutes or regulations governing the program under which the debt is
being collected; and
(10) That, unless otherwise provided by statute or contract, amounts
collected and later waived or found not owed will be promptly refunded.
(k) Alternative repayment proposal. A debtor may propose a different
offset schedule or repayment by cash installments pursuant to
(l) Request for hearing. A debtor may submit to the address
specified in the notice letter a written request for a hearing to
dispute the administrative determination of the existence or amount of
the debt, or whether the proposed offset schedule complies with this
section, before the initiation of collection by offset. The request must
be postmarked no later than 15 days (unless otherwise provided by
statute or regulation) from the date the notice was mailed to the
debtor. The debtor must sign the request and briefly state each agency
conclusion being disputed and the reasons for the dispute. Supporting
facts, witnesses, and documents must be identified in the request. The
request, with supporting documents, must, on its face, sufficiently
raise a genuine issue of fact or law. Receipt of the request will be
acknowledged. The Secretary may grant an extension or excuse a delay if
the debtor shows good cause for late filing of a request for a hearing.
A reasonable extension will be granted only if the debtor shows that the
delay was caused by circumstances beyond the debtor's control or because
the debtor did not receive notice, and was not otherwise aware of the
time limit. A debtor who fails to meet the filing deadline or to request
an extension waives the right to a hearing and will be immediately
subject to offset.
(m) Denial of request. The Secretary will summarily deny a request
for an oral hearing pursuant to a written finding that the request
raises no genuine issue of fact or law, or is otherwise spurious or
frivolous. In addition, if the Secretary finds that the request raises
issues which may properly constitute grounds for waiver of the debt
under 5 U.S.C. 5584 or any other statute, the request will be deemed to
be a request for a waiver and will be so handled with notification to
(n) Hearings--(1) Type of hearing. The hearing will normally be a
review of the record, unless the hearing officer determines that a
decision cannot be made without resolving an issue of credibility or
veracity, in which case the hearing officer will provide for an oral
(2) Date and place of oral hearing. The oral hearing will normally
be held no later than 30 days from the date of receipt by the agency of
the request for a hearing. The hearing officer will give the debtor and
the Secretary at least 10 days prior notice of the hearing date, time,
place, procedures and issues. The hearing officer, for good cause, may
grant the parties each one request to change the hearing date and
reschedule the hearing for the earliest practical date. To the extent
feasible the hearing will be held at a location convenient to the
debtor, and will be open to the public.
(3) Oral hearing procedures. The hearing officer will:
(i) Make a summary record of the hearing;
(ii) Decide the order of hearing the evidence;
(iii) Allow the debtor and the agency to introduce relevant evidence
not previously submitted and informally call and cross examine
(iv) Question parties and witnesses as appropriate;
(v) Allow the debtor and the agency to be represented by counsel;
(vi) Limit review of the case to the particulars of the agency
determination challenged by the debtor.
(o) Decision of hearing officer. The hearing officer will issue a
written decision at the earliest practical date; but not later than 60
days after a request for a hearing or extension is filed under 5 U.S.C.
5514. The decision will, at a minimum, state the relevant facts, include
the hearing officer's analysis, findings and conclusions based on the
issues and, if unfavorable to the debtor, inform the debtor of any
available rights or remedies.
(p) Employee waiver requests. Requests for waiver of overpayments of
pay under 5 U.S.C. 5584 will continue to be handled under 4 CFR parts
91-93 and Chapter 4-40 of the HHS General Administration Manual, except
that a waiver request made simultaneously
with, or during the pendency of a request for review under this section
may be referred for a decision under the waiver standards to the hearing
officer reviewing the debt under this section.
(q) Deductions. Unless an alternative repayment arrangement has been
accepted, the Secretary may initiate offset 30 days after the date that
notice of the proposed action was mailed to the debtor if no review or
hearing is pending, or as soon as practical after a hearing officer's
decision affirming the debt.
(r) Protection of the Government's interest. Notwithstanding the
provisions of paragraphs (j) through (q) of this section, the Secretary
may take immediate action to delay a lump sum or final payment to the
debtor whenever such action is necessary to protect the Government's
ability to recover the debt by offset. The amount withheld may not
exceed the amount of the debt plus any accrued or anticipated interest,
administrative cost charges and penalties. The Secretary shall promptly
send the debtor the notice specified in paragraph (j) of this section.
The Secretary may not take final action to effect offset of the debt
from the withheld amount until the procedures required by paragraphs (j)
through (l) of this section have been exhausted. The appropriate amount
will be paid to the debtor as soon as practical after the debt, or a
portion of the debt, is found not to be owed.
(s) Interagency offsets. The Secretary may offset a debt owed to
another Federal agency from amounts due or payable by the Department to
the debtor; or request another Federal agency to offset a debt owed to
the Department. Pursuant to 31 U.S.C. 3720a, Department of the Treasury
regulations, 26 CFR part 301, and HHS' implementing regulations, 45 CFR
part 31, the Secretary may seek to offset an overdue debt from a Federal
income tax refund due the debtor where reasonable attempts to obtain
payment from the debtor have failed.
(1) In attempting to collect a debt from an employee of another
Federal agency by deduction from the debtor's pay, the Secretary will
follow the procedures set forth in this section. When those procedures
are exhausted, a written request for offset will be submitted to the
employing agency. The request will--
(i) Certify that the debt is valid;
(ii) Certify the amount and basis of the debt;
(iii) Certify the date the Government's right to collect the debt
(iv) Certify that this section has been approved by OPM;
(A) Certify that the procedures required by this section have been
(B) Include the employee's written consent to the offset or
acknowledgment of receipt of the required procedures; or
(C) If the debt is reduced to judgment, include a copy of the court
(vi) Indicate whether collection is to be made in a lump sum or by
installments and the number, amount and beginning date of the
(2)(i) The Secretary may deduct from an employee's pay a debt owed
to another Federal agency in accordance with this section. The creditor
agency must submit the properly certified claim form described in
paragraph (s)(1) of this section. No deductions will be made until a
properly completed claim form is received.
(ii) Before initiating deductions, the Secretary must send the
employee a letter:
(A) Transmitting a copy of the creditor agency's request;
(B) Notifying the employee of the proposed action;
(C) Instructing the employee to contact the creditor agency
regarding payment or any dispute of the debt, the certification or the
proposed collection; and
(D) Informing the employee of the date that deduction will begin
(which should be at the next officially established pay interval) and
that deductions will continue until the debt is paid unless the creditor
agency directs otherwise.
(iii) The creditor agency must resolve any disputes concerning the
debt or the offset and promptly inform the Department of any
circumstances affecting the collection by offset. The
Department may not review the merits of the creditor agency's decisions.
(iv) The Secretary may temporarily withhold lump sum or final leave
payments to the employee who is in the process of separating or to a
former employee for no more than 30 days beyond normal processing time
periods pending certification.
(v) If the employee subject to salary offset is in the process of
separating, and is entitled to payment from the Civil Service Retirement
and Disability Fund, the Secretary will send OPM a copy of the creditor
agency's original offset request. If the employee transfers to another
Federal agency, the Secretary will certify in writing the total amount
collected on the debt and send one copy of the certification to the
employee and another to the creditor agency, with notice of the
transfer. A copy of the certification, along with the creditor agency's
original offset request will be inserted in the employee's official
(vi) When a new Department employee transfers from another Federal
agency and the employee's official personnel folder contains a creditor
agency's offset request to the former employing agency and the former
employing agency's certification of the amount of the debt already
collected, the Secretary will resume collection by offset. If either
item is missing, the creditor agency must comply with paragraph (s)(1).
(t) Non-waiver of debtor rights by payment. Unless a statute or
contract provides otherwise, a debtor does not waive any rights under
law or contract by paying all or part of a debt by offset or cash
(Approved by the Office of Management and Budget under control number