Federal Policy for the Protection of Human Subjects, 36325-36328 [05-12394]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS
• DEPARTMENT OF TRANSPORTATION
• NATIONAL SCIENCE FOUNDATION
• National Aeronautics and Space Administration
• Department of Justice
• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• ENVIRONMENTAL PROTECTION AGENCY
• DEPARTMENT OF ENERGY
• DEPARTMENT OF EDUCATION
• DEPARTMENT OF DEFENSE
• Consumer Product Safety Commission
• DEPARTMENT OF COMMERCE
• DEPARTMENT OF AGRICULTURE
• Agency for International Development

[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Rules and Regulations]
[Pages 36325-36328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12394]



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Rules and Regulations
                                                Federal Register
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Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Rules 
and Regulations

[[Page 36325]]



DEPARTMENT OF AGRICULTURE

7 CFR Part 1c

DEPARTMENT OF ENERGY

10 CFR Part 745

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

14 CFR Part 1230

DEPARTMENT OF COMMERCE

15 CFR Part 27

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1028

AGENCY FOR INTERNATIONAL DEVELOPMENT

22 CFR Part 225

DEPARTMENT OF JUSTICE

28 CFR Part 46

DEPARTMENT OF DEFENSE

32 CFR Part 219

DEPARTMENT OF EDUCATION

34 CFR Part 97

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 16

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

NATIONAL SCIENCE FOUNDATION

45 CFR Part 690

DEPARTMENT OF TRANSPORTATION

49 CFR Part 11


Federal Policy for the Protection of Human Subjects

AGENCIES: Department of Agriculture; Department of Energy; National 
Aeronautics and Space Administration; Department of Commerce; Consumer 
Product Safety Commission; Agency for International Development; 
Department of Justice; Department of Defense; Department of Education; 
Department of Veterans Affairs; Environmental Protection Agency; 
Department of Health and Human Services; National Science Foundation; 
and Department of Transportation.

ACTION: Final rule; technical amendments.

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

SUMMARY: The agencies listed in this document are amending the Federal 
Policy for the Protection of Human Subjects, which was published in the 
Federal Register on June 18, 1991, to change all references to the 
Office for Protection from Research Risks (OPRR) to the Office for 
Human Research Protections (OHRP); revise the footnote found at the end 
of Sec.  --.101(i) by deleting references to research involving 
fetuses, pregnant women, or human in vitro fertilization and subpart B 
of 45 CFR part 46; and update the Control Number for the approval by 
the Office of Management and Budget (OMB) of the information collection 
requirements of this Federal Policy.

DATES: Effective Date: June 23, 2005.

FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., OHRP, The 
Tower Building, Suite 200, 1101 Wootton Parkway, Rockville, MD 20852; 
telephone: 301-496-7005; facsimile: 301-402-2071; e-mail: 
mcarome@osophs.dhhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Policy for the Protection of Human Subjects (hereafter 
referred to as the Federal Policy) was promulgated by 15 Federal 
departments and agencies on June 18, 1991 (56 FR 28003). The Central 
Intelligence Agency also is required to comply with this policy under 
Executive Order 12333. On July 10, 1996, the Department of Housing and 
Urban Development revised its codification of the Federal Policy at 24 
CFR part 60 to cross-reference the provisions of the Department of 
Health and Human Services (HHS) regulations at 45 CFR part 46, subpart 
A (61 FR 36462).
    Except for research that is exempt under Sec.  ----.101(b), the 
Federal Policy applies to all research involving human subjects 
conducted, supported or otherwise subject to regulation by any Federal 
department or agency which has taken appropriate administrative action 
to make the Federal Policy applicable to such research. The basic 
provisions of the Federal Policy include, among other things, 
requirements related to the review of human subjects research by an 
institutional review board, the obtaining and documenting of informed 
consent of human subjects, and the submission of a written assurance of 
institutional compliance with the Federal Policy.

II. Description of Changes to the Federal Policy

    The Federal Policy has several provisions that reference OPRR. For 
example, the Federal Policy includes provisions that require submission 
of certain reports and notices to OPRR (see Sec.  ----.101(i), Sec.  --
--.103(a), and Sec.  ----.103(b)(3)). At the time the Federal Policy 
was promulgated, OPRR was a unit of the National Institutes of Health, 
HHS, and was responsible for fulfilling responsibilities set forth in 
section 491 of the Public Health Service Act (42 U.S.C. 289). On June 
18, 2000, OPRR was dissolved, OHRP was established, and all 
responsibilities and authorities for human subject protections held by 
OPRR were transferred to OHRP (65 FR 37136, June 13, 2000). The Federal 
Policy is being amended throughout to reflect this name and 
organizational change from OPRR to OHRP.
    At the time the Federal Policy was promulgated, the HHS regulations 
for the protection of human subjects at 45 CFR part 46 included the 
following

[[Page 36326]]

three subparts that provided additional protections for specific groups 
of vulnerable subjects: subpart B (Additional Protections Pertaining to 
Research, Development, and Related Activities Involving Fetuses, 
Pregnant Women, and Human In Vitro Fertilization); subpart C 
(Additional Protections Pertaining to Biomedical and Behavioral 
Research Involving Prisoners as Subjects); and subpart D (Additional 
Protections for Children Involved as Subjects in Research). These 
subparts are not part of the Federal Policy. However, the Federal 
Policy includes a footnote at the end of Sec.  ----.101(i) which 
states, in part, that ``the exemptions at 45 CFR 46.101(b) do not apply 
to research involving * * * fetuses, pregnant women, or human in vitro 
fertilization, subparts B * * *.''
    On November 13, 2001, HHS published a revised version of 45 CFR 
part 46, subpart B (Additional Protections for Pregnant Women, Human 
Fetuses and Neonates Involved in Research) after soliciting public 
comment through a Notice of Proposed Rulemaking (66 FR 56775; 66 FR 
35576). The revised subpart B, which became effective on December 13, 
2001, states that the exemptions at 45 CFR 46.101(b)(1) through (6) are 
applicable to this subpart. In order to make the footnote at the end of 
Sec.  ----.101(i) of the Federal Policy consistent with the revised 
subpart B of 45 CFR part 46, references to research involving fetuses, 
pregnant women, or human in vitro fertilization and subpart B are being 
deleted from the footnote.
    Finally, the information collection requirements of the Federal 
Policy (see Sec. Sec.  ----.103, 109, 113, 115, 116, and 117) were 
approved by OMB on July 30, 1991 under Control Number 9999-0020. OMB 
approval under Control Number 9999-0020 expired on December 31, 1997. 
The current OMB approval of the information collection requirements of 
the Federal Policy is under Control Number 0990-0260. Therefore, all 
references to Control Number 9999-0020 are being changed to Control 
Number 0990-0260.

III. Implementation

    Pursuant to 5 U.S.C. 553(b)(B) of the Administrative Procedure Act, 
5 U.S.C. 551-559, the agencies find that there is good cause to issue 
these amendments without advance notice and an opportunity for public 
comment. Because these amendments merely (i) change references in the 
Federal Policy from the OPRR to the OHRP, to reflect the organizational 
change that already dissolved OPRR and moved its responsibilities to 
OHRP; (ii) delete references to research involving fetuses, pregnant 
women, or human in vitro fertilization and to subpart B of 45 CFR part 
46 to conform the Federal Policy to recent amendments to subpart B of 
45 CFR part 46; and (iii) update the Control Number for the approval by 
OMB of the information collection requirements of the Federal Policy, 
public comment is unnecessary. Pursuant to 5 U.S.C. 553(d)(3) of the 
Administrative Procedure Act, the agencies also find there is good 
cause to make these amendments effective immediately because the 
changes in the Federal Policy are merely conforming amendments to 
reflect changes that have already been made and are in effect with 
respect to OHRP and 45 CFR part 46.

IV. Legal Authority

    Department of Agriculture, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). 
Department of Energy, 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-
1(b). National Aeronautics and Space Administration, 5 U.S.C. 301; 42 
U.S.C. 300v-1(b). Department of Commerce, 5 U.S.C. 301; 42 U.S.C. 300v-
1(b). Consumer Product Safety Commission, 5 U.S.C. 301; 42 U.S.C. 300v-
1(b). Agency for International Development, 5 U.S.C. 301; 42 U.S.C. 
300v-1(b). Department of Justice, 5 U.S.C. 301; 28 U.S.C. 509-510; 42 
U.S.C. 300v-1(b). Department of Defense, 5 U.S.C. 301; 42 U.S.C. 300v-
1(b). Department of Education, 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 
42 U.S.C. 300v-1(b). Department of Veterans Affairs, 5 U.S.C. 301; 38 
U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b). Environmental Protection 
Agency, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Health and 
Human Services, 5 U.S.C. 301; 42 U.S.C. 289; 42 U.S.C. 300v-1(b). 
National Science Foundation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). 
Department of Transportation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

V. Executive Order 12866

    Executive Order 12866 requires that all regulatory actions of 
Executive Branch departments and agencies reflect consideration of the 
costs and benefits that they generate and that they meet certain 
standards, such as avoiding imposition of unnecessary burdens on the 
affected public. If an action is deemed to fall within the scope of the 
definition of the term ``significant regulatory action'' contained in 
Sec. 3(f) of the order, a pre-publication review by OMB's Office of 
Information and Regulatory Affairs (OIRA) is necessary. OMB deemed 
these amendments of the Federal Policy not to be a significant 
regulatory action. Therefore, these amendments were not submitted to 
OIRA for review prior to publication.

VI. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), an agency 
is generally required to review proposed regulations to analyze whether 
they create a significant impact on a substantial number of small 
entities unless the agency can certify that there is no such impact. 
Agencies must similarly analyze any final rules that were preceded by 
proposed rules. Because these technical amendments did not require the 
agencies to publish a proposed rule, they are not required to prepare a 
Regulatory Flexibility Act analysis for this final rule. However, even 
if the agencies were required to consider that impact, the agencies 
would certify that there was no impact at all on small entities because 
these amendments make no substantive change to the Federal Policy.

VII. Paperwork Reduction Act of 1995

    These amendments to the Federal Policy do not contain any new 
information collection requirements which are subject to OMB approval 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

VIII. Federalism

    These amendments to the Federal Policy have been analyzed in 
accordance with the principles set forth in Executive Order 13132. 
These amendments to the Federal Policy do not contain policies that 
have substantial direct effects on the States, on the relationship 
between the Federal Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the departments and agencies that have promulgated the 
Federal Policy have concluded that these amendments do not contain 
policies that have federalism implications as defined in the order and, 
consequently, a federalism summary impact statement is not required.

Department of Agriculture

7 CFR Part 1c

RIN 0518-AA02

List of Subjects in 7 CFR Part 1c

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of 
Agriculture amends 7 CFR part 1c, as set forth at the end of this 
document.

[[Page 36327]]

    The authority for part 1c continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: August 18, 2004.
Ann M. Veneman,
Secretary of Agriculture.

Department of Energy

10 CFR Part 745

RIN 1901-AB14

List of Subjects in 10 CFR Part 745

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of Energy 
amends 10 CFR part 745, as set forth at the end of this document.
    The authority for part 745 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b).

    Dated: April 5, 2005.
Samuel W. Bodman,
Secretary of Energy.

National Aeronautics and Space Administration

14 CFR Part 1230

RIN 2700-AC99

List of Subjects in 14 CFR Part 1230

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the National Aeronautics 
and Space Administration amends 14 CFR part 1230, as set forth at the 
end of this document.
    The authority for part 1230 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: February 18, 2005.
Richard S. Williams,
Chief Health and Medical Officer, Office of Health and Medical Systems.

Department of Commerce

15 CFR Part 27

RIN 0605-AA17

List of Subjects in 15 CFR Part 27

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of Commerce 
amends 15 CFR part 27, as set forth at the end of this document.
    The authority for part 27 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: February 18, 2005.
Michael S. Sade,
Director, Office of Acquisition Management.

Consumer Product Safety Commission

16 CFR Part 1028

RIN 3041-AC21

List of Subjects in 16 CFR Part 1028

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Consumer Product Safety 
Commission amends 16 CFR part 1028, as set forth at the end of this 
document.
    The authority for part 1028 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: July 22, 2004.
Harold D. Stratton,
Chairman.

Agency for International Development

22 CFR Part 225

RIN 0412-AA53

List of Subjects in 22 CFR Part 225

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Agency for 
International Development amends 22 CFR part 225, as set forth at the 
end of this document.
    The authority for part 225 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: June 10, 2004.
James D. Shelton,
Cognizant Human Subjects Officer.

Department of Justice

28 CFR Part 46

RIN 1121-AA70

List of Subjects in 28 CFR Part 46

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of Justice 
amends 28 CFR part 46, as set forth at the end of this document.
    The authority for part 46 continues to read as follows:

    Authority: 5 U.S.C. 301; 28 U.S.C. 509-510; 42 U.S.C. 300v-1(b).

    Dated: March 14, 2005.
Alberto R. Gonzales,
Attorney General.

Department of Defense

32 CFR Part 219

RIN 0790-AH79

List of Subjects in 32 CFR Part 219

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of Defense 
amends 32 CFR part 219, as set forth at the end of this document.
    The authority for part 219 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: August 4, 2004.
Ronald M. Sega,
Director, Defense Research and Engineering.

Department of Education

34 CFR Part 97

RIN 1890-AA08

List of Subjects in 34 CFR Part 97

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of Education 
amends 34 CFR part 97, as set forth at the end of this document.
    The authority for part 97 continues to read as follows:

    Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 
300v-1(b).

    Dated: June 30, 2004.
Rod Paige,
Secretary of Education.

Department of Veterans Affairs

38 CFR Part 16

RIN 2900-AL99

List of Subjects in 38 CFR Part 16

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of Veterans 
Affairs amends 38 CFR part 16, as set forth at the end of this 
document.
    The authority for part 16 continues to read as follows:

    Authority: 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 
300v-1(b).


[[Page 36328]]


    Dated: August 27, 2004.
Anthony J. Principi,
Secretary of Veterans Affairs.

Environmental Protection Agency

40 CFR Part 26

RIN 2080-AA10

List of Subjects in 40 CFR Part 26

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Environmental 
Protection Agency amends 40 CFR part 26, as set forth at the end of 
this document.
    The authority for part 26 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: May 16, 2005.
Stephen L. Johnson,
Acting Administrator.

Department of Health and Human Services

45 CFR Part 46

RIN 0940-AA10

List of Subjects in 45 CFR Part 46

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of Health 
and Human Services amends 45 CFR part 46, as set forth at the end of 
this document.
    The authority for part 46 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 289; 42 U.S.C. 300v-1(b).

    Dated: June 15, 2005.
Ann Agnew,
Executive Secretary to the Department.

National Science Foundation

45 CFR Part 690

RIN 3145-AA42

List of Subjects in 45 CFR Part 690

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the National Science 
Foundation amends 45 CFR part 690, as set forth at the end of this 
document.
    The authority for part 690 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: June 30, 2004.
Lawrence Rudolph,
General Counsel.

Department of Transportation

49 CFR Part 11

RIN 2105-XX97

List of Subjects in 49 CFR Part 11

    Human research subjects, Reporting and recordkeeping requirements, 
Research.
    For the reasons stated in the preamble, the Department of 
Transportation amends 49 CFR part 11, as set forth at the end of this 
document.
    The authority for part 11 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

    Dated: September 18, 2004.
Norman Y. Mineta,
Secretary of Transportation.

    Editorial Note: This document was received at the Office of the 
Federal Register on June 17, 2005.

0
Accordingly, the Federal Policy for the Protection of Human Subjects is 
amended as follows:


Sec.  ----.101  [Amended]

0
1. Amend Sec.  ----.101 as follows:
0
a. In paragraph (i), remove the words ``Office for Protection from 
Research Risks, Department of Health and Human Services (HHS),''and 
add, in their place, ``Office for Human Research Protections, 
Department of Health and Human Services (HHS), or any successor 
office,''.
0
b. In footnote 1 at the end of paragraph (i), remove the words 
``prisoners, fetuses, pregnant women, or human in vitro fertilization, 
subparts B and C.'' and add, in their place, ``prisoners, subpart C.''.


Sec.  ----.103  [Amended]

0
2. Amend Sec.  ----.103 as follows:

0
a. In paragraph (a), in the second and last sentences, remove the 
words, ``Office for Protection from Research Risks, HHS'' and add, in 
their place, ``Office for Human Research Protections, HHS, or any 
successor office''.
0
b. In paragraph (b)(3), remove the words ``Office for Protection from 
Research Risks, HHS'' and add, in their place, ``Office for Human 
Research Protections, HHS, or any successor office''.
0
c. Revise the parenthetical at the end of the section to read as 
follows:


Sec.  ----.103  Assuring compliance with this policy--research 
conducted or supported by any Federal Department or Agency.

* * * * *
    (Approved by the Office of Management and Budget under Control 
Number 0990-0260.)

0
3. Revise the parenthetical at the end of Sec.  ----.109 to read as 
follows:
    Sec.  ----.109 IRB review of research.
* * * * *
    (Approved by the Office of Management and Budget under Control 
Number 0990-0260.)


Sec.  ----.110  [Amended]

0
4. In paragraph (a), remove the words ``Office for Protection from 
Research Risks, National Institutes of Health, HHS, Bethesda, Maryland 
20892.'' and add, in their place, ``Office for Human Research 
Protections, HHS, or any successor office.''.

0
5. Revise the parenthetical at the end of Sec.  ----.113 to read as 
follows:


Sec.  ----.113  Suspension or termination of IRB approval of research.

* * * * *
    (Approved by the Office of Management and Budget under Control 
Number 0990-0260.)

0
6. Revise the parenthetical at the end of Sec.  ----.115 to read as 
follows:


Sec.  ----.115  IRB records.

* * * * *
    (Approved by the Office of Management and Budget under Control 
Number 0990-0260.)

0
7. Revise the parenthetical at the end of Sec.  ----.116 to read as 
follows:


Sec.  ----.116  General requirements for informed consent.

* * * * *
    (Approved by the Office of Management and Budget under Control 
Number 0990-0260.)

0
8. Revise the parenthetical at the end of Sec.  ----.117 to read as 
follows:


Sec.  ----.117  Documentation of informed consent.

* * * * *
    (Approved by the Office of Management and Budget under Control 
Number 0990-0260.)
[FR Doc. 05-12394 Filed 6-22-05; 8:45 am]
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