80 FR 59092 - Federal Policy for the Protection of Human Subjects

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

Federal Register Volume 80, Issue 190 (October 1, 2015)

Page Range		59092-59094
FR Document		2015-24831

On September 8, 2015, 16 Federal departments and agencies published a proposed rule pertaining to Federal Policy for the Protection of Human Subjects. Due to certain statutory prepublication requirements applicable to HUD rules, HUD was unable to be a signatory to the September 8, 2015, proposed rule. Through this HUD proposed rule, HUD adopts the September 8, 2015, proposal and solicits public comment on the proposal.

Federal Register, Volume 80 Issue 190 (Thursday, October 1, 2015)

[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Proposed Rules]
[Pages 59092-59094]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24831]


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DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

24 CFR Part 60

[Docket No FR-5888-P-01]


Federal Policy for the Protection of Human Subjects

AGENCY: Office of the Assistant Secretary for Policy, Development and 
Research, HUD.

ACTION: Proposed rule.

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SUMMARY: On September 8, 2015, 16 Federal departments and agencies 
published a proposed rule pertaining to Federal Policy for the 
Protection of Human Subjects. Due to certain statutory prepublication 
requirements applicable to HUD rules, HUD was unable to be a signatory 
to the September 8, 2015, proposed rule. Through this HUD proposed 
rule, HUD adopts the September 8, 2015, proposal and solicits public 
comment on the proposal.

DATES: Comment Due Date: No later than 5:00 p.m. on December 7, 2015.

ADDRESSES: You may submit comments, identified by docket ID number HHS-
OPHS-2015-0008, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Enter the above

[[Page 59093]]

docket ID number in the ``Enter Keyword or ID'' field and click on 
``Search.'' On the next Web page, click on ``Submit a Comment'' action 
and follow the instructions.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852.
    Comments received, including any personal information, will be 
posted without change to www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Barry L. Steffen, Policy Development 
Division, Office of Policy Development and Research, Department of 
Housing and Urban Development, 451 7th Street SW., Room 8114, 
Washington, DC 20410-8000, telephone 202-402-5926. (This is not a toll-
free number.) Persons with hearing- or speech-impairments may access 
this number through TTY number by calling the Federal Relay Service 
number at 800-877-8339 (this a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal departments and agencies that were signatories to the 
proposed Common Rule, published on September 6, 2015, at 80 FR 53933, 
and HUD (collectively the ``Federal Agencies''), through this proposed 
rule are proposing revisions to modernize, strengthen, and make more 
effective the Federal Policy for the Protection of Human Subjects that 
was promulgated as a Common Rule in 1991. The Federal Agencies seek 
comment on proposals to better protect human subjects involved in 
research, while facilitating valuable research and reducing burden, 
delay, and ambiguity for investigators. The September 8, 2015, proposal 
is an effort to modernize, simplify, and enhance the current system of 
oversight. The Federal Agencies propose these revisions to the 
regulations governing the protection of human subjects because they 
believe these changes would strengthen protections for research 
subjects while facilitating important research.
    Federal regulations governing the protection of human subjects 
recognize that individuals who are the subjects of research may be 
asked to contribute their time and assume risk to advance the research 
enterprise, which benefits society at large. Federal regulations 
governing the protection of human subjects in research have been in 
existence for more than three decades. The Department of Health, 
Education, and Welfare (HEW) first published regulations for the 
protection of human subjects in 1974, and the Department of Health and 
Human Services (HHS) revised them in the early 1980s. During the 1980s, 
HHS began a process that eventually led to the adoption of a revised 
version of the regulations by 15 U.S. Federal departments and agencies 
in 1991. The purpose of this effort was to promote uniformity, 
understanding, and compliance with human subject protections as well as 
to create a uniform body of regulations across Federal departments and 
agencies (subpart A of 45 CFR part 46), often referred to as the 
``Common Rule for the Protection of Human Subjects'' or more succinctly 
the ``Common Rule.''
    Since the Common Rule was promulgated, the volume and landscape of 
research involving human subjects has changed considerably. Research 
with human subjects has grown in scale and become more diverse. 
Examples of developments include: An expansion in the number and type 
of clinical trials, as well as observational studies and cohort 
studies; a diversification of the types of social and behavioral 
research being used in human subjects research; increased use of 
sophisticated analytic techniques for use with human biospecimens; and 
the growing use of electronic health data and other digital records to 
enable very large data sets to be analyzed and combined in novel ways. 
Yet these developments have not been accompanied by major change in the 
oversight system of research involving human subjects, which has 
remained largely unchanged over the last two decades.
    The goals of the September 8, 2015, proposed rule are to address 
overdue changes to the Common Rule; specifically to increase human 
subjects' ability and opportunity to make informed decisions; reduce 
potential for harm and increase justice by increasing the uniformity of 
human subject protections in areas such as information disclosure risk, 
coverage of clinical trials; and facilitate current and evolving types 
of research that offer promising approaches to treating and preventing 
medical and societal problems through reduced ambiguity in 
interpretation of the regulations, increased efficiencies in the 
performance of the review system, and reduced burdens on researchers 
that do not appear to provide commensurate protections to human 
subjects. It is hoped that these changes will also build public trust 
in the research system.
    The full description of the Federal Agencies' proposal is set out 
in the September 8, 2015 rule. By cross-reference to the September 8, 
2015, proposed rule, HUD advises of its adoption of this proposal and 
solicits comment from HUD program participants and the general public 
on the September 8, 2015, proposed Common Rule. HUD's regulation on the 
Protection of Human Subjects is found in 24 CFR part 60. HUD's 
regulation on this subject cross-references to the HHS regulations in 
45 CFR part 46. HUD's regulation at Sec.  60.101, entitled ``Cross-
reference,'' reads as follows: ``The provisions set forth at 45 CFR 
part 46, subpart A, concerning the protection of human research 
subjects, apply to all research conducted, supported, or otherwise 
subject to regulation by HUD.''

II. HUD's Proposed Regulatory Text--No Change Proposed

    HUD's current regulations on the protection of human subjects are, 
by cross-reference, the regulations on the protection of human subjects 
promulgated by HHS, and this proposed rule would apply that approach to 
the September 8, 2015, proposed Common Rule published by 16 U.S. 
Federal departments and agencies.

III. Findings and Certifications

Environmental Impact

    This rule does not direct, provide for assistance or loan and 
mortgage insurance for, or otherwise govern or regulate, real property 
acquisition, disposition, leasing, rehabilitation, alteration, 
demolition or new construction, or establish, revise, or provide for 
standards for construction or construction materials, manufactured 
housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this rule 
is categorically excluded from environmental review under the National 
Environmental Policy Act (42 U.S.C. 4321).

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 
1531-1538) (UMRA) establishes requirements for federal agencies to 
assess the effects of their regulatory actions on state, local, and 
tribal governments and the private sector. This proposed rule does not 
impose any federal mandates on any state, local, or tribal governments 
or the private sector within the meaning of UMRA.

Executive Order 13132, Federalism

    Executive Order 13132 (entitled ``Federalism'') prohibits an agency 
from publishing any rule that has federalism implications if the rule 
either (1) imposes substantial, direct compliance costs on state and 
local governments, and is not required by statute, or (2) preempts 
state law, unless the agency

[[Page 59094]]

meets the consultation and funding requirements of section 6 of the 
Executive Order. This rule would not have federalism implications and 
would not impose substantial direct compliance costs on state and local 
governments or preempt state law within the meaning of the Executive 
Order.

List of Subjects for 24 CFR Part 60

    Human research subjects, Reporting and recordkeeping requirements.

    Dated: September 9, 2015.
Katherine M. O'Regan,
Assistant Secretary for Policy Development and Research.
[FR Doc. 2015-24831 Filed 9-30-15; 8:45 am]
BILLING CODE 4210-67-P

59092 Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Proposed Rules

required for both subsidiaries and both Additional Request for Comment on 58. Are there ways that we could
will include Subsidiary B’s assets, Rule 3–16 and Related Requirements further facilitate the use of information
liabilities, operations, and cash flows. 54. Should smaller reporting by all types of investors? If so, please
The test used in applying Rule 3–16 companies and emerging growth explain. For example, should we
employs a bright-line percentage companies continue to be subject to the consider alternative ways of presenting
threshold that a registrant must apply to same requirements or should the information, such as specifically
a limited set of measures similar to requirements for those registrants be allowing or requiring registrants to
Rules 3–05 and 3–09. Unlike those scaled? If they should be scaled, in what provide a summary along with more
rules, the market value of an affiliate’s way? If not, why? detailed required information to enable
securities may not be readily available investors to review the information at
VI. Other Requirements the level of detail that they prefer?
in the absence of a public market for
those securities. In addition to the issues raised in this VII. Closing
request for comment, we encourage all
Request for Comment interested persons to submit their views This request for comment is not
on any issues relating to the financial intended in any way to limit the scope
46. Do the Rule 3–16 requirements of comments, views, issues or
information about entities, or portions
influence the structure of collateral approaches to be considered. In
of entities, other than a registrant. For
arrangements? If so, how and what are addition to investors and registrants, the
example, Rule 3–14, Special
the consequences, if any, to investors Instructions for Real Estate Operations Commission welcomes comment from
and registrants? to be Acquired,88 while separate and other market participants and
47. How do investors use Rule 3–16 distinct from Rule 3–05, is intended to particularly welcomes statistical,
Financial Statements and the Rule achieve similar objectives within a empirical, and other data from
4–08(b) footnote disclosures? Are there particular industry. In addition, Item commenters that may support their
challenges that investors face in using 2.01 of Form 8–K uses significance tests views and/or support or refute the views
the disclosures? to determine when to provide disclosure or issues raised.
48. Are there changes to these about asset acquisitions. The By the Commission.
requirements we should consider to requirements addressed in this request Dated: September 25, 2015.
further facilitate the disclosure of useful for comment may apply more broadly Robert W. Errett,
information to investors? For example, than the situations described. To the Deputy Secretary.
is there different or additional extent there may be additional effects, [FR Doc. 2015–24875 Filed 9–30–15; 8:45 am]
information that investors need about please provide comments. BILLING CODE 8011–01–P
affiliates whose securities collateralize Request for Comment
registered securities? If so, what
55. As we continue our ongoing
information is needed and are there DEPARTMENT OF HOUSING AND
efforts to review disclosure rules, what
challenges that registrants would face in URBAN DEVELOPMENT
other rules and forms should be
preparing and providing it?
considered for review and why? 24 CFR Part 60
49. Are there challenges that 56. Currently, financial disclosures
registrants face in preparing and related to entities other than a registrant [Docket No FR–5888–P–01]
providing the required disclosures? If are filed in XBRL format to the extent
so, what are the challenges? Are there that they are part of the registrant’s Federal Policy for the Protection of
changes to these requirements we financial statements.89 Other Human Subjects
should consider to address those disclosures, such as the separate AGENCY: Office of the Assistant
challenges? If so, what changes and how financial statements of entities other Secretary for Policy, Development and
would those changes affect investors’ than the registrant and Pro Forma Research, HUD.
ability to make informed decisions? Financial Information are not required ACTION: Proposed rule.
50. Are there requirements that result to be presented in a structured,
in disclosures that investors do not machine-readable format. Would SUMMARY: On September 8, 2015, 16
consider useful? If so, what changes investors benefit from having all of the Federal departments and agencies
would make them useful or should we disclosures related to these entities published a proposed rule pertaining to
consider eliminating or replacing all or made in an interactive data format? Federal Policy for the Protection of
part of those requirements? Would it depend on the nature of the Human Subjects. Due to certain
information being disclosed (e.g., statutory prepublication requirements
51. How could we improve the disclosure related to a one-time applicable to HUD rules, HUD was
usefulness of the Rule 4–08(b) footnote transaction such as an acquisition or unable to be a signatory to the
disclosure? Could we do so by adding ongoing disclosure related to an September 8, 2015, proposed rule.
a requirement to disclose additional Investee)? What would be the cost to Through this HUD proposed rule, HUD
details about the affiliates? If so, what registrants? adopts the September 8, 2015, proposal
additional details should we require? 57. In what other ways could we and solicits public comment on the
52. If we make changes to improve the utilize technology to further facilitate proposal.
usefulness of the footnote disclosure, the disclosure of useful information to DATES: Comment Due Date: No later
tkelley on DSK3SPTVN1PROD with PROPOSALS

would it be appropriate to modify the investors or address challenges faced by than 5:00 p.m. on December 7, 2015.
requirement to provide Rule 3–16 investors and registrants? ADDRESSES: You may submit comments,
Financial Statements? If so, how? If not, identified by docket ID number HHS–
why? 88 17CFR 210.3–14.
OPHS–2015–0008, by one of the
89 Forexample, the Summarized Financial
53. Should we revise the test used in Information required by Rule 4–08(g) of Regulation following methods:
applying Rule 3–16? If so, how? If not, S–X and the Consolidating Information required by • Federal eRulemaking Portal: http://
why? Rule 3–10 of Regulation S–X. www.regulations.gov. Enter the above

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59094 Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Proposed Rules

meets the consultation and funding comments received will be addressed in of encryption, and be free of any defects
requirements of section 6 of the a subsequent final rule based on this or viruses.
Executive Order. This rule would not proposed rule. EPA will not institute a Docket: All documents in the
have federalism implications and would second comment period. Any parties electronic docket are listed in the
not impose substantial direct interested in commenting on this action www.regulations.gov index. Although
compliance costs on state and local should do so at this time. listed in the index, some information is
governments or preempt state law DATES: Comments must be received in not publicly available, i.e., CBI or other
within the meaning of the Executive writing by November 2, 2015. information whose disclosure is
Order. restricted by statute. Certain other
ADDRESSES: Submit your comments, material, such as copyrighted material,
List of Subjects for 24 CFR Part 60 identified by Docket ID Number EPA– is not placed on the Internet and will be
Human research subjects, Reporting R03–OAR–2015–0455 by one of the publicly available only in hard copy
and recordkeeping requirements. following methods: form. Publicly available docket
Dated: September 9, 2015.
A. www.regulations.gov. Follow the materials are available either
on-line instructions for submitting electronically in www.regulations.gov or
Katherine M. O’Regan,
comments. in hard copy during normal business
Assistant Secretary for Policy Development
and Research.
B. Email: fernandez.cristina@epa.gov. hours at the Air Protection Division,
[FR Doc. 2015–24831 Filed 9–30–15; 8:45 am]
C. Mail: EPA–R03–OAR–2015–0455, U.S. Environmental Protection Agency,
Cristina Fernandez, Associate Director, Region III, 1650 Arch Street,
BILLING CODE 4210–67–P
Office of Air Program Planning, Philadelphia, Pennsylvania 19103.
Mailcode 3AP30, U.S. Environmental Copies of the State submittal are
Protection Agency, Region III, 1650 available at the Delaware Department of
ENVIRONMENTAL PROTECTION Arch Street, Philadelphia, Pennsylvania Natural Resources and Environmental
AGENCY 19103. Control, 89 Kings Highway, P.O. Box
D. Hand Delivery: At the previously- 1401, Dover, Delaware 19903.
40 CFR Part 52
listed EPA Region III address. Such FOR FURTHER INFORMATION CONTACT:
[EPA–R03–OAR–2015–0455; FRL–9934–80- deliveries are only accepted during the Maria A. Pino, (215) 814–2181, or by
Region 3] Docket’s normal hours of operation, and email at pino.maria@epa.gov.
special arrangements should be made SUPPLEMENTARY INFORMATION: For
Approval and Promulgation of Air for deliveries of boxed information.
Quality Implementation Plans; further information regarding
Instructions: Direct your comments to Delaware’s 2011 base year inventories
Delaware; 2011 Base Year Inventories
Docket ID No. EPA–R03–OAR–2015– for the 2008 8-hour ozone NAAQS for
for the 2008 8-Hour Ozone National
0455. EPA’s policy is that all comments New Castle and Sussex Counties, please
Ambient Air Quality Standard for New
received will be included in the public see the information provided in the
Castle and Sussex Counties
docket without change, and may be direct final action with the same title,
AGENCY: Environmental Protection made available online at located in the ‘‘Rules and Regulations’’
Agency (EPA). www.regulations.gov, including any section of this Federal Register
ACTION: Proposed rule. personal information provided, unless publication.
the comment includes information
Dated: September 17, 2015.
SUMMARY: The Environmental Protection claimed to be Confidential Business
Agency (EPA) proposes to approve the Information (CBI) or other information Shawn M. Garvin,
2011 base year inventories for the 2008 whose disclosure is restricted by statute. Regional Administrator, Region III.
8-hour ozone National Ambient Air Do not submit information that you [FR Doc. 2015–24879 Filed 9–30–15; 8:45 am]
Quality Standard (NAAQS) for New consider to be CBI or otherwise BILLING CODE 6560–50–P
Castle and Sussex Counties, submitted protected through www.regulations.gov
by the State of Delaware as a revision to or email. The www.regulations.gov Web
the Delaware State Implementation Plan site is an ‘‘anonymous access’’ system, GENERAL SERVICES
(SIP). In the Final Rules section of this which means EPA will not know your ADMINISTRATION
Federal Register, EPA is approving the identity or contact information unless
State’s SIP submittal as a direct final you provide it in the body of your 41 CFR Parts 102–117 and 102–118
rule without prior proposal because the comment. If you send an email [FMR Case 2015–102–2; Docket 2015–0014;
Agency views this as a noncontroversial comment directly to EPA without going Sequence 1]
submittal and anticipates no adverse through www.regulations.gov, your
comments. The rationale for the email address will be automatically RIN 3090–AJ59
approval is set forth in the direct final captured and included as part of the
Federal Management Regulation
rule. A more detailed description of the comment that is placed in the public
(FMR); Transportation Payment and
state submittal and EPA’s evaluation is docket and made available on the
Audit
included in a Technical Support Internet. If you submit an electronic
Document (TSD) prepared in support of comment, EPA recommends that you AGENCY: Office of Government-wide
this rulemaking action. A copy of the include your name and other contact Policy (OGP), General Services
tkelley on DSK3SPTVN1PROD with PROPOSALS

TSD is available, upon request, from the information in the body of your Administration (GSA).
EPA Regional Office listed in the comment and with any disk or CD–ROM ACTION: Proposed rule.
ADDRESSES section of this document. If you submit. If EPA cannot read your
no adverse comments are received in comment due to technical difficulties SUMMARY: GSA is proposing to amend
response to this action, no further and cannot contact you for clarification, the Federal Management Regulation
activity is contemplated. If EPA receives EPA may not be able to consider your (FMR), Transportation Payment and
adverse comments, the direct final rule comment. Electronic files should avoid Audit, to clarify agency and Department
will be withdrawn and all public the use of special characters, any form of Defense (DOD) transportation

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Document Created: 2015-12-15 08:40:25
Document Modified: 2015-12-15 08:40:25

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule.
Contact		Barry L. Steffen, Policy Development Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street SW., Room 8114, Washington, DC 20410-8000, telephone 202-402-5926. (This is not a toll- free number.) Persons with hearing- or speech-impairments may access this number through TTY number by calling the Federal Relay Service number at 800-877-8339 (this a toll-free number).
FR Citation		80 FR 59092
CFR Associated		Human Research Subjects and Reporting and Recordkeeping Requirements