Federal Policy for the Protection of Human Subjects, 59092-59094 [2015-24831]
Download as PDF
59092
Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Proposed Rules
required for both subsidiaries and both
will include Subsidiary B’s assets,
liabilities, operations, and cash flows.
The test used in applying Rule 3–16
employs a bright-line percentage
threshold that a registrant must apply to
a limited set of measures similar to
Rules 3–05 and 3–09. Unlike those
rules, the market value of an affiliate’s
securities may not be readily available
in the absence of a public market for
those securities.
tkelley on DSK3SPTVN1PROD with PROPOSALS
Request for Comment
46. Do the Rule 3–16 requirements
influence the structure of collateral
arrangements? If so, how and what are
the consequences, if any, to investors
and registrants?
47. How do investors use Rule 3–16
Financial Statements and the Rule
4–08(b) footnote disclosures? Are there
challenges that investors face in using
the disclosures?
48. Are there changes to these
requirements we should consider to
further facilitate the disclosure of useful
information to investors? For example,
is there different or additional
information that investors need about
affiliates whose securities collateralize
registered securities? If so, what
information is needed and are there
challenges that registrants would face in
preparing and providing it?
49. Are there challenges that
registrants face in preparing and
providing the required disclosures? If
so, what are the challenges? Are there
changes to these requirements we
should consider to address those
challenges? If so, what changes and how
would those changes affect investors’
ability to make informed decisions?
50. Are there requirements that result
in disclosures that investors do not
consider useful? If so, what changes
would make them useful or should we
consider eliminating or replacing all or
part of those requirements?
51. How could we improve the
usefulness of the Rule 4–08(b) footnote
disclosure? Could we do so by adding
a requirement to disclose additional
details about the affiliates? If so, what
additional details should we require?
52. If we make changes to improve the
usefulness of the footnote disclosure,
would it be appropriate to modify the
requirement to provide Rule 3–16
Financial Statements? If so, how? If not,
why?
53. Should we revise the test used in
applying Rule 3–16? If so, how? If not,
why?
VerDate Sep<11>2014
19:05 Sep 30, 2015
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Additional Request for Comment on
Rule 3–16 and Related Requirements
54. Should smaller reporting
companies and emerging growth
companies continue to be subject to the
same requirements or should
requirements for those registrants be
scaled? If they should be scaled, in what
way? If not, why?
VI. Other Requirements
In addition to the issues raised in this
request for comment, we encourage all
interested persons to submit their views
on any issues relating to the financial
information about entities, or portions
of entities, other than a registrant. For
example, Rule 3–14, Special
Instructions for Real Estate Operations
to be Acquired,88 while separate and
distinct from Rule 3–05, is intended to
achieve similar objectives within a
particular industry. In addition, Item
2.01 of Form 8–K uses significance tests
to determine when to provide disclosure
about asset acquisitions. The
requirements addressed in this request
for comment may apply more broadly
than the situations described. To the
extent there may be additional effects,
please provide comments.
Request for Comment
55. As we continue our ongoing
efforts to review disclosure rules, what
other rules and forms should be
considered for review and why?
56. Currently, financial disclosures
related to entities other than a registrant
are filed in XBRL format to the extent
that they are part of the registrant’s
financial statements.89 Other
disclosures, such as the separate
financial statements of entities other
than the registrant and Pro Forma
Financial Information are not required
to be presented in a structured,
machine-readable format. Would
investors benefit from having all of the
disclosures related to these entities
made in an interactive data format?
Would it depend on the nature of the
information being disclosed (e.g.,
disclosure related to a one-time
transaction such as an acquisition or
ongoing disclosure related to an
Investee)? What would be the cost to
registrants?
57. In what other ways could we
utilize technology to further facilitate
the disclosure of useful information to
investors or address challenges faced by
investors and registrants?
88 17
CFR 210.3–14.
example, the Summarized Financial
Information required by Rule 4–08(g) of Regulation
S–X and the Consolidating Information required by
Rule 3–10 of Regulation S–X.
89 For
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Sfmt 4702
58. Are there ways that we could
further facilitate the use of information
by all types of investors? If so, please
explain. For example, should we
consider alternative ways of presenting
the information, such as specifically
allowing or requiring registrants to
provide a summary along with more
detailed required information to enable
investors to review the information at
the level of detail that they prefer?
VII. Closing
This request for comment is not
intended in any way to limit the scope
of comments, views, issues or
approaches to be considered. In
addition to investors and registrants, the
Commission welcomes comment from
other market participants and
particularly welcomes statistical,
empirical, and other data from
commenters that may support their
views and/or support or refute the views
or issues raised.
By the Commission.
Dated: September 25, 2015.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015–24875 Filed 9–30–15; 8:45 am]
BILLING CODE 8011–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 60
[Docket No FR–5888–P–01]
Federal Policy for the Protection of
Human Subjects
Office of the Assistant
Secretary for Policy, Development and
Research, HUD.
ACTION: Proposed rule.
AGENCY:
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: https://
www.regulations.gov. Enter the above
SUMMARY:
E:\FR\FM\01OCP1.SGM
01OCP1
Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Proposed Rules
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:
tkelley on DSK3SPTVN1PROD with PROPOSALS
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
VerDate Sep<11>2014
19:05 Sep 30, 2015
Jkt 238001
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 crossreference to the September 8, 2015,
proposed rule, HUD advises of its
adoption of this proposal and solicits
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59093
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 § 60.101, entitled ‘‘Crossreference,’’ 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
E:\FR\FM\01OCP1.SGM
01OCP1
59094
Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Proposed Rules
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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2015–0455; FRL–9934–80Region 3]
Approval and Promulgation of Air
Quality Implementation Plans;
Delaware; 2011 Base Year Inventories
for the 2008 8-Hour Ozone National
Ambient Air Quality Standard for New
Castle and Sussex Counties
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) proposes to approve the
2011 base year inventories for the 2008
8-hour ozone National Ambient Air
Quality Standard (NAAQS) for New
Castle and Sussex Counties, submitted
by the State of Delaware as a revision to
the Delaware State Implementation Plan
(SIP). In the Final Rules section of this
Federal Register, EPA is approving the
State’s SIP submittal as a direct final
rule without prior proposal because the
Agency views this as a noncontroversial
submittal and anticipates no adverse
comments. The rationale for the
approval is set forth in the direct final
rule. A more detailed description of the
state submittal and EPA’s evaluation is
included in a Technical Support
Document (TSD) prepared in support of
this rulemaking action. A copy of the
TSD is available, upon request, from the
EPA Regional Office listed in the
ADDRESSES section of this document. If
no adverse comments are received in
response to this action, no further
activity is contemplated. If EPA receives
adverse comments, the direct final rule
will be withdrawn and all public
tkelley on DSK3SPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
19:05 Sep 30, 2015
Jkt 238001
comments received will be addressed in
a subsequent final rule based on this
proposed rule. EPA will not institute a
second comment period. Any parties
interested in commenting on this action
should do so at this time.
DATES: Comments must be received in
writing by November 2, 2015.
ADDRESSES: Submit your comments,
identified by Docket ID Number EPA–
R03–OAR–2015–0455 by one of the
following methods:
A. www.regulations.gov. Follow the
on-line instructions for submitting
comments.
B. Email: fernandez.cristina@epa.gov.
C. Mail: EPA–R03–OAR–2015–0455,
Cristina Fernandez, Associate Director,
Office of Air Program Planning,
Mailcode 3AP30, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103.
D. Hand Delivery: At the previouslylisted EPA Region III address. Such
deliveries are only accepted during the
Docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–R03–OAR–2015–
0455. EPA’s policy is that all comments
received will be included in the public
docket without change, and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or email. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an email
comment directly to EPA without going
through www.regulations.gov, your
email address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
PO 00000
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Fmt 4702
Sfmt 4702
of encryption, and be free of any defects
or viruses.
Docket: All documents in the
electronic docket are listed in the
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically in www.regulations.gov or
in hard copy during normal business
hours at the Air Protection Division,
U.S. Environmental Protection Agency,
Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
Copies of the State submittal are
available at the Delaware Department of
Natural Resources and Environmental
Control, 89 Kings Highway, P.O. Box
1401, Dover, Delaware 19903.
FOR FURTHER INFORMATION CONTACT:
Maria A. Pino, (215) 814–2181, or by
email at pino.maria@epa.gov.
SUPPLEMENTARY INFORMATION: For
further information regarding
Delaware’s 2011 base year inventories
for the 2008 8-hour ozone NAAQS for
New Castle and Sussex Counties, please
see the information provided in the
direct final action with the same title,
located in the ‘‘Rules and Regulations’’
section of this Federal Register
publication.
Dated: September 17, 2015.
Shawn M. Garvin,
Regional Administrator, Region III.
[FR Doc. 2015–24879 Filed 9–30–15; 8:45 am]
BILLING CODE 6560–50–P
GENERAL SERVICES
ADMINISTRATION
41 CFR Parts 102–117 and 102–118
[FMR Case 2015–102–2; Docket 2015–0014;
Sequence 1]
RIN 3090–AJ59
Federal Management Regulation
(FMR); Transportation Payment and
Audit
Office of Government-wide
Policy (OGP), General Services
Administration (GSA).
ACTION: Proposed rule.
AGENCY:
GSA is proposing to amend
the Federal Management Regulation
(FMR), Transportation Payment and
Audit, to clarify agency and Department
of Defense (DOD) transportation
SUMMARY:
E:\FR\FM\01OCP1.SGM
01OCP1
Agencies
[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Proposed Rules]
[Pages 59092-59094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24831]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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