Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects, 2885-2894 [2018-00997]
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Rules and Regulations
Federal Register
Vol. 83, No. 14
Monday, January 22, 2018
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents.
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 16
ENVIRONMENTAL PROTECTION
AGENCY
DEPARTMENT OF HOMELAND
SECURITY
40 CFR Part 26
6 CFR Part 46
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF AGRICULTURE
45 CFR Part 46
RIN 0937–AA06
7 CFR Part 1c
NATIONAL SCIENCE FOUNDATION
DEPARTMENT OF ENERGY
45 CFR Part 690
10 CFR Part 745
DEPARTMENT OF TRANSPORTATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
49 CFR Part 11
Federal Policy for the Protection of
Human Subjects: Delay of the
Revisions to the Federal Policy for the
Protection of Human Subjects
14 CFR Part 1230
DEPARTMENT OF COMMERCE
DEPARTMENT OF LABOR
Department of Homeland
Security; Department of Agriculture;
Department of Energy; National
Aeronautics and Space Administration;
Department of Commerce; Consumer
Product Safety Commission; Social
Security Administration; Agency for
International Development; Department
of Labor; 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: Interim final rule; delay of
effective and compliance dates; request
for comments.
29 CFR Part 21
SUMMARY:
AGENCY:
15 CFR Part 27
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1028
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 431
AGENCY FOR INTERNATIONAL
DEVELOPMENT
22 CFR Part 225
DEPARTMENT OF DEFENSE
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32 CFR Part 219
DEPARTMENT OF EDUCATION
34 CFR Part 97
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In a final rule published on
January 19, 2017, federal departments
and agencies listed in this document
made revisions to the Federal Policy for
the Protection of Human Subjects. The
Consumer Product Safety Commission
(CPSC) adopted the same regulatory
changes in a separate final rule
published on September 18, 2017. The
revised policy, reflected in both final
rules, is described here as the ‘‘2018
Requirements.’’ The 2018 Requirements
are scheduled to become effective on
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January 19, 2018, with a general
compliance date of January 19, 2018
(with the exception of the revisions to
the cooperative research provision).
This interim final rule delays the
effective date and general compliance
date of the 2018 Requirements to July
19, 2018. The federal departments and
agencies listed in this document are in
the process of developing a proposed
rule to further delay implementation of
the 2018 Requirements. The limited
implementation delay accomplished by
this interim final rule both provides
additional time to regulated entities for
the preparations necessary to implement
the 2018 Requirements, and additional
time for the departments and agencies
listed in this document to seek input
from interested stakeholders through a
notice and comment rulemaking process
that allows for public engagement on
the proposal for a further
implementation delay.
DATES: This interim final rule is
effective on July 19, 2018. This interim
final rule delays until July 19, 2018, the
effective date and general compliance
date of the final rule published in the
Federal Register (82 FR 7149, Jan. 19
2017) and of the final rule published by
the Consumer Product Safety
Commission in the Federal Register (82
FR 43459, Sept. 18, 2017). To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 11:59
p.m. Eastern Standard Time on March
19, 2018.
ADDRESSES: You may submit comments,
identified by docket ID number HHS–
OPHS–2017–0001 by one of the
following methods:
• Federal eRulemaking Portal (https://
www.regulations.gov):
Æ Enter the following link into your
web browser’s address bar: https://www.
regulations.gov/document?D=HHSOPHS-2017-0001.
Æ Click the blue ‘‘Comment Now!’’
button in the upper right hand corner
and follow the instructions on how to
submit a comment.
Æ Alternatively, you can enter the
docket ID number into the ‘‘search’’ box
on the main page of the Federal
eRulemaking Portal (https://
www.regulations.gov) to find the
electronic docket.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]
to: Jerry Menikoff, M.D., J.D., OHRP,
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1101 Wootton Parkway, Suite 200,
Rockville, MD 20852.
• Comments received, including any
personal information, will be posted
without change to https://
www.regulations.gov.
Jerry
Menikoff, M.D., J.D., Office for Human
Research Protections (OHRP),
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852; telephone:
240–453–6900 or 1–866–447–4777;
facsimile: 301–402–2071; email
Jerry.Menikoff@hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
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On September 8, 2015, HHS and 15
other federal departments and agencies
published a Notice of Proposed
Rulemaking (NPRM) proposing
revisions to each agency’s codification
of the Federal Policy for the Protection
of Human Subjects, originally
promulgated as a Common Rule in 1991.
80 FR 53931. On January 19, 2017, HHS
and other federal departments and
agencies published a final rule revising
the Federal Policy for the Protection of
Human Subjects. 82 FR 7149. The
revised policy is hereafter referred to as
the ‘‘2018 Requirements.’’ The 2018
Requirements are scheduled to become
effective on January 19, 2018, with a
general compliance date of January 19,
2018 (with the exception of the
revisions to the cooperative research
provision at § l.114(b), for which the
compliance date is January 20, 2020).
After publication of the 2018
Requirements, representatives of the
regulated community, including
organizations representing recipients of
federal human subjects research awards,
expressed concern regarding the
regulated community’s ability to
implement all of the 2018 Requirements
by the scheduled general compliance
date.1 Some of these stakeholders asked
for a delay in the general compliance
date of the 2018 Requirements with the
exception of certain burden-reducing
provisions of the 2018 Requirements,
including certain carve-outs from the
definition of ‘‘research,’’ exemptions,
elimination of the continuing review
1 See the June 21, 2017 letter to Jerry Menikoff
from the Association of American Medical Colleges,
Association of American Universities, Association
of Public & Land-grant Universities, and Council on
Governmental Relations, available at https://www.
cogr.edu/sites/default/files/AAMC_AAU_APLU_
COGR%20Common%20Rule%20Delay%20Letter%
206-21-2017.pdf. See the June 9, 2017 letter to
Secretary Thomas Price from the American Medical
Informatics Association at https://www.amia.org/
sites/default/files/AMIA%20Letter%20
Regarding%20the%20Common%20Rule.pdf.
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requirement for certain categories of
research, and the elimination of the
requirement that institutional review
boards (IRBs) review grant applications.
The HHS Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) also
recommended in August 2017 that
implementation of the 2018
Requirements should be delayed.2
II. Delay of the Effective Date and
General Compliance Date
Through this interim final rule, we are
delaying the effective date and the
general compliance date of the 2018
Requirements for six months, until July
19, 2018. As described below, we revise
§ l.101(l)(3)–(4) to specify that the
general compliance date for the 2018
Requirements is July 19, 2018.
Prior to July 19, 2018, regulated
entities will continue to comply with
the pre-2018 Requirements and those
requirements will be enforced by the
Common Rule departments and
agencies. To clarify, regulated entities
are not allowed, prior to July 19, 2018,
to comply with the 2018 Requirements
in lieu of the pre-2018 Requirements.
Unless further regulatory action is
taken, studies initiated on or after July
19, 2018, will be required to comply
with the 2018 Requirements. Studies
initiated prior to July 19, 2018 (i.e.,
studies initially approved by an IRB,
studies for which IRB review was
waived pursuant to § l.101(i), or
studies determined to be exempt, before
July 19, 2018) would, as a default,
continue to be subject to the pre-2018
Requirements for their duration. This
will maintain the ability of institutions
to hold such studies to the same set of
standards throughout the studies’
duration, and will avoid a requirement
that such research be subject to two sets
of rules. However, on or after July 19,
2018, institutions may elect instead to
conduct such studies in compliance
with the 2018 Requirements, as set forth
in § l.101(l)(3).
This interim final rule does not delay
the compliance date for the cooperative
research provision of the 2018
Requirements (§ l.114(b)), which
remains January 20, 2020.
III. Good Cause for Interim Final Rule
Under Section 553(b) of the
Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.), a notice of proposed
rulemaking is not required when an
agency, for good cause, finds that notice
and public comment thereon are
2 SACHRP Recommendations of August 2, 2017,
Attachment A: https://www.hhs.gov/ohrp/sachrpcommittee/recommendations/attachment-a-august2-2017/.
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impracticable, unnecessary, or contrary
to the public interest. Pursuant to 5
U.S.C. 553(b)(3)(B), we find that good
cause exists to waive normal rulemaking
requirements for the delay of the
effective date and general compliance
date to July 19, 2018. We believe that a
notice-and-comment procedure, in this
limited instance, is impracticable,
unnecessary, or contrary to the public
interest.
Representatives of the regulated
community, and HHS’s own advisory
committee, have requested a delay in
implementation of the 2018
Requirements, citing the final rule’s
complexity, the absence of needed
guidance, and the need to revamp
institutional procedures and electronic
systems in order to come into
compliance with the requirements of the
rule. We agree that regulated entities
need additional time for
implementation and compliance, which
would be furthered by the issuance of
guidance by the Common Rule agencies.
Without a delay, and without guidance,
institutions that have expected a delay
who hastily attempt to implement the
revised rule without adequate
preparation are bound to make mistakes,
the consequences of which may
jeopardize the proper conduct of
research and the safety and wellbeing of
human subjects. At this point, it is
impracticable to gather comments on an
implementation delay prior to January
19, 2018, the scheduled effective date of
the 2018 Requirements.
In addition, the benefits underlying
this interim final rule, i.e., providing
certainty to entities in the regulated
community that they will be afforded
additional time before being subject to
compliance with the 2018 Requirements
prior to the date such requirements are
scheduled to go into effect, would be
substantially undermined if a notice and
comment process were to occur before
the delay set forth in this interim final
rule was finalized. For example, we
understand that regulated entities may
need to devise new policies and
procedures and new information
technology systems to accommodate the
2018 Requirements in advance of the
applicable effective and compliance
date. In addition, the effect of this
interim final rule is simply to maintain
the status quo by continuing to require
compliance with the pre-2018
Requirements for several months.
Further, the federal departments and
agencies named in this interim final rule
are developing a notice of proposed
rulemaking in order to fully engage
regulated entities and the public
regarding further delay of the 2018
Requirements until January 21, 2019.
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The additional time provided by the six
month delay in this interim final rule
will allow sufficient time for the notice
and comment rulemaking process to be
completed. Issuance of this interim final
rule avoids the possible result of having
the federal departments and agencies
propose an implementation delay but be
unable to complete the rulemaking
process and publish a final rule that
would be effective by January 19, 2018.
This could have resulted in the absurd
circumstance in which regulated
entities would be technically required to
come into compliance with the 2018
Requirements on January 19, 2018, only
until the date a final rule implementing
the delay became effective. In this
unique circumstance, allowing the
regulation to become effective while
further rulemaking for delay is ongoing
would create confusion for, and impose
unnecessary burdens on, the regulated
community.
We also find that good cause exists for
immediate implementation of this
interim final rule and waiver of the 30day delay in the effective date generally
required by the APA. The APA provides
that an agency is not required to delay
the effective date when the agency, for
good cause, finds that the requirement
is impracticable, unnecessary, or
contrary to the public interest (5 U.S.C.
553(d)(3)). Given the reasons identified
above for the good cause to dispense
with notice and comment, we believe
that this requirement is also met here.
Further, the 30-day delay in the
effective date is normally intended to
give affected parties time to adjust their
business practices and make
preparations before a final rule takes
effect. Because the action being taken
delays the effective date to July 19, 2018
and thus maintains the status quo, an
additional 30-day delay of this action is
unnecessary.
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Department of Homeland Security
The rule issued by the Department of
Homeland Security (DHS) is consistent
with section 8306 of Public Law 108–
458, the Intelligence Reform and
Terrorism Prevention Act of 2004, under
which DHS shall comply with 45 CFR
part 46 or equivalent regulations issued
by DHS; continued adherence to the
HHS standard best ensures that DHS
does not lose critical research
opportunities as a result of inconsistent
federal standards. The DHS rule is also
consistent with DHS’s waiver authority
under forthcoming 6 CFR 46.101(i), as
well as the exemption at 5 U.S.C.
553(a)(2) for rules related to ‘‘loans,
grants, benefits, or contracts.’’
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Department of Education
Continued adherence to the HHS
standard protects the Department of
Education (ED) from the potential loss
of critical research opportunities as a
result of inconsistent federal standards.
The ED rule is also consistent with ED’s
waiver authority under 34 CFR
97.101(i).
IV. Legal Authorities
The legal authorities for the
departments and agencies that are
signatories to this action are as follows:
Department of Homeland Security, 5
U.S.C. 301; Public Law 107–296, sec.
102, 306(c); Public Law 108–458, sec.
8306. 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).
Social Security Administration, 5 U.S.C.
301; 42 U.S.C. 289(a). Agency for
International Development, 5 U.S.C.
301; 42 U.S.C. 300v–1(b), unless
otherwise noted. Department of Labor, 5
U.S.C. 301; 29 U.S.C. 551. Department
of Defense, 5 U.S.C. 301. Department of
Education, 5 U.S.C. 301; 20 U.S.C.
1221e–3, 3474. 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; 7 U.S.C. 136a(a) and
136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec.
201, Public Law 109–54, 119 Stat. 531;
and 42 U.S.C. 300v–1(b). Department of
Health and Human Services, 5 U.S.C.
301; 42 U.S.C. 289(a); 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. Regulatory Impact Analyses
We have examined the effects of this
interim final rule under Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), Executive Order 13771 on
Reducing Regulation and Controlling
Regulatory Costs (January 30, 2017), the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13), the Regulatory Flexibility
Act, (Pub. L. 96–354, September 19,
1980), the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104–4), and
Executive Order 13132 on Federalism
(August 4, 1999).
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A. Executive Orders 12866, 13563, and
13771
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects; distributive impacts; and
equity). Executive Order 13563 is
supplemental to and reaffirms the
principles, structures, and definitions
governing regulatory review as
established in Executive Order 12866,
emphasizing the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. In
accordance with the provisions of
Executive Order 12866, this interim
final rule has been determined to be a
‘‘significant’’ regulatory action and was
submitted to the Office of Management
and Budget (OMB) for review.
Executive Order 13771 directs
Agencies to identify at least two existing
regulations to be repealed for every new
regulation unless prohibited by law. The
total incremental cost of all regulations
issued in a given fiscal year must have
costs within the amount of incremental
costs allowed by the Director of the
Office of Management and Budget,
unless otherwise required by law or
approved in writing by the Director of
the Office of Management and Budget.
This action’s designation as regulatory
or deregulatory will be informed by
comments received in response to this
interim final rule. Details on the interim
estimates of costs and cost savings of
this rule can be found in the economic
analysis below.
1. Need for Final Rule and Summary
This interim final rule is intended to
provide additional time to regulated
entities for the preparations necessary to
implement the 2018 Requirements. This
interim final rule further allows time for
the federal departments and agencies
named in this interim final rule to
conduct a notice and comment
rulemaking process that will allow for
public engagement as to whether a
further delay in the implementation of
the 2018 Requirements would be
desirable.
2. Analysis of Benefits (Cost-Savings)
and Costs (Foregone Benefits) 3
The RIA for the 2018 Requirements
described the benefits and costs of 16
3 Note, that the terms ‘‘benefits’’ and ‘‘costsavings’’ are used interchangeably in this RIA.
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broad categories of changes finalized.
The RIA for this interim final rule uses
the information and calculations
described in the preamble to the 2018
Requirements as a base for estimating
benefits and costs of delaying
implementation of the 2018
Requirements by six months. The time
period for the analysis in this RIA is
January 2018 to July 2018.
Table 1 summarizes the quantified
costs and cost savings of delaying
implementation of 2018 Requirements.
Over the period of January 2018 to July
2018, annualized cost savings of $7.4
million are estimated using a 3 percent
discount rate; and $6.9 million using a
7 percent discount rate. Annualized
costs of $49.5 million are estimated
using a 3 percent discount rate; and
$45.9 million using a 7 percent discount
rate. Note that all values are represented
in millions of 2016 dollars, and 2016 is
used as the frame of reference for
discounting.
TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE 2018 REQUIREMENTS BY SIX MONTHS
Annualized value by discount rate
(millions of 2016 dollars)
BENEFITS (COST-SAVINGS) ..........................................
Quantified Benefits ...........................................................
COSTS (FOREGONE BENEFITS) ...................................
Quantified Costs ...............................................................
The estimated benefits and costs of
delaying the 2018 Requirements by six
3 Percent ..................................................
7.4 .............................................................
3 Percent ..................................................
49.5 ...........................................................
months are shown in Table 2 below.
Note that the categorization shown
7 Percent.
6.9.
7 Percent.
45.9.
below includes the same 16 categories
used in the RIA of 2018 Requirements.
TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF
DELAYING THE 2018 REQUIREMENTS BY SIX MONTHS 4
Annualized value over 1 year by discount rate
(millions of 2016 dollars)
2018 Requirement RIA category
Benefits
(cost-savings)
3%
Regulated Community Learning New Requirements and Developing Training Materials; OHRP Developing Training and Guidance Materials, and
Implementing the 2018 Requirements .........................................................
Extending Oversight to IRBs Unaffiliated with an Institution Holding an FWA
(impact to IRBs not operated by an FWA-holding institution) .....................
Excluding Activities from the Requirements of the Common Rule because
They are not Research ................................................................................
Clarifying and Harmonizing Regulatory Requirements and Agency Guidance
Modifying the Assurance Requirements ..........................................................
Requirement for Written Procedures and Agreements for Reliance on IRBs
Not Operated by the Engaged Institution (impact to FWA-holding institutions) .............................................................................................................
Eliminating the Requirement that the Grant Application Undergo IRB Review and Approval ........................................................................................
Expansion of Research Activities Exempt from Full IRB Review ...................
Elimination of Continuing Review of Research Under Specific Conditions ....
Amending the Expedited Review Procedures .................................................
Cooperative Research (single IRB mandate in multi-institutional research) 5
Changes in the Basic Elements of Consent, Including Documentation ..........
Obtaining Consent to Secondary Use of Identifiable biospecimens and Identifiable private information ............................................................................
Elimination of Pre-2018 Rule Requirement to Waive Consent in Certain
Subject Recruitment Activities .....................................................................
Requirement for Posting of Consent Forms for Clinical Trials Conducted or
supported by Common Rule Department or Agencies ................................
Alteration in Waiver for Documentation of Informed Consent in Certain Circumstances ..................................................................................................
Costs
(foregone benefits)
7%
3%
–
–
–
–
4.47
4.14
–
–
–
–
–
–
–
–
0.94
–
0.31
0.88
–
0.29
–
–
–
–
–
0.01
2.07
–
–
–
–
0.01
1.92
–
–
–
17.0
20.8
7.73
2.66
–
–
15.7
19.3
7.17
2.47
–
–
–
–
–
–
–
–
0.07
0.06
0.85
0.79
–
–
–
–
–
–
4 Zeroes
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7%
in Table 2 (represented by ‘‘–’’) signify that the category has been unaffected by the six month delay of the 2018 Requirements, The
category could be unaffected for one of two reasons: (1) No costs or benefits were associated with the category in the RIA for the 2018 Requirements; or (2) the costs and benefits of the provision during the six month delay are the same as those estimated in the RIA for the 2018 Requirements.
5 Because compliance with this provision is not required until 2020, benefits and costs here are not included.
Similarly, the terms ‘‘costs’’ and ‘‘foregone benefits’’
are also used interchangeably.
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We assume that, in almost all
categories described in the RIA for the
2018 Requirements, the foregone
benefits (costs) of delaying the 2018
Requirements by six months are what
would have been the benefits of
implementing the 2018 Requirements
during the period of January through
July of 2018. Similarly, we assume that,
in almost all categories described in the
RIA for the 2018 Requirements, the
benefits (cost-savings) associated with
delaying the 2018 Requirements by six
months are what would have been the
costs of implementing the 2018
Requirements during the period of
January through July of 2018. We
assume this because these categories
generally would not have required
significant guidance from Common Rule
departments or agencies in order to
implement the provisions, and thus
could have been implemented as
assumed in the economic analysis
contained in the RIA for the 2018
Requirements.
The exceptions to the above
assumption relate to two RIA categories:
(1) Excluding activities from the
Common Rule because they are not
research; and (2) the expansion of
research activities exempt from full IRB
review. The 2018 Requirements include
four explicit categories of activities that
have been deemed not research for the
purposes of the Common Rule. In the
absence of guidance, it would be
difficult for institutions to fully take
advantage of the exclusion of activities
from the definition of research; therefore
we now assume that many institutions
would not have used these categories
without guidance.
The 2018 Requirements also include
five new exemption categories, and
modify all but one exemption that exists
in the pre-2018 Requirements. We have
received feedback from SACHRP that
many of the exemption categories will
require significant guidance in order to
be implemented.6 Areas where
significant guidance is needed include:
Applying the categories of the new
exemptions themselves, conducting
limited IRB review (as required in four
exemptions), developing and using
broad consent (as required in two
exemptions), utilizing the exemption for
certain HIPAA covered activities, and
understanding which federally
supported or conducted nonresearch
information collections qualify for
exemption.
6 SACHRP Recommendations of August 2, 2017:
https://www.hhs.gov/ohrp/sachrp-committee/
recommendations/sachrp-recommendations/
index.html.
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Because the guidance necessary to
implement these provisions has not yet
been developed, we now assume that 50
percent of the regulated entities would
not have taken advantage of the
expansion in exemptions or the revised
definition of research during the sixmonth delay. For these entities, we
assume that there are no benefits and
costs of the proposed delay, because
they would not have changed their
operations. We assume that 50 percent
of the regulated entities would have
gone forward with using the new or
expanded exemption categories under
the 2018 Requirements; for these
entities, there are costs of delaying the
implementation of this provision during
the six-month delay of this interim final
rule. We are seeking comment on these
assumptions.
B. Paperwork Reduction Act (PRA)
This interim final rule does not
impose any additional information
collection burden under the PRA, and
does not contain any information
collection activities beyond the
information collection already approved
by OMB under control number 0990–
0260.
C. Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.) (RFA) and the Small
Business Regulatory Enforcement
Fairness Act of 1996, which amended
the RFA, require agencies that issue a
regulation to analyze options for
regulatory relief for small businesses. If
a rule has a significant impact on a
substantial number of small entities,
agencies must specifically consider the
economic effect of the rule on small
entities and analyze regulatory options
that could lessen the impact of the rule.
The RFA generally defines a ‘‘small
entity’’ as (1) a proprietary firm meeting
the size standards of the Small Business
Administration (SBA); (2) a nonprofit
organization that is not dominant in its
field; or (3) a small government
jurisdiction with a population of less
than 50,000 (states and individuals are
not included in the definition of ‘‘small
entity’’). HHS considers a rule to have
a significant economic impact on a
substantial number of small entities if at
least 5 percent of small entities
experience an impact of more than 3
percent of revenue.
This action does not have a significant
economic impact on a substantial
number of small entities under the RFA.
In making this determination, the
impact of concern is any significant
adverse economic impact on small
entities. An agency may certify that a
rule will not have a significant
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
2889
economic impact on a substantial
number of small entities if the rule
relieves regulatory burden, has no net
burden or otherwise has a positive
economic effect on the small entities
subject to the rule. This interim final
rule does not impose a regulatory
burden for regulated small entities
because it delays the effective date and
general compliance date of the 2018
Requirements, allowing the status quo
to be retained for the period of delay.
We have, therefore, concluded that this
action will have no net regulatory
burden for all directly regulated small
entities.
D. Unfunded Mandates Reform Act
(UMRA)
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $148
million, using the most current (2016)
implicit price deflator for the gross
domestic product. We do not expect this
interim final rule to result in
expenditures that will exceed this
amount. This action does not contain
any unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments.
E. Executive Order 13132: Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a rule
that imposes substantial direct
requirement costs on state and local
governments or has federalism
implications. We have determined that
the interim final rule does 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. The
changes to the 2018 Requirements
contained in this interim final rule
represent the Federal Government
regulating its own program.
Accordingly, we conclude that the
interim final rule does not contain
policies that have federalism
implications as defined in Executive
Order 13132 and, consequently, a
federalism summary impact statement is
not required.
E:\FR\FM\22JAR1.SGM
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Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations
For the reasons set forth in the
preamble, the Federal Policy for the
Protection of Human Subjects, as
published in the Federal Register on
January 19, 2017 (82 FR 7149) and as
adopted in a final rule published by the
CPSC on September 18, 2017 (82 FR
43459), this common rule is further
amended as follows:
Text of the Amended Common Rule
PART l—PROTECTION OF HUMAN
SUBJECTS
1. Amend § l.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ l.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § l.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § l.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
§ 46.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) For purposes of this section, the
pre-2018 Requirements means Subpart
A to 45 CFR part 46, as published in the
2016 edition of the Code of Federal
Regulations, which is the rule that DHS
applied before it first promulgated this
subpart.
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is July 19, 2019.
The compliance date for § 46.114(b)
(cooperative research) of the 2018
Requirements is January 20, 2020.
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 46.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 46.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Agriculture
further amends 7 CFR part 1c as
published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
PART 46—PROTECTION OF HUMAN
SUBJECTS
ethrower on DSK3G9T082PROD with RULES
DEPARTMENT OF ENERGY
List of Subjects in 10 CFR Part 745
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Energy
further amends 10 CFR part 745 as
published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
■
List of Subjects in 7 CFR Part 1c
PART 1c—PROTECTION OF HUMAN
SUBJECTS
■
1. The authority citation for 46
continues to read as follows:
■
Authority: 5 U.S.C. 301; P.L. 107–296, sec.
102, 306(c); P.L. 108–458, sec. 8306.
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 46.101 by revising
paragraphs (l)(1), (2), (3), and (4) to read
as follows:
■
Jkt 244001
Chavonda Jacobs-Young,
Acting Deputy Under Secretary for Research,
Education, and Economics, USDA.
PART 745—PROTECTION OF HUMAN
SUBJECTS
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Homeland
Security further amends 6 CFR part 46
as published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
15:52 Jan 19, 2018
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 1c.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 1c.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
William Bryan,
Deputy Under Secretary for Science &
Technology.
List of Subjects in 6 CFR Part 46
VerDate Sep<11>2014
To what does this policy apply?
*
DEPARTMENT OF AGRICULTURE
DEPARTMENT OF HOMELAND
SECURITY
■
§ 1c.101
1. The authority citation for 1c
continues to read as follows:
2. Amend § 1c.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
1. The authority citation for 745
continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 7254;
42 U.S.C. 300v–1(b).
2. Amend § 745.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 745.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 745.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
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Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 745.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
DEPARTMENT OF COMMERCE
List of Subjects in 15 CFR Part 27
Human research subjects, Reporting
and record-keeping requirements,
Research.
Dan Brouillette,
Deputy Secretary of Energy.
For the reasons stated in the
preamble, the Department of Commerce
further amends 15 CFR part 27 as
published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
PART 27—PROTECTION OF HUMAN
SUBJECTS
List of Subjects in 14 CFR Part 1230
■
Human research subjects, Reporting
and record-keeping requirements,
Research.
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
For the reasons stated in the
preamble, the National Aeronautics and
Space Administration further amends
14 CFR part 1230 as published in the
Federal Register on January 19, 2017
(82 FR 7149) as follows:
PART 1230—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 1230
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 1230.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 1230.101
To what does this policy apply?
ethrower on DSK3G9T082PROD with RULES
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 1230.101(i), or for which
a determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 1230.101(i), or for which
a determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
James D. Polk,
Chief Health & Medical Officer, National
Aeronautics and Space Administration.
VerDate Sep<11>2014
15:52 Jan 19, 2018
Jkt 244001
1. The authority citation for 27
continues to read as follows:
2. Amend § 27.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 27.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 27.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 27.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Wilbur L. Ross,
The Secretary of Commerce.
CONSUMER PRODUCT SAFETY
COMMISSION
List of Subjects in 16 CFR Part 1028
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Consumer Product Safety
Commission further amends 16 CFR
part 1028 as published in the Federal
Register on January 19, 2017 (82 FR
7149) and as adopted in a final rule
published by the CPSC on September
18, 2017 (82 FR 43459) as follows:
PO 00000
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Fmt 4700
Sfmt 4700
2891
PART 1028—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 1028
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 1028.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 1028.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 1028.101(i), or for which
a determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 1028.101(i), or for which
a determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Alberta E. Mills,
Acting Secretary, Consumer Product Safety
Commission.
SOCIAL SECURITY ADMINISTRATION
List of Subjects in 20 CFR Part 431
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Social Security
Administration further amends 20 CFR
part 431 as published in the Federal
Register on January 19, 2017 (82 FR
7149) as follows:
PART 431—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 431
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
2. Amend § 431.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 431.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 431.101(i), or for which a
determination was made that the
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Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 431.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Nancy Berryhill,
Acting Commissioner, Social Security
Administration.
PART 225—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 225
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b), unless otherwise noted.
2. Amend § 225.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
To what does this policy apply?
ethrower on DSK3G9T082PROD with RULES
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 225.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 225.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
VerDate Sep<11>2014
15:52 Jan 19, 2018
Jkt 244001
PART 219—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 219
continues to read as follows:
■
Authority: 5 U.S.C. 301.
List of Subjects in 29 CFR Part 21
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Labor
further amends 29 CFR part 21 as
published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
1. The authority citation for 21
continues to read as follows:
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Agency for International
Development further amends 22 CFR
part 225 as published in the Federal
Register on January 19, 2017 (82 FR
7149) as follows:
January 19, 2017 (82 FR 7149) as
follows:
DEPARTMENT OF LABOR
■
List of Subjects in 22 CFR Part 225
*
Irene Koek,
Senior Deputy Assistant Administrator for
Global Health, U.S. Agency for International
Development.
PART 21—PROTECTION OF HUMAN
SUBJECTS
AGENCY FOR INTERNATIONAL
DEVELOPMENT
§ 225.101
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Authority: 5 U.S.C. 301; 29 U.S.C. 551.
2. Amend § 21.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 21.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 21.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 21.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
R. Alexander Acosta,
Secretary of Labor.
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Defense
further amends 32 CFR part 219 as
published in the Federal Register on
Fmt 4700
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 219.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 219.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Mary J. Miller,
Principal Deputy, Assistant Secretary of
Defense for Research and Engineering.
DEPARTMENT OF EDUCATION
List of Subjects in 34 CFR Part 97
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Education
further amends 34 CFR part 97 as
published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
PART 97—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 97
continues to read as follows:
List of Subjects in 32 CFR Part 219
Frm 00008
§ 219.101
■
DEPARTMENT OF DEFENSE
PO 00000
2. Amend § 219.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
Sfmt 4700
Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–
3, 3474.
2. Amend § 97.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 97.101
*
To what does this policy apply?
*
*
(l) * * *
E:\FR\FM\22JAR1.SGM
22JAR1
*
*
Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 97.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 97.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
pursuant to § 16.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Gina S. Farrisee,
Deputy Chief of Staff, Department of
Veterans Affairs.
ENVIRONMENTAL PROTECTION
AGENCY
List of Subjects in 40 CFR Part 26
Human research subjects, Reporting
and record-keeping requirements,
Research.
Betsy DeVos,
Secretary of Education.
For the reasons stated in the
preamble, the Environmental Protection
Agency further amends 40 CFR part 26
as published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
DEPARTMENT OF VETERANS
AFFAIRS
PART 26—PROTECTION OF HUMAN
SUBJECTS
List of Subjects in 38 CFR Part 16
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Veterans
Affairs further amends 38 CFR part 16
as published in the Federal Register on
January 19, 2017 (82 FR 7149) as
follows:
1. The authority citation for 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).
2. Amend § 16.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 16.101
To what does this policy apply?
ethrower on DSK3G9T082PROD with RULES
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 16.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
VerDate Sep<11>2014
15:52 Jan 19, 2018
Jkt 244001
1. The authority citation for 26
continues to read as follows:
■
Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a)
and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec.
201, Pub. L. 109–54, 119 Stat. 531; and 42
U.S.C. 300v–1(b).
2. Amend § 26.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
To what does this policy apply?
*
■
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects in 45 CFR Part 46
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of Health and
Human Services further amends 45 CFR
part 46 as published in the Federal
Register on January 19, 2017 (82 FR
7149) as follows:
PART 46—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 46
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a);
42 U.S.C. 300v–1(b).
2. Amend § 46.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 46.101
To what does this policy apply?
*
§ 26.101
PART 16—PROTECTION OF HUMAN
SUBJECTS
2893
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 26.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 26.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
E. Scott Pruitt,
Administrator, Environmental Protection
Agency.
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 46.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 46.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Eric D. Hargan,
Acting Secretary, Department of Health and
Human Services.
NATIONAL SCIENCE FOUNDATION
List of Subjects in 45 CFR Part 690
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the National Science
Foundation further amends 45 CFR part
690 as published in the Federal Register
on January 19, 2017 (82 FR 7149) as
follows:
E:\FR\FM\22JAR1.SGM
22JAR1
2894
Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations
PART 690—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 690
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 690.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
■
§ 690.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
pursuant to § 690.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 690.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Lawrence Rudolph,
General Counsel.
pursuant to § 11.101(i), or for which a
determination was made that the
research was exempt before July 19,
2018, shall comply with the pre-2018
Requirements, except that an institution
engaged in such research on or after July
19, 2018 may instead comply with the
2018 Requirements if the institution
determines that such ongoing research
will comply with the 2018
Requirements and an IRB documents
such determination.
(4) Research initially approved by an
IRB, for which such review was waived
pursuant to § 11.101(i), or for which a
determination was made that the
research was exempt on or after July 19,
2018, shall comply with the 2018
Requirements.
*
*
*
*
*
Elaine L. Chao,
Secretary of Transportation.
[FR Doc. 2018–00997 Filed 1–17–18; 4:15 pm]
BILLING CODE 4150–36–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2018–0023; Product
Identifier 2017–NM–084–AD; Amendment
39–19164; AD 2018–02–11]
RIN 2120–AA64
DEPARTMENT OF TRANSPORTATION
Airworthiness Directives; Airbus
Airplanes
49 CFR Part 11
AGENCY:
List of Subjects in 49 CFR Part 11
Human research subjects, Reporting
and record-keeping requirements,
Research.
For the reasons stated in the
preamble, the Department of
Transportation further amends 49 CFR
part 11 as published in the Federal
Register on January 19, 2017 (82 FR
7149) as follows:
PART 11—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 11
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 11.101 by revising
paragraphs (l)(3) and (4) to read as
follows:
ethrower on DSK3G9T082PROD with RULES
■
§ 11.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(3) Research initially approved by an
IRB, for which such review was waived
VerDate Sep<11>2014
15:52 Jan 19, 2018
Jkt 244001
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; request for
comments.
We are adopting a new
airworthiness directive (AD) for certain
Airbus Model A330–301, –321, –322
and –342 airplanes. This AD requires
contacting the FAA to obtain
instructions for addressing the unsafe
condition on these products, and doing
the actions specified in those
instructions. This AD was prompted by
a report of cracking in the top skin of
the horizontal stabilizer (HS) center box
(CB) of an airplane in pre-modification
41330 configuration. We are issuing this
AD to address the unsafe condition on
these products.
DATES: This AD becomes effective
February 6, 2018.
We must receive comments on this
AD by March 8, 2018.
ADDRESSES: You may send comments,
using the procedures found in 14 CFR
11.43 and 11.45, by any of the following
methods:
SUMMARY:
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations,
M–30, West Building Ground Floor,
Room W12–140, 1200 New Jersey
Avenue SE, Washington, DC 20590.
• Hand Delivery: U.S. Department of
Transportation, Docket Operations,
M–30, West Building Ground Floor,
Room W12–140, 1200 New Jersey
Avenue SE, Washington, DC, between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
Examining the AD Docket
You may examine the AD docket on
the internet at https://
www.regulations.gov by searching for
and locating Docket No. FAA–2018–
0023; or in person at the Docket
Operations office between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. The AD docket
contains this AD, the regulatory
evaluation, any comments received, and
other information. The street address for
the Docket Operations office (telephone:
800–647–5527) is in the ADDRESSES
section. Comments will be available in
the AD docket shortly after receipt.
FOR FURTHER INFORMATION CONTACT:
Vladimir Ulyanov, Aerospace Engineer,
International Section, Transport
Standards Branch, FAA, 1601 Lind
Avenue SW, Renton, WA 98057–3356;
telephone: 425–227–1138; fax: 425–
227–1149.
SUPPLEMENTARY INFORMATION:
Discussion
The European Aviation Safety Agency
(EASA), which is the Technical Agent
for the Member States of the European
Union, has issued EASA AD 2017–0078,
dated May 3, 2017 (referred to after this
as the Mandatory Continuing
Airworthiness Information, or ‘‘the
MCAI’’), to correct an unsafe condition
for certain Airbus Model A330–301,
–321, –322 and –342 airplanes. The
MCAI states:
Cracks were found in the horizontal
stabilizer (HS) centre box (CB) top skin of an
aeroplane in pre-modification 41330
configuration. The cracks were initiated at
the upper flange corner at Rib 3 rear spar area
on left hand side of the CB.
This condition, if not detected and
corrected, could lead to reduced structural
integrity of the HS CB of the aeroplane.
To address this unsafe condition, Airbus
published Service Bulletin (SB) A330–55–
3046 to provide inspection instructions for
the affected area.
For the reason described above, this
[EASA] AD requires a one-time special
detailed inspection (SDI) of the HS CB top
E:\FR\FM\22JAR1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Rules and Regulations]
[Pages 2885-2894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00997]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules
and Regulations
[[Page 2885]]
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
6 CFR Part 46
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
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 431
AGENCY FOR INTERNATIONAL DEVELOPMENT
22 CFR Part 225
DEPARTMENT OF LABOR
29 CFR Part 21
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
RIN 0937-AA06
NATIONAL SCIENCE FOUNDATION
45 CFR Part 690
DEPARTMENT OF TRANSPORTATION
49 CFR Part 11
Federal Policy for the Protection of Human Subjects: Delay of the
Revisions to the Federal Policy for the Protection of Human Subjects
AGENCY: Department of Homeland Security; Department of Agriculture;
Department of Energy; National Aeronautics and Space Administration;
Department of Commerce; Consumer Product Safety Commission; Social
Security Administration; Agency for International Development;
Department of Labor; 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: Interim final rule; delay of effective and compliance dates;
request for comments.
-----------------------------------------------------------------------
SUMMARY: In a final rule published on January 19, 2017, federal
departments and agencies listed in this document made revisions to the
Federal Policy for the Protection of Human Subjects. The Consumer
Product Safety Commission (CPSC) adopted the same regulatory changes in
a separate final rule published on September 18, 2017. The revised
policy, reflected in both final rules, is described here as the ``2018
Requirements.'' The 2018 Requirements are scheduled to become effective
on January 19, 2018, with a general compliance date of January 19, 2018
(with the exception of the revisions to the cooperative research
provision).
This interim final rule delays the effective date and general
compliance date of the 2018 Requirements to July 19, 2018. The federal
departments and agencies listed in this document are in the process of
developing a proposed rule to further delay implementation of the 2018
Requirements. The limited implementation delay accomplished by this
interim final rule both provides additional time to regulated entities
for the preparations necessary to implement the 2018 Requirements, and
additional time for the departments and agencies listed in this
document to seek input from interested stakeholders through a notice
and comment rulemaking process that allows for public engagement on the
proposal for a further implementation delay.
DATES: This interim final rule is effective on July 19, 2018. This
interim final rule delays until July 19, 2018, the effective date and
general compliance date of the final rule published in the Federal
Register (82 FR 7149, Jan. 19 2017) and of the final rule published by
the Consumer Product Safety Commission in the Federal Register (82 FR
43459, Sept. 18, 2017). To be assured consideration, comments must be
received at one of the addresses provided below, no later than 11:59
p.m. Eastern Standard Time on March 19, 2018.
ADDRESSES: You may submit comments, identified by docket ID number HHS-
OPHS-2017-0001 by one of the following methods:
Federal eRulemaking Portal (https://www.regulations.gov):
[cir] Enter the following link into your web browser's address bar:
https://www.regulations.gov/document?D=HHS-OPHS-2017-0001.
[cir] Click the blue ``Comment Now!'' button in the upper right
hand corner and follow the instructions on how to submit a comment.
[cir] Alternatively, you can enter the docket ID number into the
``search'' box on the main page of the Federal eRulemaking Portal
(https://www.regulations.gov) to find the electronic docket.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions] to: Jerry Menikoff, M.D., J.D., OHRP,
[[Page 2886]]
1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
Comments received, including any personal information,
will be posted without change to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Office for
Human Research Protections (OHRP), Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852;
telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071;
email [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On September 8, 2015, HHS and 15 other federal departments and
agencies published a Notice of Proposed Rulemaking (NPRM) proposing
revisions to each agency's codification of the Federal Policy for the
Protection of Human Subjects, originally promulgated as a Common Rule
in 1991. 80 FR 53931. On January 19, 2017, HHS and other federal
departments and agencies published a final rule revising the Federal
Policy for the Protection of Human Subjects. 82 FR 7149. The revised
policy is hereafter referred to as the ``2018 Requirements.'' The 2018
Requirements are scheduled to become effective on January 19, 2018,
with a general compliance date of January 19, 2018 (with the exception
of the revisions to the cooperative research provision at Sec.
_.114(b), for which the compliance date is January 20, 2020).
After publication of the 2018 Requirements, representatives of the
regulated community, including organizations representing recipients of
federal human subjects research awards, expressed concern regarding the
regulated community's ability to implement all of the 2018 Requirements
by the scheduled general compliance date.\1\ Some of these stakeholders
asked for a delay in the general compliance date of the 2018
Requirements with the exception of certain burden-reducing provisions
of the 2018 Requirements, including certain carve-outs from the
definition of ``research,'' exemptions, elimination of the continuing
review requirement for certain categories of research, and the
elimination of the requirement that institutional review boards (IRBs)
review grant applications. The HHS Secretary's Advisory Committee on
Human Research Protections (SACHRP) also recommended in August 2017
that implementation of the 2018 Requirements should be delayed.\2\
---------------------------------------------------------------------------
\1\ See the June 21, 2017 letter to Jerry Menikoff from the
Association of American Medical Colleges, Association of American
Universities, Association of Public & Land-grant Universities, and
Council on Governmental Relations, available at https://www.cogr.edu/sites/default/files/AAMC_AAU_APLU_COGR%20Common%20Rule%20Delay%20Letter%206-21-2017.pdf.
See the June 9, 2017 letter to Secretary Thomas Price from the
American Medical Informatics Association at https://www.amia.org/sites/default/files/AMIA%20Letter%20Regarding%20the%20Common%20Rule.pdf.
\2\ SACHRP Recommendations of August 2, 2017, Attachment A:
https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-august-2-2017/.
---------------------------------------------------------------------------
II. Delay of the Effective Date and General Compliance Date
Through this interim final rule, we are delaying the effective date
and the general compliance date of the 2018 Requirements for six
months, until July 19, 2018. As described below, we revise Sec.
_.101(l)(3)-(4) to specify that the general compliance date for the
2018 Requirements is July 19, 2018.
Prior to July 19, 2018, regulated entities will continue to comply
with the pre-2018 Requirements and those requirements will be enforced
by the Common Rule departments and agencies. To clarify, regulated
entities are not allowed, prior to July 19, 2018, to comply with the
2018 Requirements in lieu of the pre-2018 Requirements. Unless further
regulatory action is taken, studies initiated on or after July 19,
2018, will be required to comply with the 2018 Requirements. Studies
initiated prior to July 19, 2018 (i.e., studies initially approved by
an IRB, studies for which IRB review was waived pursuant to Sec.
_.101(i), or studies determined to be exempt, before July 19, 2018)
would, as a default, continue to be subject to the pre-2018
Requirements for their duration. This will maintain the ability of
institutions to hold such studies to the same set of standards
throughout the studies' duration, and will avoid a requirement that
such research be subject to two sets of rules. However, on or after
July 19, 2018, institutions may elect instead to conduct such studies
in compliance with the 2018 Requirements, as set forth in Sec.
_.101(l)(3).
This interim final rule does not delay the compliance date for the
cooperative research provision of the 2018 Requirements (Sec.
_.114(b)), which remains January 20, 2020.
III. Good Cause for Interim Final Rule
Under Section 553(b) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.), a notice of proposed rulemaking is not required
when an agency, for good cause, finds that notice and public comment
thereon are impracticable, unnecessary, or contrary to the public
interest. Pursuant to 5 U.S.C. 553(b)(3)(B), we find that good cause
exists to waive normal rulemaking requirements for the delay of the
effective date and general compliance date to July 19, 2018. We believe
that a notice-and-comment procedure, in this limited instance, is
impracticable, unnecessary, or contrary to the public interest.
Representatives of the regulated community, and HHS's own advisory
committee, have requested a delay in implementation of the 2018
Requirements, citing the final rule's complexity, the absence of needed
guidance, and the need to revamp institutional procedures and
electronic systems in order to come into compliance with the
requirements of the rule. We agree that regulated entities need
additional time for implementation and compliance, which would be
furthered by the issuance of guidance by the Common Rule agencies.
Without a delay, and without guidance, institutions that have expected
a delay who hastily attempt to implement the revised rule without
adequate preparation are bound to make mistakes, the consequences of
which may jeopardize the proper conduct of research and the safety and
wellbeing of human subjects. At this point, it is impracticable to
gather comments on an implementation delay prior to January 19, 2018,
the scheduled effective date of the 2018 Requirements.
In addition, the benefits underlying this interim final rule, i.e.,
providing certainty to entities in the regulated community that they
will be afforded additional time before being subject to compliance
with the 2018 Requirements prior to the date such requirements are
scheduled to go into effect, would be substantially undermined if a
notice and comment process were to occur before the delay set forth in
this interim final rule was finalized. For example, we understand that
regulated entities may need to devise new policies and procedures and
new information technology systems to accommodate the 2018 Requirements
in advance of the applicable effective and compliance date. In
addition, the effect of this interim final rule is simply to maintain
the status quo by continuing to require compliance with the pre-2018
Requirements for several months.
Further, the federal departments and agencies named in this interim
final rule are developing a notice of proposed rulemaking in order to
fully engage regulated entities and the public regarding further delay
of the 2018 Requirements until January 21, 2019.
[[Page 2887]]
The additional time provided by the six month delay in this interim
final rule will allow sufficient time for the notice and comment
rulemaking process to be completed. Issuance of this interim final rule
avoids the possible result of having the federal departments and
agencies propose an implementation delay but be unable to complete the
rulemaking process and publish a final rule that would be effective by
January 19, 2018. This could have resulted in the absurd circumstance
in which regulated entities would be technically required to come into
compliance with the 2018 Requirements on January 19, 2018, only until
the date a final rule implementing the delay became effective. In this
unique circumstance, allowing the regulation to become effective while
further rulemaking for delay is ongoing would create confusion for, and
impose unnecessary burdens on, the regulated community.
We also find that good cause exists for immediate implementation of
this interim final rule and waiver of the 30-day delay in the effective
date generally required by the APA. The APA provides that an agency is
not required to delay the effective date when the agency, for good
cause, finds that the requirement is impracticable, unnecessary, or
contrary to the public interest (5 U.S.C. 553(d)(3)). Given the reasons
identified above for the good cause to dispense with notice and
comment, we believe that this requirement is also met here. Further,
the 30-day delay in the effective date is normally intended to give
affected parties time to adjust their business practices and make
preparations before a final rule takes effect. Because the action being
taken delays the effective date to July 19, 2018 and thus maintains the
status quo, an additional 30-day delay of this action is unnecessary.
Department of Homeland Security
The rule issued by the Department of Homeland Security (DHS) is
consistent with section 8306 of Public Law 108-458, the Intelligence
Reform and Terrorism Prevention Act of 2004, under which DHS shall
comply with 45 CFR part 46 or equivalent regulations issued by DHS;
continued adherence to the HHS standard best ensures that DHS does not
lose critical research opportunities as a result of inconsistent
federal standards. The DHS rule is also consistent with DHS's waiver
authority under forthcoming 6 CFR 46.101(i), as well as the exemption
at 5 U.S.C. 553(a)(2) for rules related to ``loans, grants, benefits,
or contracts.''
Department of Education
Continued adherence to the HHS standard protects the Department of
Education (ED) from the potential loss of critical research
opportunities as a result of inconsistent federal standards. The ED
rule is also consistent with ED's waiver authority under 34 CFR
97.101(i).
IV. Legal Authorities
The legal authorities for the departments and agencies that are
signatories to this action are as follows:
Department of Homeland Security, 5 U.S.C. 301; Public Law 107-296,
sec. 102, 306(c); Public Law 108-458, sec. 8306. 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). Social Security
Administration, 5 U.S.C. 301; 42 U.S.C. 289(a). Agency for
International Development, 5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless
otherwise noted. Department of Labor, 5 U.S.C. 301; 29 U.S.C. 551.
Department of Defense, 5 U.S.C. 301. Department of Education, 5 U.S.C.
301; 20 U.S.C. 1221e-3, 3474. 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; 7 U.S.C. 136a(a) and 136w(a)(1); 21
U.S.C. 346a(e)(1)(C); sec. 201, Public Law 109-54, 119 Stat. 531; and
42 U.S.C. 300v-1(b). Department of Health and Human Services, 5 U.S.C.
301; 42 U.S.C. 289(a); 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. Regulatory Impact Analyses
We have examined the effects of this interim final rule under
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), Executive Order 13771 on Reducing Regulation
and Controlling Regulatory Costs (January 30, 2017), the Paperwork
Reduction Act of 1995 (Pub. L. 104-13), the Regulatory Flexibility Act,
(Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism
(August 4, 1999).
A. Executive Orders 12866, 13563, and 13771
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 is supplemental to and reaffirms the principles,
structures, and definitions governing regulatory review as established
in Executive Order 12866, emphasizing the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. In accordance with the provisions of
Executive Order 12866, this interim final rule has been determined to
be a ``significant'' regulatory action and was submitted to the Office
of Management and Budget (OMB) for review.
Executive Order 13771 directs Agencies to identify at least two
existing regulations to be repealed for every new regulation unless
prohibited by law. The total incremental cost of all regulations issued
in a given fiscal year must have costs within the amount of incremental
costs allowed by the Director of the Office of Management and Budget,
unless otherwise required by law or approved in writing by the Director
of the Office of Management and Budget. This action's designation as
regulatory or deregulatory will be informed by comments received in
response to this interim final rule. Details on the interim estimates
of costs and cost savings of this rule can be found in the economic
analysis below.
1. Need for Final Rule and Summary
This interim final rule is intended to provide additional time to
regulated entities for the preparations necessary to implement the 2018
Requirements. This interim final rule further allows time for the
federal departments and agencies named in this interim final rule to
conduct a notice and comment rulemaking process that will allow for
public engagement as to whether a further delay in the implementation
of the 2018 Requirements would be desirable.
2. Analysis of Benefits (Cost-Savings) and Costs (Foregone Benefits)
\3\
---------------------------------------------------------------------------
\3\ Note, that the terms ``benefits'' and ``cost-savings'' are
used interchangeably in this RIA. Similarly, the terms ``costs'' and
``foregone benefits'' are also used interchangeably.
---------------------------------------------------------------------------
The RIA for the 2018 Requirements described the benefits and costs
of 16
[[Page 2888]]
broad categories of changes finalized. The RIA for this interim final
rule uses the information and calculations described in the preamble to
the 2018 Requirements as a base for estimating benefits and costs of
delaying implementation of the 2018 Requirements by six months. The
time period for the analysis in this RIA is January 2018 to July 2018.
Table 1 summarizes the quantified costs and cost savings of
delaying implementation of 2018 Requirements. Over the period of
January 2018 to July 2018, annualized cost savings of $7.4 million are
estimated using a 3 percent discount rate; and $6.9 million using a 7
percent discount rate. Annualized costs of $49.5 million are estimated
using a 3 percent discount rate; and $45.9 million using a 7 percent
discount rate. Note that all values are represented in millions of 2016
dollars, and 2016 is used as the frame of reference for discounting.
Table 1--All Benefits and Costs of Delaying the 2018 Requirements by Six
Months
------------------------------------------------------------------------
------------------------------------------------------------------------
Annualized value by discount rate
(millions of 2016 dollars)
------------------------------------------------------------------------
BENEFITS (COST-SAVINGS)......... 3 Percent......... 7 Percent.
Quantified Benefits............. 7.4............... 6.9.
COSTS (FOREGONE BENEFITS)....... 3 Percent......... 7 Percent.
Quantified Costs................ 49.5.............. 45.9.
------------------------------------------------------------------------
The estimated benefits and costs of delaying the 2018 Requirements
by six months are shown in Table 2 below. Note that the categorization
shown below includes the same 16 categories used in the RIA of 2018
Requirements.
Table 2--Accounting Table of Quantified Benefits (Cost-Savings) and Costs (Foregone Benefits) of Delaying the
2018 Requirements by Six Months \4\
----------------------------------------------------------------------------------------------------------------
Annualized value over 1 year by discount rate (millions of
2016 dollars)
---------------------------------------------------------------
2018 Requirement RIA category Benefits (cost-savings) Costs (foregone benefits)
---------------------------------------------------------------
3% 7% 3% 7%
----------------------------------------------------------------------------------------------------------------
Regulated Community Learning New Requirements - - - -
and Developing Training Materials; OHRP
Developing Training and Guidance Materials, and
Implementing the 2018 Requirements.............
Extending Oversight to IRBs Unaffiliated with an 4.47 4.14 - -
Institution Holding an FWA (impact to IRBs not
operated by an FWA-holding institution)........
Excluding Activities from the Requirements of - - 0.94 0.88
the Common Rule because They are not Research..
Clarifying and Harmonizing Regulatory - - - -
Requirements and Agency Guidance...............
Modifying the Assurance Requirements............ - - 0.31 0.29
Requirement for Written Procedures and - - - -
Agreements for Reliance on IRBs Not Operated by
the Engaged Institution (impact to FWA-holding
institutions)..................................
Eliminating the Requirement that the Grant - - 17.0 15.7
Application Undergo IRB Review and Approval....
Expansion of Research Activities Exempt from 0.01 0.01 20.8 19.3
Full IRB Review................................
Elimination of Continuing Review of Research 2.07 1.92 7.73 7.17
Under Specific Conditions......................
Amending the Expedited Review Procedures........ - - 2.66 2.47
Cooperative Research (single IRB mandate in - - - -
multi-institutional research) \5\..............
Changes in the Basic Elements of Consent, - - - -
Including Documentation........................
Obtaining Consent to Secondary Use of - - - -
Identifiable biospecimens and Identifiable
private information............................
Elimination of Pre-2018 Rule Requirement to - - 0.07 0.06
Waive Consent in Certain Subject Recruitment
Activities.....................................
Requirement for Posting of Consent Forms for 0.85 0.79 - -
Clinical Trials Conducted or supported by
Common Rule Department or Agencies.............
Alteration in Waiver for Documentation of - - - -
Informed Consent in Certain Circumstances......
----------------------------------------------------------------------------------------------------------------
\4\ Zeroes in Table 2 (represented by ``-'') signify that the category has been unaffected by the six month
delay of the 2018 Requirements, The category could be unaffected for one of two reasons: (1) No costs or
benefits were associated with the category in the RIA for the 2018 Requirements; or (2) the costs and benefits
of the provision during the six month delay are the same as those estimated in the RIA for the 2018
Requirements.
\5\ Because compliance with this provision is not required until 2020, benefits and costs here are not included.
[[Page 2889]]
We assume that, in almost all categories described in the RIA for
the 2018 Requirements, the foregone benefits (costs) of delaying the
2018 Requirements by six months are what would have been the benefits
of implementing the 2018 Requirements during the period of January
through July of 2018. Similarly, we assume that, in almost all
categories described in the RIA for the 2018 Requirements, the benefits
(cost-savings) associated with delaying the 2018 Requirements by six
months are what would have been the costs of implementing the 2018
Requirements during the period of January through July of 2018. We
assume this because these categories generally would not have required
significant guidance from Common Rule departments or agencies in order
to implement the provisions, and thus could have been implemented as
assumed in the economic analysis contained in the RIA for the 2018
Requirements.
The exceptions to the above assumption relate to two RIA
categories: (1) Excluding activities from the Common Rule because they
are not research; and (2) the expansion of research activities exempt
from full IRB review. The 2018 Requirements include four explicit
categories of activities that have been deemed not research for the
purposes of the Common Rule. In the absence of guidance, it would be
difficult for institutions to fully take advantage of the exclusion of
activities from the definition of research; therefore we now assume
that many institutions would not have used these categories without
guidance.
The 2018 Requirements also include five new exemption categories,
and modify all but one exemption that exists in the pre-2018
Requirements. We have received feedback from SACHRP that many of the
exemption categories will require significant guidance in order to be
implemented.\6\ Areas where significant guidance is needed include:
Applying the categories of the new exemptions themselves, conducting
limited IRB review (as required in four exemptions), developing and
using broad consent (as required in two exemptions), utilizing the
exemption for certain HIPAA covered activities, and understanding which
federally supported or conducted nonresearch information collections
qualify for exemption.
---------------------------------------------------------------------------
\6\ SACHRP Recommendations of August 2, 2017: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/.
---------------------------------------------------------------------------
Because the guidance necessary to implement these provisions has
not yet been developed, we now assume that 50 percent of the regulated
entities would not have taken advantage of the expansion in exemptions
or the revised definition of research during the six-month delay. For
these entities, we assume that there are no benefits and costs of the
proposed delay, because they would not have changed their operations.
We assume that 50 percent of the regulated entities would have gone
forward with using the new or expanded exemption categories under the
2018 Requirements; for these entities, there are costs of delaying the
implementation of this provision during the six-month delay of this
interim final rule. We are seeking comment on these assumptions.
B. Paperwork Reduction Act (PRA)
This interim final rule does not impose any additional information
collection burden under the PRA, and does not contain any information
collection activities beyond the information collection already
approved by OMB under control number 0990-0260.
C. Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the
Small Business Regulatory Enforcement Fairness Act of 1996, which
amended the RFA, require agencies that issue a regulation to analyze
options for regulatory relief for small businesses. If a rule has a
significant impact on a substantial number of small entities, agencies
must specifically consider the economic effect of the rule on small
entities and analyze regulatory options that could lessen the impact of
the rule. The RFA generally defines a ``small entity'' as (1) a
proprietary firm meeting the size standards of the Small Business
Administration (SBA); (2) a nonprofit organization that is not dominant
in its field; or (3) a small government jurisdiction with a population
of less than 50,000 (states and individuals are not included in the
definition of ``small entity''). HHS considers a rule to have a
significant economic impact on a substantial number of small entities
if at least 5 percent of small entities experience an impact of more
than 3 percent of revenue.
This action does not have a significant economic impact on a
substantial number of small entities under the RFA. In making this
determination, the impact of concern is any significant adverse
economic impact on small entities. An agency may certify that a rule
will not have a significant economic impact on a substantial number of
small entities if the rule relieves regulatory burden, has no net
burden or otherwise has a positive economic effect on the small
entities subject to the rule. This interim final rule does not impose a
regulatory burden for regulated small entities because it delays the
effective date and general compliance date of the 2018 Requirements,
allowing the status quo to be retained for the period of delay. We
have, therefore, concluded that this action will have no net regulatory
burden for all directly regulated small entities.
D. Unfunded Mandates Reform Act (UMRA)
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the most current (2016) implicit
price deflator for the gross domestic product. We do not expect this
interim final rule to result in expenditures that will exceed this
amount. This action does not contain any unfunded mandate as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments.
E. Executive Order 13132: Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that imposes substantial
direct requirement costs on state and local governments or has
federalism implications. We have determined that the interim final rule
does 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. The changes to the 2018 Requirements
contained in this interim final rule represent the Federal Government
regulating its own program. Accordingly, we conclude that the interim
final rule does not contain policies that have federalism implications
as defined in Executive Order 13132 and, consequently, a federalism
summary impact statement is not required.
[[Page 2890]]
For the reasons set forth in the preamble, the Federal Policy for
the Protection of Human Subjects, as published in the Federal Register
on January 19, 2017 (82 FR 7149) and as adopted in a final rule
published by the CPSC on September 18, 2017 (82 FR 43459), this common
rule is further amended as follows:
Text of the Amended Common Rule
PART _--PROTECTION OF HUMAN SUBJECTS
0
1. Amend Sec. _.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. _.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. _.101(i), or for which a determination was
made that the research was exempt before July 19, 2018, shall comply
with the pre-2018 Requirements, except that an institution engaged in
such research on or after July 19, 2018 may instead comply with the
2018 Requirements if the institution determines that such ongoing
research will comply with the 2018 Requirements and an IRB documents
such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. _.101(i), or for which a determination was
made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
DEPARTMENT OF HOMELAND SECURITY
List of Subjects in 6 CFR Part 46
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Homeland
Security further amends 6 CFR part 46 as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:
PART 46--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 46 continues to read as follows:
Authority: 5 U.S.C. 301; P.L. 107-296, sec. 102, 306(c); P.L.
108-458, sec. 8306.
0
2. Amend Sec. 46.101 by revising paragraphs (l)(1), (2), (3), and (4)
to read as follows:
Sec. 46.101 To what does this policy apply?
* * * * *
(l) * * *
(1) For purposes of this section, the pre-2018 Requirements means
Subpart A to 45 CFR part 46, as published in the 2016 edition of the
Code of Federal Regulations, which is the rule that DHS applied before
it first promulgated this subpart.
(2) For purposes of this section, the 2018 Requirements means the
Federal Policy for the Protection of Human Subjects requirements
contained in this part. The general compliance date for the 2018
Requirements is July 19, 2019. The compliance date for Sec. 46.114(b)
(cooperative research) of the 2018 Requirements is January 20, 2020.
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 46.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 46.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
William Bryan,
Deputy Under Secretary for Science & Technology.
DEPARTMENT OF AGRICULTURE
List of Subjects in 7 CFR Part 1c
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of
Agriculture further amends 7 CFR part 1c as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:
PART 1c--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 1c continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 1c.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 1c.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 1c.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 1c.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Chavonda Jacobs-Young,
Acting Deputy Under Secretary for Research, Education, and
Economics, USDA.
DEPARTMENT OF ENERGY
List of Subjects in 10 CFR Part 745
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Energy
further amends 10 CFR part 745 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:
PART 745--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 745 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 745.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 745.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 745.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018
[[Page 2891]]
Requirements and an IRB documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 745.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Dan Brouillette,
Deputy Secretary of Energy.
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
List of Subjects in 14 CFR Part 1230
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the National Aeronautics
and Space Administration further amends 14 CFR part 1230 as published
in the Federal Register on January 19, 2017 (82 FR 7149) as follows:
PART 1230--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 1230 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 1230.101 by revising paragraphs (l)(3) and (4) to read
as follows:
Sec. 1230.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 1230.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 1230.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
James D. Polk,
Chief Health & Medical Officer, National Aeronautics and Space
Administration.
DEPARTMENT OF COMMERCE
List of Subjects in 15 CFR Part 27
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Commerce
further amends 15 CFR part 27 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:
PART 27--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 27 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 27.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 27.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 27.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 27.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Wilbur L. Ross,
The Secretary of Commerce.
CONSUMER PRODUCT SAFETY COMMISSION
List of Subjects in 16 CFR Part 1028
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Consumer Product Safety
Commission further amends 16 CFR part 1028 as published in the Federal
Register on January 19, 2017 (82 FR 7149) and as adopted in a final
rule published by the CPSC on September 18, 2017 (82 FR 43459) as
follows:
PART 1028--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 1028 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 1028.101 by revising paragraphs (l)(3) and (4) to read
as follows:
Sec. 1028.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 1028.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 1028.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
SOCIAL SECURITY ADMINISTRATION
List of Subjects in 20 CFR Part 431
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Social Security
Administration further amends 20 CFR part 431 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:
PART 431--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 431 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
0
2. Amend Sec. 431.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 431.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 431.101(i), or for which a determination
was made that the
[[Page 2892]]
research was exempt before July 19, 2018, shall comply with the pre-
2018 Requirements, except that an institution engaged in such research
on or after July 19, 2018 may instead comply with the 2018 Requirements
if the institution determines that such ongoing research will comply
with the 2018 Requirements and an IRB documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 431.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Nancy Berryhill,
Acting Commissioner, Social Security Administration.
AGENCY FOR INTERNATIONAL DEVELOPMENT
List of Subjects in 22 CFR Part 225
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Agency for
International Development further amends 22 CFR part 225 as published
in the Federal Register on January 19, 2017 (82 FR 7149) as follows:
PART 225--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 225 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless otherwise
noted.
0
2. Amend Sec. 225.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 225.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 225.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 225.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Irene Koek,
Senior Deputy Assistant Administrator for Global Health, U.S. Agency
for International Development.
DEPARTMENT OF LABOR
List of Subjects in 29 CFR Part 21
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Labor
further amends 29 CFR part 21 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:
PART 21--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 21 continues to read as follows:
Authority: 5 U.S.C. 301; 29 U.S.C. 551.
0
2. Amend Sec. 21.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 21.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 21.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 21.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
R. Alexander Acosta,
Secretary of Labor.
DEPARTMENT OF DEFENSE
List of Subjects in 32 CFR Part 219
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Defense
further amends 32 CFR part 219 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:
PART 219--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 219 continues to read as follows:
Authority: 5 U.S.C. 301.
0
2. Amend Sec. 219.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 219.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 219.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 219.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Mary J. Miller,
Principal Deputy, Assistant Secretary of Defense for Research and
Engineering.
DEPARTMENT OF EDUCATION
List of Subjects in 34 CFR Part 97
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Education
further amends 34 CFR part 97 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:
PART 97--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 97 continues to read as follows:
Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474.
0
2. Amend Sec. 97.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 97.101 To what does this policy apply?
* * * * *
(l) * * *
[[Page 2893]]
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 97.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 97.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Betsy DeVos,
Secretary of Education.
DEPARTMENT OF VETERANS AFFAIRS
List of Subjects in 38 CFR Part 16
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Veterans
Affairs further amends 38 CFR part 16 as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:
PART 16--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 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).
0
2. Amend Sec. 16.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 16.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 16.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 16.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Gina S. Farrisee,
Deputy Chief of Staff, Department of Veterans Affairs.
ENVIRONMENTAL PROTECTION AGENCY
List of Subjects in 40 CFR Part 26
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Environmental
Protection Agency further amends 40 CFR part 26 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:
PART 26--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 26 continues to read as follows:
Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21
U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and
42 U.S.C. 300v-1(b).
0
2. Amend Sec. 26.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 26.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 26.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 26.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
E. Scott Pruitt,
Administrator, Environmental Protection Agency.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
List of Subjects in 45 CFR Part 46
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of Health
and Human Services further amends 45 CFR part 46 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:
PART 46--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 46 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 46.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 46.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 46.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 46.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
NATIONAL SCIENCE FOUNDATION
List of Subjects in 45 CFR Part 690
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the National Science
Foundation further amends 45 CFR part 690 as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:
[[Page 2894]]
PART 690--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 690 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 690.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 690.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 690.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 690.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Lawrence Rudolph,
General Counsel.
DEPARTMENT OF TRANSPORTATION
49 CFR Part 11
List of Subjects in 49 CFR Part 11
Human research subjects, Reporting and record-keeping requirements,
Research.
For the reasons stated in the preamble, the Department of
Transportation further amends 49 CFR part 11 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:
PART 11--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for 11 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 11.101 by revising paragraphs (l)(3) and (4) to read as
follows:
Sec. 11.101 To what does this policy apply?
* * * * *
(l) * * *
(3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 11.101(i), or for which a determination
was made that the research was exempt before July 19, 2018, shall
comply with the pre-2018 Requirements, except that an institution
engaged in such research on or after July 19, 2018 may instead comply
with the 2018 Requirements if the institution determines that such
ongoing research will comply with the 2018 Requirements and an IRB
documents such determination.
(4) Research initially approved by an IRB, for which such review
was waived pursuant to Sec. 11.101(i), or for which a determination
was made that the research was exempt on or after July 19, 2018, shall
comply with the 2018 Requirements.
* * * * *
Elaine L. Chao,
Secretary of Transportation.
[FR Doc. 2018-00997 Filed 1-17-18; 4:15 pm]
BILLING CODE 4150-36-P
