Document ID: EPA_FRDOC_0001-21823
Agency: epa
Document Type: Rule
Title: Federal Policy for the Protection of Human Subjects: Delay of Revisions to Federal Policy for Protection of Human Subjects
Posted Date: 2018-01-22T05:00Z

[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 (http://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 
(http://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 http://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 http://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/index.html.
---------------------------------------------------------------------------

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/index.html.
---------------------------------------------------------------------------

    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