83 FR 17595 - Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period
DEPARTMENT OF HOMELAND SECURITY
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
DEPARTMENT OF TRANSPORTATION
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 HOUSING AND URBAN DEVELOPMENT Federal Register Volume 83, Issue 77 (April 20, 2018)
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
DEPARTMENT OF TRANSPORTATION
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 HOUSING AND URBAN DEVELOPMENT
Federal Register Volume 83, Issue 77 (April 20, 2018)
| Page Range | 17595-17613 | |
| FR Document | 2018-08231 |
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)] [Proposed Rules] [Pages 17595-17613] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08231] [[Page 17593]] Vol. 83 Friday, No. 77 April 20, 2018 Part II Department of Homeland Security ----------------------------------------------------------------------- 6 CFR Part 46 Department of Agriculture ----------------------------------------------------------------------- 7 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 [[Page 17594]] Agency for International Development ----------------------------------------------------------------------- 22 CFR Part 225 Department of Housing and Urban Development ----------------------------------------------------------------------- 24 CFR Part 60 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 National Science Foundation ----------------------------------------------------------------------- 45 CFR Part 690 Department of Transportation ----------------------------------------------------------------------- 49 CFR Part 11 Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period; Proposed Rule Federal Register / Vol. 83 , No. 77 / Friday, April 20, 2018 / Proposed Rules [[Page 17595]] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY 6 CFR Part 46 DEPARTMENT OF AGRICULTURE 7 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 HOUSING AND URBAN DEVELOPMENT 24 CFR Part 60 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 NATIONAL SCIENCE FOUNDATION 45 CFR Part 690 DEPARTMENT OF TRANSPORTATION 49 CFR Part 11 Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period 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 Housing and Urban 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: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects (hereafter the ``2018 Requirements''). The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The 2018 Requirements were 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). The departments and agencies listed in this document have also published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, to cover the time period of January 19, 2018 until July 19, 2018. As per the interim final rule, the effective date of the 2018 Requirements is now July 19, 2018. The departments and agencies listed in this document propose delaying the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. This proposed rule, if finalized, would require regulated entities to continue to comply with the requirements of the current Federal Policy for the Protection of Human Subjects (hereafter the ``pre-2018 Requirements'') until January 21, 2019. This proposal also takes comment on whether to permit institutions to implement, for certain research studies, the following provisions in the 2018 Requirements during the period from July 19, 2018, until January 21, 2019, that the general compliance date is delayed. Those three provisions, intended to reduce burdens on regulated entities, are the 2018 Requirements' definition of ``research,'' which deems certain activities not to be research, the allowance for no annual continuing review of certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications related to the research. The way that this option is proposed, regulated entities would be required to comply with all pre- 2018 Requirements during the period that the general compliance date is delayed, except for provisions substituted by the three burden-reducing provisions of the 2018 Requirements. As described in section III, below, this flexibility is proposed only for studies for which an institution makes a choice to transition to comply with the 2018 Requirements, beginning on July 19, 2018. In order to clearly describe this proposed flexibility, including how it would impact institutions choosing to transition research to comply with the 2018 Requirements, this document proposes a redrafted transition provision. DATES: 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 May 21, 2018. ADDRESSES: You may submit comments, identified by docket ID number HHS- OPHS-2018-0007 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-2018-0007. [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. [[Page 17596]] Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted without change to 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 CPSC adopted the same regulatory changes, also with a scheduled effective date of January 19, 2018, in a separate final rule published on September 18, 2017. 82 FR 43459. For this reason, references in this document to the January 2017 final rule also extend to the CPSC's September 2017 final rule. The revised policy, reflected in both final rules, is hereafter referred to as the ``2018 Requirements.'' The 2018 Requirements were originally 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, some 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\ One of the two letters asked for a delay in the general compliance date of the 2018 Requirements, with the option to adopt burden-reducing provisions of the 2018 Requirements during the delay period, 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 the required implementation of the 2018 Requirements should be delayed.\2\ On January 17, 2018, HHS and other federal departments and agencies placed on display in the Federal Register an interim final rule delaying the effective date and general compliance date of the 2018 requirements to July 19, 2018. 83 FR 2885 (published January 22, 2018). On January 26, 2018, HUD published an interim final rule adopting the January 17, 2018 interim final rule. 83 FR 3589. --------------------------------------------------------------------------- \1\ Two unsolicited comments were received. 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\ August 2, 2017 SACHRP Letter to HHS Secretary, Attachment A- Recommendations on Compliance Dates and Transition Provisions, https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-august-2-2017/index.html. --------------------------------------------------------------------------- This NPRM proposes to delay the general compliance date of the 2018 Requirements by an additional six months, during the time period of July 19, 2018 to January 21, 2019. II. Proposed Delay of the General Compliance Date We propose to delay the general compliance date of the 2018 Requirements for six months after the effective date of July 19, 2018 until January 21, 2019. Given the degree of complexity involved with implementing the revised rule, we believe the delay we are proposing in this action is both an appropriate action to take at this juncture, and a reasonable time period to allow the regulated community to be prepared for compliance with the 2018 Requirements and for HHS and the other Common Rule agencies to develop implementation guidance. The 2018 requirements include new exemptions, new IRB review procedures, and new provisions pertaining to informed consent, among other revisions, and guidance would be helpful to the regulated community in understanding and complying with these requirements. As described below, we propose to revise Sec. __.101(l)(2) to specify that the general compliance date for the 2018 Requirements is January 21, 2019. We also propose to revise the dates in the transition provision at Sec. __.101(l)(3),(4) and (5) to reflect this revised general compliance date. As proposed, regulated entities would be required to comply with the pre-2018 Requirements prior to January 21, 2019, and the pre-2018 Requirements would be applied by the Common Rule departments and agencies during this period. To clarify, under this proposal, regulated entities would not be allowed, prior to January 21, 2019, to comply with all provisions of the 2018 Requirements in lieu of all provisions of the pre-2018 Requirements. As described below in section III, an exception would exist during the six-month period between July 19, 2018, and January 21, 2019, with respect to three specified burden- reducing provisions contained in the 2018 Requirements. Research initiated (i.e., initially approved by an IRB, or for which IRB review was waived pursuant to Sec. __.101(i), or determined to be exempt) before the general compliance date of the 2018 Requirements (which would now become January 21, 2019) 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. Research initiated (i.e., initially approved by an IRB, or for which IRB review was waived pursuant to Sec. __.101(i), or determined to be exempt) on or after January 21, 2019 (proposed as the new general compliance date), would need to be conducted entirely in compliance with the 2018 Requirements. This document proposes to restructure Sec. __.101(1)(3) and (4) (now numbered (5)) to aid readability. A new section Sec. __.101(l)(4) is proposed to be inserted to explain how the requirements would apply to research transitioning to take advantage of the burden-reducing provisions. We do not propose delaying the compliance date for the cooperative research provision of the 2018 Requirements (Sec. _.114(b)), which will remain January 20, 2020. [[Page 17597]] III. Proposed Flexibility for Taking Advantage of Certain Burden- Reducing Provisions Without a Delay This proposed rule also proposes to permit institutions, during the period from July 19, 2018, until January 21, 2019, that the general compliance date is proposed to be delayed, to take advantage of three provisions in the 2018 Requirements intended to minimize burdens on regulated entities (hereinafter ``three burden-reducing 2018 Requirements''). As under the January 2017 final rule, under this proposed rule, studies initiated prior to the general compliance date of the 2018 Requirements, would, as a default, remain subject to the pre-2018 Requirements for their duration unless and until a decision to transition to the 2018 Requirements (i.e., the institution chooses to have a study be subject to the 2018 Requirements) is made and documented. The January 2017 final rule provided an option for institutions to transition ongoing studies from compliance with the pre-2018 Requirements to compliance with the 2018 Requirements for the studies' duration. This proposed rule would preserve that option, and proposes an additional flexibility for ongoing studies to transition to the 2018 Requirements if the decision to transition is documented prior to January 21, 2019, which would be the new general compliance date of the 2018 Requirements. Between July 19, 2018 and January 21, 2019, institutions that elect to transition studies to the 2018 Requirements would, after the decision to transition has been documented, be able to take advantage of the three burden-reducing 2018 Requirements. This option is available for ongoing studies, as well as for studies newly initiated after July 19, 2018. This option is described in a proposed revision to Sec. __.101(l). In order to clearly outline the operation of this proposed flexibility, we propose to redraft Sec. __.101(l) to describe how the transition provision applies to research subject to the pre-2018 Requirements, research transitioned from the pre-2018 Requirements to the 2018 Requirements, and research subject to the 2018 Requirements. The revised Sec. __.101(l) describes how the pre-2018 Requirements and the 2018 Requirements apply to research initiated (i.e., initially approved by an IRB, waived under Sec. __.101(i), or determined to be exempt), during three time periods: Prior to July 19, 2018, between July 19, 2018 and January 21, 2019, and on or after January 21, 2019. As described, studies taking advantage of this option would be subject to the three burden-reducing 2018 Requirements instead of, or in addition to, the comparable provisions of the pre-2018 Requirements. The three burden-reducing 2018 Requirements are (1) the 2018 Requirements' definition of ``research'' at Sec. __.102(l) (instead of Sec. __.102(d) of the pre-2018 Requirements), which deems certain activities not to be research, (2) the elimination of the requirement that an IRB review the grant application related to the research at Sec. __.103(d) of the 2018 Requirements (instead of Sec. __.103(f) of the pre-2018 Requirements), and (3) the allowance for no annual continuing review of certain categories of research at Sec. __.109(f)(1)(i) and (iii) of the 2018 Requirements (instead of Sec. __.103(b), as related to the requirement for continuing review, and in addition to Sec. __.109, of the pre-2018 Requirements). Given that studies taking advantage of this flexibility would, if this proposal is adopted, temporarily be subject to the three burden- reducing 2018 Requirements, but not other provisions in the 2018 Requirements, we are clarifying our intended interpretations of these provisions during a transition period. First, the definition of ``research'' in the 2018 Requirements references a ``public health authority,'' a term defined in the 2018 Requirements, but not included in the pre-2018 Requirements. The reference to a ``public health authority'' in Sec. __.102(l)(3) of the 2018 Requirements would be interpreted consistent with the definition of ``public health authority'' included in the 2018 Requirements (Sec. __.102(k)). Second, Sec. __.103(d) of the 2018 Requirements refers to research ``exempted under Sec. __.104.'' Because the exemptions that will be in place during any transition period are set forth in Sec. __.101(b) of the pre-2018 Requirements, this reference to research ``exempted under Sec. __.104'' would be interpreted, during this transition period and prior to the general compliance date of the 2018 Requirements, as a reference to research exempted under Sec. __.101(b) of the pre-2018 Requirements. Third, the reference in Sec. __.109(f)(1)(i) of the 2018 Requirements to research eligible for expedited review under Sec. __.110 would be interpreted as a reference to that section in the pre- 2018 Requirements. Moreover, the documentation requirements set forth in Sec. __.115(a)(3) of the 2018 Requirements (documenting an IRB's rationale for conducting continuing review that would not otherwise be required under Sec. __.109(f)(1) of the 2018 Requirements) would not be applicable during this transition period as proposed. As proposed above, for institutions electing to transition a research study to compliance with the 2018 Requirements in order to take advantage of the three burden-reducing provisions, Sec. __.103(d) of the 2018 Requirements would be substituted for Sec. __.103(f) of the pre-2018 Requirements. Both sections address the requirement for certification of research supported by a Federal department or agency. In addition to removing the requirement that IRBs review grant applications or proposals, Sec. __.103(d) of the 2018 Requirements reflects other minor wording changes necessary to accommodate the removal of the grant application or proposal review requirement or to provide additional clarifications. Except for the three burden-reducing 2018 Requirements identified in proposed Sec. __.101(l)(4)(i)(A), institutions that elect to transition a research study to comply with the 2018 Requirements and document that decision, at any time between July 19, 2018, and January 21, 2019, would be required to comply with the pre-2018 Requirements until January 21, 2019. This approach would afford institutions additional time before they are required to comply with all provisions of the 2018 Requirements, while enabling them to take advantage of the three burden-reducing 2018 Requirements more quickly. The option of applying the three burden-reducing 2018 Requirements would only be available for studies that institutions decided to transition to comply with the 2018 Requirements on or after July 19, 2018. If an institution so chooses to apply the three burden-reducing 2018 Requirements to certain research, those studies would be required to comply with all of the 2018 Requirements beginning on January 21, 2019. An institution's decision about whether to transition a study to the 2018 requirements to take advantage of the three burden-reducing provisions might vary depending on the nature and progress of the study, including any elements of the study to be conducted on or after January 21, 2019. For example, studies planning to recruit some subjects on or after January 21, 2019 would have to meet the new requirements for obtaining the informed consent of those subjects. In contrast, for studies whose remaining activities [[Page 17598]] consist only of completing data analyses, the new requirements for informed consent generally would not be applicable. We considered stakeholder suggestions to extend this approach to other burden-reducing sections of the 2018 Requirements, such as the revised exemption categories. We do not propose adding the revised exemption categories to Sec. __.101(l)(4)(i)(A) because implementation of these categories would involve significantly greater complications. For example, these categories use terms that are newly defined or for which revised definitions have been included in the 2018 Requirements, and permitting compliance with these categories without also selectively adopting revised definitions could be problematic. To minimize confusion, this proposed rule limits those provisions for which early adoption would be permitted to those that would minimize burdens without creating significant complexities. We also considered a delay to the effective and general compliance dates without proposing this additional option in the interim period. Such an approach would be simple to implement. We decided against proposing this alternative to be responsive to public comments received and in an effort to minimize burdens with respect to new provisions that will not be difficult to implement prior to the general compliance date of the 2018 Requirements. As proposed for Sec. __.101(l)(4)(ii), if the determination to transition previously initiated studies to the 2018 Requirements is not made until on or after January 21, 2019, such studies would not benefit from the additional flexibilities created for the period between July 19, 2018 and January 21, 2019. Such studies would be required to comply with the 2018 Requirements after the date of transition. The regulatory provisions are not prescriptive regarding how an institution chooses to make its transition decisions. An institution may elect to transition research protocols to the 2018 Requirements on a protocol-by-protocol basis, or for a class of protocols (e.g., all minimal risk research), or for the institution's entire research portfolio. While these three burden reducing provisions are a regulatory package, an institution that took advantage of the flexibility proposed in this NPRM, as a matter of institutional policy, could adopt a more stringent standard (such as that of the pre-2018 rule) for any or all of these three provisions. We also propose a revision to Sec. __.101(l)(4) regarding documentation of an institution's decision to transition research begun under the pre-2018 Requirements to the 2018 Requirements. This proposal is intended to offer institutions greater flexibility regarding who documents that decision. Under the January 19, 2017, final rule, if an institution determines that ongoing research will transition to comply with the 2018 Requirements, this determination must be documented by an IRB before the transition can take effect. We now propose that, to allow ease in implementing this documentation requirement, the documentation of an institution's transition determination may be performed either by an institution (through officials who have the authority to make such determinations on behalf of the institution) or an IRB. As proposed, this documentation must include the date of the transition determination. Records documenting the transition decision must be retained as per Sec. __.115(b). Once the institution makes the determination to transition the research to the revised rule and that determination is documented, the date of documentation will serve as the de facto compliance date as applied to the research. For a study that is transitioned in accordance with Sec. __.101(l)(4)(i), between July 19, 2018, and January 20, 2019, one set of rules would apply until the general compliance date of the final rule and another would apply beginning on such general compliance date. As of the date the decision to transition is documented until January 20, 2019, the pre-2018 Requirements would be applicable, except that the three burden-reducing 2018 Requirements would apply instead of or in addition to the pre-2018 Requirements specified in Sec. __.101(l)(4)(i)(A). Beginning on January 21, 2019, the 2018 Requirements would apply for the duration of the study. As proposed, all studies that are transitioned in accordance with Sec. __.101(l)(4)(ii) on or after January 21, 2019, and all studies that are newly initiated on and after January 21, 2019, would be required to follow all of the 2018 Requirements. In summary, the proposed rule would create three options that would be available beginning July 19, 2018, that institutions may choose to follow for research studies initiated before January 21, 2019. The first option, and default, is to continue to follow all of the pre-2018 Requirements for the duration of the study. The second option is to choose to follow the pre-2018 Requirements, except for the three burden-reducing 2018 Requirements, until January 21, 2019, when all of 2018 Requirements would become applicable. The third option would be to follow the pre-2018 requirements until January 21, 2019, and at some point thereafter choose to follow all of the 2018 Requirements for the duration of the study. We also solicit comments about the advisability of the alternative of delaying the effective date and general compliance date until January 21, 2019, but without the option to implement certain 2018 Requirements during that delay period. In addition, we solicit comments on the desirability of the alternative of delaying the effective date and general compliance date beyond January 21, 2019. We do not believe the regulated community will require this additional time to come into compliance with the revised rule, but we are interested in receiving public comments on this alternative. While we considered the alternative of proposing to amend the transition provision to permit institutions to voluntarily comply with the revised rule beginning on July 19, 2018, and not requiring compliance with the new rule until January 21, 2019 or later, we believe this approach could result in confusion regarding implementation of the revised Common Rule that could be minimized with the issuance of guidance from the Common Rule departments and agencies. By making the changes proposed above, we believe the Common Rule departments and agencies will be able to issue relevant guidance documents that will better enable the regulated community to comply with the revised rule. We also solicit comments about the advisability of not making the changes proposed in this NPRM (i.e., allowing the effective date and general compliance date to remain as July 19, 2018). Finally, we note that we will consider public comments submitted in response to the interim final rules described above. 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. [[Page 17599]] 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 Housing and Urban Development, 5 U.S.C. 301; 42 U.S.C. 300v-1(b); 3535(d). 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 proposed 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 proposed rule was submitted to the Office of Management and Budget (OMB) for review, and has been determined to be a ``significant'' regulatory action. The designation, as regulatory or deregulatory under Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs, issued on January 30, 2017), of any final rule resulting from this notice of proposed rulemaking will be informed by comments received on the costs and cost savings of delaying the 2018 Requirements. Details on the preliminary estimated costs of this proposed rule can be found in the economic analysis below. 1. Need for This NPRM and Summary On January 19, 2017, HHS and 15 other federal departments and agencies published the 2018 Requirements designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies. In addition, the CPSC adopted the same regulatory changes on September 18, 2017. This proposed rule, if finalized, would allow regulated entities to continue to comply with the pre-2018 requirements until January 21, 2019. As discussed above, this proposed rule also proposes to permit institutions, during the period between July 19, 2018, and January 21, 2019, to take advantage of three provisions in the 2018 Requirements intended to minimize burdens on regulated entities. Those three burden- reducing 2018 Requirements are (1) the 2018 Requirements' definition of ``research,'' which deems certain activities not to be research, (2) the allowance for no annual continuing review of certain categories of research, and (3) the elimination of the requirement that IRBs review grant applications related to the research. As described in section III above, this flexibility is proposed for studies for which an institution makes a choice to have those studies be subject to the 2018 Requirements. 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 broad categories of changes finalized. The RIA for this NPRM uses the information and calculations described in the preamble to the 2018 Requirements as a base for estimating benefits and costs of delaying the general implementation of the 2018 Requirements by six months. The time period for the analysis in this RIA is the six month period from July 2018 to January 2019. Table 1 summarizes the quantified benefits and costs of delaying the general implementation of 2018 Requirements. Over the period of July 2018 to January 2019, annualized benefits of $6.4 million are estimated using a 3 percent discount rate; annualized benefits of $5.9 million are estimated using a 7 percent discount rate. Annualized costs of $37.2 million are estimated using a 3 percent discount rate; annualized costs of $34.4 million are estimated 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 General Compliance Date of the 2018 Requirements by Six Months [From July 19, 2018 to January 21, 2019] ------------------------------------------------------------------------ Annualized value by discount rate (millions of 2016 dollars) --------------------------------- 3 Percent 7 Percent ------------------------------------------------------------------------ Benefits (Cost-Savings): Quantified Benefits............... 6.4 5.9 Costs (Foregone Benefits): [[Page 17600]] Quantified Costs.................. 37.4 34.7 ------------------------------------------------------------------------ The estimated benefits and costs of delaying the general implementation date of 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 the 2018 Requirements. Table 2--Accounting Table of Quantified Benefits (Cost-Savings) and Costs (Foregone Benefits) of Delaying Compliance With 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) (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 -- -- 0.95 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 -- -- 8.5 7.9 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 1.04 0.96 4.10 3.80 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 Departments or Agencies............ Alteration in Waiver for Documentation of -- -- -- -- Informed Consent in Certain Circumstances...... -------------------------------- Cost Savings, as indicated by public comments -- -- (unable to attribute to particular provisions). unquantified ---------------------------------------------------------------------------------------------------------------- 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 July 2018 through January of 2019. 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 July 2018 through January of 2019. We assume this because regulated entities likely would not have difficulty implementing these provisions in the absence of guidance from Common Rule departments or agencies, and thus could have been implemented as assumed in the economic analysis contained in the RIA for the 2018 Requirements. We seek comment on these assumptions. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- Categories with different assumptions are described below: [[Page 17601]] a. Regulated Community Learning New Requirements and Developing Training Materials; OHRP Developing Training and Guidance Materials, and Implementing the 2018 Requirements We assume that even with the proposed six month delay, regulated entities and OHRP would still assume costs related to learning the new requirements and developing training materials. Thus, there are no effects estimated here. We expect that some entities would experience cost savings as a result of this proposed rule, and some entities would experience costs as a result of this proposed rule, but we lack data to quantify these effects. We request comments which provide data that can be used to quantify these effects. b. Early Implementation of the Three Burden-Reducing Provisions of the 2018 Requirements (Explicit Carve-Outs of Activities From the Definition of Research [Sec. __.102(I)]; Eliminating the Requirement That the Grant Application Undergo IRB Review and Approval [Pre-2018 Rule at Sec. __.103(f)]; Elimination of Continuing Review of Research Under Specific Conditions [Sec. Sec. __.109(f) and __.115(a)(3)] We assume that 50 percent of regulated entities will take advantage of the option proposed in this NPRM to implement three burden-reducing provisions of the 2018 Requirements early. We assume this because an institution's decision about whether to transition a study to the 2018 requirements to take advantage of the three burden-reducing provisions might vary depending on the nature and progress of the study, including any elements of the study to be conducted after January 21, 2019. For example, studies planning to recruit some subjects after January 21, 2019 would have to meet the new requirements for obtaining the informed consent of those subjects. In contrast, for studies whose remaining activities consist only of completing data analyses, the new requirements for informed consent would generally not be applicable. Therefore, we assume that there are situations where an institution would want to take advantage of the three burden-reducing provisions, and situations where an institution would not want to take advantage of this flexibility. We note that we intend to publish guidance on the carve-outs from the definition of research prior to July 2018, which may also impact an institution's decision to elect to implement the three burden-reducing provisions or not. Thus, these entities will still obtain the benefits and costs described in the RIA for the 2018 Requirements, implying no effects of this rule for 50 percent of regulated entities. For the regulated entities that do not take advantage of these flexibilities, we assume that the foregone benefits (costs) of delaying implementation of these provisions are what would have been the benefits of implementing these provisions in January of 2018. Similarly, we assume that the benefits (cost-savings) associated with delaying the implementation of these provisions are what would have been the costs of implementing these provisions in July of 2018. We assume that these regulated entities account for 50 percent of the costs and benefits that would have been experienced in 2018 absent this delay. We also assume that institutional staff at the IRB Administrative staff level \6\ will spend 5 minutes per protocol documenting the voluntary election to use the three burden-reducing 2018 provisions during the time period of July 19, 2018 to January 21, 2019. --------------------------------------------------------------------------- \6\ See the RIA to the 2018 Requirements (82 FR 7149) for more information about the labor categories used in this analysis. --------------------------------------------------------------------------- We request comment on our assumption that 50 percent of regulated entities will take advantage of the option proposed in this NPRM to implement three burden-reducing provisions of the 2018 Requirements early. Some members of the regulated community have indicated that even though the 2018 Requirements yield cost savings, these institutions are still hesitant to transition ongoing research to the 2018 Requirements, largely because of the burden of making studies already in compliance with the pre-2018 requirements comply with the 2018 requirements. Also, some institutions seem inclined to make all of the transitions at once. This interconnectedness is key to some of the assumptions noted elsewhere in this analysis. For example, if the three burden-reducing provisions are considered on their own, a reasonable assumption would be that 100 percent of affected entities would realize the associated cost savings as soon as possible. The use, instead, of a 50 percent estimate reflects entities' possible inclinations to make all transitions at once. We request comment that would provide insight into entities' views regarding the interconnectedness of the 2018 Requirements' provisions and thus allow for refinement of the 50 percent estimate. c. Expansion of Research Activities Exempt From Full IRB Review (Sec. __.104(d)) The 2018 Requirements include five new exemption categories, and modify all but one exemption that exist in the pre-2018 Requirements. We have received feedback from SACHRP that guidance will be useful for regulated entities to implement many of the exemption categories.\7\ Areas where significant guidance will be helpful 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. --------------------------------------------------------------------------- \7\ See for example, SACHRP Recommendations of August 2, 2017: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/index.html. --------------------------------------------------------------------------- Because the guidance documents that would be helpful to assist regulated entities in implementing these 2018 Common Rule provisions have not yet been developed, we assume that 50 percent of the regulated entities would not have taken advantage of the expansion in exemptions during this 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 proposed in this NPRM. We do not have data to support our assumption of what percent of regulated entities would have gone forward with the implementation of these provisions in the absence of additional guidance, and what percent would not have gone forward. We request comments on these assumptions and solicit data that can be used to quantify these effects. 3. Analysis of NPRM Alternative This NPRM includes a primary alternative proposal of delaying the general effective and compliance date to January 2019. Table 3 summarizes the quantified benefits and costs of the alternative proposal of delaying the general implementation of 2018 Requirements without the option to implement certain [[Page 17602]] 2018 Requirements. Over the period of July 2018 to January 2019, annualized benefits of $7.4 million are estimated using a 3 percent discount rate; annualized benefits of $6.9 million are estimated using a 7 percent discount rate. Annualized costs of $50.8 million are estimated using a 3 percent discount rate; annualized costs of $47.0 million are estimated 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 3--All Benefits and Costs of Delaying Compliance With the 2018 Requirements Under the Alternative Proposal ------------------------------------------------------------------------ Annualized value by discount rate (millions of 2016 dollars) --------------------------------- 3 Percent 7 Percent ------------------------------------------------------------------------ Benefits (Cost-Savings): Quantified Benefits............... 7.4 6.9 Costs (Foregone Benefits): Quantified Costs.................. 50.8 47.0 ------------------------------------------------------------------------ B. Paperwork Reduction Act (PRA) This proposed rule contains collections of information that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), as amended (44 U.S.C. 3501-3520). A description of these provisions is given in this document with an estimate of the annual reporting and recordkeeping burden. Title: Federal Policy for the Protection of Human Subjects. Description: In this document is a discussion of the regulatory provisions we believe are subject to the PRA and the probable information collection burden associated with these provisions. In general, the following actions trigger the PRA: (i) Reporting; (ii) Recordkeeping. Description of Respondents: The reporting and recordkeeping requirements in this document are imposed on institutions, institutional review boards, and investigators involved in human subjects research conducted or supported or otherwise subject to regulation by any federal department or agency that takes administrative action that makes the policy applicable to such research. Sec. __.101(l)(4). Compliance Date and Transition Provision (OMB Control No 0990-0260) Section 101(l)(4)(i) would permit studies to transition to the 2018 Requirements between July 19, 2018 and January 21, 2019 (which would be the new general compliance date of the 2018 Requirements). Between July 19, 2018 and January 21, 2019, institutions that elect to transition studies to the 2018 Requirements would, after the decision to transition has been documented, be able to take advantage of the three burden-reducing 2018 Requirements. This option is described in a proposed revision to Sec. __.101(l)(4)(i). As described, studies taking advantage of this option would be subject to the three burden-reducing 2018 Requirements instead of, or in addition to, the comparable provisions of the pre-2018 Requirements. As discussed above, the three burden-reducing 2018 Requirements are (1) the 2018 Requirements' definition of ``research'' at Sec. __.102(l) (instead of Sec. __.102(d) of the pre-2018 Requirements), which deems certain activities not to be research, (2) the elimination of the requirement that an IRB review the grant application or proposal related to the research at Sec. __.103(d) of the 2018 Requirements (instead of Sec. __.103(f) of the pre-2018 Requirements), and (3) the allowance for no annual continuing review of certain categories of research at Sec. __.109(f)(1)(i) and (iii) of the 2018 Requirements (instead of Sec. __.103(b), as related to the requirement for continuing review, and in addition to Sec. __.109 of the pre-2018 Requirements). We estimate that approximately 92,084 protocols would take advantage of the voluntary election described in Sec. __.101(l)(4)(i). We estimate that institutional staff would spend 5 minutes per protocol documenting that the study will be subject to the three burden-reducing 2018 Requirements during the time period of July 19, 2018 through January 21, 2019. We estimate that this provision includes 7,673 burden hours. C. Regulatory Flexibility Act (RFA) The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the Small Business Regulatory Enforcement and 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 economic 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. If finalized, this action will 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 proposed rule would not impose a regulatory burden for regulated small entities because it would delay the general compliance date of the 2018 Requirements, allowing the status quo to be retained for the period of delay, and also would allow regulated small entities to elect to implement the 2018 Requirements as scheduled if the entities so choose. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities. We request [[Page 17603]] comment on this conclusion, including specific data and information to support commenters' views. 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 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 proposed rule would not contain policies that would 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 in the proposed rule represent the Federal Government regulating its own program. Accordingly, we conclude that the rule does not propose policies that have federalism implications as defined in Executive Order 13132 and, consequently, a federalism summary impact statement is not required. 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), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885) and adopted by HUD through a final rule published on January 26, 2018 (83 FR 3589), is proposed to be amended as follows: Text of the Amended Common Rule PART __--PROTECTION OF HUMAN SUBJECTS 0 1. Amend Sec. __.101 by revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. __.101 To what does this policy apply? * * * * * (l) * * * (2) For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this part/subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for Sec. __.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. __.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. __.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section __.102(l) of the 2018 Requirements (definition of research) (instead of Sec. __.102(d) of the pre-2018 Requirements), (2) Section __.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. __.103(f) of the pre-2018 Requirements), and (3) Section __.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. __.103(b), as related to the requirement for continuing review, and in addition to Sec. __.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. Department of Homeland Security List of Subjects in 6 CFR Part 46 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Homeland Security proposes to further amend 6 CFR part 46 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 46--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 46.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 46.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the [[Page 17604]] following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 46.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 46.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 46.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 46.102(d) of the pre-2018 Requirements), (2) Section 46.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 46.103(f) of the pre-2018 Requirements), and (3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 46.103(b), as related to the requirement for continuing review, and in addition to Sec. 46.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Elaine C. Duke, Deputy Secretary, Department of Homeland Security. Department of Agriculture List of Subjects in 7 CFR Part 1c Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Agriculture proposes to further amend 7 CFR part 1c as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 1c--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 1c.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 1c.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 1c.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 1c.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 1c.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 1c.102(d) of the pre-2018 Requirements), (2) Section 1c.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 1c.103(f) of the pre-2018 Requirements), and (3) Section 1c.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 1c.103(b), as related to the requirement for continuing review, and in addition to Sec. 1c.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * 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 recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Energy proposes to further amend 10 CFR part 745 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 745--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 745 continues to read as follows: [[Page 17605]] 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 745.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 745.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 745.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 745.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 745.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 745.102(d) of the pre-2018 Requirements), (2) Section 745.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 745.103(f) of the pre-2018 Requirements), and (3) Section 745.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 745.103(b), as related to the requirement for continuing review, and in addition to Sec. 745.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Dan Brouillette, Deputy Secretary of Energy. National Aeronautics and Space Administration List of Subjects in 14 CFR Part 1230 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, National Aeronautics and Space Administration proposes to further amend 14 CFR part 1230 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 1230--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 1230.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 1230.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 1230.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 1230.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 1230.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 1230.102(d) of the pre-2018 Requirements), (2) Section 1230.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 1230.103(f) of the pre-2018 Requirements), and (3) Section 1230.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 1230.103(b), as related to the requirement for continuing review, and in addition to Sec. 1230.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and [[Page 17606]] (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * 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 recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Commerce proposes to further amend 15 CFR part 27 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 27--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 27.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 27.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 27.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 27.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 27.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 27.102(d) of the pre-2018 Requirements), (2) Section 27.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 27.103(f) of the pre-2018 Requirements), and (3) Section 27.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 27.103(b), as related to the requirement for continuing review, and in addition to Sec. 27.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Wilbur L. Ross, Secretary of Commerce. Consumer Product Safety Commission List of Subjects in 16 CFR Part 1028 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Consumer Product Safety Commission proposes to further amend 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), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 1028--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 1028.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 1028.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 1028.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 1028.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 1028.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 1028.102(d) of the pre-2018 Requirements), (2) Section 1028.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of [[Page 17607]] Sec. 1028.103(f) of the pre-2018 Requirements), and (3) Section 1028.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 1028.103(b), as related to the requirement for continuing review, and in addition to Sec. 1028.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Alberta E. Mills, Secretary, Consumer Product Safety Commission. Social Security Administration List of Subjects in 20 CFR Part 431 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Social Security Administration proposes to further amend 20 CFR part 431 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 431--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 431.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 431.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 431.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 431.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 431.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 431.102(d) of the pre-2018 Requirements), (2) Section 431.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 431.103(f) of the pre-2018 Requirements), and (3) Section 431.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 431.103(b), as related to the requirement for continuing review, and in addition to Sec. 431.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Nancy Berryhill, Deputy Commissioner for Operations, performing the duties and functions not reserved to the Commissioner of Social Security. Agency for International Development List of Subjects in 22 CFR Part 225 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Agency for International Development proposes to further amend 22 CFR part 225 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 225--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 225.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 225.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 225.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the [[Page 17608]] research was exempt under Sec. 225.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 225.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 225.102(d) of the pre-2018 Requirements), (2) Section 225.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 225.103(f) of the pre-2018 Requirements), and (3) Section 225.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 225.103(b), as related to the requirement for continuing review, and in addition to Sec. 225.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Kerry Pelzman, Acting Senior Deputy Assistant Administrator for Global Health, U.S. Agency for International Development. Department of Housing and Urban Development List of Subjects in 24 CFR Part 60 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Housing and Urban Development proposes to further amend 24 CFR part 60 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885) and adopted by HUD through a final rule published on January 26, 2018 (83 FR 3589), as follows: PART 60--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 60 continues to read as follows: Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b) and 3535(d). 0 2. Amend Sec. 60.101 by revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 60.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 60.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 60.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 60.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 60.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 60.102(d) of the pre-2018 Requirements), (2) Section 60.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 60.103(f) of the pre-2018 Requirements), and (3) Section 60.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 60.103(b), as related to the requirement for continuing review, and in addition to Sec. 60.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Todd M. Richardson, Acting General Deputy Assistant Secretary for Policy Development and Research, U.S. Department of Housing and Urban Development. Department of Labor List of Subjects in 29 CFR Part 21 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Labor proposes to further amend 29 CFR part 21 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 21--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: [[Page 17609]] Sec. 21.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 21.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 21.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 21.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 21.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 21.102(d) of the pre-2018 Requirements), (2) Section 21.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 21.103(f) of the pre-2018 Requirements), and (3) Section 21.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 21.103(b), as related to the requirement for continuing review, and in addition to Sec. 21.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Dated: April 2, 2018. R. Alexander Acosta, Secretary of Labor. Department of Defense List of Subjects in 32 CFR Part 219 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Defense proposes to further amend 32 CFR part 219 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 219--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 219 continues to read as follows: Authority: 5 U.S.C. 301. 0 2. Amend Sec. 219.101 by revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 219.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 219.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 219.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 219.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 219.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 219.102(d) of the pre-2018 Requirements), (2) Section 219.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 219.103(f) of the pre-2018 Requirements), and (3) Section 219.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 219.103(b), as related to the requirement for continuing review, and in addition to Sec. 219.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Mary J. Miller, Principal Deputy, Assistant Secretary of Defense for Research and Engineering, U.S. Department of Defense. [[Page 17610]] Department of Education List of Subjects in 34 CFR Part 97 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Education proposes to further amend 34 CFR part 97 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 97--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 97.101 To what does this policy apply? * * * * * (l) * * * (2) For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for Sec. 97.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 97.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 97.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 97.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 97.102(d) of the pre-2018 Requirements), (2) Section 97.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 97.103(f) of the pre-2018 Requirements), and (3) Section 97.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 97.103(b), as related to the requirement for continuing review, and in addition to Sec. 97.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Betsy DeVos, Secretary of Education. Department of Veterans Affairs List of Subjects in 38 CFR Part 16 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Veterans Affairs proposes to further amend 38 CFR part 16 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 16--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 16 continues to read as follows: Authority: 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b). 0 2. Amend Sec. 16.101 by revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 16.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 16.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 16.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 16.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 16.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 16.102(d) of the pre-2018 Requirements), (2) Section 16.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 16.103(f) of the pre-2018 Requirements), and (3) Section 16.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 16.103(b), as related to the requirement for continuing review, and [[Page 17611]] in addition to Sec. 16.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Jacquelyn Hayes-Byrd, Deputy Chief of Staff, Department of Veterans Affairs. Environmental Protection Agency List of Subjects in 40 CFR Part 26 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Environmental Protection Agency proposes to further amend 40 CFR part 26 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 26--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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; 42 U.S.C. 300v-1(b). 0 2. Amend Sec. 26.101 by revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 26.101 To what does this policy apply? * * * * * (l) * * * (2) For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for Sec. 26.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 26.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 26.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 26.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 26.102(d) of the pre-2018 Requirements), (2) Section 26.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 26.103(f) of the pre-2018 Requirements), and (3) Section 26.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 26.103(b), as related to the requirement for continuing review, and in addition to Sec. 26.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * 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 recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Health and Human Services proposes to further amend 45 CFR part 46 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 46--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 46.101 To what does this policy apply? * * * * * (l) * * * (2) For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for Sec. 46.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 46.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 46.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution [[Page 17612]] engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 46.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 46.102(d) of the pre-2018 Requirements), (2) Section 46.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 46.103(f) of the pre-2018 Requirements), and (3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 46.103(b), as related to the requirement for continuing review, and in addition to Sec. 46.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Alex M. Azar II, Secretary, U.S. Department of Health and Human Services. National Science Foundation List of Subjects in 45 CFR Part 690 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, National Science Foundation proposes to further amend 45 CFR part 690 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 690--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 690.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for Sec. 690.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 690.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 690.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 690.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 690.102(d) of the pre-2018 Requirements), (2) Section 690.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 690.103(f) of the pre-2018 Requirements), and (3) Section 690.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 690.103(b), as related to the requirement for continuing review, and in addition to Sec. 690.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Lawrence Rudolph, General Counsel, National Science Foundation. Department of Transportation List of Subjects in 49 CFR Part 11 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, Department of Transportation proposes to further amend 49 CFR part 11 as published in the Federal Register on January 19, 2017 (82 FR 7149), and as amended in a final rule published in the Federal Register on January 22, 2018 (83 FR 2885), as follows: PART 11--PROTECTION OF HUMAN SUBJECTS 0 1. The authority citation for Part 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)(2), (3), and (4), and adding paragraph (l)(5), to read as follows: Sec. 11.101 To what does this policy apply? * * * * * (l) * * * (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 January 21, 2019. The compliance date for [[Page 17613]] Sec. 11.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to Sec. 11.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determination was made that the research was exempt under Sec. 11.101(b) of the pre-2018 Requirements before January 21, 2019. (4) Transitioning research. If, on or after July 19, 2018, an institution engaged in research otherwise covered by paragraph (l)(3) of this section determines that such ongoing research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation until January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following: (1) Section 11.102(l) of the 2018 Requirements (definition of research) (instead of Sec. 11.102(d) of the pre-2018 Requirements), (2) Section 11.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of Sec. 11.103(f) of the pre-2018 Requirements), and (3) Section 11.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of Sec. 11.103(b), as related to the requirement for continuing review, and in addition to Sec. 11.109, of the pre-2018 Requirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements. (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019, (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019, and (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019. * * * * * Elaine L. Chao, Secretary of Transportation. [FR Doc. 2018-08231 Filed 4-19-18; 8:45 am] BILLING CODE 4150-36-P
![17596 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Proposed Rules
• Mail/Hand delivery/Courier [For a delay in the general compliance date and complying with these requirements.
paper, disk, or CD–ROM submissions] of the 2018 Requirements, with the As described below, we propose to
to: Jerry Menikoff, M.D., J.D., OHRP, option to adopt burden-reducing revise § ll.101(l)(2) to specify that the
1101 Wootton Parkway, Suite 200, provisions of the 2018 Requirements general compliance date for the 2018
Rockville, MD 20852. during the delay period, including Requirements is January 21, 2019. We
• Comments received, including any certain carve-outs from the definition of also propose to revise the dates in the
personal information, will be posted ‘‘research,’’ exemptions, elimination of transition provision at
without change to http:// the continuing review requirement for § ll.101(l)(3),(4) and (5) to reflect this
www.regulations.gov. certain categories of research, and the revised general compliance date.
FOR FURTHER INFORMATION CONTACT: Jerry elimination of the requirement that
institutional review boards (IRBs) As proposed, regulated entities would
Menikoff, M.D., J.D., Office for Human be required to comply with the pre-2018
Research Protections (OHRP), review grant applications. The HHS
Secretary’s Advisory Committee on Requirements prior to January 21, 2019,
Department of Health and Human and the pre-2018 Requirements would
Services, 1101 Wootton Parkway, Suite Human Research Protections (SACHRP)
also recommended in August 2017 that be applied by the Common Rule
200, Rockville, MD 20852; telephone:
the required implementation of the 2018 departments and agencies during this
240–453–6900 or 1–866–447–4777;
Requirements should be delayed.2 On period. To clarify, under this proposal,
facsimile: 301–402–2071; email
Jerry.Menikoff@hhs.gov. January 17, 2018, HHS and other federal regulated entities would not be allowed,
departments and agencies placed on prior to January 21, 2019, to comply
SUPPLEMENTARY INFORMATION:
display in the Federal Register an with all provisions of the 2018
I. Background interim final rule delaying the effective Requirements in lieu of all provisions of
On September 8, 2015, HHS and 15 date and general compliance date of the the pre-2018 Requirements. As
other federal departments and agencies 2018 requirements to July 19, 2018. 83 described below in section III, an
published a notice of proposed FR 2885 (published January 22, 2018). exception would exist during the six-
rulemaking (NPRM) proposing revisions On January 26, 2018, HUD published an month period between July 19, 2018,
to each agency’s codification of the interim final rule adopting the January and January 21, 2019, with respect to
Federal Policy for the Protection of 17, 2018 interim final rule. 83 FR 3589. three specified burden-reducing
Human Subjects, originally promulgated This NPRM proposes to delay the provisions contained in the 2018
as a Common Rule in 1991. 80 FR general compliance date of the 2018 Requirements.
53931. On January 19, 2017, HHS and Requirements by an additional six
months, during the time period of July Research initiated (i.e., initially
other federal departments and agencies approved by an IRB, or for which IRB
published a final rule revising the 19, 2018 to January 21, 2019.
review was waived pursuant to
Federal Policy for the Protection of II. Proposed Delay of the General § ll.101(i), or determined to be
Human Subjects. 82 FR 7149. The CPSC Compliance Date exempt) before the general compliance
adopted the same regulatory changes, We propose to delay the general date of the 2018 Requirements (which
also with a scheduled effective date of compliance date of the 2018 would now become January 21, 2019)
January 19, 2018, in a separate final rule Requirements for six months after the would, as a default, continue to be
published on September 18, 2017. 82 FR effective date of July 19, 2018 until subject to the pre-2018 Requirements for
43459. For this reason, references in this January 21, 2019. Given the degree of their duration. This will maintain the
document to the January 2017 final rule complexity involved with implementing ability of institutions to hold such
also extend to the CPSC’s September the revised rule, we believe the delay studies to the same set of standards
2017 final rule. The revised policy, we are proposing in this action is both throughout the studies’ duration, and
reflected in both final rules, is hereafter an appropriate action to take at this
referred to as the ‘‘2018 Requirements.’’ will avoid a requirement that such
juncture, and a reasonable time period research be subject to two sets of rules.
The 2018 Requirements were originally to allow the regulated community to be
scheduled to become effective on Research initiated (i.e., initially
prepared for compliance with the 2018
January 19, 2018, with a general approved by an IRB, or for which IRB
Requirements and for HHS and the
compliance date of January 19, 2018 other Common Rule agencies to develop review was waived pursuant to
(with the exception of the revisions to implementation guidance. The 2018 § ll.101(i), or determined to be
the cooperative research provision at requirements include new exemptions, exempt) on or after January 21, 2019
§ ll.114(b), for which the compliance new IRB review procedures, and new (proposed as the new general
date is January 20, 2020). provisions pertaining to informed compliance date), would need to be
After publication of the 2018 consent, among other revisions, and conducted entirely in compliance with
Requirements, some representatives of guidance would be helpful to the the 2018 Requirements. This document
the regulated community, including regulated community in understanding proposes to restructure § ll.101(1)(3)
organizations representing recipients of and (4) (now numbered (5)) to aid
federal human subjects research awards, www.cogr.edu/sites/default/files/AAMC_AAU_ readability. A new section
expressed concern regarding the APLU_COGR%20Common%20Rule § ll.101(l)(4) is proposed to be
regulated community’s ability to %20Delay%20Letter%206-21-2017.pdf. See the
inserted to explain how the
sradovich on DSK3GMQ082PROD with PROPOSALS2
implement all of the 2018 Requirements June 9, 2017 letter to Secretary Thomas Price from
the American Medical Informatics Association at requirements would apply to research
by the scheduled general compliance https://www.amia.org/sites/default/files/AMIA%20 transitioning to take advantage of the
date.1 One of the two letters asked for Letter%20Regarding%20the%20Common burden-reducing provisions.
%20Rule.pdf.
1 Two unsolicited comments were received. See 2 August 2, 2017 SACHRP Letter to HHS We do not propose delaying the
the June 21, 2017 letter to Jerry Menikoff from the Secretary, Attachment A-Recommendations on compliance date for the cooperative
Association of American Medical Colleges, Compliance Dates and Transition Provisions, research provision of the 2018
Association of American Universities, Association https://www.hhs.gov/ohrp/sachrp-committee/
of Public & Land-grant Universities, and Council on recommendations/attachment-a-august-2-2017/ Requirements (§ l.114(b)), which will
Governmental Relations, available at http:// index.html. remain January 20, 2020.
VerDate Sep<11>2014 19:24 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\20APP2.SGM 20APP2](https://thefederalregister.org/doc/83_FR_17672/page/2.svg)
![Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Proposed Rules 17599
300v–1(b). Department of Commerce, 5 alternatives and, if regulation is the period between July 19, 2018, and
U.S.C. 301; 42 U.S.C. 300v–1(b). necessary, to select regulatory January 21, 2019, to take advantage of
Consumer Product Safety Commission, approaches that maximize net benefits three provisions in the 2018
5 U.S.C. 301; 42 U.S.C. 300v–1(b). (including potential economic, Requirements intended to minimize
Social Security Administration, 5 U.S.C. environmental, public health and safety burdens on regulated entities. Those
301; 42 U.S.C. 289(a). Agency for effects; distributive impacts; and three burden-reducing 2018
International Development, 5 U.S.C. equity). Executive Order 13563 is Requirements are (1) the 2018
301; 42 U.S.C. 300v–1(b), unless supplemental to and reaffirms the Requirements’ definition of ‘‘research,’’
otherwise noted. Department of Housing principles, structures, and definitions which deems certain activities not to be
and Urban Development, 5 U.S.C. 301; governing regulatory review as research, (2) the allowance for no
42 U.S.C. 300v–1(b); 3535(d). established in Executive Order 12866, annual continuing review of certain
Department of Labor, 5 U.S.C. 301; 29 emphasizing the importance of categories of research, and (3) the
U.S.C. 551. Department of Defense, 5 quantifying both costs and benefits, of elimination of the requirement that IRBs
U.S.C. 301. Department of Education, 5 reducing costs, of harmonizing rules, review grant applications related to the
U.S.C. 301; 20 U.S.C. 1221e–3, 3474. and of promoting flexibility. In research. As described in section III
Department of Veterans Affairs, 5 U.S.C. accordance with the provisions of above, this flexibility is proposed for
301; 38 U.S.C. 501, 7331, 7334; 42 Executive Order 12866, this proposed studies for which an institution makes
U.S.C. 300v–1(b). Environmental rule was submitted to the Office of a choice to have those studies be subject
Protection Agency, 5 U.S.C. 301; 7 Management and Budget (OMB) for to the 2018 Requirements.
U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. review, and has been determined to be
346a(e)(1)(C); sec. 201, Public Law 109– 2. Analysis of Benefits (Cost-Savings)
a ‘‘significant’’ regulatory action. The
54, 119 Stat. 531; and 42 U.S.C. 300v– and Costs (Foregone Benefits) 3
designation, as regulatory or
1(b). Department of Health and Human deregulatory under Executive Order The RIA for the 2018 Requirements
Services, 5 U.S.C. 301; 42 U.S.C. 289(a); 13771 (Reducing Regulation and described the benefits and costs of 16
42 U.S.C. 300v–1(b). National Science Controlling Regulatory Costs, issued on broad categories of changes finalized.
Foundation, 5 U.S.C. 301; 42 U.S.C. January 30, 2017), of any final rule The RIA for this NPRM uses the
300v–1(b). Department of resulting from this notice of proposed information and calculations described
Transportation, 5 U.S.C. 301; 42 U.S.C. rulemaking will be informed by in the preamble to the 2018
300v–1(b). comments received on the costs and Requirements as a base for estimating
V. Regulatory Impact Analyses cost savings of delaying the 2018 benefits and costs of delaying the
Requirements. Details on the general implementation of the 2018
We have examined the effects of this
preliminary estimated costs of this Requirements by six months. The time
proposed rule under Executive Order
proposed rule can be found in the period for the analysis in this RIA is the
12866 on Regulatory Planning and
economic analysis below. six month period from July 2018 to
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation 1. Need for This NPRM and Summary January 2019.
and Regulatory Review (January 18, Table 1 summarizes the quantified
2011), Executive Order 13771 on On January 19, 2017, HHS and 15 benefits and costs of delaying the
Reducing Regulation and Controlling other federal departments and agencies general implementation of 2018
Regulatory Costs (January 30, 2017), the published the 2018 Requirements Requirements. Over the period of July
Paperwork Reduction Act of 1995 (Pub. designed to more thoroughly address 2018 to January 2019, annualized
L. 104–13), the Regulatory Flexibility the broader types of research conducted benefits of $6.4 million are estimated
Act, (Pub. L. 96–354, September 19, or otherwise supported by all of the using a 3 percent discount rate;
1980), the Unfunded Mandates Reform Common Rule departments and annualized benefits of $5.9 million are
Act of 1995 (Pub. L. 104–4), and agencies. In addition, the CPSC adopted estimated using a 7 percent discount
Executive Order 13132 on Federalism the same regulatory changes on rate. Annualized costs of $37.2 million
(August 4, 1999). September 18, 2017. are estimated using a 3 percent discount
This proposed rule, if finalized, rate; annualized costs of $34.4 million
A. Executive Orders 12866, 13563, and would allow regulated entities to are estimated using a 7 percent discount
13771 continue to comply with the pre-2018 rate. Note that all values are represented
Executive Orders 12866 and 13563 requirements until January 21, 2019. As in millions of 2016 dollars, and 2016 is
direct agencies to assess all costs and discussed above, this proposed rule also used as the frame of reference for
benefits of available regulatory proposes to permit institutions, during discounting.
TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE GENERAL COMPLIANCE DATE OF THE 2018 REQUIREMENTS BY
SIX MONTHS
[From July 19, 2018 to January 21, 2019]
Annualized value
by discount rate
(millions of 2016 dollars)
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3 Percent 7 Percent
Benefits (Cost–Savings):
Quantified Benefits ........................................................................................................................................... 6.4 5.9
Costs (Foregone Benefits):
3 Note, that the terms ‘‘benefits’’ and ‘‘cost- Similarly, the terms ‘‘costs’’ and ‘‘foregone benefits’’
savings’’ are used interchangeably in this RIA. are also used interchangeably.
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TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE GENERAL COMPLIANCE DATE OF THE 2018 REQUIREMENTS BY
SIX MONTHS—Continued
[From July 19, 2018 to January 21, 2019]
Annualized value
by discount rate
(millions of 2016 dollars)
3 Percent 7 Percent
Quantified Costs ............................................................................................................................................... 37.4 34.7
The estimated benefits and costs of months are shown in Table 2 below. used in the RIA of the 2018
delaying the general implementation Note that the categorization shown Requirements.
date of the 2018 Requirements by six below includes the same 16 categories
TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF
DELAYING COMPLIANCE WITH 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) (Foregone benefits)
3% 7% 3% 7%
Regulated Community Learning New Requirements and Developing Train-
ing 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) ..................... 4.47 4.14 — —
Excluding Activities from the Requirements of the Common Rule because
They are not Research ................................................................................ — — 0.95 0.88
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 institu-
tions) ............................................................................................................. — — — —
Eliminating the Requirement that the Grant Application Undergo IRB Re-
view and Approval ........................................................................................ — — 8.5 7.9
Expansion of Research Activities Exempt from Full IRB Review ................... 0.01 0.01 20.8 19.3
Elimination of Continuing Review of Research Under Specific Conditions .... 1.04 0.96 4.10 3.80
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 Iden-
tifiable private information ............................................................................ — — — —
Elimination of Pre-2018 Rule Requirement to Waive Consent in Certain
Subject Recruitment Activities ..................................................................... — — 0.07 0.06
Requirement for Posting of Consent Forms for Clinical Trials Conducted or
supported by Common Rule Departments or Agencies .............................. 0.85 0.79 — —
Alteration in Waiver for Documentation of Informed Consent in Certain Cir-
cumstances .................................................................................................. — — — —
Cost Savings, as indicated by public comments (unable to attribute to par-
ticular provisions) ......................................................................................... unquantified — —
We assume that, in almost all benefits (costs) of delaying the 2018 2018 through January of 2019. We
categories described in the RIA for the Requirements by six months are what assume this because regulated entities
2018 Requirements, the foregone would have been the benefits of likely would not have difficulty
implementing the 2018 Requirements implementing these provisions in the
4 Zeroes in Table 2 (represented by ‘‘—’’) signify
during the period of July 2018 through absence of guidance from Common Rule
sradovich on DSK3GMQ082PROD with PROPOSALS2
that the category has been unaffected by the six
month delay of the 2018 Requirements. The January of 2019. Similarly, we assume departments or agencies, and thus could
category could be unaffected for one of two reasons: that, in almost all categories described have been implemented as assumed in
(1) No costs or benefits were associated with the in the RIA for the 2018 Requirements, the economic analysis contained in the
category in the RIA for the 2018 Requirements; or
(2) the costs and benefits of the provision during the
the benefits (cost-savings) associated RIA for the 2018 Requirements. We seek
six month delay are the same as those estimated in with delaying the 2018 Requirements by comment on these assumptions.
the RIA for the 2018 Requirements. six months are what would have been Categories with different assumptions
5 Because compliance with this provision is not
the costs of implementing the 2018 are described below:
required until 2020, benefits and costs here are not
included. Requirements during the period of July
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a. Regulated Community Learning New Thus, these entities will still obtain c. Expansion of Research Activities
Requirements and Developing Training the benefits and costs described in the Exempt From Full IRB Review
Materials; OHRP Developing Training RIA for the 2018 Requirements, (§ ll.104(d))
and Guidance Materials, and implying no effects of this rule for 50 The 2018 Requirements include five
Implementing the 2018 Requirements percent of regulated entities. For the new exemption categories, and modify
We assume that even with the regulated entities that do not take all but one exemption that exist in the
proposed six month delay, regulated advantage of these flexibilities, we pre-2018 Requirements. We have
entities and OHRP would still assume assume that the foregone benefits (costs) received feedback from SACHRP that
costs related to learning the new of delaying implementation of these guidance will be useful for regulated
requirements and developing training provisions are what would have been entities to implement many of the
materials. Thus, there are no effects the benefits of implementing these exemption categories.7 Areas where
estimated here. provisions in January of 2018. Similarly, significant guidance will be helpful
We expect that some entities would we assume that the benefits (cost- include: Applying the categories of the
experience cost savings as a result of savings) associated with delaying the new exemptions themselves, conducting
this proposed rule, and some entities implementation of these provisions are limited IRB review (as required in four
would experience costs as a result of what would have been the costs of exemptions), developing and using
this proposed rule, but we lack data to implementing these provisions in July broad consent (as required in two
quantify these effects. We request of 2018. We assume that these regulated exemptions), utilizing the exemption for
comments which provide data that can entities account for 50 percent of the certain HIPAA covered activities, and
be used to quantify these effects. costs and benefits that would have been understanding which federally
experienced in 2018 absent this delay. supported or conducted nonresearch
b. Early Implementation of the Three We also assume that institutional staff information collections qualify for
Burden-Reducing Provisions of the 2018 at the IRB Administrative staff level 6 exemption.
Requirements (Explicit Carve-Outs of will spend 5 minutes per protocol Because the guidance documents that
Activities From the Definition of documenting the voluntary election to would be helpful to assist regulated
Research [§ ll.102(I)]; Eliminating the use the three burden-reducing 2018 entities in implementing these 2018
Requirement That the Grant Application provisions during the time period of Common Rule provisions have not yet
Undergo IRB Review and Approval [Pre- July 19, 2018 to January 21, 2019. been developed, we assume that 50
2018 Rule at § ll.103(f)]; Elimination percent of the regulated entities would
We request comment on our
of Continuing Review of Research not have taken advantage of the
assumption that 50 percent of regulated
Under Specific Conditions expansion in exemptions during this six
entities will take advantage of the
[§§ ll.109(f) and ll.115(a)(3)] month-delay. For these entities, we
option proposed in this NPRM to
We assume that 50 percent of implement three burden-reducing assume that there are no benefits and
regulated entities will take advantage of provisions of the 2018 Requirements costs of the proposed delay, because
the option proposed in this NPRM to early. they would not have changed their
implement three burden-reducing Some members of the regulated operations. We assume that 50 percent
provisions of the 2018 Requirements community have indicated that even of the regulated entities would have
early. We assume this because an though the 2018 Requirements yield gone forward with using the new or
institution’s decision about whether to cost savings, these institutions are still expanded exemption categories under
transition a study to the 2018 hesitant to transition ongoing research the 2018 Requirements; for these
requirements to take advantage of the to the 2018 Requirements, largely entities, there are costs of delaying the
three burden-reducing provisions might because of the burden of making studies implementation of this provision during
vary depending on the nature and already in compliance with the pre-2018 the six-month delay proposed in this
progress of the study, including any requirements comply with the 2018 NPRM.
elements of the study to be conducted requirements. Also, some institutions We do not have data to support our
after January 21, 2019. For example, seem inclined to make all of the assumption of what percent of regulated
studies planning to recruit some transitions at once. This entities would have gone forward with
subjects after January 21, 2019 would interconnectedness is key to some of the the implementation of these provisions
have to meet the new requirements for assumptions noted elsewhere in this in the absence of additional guidance,
obtaining the informed consent of those analysis. For example, if the three and what percent would not have gone
subjects. In contrast, for studies whose burden-reducing provisions are forward. We request comments on these
remaining activities consist only of considered on their own, a reasonable assumptions and solicit data that can be
completing data analyses, the new assumption would be that 100 percent used to quantify these effects.
requirements for informed consent of affected entities would realize the 3. Analysis of NPRM Alternative
would generally not be applicable. associated cost savings as soon as
Therefore, we assume that there are This NPRM includes a primary
possible. The use, instead, of a 50 alternative proposal of delaying the
situations where an institution would percent estimate reflects entities’
want to take advantage of the three general effective and compliance date to
possible inclinations to make all January 2019.
burden-reducing provisions, and transitions at once. We request comment Table 3 summarizes the quantified
sradovich on DSK3GMQ082PROD with PROPOSALS2
situations where an institution would that would provide insight into entities’
not want to take advantage of this benefits and costs of the alternative
views regarding the interconnectedness proposal of delaying the general
flexibility. We note that we intend to of the 2018 Requirements’ provisions
publish guidance on the carve-outs from implementation of 2018 Requirements
and thus allow for refinement of the 50 without the option to implement certain
the definition of research prior to July percent estimate.
2018, which may also impact an 7 See for example, SACHRP Recommendations of
institution’s decision to elect to 6 See the RIA to the 2018 Requirements (82 FR August 2, 2017: https://www.hhs.gov/ohrp/sachrp-
implement the three burden-reducing 7149) for more information about the labor committee/recommendations/sachrp-
provisions or not. categories used in this analysis. recommendations/index.html.
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§ 11.114(b) (cooperative research) of the the 2018 Requirements, the institution in addition to § 11.109, of the pre-2018
2018 Requirements is January 20, 2020. or an IRB must document and date such Requirements); and
(3) Research subject to pre-2018 determination. (B) Beginning on January 21, 2019,
requirements. The pre-2018 (i) If the determination to transition is comply with the 2018 Requirements.
Requirements shall apply to the documented between July 19, 2018, and (ii) If the determination to transition
following research, unless the research January 20, 2019, the research shall: is documented on or after January 21,
is transitioning to comply with the 2018 (A) Beginning on the date of such 2019, the research shall, beginning on
Requirements in accordance with documentation until January 20, 2019, the date of such documentation, comply
paragraph (l)(4) of this section: comply with the pre-2018 with the 2018 Requirements.
(i) Research initially approved by an Requirements, except that the research
IRB under the pre-2018 Requirements (5) Research subject to 2018
shall comply with the following: Requirements. The 2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review (1) Section 11.102(l) of the 2018 shall apply to the following research:
was waived pursuant to § 11.101(i) of Requirements (definition of research) (i) Research initially approved by an
the pre-2018 Requirements before (instead of § 11.102(d) of the pre-2018 IRB on or after January 21, 2019,
January 21, 2019; and Requirements),
(ii) Research for which IRB review is
(iii) Research for which a (2) Section 11.103(d) of the 2018 waived pursuant to paragraph (i) of this
determination was made that the Requirements (revised certification section on or after January 21, 2019, and
research was exempt under § 11.101(b) requirement that eliminates IRB review
of application or proposal) (instead of (iii) Research for which a
of the pre-2018 Requirements before determination is made that the research
January 21, 2019. § 11.103(f) of the pre-2018
Requirements), and is exempt on or after January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution (3) Section 11.109(f)(1)(i) and (iii) of * * * * *
the 2018 Requirements (exceptions to Elaine L. Chao,
engaged in research otherwise covered
by paragraph (l)(3) of this section mandated continuing review) (instead of Secretary of Transportation.
determines that such ongoing research § 11.103(b), as related to the [FR Doc. 2018–08231 Filed 4–19–18; 8:45 am]
instead will transition to comply with requirement for continuing review, and BILLING CODE 4150–36–P
sradovich on DSK3GMQ082PROD with PROPOSALS2
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Document Created: 2018-04-20 00:03:12
Document Modified: 2018-04-20 00:03:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of proposed rulemaking. | |
| Dates | To be assured consideration, comments must be received at one of | |
| 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] | |
| FR Citation | 83 FR 17595 | |
| CFR Citation | 10
CFR
745 14 CFR 1230 15 CFR 27 16 CFR 1028 20 CFR 431 22 CFR 225 24 CFR 60 29 CFR 21 32 CFR 219 34 CFR 97 38 CFR 16 40 CFR 26 45 CFR 46 45 CFR 690 49 CFR 11 6 CFR 46 | |
| CFR Associated | Human Research Subjects; Reporting and Recordkeeping Requirements and Research |
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