83 FR 22987 - Agency Information Collection Request. 30-Day Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 96 (May 17, 2018)
Federal Register Volume 83, Issue 96 (May 17, 2018)
| Page Range | 22987-22988 | |
| FR Document | 2018-10511 |
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)] [Notices] [Pages 22987-22988] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10511] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-0260] Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of the Secretary, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. [[Page 22988]] DATES: Comments on the ICR must be received on or before June 18, 2018. ADDRESSES: Submit your comments to [email protected] or by calling (202) 795-7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990-New-30D and project title for reference., to [email protected], or call the Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: 0990-0260-Extension Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation. Abstract: Assistant secretary for Health, Office for Human Research Protections is requesting an extension on a currently approved information collection by the Office of Management and Budget, on the Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation. The purpose of the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) is to provide a uniform government-wide standard for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to apply regarding the protection of human subjects involved in research. The HHS codification of the Common Rule is at 45 CFR part 46 subpart A. The respondents for this collection are institutions engaged in such research. Institutional adherence to the Common Rule also is required by other federal departments and agencies that have codified or follow the Common Rule which is identical to 45 CFR part 46, subpart A. Likely Respondents: Institutions engaged in nonexempt human subjects research. Estimate Annualized Burden in Hours Table ---------------------------------------------------------------------------------------------------------------- Number of Average burden Title Number of responses per per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- .103(b)(4), .109(d)IRB Actions, .116 and .117 6,000 39.33 1 235,980 Informed Consent............................... .115(a) IRB Recordkeeping....................... 6,000 15 10 900,000 .103(b)(5) Incident Reporting, .113 Suspension 6,000 0.5 45/60 2,250 or Termination Reporting....................... rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total....................................... .............. .............. .............. 1,138,230 ---------------------------------------------------------------------------------------------------------------- Terry Clark, Asst Information Collection Clearance Officer. [FR Doc. 2018-10511 Filed 5-16-18; 8:45 am] BILLING CODE 4150-36-P
![Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices 22987
except in accordance with 21 CFR 10.20 help to ensure the protection of human requirements of the applicable statutes
and other applicable disclosure law. For research subjects. The Checklist and regulations. This guidance is not
more information about FDA’s posting incorporates the HHS and FDA subject to Executive Order 12866.
of comments to public dockets, see 80 regulatory requirements in 45 CFR
II. Paperwork Reduction Act of 1995
FR 56469, September 18, 2015, or access 46.103(b)(4) and (5) and 21 CFR
the information at: https://www.gpo.gov/ 56.108(a) and (b) for written procedures This guidance refers to previously
fdsys/pkg/FR-2015-09-18/pdf/2015- for the IRB and recommendations about approved collections of information.
23389.pdf. operational details to include to support These collections of information are
Docket: For access to the docket to each of these requirements. In addition, subject to review by the Office of
read background documents or the the Checklist identifies some additional Management and Budget (OMB) under
electronic and written/paper comments topics the institution/IRB may consider the Paperwork Reduction Act of 1995
received, go to https:// when developing comprehensive (44 U.S.C. 3501–3520). The collections
www.regulations.gov and insert the procedures. This guidance supersedes of information referenced in this
docket number, found in brackets in the OHRP’s July 1, 2011, ‘‘Guidance on guidance that are related to IRB
heading of this document, into the Written IRB Procedures’’ and FDA’s recordkeeping requirements under 21
‘‘Search’’ box and follow the prompts 1998 ‘‘Appendix H: A Self-Evaluation CFR 56.115, including the information
and/or go to the Dockets Management Checklist for IRBs’’ (formerly part of collection activities in the provisions in
Staff, 5630 Fishers Lane, Rm. 1061, FDA’s Information Sheet Guidance for 21 CFR 56.108(a) and (b), have been
Rockville, MD 20852. IRBs, Clinical Investigators, and approved under OMB control numbers
You may submit comments on any Sponsors). 0910–0755 and 0910–0130. The
guidance at any time (see 21 CFR This document is a final guidance collections of information referenced in
10.115(g)(5)). document, based on the Agencies’ this guidance that are related to IRB
Submit written requests for single review of submitted comments. The recordkeeping requirements under 45
copies of the guidance to the Office of Agencies are always open to additional CFR 46.115, including the information
Good Clinical Practice (OGCP), Office of comments on this and other Agency collection activities in the provisions in
Special Medical Programs, Office of guidance. 45 CFR 46.103(b)(4) and (5) have been
Medical Products and Tobacco, Food To enhance human subject protection approved under OMB control number
and Drug Administration, 10903 New and reduce regulatory burden, OHRP 0990–0260.
Hampshire Ave., Bldg. 32, Rm. 5103, and FDA have been actively working to
harmonize the Agencies’ regulatory III. Electronic Access
Silver Spring, MD 20993; or Division of
Policy and Assurances, Office for requirements and guidance for human Persons with access to the internet
Human Research Protections, 1101 subject research. This guidance may obtain the document at https://
Wootton Pkwy., Suite 200, Rockville, document was developed as a part of www.fda.gov/ScienceResearch/
MD 20852. Send one self-addressed these efforts. In addition, on December SpecialTopics/RunningClinicalTrials/
adhesive label to assist the office in 13, 2016, the 21st Century Cures Act GuidancesInformationSheetsand
processing your requests. The guidance (Cures Act) (Pub. L. 114–255) was Notices/ucm219433.htm, https://
may also be obtained by mail by calling signed into law. Title III, section 3023 www.hhs.gov/ohrp/regulations-and-
OGCP at 301–796–8340 or OHRP at of the Cures Act requires the Secretary policy/guidance/alphabetical-list/
240–453–6900 or 866–447–4777. See of HHS to harmonize differences index.html, or https://
the SUPPLEMENTARY INFORMATION section between the HHS human subject www.regulations.gov.
for electronic access to the guidance regulations and FDA’s human subject
Dated: April 27, 2018.
document. regulations. This guidance document is
consistent with the goals of section 3023 Brett P. Giroir,
FOR FURTHER INFORMATION CONTACT: of the Cures Act. ADM, USPHS, Assistant Secretary for Health.
Janet Donnelly, Office of Good Clinical In the Federal Register of August 2, Dated: May 9, 2018.
Practice, Food and Drug Administration, 2016 (81 FR 50711), OHRP and FDA Leslie Kux,
10903 New Hampshire Ave., Bldg. 32, announced the availability of a draft Associate Commissioner for Policy.
Rm. 5167, Silver Spring, MD 20993, guidance of the same title dated August [FR Doc. 2018–10441 Filed 5–16–18; 8:45 am]
301–796–4187; or Irene Stith-Coleman, 2016. OHRP and FDA received several BILLING CODE 4164–01–P
Office for Human Research Protections, comments on the draft guidance, and
1101 Wootton Pkwy., Suite 200, considered all comments in finalizing
Rockville, MD 20852, 240–453–6900. this guidance. OHRP and FDA revised DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION: the guidance to clarify which written HUMAN SERVICES
procedures are specifically required,
I. Background and which are recommended. In [Document Identifier: OS–0990–0260]
OHRP and FDA are announcing the addition, editorial changes were made
availability of a guidance document Agency Information Collection
to improve clarity. The guidance
entitled ‘‘Institutional Review Board Request. 30-Day Public Comment
announced in this notice finalizes the
(IRB) Written Procedures: Guidance for Request
draft guidance dated August 2016.
Institutions and IRBs.’’ OHRP and FDA This guidance is being issued AGENCY: Office of the Secretary, HHS.
frequently receive questions about the consistent with FDA’s good guidance ACTION: Notice.
scope and content of written practices regulation (21 CFR 10.115).
daltland on DSKBBV9HB2PROD with NOTICES
procedures. We created a Written The guidance represents the current SUMMARY: In compliance with the
Procedures Checklist (also referred to as thinking of OHRP and FDA on written requirement of the Paperwork
the Checklist) to assist institutions and procedures for institutions and IRBs. It Reduction Act of 1995, the Office of the
IRBs in preparing and maintaining does not establish any rights for any Secretary (OS), Department of Health
written procedures. The Checklist is person and is not binding on OHRP, and Human Services, is publishing the
designed to prompt a thorough FDA, or the public. You can use an following summary of a proposed
evaluation of written procedures that alternative approach if it satisfies the collection for public comment.
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![22988 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
DATES: Comments on the ICR must be enhance the quality, utility, and clarity the Federal Policy for the Protection of
received on or before June 18, 2018. of the information to be collected; and Human Subjects (also known as the
ADDRESSES: Submit your comments to (4) the use of automated collection Common Rule) is to provide a uniform
Sherrette.Funn@hhs.gov or by calling techniques or other forms of information government-wide standard for
(202) 795–7714. technology to minimize the information institutions engaged in research
FOR FURTHER INFORMATION CONTACT: collection burden. conducted or supported by the
When submitting comments or Information Collection Request Title: Department of Health and Human
requesting information, please include 0990–0260–Extension Protection of Services (HHS) to apply regarding the
the document identifier 0990–New–30D Human Subjects: Assurance of protection of human subjects involved
and project title for reference., to Compliance with Federal Policy/IRB in research. The HHS codification of the
Sherrette.funn@hhs.gov, or call the Review/IRB Recordkeeping/Informed Common Rule is at 45 CFR part 46
Reports Clearance Officer. Consent/Consent Documentation. subpart A. The respondents for this
SUPPLEMENTARY INFORMATION: Interested Abstract: Assistant secretary for collection are institutions engaged in
persons are invited to send comments Health, Office for Human Research such research. Institutional adherence to
regarding this burden estimate or any Protections is requesting an extension the Common Rule also is required by
other aspect of this collection of on a currently approved information other federal departments and agencies
information, including any of the collection by the Office of Management that have codified or follow the
following subjects: (1) The necessity and and Budget, on the Protection of Human Common Rule which is identical to 45
utility of the proposed information Subjects: Assurance of Compliance with CFR part 46, subpart A.
collection for the proper performance of Federal Policy/IRB Review/IRB Likely Respondents: Institutions
the agency’s functions; (2) the accuracy Recordkeeping/Informed Consent/ engaged in nonexempt human subjects
of the estimated burden; (3) ways to Consent Documentation. The purpose of research.
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Average
Number of
Number of burden per Total burden
Title responses per
respondents response hours
respondent (in hours)
.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent .................. 6,000 39.33 1 235,980
.115(a) IRB Recordkeeping ............................................................................. 6,000 15 10 900,000
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting .... 6,000 0.5 45/60 2,250
Total .......................................................................................................... ........................ ........................ ........................ 1,138,230
Terry Clark, DATES: We must receive comments by FOR FURTHER INFORMATION CONTACT:
Asst Information Collection Clearance June 18, 2018. Brenda Tapia, (703) 358–2104
Officer. (telephone); DMAFR@fws.gov (email).
ADDRESSES:
[FR Doc. 2018–10511 Filed 5–16–18; 8:45 am] SUPPLEMENTARY INFORMATION:
Document availability: The
BILLING CODE 4150–36–P
applications, as well as any comments I. Public Comment Procedures
and other materials that we receive, will
be available for public inspection online A. How do I comment on submitted
DEPARTMENT OF THE INTERIOR in Docket No. FWS–HQ–IA–2018–0011 applications?
at http://www.regulations.gov. You may submit your comments and
Fish and Wildlife Service
Submitting Comments: You may materials by one of the methods listed
[Docket No. FWS–HQ–IA–2018–0011; submit comments by one of the above under Submitting Comments in
FXIA16710900000–178–FF09A30000] ADDRESSES. We will not consider
following methods:
comments sent by email or fax, or to an
June 18, 2018 Foreign Endangered • Federal eRulemaking Portal: http://
address not in ADDRESSES.
Species; Receipt of Permit www.regulations.gov. Follow the Please make your requests or
Applications instructions for submitting comments comments as specific as possible,
on Docket No. FWS–HQ–IA–2018–0011. confine your comments to issues for
AGENCY: Fish and Wildlife Service,
Interior. • U.S. mail or hand-delivery: Public which we seek comments in this notice,
Comments Processing, Attn: Docket No. and explain the basis for your
ACTION: Notice of receipt of permit
FWS–HQ–IA–2018–0011 U.S. Fish and comments. Include sufficient
applications. Wildlife Service Headquarters, MS: information with your comments to
SUMMARY: We, the U.S. Fish and BPHC; 5275 Leesburg Pike, Falls allow us to authenticate any scientific or
Wildlife Service, invite the public to Church, VA 22041–3803. commercial data you include.
comment on applications to conduct When submitting comments, please The comments and recommendations
certain activities with foreign indicate the name of the applicant and that will be most useful and likely to
daltland on DSKBBV9HB2PROD with NOTICES
endangered species. With some the PRT# at the beginning of your influence agency decisions are: (1)
exceptions, the Endangered Species Act comment. We will post all comments on Those supported by quantitative
(ESA) prohibits activities with listed http://www.regulations.gov. This information or studies; and (2) those
species unless Federal authorization is generally means that we will post any that include citations to, and analyses
acquired that allows such activities. The personal information you provide us of, the applicable laws and regulations.
ESA also requires that we invite public (see SUPPLEMENTARY INFORMATION for We will not consider or include in our
comment before issuing these permits. more information). administrative record comments we
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Document Created: 2018-05-17 00:50:20
Document Modified: 2018-05-17 00:50:20
| 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 | Notices | |
| Action | Notice. | |
| Dates | Comments on the ICR must be received on or before June 18, 2018. | |
| Contact | When submitting comments or requesting information, please include the document identifier 0990-New-30D and project title for reference., to [email protected], or call the Reports Clearance Officer. | |
| FR Citation | 83 FR 22987 |
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