Agency Information Collection Request. 30-Day Public Comment Request, 22987-22988 [2018-10511]
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Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
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of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Good Clinical Practice (OGCP), Office of
Special Medical Programs, Office of
Medical Products and Tobacco, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993; or Division of
Policy and Assurances, Office for
Human Research Protections, 1101
Wootton Pkwy., Suite 200, Rockville,
MD 20852. Send one self-addressed
adhesive label to assist the office in
processing your requests. The guidance
may also be obtained by mail by calling
OGCP at 301–796–8340 or OHRP at
240–453–6900 or 866–447–4777. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
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Janet Donnelly, Office of Good Clinical
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5167, Silver Spring, MD 20993,
301–796–4187; or Irene Stith-Coleman,
Office for Human Research Protections,
1101 Wootton Pkwy., Suite 200,
Rockville, MD 20852, 240–453–6900.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP and FDA are announcing the
availability of a guidance document
entitled ‘‘Institutional Review Board
(IRB) Written Procedures: Guidance for
Institutions and IRBs.’’ OHRP and FDA
frequently receive questions about the
scope and content of written
procedures. We created a Written
Procedures Checklist (also referred to as
the Checklist) to assist institutions and
IRBs in preparing and maintaining
written procedures. The Checklist is
designed to prompt a thorough
evaluation of written procedures that
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help to ensure the protection of human
research subjects. The Checklist
incorporates the HHS and FDA
regulatory requirements in 45 CFR
46.103(b)(4) and (5) and 21 CFR
56.108(a) and (b) for written procedures
for the IRB and recommendations about
operational details to include to support
each of these requirements. In addition,
the Checklist identifies some additional
topics the institution/IRB may consider
when developing comprehensive
procedures. This guidance supersedes
OHRP’s July 1, 2011, ‘‘Guidance on
Written IRB Procedures’’ and FDA’s
1998 ‘‘Appendix H: A Self-Evaluation
Checklist for IRBs’’ (formerly part of
FDA’s Information Sheet Guidance for
IRBs, Clinical Investigators, and
Sponsors).
This document is a final guidance
document, based on the Agencies’
review of submitted comments. The
Agencies are always open to additional
comments on this and other Agency
guidance.
To enhance human subject protection
and reduce regulatory burden, OHRP
and FDA have been actively working to
harmonize the Agencies’ regulatory
requirements and guidance for human
subject research. This guidance
document was developed as a part of
these efforts. In addition, on December
13, 2016, the 21st Century Cures Act
(Cures Act) (Pub. L. 114–255) was
signed into law. Title III, section 3023
of the Cures Act requires the Secretary
of HHS to harmonize differences
between the HHS human subject
regulations and FDA’s human subject
regulations. This guidance document is
consistent with the goals of section 3023
of the Cures Act.
In the Federal Register of August 2,
2016 (81 FR 50711), OHRP and FDA
announced the availability of a draft
guidance of the same title dated August
2016. OHRP and FDA received several
comments on the draft guidance, and
considered all comments in finalizing
this guidance. OHRP and FDA revised
the guidance to clarify which written
procedures are specifically required,
and which are recommended. In
addition, editorial changes were made
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated August 2016.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of OHRP and FDA on written
procedures for institutions and IRBs. It
does not establish any rights for any
person and is not binding on OHRP,
FDA, or the public. You can use an
alternative approach if it satisfies the
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22987
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information referenced in this
guidance that are related to IRB
recordkeeping requirements under 21
CFR 56.115, including the information
collection activities in the provisions in
21 CFR 56.108(a) and (b), have been
approved under OMB control numbers
0910–0755 and 0910–0130. The
collections of information referenced in
this guidance that are related to IRB
recordkeeping requirements under 45
CFR 46.115, including the information
collection activities in the provisions in
45 CFR 46.103(b)(4) and (5) have been
approved under OMB control number
0990–0260.
III. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
GuidancesInformationSheetsand
Notices/ucm219433.htm, https://
www.hhs.gov/ohrp/regulations-andpolicy/guidance/alphabetical-list/
index.html, or https://
www.regulations.gov.
Dated: April 27, 2018.
Brett P. Giroir,
ADM, USPHS, Assistant Secretary for Health.
Dated: May 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10441 Filed 5–16–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0260]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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.
SUMMARY:
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Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
Comments on the ICR must be
received on or before June 18, 2018.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov 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
Sherrette.funn@hhs.gov, 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
DATES:
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
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Title
Total burden
hours
.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent ..................
.115(a) IRB Recordkeeping .............................................................................
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting ....
6,000
6,000
6,000
39.33
15
0.5
1
10
45/60
235,980
900,000
2,250
Total ..........................................................................................................
........................
........................
........................
1,138,230
Terry Clark,
Asst Information Collection Clearance
Officer.
We must receive comments by
June 18, 2018.
DATES:
ADDRESSES:
[FR Doc. 2018–10511 Filed 5–16–18; 8:45 am]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[Docket No. FWS–HQ–IA–2018–0011;
FXIA16710900000–178–FF09A30000]
June 18, 2018 Foreign Endangered
Species; Receipt of Permit
Applications
Fish and Wildlife Service,
Interior.
ACTION: Notice of receipt of permit
applications.
AGENCY:
We, the U.S. Fish and
Wildlife Service, invite the public to
comment on applications to conduct
certain activities with foreign
endangered species. With some
exceptions, the Endangered Species Act
(ESA) prohibits activities with listed
species unless Federal authorization is
acquired that allows such activities. The
ESA also requires that we invite public
comment before issuing these permits.
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SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Brenda Tapia, (703) 358–2104
(telephone); DMAFR@fws.gov (email).
SUPPLEMENTARY INFORMATION:
Document availability: The
applications, as well as any comments
and other materials that we receive, will
be available for public inspection online
in Docket No. FWS–HQ–IA–2018–0011
at https://www.regulations.gov.
Submitting Comments: You may
submit comments by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments
on Docket No. FWS–HQ–IA–2018–0011.
• U.S. mail or hand-delivery: Public
Comments Processing, Attn: Docket No.
FWS–HQ–IA–2018–0011 U.S. Fish and
Wildlife Service Headquarters, MS:
BPHC; 5275 Leesburg Pike, Falls
Church, VA 22041–3803.
When submitting comments, please
indicate the name of the applicant and
the PRT# at the beginning of your
comment. We will post all comments on
https://www.regulations.gov. This
generally means that we will post any
personal information you provide us
(see SUPPLEMENTARY INFORMATION for
more information).
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I. Public Comment Procedures
A. How do I comment on submitted
applications?
You may submit your comments and
materials by one of the methods listed
above under Submitting Comments in
ADDRESSES. We will not consider
comments sent by email or fax, or to an
address not in ADDRESSES.
Please make your requests or
comments as specific as possible,
confine your comments to issues for
which we seek comments in this notice,
and explain the basis for your
comments. Include sufficient
information with your comments to
allow us to authenticate any scientific or
commercial data you include.
The comments and recommendations
that will be most useful and likely to
influence agency decisions are: (1)
Those supported by quantitative
information or studies; and (2) those
that include citations to, and analyses
of, the applicable laws and regulations.
We will not consider or include in our
administrative record comments we
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]]>Agencies
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22987-22988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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