Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability, 68545-68547 [2015-27986]
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68545
Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–28153 Filed 11–4–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–New–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for a
new collection. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
SUMMARY:
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before December 7, 2015.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
Information Collection Request Title
and document identifier HHS–OS–
0990–New–30D for reference.
Information Collection Request Title:
Information Collection Request Title:
Evaluation of the Office on Women’s
Health Coalition for a Healthier
Community Initiative.
Abstract: This collection is to provide
data for the national evaluation of the
U.S. Department of Health and Human
Services (HHS), Office on Women’s
Health (OWH) Coalition for a Healthier
Community (CHC) Initiative. The
initiative supports 10 communities with
grants to support coalitions in
implementing gender-based public
health systems approaches, evidencebased health interventions, and
outreach and education activities to
reduce barriers to and enhance
facilitators of improvements in women
and girls’ health. Each of the grantees
has implemented an IRB-approved local
evaluation; however, OWH is seeking to
collect core data across grantees to
examine the extent to which the
Government’s investment has resulted
in achieving OWH-related Healthy
People 2020 priorities and yields
lessons learned upon which to plan
future initiatives related to its mission.
Likely Respondents: The proposed
collection includes plans for interviews
with key staff (project directors, project
coordinators, local evaluators), coalition
members (including chairs and cochairs), and community leaders
connected to the coalitions. These
respondents will also complete online
surveys about their perceptions of the
changes in their community as a result
of coalition activities. Program
participants and other community
members exposed to the coalitions’
activities through social media will also
complete online surveys. Project
directors and local evaluators also
annually provide information to OWH
on their coalition’s functioning, the
status of the cost-effectiveness analysis
for their coalition’s interventions, and
the coalition’s plans for sustainability.
The following table summarizes the
‘‘Total Estimated Annualized Burden—
Hours’’ by form and type of respondent.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Average
burden per
response
(in hrs)
Number of
responses per
respondent
Total burden
hours
1—Key Persons Discussion Guide for Telephone Interviews .........................
2—Key Persons, Coalition Members, and Community Leaders Online Survey ................................................................................................................
3—Coalition Participants and Other Community Members Online Survey .....
4—Grantee Annual Report on Coalition Functioning, Cost-Effectiveness,
and Sustainability Planning ..........................................................................
90
2
1
180
200
510
1
1
20/60
20/60
67
170
10
2
2
40
Total ..........................................................................................................
........................
........................
........................
457
Terry Clark,
Asst Information Collection Clearance
Officer.
[FR Doc. 2015–28156 Filed 11–4–15; 8:45 am]
[Docket No. FDA–2015–D–3638]
Minutes of Institutional Review Board
Meetings: Guidance for Institutions
and Institutional Review Boards; Draft
Guidance; Availability
BILLING CODE 4150–33–P
jstallworth on DSK7TPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, and the Food and Drug
Administration, HHS.
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
15:06 Nov 04, 2015
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The Office for Human
Research Protections (OHRP), Office of
the Assistant Secretary for Health, and
the Food and Drug Administration
(FDA) are announcing the availability of
a draft guidance entitled ‘‘Minutes of
Institutional Review Board (IRB)
Meetings: Guidance for Institutions and
IRBs.’’ The draft guidance is intended
for institutions and IRBs that are
responsible for the review and oversight
of human subject research conducted or
supported by the U.S. Department of
Health and Human Services (HHS) or
regulated by FDA. The purpose of the
SUMMARY:
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68546
Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices
draft guidance is to assist institutions
and IRBs in preparing and maintaining
minutes of IRB meetings (also referred
to in the guidance as minutes) that meet
the regulatory requirements for minutes
set forth in FDA and HHS regulations.
The draft guidance also provides general
recommendations on the type and
amount of information to be included in
the minutes.
DATES: You can comment on any
guidance at any time (21 CFR
10.115(g)(5)). To ensure that we
consider your comment on this draft
guidance before we begin work on the
final version of the guidance, submit
either written or electronic comments
by January 4, 2016.
ADDRESSES: You may submit comments
as follows:
jstallworth on DSK7TPTVN1PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
VerDate Sep<11>2014
15:06 Nov 04, 2015
Jkt 238001
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–3638 for ‘‘Minutes of
Institutional Review Board Meetings:
Guidance for Institutions and
Institutional Review Boards; Draft
Guidance; Availability’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential’’. Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Janet Donnelly, Office of Good Clinical
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5167, Silver Spring, MD 20993–
0002, 301–796–4187; or Irene StithColeman, Office for Human Research
Protections, 1101 Wootton Pkwy., Suite
PO 00000
Frm 00055
Fmt 4703
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200, Rockville, MD 20852, 240–453–
6900.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP and FDA are announcing the
availability of a draft guidance
document entitled ‘‘Minutes of
Institutional Review Board Meetings:
Guidance for Institutions and
Institutional Review Boards; Draft
Guidance; Availability.’’ Because IRBs
have been cited in OHRP determination
letters and FDA warning letters as
having inadequate minutes, OHRP and
FDA are providing recommendations on
the type and amount of information to
include in minutes in order to help IRBs
meet the regulatory requirements for
minutes.
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 draft guidance
document was developed as a part of
these efforts. OHRP and FDA believe
that it will be most helpful to the
regulated community to issue a joint
draft guidance document which will
clearly demonstrate the Agencies’
harmonious approach to the topic of
preparing and maintaining minutes of
IRB meetings.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of OHRP
and FDA on minutes of IRB meetings. 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
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft 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 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 have
been approved under OMB control
number 0990–0260.
E:\FR\FM\05NON1.SGM
05NON1
Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
ProposedRegulationsand
DraftGuidances/default.htm, or https://
www.hhs.gov/ohrp/newsroom/
index.html, or https://
www.regulations.gov.
Dated: October 23, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health. U.S.
Department of Health and Human Services.
Dated: October 27, 2015.
Leslie Kux,
Assistant Commissioner for Policy, U.S. Food
and Drug Administration.
[FR Doc. 2015–27986 Filed 11–4–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute on
Aging Special Emphasis Panel,
November 12, 2015, 10:00 a.m. to
November 12, 2015, 02:00 p.m.,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD, 20892 which was
published in the Federal Register on
October 19, 2015, 80 FR 63236.
The meeting notice is amended to
change the date of the meeting from
November 12, 2015 to November 24,
2015. The meeting is closed to the
public.
Dated: October 30, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–28230 Filed 11–4–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jstallworth on DSK7TPTVN1PROD with NOTICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of Therapeutics
To Treat Brain Injury and
Neurodegenerative Disease
National Institute of Diabetes
and Digestive and Kidney Diseases,
National Institutes of Health, Public
Health Service, DHHS.
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
15:06 Nov 04, 2015
Jkt 238001
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7, that the National Institute of
Diabetes and Digestive and Kidney
Diseases, National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to Astrocyte
Pharmaceuticals, Inc., (‘‘Astrocyte’’), a
company incorporated under the laws of
Delaware and having an office in
Cambridge, Massachusetts, to practice
the following inventions embodied in
the following patent applications: US
Provisional Patent Appl. No. 60/176,373
entitled, ‘‘Methanocarba cycloalkyl
nucleoside analogues,’’ filed 14 Jan 2000
[HHS reference E–176–1999/0–US–01];
Intl. Appl. No. PCT/US01/00981,
entitled, ‘‘Methanocarba cycloalkyl
nucleoside analogues,’’ filed 12 Jan 2001
[HHS reference E–176–1999/0–PCT–02];
Australia Patent No. 2001230913, issued
13 Oct 2005 [HHS reference E–176–
1999/0–AU–03]; Canada Patent No.
2.397,366, issued 15 Mar 2011 [HHS
reference E–176–1999/0–CA–04];
European Patent Appl. No. 01903043.6
entitled, filed 12 Jan 2001 [HHS Ref No
E–176–1999/0–EP–05]; US Patent No.
7,087,589, issued 8 Aug 2006 [HHS
reference E–176–1999/0–US–06]; US
patent No. 7,790,735, issued 8 Aug 2006
[HHS reference E–176–1999/0–US–07];
and Great Britain patent No. 1252160,
issued 16 Aug 2006 [HHS reference E–
176–1999/0–US–08]. The patent rights
in these inventions have been assigned
to the United States of America. The
territories included in this license may
be worldwide. The field of use may be
related to ‘‘Use of the patent rights in
the development and sale of
therapeutics for cerebral trauma, stroke,
and neurodegenerative disorders.’’
DATES: Only written comments or
applications for a license (or both)
which are received by the Technology
Advancement Office of the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) on or before
November 20, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent application, patents, inquiries,
comments, and other materials relating
to the contemplated exclusive license
should be directed to: Patrick McCue,
Ph.D., Senior Licensing and Patenting
Manager, Technology Advancement
Office, The National Institute of
Diabetes and Digestive and Kidney
Diseases, 12A South Drive, Bethesda,
MD 20892, Telephone: (301) 435–5560;
Email: patrick.mccue@nih.gov. A signed
confidentiality non-disclosure
agreement will be required to receive
copies of any patent applications that
have not been published by the United
SUMMARY:
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68547
States Patent and Trademark Office or
the World Intellectual Property
Organization.
SUPPLEMENTARY INFORMATION:
The technology provides novel
nucleoside and nucleotide derivatives
that are agonist or antagonists of P1 and
P2 receptors and may be useful in the
treatment or prevention of various
diseases including airway diseases,
cancer, cardiac arrhythmias, cardiac
ischemia, epilepsy, and Huntington’s
Disease.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the NIDDK receives written evidence
and argument that establishes that the
grant of the license would not be
consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.
Properly filed competing applications
for a license received by the NIDDK in
response to this notice will be treated as
objections to the contemplated license.
Comments and objections submitted in
response to this notice will not be made
available for public inspection and, to
the extent permitted by law, will not be
released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: October 30, 2015.
Anna Z. Amar,
Acting Deputy Director, Technology
Advancement Office, National Institute of
Diabetes and Digestive and Kidney Diseases,
National Institutes of Health.
[FR Doc. 2015–28245 Filed 11–4–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\05NON1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68545-68547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27986]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. FDA-2015-D-3638]
Minutes of Institutional Review Board Meetings: Guidance for
Institutions and Institutional Review Boards; Draft Guidance;
Availability
AGENCY: The Office for Human Research Protections, Office of the
Assistant Secretary for Health, Office of the Secretary, and the Food
and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office for Human Research Protections (OHRP), Office of
the Assistant Secretary for Health, and the Food and Drug
Administration (FDA) are announcing the availability of a draft
guidance entitled ``Minutes of Institutional Review Board (IRB)
Meetings: Guidance for Institutions and IRBs.'' The draft guidance is
intended for institutions and IRBs that are responsible for the review
and oversight of human subject research conducted or supported by the
U.S. Department of Health and Human Services (HHS) or regulated by FDA.
The purpose of the
[[Page 68546]]
draft guidance is to assist institutions and IRBs in preparing and
maintaining minutes of IRB meetings (also referred to in the guidance
as minutes) that meet the regulatory requirements for minutes set forth
in FDA and HHS regulations. The draft guidance also provides general
recommendations on the type and amount of information to be included in
the minutes.
DATES: You can comment on any guidance at any time (21 CFR
10.115(g)(5)). To ensure that we consider your comment on this draft
guidance before we begin work on the final version of the guidance,
submit either written or electronic comments by January 4, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-D-3638 for ``Minutes of Institutional Review Board Meetings:
Guidance for Institutions and Institutional Review Boards; Draft
Guidance; Availability'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential''. Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Janet Donnelly, Office of Good
Clinical Practice, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5167, Silver Spring, MD 20993-0002, 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 draft guidance
document entitled ``Minutes of Institutional Review Board Meetings:
Guidance for Institutions and Institutional Review Boards; Draft
Guidance; Availability.'' Because IRBs have been cited in OHRP
determination letters and FDA warning letters as having inadequate
minutes, OHRP and FDA are providing recommendations on the type and
amount of information to include in minutes in order to help IRBs meet
the regulatory requirements for minutes.
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
draft guidance document was developed as a part of these efforts. OHRP
and FDA believe that it will be most helpful to the regulated community
to issue a joint draft guidance document which will clearly demonstrate
the Agencies' harmonious approach to the topic of preparing and
maintaining minutes of IRB meetings.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of OHRP and FDA on
minutes of IRB meetings. 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 requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft 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 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 have been approved under OMB control
number 0990-0260.
[[Page 68547]]
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm,
or https://www.hhs.gov/ohrp/newsroom/, or https://www.regulations.gov.
Dated: October 23, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health. U.S. Department of Health and
Human Services.
Dated: October 27, 2015.
Leslie Kux,
Assistant Commissioner for Policy, U.S. Food and Drug Administration.
[FR Doc. 2015-27986 Filed 11-4-15; 8:45 am]
BILLING CODE 4164-01-P
