82 FR 44630 - Minutes of Institutional Review Board Meetings; Guidance for Institutions and Institutional Review Boards; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 184 (September 25, 2017)
Federal Register Volume 82, Issue 184 (September 25, 2017)
| Page Range | 44630-44631 | |
| FR Document | 2017-20405 |
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)] [Notices] [Pages 44630-44631] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20405] ----------------------------------------------------------------------- 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; 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 of availability. ----------------------------------------------------------------------- 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 guidance entitled ``Minutes of Institutional Review Board Meetings; Guidance for Institutions and Institutional Review Boards.'' The guidance is intended for institutions and Institutional Review Boards (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 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 guidance also provides general recommendations on the type and amount of information to be included in the minutes. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2015. DATES: The announcement of the guidance is published in the Federal Register on September 25, 2017. 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the office of Dockets Management Staff 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 [[Page 44631]] redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.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, Rockville, MD 20852. 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: 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 ``Minutes of Institutional Review Board Meetings; Guidance for Institutions and Institutional Review Boards.'' OHRP and FDA are providing recommendations on the type and amount of information to include in 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 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 November 5, 2015 (80 FR 68545), OHRP and FDA announced the availability of the draft guidance of the same title dated November 2015. OHRP and FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized. Changes include modifying certain recommendations for inclusion of information in minutes when such information may be addressed in other IRB records. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated November 2015. II. Significance of Guidance The 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 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. This guidance is not subject to Executive Order 12866. III. 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 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. IV. Electronic Access Persons with access to the Internet may obtain the document at https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/alphabetical-list/index.html, or https://www.regulations.gov. Dated: August 30, 2017. Don Wright, Acting Assistant Secretary for Health. Dated: Sept. 15, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20405 Filed 9-22-17; 8:45 am] BILLING CODE 4164-01-P
![44630 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
ET, and November 8, 2017, 8:30 a.m. to should notify the DFO at least 10 days including attachments, to https://
5:00 p.m. ET. prior to the meeting. www.regulations.gov will be posted to
the docket unchanged. Because your
ADDRESSES: The address for the meeting Amy McNulty,
comment will be made public, you are
is Doubletree by Hilton Raleigh Acting Director, Division of the Executive solely responsible for ensuring that your
Brownstone-University, 1707 Secretariat.
comment does not include any
Hillsborough Street, Raleigh, NC 27605. [FR Doc. 2017–20422 Filed 9–22–17; 8:45 am] confidential information that you or a
Phone: (919) 828–0811. BILLING CODE 4165–15–P third party may not wish to be posted,
FOR FURTHER INFORMATION CONTACT: All such as medical information, your or
requests for information regarding the anyone else’s Social Security number, or
NACMH should be sent to Esther Paul, DEPARTMENT OF HEALTH AND confidential business information, such
DFO, NACMH, HRSA, in one of three HUMAN SERVICES as a manufacturing process. Please note
ways: (1) By mail to: Esther Paul, Office [Docket No. FDA–2015–D–3638] that if you include your name, contact
of Policy and Program Development, information, or other information that
Bureau of Primary Health Care, HRSA, Minutes of Institutional Review Board identifies you in the body of your
5600 Fishers Lane, 16N38B, Rockville, Meetings; Guidance for Institutions comments, that information will be
Maryland 20857; (2) by phone: (301) and Institutional Review Boards; posted on https://www.regulations.gov.
594–4300; or (3) by email: epaul@ Availability • If you want to submit a comment
hrsa.gov. with confidential information that you
AGENCY: The Office for Human Research do not wish to be made available to the
SUPPLEMENTARY INFORMATION: The Protections, Office of the Assistant public, submit the comment as a
NACMH is a non-discretionary advisory Secretary for Health, Office of the written/paper submission and in the
body mandated by the Public Health Secretary, and the Food and Drug manner detailed (see ‘‘Written/Paper
Service (PHS) Act, Title 42 U.S.C. 218, Administration, HHS. Submissions’’ and ‘‘Instructions’’).
to advise, consult with, and make ACTION: Notice of availability.
recommendations to the Secretary of Written/Paper Submissions
SUMMARY: The Office for Human Submit written/paper submissions as
HHS and the Administrator of HRSA
Research Protections (OHRP), Office of follows:
regarding the organization, operation,
the Assistant Secretary for Health, and • Mail/Hand delivery/Courier (for
selection, and funding of migrant health
the Food and Drug Administration written/paper submissions): Dockets
centers and other entities funded under
(FDA) are announcing the availability of Management Staff (HFA–305), Food and
section 330(g) of the PHS Act (42 U.S.C.
a guidance entitled ‘‘Minutes of Drug Administration, 5630 Fishers
254b). The NACMH Charter requires
Institutional Review Board Meetings; Lane, Rm. 1061, Rockville, MD 20852.
that the Council meet at least twice per
Guidance for Institutions and • For written/paper comments
year to discuss services and issues
Institutional Review Boards.’’ The submitted to the Dockets Management
related to the health of migrant and
guidance is intended for institutions Staff, FDA will post your comment, as
seasonal agricultural workers and their
and Institutional Review Boards (IRBs) well as any attachments, except for
families and to formulate their
that are responsible for the review and information submitted, marked and
recommendations to the HHS Secretary
oversight of human subject research identified, as confidential, if submitted
and HRSA Administrator.
conducted or supported by the U.S. as detailed in ‘‘Instructions.’’
Agenda: The agenda includes an Department of Health and Human Instructions: All submissions received
overview of the Council’s general Services (HHS) or regulated by FDA. must include the Docket No. FDA–
business activities. The Council will The purpose of the guidance is to assist 2015–D–3638 for ‘‘Minutes of
also hear presentations from a federal institutions and IRBs in preparing and Institutional Review Board Meetings;
official and experts on issues facing maintaining minutes of IRB meetings Guidance for Institutions and
agricultural workers, including the (also referred to in the guidance as Institutional Review Boards.’’ Received
status of agricultural worker health at minutes) that meet the regulatory comments will be placed in the docket
the local and national levels. In requirements for minutes set forth in and, except for those submitted as
addition, the Council will hold a public FDA and HHS regulations. The ‘‘Confidential Submissions,’’ publicly
hearing where migratory and seasonal guidance also provides general viewable at https://www.regulations.gov
agricultural workers will testify recommendations on the type and or at the office of Dockets Management
regarding matters affecting them. This amount of information to be included in Staff between 9 a.m. and 4 p.m.,
hearing is scheduled for Tuesday, the minutes. The guidance announced Monday through Friday.
November 7, 2017 from 1:30 p.m. to in this notice finalizes the draft • Confidential Submissions—To
5:00 p.m. at the Doubletree by Hilton guidance of the same title dated submit a comment with confidential
Raleigh Brownstone-University. Agenda November 2015. information that you do not wish to be
items are subject to change as priorities DATES: The announcement of the made publicly available, submit your
indicate. guidance is published in the Federal comments only as a written/paper
Public Participation: Members of the Register on September 25, 2017. submission. You should submit two
public will not be able to provide oral ADDRESSES: You may submit comments copies total. One copy will include the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comments during the meeting. Please as follows: information you claim to be confidential
provide any written questions or with a heading or cover note that states
comments for the NACMH to the DFO Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
by October 27, 2017, using the address, Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
phone number, or email provided following way: Agency will review this copy, including
above. Individuals who plan to attend • Federal eRulemaking Portal: the claimed confidential information, in
the meeting and need special assistance, https://www.regulations.gov. Follow the its consideration of comments. The
such as sign language interpretation or instructions for submitting comments. second copy, which will have the
other reasonable accommodations, Comments submitted electronically, claimed confidential information
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![Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44631
redacted/blacked out, will be available recommendations on the type and that are related to IRB recordkeeping
for public viewing and posted on amount of information to include in requirements under 45 CFR 46.115 have
https://www.regulations.gov. Submit minutes. been approved under OMB control
both copies to the Dockets Management To enhance human subject protection number 0990–0260.
Staff. If you do not wish your name and and reduce regulatory burden, OHRP
and FDA have been actively working to IV. Electronic Access
contact information to be made publicly
available, you can provide this harmonize the Agencies’ regulatory Persons with access to the Internet
information on the cover sheet and not requirements and guidance for human may obtain the document at https://
in the body of your comments and you subject research. This guidance www.fda.gov/ScienceResearch/
must identify this information as document was developed as a part of SpecialTopics/RunningClinicalTrials/
‘‘confidential.’’ Any information marked these efforts. In addition, on December GuidancesInformationSheetsand
as ‘‘confidential’’ will not be disclosed 13, 2016, the 21st Century Cures Act Notices/ucm219433.htm, https://
except in accordance with 21 CFR 10.20 (Cures Act) (Pub. L. 114–255) was www.hhs.gov/ohrp/regulations-and-
and other applicable disclosure law. For signed into law. Title III, section 3023 policy/guidance/alphabetical-list/
more information about FDA’s posting of the Cures Act requires the Secretary index.html, or https://www.regulations.
of comments to public dockets, see 80 of HHS to harmonize differences gov.
FR 56469, September 18, 2015, or access between the HHS human subject Dated: August 30, 2017.
the information at: https://www.gpo.gov/ regulations and FDA’s human subject
Don Wright,
fdsys/pkg/FR-2015-09-18/pdf/2015- regulations. This guidance document is
consistent with the goals of section 3023 Acting Assistant Secretary for Health.
23389.pdf.
of the Cures Act. Dated: Sept. 15, 2017.
Docket: For access to the docket to
read background documents or the In the Federal Register of November Anna K. Abram,
electronic and written/paper comments 5, 2015 (80 FR 68545), OHRP and FDA Deputy Commissioner for Policy, Planning,
received, go to https://www.regulations. announced the availability of the draft Legislation, and Analysis.
gov and insert the docket number, found guidance of the same title dated [FR Doc. 2017–20405 Filed 9–22–17; 8:45 am]
in brackets in the heading of this November 2015. OHRP and FDA BILLING CODE 4164–01–P
document, into the ‘‘Search’’ box and received several comments on the draft
follow the prompts and/or go to the guidance, and those comments were
Dockets Management Staff, 5630 Fishers considered as the guidance was DEPARTMENT OF HEALTH AND
Lane, Rm. 1061, Rockville, MD 20852. finalized. Changes include modifying HUMAN SERVICES
Submit written requests for single certain recommendations for inclusion
of information in minutes when such National Institutes of Health
copies of the guidance to the Office of
Good Clinical Practice (OGCP), Office of information may be addressed in other
IRB records. In addition, editorial Proposed Collection; 60-Day Comment
Special Medical Programs, Office of Request; Generic Clearance to
Medical Products and Tobacco, Food changes were made to improve clarity.
The guidance announced in this notice Conduct Formative Research (NIAID)
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103, finalizes the draft guidance dated AGENCY: National Institutes of Health,
Silver Spring, MD 20993; or Division of November 2015. Department of Health and Human
Policy and Assurances, Office for II. Significance of Guidance Services.
Human Research Protections, 1101 ACTION: Notice.
The guidance is being issued
Wootton Pkwy., Suite 200, Rockville,
consistent with FDA’s good guidance SUMMARY: In compliance with the
MD 20852. Send one self-addressed
practices regulation (21 CFR 10.115). requirement of the Paperwork
adhesive label to assist the office in
The guidance represents the current Reduction Act of 1995 to provide
processing your requests. The guidance
thinking of OHRP and FDA on minutes opportunity for public comment on
may also be obtained by mail by calling
of IRB meetings. It does not establish proposed data collection projects, the
OGCP at 301–796–8340 or OHRP at
any rights for any person and is not National Institute of Allergy and
240–453–6900 or 866–447–4777. See
binding on OHRP, FDA, or the public. Infectious Diseases (NIAID) will publish
the SUPPLEMENTARY INFORMATION section
You can use an alternative approach if periodic summaries of propose projects
for electronic access to the guidance
it satisfies the requirements of the to be submitted to the Office of
document.
applicable statutes and regulations. This Management and Budget (OMB) for
FOR FURTHER INFORMATION CONTACT: guidance is not subject to Executive review and approval.
Janet Donnelly, Office of Good Clinical Order 12866. DATES: Comments regarding this
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, III. Paperwork Reduction Act of 1995 information collection are best assured
Rm. 5167, Silver Spring, MD 20993, This guidance refers to previously of having their full effect if received
301–796–4187; or Irene Stith-Coleman, approved collections of information. within 60 days of the date of this
Office for Human Research Protections, These collections of information are publication.
1101 Wootton Pkwy., Suite 200, subject to review by the Office of FOR FURTHER INFORMATION CONTACT: To
Rockville, MD 20852, 240–453–6900. Management and Budget (OMB) under obtain a copy of the data collection
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION: the Paperwork Reduction Act of 1995 plans and instruments, submit
(44 U.S.C. 3501–3520). The collections comments in writing, or request more
I. Background of information referenced in this information on the proposed project,
OHRP and FDA are announcing the guidance that are related to IRB contact: Dione Washington, Health
availability of a guidance document recordkeeping requirements under 21 Science Policy Analyst, Strategic
entitled ‘‘Minutes of Institutional CFR 56.115 have been approved under Planning and Evaluation Branch, 5601
Review Board Meetings; Guidance for OMB control numbers 0910–0755 and Fishers Lane, Room 5F32, Rockville,
Institutions and Institutional Review 0910–0130. The collections of Maryland, 20892 or Email your request,
Boards.’’ OHRP and FDA are providing information referenced in this guidance including your address to:
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Document Created: 2018-10-24 14:43:43
Document Modified: 2018-10-24 14:43:43
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on September 25, 2017. | |
| Contact | 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. | |
| FR Citation | 82 FR 44630 |
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