Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Extension of the Comment Period, 78238-78239 [2015-31593]

Download as PDF 78238 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices associated with the international migration and recruitment of health personnel, foreign and immigrant health workers, and veterans. (13) Division of National Health Service Corps (RQB3); and (14) Division of Regional Operations (RQB4). Office of External Engagement (RA57) (1) Serves as the principal Agency resource for facilitating external engagement; (2) coordinates the Agency’s intergovernmental activities; (3) provides the Administrator with a single point of contact on all activities related to important state and local government, stakeholder association, and interest group activities; (4) coordinates Agency cross-Bureau cooperative agreements and activities with organizations such as the National Governors Association, National Conference of State Legislature, Association of State and Territorial Health Officials, National Association of Counties, and National Association of County and City Health Officials; (5) interacts with various commissions such as the Delta Regional Authority, Appalachian Regional Commission, and Denali Commission; (6) serves as the primary liaison to Department intergovernmental staff; and (7) serves as the Agency liaison to manage and coordinate study engagements with the Government Accountability Office and the HHS Office of the Inspector General, Office of Evaluation and Inspections. Section RQ–20, Functions tkelley on DSK9F6TC42PROD with NOTICES Chapter RQ—Bureau of Health Workforce (RQ) Section RQ–10, Organization Delete the organizational structure for the Bureau of Health Workforce (RQ) and replace in its entirety. The Bureau of Health Workforce is headed by the Associate Administrator, who reports directly to the Administrator, Health Resources and Services Administration. (1) Office of the Associate Administrator (RQ); (2) Division of Policy and Shortage Designation (RQ1); (3) Division of Business Operations (RQ2); (4) Division of External Affairs (RQ3); (5) Office of Workforce Development and Analysis (RQA); (6) National Center for Health Workforce Analysis (RQA2); (7) Division of Medicine and Dentistry (RQA3); (8) Division of Nursing and Public Health (RQA4); (9) Division of Practitioner Data Bank (RQA5); (10) Office of Health Careers (RQB); (11) Division of Participant Support and Compliance (RQB1); (12) Division of Health Careers and Financial Support (RQB2); VerDate Sep<11>2014 17:21 Dec 15, 2015 Jkt 238001 This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Bureau of Health Workforce (RQ). Specifically, this notice: (1) Transfers the function of the Office of Global Health Affairs (RQA1) to the Office of the Administrator (RA); and (2) updates the functional statement for the Bureau of Health Workforce (RQ) and the Office of the Administrator (RA). Secretary for Health, Office of the Secretary, and the Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. The Bureau of Health Workforce (BHW) improves the health of the nation’s underserved communities and vulnerable populations by developing, implementing, evaluating, and refining programs that strengthen the nation’s health care workforce. BHW programs support a diverse, culturally competent workforce by addressing components including: education and training; recruitment and retention; financial support for students, faculty, and practitioners; supporting institutions; data analysis; and evaluation and coordination of health workforce activities. These efforts support development of a skilled health workforce serving in areas of the nation with the greatest need. The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are extending the comment period for the draft guidance entitled ‘‘Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.’’ A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of November 5, 2015. The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. This extension will allow interested persons additional time to submit comments. DATES: OHRP and FDA are extending the comment period on the draft guidance entitled ‘‘Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.’’ Submit either electronic or written comments by February 3, 2016. ADDRESSES: You may submit comments as follows: Delegations of Authority Electronic Submissions All delegations of authority and redelegations of authority made to HRSA officials that were in effect immediately prior to this reorganization, and that are consistent with this reorganization, shall continue in effect pending further re-delegation. This reorganization is effective upon date of signature. 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 Bureau of Health Workforce (RQ) Dated: December 8, 2015. James Macrae, Acting Administrator. [FR Doc. 2015–31594 Filed 12–15–15; 8:45 am] BILLING CODE 4165–15–P 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; Extension of the Comment Period The Office for Human Research Protections, Office of the Assistant AGENCY: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\16DEN1.SGM 16DEN1 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices tkelley on DSK9F6TC42PROD with NOTICES 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 VerDate Sep<11>2014 17:21 Dec 15, 2015 Jkt 238001 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 200, Rockville, MD 20852, 240–453– 6900. In the Federal Register of November 5, 2015 (80 FR 68545), OHRP and FDA published a notice of availability with a 60-day comment period to request comments on a draft guidance document entitled ‘‘Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability.’’ The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. We believe that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance on these important issues. SUPPLEMENTARY INFORMATION: Dated: December 9, 2015. Leslie Kux, Associate Commissioner for Policy, U.S. Food and Drug Administration. Dated: December 4, 2015. Karen B. DeSalvo, Acting Assistant Secretary for Health, U.S. Department of Health and Human Services. [FR Doc. 2015–31593 Filed 12–15–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of meetings of the National PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 78239 Center for Advancing Translational Sciences. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. 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 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Cures Acceleration Network Review Board. Date: January 14, 2016. Time: 8:30 a.m. to 4:30 p.m. Agenda: Report from the Institute Director. Place: National Institutes of Health, Building 31, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, 1 Democracy Plaza, Room 1072, Bethesda, MD 20892, 301–435–0809, anna.ramseyewing@ nih.gov. Name of Committee: National Center for Advancing Translational Sciences Advisory Council. Date: January 14, 2016. Open: 8:30 a.m. to 4:30 p.m. Agenda: Report from the Institute Director and other staff. Place: National Institutes of Health, Building 31, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. Closed: 3:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive Secretary, National Center for Advancing Translational Sciences, 1 Democracy Plaza, Room 1072, Bethesda, MD 20892, 301–435–0809, anna.ramseyewing@ nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Pages 78238-78239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31593]


-----------------------------------------------------------------------

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; Extension 
of the Comment Period

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; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health, and the Food and Drug 
Administration (FDA) are extending the comment period for the draft 
guidance entitled ``Minutes of Institutional Review Board (IRB) 
Meetings: Guidance for Institutions and IRBs.'' A notice of 
availability requesting comments on the draft guidance document 
appeared in the Federal Register of November 5, 2015. The Agencies are 
taking the initiative to extend the comment period for an additional 30 
days because the timing of the due date for comments intersects with 
comment periods on other Federal Register documents requiring review by 
the same group of stakeholders. This extension will allow interested 
persons additional time to submit comments.

DATES: OHRP and FDA are extending the comment period on the draft 
guidance entitled ``Minutes of Institutional Review Board (IRB) 
Meetings: Guidance for Institutions and IRBs.'' Submit either 
electronic or written comments by February 3, 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

[[Page 78239]]

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: In the Federal Register of November 5, 2015 
(80 FR 68545), OHRP and FDA published a notice of availability with a 
60-day comment period to request comments on a draft guidance document 
entitled ``Minutes of Institutional Review Board Meetings: Guidance for 
Institutions and Institutional Review Boards; Draft Guidance; 
Availability.'' The Agencies are taking the initiative to extend the 
comment period for an additional 30 days because the timing of the due 
date for comments intersects with comment periods on other Federal 
Register documents requiring review by the same group of stakeholders. 
We believe that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying finalizing 
the guidance on these important issues.

    Dated: December 9, 2015.
Leslie Kux,
Associate Commissioner for Policy, U.S. Food and Drug Administration.
    Dated: December 4, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, U.S. Department of Health and 
Human Services.
[FR Doc. 2015-31593 Filed 12-15-15; 8:45 am]
BILLING CODE 4164-01-P
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