80 FR 78238 - Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Extension of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 241 (December 16, 2015)
Federal Register Volume 80, Issue 241 (December 16, 2015)
| Page Range | 78238-78239 | |
| FR Document | 2015-31593 |
[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)] [Notices] [Pages 78238-78239] From the Federal Register Online [www.thefederalregister.org] [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Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Extension of the Comment Period AGENCY: The Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, and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the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are extending the comment period for the draft guidance entitled ``Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.'' A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of November 5, 2015.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 DATES: OHRP and FDA are extending the comment period on the draft guidance entitled ``Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.''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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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
![78238 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices
associated with the international (13) Division of National Health Secretary for Health, Office of the
migration and recruitment of health Service Corps (RQB3); and Secretary, and the Food and Drug
personnel, foreign and immigrant health (14) Division of Regional Operations Administration, HHS.
workers, and veterans. (RQB4). ACTION: Notice of availability; extension
Office of External Engagement (RA57) Section RQ–20, Functions of comment period.
(1) Serves as the principal Agency This notice reflects organizational SUMMARY: The Office for Human
resource for facilitating external changes in the Health Resources and Research Protections (OHRP), Office of
engagement; (2) coordinates the Services Administration (HRSA), the Assistant Secretary for Health, and
Agency’s intergovernmental activities; Bureau of Health Workforce (RQ). the Food and Drug Administration
(3) provides the Administrator with a Specifically, this notice: (1) Transfers (FDA) are extending the comment
single point of contact on all activities the function of the Office of Global period for the draft guidance entitled
related to important state and local Health Affairs (RQA1) to the Office of ‘‘Minutes of Institutional Review Board
government, stakeholder association, the Administrator (RA); and (2) updates (IRB) Meetings: Guidance for
and interest group activities; (4) the functional statement for the Bureau Institutions and IRBs.’’ A notice of
coordinates Agency cross-Bureau of Health Workforce (RQ) and the Office availability requesting comments on the
cooperative agreements and activities of the Administrator (RA). draft guidance document appeared in
with organizations such as the National the Federal Register of November 5,
Governors Association, National Bureau of Health Workforce (RQ)
2015. The Agencies are taking the
Conference of State Legislature, The Bureau of Health Workforce initiative to extend the comment period
Association of State and Territorial (BHW) improves the health of the for an additional 30 days because the
Health Officials, National Association of nation’s underserved communities and timing of the due date for comments
Counties, and National Association of vulnerable populations by developing, intersects with comment periods on
County and City Health Officials; (5) implementing, evaluating, and refining other Federal Register documents
interacts with various commissions programs that strengthen the nation’s requiring review by the same group of
such as the Delta Regional Authority, health care workforce. BHW programs stakeholders. This extension will allow
Appalachian Regional Commission, and support a diverse, culturally competent interested persons additional time to
Denali Commission; (6) serves as the workforce by addressing components submit comments.
primary liaison to Department including: education and training; DATES: OHRP and FDA are extending
intergovernmental staff; and (7) serves recruitment and retention; financial the comment period on the draft
as the Agency liaison to manage and support for students, faculty, and guidance entitled ‘‘Minutes of
coordinate study engagements with the practitioners; supporting institutions; Institutional Review Board (IRB)
Government Accountability Office and data analysis; and evaluation and Meetings: Guidance for Institutions and
the HHS Office of the Inspector General, coordination of health workforce IRBs.’’ Submit either electronic or
Office of Evaluation and Inspections. activities. These efforts support written comments by February 3, 2016.
development of a skilled health
Chapter RQ—Bureau of Health ADDRESSES: You may submit comments
workforce serving in areas of the nation
Workforce (RQ) as follows:
with the greatest need.
Section RQ–10, Organization Electronic Submissions
Delegations of Authority
Delete the organizational structure for Submit electronic comments in the
the Bureau of Health Workforce (RQ) All delegations of authority and re-
following way:
delegations of authority made to HRSA
and replace in its entirety. • Federal eRulemaking Portal: http://
The Bureau of Health Workforce is officials that were in effect immediately
www.regulations.gov. Follow the
headed by the Associate Administrator, prior to this reorganization, and that are
instructions for submitting comments.
who reports directly to the consistent with this reorganization,
Comments submitted electronically,
Administrator, Health Resources and shall continue in effect pending further
including attachments, to http://
Services Administration. re-delegation.
www.regulations.gov will be posted to
(1) Office of the Associate This reorganization is effective upon
the docket unchanged. Because your
Administrator (RQ); date of signature.
comment will be made public, you are
(2) Division of Policy and Shortage Dated: December 8, 2015. solely responsible for ensuring that your
Designation (RQ1); James Macrae, comment does not include any
(3) Division of Business Operations Acting Administrator. confidential information that you or a
(RQ2); third party may not wish to be posted,
[FR Doc. 2015–31594 Filed 12–15–15; 8:45 am]
(4) Division of External Affairs (RQ3); such as medical information, your or
(5) Office of Workforce Development BILLING CODE 4165–15–P
anyone else’s Social Security number, or
and Analysis (RQA);
(6) National Center for Health confidential business information, such
Workforce Analysis (RQA2); DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
(7) Division of Medicine and Dentistry HUMAN SERVICES that if you include your name, contact
(RQA3); information, or other information that
[Docket No. FDA–2015–D–3638] identifies you in the body of your
(8) Division of Nursing and Public
Health (RQA4); Minutes of Institutional Review Board comments, that information will be
tkelley on DSK9F6TC42PROD with NOTICES
(9) Division of Practitioner Data Bank Meetings: Guidance for Institutions posted on
(RQA5); and Institutional Review Boards; Draft http://www.regulations.gov.
(10) Office of Health Careers (RQB); Guidance; Extension of the Comment • If you want to submit a comment
(11) Division of Participant Support Period with confidential information that you
and Compliance (RQB1); do not wish to be made available to the
(12) Division of Health Careers and AGENCY: The Office for Human Research public, submit the comment as a
Financial Support (RQB2); Protections, Office of the Assistant written/paper submission and in the
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![Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices 78239
manner detailed (see ‘‘Written/Paper electronic and written/paper comments Center for Advancing Translational
Submissions’’ and ‘‘Instructions’’). received, go to http:// Sciences.
www.regulations.gov and insert the The meetings will be open to the
Written/Paper Submissions
docket number, found in brackets in the public as indicated below, with
Submit written/paper submissions as heading of this document, into the attendance limited to space available.
follows: ‘‘Search’’ box and follow the prompts Individuals who plan to attend and
• Mail/Hand delivery/Courier (for and/or go to the Division of Dockets need special assistance, such as sign
written/paper submissions): Division of Management, 5630 Fishers Lane, Rm. language interpretation or other
Dockets Management (HFA–305), Food 1061, Rockville, MD 20852. reasonable accommodations, should
and Drug Administration, 5630 Fishers notify the Contact Person listed below
Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
in advance of the meeting.
• For written/paper comments Janet Donnelly, Office of Good Clinical
The meetings will be closed to the
submitted to the Division of Dockets Practice, Food and Drug Administration,
public in accordance with the
Management, FDA will post your 10903 New Hampshire Ave., Bldg. 32,
provisions set forth in sections
comment, as well as any attachments, Rm. 5167, Silver Spring, MD 20993–
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
except for information submitted, 0002, 301–796–4187; or Irene Stith-
as amended. The grant applications and
marked and identified, as confidential, Coleman, Office for Human Research
the discussions could disclose
if submitted as detailed in Protections, 1101 Wootton Pkwy., Suite
confidential trade secrets or commercial
‘‘Instructions.’’ 200, Rockville, MD 20852, 240–453–
Instructions: All submissions received property such as patentable material,
6900.
must include the Docket No. FDA– and personal information concerning
2015–D–3638 for ‘‘Minutes of SUPPLEMENTARY INFORMATION: In the individuals associated with the grant
Institutional Review Board Meetings: Federal Register of November 5, 2015 applications, the disclosure of which
Guidance for Institutions and (80 FR 68545), OHRP and FDA would constitute a clearly unwarranted
Institutional Review Boards; Draft published a notice of availability with a invasion of personal privacy.
Guidance; Availability’’ publicly 60-day comment period to request Name of Committee: Cures Acceleration
viewable at http://www.regulations.gov comments on a draft guidance Network Review Board.
or at the Division of Dockets document entitled ‘‘Minutes of Date: January 14, 2016.
Management between 9 a.m. and 4 p.m., Institutional Review Board Meetings: Time: 8:30 a.m. to 4:30 p.m.
Guidance for Institutions and Agenda: Report from the Institute Director.
Monday through Friday. Place: National Institutes of Health,
• Confidential Submissions—To Institutional Review Boards; Draft
Building 31, Conference Room 10, 31 Center
submit a comment with confidential Guidance; Availability.’’ The Agencies
Drive, Bethesda, MD 20892.
information that you do not wish to be are taking the initiative to extend the Contact Person: Anna L. Ramsey-Ewing,
made publicly available, submit your comment period for an additional 30 Ph.D., Executive Secretary, National Center
comments only as a written/paper days because the timing of the due date for Advancing Translational Sciences, 1
submission. You should submit two for comments intersects with comment Democracy Plaza, Room 1072, Bethesda, MD
copies total. One copy will include the periods on other Federal Register 20892, 301–435–0809, anna.ramseyewing@
information you claim to be confidential documents requiring review by the same nih.gov.
with a heading or cover note that states group of stakeholders. We believe that a Name of Committee: National Center for
‘‘THIS DOCUMENT CONTAINS 30-day extension allows adequate time Advancing Translational Sciences Advisory
CONFIDENTIAL INFORMATION.’’ The for interested persons to submit Council.
comments without significantly Date: January 14, 2016.
Agency will review this copy, including Open: 8:30 a.m. to 4:30 p.m.
the claimed confidential information, in delaying finalizing the guidance on
Agenda: Report from the Institute Director
its consideration of comments. The these important issues. and other staff.
second copy, which will have the Dated: December 9, 2015. Place: National Institutes of Health,
claimed confidential information Leslie Kux, Building 31, Conference Room 10, 31 Center
redacted/blacked out, will be available Drive, Bethesda, MD 20892.
Associate Commissioner for Policy, U.S. Food
for public viewing and posted on http:// Closed: 3:00 p.m. to 4:30 p.m.
and Drug Administration.
www.regulations.gov. Submit both Agenda: To review and evaluate grant
Dated: December 4, 2015. applications.
copies to the Division of Dockets Karen B. DeSalvo, Place: National Institutes of Health,
Management. If you do not wish your Building 31, Conference Room 10, 31 Center
Acting Assistant Secretary for Health, U.S.
name and contact information to be Department of Health and Human Services. Drive, Bethesda, MD 20892.
made publicly available, you can Contact Person: Anna L. Ramsey-Ewing,
[FR Doc. 2015–31593 Filed 12–15–15; 8:45 am]
provide this information on the cover Ph.D., Executive Secretary, National Center
BILLING CODE 4164–01–P
sheet and not in the body of your for Advancing Translational Sciences, 1
comments and you must identify this Democracy Plaza, Room 1072, Bethesda, MD
information as ‘‘confidential.’’ Any 20892, 301–435–0809, anna.ramseyewing@
DEPARTMENT OF HEALTH AND nih.gov.
information marked as ‘‘confidential’’
HUMAN SERVICES In the interest of security, NIH has
will not be disclosed except in
accordance with 21 CFR 10.20 and other instituted stringent procedures for entrance
National Institutes of Health onto the NIH campus. All visitor vehicles,
applicable disclosure law. For more
including taxicabs, hotel, and airport shuttles
information about FDA’s posting of National Center for Advancing will be inspected before being allowed on
tkelley on DSK9F6TC42PROD with NOTICES
comments to public dockets, see 80 FR Translational Sciences; Notice of campus. Visitors will be asked to show one
56469, September 18, 2015, or access Meetings form of identification (for example, a
the information at: http://www.fda.gov/ government-issued photo ID, driver’s license,
regulatoryinformation/dockets/ Pursuant to section 10(d) of the or passport) and to state the purpose of their
default.htm. Federal Advisory Committee Act, as visit.
Docket: For access to the docket to amended (5 U.S.C. App.), notice is (Catalogue of Federal Domestic Assistance
read background documents or the hereby given of meetings of the National Program Nos. 93.859, Pharmacology,
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Document Created: 2015-12-16 01:00:50
Document Modified: 2015-12-16 01:00:50
| 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; extension of comment period. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 78238 |
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