Council on Graduate Medical Education, 69538 [2016-24167]
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69538
Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices
approval for pharmaceutical treatments
for these diseases. Under section 524, a
sponsor of a human drug application for
a qualified tropical disease may be
eligible for a voucher that can be used
to obtain a priority review for any
application submitted under section
505(b)(1) of the FD&C Act or section 351
of the Public Health Service Act. The
guidance also provides information on
using the priority review vouchers and
on transferring priority review vouchers
to other sponsors.
This guidance finalizes the draft
guidance of the same name issued
October 2008 and includes the
following substantive changes based on
public comment.
• The procedure for FDA to add
diseases to the list is described
• Clarification is provided for when a
voucher can be used
• A statement was added to say that
FDA may provide a preliminary
nonbinding opinion, before approval,
that an application appears to meet the
criteria for voucher eligibility
• Clarification is provided regarding
the eligibility of combination products
to receive a voucher
• Clarification is provided regarding
the timing of payment of the priority
review user fee
• Clarification is provided regarding
whether FDA can remove tropical
diseases from the list
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on obtaining tropical
disease priority review vouchers. It does
not establish any rights for any person
and is not binding on 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 guidance contains information
collection provisions that 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 collection of information in
this guidance was approved under OMB
control number 0910–0822.
sradovich on DSK3GMQ082PROD with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
VerDate Sep<11>2014
18:46 Oct 05, 2016
Jkt 241001
Dated: September 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–24232 Filed 10–5–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Council on Graduate Medical
Education
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given that a meeting is
scheduled for the Council on Graduate
Medical Education (COGME). This
meeting will be open to the public.
Information about COGME and the
agenda for this meeting can be obtained
by accessing the COGME Web site at
https://www.hrsa.gov/
advisorycommittees/bhpradvisory/
COGME.
SUMMARY:
October 20, 2016, 10:00 a.m.–
4:30 p.m. ET
ADDRESSES: This meeting will be held
by webinar only. Information on
connecting to the webinar can be found
on the COGME Web site.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding COGME should contact Dr.
Kennita Carter, Designated Federal
Official, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, in one of three ways: (1) Send a
request to the following address: Dr.
Kennita Carter, Designated Federal
Official, Division of Medicine and
Dentistry, HRSA, 5600 Fishers Lane,
15N–116, Rockville, Maryland 20857;
(2) call 301–945–3505; or (3) send an
email to KCarter@hrsa.gov.
SUPPLEMENTARY INFORMATION: COGME
provides advice and recommendations
to the Secretary of HHS and to Congress
on a range of issues including the
supply and distribution of physicians in
the United States, current and future
physician shortages or excesses, foreign
medical school graduates, the nature
and financing of medical education
training, and the development of
performance measures and longitudinal
evaluation of medical education
programs.
During the meeting, COGME members
will discuss topics and issues related to
DATES:
PO 00000
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the preparation of its 23rd report.
COGME’s reports are submitted to the
Secretary of HHS; the Committee on
Health, Education, Labor, and Pensions
of the Senate; and the Committee on
Energy and Commerce of the House of
Representatives.
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to make oral
comments or provide written comments
to COGME should be made using the
contact address or phone number above
by October 13, 2016.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–24167 Filed 10–5–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Secretary, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold a
meeting that will be open to the public.
Information about SACHRP and the full
meeting agenda will be posted on the
SACHRP Web site at: https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Tuesday, October 25, 2016, from 8:30
a.m. until 5:00 p.m. and Wednesday,
October 26, 2016, from 8:30 a.m. until
4:30 p.m.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director, SACHRP
or Jerry Menikoff, M.D., J.D., Director,
Office for Human Research Protections
(OHRP); U.S. Department of Health and
Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
SUMMARY:
E:\FR\FM\06OCN1.SGM
06OCN1
]]>Agencies
[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Page 69538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24167]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Council on Graduate Medical Education
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, notice
is hereby given that a meeting is scheduled for the Council on Graduate
Medical Education (COGME). This meeting will be open to the public.
Information about COGME and the agenda for this meeting can be obtained
by accessing the COGME Web site at https://www.hrsa.gov/advisorycommittees/bhpradvisory/COGME.
DATES: October 20, 2016, 10:00 a.m.-4:30 p.m. ET
ADDRESSES: This meeting will be held by webinar only. Information on
connecting to the webinar can be found on the COGME Web site.
FOR FURTHER INFORMATION CONTACT: Anyone requesting information
regarding COGME should contact Dr. Kennita Carter, Designated Federal
Official, Division of Medicine and Dentistry, Bureau of Health
Workforce, HRSA, in one of three ways: (1) Send a request to the
following address: Dr. Kennita Carter, Designated Federal Official,
Division of Medicine and Dentistry, HRSA, 5600 Fishers Lane, 15N-116,
Rockville, Maryland 20857; (2) call 301-945-3505; or (3) send an email
to KCarter@hrsa.gov.
SUPPLEMENTARY INFORMATION: COGME provides advice and recommendations to
the Secretary of HHS and to Congress on a range of issues including the
supply and distribution of physicians in the United States, current and
future physician shortages or excesses, foreign medical school
graduates, the nature and financing of medical education training, and
the development of performance measures and longitudinal evaluation of
medical education programs.
During the meeting, COGME members will discuss topics and issues
related to the preparation of its 23rd report. COGME's reports are
submitted to the Secretary of HHS; the Committee on Health, Education,
Labor, and Pensions of the Senate; and the Committee on Energy and
Commerce of the House of Representatives.
Members of the public will have the opportunity to provide
comments. Oral comments will be honored in the order they are requested
and may be limited as time allows. Requests to make oral comments or
provide written comments to COGME should be made using the contact
address or phone number above by October 13, 2016.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-24167 Filed 10-5-16; 8:45 am]
BILLING CODE 4165-15-P
