Center For Scientific Review; Notice of Closed Meetings, 75572 [2013-29613]
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Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
II of FDASIA is MDUFA III, which gives
FDA the authority to collect device user
fees from industry for fiscal years 2013
to 2017. MDUFA III took effect on
October 1, 2012, and will continue
through September 30, 2017.
Device user fees were first established
by Congress in 2002. Medical device
companies pay fees to FDA when they
register their establishment and list their
devices with the Agency, whenever they
submit an application or a notification
to market a new medical device in the
United States, and for certain other
types of submissions. Under MDUFA III,
FDA is authorized to collect user fees
that will total approximately $595
million (plus adjustments for inflation)
over 5 years. With this additional
funding, FDA will be able to hire more
than 200 full-time-equivalent workers
over the course of MDUFA III. In
exchange, FDA has committed to meet
certain performance goals outlined in
the MDUFA III Commitment Letter.4
maindgalligan on DSK5TPTVN1PROD with NOTICES
II. Assessment of FDA’s Process for the
Review of Device Submissions
Section V of the MDUFA III
Commitment Letter states that FDA and
the device industry will participate in a
comprehensive assessment of the
process for the review of device
applications. The assessment will
include consultation with both FDA and
industry. The assessment will be
conducted in two phases by a private,
independent consulting firm, under
contract with FDA, that is capable of
performing the technical analysis,
management assessment, and program
evaluation tasks required to address the
assessment as described in the MDUFA
III Commitment Letter.
FDA awarded the contract in June
2013 to the consulting firm Booz Allen
Hamilton. Findings on high-priority
recommendations (i.e., those likely to
have a significant impact on review
times) were scheduled to be published
within 6 months of award and are
included in the report available through
the link near the end of this notice.
Final comprehensive findings and
recommendations are scheduled to be
published within 1 year of contract
award. FDA agreed to publish an
implementation plan within 6 months
of receipt of each set of
recommendations. For Phase 2 of the
independent assessment, the contractor
will evaluate the implementation of
recommendations and publish a written
assessment no later than February 1,
2016.
4 www.fda.gov/downloads/MedicalDevices/News
The assessment includes, but is not
limited to, the following areas:
1. Identification of process
improvements and best practices for
conducting predictable, efficient, and
consistent premarket reviews that meet
regulatory review standards.
2. Analysis of elements of the review
process (including the presubmission
process, and investigational device
exemption, premarket notification
(510(k)), and premarket approval
application reviews) that consume or
save time to facilitate a more efficient
process. This includes analysis of root
causes for inefficiencies that may affect
review performance and total time to
decision. This will also include
recommended actions to correct any
failures to meet MDUFA goals. Analysis
of the review process will include the
impact of combination products,
companion diagnostic products, and
laboratory developed tests on the review
process.
3. Assessment of FDA methods and
controls for collecting and reporting
information on premarket review
process resource use and performance.
4. Assessment of effectiveness of
FDA’s Reviewer Training Program
implementation.
5. Recommendations for ongoing
periodic assessments and any
additional, more detailed, or focused
assessments.
FDA will incorporate findings and
recommendations, as appropriate, into
its management of the premarket review
program. FDA will analyze the
recommendations for improvement
opportunities identified in the
assessment, develop and implement a
corrective action plan, and assure its
effectiveness. FDA also will incorporate
the results of the assessment into a Good
Review Management Practices (GRMP)
guidance document. FDA’s
implementation of the GRMP guidance
will include initial and ongoing training
of FDA staff, and periodic audits of
compliance with the guidance.
The contractor’s Phase 1 findings on
high priority recommendations are
available at https://www.fda.gov/Medical
Devices/DeviceRegulationandGuidance/
Overview/MDUFAIII/ucm314036.htm.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–29612 Filed 12–6–13; 8:45 am]
Dated: December 6, 2013.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
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[FR Doc. 2013–29613 Filed 12–11–13; 8:45 am]
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National Institutes of Health
Center For Scientific Review; 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Obesity,
Insulin Action, and Metabolic Dysfunction.
Date: January 9, 2014.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Reed A Graves, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6166,
MSC 7892, Bethesda, MD 20892, (301) 402–
6297, gravesr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Immune and Radiotherapy.
Date: January 16, 2014.
Time: 9:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Lawrence Ka-Yun Ng,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7804, Bethesda, MD 20892, 301–435–
1719, ngkl@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Notices]
[Page 75572]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29613]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; 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 would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Obesity, Insulin Action, and Metabolic Dysfunction.
Date: January 9, 2014.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Reed A Graves, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6166, MSC 7892, Bethesda, MD 20892, (301) 402-
6297, gravesr@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Immune and Radiotherapy.
Date: January 16, 2014.
Time: 9:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Lawrence Ka-Yun Ng, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152, MSC 7804, Bethesda, MD
20892, 301-435-1719, ngkl@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: December 6, 2013.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-29613 Filed 12-11-13; 8:45 am]
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