[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Pages 85231-85232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Request for Nominations on the Blood Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting industry representative to serve on the Blood Products
Advisory Committee for the Center for Biologics Evaluation and Research
(CBER) notify FDA in writing. FDA is also requesting nominations for a
nonvoting industry representative(s) to serve on the Blood Products
Advisory Committee. A nominee may either be self-nominated or nominated
by an organization to serve as a nonvoting industry representative.
Nominations will be accepted for current vacancies effective with this
notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by December
23, 2016. See sections I and II of this document for further details.
Concurrently, nomination materials for prospective candidates should be
sent to FDA by December 23, 2016.
ADDRESSES: All statements of interest from industry organizations that
wish to participate in the selection process of nonvoting industry
representative nomination should be sent to Bryan Emery (see FOR
FURTHER INFORMATION CONTACT). All nominations for nonvoting industry
representatives may be submitted electronically by accessing the FDA
Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail
to Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002. Information about becoming a member of an FDA
advisory committee can also be obtained by visiting FDA's Web site
http://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific
Advisors and Consultants, CBER, 10903 New Hampshire Ave., Bldg. 71, Rm.
6128, Silver Spring, MD 20993-0002, 240-402-8054, Fax: 301-595-1307,
email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. CBER Blood Products Advisory Committee
The Committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood; products derived
from blood and serum or biotechnology intended for use in the
diagnosis, prevention, or treatment of human diseases; and, as
required, any other product for which FDA has regulatory
responsibility. The Committee then advises the Commissioner of Food and
Drugs of its findings regarding screening, testing, and labeling of
products on clinical and laboratory studies involving such products on
the affirmation or revocation of biological products licenses, as well
as on the quality and relevance of FDA's research program that provides
the scientific support for regulating these agents. The Committee will
function at times as a medical device panel under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) Medical Device Amendments of
1976. As such, the Committee: (1) Recommends classification of devices
subject to its review into regulatory categories, (2) recommends the
assignment of a priority for the application of regulatory requirements
for devices classified in the standards or premarket approval category,
(3) advises on formulation of product development protocols and reviews
premarket approval applications for those devices to recommend changes
in classification as appropriate, (4) recommends exemption of certain
devices from the application of portions of the FD&C Act, (5) advises
on the necessity to ban a device, and (6) responds to requests from the
Agency to review and make recommendations on specific issues or
problems concerning the safety and effectiveness of devices.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for the committee. The interested organizations are not bound
by the list of nominees in selecting a candidate. However, if no
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this document (see DATES). FDA will forward
all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process).
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FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: November 18, 2016.
Janice M. Soreth,
Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-28306 Filed 11-23-16; 8:45 am]
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