[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3923-3924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01057]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives 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 or Agency) 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 (BPAC) for the Center for Biologics
Evaluation and Research notify FDA in writing. FDA is also requesting
nominations for a nonvoting industry representative(s) to serve on the
BPAC. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
Nominations will be accepted for future vacancies effective October 1,
2020, 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 February
24, 2020 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by February 24, 2020.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent via email to
Christina Vert (see FOR FURTHER INFORMATION CONTACT). All nominations
for nonvoting industry representatives must be submitted electronically
by accessing the FDA Advisory Committee Membership Nomination Portal
at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. Information about becoming a member of an FDA advisory
committee can also
[[Page 3924]]
be obtained by visiting FDA's website at: http://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-
402-8054, Fax: 301-595-1309, email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. Blood Products Advisory Committee
BPAC reviews and evaluates available data concerning the safety,
effectiveness, and appropriate use of blood, products derived from
blood and serum or biotechnology which are intended for use in the
diagnosis, prevention, or treatment of human diseases, and, as
required, any other product for which FDA has regulatory
responsibility, and advises the Commissioner of Food and Drugs (the
Commissioner) of its findings regarding screening and testing (to
determine eligibility) of donors and labeling of the products, on
clinical and laboratory studies involving such products, on the
affirmation or revocation of biological products licenses, and on the
quality and relevance of FDA's research program which provides the
scientific support for regulating these agents. BPAC will function at
times as a medical device panel under the Federal Food, Drug, and
Cosmetic Act Medical Device Amendments of 1976. As such, BPAC
recommends classification of devices subject to its review into
regulatory categories; recommends the assignment of a priority for the
application of regulatory requirements for devices classified in the
standards or premarket approval category; advises on formulation of
product development protocols and reviews premarket approval
applications for those devices to recommend changes in classification
as appropriate; recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
advises on the necessity to ban a device; and 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 via email stating that interest to 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 notification 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
r[eacute]sum[eacute]s. 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.)
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: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01057 Filed 1-22-20; 8:45 am]
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