[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43141-43142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17924]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0573]
Request for Nominations for Voting Members on a Public Advisory
Committee; 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
nominations for voting members to serve on the Blood Products Advisory
Committee (the Committee) in the Center for Biologics Evaluation and
Research. Nominations will be accepted for upcoming vacancies effective
with this notice. 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.
DATES: Nominations received on or before October 21, 2019 will be given
first consideration for membership on the Blood Products Advisory
Committee. Nominations received after October 21, 2019 will be
considered for nomination to the committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/factrsportal/factrs/index.cfm.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's website at https://www.fda.gov/advisory-committees.
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: FDA is requesting nominations for voting
members to fill upcoming vacancies on the Blood Products Advisory
Committee.
I. General Description of the Committee Duties
The Committee 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. The Committee will
function at times as a medical device panel under the Federal Food,
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the
Committee 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 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. Criteria for Voting Members
The Committee consists of a core of 17 voting members including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of clinical
and administrative medicine, hematology, immunology, blood banking,
surgery, internal medicine, biochemistry, engineering, biological and
physical sciences, biotechnology, computer technology, statistics,
epidemiology, sociology/ethics, and other related professions. Almost
all non-Federal members of this committee serve as Special Government
Employees. Members will be invited to serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on the advisory committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address, telephone number, and email address if
available and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must specify the advisory committee for which the nominee
is recommended. Nominations must also acknowledge that the nominee is
aware of the nomination unless self-nominated. FDA will ask
[[Page 43142]]
potential candidates to provide detailed information concerning such
matters related to financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflicts
of interest.
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: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17924 Filed 8-19-19; 8:45 am]
BILLING CODE 4164-01-P