[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: Christina.Vert@fda.hhs.gov.

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]
 BILLING CODE 4164-01-P


