[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16266-16267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-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 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 April 17, 
2023 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by April 17, 2023.

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 be obtained by visiting FDA's website at: https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Christina Vert or Marie DeGregorio, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver 
Spring, MD 20993-0002, 240-402-8054, 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 that are

[[Page 16267]]

intended for use in the diagnosis, prevention, or treatment of human 
diseases, and, as required, any other product for which FDA has 
regulatory responsibility. BPAC also 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 that 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 (FD&C 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 FD&C 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 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 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. Nomination must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee, including 
current business address and telephone number, email address if 
available, and a signed copy of the Acknowledgement and Consent form 
available at the FDA Advisory Committee Membership Nomination Portal 
(see ADDRESSES) within 30 days of publication of this document (see 
DATES). Nominations must also 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 
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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05358 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P


