81 FR 85231 - Request for Nominations on the Blood Products Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 227 (November 25, 2016)

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.

[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Pages 85231-85232]
From the Federal Register Online  [www.thefederalregister.org]
[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).

[[Page 85232]]

    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]
 BILLING CODE 4164-01-P