[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Page 35497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for a Nonvoting Industry 
Representative on the Allergenic Products Advisory Committee and 
Request for Nominations for a Nonvoting Industry Representative on the 
Allergenic 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 its Allergenic Products 
Advisory Committee for the Center for Biologics Evaluation and Research 
(CBER) notify FDA in writing. A nominee may either be self-nominated or 
nominated by an organization to serve as a nonvoting industry 
representative. Nomination 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 the interest to FDA by July 30, 
2007, for vacancies listed in the notice. Concurrently, nomination 
material for prospective candidates should be sent to FDA by July 30, 
2007.

ADDRESSES: All letters of interest and nominations should be submitted 
in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics 
Evaluation and Research, Food and Drug Administration (HFM-71), 1401 
Rockville Pike, Rockville, MD 20892, 301-827-1289, 
[email protected]

SUPPLEMENTARY INFORMATION: Section 120 of the FDA Modernization Act of 
1997 (FDAMA) (21 U.S.C. 355) requires that newly formed FDA advisory 
committees include representatives from the biologic manufacturing 
industries. Although not required for existing committees, to keep 
within the spirit of FDAMA, the agency intends to add nonvoting 
industry representatives to its CBER advisory committee identified 
below.

I. CBER Allergenic Products Advisory Committee

    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and adequacy of labeling of marketed and 
investigational allergenic biological products or materials that are 
administered to humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease, and makes appropriate recommendations 
to the Commissioner of Food and Drugs of its findings regarding the 
affirmation or revocation of biological product licenses, on the 
safety, effectiveness, and labeling of the products, on clinical and 
laboratory studies of such products, on amendments or revisions to 
regulations governing the manufacture, testing and licensing of 
allergenic biological products, and on the quality and relevance of 
FDA's research programs which provide the scientific support for 
regulating these agents.

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 ADDRESSES) within 30 days of publication of this document. 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 
Allergenic Products Advisory 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 
of Food and Drugs 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. A current curriculum vitae and the name of the 
committee of interest should be sent to the FDA contact person within 
the 30 days. 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 has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its advisory committees, and therefore, 
encourages, nominations for appropriately qualified candidates from 
these groups. Specifically, in this document, nominations for nonvoting 
representatives of industry interests are encouraged from the 
allergenic product manufacturing industry.
    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: June 21, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-12527 Filed 6-27-07; 8:45 am]
BILLING CODE 4160-01-S