
[Federal Register Volume 78, Number 120 (Friday, June 21, 2013)]
[Notices]
[Pages 37551-37553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14889]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Request for Nominations for Voting and/or Nonvoting Consumer 
Representatives on Public Advisory Committees or Panels and Request for 
Notification From Consumer Organizations Interested in Participating in 
the Selection Process for Nominations for Voting and/or Nonvoting 
Consumer Representatives on Public Advisory Committees or Panels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any 
consumer organizations interested in participating in the selection of 
voting and/or nonvoting consumer representatives to serve on its 
advisory committees or panels notify FDA in writing. FDA is also 
requesting nominations for voting and/or nonvoting consumer 
representatives to serve on advisory committees and/or panels for which 
vacancies currently exist or are expected to occur in the near future. 
Nominees recommended to serve as a voting or nonvoting consumer 
representative may either be self-nominated or may be nominated by a 
consumer organization. Nominations will be accepted for current 
vacancies and for those that will or may occur through December 2013.

DATES: Any consumer organization interested in participating in the 
selection of an appropriate voting or nonvoting member to represent 
consumer interests on an FDA advisory committee or panel may send a 
letter or email stating that interest to FDA (see ADDRESSES) by July 
22, 2013, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by July 22, 2013.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should be sent electronically to 
CV@OC.FDA.GOV, by mail to Advisory Committee Oversight and Management 
Staff, 10903 New Hampshire Ave., WO32 Rm. 5129, Silver Spring Maryland 
20993-0002, or by fax to 301-847-8640. Information about becoming a 
member of an FDA advisory committee can be obtained by

[[Page 37552]]

visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory 
Committee Oversight and Management Staff, Food and Drug Administration, 
White Oak Bldg. 32, 10903 New Hampshire Ave., Rm. 5129, Silver Spring, 
MD 20993-0002, 301-796-8224, email: dornette.spelllesane@fda.hhs.gov.
    For questions relating to specific advisory committees or panels, 
contact the following persons listed in table 1:

                       Table 1--Committee Contact
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                Contact person                      Committee/panel
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Stephanie Begansky, Center for Drug            Anesthetic and Analgesic
 Evaluation and Research, Food and Drug         Drugs.
 Administration, White Oak Bldg 31, 10903 New
 Hampshire Ave., rm. 2408, Silver Spring, MD
 20993-0002, 301-796-3693, FAX: 301-847-8533,
 email: Stephanie.Bregansky@fda.hhs.gov.
Diane Goyette, Center for Drug Evaluation and  Anti-Infective Drugs.
 Research, Food and Drug Administration,
 White Oak Bldg 31, 10903 New Hampshire Ave.,
 rm. 2408, Silver Spring, MD 20993-0002, 301-
 796-9014, FAX: 301-847-8533, email:
 Diane.Goyette@fda.hhs.gov.
Nicole Vesely, Center for Drug Evaluation and  Cardiovascular & Renal
 Research, Food and Drug Administration,        Drugs.
 White Oak Bldg 31, 10903 New Hampshire Ave.,
 rm. 2408, Silver Spring, MD 20993-0002, 301-
 796-0063, FAX: 301-847-8533, email:
 Nicole.Vesely@fda.hhs.gov.
Cindy Hong, Center for Drug Evaluation and     Pulmonary Allergy Drugs.
 Research, Food and Drug Administration,
 White Oak Bldg 31, 10903 New Hampshire Ave.,
 rm. 2528, Silver Spring, MD 20993-0002, 301-
 796-0889, FAX: 301-847-8533, email:
 Cindy.Hong@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and       Circulatory System
 Radiological Devices, Food and Drug            Devices.
 Administration, White Oak Bldg 66, 10903 New
 Hampshire Ave., rm. 1611, Silver Spring, MD
 20993-0002, 301-796-3063, FAX: 301-847-8116,
 email: Jamie.Waterhouse@fda.hhs.gov.
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SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 2:

      Table 2--Committee Description, Type of Consumer Representative Vacancy, and Approximate Time Needed
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  Committee/panel/areas of expertise
                needed                     Current and upcoming vacancies          Approximate date needed
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Anesthetic and Analgesic Drugs--        1--Voting..........................  Immediately.
 Knowledgeable in the fields of
 anesthesiology, analgesics (such as
 abuse deterrent opioids, novel
 analgesics, and issues related to
 opioid abuse) epidemiology or
 statistics, and related specialties.
Anti-Infective Drugs--Knowledgeable in  1--Voting..........................  December 1, 2013.
 the fields of infectious disease,
 internal medicine, microbiology,
 pediatrics, epidemiology or
 statistics, and related specialties.
Cardiovascular and Renal Drugs--        1--Voting..........................  July 1, 2013.
 Knowledgeable in the fields of
 cardiology, hypertension, arrhythmia,
 angina, congestive heart failure,
 diuresis, and biostatistics.
Pulmonary Allergy Drugs--Knowledgeable  1--Voting..........................  June 1, 2013.
 in the fields of pulmonary medicine,
 allergy, clinical immunology, and
 epidemiology or statistics.
Circulatory System Devices--            1 Non-Voting.......................  July 1, 2013.
 Knowledgeable in the safety and
 effectiveness of marked and
 investigational devices for use in
 the circulatory and vascular systems.
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I. Functions

A. Anesthetic and Analgesic Drug Products

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in anesthesiology and surgery and makes appropriate 
recommendations to the Commissioner of Food and Drugs.

B. Anti-Infective Drugs

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of infectious diseases and disorders 
and makes appropriate recommendations to the Commissioner of Food and 
Drugs.

C. Cardiovascular and Renal Drugs

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of cardiovascular and renal disorders 
and makes appropriate recommendations to the Commissioner of Food and 
Drugs.

D. Pulmonary-Allergy Drugs

    The committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of pulmonary disease and diseases 
with allergic and/or immunologic mechanisms and makes appropriate 
recommendations to the Commissioner of Food and Drugs.

E. Certain Panels of the Medical Devices Advisory Committee

    The committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation. With the exception of the Medical 
Devices Dispute Resolution Panel, each panel, according to its 
specialty area: Advises on the classification or reclassification of 
devices into one of three regulatory categories; advises on any 
possible risks to health associated with the use of devices; advises on 
formulation of product development protocols; reviews premarket 
approval applications for medical devices; reviews guidelines and 
guidance documents; recommends exemption of certain devices from the 
application of portions of the Federal Food, Drug, and Cosmetic Act; 
advises

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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. With the 
exception of the Medical Devices Dispute Resolution Panel, each panel, 
according to its specialty area, may also make appropriate 
recommendations to the Commissioner of Food and Drugs on issues 
relating to the design of clinical studies regarding the safety and 
effectiveness of marketed and investigational devices.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on the 
committees or panels should meet the following criteria: (1) 
Demonstrate ties to consumer and community-based organizations, (2) be 
able to analyze technical data, (3) understand research design, (4) 
discuss benefits and risks, and (5) evaluate the safety and efficacy of 
products under review. The consumer representative should be able to 
represent the consumer perspective on issues and actions before the 
advisory committee; serve as a liaison between the committee and 
interested consumers, associations, coalitions, and consumer 
organizations; and facilitate dialogue with the advisory committee on 
scientific issues that affect consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted 
through procedures that include the use of organizations representing 
the public interest and public advocacy groups. These organizations 
recommend nominees for the Agency's selection. Representatives from the 
consumer health branches of Federal, State, and local governments also 
may participate in the selection process. Any consumer organization 
interested in participating in the selection of an appropriate voting 
or nonvoting member to represent consumer interests should send a 
letter stating that interest to FDA (see ADDRESSES) within 30 days of 
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer 
organizations that will participate in the selection process and will 
forward to each such organization a ballot listing at least two 
qualified nominees selected by the Agency based on the nominations 
received, together with each nominee's current curriculum vitae or 
resume. Ballots are to be filled out and returned to FDA within 30 
days. The nominee receiving the highest number of votes ordinarily will 
be selected to serve as the member representing consumer interests for 
that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more 
qualified persons to represent consumer interests on the Agency's 
advisory committees or panels. Self-nominations are also accepted. 
Potential candidates will be required to provide detailed information 
concerning such matters as financial holdings, employment, and research 
grants and/or contracts to permit evaluation of possible sources of 
conflicts of interest.
    All nominations should include: A cover letter; a curriculum vitae 
or resume that includes the nominee's office address, telephone number, 
and email address; and a list of consumer or community-based 
organizations for which the candidate can demonstrate active 
participation.
    Nominations also should specify the advisory committee(s) or 
panel(s) for which the nominee is recommended. In addition, nominations 
should include confirmation that the nominee is aware of the nomination 
and is willing to serve as a member of the advisory committee or panel 
if selected.
    The term of office is up to 4 years. FDA will review all 
nominations received within the specified timeframes and prepare a 
ballot containing the names of qualified nominees. Names not selected 
will remain on a list of eligible nominees and be reviewed periodically 
by FDA to determine continued interest. Upon selecting qualified 
nominees for the ballot, FDA will provide those consumer organizations 
that are participating in the selection process with the opportunity to 
vote on the listed nominees. Only organizations vote in the selection 
process. Persons who nominate themselves to serve as voting or 
nonvoting consumer 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.

    Dated: June 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-14889 Filed 6-20-13; 8:45 am]
BILLING CODE 4160-01-P


