[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7591-7593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3198]



[[Page 7591]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Request for Notification From Consumer Organizations Interested 
in Participating in the Selection Process for Nominations for Voting 
and/or Nonvoting Consumer Representatives and 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 February 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 March 
14, 2012, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by March 14, 2012.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should be sent electronically to 
[email protected], by mail to Advisory Committee Oversight and Management 
Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 
20993-0002, or by fax to 301-847-8640. Information about becoming a 
member of an FDA advisory committee can be obtained by visiting FDA's 
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Doreen Brandes, Advisory Committee 
Oversight and Management Staff, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, rm. 5122, Silver Spring, MD 20993-0002, 301-
796-8858, [email protected].
    For questions relating to specific advisory committees or panels, 
contact the persons listed in table 2 in the SUPPLEMENTARY INFORMATION 
section of this document:

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 1 of this document:

                                                     Table 1
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  Committee/panel/areas of expertise
                needed                     Current and upcoming vacancies          Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenic Products--Knowledgeable in   1--Voting..........................  08/31/12.
 the field of allergenic extracts that
 are used for the diagnosis and
 treatment of allergic diseases such
 as allergic rhinitis (``hay fever''),
 allergic sinusitis, allergic
 conjunctivitis, bee venom allergy,
 and food allergy.
Peripheral and Central Nervous          1--Voting..........................  01/31/13.
 Systems--Knowledgeable in the fields
 of neurology, neuropharmacology,
 neuropathology, otolaryngology,
 epidemiology or statistics, and
 related specialties.
Non-Prescription Drugs--Knowledgeable   1--Voting..........................  01/31/13.
 in the fields of internal medicine,
 family practice, clinical toxicology,
 clinical pharmacology, pharmacy,
 dentistry, and related specialties.
National Mammography Quality            2--Nonvoting.......................  01/31/13.
 Assurance--Knowledgeable in clinical
 practice, research specialization, or
 professional work that has a
 significant focus on mammography.
----------------------------------------------------------------------------------------------------------------
                            Certain Panels of the Medical Devices Advisory Committee
----------------------------------------------------------------------------------------------------------------
Clinical Chemistry and Clinical         1--Nonvoting.......................  02/28/13.
 Toxicology Devices--Knowledgeable in
 the fields of clinical chemistry and
 toxicology in vitro diagnostic
 devices (IVDs); clinical use of
 related IVDs in laboratories and in
 home; data concerning safety and
 effectiveness of related IVDs for
 clinical use in diseases/disorders/
 conditions such as diabetes,
 cardiovascular disease, endocrine
 disorders, women's health, drug
 abuse, therapeutic drug monitoring,
 and general chemistry conditions.
Microbiology Devices Panel--            1--Voting..........................  Immediately.
 Knowledgeable in infectious and
 pulmonary disease, pediatric
 infectious diseases, tropical
 diseases, and clinical microbiology.
----------------------------------------------------------------------------------------------------------------

I. Functions

A. 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.

B. Peripheral and Central Nervous Systems Advisory Committee

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

C. Non-Prescription Drugs Advisory Committee

    The Committee reviews and evaluates available data concerning the 
safety and effectiveness of over-the-counter (non-prescription) human 
drug products, or any other FDA-regulated product, for use in the 
treatment of a broad spectrum of human symptoms and diseases and 
advises the Commissioner either on the promulgation of monographs 
establishing conditions under which these drugs are generally 
recognized as

[[Page 7592]]

safe and effective and not misbranded or on the approval of new drug 
applications for such drugs. The Committee will serve as a forum for 
the exchange of views regarding the prescription and non-prescription 
status, including switches from one status to another, of these various 
drug products and combinations thereof. The Committee may also conduct 
peer review of Agency-sponsored intramural and extramural scientific 
biomedical programs in support of FDA's mission and regulatory 
responsibilities.

D. National Mammography and Quality Assurance Advisory Committee

    The Committee reviews and evaluates (1) Developing appropriate 
quality standards and regulations for mammography facilities; (2) 
developing appropriate standards and regulations for bodies accrediting 
mammography facilities under this program; (3) developing regulations 
with respect to sanctions; (4) developing procedures for monitoring 
compliance with standards; (5) establishing a mechanism to investigate 
consumer complaints; (6) reporting new developments concerning breast 
imaging that should be considered in the oversight of mammography 
facilities; and (7) determining whether there exists a shortage of 
mammography facilities in rural and health professional shortage areas 
and determining the effects of personnel on access to the services of 
such facilities in such areas; (8) determining whether there will exist 
a sufficient number of medical physicists after October 1, 1999; and 
(9) determining the costs and benefits of compliance with these 
requirements.

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 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. 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 committees 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 three to five 
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 home or 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 three to five 
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 has a special interest in ensuring that women, minority groups, 
and individuals with physical disabilities are adequately represented 
on its advisory committees and panels and, therefore, encourages 
nominations for appropriately qualified candidates from these groups.
    For questions relating to specific advisory committees or panels, 
contact the following persons listed in table 2 of this document:

[[Page 7593]]



                                                     Table 2
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                               Contact person                                          Committee/panel
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Donald Jehn, Center for Biologics Evaluation and Research, Food and Drug     Allergenic Products.
 Administration, 5515 Security Lane, Rockwall Bldg. 2 (HFM-71), rm. 1118, ,
 Rockville, MD 20852, 301-827-1293, Fax: 301-827-0294,
 [email protected].
CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug    Peripheral and Central Nervous
 Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver         Systems Drugs.
 Spring, MD 20993-0002, 301-796-9021, Fax: 301-847-8533,
 [email protected].
CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug    Non-Prescription Drugs.
 Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver
 Spring, MD 20993-0002, 301-796-9021, Fax: 301-847-8533,
 [email protected].
LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and  National Mammography and Quality
 Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver    Assurance.
 Spring, MD 20993-0002, 301-796-7047, Fax: 301-847-8121,
 [email protected].
LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and  Clinical Chemistry and Clinical
 Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver    Toxicology Devices.
 Spring, MD 20993-0002, 301-796-7047, Fax: 301-847-8121,
 [email protected].
Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug  Ear, Nose, and Throat Devices.
 Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver
 Spring, MD 20993-0003, 301-796-3063, Fax: 301-847-8121,
 [email protected].
Shanika Craig, Center for Devices and Radiological Health, Food and Drug     Microbiology Devices Panel.
 Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1613, Silver
 Spring, MD 20993-0003, 301-796-6639, Fax: 301-847-8121,
 [email protected].
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    Dated: February 7, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-3198 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P