[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16010-16013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-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 be self-nominated or may be nominated by a consumer 
organization. Nominations will be

[[Page 16011]]

accepted for current vacancies and for those that will or may occur 
through December 2014.
    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.

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 the FDA (see ADDRESSES) by 
April 23, 2014, for vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
(see ADDRESSES) by April 23, 2014.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process should be 
submitted electronically to [email protected]. or by 
mail to Advisory Committee Oversight and Management Staff, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by 
FAX to 301-847-8640.
    Consumer Representative nominations should be submitted 
electronically by logging accessing the FDA Advisory Committee 
Membership Nomination Portal at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee 
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 
5103, Silver Spring, MD 20993-0002, or by FAX to 301-847-8640. 
Additional information about becoming a member on an FDA advisory 
committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER GENERAL INFORMATION CONTACT: Dornette Spell-LeSane, 
Advisory Committee Oversight and Management Staff (ACOMS), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, 
Silver Spring, MD 20993-0002, 301 796-8224, 
[email protected].
    For questions relating to specific advisory committees or panels, 
contact the following persons listed in Table 1 of this document:

                  Table 1--Advisory Committee Contacts
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             Contact person                      Committee/panel
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Karen Strambler, Center for Food Safety  Food Advisory Committee.
 and Applied Nutrition, FDA College
 Park, CPK1, Rm. 1C016, College Park,
 MD 20740, 240-402-2589, FAX: 301-436-
 2637, [email protected].
Avena Russell, ABD, Center for Devices   General and Plastic Surgery
 and Radiological Health, Office of       Devices Panel.
 Device Evaluation, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 1535, Silver
 Spring, MD 20993, 301-796-3805, FAX:
 301-847-8122,
 [email protected].
Sara J. Anderson, LCDR, U.S. Public      Hematology and Pathology
 Health Service, Center for Devices and   Devices Panel, Orthopaedic and
 Radiological Health, Office of Device    Rehabilitation Devices Panel
 Evaluation, 10903 New Hampshire Ave.,    and National Mammography and
 Bldg. 66, Rm.1544, Silver Spring, MD     Quality Assurance.
 20903, 301-796-7047, FAX: 301-847-
 8122, [email protected].
Pamela Scott, Center for Devices and     Medical Devices Dispute
 Radiological Health. Office of the       Resolution Panel.
 Center Director, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5406, Silver
 Spring, MD 20993, 301-796-5433, FAX:
 301-847-8510, [email protected].
Shanika Craig, Food and Drug             Obstetrics and Gynecology
 Administration, Bldg. 66, Rm. 1613,      Devices Panel.
 10903 New Hampshire Ave., Silver
 Spring, MD 20993-0002, 301-796-6639,
 FAX: 301-847-812,
 [email protected].
Walter Ellenberg, Office of the          Pediatrics Advisory Committee.
 Commissioner, Office of Pediatric
 Therapeutics, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Silver Spring, MD 20993-0002,
 301-796-0885, FAX: 301-847-8640,
 [email protected].
Kalyani Bhatt, Center for Drug           Psychopharmacologic Drugs
 Evaluation and Research, Food and Drug   Advisory Committee and
 Administration, 10903 New Hampshire      Reproductive Health Drugs
 Ave., Bldg. 31, Silver Spring, MD        Advisory Committee.
 20993-0002, 301-796-0063, FAX: 301-847-
 8533, [email protected].
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SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
Table 2 of this document:

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy and Approximate Date Needed
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   Committee/Panel/Areas of expertise
                 needed                      Current & upcoming vacancies           Approximate date needed
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Food Advisory Committee--Knowledgeable   1-voting...........................  Immediately.
 in the fields of physical sciences,
 biological and life sciences, food
 science, risk assessment, nutrition,
 food technology, molecular biology,
 and other relevant scientific and
 technical disciplines.
Medical Devices Advisory Committee,      1-nonvoting........................  9/1/2014.
 General and Plastic Surgery Devices
 Panel--Knowledgeable in the fields of
 general, plastic, reconstructive,
 pediatric, thoracic, abdominal, pelvic
 and endoscopic surgery; biomaterials,
 lasers, wound healing, and quality of
 life issues.
Medical Devices Advisory Committee,      1-nonvoting........................  3/1/2014.
 Hematology and Pathology Devices
 Panel--Knowledgeable in the fields of
 hematology, hematopathology,
 coagulation and homeostasis,
 hematological oncology, gynecological
 oncology.

[[Page 16012]]

 
Medical Devices Advisory Committee,      1-nonvoting........................  10/1/2014.
 Medical Devices Dispute Resolution
 Panel--Experts with broad, cross-
 cutting scientific, clinical,
 analytical or mediation skills.
National Mammography Quality Assurance-- 1-nonvoting........................  Immediately.
 Knowledgeable in clinical practice,
 research specialization, or
 professional work that has a
 significant focus on mammography.
Medical Devices Advisory Committee,      1-nonvoting........................  Immediately.
 Obstetrics and Gynecology Devices
 Panel--Knowledgeable in the fields of
 perinatology, embryology, reproductive
 endocrinology, pediatric gynecology,
 gynecological oncology, operative
 hysteroscopy, pelviscopy,
 electrosurgery, laser surgery,
 assisted reproductive technologies,
 contraception, postoperative
 adhesions, and cervical cancer and
 colposcopy; obstetrics/gynecology
 devices; gynecology in the older
 patient; midwifery; labor and delivery
 nursing.
Orthopaedic and Rehabilitation Devices   1-nonvoting........................  Immediately.
 Panel--Knowledgeable in data
 concerning the safety and
 effectiveness of marketed and
 investigational orthopaedic and
 rehabilitation devices.
Pediatrics Advisory Committee--          1-voting...........................  7/1/2014.
 Knowledgeable in pediatric research,
 pediatric subspecialties, statistics,
 and/or biomedical ethics.
Psychopharmacologic Drugs Advisory       1-voting...........................  7/1/2014.
 Committee--Knowledgeable in the fields
 of psychopharmacology, psychiatry,
 epidemiology or statistics, and
 related specialties.
Reproductive Health Drugs Advisory       1-voting...........................  7/1/2014.
 Committee--Knowledgeable in the fields
 of obstetrics, gynecology,
 endocrinology, pediatrics,
 epidemiology or statistics and related
 specialties.
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I. Functions

A. 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. The panels engage in a number of 
activities to fulfill the functions the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) envisions for device advisory panels. With the 
exception of the Medical Devices Dispute Resolution Panel, each panel, 
according to its specialty area, advises the Commissioner of Food and 
Drugs (the Commissioner) regarding recommended 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 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. 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 on issues relating to the design of clinical studies 
regarding the safety and effectiveness of marketed and investigational 
devices.

B. The Medical Devices Dispute Resolution Panel

    The Panel provides advice to the Commissioner on complex or 
contested scientific issues between the FDA and medical device 
sponsors, applicants, or manufacturers relating to specific products, 
marketing applications, regulatory decisions and actions by FDA, and 
Agency guidance and policies. The Panel makes recommendations on issues 
that are lacking resolution, are highly complex in nature, or result 
from challenges to regular advisory panel proceedings or Agency 
decisions or actions.

C. Food Advisory Committee

    The Committee provides advice to the Commissioner of Food and Drugs 
and other appropriate officials, on emerging food safety, food science, 
nutrition, and other food-related health issues that the FDA considers 
of primary importance for its food and cosmetics programs. The 
Committee may be charged with reviewing and evaluating available data 
and making recommendations on matters such as those relating to: (1) 
Broad scientific and technical food or cosmetic related issues; (2) the 
safety of new foods and food ingredients; (3) labeling of foods and 
cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe 
exposure limits for food contaminants. The Committee may also be asked 
to provide advice and make recommendations on ways of communicating to 
the public the potential risks associated with these issues and on 
approaches that might be considered for addressing the issues.

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 which should be considered in the oversight of mammography 
facilities; (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. Pediatric Advisory Committee

    The Committee advises and makes recommendations to the Commissioner 
of Food and Drugs regarding (1) pediatric research; (2) identification 
of research priorities related to pediatric therapeutics and the need 
for additional treatments of specific pediatric diseases or conditions; 
(3) the ethics, design, and analysis of clinical trials related to 
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric 
labeling changes; (6) adverse event reports for drugs granted pediatric 
exclusivity and

[[Page 16013]]

any safety issues that may occur; (7) any other pediatric issue or 
pediatric labeling dispute involving FDA regulated products; (8) 
research involving children as subjects; and (9) any other matter 
involving pediatrics for which FDA has regulatory responsibility. The 
Committee also advises and makes recommendations to the Secretary 
directly or to the Secretary through the Commissioner on research 
involving children as subjects that is conducted or supported by the 
Department of Health and Human Services.

F. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
practice of psychiatry and related fields.

G. Reproductive Health Drugs Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of 
marketed and investigational human drugs for use in the practice of 
obstetrics, gynecology, and related specialties.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on 
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 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. 
Nominations should include a cover letter and a current curriculum 
vitae or r[eacute]sum[eacute] for each nominee, including a current 
business and/or home address, telephone number, and email address if 
available, and a list of consumer or community-based organizations for 
which the candidate can demonstrate active participation.
    Nominations should also 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, and appears to have no conflicts of interest. FDA will ask 
potential candidates 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. Members will be invited to serve for terms 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.

    Dated: March 18, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-06326 Filed 3-21-14; 8:45 am]
BILLING CODE 4160-01-P