
[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49328-49331]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1179]


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 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 
September 19, 2014, for vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
(see ADDRESSES) by September 19, 2014.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should submit their information 
electronically to kimberly.hamilton@fda.hhs.gov or by mail to Advisory 
Committee Oversight and Management Staff, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, FAX 301-847-8640.
    Consumer representative nominations should be submitted 
electronically by logging into 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: Kimberly Hamilton, 
Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5117, Silver 
Spring, MD 20993-0002, 301-796-6319, email: 
kimberly.hamilton@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: For questions relating to specific advisory 
committees or panels, contact the following persons listed in table 1:

[[Page 49329]]



                  Table 1--Advisory Committee Contacts
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                  Contact person                       Committee/panel
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Jamie Waterhouse, Center for Devices and            Circulatory System
 Radiological Health, Office of Device Evaluation,   Devices Panel.
 Food and Drug Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 1611, Silver Spring, MD
 20993, 301-796-3063, FAX: 301-796-3063, email:
 Jamie.Waterhouse@fda.hhs.gov.
Karen Strambler, Center for Food Safety and         Food Advisory
 Applied Nutrition, FDA College Park, CPK1, Rm.      Committee.
 1C016, College Park, MD 20740, 240-402-2589, FAX:
 301-436-2637, email: Karen.Strambler@fda.hhs.gov.
Patricio Garcia, Center for Devices and             General and Plastic
 Radiological Health, Office of Device Evaluation,   Surgery Devices
 Food and Drug Administration, 10903 New Hampshire   Panel.
 Ave., Bldg. 66, Rm. 3631, Silver Spring, MD
 20903, 301-796-6875, FAX: 301-847-8120, email:
 Patricio.Garcia@fda.hhs.gov.
Sara J. Anderson, LCDR, U.S. Public Health          Hematology and
 Service, Center for Devices and Radiological        Pathology Devices
 Health, Office of Device Evaluation, Food and       Panel, Orthopaedic
 Drug Administration, 10903 New Hampshire Ave.,      and Rehabilitation
 Bldg. 66, Rm. 1643, Silver Spring, MD 20903, 301-   Devices Panel,
 796-7047, FAX: 301-847-8122, email:                 National
 Sara.Anderson@fda.hhs.gov.                          Mammography and
                                                     Quality Assurance
                                                     Advisory Committee.
Pamela Scott, Center for Devices and Radiological   Medical Devices
 Health, Office of the Center Director, Food and     Dispute Resolution
 Drug Administration, 10903 New Hampshire Ave.,      Panel.
 Bldg. 66, Rm. 3611, Silver Spring, MD 20993, 301-
 796-5433, FAX: 301-847-8510, email:
 Pamela.Scott@fda.hhs.gov.
Shanika Craig, Center for Devices and Radiological  Obstetrics and
 Health, Food and Drug Administration, 10903 New     Gynecology Devices
 Hampshire Ave., Bldg. 66, Rm. 1613, Silver          Panel.
 Spring, MD 20993-0002, 301-796-6639, FAX: 301-847-
 8122, email: Shanika.Craig@fda.hhs.gov.
Walter Ellenberg, Office of the Commissioner,       Pediatrics Advisory
 Office of Pediatric Therapeutics, Food and Drug     Committee.
 Administration, Bldg. 32, Rm. 5154, 10903 New
 Hampshire Ave., Silver Spring, MD 20993-0002, 301-
 796-0885, FAX: 301-847-8640, email:
 Walter.Ellenberg@fda.hhs.gov.
Kalyani Bhatt, Center for Drug Evaluation and       Psychopharmacologic
 Research, Food and Drug Administration, 10903 New   Drugs Advisory
 Hampshire Ave., Bldg. 31, Rm. 2438, Silver          Committee,
 Spring, MD 20993-0002, 301-796-9005, FAX: 301-847-  Reproductive Health
 8533, email: Kalyani.Bhatt@fda.hhs.gov.             Drugs Advisory
                                                     Committee.
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    FDA is requesting nominations for voting and/or nonvoting consumer 
representatives for the vacancies listed in table 2:

      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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Circulatory System Devices--Knowledgeable in the      Nonvoting...................  Immediately.
 safety and effectiveness of marked and
 investigational devices for use in the circulatory
 and vascular systems.
Food Advisory Committee--Knowledgeable in the fields  Voting......................  Immediately.
 of physical sciences, biological and life sciences,
 food science, risk assessment, nutrition, food
 technology, molecular biology, and other relevant
 scientific and technical disciplines.
General and Plastic Surgery Devices Panel of the      1-Nonvoting.................  9/1/2014.
 Medical Devices Advisory Committee--Knowledgeable
 in the fields of general, plastic, reconstructive,
 pediatric, thoracic, abdominal, pelvic and
 endoscopic surgery; biomaterials, lasers, wound
 healing, and quality of life issues.
Hematology and Pathology Devices Panel of the         1-Nonvoting.................  Immediately.
 Medical Devices Advisory Committee--Knowledgeable
 in the fields of hematology, hematopathology,
 coagulation and homeostasis, hematological
 oncology, and gynecological oncology.
Medical Devices Dispute Resolution Panel of the       1-Nonvoting.................  10/1/2014.
 Medical Devices Advisory Committee--Knowledgeable
 experts with broad, cross-cutting scientific,
 clinical, analytical, or mediation skills.
National Mammography Quality Assurance Advisory       1-Nonvoting.                  ............................
 Committee--Knowledgeable in clinical practice,
 research specialization, or professional work that
 has a significant focus on mammography.
Obstetrics and Gynecology Devices Panel of the        1-Nonvoting.................  Immediately.
 Medical Devices Advisory Committee--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 Panel--        1-Nonvoting.................  Immediately.
 Knowledgeable in data concerning the safety and
 effectiveness of marketed and investigational
 orthopaedic and rehabilitation devices.
Pediatrics Advisory Committee--Knowledgeable in       1-Voting....................  Immediately.
 pediatric research, pediatric subspecialties,
 statistics, and/or biomedical ethics.
Psychopharmacologic Drugs Advisory Committee--        1-Voting....................  Immediately.
 Knowledgeable in the fields of psychopharmacology,
 psychiatry, epidemiology or statistics, and related
 specialties.
Bone, Reproductive, and Urologic Drugs Advisory       1-Voting....................  Immediately.
 Committee--Knowledgeable in the fields of
 obstetrics, gynecology, endocrinology, pediatrics,
 epidemiology, or statistics and related
 specialties.
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[[Page 49330]]

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 (the 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. 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.

C. 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.

D. 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 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.

E. 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.

F. Bone, Reproductive, and Urologic 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.

G. 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.

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

[[Page 49331]]

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 r[eacute]sum[eacute]. 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, 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, unless self-nominated. 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: August 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19696 Filed 8-19-14; 8:45 am]
BILLING CODE 4164-01-P


