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, 37551-37553 [2013-14889]

Download as PDF TKELLEY on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices multistage and single-stage incubation. The Prestage Department of Poultry Science Research and Teaching Units in Raleigh, NC conduct research at the Piedmont Research Station. Research at both unit locations includes commercial layers, commercial broiler breeders, broilers, and commercial-style incubation. Piedmont Research Station routinely conducts the Layer Performance Management Test in North America, with studies in applied production practices and nutrition management. These facilities are able to evaluate the effects of a research project on a size and scale that mimics commercial poultry operations. The North Carolina State University feed mill is a research and educational feed mill that is designed and equipped to manufacture a variety of feed mix characteristics, formulations, and feed forms. It is currently used by FDA for training purposes associated with the safe feed-safe food program, and is among the few research feed mills in the country that is associated with animal research facilities. The mill has all of the typical process equipment found in commercial feed mills, including an 8 ton/hr CPM hammer mill, 8 ton/hr RMS roller mill, micro bin-batching system, a 500 lb horizontal ribbon mixer, a 2 ton double-shaft ribbon mixer, a 1 ton/hr CPM pellet mill with counter-flow cooler, a 10 ton/hr Bliss pellet mill with counter-flow cooler, pellet screener, bagger, bulk ingredient bins, finished feed bins, and an automated computercontrolled batch mixing and process operation. This feed mill is able to manufacture feed of various feed ingredient grind size in mash or pellet forms. While other academic institutions also have outstanding poultry and egg research programs, they do not have commercial style research facilities, feed mill, and resources to conduct largescale commercial size research projects. Moreover, the North Carolina State University, Prestage Department of Poultry Science and Piedmont Research Facility are within close geographic proximity for collaboration with FDA’s Department of Immunobiology. This will allow FDA’s investigational scientists to travel by automobile on key experimental dates to initiate research experiments and to collect tissue and environmental samples. These samples will be transported within 24 hours back to FDA’s Department of Immunobiology for microbiological testing and analysis. VerDate Mar<15>2010 18:32 Jun 20, 2013 Jkt 229001 II. Award Information/Funds Available A. Award Amount The Center for Food Safety and Applied Nutrition (CFSAN) intends to fund one award up to $50,000 total costs (direct plus indirect costs) for FY 2013. Future year amounts will depend on annual appropriations and successful performance. B. Length of Support The award will provide 1 year of support and include future recommended support for 4 additional years, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations. 37551 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. The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of Only electronic applications will be voting and/or nonvoting consumer accepted. To submit an electronic representatives to serve on its advisory application in response to this FOA, committees or panels notify FDA in applicants should first review the full writing. FDA is also requesting announcement located at www.fda.gov/ food/newsevents/default.htm. (FDA has nominations for voting and/or nonvoting consumer representatives to verified the Web site addresses serve on advisory committees and/or throughout this document, but FDA is panels for which vacancies currently not responsible for any subsequent exist or are expected to occur in the near changes to the Web sites after this future. Nominees recommended to serve document publishes in the Federal as a voting or nonvoting consumer Register.) For all electronically representative may either be selfsubmitted applications, the following nominated or may be nominated by a steps are required. consumer organization. Nominations • Step 1: Obtain a Dun and Bradstreet will be accepted for current vacancies (DUNS) Number and for those that will or may occur through December 2013. • Step 2: Register With System for DATES: Any consumer organization Award Management (SAM) interested in participating in the • Step 3: Obtain Username & Password selection of an appropriate voting or • Step 4: Authorized Organization nonvoting member to represent Representative (AOR) Authorization consumer interests on an FDA advisory committee or panel may send a letter or • Step 5: Track AOR Status email stating that interest to FDA (see • Step 6: Register With Electronic ADDRESSES) by July 22, 2013, for Research Administration (eRA) vacancies listed in this notice. Commons Concurrently, nomination materials for prospective candidates should be sent to Steps 1 through 5, in detail, can be FDA (see ADDRESSES) by July 22, 2013. found at https://www07.grants.gov/ applicants/organization_registration.jsp. ADDRESSES: All statements of interest Step 6, in detail, can be found at from consumer organizations interested https://commons.era.nih.gov/commons/ in participating in the selection process registration/registrationInstructions.jsp. and consumer representative After you have followed these steps, nominations should be sent submit electronic applications to: electronically to CV@OC.FDA.GOV, by https://www.grants.gov. mail to Advisory Committee Oversight and Management Staff, 10903 New Dated: June 17, 2013. Hampshire Ave., WO32 Rm. 5129, Leslie Kux, Silver Spring Maryland 20993–0002, or Assistant Commissioner for Policy. by fax to 301–847–8640. Information [FR Doc. 2013–14824 Filed 6–20–13; 8:45 am] about becoming a member of an FDA advisory committee can be obtained by BILLING CODE 4160–01–P III. Electronic Application, Registration, and Submission PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\21JNN1.SGM 21JNN1 37552 Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices visiting FDA’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm. Committee Oversight and Management Staff, Food and Drug Administration, White Oak Bldg. 32, 10903 New Hampshire Ave., Rm. 5129, Silver FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory 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 Contact person Committee/panel Stephanie Begansky, Center for Drug Evaluation and Research, Food and Drug 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 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 Research, Food and Drug Administration, 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 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 Radiological Devices, Food and Drug 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. FDA is requesting nominations for voting and/ SUPPLEMENTARY INFORMATION: Anesthetic and Analgesic Drugs. Anti-Infective Drugs. Cardiovascular & Renal Drugs. Pulmonary Allergy Drugs. Circulatory System Devices. or nonvoting consumer representatives for the vacancies listed in table 2: TABLE 2—COMMITTEE DESCRIPTION, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE TIME NEEDED Committee/panel/areas of expertise needed Current and upcoming vacancies Anesthetic and Analgesic Drugs—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 the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Cardiovascular and Renal Drugs—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Pulmonary Allergy Drugs—Knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics. Circulatory System Devices—Knowledgeable in the safety and effectiveness of marked and investigational devices for use in the circulatory and vascular systems. 1—Voting ................... Immediately. 1—Voting ................... December 1, 2013. 1—Voting ................... July 1, 2013. 1—Voting ................... June 1, 2013. 1 Non-Voting ............. July 1, 2013. I. Functions C. Cardiovascular and Renal Drugs 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 the treatment of cardiovascular and renal disorders 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 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. TKELLEY on DSK3SPTVN1PROD with NOTICES 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. VerDate Mar<15>2010 18:32 Jun 20, 2013 Jkt 229001 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. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Approximate date needed 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 E:\FR\FM\21JNN1.SGM 21JNN1 Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices 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. TKELLEY on DSK3SPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 18:32 Jun 20, 2013 Jkt 229001 37553 the member representing consumer interests for that particular advisory committee or panel. DEPARTMENT OF HEALTH AND HUMAN SERVICES IV. Nomination Procedures Health Resources and Services Administration 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Maternal Health Town Hall Listening Session; Notice of Meeting Name: Maternal Health Town Hall Listening Session. Date and Time: August 27, 2013, 2:00 p.m.–3:30 p.m. (EST). Place: Virtual via Webinar. Status: The meeting is open to the public. The meeting will be hosted virtually through webinar and by phone. Participants will have an opportunity to interact with presenters via the chat function in the public comment section of the webinar system. In addition, there will be up to 100 phone lines available to individuals who choose to participate by phone. The phone lines will be made available on a first-come, first-served basis. To register for this meeting please go to: https://learning.mchb.hrsa.gov/ LiveWebcastDetail.asp?leid=333. Registrations will be accepted through 5:00 p.m. EST on August 19, 2013. Call information for this meeting will be provided upon registration. Purpose: The purpose of the meeting is to share and discuss proposed strategies and to solicit ideas in support of the National Maternal Health Initiative. The Town Hall Listening Session will serve as a platform to engage and obtain feedback from the public on HRSA’s strategic thinking around a national strategy to reduce maternal morbidity and mortality, and improve the quality and safety of maternity care in the United States. The desired outcomes of the meeting are: I. To share with the public the Health Resources and Services Administration, Maternal and Child Health Bureau’s (HRSA/MCHB): (1) Vision for promoting maternal health in the United States; (2) strategic direction for the National Maternal Health Initiative including mission, goals and objectives; and (3) identified priority areas to focus efforts to improve maternal health; II. Enhance, guide, and strengthen HRSA’s strategic thinking related to maternal health using input from maternal health experts, representatives of professional organizations, and the public at large. Agenda: Topics that will be discussed include the following: Maternal health in the United States; current efforts to improve maternal health; gaps in the field; opportunities for collaborative efforts; and an overview of the National Maternal Health Initiative. Proposed E:\FR\FM\21JNN1.SGM 21JNN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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
------------------------------------------------------------------------
                Contact person                      Committee/panel
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


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
----------------------------------------------------------------------------------------------------------------
  Committee/panel/areas of expertise
                needed                     Current and upcoming vacancies          Approximate date needed
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

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

[[Page 37553]]

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
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