
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37608-37611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Request for Nominations for Individuals and Consumer 
Organizations for Advisory Committees

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.
    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 FDA (see ADDRESSES) by July 
11, 2016, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by July 11, 2016. Nominations will be accepted for current 
vacancies and for those that will or may occur through August 31, 2016.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should be submitted electronically to 
kimberly.hamilton@fda.hhs.gov, 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: 301-847-8640.
    Consumer representative nominations should be submitted 
electronically by logging into the FDA Advisory Committee Membership 
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, 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: 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 INFORMATION CONTACT: For questions relating to 
participation in the selection process: Kimberly Hamilton, Advisory 
Committee Oversight and Management Staff (ACOMS), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993-0002, 301-796-8220 email: 
kimberly.hamilton@fda.hhs.gov.
    For questions relating to specific advisory committees or panels, 
contact the appropriate Contact Person listed in table 1 in the 
SUPPLEMENTARY INFORMATION section:

SUPPLEMENTARY INFORMATION:

I. Background

    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 (see table 1 for Contact Person).

                  Table 1--Advisory Committee Contacts
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              Contact person                       Committee/panel
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Janie Kim, Center for Biologics Evaluation  Allergenic Products Advisory
 and Research, Food and Drug                 Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 6129, Silver Spring, MD
 20993-0002, Phone: 301-796-9016, Email:
 Janie.Kim@fda.hhs.gov.

[[Page 37609]]

 
Shanika Craig, Center for Devices and       Anesthesiology and
 Radiological Health, Food and Drug          Respiratory Therapy Devices
 Administration, 10903 New Hampshire Ave.,   Panel.
 Bldg. 66, Rm. 1613, Silver Spring, MD
 20993-0002, Phone: 301-796-6639, Email:
 Shanika.Craig@fda.hhs.gov.
Patricio Garcia, Center for Devices and     Gastroenterology and Urology
 Radiological Health, Food and Drug          Devices Panel; General and
 Administration, 10903 New Hampshire Ave.,   Plastic Surgery Devices
 Bldg. 66, Rm. 1611, Silver Spring, MD       Panel; Neurological Devices
 20993-0002, Phone: 301-796-6875, Email:     Panel.
 Patricio.Garcia@fda.hhs.gov.
Natasha Facey, Center for Devices and       Ophthalmic Devices Panel.
 Radiological Health, Food and Drug
 Administration, 10903 New Hampshire Ave.,
 Bldg. 32, Rm. 3354, Silver Spring, MD
 20993-0002, Phone: 301-796-5290, Email:
 Natasha.Facey@fda.hhs.gov.
Evella Washington, Center for Devices and   Molecular and Clinical
 Radiological Health, Food and Drug          Genetics Devices Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 1535, Silver Spring, MD
 20993-0002, Phone: 301-796-6683, Email:
 Evella.Washington@fda.hhs.gov.
Cindy Hong, Center for Drug Evaluation and  Gastrointestinal Drugs
 Research, Food and Drug Administration,     Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2430, Silver Spring, MD 20993-0002,
 Phone: 301-796-0889, Email:
 Cindy.Hong@fda.hhs.gov.
Jennifer Shepherd, Center for Drug          Medical Imaging Advisory
 Evaluation and Research, Food and Drug      Committee; Pharmaceutical
 Administration, 10903 New Hampshire Ave.,   Science and Clinical
 Bldg. 31, Rm. 2434, Silver Spring, MD       Pharmacology Advisory
 20993-0002, Phone: 301-796-4043, Email:     Committee.
 Jennifer.Shepherd@fda.hhs.gov.
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    Table 2--Committee Descriptions, Type of Consumer Representative
                        Vacancy, and Approximate
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    Committee/panel/areas of                           Approximate date
        expertise needed            Type of vacancy         needed
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Allergenic Products Advisory      1--Voting.........  August 31, 2016.
 Committee--Knowledgeable in the
 fields of allergy, immunology,
 pediatrics, internal medicine,
 biochemistry, and related
 specialties.
Anesthesiology and Respiratory    1--Non-Voting.....  Immediately.
 Therapy Devices Panel--
 Anesthesiologists, pulmonary
 medicine specialists, or other
 experts who have specialized
 interests in ventilator
 support, pharmacology,
 physiology, or the effects and
 complications of anesthesia.
Gastroenterology and Urology      1--Non-Voting.....  Immediately.
 Devices Panel Science Advisory
 Board to the National Center
 for Toxicological Research--
 Knowledgeable in the fields
 related to toxicological
 research.
General and Plastic Surgery       1--Non-Voting.....  Immediately.
 Devices Panel--Surgeons
 (general, plastic,
 reconstructive, pediatric,
 thoracic, abdominal, pelvic and
 endoscopic); dermatologists;
 experts in biomaterials,
 lasers, wound healing, and
 quality of life; and
 biostatisticians.
Neurological Devices Panel--      1--Non-Voting.....  Immediately.
 Neurosurgeons (cerebrovascular
 and pediatric), neurologists
 (stroke, pediatric, pain
 management, and movement
 disorders), interventional
 neuroradiologists,
 psychiatrists, and
 biostatisticians.
Ophthalmic Devices Panel--        1--Non-Voting.....  Immediately.
 Ophthalmologists with expertise
 in corneal-external disease,
 vitreo-retinal surgery,
 glaucoma, ocular immunology,
 ocular pathology; optometrists;
 vision scientists; and
 ophthalmic professionals with
 expertise in clinical trial
 design, quality of life
 assessment, electrophysiology,
 low vision rehabilitation, and
 biostatistics.
Molecular and Clinical Genetics   1--Non-Voting.....  Immediately.
 Devices Panel--Experts in human
 genetics and in the clinical
 management of patients with
 genetic disorders, e.g.,
 pediatricians, obstetricians,
 neonatologists. The Agency is
 also interested in considering
 candidates with training in
 inborn errors of metabolism,
 biochemical and/or molecular
 genetics, population genetics,
 epidemiology and related
 statistical training.
 Additionally, individuals with
 experience in genetic
 counseling, medical ethics as
 well as ancillary fields of
 study will be considered.
Gastrointestinal Drugs Advisory   1--Voting.........  June 30, 2016.
 Committee--Knowledgeable in the
 fields of gastroenterology,
 endocrinology, surgery,
 clinical pharmacology,
 physiology, pathology, liver
 function, motility,
 esophagitis, and statistics.
Medical Imaging Advisory          1--Voting.........  June 30, 2016.
 Committee--Knowledgeable in the
 fields of nuclear medicine,
 radiology, epidemiology,
 statistics and related
 specialties.
Pharmaceutical Science and        1--Voting.........  Immediately.
 Clinical Pharmacology Advisory
 Committee--Knowledgeable in the
 fields of pharmaceutical
 manufacturing, clinical
 pharmacology, pharmacokinetics,
 bioavailability and
 bioequivalence research, the
 design and evaluation of
 clinical trials, laboratory
 analytical techniques,
 pharmaceutical chemistry,
 physiochemistry, biochemistry,
 biostatistics and related
 biomedical and pharmacological
 specialties.
------------------------------------------------------------------------

II. Functions and General Description of the Committee Duties

A. Allergenic Products Advisory 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 as well as the affirmation or revocation of biological 
product licenses, on the safety, effectiveness, and labeling of the 
product; on clinical and laboratory studies of such products; on 
amendments or revisions to regulations governing the manufacture, 
testing, and licensing of allergenic biological products; and on the 
quality and relevance of FDA's research programs.

[[Page 37610]]

B. Certain Panels of the Medical Devices Advisory 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 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.
    The Dental Products Panel also functions at times as a dental drug 
panel. The functions of the dental drug panel are to evaluate and 
recommend whether various prescription drug products should be changed 
to over-the-counter status and to evaluate data and make 
recommendations concerning the approval of new dental drug products for 
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the 
Commissioner on complex or contested scientific issues between 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. Gastrointestinal Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of gastrointestinal diseases.

D. Medical Imaging Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in 
diagnostic and therapeutic procedures using radioactive pharmaceuticals 
and contrast media used in diagnostic radiology.

E. Pharmaceutical Science and Clinical Pharmacology Advisory Committee

    Provide advice on scientific and technical issues concerning the 
safety and effectiveness of human generic drug products for use in the 
treatment of a broad spectrum of human diseases and, as required, any 
other product for which FDA has regulatory responsibility. The 
committee may also review Agency sponsored intramural and extramural 
biomedical research programs in support of FDA's generic drug 
regulatory responsibilities.

III. 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.

IV. 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.

V. 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 current curriculum vitae 
or resume 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, 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.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.


[[Page 37611]]


    Dated: June 3, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-13733 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P


