[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59156-59160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24835]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. FDA-2015-N-0001]


Request for Nominations for Individuals and Consumer 
Organizations for Advisory Committees

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 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 31, 2015.

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

[[Page 59157]]

committee or panel may send a letter or email stating that interest to 
FDA (see ADDRESSES) by November 2, 2015, for vacancies listed in this 
notice. Concurrently, nomination materials for prospective candidates 
should be sent to FDA (see ADDRESSES) by November 2, 2015.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should submit information 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 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, or by mail to Advisory Committee Oversight and 
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993-0002, or 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: 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 
796-8224, email: [email protected].
    For questions relating to specific advisory committees or panels, 
contact the persons listed in Table 1:

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
             Contact person                      Committee/Panel
------------------------------------------------------------------------
Shanika Craig, Center for Devices and    Anesthesiology and Respiratory
 Radiological Health, Food and Drug       Therapy Devices Panel.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 1613, Silver
 Spring, MD 20993-0002, Phone: 301-796-
 6639, Email: [email protected].
Dimitrus Culbreath, Center for Devices   Circulatory System Devices
 and Radiological Health, Food and Drug   Panel; Molecular and Clinical
 Administration, 10903 New Hampshire      Genetics Panel.
 Ave., Bldg. 31, Rm. 3530, Silver
 Spring, MD 20993, Phone: 301-796-6872,
 Email: [email protected].
Sara Anderson, Center for Devices and    Dental Products Device Panel;
 Radiological Health, Food and Drug       Hematology and Pathology
 Administration, 10903 New Hampshire      Devices Panel.
 Ave., Bldg. 66, Rm. 1544, Silver
 Spring, MD 20993-0002, Phone: 301-796-
 1643, Email: [email protected].
Yvette Waples, Center for Drug           Dermatologic and Ophthalmic
 Evaluation and Research, Food and Drug   Drugs Advisory Committee;
 Administration, 10903 New Hampshire      Pharmaceutical Science &
 Ave., Bldg. 31, Rm. 2510, Silver         Clinical Pharmacology Advisory
 Spring, MD 20993-0002, Phone: 301-796-   Committee.
 9034, Email: [email protected].
Patricio Garcia, Center for Devices and  General and Plastic Surgery
 Radiological Health, Food and Drug       Devices Panel; Neurological
 Administration, 10903 New Hampshire      Devices Panel.
 Ave., Bldg. 66, Rm. 1535, Silver
 Spring, MD 20993-0002, Phone: 301-796-
 6875, Email:
 [email protected].
Natasha Facey, Center for Devices and    General Hospital and Personal
 Radiological Health, Food and Drug       Use Devices Panel; Ophthalmic
 Administration, 10903 New Hampshire      Devices Panel.
 Ave., Bldg. 66, Rm. 1552, Silver
 Spring, MD 20993-0002, Phone: 301-796-
 5290, FAX: 301-874-8120, Email:
 [email protected].
Rakesh Raghuwanshi, Office of the        Science Advisory Board to the
 Commissioner, Food and Drug              Food and Drug Administration.
 Administration, 10903 New Hampshire
 Ave., Bldg. 1, Rm. 4308, Silver
 Spring, MD 20993-0002, Phone: 301-796-
 4769, Email:
 [email protected].
Donna Mendrick, National Center for      Science Advisory Board to
 Toxicological Research, Food and Drug    National Center for
 Administration, 10903 New Hampshire      Toxicological Research (NCTR).
 Ave., Bldg. 32, Rm. 2208, Silver
 Spring, MD 20993-0002, Phone: 301-796-
 8892, FAX: 301-847-8600, Email:
 [email protected].
Sujata Vijh, Center for Biologics        Vaccines and Related Biological
 Evaluation and Research, Food and Drug   Products Advisory Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 71, Rm. 6128, Silver
 Spring, MD 20993-0002, Phone: 240-402-
 7107, Email: [email protected].
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 2:

[[Page 59158]]



      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
   Committee/Panel/Areas of expertise
                 needed                            Type of vacancy                  Approximate date needed
----------------------------------------------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy   One Non-Voting.....................  Immediately.
 Devices Panel of the Medical Devices
 Advisory Committee--Anesthesiologists,
 pulmonary medicine specialists, or
 other experts who have specialized
 interests in ventilator support,
 pharmacology, physiology, or the
 effects and complications of
 anesthesia.
Circulatory System Devices Panel of the  One Non-Voting.....................  Immediately.
 Medical Devices Advisory Committee--
 Knowledgeable in the safety and
 effectiveness of marked and
 investigational devices for use in the
 circulatory and vascular systems.
Dental Products Devices Panel of the     One Non-Voting.....................  Immediately.
 Medical Devices Advisory Committee--
 Dentists, engineers and scientists who
 have expertise in the areas of dental
 implants, dental materials,
 periodontology, tissue engineering,
 and dental anatomy.
Dermatologic and Ophthalmic Drugs        One Voting.........................  Immediately.
 Advisory Committee--Knowledgeable in
 the fields of dermatology,
 ophthalmology, internal medicine,
 pathology, immunology, epidemiology or
 statistics, and other related
 professions.
General and Plastic Surgery Devices      One Non-Voting.....................  Immediately.
 Panel of the 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.
General Hospital and Personal Use        One Non-Voting.....................  Immediately.
 Devices Panel of the Medical Devices
 Advisory Committee--Internists,
 pediatricians, neonatologists,
 endocrinologists, gerontologists,
 nurses, biomedical engineers or
 microbiologists, infection control
 practitioners or experts.
Hematology and Pathology Devices Panel   One Non-Voting.....................  Immediately.
 of the Medical Devices Advisory
 Committee --Knowledgeable in the
 fields of hematology, hematopathology,
 coagulation and homeostasis,
 hematological oncology, and
 gynecological oncology.
Molecular and Clinical Genetics Panel    One Non-Voting.....................  Immediately.
 of the Medical Devices Advisory
 Committee--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.
Neurological Devices Panel of the        One Non-Voting.....................  Immediately.
 Medical Devices Advisory Committee--
 Neurosurgeons (cerebrovascular and
 pediatric), neurologists (stroke,
 pediatric, pain management, and
 movement disorders), interventional
 neuroradiologists, psychiatrists, and
 biostatisticians.
Obstetrics and Gynecology Devices Panel  One Non-Voting.....................  Immediately.
 of the 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; and labor and
 delivery nursing.
Ophthalmic Devices Panel of the Medical  One Non-Voting.....................  Immediately.
 Devices Advisory Committee--
 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.
Pharmaceutical Science and Clinical      One Voting.........................  Immediately.
 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.
Science Board Advisory Committee for     One Voting.........................  Immediately.
 the Food and Drug Administration--
 Knowledgeable in the fields of food
 science, safety, and nutrition;
 chemistry; pharmacology; translational
 and clinical medicine and research;
 toxicology; biostatistics; medical
 devices; imaging; robotics; cell and
 tissue based products; regenerative
 medicine; public health and
 epidemiology; international health and
 regulation; product safety; product
 manufacturing sciences and quality;
 and other scientific areas relevant to
 FDA regulated products such as systems
 biology, informatics, nanotechnology,
 and combination products.
Science Advisory Board to the NCTR--     One Voting.........................  Immediately.
 Knowledgeable in the fields related to
 toxicological research.
Vaccines and Related Biological          One Voting.........................  Immediately.
 Products--Knowledgeable in the fields
 of immunology, molecular biology,
 rDNA, virology, bacteriology,
 epidemiology or biostatistics,
 allergy, preventive medicine,
 infectious diseases, pediatrics,
 microbiology, and biochemistry.
----------------------------------------------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

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

[[Page 59159]]

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. 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.

B. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic disorders.

C. 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 the 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.

D. Science Board

    Provides advice primarily to the Commissioner of Food and Drugs and 
other appropriate officials on specific complex and technical issues as 
well as emerging issues in the scientific community, industry, and 
academia. Additionally, the Board will provide advice to the Agency on 
keeping pace with technical and scientific evolutions in the fields of 
regulatory science, on formulating an appropriate research agenda, and 
on upgrading its scientific and research facilities to keep pace with 
these changes. It will also provide the means for critical review of 
Agency sponsored intramural and extramural scientific research 
programs.

E. Science Advisory Board to the National Center for Toxicological 
Research

    Reviews and advises the Agency on the establishment, 
implementation, and evaluation of the research programs and regulatory 
responsibilities as it relates to NCTR. The Board will also provide an 
extra-Agency review in ensuring that the research programs at NCTR are 
scientifically sound and pertinent.

F. Vaccines and Related Biological Products Advisory Committee

    Reviews and evaluates data concerning the safety, effectiveness, 
and appropriate use of vaccines and related biological products which 
are intended for use in the prevention, treatment, or diagnosis of 
human diseases, as well as considers the quality and relevance of FDA's 
research program which provides scientific support for the regulation 
of these products.

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 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. 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.
    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

[[Page 59160]]

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: September 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-24835 Filed 9-30-15; 8:45 am]
BILLING CODE 4164-01-P