[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18235-18238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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.

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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 September 30, 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 committee or panel may send a 
letter or email stating that interest to the FDA (see ADDRESSES) by May 
4, 2015, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by May 4, 2015.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should submit your information 
electronically to

[[Page 18236]]

<a href="/cdn-cgi/l/email-protection#bad1d3d7d8dfc8d6c394d2dbd7d3d6ced5d4fadcdedb94d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="1f7476727d7a6d736631777e7276736b70715f797b7e3177776c31787069">[email protected]</span></a> 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: <a href="/cdn-cgi/l/email-protection#aac1c3c7c8cfd8c6d384c2cbc7c3c6dec5c4eacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="d0bbb9bdb2b5a2bca9feb8b1bdb9bca4bfbe90b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
    For questions relating to specific advisory committees or panels, 
contact the following persons listed in table 1 of this document:

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
                Contact person                      Committee/Panel
------------------------------------------------------------------------
Janie Kim, Center for Biologics Evaluation     Allergenic Products
 and Research, Food and Drug Administration,    Advisory Committee.
 10903 New Hampshire Ave., Bldg. 71, Rm.
 6129, Silver Spring, MD 20993; 301-796-9016,
 email: <a href="/cdn-cgi/l/email-protection#79331817101c57321014391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="652f040b0c004b2e0c08250301044b0d0d164b020a13">[email protected]</span></a>.
Stephanie Begansky, Center for Drug            Arthritis Advisory
 Evaluation and Research, Division of           Committee.
 Advisory Committee and Consultant
 Management, Office of Executive Programs,
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2426, Silver Spring, MD 20993-0002; 301-796-
 3693, FAX: 301-847-8533, email:
 <a href="/cdn-cgi/l/email-protection#05567160756d646b6c602b476062646b766e7c456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="f6a58293869e97989f93d8b493919798859d8fb6909297d89e9e85d8919980">[email protected]</span></a>.
Jamie Waterhouse, Center for Devices and       Circulatory System
 Radiological Health, Office of Device          Devices Panel, Molecular
 Evaluation, 10903 New Hampshire Ave., Bldg.    and Clinical Genetics
 66, Rm. 1544, Silver Spring, MD 20993-0002;    Panel.
 301-796-3063, FAX: 301-847-8122, email:
 <a href="/cdn-cgi/l/email-protection#1c567d717579324b7d68796e7473696f795c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="18527975717d364f796c7d6a70776d6b7d587e7c793670706b367f776e">[email protected]</span></a>.
Yvette Waples, Center for Drug Evaluation &    Dermatologic and
 Research, Division of Advisory Committee and   Ophthalmic Drugs
 Consultant Management, Office of Executive     Advisory Committee.
 Programs, 10993 New Hampshire Ave., Bldg.
 31, Rm. 2510, Silver Spring, MD 20993-0002;
 301-796-9034 FAX: 301-847-8533 email:
 <a href="/cdn-cgi/l/email-protection#bbe2cddecfcfde95ecdacbd7dec8fbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="520b24372626377c0533223e3721123436337c3a3a217c353d24">[email protected]</span></a>.
Patricio Garcia, Center for Devices and        General and Plastic
 Radiological Health, Office of Device          Surgery Devices Panel.
 Evaluation, 10903 New Hampshire Ave., Bldg.
 66, Rm. RMG 465 HFZ-410, Silver Spring, MD
 20903-0002, 301-796-6875, FAX: 301-847-8120,
 email: <a href="/cdn-cgi/l/email-protection#a8f8c9dcdac1cbc1c786efc9dacbc1c9e8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="96c6f7e2e4fff5fff9b8d1f7e4f5fff7d6f0f2f7b8fefee5b8f1f9e0">[email protected]</span></a>.
Sara J. Anderson, Center for Devices and       Hematology & Pathology
 Radiological Health, Office of Device          Devices Panel,
 Evaluation, 10903 New Hampshire Ave., Bldg.    Orthopaedic and
 66, Rm. 1544, Silver Spring, MD 20903-0002;    Rehabilitation Devices
 301-796-7047, FAX: 301-847-8122, email:        Panel, and National
 <a href="/cdn-cgi/l/email-protection#0e5d6f7c6f204f606a6b7c7d61604e686a6f2066667d20696178"><span class="__cf_email__" data-cfemail="cb98aab9aae58aa5afaeb9b8a4a58badafaae5a3a3b8e5aca4bd">[email protected]</span></a>.                     Mammography and Quality
                                                Assurance Advisory
                                                Committee.
Shanika Craig, Food and Drug Administration,   Obstetrics and Gynecology
 10903 New Hampshire Ave., Bldg. 66 Rm. 1613,   Devices Panel.
 Silver Spring, MD 20993-0002; 301-796-6639,
 FAX: 301-847-8120, email:
 <a href="/cdn-cgi/l/email-protection#dd8eb5bcb3b4b6bcf39eafbcb4ba9dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="104378717e797b713e5362717977507674713e7878633e777f66">[email protected]</span></a>.
Lauren Tesh, Center for Drug Evaluation and    Oncologic Drugs Advisory
 Research, 10903 New Hampshire Ave., Bldg.      Committee.
 31, Rm. 2426, Silver Spring, MD 20993-0002;
 301-796-2721, email: <a href="/cdn-cgi/l/email-protection#d599b4a0a7b0bbfb81b0a6bd95b3b1b4fbbdbda6fbb2baa3"><span class="__cf_email__" data-cfemail="bbf7dacec9ded595efdec8d3fbdddfda95d3d3c895dcd4cd">[email protected]</span></a>.
Donna Mendrick, National Center for            Science Advisory Board to
 Toxicological Research, Bldg. 32, Rm. 2208,    National Center for
 10903 New Hampshire Ave., Silver Spring, MD    Toxicological Research
 20993-0002, 301-796-8892, FAX: 301-847-8600,   (NCTR).
 email: <a href="/cdn-cgi/l/email-protection#b7f3d8d9d9d699fad2d9d3c5ded4dcf7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="75311a1b1b145b38101b11071c161e351311145b1d1d065b121a03">[email protected]</span></a>.
Sujata Vijh, Center for Biologics Evaluation   Vaccines and Related
 and Research, Division of Scientific           Biological Products
 Advisors and Consultants, 10903 New            Advisory Committee.
 Hampshire Ave., Silver Spring, MD 20993-
 0002; 240-402-7107, FAX: 301-595-1307,
 email: <a href="/cdn-cgi/l/email-protection#bbe8ced1dacfda95edd2d1d3fbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="a5f6d0cfc4d1c48bf3cccfcde5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>.
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: 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 Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
  Committee/Panel/Areas of expertise
                needed                     Current and upcoming vacancies          Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenic Products Advisory            One Voting.........................  June 30, 2015.
 Committee: Knowledgeable in the
 fields of allergy, immunology,
 pediatrics, internal medicine,
 biochemistry, and related specialties.
Arthritis Drugs Advisory Committee:     One Voting.........................  September 30, 2015.
 Knowledgeable in the fields of
 arthritis, rheumatology, orthopedics,
 epidemiology or statistics,
 analgesics, and related specialties.
Circulatory System Devices Panel of     One Non-Voting.....................  Immediately.
 the Medical Devices Advisory
 Committee: Knowledgeable in the
 safety and effectiveness of marked
 and investigational devices for use
 in the circulatory and vascular
 systems.
Dermatologic & Ophthalmic Drugs         One Voting.........................  August 31, 2015.
 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.

[[Page 18237]]

 
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,
 gynecological oncology.
Molecular & Clinical Genetics Panel of  One Non-Voting.....................  May 31, 2015.
 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.
Obstetrics and Gynecology Devices       One Non-Voting.....................  Immediately.
 Panel 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; labor and
 delivery nursing.
Oncologic Drugs Advisory Committee:     One Voting.........................  Immediately.
 Knowledgeable in the fields of
 general oncology, pediatric oncology,
 hematologic oncology, immunologic
 oncology, biostatistics, and other
 related professions.
National Mammography Quality Assurance  Two Voting.........................  Immediately.
 Advisory Committee: Knowledgeable in
 clinical practice, research
 specialization, or professional work
 that has a significant focus on
 mammography.
Orthopaedic and Rehabilitation Devices  Two Non-Voting.....................  Immediately.
 Panel of the Medical Devices Advisory
 Committee: Knowledgeable in data
 concerning the safety and
 effectiveness of marketed and
 investigational orthopaedic and
 rehabilitation devices.
Science Advisory Board to the NCTR:     One Voting.........................  June 30, 2015.
 Knowledgeable in the fields related
 to toxicological research.
Vaccines and Related Biological         One Voting.........................  Immediately.
 Products Advisory Committee
 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

    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 products, 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.
    B. Arthritis Drugs Advisory Committee: Reviews and evaluates data 
concerning the safety and effectiveness of marketed and investigational 
human drug products for use in the treatment of arthritis, rheumatism, 
and related diseases.
    C. 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.
    D. 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.
    E. 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.
    F. Oncologic Drugs Advisory Committee: Reviews and evaluates data 
concerning the safety and effectiveness

[[Page 18238]]

of marketed and investigational human drug products for use in the 
treatment of cancer.
    G. 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.
    H. 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 a 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 vote in the selection process. Persons who nominate 
themselves to serve as voting or nonvoting consumer representatives 
will not participate in the selection process.

    Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07605 Filed 4-2-15; 8:45 am]
 BILLING CODE 4164-01-P


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