[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Pages 27785-27788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12566]



[[Page 27785]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2256]


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 
15, 2019, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by July 15, 2019. Nominations will be accepted for current 
vacancies and for those that will or may occur through December 31, 
2019.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process should be 
submitted electronically to ACOMSSubmissions@fda.hhs.gov, by mail to 
Advisory Committee Oversight and Management Staff, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5122, 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. 5122, Silver 
Spring, MD 20993-0002, or by Fax: 301-847-8640. Additional information 
about becoming a member of an FDA advisory committee can also be 
obtained by visiting FDA's website at https://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, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, 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.

                  Table 1--Advisory Committee Contacts
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             Contact person                       Committee/panel
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Yinghua Wang, Center for Drug Evaluation  Arthritis Advisory Committee.
 and Research, Food and Drug
 Administration, 10903 New Hampshire
 Ave. Bldg. 31, Rm. 2412, Silver Spring,
 MD 20993-0002, 301-796-9033, email:
 Yinghua.Wang@fda.hhs.gov.
Kalyani Bhatt, Center for Drug            Bone, Reproductive and
 Evaluation and Research, Food and Drug    Urological Drugs Advisory
 Administration, 10903 New Hampshire       Committee;
 Ave., Bldg. 31, Rm. 2438, Silver          Psychopharmacologic Drugs
 Spring, MD 20993-0002, 301-796-9005,      Advisory Committee.
 email: Kalyani.Bhatt@fda.hhs.gov.
Jennifer Shepherd, Center for Drug        Medical Imaging Drugs Advisory
 Evaluation and Research, Food and Drug    Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2434, Silver
 Spring, MD 20993-0002, 301-796-4043,
 email: Jennifer.Shepherd@fda.hhs.gov.
Lauren Hotaki, Center for Drug            Oncologic Drugs Advisory
 Evaluation and Research, Food and Drug    Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2426, Silver
 Spring, MD 20993-0002, 301-796-2721,
 email: Lauren.Hotaki@fda.hhs.gov.
Cindy Chee, Center for Drug Evaluation    Pharmacy Compounding Advisory
 and Research, Food and Drug               Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2430, Silver
 Spring, MD 20993-0002, 301-796-0889,
 email: Cindy.Chee@fda.hhs.gov.
Patricio Garcia, Center for Devices and   Clinical Chemistry and
 Radiological Health, Food and Drug        Clinical Toxicology Devices
 Administration, 10903 New Hampshire       Panel; Gastroenterology and
 Ave., Bldg. 66, Rm. G610, Silver          Urology Devices Panel;
 Spring, MD 20993-0002, 301-796-6875,      Obstetrics and Gynecology
 email: Patricio.Garcia@fda.hhs.gov.       Devices Panel.
Sara Anderson, Center for Devices and     Dental Products Devices Panel;
 Radiological Health, Food and Drug        National Mammography Advisory
 Administration, 10903 New Hampshire       Committee; Orthopaedic and
 Ave., Bldg. 66, Rm. G616, Silver          Rehabilitation Devices Panel.
 Spring, MD 20993-0002, 301-796-7047,
 email: Sara.Anderson@fda.hhs.gov.
Evella Washington, Center for Devices     Circulatory Systems Devices
 and Radiological Health, Food and Drug    Panel.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. G640, Silver
 Spring, MD 20993-0002, 301-796-6683,
 email: Evella.Washington@fda.hhs.gov.
Joannie Adams-White, Center for Devices   Medical Devices Dispute
 and Radiological Health, Food and Drug    Resolution Panel.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5519, Silver
 Spring, MD 20993-0002, 301-796-5421,
 email: Joannie.Adams-White@fda.hhs.gov.
Aden Asefa, Center for Devices and        Immunology Devices Panel;
 Radiological Health, Food and Drug        Microbiology Devices Panel;
 Administration, 10903 New Hampshire       Radiological Devices Panel.
 Ave., Bldg. 66, Rm. G642, Silver
 Spring, MD 20993-0002, 301-796-0400,
 email: Aden.Asefa@fda.hhs.gov.
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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 Representative Vacancy, and Approximate Date Needed
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     Committee/panel/areas of expertise needed             Type of vacancy            Approximate date needed
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Arthritis Advisory Committee--Knowledgeable in the  1--Voting....................  September 30, 2019.
 fields of arthritis, rheumatology, orthopedics,
 epidemiology or statistics, analgesics, and
 related specialties.
Bone, Reproductive and Urological Drugs Advisory    1--Voting....................  Immediately.
 Committee--Knowledgeable in the fields of
 obstetrics, gynecology, endocrinology,
 pediatrics, epidemiology or statistics, and
 related specialties.
Psychopharmacologic Drugs Advisory Committee--      1--Voting....................  June 30, 2019.
 Knowledgeable in the fields of
 psychopharmacology, psychiatry, epidemiology or
 statistics, and related specialties.
Medical Imaging Drugs Advisory Committee--          1--Voting....................  Immediately.
 Knowledgeable in the fields of nuclear medicine,
 radiology, epidemiology, statistics, and related
 specialties.
Oncologic Drugs Advisory Committee--Knowledgeable   1--Voting....................  June 30, 2019.
 in the fields of general oncology, pediatric
 oncology, hematologic oncology, immunologic
 oncology, biostatistics, and other related
 professions.
Pharmacy Compounding Advisory Committee--           1--Voting....................  Immediately.
 Knowledgeable in the fields of pharmaceutical
 compounding, pharmaceutical manufacturing,
 pharmacy, medicine, and other related specialties.
Clinical Chemistry and Clinical Toxicology Devices  1--Non-Voting................  Immediately.
 Panel--Doctors of Medicine or Philosophy with
 experience in clinical chemistry (e.g., cardiac
 markers), clinical toxicology, clinical
 pathology, clinical laboratory medicine, and
 endocrinology.
Gastroenterology and Urology Devices Panel--        1--Non-Voting................  Immediately.
 Gastroenterologists, urologists, and
 nephrologists.
Obstetrics and Gynecology Devices Panel--Experts    1--Non-Voting................  Immediately.
 in perinatology, embryology, reproductive
 endocrinology, pediatric gynecology,
 gynecological oncology, operative hysteroscopy,
 pelviscopy, electro-surgery, laser surgery,
 assisted reproductive technologies,
 contraception, postoperative adhesions, and
 cervical cancer and colposcopy; biostatisticians
 and engineers with experience in obstetrics/
 gynecology devices; urogynecologists; experts in
 breast care; experts in gynecology in the older
 patient; experts in diagnostic (optical)
 spectroscopy; experts in midwifery; labor and
 delivery nursing.
Dental Products Device Panel--Dentists, engineers,  1--Non-Voting................  October 30, 2019.
 and scientists who have expertise in the areas of
 dental implants, dental materials,
 periodontology, tissue engineering, and dental
 anatomy.
National Mammography Advisory Committee--           1--Non-Voting................  Immediately.
 Physician, practitioner, or other health
 professional whose clinical practice, research
 specialization, or professional expertise
 includes a significant focus on mammography.
Orthopaedic and Rehabilitation Devices Panel--      1--Non-Voting................  Immediately.
 Orthopedic surgeons (joint spine, trauma, and
 pediatric); rheumatologists; engineers
 (biomedical, biomaterials, and biomechanical);
 experts in rehabilitation medicine, sports
 medicine, and connective tissue engineering; and
 biostatisticians.
Circulatory Systems Devices Panel--Interventional   1--Non-Voting................  Immediately.
 cardiologists, electrophysiologists, invasive
 (vascular) radiologists, vascular and
 cardiothoracic surgeons, and cardiologists with
 special interest in congestive heart failure.
Medical Devices Dispute Resolution--Experts with    1--Non-Voting................  Immediately.
 broad, cross-cutting scientific, clinical,
 analytical, or mediation skills.
Immunology Devices Panel--Persons with experience   1--Non-Voting................  Immediately.
 in medical, surgical, or clinical oncology,
 internal medicine, clinical immunology, allergy,
 molecular diagnostics, or clinical laboratory
 medicine.
Microbiology Devices Panel--Clinicians with an      1--Non-Voting................  Immediately.
 expertise in infectious disease, e.g., pulmonary
 disease specialists, sexually transmitted disease
 specialists, pediatric infectious disease
 specialists, experts in tropical medicine and
 emerging infectious diseases, mycologists;
 clinical microbiologists and virologists;
 clinical virology and microbiology laboratory
 directors, with expertise in clinical diagnosis
 and in vitro diagnostic assays, e.g.,
 hepatologists; molecular biologists.
Radiology Devices Panel--Physicians with            1--Non-Voting................  Immediately.
 experience in general radiology, mammography,
 ultrasound, magnetic resonance, computed
 tomography, other radiological subspecialties and
 radiation oncology; scientists with experience in
 diagnostic devices, radiation physics,
 statistical analysis, digital imaging, and image
 analysis.
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I. Functions and General Description of the Committee Duties

A. Arthritis 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.

B. Bone, Reproductive and Urologic Drugs Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of 
marketed and investigational human drugs for use in the practice of 
obstetrics, gynecology, and related specialties.

C. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
practice of psychiatry and related fields.

D. Medical Imaging Drugs 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. Oncologic 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 cancer.

F. Pharmacy Compounding Advisory Committee

    Provides advice on scientific, technical, and medical issues 
concerning drug compounding by pharmacists and licensed practitioners.

G. 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.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on 
committees or panels should meet the following criteria: (1) 
Demonstrate an affiliation with and/or active participation in consumer 
or 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 
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA 
within 30 days. The nominee receiving the highest number of votes 
ordinarily will be selected to serve as the member representing 
consumer interests for that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more 
qualified persons to represent consumer interests on the Agency's 
advisory committees or panels. Self-nominations are also accepted. 
Nominations must include a current, complete r[eacute]sum[eacute] or 
curriculum vitae for each nominee and a signed copy of the 
Acknowledgement and Consent form available at the FDA Advisory 
Nomination Portal (see ADDRESSES section of this document), and a list 
of consumer or community-based organizations for which the candidate 
can demonstrate active participation.
    Nominations must also specify the advisory committee(s) or panel(s) 
for which the nominee is recommended. In addition, nominations must 
also acknowledge 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.

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    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.

    Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12566 Filed 6-13-19; 8:45 am]
 BILLING CODE 4164-01-P


