Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Federal Register, Volume 80 Issue 190 (Thursday, October 1, 2015)
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
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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.
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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 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
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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 kimberly.hamilton@fda.hhs.gov, 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: kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels, contact the persons listed in Table 1:
Table 1--Advisory Committee Contacts
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Contact person Committee/Panel
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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: Shanika.Craig@fda.hhs.gov.
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: Dimitrus.Culbreath@fda.hhs.gov.
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: Sara.Anderson@fda.hhs.gov.
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: Yvette.Waples@fda.hhs.gov.
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:
Patricio.Garcia@fda.hhs.gov.
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:
Natasha.Facey@fda.hhs.gov.
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:
Rakesh.Raghuwanshi@fda.hhs.gov.
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:
Donna.Mendrick@fda.hhs.gov.
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: Sujata.Vijh@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:
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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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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.
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Functions and General Description of the Committee Duties
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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
