Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 27785-27788 [2019-12566]
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Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
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.
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:
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.
DATES:
Notice.
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.
SUMMARY:
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,
ADDRESSES:
27785
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
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.
FOR FURTHER INFORMATION CONTACT:
TABLE 1—ADVISORY COMMITTEE CONTACTS
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Contact person
Committee/panel
Yinghua Wang, Center for Drug Evaluation 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 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD
20993–0002, 301–796–9005, email: Kalyani.Bhatt@fda.hhs.gov.
Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug 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 Evaluation and Research, Food and Drug 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 and Research, Food and Drug 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 Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993–0002, 301–796–6875, email: Patricio.Garcia@fda.hhs.gov.
Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring,
MD 20993–0002, 301–796–7047, email: Sara.Anderson@fda.hhs.gov.
Evella Washington, Center for Devices and Radiological Health, Food and Drug
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 and Radiological Health, Food and
Drug 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 Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD
20993–0002, 301–796–0400, email: Aden.Asefa@fda.hhs.gov.
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Arthritis Advisory Committee.
Bone, Reproductive and Urological Drugs Advisory Committee; Psychopharmacologic Drugs Advisory Committee.
Medical Imaging Drugs Advisory Committee.
Oncologic Drugs Advisory Committee.
Pharmacy Compounding Advisory Committee.
Clinical Chemistry and Clinical Toxicology Devices Panel;
Gastroenterology and Urology Devices Panel; Obstetrics
and Gynecology Devices Panel.
Dental Products Devices Panel; National Mammography Advisory Committee; Orthopaedic and Rehabilitation Devices
Panel.
Circulatory Systems Devices Panel.
Medical Devices Dispute Resolution Panel.
Immunology Devices Panel; Microbiology Devices Panel;
Radiological Devices Panel.
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27786
Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
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
Committee/panel/areas of expertise needed
Type of vacancy
Arthritis Advisory Committee—Knowledgeable in the fields of arthritis,
rheumatology, orthopedics, epidemiology or statistics, analgesics,
and related specialties.
Bone, Reproductive and Urological Drugs Advisory Committee—Knowledgeable in the fields of obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics, and related specialties.
Psychopharmacologic Drugs Advisory Committee—Knowledgeable in
the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties.
Medical Imaging Drugs Advisory Committee—Knowledgeable in the
fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties.
Oncologic Drugs Advisory Committee—Knowledgeable in the fields of
general oncology, pediatric oncology, hematologic oncology,
immunologic oncology, biostatistics, and other related professions.
Pharmacy Compounding Advisory Committee—Knowledgeable in the
fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine, and other related specialties.
Clinical Chemistry and Clinical Toxicology Devices 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—Gastroenterologists,
urologists, and nephrologists.
Obstetrics and Gynecology Devices Panel—Experts 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, and scientists who
have expertise in the areas of dental implants, dental materials,
periodontology, tissue engineering, and dental anatomy.
National Mammography Advisory Committee—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—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 cardiologists,
electrophysiologists, invasive (vascular) radiologists, vascular and
cardiothoracic surgeons, and cardiologists with special interest in
congestive heart failure.
Medical Devices Dispute Resolution—Experts with broad, cross-cutting
scientific, clinical, analytical, or mediation skills.
Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.
Microbiology Devices Panel—Clinicians with an 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 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.
1—Voting ......................................
September 30, 2019.
1—Voting ......................................
Immediately.
1—Voting ......................................
June 30, 2019.
1—Voting ......................................
Immediately.
1—Voting ......................................
June 30, 2019.
1—Voting ......................................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
October 30, 2019.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
1—Non-Voting ...............................
Immediately.
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Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
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.
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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;
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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-thecounter 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.
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27787
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 re´sume´.
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 re´sume´ 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 communitybased 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 selfnominated. 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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27788
Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
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.
[FR Doc. 2019–12566 Filed 6–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0163]
Hospira, Inc., et al.; Withdrawal of
Approval of 12 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 12 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
SUMMARY:
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of July
15, 2019.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 040664 .........
Hospira, Inc., 275 North Field Dr., Building H1, Lake Forest, IL 60045.
ANDA 071052 .........
ANDA 071053 .........
ANDA 075656 .........
A-Methapred (methylprednisolone sodium succinate) for Injection USP, Equivalent to (EQ) 40 milligrams (mg) base/
vial.
A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 125 mg base/vial.
Garamycin (gentamicin sulfate) Cream USP, EQ 0.1%
base.
Mycostatin (nystatin) Oral Suspension USP, 100,000 units/
milliliter (mL).
Astramorph/PF (morphine sulfate) Injection USP, 0.5 mg/
mL.
Astramorph/PF (morphine sulfate) Injection USP, 1 mg/mL
Astramorph/PF (morphine sulfate) Injection USP, 1 mg/mL
Morphine Sulfate Extended-Release Tablets, 100 mg .........
ANDA 078815 .........
ANDA 088119 .........
Oxaliplatin for Injection, 50 mg/vial and 100 mg/vial ............
Isoniazid Tablets USP, 300 mg .............................................
ANDA 088231 .........
ANDA 091597 .........
Isoniazid Tablets USP, 100 mg .............................................
Gemcitabine for Injection USP, EQ 200 mg base/vial and
EQ 1 gram base/vial.
ANDA 040665 .........
ANDA 060462 .........
ANDA 061533 .........
ANDA 071051 .........
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Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 15, 2019.
Approval of each entire application is
withdrawn, including any strengths or
products inadvertently missing from the
table. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on July 15, 2019,
may continue to be dispensed until the
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Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ
07033.
Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ
08543.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Do.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Hospira, Inc.
Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pky., Morris Corporate Center III, Parsippany, NJ 07054.
Do.
Sagent Pharmaceuticals, Inc., 1901 North Roselle Rd.,
Suite 450, Schaumburg, IL 60195.
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[Docket No. FDA–2019–N–2224]
[FR Doc. 2019–12560 Filed 6–13–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Food and Drug Administration
Arthritis Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
SUMMARY:
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]]>Agencies
[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.
-----------------------------------------------------------------------
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 [email protected], 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: [email protected].
For questions relating to specific advisory committees or panels:
contact the appropriate contact person listed in table 1.
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
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:
[email protected].
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: [email protected].
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: [email protected].
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: [email protected].
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: [email protected].
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: [email protected]. 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: [email protected].
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: [email protected].
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: [email protected].
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: [email protected].
------------------------------------------------------------------------
[[Page 27786]]
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
----------------------------------------------------------------------------------------------------------------
Committee/panel/areas of expertise needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
[[Page 27787]]
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.
[[Page 27788]]
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
