Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 15578-15581 [2018-07426]
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15578
Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
Application No.
Drug
Applicant
ANDA 077173 ........
Ondansetron Injection USP, EQ 2 mg base/milliliter (mL) ....
ANDA 078598 ........
Ciprofloxacin Ophthalmic Solution USP, EQ 0.3% base .......
ANDA 078805 ........
Irinotecan HCl Injection, 20 mg/mL ........................................
ANDA 086024 ........
Capital and Codeine (acetaminophen and codeine phosphate) Oral Suspension USP, 120 mg/12 mg per 5 mL.
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution,
EQ 2% base/EQ 0.5% base.
Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical
Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., Suite
205, Berwyn, PA 19312.
Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Zambon S.p.A., c/o Camargo Pharmaceutical Services,
LLC, 9825 Kenwood Rd., Suite 203, Cincinnati, OH
45242.
Technology Organized, LLC, 9191 Point Replete Dr., Fort
Belvoir, VA 22060.
Sovereign Pharmaceuticals, LLC, 7590 Sand St., Fort
Worth, TX 76118.
Zydus Pharmaceuticals USA, Inc., 73 Route 31 North, Pennington, NJ 08534.
ANDA 091180 ........
ANDA 203176 ........
Nevirapine Tablets USP, 200 mg ..........................................
ANDA 204900 ........
Amlodipine Besylate Tablets USP, EQ 2.5 mg base, EQ 5
mg base, and EQ 10 mg base.
Clozapine Tablets USP, 25 mg, 50 mg, 100 mg, and 200
mg.
ANDA 209480 ........
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of May 11, 2018.
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 May 11, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07440 Filed 4–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1095]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
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SUMMARY:
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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 May 11, 2018, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by May 11, 2018.
Nominations will be accepted for
current vacancies and for those that will
or may occur through July 31, 2018.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
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and consumer representative
nominations should be submitted
electronically to ACOMSSubmissions@
fda.hhs.gov, by mail or delivery service
to Advisory Committee Oversight and
Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
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 or delivery service to
Advisory Committee Oversight and
Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
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 (ACOMS), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
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:
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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person
Committee/panel
Moon Hee V. Choi, 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–
2894, email: MoonHee.Choi@fda.hhs.gov.
Lauren Tesh, 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.Tesh@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.
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.
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.
Joan Adams-White, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm., 5572, 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.
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.
Anesthetic and Analgesic Drug Products Advisory Committee.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
Antimicrobial Advisory Committee.
Bone, Reproductive and Urological Drugs Advisory Committee.
Cardiovascular and Renal Drugs Advisory
Committee, Medical Imaging Advisory Committee.
Pulmonary-Allergy Drugs Advisory Committee.
Clinical Chemistry and Clinical Toxicology Devices Panel, Gastroenterology and Urology
Devices Panel.
Ear, Nose and Throat Devices Panel.
Medical Devices Dispute Resolution Panel.
Microbiology Devices Panel, Radiology Devices Panel.
Orthopaedic and Rehabilitation Devices Panel,
Radiological Devices Panel.
or nonvoting consumer representatives
for the vacancies listed in table 2:
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Approximate
date needed
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Committee/panel/areas of expertise needed
Type of vacancy
Anesthetic and Analgesic Drug Products Advisory Committee—Knowledgeable in
the fields of anesthesiology, surgery, epidemiology or statistics, and related specialties.
Antimicrobial Advisory Committee—Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, 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.
Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the
fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure,
diuresis, and biostatistics.
Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear
medicine, radiology, epidemiology, statistics and related specialties.
Pulmonary- Allergy Drugs Advisory Committee—Knowledgeable in the fields of
pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics.
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.
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.
Ear, Nose and Throat Devices Panel—Experts in Otologists, neurologists, audiologists.
1—Voting .................................................
Immediately.
1—Voting .................................................
Immediately.
1—Voting .................................................
Immediately.
1—Voting .................................................
July 1, 2018.
1—Voting .................................................
Immediately.
1—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. 83, No. 70 / Wednesday, April 11, 2018 / Notices
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Approximate
date needed
Committee/panel/areas of expertise needed
Type of vacancy
Medical Devices Dispute Resolution—Experts with broad, cross-cutting scientific,
clinical, analytical or mediation skills.
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.
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.
1—Non-Voting .........................................
Immediately.
1—Non-Voting .........................................
Immediately.
1—Non-Voting .........................................
Immediately.
I. Functions and General Description of
the Committee Duties
A. Anesthetic and Analgesic Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
B. Antimicrobial 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 infectious diseases and disorders.
C. Bone, Reproductive & 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.
D. Cardiovascular and Renal 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 cardiovascular and renal disorders.
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E. Medical Imaging 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.
F. Pulmonary-Allergy Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
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drug products for use in the treatment
of pulmonary disease and diseases with
allergic and/or immunologic
mechanisms.
G. Certain Panels of the Medical
Devices Advisory Committee
Review and evaluate data on the
safety and effectiveness of marketed and
investigational devices and make
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-thecounter status and to evaluate data and
make recommendations concerning the
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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
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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
amozie on DSK30RV082PROD with NOTICES
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 must 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 resume 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.
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
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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: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07426 Filed 4–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–3848]
E11(R1) Addendum: Clinical
Investigation of Medicinal Products in
the Pediatric Population; International
Council for Harmonisation; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘E11(R1)
Addendum: Clinical Investigation of
Medicinal Products in the Pediatric
Population’’ (E11(R1) addendum or
addendum). The guidance was prepared
under the auspices of the International
Council for Harmonisation (ICH),
formerly the International Conference
on Harmonisation. The guidance is an
addendum to the guidance published in
2000 entitled ‘‘E11 Clinical
Investigation of Medicinal Products in
the Pediatric Population’’ (ICH E11
(2000)), and provides updates to the
original guidance. This addendum does
not alter the scope of the original
guidance, which outlines an approach
to the safe, efficient, and ethical study
of medicinal products in the pediatric
population. This addendum
complements and provides clarification
and current regulatory perspective on
topics in pediatric drug development.
The guidance is intended to provide
high-level guidance on the
implementation of important
approaches in pediatric drug
development. This harmonized
addendum will help to define the
current recommendations and reduce
SUMMARY:
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15581
the likelihood that substantial
differences will exist among regions for
the acceptance of data generated in
pediatric global drug development
programs and ensure timely access to
medicines for children.
DATES: The announcement of the
guidance is published in the Federal
Register on April 11, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–3848 for ‘‘E11(R1) Addendum:
Clinical Investigation of Medicinal
Products in the Pediatric Population.’’
Received comments will be placed in
the docket and, except for those
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]]>Agencies
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15578-15581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1095]
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 or Agency) 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 May 11,
2018, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by May 11, 2018. Nominations will be accepted for current
vacancies and for those that will or may occur through July 31, 2018.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
[email protected], by mail or delivery service to Advisory
Committee Oversight and Management Staff, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5103, 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 or delivery service to Advisory Committee
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm.
5103, 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 (ACOMS), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, 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.
[[Page 15579]]
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Moon Hee V. Choi, Center for Drug Evaluation Anesthetic and Analgesic
and Research, Food and Drug Administration, Drug Products Advisory
10903 New Hampshire Ave., Bldg. 31, Rm. Committee.
2434, Silver Spring, MD 20993-0002, 301-796-
2894, email: [email protected].
Lauren Tesh, Center for Drug Evaluation and Antimicrobial Advisory
Research, Food and Drug Administration, Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2426, Silver Spring, MD 20993-0002, 301-796-
2721, email: [email protected].
Kalyani Bhatt, Center for Drug Evaluation and Bone, Reproductive and
Research, Food and Drug Administration, Urological Drugs
10903 New Hampshire Ave., Bldg. 31, Rm. Advisory Committee.
2438, Silver Spring, MD 20993-0002, 301-796-
9005, email: [email protected].
Jennifer Shepherd, Center for Drug Evaluation Cardiovascular and Renal
and Research, Food and Drug Administration, Drugs Advisory
10903 New Hampshire Ave., Bldg. 31, Rm. Committee, Medical
2434, Silver Spring, MD 20993-0002, 301-796- Imaging Advisory
4043, email: [email protected]. Committee.
Cindy Chee, Center for Drug Evaluation and Pulmonary-Allergy Drugs
Research, Food and Drug Administration, Advisory Committee.
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
Administration, 10903 New Hampshire Ave., Devices Panel,
Bldg. 66, Rm. G610, Silver Spring, MD 20993- Gastroenterology and
0002, 301-796-6875, email: Urology Devices Panel.
[email protected].
Evella Washington, Center for Devices and Ear, Nose and Throat
Radiological Health, Food and Drug Devices Panel.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. G640, Silver Spring, MD 20993-
0002, 301-796-6683, email:
[email protected].
Joan Adams-White, Center for Devices and Medical Devices Dispute
Radiological Health, Food and Drug Resolution Panel.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm., 5572, Silver Spring, MD 20993-
0002, 301-796-5421, email: [email protected].
Aden Asefa, Center for Devices and Microbiology Devices
Radiological Health, Food and Drug Panel, Radiology Devices
Administration, 10903 New Hampshire Ave., Panel.
Bldg. 66, Rm. G642, Silver Spring, MD 20993-
0002, 301-796-0400, email:
[email protected].
Sara Anderson, Center for Devices and Orthopaedic and
Radiological Health, Food and Drug Rehabilitation Devices
Administration, 10903 New Hampshire Ave., Panel, Radiological
Bldg. 66, Rm. G616 Silver Spring, MD 20993- Devices Panel.
0002, 301-796-7047, email:
[email protected].
------------------------------------------------------------------------
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 Approximate date
expertise needed Type of vacancy needed
------------------------------------------------------------------------
Anesthetic and Analgesic Drug 1--Voting........ Immediately.
Products Advisory Committee--
Knowledgeable in the fields
of anesthesiology, surgery,
epidemiology or statistics,
and related specialties.
Antimicrobial Advisory 1--Voting........ Immediately.
Committee--Knowledgeable in
the fields of infectious
disease, internal medicine,
microbiology, pediatrics,
epidemiology or statistics,
and related specialties.
Bone, Reproductive and 1--Voting........ Immediately.
Urological Drugs Advisory
Committee--Knowledgeable in
the fields of obstetrics,
gynecology, endocrinology,
pediatrics, epidemiology or
statistics and related
specialties.
Cardiovascular and Renal Drugs 1--Voting........ July 1, 2018.
Advisory Committee--
Knowledgeable in the fields
of cardiology, hypertension,
arrhythmia, angina,
congestive heart failure,
diuresis, and biostatistics.
Medical Imaging Advisory 1--Voting........ Immediately.
Committee--Knowledgeable in
the fields of nuclear
medicine, radiology,
epidemiology, statistics and
related specialties.
Pulmonary- Allergy Drugs 1--Voting........ Immediately.
Advisory Committee--
Knowledgeable in the fields
of pulmonary medicine,
allergy, clinical immunology,
and epidemiology or
statistics.
Clinical Chemistry and 1--Non-Voting.... Immediately.
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 1--Non-Voting.... Immediately.
Devices Panel--
Gastroenterologists,
urologists and nephrologists.
Radiology Devices Panel-- 1--Non-Voting.... Immediately.
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.
Ear, Nose and Throat Devices 1--Non-Voting.... Immediately.
Panel--Experts in Otologists,
neurologists, audiologists.
[[Page 15580]]
Medical Devices Dispute 1--Non-Voting.... Immediately.
Resolution--Experts with
broad, cross-cutting
scientific, clinical,
analytical or mediation
skills.
Microbiology Devices Panel-- 1--Non-Voting.... Immediately.
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.
Orthopaedic and Rehabilitation 1--Non-Voting.... Immediately.
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.
------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. Anesthetic and Analgesic Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.
B. Antimicrobial 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 infectious diseases and disorders.
C. Bone, Reproductive & 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.
D. Cardiovascular and Renal 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 cardiovascular and renal disorders.
E. Medical Imaging 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.
F. Pulmonary-Allergy 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 pulmonary disease and diseases with allergic
and/or immunologic mechanisms.
G. Certain Panels of the Medical Devices Advisory Committee
Review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make 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
[[Page 15581]]
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 must 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.
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: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07426 Filed 4-10-18; 8:45 am]
BILLING CODE 4164-01-P
