Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 7803-7806 [2016-03010]
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Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02965 Filed 2–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
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) 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 March 17, 2016, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by March 17,
2016. Nominations will be accepted for
current vacancies and for those that will
or may occur through March 31, 2016.
SUMMARY:
7803
All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should be submitted
electronically to kimberly.hamilton@
fda.hhs.gov, by mail 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 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
on an FDA advisory committee can also
be obtained by visiting FDA’s Web site
at https://www.fda.gov/
AdvisoryCommittees/default.htm.
ADDRESSES:
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. 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 appropriate Contact Person listed in
table 1 in the SUPPLEMENTARY
INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
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 (see table
1 for Contact Person).
TABLE 1—ADVISORY COMMITTEE CONTACTS
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Contact person
Committee/panel
Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993–0002, Phone: 301–796–9016, Email:
Janie.Kim@fda.hhs.gov.
Philip Bautista, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2410, Silver Spring, MD 20993–0002, Phone: 301–796–9006, Email:
Philip.Bautista@fda.hhs.gov.
Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1552, Silver Spring, MD 20993–0002, Phone: 301–796–5290, Email:
Natasha.Facey@fda.hhs.gov.
Cellular, Tissue and Gene Therapies.
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Drug Safety and Risk Management
Advisory Committee.
Immunology Devices Panel.
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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued
Contact person
Committee/panel
Terri Crescenzi, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5152, Silver Spring, MD 20993–0002, Phone: 301–796–8646, Email: Terrie.Crescenzi@
fda.hhs.gov.
Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993–0002, Phone: 301–796–8892, Email:
Donna.Mendrick@fda.hhs.gov.
Bryan Emery, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993–0002, Phone: 240–402–8054, Email:
Bryan.Emery@fda.hhs.gov.
Sujata Vijh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993–0002, Phone: 240–402–7107, Email:
Sujata.Vijh@fda.hhs.gov.
FDA is requesting nominations for
voting and/or nonvoting consumer
Pediatrics Advisory Committee.
Science Advisory Board to National
Center for Toxicological Research (NCTR).
Transmissible
Spongiform
Encephalopathies Advisory Committee.
Vaccines and Related Biological
Products Advisory Committee.
representatives for the vacancies listed
in table 2.
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY AND APPROXIMATE DATE NEEDED
Approximate
date needed
Committee/panel/areas of expertise needed
Type of vacancy
Cellular, Tissue and Gene Therapies Advisory Committee—Knowledgeable in the fields of cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation (biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and
various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell
biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene
therapy, infectious diseases, and cellular kinetics.
Drug Safety and Risk Management Advisory Committee—Knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management,
and drug abuse.
Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal
medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.
Pediatrics Advisory Committee—Knowledgeable in pediatric research, pediatric subspecialties, statistics,
and/or biomedical ethics. The core of voting members shall also include one representative from a pediatric health organization and one representative from a relevant patient or patient-family organization
and may include one technically qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include
one non-voting member who is identified with industry interests.
Science Advisory Board to the NCTR—Knowledgeable in the fields related to toxicological research ..........
Transmissible Spongiform Encephalopathies Advisory Committee—Knowledgeable in the fields of clinical
and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, and other related professions.
Vaccines and Related Biological Products Advisory Committee—Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive
medicine, infectious diseases, pediatrics, microbiology, and biochemistry.
1-Voting ............
3/31/2016.
1-Voting ............
Immediately.
1-Non-Voting ....
2/28/2016.
1-Voting ............
Immediately.
1-Voting ............
1-Voting ............
Immediately.
Immediately.
1-Voting ............
Immediately.
scientific support for the regulation of
these products.
A. Cellular, Tissue, and Gene Therapies
Advisory Committee
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II. Functions and General Description
of the Committee Duties
B. Drug Safety and Risk Management
Advisory Committee
Reviews and evaluates available data
relating to the safety, effectiveness, and
appropriate use of human cells, human
tissues, gene transfer therapies and
xenotransplantation products which are
intended for transplantation,
implantation, infusion and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair or replacement of
tissues for various conditions, as well as
considers the quality and relevance of
FDA’s research program which provides
Risk management, risk
communication, and quantitative
evaluation of spontaneous reports for
drugs for human use and for any other
product for which the FDA has
regulatory responsibility. Scientific and
medical evaluation of all information
gathered by the Department of Health
and Human Service (DHHS) and the
Department of Justice with regard to
safety, efficacy, and abuse potential of
drugs or other substances, and
recommends actions to be taken by
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DHHS with regard to the marketing,
investigation, and control of such drugs
or other substances.
C. Certain Panels of the Medical Devices
Advisory Committee
The committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational devices
and makes recommendations for their
regulation. The panels engage in a
number of activities to fulfill the
functions the Federal Food, Drug, and
Cosmetic Act (the act) envisions for
device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, advises
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the Commissioner of Food and Drugs
(the Commissioner) regarding
recommended classification or
reclassification of devices into one of
three regulatory categories, advises on
any possible risks to health associated
with the use of devices, advises on
formulation of product development
protocols, reviews premarket approval
applications for medical devices,
reviews guidelines and guidance
documents, recommends exemption of
certain devices from the application of
portions of the 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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D. Pediatrics Advisory Committee
The Committee advises and makes
recommendations to the Commissioner
of Food and Drugs regarding: (1)
Pediatric research; (2) identification of
research priorities related to pediatric
therapeutics and the need for additional
treatments of specific pediatric diseases
or conditions; (3) the ethics, design, and
analysis of clinical trials related to
pediatric therapeutics; (4) pediatric
labeling disputes; (5) pediatric labeling
changes; (6) adverse event reports for
drugs granted pediatric exclusivity and
any safety issues that may occur; (7) any
other pediatric issue or pediatric
labeling dispute involving FDA
regulated products; (8) research
involving children as subjects; and (9)
any other matter involving pediatrics for
which FDA has regulatory
responsibility. The Committee also
advises and makes recommendations to
the Secretary directly or to the Secretary
through the Commissioner on research
involving children as subjects that is
conducted or supported by DHHS.
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E. 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.
F. Transmissible Spongiform
Encephalopathies Advisory Committee
Reviews and evaluates available
scientific data concerning the safety of
products which may be at risk for
transmission of spongiform
encephalopathies having an impact on
the public health, as well as considers
the quality and relevance of FDA’s
research program which provides
scientific support for the regulation of
these products.
G. 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.
III. 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.
IV. 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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7805
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.
V. 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.
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 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
participating in the selection process
with the opportunity to vote on the
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Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–03010 Filed 2–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0382]
Building the National Evaluation
System for Medical Devices: Using
Real-World Evidence To Improve
Device Safety and Effectiveness;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA), in collaboration
with the University of Maryland Center
of Excellence in Regulatory Science and
Innovation, is announcing a public
workshop titled ‘‘Building the National
Evaluation System for Medical Devices:
Using Real-World Evidence to Improve
Device Safety and Effectiveness.’’ The
objective of the workshop is to discuss
the scientific progress being made in
harnessing evidence generated from the
real-world use of medical devices to
improve device safety and effectiveness.
A national evaluation system for
medical devices, which leverages realworld evidence, can help FDA more
efficiently strike the right balance
between premarket and postmarket data
collection, facilitate access to medical
devices, and more quickly and robustly
identify safety signals that may arise in
the postmarket period. The promise of
using real-world evidence to promote
the safety and effectiveness of medical
devices can only be achieved through
robust public-private partnerships and
new approaches to informatics,
epidemiology, biostatistics, and
healthcare data systems integration.
DATES: The public workshop will be
held on March 24, 2016, from 8:30 a.m.
to 4:30 p.m.
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SUMMARY:
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The public workshop will
be held at the University of Maryland,
Pharmacy Hall, 20 North Pine St.,
Baltimore, MD 21201. For additional
travel and hotel information, please
refer to www.pharmacy.umaryland.edu/
DeviceEval. (FDA has verified the Web
site addresses throughout this notice,
but FDA is not responsible for
subsequent changes to the Web sites
after this document publishes in the
Federal Register).
You may submit comments as
follows:
ADDRESSES:
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–N–0382 for ‘‘Building the National
Evaluation System for Medical Devices:
Using Real-World Evidence to Improve
Device Safety and Effectiveness; Public
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Workshop; Request for Comments’’.
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Ann
Anonsen, University of Maryland,
Fischell Department of Bioengineering,
2207 Jeong H. Kim Bldg., College Park,
MD 20742, 301–405–0285, FAX: 304–
405–9953, aanonsen@umd.edu; or
Audrey Thomas, Office of Regulatory
Science and Innovation, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4220, Silver Spring,
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7803-7806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03010]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
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 March
17, 2016, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by March 17, 2016. Nominations will be accepted for current
vacancies and for those that will or may occur through March 31, 2016.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
kimberly.hamilton@fda.hhs.gov, by mail 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 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 on an FDA advisory committee can also be
obtained by visiting FDA's Web site 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. 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 appropriate Contact Person listed in table 1 in the
SUPPLEMENTARY INFORMATION section.
SUPPLEMENTARY INFORMATION:
I. Background
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 (see table 1 for Contact Person).
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Janie Kim, Center for Biologics Evaluation Cellular, Tissue and Gene
and Research, Food and Drug Therapies.
Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6129, Silver Spring, MD
20993-0002, Phone: 301-796-9016, Email:
Janie.Kim@fda.hhs.gov.
Philip Bautista, Center for Drugs Drug Safety and Risk
Evaluation and Research, Food and Drug Management Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 31, Rm. 2410, Silver Spring, MD
20993-0002, Phone: 301-796-9006, Email:
Philip.Bautista@fda.hhs.gov.
Natasha Facey, Center for Devices and Immunology Devices Panel.
Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 1552, Silver Spring, MD
20993-0002, Phone: 301-796-5290, Email:
Natasha.Facey@fda.hhs.gov.
[[Page 7804]]
Terri Crescenzi, Office of the Pediatrics Advisory
Commissioner, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5152, Silver Spring, MD
20993-0002, Phone: 301-796-8646, Email:
Terrie.Crescenzi@fda.hhs.gov.
Donna Mendrick, National Center for Science Advisory Board to
Toxicological Research, Food and Drug National Center for
Administration, 10903 New Hampshire Ave., Toxicological Research
Bldg. 32, Rm. 2208, Silver Spring, MD (NCTR).
20993-0002, Phone: 301-796-8892, Email:
Donna.Mendrick@fda.hhs.gov.
Bryan Emery, Center for Biologics Transmissible Spongiform
Evaluation and Research, Food and Drug Encephalopathies Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 71, Rm. 6132, Silver Spring, MD
20993-0002, Phone: 240-402-8054, Email:
Bryan.Emery@fda.hhs.gov.
Sujata Vijh, Center for Biologics Vaccines and Related
Evaluation and Research, Food and Drug Biological Products
Administration, 10903 New Hampshire Ave., Advisory Committee.
Bldg. 71, Rm. 6128, Silver Spring, MD
20993-0002, Phone: 240-402-7107, Email:
Sujata.Vijh@fda.hhs.gov.
------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Cellular, Tissue and Gene Therapies Advisory 1-Voting..................... 3/31/2016.
Committee--Knowledgeable in the fields of
cellular therapies, tissue transplantation, gene
transfer therapies and xenotransplantation
(biostatistics, bioethics, hematology/oncology,
human tissues and transplantation, reproductive
medicine, general medicine and various medical
specialties including surgery and oncology,
immunology, virology, molecular biology, cell
biology, developmental biology, tumor biology,
biochemistry, rDNA technology, nuclear medicine,
gene therapy, infectious diseases, and cellular
kinetics.
Drug Safety and Risk Management Advisory 1-Voting..................... Immediately.
Committee--Knowledgeable in risk communication,
risk management, drug safety, medical,
behavioral, and biological sciences as they apply
to risk management, and drug abuse.
Immunology Devices Panel--Persons with experience 1-Non-Voting................. 2/28/2016.
in medical, surgical, or clinical oncology,
internal medicine, clinical immunology, allergy,
molecular diagnostics, or clinical laboratory
medicine.
Pediatrics Advisory Committee--Knowledgeable in 1-Voting..................... Immediately.
pediatric research, pediatric subspecialties,
statistics, and/or biomedical ethics. The core of
voting members shall also include one
representative from a pediatric health
organization and one representative from a
relevant patient or patient-family organization
and may include one technically qualified member,
selected by the Commissioner or designee, who is
identified with consumer interests and is
recommended by either a consortium of consumer-
oriented organizations or other interested
persons. In addition to the voting members, the
Committee may include one non-voting member who
is identified with industry interests.
Science Advisory Board to the NCTR--Knowledgeable 1-Voting..................... Immediately.
in the fields related to toxicological research.
Transmissible Spongiform Encephalopathies Advisory 1-Voting..................... Immediately.
Committee--Knowledgeable in the fields of
clinical and administrative medicine, hematology,
virology, neurovirology, neurology, infectious
diseases, immunology, transfusion medicine,
surgery, internal medicine, biochemistry,
biostatistics, epidemiology, biological and
physical sciences, sociology/ethics, and other
related professions.
Vaccines and Related Biological Products Advisory 1-Voting..................... Immediately.
Committee--Knowledgeable in the fields of
immunology, molecular biology, rDNA, virology,
bacteriology, epidemiology or biostatistics,
allergy, preventive medicine, infectious
diseases, pediatrics, microbiology, and
biochemistry.
----------------------------------------------------------------------------------------------------------------
II. Functions and General Description of the Committee Duties
A. Cellular, Tissue, and Gene Therapies Advisory Committee
Reviews and evaluates available data relating to the safety,
effectiveness, and appropriate use of human cells, human tissues, gene
transfer therapies and xenotransplantation products which are intended
for transplantation, implantation, infusion and transfer in the
prevention and treatment of a broad spectrum of human diseases and in
the reconstruction, repair or replacement of tissues for various
conditions, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.
B. Drug Safety and Risk Management Advisory Committee
Risk management, risk communication, and quantitative evaluation of
spontaneous reports for drugs for human use and for any other product
for which the FDA has regulatory responsibility. Scientific and medical
evaluation of all information gathered by the Department of Health and
Human Service (DHHS) and the Department of Justice with regard to
safety, efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by DHHS with regard to the marketing,
investigation, and control of such drugs or other substances.
C. Certain Panels of the Medical Devices Advisory Committee
The committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (the act) envisions for device advisory panels. With the
exception of the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, advises
[[Page 7805]]
the Commissioner of Food and Drugs (the Commissioner) regarding
recommended classification or reclassification of devices into one of
three regulatory categories, advises on any possible risks to health
associated with the use of devices, advises on formulation of product
development protocols, reviews premarket approval applications for
medical devices, reviews guidelines and guidance documents, recommends
exemption of certain devices from the application of portions of the
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.
D. Pediatrics Advisory Committee
The Committee advises and makes recommendations to the Commissioner
of Food and Drugs regarding: (1) Pediatric research; (2) identification
of research priorities related to pediatric therapeutics and the need
for additional treatments of specific pediatric diseases or conditions;
(3) the ethics, design, and analysis of clinical trials related to
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric
labeling changes; (6) adverse event reports for drugs granted pediatric
exclusivity and any safety issues that may occur; (7) any other
pediatric issue or pediatric labeling dispute involving FDA regulated
products; (8) research involving children as subjects; and (9) any
other matter involving pediatrics for which FDA has regulatory
responsibility. The Committee also advises and makes recommendations to
the Secretary directly or to the Secretary through the Commissioner on
research involving children as subjects that is conducted or supported
by DHHS.
E. 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.
F. Transmissible Spongiform Encephalopathies Advisory Committee
Reviews and evaluates available scientific data concerning the
safety of products which may be at risk for transmission of spongiform
encephalopathies having an impact on the public health, as well as
considers the quality and relevance of FDA's research program which
provides scientific support for the regulation of these products.
G. 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.
III. 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.
IV. 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.
V. 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 r[eacute]sum[eacute] 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.
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
[[Page 7806]]
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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03010 Filed 2-12-16; 8:45 am]
BILLING CODE 4164-01-P
