Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels, 12331-12334 [2013-04059]
Download as PDF
Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
SAPIEN TRANSCATHETER HEART
VALVE is 2,473 days. Of this time,
2,106 days occurred during the testing
phase of the regulatory review period,
while 367 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360j(g)) involving this device
became effective: January 26, 2005. The
applicant claims that the investigational
device exemption (IDE) required under
section 520(g) of the FD&C Act for
human tests to begin became effective
on March 24, 2003. However, FDA
records indicate that the IDE was
determined substantially complete for
clinical studies to have begun on
January 26, 2005, which represents the
IDE effective date.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): November 1, 2010.
The applicant claims October 29, 2010,
as the date the premarket approval
application (PMA) for SAPIEN
Transcatheter Heart Valve (PMA
P100041) was initially submitted.
However, FDA records indicate that
PMA P100041 was submitted on
November 1, 2010.
3. The date the application was
approved: November 2, 2011. FDA has
verified the applicant’s claim that PMA
P100041 was approved on November 2,
2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,757 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by April 23, 2013.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 21, 2013. To meet its burden, the
petition must contain sufficient facts to
merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. However, if you submit a
written petition, you must submit three
copies of the petition. Identify
comments with the docket number
found in brackets in the heading of this
document. Comments and petitions that
have not been made publicly available
on https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–04016 Filed 2–21–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Request for Nominations for Voting
and/or Nonvoting Consumer
Representatives on Public Advisory
Committees or Panels and Request for
Notification From Consumer
Organizations Interested in
Participating in the Selection Process
for Nominations for Voting and/or
Nonvoting Consumer Representatives
on Public Advisory Committees or
Panels
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
SUMMARY:
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 either be selfnominated or may be nominated by a
consumer organization. Nominations
will be accepted for current vacancies
and for those that will or may occur
through December 2013.
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 by
March 25, 2013, for vacancies listed in
this notice. Concurrently, nomination
materials for prospective candidates
should be sent to FDA by March 25,
2013.
All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should be sent
electronically to CV@OC.FDA.GOV, by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, rm. 5129,
Silver Spring, MD 20993–0002, or by fax
to 301–847–8640. Information about
becoming a member of an FDA advisory
committee can be obtained by visiting
FDA’s Web site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Dornette Spell-LeSane, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
rm. 5129, Silver Spring, MD 20993–
0002, 301–796–8224,
dornette.spelllesane@fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the appropriate person listed in table 1
in the SUPPLEMENTARY INFORMATION
section of this document.
SUPPLEMENTARY INFORMATION:
For questions relating to specific
advisory committees or panels, contact
the appropriate person listed in table 1
of this document.
ADDRESSES:
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person
Committee/panel
Diane Goyette, Center for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 31, Rm. 2408, Silver Spring, MD 20993–0002, 301–796–9014, FAX:
301–847–8533, Diane.Goyette@fda.hhs.gov.
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Anti-Infective Drugs.
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Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued
Contact person
Committee/panel
Kristina Toliver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 31, Rm. 2408, Silver Spring, MD 20993–0002, 301–796–0063, FAX:
301–847–8533, Kristina.Tolliver@fda.hhs.gov.
Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 31, Rm. 2408, Silver Spring, MD 20993–0002, 301–796–9001 X9021,
FAX: 301–847–8533, Diem.Ngo@fda.hhs.gov.
Glendolynn Johnson, Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, Glendolynn.Johnson@fda.hhs.gov.
Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2528, Silver Spring, MD 20993–0002, 301–796–0889, FAX: 301–
847–8533, Cindy.Hong@fda.hhs.gov.
Karen Strambler, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100
Paint Branch Pkwy., Rm. 1C016, College Park, MD 20740, 240–402–2589, FAX: 301–436–2657.
FoodAdvisoryCommittee@fda.hhs.gov.
Donald Jehn, Center for Biologics Evaluation and Research, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, 301–827–1293, FAX: 301–827–0294, Donald.Jehn@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and Radiological Devices, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993–0002, 301–796–3063,
FAX: 301–847–8116, Jamie.Waterhouse@fda.hhs.gov.
Shanika Craig, Center for Devices and Radiological Devices, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993–0002, 301–796–6639, FAX:
301–847–8121, Shanika.Craig@fda.hhs.gov.
Sara J. Anderson, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg.
66, Rm. 1544, Silver Spring, MD 20903, 301–796–7047, FAX: 301–847–8121,
Sara.Anderson@fda.hhs.gov.
FDA is requesting nominations for
voting and/or nonvoting consumer
Cardiovascular and Renal Drugs.
Endocrinologic and Metabolic Drugs.
Nonprescription Drugs and Peripheral
and Central Nervous System Drugs.
Pulmonary Allergy Drugs.
Food Advisory Committee.
Vaccines and Related Biological Products.
Circulatory System Devices and Ear,
Nose and Throat Devices Panel.
Microbiology Devices Panel.
Orthopaedic and Rehabilitation Devices
Panel.
representatives for the vacancies listed
in table 2 of this document:
TABLE 2—COMMITTEE/PANEL VACANCIES
Current and
upcoming
vacancies
Approximate date
needed
1-Voting ........................
December 1, 2013.
1-Voting ........................
July 1, 2013.
1-Voting ........................
July 1, 2013.
1-Voting ........................
July 1, 2013.
1-Voting ........................
Immediately.
1-Voting ........................
June 1, 2013.
1-Voting ........................
July 1, 2013.
1-Voting ........................
Immediately.
1-Nonvoting ..................
July 1, 2013.
1-Nonvoting ..................
Immediately.
1-Nonvoting ..................
Immediately.
sroberts on DSK5SPTVN1PROD with NOTICES
Committee/panel/areas of expertise needed
Anti-Infective Drugs ...........................................................................................................................
Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics,
epidemiology or statistics, and related specialties
Cardiovascular and Renal Drugs ......................................................................................................
Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive
heart failure, diuresis, and biostatistics.
Endocrinologic and Metabolic Drugs .................................................................................................
Reviews and evaluates data concerning the safety and efficacy of marketed and investigational human drugs products for use in the treatment of endocrine and metabolic disorders.
Nonprescription Drugs .......................................................................................................................
Knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical
pharmacology, pharmacy, dentistry, and related specialties.
Peripheral and Central Nervous System Drugs ................................................................................
Knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties
Pulmonary Allergy Drugs ...................................................................................................................
Knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics
Food Committee ................................................................................................................................
Knowledgeable in the areas of food technology, pediatric development, nutrition, food microbiology and toxicology
Vaccines and Related Biological Products .......................................................................................
Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology,
epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics,
microbiology, and biochemistry
Circulatory System Devices Panel ....................................................................................................
Knowledgeable in the safety and effectiveness of marked and investigational devices for use
in the circulatory and vascular systems.
Ear, Nose, and Throat Devices Panel ..............................................................................................
Knowledgeable in the safety and effectiveness of marketed and investigational ear, nose
and throat devices
Microbiology Devices Panel ..............................................................................................................
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Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
TABLE 2—COMMITTEE/PANEL VACANCIES—Continued
Current and
upcoming
vacancies
Committee/panel/areas of expertise needed
Knowledgeable in data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including microbiology, virology, and infectious disease and makes appropriate recommendations
Orthopaedic and Rehabilitation Devices Panel .................................................................................
1-Nonvoting ..................
Approximate date
needed
September 1,
2013.
Knowledgeable in data concerning the safety and effectiveness of marketed and investigational orthopaedic and rehabilitation devices
I. Functions
A. Anti-Infective Drugs
The 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 and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
B. Cardiovascular and Renal Drugs
The 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 and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
sroberts on DSK5SPTVN1PROD with NOTICES
B. Endocrinologic and Metabolic Drugs
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of endocrine and
metabolic disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
C. Nonprescription Drugs
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of over-the-counter
(nonprescription) human drug products,
or any other FDA-regulated product, for
use in the treatment of a broad spectrum
of human symptoms and diseases and
advises the Commissioner of Food and
Drugs either on the issuance of
monographs establishing conditions
under which these drugs are generally
recognized as safe and effective and not
misbranded or on the approval of new
drug applications for such drugs. The
Committee will serve as a forum for the
exchange of views regarding the
prescription and nonprescription status,
including switches from one status to
another, of these various drug products
and combinations thereof. The
Committee may also conduct peer
review of Agency sponsored intramural
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and extramural scientific biomedical
programs in support of FDA’s mission
and regulatory responsibilities.
D. Peripheral and Central Nervous
system Drugs
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of neurologic
diseases and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
E. Pulmonary Allergy Drugs
The 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 and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
F. Food Advisory Committee
The Committee provides advice to the
Commissioner of Food and Drugs and
other appropriate officials, on emerging
food safety, food science, nutrition, and
other food-related health issues that
FDA considers of primary importance
for its food and cosmetics programs. The
Committee may be charged with
reviewing and evaluating available data
and making recommendations on
matters such as those relating to: (1)
Broad scientific and technical food or
cosmetic related issues, (2) the safety of
new foods and food ingredients, (3)
labeling of foods and cosmetics, (4)
nutrient needs and nutritional
adequacy, and (5) safe exposure limits
for food contaminants. The Committee
may also be asked to provide advice and
make recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
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G. Vaccines and Related Biologic
Products
The 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, and, as required, any
other products for which FDA has
regulatory responsibility. The
Committee also considers the quality
and relevance of FDA’s research
program which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
H. 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. 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
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Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
the safety and effectiveness of marketed
and investigational devices.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on the
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.
sroberts on DSK5SPTVN1PROD with NOTICES
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
three to five 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.
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. Potential candidates will be
required to provide detailed information
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16:18 Feb 21, 2013
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concerning such matters as financial
holdings, employment, and research
grants and/or contracts to permit
evaluation of possible sources of
conflicts of interest.
All nominations should include: a
cover letter; a curriculum vitae or
resume that includes the nominee’s
office address, telephone number, and
email address; and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Nominations also should 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 and is willing to serve
as a member of the advisory committee
or panel if selected.
The term of office is 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.
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.
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 15, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04059 Filed 2–21–13; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request: Federal Interagency
Traumatic Brain Injury Research
(FITBIR) Informatics System Data
Access Request
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Neurological
Disorders and Stroke (NINDS), the
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
The quality, utility, and clarity of the
information to be collected; and (4)
Minimize the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project, obtain a copy of the
data collection plans and instruments,
or to submit written comments, contact
Rebecca L. Frederick, Office of Science
Policy and Planning, OSPP, NINDS,
NIH, 31 Center Drive, Building 31,
Room 8A03, Bethesda, MD 20892; call
301–496–9271; or Email:
rebecca.frederick@nih.gov.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Proposed Collection: Federal
Interagency Traumatic Brain Injury
Research (FITBIR) Informatics System
Data Access Request.
Need and Use of Information
Collection: The FITBIR Informatics
System Data Access Request form is
necessary for ‘‘Recipient’’ Principal
SUMMARY:
E:\FR\FM\22FEN1.SGM
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Agencies
[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12331-12334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Request for Nominations for Voting and/or Nonvoting Consumer
Representatives on Public Advisory Committees or Panels and Request for
Notification From Consumer Organizations Interested in Participating in
the Selection Process for Nominations for Voting and/or Nonvoting
Consumer Representatives on Public Advisory Committees or Panels
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 either be self-nominated or may be nominated by a
consumer organization. Nominations will be accepted for current
vacancies and for those that will or may occur through December 2013.
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 by March 25, 2013, for
vacancies listed in this notice. Concurrently, nomination materials for
prospective candidates should be sent to FDA by March 25, 2013.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be sent electronically to
CV@OC.FDA.GOV, by mail to Advisory Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD
20993-0002, or by fax to 301-847-8640. Information about becoming a
member of an FDA advisory committee can be obtained by visiting FDA's
Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-
0002, 301-796-8224, dornette.spelllesane@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the appropriate person listed in table 1 in the SUPPLEMENTARY
INFORMATION section of this document.
SUPPLEMENTARY INFORMATION:
For questions relating to specific advisory committees or panels,
contact the appropriate person listed in table 1 of this document.
Table 1--Advisory Committee Contacts
----------------------------------------------------------------------------------------------------------------
Contact person Committee/panel
----------------------------------------------------------------------------------------------------------------
Diane Goyette, Center for Drug Evaluation and Anti-Infective Drugs.
Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2408, Silver
Spring, MD 20993-0002, 301-796-9014, FAX: 301-847-
8533, Diane.Goyette@fda.hhs.gov.
[[Page 12332]]
Kristina Toliver, Center for Drug Evaluation and Cardiovascular and Renal Drugs.
Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2408, Silver
Spring, MD 20993-0002, 301-796-0063, FAX: 301-847-
8533, Kristina.Tolliver@fda.hhs.gov.
Diem-Kieu Ngo, Center for Drug Evaluation and Endocrinologic and Metabolic Drugs.
Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2408, Silver
Spring, MD 20993-0002, 301-796-9001 X9021, FAX:
301-847-8533, Diem.Ngo@fda.hhs.gov.
Glendolynn Johnson, Center for Drug Evaluation and Nonprescription Drugs and Peripheral and Central Nervous
Research, Food and Drug Administration, 10903 New System Drugs.
Hampshire Ave., Bldg. 31, Rm. 2434, Silver
Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, Glendolynn.Johnson@fda.hhs.gov.
Cindy Hong, Center for Drug Evaluation and Pulmonary Allergy Drugs.
Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2528, Silver
Spring, MD 20993-0002, 301-796-0889, FAX: 301-847-
8533, Cindy.Hong@fda.hhs.gov.
Karen Strambler, Center for Food Safety and Food Advisory Committee.
Applied Nutrition, Food and Drug Administration,
5100 Paint Branch Pkwy., Rm. 1C016, College Park,
MD 20740, 240-402-2589, FAX: 301-436-2657.
FoodAdvisoryCommittee@fda.hhs.gov.
Donald Jehn, Center for Biologics Evaluation and Vaccines and Related Biological Products.
Research, 1401 Rockville Pike (HFM-71),
Rockville, MD 20852, 301-827-1293, FAX: 301-827-
0294, Donald.Jehn@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and Circulatory System Devices and Ear, Nose and Throat Devices
Radiological Devices, Food and Drug Panel.
Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1611, Silver Spring, MD 20993-0002, 301-
796-3063, FAX: 301-847-8116,
Jamie.Waterhouse@fda.hhs.gov.
Shanika Craig, Center for Devices and Radiological Microbiology Devices Panel.
Devices, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1613, Silver
Spring, MD 20993-0002, 301-796-6639, FAX: 301-847-
8121, Shanika.Craig@fda.hhs.gov.
Sara J. Anderson, Center for Devices and Orthopaedic and Rehabilitation Devices Panel.
Radiological Health, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 1544, Silver Spring, MD 20903, 301-
796-7047, FAX: 301-847-8121,
Sara.Anderson@fda.hhs.gov.
----------------------------------------------------------------------------------------------------------------
FDA is requesting nominations for voting and/or nonvoting consumer
representatives for the vacancies listed in table 2 of this document:
Table 2--Committee/Panel Vacancies
----------------------------------------------------------------------------------------------------------------
Current and upcoming
Committee/panel/areas of expertise needed vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
Anti-Infective Drugs.............................. 1-Voting................. December 1, 2013.
Knowledgeable in the fields of infectious
disease, internal medicine, microbiology,
pediatrics, epidemiology or statistics, and
related specialties
Cardiovascular and Renal Drugs.................... 1-Voting................. July 1, 2013.
Knowledgeable in the fields of cardiology,
hypertension, arrhythmia, angina, congestive
heart failure, diuresis, and biostatistics.
Endocrinologic and Metabolic Drugs................ 1-Voting................. July 1, 2013.
Reviews and evaluates data concerning the
safety and efficacy of marketed and
investigational human drugs products for use
in the treatment of endocrine and metabolic
disorders.
Nonprescription Drugs............................. 1-Voting................. July 1, 2013.
Knowledgeable in the fields of internal
medicine, family practice, clinical
toxicology, clinical pharmacology, pharmacy,
dentistry, and related specialties.
Peripheral and Central Nervous System Drugs....... 1-Voting................. Immediately.
Knowledgeable in the fields of neurology,
neuropharmacology, neuropathology,
otolaryngology, epidemiology or statistics,
and related specialties
Pulmonary Allergy Drugs........................... 1-Voting................. June 1, 2013.
Knowledgeable in the fields of pulmonary
medicine, allergy, clinical immunology, and
epidemiology or statistics
Food Committee.................................... 1-Voting................. July 1, 2013.
Knowledgeable in the areas of food technology,
pediatric development, nutrition, food
microbiology and toxicology
Vaccines and Related Biological Products.......... 1-Voting................. Immediately.
Knowledgeable in the fields of immunology,
molecular biology, rDNA, virology,
bacteriology, epidemiology or biostatistics,
allergy, preventive medicine, infectious
diseases, pediatrics, microbiology, and
biochemistry
Circulatory System Devices Panel.................. 1-Nonvoting.............. July 1, 2013.
Knowledgeable in the safety and effectiveness
of marked and investigational devices for use
in the circulatory and vascular systems.
Ear, Nose, and Throat Devices Panel............... 1-Nonvoting.............. Immediately.
Knowledgeable in the safety and effectiveness
of marketed and investigational ear, nose and
throat devices
Microbiology Devices Panel........................ 1-Nonvoting.............. Immediately.
[[Page 12333]]
Knowledgeable in data concerning the safety
and effectiveness of marketed and
investigational in vitro devices for use in
clinical laboratory medicine including
microbiology, virology, and infectious
disease and makes appropriate recommendations
Orthopaedic and Rehabilitation Devices Panel...... 1-Nonvoting.............. September 1, 2013.
Knowledgeable in data concerning the safety
and effectiveness of marketed and
investigational orthopaedic and
rehabilitation devices
----------------------------------------------------------------------------------------------------------------
I. Functions
A. Anti-Infective Drugs
The 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
and makes appropriate recommendations to the Commissioner of Food and
Drugs.
B. Cardiovascular and Renal Drugs
The 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
and makes appropriate recommendations to the Commissioner of Food and
Drugs.
B. Endocrinologic and Metabolic Drugs
The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of endocrine and metabolic disorders and makes
appropriate recommendations to the Commissioner of Food and Drugs.
C. Nonprescription Drugs
The Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products, or any other FDA-regulated product, for use in the
treatment of a broad spectrum of human symptoms and diseases and
advises the Commissioner of Food and Drugs either on the issuance of
monographs establishing conditions under which these drugs are
generally recognized as safe and effective and not misbranded or on the
approval of new drug applications for such drugs. The Committee will
serve as a forum for the exchange of views regarding the prescription
and nonprescription status, including switches from one status to
another, of these various drug products and combinations thereof. The
Committee may also conduct peer review of Agency sponsored intramural
and extramural scientific biomedical programs in support of FDA's
mission and regulatory responsibilities.
D. Peripheral and Central Nervous system Drugs
The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases and makes appropriate
recommendations to the Commissioner of Food and Drugs.
E. Pulmonary Allergy Drugs
The 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 and makes appropriate
recommendations to the Commissioner of Food and Drugs.
F. Food Advisory Committee
The Committee provides advice to the Commissioner of Food and Drugs
and other appropriate officials, on emerging food safety, food science,
nutrition, and other food-related health issues that FDA considers of
primary importance for its food and cosmetics programs. The Committee
may be charged with reviewing and evaluating available data and making
recommendations on matters such as those relating to: (1) Broad
scientific and technical food or cosmetic related issues, (2) the
safety of new foods and food ingredients, (3) labeling of foods and
cosmetics, (4) nutrient needs and nutritional adequacy, and (5) safe
exposure limits for food contaminants. The Committee may also be asked
to provide advice and make recommendations on ways of communicating to
the public the potential risks associated with these issues and on
approaches that might be considered for addressing the issues.
G. Vaccines and Related Biologic Products
The 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, and, as required, any other products for
which FDA has regulatory responsibility. The Committee also considers
the quality and relevance of FDA's research program which provides
scientific support for the regulation of these products and makes
appropriate recommendations to the Commissioner of Food and Drugs.
H. 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. 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
[[Page 12334]]
the safety and effectiveness of marketed and investigational devices.
II. Criteria for Members
Persons nominated for membership as consumer representatives on the
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.
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 three to five
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.
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.
Potential candidates will be required 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.
All nominations should include: a cover letter; a curriculum vitae
or resume that includes the nominee's office address, telephone number,
and email address; and a list of consumer or community-based
organizations for which the candidate can demonstrate active
participation.
Nominations also should 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
and is willing to serve as a member of the advisory committee or panel
if selected.
The term of office is 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.
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.
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 15, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04059 Filed 2-21-13; 8:45 am]
BILLING CODE 4160-01-P