Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 18235-18238 [2015-07605]
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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
trading in a range from 0 to 1⁄4 percent.
The Committee directs the Desk to
undertake open market operations as
necessary to maintain such conditions.
The Committee directs the Desk to
maintain its policy of rolling over
maturing Treasury securities into new
issues and its policy of reinvesting
principal payments on all agency debt
and agency mortgage-backed securities
in agency mortgage-backed securities.
The Committee also directs the Desk to
engage in dollar roll and coupon swap
transactions as necessary to facilitate
settlement of the Federal Reserve’s
agency mortgage-backed securities
transactions. The System Open Market
Account manager and the secretary will
keep the Committee informed of
ongoing developments regarding the
System’s balance sheet that could affect
the attainment over time of the
Committee’s objectives of maximum
employment and price stability.
By order of the Federal Open Market
Committee, March 24, 2015.
Thomas Laubach,
Secretary, Federal Open Market Committee.
[FR Doc. 2015–07708 Filed 4–2–15; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
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Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than April 30, 2015.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Foresight Financial Group, Inc.,
Rockford, Illinois; to acquire 100
percent of the voting shares of State
Bank of Herscher, Herscher, Illinois.
18235
information collection and has assigned
OMB control number 0910–0783. The
approval expires on March 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07655 Filed 4–2–15; 8:45 am]
BILLING CODE 4164–01–P
Board of Governors of the Federal Reserve
System, March 31, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–07663 Filed 4–2–15; 8:45 am]
Food and Drug Administration
BILLING CODE 6210–01–P
[Docket No. FDA–2015–N–0001]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
Food and Drug Administration
AGENCY:
[Docket No. FDA–2011–F–0172]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Food Labeling; Nutrition Labeling of
Standard Menu Items in Restaurants
and Similar Retail Food
Establishments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Food Labeling; Nutrition Labeling of
Standard Menu Items in Restaurants
and Similar Retail Food
Establishments,’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
February 5, 2015, the Agency submitted
a proposed collection of information
entitled ‘‘Food Labeling; Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
SUMMARY:
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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. Nominations will be
accepted for current vacancies and for
those that will or may occur through
September 30, 2015.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to the FDA
(see ADDRESSES) by May 4, 2015, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by May 4, 2015.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should submit your
information electronically to
SUMMARY:
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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
kimberly.hamilton@fda.hhs.gov or by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, or FAX:
301–847–8640.
Consumer Representative
nominations should be submitted
electronically by logging into the FDA
advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, or FAX:
301–847–8640. Additional information
about becoming a member on an FDA
advisory committee can also be obtained
by visiting FDA’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Kimberly Hamilton, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5117, Silver Spring, MD 20993–
0002;. 301–796–8224, email:
kimberly.hamilton@fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the following persons listed in table 1 of
this document:
TABLE 1—ADVISORY COMMITTEE CONTACTS
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; 301–796–9016,
email: Janie.Kim@fda.hhs.gov.
Stephanie Begansky, Center for Drug Evaluation and Research, Division of Advisory Committee and Consultant Management, Office of Executive Programs, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–0002; 301–796–3693, FAX: 301–847–
8533, email: Stephanie.Begansky@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and Radiological Health, Office of Device Evaluation,
10903 New Hampshire Ave., Bldg. 66, Rm. 1544, Silver Spring, MD 20993–0002; 301–796–
3063, FAX: 301–847–8122, email: Jamie.Waterhouse@fda.hhs.gov.
Yvette Waples, Center for Drug Evaluation & Research, Division of Advisory Committee and
Consultant Management, Office of Executive Programs, 10993 New Hampshire Ave., Bldg.
31, Rm. 2510, Silver Spring, MD 20993–0002; 301–796–9034 FAX: 301–847–8533 email:
Yvette.Waples@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Office of Device Evaluation, 10903
New Hampshire Ave., Bldg. 66, Rm. RMG 465 HFZ–410, Silver Spring, MD 20903–0002,
301–796–6875, FAX: 301–847–8120, email: Patricio.Garcia@fda.hhs.gov.
Sara J. Anderson, Center for Devices and Radiological Health, Office of Device Evaluation,
10903 New Hampshire Ave., Bldg. 66, Rm. 1544, Silver Spring, MD 20903–0002; 301–796–
7047, FAX: 301–847–8122, email: Sara.Anderson@fda.hhs.gov.
Shanika Craig, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66 Rm.
1613, Silver Spring, MD 20993–0002; 301–796–6639, FAX: 301–847–8120, email:
Shanika.Craig@fda.hhs.gov.
Lauren Tesh, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 31,
Rm. 2426, Silver Spring, MD 20993–0002; 301–796–2721, email: Lauren.Tesh@fda.hhs.gov.
Donna Mendrick, National Center for Toxicological Research, Bldg. 32, Rm. 2208, 10903 New
Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8892, FAX: 301–847–8600,
email: Donna.Mendrick@fda.hhs.gov.
Sujata Vijh, Center for Biologics Evaluation and Research, Division of Scientific Advisors and
Consultants, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002; 240–402–7107,
FAX: 301–595–1307, email: Sujata.Vijh@fda.hhs.gov.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
Allergenic Products Advisory Committee.
Arthritis Advisory Committee.
Circulatory System Devices Panel, Molecular
and Clinical Genetics Panel.
Dermatologic and Ophthalmic Drugs Advisory
Committee.
General and Plastic Surgery Devices Panel.
Hematology & Pathology Devices Panel,
Orthopaedic and Rehabilitation Devices
Panel, and National Mammography and
Quality Assurance Advisory Committee.
Obstetrics and Gynecology Devices Panel.
Oncologic Drugs Advisory Committee.
Science Advisory Board to National Center for
Toxicological Research (NCTR).
Vaccines and Related Biological Products Advisory Committee.
or nonvoting consumer representatives
for the vacancies listed in Table 2:
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER VACANCY, AND APPROXIMATE DATE NEEDED
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Committee/Panel/Areas of expertise needed
Current and upcoming vacancies
Allergenic Products Advisory Committee: Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties.
Arthritis Drugs Advisory Committee: Knowledgeable in the fields of arthritis, rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties.
Circulatory System Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in
the safety and effectiveness of marked and investigational devices for use in the circulatory and
vascular systems.
Dermatologic & Ophthalmic Drugs Advisory Committee: Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics,
and other related professions.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in the fields of general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic
and endoscopic surgery; biomaterials, lasers, wound healing, and quality of life issues.
One Voting ..............
June 30, 2015.
One Voting ..............
September 30, 2015.
One Non-Voting .......
Immediately.
One Voting ..............
August 31, 2015.
One Non-Voting .......
Immediately.
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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER VACANCY, AND APPROXIMATE DATE NEEDED—Continued
Current and upcoming vacancies
Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in the fields of hematology, hematopathology, coagulation and homeostasis,
hematological oncology, gynecological oncology.
Molecular & Clinical Genetics Panel of the Medical Devices Advisory Committee: Experts in
human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is also interested in considering candidates
with training in inborn errors of metabolism, biochemical and/or molecular genetics, population
genetics, epidemiology and related statistical training. Additionally, individuals with experience
in genetic counseling, medical ethics as well as ancillary fields of study will be considered.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in the fields of perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical
cancer and colposcopy; obstetrics/gynecology devices; gynecology in the older patient; midwifery; labor and delivery nursing.
Oncologic Drugs Advisory Committee: Knowledgeable in the fields of general oncology, pediatric
oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions.
National Mammography Quality Assurance Advisory Committee: Knowledgeable in clinical practice, research specialization, or professional work that has a significant focus on mammography.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee:
Knowledgeable in data concerning the safety and effectiveness of marketed and investigational
orthopaedic and rehabilitation devices.
Science Advisory Board to the NCTR: Knowledgeable in the fields related to toxicological research.
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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Committee/Panel/Areas of expertise needed
One Non-Voting .......
Immediately.
One Non-Voting .......
May 31, 2015.
One Non-Voting .......
Immediately.
One Voting ..............
Immediately.
Two Voting ..............
Immediately.
Two Non-Voting .......
Immediately.
One Voting ..............
June 30, 2015.
One Voting ..............
Immediately.
I. Functions
A. Allergenic Products Advisory
Committee: Reviews and evaluates
available data concerning the safety,
effectiveness, and adequacy of labeling
of marketed and investigational
allergenic biological products or
materials that are administered to
humans for the diagnosis, prevention, or
treatment of allergies and allergic
disease as well as the affirmation or
revocation of biological product
licenses, on the safety, effectiveness,
and labeling of the products, on clinical
and laboratory studies of such products,
on amendments or revisions to
regulations governing the manufacture,
testing and licensing of allergenic
biological products, and on the quality
and relevance of FDA’s research
programs.
B. Arthritis Drugs Advisory
Committee: Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of arthritis, rheumatism, and related
diseases.
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
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functions the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) envisions
for device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, advises
the Commissioner of Food and Drugs
(the Commissioner) regarding
recommended classification or
reclassification of devices into one of
three regulatory categories, advises on
any possible risks to health associated
with the use of devices, advises on
formulation of product development
protocols, reviews premarket approval
applications for medical devices,
reviews guidelines and guidance
documents, recommends exemption of
certain devices from the application of
portions of the FD&C Act, advises on the
necessity to ban a device, and responds
to requests from the Agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
the commissioner on issues relating to
the design of clinical studies regarding
the safety and effectiveness of marketed
and investigational devices.
D. Dermatologic and Ophthalmic
Drugs Advisory Committee: Reviews
and evaluates available data concerning
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needed
the safety and effectiveness of marketed
and investigational human drug
products for use in the treatment of
dermatologic and ophthalmic disorders.
E. National Mammography and
Quality Assurance Advisory Committee:
The committee reviews and evaluates
(1) Developing appropriate quality
standards and regulations for
mammography facilities; (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program; (3)
developing regulations with respect to
sanctions; (4) developing procedures for
monitoring compliance with standards;
(5) establishing a mechanism to
investigate consumer complaints; (6)
reporting new developments concerning
breast imaging which should be
considered in the oversight of
mammography facilities; (7)
determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in such areas; (8)
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999; and (9)
determining the costs and benefits of
compliance with these requirements.
F. Oncologic Drugs Advisory
Committee: Reviews and evaluates data
concerning the safety and effectiveness
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03APN1
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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
of marketed and investigational human
drug products for use in the treatment
of cancer.
G. 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 extraAgency review in ensuring that the
research programs at NCTR are
scientifically sound and pertinent.
H. 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.
II. 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.
asabaliauskas on DSK5VPTVN1PROD 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.
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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.
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 should include a
cover letter and a current curriculum
vitae or resume for each nominee,
including a current business and/or
home address, telephone number, and
email address if available, and a list of
consumer or community-based
organizations for which the candidate
can demonstrate active participation.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Nominations should also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations should include
confirmation that the nominee is aware
of the nomination, unless 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
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
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voting or nonvoting consumer
representatives will not participate in
the selection process.
Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07605 Filed 4–2–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0929]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
E:\FR\FM\03APN1.SGM
03APN1
Agencies
[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18235-18238]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07605]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. Nominations will be accepted for current vacancies and
for those that will or may occur through September 30, 2015.
DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to the FDA (see ADDRESSES) by May
4, 2015, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by May 4, 2015.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should submit your information
electronically to
[[Page 18236]]
kimberly.hamilton@fda.hhs.gov or by mail to Advisory Committee
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm.
5103, Silver Spring, MD 20993-0002, or FAX: 301-847-8640.
Consumer Representative nominations should be submitted
electronically by logging into the FDA advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, or FAX: 301-847-8640. Additional information
about becoming a member on an FDA advisory committee can also be
obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Kimberly Hamilton, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, MD 20993-0002;. 301-
796-8224, email: kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the following persons listed in table 1 of this document:
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/Panel
------------------------------------------------------------------------
Janie Kim, Center for Biologics Evaluation Allergenic Products
and Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 71, Rm.
6129, Silver Spring, MD 20993; 301-796-9016,
email: Janie.Kim@fda.hhs.gov.
Stephanie Begansky, Center for Drug Arthritis Advisory
Evaluation and Research, Division of Committee.
Advisory Committee and Consultant
Management, Office of Executive Programs,
10903 New Hampshire Ave., Bldg. 31, Rm.
2426, Silver Spring, MD 20993-0002; 301-796-
3693, FAX: 301-847-8533, email:
Stephanie.Begansky@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and Circulatory System
Radiological Health, Office of Device Devices Panel, Molecular
Evaluation, 10903 New Hampshire Ave., Bldg. and Clinical Genetics
66, Rm. 1544, Silver Spring, MD 20993-0002; Panel.
301-796-3063, FAX: 301-847-8122, email:
Jamie.Waterhouse@fda.hhs.gov.
Yvette Waples, Center for Drug Evaluation & Dermatologic and
Research, Division of Advisory Committee and Ophthalmic Drugs
Consultant Management, Office of Executive Advisory Committee.
Programs, 10993 New Hampshire Ave., Bldg.
31, Rm. 2510, Silver Spring, MD 20993-0002;
301-796-9034 FAX: 301-847-8533 email:
Yvette.Waples@fda.hhs.gov.
Patricio Garcia, Center for Devices and General and Plastic
Radiological Health, Office of Device Surgery Devices Panel.
Evaluation, 10903 New Hampshire Ave., Bldg.
66, Rm. RMG 465 HFZ-410, Silver Spring, MD
20903-0002, 301-796-6875, FAX: 301-847-8120,
email: Patricio.Garcia@fda.hhs.gov.
Sara J. Anderson, Center for Devices and Hematology & Pathology
Radiological Health, Office of Device Devices Panel,
Evaluation, 10903 New Hampshire Ave., Bldg. Orthopaedic and
66, Rm. 1544, Silver Spring, MD 20903-0002; Rehabilitation Devices
301-796-7047, FAX: 301-847-8122, email: Panel, and National
Sara.Anderson@fda.hhs.gov. Mammography and Quality
Assurance Advisory
Committee.
Shanika Craig, Food and Drug Administration, Obstetrics and Gynecology
10903 New Hampshire Ave., Bldg. 66 Rm. 1613, Devices Panel.
Silver Spring, MD 20993-0002; 301-796-6639,
FAX: 301-847-8120, email:
Shanika.Craig@fda.hhs.gov.
Lauren Tesh, Center for Drug Evaluation and Oncologic Drugs Advisory
Research, 10903 New Hampshire Ave., Bldg. Committee.
31, Rm. 2426, Silver Spring, MD 20993-0002;
301-796-2721, email: Lauren.Tesh@fda.hhs.gov.
Donna Mendrick, National Center for Science Advisory Board to
Toxicological Research, Bldg. 32, Rm. 2208, National Center for
10903 New Hampshire Ave., Silver Spring, MD Toxicological Research
20993-0002, 301-796-8892, FAX: 301-847-8600, (NCTR).
email: Donna.Mendrick@fda.hhs.gov.
Sujata Vijh, Center for Biologics Evaluation Vaccines and Related
and Research, Division of Scientific Biological Products
Advisors and Consultants, 10903 New Advisory Committee.
Hampshire Ave., Silver Spring, MD 20993-
0002; 240-402-7107, FAX: 301-595-1307,
email: Sujata.Vijh@fda.hhs.gov.
------------------------------------------------------------------------
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 Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/Panel/Areas of expertise
needed Current and upcoming vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenic Products Advisory One Voting......................... June 30, 2015.
Committee: Knowledgeable in the
fields of allergy, immunology,
pediatrics, internal medicine,
biochemistry, and related specialties.
Arthritis Drugs Advisory Committee: One Voting......................... September 30, 2015.
Knowledgeable in the fields of
arthritis, rheumatology, orthopedics,
epidemiology or statistics,
analgesics, and related specialties.
Circulatory System Devices Panel of One Non-Voting..................... Immediately.
the Medical Devices Advisory
Committee: Knowledgeable in the
safety and effectiveness of marked
and investigational devices for use
in the circulatory and vascular
systems.
Dermatologic & Ophthalmic Drugs One Voting......................... August 31, 2015.
Advisory Committee: Knowledgeable in
the fields of dermatology,
ophthalmology, internal medicine,
pathology, immunology, epidemiology
or statistics, and other related
professions.
General and Plastic Surgery Devices One Non-Voting..................... Immediately.
Panel of the Medical Devices Advisory
Committee: Knowledgeable in the
fields of general, plastic,
reconstructive, pediatric, thoracic,
abdominal, pelvic and endoscopic
surgery; biomaterials, lasers, wound
healing, and quality of life issues.
[[Page 18237]]
Hematology and Pathology Devices Panel One Non-Voting..................... Immediately.
of the Medical Devices Advisory
Committee: Knowledgeable in the
fields of hematology,
hematopathology, coagulation and
homeostasis, hematological oncology,
gynecological oncology.
Molecular & Clinical Genetics Panel of One Non-Voting..................... May 31, 2015.
the Medical Devices Advisory
Committee: Experts in human genetics
and in the clinical management of
patients with genetic disorders,
e.g., pediatricians, obstetricians,
neonatologists. The Agency is also
interested in considering candidates
with training in inborn errors of
metabolism, biochemical and/or
molecular genetics, population
genetics, epidemiology and related
statistical training. Additionally,
individuals with experience in
genetic counseling, medical ethics as
well as ancillary fields of study
will be considered.
Obstetrics and Gynecology Devices One Non-Voting..................... Immediately.
Panel of the Medical Devices Advisory
Committee: Knowledgeable in the
fields of perinatology, embryology,
reproductive endocrinology, pediatric
gynecology, gynecological oncology,
operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery,
assisted reproductive technologies,
contraception, postoperative
adhesions, and cervical cancer and
colposcopy; obstetrics/gynecology
devices; gynecology in the older
patient; midwifery; labor and
delivery nursing.
Oncologic Drugs Advisory Committee: One Voting......................... Immediately.
Knowledgeable in the fields of
general oncology, pediatric oncology,
hematologic oncology, immunologic
oncology, biostatistics, and other
related professions.
National Mammography Quality Assurance Two Voting......................... Immediately.
Advisory Committee: Knowledgeable in
clinical practice, research
specialization, or professional work
that has a significant focus on
mammography.
Orthopaedic and Rehabilitation Devices Two Non-Voting..................... Immediately.
Panel of the Medical Devices Advisory
Committee: Knowledgeable in data
concerning the safety and
effectiveness of marketed and
investigational orthopaedic and
rehabilitation devices.
Science Advisory Board to the NCTR: One Voting......................... June 30, 2015.
Knowledgeable in the fields related
to toxicological research.
Vaccines and Related Biological One Voting......................... Immediately.
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.
----------------------------------------------------------------------------------------------------------------
I. Functions
A. Allergenic Products Advisory Committee: Reviews and evaluates
available data concerning the safety, effectiveness, and adequacy of
labeling of marketed and investigational allergenic biological products
or materials that are administered to humans for the diagnosis,
prevention, or treatment of allergies and allergic disease as well as
the affirmation or revocation of biological product licenses, on the
safety, effectiveness, and labeling of the products, on clinical and
laboratory studies of such products, on amendments or revisions to
regulations governing the manufacture, testing and licensing of
allergenic biological products, and on the quality and relevance of
FDA's research programs.
B. Arthritis Drugs Advisory Committee: Reviews and evaluates data
concerning the safety and effectiveness of marketed and investigational
human drug products for use in the treatment of arthritis, rheumatism,
and related diseases.
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
FD&C Act) envisions for device advisory panels. With the exception of
the Medical Devices Dispute Resolution Panel, each panel, according to
its specialty area, advises the Commissioner of Food and Drugs (the
Commissioner) regarding recommended classification or reclassification
of devices into one of three regulatory categories, advises on any
possible risks to health associated with the use of devices, advises on
formulation of product development protocols, reviews premarket
approval applications for medical devices, reviews guidelines and
guidance documents, recommends exemption of certain devices from the
application of portions of the FD&C Act, advises on the necessity to
ban a device, and responds to requests from the Agency to review and
make recommendations on specific issues or problems concerning the
safety and effectiveness of devices. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, may also make appropriate recommendations to the
commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
D. Dermatologic and Ophthalmic Drugs Advisory Committee: Reviews
and evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of dermatologic and ophthalmic disorders.
E. National Mammography and Quality Assurance Advisory Committee:
The committee reviews and evaluates (1) Developing appropriate quality
standards and regulations for mammography facilities; (2) developing
appropriate standards and regulations for bodies accrediting
mammography facilities under this program; (3) developing regulations
with respect to sanctions; (4) developing procedures for monitoring
compliance with standards; (5) establishing a mechanism to investigate
consumer complaints; (6) reporting new developments concerning breast
imaging which should be considered in the oversight of mammography
facilities; (7) determining whether there exists a shortage of
mammography facilities in rural and health professional shortage areas
and determining the effects of personnel on access to the services of
such facilities in such areas; (8) determining whether there will exist
a sufficient number of medical physicists after October 1, 1999; and
(9) determining the costs and benefits of compliance with these
requirements.
F. Oncologic Drugs Advisory Committee: Reviews and evaluates data
concerning the safety and effectiveness
[[Page 18238]]
of marketed and investigational human drug products for use in the
treatment of cancer.
G. 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.
H. 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.
II. 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.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
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.
Nominations should include a cover letter and a current curriculum
vitae or resume for each nominee, including a current business and/or
home address, telephone number, and email address if available, and a
list of consumer or community-based organizations for which the
candidate can demonstrate active participation. FDA seeks to include
the views of women and men, members of all racial and ethnic groups,
and individuals with and without disabilities on its advisory
committees and therefore, encourages nominations of appropriately
qualified candidates from these groups.
Nominations should also specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the
nomination, unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts to permit
evaluation of possible sources of conflicts of interest. Members will
be invited to serve for terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07605 Filed 4-2-15; 8:45 am]
BILLING CODE 4164-01-P