Request for Nominations for Voting Members on Public Advisory Committees, 13500-13501 [E7-5193]
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13500
Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices
TABLE 1. —ESTIMATED ANNUAL REPORTING BURDEN1
170.39
1 There
Annual
Frequencyper
Response
No. of
Respondents
21 CFR Section
Total Annual
Responses
15
1
Hours per
Response
15
Total Hours
48
720
are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA
consulted its records of the number of
regulation exemption requests received
in the past 3 years. The annual hours
per response reporting estimate is based
on information received from
representatives of the food packaging
and processing industries and agency
records.
FDA estimates that approximately 15
requests per year will be submitted
under the threshold of regulation
exemption process of § 170.39. The
threshold of regulation process offers
one advantage over the premarket
notification process for food-contact
substances established by section 409(h)
of the act (OMB control number 0910–
0495) in that the use of a substance
exempted by the agency is not limited
to only the manufacturer or supplier
who submitted the request for an
exemption. Other manufacturers or
suppliers may use exempted substances
in food-contact articles as long as the
conditions of use (e.g., use levels,
temperature, type of food contacted,
etc.) are those for which the exemption
was issued. As a result, the overall
burden on both the agency and the
regulated industry would be
significantly less in that other
manufacturers and suppliers would not
have to prepare, and FDA would not
have to review, similar submissions for
identical components of food-contact
articles used under identical conditions.
Manufacturers and other interested
persons can easily access an up-to-date
list of exempted substances which is on
display at FDA’s Division of Dockets
Management and on the Web site at
https://www.cfsan.fda.gov. Having the
list of exempted substances publicly
available decreases the likelihood that a
company would submit a food additive
petition or a notification for the same
type of food-contact application of a
substance for which the agency has
previously granted an exemption from
the food additive listing regulation
requirement.
Dated: March 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–5196 Filed 3–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Members on Public Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Allergenic Products
Advisory Committee, Blood Products
Advisory Committee, Cellular, Tissue
and Gene Therapies Advisory
Committee, Transmissible Spongiform
Encephalopathies Advisory Committee,
and the Vaccines and Related Biological
Products Advisory Committee in the
Center for Biologics Evaluation and
Research (CBER). Nominations will be
accepted for vacancies that will or may
occur through January 31, 2008.
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees, and therefore, encourages
nominations of qualified candidates
from these groups.
Because scheduled vacancies
occur on various dates throughout each
year, no cutoff date is established for the
receipt of nominations. However, when
possible, nominations should be
received 6 months before the date of
scheduled vacancies for each year, as
indicated in this notice.
DATES:
All nominations and
curricula vitae should be sent to the
contact person listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Donald Jehn, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research
(HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448, 301–827–
0314, e-mail: donald.jehn@fda.hhs.gov.
FDA is
requesting nominations of voting
members with appropriate expertise for
vacancies listed below:
SUPPLEMENTARY INFORMATION:
TABLE 1.
No. of
Vacancies
Advisory Committee and Expertise Needed to Fill Vacancies
Allergenic Products Advisory Committee—allergy, immunology, pediatrics, internal medicine, biochemistry, statistics, and related scientific fields
2
2
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As soon as possible
August 31, 2007
2
Blood Products Advisory Committee—clinical and administrative medicine, hematology, immunology,
blood banking, surgery, internal medicine, biochemistry, engineering, statistics, biological and physical sciences, biotechnology, computer technology, epidemiology, consumer advocacy, sociology/ethics, clinical trials, behavioral science, risk communication and other related professions
VerDate Aug<31>2005
Approximate Date
Members are Needed
September 30, 2007
13501
Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices
TABLE 1.—Continued
No. of
Vacancies
Advisory Committee and Expertise Needed to Fill Vacancies
Cellular, Tissue, and Gene Therapies Advisory Committee—cellular therapies, tissue transplantation,
gene transfer therapies and xenotransplantation including biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology,
developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics
1
A. Allergenic Products Advisory
Committee
The 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
diseases.
B. Blood Products Advisory Committee
The committee reviews and evaluates
available data concerning the safety,
effectiveness, and appropriate use of
blood and products derived from blood
and serum or biotechnology which are
intended for use in the diagnosis,
prevention, or treatment of human
diseases.
rwilkins on PROD1PC63 with NOTICES
C. Cellular, Tissue and Gene Therapies
Advisory Committee
The committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies and
xenotransplantation products which are
intended for transplantation,
implantation, infusion and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in
reconstruction, repair, or replacement of
tissues for various conditions.
D. Transmissible Spongiform
Encephalopathies Advisory Committee
The committee reviews and evaluates
available scientific data concerning the
safety of products which may be at risk
for transmission of spongiform
encephalopathies having an impact on
the public health.
VerDate Aug<31>2005
16:11 Mar 21, 2007
Jkt 211001
E. Vaccines and Related Biological
Products Advisory Committee
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.
II. Qualifications
Persons nominated for membership
on the committees shall have adequately
diversified experience appropriate to
the work of the committee in such fields
as clinical and administrative medicine,
engineering, biological and physical
sciences, statistics, and other related
professions. The nature of specialized
training and experience necessary to
qualify the nominee as an expert
suitable for appointment may include
experience in medical practice,
teaching, and/or research relevant to the
field of activity of the committee. The
particular need for vacancies on each
committee through January 31, 2008, is
shown in Table 1 of this document. The
term of office is up to 4 years,
depending on the appointment date.
III. Nomination Procedures
Any interested person may nominate
one or more qualified persons for
membership on one or more of the
advisory committees. Self-nominations
are also accepted. Nominations shall
include the name of the committee, a
complete curriculum vitae of each
nominee, current business address and
telephone number, and shall state that
the nominee is aware of the nomination,
is willing to serve as a member (name
of committee(s) must be specified), and
appears to have no conflict of interest
that would preclude membership. FDA
PO 00000
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As soon as possible
January 31, 2008
3
5
Vaccines and Related Biological Products Advisory Committee—immunology, molecular biology, rDNA,
virology, bacteriology, epidemiology, biostatistics, allergy, preventive medicine, infectious diseases,
pediatrics, microbiology, biochemistry, and other related scientific fields
March 31, 2007
4
3
Transmissible Spongiform Encephalopathies Advisory Committee—clinical and administrative medicine,
hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical
sciences, consumer advocacy, sociology/ethics, and other related professions
I. Functions
Approximate Date
Members are Needed
As soon as possible
January 31, 2008
will ask the 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 conflict of interest.
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: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy.
[FR Doc. E7–5193 Filed 3–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 1, 2007, from 8 a.m. to 5:30
p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD.
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]]>Agencies
[Federal Register Volume 72, Number 55 (Thursday, March 22, 2007)]
[Notices]
[Pages 13500-13501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting Members on Public Advisory
Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Allergenic Products
Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue
and Gene Therapies Advisory Committee, Transmissible Spongiform
Encephalopathies Advisory Committee, and the Vaccines and Related
Biological Products Advisory Committee in the Center for Biologics
Evaluation and Research (CBER). Nominations will be accepted for
vacancies that will or may occur through January 31, 2008.
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees, and therefore, encourages nominations of qualified
candidates from these groups.
DATES: Because scheduled vacancies occur on various dates throughout
each year, no cutoff date is established for the receipt of
nominations. However, when possible, nominations should be received 6
months before the date of scheduled vacancies for each year, as
indicated in this notice.
ADDRESSES: All nominations and curricula vitae should be sent to the
contact person listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
FOR FURTHER INFORMATION CONTACT: Donald Jehn, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research
(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448, 301-827-0314, e-mail: donald.jehn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members with appropriate expertise for vacancies listed below:
Table 1.
------------------------------------------------------------------------
Advisory Committee and Expertise No. of Approximate Date
Needed to Fill Vacancies Vacancies Members are Needed
------------------------------------------------------------------------
Allergenic Products Advisory 2 As soon as possible
Committee--allergy, immunology,
pediatrics, internal medicine,
biochemistry, statistics, and
related scientific fields
2 August 31, 2007
------------------------------------------------------------------------
Blood Products Advisory Committee-- 2 September 30, 2007
clinical and administrative
medicine, hematology, immunology,
blood banking, surgery, internal
medicine, biochemistry, engineering,
statistics, biological and physical
sciences, biotechnology, computer
technology, epidemiology, consumer
advocacy, sociology/ethics, clinical
trials, behavioral science, risk
communication and other related
professions
------------------------------------------------------------------------
[[Page 13501]]
Cellular, Tissue, and Gene Therapies 1 March 31, 2007
Advisory Committee--cellular
therapies, tissue transplantation,
gene transfer therapies and
xenotransplantation including
biostatistics, bioethics, hematology/
oncology, human tissues and
transplantation, reproductive
medicine, general medicine and
various medical specialties
including surgery and oncology,
immunology, virology, molecular
biology, cell biology, developmental
biology, tumor biology,
biochemistry, rDNA technology,
nuclear medicine, gene therapy,
infectious diseases, and cellular
kinetics
------------------------------------------------------------------------
Transmissible Spongiform 4 As soon as possible
Encephalopathies Advisory Committee--
clinical and administrative
medicine, hematology, virology,
neurovirology, neurology, infectious
diseases, immunology, transfusion
medicine, surgery, internal
medicine, biochemistry,
biostatistics, epidemiology,
biological and physical sciences,
consumer advocacy, sociology/ethics,
and other related professions
3 January 31, 2008
------------------------------------------------------------------------
Vaccines and Related Biological 3 As soon as possible
Products Advisory Committee--
immunology, molecular biology, rDNA,
virology, bacteriology,
epidemiology, biostatistics,
allergy, preventive medicine,
infectious diseases, pediatrics,
microbiology, biochemistry, and
other related scientific fields
5 January 31, 2008
------------------------------------------------------------------------
I. Functions
A. Allergenic Products Advisory Committee
The 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 diseases.
B. Blood Products Advisory Committee
The committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood and products
derived from blood and serum or biotechnology which are intended for
use in the diagnosis, prevention, or treatment of human diseases.
C. Cellular, Tissue and Gene Therapies Advisory Committee
The committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies and xenotransplantation products which
are intended for transplantation, implantation, infusion and transfer
in the prevention and treatment of a broad spectrum of human diseases
and in reconstruction, repair, or replacement of tissues for various
conditions.
D. Transmissible Spongiform Encephalopathies Advisory Committee
The committee reviews and evaluates available scientific data
concerning the safety of products which may be at risk for transmission
of spongiform encephalopathies having an impact on the public health.
E. Vaccines and Related Biological Products Advisory Committee
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.
II. Qualifications
Persons nominated for membership on the committees shall have
adequately diversified experience appropriate to the work of the
committee in such fields as clinical and administrative medicine,
engineering, biological and physical sciences, statistics, and other
related professions. The nature of specialized training and experience
necessary to qualify the nominee as an expert suitable for appointment
may include experience in medical practice, teaching, and/or research
relevant to the field of activity of the committee. The particular need
for vacancies on each committee through January 31, 2008, is shown in
Table 1 of this document. The term of office is up to 4 years,
depending on the appointment date.
III. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory committees. Self-
nominations are also accepted. Nominations shall include the name of
the committee, a complete curriculum vitae of each nominee, current
business address and telephone number, and shall state that the nominee
is aware of the nomination, is willing to serve as a member (name of
committee(s) must be specified), and appears to have no conflict of
interest that would preclude membership. FDA will ask the 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 conflict of interest.
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: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy.
[FR Doc. E7-5193 Filed 3-21-07; 8:45 am]
BILLING CODE 4160-01-S
