Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees, 48427 [05-16330]
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Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Notices
provide for the safe use of Color Index
(C.I.) Pigment Violet 19, C.I. Pigment
Yellow 154, and C.I. Pigment Red 122
as color additives in contact lenses.
FOR FURTHER INFORMATION CONTACT:
Regarding CAPs 5C0278 and 5C0280:
Celeste Johnston, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–
3835, 301–436–1282.
Regarding CAP 5C0279: Harold
Woodall, Center for Food Safety
and Applied Nutrition (HFS–206),
Food and Drug Administration,
5100 Paint Branch Pkwy., College
Park, MD 20740–3835, 301–436–
1259.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 721(d)(1) (21 U.S.C. 379e(d)(1))),
notice is given that three color additive
petitions (CAP 5C0278, Docket No.
2005C–0302; CAP 5C0279, Docket No.
2005C–0303; CAP 5C0280, Docket No.
2005C–0304) have been filed by CIBA
Vision Corp., 11460 Johns Creek Pkwy.,
Duluth, GA 30097–1556. The petitions
propose to amend the color additive
regulations in 21 CFR part 73 to provide
for the safe use of C.I. Pigment Violet 19
(CAP 5C0278), C.I. Pigment Yellow 154
(CAP 5C0279), and C.I. Pigment Red 122
(CAP 5C0280), as color additives in
contact lenses.
The agency has determined under 21
CFR 25.32(l) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
Dated: July 22, 2005.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. 05–16332 Filed 8–16–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Consumer Representative 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 consumer
representatives to serve on the National
VerDate jul<14>2003
13:34 Aug 16, 2005
Jkt 205001
Mammography Quality Assurance
Advisory Committee (NMQAAC) in the
Center for Devices and Radiological
Health (CDRH). 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: Nominations will be accepted
through January 31, 2006.
ADDRESSES: All nominations should be
sent to the contact person listed in the
FOR FURTHER INFORMATION CONTACT
section of this document.
FOR FURTHER INFORMATION CONTACT:
Michael Ortwerth, Advisory Committee
Oversight and Management Staff (HF–
4), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, email: Michael.Ortwerth@fda.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
consumer representatives to serve on
the NMQAAC.
I. Functions of NMQAAC
The functions of the committee are to
advise FDA on the following topics: (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.
II. Criteria for Members
Persons nominated for membership
on the committee as a consumer
representative must meet the following
criteria: (1) Must be from among
national breast cancer or consumer
health organization with expertise in
mammography, (2) be able to analyze
technical data, (3) understand research
design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy
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48427
of products under review. The
consumer representative must 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 use of
organizations representing the public
interest and consumer advocacy groups.
The organizations have the
responsibility of recommending
candidates of the agency’s selection.
IV. Nomination Procedures
All nominations must include a cover
letter, a curriculum vita or resume
(which should include nominee’s office
address, telephone number, and e-mail
address), and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Any interested person or organization
may nominate one or more qualified
persons for membership on the
NMQAAC to represent consumer
interests. Self-nominations are also
accepted. Nominations shall include
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, 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.
The term of office is up to 4 years,
depending on the appointment date.
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: August 10, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05–16330 Filed 8–16–05; 8:45 am]
BILLING CODE 4160–01–S
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[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Notices]
[Page 48427]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting Consumer Representative
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 consumer representatives to serve on the
National Mammography Quality Assurance Advisory Committee (NMQAAC) in
the Center for Devices and Radiological Health (CDRH). 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: Nominations will be accepted through January 31, 2006.
ADDRESSES: All nominations should be sent to the contact person listed
in the FOR FURTHER INFORMATION CONTACT section of this document.
FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Advisory Committee
Oversight and Management Staff (HF-4), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, e-mail:
Michael.Ortwerth@fda.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
consumer representatives to serve on the NMQAAC.
I. Functions of NMQAAC
The functions of the committee are to advise FDA on the following
topics: (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.
II. Criteria for Members
Persons nominated for membership on the committee as a consumer
representative must meet the following criteria: (1) Must be from among
national breast cancer or consumer health organization with expertise
in mammography, (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 must 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 use of organizations representing the
public interest and consumer advocacy groups. The organizations have
the responsibility of recommending candidates of the agency's
selection.
IV. Nomination Procedures
All nominations must include a cover letter, a curriculum vita or
resume (which should include nominee's office address, telephone
number, and e-mail address), and a list of consumer or community-based
organizations for which the candidate can demonstrate active
participation.
Any interested person or organization may nominate one or more
qualified persons for membership on the NMQAAC to represent consumer
interests. Self-nominations are also accepted. Nominations shall
include 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, 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. The term of office is up to 4 years, depending on the
appointment date.
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: August 10, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16330 Filed 8-16-05; 8:45 am]
BILLING CODE 4160-01-S
