Request for Nominations for Nonvoting Members Representing Industry Interests on Public Advisory Panels or Committees; Medical Devices Advisory Committee, 39516-39517 [05-13421]
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Federal Register / Vol. 70, No. 130 / Friday, July 8, 2005 / Notices
to other services within the APC);
• Recommendations and rationale for
change;
• Expected outcome of change; and
• Potential consequences of not
making the change(s).
VI. Oral Comments
In addition to formal oral
presentations, there will be opportunity
during the meeting for public oral
comments that will be limited to 1
minute for each individual and a total
of 5 minutes per organization.
VII. Meeting Attendance
The meeting is open to the public;
however, attendance is limited to space
available. Attendance will be
determined on a first-come, first-served
basis.
Persons wishing to attend this
meeting, which is located on Federal
property, must call or e-mail the Panel
DFO to register in advance no later than
5 p.m. (e.d.t.), Wednesday, August 10,
2005.
The following information must be emailed or telephoned to the DFO by the
date and time above:
• Name(s) of attendee(s);
• Title(s);
• Organization;
• E-mail address(es); and
• Telephone number(s).
VIII. Security, Building, and Parking
Guidelines
Persons attending the meeting must
present photographic identification to
the Federal Protective Service or Guard
Service personnel before they will be
allowed to enter the building.
Security measures will include
inspection of vehicles, inside and out, at
the entrance to the grounds. In addition,
all persons entering the building must
pass through a metal detector. All items
brought to CMS, including personal
items such as desktops, cell phones,
palm pilots, are subject to physical
inspection.
Individuals who are not registered in
advance will not be permitted to enter
the building and will be unable to
attend the meeting. The public may not
enter the building earlier than 30–45
minutes prior to the convening of the
meeting each day. (Please note that the
meeting on Wednesday, August 17,
2005, does not convene until 1 p.m.)
All visitors must be escorted in areas
other than the lower and first-floor
levels in the Central Building.
Parking permits and instructions are
issued upon arrival by the guards at the
main entrance.
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IX. Special Accommodations
Individuals requiring sign-language
interpretation or other special
accommodations must send a request
for these services to the DFO by 5 p.m.
(e.d.t.), Wednesday, August 10, 2005.
Authority: Section 1833(t) of the Act (42
U.S.C. 1395l(t)). The Panel is governed by the
provisions of Pub. L. 92–463, as amended (5
U.S.C. Appendix 2).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare-Hospital
Insurance; and Program No. 93.774,
Medicare-Supplementary Medical Insurance
Program)
Dated: June 21, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–13562 Filed 7–7–05; 8:45 am]
Section
520(f)(3) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360j(f)(3)), as amended by the Medical
Device Amendments of 1976, provides
that each medical device panel include
one nonvoting member to represent the
interests of the medical device
manufacturing industry.
FDA is requesting nominations for
nonvoting members representing
industry interests for the vacancies
listed in table 1 of this document.
SUPPLEMENTARY INFORMATION:
TABLE 1.—MEDICAL DEVICE PANEL
VACANCIES
Medical Devices
Panels
Approximate Date
Representative is
Needed
Anesthesiology and
Respiratory Therapy
Devices Panel
December 1, 2005
Dental Products Panel
November 1, 2005
General Hospital and
Personal Use Devices Panel
January 1, 2006
Immunology Devices
Panel
Immediate
Ophthalmic Devices
Panel
November 1, 2005
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for
Nonvoting Members Representing
Industry Interests on Public Advisory
Panels or Committees; Medical
Devices Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
I. Functions
The Food and Drug
Administration (FDA) is requesting
nominations for nonvoting industry
representatives to serve on certain
device panels of the Medical Devices
Advisory Committee in the Center for
Devices and Radiological Health.
DATES: Industry organizations interested
in participating in the selection of a
nonvoting member to represent industry
for the vacancies listed in this document
must send a letter to FDA by August 8,
2005, stating their interest in one or
more panels. Concurrently, nomination
materials for prospective candidates
should be sent to FDA by August 8,
2005. A nominee may either be selfnominated or nominated by an
organization to serve as a nonvoting
industry representative.
ADDRESSES: All letters of interest and
nominations should be sent to Kathleen
L. Walker (see FOR FURTHER INFORMATION
CONTACT).
FOR FURTHER INFORMATION CONTACT:
Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ–17), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0450, ext. 114, e-mail:
klw@cdrh.fda.gov.
SUMMARY:
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The medical device panels perform
the following functions: (1) Review and
evaluate data on the safety and
effectiveness of marketed and
investigational devices and make
recommendations for their regulation,
(2) advise the Commissioner of Food
and Drugs (the Commissioner) regarding
recommended classification or
reclassification of these devices into one
of three regulatory categories, (3) advise
on any possible risks to health
associated with the use of devices, (4)
advise on formulation of product
development protocols, (5) review
premarket approval applications for
medical devices, (6) review guidelines
and guidance documents, (7)
recommend exemption to certain
devices from the application of portions
of the act, (8) advise on the necessity to
ban a device, (9) respond to requests
from the agency to review and make
recommendations on specific issues or
problems concerning the safety and
effectiveness of devices, and (10) make
recommendations on the quality in the
design of clinical studies regarding the
safety and effectiveness of marketed and
investigational devices.
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Federal Register / Vol. 70, No. 130 / Friday, July 8, 2005 / Notices
II. Selection Procedure
Any organization in the medical
device manufacturing industry wishing
to participate in the selection of a
nonvoting member to represent industry
on a particular panel should send a
letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document. Persons who
nominate themselves as industry
representatives for the panels will not
participate in the selection process. It is,
therefore, recommended that
nominations be made by someone
within an organization, trade
association, or firm who is willing to
participate in the selection process.
Within the subsequent 30 days, FDA
will send a letter to each organization
and a list of all nominees along with
their resumes. The letter will state that
the interested organizations are
responsible for conferring with one
another to select a candidate, within 60
days after receiving the letter, to serve
as the nonvoting industry representative
on a particular device panel. If no
individual is selected within that 60
days, the Commissioner may select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may nominate themselves
or an organization representing the
medical device industry may nominate
one or more individuals to serve as a
nonvoting industry representative. A
current curriculum vitae (which
includes the nominee’s business
address, telephone number, and e-mail
address) and the name of the panel of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT). FDA will
forward all nominations to the
organizations that have expressed
interest in participating in the selection
process for that panel.
FDA has a special interest in ensuring
that women, minority groups,
individuals with disabilities, and small
businesses are adequately represented
on its advisory committees. Therefore,
the agency encourages nominations for
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: June 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–13421 Filed 7–7–05; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines Request for Nominations for
Voting Members
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill three
vacancies on the Advisory Commission
on Childhood Vaccines (ACCV). The
ACCV was established by Title XXI of
the Public Health Service Act (the Act),
as enacted by Public Law (Pub. L.) 99–
660 and as subsequently amended, and
advises the Secretary of Health and
Human Services (the Secretary) on
issues related to implementation of the
National Vaccine Injury Compensation
Program (VICP).
DATES: The agency must receive
nominations on or before August 8,
2005.
All nominations are to be
submitted to the Acting Director,
Division of Vaccine Injury
Compensation, Healthcare Systems
Bureau, HRSA, Parklawn Building,
Room 11C–26, 5600 Fishers Lane,
Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Ms.
Cheryl A. Lee, Principal Staff Liaison,
Policy Analysis Branch, Division of
Vaccine Injury Compensation, HSB,
HRSA, at (301) 443–2124 or e-mail:
clee@hrsa.gov.
ADDRESSES:
Under the
authorities that established the ACCV,
the Federal Advisory Committee Act of
October 6, 1972 (Pub. L. 92–463), and
section 2119 of the Act, 42 U.S.C.
300aa–19, as added by Pub. L. 99–660
and amended, HRSA is requesting
nominations for three voting members
of the ACCV.
The ACCV advises the Secretary on
the implementation of the VICP. The
activities of the ACCV include:
recommending changes in the Vaccine
Injury Table at its own initiative or as
the result of the filing of a petition;
advising the Secretary in implementing
section 2127 regarding the need for
childhood vaccination products that
result in fewer or no significant adverse
reactions; surveying Federal, State, and
local programs and activities related to
gathering information on injuries
associated with the administration of
childhood vaccines, including the
SUPPLEMENTARY INFORMATION:
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39517
adverse reaction reporting requirements
of section 2125(b); advising the
Secretary on the methods of obtaining,
compiling, publishing, and using
credible data related to the frequency
and severity of adverse reactions
associated with childhood vaccines; and
recommending to the Director of the
National Vaccine Program that vaccine
safety research be conducted on various
vaccine injuries.
The ACCV consists of nine voting
members appointed by the Secretary as
follows: Three health professionals, who
are not employees of the United States
Government and have expertise in the
health care of children; and the
epidemiology, etiology, and prevention
of childhood diseases; and the adverse
reactions associated with vaccines, at
least two shall be pediatricians; three
members from the general public, at
least two shall be legal representatives
(parents or guardians) of children who
have suffered a vaccine-related injury or
death; and three attorneys, at least one
shall be an attorney whose specialty
includes representation of persons who
have suffered a vaccine-related injury or
death, and one shall be an attorney
whose specialty includes representation
of vaccine manufacturers. In addition,
the Director of the National Institutes of
Health, the Assistant Secretary for
Health, the Director of the Centers for
Disease Control and Prevention, and the
Commissioner of the Food and Drug
Administration (or the designees of such
officials) serve as nonvoting ex officio
members.
Specifically, HRSA is requesting
nominations for three voting members
of the ACCV representing: (1) A health
professional, who has expertise in the
health care of children; and the
epidemiology, etiology, and prevention
of childhood diseases; (2) an attorney
with no specific affiliation; and (3) a
legal representative (parent or guardian)
of a child who has suffered a vaccinerelated injury or death. Nominees will
be invited to serve a 3-year term
beginning January 1, 2006, and ending
December 31, 2008.
Interested persons may nominate one
or more qualified persons for
membership on the ACCV. Nominations
shall state that the nominee is willing to
serve as a member of the ACCV and
appears to have no conflict of interest
that would preclude the ACCV
membership. Potential candidates will
be asked to provide detailed information
concerning consultancies, research
grants, or contracts to permit evaluation
of possible sources of conflicts of
interest. A curriculum vitae or resume
should be submitted with the
nomination.
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]]>Agencies
[Federal Register Volume 70, Number 130 (Friday, July 8, 2005)]
[Notices]
[Pages 39516-39517]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13421]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Nonvoting Members Representing
Industry Interests on Public Advisory Panels or Committees; Medical
Devices Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for nonvoting industry representatives to serve on certain
device panels of the Medical Devices Advisory Committee in the Center
for Devices and Radiological Health.
DATES: Industry organizations interested in participating in the
selection of a nonvoting member to represent industry for the vacancies
listed in this document must send a letter to FDA by August 8, 2005,
stating their interest in one or more panels. Concurrently, nomination
materials for prospective candidates should be sent to FDA by August 8,
2005. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
ADDRESSES: All letters of interest and nominations should be sent to
Kathleen L. Walker (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0450, ext. 114, e-mail:
klw@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION: Section 520(f)(3) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 360j(f)(3)), as amended by the
Medical Device Amendments of 1976, provides that each medical device
panel include one nonvoting member to represent the interests of the
medical device manufacturing industry.
FDA is requesting nominations for nonvoting members representing
industry interests for the vacancies listed in table 1 of this
document.
Table 1.--Medical Device Panel Vacancies
------------------------------------------------------------------------
Approximate Date Representative is
Medical Devices Panels Needed
------------------------------------------------------------------------
Anesthesiology and Respiratory December 1, 2005
Therapy Devices Panel
------------------------------------------------------------------------
Dental Products Panel November 1, 2005
------------------------------------------------------------------------
General Hospital and Personal Use January 1, 2006
Devices Panel
------------------------------------------------------------------------
Immunology Devices Panel Immediate
------------------------------------------------------------------------
Ophthalmic Devices Panel November 1, 2005
------------------------------------------------------------------------
I. Functions
The medical device panels perform the following functions: (1)
Review and evaluate data on the safety and effectiveness of marketed
and investigational devices and make recommendations for their
regulation, (2) advise the Commissioner of Food and Drugs (the
Commissioner) regarding recommended classification or reclassification
of these devices into one of three regulatory categories, (3) advise on
any possible risks to health associated with the use of devices, (4)
advise on formulation of product development protocols, (5) review
premarket approval applications for medical devices, (6) review
guidelines and guidance documents, (7) recommend exemption to certain
devices from the application of portions of the act, (8) advise on the
necessity to ban a device, (9) respond to requests from the agency to
review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices, and (10) make
recommendations on the quality in the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
[[Page 39517]]
II. Selection Procedure
Any organization in the medical device manufacturing industry
wishing to participate in the selection of a nonvoting member to
represent industry on a particular panel should send a letter stating
that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT)
within 30 days of publication of this document. Persons who nominate
themselves as industry representatives for the panels will not
participate in the selection process. It is, therefore, recommended
that nominations be made by someone within an organization, trade
association, or firm who is willing to participate in the selection
process. Within the subsequent 30 days, FDA will send a letter to each
organization and a list of all nominees along with their resumes. The
letter will state that the interested organizations are responsible for
conferring with one another to select a candidate, within 60 days after
receiving the letter, to serve as the nonvoting industry representative
on a particular device panel. If no individual is selected within that
60 days, the Commissioner may select the nonvoting member to represent
industry interests.
III. Application Procedure
Individuals may nominate themselves or an organization representing
the medical device industry may nominate one or more individuals to
serve as a nonvoting industry representative. A current curriculum
vitae (which includes the nominee's business address, telephone number,
and e-mail address) and the name of the panel of interest should be
sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT).
FDA will forward all nominations to the organizations that have
expressed interest in participating in the selection process for that
panel.
FDA has a special interest in ensuring that women, minority groups,
individuals with disabilities, and small businesses are adequately
represented on its advisory committees. Therefore, the agency
encourages nominations for 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: June 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13421 Filed 7-7-05; 8:45 am]
BILLING CODE 4160-01-S
