Request for Nominations for Nonvoting Members Representing Industry Interests on Public Advisory Panels or Committees, 58866-58868 [E6-16438]
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Federal Register / Vol. 71, No. 193 / Thursday, October 5, 2006 / Notices
Dated: September 29, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–16455 Filed 10–4–06; 8:45 am]
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[FR Doc. E6–16464 Filed 10–4–06; 8:45 am]
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Discontinued Publication of Funding
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ACTION: Notice of New Procedure.
AGENCY:
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Dated: September 26, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E6–16322 Filed 10–4–06; 8:45 am]
BILLING CODE 4163–18–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
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 the National
Mammography Quality Assurance
Advisory Committee (NMQAAC) and
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 November
6, 2006, stating their interest in the
NMQAAC or one or more panels.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by November 6, 2006. A nominee
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05OCN1
Federal Register / Vol. 71, No. 193 / Thursday, October 5, 2006 / Notices
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, 7520 Standish
Pl. (MPN1), Rockville, MD 20855, 301–
827–7293, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. NMQAAC
The Mammography Quality Standards
Reauthorization Act of 2004 (Public Law
108–365) requires the addition of at
least two industry representatives with
expertise in mammography equipment
to the NMQAAC.
B. Medical Devices Advisory Committee
Section 520(f)(3) of the Federal Food,
Drug and Cosmetic Act (the act) (21
58867
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 following
vacancies listed in table 1 of this
document:
TABLE 1.
Approximate Date
Representatives Needed
Committee/Panel
NMQAAC
February 1, 2007
Certain Panels of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel
Immediate
Hematology and Pathology Devices Panel
Immediate
II. Functions
mstockstill on PROD1PC61 with NOTICES
A. NMQAAC
The functions of the NMQAAC 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.
B. Medical Devices Advisory Committee
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
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15:42 Oct 04, 2006
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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.
II. Selection Procedure
Any organization representing the
mammography device industry or the
medical device manufacturing industry
wishing to participate in the selection of
a nonvoting member to represent
industry should send a letter stating that
interest to the contact person (see FOR
FURTHER INFORMATION CONTACT) within
30 days of publication of this notice.
Persons who nominate themselves as
industry representatives 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
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Fmt 4703
Sfmt 4703
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 committee or device
panel. If no individual is selected
within that 60 days, the Commissioner
may select the nonvoting member to
represent industry interests.
IV. Qualifications
A. NMQAAC
Persons nominated for membership as
an industry representative on the
NMQAAC must meet the following
criteria: (1) Demonstrate expertise in
mammography equipment and (2) be
able to discuss equipment specifications
and quality control procedures affecting
mammography equipment. The industry
representative must be able to represent
the industry perspective on issues and
actions before the advisory committee,
serve as liaison between the committee
and interested industry parties, and
facilitate dialogue with the advisory
committee on mammography equipment
issues.
B. Medical Devices Advisory Committee
Persons nominated for the device
panels should be full time employees of
firms that manufacture products that
would come before the panel, or
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05OCN1
58868
Federal Register / Vol. 71, No. 193 / Thursday, October 5, 2006 / Notices
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
V. Application Procedure
Individuals may nominate
themselves, or an organization
representing the mammography device
industry or 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
committee or panel of interest should be
sent to the 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 committee or 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: September 28, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–16438 Filed 10–4–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: Protection and
Advocacy for Individuals With Mental
Illness (PAIMI) Final Rule, 42 CFR Part
51 (OMB No. 0930–0172)—Extension
These regulations meet the directive
under 42 U.S.C. 10826(b) requiring the
Secretary to promulgate final
regulations to carry out the PAIMI Act.
The regulations contain information
collection requirements. The Act
authorized funds to support activities
on behalf of individuals with significant
(severe) mental illness (adults) or
emotional impairment (children/youth)
[42 U.S.C. at 10802(4)]. However, only
entities designated by the governor of
each State and six (6) territories (the
American Indian Consortium, American
Samoa, Guam, the Northern Mariana
Islands, Puerto Rico, and the U.S. Virgin
Islands), and the Mayor of the District
of Columbia to protect and advocate the
rights of persons with developmental
disabilities under Title I, Subtitle C—
Protection and Advocacy of Individual
Rights, of the Developmental
Disabilities Assistance and Bill of Rights
Act of 2000 [42 U.S.C. 150041 et seq.]
are eligible to receive PAIMI grants [42
U.S.C. at 10802(2)]. PAIMI grants are
based on a formula prescribed by the
Secretary [42 U.S.C. at 10822(a)(1)(A)].
On January 1, each eligible State
protection and advocacy (P&A) system
is required to prepare and transmit to
the Secretary and head of the State
Mental Health Agency, in which the
system is located, a report describing its
activities, accomplishments, and
expenditures during the most recently
completed fiscal year. Section 10824(a)
of the Act requires that the State P&A
system’s annual reports to the Secretary,
shall describe its activities,
accomplishments, and expenditures to
protect the rights of individuals with
mental illness supported with payments
from PAIMI Program allotments. These
include:
• The number of (PAIMI-eligible)
individuals with mental illness served;
Number of
respondents
mstockstill on PROD1PC61 with NOTICES
42 CFR citation
51.(8)(a)(2) Program Performance Report ....................................................
51.8(8)(a)(8) Advisory Council Report ...........................................................
51.10 Remedial Actions.
Corrective Action Plan ............................................................................
Implementation Status Report ................................................................
51.23(c) Reports, materials and fiscal data provided to advisory Council ....
51.25(b)(2) Grievance Procedure ..................................................................
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• A description of the types of
activities undertaken;
• A description of the types of
facilities providing care or treatment to
which such activities are undertaken;
• A description of the manner in
which the activities are initiated;
• A description of the
accomplishments resulting from such
activities;
• A description of systems to protect
and advocate the rights of individuals
with mental illness supported with
payments from PAIMI Program
allotments;
• A description of activities
conducted by States to protect and
advocate such rights;
• A description of mechanisms
established by residential facilities for
individuals with mental illness to
protect such rights; and,
• A description of the coordination
among such systems, activities and
mechanisms;
• Specification of the number systems
that are public and nonprofit systems
established with PAIMI Program
allotments;
• Recommendations for activities and
services to improve the protection and
advocacy of the rights of individuals
with mental illness and a description of
the needs for such activities and
services which have not been met by the
State P&A systems established under the
PAIMI Act * * * [The PAIMI Rules 42
CFR Part 51 at section 51.32(b) states
that P&A systems may place restrictions
on case or client acceptance criteria
developed as part of its annual PAIMI
priorities. However, prospective clients
must be informed of any such
restrictions at the time they request
service].
This summary report must include a
separate section, prepared by the PAIMI
Advisory Council, that describes the
council’s activities and its assessment of
the operations of the State P&A system.
[42 U.S.C. 10805(7)].
The burden estimate for the annual
State P&A system reporting
requirements for these regulations is as
follows.
Responses
per respondent
Burden per
response (hrs.)
Total annual
burden
57
57
1
1
26.0
10.0
1 1,482
7
7
57
57
1
3
1
1
8.0
2.0
1.0
.5
56
42
57
29
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05OCN1
1 570
]]>Agencies
[Federal Register Volume 71, Number 193 (Thursday, October 5, 2006)]
[Notices]
[Pages 58866-58868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16438]
-----------------------------------------------------------------------
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
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 the
National Mammography Quality Assurance Advisory Committee (NMQAAC) and
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 November 6, 2006,
stating their interest in the NMQAAC or one or more panels.
Concurrently, nomination materials for prospective candidates should be
sent to FDA by November 6, 2006. A nominee
[[Page 58867]]
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, 7520
Standish Pl. (MPN1), Rockville, MD 20855, 301-827-7293, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. NMQAAC
The Mammography Quality Standards Reauthorization Act of 2004
(Public Law 108-365) requires the addition of at least two industry
representatives with expertise in mammography equipment to the NMQAAC.
B. Medical Devices Advisory Committee
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 following vacancies listed in table 1 of
this document:
Table 1.
------------------------------------------------------------------------
Approximate Date
Committee/Panel Representative is Needed
------------------------------------------------------------------------
NMQAAC February 1, 2007
------------------------------------------------------------------------
Certain Panels of the Medical Devices Advisory Committee
------------------------------------------------------------------------
General and Plastic Surgery Devices Panel Immediate
------------------------------------------------------------------------
Hematology and Pathology Devices Panel Immediate
------------------------------------------------------------------------
II. Functions
A. NMQAAC
The functions of the NMQAAC 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.
B. Medical Devices Advisory Committee
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.
II. Selection Procedure
Any organization representing the mammography device industry or
the medical device manufacturing industry wishing to participate in the
selection of a nonvoting member to represent industry should send a
letter stating that interest to the contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of publication of this notice.
Persons who nominate themselves as industry representatives 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 committee or device panel. If no individual is selected
within that 60 days, the Commissioner may select the nonvoting member
to represent industry interests.
IV. Qualifications
A. NMQAAC
Persons nominated for membership as an industry representative on
the NMQAAC must meet the following criteria: (1) Demonstrate expertise
in mammography equipment and (2) be able to discuss equipment
specifications and quality control procedures affecting mammography
equipment. The industry representative must be able to represent the
industry perspective on issues and actions before the advisory
committee, serve as liaison between the committee and interested
industry parties, and facilitate dialogue with the advisory committee
on mammography equipment issues.
B. Medical Devices Advisory Committee
Persons nominated for the device panels should be full time
employees of firms that manufacture products that would come before the
panel, or
[[Page 58868]]
consulting firms that represent manufacturers, or have similar
appropriate ties to industry.
V. Application Procedure
Individuals may nominate themselves, or an organization
representing the mammography device industry or 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 committee or panel of interest should be sent to the
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 committee or 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: September 28, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16438 Filed 10-4-06; 8:45 am]
BILLING CODE 4160-01-S
