Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees, 31841-31842 [E7-11065]
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pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 110 / Friday, June 8, 2007 / Notices
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
Waiver Demonstration Application; Use:
The Medicare Waiver Demonstration
Application will be used to collect
standard information needed to
implement congressionally mandated
and administration high priority
demonstrations. The application will be
used to gather information about the
characteristics of the applicant’s
organization, benefits, and services they
propose to offer, success in operating
the model, and evidence that the model
is likely to be successful in the Medicare
program. The standard application will
be used for all waiver demonstrations
and will reduce the burden on
applicants, provide for consistent and
timely information collections across
demonstrations, and provide a userfriendly format for respondents; Form
Number: CMS–10069 (OMB#: 0938–
0880); Frequency: Reporting: Once;
Affected Public: Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 75; Total
Annual Responses: 75; Total Annual
Hours: 6000.
3. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
CAHPS Survey; Use: The collection of
Consumer Assessment of Healthcare
Providers and Systems (CAHPS) Survey
measures is necessary to hold health
and prescription drug plans accountable
for the quality of care and services they
deliver. This requirement will allow
CMS to obtain information for the
proper oversight of the program. This
information is used to help beneficiaries
choose among plans, contribute to
improved quality of care through
identification of quality improvement
opportunities, and assist CMS in
carrying out its responsibilities; Form
Number: CMS–R–246 (OMB#: 0938–
0732); Frequency: Reporting: Yearly;
Affected Public: Individuals or
households; Number of Respondents:
660,000; Total Annual Responses:
660,000; Total Annual Hours: 217,800.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
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Written comments and
recommendations for the proposed
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: May 31, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–10985 Filed 6–7–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
31841
Consultants Staff (HFD–21), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
7001, e-mail:
jayne.peterson@fda.hhs.gov.
Section
120 of the FDA Modernization Act of
1997 (FDAMA) (21 U.S.C. 355) requires
that newly formed FDA advisory
committees include representatives
from the drug manufacturing industries.
Although not required for committees
existing prior to the passage of FDAMA,
to keep within the spirit of FDAMA, the
agency has added nonvoting industry
representatives to CDER advisory
committees identified in the following
paragraphs.
SUPPLEMENTARY INFORMATION:
I. CDER Advisory Committees
Food and Drug Administration
Request for Notification From Industry
Organizations Interested in
Participating in Selection Process for
Nonvoting Industry Representatives on
Public Advisory Committees and
Request for Nominations for
Nonvoting Industry Representatives on
Public Advisory Committees
1. Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology (Formerly Advisory
Committee for Pharmaceutical Science)
Advises on scientific and technical
issues concerning the safety and
effectiveness of human generic drug
products for use in the treatment of a
broad spectrum of human diseases.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on its public advisory committees
for the Center for Drug Evaluation
Research (CDER) notify FDA in writing.
FDA is also requesting nominations for
nonvoting industry representatives to
serve on CDER’s public advisory
committees. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by July 9, 2007, for vacancies listed
in this notice. Concurrently, nomination
materials for prospective candidates
should be sent to FDA by July 9, 2007.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Jayne Peterson (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Jayne Peterson, Advisors and
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2. Advisory Committee for Reproductive
Health Drugs
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in obstetrics,
gynecology, and contraception.
3. Anesthetic and Life Support Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
4. Anti-Infective 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 infectious diseases and disorders.
5. Antiviral 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 acquired immune deficiency
syndrome (AIDS), HIV-related illnesses,
and other viral, fungal, and
mycobacterial infections.
6. Arthritis Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
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08JNN1
31842
Federal Register / Vol. 72, No. 110 / Friday, June 8, 2007 / Notices
drug products for use in the treatment
of arthritis, rheumatism, and related
diseases.
7. Cardiovascular and Renal 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 cardiovascular and renal disorders.
8. 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.
9. Drug Safety and Risk Management
Advisory Committee
Advises the Commissioner of Food
and Drugs (the Commissioner) regarding
the scientific and medical evaluation of
all information gathered by the
Department of Health and Human
Services and the Department of Justice
with the regard to safety, efficacy, and
abuse potential, risk management, risk
communication, and quantitative
evaluation of spontaneous reports, and
recommends actions to be taken by FDA
with regard to marketing, investigation,
and control of such drugs or other
substances.
10. Endocrinologic and Metabolic 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 endocrine and metabolic disorders.
11. Gastrointestinal 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 gastrointestinal disorders.
pwalker on PROD1PC71 with NOTICES
12. Nonprescription Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of over-the-counter (nonprescription)
human drug products for use in the
treatment of a broad spectrum of human
symptoms and diseases.
13. Oncologic 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 cancer.
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Jkt 211001
14. Peripheral and Central Nervous
System 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 neurologic diseases.
15. Psychopharmacologic Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the practice of
psychiatry and related fields.
16. Pulmonary-Allergy 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 pulmonary disease and diseases with
allergic and/or immunologic
mechanisms.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed and interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. A current
curriculum vitae and the name of the
committee of interest should be sent to
the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within
30 days (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for that committee.
(Persons who nominate themselves as
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nonvoting industry representatives will
not participate in the selection process.)
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the drug
manufacturing industry.
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: May 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–11065 Filed 6–7–07; 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: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Participant
Feedback on Training Under the
Cooperative Agreement for Mental
E:\FR\FM\08JNN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 110 (Friday, June 8, 2007)]
[Notices]
[Pages 31841-31842]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11065]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Notification From Industry Organizations Interested
in Participating in Selection Process for Nonvoting Industry
Representatives on Public Advisory Committees and Request for
Nominations for Nonvoting Industry Representatives on Public Advisory
Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on its public advisory
committees for the Center for Drug Evaluation Research (CDER) notify
FDA in writing. FDA is also requesting nominations for nonvoting
industry representatives to serve on CDER's public advisory committees.
A nominee may either be self-nominated or nominated by an organization
to serve as a nonvoting industry representative. Nominations will be
accepted for current vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by July 9,
2007, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by July 9,
2007.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Jayne Peterson (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Jayne Peterson, Advisors and
Consultants Staff (HFD-21), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-7001, e-mail:
jayne.peterson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section 120 of the FDA Modernization Act of
1997 (FDAMA) (21 U.S.C. 355) requires that newly formed FDA advisory
committees include representatives from the drug manufacturing
industries. Although not required for committees existing prior to the
passage of FDAMA, to keep within the spirit of FDAMA, the agency has
added nonvoting industry representatives to CDER advisory committees
identified in the following paragraphs.
I. CDER Advisory Committees
1. Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology (Formerly Advisory Committee for Pharmaceutical Science)
Advises on scientific and technical issues concerning the safety
and effectiveness of human generic drug products for use in the
treatment of a broad spectrum of human diseases.
2. Advisory Committee for Reproductive Health Drugs
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in obstetrics, gynecology, and contraception.
3. Anesthetic and Life Support Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.
4. Anti-Infective 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 infectious diseases and disorders.
5. Antiviral 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 acquired immune deficiency syndrome (AIDS),
HIV-related illnesses, and other viral, fungal, and mycobacterial
infections.
6. Arthritis Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human
[[Page 31842]]
drug products for use in the treatment of arthritis, rheumatism, and
related diseases.
7. Cardiovascular and Renal 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 cardiovascular and renal disorders.
8. 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.
9. Drug Safety and Risk Management Advisory Committee
Advises the Commissioner of Food and Drugs (the Commissioner)
regarding the scientific and medical evaluation of all information
gathered by the Department of Health and Human Services and the
Department of Justice with the regard to safety, efficacy, and abuse
potential, risk management, risk communication, and quantitative
evaluation of spontaneous reports, and recommends actions to be taken
by FDA with regard to marketing, investigation, and control of such
drugs or other substances.
10. Endocrinologic and Metabolic 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 endocrine and metabolic disorders.
11. Gastrointestinal 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 gastrointestinal disorders.
12. Nonprescription Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug products
for use in the treatment of a broad spectrum of human symptoms and
diseases.
13. Oncologic 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 cancer.
14. Peripheral and Central Nervous System 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 neurologic diseases.
15. Psychopharmacologic Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of psychiatry and related fields.
16. Pulmonary-Allergy 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 pulmonary disease and diseases with allergic
and/or immunologic mechanisms.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed and interest,
attaching a complete list of all such organizations; and a list of all
nominees along with their current resumes. The letter will also state
that it is the responsibility of the interested organizations to confer
with one another and to select a candidate, within 60 days after the
receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for a particular committee. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within 60 days, the
Commissioner will select the nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. A current curriculum vitae and the name of the
committee of interest should be sent to the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within 30 days (see DATES). FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for that committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.)
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages nominations for appropriately qualified candidates from
these groups. Specifically, in this document, nominations for nonvoting
representatives of industry interests are encouraged from the drug
manufacturing industry.
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: May 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-11065 Filed 6-7-07; 8:45 am]
BILLING CODE 4160-01-S
