Proposed Information Collection Activity; Comment Request, 58969-58970 [E8-23798]
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Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices
grant application derived from those
figures were also false.
5. Two figures in NIAID, NIH, grant
application P01 AI44236–05 contained
falsified data: In Figure 1b, panels of
confocal microscopy images of
intestinal biopsies from four patients
were falsified by duplication; and in
Figure 3, one panel of PCR data was
duplicated and similarly misrepresented
as data from the same four biopsy
specimens.
Dr. Sperber has entered into a
Voluntary Exclusion Agreement in
which he neither admitted or denied
HHS’ findings of scientific misconduct.
However, he recognized that if this
matter were to proceed to an
administrative hearing, there is
sufficient evidence upon which an
Administrative Law Judge could make
findings of scientific misconduct against
him. Dr. Sperber agreed not to contest
or appeal the jurisdiction of the PHS or
HHS findings of scientific misconduct
as set forth above and in the MSSM
Report. Dr. Sperber has voluntarily
agreed, for a period of four (4) years,
beginning on September 12, 2008:
(1) To exclude himself from any
contracting or subcontracting with any
agency of the United States Government
and from eligibility or involvement in
nonprocurement programs of the United
States pursuant to HHS’ Implementation
(2 CFR Part 376 et seq.) of OMB
Guidelines to Agencies on Government
wide Debarment and Suspension (2
C.F.R., Part 180); and
(2) To exclude himself from serving in
any advisory capacity to PHS, including
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant or
contractor to PHS.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E8–23820 Filed 10–7–08; 8:45 am]
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18:10 Oct 07, 2008
Centers for Disease Control and
Prevention
Breast and Cervical Cancer Early
Detection and Control Advisory
Committee: Notice of Charter Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Breast
and Cervical Cancer Early Detection and
Control Advisory Committee,
Department of Health and Human
Services, has been renewed for a 2-year
period through September 12, 2010.
For information, contact Debra
Younginer, Executive Secretary, Breast
and Cervical Cancer Early Detection and
Control Advisory Committee,
Department of Health and Human
Services, 4770 Buford Highway, NE.,
Mailstop K57, Chamblee, Georgia 30341,
telephone (770) 488–1074; fax (770)
488–3230.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: October 1, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–23815 Filed 10–7–08; 8:45 am]
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Status: Open to the public, limited only by
the space available.
Purpose: The mission of the Task Force is
to develop and publish the Guide to
Community Preventive Services (Community
Guide), which consists of systematic reviews
of the best available scientific evidence and
associated recommendations regarding what
works in the delivery of essential public
health services.
Topics include:
• Sexual Behavior: Group-based
interventions to reduce adolescent
pregnancy, HIV, and other Sexually
Transmitted Diseases.
• Vaccine Preventable Diseases:
Interventions to reduce out-of-pocket costs.
• Vaccine Preventable Diseases:
Immunization Information Systems.
• Physical Activity Updates.
Agenda items are subject to change as
priorities dictate.
Persons interested in reserving a space for
this meeting should call Charmen Crawford
at 404. 498.2498 by close of business on
October 17, 2008.
Contact person for additional information:
Charmen Crawford, Coordinating Center for
Health Information and Services, National
Center for Health Marketing, Office of the
Director, Centers for Disease Control and
Prevention, 1600 Clifton Road, M/S E–69,
Atlanta, GA 30329, phone: 404.4982498.
Dated: September 30, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Administration for Children and
Families
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Information Collection
Activity; Comment Request
Centers for Disease Control and
Prevention
Proposed Projects
Task Force on Community Preventive
Services
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Name: Task Force on Community
Preventive Services.
Times and Dates: 8 a.m.–6 p.m. EST,
October 22, 2008; 8 a.m.–1 p.m. EST, October
23, 2008.
Place: Centers for Disease Control and
Prevention, 2500 Century Parkway, Atlanta,
Georgia 30345.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
58969
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Title: Head Start Grants
Administration (45 CFR Part 1301).
OMB No.: 0980–0243.
Description: 45 CFR contains
provisions applicable to program
administration and grants
administration under the Head Start
Act, as amended. The provisions specify
the requirements for grantee agencies for
insurance, bonding, the submission of
audits, matching of federal funds,
accounting systems certifications and
other provisions applicable to personnel
administration.
Respondents: Head Start and Early
Start grantees.
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Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices
ANNUAL BURDEN ESTIMATES
45 CFR Part 1301 ...........................................................................
Estimated Total Annual Burden
Hours: 10,000.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: October 3, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–23798 Filed 10–7–08; 8:45 am]
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Number of
responses per
respondent
Number of
respondents
Instrument
2,500
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0521]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Clinical Trial Sponsors: Establishment
and Operation of Clinical Trial Data
Monitoring Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information concerning
the establishment and operation of
clinical trial data monitoring
committees.
Submit written or electronic
comments on the collection of
information by December 8, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
DATES:
PO 00000
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Average burden
hours per
response
2
2
Total burden
hours
10,000
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Clinical Trial Sponsors:
Establishment and Operation of
Clinical Trial Data Monitoring
Committees—(OMB Control Number
0910–0581)—Extension
Sponsors are required to monitor
studies evaluating new drugs, biologics,
and devices (21 CFR 312.50 and 312.56
for drugs and biologics, and 21 CFR
812.40 and 812.46 for devices). Various
individuals and groups play different
roles in clinical trial monitoring. One
such group is a Data Monitoring
Committee (DMC), appointed by a
sponsor to evaluate the accumulating
outcome data in some trials. A clinical
trial DMC is a group of individuals with
pertinent expertise that reviews on a
regular basis accumulating data from an
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[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Notices]
[Pages 58969-58970]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23798]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Head Start Grants Administration (45 CFR Part 1301).
OMB No.: 0980-0243.
Description: 45 CFR contains provisions applicable to program
administration and grants administration under the Head Start Act, as
amended. The provisions specify the requirements for grantee agencies
for insurance, bonding, the submission of audits, matching of federal
funds, accounting systems certifications and other provisions
applicable to personnel administration.
Respondents: Head Start and Early Start grantees.
[[Page 58970]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
45 CFR Part 1301........................ 2,500 2 2 10,000
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 10,000.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is 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) 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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: October 3, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8-23798 Filed 10-7-08; 8:45 am]
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