Proposed Information Collection Activity; Comment Request, 58969-58970 [E8-23798]

Download as PDF 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] jlentini on PROD1PC65 with NOTICES 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] Jkt 217001 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. [FR Doc. E8–23814 Filed 10–7–08; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4163–18–P 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. BILLING CODE 4150–31–P VerDate Aug<31>2005 DEPARTMENT OF HEALTH AND HUMAN SERVICES 58969 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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. E:\FR\FM\08OCN1.SGM 08OCN1 58970 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] jlentini on PROD1PC65 with NOTICES BILLING CODE 4184–01–P VerDate Aug<31>2005 18:10 Oct 07, 2008 Jkt 217001 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 http:// 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 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\08OCN1.SGM 08OCN1

Agencies

[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]
BILLING CODE 4184-01-P