Notice of Secretary's Advisory Committee Meeting, 54387-54388 [05-18257]

Download as PDF 54387 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board’s Web site at http:// www.federalreserve.gov for an electronic announcement that not only lists applications, but also indicates procedural and other information about the meeting. Board of Governors of the Federal Reserve System, September 9, 2005. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 05–18303 Filed 9–9–05; 4:11 pm] BILLING CODE 6210–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Performance Measurement Online Tool (PMOTOOL). OMB No.: New Collection. Description: The Performance Measurement On-line Tool was designed by the Children’s Bureau to collect data, in an automated format, from specified discretionary grants funded by the Children’s Bureau. The data collected by this instrument will be submitted by individual discretionary grantees funded under the following programs: Abandoned Infants Assistance Program, Infant Adoption Awareness Training Program, Adoption Opportunities Program, Child Abuse and Neglect Program and the Child Welfare Training Program. Grantees will submit this information on a semiannual basis in conjunction with their semi-annual program progress report. The purpose of this data collection is to assist the Children’s Bureau in responding to the Program Assessment Rating Tool (PART), an OMB-mandated reporting system that focuses on quantifiable outcome measures, directly related to the expected social impact or public benefit of each federal program. The Children’s Bureau will use the aggregated data collected under each federal program. These measurable outcomes will serve as evidence that the federally funded programs are making progress toward achieving broad, legislated program goals. Respondents: All competitive discretionary grant programs funded by the Children’s Bureau. ANNUAL BURDEN ESTIMATES Number of responses per respondent (per fiscal year) Instrument Number of respondents Performance Measurement On-line Tool ....... Abandoned Infants Assistance Program— Range 30–36. Infant Adoption Awareness Program—Range 4–6. Adoption Opportunities Program—Range 45–55. Child Abuse and Neglect Program—Range 25–32. Child Welfare Training Program—Range 45– 55. Range 149–184 .............................................. Performance Measurement On-line Tool ....... Performance Measurement On-line Tool ....... Performance Measurement On-line Tool ....... Performance Measurement On-line Tool ....... Total ......................................................... In compliance with the requirement of Section 3506(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 Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. The e-mail address is: grjohnson@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comment on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including VerDate Aug<18>2005 16:17 Sep 13, 2005 Jkt 205001 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 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 publication. Dated: September 8, 2005. Robert Sargis, Reports Clearance Officer. [FR Doc. 05–18258 Filed 9–13–05; 8:45 am] BILLING CODE 4184–01–M PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Average burden hours per response Total burden hours (range) 2 1 60–72 2 1 8–12 2 1 90–110 2 1 50–64 2 1 90–110 ........................ ........................ 298–368 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Notice of Secretary’s Advisory Committee Meeting Office of Planning, Research and Evaluation, ACF, HHS. ACTION: Notice of meeting; Advisory Committee on Head Start Research and Evaluation. AGENCY: SUMMARY: The 1998 Head Start Reauthorization (42 U.S.C. 9844(g); section 649(g)(1) of the Head Start Act, as amended) called on the Secretary of Health and Human Services to form an independent panel of experts (i.e., an Advisory Committee) to offer advice concerning research designs that would provide a national analysis of the E:\FR\FM\14SEN1.SGM 14SEN1 54388 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices impact of Head Start Programs. The September 28–29, 2005 meeting provides an opportunity for the Advisory Committee to provide advice on the analysis plans for the study following the June 2005 release on the first impact findings. DATES: September 28 (9 a.m.–4 p.m.) and 29 (9 a.m.–12:30 p.m.), 2005. Place: Bethesda Park Clarion Hotel, 8400 Wisconsin Avenue, Bethesda, MD 20814; Phone: (301) 654–1000; Fax: (301) 654–0751. SUPPLEMENTARY INFORMATION: This meeting is open to the public and is barrier free. Meeting records will also be open to the public and will be kept at the Aerospace Building, 370 L’Enfant Promenade, SW., Washington, DC 20447. The Administration for Children and Families also intends to make material related to this meeting available on the Office of Planning, Research and Evaluation Web site (http://www.acf.hhs.gov/programs/opre/ index.html). An interpreter for the deaf and hearing impaired will be available upon advance request by calling Xtria at 703–821–6182. FOR FURTHER INFORMATION CONTACT: Maria Woolverton at 202–205–4039 for substantive information. Contact ACF Office of Public Affairs at 202–401–9215 for press inquiries. Contact Xtria at 703– 821–6182 for logistical information. Dated: September 7, 2005. Naomi Goldstein, Director, Office of Planning, Research and Evaluation, ACF. [FR Doc. 05–18257 Filed 9–13–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0353] Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Development Study 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 and to allow 60 days for VerDate Aug<18>2005 16:17 Sep 13, 2005 Jkt 205001 public comment in response to the notice. This notice solicits comments on a proposed Pharmaceutical Development Study. DATES: Submit written or electronic comments on the collection of information by November 14, 2005. ADDRESSES: Submit electronic comments on the collection of information to: http://www.fda.gov/ dockets/ecomments. 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: Karen L. Nelson, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1482. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (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 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. Pharmaceutical Development Study FDA’s Office of Pharmaceutical Science (OPS) of the Center for Drug PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Evaluation and Research is proposing collaboration under a Cooperative Research and Development Agreement (CRADA) with Conformia Software, Inc. of Redwood City, CA (hereafter referred to as ‘‘CRADA Partner’’), to collect information using focus group discussions with firms to determine what factors may influence pharmaceutical development. These factors include development information bottlenecks, pilot plant information management, manufacturing science, information retrieval, quality systems and preclinical development challenges. The FDA has introduced three new initiatives to help manufacturers develop higher quality drugs faster and cheaper. These initiatives include, but are not limited to, the following: • Challenge and Opportunity on the Critical Path to New Medical Products (commonly referred to as the ‘‘Critical Path Initiative’’) • Pharmaceutical cGMPs for the 21st Century—A Risk Based Approach • International Conference on Harmonization (ICH) Steering Committee Guidelines—Pharmaceutical Development, ICH Q8 (Defining the Design Space) The proposed study is designed to augment and support these initiatives by providing practical industry experiences and feedback to help FDA refine these initiatives. The scope of the proposed collaboration is aligned with FDA’s ‘‘Critical Path’’ of development-specifically, the area between selection of drug candidates and commercial manufacturing. Gathering information through this collaboration represents an opportunity for FDA to gain insights into current industry practices and provide the opportunity to better understand the specific factors that contribute to drug development difficulties. There is a perceived reluctance by industry to share information with regulatory bodies (outside of the formal review processes). Therefore, obtaining necessary and timely information through this collaboration will help the Critical Path Initiative progress. The information collected will be used to create a clearer picture of current development bottlenecks, identify current state practices, highlight potential improvements in production, and provide feedback to FDA on the impact of current regulatory guidance. Use of information: The three groups who will be involved with the study may benefit by the collection of this information as follows: E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Notices]
[Pages 54387-54388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18257]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Notice of Secretary's Advisory Committee Meeting

AGENCY: Office of Planning, Research and Evaluation, ACF, HHS.

ACTION: Notice of meeting; Advisory Committee on Head Start Research 
and Evaluation.

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SUMMARY: The 1998 Head Start Reauthorization (42 U.S.C. 9844(g); 
section 649(g)(1) of the Head Start Act, as amended) called on the 
Secretary of Health and Human Services to form an independent panel of 
experts (i.e., an Advisory Committee) to offer advice concerning 
research designs that would provide a national analysis of the

[[Page 54388]]

impact of Head Start Programs. The September 28-29, 2005 meeting 
provides an opportunity for the Advisory Committee to provide advice on 
the analysis plans for the study following the June 2005 release on the 
first impact findings.

DATES: September 28 (9 a.m.-4 p.m.) and 29 (9 a.m.-12:30 p.m.), 2005.
    Place: Bethesda Park Clarion Hotel, 8400 Wisconsin Avenue, 
Bethesda, MD 20814; Phone: (301) 654-1000; Fax: (301) 654-0751.

SUPPLEMENTARY INFORMATION: This meeting is open to the public and is 
barrier free. Meeting records will also be open to the public and will 
be kept at the Aerospace Building, 370 L'Enfant Promenade, SW., 
Washington, DC 20447. The Administration for Children and Families also 
intends to make material related to this meeting available on the 
Office of Planning, Research and Evaluation Web site (http://
www.acf.hhs.gov/programs/opre/index.html). An interpreter for the deaf 
and hearing impaired will be available upon advance request by calling 
Xtria at 703-821-6182.

FOR FURTHER INFORMATION CONTACT: Maria Woolverton at 202-205-4039 for 
substantive information. Contact ACF Office of Public Affairs at 202-
401-9215 for press inquiries. Contact Xtria at 703-821-6182 for 
logistical information.

    Dated: September 7, 2005.
Naomi Goldstein,
Director, Office of Planning, Research and Evaluation, ACF.
[FR Doc. 05-18257 Filed 9-13-05; 8:45 am]
BILLING CODE 4184-01-M