Submission for OMB Review; Comment Request, 9418-9419 [2010-4209]

Download as PDF 9418 Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Notices also conserve agency resources by reducing the current volume of inquiries individual FDA offices and employees must handle concerning advisory committee schedules and procedures. 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: February 24, 2010. Joanne Less, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–4258 Filed 3–1–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health WReier-Aviles on DSKGBLS3C1PROD with NOTICES Submission for OMB Review; Comment Request; Reinstatement of OMB No. 0925–0601/exp. 02/28/2010, Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a reinstatement of approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on September 25, 2009, page 48973 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number. Proposed Collection: Title: Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research. Type of Information Collection Request: Revision, OMB 0925–0601, Expiration Date 02/28/2010, Form Number: NIH 2890. Need and Use of Information Collection: The form is used by applicants to request that human embryonic stem cell lines be approved for use in NIH funded research. Frequency of response: Applicants may submit applications at any time; this request is a one-time submission. Affected Public: Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type VerDate Nov<24>2008 15:07 Mar 01, 2010 Jkt 220001 of Respondents: Adult scientific professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 160,135; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 14; and Estimated Total Annual Burden Hours Requested: 2,251,500. The estimated annualized cost to respondents is $78,802,500. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Mikia Currie, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892–7974, or call non-toll-free number (301) 435– 0941, or E-mail your request, including your address to: curriem@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. Dated: February 25, 2010. Mikia Currie, Office of Policy for Extramural Research Administration, OD, NIH. [FR Doc. 2010–4301 Filed 3–1–10; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Evaluation of Adolescent Pregnancy Prevention Approaches— Baseline Data Collection. OMB No.: ICRAS: 0970–0360. Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA). PPA is being undertaken to expand available evidence on effective ways to reduce teen pregnancy. The evaluation will document and test a range of pregnancy prevention approaches in up to eight program sites. Program impacts will be estimated using a random assignment design, involving random assignment at the school, individual, or other level, depending on the program setting. The findings of the evaluation will be of interest to the general public, to policymakers, and to organizations interested in teen pregnancy prevention. This proposed information collection activity focuses on collecting baseline data from a self-administered questionnaire which will be used to perform meaningful analysis to determine significant program effects. Through a survey instrument, respondents will be asked to answer carefully selected questions about demographics and risk and protective factors related to teen pregnancy. As appropriate to each program being evaluated, youth records, performance, and program participation data will also be collected. Respondents: The data will be collected through private, selfadministered questionnaires completed by study participants, i.e. adolescents assigned to a select school or community teen pregnancy prevention program or a control group. Surveys will be distributed and collected by trained professional staff. Youth school records, performance, and program participation data will also be collected from participating schools and organizations, as appropriate to the site. BILLING CODE 4140–01–P PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1 9419 Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Notices ANNUAL BURDEN ESTIMATES Annual number of respondents Instrument Baseline Instrument ......................................................................................... School Records, Performance, and Program Participation Data Collection ... Estimated Total Annual Burden Hours: 1,864. Additional Information Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: OPREinfocollection@acf.hhs.gov. OMB Comment ONE is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: February 23, 2010. Steven M. Hanmer, OPRE Reports Clearance Officer. [FR Doc. 2010–4209 Filed 3–1–10; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] WReier-Aviles on DSKGBLS3C1PROD with NOTICES Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. VerDate Nov<24>2008 15:07 Mar 01, 2010 Jkt 220001 Contact Person: Nicole Vesely, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–6793, FAX: 301– 827–6776, e-mail: nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: During the morning session of March 22, 2010, the committee will discuss new drug application (NDA) 022–481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who have received two or more prior lines of therapy. During the afternoon session, the committee will discuss NDA 022–374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for Frm 00040 Fmt 4703 Sfmt 4703 Average burden hours per response 1 1 .5 8 3,600 8 Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 22, 2010, from 8 a.m. to 5 p.m. This meeting is a reschedule of a postponed meeting originally announced in the Federal Register of December 17, 2009 (74 FR 66986) to take place on February 10, 2010. Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301–977– 8900. PO 00000 Number of responses per respondent Total annual burden hours 1,800 64 injection, by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib. Due to the postponement of the February 10, 2010, Oncologic Drugs Advisory Committee meeting because of severe weather conditions and the urgency to reschedule this meeting, FDA regrets that it was unable to publish this notice 15 days prior to the March 22, 2010, Oncologic Drugs Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Oncologic Drugs Advisory Committee were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice. Background materials from the originally scheduled February 10, 2010, Oncologic Drugs Advisory Committee meeting are currently available at http:// www.fda.gov/AdvisoryCommittees/ Calendar/default.htm. Scroll down to the appropriate advisory committee link. Should any additional background materials become available, they will be posted 2 days before the March 22, 2010, meeting at this same Web site. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 17, 2010. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 12, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9418-9419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4209]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Evaluation of Adolescent Pregnancy Prevention Approaches--
Baseline Data Collection.
    OMB No.: ICRAS: 0970-0360.
    Description: The Administration for Children and Families (ACF), 
U.S. Department of Health and Human Services (HHS), is proposing a data 
collection activity as part of the Evaluation of Adolescent Pregnancy 
Prevention Approaches (PPA). PPA is being undertaken to expand 
available evidence on effective ways to reduce teen pregnancy. The 
evaluation will document and test a range of pregnancy prevention 
approaches in up to eight program sites. Program impacts will be 
estimated using a random assignment design, involving random assignment 
at the school, individual, or other level, depending on the program 
setting. The findings of the evaluation will be of interest to the 
general public, to policy-makers, and to organizations interested in 
teen pregnancy prevention.
    This proposed information collection activity focuses on collecting 
baseline data from a self-administered questionnaire which will be used 
to perform meaningful analysis to determine significant program 
effects. Through a survey instrument, respondents will be asked to 
answer carefully selected questions about demographics and risk and 
protective factors related to teen pregnancy. As appropriate to each 
program being evaluated, youth records, performance, and program 
participation data will also be collected.
    Respondents: The data will be collected through private, self-
administered questionnaires completed by study participants, i.e. 
adolescents assigned to a select school or community teen pregnancy 
prevention program or a control group. Surveys will be distributed and 
collected by trained professional staff. Youth school records, 
performance, and program participation data will also be collected from 
participating schools and organizations, as appropriate to the site.

[[Page 9419]]



                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                      Annual number   responses per     hours per     Total annual
                                                  of respondents    respondent       response      burden hours
----------------------------------------------------------------------------------------------------------------
Baseline Instrument.............................           3,600               1              .5           1,800
School Records, Performance, and Program                       8               1               8              64
 Participation Data Collection..................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 1,864.

Additional Information

    Copies of the proposed collection may be obtained by writing to the 
Administration for Children and Families, Office of Planning, Research 
and Evaluation, 370 L'Enfant Promenade, SW., Washington, DC 20447, 
Attn: OPRE Reports Clearance Officer. All requests should be identified 
by the title of the information collection. E-mail address: 
OPREinfocollection@acf.hhs.gov.

OMB Comment

    ONE is required to make a decision concerning the collection of 
information between 30 and 60 days after publication of this document 
in the Federal Register. Therefore, a comment is best assured of having 
its full effect if OMB receives it within 30 days of publication.
    Written comments and recommendations for the proposed information 
collection should be sent directly to the following: Office of 
Management and Budget, Paperwork Reduction Project, Fax: 202-395-6974, 
Attn: Desk Officer for the Administration for Children and Families.

    Dated: February 23, 2010.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2010-4209 Filed 3-1-10; 8:45 am]
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