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 

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 

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] 

BILLING CODE 4140–01–P 

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. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Notices 9419 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual number of respondents Number of responses per 

respondent 

Average burden hours per 

response 

Total annual 

burden hours 

Baseline Instrument ......................................................................................... 3,600 1 .5 1,800 

School Records, Performance, and Program Participation Data Collection ... 8 1 8 64 

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] 

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. 

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. 

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 

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 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES