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

9420 Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Notices 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 15, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Nicole 

Vesely at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 24, 2010. 

Joanne Less, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–4261 Filed 3–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Pulmonary-Allergy 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: PulmonaryAllergy 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 April 7, 2010, from 8 a.m. to 5 

p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Kristine T. Khuc, 

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– 

7001, FAX: 301–827–6776, e-mail: 

Kristine.Khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512545. 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: On April 7, 2010, the 

committee will discuss new drug 

application (NDA) 22–522, roflumilast 

(DAXAS), Forest Research Institute, for 

the maintenance treatment of chronic 

obstructive pulmonary disease 

associated with chronic bronchitis in 

patients at risk of exacerbations 

(worsening symptoms). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

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 April 1, 2010. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 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 24, 2010. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 25, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Kristine T. 

Khuc at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2) 

Dated: February 24, 2010. 

Joanne Less, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–4262 Filed 3–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES