82032 Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Notices 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: 

kristine.khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. 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 March 8, 2011, the 

committee will discuss new drug 

application (NDA) 022–383, indacaterol 

maleate (ARCAPTA NEOHALER), by 

Novartis Pharmaceuticals Corp., for the 

long-term once daily maintenance 

bronchodilator treatment of airflow 

obstruction in patients with chronic 

obstructive pulmonary disease, 

including chronic bronchitis and/or 

emphysema. 

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 February 22, 2011. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 2 p.m. Those individuals 

interested in making 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 February 

11, 2011. 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 February 14, 2011. 

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/ 

AdvisoryCommittees/ 

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: December 21, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–32735 Filed 12–28–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to OMB for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Ryan White HIV/ 

AIDS Program Allocation and 

Expenditure Forms (OMB No. 0915– 

0318)—[Extension] 

The Ryan White HIV/AIDS Program 

Allocation and Expenditure Reports will 

enable the Health Resources and 

Services Administration’s HIV/AIDS 

Bureau to track spending requirements 

for each program as outlined in the 

legislation. Grantees funded under Parts 

A, B, C, and D of the Ryan White HIV/ 

AIDS Program (codified under Title 

XXVI of the Public Health Service Act) 

would be required to report financial 

data to HRSA at the beginning and end 

of their grant cycle. 

All parts of the Ryan White HIV/AIDS 

Program specify HRSA’s responsibilities 

in the administration of grant funds. 

Accurate allocation and expenditure 

records of the grantees receiving Ryan 

White HIV/AIDS Program funding are 

critical to the implementation of the 

legislation and thus are necessary for 

HRSA to fulfill its responsibilities. 

The forms would require grantees to 

report on how funds are allocated and 

spent on core and non-core services, 

and on various program components, 

such as administration, planning, 

evaluation, and quality management. 

The two forms are identical in the types 

of information that are collected. 

However, the first report would track 

the allocation of the award at the 

beginning of the grant cycle and the 

second report would track actual 

expenditures (including carryover 

dollars) at the end of the grant cycle. 

The primary purposes of these forms 

are to (1) provide information on the 

number of grant dollars spent on various 

services and program components, and 

(2) oversee compliance with the intent 

of Congressional appropriations in a 

timely manner. In addition to meeting 

the goal of accountability to the 

Congress, clients, advocacy groups, and 

the general public, information 

collected on these reports is critical for 

HRSA, state and local grantees, and 

individual providers for the evaluation 

of the effectiveness of these programs. 

The response burden for grantees is 

estimated as: 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Notices 82033 

Program under which grantee is funded 

Number of 

grantee 

respondents 

Responses 

per grantee 

Total 

responses 

Hours to 

complete 

each form 

Total hours 

Part A ................................................................................... 56 2 112 8 896 

Part B ................................................................................... 59 2 118 12 1416 

Part A MAI ........................................................................... 56 2 112 4 448 

Part B MAI ........................................................................... 59 2 118 4 472 

Part C ................................................................................... 361 2 722 7 5054 

Part D ................................................................................... 90 2 180 7 1260 

Total .............................................................................. 681 ........................ 1,362 ........................ 9,546 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this Federal 

Register Notice to the desk officer for 

HRSA, either by e-mail to 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. Please direct all 

correspondence to the ‘‘attention of the 

desk officer for HRSA.’’ 

Dated: December 22, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–32708 Filed 12–28–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental and 

Craniofacial Research; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

National Advisory Dental and 

Craniofacial Research Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Dental and Craniofacial Research Council. 

Date: January 24, 2011. 

Open: 8:30 a.m. to 11:30 a.m. 

Agenda: Report to the Director, NIDCR. 

Place: National Institutes of Health, 

Building 31C, 31 Center Drive, 6th Floor, 

Conference Room 10, Bethesda, MD 20892. 

Closed: 1 p.m. to Adjournment. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31C, 31 Center Drive, 6th Floor, 

Conference Room 10, Bethesda, MD 20892. 

Contact Person: Alicia J. Dombroski, PhD, 

Director, Division of Extramural Activities, 

Natl. Inst. of Dental and Craniofacial 

Research, National Institutes of Health, 

Bethesda, MD 20892. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nidcr.nih.gov/about, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: December 21, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–32746 Filed 12–28–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meetings 

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 meetings. 

The meetings 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. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel. Application of ‘‘Omics’’ 

Technologies in Tissue Samples. 

Date: January 18, 2011. 

Time: 9:30 a.m. to 10:45 a.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: NIEHS/National Institutes of Health 

Sciences, Keystone Bldg., 530 Davis Drive, 

Research Triangle Park, NC 27709. 

(Telephone Conference Call). 

Contact Person: RoseAnne M McGee, 

Associate Scientific Review Administrator, 

Scientific Review Branch, Division of 

Extramural Research and Training, Nat. 

Institute of Environmental Health Sciences, 

P.O. Box 12233, MD EC–30, Research 

Triangle Park, NC 27709. (919) 541–0752. 

mcgee1@niehs.nih.gov. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel. High Throughput Screening 

for Reactive Oxygen Species. 

Date: January 18, 2011. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. (Telephone Conference 

Call). 

Contact Person: RoseAnne M McGee, 

Associate Scientific Review Administrator, 

Scientific Review Branch, Division of 

Extramural Research and Training, Nat. 

Institute of Environmental Health Sciences, 

P.O. Box 12233, MD EC–30, Research 

Triangle Park, NC 27709. (919) 541–0752. 

mcgee1@niehs.nih.gov. 

Name of Commitee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel. In Vitro 3–D Tissue Models 

for Toxicity Testing. 

Date: January 18, 2011. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: NIEHS/National Institutes of Health, 

Keystone Bldg., 530 Davis Drive, Research 

Triangle Park, NC 27709. (Telephone 

Conference Call). 

Contact Person: RoseAnne M McGee, 

Associate Scientific Review Administrator, 

Scientific Review Branch, Division of 

Extramural Research and Training, Nat. 

Institute of Environmental Health Sciences, 


srobinson on DSKHWCL6B1PROD with NOTICES