Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 50809 

to http://www.fda.gov/ForIndustry/ 

ElectronicSubmissionsGateway/ 

default.htm. 

4. Communications Concerning the 

Planned Submission 

Applicants participating in the pilot 

program should contact the appropriate 

center point-of-contact by e-mail (see 

FOR FURTHER INFORMATION CONTACT) 120 

days prior to the intended date of the 

proposed proprietary name submission 

to discuss specific details of the planned 

submission. If applicants plan to use 

alternative or additional methods to 

evaluate the safety of their proposed 

proprietary name(s), they should inform 

the appropriate center 120 days prior to 

their planned submission date. FDA 

does not have the resources to review 

the proposed alternative methodologies 

with the intent of coming to agreement 

with an applicant on the 

appropriateness of these alternative 

methodologies prior to submission. In 

such cases, FDA will review the 

alternative methodologies during the 

review of the actual submission. 

If applicants have questions 

concerning the planned submission 

under the pilot program, they should 

contact the appropriate center point-ofcontact by e-mail (see FOR FURTHER

INFORMATION CONTACT) to discuss their 

questions. If necessary, applicants will 

be asked to submit their questions in 

writing; in some cases, a teleconference 

or face-to-face meeting to discuss the 

planned submission may be 

appropriate. 

E. Process To Request FDA Review of an 

Alternate Proposed Proprietary Name 

If, after parallel reviews of the 

proprietary name submission, FDA 

informs the applicant that the primary 

proposed proprietary name is 

unacceptable, the applicant should 

confirm in writing that it would like its 

previously identified alternate proposed 

proprietary name to be reviewed or 

submit a different alternate proprietary 

name. At this time, the applicant can 

request to have the alternate proprietary 

name evaluated by FDA under the pilot 

program or by the traditional review 

method. If the request is to have the 

alternate proprietary name reviewed 

under the pilot program, the applicant 

should submit the comprehensive 

evaluation of the alternate proposed 

proprietary name, including the 

information and data described in 

section II.D.2 of this document. If the 

request is to have the alternate 

proprietary name evaluated by the 

traditional method, the applicant may 

reference the information previously 

submitted for parallel review of the 

proposed primary proprietary name 

(Section I of the pilot program 

submission labeled ‘‘TRADITIONAL 

REVIEW’’). 

A new proprietary name review clock 

for an alternate proposed proprietary 

name will not start until: 

(1) The applicant has confirmed to the 

appropriate center, in writing, that it 

would like its alternate proprietary 

name evaluated by traditional review 

method or 

(2) FDA receives the applicant’s 

submission of an alternate proposed 

proprietary name along with the 

comprehensive information for section 

II ‘‘PILOT REVIEW’’ described in 

section II.D.2 of this document. 

For either review method requested 

(traditional or pilot), the same PDUFA 

IV review performance goal timeframes 

apply to the review of the submission of 

an alternate proposed proprietary name 

(i.e., IND—180 days from receipt of 

complete submission; NDA or BLA—90 

days from receipt of complete 

submission). 

If the applicant requests that its 

alternate proprietary name be evaluated 

under the pilot program, the agency will 

take into account the date of the 

alternate proprietary name submission 

as it relates to the PDUFA IV goal for the 

application. The responsible center will 

use discretion to determine whether the 

agency will conduct a parallel review of 

the applicant’s analysis or only a 

proprietary name evaluation using 

FDA’s traditional approach. Although 

FDA would ideally also review the 

applicant’s completed proprietary name 

analysis for the alternate name under 

the pilot program, resources may not 

permit such a review. Factors such as 

staffing will be used in making this 

determination. 

F. Duration and Evaluation of the Pilot 

Program 

At the end of fiscal year 2011, or after 

accruing 2 years of experience with 

pilot program submissions, FDA intends 

to evaluate the pilot program to 

determine whether to have applicants 

perform their own proprietary name 

analysis and submit resulting data to 

FDA for review. The results of this pilot 

program and recommended additions 

and/or changes to methods based on the 

reported results will be discussed in a 

future public meeting. Following that 

meeting, FDA will publish a draft 

guidance describing the best test 

methods for proprietary name 

evaluation. 

III. Paperwork Reduction Act of 1995 

The information collection provisions 

of this pilot program, excluding the 

submission of information that is part of 

the agency’s traditional review of 

proprietary names, have been submitted 

to the Office of Management and Budget 

(OMB) for review, as required by section 

3507 of the Paperwork Reduction Act of 

1995. The provisions were approved 

and assigned OMB control number 

0910–0648. This approval expires 

September 30, 2012. The proprietary 

name information submitted as part of 

the traditional review of proprietary 

names is approved under OMB control 

numbers 0910–0001 and 0910–0338. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the concept paper at http:// 

www.fda.gov/downloads/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

ucm072229.pdf. 

Dated: September 25, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23620 Filed 9–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Community Services, 

Program Expansion Supplement Grant 

Award 

AGENCY: Office of Community Services, 

ACF, HHS. 

ACTION: Notice to award a Program 

Expansion Supplement Grant. 

CFDA Number: 93.710. 

Legislative Authority: The legislative 

authority is provided in the American 

Recovery and Reinvestment Act of 2009 

(ARRA) [Pub. L. 111–5]. Additional 

legislative authority and requirements 

are provided in Section 674(b)(2)(B) of 

the Community Services Block Grant 

Act (CSBG), as amended, by the 

Community Opportunity 

Accountability, and Training and 

Educational Services (Coats Human 

Services Reauthorization Act of 1998) 

[Pub. L. 105–285]. 

Amount of Award: $500,000. 

Project Period: July 1, 2009–June 30, 

2010. 

Summary: The Office of Community 

Services (OCS) announces the award of 

a $500,000 single source program 


PWALKER on DSK8KYBLC1PROD with NOTICES
50810 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 

expansion supplement to the National 

Association for State Community 

Services Programs (NASCSP), located in 

Washington, DC, to support 

performance training and technical 

assistance on data collection, analysis 

and dissemination issues faced by state 

community services programs within 

the Community Services Block Grant 

(CSBG) Network; develop performance 

based reporting tools for ARRA CSBG 

funded activities; develop and maintain 

a catalog of innovative programs and 

practices related to the American 

Recovery and Reinvestment Act of 2009 

(ARRA). The project activities are 

designed to support and strengthen the 

ability of the CSBG Network to comply 

with and carry out CSBG activities 

funded by ARRA. The training projects 

and resources developed under the 

award will include analysis and 

explanation of the practical impact of 

ARRA for States and CSBG-eligible 

entities so that they can work more 

effectively to reach the ARRA goals and 

document how they have in fact reached 

those goals and used the ARRA funds. 

Contact for Further Information: 

Danielle Williams, U.S. Department of 

Health and Human Services, Office of 

Community Services, Administration 

for Children and Families, 370 L’Enfant 

Promenade, SW., Washington, DC 

20047, Telephone: (202) 205–4717, Email: Danielle.Williams@acf.hhs.gov. 

Dated: September 25, 2009. 

Yolanda J. Butler, 

Acting Director, Office of Community 

Services. 

[FR Doc. E9–23726 Filed 9–30–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0294] 

Regulation of Tobacco Products; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

December 28, 2009, the comment period 

for the notice that appeared in the 

Federal Register of July 1, 2009 (74 FR 

31457). In the notice, FDA requested 

comments on the implementation of the 

Family Smoking Prevention and 

Tobacco Control Act (the Tobacco Act). 

The agency is taking this action in 

response to a request for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: Submit electronic and written 

comments by December 28, 2009. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Erik 

Mettler, Center for Tobacco Products, 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD, 20850– 

3229, 301–796–4830, 

Erik.Mettler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 1, 2009 

(74 FR 31457), FDA published a notice 

with a 90-day comment period to 

request comments on the 

implementation of the Tobacco Act. 

Comments from the public will inform 

FDA’s actions implementing the 

Tobacco Act. 

The agency has received a request for 

an extension of the comment period for 

the notice. This request conveyed 

concern that the current 90-day 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the notice. 

FDA has considered the request and 

is extending the comment period for the 

notice for 90 days, until December 28, 

2009. The agency believes that a 90-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying 

rulemaking on these important issues. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments on this document. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: September 25, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23607 Filed 9–28–09; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form N–600; Extension of 

an Existing Information Collection; 

Comment Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: Form N–600, 

Application for Certificate of 

Citizenship; OMB Control Number 

1615–0057. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on June 25, 2009, at 74 FR 

30315, allowing for a 60-day public 

comment period. USCIS did not receive 

any comments. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until November 2, 

2009. This process is conducted in 

accordance with 5 CFR 1320.10. 

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 

Department of Homeland Security 

(DHS), and to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), USCIS 

Desk Officer. Comments may be 

submitted to: USCIS, Chief, Regulatory 

Products Division, Clearance Office, 111 

Massachusetts Avenue, Washington, DC 

20529–2210. Comments may also be 

submitted to DHS via facsimile to 202– 

272–8352 or via e-mail at 

rfs.regs@dhs.gov, and to the OMB USCIS 

Desk Officer via facsimile at 202–395– 

5806 or via e-mail at 

oira_submission@omb.eop.gov. 

When submitting comments by email, please make sure to add OMB 

Control No. 1615–0057 in the subject 

box. Written comments and suggestions 

from the public and affected agencies 

should address one or more of the 

following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 


PWALKER on DSK8KYBLC1PROD with NOTICES