Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices 28985 

IND effective date was January 16, 1997, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: January 16, 2001. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

Bextra (NDA 21–341) was initially 

submitted on January 16, 2001. 

3. The date the application was 

approved: November 16, 2001. FDA has 

verified the applicant’s claim that NDA 

21–341 was approved on November 16, 

2001. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 276 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by July 23, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

November 19, 2007. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: May 2, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–9957 Filed 5–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: Pretesting of Substance Abuse 

Prevention and Treatment and Mental 

Health Services Communication 

Messages—(OMB No. 0930–0196)— 

Extension 

As the Federal agency responsible for 

developing and disseminating 

authoritative knowledge about 

substance abuse prevention, addiction 

treatment, and mental health services 

and for mobilizing consumer support 

and increasing public understanding to 

overcome the stigma attached to 

addiction and mental illness, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) is 

responsible for development and 

dissemination of a wide range of 

education and information materials for 

both the general public and the 

professional communities. This 

submission is for generic approval and 

will provide for formative and 

qualitative evaluation activities to (1) 

assess audience knowledge, attitudes, 

behavior and other characteristics for 

the planning and development of 

messages, communication strategies and 

public information programs; and (2) 

test these messages, strategies and 

program components in developmental 

form to assess audience comprehension, 

reactions and perceptions. Information 

obtained from testing can then be used 

to improve materials and strategies 

while revisions are still affordable and 

possible. The annual burden associated 

with these activities is summarized 

below. 

Activity No. of 

respondents 

Responses 

respondent 

Hours per 

response Total hours 

Individual In-depth Interviews: 

General Public .......................................................................................... 400 1 .75 300 

Service Providers ..................................................................................... 200 1 .75 150 

Focus Group Interviews: 

General Public .......................................................................................... 3,000 1 1.5 4,500 

Service Providers ..................................................................................... 1,500 1 1.5 2,250 

Telephone Interviews: 

General Public .......................................................................................... 335 1 .08 27 

Service Providers ..................................................................................... 165 1 .08 13 

Self-Administered Questionnaires: 

General Public .......................................................................................... 2,680 1 .25 670 

Service Providers ..................................................................................... 1,320 1 .25 330 

Gatekeeper Reviews: 

General Public .......................................................................................... 1,200 1 .50 600 

Service Providers ..................................................................................... 900 1 .50 450 

Total ................................................................................................... 11,700 ........................ ........................ 9,290 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by June 22, 2007 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 


pwalker on PROD1PC71 with NOTICES
28986 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Notices 

Dated: May 7, 2007. 

Elaine Parry, 

Acting Director, Office of Program Services. 

[FR Doc. E7–9900 Filed 5–22–07; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5117–N–44] 

Notice of Submission of Proposed 

Information Collection to OMB; Early 

Doctoral Student Research Grant 

Program 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

has been submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

Doctoral students will receive grants 

to complete their dissertations related to 

HUD subjects. 

DATES: Comments Due Date: June 22, 

2007. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

approval Number (2528–0216) and 

should be sent to: HUD Desk Officer, 

Office of Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Deitzer, Departmental Reports 

Management Officer, QDAM, 

Department of Housing and Urban 

Development, 451 Seventh Street, SW., 

Washington, DC 20410; e-mail 

Lillian_L._Deitzer@HUD.gov or 

telephone (202) 708–2374. This is not a 

toll-free number. Copies of available 

documents submitted to OMB may be 

obtained from Ms. Deitzer or from 

HUD’s Web site at http:// 

www5.hud.gov:63001/po/i/icbts/ 

collectionsearch.cfm. 

SUPPLEMENTARY INFORMATION: This 

notice informs the public that the 

Department of Housing and Urban 

Development has submitted to OMB a 

request for approval of the information 

collection described below. This notice 

is soliciting comments from members of 

the public and affecting agencies 

concerning the proposed collection of 

information to: (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; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (3) Enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) Minimize the 

burden of the collection of information 

on those who are to respond; including 

through the use of appropriate 

automated collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

This notice also lists the following 

information: 

Title of Proposal: Early Doctoral 

Student Research Grant Program. 

OMB Approval Number: 2528–0216. 

Form Numbers: SF–424, SF–424 

Supplement, HUD–424CB, SFLLL, 

HUD–27300, HUD–2880, HUD–2944A, 

HUD–96010, HUD–96011. 

Description of the Need for the 

Information and Its Proposed Use: 

Doctoral students will receive grants to 

complete their dissertations related to 

HUD subjects. 

Frequency of Submission: On 

occasion, Semi-annually, Other Final 

Report. 

Number of 

respondents 

Annual 

responses x Hours per response = Burden hours 

Reporting Burden .............................................................. 80 1.56 21.68 2710 

Total Estimated Burden Hours: 2,710. 

Status: Extension of a current 

collection. 

Authority: Section 3507 of the Paperwork 

Reduction Act of 1995, 44 U.S.C. 35, as 

amended. 

Dated: May 18, 2007. 

Lillian L. Deitzer, 

Departmental Paperwork Reduction Act 

Officer, Office of the Chief Information 

Officer. 

[FR Doc. E7–9953 Filed 5–22–07; 8:45 am] 

BILLING CODE 4210–67–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5117–N–43] 

Notice of Submission of Proposed 

Information Collection to OMB; 

Mortgage Insurance Termination; 

Application for Premium Refund or 

Distributive Share Payment 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

has been submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

The Mortgage Insurance Termination 

Information is used by FHA-approved 

lenders to terminate FHA insurance to 

comply with HUD requirements. The 

Application for Premium Refund or 

Distributive Share Payment is used by 

homeowners to apply for the unearned 

portion of the mortgage insurance 

premium or a distributive share 

payment. 

DATES: Comments Due Date: June 22, 

2007. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

approval Number (2502–0414) and 

should be sent to: HUD Desk Officer, 

Office of Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Deitzer, Departmental Reports 

Management Officer, QDAM, 

Department of Housing and Urban 

Development, 451 Seventh Street, SW., 

Washington, DC 20410; e-mail 

Lillian_L._Deitzer@HUD.gov or 

telephone (202) 708–2374. This is not a 

toll-free number. Copies of available 

documents submitted to OMB may be 

obtained from Ms. Deitzer or from 

HUD’s Web site at http:// 

www5.hud.gov:63001/po/i/icbts/ 

collectionsearch.cfm. 

SUPPLEMENTARY INFORMATION: This 

notice informs the public that the 

Department of Housing and Urban 

Development has submitted to OMB a 

request for approval of the information 

collection described below. This notice 

is soliciting comments from members of 

the public and affecting agencies 

concerning the proposed collection of 


pwalker on PROD1PC71 with NOTICES