Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 58177

time were derived from the following 

dates:

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

and Cosmetic Act involving this device 

became effective: August 29, 1990. The 

applicant claims that the investigational 

device exemption (IDE) required under 

section 520(g) of the Federal Food, Drug, 

and Cosmetic Act for human tests to 

begin became effective on September 2, 

1992. FDA records confirm that one IDE 

for this medical device did become 

effective on September 2, 1992. 

However, FDA records also indicate that 

another IDE for this medical device was 

determined substantially complete for 

clinical studies to have begun on August 

29, 1990, which represents the IDE 

effective date. Although this IDE was for 

a different indication, it is material to 

the approval of DERMAGRAFT. FDA 

considers all investigational exemptions 

for a particular product to be material to 

the approval of the product regardless of 

any difference between the indications 

studied and those ultimately approved.

2. The date the application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): August 25, 2000. The 

applicant claims August 24, 2000, as the 

date the premarket approval application 

(PMA) for DERMAGRAFT (PMA 

P00036) was initially submitted. 

However, FDA records indicate that 

PMA P00036 was submitted on August 

25, 2000.

3. The date the application was 

approved: September 28, 2001. FDA has 

verified the applicant’s claim that PMA 

P00036 was approved on September 28, 

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 5 years of patent 

term extension.

Anyone with knowledge that any of 

the dates as published is incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by November 29, 2004. 

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 

March 28, 2005. 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 and 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: August 30, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–21749 Filed 9–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Citizenship and Immigration Services 

Agency Information Collection 

Activities: Extension of Existing 

Collection; Comment Request

ACTION: Request OMB Emergency 

Approval: Request to Enforce Affidavit 

of Financial Support and Intent to 

Petition for Custody for Public Law 97–

359 Amerasian; Form I–363. 

The Department of Homeland 

Security (DHS), Citizenship and 

Immigration Services (CIS) has 

submitted an emergency information 

collection request (ICR) utilizing 

emergency review procedures, to the 

Office of Management and Budget 

(OMB) for review and clearance in 

accordance with section 

1320.13(a)(1)(ii) and (a)(2)(iii) of the 

Paperwork Reduction Act of 1995. The 

DHS has determined that it cannot 

reasonably comply with the normal 

clearance procedures under this part 

because normal clearance procedures 

are reasonably likely to prevent or 

disrupt the collection of information. 

Therefore, OMB approval has been 

requested by October 31, 2004. 

If granted, the emergency approval is 

only valid for 90 days. ALL comments 

and/or questions pertaining to this 

pending request for emergency approval 

MUST be directed to OMB, Office of 

Information and Regulatory Affairs, 

Attention: Desk Officer, Department of 

Homeland Security, 725–17th Street, 

NW., Suite 10235, Washington, DC 

20503; 202–395–5806. 

During the first 60 days of this same 

period, a regular review of this 

information collection is also being 

undertaken. During the regular review 

period, the DHS requests written 

comments and suggestions from the 

public and affected agencies concerning 

this information collection. Comments 

are encouraged and will be accepted 

until November 29, 2004. During the 60-

day regular review, ALL comments and 

suggestions, or questions regarding 

additional information, as well as 

requests to obtain a copy of the 

information collection instrument with 

instructions, should be directed to Mr. 

Richard A. Sloan, 202–616–7600, 

Director, Regulatory Management 

Division, Department of Homeland 

Security, 111 Massachusetts Avenue, 

NW., Washington, DC 20529. Written 

comments and suggestions from the 

public and affected agencies concerning 

the proposed collection of information 

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; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(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, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of this information 

collection:

(1) Type of Information Collection:

Extension of a currently approved 

information collection.

(2) Title of the Form/Collection:

Request to Enforce Affidavit of 

Financial Support and Intent to Petition 

for Custody for Public Law 97–359 

Amerasian. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: Form I–363. Citizenship and 

Immigration Services (CIS). 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

Households. This form is used to 

determine whether an Affidavit of 

Financial Support and Intent to Petition 

for Legal Custody requires enforcement. 

58178 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 50 responses at 30 minutes (.50 

hours) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 25 annual burden hours. 

If you have additional comments, 

suggestions, or need a copy of the 

proposed information collection 

instrument with instructions, or 

additional information, please contact 

Richard A. Sloan 202–616–7600, 

Director, Regulatory Management 

Division, Citizenship and Immigration 

Services, Department of Homeland 

Security, 111 Massachusetts Avenue, 

NW., Washington, DC 20529. 

Additionally, comments and/or 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time may also 

be directed to Mr. Richard A. Sloan.

Dated: September 24, 2004. 

Richard A. Sloan, 

Department Clearance Officer, Department of 

Homeland Security, Citizenship and 

Immigration Services.

[FR Doc. 04–21791 Filed 9–28–04; 8:45 am] 

BILLING CODE 4410–10–M

DEPARTMENT OF HOMELAND 

SECURITY 

Citizenship and Immigration Services 

Agency Information Collection 

Activities: Extension of Existing 

Collection; Comment Request

ACTION: Request OMB Emergency 

Approval; Petition for Nonimmigrant 

Worker; Form I–129

The Department of Homeland 

Security, Citizenship and Immigration 

Services (CIS) has submitted the 

following information collection request 

(ICR) utilizing emergency review 

procedures to the Office of Management 

and Budget (OMB) for review and 

clearance in accordance with section 

1320.13(a)(1)(ii) and (1)(2)(iii) of the 

Paperwork Reduction Act of 1995. The 

DHS has determined that it cannot 

reasonably comply with the normal 

clearance procedures under this part 

because normal clearance procedures 

are reasonably likely to prevent or 

disrupt the collection of information. 

Emergency review and approval of this 

information collection will ensure that 

the collection may continue. Therefore, 

OMB approval has been requested by 

October 31, 2004. 

If grant, the emergency approval is 

only valid for 90 days. ALL comments 

and/or questions pertaining to this 

pending request for emergency approval 

MUST be directed to OMB, Office of 

Information and Regulatory Affairs, 

Attention: Desk Officer, Department of 

Homeland Security, 725—17th Street, 

NW., Suite 10235, Washington, DC 

20503, 202–395–5806. 

During the first 60 days of this same 

period, a regular review of this 

information collection is also being 

undertaken. During the regular review 

period, the DHS requests written 

comments and suggestions from the 

public and affected agencies concerning 

this information collection. Comments 

are encouraged and will be accepted for 

sixty days until November 29, 2004. 

During the 60-day regular review. ALL 

comments and suggestions, or questions 

regarding additional information, as 

well as requests to obtain a copy of the 

information collection instrument with 

instructions, should be directed to Mr. 

Richard A. Sloan, 202–616–7600, 

Director, Regulatory Management 

Division, Citizenship and Immigration, 

U.S. Department of Homeland Security, 

111 Massachusetts Avenue, NW., 

Washington, DC 20529. Written 

comments and suggestions from the 

public and affected agencies concerning 

the proposed collection of information 

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; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(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, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of this information 

collection:

(1) Type of Information Collection: 

Extension of a previously approved 

information collection.

(2) Title of the Form/Collection:

Petition for Nonimmigrant Worker. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form I–129, 

Citizenship and Immigration Services. 

(4) Affected public who will be asked 

or required to respond, as well as brief 

abstract: Primary: Individuals or 

households. This form is used by an 

employer to petition for aliens to come 

to the U.S. temporarily to perform 

services, labor, training or to request 

extensions of stay or changes in 

nonimmigrant status for nonimmigrant 

workers. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 368,948 responses at 2.75 

hours per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 998,357 annual burden 

hours. 

If you have additional comments, 

suggestions, or need a copy of the 

proposed information collection 

instrument with instructions, or 

additional information, please contact 

Richard A. Sloan, 202–616–7600, 

Director, Regulatory Management 

Division, U.S. Department of Homeland 

Security, 111 Massachusetts Avenue, 

NW., Washington, DC 20529. 

Additionally, comments and/or 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time may also 

be directed to Mr. Richard A. Sloan.

Dated: September 24, 2004. 

Richard A. Sloan, 

Departmental Clearance Officer, U.S. 

Department of Homeland Security, 

Citizenship and Immigrant Services.

[FR Doc. 04–21792 Filed 9–28–04; 8:45 am] 

BILLING CODE 4410–10–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service 

Information Collection Renewal 

Submitted to the Office of Management 

and Budget (OMB) for Approval Under 

the Paperwork Reduction Act; OMB 

Control Number 1018–0111; Summary 

Information for Ranking National 

Coastal Wetlands Grant Program 

Proposals, 50 CFR Part 84

AGENCY: Fish and Wildlife Service, 

Interior.

ACTION: Notice; request for comments.

SUMMARY: The Fish and Wildlife Service 

(We) has submitted the collection of 

information listed below to OMB for 

approval under the provisions of the 

Paperwork Reduction Act of 1995. If