Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 58175

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents 

Number of

responses per

respondent 

Average burden hours per

response 

Total burden

hours 

Carryover and Reallotment .............................................................................. 177 1 3 531 

Estimated Total Annual Burden 

Hours: 531. 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Information Services, 

370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. e-mail: 

grjohnson@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication.

Dated: September 23, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–21787 Filed 9–28–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Guidance for the Tribal 

Temporary Assistance for Needy 

Families (TANF) Program. 

OMB No.: 0970-0157. 

Description: 42 U.S.C. 612 (Section 

412 of the Social Security Act) requires 

each Indian tribe that elects to 

administer and operate a TANF program 

to submit a TANF Tribal Plan. The 

TANF Tribal Plan is a mandatory 

statement submitted to the Secretary by 

the Indian tribe, which consists of an 

outline of how the Indian tribe’s TANF 

program will be administered and 

operated. It is used by the Secretary to 

determine whether the plan is 

approvable and to determine that the 

Indian tribe is eligible to receive a 

TANF assistance grant. It is also made 

available to the public. 

Respondents: Indian Tribes applying 

to operate a TANF program.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents 

Number of

responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Request for State Data Needed to Determine the Amount of a Tribal Family 

Assistance Grant .......................................................................................... 20 1 60 1200 

Estimated Total Annual Burden 

Hours: 1200

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

grjohnson@acf.hhs.gov.

OMB Comment: OMB 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, Attn: Desk Officer for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov.

Dated: September 22, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–21788 Filed 9–28–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N–0565]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Generic Food and Drug Administration 

Rapid Response Surveys

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Generic Food and Drug Administration 

Rapid Response Surveys’’ has been 

58176 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of 

Information Resources Management 

(HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 6, 2004, (69 FR 

25404), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. 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. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0500. The 

approval expires on February 28, 2006. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: September 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–21748 Filed 9–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0017]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Adverse Event Pilot Program for 

Medical Devices

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Adverse Event Pilot Program for 

Medical Devices’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 14, 2004 (69 FR 

33034), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. 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. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0471. The 

approval expires on September 30, 

2007. A copy of the supporting 

statement for this information collection 

is available on the Internet at http://

www.fda.gov/ohrms/dockets.

Dated: September 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–21750 Filed 9–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003E–0033]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; DERMAGRAFT

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

DERMAGRAFT and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

medical device.

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/docket/ecomments.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive.

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B).

FDA recently approved for marketing 

the medical device DERMAGRAFT. 

DERMAGRAFT is indicated for use in 

the treatment of full-thickness diabetic 

foot ulcers greater than 6–weeks 

duration, which extend through the 

dermis, but without tendon, muscle, 

joint capsule, or bone exposure. 

DERMAGRAFT should be used in 

conjunction with standard wound care 

regimens and in patients that have 

adequate blood supply to the involved 

foot. Subsequent to this approval, the 

Patent and Trademark Office received a 

patent term restoration application for 

Dermagraft (U.S. Patent No. 4,963,489) 

from Advanced Tissue Sciences, Inc., 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

March 10, 2003, FDA advised the Patent 

and Trademark Office that this medical 

device had undergone a regulatory 

review period and that the approval of 

DERMAGRAFT represented the first 

permitted commercial marketing or use 

of the product. Shortly thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period.

FDA has determined that the 

applicable regulatory review period for 

DERMAGRAFT is 4,050 days. Of this 

time, 3,650 days occurred during the 

testing phase of the regulatory review 

period, while 400 days occurred during 

the approval phase. These periods of