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 

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.