57940 Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 

IND effective date was July 17, 1991, 

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: August 16, 1999. The 

applicant claims August 24, 1999, as the 

date the new drug application (NDA) for 

VISUDYNE (NDA 21–119) was initially 

submitted. However, FDA records 

indicate that NDA 21–119 was 

submitted on August 16, 1999.

3. The date the application was 

approved: April 12, 2000. FDA has 

verified the applicant’s claim that NDA 

21–119 was approved on April 12, 2000.

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 are 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. 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. 04–21678 Filed 9–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0423]

Second Annual Stakeholder Meeting 

on the Implementation of the Medical 

Device User Fee and Modernization 

Act of 2002 Provisions; Public Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public meeting: Second 

Annual Stakeholder Meeting on the 

Implementation of the Medical Device 

User Fee and Modernization Act of 2002 

(MDUFMA). The topic of discussion is 

the agency’s progress in implementing 

the various MDUFMA provisions, 

including the guidances FDA has issued 

on the new law.

DATES: The public meeting will be held 

on November 18, 2004, from 9 a.m. to 

5 p.m. Registration is required by 

Friday, October 22, 2004. All 

individuals wishing to make a 

presentation or to speak on an issue 

should indicate their intent and the 

topic to be addressed and provide an 

abstract of the topic to be presented by 

October 22, 2004. Time for 

presentations will be limited to 10 

minutes.

ADDRESSES: The public meeting will be 

held at the Marriott Gaithersburg 

Washingtonian Center, 9751 

Washingtonian Blvd., Gaithersburg, MD.

Submit written requests to make an 

oral presentation to Cindy Garris, Center 

for Devices and Radiological Health 

(HFZ–220), Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–443–6597, 

ext. 121, FAX: 301–443–8818, e-mail: 

cxg@cdrh.fda.gov. Include your name, 

title, firm name, address, telephone, and 

fax number with your request. All 

requests and presentation materials 

should include the docket number 

found in brackets in the heading of this 

document. Submit all request for 

suggestions and recommendations to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Cindy Garris, Center for Devices and 

Radiological Health (HFZ–220), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 301–443–

6597, ext. 121, FAX: 301–443–8818, email: cxg@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On October 26, 2002, MDUFMA 

amended the Federal Food, Drug, and 

Cosmetic Act to include several new 

significant provisions. MDUFMA 

authorizes the following provisions: (1) 

User fees for certain premarket 

applications, (2) establishment of good 

manufacturing practice (GMP) 

inspections by FDA-accredited persons 

(third-parties), and (3) new 

requirements for reprocessed single-use 

devices. In addition, the new law 

contains several provisions that, while 

narrower in scope than the previously 

mentioned provisions, are significant 

changes to the device law. These 

include a modular review program for 

premarket approval applications 

(PMAs), electronic labeling for certain 

prescription devices, several provisions 

concerning devices for pediatric use, 

and a new labeling requirement that 

requires the manufacturer’s name to 

appear on the device itself, with certain 

exceptions.

The agency has been working to 

implement the new law since its 

passage in October 2002. During this 

time, FDA has accomplished the 

following significant milestones: (1) 

Established a user fee program with 

payment, billing, and appeals 

procedures; (2) published accreditation 

criteria for persons conducting thirdparty inspections and accredited 15 

such persons; (3) identified certain 

reprocessed single-use devices that will 

be subject to additional marketing 

requirements; and (4) published 

guidances related to the PMA, 

premarket notification (510(k)), and 

biologics license application (BLA) 

programs, bundling multiple devices in 

a single application, and premarket 

review of pediatric devices. The agency 

is drafting additional documents to be 

issued in the near future.

II. Agenda

On November 18, 2004, FDA is 

providing the opportunity for all 

interested persons to provide 

information and share their views on 

the implementation of MDUFMA. The 

following topics will be discussed:

• User Fees Process—This panel will 

consider the small business 

determination and the user fee payment 

processes.

Premarket Review Performance 

Goals—This panel will discuss the 

agency’s progress in meeting the PMA, 

510(k), and BLA review performance 

goals.

• Qualitative Performance Goals (e.g., 

Modular PMA and GMP and 

Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 57941

Bioresearch Monitoring (BIMO) 

Inspection Programs)— This panel will 

discuss the agency’s progress in 

developing various qualitative 

performance goals, such as those related 

to the modular PMA and GMP 

inspection programs. This panel will 

also discuss internally-established 

milestones for the BIMO inspection 

process.

• Third-Party Inspection Program—

This panel will discuss implementing 

guidances for the program, including 

establishment eligibility criteria for 

inspection by a third party.

• Reuse— This panel will discuss the 

FDA-identified reprocessed single-use 

devices that require submission of 

certain validation data and the guidance 

that describes the agency’s review 

procedures for such submissions. This 

panel will also report on FDA’s progress 

in reviewing the validation data 

submissions.

At the conclusion of the meeting, 

there will be a general discussion from 

the floor.

III. Registration

Online registration for the meeting is 

required by October 22, 2004. 

Acceptance will be on a first-come, firstserved basis. There will be no onsite 

registration. Please register online at 

http://www.fda.gov/cdrh/meetings/

120303.html. FDA is pleased to provide 

the opportunity for interested persons to 

listen from a remote location to the live 

proceedings of the meeting. In order to 

ensure that a sufficient number of callin lines are available, please register to 

listen to the meeting at http://

www.fda.gov/cdrh/meetings/

120303.html by October 22, 2004. 

Persons without Internet access may 

register for the onsite meeting or to 

listen remotely by calling 301–443–

6597, ext. 121 by October 22, 2004.

If you need special accommodations 

due to a disability, please contact Cindy 

Garris at 301–443–6597, ext. 121 at least 

7 days in advance.

IV. Request for Suggestions, 

Recommendations, and Materials

FDA is particularly interested in 

receiving suggestions from stakeholders 

on other topics for discussion. The 

agency is interested in receiving 

recommendations about other 

provisions yet to be implemented both 

in terms of their priority for 

implementation and specifics on the 

implementation itself. Send suggestions 

or recommendations to the Division of 

Dockets Management (see ADDRESSES).

FDA will place an additional copy of 

any material it receives on the docket 

for this document (2004N–0423). 

Suggestions, recommendations, and 

materials may be seen at the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday (see 

ADDRESSES).

V. Transcripts

Following the meeting, transcripts 

will be available for review at the 

Division of Dockets Management (see 

ADDRESSES).

Dated: September 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–21676 Filed 9–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0422]

Guidance for Industry: Animal Drug 

Sponsor Fees Under the Animal Drug 

User Fee Act; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance (#173) 

entitled ‘‘Guidance For Industry: 

Animal Drug Sponsor Fees Under the 

Animal Drug User Fee Act (ADUFA).’’

This draft guidance describes how FDA 

intends to implement the Federal Food, 

Drug, and Cosmetic Act (the act) as it 

relates to animal drug sponsor fees.

DATES: Submit written or electronic 

comments on the draft guidance by 

October 28, 2004, to ensure their 

adequate consideration in preparation of 

the final document. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document to the Communications Staff 

(HFV–12), Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests.

Submit written comments on the draft 

guidance document 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/dockets/ecomments. 

Comments should be identified with the 

full title of the draft guidance document 

and the docket number found in the 

heading of this document. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document.

FOR FURTHER INFORMATION CONTACT:

David Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: dnewkirk@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The Animal Drug User Fee Act of 

2003 (ADUFA), enacted on November 

18, 2003, amends the act by adding 

sections 739 and 740 (21 U.S.C. 379j-11 

and 379j-12). Section 740 requires FDA 

to assess and collect user fees for certain 

applications, products, establishments, 

and sponsors. This draft guidance 

represents FDA’s current thinking on 

how it intends to implement the animal 

drug sponsor fee provision of ADUFA.

II. Paperwork Reduction Act of 1995

FDA tentatively concludes that this 

draft guidance contains no collections of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required.

III. Significance of Guidance

This draft guidance is being issued as 

a level 1 guidance consistent with our 

good guidance practices regulation (21 

CFR 10.115). It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternate method may be used as 

long as it satisfies the requirements of 

the applicable statutes and regulations.

III. Comments

This draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding this draft 

guidance 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.

IV. Electronic Access

Electronic comments may be 

submitted on the Internet at http://

www.fda.gov/dockets/ecomments. Once 

on this site, select [2004D–0422]