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] 

57942 Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 

‘‘Guidance for Industry: Animal Drug 

Sponsor Fees Under the Animal Drug 

User Fee Act’’ and follow the directions. 

Copies of this guidance may be obtained 

on the Internet from the CVM home 

page at http://www.fda.gov/cvm.

Dated: September 21, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–21677 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–0410]

Draft Guidance for Industry and Food 

and Drug Administration Staff: 

Application User Fees for Combination 

Products; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry and FDA Staff: 

Application User Fees for Combination 

Products.’’ This draft guidance provides 

guidance to industry and FDA staff on 

marketing application user fees for 

combination products. The guidance 

also describes how the ‘‘barrier to 

innovation’’ waiver provision under the 

prescription drug user fee provisions of 

the Federal Food, Drug, and Cosmetic 

Act (act) may be applied to innovative 

combination products in the infrequent 

situation where FDA requires the 

submission of two marketing 

applications.

DATES: Submit written or electronic 

comments on this draft guidance by 

November 29, 2004 to ensure their 

adequate consideration in preparation of 

the final guidance. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Combination Products, 15800 

Crabbs Branch Way, suite 200, 

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

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the guidance.

Submit written comments on the draft 

guidance 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.

FOR FURTHER INFORMATION CONTACT:

Mark D. Kramer, Office of Combination 

Products (HFG–3), Food and Drug 

Administration, 15800 Crabbs Branch 

Way, suite 200, Rockville, MD 20855, 

301–427–1934.

SUPPLEMENTARY INFORMATION:

I. Background

A combination product is a product 

comprised of any combination of a drug 

and a device; a biological product and 

a device; a drug and a biological 

product; or a drug, device and a 

biological product. Depending upon the 

type of combination product, approval, 

clearance or licensure may be obtained 

through submission of a single 

marketing application, or through 

separate marketing applications for the 

individual constituent parts of the 

combination product. For most 

combination products, a single 

marketing application is sufficient for 

the product’s approval, clearance, or 

licensure. In some cases, two marketing 

applications may be submitted for a 

combination product when one 

application would suffice. For example, 

a sponsor may choose to submit two 

applications when one would suffice in 

order to receive some benefit from 

having two applications. In other cases, 

FDA may determine that two marketing 

applications are necessary.

In 1992, Congress passed the 

Prescription Drug User Fee Act 

(PDUFA). PDUFA authorized FDA to 

collect fees from companies that 

produce certain human drug and 

biological products. The Medical Device 

User Fee and Modernization Act of 2002 

amended the act to provide for user fees 

for the review of device applications. 

When a company requests approval of a 

new drug, device or biological product 

prior to marketing, it must submit an 

application along with a fee to support 

the review process.

This document provides guidance to 

industry and FDA staff on marketing 

application user fees for combination 

products as defined under 21 CFR 

3.2(e). The guidance document explains 

that combination products for which a 

single marketing application is 

submitted will be assessed the user fee 

associated with that particular type of 

marketing application. The document 

explains that, if a sponsor chooses to 

submit two marketing applications 

when one would suffice, a user fee for 

each application would ordinarily be 

assessed. The document also explains 

that, in the infrequent situation where 

FDA requires two marketing 

applications for a combination product, 

two application fees would ordinarily 

be assessed. However, the guidance also 

describes how the PDUFA ‘‘barrier to 

innovation’’ waiver provision may be 

applied to innovative combination 

products for which FDA requires the 

submission of two marketing 

applications. Such a waiver would 

provide a reduction in application user 

fees equivalent to the additional fee 

burden associated with the submission 

of two marketing applications. This 

guidance does not address how FDA 

will determine whether a single 

marketing application or multiple 

marketing applications should be 

submitted for a combination product. 

Such guidance is in development and 

will be provided separately for public 

review and comment.

II. Significance of Guidance

This draft guidance document is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized will represent the agency’s 

current thinking on application user 

fees for combination products. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations.

III. Electronic Access

To receive ‘‘Guidance for Industry 

and FDA Staff: Application User Fees 

for Combination Products,’’ you may 

either send a fax request to 301–427–

1935, or an e-mail request to 

combination@fda.gov to receive a hard 

copy or electronic copy of the 

document.

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/oc.combination/

default.htm or http://www.fda.gov/

ohrms/dockets/default.htm.

IV. Comments

The 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 the draft 

guidance. Submit written or electronic 

comments to ensure adequate 

consideration in preparation of the final 

guidance. 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 the