[Federal Register Volume 69, Number 187 (Tuesday, September 28, 2004)]
[Notices]
[Pages 57942-57943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21673]


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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Draft Guidance for Industry and Food and Drug Administration 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.

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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 This draft 
guidance provides guidance to industry and FDA staff on marketing 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DATES: Submit written or electronic comments on this draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Combination Products, 15800 Crabbs Branch 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 self-addressed 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    Submit written comments on the draft guidance to the Division of 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 [email protected] 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

[[Page 57943]]

brackets in the heading of this document. A copy of the draft guidance 
and received comments are available for public examination in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-21673 Filed 9-23-04; 3:08 pm]
BILLING CODE 4160-01-S