[Federal Register Volume 70, Number 76 (Thursday, April 21, 2005)]
[Notices]
[Pages 20758-20759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0410]


Guidance for Industry and Food and Drug Administration Staff on 
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 guidance for industry and FDA staff entitled 
``Application User Fees for Combination Products.'' This document 
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 (the 
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 guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for copies of this guidance to the 
Office of Combination Products (HFG-3), 15800 Crabbs Branch Way, 
Rockville, MD 20855, or FAX: 301-427-1935. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments concerning this 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Mark D. Kramer, Office of Combination 
Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch 
Way, Rockville, MD 20855, 301-427-1934.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Application User Fees for Combination Products.'' 
In the Federal Register of September 28, 2004 (69 FR 57942), FDA issued 
a notice of availability of a draft guidance document covering the same 
topic.
    As defined under 21 CFR 3.2(e), 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. The guidance 
document explains that combination products for which a single 
marketing application is submitted, should 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

[[Page 20759]]

fees equivalent to the additional fee burden associated with the 
submission of two marketing applications. This guidance does not 
address how FDA should determine whether a single 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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the guidance 
at any time. Submit two paper copies of any mailed comments, 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. The guidance and 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

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/oc/combination or by e-mailing the Office of 
Combination Products at [email protected]. Guidance documents are 
also available on the Division of Dockets Management Internet site at 
http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7947 Filed 4-20-05; 8:45 am]
BILLING CODE 4160-01-S