[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a notice of availability of a draft guidance document covering the same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