[Federal Register: September 28, 2004 (Volume 69, Number 187)]
[Notices]
[Page 57942-57943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se04-74]
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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Draft Guidance for Industry and Food and Drug Administration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 This draft
guidance provides guidance to industry and FDA staff on marketing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DATES: Submit written or electronic comments on this draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Combination Products, 15800 Crabbs Branch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Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc.combination/default.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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