[Federal Register: May 4, 2004 (Volume 69, Number 86)]
[Notices]
[Page 24653-24654]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04my04-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0182]
Draft Guidance for Industry on Combination Products, Timeliness
of Premarket Reviews, Dispute Resolution; 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availability of a draft guidance for industry entitled ``Combination
Products, Timeliness of Premarket Reviews, Dispute Resolution
Guidance.'' The Medical Device User Fee and Modernization Act of 2002
(MDUFMA) delegates to the Office of Combination Products (OCP)
responsibility for resolving disputes about the timeliness of premarket
review of combination products. This guidance document provides
information about presenting requests for resolution of disputes about
the timeliness of premarket review of combination products.
DATES: Submit written or electronic comments on the draft guidance by
July 6, 2004. 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Combination Products, 15800 Crabbs Branch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.
Submit written comments on the draft guidance to the Division of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. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Suzanne O'Shea, Office of Combination
Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch
Way, suite 200, Rockville, MD 20855, 301-827-9229; or
Sheryl Lard-Whiteford, Center for Biologics Evaluation and Research
(HFM-4), 1401 Rockville Pike, Rockville, MD 20857, 301-827-5413; or
Les Weinstein, Center for Devices and Radiological Health (HFZ-5),
9200 Corporate Blvd., Rockville, MD 20850, 301-827-7991; or
Warren Rumble, Center for Drug Evaluation and Research, 5515
Security Lane, suite 500, Rockville, MD 20852, 301-594-5480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Combination Products, Timeliness of Premarket Reviews,
Dispute Resolution Guidance.'' MDUFMA delegated to OCP responsibility
for resolving disputes about the timeliness of reviews of premarket
applications covering combination products. This guidance document
provides information on how an applicant submitting an application(s)
covering a combination product can submit a request that OCP resolve
such a dispute.
A timeliness dispute arises when FDA does not review and act on an
applicant's combination product application within the applicable
performance goal set by the Prescription Drug User Fee Act (PDUFA) or
MDUFMA. Under PDUFA and MDUFMA, it is not expected that every
application will meet every performance goal. Applications covering
combination products in particular often present challenging review and
regulatory issues. Nevertheless, because the PDUFA and MDUFMA
performance goals reflect current review time expectations, it is
appropriate to use them as guidelines.
The purpose of a timeliness dispute resolution request is to obtain
the relevant review as quickly as possible, rather than to impose any
sanction on the reviewing Center. In keeping with this perspective,
upon receipt of a request for resolution of a timeliness dispute, OCP
will contact the Center reviewing division and the Center Ombudsman to
determine the current status of the review and what OCP can do to
facilitate completion of the review as quickly as possible. If
necessary and feasible, a plan for the completion of the review,
including a target date for completion, will be developed.
This draft guidance 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 combination
products, timeliness of premarket reviews, and dispute resolution. 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 statutes
and regulations.
[[Page 24654]]
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Two copies of mailed comments are to be submitted, 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
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.
III. Electronic Access
Persons with access to the Internet may obtain the document 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.
Dated: April 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10027 Filed 5-3-04; 8:45 am]
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