[Federal Register Volume 69, Number 86 (Tuesday, May 4, 2004)]
[Notices]
[Pages 24653-24654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10027]


-----------------------------------------------------------------------

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Draft Guidance for Industry on Combination Products, Timeliness 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Combination 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Combination Products, 15800 Crabbs Branch 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    Submit written comments on the draft guidance to the Division of 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://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INFORMATION section for electronic access to the draft guidance 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://www.fda.gov/oc/combination/default.htm or 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]
BILLING CODE 4160-01-S