[Federal Register: April 12, 2005 (Volume 70, Number 69)]
[Notices]               
[Page 19091-19092]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap05-82]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0182]

 
Guidance for Industry and Food and Drug Administration Staff; 
Submission and Resolution of Formal Disputes Regarding the Timeliness 
of Premarket Review of a Combination Product; 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 
``Submission and Resolution of Formal Disputes Regarding the Timeliness 
of Premarket Review of a Combination Product.'' 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 agency guidances at 
any time. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES:  Submit written requests for single copies of this guidance 
document to the Office of Combination Products (HFG-3), 15800 Crabbs 
Branch Way, Rockville, MD 20855. Send one self-addressed adhesive label 
to assist that office in processing your requests. Submit written 
comments concerning the 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Suzanne O'Shea, Office of Combination 
Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch 
Way, Rockville, MD 20855, 301-427-1934, FAX: 301-427-1935.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Submission and Resolution of Formal Disputes 
Regarding the Timeliness of Premarket Review of a Combination 
Product.'' In the Federal Register of May 4, 2004 (69 FR 24653), FDA 
issued a notice of availability of a draft guidance document covering 
the same topic. The draft guidance document was 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 covering a combination 
product can submit a request that OCP resolve such a dispute.
    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 how to present to OCP disputes pertaining 
to the timeliness of reviews of 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.

II. Comments

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

[[Page 19092]]

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.

III. Electronic Access

    Additional copies of this guidance are available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/combination or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
 You may also request additional copies of the guidance by 

e-mailing combination@fda.gov.

    Dated: April 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7265 Filed 4-11-05; 8:45 am]

BILLING CODE 4160-01-S