[Federal Register Volume 71, Number 117 (Monday, June 19, 2006)]
[Notices]
[Pages 35275-35276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9505]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0063]


Guidance for Industry and Food and Drug Administration Staff; the 
Review and Inspection of Premarket Approval Application Manufacturing 
Information and Operations; 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availability of the draft guidance entitled ``The Review and Inspection 
of Premarket Approval Application Manufacturing Information and 
Operations.'' One of the performance goals, referenced in a letter that 
accompanied the Medical Device User Fee and Modernization Act of 2002 
(MDUFMA) legislation, includes a commitment to improve FDA's scheduling 
and timeliness of preapproval inspections. This draft guidance document 
is intended to assist manufacturers in preparing for FDA's review of 
their premarket approval application (PMA) manufacturing section and in 
the coordination of the

[[Page 35276]]

preapproval inspection of the manufacturing operations described in the 
PMA or PMA supplement. This draft guidance document does not address 
premarket notification (510(k)) submissions because a premarket 
inspection is not ordinarily conducted for 510(k) submissions. This 
draft guidance is not final nor is it in effect at this time.

DATES:  Submit written or electronic comments on this draft guidance by 
September 18, 2006.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``The Review and Inspection of Premarket 
Approval Application Manufacturing Information and Operations'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 240-276-3151. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this draft guidance to the 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. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Timothy A. Ulatowski, Center for 
Devices and Radiological Health (HFZ-300), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0100.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 26, 2002, MDUFMA (Public Law 107-250) was signed into 
law. Among other things, MDUFMA authorized the collection of user fees 
to improve the performance and predictability of FDA's review of 
certain marketing applications, including PMAs. FDA, in consultation 
with the industry, agreed to dedicate user fees to help the agency meet 
various performance goals as outlined in a letter from the Secretary of 
Health and Human Services to Congress that accompanied the user fee 
legislation. One such goal included a commitment to ``improve the 
scheduling and timeliness of preapproval inspections.'' User fees 
collected under MDUFMA will be used to help to cover the costs 
associated with FDA's review of the PMA manufacturing section 
information and inspection of the manufacturing facility. FDA will 
monitor its good manufacturing practice preapproval inspection program 
and include this information in its annual performance report to 
Congress.
    This draft guidance provides information on the administrative 
process that FDA intends to follow in its review of the quality system 
regulation (21 CFR part 820) information included in the manufacturing 
section of a PMA submission and the inspection of the manufacturing 
facility. The administrative process outlined in this draft guidance 
for the review of the PMA manufacturing section and the conduct of any 
related preapproval inspection should facilitate FDA's timely review of 
the application and improve the agency's coordination of the 
preapproval inspection with the applicant.

II. Significance of Guidance

    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 ``The Review 
and Inspection of Premarket Approval Application Manufacturing 
Information and Operations.'' 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

    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. To receive ``The Review and 
Inspection of Premarket Approval Application Manufacturing Information 
and Operations'' you may either send an e-mail request to 
[email protected] to receive an electronic copy of the document or 
send a fax request to 240-276-3151 to receive a hard copy. Please use 
the document number 1566 to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520) . The 
collections of information addressed in 21 CFR part 814 have been 
approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. 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 brackets in the heading of this document. Comments received may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: June 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9505 Filed 6-16-06; 8:45 am]
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