[Federal Register: June 19, 2006 (Volume 71, Number 117)]
[Notices]
[Page 35275-35276]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn06-66]
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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availability of the draft guidance entitled ``The Review and Inspection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 This draft guidance document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 This draft guidance document does not address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draft guidance is not final nor is it in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``The Review and Inspection of Premarket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Submit written comments concerning this draft guidance to the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
dsmica@fda.hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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