[Federal Register: January 8, 2008 (Volume 73, Number 5)]
[Notices]
[Page 1358-1359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja08-74]
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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 guidance entitled ``The Review and Inspection of
Premarket Approval Application Manufacturing Information and
Operations.'' This guidance document explains for premarket approval
application (PMA) applicants the process involved with the review of a
PMA manufacturing section and inspection of the manufacturing
operations described in the manufacturing section. This guidance is
also generally applicable to the process involved with the review of
manufacturing information in certain PMA supplements. The procedural
information outlined in this document should help applicants and FDA
schedule and complete their work in a timely manner.
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the 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 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 or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
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, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
0100.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250), amended the
Federal Food, Drug, and Cosmetic Act (the act). Among other things,
MDUMFA authorized the collection of user fees to improve the
performance and predictability of FDA's device premarket review
process, which includes PMAs. FDA, in consultation with the regulated
industry, agreed to dedicate user fees to help the agency achieve
performance goals, including the predictability of scheduling and
timeliness of preapproval inspections.
[[Page 1359]]
This final guidance document, ``The Review and Inspection of
Premarket Approval Application Manufacturing Information and
Operations,'' explains for PMA applicants the administrative process
FDA intends to follow in its review of the PMA manufacturing section
information and the inspection of the particular manufacturing facility
and its manufacturing operations. This final guidance document
supersedes the corresponding draft guidance issued on June 19, 2006 (71
FR 35275 through 35276).
The comment period for the draft guidance document closed on
September 18, 2006. During the comment period, we received several
comments and recommendations. Two comments recommended that the agency
inspect pilot manufacturing operations or the manufacture of a
surrogate product in lieu of inspecting the complete manufacturing
operation described in the PMA manufacturing section. FDA disagrees
with this recommendation as the statute does not provide such an
alternative. The statute requires the agency to determine whether the
manufacturing operations, as described in the PMA, conform to good
manufacturing practice requirements.
Several comments recommended clarification of certain terms related
to the process involved with scheduling inspections and factors that
affect the PMA manufacturing section review process. The agency
incorporated many of the suggested clarifications.
II. Significance of Guidance
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 ``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 guidance may 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 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 in 21 CFR part 814 have been approved under
OMB Control Number 0910-0231; and the collections of information in 21
CFR part 820 have been approved under OMB Control Number 0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. 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.
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. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: December 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-126 Filed 1-7-08; 8:45 am]
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