[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Notices]
[Page 58119-58120]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc03-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0434]
Guidance for Industry and FDA Staff: FDA and Industry Actions on
Premarket Approval Applications: Effect on FDA Review Clock and
Performance Assessment; 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 ``Guidance for Industry and FDA
Staff: FDA and Industry Actions on Premarket Approval Applications:
Effect on FDA Review Clock and Performance Assessment.'' This guidance
describes how the Food and Drug Administration (FDA) will assess its
performance in the premarket approval application (PMA) program
relative to the goals that accompany the authorization of medical
device user fees. This guidance document is immediately in effect, but
it remains subject to comment in accordance with the agency's good
guidance practices (GGPs).
[[Page 58120]]
DATES: Submit written or electronic comments on this guidance at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``FDA and Industry Actions
on Premarket Approval Applications: Effect on FDA Review Clock and
Performance Assessment'' to the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health (CDRH), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-443-8818.
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. Identify comments with the
docket number found in brackets in the heading of this document. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT:
For Device Issues: Thinh Nguyen, CDRH (HFZ-402), 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186.
For Biologics Issues: Sayah Nedjar, Center for Biologics Evaluation
and Research (CBER) (HFM-380), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-3524.
SUPPLEMENTARY INFORMATION:
I. Background
The Medical Device User Fee and Modernization Act of 2002 (Public
Law 107-250), signed into law on October 26, 2002, allows FDA to assess
user fees for certain premarket reviews. Performance goals, existing
outside of the statute, accompany the authorization of medical device
user fees. These goals represent a realistic projection of what FDA's
CDRH and CBER offices can accomplish with industry cooperation.
The guidance describes premarket review cycle and decision actions
and goals for original PMAs, original expedited PMAs, panel-track
supplements, and 180-day PMA supplements. Although it was not feasible
to obtain comments before issuing the guidance due to tight statutory
deadlines, in accordance with this agency's GGP procedures, FDA will
accept comments on the guidance at any time.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGP regulation
(21 CFR 10.115). The guidance represents the agency's current thinking
on PMA review cycle and decision actions and performance goals. 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
To receive ``FDA and Industry Actions on Premarket Approval
Applications: Effect on FDA Review Clock and Performance Assessment ``
by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. Press 1 to enter the system.
At the second voice prompt, press 1 to order a document. Enter the
document number (1218) followed by the pound sign (). Follow
the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. 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. 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 contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). The
collections of information addressed in the guidance document have been
approved by OMB in accordance with the PRA under the regulations
governing premarket approval applications (21 CFR part 814, 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. 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.
To receive `` FDA and Industry Actions on Premarket Approval
Applications: Effect on FDA Review Clock and Performance Assessment ``
by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. Press 1 to enter the system.
At the second voice prompt, press 1 to order a document. Enter the
document number (1218) followed by the pound sign (). Follow
the remaining voice prompts to complete your request.
Dated: September 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25447 Filed 10-7-03; 8:45 am]
BILLING CODE 4160-01-S