[Federal Register Volume 68, Number 195 (Wednesday, October 8, 2003)]
[Notices]
[Pages 58119-58120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25447]


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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://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://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 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