[Federal Register Volume 71, Number 245 (Thursday, December 21, 2006)]
[Notices]
[Pages 76673-76674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21901]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0348]


Guidance for Industry and Food and Drug Administration Staff; 
Procedures for Handling Post-Approval Studies Imposed by Premarket 
Approval Application Order; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Procedures for Handling Post-
Approval Studies Imposed by PMA Order.'' The guidance provides a 
standard format and content for submitting post-approval studies. The 
guidance is issued to help ensure that sponsors provide adequate 
information about the conduct of post-approval studies and that the 
Center for Devices and Radiological Health (CDRH) can properly track 
and evaluate post-approval studies.

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 ``Procedures for Handling Post-Approval Studies 
Imposed by PMA Order'' 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://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Steven H. Chasin, Center for Devices 
and Radiological Health (HFZ- 520), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3421.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides recommendations to sponsors and CDRH staff 
on expectations concerning format, content, and review of reports 
related to post-approval studies imposed by premarket approval 
application order to help ensure that the studies are conducted 
effectively and efficiently, and in a least burdensome manner. The 
guidance has been drafted in response to concerns by Congress, the 
Institute of Medicine, and FDA about the agency's ability to monitor 
and track these studies and industry's requests for more clarity about 
the agency's expectations. FDA received a few comments on the draft 
document (announced at 70 FR 54561, September 15, 2005) and has made 
minor changes to the guidance.

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 post-approval studies. 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 ``Procedures for Handling Post-Approval 
Studies Imposed by PMA Order,'' 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 (1561) 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 guidance refers to previously approved collections of 
information found in FDA's 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 U.S.C. 3501-
3520). The collections of information in 21 CFR part 814 have been 
approved under OMB Control No. 0910-0231; the collections of 
information in 21 CFR part 822 have been approved under OMB Control No. 
0910-0449.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(See ADDRESSES), written or electronic

[[Page 76674]]

comments regarding this document at any time. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. Submit two paper 
copies of any mailed comments, except that individuals may submit one 
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: December 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21901 Filed 12-20-06; 8:45 am]
BILLING CODE 4160-01-S