[Federal Register: December 21, 2006 (Volume 71, Number 245)]
[Notices]
[Page 76673-76674]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de06-51]
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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.
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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://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: 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 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 (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://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'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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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