[Federal Register: June 20, 2006 (Volume 71, Number 118)]
[Notices]
[Page 35436-35437]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn06-46]
[[Page 35436]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0228]
Draft Guidance for Industry and Food and Drug Administration
Staff; the Review and Inspection of Premarket Approval Applications
Under the Bioresearch Monitoring Program; 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availability of the draft guidance entitled ``The Review and Inspection
of Premarket Approval Applications under the Bioresearch Monitoring
Program.'' One of the performance goals, referenced in a letter to
Congress from the Secretary of Health and Human Services that
accompanied the Medical Device User Fee and Modernization Act of 2002
(MDUFMA) legislation, includes a commitment to improve FDA's scheduling
and timeliness of preapproval inspections. This draft guidance document
is intended to assist applicants in understanding the process involved
in the bioresearch monitoring (BIMO) review of the clinical and
nonclinical information in their premarket approval application (PMA)
and the process involved in any related inspections. Premarket
notification (510(k)) submissions are not addressed in this draft
guidance because a premarket inspection is not ordinarily conducted for
510(k)s. This draft guidance is not final nor is it in effect at this
time.
DATES: Submit written or electronic comments on this draft guidance by
September 18, 2006.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``The Review and Inspection of Premarket
Approval Applications under the Bioresearch Monitoring Program'' 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Submit written comments concerning this draft guidance to the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: Matthew J. Tarosky, Center for Devices
and Radiological Health (HFZ-310), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 240-270-0243.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, MDUFMA (Public Law 107-250) was signed into
law. Among other things, MDUMFA authorized the collection of user fees
to improve the performance and predictability of FDA's device review
program, including PMAs. FDA, in consultation with the regulated
industry, agreed to dedicate user fees to helping the agency meet the
performance goals outlined in a letter from the Secretary of Health and
Human Services to Congress that accompanied the user fee legislation.
One such goal included a commitment to ``improve the scheduling and
timeliness of preapproval inspections.'' A portion of the user fees
collected under MDUFMA will be used to help to cover the costs
associated with the BIMO program review of the PMA and the performance
of any clinical or nonclinical inspections. FDA will monitor its BIMO
preapproval inspection program and include this information in its
annual performance report to Congress.
This draft guidance provides information about the administrative
process and timeframes within which the BIMO review of the PMA clinical
and nonclinical sections should be completed. Use of this draft
guidance should facilitate FDA's timely review and inspection of the
PMA clinical and nonclinical information and improve the coordination
of a preapproval inspection between the applicant and FDA.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized will represent the agency's current thinking on ``The Review
and Inspection of Premarket Approval Applications under the Bioresearch
Monitoring Program.'' 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 draft guidance may
also do so by using the Internet. To receive ``The Review and
Inspection of Premarket Approval Applications under the Bioresearch
Monitoring Program,'' 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 1602 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-related
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 draft 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 PRA).
The collections of information addressed in 21 CFR part 814 have been
approved by OMB under OMB Control No. 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
copy. Comments are to be identified with the docket number found in
brackets in the
[[Page 35437]]
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: June 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9653 Filed 6-19-06; 8:45 am]
BILLING CODE 4160-01-S