[Federal Register: January 8, 2008 (Volume 73, Number 5)]
[Notices]
[Page 1359-1360]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja08-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0228]
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 guidance entitled ``The Review and Inspection of
Premarket Approval Applications Under the Bioresearch Monitoring
Program.'' This guidance provides premarket approval application (PMA)
applicants with information about the bioresearch monitoring (BIMO)
review process. This includes a BIMO evaluation of clinical and
nonclinical information in the PMA and certain PMA supplements as well
as preapproval BIMO inspections. The procedural information outlined in
this document should help applicants and FDA to better understand the
BIMO review and inspection so it can proceed in a timely manner.
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 ``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 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 or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
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
[[Page 1360]]
and Radiological Health (HFZ-300), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-0243.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, the Medical Device User Fee and Modernization
Act of 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 premarket approval applications (PMAs). One such goal
included a commitment to improve the scheduling and timeliness of PMA
preapproval inspections. A portion of the user fees collected under
MDUFMA will be used to help to cover the costs associated with the
bioresearch monitoring (BIMO) program review of a PMA and the
performance of any related clinical or nonclinical inspections. This
final guidance document supersedes the corresponding draft guidance
entitled ``The Review and Inspection of Premarket Approval Applications
Under the Bioresearch Monitoring Program,'' which was announced in the
Federal Register on June 20, 2006 (71 FR 35436 through 35437).
The comment period for the draft guidance closed on September 18,
2006. During this time, FDA received one set of comments from a device
manufacturer concerning the draft guidance. Some of the comments
suggested combining the BIMO and manufacturing preapproval inspections.
FDA did not make changes in response to these comments because
preapproval BIMO and manufacturing inspections can not be performed at
the same time. Compared to the preapproval manufacturing inspection
program, the BIMO program has different objectives, usually involves
inspections of different sites, and FDA investigators with different
expertise. FDA did modify the guidance to respond to comments that
requested further information about criteria for selecting inspection
sites and determining when followup actions are necessary.
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 ``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 guidance may 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-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 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
collections of information in 21 CFR part 814 have been approved under
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 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 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 heading of this document. Received comments received
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: December 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-143 Filed 1-7-08; 8:45 am]
BILLING CODE 4160-01-S