[Federal Register Volume 73, Number 5 (Tuesday, January 8, 2008)]
[Notices]
[Pages 1359-1360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-143]


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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://www.fda.gov/dockets/ecomments or 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 [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 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://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 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://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]
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