E6-9653. Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program;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.

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program.”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 This draft guidance document is intended to assist applicants in understanding the process involved in the bioresearch monitoring (BIMO) review of the clinical and nonclinical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 Premarket notification (510(k)) submissions are not addressed in this draft guidance because a premarket inspection is not ordinarily conducted for 510(k)s. This draft guidance is not final nor is it in effect at this time.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Submit written or electronic comments on this draft guidance by September 18, 2006.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Submit written requests for single copies of the draft guidance document entitled “The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program” to the Division of Small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Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 [e-mail] 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 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.