01-3319. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Resolution of Scientific Disputes Concerning the Regulation of Medical Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments on the collection of information by March 12, 2001.

ADDRESSES:

Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Request for Resolution of Scientific Disputes Concerning the Regulation of Medical Devices

Section 404 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) is intended to ensure that FDA has effective processes to resolve the scientific disputes that occasionally arise between FDA and the regulated industry. Section 404 of FDAMA added new section 562 to the Federal Food, Drug, and Cosmetic Act (the act) which requires FDA to establish, by regulation, a procedure under which a person who is a sponsor, applicant, or manufacturer may request a review of a scientific controversy, when no other provision of the act or regulation provides such review.

In a final rule issued in the Federal Register of November 18, 1998 (63 FR 63978), FDA amended 21 CFR 10.75 to reflect the provisions of FDAMA. Each affected FDA center is responsible for developing and administering its own processes for handling requests for section 404 of FDAMA reviews and is issuing a guidance document containing specific information of the type suggested by the comments. The draft guidance document outlines the requirements for persons who are sponsors, applicants, or manufacturers of medical devices and who wish to file a request for a review of a scientific dispute by the panel as set out in the guidance. Persons filing a request for review should provide a Center for Devices and Radiological Health ombudsman with a concise summary of the scientific issue in dispute, including a summary of the particular FDA action or decision to which the requesting party objects, any prior advisory panel action and the results of all efforts that have been made to resolve the dispute, and a clear articulated summary of the arguments and relevant data and information. They may also provide material outside the official administrative record and not in the possession of FDA at the time the decision or action in dispute was made if it has a significant bearing on the issue or related public health considerations. The information that is collected will form the basis for resolving the dispute between the requester and FDA.

The likely respondents to this collection of information are medical device sponsors, applicants, or manufacturers who have a scientific dispute with FDA and who request a review of the matter by the Medical Devices Dispute Resolution Panel.

In the Federal Register of April 27, 1999 (64 FR 22617), the agency requested comments on the proposed collection of information. No comments concerning the information collection were received.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

No. of ­Respondents	Annual ­Frequency per ­Response	Total Annual Responses	Hours per ­Response	Total Hours
6	1	6	20	120
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The Medical Devices Dispute Resolution Panel represents a new process for resolving scientific disputes. In arriving at the estimates in table 1 of this document for the burden imposed in connection with a request for review by the Medical Devices Dispute Resolution Panel, FDA considered the number and substance of similar appeals of various types made to FDA in recent years, knowledge of similar submissions, and discussions with manufacturers.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.