[Federal Register Volume 66, Number 27 (Thursday, February 8, 2001)]
[Notices]
[Pages 9585-9586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3319]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0239]


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.

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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:

[[Page 9586]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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6                                                       1               6              20            120
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\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.
[FR Doc. 01-3319 Filed 2-7-01; 8:45 am]
BILLING CODE 4160-01-F