[Federal Register Volume 65, Number 210 (Monday, October 30, 2000)]
[Notices]
[Pages 64716-64717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1426]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Emergency Health Surveys

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 
November 29, 2000.

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.

Emergency Health Surveys

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360(i)), FDA is authorized to require: (1) 
Manufacturers to report medical-device-related deaths, serious 
injuries, and malfunctions; and (2) user facilities to report device-
related deaths directly to FDA and to manufacturers, and to report 
serious injuries to the manufacturer. Section 522 of the act (21 U.S.C. 
360(l)) authorizes FDA to require manufacturers to conduct postmarket 
surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 
375(b)) authorizes FDA to collect and disseminate information regarding 
medical products or cosmetics in situations involving imminent danger 
to health or gross deception of the consumer. Section 903(b)(2) of the 
act (21 U.S.C. 393(b)(2)) authorizes the Commissioner of Food and Drugs 
(the Commissioner) to implement general powers (including conducting 
research) to effectively carry out the mission of FDA. These sections 
of the act enable FDA to enhance consumer protection from risks 
associated with medical device usage that are not foreseen or apparent 
during the premarket notification and review process. Currently FDA 
monitors medical product related postmarket adverse events via both the 
mandatory and voluntary MedWatch Reporting Systems using FDA Forms 3500 
and 3500A (OMB Control No. 0910-0281).
    FDA is seeking OMB clearance to collect information via a series of 
surveys, thus implementing section 705(b) of the act and the 
Commissioner's authority as specified in section 903(b)(2) of the act. 
Participation in these surveys will be voluntary. This request covers

[[Page 64717]]

emergency health surveys for general type medical facilities; 
specialized medical facilities (those known for cardiac surgery, 
obstetrics/gynecology services, pediatric services, etc.); and health 
professionals, but more typically risk managers working in medical 
facilities.
    FDA will use the information gathered from these surveys to quickly 
obtain vital information from the appropriate clinical sources so that 
FDA may take appropriate public health or regulatory action. FDA 
projects 10 emergency health surveys per year with a sample of between 
50 and 200 respondents per survey.
    In the Federal Register of August 3, 2000 (65 FR 47734), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden \1\
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                Annual
   No. of      Frequency   Total Annual      Hours per
 Respondents      per        Responses       Response       Total Hours
               Response
------------------------------------------------------------------------
200           10            2,000               2          4,000
               (maximum)
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    These estimates are based on the maximum sample size per 
questionnaire that FDA could analyze in a timely manner. The annual 
frequency of respondent was determined by the maximum number of 
questionnaires that will be sent to any individual respondent. Some 
respondents may be contacted only one time per year, while another 
respondent may be contacted several times, depending on the medical 
device under evaluation. It is estimated that, given the expected type 
of issues that will be addressed by the surveys, at a maximum it will 
take 2 hours for a respondent to gather the requested information and 
fill in the answers.

    Dated: October 23, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-27733 Filed 10-27-00; 8:45 am]
BILLING CODE 4160-01-F