[Federal Register Volume 67, Number 17 (Friday, January 25, 2002)]
[Notices]
[Pages 3722-3723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0399]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Rapid Response 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 
February 25, 2002.

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: 
Stuart Shapiro, 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.

Rapid Response Surveys (OMB Control No. 0910-0457)--Extension

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360i), FDA is authorized to require manufacturers to 
report medical device related deaths, serious injuries, and 
malfunctions, and 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. 360l) 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(d)(2) of the 
act (21 U.S.C. 393(d)(2)) authorizes the

[[Page 3723]]

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. 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 received a 1-year OMB approval on February 5, 2001, to 
implement Emergency Health Surveys (since that time, renamed ``Rapid 
Response Surveys''), via a series of surveys, thus implementing section 
705(b) of the act and the Commissioner's authority as specified in 
section 903(d)(2) of the act. To date, FDA has initiated one Rapid 
Response Survey (66 FR 49391, September 27, 2001), with two more in 
development. FDA is now seeking OMB clearance to continue collecting 
this information. Participation in these surveys has been, and will 
continue to be, voluntary. This request covers Rapid Response Surveys 
for general type medical facilities and specialized medical facilities 
(those known for cardiac surgery, obstetric/gynecological services, 
pediatric services, etc.), and health professionals, but more typically 
risk managers working in medical facilities.
    FDA currently uses 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 rapid response surveys per year with a sample of 
between 50 and 200 respondents per survey.
    In the Federal Register of September 27, 2001 (66 FR 49391), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    FDA originally estimated the burden of this collection to be 2 
hours per survey. However, FDA is revising the estimated burden of this 
collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                  Annual Frequency per        Total Annual
     No. of Respondents                 Response               Responses     Hours per Response    Total Hours
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200                           10 (maximum)                           2,000            .5                  1,000
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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 per response 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. Based on the questions developed for the one 
survey that has been conducted, and for the two under development, it 
is estimated, given the expected type of issues that will be addressed 
by the surveys, that at a maximum it will take 30 minutes for a 
respondent to gather the requested information and fill in the answers.

    Dated: January 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-1928 Filed 1-24-02; 8:45 am]
BILLING CODE 4160-01-S