[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Notices]
[Pages 47734-47735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1426]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on emergency health surveys to obtain data 
from health professionals and medical-device-user facilities when FDA 
must quickly determine whether or not a problem with a medical device 
impacts the public health.

DATES: Submit written comments on the collection of information by 
October 2, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under the PRA (44 U.S.C. 3501-3520) Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information

[[Page 47735]]

before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Emergency Health Surveys

    Under section 519 of the 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 
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.
    FDA estimates the 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         Respondent             Responses          Hours per Response        Total Hours
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        200            10 (maximum)                 2,000                      2                4,000
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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 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: July 28, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-19625 Filed 8-2-00; 8:45 am]
BILLING CODE 4160-01-F