[Federal Register Volume 66, Number 188 (Thursday, September 27, 2001)]
[Notices]
[Pages 49391-49392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0399]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed continued 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 Rapid Response 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 and electronic comments on the collection of 
information by November 26, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
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 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 below.
    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.

Rapid Response Surveys (OMB Control Number 0910-0457)--Extension

    Under section 519 of the 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 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 form 3500 and 3500A (OMB control number 
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

[[Page 49392]]

Response Survey, 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.
    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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                                                                                              Total Annual
                No. of Respondents                     Annual Frequency of Respondent          Responses         Hours per Responses      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 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. 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: September 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24163 Filed 9-26-01; 8:45 am]
BILLING CODE 4160-01-S