[Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)]
[Notices]
[Pages 21253-21255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0131 ]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Generic FDA 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 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

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the use of rapid response surveys to obtain data on safety information 
to support quick-turnaround decisionmaking about potential safety 
problems or risk management solutions from health care professionals, 
hospitals and other user-facilities (e.g., nursing homes, etc.), 
consumers, manufacturers of biologics, drugs and medical devices, 
distributors, and importers when FDA must quickly determine whether or 
not a problem with a biologic, drug, or medical device impacts the 
public health.

DATES: Submit written or electronic comments on the collection of 
information by July 1, 2002.

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: Mark L. Pincus, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1471.

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 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.

FDA Rapid Response Surveys--New Collection

    Section 505 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355), requires that important safety information relating to 
all human prescription drug products be made available to FDA so that 
it can take appropriate action to protect the public health when 
necessary. Section 702 of the act (21 U.S.C. 372) authorizes 
investigational powers to FDA for enforcement of the act.
    Under section 519 of the act (21 U.S.C. 360i), FDA is authorized to 
require manufacturers to report medical device-related deaths, serious 
injuries, and malfunctions to FDA and to require 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 carry out effectively the 
mission of FDA. These sections of the act enable FDA to enhance 
consumer protection from risks associated with medical products usage 
that are not foreseen or apparent during the premarket notification and 
review process.
    FDA's regulations governing application for agency approval to 
market a new drug (21 CFR part 314) and regulations governing 
biological products (21 CFR part 600) implement these statutory 
provisions.
    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. 0910-0291) and the 
vaccine adverse event reporting system.
    FDA is seeking OMB clearance to collect vital information via a 
series of rapid response surveys. Participation in these surveys will 
be voluntary. This request covers rapid response surveys for community 
based health care professionals, general type medical facilities, 
specialized medical facilities (those known for cardiac surgery, 
obstetrics/gynecology services, pediatric services, etc.), other health 
care professionals, patients, consumers, and risk managers working in 
medical facilities.
    FDA will use the information gathered from these surveys to obtain 
quickly vital information about medical product risks and interventions 
to reduce risks so the agency may take appropriate public health or 
regulatory action including dissemination of this information as 
necessary and appropriate.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table1.--Estimated Annual Reporting Burden \1\
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                                           Annual Frequency    Total Annual
           No. of Respondents                per Response        Responses    Hours per Response    Total Hours
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200                                       30 (maximum)          6,000                 0.5           3,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA projects 30 emergency risk related surveys per year with a 
sample of between 50 and 200 respondents per survey. FDA also projects 
a response time of 0.5 hours per response.
    These estimates are based on the maximum sample size per 
questionnaire that FDA can analyze in a timely manner. The annual 
frequency of response was determined by the maximum number of 
questionnaires

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that will be sent to any individual respondent. Some respondents may be 
contacted only one time per year, while other respondents may be 
contacted several times annually, depending on the human drug, 
biologic, or medical device under evaluation. It is estimated that, 
given the expected type of issues that will be addressed by the 
surveys, it will take 0.5 hours for a respondent to gather the 
requested information and fill in the answers.

    Dated: April 19, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-10564 Filed 4-29-02; 8:45 am]
BILLING CODE 4160-01-S