[Federal Register: September 27, 2001 (Volume 66, Number 188)]
[Notices]
[Page 49391-49392]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se01-86]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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