[Federal Register: May 6, 2004 (Volume 69, Number 88)]
[Notices]
[Page 25404-25405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my04-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0565]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Food and Drug
Administration 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 a
proposed collection of information has been submitted to the
[[Page 25405]]
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June 7,
2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORATION CONTACT: JonnaLynn Capezzuto, Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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.
Generic Food and Drug Administration Rapid Response Surveys--(OMB
Control Number 0910-0500--Extension)
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, 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 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 number 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.
In the Federal Register of January 7, 2004 (69 FR 923), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per
No. of Respondents Response Total Annual 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 that will be sent to any individual
respondent. Some respondents may be contacted only 1 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 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10267 Filed 5-5-04; 8:45 am]
BILLING CODE 4160-01-S