[Federal Register Volume 69, Number 4 (Wednesday, January 7, 2004)]
[Notices]
[Pages 923-924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-258]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0565]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Generic Food and Drug Administration Rapid Response 
Surveys

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the use of rapid response 
surveys to obtain data on safety information to support quick-
turnaround decision making 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 March 8, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the

[[Page 924]]

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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, including 
each proposed extension of an existing 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 these topics: (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.

Generic FDA 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, 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 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.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                          Annual Frequency per      Total Annual
   No. of Respondents           Response              Responses        Hours per Response        Total Hours
----------------------------------------------------------------------------------------------------------------
200                               30 (maximum)                 6,000                   0.5                 3,000
----------------------------------------------------------------------------------------------------------------
\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: December 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-258 Filed 1-6-04; 8:45 am]
BILLING CODE 4160-01-S