[Federal Register: May 6, 2004 (Volume 69, Number 88)]
[Page 25404-25405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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, 

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\
                       Annual Frequency per
  No. of Respondents         Response         Total Annual 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

    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]