[Federal Register Volume 72, Number 196 (Thursday, October 11, 2007)]
[Notices]
[Page 57949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0092]


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 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 
November 13, 2007.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0500. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (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 March 22, 2007 (72 FR 13498), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--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                  6000                    .5                  3000
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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 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: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20067 Filed 10-10-07; 8:45 am]
BILLING CODE 4160-01-S