
[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Page 19618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07931]



[[Page 19618]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1496]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Generic Rapid Response Surveys (Generic Clearance)

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 May 9, 
2014.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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.

Food and Drug Administration Generic Rapid Response Surveys--(OMB 
Control Number 0910-0500)--Extension

    Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
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 FD&C Act (21 U.S.C. 372) authorizes 
investigational powers to FDA for enforcement of the FD&C Act. Under 
section 519 of the FD&C 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 FD&C 
Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct 
postmarket surveillance of medical devices. Section 705(b) of the FD&C 
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 FD&C 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 FD&C 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 quickly obtain 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.
    FDA projects six emergency risk related surveys per year with a 
sample of between 50 and 10,000 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 may be able 
to obtain by working with health care professional organizations. The 
annual number of surveys was determined by the maximum number of 
surveys per year FDA has ever conducted under this collection.
    In the Federal Register of December 24, 2013 (78 FR 77686), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. 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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                                                  Number of
           Activity               Number of     responses per   Total annual     Average burden     Total hours
                                 respondents     respondent       responses       per response
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FDA Rapid Response Survey....          10,000               6          60,000  0.5 (30 minutes).          30,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07931 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P


