[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77686-77687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food and Drug Administration 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 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 decisionmaking 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 either electronic or written comments on the collection 
of information by February 24, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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 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, [email protected].

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

[[Page 77687]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

FDA Rapid Response Surveys (Generic Clearance)--(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.
    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           30,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: December 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30630 Filed 12-23-13; 8:45 am]
BILLING CODE 4160-01-P