
[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Page 28526]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0360]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Safety Communication Readership Survey

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 June 
16, 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 0910-0341. 
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.

FDA Safety Communication (Formerly Known as Public Health Notification) 
Readership Survey--(OMB Control Number 0910-0341)--(Extension)

    Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 375(b)) gives FDA authority to disseminate information 
concerning suspected or imminent danger to public health by any 
regulated product. Section 1701(a)(4) of the Public Health Service Act 
(42 U.S.C. 300u(a)(4)) also authorizes FDA to conduct research relating 
to health information.
    FDA's Center for Devices and Radiological Health (CDRH) carries out 
FDA's regulatory responsibilities regarding medical devices and 
radiological products. CDRH must be able to effectively communicate 
risk to health care practitioners, patients, caregivers, and consumers 
when there is a real or suspected threat to the public's health. CDRH 
uses safety communications to transmit information concerning these 
risks to user communities. Safety communications are released and 
available to organizations such as hospitals, nursing homes, hospices, 
home health care agencies, manufacturers, retail pharmacies, and other 
health care providers, as well as patients, caregivers, consumers, and 
patient advocacy groups. Through a process for identifying and 
addressing postmarket safety issues related to regulated products, CDRH 
determines when to release safety communications.
    FDA seeks to evaluate the clarity, timeliness, and impact of safety 
communications by surveying a sample of recipients to determine the 
impact of safety communications on the knowledge of the recipients. 
Understanding how the target audiences view these publications will aid 
in determining what, if any, changes should be considered in their 
content, format, and method of dissemination. The collection of this 
data is an important step in determining how well CDRH is communicating 
risk. The results from this survey will emphasize the quality of the 
safety communications and customer satisfaction. This will enable us to 
better serve the public by improving the effectiveness of safety 
communications.
    We updated the title of the survey from ``FDA Public Health 
Notification Readership Survey'' to ``FDA Safety Communication 
Readership Survey'' to accurately reflect the information that is being 
collected.
    In the Federal Register of February 10, 2014 (79 FR 7677), 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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Public Health Notification Readership Survey.......................             300                3              900             0.17              153
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on the history of the Safety Communication program, it is 
estimated that an average of 3 collections will be conducted per year. 
The total burden of response time is estimated at 10 minutes per 
survey. This was derived by CDRH staff completing the survey.

    Dated: May 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11326 Filed 5-15-14; 8:45 am]
BILLING CODE 4160-01-P


