[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Pages 30870-30871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13884]



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.


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 August 
2, 2017.

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 [email protected]. 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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 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 and obtain their 
voluntary responses 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.
    In the Federal Register of March 15, 2017 (82 FR 13814), 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 

[[Page 30871]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
Public Health Notification Readership Survey.......................             300                3              900           * 0.17              153
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 10 minutes.

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

    Dated: June 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13884 Filed 6-30-17; 8:45 am]