2014-02752. Agency Information Collection Activities; Proposed Collection; 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 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 FDA Safety Communication Readership Survey.

DATES:

Submit either electronic or written comments on the collection of information by April 11, 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, [e-mail].

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

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.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

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

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

Dated: February 3, 2014.

Leslie Kux,

Assistant Commissioner for Policy.