[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Pages 13814-13815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05103]



Food and Drug Administration

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

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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 Safety Communication Readership Survey.

DATES: Submit either electronic or written comments on the collection 
of information by May 15, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-N-0360 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food and Drug Administration 
Safety Communication Readership Survey.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your

[[Page 13815]]

comments only as a written/paper submission. You should submit two 
copies total. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
comments. The second copy, which will have the claimed confidential 
information redacted/blacked out, will be available for public viewing 
and posted on http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. If you do not wish your name and 
contact information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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 of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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 
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                  Number of
                  Activity                       Number of      responses per     Total annual         Average burden per response         Total hours
                                                respondents       respondent       responses
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 Safety Communication program, it is 
estimated that an average of three 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: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05103 Filed 3-14-17; 8:45 am]