Document ID: FDA-2014-N-0345-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Data To Support
Drug Product Communications as Used by the Food and Drug
Administration
Posted Date: 2017-12-13T05:00Z

[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58621-58622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26795]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0345]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Data To Support Drug 
Product Communications as Used by the Food and Drug Administration

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 January 
12, 2018.

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 0910-0695. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7729, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 58622]]

collection of information to OMB for review and clearance.

Data To Support Drug Product Communications as Used by the Food and 
Drug Administration

OMB Control Number 0910-0695--Extension

    This information collection supports Agency outreach efforts. 
Testing of communication messages in advance of a communication 
campaign provides an important role in improving FDA communications as 
they allow for an in-depth understanding of individuals' attitudes, 
beliefs, motivations, and feelings. The methods to be employed include 
individual in-depth interviews, general public focus group interviews, 
intercept interviews, self-administered surveys, gatekeeper surveys, 
and professional clinician focus group interviews, all on a voluntary 
basis. The methods to be used serve the narrowly defined need for 
direct and informal opinion on a specific topic and, as a qualitative 
research tool, have two major purposes: To obtain information that is 
useful for developing variables and measures for formulating the basic 
objectives of risk communication campaigns, and to assess the potential 
effectiveness of messages and materials in reaching and successfully 
communicating with their intended audiences.
    FDA will use these methods to test and refine its ideas and to help 
develop messages and other communications but will generally conduct 
further research before making important decisions, such as adopting 
new policies and allocating or redirecting significant resources to 
support these policies. FDA will use this mechanism to test messages 
about regulated drug products on a variety of subjects related to 
consumer, patient, or health care professional perceptions and about 
use of drug products and related materials, including but not limited 
to, direct-to-consumer prescription drug promotion, physician labeling 
of prescription drugs, medication guides, over-the-counter drug 
labeling, emerging risk communications, patient labeling, online sale 
of medical products, and consumer and professional education. Annually, 
FDA projects about 45 communication studies using the variety of test 
methods listed in this document. FDA is requesting an extension of 
these burden hours so as not to restrict the Agency's ability to gather 
information on public sentiment for its proposals in its regulatory and 
communications programs.
    In the Federal Register of June 19, 2017 (82 FR 27840), we 
published a 60-day notice requesting public comment on the proposed 
extension of the collection of information. One comment was received 
requesting that FDA publish an annual list of its planned drug product 
communication studies and strive to reflect an overall work plan. The 
comment also noted the rather broad topic areas included in the 
information collection and suggested that perhaps additional notice 
regarding individual studies would allow for more meaningful feedback 
on whether that particular study would be necessary. FDA appreciates 
this comment. In determining which drug product communications it will 
undertake, we first consider those we believe will best address current 
or immediate public health issues. We also note that, in accordance 
with the PRA, any proposed study under this information collection 
request must first be submitted to and approved by OMB to determine 
whether it falls within the scope of the collection. At the same time, 
as resources are available, we will make every effort to communicate to 
our stakeholders anticipated studies so that ongoing or related 
research can be coordinated.
    We therefore estimate the burden of this collection of information 
as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual     Average burden per response (in hours)     Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys...........................          19,822               1          19,822  0.24 (14 minutes)........................           4,757
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26795 Filed 12-12-17; 8:45 am]
 BILLING CODE 4164-01-P