[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57442-57443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23268]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2683]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Data To Support 
Social and Behavioral Research 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 
November 25, 2019.

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 0910-0847. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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.

Data To Support Social and Behavioral Research as Used by the Food and 
Drug Administration

OMB Control Number 0910-0847--Extension

    Understanding patients, consumers, and healthcare professionals' 
perceptions and behaviors plays an important role in improving FDA's 
regulatory decisionmaking processes and communications impacting 
various stakeholders. The methods used to achieve these goals include 
individual in-depth interviews, general public focus group interviews, 
intercept interviews, self-administered surveys, gatekeeper surveys, 
and focus group interviews. The methods used serve the narrowly defined 
need for direct and informal opinion on a specific topic and as a 
qualitative and quantitative research tool, and have two major 
purposes:
    1. To obtain information that is useful for developing variables 
and measures for formulating the basic objectives of social and 
behavioral research and
    2. To assess the potential effectiveness of FDA communications, 
behavioral interventions and other materials in reaching and 
successfully communicating and addressing behavioral change with their 
intended audiences.
    FDA will use these methods to test and refine its ideas and to help 
develop communication and behavioral strategies research, 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's Center for Drug Evaluation and Research, Center for Biologics 
Evaluation and Research, Office of the Commissioner, and any other 
Centers or Offices will use this mechanism to test communications and 
social and behavioral methods about regulated drug products on a 
variety of subjects related to consumer, patient, or

[[Page 57443]]

healthcare professional perceptions, beliefs, attitudes, behaviors, and 
use of drug and biological products and related materials including, 
but not limited to, social and behavioral research, decision-making 
processes, and communication and behavioral change strategies.
    Annually, FDA projects about 45 social and behavioral studies using 
the variety of test methods listed in this document. FDA is requesting 
this burden 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, 2019 (84 FR 28557), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Number of
                Activity                     Number of        responses per       Total annual        Average burden per response         Total hours
                                            respondents         respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys.....................              5,040               14.6             73,584  0.25 (15 minutes)..................             18,396
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall increase of 9,198 hours and a corresponding increase of 36,792 
responses due to an increase in grant funding for universities and 
others to perform research for FDA.

    Dated: October 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23268 Filed 10-24-19; 8:45 am]
 BILLING CODE 4164-01-P


