Document ID: FDA-2016-N-2683-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2017-06-15T04:00Z

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27492-27493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12446]

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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.

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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 July 
17, 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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--NEW and 
``Data to Support Social and Behavioral Research as Used by the Food 
and Drug Administration.'' 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, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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--NEW

    Understanding patients, consumers, and health care professionals' 
perceptions and behaviors plays an important role in improving FDA's 
regulatory decisionmaking processes and communications impacting 
various stakeholders. The methods to be employed to achieve these goals 
include individual indepth interviews, general public focus group 
interviews, intercept interviews, self-administered surveys, gatekeeper 
surveys, and focus group interviews. The methods to be 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 potentially 
other Agency components 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 health care 
professional perceptions, beliefs, attitudes, behaviors, and use of

[[Page 27493]]

drug and biological products and related materials, including, but not 
limited to, social and behavioral research, decisionmaking processes, 
and communication and behavioral change strategies.
    Annually, FDA estimates 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 September 19, 2016 (81 FR 64166), FDA 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
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Interviews/Surveys...........................           2,520            14.6          36,792  0.25 (15 minutes)........................           9,198
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12446 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P