Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2019-13001 · Docket No. FDA-2016-N-2683

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 a generic clearance to collect information to support social and behavioral research used by FDA about drug products.

Dates

Submit either electronic or written comments on the collection of information by August 19, 2019.

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. 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 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. 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 Interviews/Surveys 2,520 14.6 36,792 .25 (15 minutes) 9,198 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: June 14, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-13001 Filed 6-18-19; 8:45 am]