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 or Agency) 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:

Submit written comments (including recommendations) on the collection of information by December 14, 2022.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0847. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 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

This information collection is intended to support FDA-conducted research. Understanding patients, consumers, and healthcare professionals' perceptions and behaviors plays an important role in improving FDA's regulatory decision-making processes and communications that affect various stakeholders. FDA uses the following methods to achieve these goals: (1) individual indepth interviews, (2) general public focus group interviews, (3) intercept interviews, (4) self-administered surveys, (5) gatekeeper surveys, and (6) focus group interviews. These methods serve the narrowly defined need for direct and informal opinion on a specific topic and serve as a qualitative and quantitative research tool having two major purposes:

• Obtaining useful information for the development of variables and measures for formulating the basic objectives of social and behavioral research and
• successfully communicating and addressing behavioral changes with intended audiences to assess the potential effectiveness of FDA communications, behavioral interventions, and other materials.

While FDA will use these methods to test and refine its ideas and help develop communication and behavioral strategies research, the Agency 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 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. These subjects include social and behavioral research, decision-making processes, and communication and behavioral change strategies.

Annually, FDA projects about 25 social and behavioral studies using the variety of test methods listed in this document. FDA is revising this burden to account for the number of studies we have received in the last 3 years and to better reflect the scope of the information collection.

In the Federal Register of August 10, 2022 (87 FR 48665), FDA published a 60-day notice requesting public comment on the proposed collection of information. Three comments were received. The first comment was not responsive. The second comment requested that participants be informed that participation is voluntary and can withdraw at any time. Prior to beginning the interview and several times throughout, participants are informed that their participation is voluntary and that they can withdraw at any time. We believe no further clarification to the survey instruments are necessary. The third comment expressed concerns regarding the potential misuse of information from the collection. We have previously outlined the scope and purpose of the information collection, and we do not believe further elaboration is necessary. Further, as outlined in the supporting statement, all information collections must be non-controversial, must not retain Personally Identifiable Information, and “will not be used for substantially informing influential policy decisions.”

FDA estimates the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, our burden estimate for this information collection reflects an overall increase of 35,886 responses with a corresponding increase of 8,972 hours. We attribute this adjustment to an increase in funding and need to obtain additional information in specific areas, particularly substance abuse (for example, opioids and stimulants) and COVID-19. In addition, we attribute the increase in the number of respondents (from 7,298 to 109,470) and decrease in the number of responses per respondent (from 15 to 1) to an inadvertent administrative error reflected in the 60-day notice. These changes, however, do not impact the estimated total annual responses or burden hours.