Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and Drug Administration Regulated Products

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 (PRA).

DATES:

Submit written comments (including recommendations) on the collection of information by April 2, 2021.

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 title of this information collection is “Generic Clearance for Data to Support Cross-Center Collaboration for Social Behavioral Sciences Associated with Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products.” 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.

Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products

OMB Control Number 0910-NEW

FDA is seeking to conduct qualitative and quantitative research studies to better understand consumers', patients', caregivers', academic/scientific experts', and public health professionals' perceptions and behaviors regarding various issues and outcomes associated with disease prevention, treatment, and the safety and efficacy of all FDA-regulated products. These studies may consist of small groups, focus groups/town halls, individual indepth interviews, and surveys relating to the evaluation of disease prevention and treatment and the safety, efficacy, and usage of FDA-regulated products; the studies may also include communication messages and strategies, and other materials directed to consumers, patients, caregivers, and public health professionals (e.g., evaluate the effectiveness of communication messages, educational materials, and interventions directed toward promoting and protecting human and animal health).

Among the general provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is charged with promoting the public health through regulatory oversight as well as clinical research. Specifically, section 1003(d)(2)(C) and (D) of the FD&C Act (21 U.S.C. 393(d)(2)(C) and (D)) provides that the Commissioner of Food and Drugs shall be responsible for research. Accordingly, FDA is seeking to conduct qualitative and quantitative research studies.

The information collection is intended to support research conducted by, or on behalf of, FDA. Understanding consumers', patients', caregivers', academic/scientific experts', and public health professionals' perceptions and behaviors plays an important role in improving FDA's decision-making processes and communications impacting various stakeholders. To better understand consumers', patients', caregivers', academic/scientific experts', and public health professionals' perceptions and behaviors regarding various issues and outcomes associated with disease prevention, treatment, and the safety, efficacy, and usage of products overseen by the Agency, FDA is requesting approval of this generic information collection request.

The qualitative and quantitative research anticipated by FDA aligns with Agency objectives. For example, among eight scientific priorities is the goal to support social and behavioral sciences. Such research helps the Agency meet this goal by:

• Identifying gaps in the target audiences' knowledge regarding FDA-regulated products, and outcomes associated the disease prevention and treatment;
• reaching diverse audiences;
• assessing target audiences' knowledge, perceptions, and behaviors about FDA-regulated products;
• evaluating the effectiveness of FDA's communications;
• exploring ways to incorporate patient input into decision making;
• leveraging real-world data;
• evaluating outcomes; and
• integrating the knowledge gained from the research into Agency communications, activities, interventions, and programs.

FDA will only submit a collection for approval under this generic clearance if it meets the following condition: Information provided by respondents will be kept private and anonymous, except as otherwise required by law. This will be communicated to respondents by means of introductory letters, explanatory texts on the cover pages of questionnaires, scripts read prior to focus groups or telephone interviews, and consent forms as appropriate. Respondents also will be advised of the following: (1) The nature of the activity; (2) the intended purpose and use of the data collected; (3) FDA sponsorship (when appropriate); and (4) the fact that participation is voluntary at all times. Because responses are voluntary, respondents will be assured that there will be no penalties if they decide not to respond, either to the information collection as a whole or to any individual questions.

Only Agency or Agency-sponsored personnel will have access to individual-level surveys, interviews, or focus group data. All project staff from a contractor or cooperative agreement grantee conducting the information collection must take required measures to ensure respondent privacy and confidentiality of data. Personally identifiable information (PII) shall be limited to data that may be required in the process of respondent enrollment. PII will be accessible to only those contractors or cooperative agreement grantees who need it and will not be linked to interview data. Neither FDA employees nor any Federal employee of any other Agency will have access to PII. All PII will be destroyed by contractors as soon as feasible following data collected during interviews.

All electronic and hard-copy data will be maintained securely throughout the information collection and data processing phases. While under review, electronic data will be stored in locked files on secured computers; hard-copy data will be maintained in secure building facilities in locked filing cabinets. As a further guarantee of privacy and anonymity, all data will be reported to FDA in aggregate form, with no links to individuals preserved. Reports generated by this information collection will be used only for research purposes and for the development of communication messages.

Social and behavioral testing efforts described in this proposal are typically considered exempt from the “Regulations for the Protection of Human Subjects” in accordance with 45 CFR 46.101(b)(3). Before data are collected, FDA researchers must obtain either an exemption or an expedited or full approval for all research from FDA's institutional review board (IRB).

When FDA's IRB determines that minors are capable of giving assent, the IRB shall determine whether adequate provisions are made for soliciting assent. Generally, assent requires securing the signature of a minor potentially participating in the research on a separate assent form, in addition to the consent form the parent or legal guardian signs. An assent document should: (1) Contain an explanation of the study; (2) a description of what is required of the subject (e.g., what he or she will experience (whether the minor will be in the hospital, whether the minor's parents will be with him or her, etc.)); (3) an explanation of any risks and pain associated with the study; (4) an explanation of any anticipated change in the minor's appearance; and (5) an explanation of the benefits to the minor or others.

FDA plans to use the data collected under the generic clearance to inform the following information for education, interventions, outcomes, regulatory science programs, materials and resources, and disease prevention and treatment. FDA expects the data to guide the formulation of the Agency's educational and public health objectives on FDA-regulated products and support development of subsequent research efforts. The data will not be used to make policy or regulatory decisions. Rather, these data will: (1) Inform FDA's public education campaigns and other educational/interventional materials directed to informing consumers, patients, caregivers, and public health professionals about human and animal health issues; and (2) provide information on the safety, efficacy, and usage of FDA-regulated products.

If these conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process.

To obtain approval for a collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB, along with supporting documentation (e.g., a copy of the interview or moderator guide, screening questionnaire).

FDA will submit individual qualitative and quantitative collections under this generic clearance to the OMB. Individual collections will also undergo review by FDA's IRB, senior leadership for the primary investigator's respective offices, and PRA specialists.

Description of Respondents: The respondents to this collection of information are all FDA stakeholders, including general population individuals, as well as consumers of certain products, patients and their caregivers, academic/scientific experts, individuals from specific target labor groups, such as physicians, medical specialists, pharmacists, dentists, nurses, veterinarians, dietitians, and other public health professionals.

In the Federal Register of July 7, 2020 (85 FR 40655), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although five comments were received, they were not responsive to the four collection of information topics solicited and, therefore, will not be discussed in this document.

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

This is a new collection of information whose total estimated annual reporting burden is 9,198 hours. The number of participants to be included in each individual generic submission under this collection of information will vary, depending on the nature of the compliance efforts and the target audience.