[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12484-12486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1411]


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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that a proposed collection

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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

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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:

                                                      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/Focus Groups.............           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.

    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.

    Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04407 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P


