[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40655-40658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 
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 and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on a new collection of information to collect 
entitled ``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.''

DATES: Submit either electronic or written comments on the collection 
of information by September 8, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 8, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 8, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 40656]]

     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-N-1411 for ``Agency Information Collection Activities; 
Proposed Collection; 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 FDA Regulated Products.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), 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 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.

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 off all FDA-regulated products. These studies may consist of 
small groups, focus groups, individual indepth interviews, and surveys 
relating to the evaluation of disease prevention and treatment and the 
safety, efficacy, and usage of FDA-regulated products and 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 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. These studies may 
consist of small groups, focus groups, individual in-depth interviews, 
and surveys relating to the evaluation of disease prevention and 
treatment and the safety, efficacy, and usage of FDA-regulated products 
and 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).
    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, patient, 
caregivers, academic/scientific experts, and public health 
professionals' perceptions and behaviors regarding various issues and 
outcomes associated the 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

[[Page 40657]]

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 audience's knowledge 
regarding FDA-regulated products, and outcomes associated the disease 
prevention, 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 conditions: 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 grantee 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 in 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 this generic clearance to 
inform its FDA-regulated products educational, interventions, outcomes, 
and 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 in the 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.
    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.


[[Page 40658]]

    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: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14517 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P


