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
| Published date | 07 July 2020 |
| Citation | 85 FR 40655 |
| Record Number | 2020-14517 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 85 Issue 130 (Tuesday, July 7, 2020)
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys/Focus Groups................. 2,520 14.6 36,792 0.25 (15 minutes)................. 9,198
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
