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, 40655-40658 [2020-14517]
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
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patterns, traffic flows, and outlet
characteristics. Consumers typically
choose between nearby retail fuel
outlets with similar characteristics along
their planned routes. The geographic
markets for the retail sale of diesel are
likely similar to the corresponding
geographic markets for retail gasoline as
many diesel consumers exhibit the same
preferences and behaviors as gasoline
consumers.
The Acquisition would eliminate
competition in these local markets,
resulting in a merger to monopoly in
each market for the retail sale of
gasoline and the retail sale of diesel
fuel. Retail fuel outlets compete on
price, store format, product offerings,
and location, and pay close attention to
competitors in close proximity, on
similar traffic flows, and with similar
store characteristics. The combined
entity would be able to raise prices
unilaterally in the two local markets.
Absent the Acquisition, Tri Star and
Hollingsworth would continue to
compete head to head in these local
markets.
Entry into each relevant market would
not be timely, likely, or sufficient to
deter or counteract the anticompetitive
effects arising from the Acquisition.
Significant entry barriers include the
availability of attractive real estate, the
time and cost associated with
constructing a new retail fuel outlet, and
the time associated with obtaining
necessary permits and approvals.
V. The Proposed Consent Agreement
The proposed Consent Agreement
would remedy the Acquisition’s likely
anticompetitive effects by requiring Tri
Star to divest certain Tri Star and
Hollingsworth retail fuel assets to Cox
in each local market.
The proposed Consent Agreement
requires that the divestiture be
completed no later than 10 days after
Tri Star consummates the Acquisition.
The proposed Consent Agreement
further requires Tri Star and
Hollingsworth to maintain the economic
viability, marketability, and
competitiveness of each divestiture
asset until the divestiture to Cox is
complete. For up to twelve months
following the divestiture, Tri Star and
Hollingsworth must make available
transitional services, as needed, to assist
Cox with the divestiture assets.
In addition to requiring outlet
divestitures, the proposed Consent
Agreement also requires Respondents to
provide the Commission notice before
re-acquiring the divested outlets for ten
years. The prior notice provision is
necessary because an acquisition of
either or both divested assets would
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likely raise the same competitive
concerns and may fall below the HSR
Act premerger notification thresholds.
The proposed Consent Agreement
contains additional provisions designed
to ensure the effectiveness of the
proposed relief. For example,
Respondents have agreed to an Order to
Maintain Assets that will issue at the
time the proposed Consent Agreement is
accepted for public comment. The Order
to Maintain Assets requires
Respondents to operate and maintain
each divestiture outlet in the normal
course of business, through the date the
Respondents complete the divestiture.
The Commission may appoint an
independent third party as a Monitor to
oversee the Respondents’ compliance
with the requirements of the proposed
Consent Agreement.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent agreement, and the
Commission does not intend this
analysis to constitute an official
interpretation of the proposed Consent
Agreement or to modify its terms in any
way.
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.
By direction of the Commission,
Commissioner Slaughter not participating.
April J. Tabor,
Secretary.
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’’).
[FR Doc. 2020–14508 Filed 7–6–20; 8:45 am]
BILLING CODE 6750–01–P
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.
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
SUMMARY:
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Electronic Submissions
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.
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
• 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 CrossCenter 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-201509-18/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
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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
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various issues and outcomes associated
with disease prevention, treatment, and
the safety and efficacy off all FDAregulated 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 FDAregulated 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
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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 FDAregulated 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.
40657
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:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
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.
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1206]
Electronic Study Data Submission;
Data Standards; Support and
Requirement Begin for Study Data
Tabulation Model Version 1.7
Implementation Guide 3.3 and for
Define-Extensible Markup Language
Version 2.1; Requirement Ends for
Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Biologics Evaluation and
Research (CBER) and Center for Drug
Evaluation and Research (CDER) are
announcing the dates that support and
requirement will begin for version 1.7 of
the Clinical Data Interchange Standards
Consortium (CDISC) for Study Data
Tabulation Model (SDTM)
Implementation Guide (IG) 3.3, as well
as for version 2.1 of the DefineExtensible Markup Language (DefineXML). CBER and CDER are also
announcing the date that support and
requirement will end for version 1.3 of
the CDISC SDTM IG 3.1.3. The Agency
will update the FDA Data Standards
Catalog (Catalog) to reflect these
changes.
SUMMARY:
You may submit either
electronic or written comments at any
time as follows:
ADDRESSES:
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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://
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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.
• 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–1206 for ‘‘Electronic Study
Data Submission; Data Standards;
Support and Requirement Begin for
Study Data Tabulation Model Version
1.7 Implementation Guide 3.3 and for
Define-Extensible Markup Language
Version 2.1; Requirement Ends for
Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3.’’
Received comments 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
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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-201509-18/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:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993–
0002, 240–402–7911.
SUPPLEMENTARY INFORMATION: On
December 17, 2014, FDA published a
final guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Standardized Study
Data’’ (eStudy Data guidance), posted on
FDA’s Study Data Standards Resources
web page at https://www.fda.gov/
forindustry/datastandards/
studydatastandards/default.htm. The
eStudy Data guidance implements the
electronic submission requirements of
section 745A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
379k–1(a)) for study data contained in
new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), biologics license applications
(BLAs), and certain investigational new
drug applications (INDs) submitted to
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
