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, 12484-12486 [2021-04407]
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<![CDATA[
12484
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
forthcoming public advisory committee
meeting of the Circulatory System
Devices Panel of the Medical Devices
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will take place
virtually on April 6, 2021, from 9 a.m.
Eastern Time to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability may
be accessed at: https://www.fda.gov/
advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings.
jbell on DSKJLSW7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, aden.asefa@
fda.hhs.gov, 301–796–0400, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On April 6,
2021, the committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application for the
TransMedics Organ Care System (OCS)
Heart, by TransMedics, Inc. The
proposed Indication for Use for the
TransMedics OCS Heart, is as follows:
The TransMedics Organ Care System
(OCS) Heart System is a portable
extracorporeal heart perfusion and
monitoring system indicated for the
resuscitation, preservation, and
assessment of donor hearts in a nearphysiologic, normothermic, and beating
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state intended for a potential transplant
recipient.
OCS Heart is indicated for donor
hearts with one or more of the following
characteristics:
• Expected cross-clamp or ischemic
time ≥4 hours due to donor or
recipient characteristics (e.g.,
donor- recipient geographical
distance, expected recipient
surgical time); or
• Expected total cross-clamp time of
≥2 hours PLUS one of the following risk
factors:
• Donor Age ≥55 years; or
• Donors with history of cardiac
arrest and downtime ≥20 minutes; or
• Donor history of alcoholism; or
• Donor history of diabetes; or
• Donor Left Ventricular Ejection
Fraction ≤50 percent but ≥40 percent; or
• Donor history of Left Ventricular
Hypertrophy (septal or posterior wall
thickness of >12 and ≤16 mm); or
• Donor angiogram with luminal
irregularities but no significant coronary
artery disease.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
advisory-committees/circulatory-systemdevices-panel/2021-meeting-materialscirculatory-system-devices-panel. Select
the link for the 2021 Meeting Materials.
The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 30, 2021.
Oral presentations from the public will
be scheduled on April 6, 2021, between
approximately 1 p.m. Eastern Time and
2 p.m. Eastern Time. Those individuals
interested in making formal oral
presentations should notify the contact
person (see FOR FURTHER INFORMATION
CONTACT). The notification should
include a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
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an indication of the approximate time
requested to make their presentation on
or before March 22, 2021. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 23, 2021.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Artair Mallet
at Artair.Mallet@fda.hhs.gov or 301–
796–9638 at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/advisorycommittees/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04371 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or Agency) is
announcing that a proposed collection
SUMMARY:
E:\FR\FM\03MRN1.SGM
03MRN1
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
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.
jbell on DSKJLSW7X2PROD with NOTICES
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 FDAregulated 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
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Jkt 253001
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 FDAregulated 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
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12485
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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12486
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
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
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Interviews/Surveys/Focus Groups .................................
2,520
14.6
36,792
1 There
0.25 (15 minutes)
Total hours
9,198
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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Average
burden per
response
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
VerDate Sep<11>2014
17:29 Mar 02, 2021
Jkt 253001
meeting of the Board of Scientific
Counselors, NIAMS.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review, discussion,
and evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF ARTHRITIS
AND MUSCULOSKELETAL AND SKIN
DISEASES, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NIAMS.
Date: April 27–28, 2021.
Time: April 27, 2021, 12:30 p.m. to 4:45
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, 10
Center Drive, Bethesda, MD 20892, (Virtual
Meeting).
Time: April 28, 2021, 12:00 p.m. to 4:15
p.m.
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Sfmt 9990
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, 10
Center Drive, Bethesda, MD 20892, (Virtual
Meeting).
Contact Person: John J. O’Shea, MD, Ph.D.,
Scientific Director, National Institute of
Arthritis & Musculoskeletal and Skin
Diseases, Building 10, Room 6N204,
Bethesda, MD 20892, (301) 496–2612,
osheajo@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: _February 25, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–04366 Filed 3–2–21; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that a proposed collection
[[Page 12485]]
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,
[email protected].
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
[[Page 12486]]
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
