Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications, 44888-44890 [2018-19088]
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/;Drugs/
CardiovascularandRenalDrugsAdvisory
Committee/ucm094743.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19067 Filed 8–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3123]
Advisory Committee; Endocrinologic
and Metabolic Drugs Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Endocrinologic and
Metabolic Drugs Advisory Committee by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Endocrinologic
and Metabolic Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until
August 27, 2020.
DATES: Authority for the Endocrinologic
and Metabolic Drugs Advisory
Committee will expire on August 27,
2020, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Silver Spring, MD 20993–0002, 301–
796–9001, email: EMDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Endocrinologic and Metabolic Drugs
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of endocrine and
metabolic disorders, and makes
appropriate recommendations to the
Commissioner.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
endocrinology, metabolism,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
EndocrinologicandMetabolicDrugs
AdvisoryCommittee/ucm100261.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
PO 00000
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U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19066 Filed 8–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3037]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for Quantitative Testing for the
Development of FDA Communications
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
response to the notice. This notice
solicits comments on the creation of a
new collection of information entitled
‘‘Generic Clearance for Quantitative
Testing for the Development of FDA
Communications.’’
DATES: Submit either electronic or
written comments on the collection of
information by November 5, 2018.
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 November 5,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 5, 2018.
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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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.
• 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–
2018–N–3037 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Generic
Clearance for Quantitative Testing for
the Development of FDA
Communications.’’ 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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. 3501–3520), 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
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44889
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 Quantitative
Testing for the Development of FDA
Communications
OMB Control Number 0910—New
This notice announces the FDA
information collection request from
OMB for a generic clearance that will
allow FDA to use quantitative social/
behavioral science data collection
techniques (i.e., surveys and
experimental studies) to test consumers’
reactions to FDA communications or
educational messaging about FDAregulated food and cosmetic products,
dietary supplements, and animal food
and feed. To ensure that
communications activities and
educational campaigns have the highest
potential to be received, understood,
and accepted by those for whom they
are intended, it is important to assess
communications while they are under
development. Understanding
consumers’ attitudes, motivations, and
behaviors in response to potential
communications and education
messaging plays an important role in
improving FDA’s communications.
If the following conditions are not
met, FDA will submit an information
collection request to OMB for approval
through the normal PRA process:
• The collections are voluntary;
• The collections are low burden for
participants (based on considerations of
total burden hours, total number of
participants, or burden hours per
participant) and are low cost for both
the participants and the Federal
Government;
• The collections are
noncontroversial;
• Personally identifiable information
(PII) is collected only to the extent
necessary 1 and is not retained;
1 For example, collections that collect PII to
provide remuneration for participants of focus
groups and cognitive laboratory studies will be
submitted under this request. All Privacy Act
requirements will be met.
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions; 2
and
• Information gathered will yield
qualitative findings; the collections will
not be designed or expected to yield
statistical data or used as though the
results are generalizable to the
population of study.
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 survey or
experimental design and stimuli for
testing).
FDA will submit individual
quantitative collections under this
generic clearance to OMB. Individual
quantitative collections will also
undergo review by FDA’s Research
Involving Human Subjects Committee,
senior leadership in the Center for Food
Safety and Applied Nutrition, and PRA
specialists.
Respondents to this collection of
information may include a wide range
of consumers and other FDA
stakeholders such as producers and
manufacturers who are regulated under
FDA-regulated food and cosmetic
products, dietary supplements, and
animal food and feed.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1
Number of
respondents
Survey type
Total annual
responses
Total hours
Cognitive Interviews Screener .........................................................................
Cognitive Interviews .........................................................................................
Pre-test Study Screener ..................................................................................
Pre-testing Study .............................................................................................
Self-administered Surveys/Experimental Studies Screener ............................
Self-Administered Surveys/Experimental Studies ...........................................
720
144
2,400
480
75,000
15,000
1
1
1
1
1
1
720
144
2,400
480
75,000
15,000
60
144
199
120
6,225
3,750
Total ..........................................................................................................
........................
........................
........................
10,498
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The total estimated annual burden is
10,498 hours. Current estimates are
based on both historical numbers of
participants from past projects as well
as estimates for projects to be conducted
in the next 3 years. The number of
participants to be included in each new
survey will vary, depending on the
nature of the compliance efforts and the
target audience.
SUMMARY:
The Food and Drug
Administration (FDA or we) is
In April 1996, the ‘‘FDA Export
Reform and Enhancement Act of 1996’’
(Pub. L. 104–134, amended by Pub. L.
104–180) amended sections 801 and 802
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 381 and
382). As a result of the 1996
amendments, section 801(e)(4) of the
FD&C Act provides that persons
exporting a drug, animal drug, or device
may request FDA to certify that the
product meets the requirements of
section 801(e)(1), section 802, or other
applicable requirements of the FD&C
Act. Upon a showing that the product
meets the applicable requirements, the
law provides that FDA shall issue
export certification within 20 days of
the receipt of a request for such
certification. The law also authorizes us
to charge up to $175 for each
certification issued within the 20-day
period.
In January 2011, section 801(e)(4) of
the FD&C Act was further amended by
FSMA (Pub. L. 111–353) to authorize
FDA to issue, and charge fees for, export
certificates for food. Under section
801(e)(4)(C) of the FD&C Act, an export
certification can be made in such form
(including a publicly available listing)
as FDA determines appropriate.
This notice focuses on the fees to be
assessed with respect to export
certificates issued by the Center for
Food Safety and Applied Nutrition
(CFSAN) for food for human
2 As defined in OMB and agency Information
Quality Guidelines, ‘‘influential’’ means that ‘‘an
agency can reasonably determine that
dissemination of the information will have or does
have a clear and substantial impact on important
public policies or important private sector
decisions.’’
Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19088 Filed 8–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2700]
Food for Human Consumption; Export
Certificates; Food and Drug
Administration Food Safety
Modernization Act of 2011;
Certification Fees
AGENCY:
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:54 Aug 31, 2018
announcing the fees we will assess for
issuing export certificates for food for
human consumption, with the
exception of dietary supplements,
medical foods, and foods for special
dietary use. The FDA Food Safety
Modernization Act (FSMA) of 2011
authorizes us to charge fees to cover our
costs associated with issuing export
certificates for food. This notice
provides the fee schedule for issuing
these certificates and the basis for the
fees. We have not previously exercised
our FSMA authority to collect fees for
export certificates issued for food for
human consumption.
DATES: The fees described in this
document for export certificates for food
for human consumption, with the
exception of dietary supplements,
medical foods, and foods for special
dietary use, will be effective October 1,
2018.
FOR FURTHER INFORMATION CONTACT: Kate
Meck, International Affairs Staff, Center
for Food Safety and Applied Nutrition
(HFS–550), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2307,
CFSANExportCertification@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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]]>Agencies
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44888-44890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19088]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3037]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Quantitative Testing for the
Development of FDA Communications
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 the creation of a new collection of information
entitled ``Generic Clearance for Quantitative Testing for the
Development of FDA Communications.''
DATES: Submit either electronic or written comments on the collection
of information by November 5, 2018.
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 November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 5, 2018. 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
[[Page 44889]]
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.
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-2018-N-3037 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for
Quantitative Testing for the Development of FDA Communications.''
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.
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.gpo.gov/fdsys/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.
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. 3501-3520), 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 Quantitative Testing for the Development of FDA
Communications
OMB Control Number 0910--New
This notice announces the FDA information collection request from
OMB for a generic clearance that will allow FDA to use quantitative
social/behavioral science data collection techniques (i.e., surveys and
experimental studies) to test consumers' reactions to FDA
communications or educational messaging about FDA-regulated food and
cosmetic products, dietary supplements, and animal food and feed. To
ensure that communications activities and educational campaigns have
the highest potential to be received, understood, and accepted by those
for whom they are intended, it is important to assess communications
while they are under development. Understanding consumers' attitudes,
motivations, and behaviors in response to potential communications and
education messaging plays an important role in improving FDA's
communications.
If the following conditions are not met, FDA will submit an
information collection request to OMB for approval through the normal
PRA process:
The collections are voluntary;
The collections are low burden for participants (based on
considerations of total burden hours, total number of participants, or
burden hours per participant) and are low cost for both the
participants and the Federal Government;
The collections are noncontroversial;
Personally identifiable information (PII) is collected
only to the extent necessary \1\ and is not retained;
---------------------------------------------------------------------------
\1\ For example, collections that collect PII to provide
remuneration for participants of focus groups and cognitive
laboratory studies will be submitted under this request. All Privacy
Act requirements will be met.
---------------------------------------------------------------------------
[[Page 44890]]
Information gathered will not be used for the purpose of
substantially informing influential policy decisions; \2\ and
---------------------------------------------------------------------------
\2\ As defined in OMB and agency Information Quality Guidelines,
``influential'' means that ``an agency can reasonably determine that
dissemination of the information will have or does have a clear and
substantial impact on important public policies or important private
sector decisions.''
---------------------------------------------------------------------------
Information gathered will yield qualitative findings; the
collections will not be designed or expected to yield statistical data
or used as though the results are generalizable to the population of
study.
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 survey or experimental design and stimuli for testing).
FDA will submit individual quantitative collections under this
generic clearance to OMB. Individual quantitative collections will also
undergo review by FDA's Research Involving Human Subjects Committee,
senior leadership in the Center for Food Safety and Applied Nutrition,
and PRA specialists.
Respondents to this collection of information may include a wide
range of consumers and other FDA stakeholders such as producers and
manufacturers who are regulated under FDA-regulated food and cosmetic
products, dietary supplements, and animal food and feed.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden by Anticipated Data Collection Methods \1\
----------------------------------------------------------------------------------------------------------------
Number of
Survey type Number of responses per Total annual Total hours
respondents respondent responses
----------------------------------------------------------------------------------------------------------------
Cognitive Interviews Screener................... 720 1 720 60
Cognitive Interviews............................ 144 1 144 144
Pre-test Study Screener......................... 2,400 1 2,400 199
Pre-testing Study............................... 480 1 480 120
Self-administered Surveys/Experimental Studies 75,000 1 75,000 6,225
Screener.......................................
Self-Administered Surveys/Experimental Studies.. 15,000 1 15,000 3,750
---------------------------------------------------------------
Total....................................... .............. .............. .............. 10,498
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The total estimated annual burden is 10,498 hours. Current
estimates are based on both historical numbers of participants from
past projects as well as estimates for projects to be conducted in the
next 3 years. The number of participants to be included in each new
survey will vary, depending on the nature of the compliance efforts and
the target audience.
Dated: August 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19088 Filed 8-31-18; 8:45 am]
BILLING CODE 4164-01-P
