Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness, 12617-12619 [2019-06365]
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ONFI (clobazam) tablets, 5 mg, is the
subject of NDA 202067, held by
Lundbeck Pharmaceuticals, LLC, and
initially approved on October 21, 2011.
ONFI is indicated for the adjunctive
treatment of seizures associated with
Lennox-Gastaut syndrome in patients 2
years of age or older.
In a letter dated November 2, 2012,
Lundbeck Pharmaceuticals, LLC,
notified FDA that ONFI (clobazam)
tablets, 5 mg, was being discontinued,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Ascend Laboratories, LLC, submitted
a citizen petition dated July 17, 2018
(Docket No. FDA–2018–P–2754), under
21 CFR 10.30, requesting that the
Agency determine whether ONFI
(clobazam) tablets, 5 mg, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
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§ 314.161 that ONFI (clobazam) tablets,
5 mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that ONFI
(clobazam) tablets, 5 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ONFI
(clobazam) tablets, 5 mg, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ONFI (clobazam) tablets,
5 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to this drug product
may be approved by the Agency as long
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06381 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0430]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for Quick Turnaround Testing of
Communication Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Frm 00043
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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 entitled ‘‘Generic
Clearance for Quick Turnaround Testing
of Communication Effectiveness.’’
DATES: Submit either electronic or
written comments on the collection of
information by June 3, 2019.
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 June 3, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 3, 2019. 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
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
SUMMARY:
PO 00000
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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
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12618
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
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–
2019–N–0430 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Generic
Clearance for Quick Turnaround Testing
of Communication Effectiveness.’’
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/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.
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Jkt 247001
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
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.
FOR FURTHER INFORMATION CONTACT:
Generic Clearance for Quick
Turnaround Testing of Communication
Effectiveness
OMB Control Number 0910–New
This notice announces the FDA
information collection request to OMB
for approval of a generic clearance that
will allow FDA to use quick turnaround
surveys, focus groups, and in-depth
interviews collected from consumers
and other stakeholders to communicate
FDA issues of immediate and important
public health significance. For example,
these methods of communication might
be used when there is a foodborne
illness outbreak, food recall, or other
situation requiring expedited FDA food,
dietary supplement, cosmetics, or
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animal food or feed communications. So
that FDA may better protect the public
health, the Agency needs quick
turnaround information to help ensure
its messaging has reached the target
audience, has been effective, and, if
needed, to update its communications
during these events.
FDA will only submit individual
collections for approval under this
generic clearance if they meet the
following conditions:
• 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;
• 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 used as though the
results are generalizable to the
population of study.
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 an individual
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, focus group moderator guide, or
in-depth interviewing guide).
Individual collections will also
undergo review by FDA senior
leadership in the Center for Food Safety
and Applied Nutrition, PRA specialists,
and an institutional review board.
Respondents to this collection of
information 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.
1 For example, collections that collect PII to
provide remuneration for participants of focus
groups, in-depth interviews, and cognitive
laboratory studies will be submitted under this
request. All privacy act requirements will be met.
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.’’
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
12619
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Survey type
Total annual
responses
Average burden per
response
Total hours
In-depth Interviews, Cognitive Interviews Screener
In-depth Interviews, Cognitive Interviews ................
In-depth Interviews Screener ...................................
In-depth Interviews ...................................................
Survey Cognitive Interviews Screener .....................
Survey Cognitive Interviews ....................................
Pretest survey screener ...........................................
Pretest survey ..........................................................
Self-Administered Surveys—Study Screener ..........
Self-Administered Surveys .......................................
Focus Group/Small Group, Cognitive Groups
Screener.
Focus Group/Small Group, Cognitive Groups .........
Focus Group/Small Group Participant Screening ...
Focus Group/Small Group Discussion ....................
45
9
900
180
45
9
750
150
75,000
15,000
180
1
1
1
1
1
1
1
1
1
1
1
45
9
900
180
45
9
750
150
75,000
15,000
180
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
4
9
75
180
4
9
62.25
38
6,225
3,750
15
60
720
240
1
1
1
60
720
240
1.5 (90 minutes) ........
0.083 (5 minutes) ......
1.5 (90 minutes) ........
90
60
360
Total ..................................................................
........................
........................
........................
....................................
10,881.25
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 burden is 10,881.25 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 individual survey
will vary, depending on the nature of
the compliance efforts and the target
audience.
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1107]
Youth Tobacco Cessation: Science
and Treatment Strategies; Public
Scientific Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public scientific
workshop; request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
scientific workshop entitled ‘‘Youth
Tobacco Cessation: Science and
Treatment Strategies.’’ The purpose of
the workshop is to discuss the unique
SUMMARY:
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18:45 Apr 01, 2019
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challenges associated with youth
tobacco addiction and cessation, and the
current science regarding youth tobacco
use and addiction as well as treatment
strategies to support youth tobacco
cessation.
The public scientific workshop
will be held on May 15, 2019, from 9
a.m. to 5 p.m. Submit either electronic
or written comments on this workshop
by May 31, 2019. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
DATES:
The public scientific
workshop will be held at the FDA White
Oak Campus, 10903 New Hampshire
Ave., Bldg. 31 Conference Center, the
Great Room (Rm. 1503A), Silver Spring,
MD 20993–0002. Entrance for public
workshop participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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 May 31, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 31, 2019. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
ADDRESSES:
[FR Doc. 2019–06365 Filed 4–1–19; 8:45 am]
amozie on DSK9F9SC42PROD with NOTICES
Number of
responses per
respondent
PO 00000
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Sfmt 4703
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
E:\FR\FM\02APN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12617-12619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0430]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Quick Turnaround Testing of
Communication Effectiveness
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 entitled ``Generic
Clearance for Quick Turnaround Testing of Communication
Effectiveness.''
DATES: Submit either electronic or written comments on the collection
of information by June 3, 2019.
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 June 3, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 3, 2019. 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.
For written/paper comments submitted to the Dockets
Management
[[Page 12618]]
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-2019-N-0430 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for Quick
Turnaround Testing of Communication Effectiveness.'' 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 Quick Turnaround Testing of Communication
Effectiveness
OMB Control Number 0910-New
This notice announces the FDA information collection request to OMB
for approval of a generic clearance that will allow FDA to use quick
turnaround surveys, focus groups, and in-depth interviews collected
from consumers and other stakeholders to communicate FDA issues of
immediate and important public health significance. For example, these
methods of communication might be used when there is a foodborne
illness outbreak, food recall, or other situation requiring expedited
FDA food, dietary supplement, cosmetics, or animal food or feed
communications. So that FDA may better protect the public health, the
Agency needs quick turnaround information to help ensure its messaging
has reached the target audience, has been effective, and, if needed, to
update its communications during these events.
FDA will only submit individual collections for approval under this
generic clearance if they meet the following conditions:
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, in-depth interviews,
and cognitive laboratory studies will be submitted under this
request. All privacy act requirements will be met.
---------------------------------------------------------------------------
Information gathered will not be used for the purpose of
substantially informing influential policy decisions; \2\ and
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\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.''
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Information gathered will yield qualitative findings; the
collections will not be designed or used as though the results are
generalizable to the population of study.
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 an individual 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, focus group moderator guide, or in-depth
interviewing guide).
Individual collections will also undergo review by FDA senior
leadership in the Center for Food Safety and Applied Nutrition, PRA
specialists, and an institutional review board.
Respondents to this collection of information 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.
[[Page 12619]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Survey type Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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In-depth Interviews, Cognitive Interviews 45 1 45 0.083 (5 minutes)......................... 4
Screener.
In-depth Interviews, Cognitive Interviews... 9 1 9 1......................................... 9
In-depth Interviews Screener................ 900 1 900 0.083 (5 minutes)......................... 75
In-depth Interviews......................... 180 1 180 1......................................... 180
Survey Cognitive Interviews Screener........ 45 1 45 0.083 (5 minutes)......................... 4
Survey Cognitive Interviews................. 9 1 9 1......................................... 9
Pretest survey screener..................... 750 1 750 0.083 (5 minutes)......................... 62.25
Pretest survey.............................. 150 1 150 0.25 (15 minutes)......................... 38
Self-Administered Surveys--Study Screener... 75,000 1 75,000 0.083 (5 minutes)......................... 6,225
Self-Administered Surveys................... 15,000 1 15,000 0.25 (15 minutes)......................... 3,750
Focus Group/Small Group, Cognitive Groups 180 1 180 0.083 (5 minutes)......................... 15
Screener.
Focus Group/Small Group, Cognitive Groups... 60 1 60 1.5 (90 minutes).......................... 90
Focus Group/Small Group Participant 720 1 720 0.083 (5 minutes)......................... 60
Screening.
Focus Group/Small Group Discussion.......... 240 1 240 1.5 (90 minutes).......................... 360
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Total................................... .............. .............. .............. .......................................... 10,881.25
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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 burden is 10,881.25 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 individual survey will vary,
depending on the nature of the compliance efforts and the target
audience.
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06365 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P
