[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]
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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.
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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;
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\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.
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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