Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed, 40299-40300 [2020-14365]
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Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Mayer, R.E., & Moreno, R. (2003), Nine
Ways to Reduce Cognitive Load in
Multimedia Learning. Educational
Psychologist, 38(1), 43–52.
2. Mutlu-Bayraktar, D., Cosgun, V., &
Altan, T. (2019), Cognitive Load in
Multimedia Learning Environments: A
Systematic Review. Computers &
Education, 141, 103618.
3. Betts, K. R., Boudewyns, V., Aikin, K. J.,
Squire, C., Dolina, S., Hayes, J. J., &
Southwell, B. G. (2018), Serious and
Actionable Risks, Plus Disclosure:
Investigating an Alternative Approach
for Presenting Risk Information in
Prescription Drug Television
Advertisements. Research in Social and
Administrative Pharmacy, 14(10), 951–
963.
4. Jiang, Y. V., Lee, H. J., Asaad, A., &
Remington, R. (2016), Similarity Effects
in Visual Working Memory,
Psychonomic Bulletin & Review, 23(2),
476–482.
5. Oberauer, K., & Lange, E. B. (2008),
Interference in Verbal Working Memory:
Distinguishing Similarity-based
Confusion, Feature Overwriting, and
Feature Migration, Journal of Memory
and Language, 58(3), 730–745.
Dated: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14375 Filed 7–2–20; 8:45 am]
BILLING CODE 4164–01–P
Submit written comments
(including recommendations) on the
collection of information by August 5,
2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted 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 Qualitative Data
to Support Social and Behavioral
Research for Food, Dietary
Supplements, Cosmetics, and Animal
Food and Feed.’’ 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.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Generic Clearance for Qualitative Data
to Support Social and Behavioral
Research for Food, Dietary
Supplements, Cosmetics, and Animal
Food and Feed
OMB Control Number 0910–NEW
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5841]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for Qualitative Data To Support Social
and Behavioral Research for Food,
Dietary Supplements, Cosmetics, and
Animal Food and Feed
AGENCY:
Food and Drug Administration,
HHS.
khammond on DSKJM1Z7X2PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection 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).
SUMMARY:
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
This notice announces the FDA
information collection request from the
OMB for a generic clearance that will
allow FDA to use qualitative social/
behavioral science data collection
techniques (i.e., individual in-depth
interviews, small group discussions,
focus groups, and observations) to
understand stakeholders’ perceptions,
attitudes, motivations, and behaviors
better regarding various issues
associated with food and cosmetic
products, dietary supplements, and
animal food and feed. Understanding
consumers’, manufacturers’, and
producers’ perceptions, attitudes,
motivations, and behaviors plays an
important role in improving FDA’s
communications impacting these
various stakeholders and in assisting in
the development of quantitative study
proposals, complementing other
important research efforts in the
Agency.
FDA will only submit a collection for
approval under this generic clearance if
it meets the following conditions:
PO 00000
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Fmt 4703
Sfmt 4703
40299
• 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 information; 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.
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 collections under this
generic clearance to the OMB.
Individual qualitative collections will
also undergo review by FDA’s
institutional review board, senior
leadership in the Center for Food Safety
and Applied Nutrition, and PRA
specialists.
Description of Participants:
Participants in 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.
In the Federal Register of February
10, 2020 (85 FR 7564), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Although five comments
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.
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.’’
E:\FR\FM\06JYN1.SGM
06JYN1
40300
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices
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, BY ANTICIPATED DATA COLLECTION METHODS
Type of interview
Number of respondents
Number of responses per
respondent
4,800
1
4,800 ..............................................
0.08 (5 minutes)
384
400
10,800
1
1
400 .................................................
10,800 ............................................
1 .........................
0.08 (5 minutes)
400
864
3,600
1
3,600 ..............................................
1.5 ......................
5,400
720
144
1
1
720 .................................................
144 .................................................
0.08 (5 minutes)
2 .........................
58
288
20,464
........................
........................................................
............................
7,394
Individual
In-Depth
Interview
Screening.
Individual In-Depth Interviews ........
Focus Group/Small Group Participant Screening.
Focus Group/Small Group Discussion.
Observation Screening ...................
Observations ...................................
Total .........................................
1There are no capital costs or
operating and maintenance costs
associated with this collection of
information.
The total estimated annual burden is
7,394 hours and 20,464 responses.
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 collection will
vary, depending on the nature of the
compliance efforts and the target
audience.
The estimated burden hours for focus
groups for this collection of information
have been increased from the burden
published in the Federal Register on
February 10, 2020, to the burden
published in this Federal Register
notice. The adjustment in burden hours
for focus groups reflects the increased
need for this type of data collection
across the above-mentioned topic areas.
Dated: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14365 Filed 7–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2020–N–1261]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Study of
Disclosures to Health Care Providers
Regarding Data that Do Not Support
Unapproved Use of an Approved
Prescription Drug
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
04:41 Jul 03, 2020
Jkt 250001
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 research entitled
‘‘Study of Disclosures to Health Care
Providers Regarding Data that Do Not
Support Unapproved Use of an
Approved Prescription Drug.’’
DATES: Submit either electronic or
written comments on the collection of
information by September 4, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 4,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 4, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
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
PO 00000
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Fmt 4703
Average burden
per response
Total annual responses
Sfmt 4703
Total hours
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–1261 for ‘‘Study of Disclosures
to Health Care Providers Regarding Data
that Do Not Support Unapproved Use of
an Approved Prescription Drug.’’
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
E:\FR\FM\06JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Pages 40299-40300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5841]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Qualitative Data To Support Social and Behavioral Research for Food,
Dietary Supplements, Cosmetics, and Animal Food and Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection 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 August 5, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted 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 Qualitative Data to
Support Social and Behavioral Research for Food, Dietary Supplements,
Cosmetics, and Animal Food and Feed.'' 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 Qualitative Data to Support Social and Behavioral
Research for Food, Dietary Supplements, Cosmetics, and Animal Food and
Feed
OMB Control Number 0910-NEW
This notice announces the FDA information collection request from
the OMB for a generic clearance that will allow FDA to use qualitative
social/behavioral science data collection techniques (i.e., individual
in-depth interviews, small group discussions, focus groups, and
observations) to understand stakeholders' perceptions, attitudes,
motivations, and behaviors better regarding various issues associated
with food and cosmetic products, dietary supplements, and animal food
and feed. Understanding consumers', manufacturers', and producers'
perceptions, attitudes, motivations, and behaviors plays an important
role in improving FDA's communications impacting these various
stakeholders and in assisting in the development of quantitative study
proposals, complementing other important research efforts in the
Agency.
FDA will only submit a collection for approval under this generic
clearance if it meets 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 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.
---------------------------------------------------------------------------
\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 information;
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.
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 collections under this
generic clearance to the OMB. Individual qualitative collections will
also undergo review by FDA's institutional review board, senior
leadership in the Center for Food Safety and Applied Nutrition, and PRA
specialists.
Description of Participants: Participants in 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.
In the Federal Register of February 10, 2020 (85 FR 7564), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although five comments
[[Page 40300]]
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, by Anticipated Data Collection Methods
----------------------------------------------------------------------------------------------------------------
Number of
Type of interview Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Individual In-Depth Interview 4,800 1 4,800........... 0.08 (5 384
Screening. minutes).
Individual In-Depth 400 1 400............. 1.............. 400
Interviews.
Focus Group/Small Group 10,800 1 10,800.......... 0.08 (5 864
Participant Screening. minutes).
Focus Group/Small Group 3,600 1 3,600........... 1.5............ 5,400
Discussion.
Observation Screening........ 720 1 720............. 0.08 (5 58
minutes).
Observations................. 144 1 144............. 2.............. 288
----------------------------------------------------------------------------------
Total.................... 20,464 .............. ................ ............... 7,394
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
associated with this collection of information.
The total estimated annual burden is 7,394 hours and 20,464
responses. 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 collection will vary, depending on the nature of
the compliance efforts and the target audience.
The estimated burden hours for focus groups for this collection of
information have been increased from the burden published in the
Federal Register on February 10, 2020, to the burden published in this
Federal Register notice. The adjustment in burden hours for focus
groups reflects the increased need for this type of data collection
across the above-mentioned topic areas.
Dated: June 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14365 Filed 7-2-20; 8:45 am]
BILLING CODE 4164-01-P
