Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications, 67300-67301 [2018-28252]
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Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2018–N–3037]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for Quantitative Testing for the
Development of Food and Drug
Administration Communications
AGENCY:
Food and Drug Administration,
HHS.
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).
DATES: Fax written comments on the
collection of information by January 28,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Generic Clearance for Quantitative
Testing for the Development of FDA
Communications.’’ 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
SUMMARY:
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:
Food and Drug Administration
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;
• 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.
In the Federal Register of September
4, 2018 (83 FR 44888), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN, BY ANTICIPATED DATA COLLECTION METHODS
Number of
respondents
amozie on DSK3GDR082PROD with NOTICES1
Survey type
Cognitive Interviews Screener .................................
Cognitive Interviews .................................................
Pre-test study screener ............................................
Pre-testing study ......................................................
Self-administered surveys/experimental Studies
Screener ...............................................................
Self-Administered Surveys/Experimental Studies ...
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.
VerDate Sep<11>2014
18:13 Dec 27, 2018
Jkt 247001
Number of
responses per
respondent
Total annual
responses
Total hours
720
144
2,400
480
1
1
1
1
720
144
2,400
480
0.083 (5 minutes)
1
0.083 (5 minutes)
.25 (15 minutes)
60
144
199
120
75,000
15,000
1
1
75,000
15,000
0.083 (5 minutes)
.25 (15 minutes)
6,225
3,750
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
PO 00000
Average burden
per response
Frm 00090
Fmt 4703
Sfmt 4703
public policies or important private sector
decisions.’’
E:\FR\FM\28DEN1.SGM
28DEN1
67301
Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN, BY ANTICIPATED DATA COLLECTION METHODS—Continued
Survey type
Total ..................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average burden
per response
........................
........................
........................
....................................
Total hours
10,498
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: December 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–28252 Filed 12–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on Nurse Education and
Practice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
National Advisory Council on
Nurse Education and Practice
(NACNEP) has scheduled a public
meeting. Information about NACNEP
and the agenda for this meeting can be
found on the NACNEP website at
https://www.hrsa.gov/advisorycommittees/nursing/.
DATES: January 28, 2019, 8:30 a.m.–4:30
p.m. and January 29, 2019, 8:30 a.m.–
2:30 p.m. ET.
ADDRESSES: This meeting will be held
in-person and by teleconference and
webinar. The address for the meeting is
5600 Fishers Lane, Rockville, Maryland
20857.
• Conference call-in number: 1–888–
455–0640; passcode: HRSA COUNCIL.
• Webinar link: https://
hrsa.connectsolutions.com/nacnep/.
FOR FURTHER INFORMATION CONTACT:
Deitra W. Scott, MSN, RN, Nurse
Consultant, Division of Nursing and
Public Health, Bureau of Health
Workforce, HRSA, 5600 Fishers Lane,
11N112, Rockville, Maryland 20857;
301–945–3113; or DScott1@hrsa.gov.
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
Number of
respondents
VerDate Sep<11>2014
18:13 Dec 27, 2018
Jkt 247001
NACNEP
provides advice and recommendations
to the Secretary of HHS (Secretary) and
Congress on policy issues related to the
activities carried out under Title VIII of
the Public Health Service (PHS) Act,
including issues related to the nurse
workforce, education, and practice
improvement. NACNEP also prepares
and submits an annual report to the
Secretary and Congress describing its
activities, including NACNEP’s findings
and recommendations concerning
activities under Title VIII, as required by
the PHS Act.
During the January 28–29, 2019,
meeting, NACNEP will finalize the 15th
Report (topic is Promoting Nursing
Leadership in the Transition to ValueBased Care) and continue discussions
on potential topics for its 16th Report.
Agenda items are subject to change as
priorities dictate. The meeting agenda
will be available at the NACNEP website
at least 14 days prior to the meeting.
Refer to the NACNEP website for any
updated information concerning the
meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to NACNEP
should be sent to Deitra W. Scott, Nurse
Consultant, using the contact
information above at least 3 business
days prior to the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Deitra W. Scott at the address and
phone number listed above at least 10
business days prior to the meeting.
Since this meeting occurs in a federal
government building, attendees must go
through a security check to enter the
building. Non-U.S. Citizen attendees
must notify HRSA of their planned
attendance at least 10 business days
prior to the meeting in order to facilitate
their entry into the building. All
attendees are required to present
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
government-issued identification prior
to entry.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–28292 Filed 12–27–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, MD 20857; (301) 443–6593,
or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
SUMMARY:
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67300-67301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28252]
[[Page 67300]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3037]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Quantitative Testing for the Development of Food and Drug
Administration Communications
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: Fax written comments on the collection of information by January
28, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Generic Clearance for Quantitative Testing for the Development
of FDA Communications.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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.
---------------------------------------------------------------------------
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.
In the Federal Register of September 4, 2018 (83 FR 44888), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden, by Anticipated Data Collection Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Survey type Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive Interviews Screener..................................... 720 1 720 0.083 (5 minutes) 60
Cognitive Interviews.............................................. 144 1 144 1 144
Pre-test study screener........................................... 2,400 1 2,400 0.083 (5 minutes) 199
Pre-testing study................................................. 480 1 480 .25 (15 minutes) 120
Self-administered surveys/experimental Studies Screener........... 75,000 1 75,000 0.083 (5 minutes) 6,225
Self-Administered Surveys/Experimental Studies.................... 15,000 1 15,000 .25 (15 minutes) 3,750
[[Page 67301]]
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: December 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28252 Filed 12-27-18; 8:45 am]
BILLING CODE 4164-01-P
