Agency Information Collection Activities: Proposed Collection; Comment Request, 43239-43241 [2020-15369]
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Federal Register / Vol. 85, No. 137 / Thursday, July 16, 2020 / Notices
This matter involves the respondent’s
advertising for Thrive, CBD–EX, CBD–
RX, and CBD-Max. The complaint
alleges that respondent violated
Sections 5(a) and 12 of the FTC Act by
disseminating false and unsubstantiated
advertisements claiming that: (1) Thrive
treats, prevents, or reduces the risk of
COVID–19; (2) CBD–EX, CBD, RX, and
CBD-Max treat cancer; (3) Thrive is
clinically or scientifically proven to
treat, prevent, or reduce the risk of
COVID–19; and (4) CBD–EX, CBD, RX,
and CBD-Max are clinically or
scientifically proven to treat cancer.
The order includes injunctive relief
that prohibits these alleged violations
and fences in similar and related
conduct. The product coverage would
apply to any dietary supplement, drug,
or food the respondent sells, markets,
promotes, or advertises.
Part I prohibits respondent from
making any representation about the
efficacy of any covered product,
including that such product will: (1)
Treat, prevent or reduce the risk of
COVID–19; (2) treat cancer; or (3) cure,
mitigate or treat any disease in humans,
unless the representation is nonmisleading, including that, at the time
such representation is made, he
possesses and relies upon competent
and reliable scientific evidence that
substantiates that the representation is
true. For purposes of this Provision,
‘‘competent and reliable scientific
evidence’’ means human clinical testing
of the covered product or of an
essentially equivalent product that is
sufficient in quality and quantity, based
on standards generally accepted by
experts in the relevant disease,
condition, or function to which the
representation relates, when considered
in light of the entire body of relevant
and reliable scientific evidence, to
substantiate that the representation is
true.
Part II prohibits respondent from
making any representation, other than
representations covered under the
Provision titled Prohibited Disease
Claims, expressly or by implication,
about the health benefits, performance,
or efficacy of any covered product,
unless the representation is nonmisleading, including that, at the time
such representation is made, he
possesses and relies upon competent
and reliable scientific evidence that is
sufficient in quality and quantity based
on standards generally accepted by
experts in the relevant disease,
condition, or function to which the
representation relates, when considered
in light of the entire body of relevant
and reliable scientific evidence, to
substantiate that the representation is
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true. For purposes of this Provision,
‘‘competent and reliable scientific
evidence’’ means tests, analyses,
research, or studies that (1) have been
conducted and evaluated in an objective
manner by experts in the relevant
disease, condition, or function to which
the representation relates; (2) that are
generally accepted by such experts to
yield accurate and reliable results; and
(3) that are randomized, double-blind,
and placebo-controlled human clinical
testing of the covered product, or of an
essentially equivalent product, when
such experts would generally require
such human clinical testing to
substantiate that the representation is
true.
Part III requires that with regard to
any human clinical test or study (‘‘test’’)
upon which the respondent relies to
substantiate any claim covered by the
order, the respondent must secure and
preserve all underlying or supporting
data and documents generally accepted
by experts in the field as relevant to an
assessment of a test.
Part IV prohibits respondent from
misrepresenting the existence, contents,
validity, results, conclusions, or
interpretations of any test, study, or
other research or that any benefit of any
covered product is scientifically or
clinically proven. Part V provides
respondent a safe harbor for making
claims approved by the Food and Drug
Administration (‘‘FDA’’).
Part VI requires respondent to send
notices to consumers who purchased
Thrive, CBD–EX, CBD–RX, and CBDMax informing them about the
settlement. Part VII requires respondent
to send notices to resellers and retailers
informing them about the settlement.
Part VIII requires respondent to
submit an acknowledgement of receipt
of the order, to serve the order on
certain individuals, including all
officers or directors of any business
respondent controls and employees
having managerial responsibilities for
conduct related to the subject matter of
the order, and to obtain
acknowledgements from each
individual or entity to which
respondent has delivered a copy of the
order.
Part IX requires respondent to file
compliance reports with the
Commission, and to notify the
Commission of bankruptcy filings or
changes in corporate structure that
might affect compliance obligations.
Part X contains recordkeeping
requirements for accounting records,
personnel records, consumer
correspondence, advertising and
marketing materials, and claim
substantiation, as well as all records
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43239
necessary to demonstrate compliance or
non-compliance with the order. Part XI
contains other requirements related to
the Commission’s monitoring of the
respondent’s order compliance. Part XII
provides the effective dates of the order,
including that, with exceptions, the
order will terminate in 20 years.
The purpose of this analysis is to
facilitate public comment on the order,
and it is not intended to constitute an
official interpretation of the complaint
or order, or to modify the order’s terms
in any way.
By direction of the Commission,
Commissioner Chopra dissenting,
Commissioner Slaughter not participating.
April J. Tabor,
Secretary.
[FR Doc. 2020–15316 Filed 7–15–20; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve proposed
updates to the approved information
collection project ‘‘Safety Program in
Perinatal Care (SPPC)-II Demonstration
Project.’’
DATES: Comments on this notice must be
received by 60 days after date of
publication of this notice.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
emails at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Proposed Project
Safety Program in Perinatal Care
(SPPC)-II Demonstration Project
The SPPC–II Demonstration Project
has the following goals:
(1) To implement the integrated AIM–
SPPC II program in birthing hospitals in
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Federal Register / Vol. 85, No. 137 / Thursday, July 16, 2020 / Notices
OK and TX in coordination with the
Alliance for Innovation on Maternal
Health program (AIM) and the
respective state PQC (Perinatal Quality
Collaborative);
(2) To assess the implementation of
the integrated AIM–SPPC II program in
these hospitals; and
(3) To ascertain the short- and
medium-term impact of the integrated
AIM–SPPC II program on hospital (i.e.,
perinatal unit) teamwork and
communication, patient safety, and key
maternal health outcomes.
The information collected for this
Demonstration Project will be used to
evaluate the implementation and impact
of the SPPC–II program overlaid with
AIM patient safety bundles in birthing
hospitals in OK and TX. More
specifically, the project will:
(a) Provide information on whether
the proposed integration of AIM and
SPPC–II programs can be implemented
as intended, i.e., through the use of a
two-tier approach for training all
clinical staff in all hospitals,
coordination by the AIM Team Lead of
the rollout of training clinical staff using
e-modules on teamwork and
communication, facilitation by AIM
Team Leads of in-person sessions to
practice teamwork and communication
tools and strategies; or, what changes
are needed to better facilitate program
implementation;
(b) provide information regarding the
impact of the integrated AIM–SPPC II
program on use of teamwork and
communication tools and strategies,
teamwork and communication metrics,
patient safety culture changes, AIM
bundle implementation, and key
maternal health outcomes; and
(c) provide information regarding the
sustainability of the integrated AIM–
SPPC II program 18 months after
implementation.
Due to pandemic-related impacts on
the SPPC–II study population, we
propose updating the SPPC–II data
collection by (1) adding questions to the
approved qualitative interview guide at
3–4 months to include pandemic-related
questions to better understand the
implementation context, (2) adding an
additional qualitative interview
collection at 15–16 months with a new
interview guide to better understand the
implementation context, and (3)
increasing the total number of
qualitative interview participants from
25 to 30 participants to account for the
two qualitative interview collections at
3–4 months and 15–16 months. The
total estimated annual burden hours for
SPPC–II will increase from 54,654 hours
in the previous clearance to 54,659
hours in this clearance request, an
increase of 5 hours.
This study is being conducted by
AHRQ through its contractor, Johns
Hopkins University (JHU), and through
JHU’s subcontractor, AIM, pursuant to
AHRQ’s statutory authority to conduct
and support research on healthcare and
on systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this project the
following updates to the data collections
will be implemented:
(a) Qualitative, semi-structured
interviews with AIM Team Leads will
be conducted by phone about 3–4
months and 15–16 months after the
SPPC–II implementation start date to
assess the perceived utility of the
training and assistance needed with the
rollout of training to all frontline
clinical staff using the e-modules and
facilitation sessions to consolidate the
information, and to better understand
the implementation context (including
barriers, facilitators, and strategies). An
interview guide developed based on the
Consolidated Framework for
Implementation Research framework
will be used to conduct the interviews,
together with a corresponding consent
form.
Estimated Annual Respondent Burden
Exhibit 1 shows only the estimated
annualized burden hours for the
respondents’ time to participate in
updates to the information collection of
the SPPC–II Demonstration Project.
One-hour qualitative interviews will
be conducted with a total of 30 AIM
Team Leads in the 2 states about 3–4
months and 15–16 months after the
SPPC–II implementation start date.
The total annual burden hours are
estimated to be 54,659 hours, an
increase of 5 hours from the previous
clearance request.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form Name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Qualitative semi-structured interviews with AIM Team Leads at 3–4 months
and 15–16 months .......................................................................................
30
1
1.00
30
Total ..........................................................................................................
30
NA
NA
30
Exhibit 2 shows only the hours and
cost of updates to the collection. The
cost burden of the updated collection is
estimated to be $1,494.90 annually.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form Name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Qualitative semi-structured interviews with AIM Team Leads at 3–4 months
and 15–16 months .......................................................................................
30
30
$49.83
$1,494.90
Total ..........................................................................................................
30
30
........................
1,494.90
* National Compensation Survey: Occupational wages in the United States May 2017 ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Hourly wage for nurse-midwives ($48.36; occupation code 29–1161).
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Federal Register / Vol. 85, No. 137 / Thursday, July 16, 2020 / Notices
43241
b Weighted mean hourly wage for obstetrician-gynecologists ($113.10; occupation code 29–1064; 30%); nurse-midwives ($49.83; occupation
code 29–1161; 30%); registered nurses ($35.36; occupation code 29–1161; 20%); and nurse practitioners ($51.86; occupation code 29–1171;
20%).
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: July 13, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020–15369 Filed 7–15–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Alzheimer’s and
Dementia Program Data Reporting
Tool (ADP–DRT) OMB #0985–0022
Administration for Community
Living, Health and Human Services
(HHS).
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish a notice in the Federal Register
SUMMARY:
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concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Proposed Revision and solicits
comments on the information collection
requirements related to Alzheimer’s and
Dementia Program Data Reporting Tool
(ADP–DRT).
DATES: Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (EST) or
postmarked by September 14, 2020.
ADDRESSES: Submit electronic
comments on the collection of
information to: Erin Long (Erin.Long@
acl.gov). Submit written comments on
the collection of information to
Administration for Community Living,
Washington, DC 20201, Attention: Erin
Long.
FOR FURTHER INFORMATION CONTACT: Erin
Long, Administration for Community
Living, Washington, DC 20201,
Erin.Long@acl.gov, 202–795–7389.
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,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, ACL invites
comments on our burden estimates or
any other aspect of this collection of
information, including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
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including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates; (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.
The Older American’s Act requires
ACL to evaluate ‘‘demonstration
projects that support the objectives of
this Act, including activities to bring
effective demonstration projects to scale
with a prioritization of projects that
address the needs of underserved
populations, and promote partnerships
among aging services, community-based
organizations, and Medicare and
Medicaid providers, plans, and health
(including public health) systems.
(Section 201 (42 U.S.C. 3011) Sec. 127.
Research and Evaluation).
To fulfill the evaluation requirements
and allow for optimal federal and statelevel management of ACL’s Alzheimer’s
Disease Program, specific information
must be collected from grantees.
The current reporting tool is set to
expire June 22, 2020. The Alzheimer’s
and Dementia Program (ADP) Project
Officer has reviewed the current data
collection procedures to ensure the
acceptability of these items as
appropriate and thorough evaluation of
the program, while minimizing burden
for grantees.
The result of this process is the
proposed modifications to the existing
data collection tool. ACL is aware that
different grantees have different data
collection capabilities. It is understood
that, following the approval of the
modified data collection tool, ACL will
work with its grantees to offer regular
training to ensure minimal burden.
The proposed data collection tools
may be found on the ACL website for
review at https://nadrc.acl.gov/node/
226.
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
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]]>Agencies
[Federal Register Volume 85, Number 137 (Thursday, July 16, 2020)]
[Notices]
[Pages 43239-43241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15369]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve proposed updates to the approved
information collection project ``Safety Program in Perinatal Care
(SPPC)-II Demonstration Project.''
DATES: Comments on this notice must be received by 60 days after date
of publication of this notice.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[email protected].
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by emails at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Safety Program in Perinatal Care (SPPC)-II Demonstration Project
The SPPC-II Demonstration Project has the following goals:
(1) To implement the integrated AIM-SPPC II program in birthing
hospitals in
[[Page 43240]]
OK and TX in coordination with the Alliance for Innovation on Maternal
Health program (AIM) and the respective state PQC (Perinatal Quality
Collaborative);
(2) To assess the implementation of the integrated AIM-SPPC II
program in these hospitals; and
(3) To ascertain the short- and medium-term impact of the
integrated AIM-SPPC II program on hospital (i.e., perinatal unit)
teamwork and communication, patient safety, and key maternal health
outcomes.
The information collected for this Demonstration Project will be
used to evaluate the implementation and impact of the SPPC-II program
overlaid with AIM patient safety bundles in birthing hospitals in OK
and TX. More specifically, the project will:
(a) Provide information on whether the proposed integration of AIM
and SPPC-II programs can be implemented as intended, i.e., through the
use of a two-tier approach for training all clinical staff in all
hospitals, coordination by the AIM Team Lead of the rollout of training
clinical staff using e-modules on teamwork and communication,
facilitation by AIM Team Leads of in-person sessions to practice
teamwork and communication tools and strategies; or, what changes are
needed to better facilitate program implementation;
(b) provide information regarding the impact of the integrated AIM-
SPPC II program on use of teamwork and communication tools and
strategies, teamwork and communication metrics, patient safety culture
changes, AIM bundle implementation, and key maternal health outcomes;
and
(c) provide information regarding the sustainability of the
integrated AIM-SPPC II program 18 months after implementation.
Due to pandemic-related impacts on the SPPC-II study population, we
propose updating the SPPC-II data collection by (1) adding questions to
the approved qualitative interview guide at 3-4 months to include
pandemic-related questions to better understand the implementation
context, (2) adding an additional qualitative interview collection at
15-16 months with a new interview guide to better understand the
implementation context, and (3) increasing the total number of
qualitative interview participants from 25 to 30 participants to
account for the two qualitative interview collections at 3-4 months and
15-16 months. The total estimated annual burden hours for SPPC-II will
increase from 54,654 hours in the previous clearance to 54,659 hours in
this clearance request, an increase of 5 hours.
This study is being conducted by AHRQ through its contractor, Johns
Hopkins University (JHU), and through JHU's subcontractor, AIM,
pursuant to AHRQ's statutory authority to conduct and support research
on healthcare and on systems for the delivery of such care, including
activities with respect to the quality, effectiveness, efficiency,
appropriateness and value of healthcare services and with respect to
quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this project the following updates to the
data collections will be implemented:
(a) Qualitative, semi-structured interviews with AIM Team Leads
will be conducted by phone about 3-4 months and 15-16 months after the
SPPC-II implementation start date to assess the perceived utility of
the training and assistance needed with the rollout of training to all
frontline clinical staff using the e-modules and facilitation sessions
to consolidate the information, and to better understand the
implementation context (including barriers, facilitators, and
strategies). An interview guide developed based on the Consolidated
Framework for Implementation Research framework will be used to conduct
the interviews, together with a corresponding consent form.
Estimated Annual Respondent Burden
Exhibit 1 shows only the estimated annualized burden hours for the
respondents' time to participate in updates to the information
collection of the SPPC-II Demonstration Project.
One-hour qualitative interviews will be conducted with a total of
30 AIM Team Leads in the 2 states about 3-4 months and 15-16 months
after the SPPC-II implementation start date.
The total annual burden hours are estimated to be 54,659 hours, an
increase of 5 hours from the previous clearance request.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form Name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Qualitative semi-structured interviews with AIM 30 1 1.00 30
Team Leads at 3-4 months and 15-16 months......
---------------------------------------------------------------
Total....................................... 30 NA NA 30
----------------------------------------------------------------------------------------------------------------
Exhibit 2 shows only the hours and cost of updates to the
collection. The cost burden of the updated collection is estimated to
be $1,494.90 annually.
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form Name respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Qualitative semi-structured interviews with AIM 30 30 $49.83 $1,494.90
Team Leads at 3-4 months and 15-16 months......
---------------------------------------------------------------
Total....................................... 30 30 .............. 1,494.90
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2017 ``U.S. Department of Labor,
Bureau of Labor Statistics.''
\a\ Hourly wage for nurse-midwives ($48.36; occupation code 29-1161).
[[Page 43241]]
\b\ Weighted mean hourly wage for obstetrician-gynecologists ($113.10; occupation code 29-1064; 30%); nurse-
midwives ($49.83; occupation code 29-1161; 30%); registered nurses ($35.36; occupation code 29-1161; 20%); and
nurse practitioners ($51.86; occupation code 29-1171; 20%).
Request for Comments
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, comments on AHRQ's information collection are requested with
regard to any of the following: (a) Whether the proposed collection of
information is necessary for the proper performance of AHRQ's health
care research and health care information dissemination functions,
including whether the information will have practical utility; (b) the
accuracy of AHRQ's estimate of burden (including hours and costs) of
the proposed collection(s) of information; (c) ways to enhance the
quality, utility and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information upon
the respondents, including the use of automated collection techniques
or other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: July 13, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-15369 Filed 7-15-20; 8:45 am]
BILLING CODE 4160-90-P
