Agency Information Collection Activities; Proposed Collection; Comment Request; Title VI Program Performance Report (OMB 0985-0007), 42857-42858 [2020-15278]
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Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices
PICOTSS
(populations, interventions, comparators, outcomes,
timing, settings, study designs)
PICOTSS
Timing ...........................................................................
Setting(s) ......................................................................
Study design and other limiters ....................................
Dated: July 9, 2020.
Virginia Mackay-Smith,
Associate Director.
Exclusion
GQ3:
• Strategies will be documented regardless of
any information on outcome effects, but strategies need to aim to prevent, reduce, or mitigate disparities and barriers to survivorship
care.
GQ4:
• Changes (reduction) in disparities between
comparison groups for outcomes listed in GQ1
and GQ2.
GQ5:
• Ongoing and upcoming studies need to indicate that the study will report on outcomes eligible for GQ1, GQ2, or GQ4.
All GQs:
• No timing restriction apply. Studies may address CCS who recently or long in the past
experienced pediatric cancer and are now in
remission.
All GQs:
• All care settings applicable to US settings will
be eligible, including primary, secondary, and
tertiary care; inpatient and outpatient care; pediatric and adult care context.
All GQs:
• English-language publications.
GQ1, GQ2, GQ4, GQ5:
• Primary studies reporting empirical data (including both quantitative and qualitative data).
GQ1, GQ2:
• Studies may either report on distinct subgroups, e.g., dividing the sample by geographic characteristic and reporting data separately for rural and for urban participants or
studies may report associations with participant characteristics, e.g., reporting correlations
with a factor of interest such as gender differences.
GQ3:
• Strategies have to have been empirically tested in a research study reporting on the outcomes of interest or have been suggested by
an authoritative source such as a clinical practice guideline or relevant professional organization.
GQ 4:
• Studies with concurrent (e.g., randomized controlled trial) or historic comparator (e.g., organizational pre-post studies). Studies with results published in clinicaltrials.gov will be included regardless of whether a journal publication is available.
GQ5:
• Ongoing and upcoming studies have to have a
published protocol or are registered in a research registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–15190 Filed 7–14–20; 8:45 am]
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Title VI Program
Performance Report (OMB 0985–0007)
BILLING CODE 4160–90–P
khammond on DSKJM1Z7X2PROD with NOTICES
Inclusion
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
SUMMARY:
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42857
All GQs:
• No exclusions apply.
All GQs:
• Studies in resource-limited settings such as
developing countries will be reviewed for comparability with US settings.
All GQs:
• Evaluations reported only in abbreviated format (e.g., in a conference abstract) with the
exception of trial records.
• Studies exclusively reported in non-English
publications.
• Systematic reviews will be retained for reference mining but are not eligible for inclusion.
information listed above. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish a notice in the Federal Register
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 Revised Collection and
solicits comments on the information
collection requirements related to the
extension of the Title VI Program
Performance Report.
E:\FR\FM\15JYN1.SGM
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42858
Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices
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 Leslie Green
Leslie.Green@acl.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Leslie Green, Administration for
Community Living, leslie.green@
acl.hhs.gov, 202–868–9384.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act, Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor. A
Collection of information includes
agency requests or requirements that
members of the public submit reports,
keep records, or provide information to
a third party. The PRA requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
DATES:
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,
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
Hours per
response
Annual burden
hours
Title VI PPR .....................................................................................................
282
1
3.49
984
Total ..........................................................................................................
........................
........................
........................
984
Dated: July 8, 2020.
Mary Lazare,
Principal Deputy Administrator.
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2223]
Clinical Investigations for Prostate
Tissue Ablation Devices; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a final
guidance entitled ‘‘Clinical
Investigations for Prostate Tissue
Ablation Devices.’’ This guidance
provides recommendations for clinical
investigations for high intensity
ultrasound systems for prostate tissue
ablation and new types of prostatic
tissue ablation devices.
SUMMARY:
VerDate Sep<11>2014
17:59 Jul 14, 2020
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The announcement of the
guidance is published in the Federal
Register on July 15, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
• 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’’).
Electronic Submissions
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–
2019–D–2223 for ‘‘Clinical
Investigations for Prostate Tissue
Ablation Devices.’’ Received comments
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
DATES:
[FR Doc. 2020–15278 Filed 7–14–20; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
Responses
per
respondent
Number of
respondents
Respondent/data collection activity
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
ACL is responsible for administering
the Title VI Program Performance
Report. The purpose of this data
collection is to fulfill the annual
programmatic reporting required by the
Title VI Part A/B and C grants to
American Indians, Alaskan Native and
Native Hawaiian Programs to provide
nutrition, supportive services and
caregiver services to elders and their
caregivers.
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden: There are
282 respondents taking 3.49 hours each
to complete the response.
ACL estimates the burden associated
with this collection of information as
follows:
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.
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]]>Agencies
[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42857-42858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15278]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Comment Request; Title VI Program Performance Report (OMB 0985-0007)
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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
(PRA), Federal agencies are required to publish a notice in the Federal
Register 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 Revised Collection
and solicits comments on the information collection requirements
related to the extension of the Title VI Program Performance Report.
[[Page 42858]]
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 Leslie Green [email protected].
FOR FURTHER INFORMATION CONTACT: Leslie Green, Administration for
Community Living, [email protected], 202-868-9384.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act, Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor. A
Collection of information includes agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. The PRA 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, 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.
ACL is responsible for administering the Title VI Program
Performance Report. The purpose of this data collection is to fulfill
the annual programmatic reporting required by the Title VI Part A/B and
C grants to American Indians, Alaskan Native and Native Hawaiian
Programs to provide nutrition, supportive services and caregiver
services to elders and their caregivers.
The proposed data collection tools may be found on the ACL website
for review at https://www.acl.gov/about-acl/public-input.
Estimated Program Burden: There are 282 respondents taking 3.49
hours each to complete the response.
ACL estimates the burden associated with this collection of
information as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Title VI PPR.................................... 282 1 3.49 984
---------------------------------------------------------------
Total....................................... .............. .............. .............. 984
----------------------------------------------------------------------------------------------------------------
Dated: July 8, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020-15278 Filed 7-14-20; 8:45 am]
BILLING CODE 4154-01-P
