Request for Public Comments on the Development of the 2021-2022 IACC Strategic Plan for Autism Spectrum Disorder (ASD), 55851-55852 [2021-21883]
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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
55851
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
Consultation between the hospital or health system pharmacy and the prescriber
to document the statement of significant difference (revised draft guidance).
Consultation between the hospital or health system pharmacy and prescriber and
the notation on the prescription documenting the prescriber’s determination of
significant difference (503A copies guidance).
Hospital or health system pharmacy checking FDA’s drug shortage list and documenting on the prescription that the drug is in shortage (503A copies guidance).
1,538
30
46,140
.08 (5 minutes) .....
3,691
1,537
50
76,850
.05 (3 minutes) .....
3,843
4,613
200
922,600
.03 (2 minutes) .....
27,678
Total ....................................................................................................................
....................
........................
....................
...............................
35,212
Total annual
records
Average burden
per recordkeeping
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Records of the statement of significant difference (revised draft guidance) .............
Records of documentation of significant difference (503A copies guidance) ...........
Records of frequency and number of prescriptions filled for compounded drug
products that are essentially a copy (503A copies guidance).
1,538
1,537
3,075
30
50
20
46,140
76,850
61,500
.03 (2 minutes) .....
.03 (2 minutes) .....
.03 (2 minutes) .....
1,384
2,306
1,845
Total ....................................................................................................................
....................
........................
....................
...............................
5,535
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
IV. Electronic Access
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–21970 Filed 10–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Request for comments on the draft
Department Strategic Plan for FY
2022–2026
Office of the Secretary, Office
of the Assistant Secretary for Planning
and Evaluation, Health and Human
Services.
ACTION: Request for comments on the
draft HHS Strategic Plan FY 2022–2026.
AGENCY:
The Department of Health and
Human Services (HHS) is seeking public
comment on its draft Strategic Plan for
Fiscal Years 2022–2026 through the
Department of Health and Human
Services website at www.hhs.gov/about/
draft-strategic-plan/.
DATES: Submit comments on or before
November 7, 2021.
SUMMARY:
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23:02 Oct 06, 2021
Written comments can be
provided by email, Fax, or U.S. mail.
Email: HHSPlan@hhs.gov.
Fax: (202) 690–5882.
Mail: U.S. Department of Health and
Human Services, Office of the Assistant
Secretary for Planning and Evaluation,
Division of Strategic Planning, Attn:
Strategic Plan Comments, 200
Independence Avenue SW, Room 434E,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Margo Bailey, (202) 730–8504.
SUPPLEMENTARY INFORMATION: The draft
Department of Health and Human
Services Strategic Plan FY 2022–2026 is
provided as part of the strategic
planning process under the Government
Performance and Results Modernization
Act of 2010 (GPRA–MA)(Pub. L. 111–
352) to ensure that Agency stakeholders
are given an opportunity to comment on
this plan.
This document articulates how the
Department will achieve its mission
through five strategic goals. These five
strategic goals are (1) Protect and
Strengthen Equitable Access to High
Quality and Affordable Health Care, (2)
Safeguard and Improve National and
Global Health Conditions and
Outcomes, (3) Strengthen Social Wellbeing, Equity, and Economic Resilience,
(4) Restore Trust and Accelerate
Advancements in Science and Research
for All, and (5) Advance Strategic
Management to Build Trust,
Transparency, and Accountability. Each
goal is supported by objectives and
strategies.
ADDRESSES:
Persons with access to the internet
may obtain an electronic version of the
revised draft guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
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records per
recordkeeper
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The strategic planning consultation
process is an opportunity for the
Department to refine and strengthen the
HHS Strategic Plan FY 2022–2026. We
look forward to receiving your
comments by November 7, 2021. The
text of the draft HHS Strategic Plan FY
2022–2026 is available through the
Department of Health and Human
Services website at www.hhs.gov/about/
draft-strategic-plan/. For
comparison purposes, the current HHS
Strategic Plan FY 2018–2022 can be
viewed at https://www.hhs.gov/about/
strategic-plan/.
For those who may not have internet
access, a hard copy can be requested
from the contact point, Margo Bailey,
(202) 730–8504.
Dated: September 29, 2021.
Rebecca Haffajee,
Acting Assistant Secretary for Planning and
Evaluation (ASPE), Principal Deputy, ASPE.
[FR Doc. 2021–21939 Filed 10–5–21; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Public Comments on the
Development of the 2021–2022 IACC
Strategic Plan for Autism Spectrum
Disorder (ASD)
On behalf of the Interagency
Autism Coordinating Committee (IACC),
the National Institute of Mental Health
(NIMH) Office of Autism Research
SUMMARY:
E:\FR\FM\07OCN1.SGM
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55852
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
Coordination (OARC) is seeking public
comments to assist the IACC in
identifying priorities for the 2021–2022
update of the IACC Strategic Plan for
Autism Spectrum Disorder (ASD) as
required by the Autism Collaboration,
Accountability, Research, Education
and Support (CARES) Act of 2019. The
IACC is requesting public comments on
research, services, and policy issues
related to the seven topics addressed by
the IACC Strategic Plan: Screening and
Diagnosis, Biology, Risk Factors,
Treatments and Interventions, Services,
Lifespan Issues, and Infrastructure and
Surveillance. The IACC is also
requesting information on two
additional issues related to autism
described in two supplemental
questions that are included in this
Request for Public Comment.
DATES: Responses to this notice are
voluntary and the public comment
period will be open from October 1,
2021–November 30, 2021.
ADDRESSES: All comments must be
submitted electronically via the webbased form at: https://iacc.hhs.gov/
meetings/public-comments/requests-forinformation/2021/strategic-plan.shtml.
FOR FURTHER INFORMATION CONTACT:
Specific questions about this Request for
Public Comment should be directed to:
Rebecca Martin by phone at (301) 435–
0886 or email at iaccpublicinquiries@
mail.nih.gov.
SUPPLEMENTARY INFORMATION: The IACC
https://www.iacc.hhs.gov/ is a federal
advisory committee composed of federal
and public members that provides
advice to the Secretary of Health and
Human Services on autism spectrum
disorder. The Committee is authorized
under the Autism CARES Act of 2019,
Public Law 116–60. The law requires
that the IACC develop a Strategic Plan
for autism research and update the Plan
annually. The current IACC Strategic
Plan can be viewed at: https://
iacc.hhs.gov/publications/strategicplan/2019/. The IACC last provided an
update on the progress of the Strategic
Plan in 2019, after which the committee
went out of session as a new committee
was being appointed. The IACC
reconvened in July 2021 and is now
developing a new update of the IACC
Strategic Plan.
The IACC Strategic Plan chapters are
organized around seven topic areas that
are related to community-focused
questions:
• Question 1. How Can I Recognize the
Signs of ASD, and Why is Early
Detection So Important? (Topic:
Screening and Diagnosis)
• Question 2. What Is the Biology
Underlying ASD? (Topic: Biology)
VerDate Sep<11>2014
17:46 Oct 06, 2021
Jkt 256001
• Question 3. What Causes ASD, and
Can Disabling Aspects of ASD be
Prevented or Preempted? (Topic: Risk
Factors)
• Question 4. Which Treatments and
Interventions Will Help? (Topic:
Treatments and Interventions)
• Question 5. What Kinds of Services
and Supports Are Needed to
Maximize Quality of Life for People
on the Autism Spectrum? (Topic:
Services)
• Question 6. How Can We Meet the
Needs of People with ASD as They
Progress into and through Adulthood?
(Topic: Lifespan Issues)
• Question 7. How Do We Continue to
Build, Expand, and Enhance the
Infrastructure System to Meet the
Needs of the ASD Community?
(Topic: Infrastructure and
Surveillance)
The Committee also seeks public
comment related to the two following
questions:
• Supplemental Question 1. What are
important issues for the IACC to
consider with regard to the impact of
the COVID–19 pandemic on the autism
community?
• Supplemental Question 2. What are
important issues for the IACC to
consider with regard to the needs of
underserved populations within the
autism community, including racial and
ethnic minorities, economically
disadvantaged communities, and rural
populations?
Submission Information. For each
topic/question in the Request for Public
Comment, commenters may provide
input on what they consider to be the
most important research, services, and
policy issues and remaining gaps in the
subject area covered by that Question.
Please note that the web form will
accept a maximum of 1,500 characters
(including letters, numbers,
punctuation, etc.) per topic area. A valid
email address is required for
submission, and only one submission
per email address will be accepted. If
duplicate submissions are received (i.e.,
form letters), only one example of such
a submission will be included in the
final set of comments.
The information that commenters
provide will become part of the public
record; as such, please do not include
any personally identifiable or
confidential information in the
comments. The web form will provide
the option of submitting responses
anonymously, or the choice to include
a name and/or organization associated
with the comment. Comments are
subject to redaction in accordance with
federal policies and the IACC’s public
PO 00000
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comment guidelines and privacy policy.
To view the IACC’s public comment
guidelines and privacy policy, visit:
https://iacc.hhs.gov/meetings/publiccomments/guidelines/. All comments or
summaries of comments received will
be made publicly available on the IACC
website www.iacc.hhs.gov within 90
days of the closing deadline for this
notice. Email addresses associated with
comments will not be included as part
of the public disclosure. After the
closing deadline, responses cannot be
edited or withdrawn. No basis for
claims against the U.S. Government
shall arise as a result of a response to
this request for information or from the
Government’s use of such information.
Instructions. All comments must be
submitted through the web form at
https://iacc.hhs.gov/meetings/publiccomments/requests-for-information/
2021/strategic-plan.shtml. Individuals
submitting comments will receive an
onscreen confirmation acknowledging
receipt of the comment, but commenters
will not receive individualized feedback
or responses from the IACC. Only one
comment per email address will be
accepted, and if duplicate comments are
received, only one example will be
provided to the IACC.
Dated: September 30, 2021.
Susan A. Daniels,
Director, Office of Autism Research
Coordination, National Institute of Mental
Health.
[FR Doc. 2021–21883 Filed 10–6–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\07OCN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55851-55852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21883]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Public Comments on the Development of the 2021-2022
IACC Strategic Plan for Autism Spectrum Disorder (ASD)
SUMMARY: On behalf of the Interagency Autism Coordinating Committee
(IACC), the National Institute of Mental Health (NIMH) Office of Autism
Research
[[Page 55852]]
Coordination (OARC) is seeking public comments to assist the IACC in
identifying priorities for the 2021-2022 update of the IACC Strategic
Plan for Autism Spectrum Disorder (ASD) as required by the Autism
Collaboration, Accountability, Research, Education and Support (CARES)
Act of 2019. The IACC is requesting public comments on research,
services, and policy issues related to the seven topics addressed by
the IACC Strategic Plan: Screening and Diagnosis, Biology, Risk
Factors, Treatments and Interventions, Services, Lifespan Issues, and
Infrastructure and Surveillance. The IACC is also requesting
information on two additional issues related to autism described in two
supplemental questions that are included in this Request for Public
Comment.
DATES: Responses to this notice are voluntary and the public comment
period will be open from October 1, 2021-November 30, 2021.
ADDRESSES: All comments must be submitted electronically via the web-
based form at: https://iacc.hhs.gov/meetings/public-comments/requests-for-information/2021/strategic-plan.shtml.
FOR FURTHER INFORMATION CONTACT: Specific questions about this Request
for Public Comment should be directed to: Rebecca Martin by phone at
(301) 435-0886 or email at [email protected].
SUPPLEMENTARY INFORMATION: The IACC https://www.iacc.hhs.gov/ is a
federal advisory committee composed of federal and public members that
provides advice to the Secretary of Health and Human Services on autism
spectrum disorder. The Committee is authorized under the Autism CARES
Act of 2019, Public Law 116-60. The law requires that the IACC develop
a Strategic Plan for autism research and update the Plan annually. The
current IACC Strategic Plan can be viewed at: https://iacc.hhs.gov/publications/strategic-plan/2019/. The IACC last provided an update on
the progress of the Strategic Plan in 2019, after which the committee
went out of session as a new committee was being appointed. The IACC
reconvened in July 2021 and is now developing a new update of the IACC
Strategic Plan.
The IACC Strategic Plan chapters are organized around seven topic
areas that are related to community-focused questions:
Question 1. How Can I Recognize the Signs of ASD, and Why is
Early Detection So Important? (Topic: Screening and Diagnosis)
Question 2. What Is the Biology Underlying ASD? (Topic:
Biology)
Question 3. What Causes ASD, and Can Disabling Aspects of ASD
be Prevented or Preempted? (Topic: Risk Factors)
Question 4. Which Treatments and Interventions Will Help?
(Topic: Treatments and Interventions)
Question 5. What Kinds of Services and Supports Are Needed to
Maximize Quality of Life for People on the Autism Spectrum? (Topic:
Services)
Question 6. How Can We Meet the Needs of People with ASD as
They Progress into and through Adulthood? (Topic: Lifespan Issues)
Question 7. How Do We Continue to Build, Expand, and Enhance
the Infrastructure System to Meet the Needs of the ASD Community?
(Topic: Infrastructure and Surveillance)
The Committee also seeks public comment related to the two
following questions:
Supplemental Question 1. What are important issues for the
IACC to consider with regard to the impact of the COVID-19 pandemic on
the autism community?
Supplemental Question 2. What are important issues for the
IACC to consider with regard to the needs of underserved populations
within the autism community, including racial and ethnic minorities,
economically disadvantaged communities, and rural populations?
Submission Information. For each topic/question in the Request for
Public Comment, commenters may provide input on what they consider to
be the most important research, services, and policy issues and
remaining gaps in the subject area covered by that Question.
Please note that the web form will accept a maximum of 1,500
characters (including letters, numbers, punctuation, etc.) per topic
area. A valid email address is required for submission, and only one
submission per email address will be accepted. If duplicate submissions
are received (i.e., form letters), only one example of such a
submission will be included in the final set of comments.
The information that commenters provide will become part of the
public record; as such, please do not include any personally
identifiable or confidential information in the comments. The web form
will provide the option of submitting responses anonymously, or the
choice to include a name and/or organization associated with the
comment. Comments are subject to redaction in accordance with federal
policies and the IACC's public comment guidelines and privacy policy.
To view the IACC's public comment guidelines and privacy policy, visit:
https://iacc.hhs.gov/meetings/public-comments/guidelines/. All comments
or summaries of comments received will be made publicly available on
the IACC website www.iacc.hhs.gov within 90 days of the closing
deadline for this notice. Email addresses associated with comments will
not be included as part of the public disclosure. After the closing
deadline, responses cannot be edited or withdrawn. No basis for claims
against the U.S. Government shall arise as a result of a response to
this request for information or from the Government's use of such
information.
Instructions. All comments must be submitted through the web form
at https://iacc.hhs.gov/meetings/public-comments/requests-for-information/2021/strategic-plan.shtml. Individuals submitting comments
will receive an onscreen confirmation acknowledging receipt of the
comment, but commenters will not receive individualized feedback or
responses from the IACC. Only one comment per email address will be
accepted, and if duplicate comments are received, only one example will
be provided to the IACC.
Dated: September 30, 2021.
Susan A. Daniels,
Director, Office of Autism Research Coordination, National Institute of
Mental Health.
[FR Doc. 2021-21883 Filed 10-6-21; 8:45 am]
BILLING CODE 4140-01-P
