Notice2021-15598
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Surveys, OMB No. 0906-0014, Revision
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Published
July 22, 2021
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Full Text
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<title>Federal Register, Volume 86 Issue 138 (Thursday, July 22, 2021)</title>
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[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Pages 38726-38728]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15598]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: The
Advisory Committee on Heritable Disorders in Newborns and Children's
Public Health System Assessment Surveys, OMB No. 0906-0014, Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than September
20, 2021.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#afdfcedfcaddd8c0ddc4efc7dddcce81c8c0d9"><span class="__cf_email__" data-cfemail="daaabbaabfa8adb5a8b19ab2a8a9bbf4bdb5ac">[email protected]</span></a> or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email <a href="/cdn-cgi/l/email-protection#eb9b8a9b8e999c849980ab8399988ac58c849d"><span class="__cf_email__" data-cfemail="126273627760657d6079527a6061733c757d64">[email protected]</span></a> or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: The Advisory Committee on
Heritable Disorders in Newborns and Children's Public Health System
Assessment Surveys, OMB No. 0906-0014--Revision.
Abstract: The purpose of the Public Health System Assessment
Surveys is to inform the Advisory Committee on Heritable Disorders in
Newborns and Children (Committee) on states' ability to add newborn
screening for particular conditions, including the feasibility,
readiness, and overall capacity to screen for a new condition.
The Committee was established under the Public Health Service Act,
42 U.S.C. 217a: Advisory councils or committees, and Title XI Sec.
1111 (42 U.S.C. 300b-10). The purpose of the Committee is to provide
the Secretary with recommendations, advice, and technical information
regarding the most appropriate application of technologies, policies,
guidelines, and standards for: (a) Effectively reducing morbidity and
mortality in newborns and children having, or at risk for, heritable
disorders; and (b) enhancing the ability of state and local health
agencies to provide for newborn and child screening, counseling, and
health care services for newborns and children having, or at risk for,
heritable disorders. Specifically, the Committee makes systematic
evidence-based recommendations on newborn screening for conditions that
have the potential to change the health outcomes for newborns.
The Committee tasks an external workgroup to conduct systematic
evidence-based reviews for conditions being considered for addition to
the Recommended Uniform Screening Panel, and their corresponding
newborn screening test(s), confirmatory test(s), and treatment(s).
Reviews also include an analysis of the benefits and harms of newborn
screening for a selected condition at a population level and an
assessment of state public health newborn screening programs' ability
to implement the screening of a new condition.
Need and Proposed Use of the Information: The Committee's Evidence
Review Group administers the surveys to collect data from state newborn
screening programs in the United States.
[[Page 38727]]
The surveys have been developed to capture the following: (1) Readiness
of state public health newborn screening programs to expand newborn
screening to include the target condition, (2) specific requirements of
screening for a condition that could hinder or facilitate
implementation in each state, and (3) estimated timeframes needed for
each state to complete major milestones toward full implementation of
newborn screening for the condition.
The following is a summary of proposed changes to the Committee's
Public Health System Assessment Surveys:
Proposed changes to the ``INITIAL Survey of the Secretary's
Advisory Committee on Heritable Disorders in Newborns and Children's
Public Health System Assessment:''
<bullet> Survey title:
[cir] Current title: ``INITIAL Survey of the Secretary's Advisory
Committee on Heritable Disorders in Newborns and Children's Public
Health System Assessment''
[cir] Proposed change: (strike ``Secretary's'') ``INITIAL Survey of
the Advisory Committee on Heritable Disorders in Newborns and
Children's Public Health System Assessment''
[cir] Rationale: Per the charter signed on November 10, 2020, the
Advisory Committee on Heritable Disorders in Newborns and Children is
the correct name for the Committee.
<bullet> Introductory paragraph:
[cir] Current introductory paragraph: ``The purpose of this survey
is to inform the Secretary of Health and Human Services Advisory
Committee on Heritable Disorders in Newborns and Children (Committee)
about states' ability to add newborn screening (NBS) for [condition x]
using information gathered from most of the state and territorial NBS
programs in the U.S. . . .''
[cir] Proposed change: (strike ``Secretary of Health and Human
Services'') ``The purpose of this survey is to inform the Advisory
Committee on Heritable Disorders in Newborns and Children (Committee)
about states' ability to add newborn screening (NBS) for [condition x]
using information gathered from most of the state and territorial NBS
programs in the U.S. . . .''
[cir] Rationale: Per the charter signed November 10, 2020, the
Advisory Committee on Heritable Disorders in Newborns and Children is
the correct name of the Committee.
<bullet> Instructions for question 3 (grammatical edit):
[cir] Current instructions: ``. . . The following question asks you
to consider, in general, how much the following factors would be an
issue in considering adding [condition x] to your NBS panel.''
[cir] Proposed change: (strike ``in'' and replace with ``when'')
``. . . The following question asks you to consider, in general, how
much the following factors would be an issue when considering adding
[condition x] to your NBS panel.''
[cir] Rationale: Change made to correct a grammatical error.
Proposed changes to the ``FOLLOW-UP Survey of the Secretary's
Advisory Committee on Heritable Disorders in Newborns and Children's
Public Health System Assessment''
<bullet> Survey title:
[cir] Current title: ``INITIAL Survey of the Secretary's Advisory
Committee on Heritable Disorders in Newborns and Children's Public
Health System Assessment''
[cir] Proposed change: (strike ``Secretary's'') ``INITIAL Survey of
the Advisory Committee on Heritable Disorders in Newborns and
Children's Pub.
[cir] Rationale: Per the charter signed November 10, 2020, the
Advisory Committee on Heritable Disorders in Newborns and Children is
the correct name of the Committee.
<bullet> Question 9 (grammatical edits):
[cir] Current question: ``Have you developed a follow up protocol
and/or educational materials for [condition x]? If so please describe
the steps for short-term follow and how the plan was developed.''
[cir] Proposed change: (insert hyphen in ``follow-up'' and insert
``-up'' in the phrase ``short-term follow'') ``Have you developed a
follow-up protocol and/or educational materials for [condition x]? If
so, please describe the steps for short-term follow-up and how the plan
was developed.
[cir] Rationale: Change made to correct grammatical errors.
The data gathered informs the Committee on the following: (1)
Feasibility of implementing population-based screening for the target
condition, (2) readiness of state newborn screening programs to adopt
screening for the condition, (3) gaps or limitations related to the
feasibility or readiness of states to screen for a condition, and (4)
areas of technical assistance and resources needed to facilitate
screening for conditions with low feasibility or readiness.
Likely Respondents: The respondents to the survey will be state and
territorial newborn screening programs.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
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Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
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INITIAL Survey of the Advisory \1\ 59 \3\ 2 118 10.0 1,180
Committee on Heritable
Disorders in Newborns and
Children's Public Health System
Assessment.....................
FOLLOW-UP Survey of the Advisory \2\ 30 \3\ 2 60 2.0 120
Committee on Heritable
Disorders in Newborns and
Children's Public Health System
Assessment.....................
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Total....................... 89 .............. 178 .............. 1,300
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* It is anticipated that the proposed revisions will not impact the estimated annualized burden hours.
\1\ The respondents to the survey will be state and territorial newborn screening programs.
[[Page 38728]]
\2\ Up to 30 states and/or territories will be asked to complete a follow-up survey.
\3\ Up to two conditions may be reviewed per year.
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-15598 Filed 7-21-21; 8:45 am]
BILLING CODE 4165-15-P
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