Notice2021-22619
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; the Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Surveys, OMB No. 0906-0014, Revision
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 18, 2021
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this Notice has closed.
Full Text
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<title>Federal Register, Volume 86 Issue 198 (Monday, October 18, 2021)</title>
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[Federal Register Volume 86, Number 198 (Monday, October 18, 2021)]
[Notices]
[Pages 57678-57680]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22619]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; 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 of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the
30-day comment period for this Notice has closed.
DATES: Comments on this ICR should be received no later than November
17, 2021.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the acting
HRSA Information Collection Clearance Officer at <a href="/cdn-cgi/l/email-protection#512130213423263e233a11392322307f363e27"><span class="__cf_email__" data-cfemail="4a3a2b3a2f383d2538210a2238392b642d253c">[email protected]</span></a> or
call (301) 443-9094.
SUPPLEMENTARY INFORMATION:
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 (PDF--215 KB), 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
[[Page 57679]]
condition at a population level and an assessment of state public
health newborn screening programs' ability to implement the screening
of a new condition.
A 60-day notice published in the Federal Register, 86 FR 38726
(July 22, 2021).
There were no public comments.
Need and Proposed Use of the Information: The surveys are
administered by the Committee's Evidence Review Group to collect data
from state newborn screening programs in the United States. 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 November 10, 2020, the
ACHDNC 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. . . .''
Rationale: Per the charter signed November 10, 2020, the ACHDNC 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'', 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: Correction of 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
ACHDNC 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'', 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: Correction of 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
[It is anticipated that the proposed revisions will not impact the estimated annualized burden hours]
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Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) 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.....................
[[Page 57680]]
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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\1\ The respondents to the survey will be state and territorial newborn screening programs.
\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. 2021-22619 Filed 10-15-21; 8:45 am]
BILLING CODE 4165-15-P
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