[Federal Register Volume 86, Number 198 (Monday, October 18, 2021)]
[Notices]
[Pages 57678-57680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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 [email protected] 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'':
     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.
     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.
     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''
     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.
     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]
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