[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Pages 38726-38728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected] 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 [email protected] 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:''
     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.
     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.
     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''
     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.
     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]
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