[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Pages 26064-26065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12019]


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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 
Secretary's 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 must be received no later than August 6, 
2018.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N-39, 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 Secretary's 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 Secretary's 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 Section 1111 of the Public 
Health Service Act, 42 U.S.C. 300b-10, as amended in the Newborn 
Screening Saves Lives Reauthorization Act of 2014. The Committee is 
governed by the provisions of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), which sets forth standards for the formation 
and use of advisory committees. 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 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 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.
    HRSA anticipates the following revisions will be made to the 
surveys: (1) Editing and adding response choices as needed, to provide 
more informative options; (2) revising language throughout the survey 
to ensure the survey can accommodate different types of conditions that 
may be nominated; (3) reorder current questions as needed; and (4) add 
new questions as needed.
    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:

[[Page 26065]]



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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                         59               1              59              10             590
 Secretary's Discretionary
 Advisory Committee on Heritable
 Disorders in Newborns and
 Children's Public Health System
 Assessment \1\.................
FOLLOW-UP Survey of the                   \2\ 30               1              30               2              60
 Secretary's Discretionary
 Advisory Committee on Heritable
 Disorders in Newborns and
 Children's Public Health System
 Assessment.....................
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    Total.......................              89  ..............              89  ..............             650
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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.

    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.

Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-12019 Filed 6-4-18; 8:45 am]
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