[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42910-42911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18292]


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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 Secretary's 
Discretionary Advisory Committee on Heritable Disorders in Newborns and 
Children's Public Health System Assessment Surveys OMB No. 0906-0014--
Revised

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.

DATES: Comments on this ICR should be received no later than September 
24, 2018.

ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#deaebfaebbaca9b1acb59eb6acadbff0b9b1a8"><span class="__cf_email__" data-cfemail="453524352037322a372e052d3736246b222a33">[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 a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at <a href="/cdn-cgi/l/email-protection#f686978693848199849db69e848597d8919980"><span class="__cf_email__" data-cfemail="e19180918493968e938aa189939280cf868e97">[email protected]</span></a> or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: The Secretary's Discretionary 
Advisory Committee on Heritable Disorders in Newborns and Children's 
Public Health System Assessment Surveys OMB No. 0906-0014--Revised.
    Abstract: The purpose of the public health system assessment 
surveys is to inform the Secretary's Discretionary Advisory Committee 
on Heritable Disorders in Newborns and Children (Committee) on the 
ability to add newborn screening for particular conditions within a 
state, 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: HRSA proposes that the 
data collection surveys be administered by the Committee's external 
Evidence Review Group to all state newborn screening programs in the 
United States up to twice a year for two conditions. The surveys were 
developed to capture the following: (1) The readiness of state public 
health newborn screening programs to expand newborn screening to 
include the target condition; (2) specific requirements of screening 
for

[[Page 42911]]

the condition that could hinder or facilitate its implementation in 
each state; and (3) estimated timeframes needed for each state to 
complete major milestones toward full newborn screening of the 
condition.
    HRSA published the 60-day notice on June 5, 2018 (FR Doc. 2018-
12019). There were no comments received during the 60-day comment 
period. The survey tools have been revised to streamline responses to 
decrease the burden on the respondents, provide clarity with regard to 
what is being asked, ensure the survey can accommodate different types 
of conditions that may be nominated in the future, and offer additional 
response options. To accomplish this, questions were deleted, 
consolidated, reordered, and new questions were added to address gaps 
in information identified by those who have completed the survey and 
utilized the survey results.
    The data gathered will inform 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) identify gaps in feasibility or 
readiness to screen for the condition; and (4) identify 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                         59            ** 2             118            10.0           1,180
 Secretary's Discretionary
 Advisory Committee on Heritable
 Disorders in Newborns and
 Children's Public Health System
 Assessment.....................
FOLLOW-UP Survey of the                     * 30            ** 2              60             2.0             120
 Secretary's Discretionary
 Advisory 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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* Up to 30 States and/or Territories will be asked to complete a follow-up survey.
** Up to two conditions may be reviewed per year. Therefore, there will be two initial surveys and two follow-up
  surveys per year.


Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-18292 Filed 8-23-18; 8:45 am]
BILLING CODE 4165-15-P


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