[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62636-62637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (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 Information Collection Request must be received 
no later than December 19, 2014.

ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#90e0f1e0f5e2e7ffe2fbd0f8e2e3f1bef7ffe6"><span class="__cf_email__" data-cfemail="3b4b5a4b5e494c5449507b5349485a155c544d">[email protected]</span></a> or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 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 <a href="/cdn-cgi/l/email-protection#96e6f7e6f3e4e1f9e4fdd6fee4e5f7b8f1f9e0"><span class="__cf_email__" data-cfemail="cdbdacbda8bfbaa2bfa68da5bfbeace3aaa2bb">[email protected]</span></a> or call 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 Discretionary 
Advisory Committee on Heritable Disorders in Newborns and Children's 
Public Health System Assessment Surveys OMB No. 0915-xxxx-New
    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 the Public Health Service Act, 
42 U.S.C. 217a: Advisory Councils or Committees. This Committee 
fulfills the functions previously undertaken by the former Secretary's 
Advisory Committee on Heritable Disorders in Newborns and Children, 
established under Section 1111 of the Public Health Service Act (PHS), 
42 U.S.C. 300b-10, as amended in the Newborn Screening Saves Lives Act 
of 2008. The Committee is governed by the provisions of the Federal 
Advisory Committee Act (FACA), as

[[Page 62637]]

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. The reviews are of rare, genetic conditions 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 
Condition Review Workgroup to all state newborn screening programs in 
the United States. 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 the condition would 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.
    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 
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 Information Collection Request are summarized in the table below.
    Total 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..................              59               1              59            10.0             590
FOLLOW-UP Survey................          \1\ 30               1              30             2.0              60
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    Total.......................              59  ..............              89  ..............             650
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\1\ 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.

    Dated: October 10, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-24870 Filed 10-17-14; 8:45 am]
BILLING CODE 4165-15-P


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