[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)]
[Notices]
[Pages 9269-9270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03527]


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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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(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 March 23, 
2015.

ADDRESSES: Submit your comments, including the Information Collection 
Request Title, to the desk officer for HRSA, either by email to 
<a href="/cdn-cgi/l/email-protection#5d12140f1c022e283f30342e2e3432331d32303f7338322d733a322b"><span class="__cf_email__" data-cfemail="6926203b28361a1c0b04001a1a0006072906040b470c0619470e061f">[email protected]</span></a> or by fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at <a href="/cdn-cgi/l/email-protection#f787968792858098859cb79f858496d9909881"><span class="__cf_email__" data-cfemail="a4d4c5d4c1d6d3cbd6cfe4ccd6d7c58ac3cbd2">[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-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 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,

[[Page 9270]]

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 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 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 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.


Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-03527 Filed 2-19-15; 8:45 am]
BILLING CODE 4165-15-P


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