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, 26064-26065 [2018-12019]

Download as PDF 26064 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018–12005 Filed 6–4–18; 8:45 am] BILLING CODE 4165–15–P 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: 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 paperwork@hrsa.gov 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 paperwork@hrsa.gov 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 amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 20:19 Jun 04, 2018 Jkt 241001 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 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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 populationbased 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: E:\FR\FM\05JNN1.SGM 05JNN1 26065 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices Number of respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours INITIAL Survey of the Secretary’s Discretionary Advisory Committee on Heritable Disorders in Newborns and Children’s Public Health System Assessment 1 ............... FOLLOW–UP Survey of the Secretary’s Discretionary Advisory Committee on Heritable Disorders in Newborns and Children’s Public Health System Assessment .......... 59 1 59 10 590 2 30 1 30 2 60 Total .............................................................................. 89 ........................ 89 ........................ 650 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] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Tick-Borne Disease Working Group Office of the Secretary, Office of the Assistant Secretary for Health, Office of HIV/AIDS and Infectious Disease Policy, Department of Health and Human Services. ACTION: Notice. AGENCY: The Department of Health and Human Services (HHS) announces the sixth meeting of the Tick-Borne Disease Working Group (Working Group) on June 21, 2018, from 9:30 a.m. to 6:00 p.m., Eastern Time. The sixth meeting will be an on-line meeting held via webcast. The Working Group will focus on subcommittee findings and will review and provide input on the content of the five chapters that will be submitted into the Working Group Congressional Report. DATES: The on-line meeting will be held on June 21, 2018, from 9:30 a.m. to 6:00 p.m. Eastern Time. ADDRESSES: This will be an on-line meeting that is held via webcast. Members of the public may attend the meeting via webcast. Instructions for attending this virtual meeting will be amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 20:19 Jun 04, 2018 Jkt 241001 posted prior to the meeting at: https:// www.hhs.gov/ash/advisory-committees/ tickbornedisease/index.html. FOR FURTHER INFORMATION CONTACT: James Berger, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services; via email at tickbornedisease@ hhs.gov or by phone at 202–795–7697. SUPPLEMENTARY INFORMATION: The Working Group invites public comment on issues related to the Working Group’s charge. Comments may be provided over the phone during the meeting or in writing. Persons who wish to provide comments by phone should review directions at https://www.hhs.gov/ash/ advisory-committees/tickbornedisease/ meetings/index.html before submitting a request via email at tickbornedisease@ hhs.gov on or before June 18, 2018. Phone comments will be limited to three minutes each to accommodate as many speakers as possible. A total of 30 minutes will be allocated to public comments. If more requests are received than can be accommodated, speakers will be randomly selected. The nature of the comments will not be considered in making this selection. Public comments may also be provided in writing. Individuals who would like to provide written comment should review directions at https://www.hhs.gov/ash/ advisory-committees/tickbornedisease/ meetings/index.html before sending their comments to tickbornedisease@ hhs.gov on or before June 18, 2018. During the meeting, the Working Group will review and discuss the content of the five draft chapters that will be part of the Report to Congress. Persons who wish to receive the draft document should email the tickbornedisease@hhs.gov and request a copy. The document will be available prior to the meeting. Background and Authority: The TickBorne Disease Working Group was established on August 10, 2017, in accordance with section 2062 of the 21st Century Cures Act, and the Federal PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Advisory Committee Act, 5 U.S.C. App., as amended, to provide expertise and review all HHS, DoD and VA efforts related to tick-borne diseases to help ensure interagency coordination and minimize overlap, examine research priorities, and identify and address unmet needs. In addition, the Working Group is required to submit a report to the Secretary and Congress on their findings and any recommendations for improving the federal response to tickborne disease prevention, treatment and research, and addressing gaps in those areas. Dated: May 31, 2018. James Berger, Office of HIV/AIDS and Infectious Disease Policy, Designated Federal Officer, TickBorne Disease Working Group. [FR Doc. 2018–12045 Filed 6–4–18; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Findings of research misconduct have been made on the part of Shiladitya Sen, former graduate student, Department of Chemistry and Biochemistry, The Ohio State University (OSU). Mr. Sen engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM083114. The administrative actions, including debarment for a period of three (3) years, were implemented beginning on May 16, 2018, and are detailed below. FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8200. SUMMARY: E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

[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.

-----------------------------------------------------------------------

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]]



----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
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.....................
                                 -------------------------------------------------------------------------------
    Total.......................              89  ..............              89  ..............             650
----------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4165-15-P