83 FR 26064 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 108 (June 5, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 108 (June 5, 2018)
| Page Range | 26064-26065 | |
| FR Document | 2018-12019 |
[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)] [Notices] [Pages 26064-26065] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12019] ----------------------------------------------------------------------- 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 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 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
![26064 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices
Amy P. McNulty, Children’s Public Health System in the United States. The surveys have
Acting Director, Division of the Executive Assessment Surveys OMB No. 0906– been developed to capture the
Secretariat. 0014—Revision. following: (1) Readiness of state public
[FR Doc. 2018–12005 Filed 6–4–18; 8:45 am] Abstract: The purpose of the public health newborn screening programs to
BILLING CODE 4165–15–P health system assessment surveys is to expand newborn screening to include
inform the Secretary’s Advisory the target condition; (2) specific
Committee on Heritable Disorders in requirements of screening for a
DEPARTMENT OF HEALTH AND Newborns and Children (Committee) on condition that could hinder or facilitate
HUMAN SERVICES states’ ability to add newborn screening implementation in each state; and (3)
for particular conditions, including the estimated timeframes needed for each
Health Resources and Services feasibility, readiness and overall state to complete major milestones
Administration capacity to screen for a new condition. toward full implementation of newborn
The Committee was established under screening for the condition.
Agency Information Collection Section 1111 of the Public Health
Activities: Proposed Collection: Public The data gathered informs the
Service Act, 42 U.S.C. 300b-10, as
Comment Request Information Committee on the following: (1)
amended in the Newborn Screening
Collection Request Title: The Feasibility of implementing population-
Saves Lives Reauthorization Act of
Secretary’s Advisory Committee on based screening for the target condition;
2014. The Committee is governed by the
Heritable Disorders in Newborns and (2) readiness of state newborn screening
provisions of the Federal Advisory
Children’s Public Health System programs to adopt screening for the
Committee Act, as amended (5 U.S.C.
Assessment Surveys OMB No. 0906– condition; (3) gaps or limitations related
App.), which sets forth standards for the
0014, Revision to the feasibility or readiness of states to
formation and use of advisory
screen for a condition; and (4) areas of
AGENCY: Health Resources and Services committees. The purpose of the
technical assistance and resources
Administration (HRSA), Department of Committee is to provide the Secretary
with recommendations, advice, and needed to facilitate screening for
Health and Human Services. conditions with low feasibility or
technical information regarding the
ACTION: Notice. readiness.
most appropriate application of
SUMMARY: In compliance with the technologies, policies, guidelines, and HRSA anticipates the following
requirement for opportunity for public standards for: (a) Effectively reducing revisions will be made to the surveys:
comment on proposed data collection morbidity and mortality in newborns (1) Editing and adding response choices
projects of the Paperwork Reduction Act and children having, or at risk for, as needed, to provide more informative
of 1995, HRSA announces plans to heritable disorders; and (b) enhancing options; (2) revising language
submit an Information Collection the ability of state and local health throughout the survey to ensure the
Request (ICR), described below, to the agencies to provide for newborn and survey can accommodate different types
Office of Management and Budget child screening, counseling, and health of conditions that may be nominated; (3)
(OMB). Prior to submitting the ICR to care services for newborns and children reorder current questions as needed;
OMB, HRSA seeks comments from the having, or at risk for, heritable and (4) add new questions as needed.
public regarding the burden estimate, disorders. Specifically, the Committee Likely Respondents: The respondents
below, or any other aspect of the ICR. makes systematic evidence-based to the survey will be state and territorial
recommendations on newborn screening newborn screening programs.
DATES: Comments on this ICR must be
for conditions that have the potential to
received no later than August 6, 2018. Burden Statement: Burden in this
change the health outcomes for
ADDRESSES: Submit your comments to newborns. context means the time expended by
paperwork@hrsa.gov or mail the HRSA The Committee tasks an external persons to generate, maintain, retain,
Information Collection Clearance workgroup to conduct systematic disclose or provide the information
Officer, Room 14N–39, 5600 Fishers evidence-based reviews for conditions requested. This includes the time
Lane, Rockville, MD 20857. being considered for addition to the needed to review instructions; to
FOR FURTHER INFORMATION CONTACT: To Recommended Uniform Screening develop, acquire, install and utilize
request more information on the Panel, and their corresponding newborn technology and systems for the purpose
proposed project or to obtain a copy of screening test(s), confirmatory test(s), of collecting, validating and verifying
the data collection plans and draft and treatment(s). Reviews also include information, processing and
instruments, email paperwork@hrsa.gov an analysis of the benefits and harms of maintaining information, and disclosing
or call Lisa Wright-Solomon, the HRSA newborn screening for a selected and providing information; to train
Information Collection Clearance Officer condition at a population level and an personnel and to be able to respond to
at (301) 443–1984. assessment of state public health a collection of information; to search
SUPPLEMENTARY INFORMATION: When newborn screening programs’ ability to data sources; to complete and review
submitting comments or requesting implement the screening of a new the collection of information; and to
information, please include the condition. transmit or otherwise disclose the
information request collection title for Need and Proposed Use of the information. The total annual burden
reference. Information: The surveys are hours estimated for this ICR are
summarized in the table below.
amozie on DSK3GDR082PROD with NOTICES1
Information Collection Request Title: administered by the Committee’s
The Secretary’s Advisory Committee on Evidence Review Group to collect data Total Estimated Annualized Burden
Heritable Disorders in Newborns and from state newborn screening programs Hours:
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![Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices 26065
Average bur-
Number of
Number of Total den per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
INITIAL Survey of the Secretary’s Discretionary Advisory
Committee on Heritable Disorders in Newborns and
Children’s Public Health System Assessment 1 ............... 59 1 59 10 590
FOLLOW–UP Survey of the Secretary’s Discretionary Ad-
visory Committee on Heritable Disorders in Newborns
and Children’s Public Health System Assessment .......... 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 posted prior to the meeting at: https:// Advisory Committee Act, 5 U.S.C. App.,
on (1) the necessity and utility of the www.hhs.gov/ash/advisory-committees/ as amended, to provide expertise and
proposed information collection for the tickbornedisease/index.html. review all HHS, DoD and VA efforts
proper performance of the agency’s FOR FURTHER INFORMATION CONTACT: related to tick-borne diseases to help
functions, (2) the accuracy of the James Berger, Office of HIV/AIDS and ensure interagency coordination and
estimated burden, (3) ways to enhance Infectious Disease Policy, Office of the minimize overlap, examine research
the quality, utility, and clarity of the Assistant Secretary for Health, priorities, and identify and address
information to be collected, and (4) the Department of Health and Human unmet needs. In addition, the Working
use of automated collection techniques Services; via email at tickbornedisease@ Group is required to submit a report to
or other forms of information hhs.gov or by phone at 202–795–7697. the Secretary and Congress on their
technology to minimize the information SUPPLEMENTARY INFORMATION: The findings and any recommendations for
collection burden. Working Group invites public comment improving the federal response to tick-
Amy P. McNulty, on issues related to the Working Group’s borne disease prevention, treatment and
charge. Comments may be provided research, and addressing gaps in those
Acting Director, Division of the Executive
Secretariat. over the phone during the meeting or in areas.
[FR Doc. 2018–12019 Filed 6–4–18; 8:45 am] writing. Persons who wish to provide Dated: May 31, 2018.
BILLING CODE 4165–15–P
comments by phone should review James Berger,
directions at https://www.hhs.gov/ash/ Office of HIV/AIDS and Infectious Disease
advisory-committees/tickbornedisease/ Policy, Designated Federal Officer, Tick-
DEPARTMENT OF HEALTH AND meetings/index.html before submitting a Borne Disease Working Group.
HUMAN SERVICES request via email at tickbornedisease@ [FR Doc. 2018–12045 Filed 6–4–18; 8:45 am]
hhs.gov on or before June 18, 2018. BILLING CODE 4150–28–P
Meeting of the Tick-Borne Disease Phone comments will be limited to
Working Group three minutes each to accommodate as
many speakers as possible. A total of 30 DEPARTMENT OF HEALTH AND
AGENCY: Office of the Secretary, Office minutes will be allocated to public
of the Assistant Secretary for Health, HUMAN SERVICES
comments. If more requests are received
Office of HIV/AIDS and Infectious than can be accommodated, speakers Office of the Secretary
Disease Policy, Department of Health will be randomly selected. The nature of
and Human Services. the comments will not be considered in Findings of Research Misconduct
ACTION: Notice. making this selection. Public comments
may also be provided in writing. AGENCY: Office of the Secretary, HHS.
SUMMARY: The Department of Health and ACTION: Notice.
Human Services (HHS) announces the Individuals who would like to provide
sixth meeting of the Tick-Borne Disease written comment should review
SUMMARY: Findings of research
directions at https://www.hhs.gov/ash/
Working Group (Working Group) on misconduct have been made on the part
advisory-committees/tickbornedisease/
June 21, 2018, from 9:30 a.m. to 6:00 of Shiladitya Sen, former graduate
meetings/index.html before sending
p.m., Eastern Time. The sixth meeting student, Department of Chemistry and
their comments to tickbornedisease@
will be an on-line meeting held via Biochemistry, The Ohio State University
hhs.gov on or before June 18, 2018.
webcast. The Working Group will focus During the meeting, the Working (OSU). Mr. Sen engaged in research
on subcommittee findings and will Group will review and discuss the misconduct in research supported by
review and provide input on the content content of the five draft chapters that National Institute of General Medical
of the five chapters that will be will be part of the Report to Congress. Sciences (NIGMS), National Institutes of
submitted into the Working Group Persons who wish to receive the draft Health (NIH), grant R01 GM083114. The
Congressional Report. document should email the administrative actions, including
DATES: The on-line meeting will be held tickbornedisease@hhs.gov and request a debarment for a period of three (3)
amozie on DSK3GDR082PROD with NOTICES1
on June 21, 2018, from 9:30 a.m. to 6:00 copy. The document will be available years, were implemented beginning on
p.m. Eastern Time. prior to the meeting. May 16, 2018, and are detailed below.
ADDRESSES: This will be an on-line Background and Authority: The Tick- FOR FURTHER INFORMATION CONTACT:
meeting that is held via webcast. Borne Disease Working Group was Wanda K. Jones, Dr.P.H., Interim
Members of the public may attend the established on August 10, 2017, in Director, Office of Research Integrity,
meeting via webcast. Instructions for accordance with section 2062 of the 21st 1101 Wootton Parkway, Suite 750,
attending this virtual meeting will be Century Cures Act, and the Federal Rockville, MD 20852, (240) 453–8200.
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Document Created: 2018-11-02 11:46:21
Document Modified: 2018-11-02 11:46:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR must be received no later than August 6, 2018. | |
| 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. | |
| FR Citation | 83 FR 26064 |
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