80 FR 9269 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 34 (February 20, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 34 (February 20, 2015)
| Page Range | 9269-9270 | |
| FR Document | 2015-03527 |
[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)] [Notices] [Pages 9269-9270] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03527] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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 ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- 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..................... ------------------------------------------------------------------------------- Total....................... 89 .............. 178 .............. 1,300 ---------------------------------------------------------------------------------------------------------------- * 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
![Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices 9269
diagnosed with cancer and other 103–62). These measures cover the Burden Statement: Burden in this
radiogenic diseases caused by exposure principal topic areas of interest to the context means the time expended by
to nuclear fallout or nuclear materials Federal Office of Rural Health Policy, persons to generate, maintain, retain,
such as uranium. RESEP funds support including: (a) Demographics for the disclose or provide the information
eligible health care organizations in RESEP program medical user patient requested. This includes the time
implementing cancer screening population; (b) medical screening needed to: (1) Review instructions; (2)
programs; developing education activities for cancers and other develop, acquire, install and utilize
programs; disseminating information on radiogenic diseases; (c) exposure and technology and systems for the purpose
radiogenic diseases and the importance presentation types for eligible of collecting, validating and verifying
of early detection; screening eligible radiogenic malignant and non- information, processing and
individuals for cancer and other malignant diseases; (d) referrals for maintaining information, and disclosing
radiogenic diseases; providing appropriate medical treatment; (e) and providing information; (3) train
appropriate referrals for medical eligibility counseling and referral personnel and to be able to respond to
treatment; and facilitating assistance for the RECA and Energy a collection of information; (4) search
documentation of Radiation Exposure Employees Occupational Illness data sources; to complete and review
Compensation Act (RECA) claims. Compensation Act programs; and (f) the collection of information; and (5)
Need and Proposed Use of the
program outreach and education transmit or otherwise disclose the
Information: For this program,
performance measures were drafted to activities. These measures will speak to information. The total annual burden
provide data useful to the program and the Office’s progress toward meeting the hours estimated for this Information
to enable HRSA to provide aggregate goals set. Collection Request are summarized in
program data required by Congress Likely Respondents: Radiation the table below.
under the Government Performance and Exposure Screening and Education Total Estimated Annualized burden
Results Act (GPRA) of 1993 (Pub. L. Program award recipients. hours:
Average
Number of
Number of Total burden per Total
Form name responses per
respondents responses response burden hours
respondent (in hours)
Radiation Exposure Screening and Education Program
Performance Measures .................................................... 50 1 50 24 1,200
Total .............................................................................. 50 1 50 24 1,200
HRSA specifically requests comments SUMMARY: In compliance with section System Assessment Surveys OMB No.
on: (1) The necessity and utility of the 3507(a)(1)(D) of the Paperwork 0906–xxxx—New.
proposed information collection for the Reduction Act of 1995, the Health Abstract: The purpose of the public
proper performance of the agency’s Resources and Services Administration health system assessment surveys is to
functions; (2) the accuracy of the (HRSA) has submitted an Information inform the Secretary’s Discretionary
estimated burden; (3) ways to enhance Collection Request (ICR) to the Office of Advisory Committee on Heritable
the quality, utility, and clarity of the Management and Budget (OMB) for Disorders in Newborns and Children
information to be collected; and (4) the review and approval. Comments (Committee) on the ability to add
use of automated collection techniques submitted during the first public review newborn screening for particular
or other forms of information of this ICR will be provided to OMB. conditions within a state, including the
technology to minimize the information OMB will accept further comments from feasibility, readiness, and overall
collection burden. the public during the review and capacity to screen for a new condition.
approval period. The Committee was established under
Jackie Painter, the Public Health Service Act, 42 U.S.C.
Director, Division of the Executive Secretariat. DATES: Comments on this ICR should be 217a: Advisory Councils or Committees.
received no later than March 23, 2015. This Committee fulfills the functions
[FR Doc. 2015–03526 Filed 2–19–15; 8:45 am]
BILLING CODE 4165–15–P ADDRESSES: Submit your comments, previously undertaken by the former
including the Information Collection Secretary’s Advisory Committee on
Request Title, to the desk officer for Heritable Disorders in Newborns and
DEPARTMENT OF HEALTH AND HRSA, either by email to OIRA_ Children, established under section
HUMAN SERVICES submission@omb.eop.gov or by fax to 1111 of the Public Health Service Act
202–395–5806. (PHS), 42 U.S.C. 300b–10, as amended
Health Resources and Services FOR FURTHER INFORMATION CONTACT: To in the Newborn Screening Saves Lives
Administration request a copy of the clearance requests Act of 2008. The Committee is governed
submitted to OMB for review, email the by the provisions of the Federal
Agency Information Collection Advisory Committee Act (FACA), as
HRSA Information Collection Clearance
Activities: Submission to OMB for
TKELLEY on DSK3SPTVN1PROD with NOTICES
amended (5 U.S.C. App.), which sets
Officer at paperwork@hrsa.gov or call
Review and Approval; Public Comment forth standards for the formation and
(301) 443–1984.
Request use of advisory committees. The
SUPPLEMENTARY INFORMATION: purpose of the Committee is to provide
AGENCY:Health Resources and Services Information Collection Request Title: the Secretary with recommendations,
Administration, HHS. The Secretary’s Discretionary Advisory advice, and technical information
ACTION: Notice. Committee on Heritable Disorders in regarding the most appropriate
Newborns and Children’s Public Health application of technologies, policies,
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![9270 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices
guidelines, and standards for: (a) implement the screening of a new or readiness to screen for the condition;
Effectively reducing morbidity and condition. and (4) identify areas of technical
mortality in newborns and children Need and Proposed Use of the assistance and resources needed to
having, or at risk for, heritable Information: HRSA proposes that the facilitate screening for conditions with
disorders; and (b) enhancing the ability data collection surveys be administered low feasibility or readiness.
of state and local health agencies to by the Committee’s external Condition Likely Respondents: The respondents
provide for newborn and child Review Workgroup to all state newborn to the survey will be state newborn
screening, counseling, and health care screening programs in the United States screening programs.
services for newborns and children up to twice a year for two conditions. Burden Statement: Burden in this
having, or at risk for, heritable The surveys were developed to capture context means the time expended by
disorders. Specifically, the Committee the following: (1) The readiness of state persons to generate, maintain, retain,
makes systematic evidence-based public health newborn screening disclose or provide the information
recommendations on newborn screening programs to expand newborn screening requested. This includes the time
for conditions that have the potential to to include the target condition; (2) needed to review instructions; to
change the health outcomes for specific requirements of screening for develop, acquire, install and utilize
newborns. the condition would hinder or facilitate technology and systems for the purpose
The Committee tasks an external its implementation in each state; and (3) of collecting, validating and verifying
workgroup to conduct systematic estimated timeframes needed for each information, processing and
evidence based reviews. The reviews are state to complete major milestones maintaining information, and disclosing
of rare, genetic conditions and their toward full newborn screening of the and providing information; to train
corresponding newborn screening condition. personnel and to be able to respond to
test(s), confirmatory test(s), and The data gathered will inform the a collection of information; to search
treatment(s). Reviews also include an Committee on the following: (1) data sources; to complete and review
analysis of the benefits and harms of Feasibility of implementing population- the collection of information; and to
newborn screening for a selected based screening for the target condition; transmit or otherwise disclose the
condition at a population level and an (2) readiness of state newborn screening information. The total annual burden
assessment of state public health programs to adopt screening for the hours estimated for this ICR are
newborn screening programs’ ability to condition; (3) identify gaps in feasibility summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of Average
Number of responses Total burden per Total burden
Form name respondents per 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 ................. 59 ** 2 118 10.0 1,180
FOLLOW–UP Survey of the Secretary’s Discretionary Ad-
visory Committee on Heritable Disorders in Newborns
and Children’s Public Health System Assessment .......... * 30 ** 2 60 2.0 120
Total .............................................................................. 89 ........................ 178 ........................ 1,300
* 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, projects (section 3506(c)(2)(A) of the FOR FURTHER INFORMATION CONTACT: To
Director, Division of the Executive Secretariat. Paperwork Reduction Act of 1995), the request more information on the
[FR Doc. 2015–03527 Filed 2–19–15; 8:45 am] Health Resources and Services proposed project or to obtain a copy of
BILLING CODE 4165–15–P Administration (HRSA) announces the data collection plans and draft
plans to submit an Information instruments, email paperwork@hrsa.gov
Collection Request (ICR), described or call the HRSA Information Collection
DEPARTMENT OF HEALTH AND below, to the Office of Management and Clearance Officer at (301) 443–1984.
HUMAN SERVICES Budget (OMB). Prior to submitting the SUPPLEMENTARY INFORMATION: When
ICR to OMB, HRSA seeks comments submitting comments or requesting
Health Resources and Services information, please include the
from the public regarding the burden
Administration information request collection title for
estimate, below, or any other aspect of
the ICR. reference.
Agency Information Collection
Information Collection Request Title:
Activities: Proposed Collection: Public DATES: Comments on this ICR should be Rural Access to Emergency Devices
Comment Request received no later April 21, 2015. Grant Program OMB No. 0915–xxxx—
TKELLEY on DSK3SPTVN1PROD with NOTICES
AGENCY: Health Resources and Services ADDRESSES: Submit your comments to [New]
Administration, HHS. paperwork@hrsa.gov or mail to the Abstract: This program is authorized
ACTION: Notice. by the Public Health Improvement Act
HRSA Information Collection Clearance
title IV—Cardiac Arrest Survival Act of
Officer, Room 10–29, Parklawn
SUMMARY: In compliance with the 2000, subtitle B-Rural Access to
requirement for opportunity for public Building, 5600 Fishers Lane, Rockville, Emergency Devices, section 413, (42
comment on proposed data collection MD 20857. U.S.C. 254c (Note)) and the
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Document Created: 2015-12-18 13:02:04
Document Modified: 2015-12-18 13:02:04
| 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 should be received no later than March 23, 2015. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 80 FR 9269 |
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