82_FR_18996 82 FR 18919 - Advisory Committee on Heritable Disorders in Newborns and Children

82 FR 18919 - Advisory Committee on Heritable Disorders in Newborns and Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 77 (April 24, 2017)

Page Range18919-18920
FR Document2017-08220

In accordance with the Federal Advisory Committee Act, notice is hereby given of the following meeting for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). The meeting will be open to the public but advance registration is required. The online registration deadline is Thursday, May 4, 2017, 5:00 p.m. Eastern Time. Please check the Web site for additional guidance and registration information. The registration link is http://www.achdncmeetings.org/. Information about the agenda for this meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/ advisorycommittees/mchbadvisory/heritabledisorders.

Federal Register, Volume 82 Issue 77 (Monday, April 24, 2017)
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18919-18920]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08220]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Committee on Heritable Disorders in Newborns and 
Children

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of meeting.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, notice 
is hereby given of the following meeting for the Advisory Committee on 
Heritable Disorders in Newborns and Children (ACHDNC). The meeting will 
be open to the public but advance registration is required. The online 
registration deadline is Thursday, May 4, 2017, 5:00 p.m. Eastern Time. 
Please check the Web site for additional guidance and registration 
information. The registration link is http://www.achdncmeetings.org/. 
Information about the agenda for this meeting can be obtained by 
accessing the following Web site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

DATES: The meeting will be held on May 11, 2017, 9:00 a.m. to 5:00 p.m. 
and May 12, 2017, 9:00 a.m. to 3:00 p.m.

ADDRESSES: This meeting will be held in-person and by webcast. The 
address for the meeting is 5600 Fishers Lane, 5th Floor Pavilion, 
Rockville, MD 20857. Webcast information will be emailed to you after 
you register.

FOR FURTHER INFORMATION CONTACT: Anyone requesting information 
regarding the ACHDNC should contact Ann Ferrero, Maternal and Child 
Health Bureau (MCHB), HRSA, in one of three ways: (1) Send a request to 
Ann Ferrero, MCHB, HRSA 5600 Fishers Lane, Room 18N100C, Rockville, 
Maryland 20857; (2) call 301-443-3999 or (3) send an email to: 
[email protected]. More information on the Advisory Committee is 
available at the Advisory Committee's Web site, provided above.

SUPPLEMENTARY INFORMATION: The ACHDNC, as authorized by Public Health 
Service Act, Title XI, Sec.  1111 (42 U.S.C. 300b-10), provides advice 
to the Secretary of HHS on the development of newborn screening 
activities, technologies, policies, guidelines, and programs for 
effectively reducing morbidity and mortality in newborns and children 
having, or at risk for, heritable disorders. In addition, ACHDNC's 
recommendations regarding inclusion of additional conditions and 
inherited disorders for screening which have been adopted by the 
Secretary are then included in the Recommended Uniform Screening Panel 
(RUSP). Conditions listed on the RUSP constitute part of the 
comprehensive guidelines supported by HRSA for infants, children, and 
adolescents. Pursuant to section 2713 of the Public Health Service Act, 
codified at 42 U.S.C. 300gg-13, non-grandfathered health plans and 
health insurance issuers are required to cover screenings included in 
the HRSA-supported comprehensive guidelines without charging a co-
payment, co-insurance, or deductible for plan years (i.e., policy 
years) beginning on or after the date that is one year from the 
Secretary's adoption of the condition for screening. the meeting will 
include: (1) Presentations and discussion on the process of identifying 
and following up on out of range newborn screening results; (2) a 
presentation on newborn screening quality assurance programs; (3) 
presentations on the clinical and public health impact of Critical 
Congenital Heart Defects screening; (4) discussion and possible vote on 
a report on Medical Foods for Inborn Errors of Metabolism; (5) a 
presentation, discussion, and possible vote on whether to move a 
nomination forward to evidence review for spinal muscular atrophy 
(SMA); and (6) updates from the Laboratory Standards and Procedures 
workgroup, Follow-up and Treatment workgroup, and Education and 
Training workgroup.
    The Committee will not be voting on a proposed addition of a 
condition to the RUSP. The final meeting agenda will be available two 
(2) days prior to the meeting on the Committee's Web site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Members of the public may submit written and/or present oral 
comments at the meeting. All comments are part of the official 
Committee record. Advance registration is required to submit written 
comments and/or present oral comments. Written comments must be 
submitted by April 28, 2017, 12:00 p.m. Eastern Time to be included in 
the May meeting briefing book. Written comments should identify the 
individual's name, address, email, telephone number, professional or 
organization affiliation, background or area of expertise (i.e., 
parent, family member, researcher, clinician, public health, etc.) and 
the topic/subject matter.
    Individuals who wish to provide oral comments must register by 
Thursday, May 4, 2017, 5:00 p.m. Eastern Time. To ensure that all 
individuals who have registered to make oral comments can be 
accommodated, the allocated time may be limited. Individuals who are 
associated with groups or have similar interests may be requested to 
combine their comments and present them through a single 
representative. No audiovisual presentations are permitted.

[[Page 18920]]

For additional information or questions on public comments, please 
contact Ann Ferrero, MCHB, HRSA; email: [email protected].
    The 5600 Fishers Lane building requires a security screening on 
entry. To facilitate your access to the building, please contact Ann 
Ferrero at 301-443-3999. Individuals who plan to attend and need 
special assistance, such as sign language interpretation or other 
reasonable accommodations, should notify Ann Ferrero, MCHB, HRSA; 
email: [email protected], at least 10 days prior to the meeting.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017-08220 Filed 4-21-17; 8:45 am]
 BILLING CODE 4165-15-P



                                                                                            Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices                                                                            18919

                                                                                                                     TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                  Average
                                                                                                                                                                     Number of
                                                                                                                                                 Number of                                       Total          burden per              Total burden
                                                                                     Form name                                                                     responses per
                                                                                                                                                respondents                                   responses          response                  hours
                                                                                                                                                                     respondent                                  (in hours)

                                                  Grantee Report ....................................................................                        54                         1             54                         6               324
                                                  Client-level Report ...............................................................                        54                         1             54                        81             4,374

                                                        Total ..............................................................................                * 54   ........................           54     ........................          4,698
                                                     * The same respondents complete the Grantee Report and the Client-level Report.


                                                    HRSA specifically requests comments                                      ADDRESSES:   This meeting will be held                           newborn screening results; (2) a
                                                  on (1) the necessity and utility of the                                    in-person and by webcast. The address                            presentation on newborn screening
                                                  proposed information collection for the                                    for the meeting is 5600 Fishers Lane, 5th                        quality assurance programs; (3)
                                                  proper performance of the agency’s                                         Floor Pavilion, Rockville, MD 20857.                             presentations on the clinical and public
                                                  functions, (2) the accuracy of the                                         Webcast information will be emailed to                           health impact of Critical Congenital
                                                  estimated burden, (3) ways to enhance                                      you after you register.                                          Heart Defects screening; (4) discussion
                                                  the quality, utility, and clarity of the                                   FOR FURTHER INFORMATION CONTACT:                                 and possible vote on a report on
                                                  information to be collected, and (4) the                                   Anyone requesting information                                    Medical Foods for Inborn Errors of
                                                  use of automated collection techniques                                     regarding the ACHDNC should contact                              Metabolism; (5) a presentation,
                                                  or other forms of information                                              Ann Ferrero, Maternal and Child Health                           discussion, and possible vote on
                                                  technology to minimize the information                                     Bureau (MCHB), HRSA, in one of three                             whether to move a nomination forward
                                                  collection burden.                                                         ways: (1) Send a request to Ann Ferrero,                         to evidence review for spinal muscular
                                                                                                                             MCHB, HRSA 5600 Fishers Lane, Room                               atrophy (SMA); and (6) updates from the
                                                  Jason E. Bennett,
                                                                                                                             18N100C, Rockville, Maryland 20857;                              Laboratory Standards and Procedures
                                                  Director, Division of the Executive Secretariat.                                                                                            workgroup, Follow-up and Treatment
                                                                                                                             (2) call 301–443–3999 or (3) send an
                                                  [FR Doc. 2017–08197 Filed 4–21–17; 8:45 am]                                                                                                 workgroup, and Education and Training
                                                                                                                             email to: AFerrero@hrsa.gov. More
                                                  BILLING CODE 4165–15–P                                                     information on the Advisory Committee                            workgroup.
                                                                                                                             is available at the Advisory Committee’s                            The Committee will not be voting on
                                                                                                                             Web site, provided above.                                        a proposed addition of a condition to
                                                  DEPARTMENT OF HEALTH AND                                                                                                                    the RUSP. The final meeting agenda will
                                                                                                                             SUPPLEMENTARY INFORMATION: The
                                                  HUMAN SERVICES                                                                                                                              be available two (2) days prior to the
                                                                                                                             ACHDNC, as authorized by Public
                                                  Health Resources and Services                                              Health Service Act, Title XI, § 1111 (42                         meeting on the Committee’s Web site:
                                                  Administration                                                             U.S.C. 300b–10), provides advice to the                          http://www.hrsa.gov/
                                                                                                                             Secretary of HHS on the development of                           advisorycommittees/mchbadvisory/
                                                  Advisory Committee on Heritable                                            newborn screening activities,                                    heritabledisorders.
                                                  Disorders in Newborns and Children                                         technologies, policies, guidelines, and                             Members of the public may submit
                                                                                                                             programs for effectively reducing                                written and/or present oral comments at
                                                  AGENCY: Health Resources and Services                                      morbidity and mortality in newborns                              the meeting. All comments are part of
                                                  Administration (HRSA), Department of                                       and children having, or at risk for,                             the official Committee record. Advance
                                                  Health and Human Services (HHS).                                           heritable disorders. In addition,                                registration is required to submit written
                                                  ACTION:      Notice of meeting.                                            ACHDNC’s recommendations regarding                               comments and/or present oral
                                                                                                                             inclusion of additional conditions and                           comments. Written comments must be
                                                  SUMMARY:   In accordance with the                                          inherited disorders for screening which                          submitted by April 28, 2017, 12:00 p.m.
                                                  Federal Advisory Committee Act, notice                                     have been adopted by the Secretary are                           Eastern Time to be included in the May
                                                  is hereby given of the following meeting                                   then included in the Recommended                                 meeting briefing book. Written
                                                  for the Advisory Committee on                                              Uniform Screening Panel (RUSP).                                  comments should identify the
                                                  Heritable Disorders in Newborns and                                        Conditions listed on the RUSP                                    individual’s name, address, email,
                                                  Children (ACHDNC). The meeting will                                        constitute part of the comprehensive                             telephone number, professional or
                                                  be open to the public but advance                                          guidelines supported by HRSA for                                 organization affiliation, background or
                                                  registration is required. The online                                       infants, children, and adolescents.                              area of expertise (i.e., parent, family
                                                  registration deadline is Thursday, May                                     Pursuant to section 2713 of the Public                           member, researcher, clinician, public
                                                  4, 2017, 5:00 p.m. Eastern Time. Please                                    Health Service Act, codified at 42 U.S.C.                        health, etc.) and the topic/subject
                                                  check the Web site for additional                                          300gg–13, non-grandfathered health                               matter.
                                                  guidance and registration information.                                     plans and health insurance issuers are                              Individuals who wish to provide oral
                                                  The registration link is http://                                           required to cover screenings included in                         comments must register by Thursday,
                                                  www.achdncmeetings.org/. Information                                       the HRSA-supported comprehensive                                 May 4, 2017, 5:00 p.m. Eastern Time. To
                                                  about the agenda for this meeting can be                                   guidelines without charging a co-                                ensure that all individuals who have
                                                                                                                             payment, co-insurance, or deductible for                         registered to make oral comments can be
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  obtained by accessing the following
                                                  Web site: http://www.hrsa.gov/                                             plan years (i.e., policy years) beginning                        accommodated, the allocated time may
                                                  advisorycommittees/mchbadvisory/                                           on or after the date that is one year from                       be limited. Individuals who are
                                                  heritabledisorders.                                                        the Secretary’s adoption of the                                  associated with groups or have similar
                                                                                                                             condition for screening. the meeting                             interests may be requested to combine
                                                  DATES: The meeting will be held on May                                     will include: (1) Presentations and                              their comments and present them
                                                  11, 2017, 9:00 a.m. to 5:00 p.m. and May                                   discussion on the process of identifying                         through a single representative. No
                                                  12, 2017, 9:00 a.m. to 3:00 p.m.                                           and following up on out of range                                 audiovisual presentations are permitted.


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                                                  18920                                     Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices

                                                  For additional information or questions                                    review and approval. The ICR is for a                          interoperability. This strategy called for
                                                  on public comments, please contact                                         new collection. Comments submitted                             measuring and reporting on the state of
                                                  Ann Ferrero, MCHB, HRSA; email:                                            during the first public review of this ICR                     interoperability across the care
                                                  AFerrero@hrsa.gov.                                                         will be provided to OMB. OMB will                              continuum, including for behavioral
                                                    The 5600 Fishers Lane building                                           accept further comments from the                               health care providers; however, there
                                                  requires a security screening on entry.                                    public on this ICR during the review                           are no recent national data available for
                                                  To facilitate your access to the building,                                 and approval period.                                           this care setting. Addressing this gap is
                                                  please contact Ann Ferrero at 301–443–                                     DATES: Comments on the ICR must be                             critical in order to also determine these
                                                  3999. Individuals who plan to attend                                       received on or before May 24, 2017.                            providers’ readiness to serve as partners
                                                  and need special assistance, such as                                                                                                      in delivery system reform efforts that are
                                                                                                                             ADDRESSES: Submit your comments to
                                                  sign language interpretation or other                                                                                                     underway and that will be expanded
                                                                                                                             OIRA_submission@omb.eop.gov or via
                                                  reasonable accommodations, should                                                                                                         with the implementation of Medicare
                                                                                                                             facsimile to (202) 395–5806.
                                                  notify Ann Ferrero, MCHB, HRSA;                                                                                                           Access and CHIP Reauthorization Act of
                                                  email: AFerrero@hrsa.gov, at least 10                                      FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                                            2015 (MACRA). Although behavioral
                                                  days prior to the meeting.                                                 Information Collection Clearance staff,                        health care providers won’t be
                                                                                                                             Information.CollectionClearance@                               participating in the MACRA initiative at
                                                  Jason E. Bennett,                                                          hhs.gov or (202) 795–7714.                                     the outset, the Secretary of Health and
                                                  Director, Division of the Executive Secretariat.                           SUPPLEMENTARY INFORMATION: When                                Human Services may include behavioral
                                                  [FR Doc. 2017–08220 Filed 4–21–17; 8:45 am]                                submitting comments or requesting                              health providers, such as psychologists
                                                  BILLING CODE 4165–15–P                                                     information, please include the                                and social workers to participate in
                                                                                                                             Information Collection Request Title                           value-based payment initiatives such as
                                                                                                                             and document identifier 0955–New–                              the Merit-Based Incentive Payment
                                                  DEPARTMENT OF HEALTH AND                                                   30D for reference.                                             System (MIPs) in the future.
                                                  HUMAN SERVICES                                                               Information Collection Request Title:
                                                                                                                                                                                              Need and Proposed Use of the
                                                                                                                             National Council for Behavioral Health’s
                                                  Office of the Secretary                                                                                                                   Information: This data collection effort
                                                                                                                             Information Technology Survey.
                                                                                                                                                                                            will allow for us to assess health IT
                                                  [Document Identifier: 0955–New–30D]                                          Abstract: The Office of the National
                                                                                                                                                                                            adoption and interoperability progress
                                                                                                                             Coordinator for Health IT (ONC) in
                                                  Agency Information Collection                                                                                                             since 2015, enable comparisons to
                                                                                                                             coordination with Substance Abuse and
                                                  Activities; Submission to OMB for                                                                                                         physician and hospital settings and
                                                                                                                             Mental Health Services Administration
                                                  Review and Approval; Public Comment                                                                                                       contribute to strategic efforts to improve
                                                                                                                             (SAMHSA) seeks to conduct a survey in
                                                  Request                                                                                                                                   behavioral healthcare providers’
                                                                                                                             2017 of SAMSHA to examine the
                                                                                                                                                                                            adoption and use of health IT.
                                                  AGENCY:     Office of the Secretary, HHS.                                  adoption and use of health IT as well as
                                                                                                                             interoperability across community                                Likely Respondents: The respondents
                                                  ACTION:     Notice.                                                                                                                       will include mid-level and executive
                                                                                                                             behavioral health care settings. Data
                                                  SUMMARY:   In compliance with section                                      from the survey will help ONC and                              level staff (IT Directors, CIO, and CEOs)
                                                  3507(a)(1)(D) of the Paperwork                                             SAMSHA monitor progress and enhance                            of behavioral healthcare organizations
                                                  Reduction Act of 1995, the Office of the                                   programs and policy to improve the use                         that are involved in the management
                                                  Secretary (OS), Department of Health                                       of health IT and expand interoperability                       and maintenance of their organization’s
                                                  and Human Services, has submitted an                                       across these settings. In 2015, ONC                            health IT infrastructure.
                                                  Information Collection Request (ICR),                                      outlined a strategy by which both                                The total annual burden hours
                                                  described below, to the Office of                                          private and public stakeholders would                          estimated for this ICR are summarized
                                                  Management and Budget (OMB) for                                            work together to improve                                       in the table below.

                                                                                                                   TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                            Number of           Average
                                                                                                                                                                           Number of         responses        burden per     Total burden
                                                                                                  Form name                                                               respondents           per            response         hours
                                                                                                                                                                                            respondent         (in hours)

                                                  National Council for Behavioral Health’s Information Technology Survey ......                                                     533                  1           20/60            178

                                                       Total ..........................................................................................................             533                  1           20/60            178



                                                  Terry S. Clark,                                                            DEPARTMENT OF HEALTH AND                                       SUMMARY:   In compliance with section
                                                  Asst Information Collection Clearance                                      HUMAN SERVICES                                                 3507(a)(1)(D) of the Paperwork
                                                  Officer.                                                                                                                                  Reduction Act of 1995, the Office of the
                                                  [FR Doc. 2017–08188 Filed 4–21–17; 8:45 am]                                Office of the Secretary                                        Secretary (OS), Department of Health
                                                  BILLING CODE 4150–45–P                                                     [Document Identifier: 0990–0452–30D]                           and Human Services, has submitted an
                                                                                                                                                                                            Information Collection Request (ICR),
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                                             Agency Information Collection                                  described below, to the Office of
                                                                                                                             Activities; Submission to OMB for                              Management and Budget (OMB) for
                                                                                                                             Review and Approval; Public Comment                            review and approval. The ICR is for
                                                                                                                             Request                                                        revision of the approved information
                                                                                                                                                                                            collection assigned OMB control
                                                                                                                             AGENCY:       Office of the Secretary, HHS.
                                                                                                                                                                                            number 0990–0452, scheduled to expire
                                                                                                                             ACTION:       Notice.                                          on January 31, 2020. Comments


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Document Created: 2017-04-22 00:11:10
Document Modified: 2017-04-22 00:11:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of meeting.
DatesThe meeting will be held on May 11, 2017, 9:00 a.m. to 5:00 p.m. and May 12, 2017, 9:00 a.m. to 3:00 p.m.
ContactAnyone requesting information regarding the ACHDNC should contact Ann Ferrero, Maternal and Child Health Bureau (MCHB), HRSA, in one of three ways: (1) Send a request to Ann Ferrero, MCHB, HRSA 5600 Fishers Lane, Room 18N100C, Rockville, Maryland 20857; (2) call 301-443-3999 or (3) send an email to: [email protected] More information on the Advisory Committee is available at the Advisory Committee's Web site, provided above.
FR Citation82 FR 18919 

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