82_FR_48301 82 FR 48103 - Advisory Committee on Heritable Disorders in Newborns and Children

82 FR 48103 - 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 198 (October 16, 2017)

Page Range48103-48104
FR Document2017-22313

In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This meeting will be open to the public but advance registration is required. Please register online at http://www.achdncmeetings.org/ by 12:00 p.m. Eastern Time on November 6, 2017. Information about the ACHDNC can be obtained by accessing the following Web site: https://www.hrsa.gov/ advisorycommittees/mchbadvisory/heritabledisorders/index.html.

Federal Register, Volume 82 Issue 198 (Monday, October 16, 2017)
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48103-48104]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Advisory Committee on Heritable Disorders in Newborns and 
Children

AGENCY: Health Resources and Service 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 that a meeting is scheduled for the Advisory Committee 
on Heritable Disorders in Newborns and Children (ACHDNC). This meeting 
will be open to the public but advance registration is required. Please 
register online at http://www.achdncmeetings.org/ by 12:00 p.m. Eastern 
Time on November 6, 2017. Information about the ACHDNC can be obtained 
by accessing the following Web site: https://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/index.html.

DATES: The meeting will be held on Wednesday, November 8, 2017, 9:30 
a.m. to 5:00 p.m. Eastern Time and Thursday, November 9, 2017, 9:30 
a.m. to 3:00 p.m. Eastern Time (meeting times are tentative).

ADDRESSES: This meeting will be held in-person at 5600 Fishers Lane, 
5th Floor Pavilion, Rockville, MD 20857. The meeting will also be 
accessible via Webcast. Instructions on how to access the meeting via 
Webcast will be provided upon registration. Please note, the 5600 
Fishers Lane building requires security screening on entry. Visitors 
must provide a driver's license, passport, or other form of government-
issued photo identification to be granted entry into the facility. Non-
US Citizens planning to attend in person will need

[[Page 48104]]

to provide additional information to HRSA by October 24, 2017, 12:00 
p.m. Eastern Time. Please see contact information below.

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 
the following address: Ann Ferrero, MCHB, HRSA 5600 Fishers Lane, Room 
18N100C, Rockville, MD 20857; (2) call 301-443-3999; or (3) send an 
email to: [email protected].

SUPPLEMENTARY INFORMATION: The ACHDNC 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 preventive 
health guidelines supported by HRSA for infants and children under 
section 2713 of the Public Health Service Act, codified at 42 U.S.C. 
300gg-13. Under this provision, non-grandfathered health plans 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 agenda will include: (1) An update on states' progress 
toward the newborn screening timeliness goals outlined by the 
Committee; (2) a presentation on phase 2 of the spinal muscular atrophy 
evidence review; (3) presentations on newborn screening topics such as 
the clinical and public health impact of Severe Combined 
Immunodeficiency (SCID), carrier status in the context of newborn 
screening, and a review of long term follow up in newborn screening; 
and (4) 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. Agenda items are subject to change. The final 
meeting agenda will be available 2 days prior to the meeting on the 
Committee's Web site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Members of the public will have the opportunity to provide 
comments. All comments are part of the official Committee record. To 
submit written comments or request time for an oral comment at the 
meeting, please register online by 11:59 p.m. Eastern Time on November 
2, 2017, at http://www.achdncmeetings.org/. To ensure all individuals 
who have registered and requested time for oral comments are 
accommodated, the allocated time for comments may be limited. 
Individuals associated with groups or who plan to provide comments on 
similar topics may be asked to combine their comments and present them 
through a single representative. No audiovisual presentations are 
permitted. 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 plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify Ann Ferrero using the address and phone number above at least 10 
days prior to the meeting.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-22313 Filed 10-13-17; 8:45 am]
 BILLING CODE 4165-15-P



                                                                            Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices                                                48103

                                               In addition to the partnerships above,                  Bonus System in a fiscal year. HRSA                   structures to recognize the quality of
                                               HRSA is seeking comment on state or                     would also seek to recognize the                      hospitals’ programs considering the
                                               regional initiatives to consider when                   hospital’s level of engagement or                     different circumstances in which
                                               establishing the qualifying standards for               performance in the bonus amount.                      different children’s hospitals operate
                                               the CHGME Quality Bonus System, as                      HRSA is also interested in gathering                  (e.g., patient severity, size of training
                                               well as suggestions for how to                          views and suggestions on whether any                  programs, number of specialties trained,
                                               distinguish between levels of                           of the existing information that                      etc.)
                                               engagement and performance in a                         hospitals already report to the Centers of               Frequency of Review: HRSA plans to
                                               meaningful way.                                         Medicare and Medicaid Services, HRSA,                 review and update the CHGME Quality
                                                  Documentation: To receive a quality                  accrediting bodies, and others could be               Bonus System standards regularly to
                                               bonus payment based upon engagement                     used to measure the performance of                    reflect changes in GME and advances in
                                               in state- or regional-level pediatric                   GME programs and related health                       measuring GME outcomes.
                                               health care transformation, CHGME                       outcomes for FY 2019 or subsequent                     Dated: October 5, 2017
                                               hospitals would be required to submit a                 years. This could be individual                       George Sigounas,
                                               letter from the lead organization, which                measures or combinations of measures                  Administrator.
                                               could include the project director for a                that are reported to different entities.
                                                                                                                                                             [FR Doc. 2017–22381 Filed 10–13–17; 8:45 am]
                                               HRSA-supported program or the state
                                               Medicaid Director, confirming                           Quality Bonus Payment in FY 2020 and                  BILLING CODE 4165–15–P

                                               participation by the children’s hospital                Beyond—Areas for Public Comment
                                               in the program and delineating the roles                   In future years, HRSA will refine the
                                                                                                       CHGME Quality Bonus System to reflect                 DEPARTMENT OF HEALTH AND
                                               and responsibilities of the children’s
                                                                                                       the feedback received from                            HUMAN SERVICES
                                               hospital in the program activities. In
                                               addition, CHGME hospitals would be                      stakeholders, as well as advancements                 Health Resources and Service
                                               required to submit a brief narrative                    in the development of standardized                    Administration
                                               statement describing how CHGME                          GME quality measures. To that end,
                                               trainees are integrated into state- or                  HRSA also is requesting comments on                   Advisory Committee on Heritable
                                               regional-level pediatric health care                    several areas of the Quality Bonus                    Disorders in Newborns and Children
                                               transformation activities and the                       System that will be implemented in FY
                                               expected benefits for trainees and the                  2020 and beyond. For long-term                        AGENCY: Health Resources and Service
                                               health systems served by the children’s                 implementation, HRSA seeks public                     Administration (HRSA), Department of
                                               hospital. HRSA is seeking comment on                    comments on the following areas:                      Health and Human Services (HHS).
                                               this proposed approach including                           CHGME Hospital Eligibility: HRSA                   ACTION: Notice of meeting.
                                               opportunities to limit burden and                       proposes to include all eligible CHGME
                                                                                                       hospitals, including those newly                      SUMMARY:   In accordance with the
                                               streamline the documentation to                                                                               Federal Advisory Committee Act, notice
                                               determine whether applicants meet                       qualified, as eligible entities for the
                                                                                                       CHGME Quality Bonus System.                           is hereby given that a meeting is
                                               standards and distinguish among levels                                                                        scheduled for the Advisory Committee
                                               of engagement and performance.                             Quality Bonus System Measures:
                                                                                                       HRSA is seeking comment on                            on Heritable Disorders in Newborns and
                                                  Payment Structure: HRSA proposes
                                                                                                       appropriate GME outcome measures                      Children (ACHDNC). This meeting will
                                               that CHGME hospitals that meet the
                                                                                                       that can assess and distinguish                       be open to the public but advance
                                               standards receive a portion of the                                                                            registration is required. Please register
                                               available funds for the CHGME Quality                   performance in meaningful ways. HRSA
                                                                                                       is considering several GME outcome                    online at http://
                                               Bonus System. HRSA proposes a three                                                                           www.achdncmeetings.org/ by 12:00 p.m.
                                               tiered payment structure to recognize                   measures including resident specialty
                                                                                                       outcomes (e.g., number of graduates in                Eastern Time on November 6, 2017.
                                               the different annual payment levels                                                                           Information about the ACHDNC can be
                                               received by CHGME hospitals. Hospitals                  high need pediatric specialties), resident
                                                                                                       service outcomes (e.g., service to high               obtained by accessing the following
                                               that meet the Quality Bonus Systems                                                                           Web site: https://www.hrsa.gov/
                                               standards will be evenly divided into                   need rural or underserved
                                                                                                       communities), and children’s hospital                 advisorycommittees/mchbadvisory/
                                               three tiers based on their combined                                                                           heritabledisorders/index.html.
                                               direct and indirect fiscal year payment                 quality outcomes. As noted above, these
                                                                                                       measures could be existing measures                   DATES: The meeting will be held on
                                               amounts, as calculated per the
                                               established CHGME program formulas:                     that hospitals already report or new                  Wednesday, November 8, 2017, 9:30
                                                  Tier 1: Hospitals that qualify for the               ones that would be developed or                       a.m. to 5:00 p.m. Eastern Time and
                                               quality bonus payment that are in the                   improved for use in determining quality               Thursday, November 9, 2017, 9:30 a.m.
                                               lowest third among hospitals that                       bonuses.                                              to 3:00 p.m. Eastern Time (meeting
                                               qualify for the quality bonus payment of                   Data Sources: HRSA is seeking                      times are tentative).
                                               calculated CHGME annual payments                        comment on available data sources on                  ADDRESSES: This meeting will be held
                                               will receive a base payment.                            which to base the Quality Bonus                       in-person at 5600 Fishers Lane, 5th
                                                  Tier 2: Hospitals that qualify for the               System. HRSA is requesting comment                    Floor Pavilion, Rockville, MD 20857.
                                               quality bonus payment that are in the                   on data sources that are publicly                     The meeting will also be accessible via
                                               middle third will receive two times the                 available, will streamline reporting                  Webcast. Instructions on how to access
                                               base payment.                                           requirements, and will limit burden on                the meeting via Webcast will be
                                                  Tier 3: Hospitals that qualify for the               CHGME programs.                                       provided upon registration. Please note,
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                                               quality bonus payment that are in the                      Tiering of Quality Bonus Payments:                 the 5600 Fishers Lane building requires
                                               highest third will receive three times the              HRSA is requesting comments on                        security screening on entry. Visitors
                                               base payment.                                           payment structures to recognize                       must provide a driver’s license,
                                                  The base payment rate would be                       hospitals according to their level of                 passport, or other form of government-
                                               determined from the total amount                        engagement and/or outcomes while also                 issued photo identification to be granted
                                               available and the number of hospitals                   taking into account the different size of             entry into the facility. Non-US Citizens
                                               that qualify for the CHGME Quality                      GME programs. The goal is for payment                 planning to attend in person will need


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                                               48104                        Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices

                                               to provide additional information to                    on the Committee’s Web site: http://                  would constitute a clearly unwarranted
                                               HRSA by October 24, 2017, 12:00 p.m.                    www.hrsa.gov/advisorycommittees/                      invasion of personal privacy.
                                               Eastern Time. Please see contact                        mchbadvisory/heritabledisorders.                        Name of Committee: National Institute of
                                               information below.                                         Members of the public will have the                Allergy and Infectious Diseases Special
                                               FOR FURTHER INFORMATION CONTACT:                        opportunity to provide comments. All                  Emphasis Panel; NIAID Clinical Trial
                                               Anyone requesting information                           comments are part of the official                     Planning Grant (R34) and Implementation
                                               regarding the ACHDNC should contact                     Committee record. To submit written                   Cooperative Agreement (U01).
                                               Ann Ferrero, Maternal and Child Health                  comments or request time for an oral                    Date: November 6–9, 2017.
                                                                                                                                                               Time: 9:00 a.m. to 5:30 p.m.
                                               Bureau (MCHB), HRSA, in one of three                    comment at the meeting, please register
                                                                                                                                                               Agenda: To review and evaluate grant
                                               ways: (1) Send a request to the following               online by 11:59 p.m. Eastern Time on                  applications.
                                               address: Ann Ferrero, MCHB, HRSA                        November 2, 2017, at http://                            Place: National Institutes of Health, 5601
                                               5600 Fishers Lane, Room 18N100C,                        www.achdncmeetings.org/. To ensure                    Fishers Lane, Rockville, MD 20892,
                                               Rockville, MD 20857; (2) call 301–443–                  all individuals who have registered and               (Telephone Conference Call).
                                               3999; or (3) send an email to: AFerrero@                requested time for oral comments are                    Contact Person: Geetanjali Bansal, Ph.D.,
                                               hrsa.gov.                                               accommodated, the allocated time for                  Scientific Review Officer, Scientific Review
                                               SUPPLEMENTARY INFORMATION: The                          comments may be limited. Individuals                  Program, Division of Extramural Activities,
                                                                                                       associated with groups or who plan to                 Room 3G49, National Institutes of Health/
                                               ACHDNC provides advice to the                                                                                 NIAID, 5601 Fishers Lane, MSC 9834,
                                               Secretary of HHS on the development of                  provide comments on similar topics
                                                                                                                                                             Bethesda, MD 20892–9834, (240) 669–5073,
                                               newborn screening activities,                           may be asked to combine their                         geetanjali.bansal@nih.gov.
                                               technologies, policies, guidelines, and                 comments and present them through a
                                                                                                                                                             (Catalogue of Federal Domestic Assistance
                                               programs for effectively reducing                       single representative. No audiovisual                 Program Nos. 93.855, Allergy, Immunology,
                                               morbidity and mortality in newborns                     presentations are permitted. Written                  and Transplantation Research; 93.856,
                                               and children having, or at risk for,                    comments should identify the                          Microbiology and Infectious Diseases
                                               heritable disorders. In addition,                       individual’s name, address, email,                    Research, National Institutes of Health, HHS)
                                               ACHDNC’s recommendations regarding                      telephone number, professional or                       Dated: October 10, 2017.
                                               inclusion of additional conditions and                  organization affiliation, background or
                                                                                                                                                             Natasha M. Copeland,
                                               inherited disorders for screening which                 area of expertise (i.e., parent, family
                                                                                                                                                             Program Analyst, Office of Federal Advisory
                                               have been adopted by the Secretary are                  member, researcher, clinician, public
                                                                                                                                                             Committee Policy.
                                               then included in the Recommended                        health, etc.) and the topic/subject
                                                                                                                                                             [FR Doc. 2017–22259 Filed 10–13–17; 8:45 am]
                                               Uniform Screening Panel (RUSP).                         matter.
                                                                                                                                                             BILLING CODE 4140–01–P
                                               Conditions listed on the RUSP                              Individuals who plan to attend and
                                               constitute part of the comprehensive                    need special assistance, such as sign
                                               preventive health guidelines supported                  language interpretation or other                      DEPARTMENT OF HEALTH AND
                                               by HRSA for infants and children under                  reasonable accommodations, should                     HUMAN SERVICES
                                               section 2713 of the Public Health                       notify Ann Ferrero using the address
                                               Service Act, codified at 42 U.S.C.                      and phone number above at least 10                    National Institutes of Health
                                               300gg–13. Under this provision, non-                    days prior to the meeting.
                                               grandfathered health plans are required                                                                       National Cancer Institute; Notice of
                                                                                                       Amy McNulty,
                                               to cover screenings included in the                                                                           Closed Meeting
                                                                                                       Acting Director, Division of the Executive
                                               HRSA-supported comprehensive
                                                                                                       Secretariat.                                            Pursuant to section 10(d) of the
                                               guidelines without charging a co-
                                               payment, co-insurance, or deductible for                [FR Doc. 2017–22313 Filed 10–13–17; 8:45 am]          Federal Advisory Committee Act, as
                                               plan years (i.e., policy years) beginning               BILLING CODE 4165–15–P                                amended, notice is hereby given of the
                                               on or after the date that is one year from                                                                    following meeting.
                                               the Secretary’s adoption of the                                                                                 The meeting will be closed to the
                                                                                                       DEPARTMENT OF HEALTH AND                              public in accordance with the
                                               condition for screening.
                                                  The meeting agenda will include: (1)                 HUMAN SERVICES                                        provisions set forth in sections
                                               An update on states’ progress toward                                                                          552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                       National Institutes of Health                         as amended. The grant applications and
                                               the newborn screening timeliness goals
                                               outlined by the Committee; (2) a                        National Institute of Allergy and                     the discussions could disclose
                                               presentation on phase 2 of the spinal                   Infectious Diseases; Notice of Closed                 confidential trade secrets or commercial
                                               muscular atrophy evidence review; (3)                   Meeting                                               property such as patentable material,
                                               presentations on newborn screening                                                                            and personal information concerning
                                               topics such as the clinical and public                    Pursuant to section 10(d) of the                    individuals associated with the grant
                                               health impact of Severe Combined                        Federal Advisory Committee Act, as                    applications, the disclosure of which
                                               Immunodeficiency (SCID), carrier status                 amended, notice is hereby given of the                would constitute a clearly unwarranted
                                               in the context of newborn screening,                    following meeting.                                    invasion of personal privacy.
                                               and a review of long term follow up in                    The meeting will be closed to the                     Name of Committee: National Cancer
                                               newborn screening; and (4) updates                      public in accordance with the                         Institute Special Emphasis Panel;
                                               from the Laboratory Standards and                       provisions set forth in sections                      Translational Studies on Adducts For Cancer
                                               Procedures workgroup, Follow-up and                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            Risk Identification and Prevention.
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                                               Treatment workgroup, and Education                      as amended. The grant applications and                  Date: November 8, 2017.
                                               and Training workgroup. The                             the discussions could disclose                          Time: 1:00 p.m. to 2:00 p.m.
                                                                                                                                                               Agenda: To review and evaluate grant
                                               Committee will not be voting on a                       confidential trade secrets or commercial              applications.
                                               proposed addition of a condition to the                 property such as patentable material,                   Place: National Cancer Institute, Shady
                                               RUSP. Agenda items are subject to                       and personal information concerning                   Grove, 9609 Medical Center Drive, Room
                                               change. The final meeting agenda will                   individuals associated with the grant                 7W108, Rockville, MD 20850, (Telephone
                                               be available 2 days prior to the meeting                applications, the disclosure of which                 Conference Call).



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Document Created: 2017-10-14 01:42:37
Document Modified: 2017-10-14 01:42:37
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 Wednesday, November 8, 2017, 9:30 a.m. to 5:00 p.m. Eastern Time and Thursday, November 9, 2017, 9:30 a.m. to 3:00 p.m. Eastern Time (meeting times are tentative).
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
FR Citation82 FR 48103 

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