83 FR 3002 - Advisory Committee on Heritable Disorders in Newborns and Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration

Federal Register Volume 83, Issue 14 (January 22, 2018)

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) will hold a public meeting.

[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Notices]
[Pages 3002-3003]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00978]


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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.

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SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Advisory Committee on Heritable Disorders in 
Newborns and Children (ACHDNC) will hold a public meeting.

DATES: Thursday, February 8, 2018, from 9:30 a.m. to 5:00 p.m. and 
Friday, February 9, 2018, from 9:30 a.m. to 3:00 p.m. ET (meeting times 
are tentative).

ADDRESSES: The address for the meeting is 5600 Fishers Lane, 5th Floor 
Pavilion, Rockville, MD 20857. Participants may also access the meeting 
through Webcast. Advanced registration is required. Please register 
online at http://www.achdncmeetings.org/ by 12:00 p.m. ET on February 
5, 2018. Instructions on how to access the meeting via Webcast will be 
provided upon registration.
    Please note that 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 or they cannot 
enter the facility. Non-US Citizens planning to attend in person will 
need to provide additional information to HRSA by January 24, 2018, 
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. Information about the ACHDNC is available on 
the following website: https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.
    The meeting agenda will include a final evidence-based review 
report on the spinal muscular atrophy (SMA) condition nomination for 
possible inclusion on the RUSP. Following this report, the ACHDNC 
expects to vote on whether to recommend to the Secretary adding SMA to 
the RUSP. ACHDNC members will also hear presentations on states' 
activities to achieve newborn screening timeliness goals. An overview 
of cutoff determinations and risk assessment methods used for dried 
bloodspot newborn screening will also be given. The Committee expects 
to vote on whether to support a guidance document on cutoff 
determinations and risk assessment methods. Finally, the ACHDNC members 
will hear updates from the Laboratory Standards and Procedures 
workgroup; the Follow-up and Treatment workgroup, including a 
presentation of the final draft of a report on Quality Measures in 
Newborn Screening; and the Education and Training workgroup, including 
a presentation of the final draft of a

[[Page 3003]]

Communication Guide for relaying Newborn Screening results.
    HRSA will post the agenda two days prior to the meeting on the 
Committee's website: https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html. Please note that agenda items are 
subject to changes as priorities dictate.
    Members of the public will have the opportunity to provide comments 
and may submit written comments in advance of the meeting. 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 12:00 p.m. ET on January 31, 2018, at http://www.achdncmeetings.org/. To accommodate all individuals who have 
registered and requested time for oral comments, the allocated time for 
comments may be limited. The ACHDNC may ask individuals associated with 
groups, or individuals who plan to provide comments on similar topics, 
to combine their comments and present them through a single 
representative. Audiovisual presentations are not 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. 2018-00978 Filed 1-19-18; 8:45 am]
 BILLING CODE 4165-15-P