83 FR 18573 - Advisory Committee on Heritable Disorders in Newborns and Children
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 82 (April 27, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 82 (April 27, 2018)
| Page Range | 18573-18573 | |
| FR Document | 2018-08853 |
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)] [Notices] [Page 18573] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08853] ----------------------------------------------------------------------- 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, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) will hold a public meeting. DATES: Wednesday, May 9, 2018, from 9:30 a.m. to 5:00 p.m. Eastern Time (ET) and Thursday, May 10, 2018, from 9:30 a.m. to 1:00 p.m. ET. ADDRESSES: The public may attend this meeting in person or via Webcast. While this meeting will be open to the public, advance registration is required. Please register online at http://www.achdncmeetings.org/ by 12:00 p.m. ET on May 7, 2018. The address for the meeting is 5600 Fishers Lane, Rockville, MD 20857. Non-U.S. citizens planning to attend in person will need to provide additional information to HRSA by Monday, April 30, 2018, 12 p.m. ET. To facilitate access to the building, please contact Ann Ferrero at the contact information listed below. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Ms. Ferrero at least 10 days prior to the meeting. The meeting will also be accessible via Webcast. Instructions on how to access the meeting via Webcast will be provided upon registration. 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: Background: The ACHDNC provides advice and recommendations 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 are included in the Recommended Uniform Screening Panel (RUSP) following adoption by the Secretary. 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 (42 U.S.C. 300gg-13). Under this provision, non-grandfathered health plans and health insurance issuers are required to provide insurance coverage without cost-sharing (a co- payment, co-insurance, or deductible) for screenings included in the HRSA-supported comprehensive guidelines 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. Agenda: The meeting agenda will include: (1) Presentations and discussion on risk assessment in newborn screening; (2) presentation of educational tools for communicating newborn screening results; (3) presentations from states working toward timeliness goals in newborn screening; (4) an update on the status of newborn screening pilot studies for Guanidinoacetate Methyltransferase (GAMT) deficiency; (5) updates from the Laboratory Standards and Procedures workgroup; (6) updates from the Follow-up and Treatment workgroup; (7) updates from the Education and Training workgroup; and (8) reviewing the process for assessing the public health impact of adding conditions to the RUSP. There are no votes scheduled for this meeting. The final meeting agenda will be available two (2) days prior to the meeting on the Committee's website at https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html. Please note that agenda items and meeting times are subject to change as priorities dictate. Public Participation: Members of the public will have the opportunity to provide comments, which 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 May 3, 2018, at http://www.achdncmeetings.org/. Oral comments will be honored in the order they are requested and may be limited as time allows. 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. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018-08853 Filed 4-26-18; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices 18573
highlighting further the and Thursday, May 10, 2018, from 9:30 the date that is one year from the
interrelationship between a clinical a.m. to 1:00 p.m. ET. Secretary’s adoption of the condition for
protocol and an imaging charter. ADDRESSES: The public may attend this screening.
This guidance is being issued meeting in person or via Webcast. While Agenda: The meeting agenda will
consistent with FDA’s good guidance this meeting will be open to the public, include: (1) Presentations and
practices regulation (21 CFR 10.115). advance registration is required. Please discussion on risk assessment in
The guidance represents the current register online at http://www.achdnc
thinking of FDA on clinical trial newborn screening; (2) presentation of
meetings.org/ by 12:00 p.m. ET on May educational tools for communicating
imaging endpoint process standards. It 7, 2018.
does not establish any rights for any newborn screening results; (3)
The address for the meeting is 5600
person and is not binding on FDA or the Fishers Lane, Rockville, MD 20857. presentations from states working
public. You can use an alternative Non-U.S. citizens planning to attend in toward timeliness goals in newborn
approach if it satisfies the requirements person will need to provide additional screening; (4) an update on the status of
of the applicable statutes and information to HRSA by Monday, April newborn screening pilot studies for
regulations. This guidance is not subject 30, 2018, 12 p.m. ET. To facilitate access Guanidinoacetate Methyltransferase
to Executive Order 12866. to the building, please contact Ann (GAMT) deficiency; (5) updates from the
Ferrero at the contact information listed Laboratory Standards and Procedures
II. The Paperwork Reduction Act of
below. Individuals who plan to attend workgroup; (6) updates from the Follow-
1995
and need special assistance, such as up and Treatment workgroup; (7)
This guidance refers to previously sign language interpretation or other updates from the Education and
approved collections of information that reasonable accommodations, should Training workgroup; and (8) reviewing
are subject to review by the Office of notify Ms. Ferrero at least 10 days prior the process for assessing the public
Management and Budget (OMB) under to the meeting. health impact of adding conditions to
the Paperwork Reduction Act of 1995 The meeting will also be accessible the RUSP.
(44 U.S.C. 3501–3520). The collections via Webcast. Instructions on how to
of information in 21 CFR parts 312 and There are no votes scheduled for this
access the meeting via Webcast will be
314 have been approved under OMB meeting. The final meeting agenda will
provided upon registration.
control numbers 0910–0014 and 0910– be available two (2) days prior to the
FOR FURTHER INFORMATION CONTACT:
0001, respectively. meeting on the Committee’s website at
Anyone requesting information
https://www.hrsa.gov/advisory-
III. Electronic Access regarding the ACHDNC should contact
Ann Ferrero, Maternal and Child Health committees/heritable-disorders/
Persons with access to the internet index.html. Please note that agenda
Bureau (MCHB), HRSA, in one of three
may obtain the guidance at https:// items and meeting times are subject to
ways: (1) Send a request to the following
www.fda.gov/Drugs/ change as priorities dictate.
address: Ann Ferrero, MCHB, HRSA
GuidanceComplianceRegulatory
5600 Fishers Lane, Room 18N100C, Public Participation: Members of the
Information/Guidances/default.htm,
Rockville, MD 20857; (2) call 301–443– public will have the opportunity to
https://www.fda.gov/BiologicsBlood
3999; or (3) send an email to AFerrero@ provide comments, which are part of the
Vaccines/GuidanceCompliance
hrsa.gov. official Committee record. To submit
RegulatoryInformation/default.htm, or
https://www.regulations.gov. SUPPLEMENTARY INFORMATION: written comments or request time for an
Background: The ACHDNC provides oral comment at the meeting, please
Dated: April 24, 2018. advice and recommendations to the register online by 12:00 p.m. ET on May
Leslie Kux, Secretary of HHS on the development of 3, 2018, at http://www.achdnc
Associate Commissioner for Policy. newborn screening activities, meetings.org/. Oral comments will be
[FR Doc. 2018–08903 Filed 4–26–18; 8:45 am] technologies, policies, guidelines, and honored in the order they are requested
BILLING CODE 4164–01–P programs for effectively reducing and may be limited as time allows.
morbidity and mortality in newborns Individuals associated with groups or
and children having, or at risk for, who plan to provide comments on
DEPARTMENT OF HEALTH AND heritable disorders. In addition,
similar topics may be asked to combine
HUMAN SERVICES ACHDNC’s recommendations regarding
their comments and present them
inclusion of additional conditions and
Health Resources and Services through a single representative. No
inherited disorders for screening are
Administration included in the Recommended Uniform audiovisual presentations are permitted.
Screening Panel (RUSP) following Written comments should identify the
Advisory Committee on Heritable individual’s name, address, email,
adoption by the Secretary. Conditions
Disorders in Newborns and Children telephone number, professional or
listed on the RUSP constitute part of the
AGENCY: Health Resources and Services comprehensive preventive health organization affiliation, background or
Administration (HRSA), Department of guidelines supported by HRSA for area of expertise (i.e., parent, family
Health and Human Services (HHS). infants and children under section 2713 member, researcher, clinician, public
ACTION: Notice of Meeting. of the Public Health Service Act (42 health, etc.) and the topic/subject
U.S.C. 300gg–13). Under this provision, matter.
SUMMARY: In accordance with the non-grandfathered health plans and
daltland on DSKBBV9HB2PROD with NOTICES
Federal Advisory Committee Act, this Amy P. McNulty,
health insurance issuers are required to
notice announces that the Advisory provide insurance coverage without Acting Director, Division of the Executive
Committee on Heritable Disorders in Secretariat.
cost-sharing (a co-payment, co-
Newborns and Children (ACHDNC) will insurance, or deductible) for screenings [FR Doc. 2018–08853 Filed 4–26–18; 8:45 am]
hold a public meeting. included in the HRSA-supported BILLING CODE 4165–15–P
DATES: Wednesday, May 9, 2018, from comprehensive guidelines for plan years
9:30 a.m. to 5:00 p.m. Eastern Time (ET) (i.e., policy years) beginning on or after
VerDate Sep<11>2014 18:18 Apr 26, 2018 Jkt 244001 PO 00000 Frm 00073 Fmt 4703 Sfmt 9990 E:\FR\FM\27APN1.SGM 27APN1](https://thefederalregister.org/doc/83_FR_18655/page/1.svg)
Document Created: 2018-04-27 01:45:08
Document Modified: 2018-04-27 01:45:08
| 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 of Meeting. | |
| Dates | Wednesday, May 9, 2018, from 9:30 a.m. to 5:00 p.m. Eastern Time (ET) and Thursday, May 10, 2018, from 9:30 a.m. to 1:00 p.m. ET. | |
| 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 | |
| FR Citation | 83 FR 18573 |
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