83 FR 32312 - 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 134 (July 12, 2018)

Page Range		32312-32313
FR Document		2018-14908

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 Issue 134 (Thursday, July 12, 2018)

[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32312-32313]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14908]

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

DATES: Thursday, August 2, 2018, from 9:30 a.m. to 5:00 p.m. Eastern
Time (ET).

ADDRESSES: This meeting is a webinar only and requires advanced
registration. Please register online at http://www.achdncmeetings.org/
by 12:00 p.m. ET on July 30, 2018.

FOR FURTHER INFORMATION 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 AFerrero@hrsa.gov.

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 for screening, following
adoption by the Secretary, are evidence-informed preventive health
services provided for in the comprehensive guidelines supported by HRSA
through the Recommended Uniform Screening Panel (RUSP) pursuant to
section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13).
Under this provision, non-grandfathered group health plans and health
insurance issuers offering group or individual health insurance are
required to provide insurance coverage without cost-sharing (a co-
payment, co-insurance, or deductible) for preventive services 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: During the August 2, 2018, meeting, the ACHDNC will discuss
issues related to long-term follow-up, timeliness, education and
training, the evidence-based review process, and risk assessment in
newborn screening. Information about the ACHDNC, a roster of members,
and the meeting agenda, as well as past meeting summaries, is located
on the ACHDNC website: https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.
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
July 27, 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

[[Page 32313]]

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. 2018-14908 Filed 7-11-18; 8:45 am]
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32312 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

the SUPPLEMENTARY INFORMATION section for any person and is not binding on FOR FURTHER INFORMATION CONTACT: Ann
for electronic access to the draft FDA or the public. You can use an Ferrero, Maternal and Child Health
guidance document. alternative approach if it satisfies the Bureau (MCHB), HRSA, in one of three
FOR FURTHER INFORMATION CONTACT: requirements of the applicable statutes ways: (1) Send a request to the following
Jonathan McKnight, Center for Biologics and regulations. This guidance is not address: Ann Ferrero, MCHB, HRSA
Evaluation and Research, Food and subject to Executive Order 12866. 5600 Fishers Lane, Room 18N100C,
Drug Administration, 10903 New II. Paperwork Reduction Act of 1995 Rockville, MD 20857; (2) call 301–443–
Hampshire Ave., Bldg. 71, Rm. 7301, 3999; or (3) send an email to AFerrero@
Silver Spring, MD 20993–0002, 240– This draft guidance refers to hrsa.gov.
402–7911. previously approved collections of
SUPPLEMENTARY INFORMATION:
information found in FDA regulations.
SUPPLEMENTARY INFORMATION: Background: The ACHDNC provides
These collections of information are
advice and recommendations to the
I. Background subject to review by the Office of
Secretary of HHS on the development of
Management and Budget (OMB) under
FDA is announcing the availability of newborn screening activities,
the Paperwork Reduction Act of 1995
a draft document entitled ‘‘Long Term technologies, policies, guidelines, and
(44 U.S.C. 3501–3520). The collections
Follow-Up After Administration of programs for effectively reducing
of information in 21 CFR parts 50 and
Human Gene Therapy Products; Draft morbidity and mortality in newborns
56 have been approved under OMB
Guidance for Industry.’’ The draft and children having, or at risk for,
control number 0910–0755; the
guidance provides a brief introduction heritable disorders. In addition,
collections of information in 21 CFR
of the product characteristics, patient- ACHDNC’s recommendations regarding
part 58 have been approved under OMB
related factors, and the preclinical and inclusion of additional conditions for
control number 0910–0119; and the
clinical data that should be considered screening, following adoption by the
collections of information in 21 CFR
when assessing the need for LTFU Secretary, are evidence-informed
part 312 have been approved under
observations for your GT product. The preventive health services provided for
OMB control number 0910–0014.
draft guidance also describes the in the comprehensive guidelines
Agency’s current recommendations for III. Electronic Access supported by HRSA through the
the conduct of LTFU studies, Persons with access to the internet Recommended Uniform Screening Panel
specifically the information/data to may obtain the draft guidance at either (RUSP) pursuant to section 2713 of the
support a sponsor’s rationale for the https://www.fda.gov/BiologicsBlood Public Health Service Act (42 U.S.C.
duration and design of a LTFU protocol Vaccines/GuidanceCompliance 300gg–13). Under this provision, non-
when clinical trials are initiated. Also RegulatoryInformation/Guidances/ grandfathered group health plans and
included in the draft guidance are GT default.htm or https:// health insurance issuers offering group
product-specific clinical considerations www.regulations.gov. or individual health insurance are
for monitoring subjects under a LTFU required to provide insurance coverage
Dated: July 5, 2018.
protocol and recommendations on without cost-sharing (a co-payment, co-
patient monitoring for licensed GT Leslie Kux, insurance, or deductible) for preventive
products. The draft guidance, when Associate Commissioner for Policy. services for plan years (i.e., policy years)
finalized, is intended to supersede the [FR Doc. 2018–14867 Filed 7–11–18; 8:45 am] beginning on or after the date that is one
guidance entitled ‘‘Guidance for BILLING CODE 4164–01–P year from the Secretary’s adoption of the
Industry: Gene Therapy Clinical condition for screening.
Trials—Observing Participants for Agenda: During the August 2, 2018,
Delayed Adverse Events’’ dated DEPARTMENT OF HEALTH AND meeting, the ACHDNC will discuss
November 2006. The draft guidance, HUMAN SERVICES issues related to long-term follow-up,
when finalized, is also intended to timeliness, education and training, the
Health Resources and Services
supplement the guidance entitled evidence-based review process, and risk
Administration
‘‘Testing of Retroviral Vector-Based assessment in newborn screening.
Human Gene Therapy Products for Advisory Committee on Heritable Information about the ACHDNC, a roster
Replication Competent Retrovirus Disorders in Newborns and Children of members, and the meeting agenda, as
during Product Manufacture and Patient well as past meeting summaries, is
Follow-up; Draft Guidance for AGENCY: Health Resources and Services located on the ACHDNC website:
Industry,’’ published elsewhere in this Administration (HRSA), Department of https://www.hrsa.gov/advisory-
issue of the Federal Register. Also, Health and Human Services (HHS). committees/heritable-disorders/
elsewhere in this issue of the Federal ACTION: Notice of meeting. index.html.
Register, FDA is announcing the Public Participation: Members of the
SUMMARY: In accordance with the public will have the opportunity to
availability of another draft guidance
Federal Advisory Committee Act, this provide comments, which are part of the
entitled ‘‘Chemistry, Manufacturing,
notice announces that the Advisory official Committee record. To submit
and Control Information for Human
Committee on Heritable Disorders in written comments or request time
Gene Therapy Investigational New Drug
Newborns and Children (ACHDNC) will for an oral comment at the meeting,
Applications; Draft Guidance for
hold a public meeting. please register online by 12:00 p.m. ET
Industry.’’
This draft guidance is being issued DATES: Thursday, August 2, 2018, from on July 27, 2018, at http://
amozie on DSK3GDR082PROD with NOTICES1

consistent with FDA’s good guidance 9:30 a.m. to 5:00 p.m. Eastern Time www.achdncmeetings.org. Oral
practices regulation (21 CFR 10.115). (ET). comments will be honored in the order
The draft guidance, when finalized, will ADDRESSES: This meeting is a webinar they are requested and may be limited
represent the current thinking of FDA only and requires advanced registration. as time allows. Individuals associated
on long term follow-up after Please register online at http:// with groups or who plan to provide
administration of human gene therapy www.achdncmeetings.org/ by 12:00 p.m. comments on similar topics may be
products. It does not establish any rights ET on July 30, 2018. asked to combine their comments and

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32313

present them through a single Name of Committee: National Center for Boulevard, Bethesda, MD 20892 (Virtual
representative. No audiovisual Advancing Translational Sciences Advisory Meeting).
presentations are permitted. Written Council. Contact Person: Pamela Eugenia Jeter,
Date: September 27, 2018. Ph.D., Scientific Review Officer, Office of
comments should identify the Open: 8:30 a.m. to 3:00 p.m. Scientific Review, Division of Extramural
individual’s name, address, email, Agenda: Report from the Institute Director Activities, NCCIH, NIH, 6707 Democracy
telephone number, professional or and other staff. Boulevard, Suite 401, Bethesda, MD 20892,
organization affiliation, background or Place: National Institutes of Health, 301–435–2591, pamela.jeter@nih.gov.
area of expertise (i.e., parent, family Building 31, Conference Room 6, 31 Center (Catalogue of Federal Domestic Assistance
member, researcher, clinician, public Drive, Bethesda, MD 20892. Program Nos. 93.213, Research and Training
health, etc.) and the topic/subject Closed: 3:15 p.m. to 4:30 p.m.
in Complementary and Integrative Health,
Agenda: To review and evaluate grant
matter. National Institutes of Health, HHS)
applications.
Amy P. McNulty, Place: National Institutes of Health, Dated: July 6, 2018.
Acting Director, Division of the Executive Building 31, Conference Room 6, 31 Center Michelle D. Trout,
Drive, Bethesda, MD 20892.
Secretariat. Program Analyst, Office of Federal Advisory
Contact Person: Anna L. Ramsey-Ewing,
[FR Doc. 2018–14908 Filed 7–11–18; 8:45 am] Committee Policy.
Ph.D., Executive Secretary, National Center
BILLING CODE 4165–15–P for Advancing Translational Sciences, 1 [FR Doc. 2018–14874 Filed 7–11–18; 8:45 am]
Democracy Plaza, Room 1072, Bethesda, MD BILLING CODE 4140–01–P
20892, 301–435–0809, anna.ramseyewing@
DEPARTMENT OF HEALTH AND nih.gov.
HUMAN SERVICES (Catalogue of Federal Domestic Assistance DEPARTMENT OF HOMELAND
Program Nos. 93.859, Pharmacology, SECURITY
National Institutes of Health Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative U.S. Customs and Border Protection
National Center for Advancing Agreements; 93.859, Biomedical Research
Translational Sciences; Notice of and Research Training, National Institutes of
Accreditation and Approval of Saybolt
Meetings Health, HHS)
LP (Nederland, TX) as a Commercial
Dated: July 5, 2018. Gauger and Laboratory
Pursuant to section 10(d) of the David D. Clary,
Federal Advisory Committee Act, as Program Analyst, Office of Federal Advisory AGENCY: U.S. Customs and Border
amended, notice is hereby given of Committee Policy. Protection, Department of Homeland
meetings of the National Center for [FR Doc. 2018–14873 Filed 7–11–18; 8:45 am]
Security.
Advancing Translational Sciences. BILLING CODE 4140–01–P ACTION: Notice of accreditation and
The meetings will be open to the approval of Saybolt LP (Nederland, TX)
public as indicated below, with as a commercial gauger and laboratory.
attendance limited to space available. DEPARTMENT OF HEALTH AND
Individuals who plan to attend and HUMAN SERVICES SUMMARY: Notice is hereby given,
need special assistance, such as sign pursuant to CBP regulations, that
language interpretation or other National Institutes of Health Saybolt LP (Nederland, TX) has been
reasonable accommodations, should approved to gauge petroleum and
notify the Contact Person listed below National Center for Complementary & certain petroleum products and
in advance of the meeting. Integrative Health; Notice of Meeting accredited to test petroleum and certain
petroleum products for customs
The meetings will be closed to the Pursuant to section 10(d) of the
purposes for the next three years as of
public in accordance with the Federal Advisory Committee Act, as
August 8, 2017.
provisions set forth in sections amended (5 U.S.C. App.), notice is
hereby given of the ZAT1 PJ (02) DATES: Saybolt LP (Nederland, TX) was
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
meeting. approved and accredited as a
as amended. The grant applications and
The meeting will be closed to the commercial gauger and laboratory as of
the discussions could disclose
public in accordance with the August 8, 2017. The next triennial
confidential trade secrets or commercial
provisions set forth in sections inspection date will be scheduled for
property such as patentable material,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., August 2020.
and personal information concerning
individuals associated with the grant as amended. The grant applications and FOR FURTHER INFORMATION CONTACT:
applications and/or contract proposals, the discussions could disclose Christopher J. Mocella, Laboratories and
the disclosure of which would confidential trade secrets or commercial Scientific Services Directorate, U.S.
constitute a clearly unwarranted property such as patentable material, Customs and Border Protection, 1300
invasion of personal privacy. and personal information concerning Pennsylvania Avenue NW, Suite 1500N,
individuals associated with the grant Washington, DC 20229, tel. 202–344–
Name of Committee: Cures Acceleration 1060.
Network Review Board.
applications, the disclosure of which
Date: September 27, 2018. would constitute a clearly unwarranted SUPPLEMENTARY INFORMATION: Notice is
Time: 8:30 a.m. to 3:00 p.m. invasion of personal privacy. hereby given pursuant to 19 CFR 151.12
Agenda: Report from the Institute Director. Name of Committee: National Center for and 19 CFR 151.13, that Saybolt LP,
Place: National Institutes of Health, Complementary and Integrative Health 4144 N Twin City Hwy., Nederland, TX
amozie on DSK3GDR082PROD with NOTICES1

Building 31, Conference Room 6, 31 Center Special Emphasis Panel; Mechanisms of 77627, has been approved to gauge
Drive, Bethesda, MD 20892. Mind and Body Interventions (MMB). petroleum and certain petroleum
Contact Person: Anna L. Ramsey-Ewing, Date: August 1, 2018.
Ph.D., Executive Secretary, National Center
products and accredited to test
Time: 11:00 a.m. to 4:00 p.m.
for Advancing Translational Sciences, 1 Agenda: To review and evaluate grant petroleum and certain petroleum
Democracy Plaza, Room 1072, Bethesda, MD applications. products for customs purposes, in
20892, 301–435–0809, annn.ramseyewing@ Place: National Institutes of Health, Two accordance with the provisions of 19
nih.gov. Democracy Plaza, 6707 Democracy CFR 151.12 and 19 CFR 151.13. Saybolt

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Document Created: 2018-11-06 10:22:32
Document Modified: 2018-11-06 10:22:32

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		Thursday, August 2, 2018, from 9:30 a.m. to 5:00 p.m. Eastern Time (ET).
Contact		Ann Ferrero, Maternal and Child Health Bureau (MCHB), HRSA, in one of three ways: (1) Send a request to the
FR Citation		83 FR 32312

83 FR 32312 - Advisory Committee on Heritable Disorders in Newborns and Children

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 83, Issue 134 (July 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration