83 FR 47628 - Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 183 (September 20, 2018)

Page Range		47628-47629
FR Document		2018-20428

The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC, a roster of members, the meeting agenda, as well as past meeting summaries is located on the ACHDNC website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.html.

Federal Register, Volume 83 Issue 183 (Thursday, September 20, 2018)

[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47628-47629]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-20428]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration Meeting of the
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.

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

SUMMARY: The Advisory Committee on Heritable Disorders in Newborns and
Children (ACHDNC) has scheduled a public meeting. Information about the
ACHDNC, a roster of members, the meeting agenda, as well as past
meeting summaries is located on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.

DATES: November 1, 2018, 10:30 a.m.-5:30 p.m. ET and November 2, 2018,
9:00 a.m.-3:00 p.m. ET.

ADDRESSES: This meeting will be held in person and by webinar. Advanced
registration is required. Please register online at http://www.achdncmeetings.org/ by 12:00 p.m. ET on October 29, 2018. The
address for the meeting is 5600 Fishers Lane, Rockville, Maryland
20857.

FOR FURTHER INFORMATION CONTACT: Ann Ferrero, Maternal and Child Health
Bureau (MCHB), HRSA, 5600 Fishers Lane, Room 18N100C, Rockville,
Maryland 20857; 301-443-3999; or AFerrero@hrsa.gov.

SUPPLEMENTARY INFORMATION: The ACHDNC provides advice and
recommendations to the Secretary of HHS (Secretary) 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.
During the November meeting, the ACHDNC will hear from experts in
the field and discuss issues related to newborn screening information,
education, training activities, and training resources. The ACHDNC will
hear presentations on the use of genomic sequencing in newborn
screening as well as the clinical setting for both well and sick
infants. The ACHDNC will also discuss the nomination of
cerebrotendinous xanthomatosis (CTX) to the RUSP and vote on whether to
move the nomination forward to evidence review. Note that this vote is
not on a proposed addition of a condition to the RUSP. Agenda items are
subject to change as priorities dictate. Refer to the ACHDNC website
for any updated information concerning the meeting. 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 October 26, 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.
Individuals who plan to attend and need special assistance or
another reasonable accommodation should notify Ann Ferrero at the
address and phone number listed above at least 10 business days prior
to the meeting. Since this meeting occurs in a federal government
building, attendees must go through a security check to enter the
building. Non-U.S. Citizens attendees planning to attend must notify
HRSA of their planned attendance at least 10 business days prior to the
meeting in

[[Page 47629]]

order to facilitate their entry into the building. Contact Ann Ferrero
using the information mentioned above by Thursday, October 18, 2018,
12:00 p.m. ET. All attendees are required to present government-issued
identification prior to entry. The meeting will also be accessible via
webcast. Instructions on how to access the meeting via webcast will be
provided upon registration.

Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-20428 Filed 9-19-18; 8:45 am]
BILLING CODE 4165-15-P

47628 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices

effective date for repackagers to ‘‘affix or Dated: September 14, 2018. grandfathered group health plans and
imprint a product identifier to each Leslie Kux, health insurance issuers offering group
package and homogenous case of a Associate Commissioner for Policy. or individual health insurance are
product intended to be introduced in a [FR Doc. 2018–20502 Filed 9–19–18; 8:45 am] required to provide insurance coverage
transaction in commerce’’ under section BILLING CODE 4164–01–P
without cost-sharing (a co-payment, co-
582(e)(2)(A) of the FD&C Act, is not later insurance, or deductible) for preventive
than November 27, 2018. services for plan years (i.e., policy years)
DEPARTMENT OF HEALTH AND beginning on or after the date that is one
This guidance is intended to assist
HUMAN SERVICES year from the Secretary’s adoption of the
manufacturers and repackagers in condition for screening.
understanding the requirements to affix During the November meeting, the
Health Resources and Services
or imprint a product identifier on each Administration Meeting of the Advisory ACHDNC will hear from experts in the
package and homogenous case of Committee on Heritable Disorders in field and discuss issues related to
product that they introduce in a Newborns and Children newborn screening information,
transaction into commerce to satisfy the education, training activities, and
product identifier requirement of AGENCY: Health Resources and Services training resources. The ACHDNC will
section 582 of the FD&C Act. The Administration (HRSA), Department of hear presentations on the use of
recommendations in this guidance are Health and Human Services (HHS). genomic sequencing in newborn
intended to assist manufacturers and ACTION: Notice. screening as well as the clinical setting
repackagers in standardizing both the for both well and sick infants. The
human-readable and machine-readable SUMMARY: The Advisory Committee on ACHDNC will also discuss the
format of the information that is Heritable Disorders in Newborns and nomination of cerebrotendinous
contained in the product identifier. This Children (ACHDNC) has scheduled a xanthomatosis (CTX) to the RUSP and
guidance also intends to clarify that public meeting. Information about the vote on whether to move the
these requirements do not change the ACHDNC, a roster of members, the nomination forward to evidence review.
linear barcode requirements. meeting agenda, as well as past meeting Note that this vote is not on a proposed
summaries is located on the ACHDNC addition of a condition to the RUSP.
This draft guidance is being issued website at https://www.hrsa.gov/ Agenda items are subject to change as
consistent with FDA’s good guidance advisory-committees/heritable- priorities dictate. Refer to the ACHDNC
practices regulation (21 CFR 10.115). disorders/index.html. website for any updated information
The draft guidance, when finalized, will
DATES: November 1, 2018, 10:30 a.m.– concerning the meeting. Members of the
represent the current thinking of FDA 5:30 p.m. ET and November 2, 2018, public will have the opportunity to
on ‘‘Product Identifiers Under the 9:00 a.m.–3:00 p.m. ET. provide comments, which are part of the
Supply Chain Security Act Questions official Committee record. To submit
ADDRESSES: This meeting will be held in
and Answers.’’ It does not establish any written comments or request time for an
rights for any person and is not binding person and by webinar. Advanced
registration is required. Please register oral comment at the meeting, please
on FDA or the public. You can use an register online by 12:00 p.m. ET on
online at http://
alternative approach if it satisfies the October 26, 2018, at http://
www.achdncmeetings.org/ by 12:00 p.m.
requirements of the applicable statutes www.achdncmeetings.org. Oral
ET on October 29, 2018. The address for
and regulations. This guidance is not comments will be honored in the order
the meeting is 5600 Fishers Lane,
subject to Executive Order 12866. they are requested and may be limited
Rockville, Maryland 20857.
II. Paperwork Reduction Act of 1995 as time allows. Individuals associated
FOR FURTHER INFORMATION CONTACT: Ann
with groups or who plan to provide
Ferrero, Maternal and Child Health
This draft guidance includes comments on similar topics may be
Bureau (MCHB), HRSA, 5600 Fishers
information collection provisions that asked to combine their comments and
Lane, Room 18N100C, Rockville,
are subject to review by the Office of present them through a single
Maryland 20857; 301–443–3999; or
Management and Budget (OMB) under representative. No audiovisual
AFerrero@hrsa.gov.
the Paperwork Reduction Act (PRA) of presentations are permitted. Written
SUPPLEMENTARY INFORMATION: The comments should identify the
1995 (44 U.S.C. 3501–3520) (PRA). In
ACHDNC provides advice and individual’s name, address, email,
accordance with the PRA, prior to
recommendations to the Secretary of telephone number, professional or
publication of any final guidance
HHS (Secretary) on the development of organization affiliation, background or
document, FDA intends to solicit public newborn screening activities,
comment and obtain OMB approval for area of expertise (i.e., parent, family
technologies, policies, guidelines, and member, researcher, clinician, public
any information collections programs for effectively reducing
recommended in this guidance that are health, etc.) and the topic/subject
morbidity and mortality in newborns matter.
new or that would represent material and children having, or at risk for, Individuals who plan to attend and
modifications to those previously heritable disorders. In addition, need special assistance or another
approved collections of information ACHDNC’s recommendations regarding reasonable accommodation should
found in FDA regulations or guidances. inclusion of additional conditions for notify Ann Ferrero at the address and
III. Electronic Access screening, following adoption by the phone number listed above at least 10
Secretary, are evidence-informed business days prior to the meeting.
amozie on DSK3GDR082PROD with NOTICES1

Persons with access to the internet preventive health services provided for Since this meeting occurs in a federal
may obtain the draft guidance at either in the comprehensive guidelines government building, attendees must go
https://www.fda.gov/Drugs/ supported by HRSA through the through a security check to enter the
GuidanceCompliance Recommended Uniform Screening Panel building. Non-U.S. Citizens attendees
RegulatoryInformation/Guidances/ (RUSP) pursuant to section 2713 of the planning to attend must notify HRSA of
default.htm or https:// Public Health Service Act (42 U.S.C. their planned attendance at least 10
www.regulations.gov. 300gg–13). Under this provision, non- business days prior to the meeting in

VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1

Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices 47629

order to facilitate their entry into the government-issued photo ID, driver’s license, The VRC01-class of potent, broadly
building. Contact Ann Ferrero using the or passport) and to state the purpose of their neutralizing antibodies (bnAbs) targets
information mentioned above by visit. the conserved CD4-binding site (CD4bs)
Information is also available on the
Thursday, October 18, 2018, 12:00 p.m. Institute’s/Center’s home page: NCRA: http://
of HIV-1 Env which has been a major
ET. All attendees are required to present deainfo.nci.nih.gov/advisory/ncra/ncra.htm, target of HIV-vaccine design. The
government-issued identification prior where an agenda and any additional current best priming immunogen to
to entry. The meeting will also be information for the meeting will be posted engage the VRC01-class germline
accessible via webcast. Instructions on when available. precursors is the eOD-GT8 60mer,
how to access the meeting via webcast (Catalogue of Federal Domestic Assistance which elicits VRC01-class precursors in
will be provided upon registration. Program Nos. 93.392, Cancer Construction; multiple transgenic mouse models.
93.393, Cancer Cause and Prevention However, a large proportion of the
Amy P. McNulty, Research; 93.394, Cancer Detection and antibodies elicited by eOD-GT8 60mer
Acting Director, Division of the Executive Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
are non-CD4bs or ‘‘off-target’’
Secretariat.
Research; 93.397, Cancer Centers Support; antibodies, undermining its
[FR Doc. 2018–20428 Filed 9–19–18; 8:45 am]
93.398, Cancer Research Manpower; 93.399, effectiveness in eliciting the VRC01-
BILLING CODE 4165–15–P
Cancer Control, National Institutes of Health, class bnAb precursors.
HHS) Researchers at the Vaccine Research
Dated: September 14, 2018. Center (VRC) of the National Institute of
DEPARTMENT OF HEALTH AND Allergy and Infectious Diseases
HUMAN SERVICES Melanie J. Pantoja,
introduced multiple N-linked
Program Analyst, Office of Federal Advisory
National Institutes of Health Committee Policy.
glycosylation sites to mask non-CD4bs
regions of eOD-GT8 60mer to focus the
[FR Doc. 2018–20418 Filed 9–19–18; 8:45 am]
National Cancer Institute; Notice of antibody immune response to the
BILLING CODE 4140–01–P
Meeting CD4bs.
Several glycan-masked mutants
Pursuant to section 10(d) of the showed significantly decreased
Federal Advisory Committee Act, as DEPARTMENT OF HEALTH AND
antibody binding to non-CD4bs ‘‘off-
amended, notice is hereby given of a HUMAN SERVICES
target’’ epitopes while maintaining
meeting of the National Cancer Institute strong binding to CD4bs-specific bnAbs.
Council of Research Advocates. National Institutes of Health
Furthermore, in vivo studies showed
The meeting will be open to the Government-Owned Inventions; that immunization with the best glycan-
public, with attendance limited to space Availability for Licensing masked eOD-GT8 mutants resulted in
available. Individuals who plan to significant increases in the elicitation of
attend and need special assistance, such AGENCY: National Institutes of Health, CD4bs-specific serum antibodies,
as sign language interpretation or other HHS. CD4bs-specific B cells in the spleen, and
reasonable accommodations, should ACTION: Notice. VRC01-class precursors, compared to
notify the Contact Person listed below immunization with the parental eOD-
in advance of the meeting. The open SUMMARY: The invention listed below is
owned by an agency of the U.S. GT8 immunogen. In conclusion,
session will be videocast and can be because of their improved antigenic and
accessed from the NIH Videocasting and Government and is available for
licensing to achieve expeditious immunogenic profiles, glycan-masked
Podcasting website (http:// eOD-GT8 60mer mutants may serve as
videocast.nih.gov). commercialization of results of
federally-funded research and improved priming immunogens to elicit
Name of Committee: National Cancer
development. Foreign patent VRC01-class bnAbs in humans.
Institute Council of Research Advocates. Potential Commercial Applications:
applications are filed on selected
Date: October 19, 2018. • HIV-1 vaccine—the priming
Time: 9:00 a.m. to 4:30 p.m. inventions to extend market coverage
component in a prime-boost approach.
Agenda: Welcome and Chairman’s for companies and may also be available Competitive Advantages:
Remarks, NCI Updates, Legislative Update, for licensing. • Reduced off-target immunogenicity.
Budget Update, and Director’s Update. FOR FURTHER INFORMATION CONTACT: • Improved efficacy in eliciting
Place: National Institutes of Health, 35A Barry Buchbinder, Ph.D., 240–627– precursors for broadly neutralizing
Convent Drive, Building 35A, 640, Bethesda, 3678; barry.buchbinder@nih.gov.
MD 20892. CD4bs antibodies.
Contact Person: Amy Williams, NCI Office
Licensing information and copies of the • Facilitates the development of
of Advocacy Relations, National Cancer U.S. patent application listed below VRC01-class bnAbs in humans.
Institute, NIH, 31 Center Drive, Building 31, may be obtained by communicating Development Stage: In vivo testing
Room 10A28, Bethesda, MD 20892, 240–781– with the indicated licensing contact at (rodents).
3360 williaam@mail.nih.gov. the Technology Transfer and Inventors: John R. Mascola (NIAID),
Any interested person may file written Intellectual Property Office, National Hongying Duan (NIAID), Xuejun Chen
comments with the committee by forwarding Institute of Allergy and Infectious (NIAID), Cheng Cheng (NIAID) and
the statement to the Contact Person listed on Diseases, 5601 Fishers Lane, Rockville, Jeffrey C. Boyington (NIAID).
this notice. The statement should include the MD 20852; tel. 301–496–2644. A signed Publications: Duan, H. et al., Glycan
name, address, telephone number and when Confidential Disclosure Agreement will Masking Focuses Immune Responses to
applicable, the business or professional be required to receive copies of the HIV-1 CD4-Binding Site and
amozie on DSK3GDR082PROD with NOTICES1

affiliation of the interested person. Enhances Elicitation of VRC01-Class
unpublished patent applications.
In the interest of security, NIH has
instituted stringent procedures for entrance SUPPLEMENTARY INFORMATION: Precursor Antibodies. Immunity 49, 301
onto the NIH campus. All visitor vehicles, Technology description follows. (2018).
including taxicabs, hotel, and airport shuttles Intellectual Property: HHS Reference
Glycan-Masked Engineered Outer Number E–083–2017 includes U.S.
will be inspected before being allowed on
campus. Visitors will be asked to show one
Domains of HIV-1 GP120 and Their Use Provisional Patent Application Number
form of identification (for example, a Description of Technology: 62/476,397 filed 03/24/2017 and PCT

VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1

Document Created: 2018-09-20 02:09:07
Document Modified: 2018-09-20 02:09:07

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.
Dates		November 1, 2018, 10:30 a.m.-5:30 p.m. ET and November 2, 2018, 9:00 a.m.-3:00 p.m. ET.
Contact		Ann Ferrero, Maternal and Child Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Room 18N100C, Rockville, Maryland 20857; 301-443-3999; or [email protected]
FR Citation		83 FR 47628