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)

Page Range		3002-3003
FR Document		2018-00978

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 14 (Monday, January 22, 2018)

[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.

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

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

3002 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices

NINLARO represented the first Cong., 2d sess., pp. 41–42, 1984.) ways: (1) Send a request to the following
permitted commercial marketing or use Petitions should be in the format address: Ann Ferrero, MCHB, HRSA
of the product. Thereafter, the USPTO specified in 21 CFR 10.30. 5600 Fishers Lane, Room 18N100C,
requested that FDA determine the Submit petitions electronically to Rockville, MD 20857; (2) call 301–443–
product’s regulatory review period. https://www.regulations.gov at Docket 3999; or (3) send an email to: AFerrero@
No. FDA–2013–S–0610. Submit written hrsa.gov.
II. Determination of Regulatory Review
Period petitions (two copies are required) to the SUPPLEMENTARY INFORMATION: The
Dockets Management Staff (HFA–305), ACHDNC provides advice to the
FDA has determined that the Food and Drug Administration, 5630 Secretary of HHS on the development of
applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD newborn screening activities,
NINLARO is 2,538 days. Of this time, 20852. technologies, policies, guidelines, and
2,404 days occurred during the testing
Dated: January 16, 2018. programs for effectively reducing
phase of the regulatory review period,
Leslie Kux, morbidity and mortality in newborns
while 134 days occurred during the
Associate Commissioner for Policy. and children having, or at risk for,
approval phase. These periods of time
heritable disorders. In addition,
were derived from the following dates: [FR Doc. 2018–00994 Filed 1–19–18; 8:45 am]
1. The date an exemption under ACHDNC’s recommendations regarding
BILLING CODE 4164–01–P
section 505(i) of the Federal Food, Drug, inclusion of additional conditions and
and Cosmetic Act (FD&C Act) (21 U.S.C. inherited disorders for screening which
355(i)) became effective: December 10, DEPARTMENT OF HEALTH AND have been adopted by the Secretary are
2008. FDA has verified the applicant’s HUMAN SERVICES then included in the Recommended
claim that the date the investigational Uniform Screening Panel (RUSP).
new drug application became effective Health Resources and Service Conditions listed on the RUSP
was on December 10, 2008. Administration constitute part of the comprehensive
2. The date the application was preventive health guidelines supported
initially submitted with respect to the Advisory Committee on Heritable by HRSA for infants and children under
human drug product under section Disorders in Newborns and Children section 2713 of the Public Health
505(b) of the FD&C Act: July 10, 2015. Service Act, codified at 42 U.S.C.
AGENCY: Health Resources and Service
FDA has verified the applicant’s claim 300gg–13. Under this provision, non-
Administration (HRSA), Department of
that the new drug application (NDA) for grandfathered health plans are required
Health and Human Services (HHS).
NINLARO (NDA 208462) was initially to cover screenings included in the
ACTION: Notice of meeting. HRSA-supported comprehensive
submitted on July 10, 2015.
3. The date the application was SUMMARY: In accordance with the guidelines without charging a co-
approved: November 20, 2015. FDA has Federal Advisory Committee Act, this payment, co-insurance, or deductible for
verified the applicant’s claim that NDA notice announces that the Advisory plan years (i.e., policy years) beginning
208462 was approved on November 20, Committee on Heritable Disorders in on or after the date that is one year from
2015. Newborns and Children (ACHDNC) will the Secretary’s adoption of the
This determination of the regulatory hold a public meeting. condition for screening. Information
review period establishes the maximum about the ACHDNC is available on the
DATES: Thursday, February 8, 2018,
potential length of a patent extension. following website: https://
from 9:30 a.m. to 5:00 p.m. and Friday, www.hrsa.gov/advisory-committees/
However, the USPTO applies several February 9, 2018, from 9:30 a.m. to 3:00
statutory limitations in its calculations heritable-disorders/index.html.
p.m. ET (meeting times are tentative). The meeting agenda will include a
of the actual period for patent extension.
ADDRESSES: The address for the meeting final evidence-based review report on
In its applications for patent extension,
this applicant seeks 837 or 157 days of is 5600 Fishers Lane, 5th Floor Pavilion, the spinal muscular atrophy (SMA)
patent term extension. Rockville, MD 20857. Participants may condition nomination for possible
also access the meeting through inclusion on the RUSP. Following this
III. Petitions Webcast. Advanced registration is report, the ACHDNC expects to vote on
Anyone with knowledge that any of required. Please register online at http:// whether to recommend to the Secretary
the dates as published are incorrect may www.achdncmeetings.org/ by 12:00 p.m. adding SMA to the RUSP. ACHDNC
submit either electronic or written ET on February 5, 2018. Instructions on members will also hear presentations on
comments and, under 21 CFR 60.24, ask how to access the meeting via Webcast states’ activities to achieve newborn
for a redetermination (see DATES). will be provided upon registration. screening timeliness goals. An overview
Furthermore, as specified in § 60.30 (21 Please note that the 5600 Fishers Lane of cutoff determinations and risk
CFR 60.30), any interested person may building requires security screening on assessment methods used for dried
petition FDA for a determination entry. Visitors must provide a driver’s bloodspot newborn screening will also
regarding whether the applicant for license, passport, or other form of be given. The Committee expects to vote
extension acted with due diligence government-issued photo identification on whether to support a guidance
during the regulatory review period. To or they cannot enter the facility. Non-US document on cutoff determinations and
meet its burden, the petition must Citizens planning to attend in person risk assessment methods. Finally, the
comply with all the requirements of will need to provide additional ACHDNC members will hear updates
§ 60.30, including but not limited to: information to HRSA by January 24, from the Laboratory Standards and
ethrower on DSK3G9T082PROD with NOTICES

Must be timely (see DATES), must be 2018, 12:00 p.m. Eastern Time. Please Procedures workgroup; the Follow-up
filed in accordance with § 10.20, must see contact information below. and Treatment workgroup, including a
contain sufficient facts to merit an FDA FOR FURTHER INFORMATION CONTACT: presentation of the final draft of a report
investigation, and must certify that a Anyone requesting information on Quality Measures in Newborn
true and complete copy of the petition regarding the ACHDNC should contact Screening; and the Education and
has been served upon the patent Ann Ferrero, Maternal and Child Health Training workgroup, including a
applicant. (See H. Rept. 857, part 1, 98th Bureau (MCHB), HRSA, in one of three presentation of the final draft of a

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Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 3003

Communication Guide for relaying the discussions could disclose Date: February 12, 2018.
Newborn Screening results. confidential trade secrets or commercial Time: 8:00 a.m. to 6:00 p.m.
HRSA will post the agenda two days property such as patentable material, Agenda: To review and evaluate grant
prior to the meeting on the Committee’s applications.
and personal information concerning
website: https://www.hrsa.gov/advisory- Place: National Institutes of Health, One
individuals associated with the grant Democracy Plaza, 6701 Democracy
committees/heritable-disorders/ applications, the disclosure of which Boulevard, Bethesda, MD 20892.
index.html. Please note that agenda would constitute a clearly unwarranted Contact Person: Marilyn Moore-Hoon,
items are subject to changes as priorities invasion of personal privacy. Ph.D., Scientific Review Officer, Scientific
dictate. Name of Committee: National Institute of Review Branch, National Institute of Dental
Members of the public will have the Allergy and Infectious Diseases Special and Craniofacial Research, 6701 Democracy
opportunity to provide comments and Emphasis Panel; Partnerships for the Blvd., Rm. 676, Bethesda, MD 20892–4878,
may submit written comments in Development of Vaccines and 301–594–4861, mooremar@nidcr.nih.gov.
advance of the meeting. All comments Immunophrophylactics Targeting Multiple Name of Committee: National Institute of
are part of the official Committee record. Antibiotic-Resistant Bacteria (R01). Dental and Craniofacial Research Special
To submit written comments or request Date: February 12–13, 2018. Emphasis Panel; NIDCR DSR Member
time for an oral comment at the meeting, Time: 11:00 a.m. to 6:00 p.m. Conflict SEP.
please register online by 12:00 p.m. ET Agenda: To review and evaluate grant Date: February 14, 2018.
applications. Time: 11:00 a.m. to 2:00 p.m.
on January 31, 2018, at http:// Place: National Institutes of Health, 5601 Agenda: To review and evaluate grant
www.achdncmeetings.org/. To Fishers Lane, Rockville, MD 20892 applications.
accommodate all individuals who have (Telephone Conference Call). Place: National Institutes of Health, One
registered and requested time for oral Contact Person: Kelly Y. Poe, Ph.D., Democracy Plaza, 6701 Democracy
comments, the allocated time for Scientific Review Program, Division of Boulevard, Bethesda, MD 20892 (Telephone
comments may be limited. The Extramural Activities, Room 3F40B, National Conference Call).
ACHDNC may ask individuals Institutes of Health, NIAID, 5601 Fishers Contact Person: Marilyn Moore-Hoon,
associated with groups, or individuals Lane, MSC 9823, Bethesda, MD 20892–9823, Ph.D., Scientific Review Officer, Scientific
(240) 669–5036, poeky@mail.nih.gov. Review Branch, National Institute of Dental
who plan to provide comments on
(Catalogue of Federal Domestic Assistance and Craniofacial Research, 6701 Democracy
similar topics, to combine their
Program Nos. 93.855, Allergy, Immunology, Blvd., Rm. 676, Bethesda, MD 20892–4878,
comments and present them through a and Transplantation Research; 93.856, 301–594–4861, mooremar@nidcr.nih.gov.
single representative. Audiovisual Microbiology and Infectious Diseases Name of Committee: National Institute of
presentations are not permitted. Written Research, National Institutes of Health, HHS) Dental and Craniofacial Research Special
comments should identify the Emphasis Panel.
Dated: January 16, 2018.
individual’s name, address, email, Date: February 28, 2018.
Natasha M. Copeland,
telephone number, professional or Time: 8:00 a.m. to 5:00 p.m.
organization affiliation, background or Program Analyst, Office of Federal Advisory Agenda: To review and evaluate grant
Committee Policy. applications.
area of expertise (i.e., parent, family
member, researcher, clinician, public [FR Doc. 2018–00959 Filed 1–19–18; 8:45 am] Place: Hilton Garden Inn Bethesda, 7301
health, etc.) and the topic/subject BILLING CODE 4140–01–P Waverly Street, Bethesda, MD 20814.
Contact Person: Nisan Bhattacharyya,
matter. Individuals who plan to attend
Ph.D., Scientific Review Officer, Scientific
and need special assistance, such as Review Branch, NIDCR, NIH, 6701
sign language interpretation or other DEPARTMENT OF HEALTH AND
HUMAN SERVICES Democracy Boulevard, Suite 668, Bethesda,
reasonable accommodations, should MD 20892, 301–451–2405, nisan_
notify Ann Ferrero using the address National Institutes of Health bhattacharyya@nih.gov.
and phone number above at least 10 (Catalogue of Federal Domestic Assistance
days prior to the meeting. National Institute of Dental & Program Nos. 93.121, Oral Diseases and
Craniofacial Research; Notice of Disorders Research, National Institutes of
Amy McNulty, Health, HHS)
Acting Director, Division of the Executive
Closed Meetings
Secretariat. Dated: January 16, 2018.
Pursuant to section 10(d) of the
Natasha M. Copeland,
[FR Doc. 2018–00978 Filed 1–19–18; 8:45 am] Federal Advisory Committee Act, as
BILLING CODE 4165–15–P amended, notice is hereby given of the Program Analyst, Office of Federal Advisory
Committee Policy.
following meetings.
The meetings will be closed to the [FR Doc. 2018–00962 Filed 1–19–18; 8:45 am]
DEPARTMENT OF HEALTH AND public in accordance with the BILLING CODE 4140–01–P
HUMAN SERVICES provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
National Institutes of Health as amended. The grant applications and DEPARTMENT OF HEALTH AND
the discussions could disclose HUMAN SERVICES
National Institute of Allergy and
Infectious Diseases; Notice of Closed confidential trade secrets or commercial
National Institutes of Health
Meeting property such as patentable material,
and personal information concerning National Cancer Institute; Notice of
Pursuant to section 10(d) of the individuals associated with the grant Meeting
Federal Advisory Committee Act, as applications, the disclosure of which
ethrower on DSK3G9T082PROD with NOTICES

amended, notice is hereby given of the would constitute a clearly unwarranted Pursuant to section 10(d) of the
following meeting. invasion of personal privacy. Federal Advisory Committee Act, as
The meeting will be closed to the Name of Committee: National Institute of
amended, notice is hereby given of a
public in accordance with the Dental and Craniofacial Research Special meeting of the National Cancer
provisions set forth in sections Emphasis Panel; NIDCR Clinical Research, Advisory Board.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Clinical Trials, and Clinical Trials Planning The meeting will be open to the
as amended. The grant applications and Grants. public as indicated below, with

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Document Created: 2018-01-23 21:35:57
Document Modified: 2018-01-23 21:35:57

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, 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).
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 3002

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Service Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration