81 FR 18864 - Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 63 (April 1, 2016)

Page Range		18864-18865
FR Document		2016-07321

Federal Register, Volume 81 Issue 63 (Friday, April 1, 2016)

[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18864-18865]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07321]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Committee on Heritable Disorders in Newborns and 
Children; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463, codified at 5 U.S.C. App.), notice is 
hereby given of the following meeting:
    Name: Advisory Committee on Heritable Disorders in Newborns and 
Children.
    Dates and Times: May 9, 2016, 9:00 a.m. to 5:00 p.m. (Meeting time 
is tentative.) May 10, 2016, 9:00 a.m. to 3:00 p.m. (Meeting time is 
tentative.)
    Place: Webcast and In-Person, Fishers Lane Conference Center, 
Terrace Level, 5635 Fishers Lane, Rockville, MD 20852.
    Status: The meeting will be open to the public with attendance 
limited to space availability. Participants also have the option of 
viewing the meeting via webcast. Whether attending in-person or via 
webcast, all participants must register for the meeting. The 
registration link will be made available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/. The registration 
deadline is Friday, April 29, 2016, 11:59 p.m. Eastern Time.
    Purpose: The Advisory Committee on Heritable Disorders in Newborns 
and Children (Committee), as authorized by Public Health Service Act, 
title XI, section 1111 (42 U.S.C. 300b-10), as amended by the Newborn 
Screening Saves Lives Reauthorization Act of 2014 (Pub. L. 113-240), 
was established to advise the Secretary of the Department of Health and 
Human Services about 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, the Committee's 
recommendations regarding additional conditions/heritable disorders for 
screening that have been adopted by the Secretary are included in the 
Recommended Uniform Screening Panel (RUSP) and constitute part of the 
comprehensive guidelines supported by the Health Resources and Services 
Administration. Pursuant to section 2713 of the Public Health Service 
Act, codified at 42 U.S.C. 300gg-13, non-grandfathered health plans and 
group and individual health insurance issuers are required to cover 
evidence-informed care and screenings included in the HRSA-supported 
comprehensive guidelines without charging a co-payment, co-insurance, 
or deductible for plan years (in the individual market, policy years) 
beginning on or after the date that is 1 year from the Secretary's 
adoption of the condition for screening.
    Agenda: The Committee will hear presentations and discussions on 
topics including newborn screening long-term follow-up, the Newborn 
Sequencing in Genomic Medicine and Public Health projects, screening 
for lysosomal storage disorders, and prenatal education regarding 
newborn screening bloodspots. The Committee will also review draft 
reports from the Pilot Study and Cost Analysis workgroups and hear 
updates from the Committee's subcommittees on Laboratory Standards and 
Procedures, Follow-up and Treatment, and Education and Training 
Tentatively, the Committee is expected to review and/or vote on whether 
or not the nominated condition Guanidinoacetate Methyltransferase

[[Page 18865]]

Deficiency should be referred for a full evidence-based review. This 
vote does not involve a proposed addition of a condition to the 
Recommended Uniform Screening Panel. The meeting agenda will be 
available two (2) days prior to the meeting on the Committee's Web 
site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Public Comments: Members of the public may present oral comments 
and/or submit written comments. Comments are part of the official 
Committee record. The public comment period is tentatively scheduled 
for both days of the meeting. Advance registration is required to 
present oral comments and/or submit written comments. Registration 
information will be on the Committee Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders. The registration 
deadline for public comments is of Friday April 29, 2016, 11:59 p.m. 
(Eastern Time). Written comments must be received by the deadline of 
Friday April 29, 2016, 11:59 p.m. (Eastern Time) in order to be 
included in the May meeting briefing book. Written comments should 
identify the individual's name, address, email, telephone number, 
professional or business affiliation, type of expertise (i.e., parent, 
researcher, clinician, public health, etc.), and the topic/subject 
matter of comments. To ensure that all individuals who have registered 
to make oral comments can be accommodated, the allocated time may be 
limited. Individuals who are associated with groups or have similar 
interests may be requested to combine their comments and present them 
through a single representative. No audiovisual presentations are 
permitted. Individuals who plan to attend and need special assistance, 
such as sign language interpretation or other reasonable 
accommodations, should notify the contact person listed below at least 
10 days prior to the meeting. For additional information or questions 
on public comments, please contact Alaina Harris, Maternal and Child 
Health Bureau, Health Resources and Services Administration; phone: 
(301) 443-0721; or email: [email protected].
    Contact Person: Anyone interested in obtaining other relevant 
information should contact Alaina Harris, Maternal and Child Health 
Bureau, Health Resources and Services Administration, Room 18W66, 5600 
Fishers Lane, Rockville, Maryland 20857; phone: (301) 443-0721; or 
email: [email protected].
    More information on the Advisory Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-07321 Filed 3-31-16; 8:45 am]
BILLING CODE 4165-15-P

Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 18865

Deficiency should be referred for a full www.hrsa.gov/advisorycommittees/ The PHS Act requires that HHS issue
evidence-based review. This vote does mchbadvisory/heritabledisorders. proposed guidance on this provision, to
not involve a proposed addition of a be followed by a 60-day public
Jackie Painter,
condition to the Recommended Uniform comment period. Consistent with this
Screening Panel. The meeting agenda Director, Division of the Executive Secretariat. requirement, a notice appeared in the
will be available two (2) days prior to [FR Doc. 2016–07321 Filed 3–31–16; 8:45 am] Federal Register on October 1, 2013 (78
the meeting on the Committee’s Web BILLING CODE 4165–15–P FR 60283) notifying the public that HHS
site: http://www.hrsa.gov/ was accepting comments on such
advisorycommittees/mchbadvisory/ proposed guidance. This 60-day public
heritabledisorders. DEPARTMENT OF HEALTH AND comment period concluded in
Public Comments: Members of the HUMAN SERVICES December 2013. There were nine
public may present oral comments and/ submissions received in the public
or submit written comments. Comments Temporary Reassignment of State, comment period. Five of the
are part of the official Committee record. Tribal, and Local Personnel During a submissions were local governments,
The public comment period is Public Health Emergency one state government, and three
tentatively scheduled for both days of AGENCY: Office of the Secretary, associations. Revisions made based on
the meeting. Advance registration is Department of Health and Human feedback received included setting
required to present oral comments and/ Services (HHS). timelines for HHS to review;
or submit written comments. ACTION: Notice. standardizing the request template for
Registration information will be on the states and Indian tribes, expanding the
Committee Web site at http:// SUMMARY: The Department of Health and post event reporting requirements from
www.hrsa.gov/advisorycommittees/ Human Services, Office of the Secretary 90 to 120 days, and clarifications on
mchbadvisory/heritabledisorders. The is announcing the availability of a final which Public Health Service programs
registration deadline for public guidance entitled ‘‘Guidance for were potentially affected.
comments is of Friday April 29, 2016, Temporary Reassignment of State, The temporary reassignment
11:59 p.m. (Eastern Time). Written Tribal, and Local Personnel during a provision is applicable to state, tribal,
comments must be received by the Public Health Emergency.’’ Section 201 and local public health department or
deadline of Friday April 29, 2016, 11:59 of the Pandemic and All-Hazards agency personnel whose positions are
p.m. (Eastern Time) in order to be Preparedness Reauthorization Act of funded, in full or part, under PHS
included in the May meeting briefing 2013 (PAHPRA), Public Law 113–5, programs. This authority terminates on
book. Written comments should identify amends section 319 of the Public Health September 30, 2018.
the individual’s name, address, email, Service (PHS) Act to allow the Secretary This new provision provides an
telephone number, professional or of HHS, when she declares a public important flexibility to state and local
business affiliation, type of expertise health emergency under section 319 of health departments and tribal
(i.e., parent, researcher, clinician, public the PHS Act, to authorize, upon request organizations during an event requiring
health, etc.), and the topic/subject by a state or tribal organization or their all the resources at their disposal. The
matter of comments. To ensure that all designee, the temporary reassignment of temporary reassignment provision
individuals who have registered to make state, tribal, and local personnel funded permits state, tribal, and local personnel
oral comments can be accommodated, through programs authorized under the to be voluntarily reassigned so they can
the allocated time may be limited. PHS Act to immediately address a immediately respond to the public
Individuals who are associated with public health emergency in the state or health emergency in the affected
groups or have similar interests may be Indian tribe. This final guidance jurisdiction.
requested to combine their comments addresses that provision. Dated: September 1, 2015.
and present them through a single Sylvia Burwell,
ADDRESSES: Copy of the final guidance
representative. No audiovisual
presentations are permitted. Individuals may be obtained at Secretary.
who plan to attend and need special www.PHE.gov!femporacyReassignment. Editorial Note: This document was
assistance, such as sign language Additional Information: For received for publication by the Office of the
interpretation or other reasonable additional information, please contact: Federal Register on March 29, 2016.
accommodations, should notify the Lisa Kaplowitz, MD, MSHA, Deputy
[FR Doc. 2016–07404 Filed 3–31–16; 8:45 am]
contact person listed below at least 10 Assistant Secretary, Office of Policy and
BILLING CODE 4150–37–P
days prior to the meeting. For additional Planning, Office of the Assistant
information or questions on public Secretary for Preparedness and
comments, please contact Alaina Harris, Response, 200 Independence SW.,
Washington, DC 20004, telephone DEPARTMENT OF HOMELAND
Maternal and Child Health Bureau, SECURITY
Health Resources and Services number (202) 205–2882.
Administration; phone: (301) 443–0721; SUPPLEMENTARY INFORMATION: Section U.S. Customs and Border Protection
or email: aharris@hrsa.gov. 201 of PAHPRA, Public Law 113–5,
Contact Person: Anyone interested in amends section 319 of the PHS Act to [Docket No. USCBP–2016–0016]
obtaining other relevant information allow the Secretary of HHS, when she
Termination of the Advisory
should contact Alaina Harris, Maternal declares a public health emergency
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Committee on Commercial Operations
and Child Health Bureau, Health under section 319 of the PHS Act, to
to U.S. Customs and Border
Resources and Services Administration, authorize, upon request by a state or
Protection; Establishment of the
Room 18W66, 5600 Fishers Lane, tribal organization or their designee, the
Commercial Customs Operations
Rockville, Maryland 20857; phone: temporary reassignment of state, tribal,
Advisory Committee
(301) 443–0721; or email: aharris@ and local personnel funded though
hrsa.gov. programs authorized under the PHS Act AGENCY: U.S. Customs and Border
More information on the Advisory to immediately address a public health Protection, Department of Homeland
Committee is available at http:// emergency in the state or Indian tribe. Security.

VerDate Sep<11>2014 17:25 Mar 31, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1

Document Created: 2016-04-06 00:08:44
Document Modified: 2016-04-06 00:08:44

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
FR Citation		81 FR 18864

81 FR 18864 - Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 81, Issue 63 (April 1, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration