[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25447-25448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Establishment of the Discretionary Advisory Committee on 
Heritable Disorders in Newborns and Children and Notice of Meeting

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of establishment of the Discretionary Advisory Committee 
on Heritable Disorders in Newborns and Children and Notice of Meeting.

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    Authority: The Committee is governed by Public Health Service 
Act (PHS), 42 U.S.C. 217a: Advisory councils or committees as well 
as provisions of Public Law 92-463, as amended, (5 U.S.C. App. 2), 
which sets forth standards for the formation and use of advisory 
committees.

SUMMARY: The U.S. Department of Health and Human Services announces the 
establishment of the Discretionary Advisory Committee on Heritable 
Disorders in Newborns and Children. This notice also announces the 
Committee's first meeting.

FOR FURTHER INFORMATION CONTACT: Debi Sarkar, Health Resources and 
Services Administration, Maternal and Child Health Bureau; Telephone: 
301-443-1080; Email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Authority

    Under the Public Health Service Act (PHS), 42 U.S.C. 217a, the 
Secretary of Health and Human Services directed that the Discretionary 
Advisory Committee on Heritable Disorders in Newborns and Children 
(DACHDNC) shall be established within the Department of Health and 
Human Services (HHS). To comply with the authorizing directive and 
guidelines under the Federal Advisory Committee Act (FACA), a charter 
was filed with the Committee Management Secretariat in the General 
Services Administration (GSA), the appropriate committees in the Senate 
and U.S. House of Representatives, and the Library of Congress to 
establish the Committee as a discretionary federal advisory committee.
    The purpose of the Discretionary Advisory Committee on Heritable 
Disorders in Newborns and Children (DACHDNC) is to advise the Secretary 
of Health and Human Services about aspects of newborn and childhood 
screening and technical information for the development of policies and 
priorities that will enhance the ability of the State and local health 
agencies to provide for newborn and child screening, counseling and 
health care services for newborns and children having, or at risk for, 
heritable disorders. The DACHDNC will review and report regularly on 
newborn and childhood screening practices, recommend improvements for 
newborn and childhood screening programs, as well as fulfill the list 
of requirements stated in the original authorizing legislation.

II. Structure

    The Committee consists of fifteen (15) voting members, including 
the Chair. The members of the Committee were appointed by the 
Secretary. Membership is composed of the Chair, Special Government 
Employees (SGEs) and federal ex-officio members. Federal ex-officio 
members include the Administrator of the Health Resources and Services 
Administration; the Directors of the Centers for Disease Control and 
Prevention; the National Institutes of Health; the Agency for 
Healthcare Research and Quality; and the Commissioner of the Food and 
Drug Administration--or their designees. The Chair and other members 
are (a) medical, technical, public health or scientific professionals 
with special expertise in the field of heritable disorders or in 
providing screening, counseling, testing, or specialty services for 
newborns and children at risk for heritable disorders; (b) experts in 
ethics and heritable disorders who have worked and published material 
in the area of public health and genetic conditions; and (c) members 
from the public sector who have expertise, either professional or 
personal, about or concerning heritable disorders in order to achieve a 
fairly balanced membership.
    The DACHDNC also includes nonvoting liaisons or representatives 
from Federal Agencies, public health constituencies, advocacy 
organizations and medical professional societies, as determined to be 
necessary by the Chair and/or the Designated Federal Official, to 
fulfill the duties of the DACHDNC. In addition, the DACHDNC is 
encouraged to work closely with other relevant HHS entities that focus 
on reviewing scientific evidence and making recommendations on clinical 
preventive services.

III. First Meeting of the DACHDNC

    Dates and Times: May 16, 2013, 10:00 a.m. to 2:00 p.m.
    May 17, 2013, 10:00 a.m. to 2:00 p.m.
    Place: Virtual via Webinar.
    Status: The meeting is open to the public. For more information on 
registration and webinar details, please visit the Committee's Web 
site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Purpose: The Discretionary Advisory Committee on Heritable 
Disorders in Newborns and Children (Committee), as authorized by Public 
Health Service Act (PHS), 42 U.S.C. 217a: Advisory councils or 
committees, was established to advise the Secretary of the Department 
of Health and Human Services regarding 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. The Committee's 
recommendations regarding additional conditions/inherited disorders for 
screening that have been adopted by the Secretary are included in the 
Recommended Uniform Screening Panel (RUSP) that constitutes 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 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.
    Agenda: The meeting will include: (1) A final report on the Pompe 
Condition Nomination for inclusion in the RUSP, and (2) updates on 
priority projects from the Committee's subcommittees on Laboratory 
Standards and Procedures, Follow-up and Treatment, and Education and 
Training.
    The Committee is expected to vote on whether or not to recommend to 
the

[[Page 25448]]

Secretary the addition of Pompe Disease to the Recommended Uniform 
Screening Panel (RUSP).
    Certain proposed agenda items may be subject to change as necessary 
or appropriate. The agenda, webinar information, Committee Roster, 
Charter, presentations, and meeting materials are located on the 
Committee's Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Public Comments: Members of the public can submit written comments 
and/or register to present oral comments during the public comment 
period of the meeting. All comments, whether oral or written, are part 
of the official Committee record and will be available for public 
inspection and copying. Advance registration is required to present 
oral comments or submit written comments. Individuals who wish to make 
public comments are required to email Lisa Vasquez ([email protected]) 
by Tuesday, May 7, 2013. The public comment period is scheduled for the 
morning of May 17, 2013.
    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 comment. 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.
    Contact Person: Anyone interested in obtaining other relevant 
information should contact Debi Sarkar, Maternal and Child Health 
Bureau, Health Resources and Services Administration, Room 18A-19, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; 
telephone: (301) 443-1080; email: [email protected]. The logistical 
challenges of coordinating this meeting hindered an earlier publication 
of this meeting notice.
    More information on the Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

    Dated: April 25, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-10241 Filed 4-30-13; 8:45 am]
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