Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 49231-49232 [2016-17724]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. 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FOR FURTHER INFORMATION CONTACT: Gerry Gray, Center for Devices and VerDate Sep<11>2014 17:01 Jul 26, 2016 Jkt 238001 Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2112, Silver Spring, MD 20993–0002, 301–796–6012; or the Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993–0002, 301–796–5750; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring MD 20993, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. 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[FR Doc. 2016–17651 Filed 7–26–16; 8:45 am] BILLING CODE 4164–01–P 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: E:\FR\FM\27JYN1.SGM 27JYN1 sradovich on DSK3GMQ082PROD with NOTICES 49232 Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices Name: Advisory Committee on Heritable Disorders in Newborns and Children. Dates and Times: August 25, 2016, 9:00 a.m. to 5:00 p.m. (Meeting time is tentative.) August 26, 2016, 9:00 a.m. to 3:00 p.m. (Meeting time is tentative.) Place: Webcast and In-Person, 5635 Fishers Lane, Rockville, MD 20852. Status: The meeting will be open to the public with attendance limited to space availability. Attendees and participants also have the option of viewing the meeting via webcast. Whether attending in-person or via webcast, all attendees and participants must register for the meeting. The registration link is https:// www.blsmeetings.net/ ACHDNCAugust2016. The registration deadline is Friday, August 19, 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, § 1111, as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014 (Pub. L. 113–240) (42 U.S.C. 300b–10), 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 an introduction on sequencing and potential impact on newborn screening and public health, screening for Lysosomal Storage Disorders, newborn screening VerDate Sep<11>2014 17:01 Jul 26, 2016 Jkt 238001 timeliness, pilot studies for future nominated conditions, and the National Contingency Plan for Newborn Screening. The Committee will hear updates from the Laboratory Standards and Procedures workgroup, Follow-up and Treatment workgroup, and Education and Training workgroup, Timeliness workgroup, and the Cost Analysis workgroup. Agenda items are subject to changes as priorities indicate. Tentatively, the Committee is expected to review and/or vote on the recommendations regarding the information needed from pilot studies for future nominated conditions. This vote does not involve a proposed addition of a condition to the RUSP. The meeting agenda will be available 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 is at https:// www.blsmeetings.net/ ACHDNCAugust2016. The registration deadline for public comments is Friday, August 19, 2016, 11:59 p.m. Eastern Time. Written comments must be received by the deadline of Friday, August 5, 2016, 11:59 p.m. Eastern Time to be included in the August 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. For additional information or questions on public comments, please contact Alaina Harris, Maternal and Child Health Bureau, Health Resources and Services Administration; email: aharris@ hrsa.gov. 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, PO 00000 Frm 00025 Fmt 4703 Sfmt 9990 Rockville, Maryland 20857; email: aharris@hrsa.gov. More information on the Advisory Committee is available at http:// www.hrsa.gov/advisorycommittees/ mchbadvisory/heritabledisorders. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–17724 Filed 7–26–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering, Special Emphasis Panel, Center for Complex Tissues (2017/01). Date: October 24, 2016. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, Suite 920, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Contact Person: John K. Hayes, Ph.D., Scientific Review Officer, 6707 Democracy Boulevard, Suite 959, Bethesda, MD 20892, (240) 451–3398, hayesj@mail.nih.gov. Dated: July 20, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–17655 Filed 7–26–16; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Pages 49231-49232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17724]


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

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:

[[Page 49232]]

    Name: Advisory Committee on Heritable Disorders in Newborns and 
Children.
    Dates and Times: August 25, 2016, 9:00 a.m. to 5:00 p.m. (Meeting 
time is tentative.)
    August 26, 2016, 9:00 a.m. to 3:00 p.m. (Meeting time is 
tentative.)
    Place: Webcast and In-Person, 5635 Fishers Lane, Rockville, MD 
20852.
    Status: The meeting will be open to the public with attendance 
limited to space availability. Attendees and participants also have the 
option of viewing the meeting via webcast. Whether attending in-person 
or via webcast, all attendees and participants must register for the 
meeting. The registration link is https://www.blsmeetings.net/ACHDNCAugust2016. The registration deadline is Friday, August 19, 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, Sec.  1111, as amended by the Newborn Screening Saves Lives 
Reauthorization Act of 2014 (Pub. L. 113-240) (42 U.S.C. 300b-10), 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 an introduction on sequencing and potential impact on 
newborn screening and public health, screening for Lysosomal Storage 
Disorders, newborn screening timeliness, pilot studies for future 
nominated conditions, and the National Contingency Plan for Newborn 
Screening. The Committee will hear updates from the Laboratory 
Standards and Procedures workgroup, Follow-up and Treatment workgroup, 
and Education and Training workgroup, Timeliness workgroup, and the 
Cost Analysis workgroup. Agenda items are subject to changes as 
priorities indicate. Tentatively, the Committee is expected to review 
and/or vote on the recommendations regarding the information needed 
from pilot studies for future nominated conditions. This vote does not 
involve a proposed addition of a condition to the RUSP. The meeting 
agenda will be available 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 is at https://www.blsmeetings.net/ACHDNCAugust2016. The 
registration deadline for public comments is Friday, August 19, 2016, 
11:59 p.m. Eastern Time. Written comments must be received by the 
deadline of Friday, August 5, 2016, 11:59 p.m. Eastern Time to be 
included in the August 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. For additional information or questions on public comments, 
please contact Alaina Harris, Maternal and Child Health Bureau, Health 
Resources and Services Administration; email: aharris@hrsa.gov.
    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; email: aharris@hrsa.gov.
    More information on the Advisory Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-17724 Filed 7-26-16; 8:45 am]
BILLING CODE 4165-15-P