81 FR 49231 - 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 144 (July 27, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 144 (July 27, 2016)
| Page Range | 49231-49232 | |
| FR Document | 2016-17724 |
[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)] [Notices] [Pages 49231-49232] From the Federal Register Online [www.thefederalregister.org] [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: [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; email: [email protected]. 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
![Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices 49231
copies total. One copy will include the Radiological Health, Food and Drug DeviceRegulationandGuidance/
information you claim to be confidential Administration, 10903 New Hampshire GuidanceDocuments/default.htm.
with a heading or cover note that states Ave., Bldg. 66, Rm. 2112, Silver Spring, Guidance documents are also available
‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 301–796–6012; or the at http://www.fda.gov/BiologicsBlood
CONFIDENTIAL INFORMATION.’’ The Division of Biostatistics, Center for Vaccines/GuidanceCompliance
Agency will review this copy, including Devices and Radiological Health, Food RegulatoryInformation/default.htm or
the claimed confidential information, in and Drug Administration, 10903 New http://www.regulations.gov. Persons
its consideration of comments. The Hampshire Ave., Bldg. 66, Silver Spring, unable to download an electronic copy
second copy, which will have the MD 20993–0002, 301–796–5750; or of ‘‘Adaptive Designs for Medical
claimed confidential information Stephen Ripley, Center for Biologics Device Clinical Studies’’ may send an
redacted/blacked out, will be available Evaluation and Research, Food and email request to CDRH-Guidance@
for public viewing and posted on http:// Drug Administration, 10903 New fda.hhs.gov to receive an electronic
www.regulations.gov. Submit both Hampshire Ave., Bldg. 71, Rm. 7301, copy of the document. Please use the
copies to the Division of Dockets Silver Spring MD 20993, 240–402–7911. document number GUD1500005 to
Management. If you do not wish your SUPPLEMENTARY INFORMATION: identify the guidance you are
name and contact information to be requesting.
I. Background
made publicly available, you can IV. Paperwork Reduction Act of 1995
provide this information on the cover This guidance provides sponsors and
sheet and not in the body of your FDA staff with guidance on how to plan This guidance refers to previously
comments and you must identify this and implement adaptive designs for approved collections of information
information as ‘‘confidential.’’ Any clinical studies when used in medical found in FDA regulations. These
information marked as ‘‘confidential’’ device development programs. This collections of information are subject to
will not be disclosed except in document addresses adaptive designs review by the Office of Management and
accordance with 21 CFR 10.20 and other for medical device clinical trials and is Budget (OMB) under the Paperwork
applicable disclosure law. For more applicable to premarket medical device Reduction Act of 1995 (44 U.S.C. 3501–
information about FDA’s posting of submissions including premarket 3520). The collections of information in
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56469, September 18, 2015, or access notification (510(k)) submissions, de approved under OMB control number
the information at: http://www.fda.gov/ novo submissions (evaluation of 0910–0120; the collections of
regulatoryinformation/dockets/ automatic class III designation), information in 21 CFR part 812, have
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Docket: For access to the docket to applications, and investigational device number 0910–0078; the collections of
read background documents or the exemption (IDE) submissions. This information in 21 CFR part 814,
electronic and written/paper comments guidance can be applied throughout the subparts A through E, have been
received, go to http:// clinical development program of a approved under OMB control number
www.regulations.gov and insert the medical device, from feasibility studies 0910–0231; the collections of
docket number, found in brackets in the to pivotal clinical trials. This guidance information in 21 CFR part 814,subpart
heading of this document, into the does not apply to clinical studies of H, have been approved under OMB
‘‘Search’’ box and follow the prompts combination products or codevelopment control number 0910–0332; and the
and/or go to the Division of Dockets of a pharmaceutical product with an collections of information in the
Management, 5630 Fishers Lane, Rm. unapproved diagnostic test. The draft guidance document ‘‘Requests for
1061, Rockville, MD 20852. guidance was available from May 18, Feedback on Medical Device
An electronic copy of the guidance 2015, to August 17, 2015. FDA received Submissions: The Pre-Submission
document is available for download 151 comments from seven entities and Program and Meetings with Food and
from the Internet. See the has incorporated most of them in this Drug Administration Staff’’ have been
SUPPLEMENTARY INFORMATION section for final guidance. approved under OMB control number
information on electronic access to the II. Significance of Guidance 0910–0756.
guidance. Submit written requests for a Dated: July 21, 2016.
This guidance is being issued
single hard copy of the guidance Leslie Kux,
consistent with FDA’s good guidance
document entitled ‘‘Adaptive Designs Associate Commissioner for Policy.
practices regulation (21 CFR 10.115).
for Medical Device Clinical Studies’’ to [FR Doc. 2016–17651 Filed 7–26–16; 8:45 am]
The guidance represents the current
the Office of the Center Director,
thinking of FDA on ‘‘Adaptive Designs BILLING CODE 4164–01–P
Guidance and Policy Development,
for Medical Device Clinical Studies.’’ It
Center for Devices and Radiological
does not establish any rights for any
Health, Food and Drug Administration, DEPARTMENT OF HEALTH AND
person and is not binding on FDA or the
10903 New Hampshire Ave., Bldg. 66, HUMAN SERVICES
public. You can use an alternative
Rm. 5431, Silver Spring, MD 20993–
approach if it satisfies the requirements
0002; or the Office of Communication, Health Resources and Services
of the applicable statutes and
Outreach, and Development, Center for Administration
regulations.
Biologics Evaluation and Research,
Food and Drug Administration, 10903 III. Electronic Access Advisory Committee on Heritable
sradovich on DSK3GMQ082PROD with NOTICES
New Hampshire Ave., Bldg. 71, Rm. Disorders in Newborns and Children;
Persons interested in obtaining a copy
3128, Silver Spring, MD 20993–0002. Notice of Meeting
of the guidance may do so by
Send one self-addressed adhesive label downloading an electronic copy from In accordance with section 10(a)(2) of
to assist that office in processing your the Internet. A search capability for all the Federal Advisory Committee Act
request. Center for Devices and Radiological (Pub. L. 92–463, codified at 5 U.S.C.
FOR FURTHER INFORMATION CONTACT: Health guidance documents is available App.), notice is hereby given of the
Gerry Gray, Center for Devices and at http://www.fda.gov/MedicalDevices/ following meeting:
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![49232 Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices
Name: Advisory Committee on timeliness, pilot studies for future Rockville, Maryland 20857; email:
Heritable Disorders in Newborns and nominated conditions, and the National aharris@hrsa.gov.
Children. Contingency Plan for Newborn More information on the Advisory
Dates and Times: August 25, 2016, Screening. The Committee will hear Committee is available at http://
9:00 a.m. to 5:00 p.m. (Meeting time is updates from the Laboratory Standards
tentative.) www.hrsa.gov/advisorycommittees/
and Procedures workgroup, Follow-up
August 26, 2016, 9:00 a.m. to 3:00 mchbadvisory/heritabledisorders.
and Treatment workgroup, and
p.m. (Meeting time is tentative.) Education and Training workgroup, Jason E. Bennett,
Place: Webcast and In-Person, 5635 Timeliness workgroup, and the Cost Director, Division of the Executive Secretariat.
Fishers Lane, Rockville, MD 20852. Analysis workgroup. Agenda items are
Status: The meeting will be open to [FR Doc. 2016–17724 Filed 7–26–16; 8:45 am]
subject to changes as priorities indicate.
the public with attendance limited to Tentatively, the Committee is expected BILLING CODE 4165–15–P
space availability. Attendees and to review and/or vote on the
participants also have the option of recommendations regarding the
viewing the meeting via webcast. information needed from pilot studies DEPARTMENT OF HEALTH AND
Whether attending in-person or via for future nominated conditions. This HUMAN SERVICES
webcast, all attendees and participants vote does not involve a proposed
must register for the meeting. The National Institutes of Health
addition of a condition to the RUSP.
registration link is https:// The meeting agenda will be available 2
www.blsmeetings.net/ National Institute of Biomedical
days prior to the meeting on the
ACHDNCAugust2016. The registration Imaging and Bioengineering; Notice of
Committee’s Web site: http://
deadline is Friday, August 19, 2016, Closed Meeting
www.hrsa.gov/advisorycommittees/
11:59 p.m. Eastern Time. mchbadvisory/heritabledisorders.
Purpose: The Advisory Committee on Pursuant to section 10(d) of the
Public Comments: Members of the
Heritable Disorders in Newborns and public may present oral comments and/ Federal Advisory Committee Act, as
Children (Committee), as authorized by or submit written comments. Comments amended (5 U.S.C. App.), notice is
Public Health Service Act, Title XI, are part of the official Committee record. hereby given of the following meeting.
§ 1111, as amended by the Newborn The public comment period is The meeting will be closed to the
Screening Saves Lives Reauthorization tentatively scheduled for both days of public in accordance with the
Act of 2014 (Pub. L. 113–240) (42 U.S.C. the meeting. Advance registration is provisions set forth in sections
300b–10), was established to advise the required to present oral comments and/ 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Secretary of the Department of Health or submit written comments. as amended. The grant applications and
and Human Services about the Registration information is at https://
development of newborn screening the discussions could disclose
www.blsmeetings.net/ confidential trade secrets or commercial
activities, technologies, policies, ACHDNCAugust2016. The registration
guidelines, and programs for effectively property such as patentable material,
deadline for public comments is Friday, and personal information concerning
reducing morbidity and mortality in August 19, 2016, 11:59 p.m. Eastern
newborns and children having, or at risk individuals associated with the grant
Time. Written comments must be
for, heritable disorders. In addition, the applications, the disclosure of which
received by the deadline of Friday,
Committee’s recommendations August 5, 2016, 11:59 p.m. Eastern Time would constitute a clearly unwarranted
regarding additional conditions/ to be included in the August meeting invasion of personal privacy.
heritable disorders for screening that briefing book. Written comments should Name of Committee: National Institute of
have been adopted by the Secretary are identify the individual’s name, address, Biomedical Imaging and Bioengineering,
included in the Recommended Uniform email, telephone number, professional Special Emphasis Panel, Center for Complex
Screening Panel (RUSP) and constitute or business affiliation, type of expertise Tissues (2017/01).
part of the comprehensive guidelines (i.e., parent, researcher, clinician, public Date: October 24, 2016.
supported by the Health Resources and health, etc.), and the topic/subject Time: 9:00 a.m. to 8:00 p.m.
Services Administration. Pursuant to matter of comments. To ensure that all Agenda: To review and evaluate grant
section 2713 of the Public Health individuals who have registered to make applications.
Service Act, codified at 42 U.S.C. oral comments can be accommodated, Place: National Institutes of Health, Two
300gg–13, non-grandfathered health the allocated time may be limited. Democracy Plaza, Suite 920, 6707 Democracy
plans and group and individual health Individuals who are associated with Boulevard, Bethesda, MD 20892, (Virtual
insurance issuers are required to cover groups or have similar interests may be Meeting).
evidence-informed care and screenings requested to combine their comments Contact Person: John K. Hayes, Ph.D.,
included in the HRSA-supported and present them through a single Scientific Review Officer, 6707 Democracy
comprehensive guidelines without representative. No audiovisual Boulevard, Suite 959, Bethesda, MD 20892,
charging a co-payment, co-insurance, or presentations are permitted. For (240) 451–3398, hayesj@mail.nih.gov.
deductible for plan years (in the additional information or questions on Dated: July 20, 2016.
individual market, policy years) public comments, please contact Alaina David Clary,
beginning on or after the date that is 1 Harris, Maternal and Child Health Program Analyst, Office of Federal Advisory
year from the Secretary’s adoption of the Bureau, Health Resources and Services Committee Policy.
sradovich on DSK3GMQ082PROD with NOTICES
condition for screening. Administration; email: aharris@
[FR Doc. 2016–17655 Filed 7–26–16; 8:45 am]
Agenda: The Committee will hear hrsa.gov.
presentations and discussions on topics Contact Person: Anyone interested in BILLING CODE 4140–01–P
including an introduction on obtaining other relevant information
sequencing and potential impact on should contact Alaina Harris, Maternal
newborn screening and public health, and Child Health Bureau, Health
screening for Lysosomal Storage Resources and Services Administration,
Disorders, newborn screening Room 18W66, 5600 Fishers Lane,
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Document Created: 2018-02-08 08:02:24
Document Modified: 2018-02-08 08:02:24
| 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 49231 |
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