81 FR 4312 - 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 16 (January 26, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 16 (January 26, 2016)
| Page Range | 4312-4313 | |
| FR Document | 2016-01432 |
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)] [Notices] [Pages 4312-4313] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01432] ----------------------------------------------------------------------- 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 (Public Law 92-463, codified at 5 U.S.C. [[Page 4313]] App.), notice is hereby given of the following meeting: Name: Advisory Committee on Heritable Disorders in Newborns and Children Dates and Times: February 11, 2016, 8:30 a.m. to 5:00 p.m., February 12, 2016, 8:30 a.m. to 3:00 p.m. Place: Webinar and In-Person, National Institutes of Health, 45 Center Drive Room, Bethesda, MD 20892. 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 webinar. Whether attending in-person or via webinar, 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, February 5, 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 (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 meeting will include: (1) A panel discussion on Long Term Follow-up activities regarding newborns and children identified with a condition via newborn screening. Presentations may include perspectives from state public health experts, researchers, and providers; (2) updates from workgroups focused on cost analysis in newborn screening, newborn screening timeliness, and pilot studies for future nominated conditions; and (3) a discussion on proposed priorities and action items from the three subcommittees (Laboratory Standards and Procedures, Follow-up and Treatment, and Education and Training) to develop a plan for 2016. There are no votes that involve proposed additions of a condition to the RUSP scheduled for this meeting. Agenda items are subject to change as necessary or appropriate. The agenda, webinar information, Committee Roster, Charter, presentations, and other meeting materials will be available on the Committee's Web site at 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 Friday, February 5, 2016, 11:59 p.m. Eastern Time. Written comments must be received by the deadline of January 29, 2016, 11:59 p.m. Eastern Time in order to be included in the February 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. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2016-01432 Filed 1-25-16; 8:45 am] BILLING CODE 4165-15-P
![4312 Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices
University, is announcing a public lunches for the 2.5 days of the • Medicines and Healthcare products
conference entitled ‘‘FDA/Xavier conference. There will be onsite Regulatory Agency (MHRA) Update:
University PharmaLink Conference: registration. The cost of registration is as Strategic Priorities and Initiatives
Increasing Product Confidence’’. The follows: • Operating in India and Southeast
PharmaLink conference seeks solutions Asia
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challenges the status quo and • Pharmaceutical Metrics and the
Small Business (<100 employees) 1,295
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Harmonisation Q12: Technical and
DATES: The public conference will be pany is free; all four attendees must register at Regulatory Considerations for
held on March 16, 2016, from 8:30 a.m. the same time. Pharmaceutical Product Lifecycle
to 5 p.m.; March 17, 2016, from 8:30 Management
The following forms of payment will • Barriers to Quality and Supply
a.m. to 5p.m.; and March 18, 2016, from
be accepted: American Express, Visa, Chain Excellence
8:30 a.m. to 12:20 p.m.
ADDRESSES: The public conference will
Mastercard, and company checks. To • Proactive and Systematic Quality
register online for the public conference, Implementation: Case Studies across
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University, 3800 Victory Pkwy., functional areas
Cincinnati, OH 45207; 513–745–3016.
the conference Web site at http://www. • FDA and MHRA Investigator
XavierPharmaLink.com. FDA has Insights
FOR FURTHER INFORMATION CONTACT: For verified the Web site address, but is not The conference includes:
information regarding this document: responsible for subsequent changes to • Networking by topic
Steven Eastham, Food and Drug the Web site after this document • Case Studies
Administration, Cincinnati South publishes in the Federal Register. • Small Group Discussions
Office, 36 East 7th St., Cincinnati, OH • Action Plans
To register by mail, please send your
45202; 513–246–4134, steven.eastham@ • Keynote dinner at Paul Brown
name, title, firm name, address,
fda.hhs.gov. Stadium (Home of the Cincinnati
For information regarding the telephone number, email address, and
payment information to: Xavier Bengals)
conference and registration: Mason
University, Attention: Mason Rick, 3800 The conference helps to achieve
Rick, Xavier University, 3800 Victory
Victory Pkwy., Cincinnati, OH 45207– objectives set forth in section 406 of the
Pkwy., Cincinnati, OH 45207–5471;
5471. An email will be sent confirming Food and Drug Administration
513–745–3016, rickm@xavier.edu.
your registration. Modernization Act of 1997 (21 U.S.C.
SUPPLEMENTARY INFORMATION: 393), which includes working closely
Attendees are responsible for their
I. Background own accommodations. The conference with stakeholders and maximizing the
The most pressing challenges of the headquarters hotel is the Downtown availability and clarity of information to
global pharmaceutical industry require Cincinnati Hilton Netherlands Plaza, 35 stakeholders and the public. The
solutions, which are inspired by West 5th St., Cincinnati, OH 45202, conference also is consistent with the
collaboration, to ensure the ongoing 513–421–9100. To make reservations Small Business Regulatory Enforcement
health and safety of patients. These online, please visit the ‘‘Venue & Fairness Act of 1996 (Pub. L. 104–121)
challenges include designing products Logistics’’ link at http://www.Xavier by providing outreach activities by
with the patient in mind, building PharmaLink.com. The hotel is expected Government Agencies to small
quality into the product from the onset, to sell out during this timeframe, so businesses.
selecting the right suppliers, and early reservation in the conference Dated: January 21, 2016.
considering total product lifecycle room-block is encouraged. Leslie Kux,
systems. Meeting these challenges If you need special accommodations Associate Commissioner for Policy.
requires vigilance, innovation, supply due to a disability, please contact Mason [FR Doc. 2016–01486 Filed 1–25–16; 8:45 am]
chain strategy, relationship Rick (see FOR FURTHER INFORMATION BILLING CODE 4164–01–P
management, proactive change CONTACT) at least 7 days in advance of
management, and a commitment to the conference.
doing the job right the first time. FDA B. Purpose and Scope of Meeting DEPARTMENT OF HEALTH AND
has made education of the drug and HUMAN SERVICES
device manufacturing community a high The public conference helps fulfill the
priority to help ensure the quality of Department of Health and Human Health Resources and Services
FDA-regulated drugs and devices. Services and FDA’s important mission Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
to protect the public health. The
II. Meeting Information Advisory Committee on Heritable
conference will engage those involved
A. Registration in FDA-regulated global supply chain Disorders in Newborns and Children;
quality and management through the Notice of Meeting
There is a registration fee. The
conference registration fees cover the following topics: In accordance with section 10(a)(2) of
cost of the presentations, training • Office of Compliance Update the Federal Advisory Committee Act
materials, receptions, breakfasts and • Data Integrity (Public Law 92–463, codified at 5 U.S.C.
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![Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 4313
App.), notice is hereby given of the providers; (2) updates from workgroups Rockville, Maryland 20857; email:
following meeting: focused on cost analysis in newborn aharris@hrsa.gov.
Name: Advisory Committee on screening, newborn screening More information on the Advisory
Heritable Disorders in Newborns and timeliness, and pilot studies for future Committee is available at http://www.
Children nominated conditions; and (3) a hrsa.gov/advisorycommittees/
Dates and Times: February 11, 2016, discussion on proposed priorities and mchbadvisory/heritabledisorders.
8:30 a.m. to 5:00 p.m., February 12, action items from the three
2016, 8:30 a.m. to 3:00 p.m. subcommittees (Laboratory Standards Jackie Painter,
Place: Webinar and In-Person, and Procedures, Follow-up and Director, Division of the Executive Secretariat.
National Institutes of Health, 45 Center Treatment, and Education and Training) [FR Doc. 2016–01432 Filed 1–25–16; 8:45 am]
Drive Room, Bethesda, MD 20892. to develop a plan for 2016. There are no BILLING CODE 4165–15–P
Status: The meeting will be open to votes that involve proposed additions of
the public with attendance limited to a condition to the RUSP scheduled for
space availability. Participants also have this meeting. DEPARTMENT OF HEALTH AND
the option of viewing the meeting via Agenda items are subject to change as HUMAN SERVICES
webinar. Whether attending in-person necessary or appropriate. The agenda,
or via webinar, all participants must webinar information, Committee Roster, National Institutes of Health
register for the meeting. The registration Charter, presentations, and other
link will be made available at http:// National Institute of Diabetes and
meeting materials will be available on
www.hrsa.gov/advisorycommittees/ Digestive and Kidney Diseases; Notice
the Committee’s Web site at http://www.
mchbadvisory/heritabledisorders/. The of Closed Meetings
hrsa.gov/advisorycommittees/mchb
registration deadline is Friday, February advisory/heritabledisorders. Pursuant to section 10(d) of the
5, 2016, 11:59 p.m. Eastern Time. Public Comments: Members of the Federal Advisory Committee Act, as
Purpose: The Advisory Committee on public may present oral comments and/ amended (5 U.S.C. App.), notice is
Heritable Disorders in Newborns and or submit written comments. Comments hereby given of the following meetings.
Children (Committee), as authorized by are part of the official Committee record. The meetings will be closed to the
Public Health Service Act, Title XI, The public comment period is public in accordance with the
§ 1111 (42 U.S.C. 300b–10), as amended tentatively scheduled for both days of provisions set forth in sections
by the Newborn Screening Saves Lives the meeting. Advance registration is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Reauthorization Act of 2014 (Pub. L. required to present oral comments and/ as amended. The grant applications and
113–240), was established to advise the or submit written comments.
Secretary of the Department of Health the ≤discussions could disclose
Registration information will be on the confidential trade secrets or commercial
and Human Services about the Committee Web site at http://www.hrsa.
development of newborn screening property such as patentable material,
gov/advisorycommittees/mchbadvisory/ and personal information concerning
activities, technologies, policies, heritabledisorders. The registration
guidelines, and programs for effectively individuals associated with the grant
deadline for public comments is Friday, applications, the disclosure of which
reducing morbidity and mortality in February 5, 2016, 11:59 p.m. Eastern
newborns and children having, or at risk would constitute a clearly unwarranted
Time. Written comments must be invasion of personal privacy.
for, heritable disorders. In addition, the received by the deadline of January 29,
Committee’s recommendations 2016, 11:59 p.m. Eastern Time in order Name of Committee: National Institute of
regarding additional conditions/ to be included in the February meeting Diabetes and Digestive and Kidney Diseases
heritable disorders for screening that Special Emphasis Panel; R24 Telephone
briefing book. Written comments should
have been adopted by the Secretary are Review SEP.
identify the individual’s name, address, Date: February 17, 2016.
included in the Recommended Uniform email, telephone number, professional Time: 3:00 p.m. to 4:00 p.m.
Screening Panel (RUSP) and constitute or business affiliation, type of expertise Agenda: To review and evaluate grant
part of the comprehensive guidelines (i.e., parent, researcher, clinician, public applications.
supported by the Health Resources and health, etc.), and the topic/subject Place: National Institutes of Health, Two
Services Administration. Pursuant to matter of comments. To ensure that all Democracy Plaza, 6707 Democracy
section 2713 of the Public Health individuals who have registered to make Boulevard, Bethesda, MD 20892 (Telephone
Service Act, codified at 42 U.S.C. oral comments can be accommodated, Conference Call).
300gg–13, non-grandfathered health the allocated time may be limited. Contact Person: Xiaodu Guo, MD, Ph.D.,
plans and group and individual health Scientific Review Officer, Review Branch,
Individuals who are associated with
DEA, Niddk, National Institutes of Health,
insurance issuers are required to cover groups or have similar interests may be Room 761, 6707 Democracy Boulevard,
evidence-informed care and screenings requested to combine their comments Bethesda, MD 20892–5452, (301) 594–4719,
included in the HRSA-supported and present them through a single guox@extra.niddk.nih.gov.
comprehensive guidelines without representative. No audiovisual Name of Committee: National Institute of
charging a co-payment, co-insurance, or presentations are permitted. For Diabetes and Digestive and Kidney Diseases
deductible for plan years (in the additional information or questions on Special Emphasis Panel; A Community
individual market, policy years) public comments, please contact Alaina Research Resource of Microbiome-Derived
beginning on or after the date that is 1 Harris, Maternal and Child Health Factors Modulating Host Physiology in
year from the Secretary’s adoption of the Bureau, Health Resources and Services Obesity, Digestive and Liver Diseases and
Nutrition (R24).
mstockstill on DSK4VPTVN1PROD with NOTICES
condition for screening. Administration; email: aharris@
Agenda: The meeting will include: (1) hrsa.gov. Date: February 29, 2016.
A panel discussion on Long Term Contact Person: Anyone interested in Time: 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
Follow-up activities regarding newborns obtaining other relevant information applications.
and children identified with a condition should contact Alaina Harris, Maternal Place: National Institutes of Health, Two
via newborn screening. Presentations and Child Health Bureau, Health Democracy Plaza, 6707 Democracy
may include perspectives from state Resources and Services Administration, Boulevard, Bethesda, MD 20892 (Telephone
public health experts, researchers, and Room 18W66, 5600 Fishers Lane, Conference Call).
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Document Created: 2018-02-02 12:37:49
Document Modified: 2018-02-02 12:37:49
| 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 4312 |
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