Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 4312-4313 [2016-01432]

Download as PDF 4312 Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES University, is announcing a public conference entitled ‘‘FDA/Xavier University PharmaLink Conference: Increasing Product Confidence’’. The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, featuring presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom, to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialogue, which has led to innovative initiatives. DATES: The public conference will be held on March 16, 2016, from 8:30 a.m. to 5 p.m.; March 17, 2016, from 8:30 a.m. to 5p.m.; and March 18, 2016, from 8:30 a.m. to 12:20 p.m. ADDRESSES: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207; 513–745–3016. FOR FURTHER INFORMATION CONTACT: For information regarding this document: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East 7th St., Cincinnati, OH 45202; 513–246–4134, steven.eastham@ fda.hhs.gov. For information regarding the conference and registration: Mason Rick, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207–5471; 513–745–3016, rickm@xavier.edu. SUPPLEMENTARY INFORMATION: I. Background The most pressing challenges of the global pharmaceutical industry require solutions, which are inspired by collaboration, to ensure the ongoing health and safety of patients. These challenges include designing products with the patient in mind, building quality into the product from the onset, selecting the right suppliers, and considering total product lifecycle systems. Meeting these challenges requires vigilance, innovation, supply chain strategy, relationship management, proactive change management, and a commitment to doing the job right the first time. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. II. Meeting Information A. Registration There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts and VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 • Medicines and Healthcare products Regulatory Agency (MHRA) Update: Strategic Priorities and Initiatives • Operating in India and Southeast Asia • Serialization TABLE 1—REGISTRATION FEES 1 • Integrity of Supply Standard • Office of Pharmaceutical Quality Attendee type rate Update • How to Measure Quality Culture Industry ......................................... $1,895 • Pharmaceutical Metrics and the Small Business (<100 employees) 1,295 Supplier ......................................... 600 Value Proposition • Office of Regulatory Affairs Update Start-up Manufacturer ................... 300 • The 21st Century Cures Act: Goals Academic ...................................... 300 Media ............................................ Free and Impact • International Conference on Government .................................. Free Harmonisation Q12: Technical and 1 The fourth registration from the same company is free; all four attendees must register at Regulatory Considerations for Pharmaceutical Product Lifecycle the same time. Management The following forms of payment will • Barriers to Quality and Supply be accepted: American Express, Visa, Chain Excellence Mastercard, and company checks. To • Proactive and Systematic Quality register online for the public conference, Implementation: Case Studies across please visit the ‘‘Registration’’ link on functional areas the conference Web site at https://www. • FDA and MHRA Investigator XavierPharmaLink.com. FDA has Insights verified the Web site address, but is not The conference includes: responsible for subsequent changes to • Networking by topic the Web site after this document • Case Studies publishes in the Federal Register. • Small Group Discussions • Action Plans To register by mail, please send your • Keynote dinner at Paul Brown name, title, firm name, address, Stadium (Home of the Cincinnati telephone number, email address, and Bengals) payment information to: Xavier The conference helps to achieve University, Attention: Mason Rick, 3800 objectives set forth in section 406 of the Victory Pkwy., Cincinnati, OH 45207– Food and Drug Administration 5471. An email will be sent confirming Modernization Act of 1997 (21 U.S.C. your registration. 393), which includes working closely Attendees are responsible for their with stakeholders and maximizing the own accommodations. The conference availability and clarity of information to headquarters hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 stakeholders and the public. The conference also is consistent with the West 5th St., Cincinnati, OH 45202, Small Business Regulatory Enforcement 513–421–9100. To make reservations Fairness Act of 1996 (Pub. L. 104–121) online, please visit the ‘‘Venue & by providing outreach activities by Logistics’’ link at https://www.Xavier PharmaLink.com. The hotel is expected Government Agencies to small businesses. to sell out during this timeframe, so early reservation in the conference Dated: January 21, 2016. room-block is encouraged. Leslie Kux, If you need special accommodations Associate Commissioner for Policy. due to a disability, please contact Mason [FR Doc. 2016–01486 Filed 1–25–16; 8:45 am] Rick (see FOR FURTHER INFORMATION BILLING CODE 4164–01–P CONTACT) at least 7 days in advance of the conference. DEPARTMENT OF HEALTH AND B. Purpose and Scope of Meeting HUMAN SERVICES The public conference helps fulfill the Health Resources and Services Department of Health and Human Administration Services and FDA’s important mission to protect the public health. The Advisory Committee on Heritable conference will engage those involved Disorders in Newborns and Children; in FDA-regulated global supply chain Notice of Meeting quality and management through the following topics: In accordance with section 10(a)(2) of • Office of Compliance Update the Federal Advisory Committee Act • Data Integrity (Public Law 92–463, codified at 5 U.S.C. lunches for the 2.5 days of the conference. There will be onsite registration. The cost of registration is as follows: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 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 https:// 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, § 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 VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 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 https://www. hrsa.gov/advisorycommittees/mchb advisory/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 https://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: 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 00069 Fmt 4703 Sfmt 4703 4313 Rockville, Maryland 20857; email: aharris@hrsa.gov. More information on the Advisory Committee is available at https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings 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 meetings. The meetings 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 Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; R24 Telephone Review SEP. Date: February 17, 2016. Time: 3:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Xiaodu Guo, MD, Ph.D., Scientific Review Officer, Review Branch, DEA, Niddk, National Institutes of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; A Community Research Resource of Microbiome-Derived Factors Modulating Host Physiology in Obesity, Digestive and Liver Diseases and Nutrition (R24). Date: February 29, 2016. Time: 12:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). E:\FR\FM\26JAN1.SGM 26JAN1

Agencies

[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4312-4313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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 https://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 https://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: 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 https://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

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