Meeting of the Advisory Committee on Infant Mortality, 59390-59391 [2019-24060]

Download as PDF 59390 Federal Register / Vol. 84, No. 213 / Monday, November 4, 2019 / Notices modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will be asked to discuss new drug application (NDA) 022034, for vernakalant HCl solution, for intravenous injection, submitted by Correvio International Sa`rl, for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients: Atrial fibrillation ≤7 days duration, and for post-cardiac surgery patients: Atrial fibrillation ≤3 days duration. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before November 25, 2019, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 15, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public VerDate Sep<11>2014 20:48 Nov 01, 2019 Jkt 250001 hearing session. The contact person will notify interested persons regarding their request to speak by November 18, 2019. Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Yinghua S. Wang (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 29, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–23978 Filed 11–1–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Infant Mortality Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary’s Advisory Committee on Infant Mortality (ACIM or Committee) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisorycommittees/infant-mortality/index.html. DATES: December 4–5, 2019, 9:00 a.m.– 5:00 p.m. Eastern Time (ET). ADDRESSES: This meeting will be held in-person and via webinar. The address for the meeting is 5600 Fishers Lane, Rockville, Maryland 20857. SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 • The webinar link will be available at ACIM’s website: https:// www.hrsa.gov/advisory-committees/ infant-mortality/index.html. • The conference call-in number will be available at ACIM’s website: https:// www.hrsa.gov/advisory-committees/ infant-mortality/index.html. FOR FURTHER INFORMATION CONTACT: David S. de la Cruz, Ph.D., MPH, Designated Federal Official, (DFO), Maternal and Child Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Room 18N25, Rockville, Maryland 20857; at 301–443–0543 or dcruz@ hrsa.gov. SUPPLEMENTARY INFORMATION: The ACIM advises the Secretary of HHS on department activities and programs directed at reducing infant mortality and improving the health status of pregnant women and infants. The ACIM represents a public-private partnership at the highest level to provide guidance and focus attention on the policies and resources required to address the reduction of infant mortality and the improvement of the health status of pregnant women and infants. With a focus on life course, the ACIM addresses disparities in maternal health to improve maternal health outcomes, including preventing and reducing maternal mortality and severe maternal morbidity. The ACIM provides advice on how best to coordinate the myriad of federal, state, local, and private programs and efforts that are designed to deal with the health and social problems impacting infant mortality and maternal health, including implementation of the Healthy Start program and maternal and infant health objectives from the National Health Promotion and Disease Prevention Objectives. The ACIM is authorized by section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended. The Committee is governed by 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. The agenda for the December 4–5, 2019, meeting is being finalized and may include the following: Updates from the HRSA Maternal and Child Health Bureau (MCHB), Centers for Disease Control and Prevention, and the MCHB Healthy Start program; introduction of members; briefing on infant mortality and health disparity data in the U.S.; the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Act; and discussions on future topics areas for ACIM to address. Agenda items are subject to change as E:\FR\FM\04NON1.SGM 04NON1 Federal Register / Vol. 84, No. 213 / Monday, November 4, 2019 / Notices priorities dictate. The final meeting agenda will be available 2 days prior to the meeting on the Committee’s website: https://www.hrsa.gov/advisorycommittees/Infant-Mortality/index.html. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to the ACIM should be sent to David S. de la Cruz, DFO, using the contact information above at least 3 business days prior to the meeting. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify David S. de la Cruz at the address and phone number listed above at least 10 business days prior to the meeting. Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2019–24060 Filed 11–1–19; 8:45 am] Dated: October 29, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2019–23991 Filed 11–1–19; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. VerDate Sep<11>2014 20:48 Nov 01, 2019 Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; STIMULATE: T4 Implementation Research for HLBS Diseases and Disorders. Date: December 10, 2019. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015. Contact Person: Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National, Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 20892, susan.sunnarborg@nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Mentored Career Development Awards—K01, K08, K23. Date: December 16, 2019. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Lindsay M. Garvin, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Suite 7189, Bethesda, MD 20892, 301–827–7911, lindsay.garvin@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Jkt 250001 National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 59391 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Endocrinology, Metabolism and Nutrition. Date: November 20, 2019. Time: 1:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive Bethesda, MD 20892 (Virtual Meeting). Contact Person: Gregory S. Shelness, Ph.D., Scientific Review Officer Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6156, Bethesda, MD 20892–7892, (301) 435–0492, shelnessgs@ csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–HL– 20–005: Late-Stage Implementation Research Addressing Hypertension in Low and Middle-Income Countries: Scaling Up Proven-Effective Interventions. Date: November 21, 2019. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive Bethesda, MD 20892 (Virtual Meeting). Contact Person: Brian H. Scott, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301– 827–7490, brianscott@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel RFA–HL– 20–005: Late-Stage Implementation Research Addressing Hypertension in Low- and Middle-Income Countries: Scaling Up Proven-Effective Interventions. Date: November 21, 2019. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892, (301) 237– 9838, bhagavas@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Toxicology and Digestive, Kidney and Urological Systems AREA/REAP Review. Date: November 21, 2019. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive Bethesda, MD 20892 (Virtual Meeting). Contact Person: Aiping Zhao, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2188, MSC 7818, Bethesda, MD 20892–7818, (301) 435–0682, zhaoa2@csr.nih.gov. E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 84, Number 213 (Monday, November 4, 2019)]
[Notices]
[Pages 59390-59391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Meeting of the Advisory Committee on Infant Mortality

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Secretary's Advisory Committee on Infant 
Mortality (ACIM or Committee) has scheduled a public meeting. 
Information about ACIM and the agenda for this meeting can be found on 
the ACIM website at https://www.hrsa.gov/advisory-committees/infant-mortality/index.html.

DATES: December 4-5, 2019, 9:00 a.m.-5:00 p.m. Eastern Time (ET).

ADDRESSES: This meeting will be held in-person and via webinar. The 
address for the meeting is 5600 Fishers Lane, Rockville, Maryland 
20857.
     The webinar link will be available at ACIM's website: 
https://www.hrsa.gov/advisory-committees/infant-mortality/index.html.
     The conference call-in number will be available at ACIM's 
website: https://www.hrsa.gov/advisory-committees/infant-mortality/index.html.

FOR FURTHER INFORMATION CONTACT: David S. de la Cruz, Ph.D., MPH, 
Designated Federal Official, (DFO), Maternal and Child Health Bureau 
(MCHB), HRSA, 5600 Fishers Lane, Room 18N25, Rockville, Maryland 20857; 
at 301-443-0543 or [email protected].

SUPPLEMENTARY INFORMATION: The ACIM advises the Secretary of HHS on 
department activities and programs directed at reducing infant 
mortality and improving the health status of pregnant women and 
infants. The ACIM represents a public-private partnership at the 
highest level to provide guidance and focus attention on the policies 
and resources required to address the reduction of infant mortality and 
the improvement of the health status of pregnant women and infants. 
With a focus on life course, the ACIM addresses disparities in maternal 
health to improve maternal health outcomes, including preventing and 
reducing maternal mortality and severe maternal morbidity. The ACIM 
provides advice on how best to coordinate the myriad of federal, state, 
local, and private programs and efforts that are designed to deal with 
the health and social problems impacting infant mortality and maternal 
health, including implementation of the Healthy Start program and 
maternal and infant health objectives from the National Health 
Promotion and Disease Prevention Objectives. The ACIM is authorized by 
section 222 of the Public Health Service Act (42 U.S.C. 217a), as 
amended. The Committee is governed by 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.
    The agenda for the December 4-5, 2019, meeting is being finalized 
and may include the following: Updates from the HRSA Maternal and Child 
Health Bureau (MCHB), Centers for Disease Control and Prevention, and 
the MCHB Healthy Start program; introduction of members; briefing on 
infant mortality and health disparity data in the U.S.; the Prematurity 
Research Expansion and Education for Mothers who deliver Infants Early 
(PREEMIE) Act; and discussions on future topics areas for ACIM to 
address. Agenda items are subject to change as

[[Page 59391]]

priorities dictate. The final meeting agenda will be available 2 days 
prior to the meeting on the Committee's website: https://www.hrsa.gov/
advisory-committees/Infant-Mortality/index.html.
    Members of the public will have the opportunity to provide 
comments. Public participants may submit written statements in advance 
of the scheduled meeting. Oral comments will be honored in the order 
they are requested and may be limited as time allows. Requests to 
submit a written statement or make oral comments to the ACIM should be 
sent to David S. de la Cruz, DFO, using the contact information above 
at least 3 business days prior to the meeting.
    Individuals who plan to attend and need special assistance or 
another reasonable accommodation should notify David S. de la Cruz at 
the address and phone number listed above at least 10 business days 
prior to the meeting. Since this meeting occurs in a federal government 
building, attendees must go through a security check to enter the 
building. Non-U.S. Citizen attendees must notify HRSA of their planned 
attendance at least 20 business days prior to the meeting in order to 
facilitate their entry into the building. All attendees are required to 
present government-issued identification prior to entry.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-24060 Filed 11-1-19; 8:45 am]
 BILLING CODE 4165-15-P