Notice of Public Meeting of the President's Emergency Plan for AIDS Relief (PEPFAR) Scientific Advisory Board, 50739-50740 [2018-21856]

Download as PDF Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices Commission’s headquarters, 100 F Street NE, Washington, DC 20549. STATUS: This meeting will begin at 1:00 p.m. (ET) and will be open to the public. Seating will be on a first-come, firstserved basis. Visitors will be subject to security checks. The meeting will be webcast on the Commission’s website at www.sec.gov. MATTERS TO BE CONSIDERED: 1. The Commission will consider whether to reopen the comment period and request additional comment (including potential modifications to proposed rule language) regarding: (1) Capital, margin, and segregation requirements for security-based swap dealers and major security-based swap participants, and amendments to Rule 15c3–1 for broker-dealers proposed in October 2012; (2) amendments proposed in May 2013 that would establish the cross-border treatment of security-based swap capital, margin, and segregation requirements; and (3) an amendment proposed in April 2014 that would establish an additional capital requirement for security-based swap dealers that do not have a prudential regulator. At times, changes in Commission priorities require alterations in the scheduling of meeting items. CONTACT PERSON FOR MORE INFORMATION: For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Brent J. Fields from the Office of the Secretary at (202) 551–5400. Dated: October 3, 2018. Brent J. Fields, Secretary. [FR Doc. 2018–21995 Filed 10–4–18; 4:15 pm] BILLING CODE 8011–01–P DEPARTMENT OF STATE [Delegation of Authority No. 460] amozie on DSK3GDR082PROD with NOTICES1 Delegation of Authority by the Secretary of State to the Administrator of the United States Agency for International Development of Functions and Authorities Under the Reinforcing Education Accountability in Development Act By virtue of the authority vested in the Secretary of State by the laws of the United States, including section 1 of the State Department Basic Authorities Act (22 U.S.C. 2651a), and the Memorandum of the President dated August 31, 2018, I hereby delegate to the Administrator of the United States Agency for International Development the functions and authorities conferred VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 upon the President by sections 4, 6, and 7 of the Reinforcing Education Accountability in Development (READ) Act (Div. A, Pub. L. 115–56). Any reference in this delegation of authority to any act shall be deemed to be a reference to such act as amended from time to time. The Administrator of the United States Agency for International Development may redelegate the functions delegated by this delegation of authority, as appropriate, to the extent authorized by law. This document shall be published in the Federal Register. Dated: September 13, 2018. Michael R. Pompeo, Secretary of State, Department of State. [FR Doc. 2018–21897 Filed 10–5–18; 8:45 am] BILLING CODE 4710–10–P DEPARTMENT OF STATE [Public Notice: 10583] Notice of Public Meeting of the President’s Emergency Plan for AIDS Relief (PEPFAR) Scientific Advisory Board In accordance with the Federal Advisory Committee Act (FACA), the PEPFAR Scientific Advisory Board (hereinafter referred to as ‘‘the Board’’) will meet on Friday, October 12, 2018 at 1800 G St. NW, Suite 10300, Washington, DC 20006. The meeting will last from 8:30 a.m. until approximately 5:00 p.m. and is open to the public. The meeting will be hosted by the Office of the U.S. Global AIDS Coordinator and Health Diplomacy, and led by Ambassador Deborah Birx, who leads implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR), and the Board Chair, Dr. Carlos del Rio. The Board serves solely in an advisory capacity concerning scientific developments, program implementation, and policy matters related to the global response to the HIV epidemic, which can influence the priorities and direction of PEPFAR evaluation and research, the content of national and international strategies, and the role of PEPFAR in international discourse regarding an appropriate and resourced response. Topics for the meeting will include the risks and benefits of fixed-dose Dolutegravir in light of a preliminary safety signal for women using it at the time of conception; approaches for monitoring progress as countries approach epidemic control; HPV vaccination to prevent cervical cancer; and new data from the Determined, Resilient, PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 50739 Empowered, AIDS-Free, Mentored, and Safe (DREAMS) initiative. The public may attend this meeting as seating capacity allows. Admittance to the meeting will be by means of a prearranged clearance list. In order to be placed on the list and, if applicable, to request reasonable accommodation, please register online as soon as possible (https://docs.google.com/forms/d/e/ 1FAIpQLSccvU95o_2MsSn8jRwGI4r9 kpxBSkOQ-nARjdwNaa3HIn8PMg/ viewform?c=0&w=1). While the meeting is open to public attendance, the Board will determine procedures for public participation. This announcement will appear in the Federal Register less than 15 days prior to the meeting. The Department of State finds that there is an exceptional circumstance in that this advisory committee meeting must be held on October 12th for the following reasons: • On May 18, the World Health Organization (WHO) issued recommendations for Dolutegravir use by women of childbearing age living with HIV, following unscheduled, interim analysis of an ongoing observational study in Botswana that found an increased risk of neural tube defects in children born to women taking Dolutegravir at the time of conception. • The final results of the study, which are needed to confirm or dispel these observations, are expected in early 2019. • However, many countries have taken a very conservative interpretation of WHO’s recommendations and are withholding a preferred first-line antiretroviral medication from women of child-bearing age, who constitute the majority of persons receiving HIV medical treatment in PEPFARsupported programs. • These policies deny women access to a regimen that offers superior time-toviral suppression, side effect, and resistance profiles. • Two independent modeling studies have shown that the clinical and public health benefits of Dolutegravir vastly outweigh the risk of possible and rare, birth defects. A consultation with African women living with HIV infection underscored that they be permitted to make informed decisions about their own medical care and to opt to take Dolutegravir rather than other, inferior regimens. Given the above facts, the Department urgently needs the advice of the PEPFAR SAB to inform treatment considerations that the Department must release as part of its 2019 Country Operational Plan guidance that will be developed in November-December 2018, for release in January 2019. October E:\FR\FM\09OCN1.SGM 09OCN1 50740 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices 12th is the only date in the near future when both the members of the SAB and Ambassador Birx are available to meet on this issue. For further information about the meeting, please contact Dr. Andrew Forsyth, Designated Federal Officer for the Board, Office of the U.S. Global AIDS Coordinator and Health Diplomacy (ForsythAD@state.gov). Andrew D. Forsyth, Office of the U.S. Global AIDS Coordinator and Health Diplomacy, Department of State. [FR Doc. 2018–21856 Filed 10–5–18; 8:45 am] BILLING CODE 4710–10–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Reinstated Approval of Information Collection: Flight Simulation Device Initial and Continuing Qualification and Use Federal Aviation Administration (FAA), DOT. ACTION: Notice and request for comments. AGENCY: In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. This request for clearance reflects requirements necessary under regulations to ensure safety-of-flight by ensuring that complete and adequate training, testing, checking, and experience is obtained and maintained by those who operate under regulation and use flight simulation in lieu of aircraft for these functions. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on November 30, 2017. DATES: Written comments should be submitted by November 8, 2018. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/FAA, and sent via electronic mail to oira_ submission@omb.eop.gov, or faxed to (202) 395–6974, or mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503. Public Comments Invited: You are asked to comment on any aspect of this information collection, including (a) Whether the proposed collection of information is necessary for FAA’s performance; (b) the accuracy of the estimated burden; (c) ways for FAA to enhance the quality, utility and clarity of the information collection; and (d) ways that the burden could be minimized without reducing the quality of the collected information. The agency will summarize and/or include your comments in the request for OMB’s clearance of this information collection. FOR FURTHER INFORMATION CONTACT: Barbara Hall by email at: Barbara.L.Hall@faa.gov; phone: 940– 594–5913. SUPPLEMENTARY INFORMATION: OMB Control Number: 2120–0680. Title: Flight Simulation Device Initial and Continuing Qualification and Use. Form Numbers: (Pending) Forms T001A, T002, T004, T011, T011–FD2, T012, T023, T024, T025. Type of Review: This is a reinstatement of an information collection. Background: This information collection requires sponsors of flight simulation training devices (FSTD) to systematically plan for and implement the requirements of part 60 and the associated Qualification Performance Standard (QPS). Sponsors have been sub-grouped into small, medium, and large based on the number of training centers. A sponsor will be guided through the administrative requirements by the local principal operations inspector or training center program manager and by representatives of the National Simulator Program staff regarding any FSTD for which the sponsor applicant seeks qualification. The FAA has determined this information collection is necessary to amend the Qualification Performance Standards for FSTDs for the primary purpose of improving existing technical standards and introducing new technical standards for full stall and stick pusher maneuvers, upset recognition and recovery maneuvers, maneuvers conducted in airborne icing conditions, takeoff and landing maneuvers in gusting crosswinds, and bounced landing recovery maneuvers. These new and improved technical standards are intended to fully define FSTD fidelity requirements for conducting new flight training tasks introduced through changes to the air carrier training requirements. This information collection also addresses PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 updated FSTD technical standards to better align with the current international FSTD evaluation guidance and introduces a new FSTD level that expands the number of qualified flight training tasks in a fixed base flight training device. This information collection will help ensure that the training and testing environment is accurate and realistic, in accordance with regulations. The specific regulations are Title 14 CFR part 61, part 63, part 91, part 121, part 135, part 141, and part 142. Respondents: The estimate is based on a current sponsor count of 68 that changes on a continuous basis. Frequency: Annual. Estimated Average Burden per Response: 44 minutes. Estimated Total Annual Burden: 93,385 hours. Issued in Fort Worth, TX, on September 4, 2018. Barbara L. Hall, FAA Information Collection Clearance Officer, Performance, Policy, and Records Management Branch, ASP–110. [FR Doc. 2018–21885 Filed 10–5–18; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: 2120–0043 Federal Aviation Administration (FAA), DOT. ACTION: Notice and request for comments. AGENCY: In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The collection involves return to the Civil Aviation Aircraft Registry of information relating to the release of a lien that has been recorded with the Registry. Regulations provide for establishing and maintaining a system for the recording of security conveyances affecting title to, or interest in U.S. civil aircraft, as well as certain specifically identified engines, propellers, or spare parts locations, and for recording of releases relating to those conveyances. Federal Aviation Regulations establish procedures for implementation. Regulations describe what information must be contained in a security conveyance in order for it to SUMMARY: E:\FR\FM\09OCN1.SGM 09OCN1

Agencies

[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Pages 50739-50740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21856]


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

DEPARTMENT OF STATE

[Public Notice: 10583]


Notice of Public Meeting of the President's Emergency Plan for 
AIDS Relief (PEPFAR) Scientific Advisory Board

    In accordance with the Federal Advisory Committee Act (FACA), the 
PEPFAR Scientific Advisory Board (hereinafter referred to as ``the 
Board'') will meet on Friday, October 12, 2018 at 1800 G St. NW, Suite 
10300, Washington, DC 20006. The meeting will last from 8:30 a.m. until 
approximately 5:00 p.m. and is open to the public. The meeting will be 
hosted by the Office of the U.S. Global AIDS Coordinator and Health 
Diplomacy, and led by Ambassador Deborah Birx, who leads implementation 
of the President's Emergency Plan for AIDS Relief (PEPFAR), and the 
Board Chair, Dr. Carlos del Rio.
    The Board serves solely in an advisory capacity concerning 
scientific developments, program implementation, and policy matters 
related to the global response to the HIV epidemic, which can influence 
the priorities and direction of PEPFAR evaluation and research, the 
content of national and international strategies, and the role of 
PEPFAR in international discourse regarding an appropriate and 
resourced response. Topics for the meeting will include the risks and 
benefits of fixed-dose Dolutegravir in light of a preliminary safety 
signal for women using it at the time of conception; approaches for 
monitoring progress as countries approach epidemic control; HPV 
vaccination to prevent cervical cancer; and new data from the 
Determined, Resilient, Empowered, AIDS-Free, Mentored, and Safe 
(DREAMS) initiative.
    The public may attend this meeting as seating capacity allows. 
Admittance to the meeting will be by means of a pre-arranged clearance 
list. In order to be placed on the list and, if applicable, to request 
reasonable accommodation, please register online as soon as possible 
(https://docs.google.com/forms/d/e/1FAIpQLSccvU95o_2MsSn8jRwGI4r9kpxBSkOQ-nARjdwNaa3HIn8PMg/viewform?c=0&w=1). While the meeting is open to public attendance, the 
Board will determine procedures for public participation.
    This announcement will appear in the Federal Register less than 15 
days prior to the meeting. The Department of State finds that there is 
an exceptional circumstance in that this advisory committee meeting 
must be held on October 12th for the following reasons:
     On May 18, the World Health Organization (WHO) issued 
recommendations for Dolutegravir use by women of childbearing age 
living with HIV, following unscheduled, interim analysis of an ongoing 
observational study in Botswana that found an increased risk of neural 
tube defects in children born to women taking Dolutegravir at the time 
of conception.
     The final results of the study, which are needed to 
confirm or dispel these observations, are expected in early 2019.
     However, many countries have taken a very conservative 
interpretation of WHO's recommendations and are withholding a preferred 
first-line antiretroviral medication from women of child-bearing age, 
who constitute the majority of persons receiving HIV medical treatment 
in PEPFAR-supported programs.
     These policies deny women access to a regimen that offers 
superior time-to-viral suppression, side effect, and resistance 
profiles.
     Two independent modeling studies have shown that the 
clinical and public health benefits of Dolutegravir vastly outweigh the 
risk of possible and rare, birth defects. A consultation with African 
women living with HIV infection underscored that they be permitted to 
make informed decisions about their own medical care and to opt to take 
Dolutegravir rather than other, inferior regimens.
    Given the above facts, the Department urgently needs the advice of 
the PEPFAR SAB to inform treatment considerations that the Department 
must release as part of its 2019 Country Operational Plan guidance that 
will be developed in November-December 2018, for release in January 
2019. October

[[Page 50740]]

12th is the only date in the near future when both the members of the 
SAB and Ambassador Birx are available to meet on this issue.
    For further information about the meeting, please contact Dr. 
Andrew Forsyth, Designated Federal Officer for the Board, Office of the 
U.S. Global AIDS Coordinator and Health Diplomacy 
([email protected]).

Andrew D. Forsyth,
Office of the U.S. Global AIDS Coordinator and Health Diplomacy, 
Department of State.
[FR Doc. 2018-21856 Filed 10-5-18; 8:45 am]
 BILLING CODE 4710-10-P
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