[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]


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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