National Institute of Allergy & Infectious Diseases, NIH DAIDS Multinational Data and Safety Monitoring Board

Clinical Trials Review Meeting

November 8, 2017

LOGISTICAL FACT SHEET FOR DSMB MEMBERS

Meeting Location: Department of Health and Human Services National Institutes of Health Room LD30A&B / Break-out Room LD40 5601 Fishers Lane Rockville, MD 20892 Telephone: 240.292.4701 Fax: 240.627.3110

Security Requirements: Please allow time for security screening when entering the building. A photo identification is required and all personal effects will be screened. Visitors will receive an ID badge that will allow access to the lower ground and lobby levels ONLY and must be visible at all times.

Tentative Agenda: Wednesday, November 8, 2017 9:00 a.m.-9:15 a.m. EST ADMINISTRATIVE SESSION: (CLOSED) 9:15 a.m.-10:15 a.m. EST WRHI 060/ADVANCE: SAFETY REVIEW 10:15 a.m.-11:15 a.m. EST WRHI 052: SAFETY REVIEW 11:15 a.m.-11:30 a.m. EST BREAK 11:30 a.m.-12:00 p.m. EST SSAT 062: ADMINISTRATIVE UPDATE 12:00 p.m.-12:30 p.m. EST LUNCH 12:30 p.m.-2:30 p.m. EST HPTN 084: PROTOCOL INITATION REVIEW 2:30 p.m.-2:45 p.m. EST BREAK 2:45 p.m.-4:15 p.m. EST HPTN 083: SAFETY REVIEW 4:15 p.m.-6:00 p.m. EST NICHD-P1081: FULL REVIEW 6:00 p.m.-6:15 p.m. EST ADMINISTRATIVE SESSION (CLOSED): ADJOURN (Sessions may be moved forward or delayed depending on the extent of discussions.)

Request for Updated Curriculum Vitae: Please provide an updated copy of your Curriculum Vitae for our files by October 11, 2017. Please date the CV.

Immigration Information: Travel to Washington, DC may require you to have a valid passport and depending upon nationality, a visa may be required for entry. You are responsible for obtaining and completing the required application and for the submission of the appropriate documents and fees to obtain a visa from a United States Embassy in your respective country. Please visit the following link for additional information http://usembassy.state.gov/

Travel Arrangements: Capital Consulting Corporation, a contractor to NIAID DAIDS will provide logistical support for this meeting. You will receive a tentative travel itinerary by email, or you may contact Jennifer Adona at (301) 468-6073 or [email protected] regarding your travel arrangements. Please note that all travel arrangements are made in accordance with the Federal Travel Regulation using a U.S. Flag carrier.

Multinational DSMB Member Factsheet – November 8, 2017 Page 1 of 4 Personal Travel: If you will be extending your trip or altering your travel arrangements to accommodate personal or other travel plans, please note you will be responsible for making the appropriate changes to your airline and/or lodging reservation. You will be responsible for all expenses incurred beyond the approved dates of travel. You are also responsible for coordinating any upgrades directly with the airline or hotel. If you are traveling with family members or friends, you will be responsible for all additional costs related to their travel. Please note additional expenses are not reimbursable.

Hotel Information: Hilton Washington DC/Rockville Hotel & Executive Meeting Center 1750 Rockville Pike Rockville, MD 20852 Telephone: 301.468.1100 Fax: 301.468.0308 http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc- rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html

A single sleeping room will be reserved in your name at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center. Your room and taxes are prepaid according to your final travel itinerary; however, you will be responsible for the guarantee and payment of incidental expenses, such as telephone calls and meals. The hotel accepts all major credit cards. Check-in time is at 4:00 p.m., and check-out time is at 12:00 noon. Individual sleeping room reservations must be cancelled 24 hours prior to check-in. Otherwise, a no-show fee equivalent to one night's room and tax expenses will be charged.

If your plans change after your itinerary has been confirmed, please notify Jennifer Adona within three business days before your arrival so that your reservation can be revised or cancelled and no-show fees can be avoided.

Honorarium: Upon completion of travel and after submission of an itemized travel expense report with original receipts, you will receive and honorarium at the rate of $200 per meeting day for your participation.

Meals: Because of the Executive Order to “Promote Efficient Spending”, federal and contract employees are forbidden to be involved in the provision or facilitation of food and/or light refreshments for meeting attendees. Therefore, we sincerely apologize we will not be able to provide any refreshments for you during this meeting or take pre-ordered food requests to provide during a working lunch session. For your convenience, there are several cafés and restaurants located inside the building that offers sandwiches, salads, beverages and other food items.

Expense Reimbursement: Meeting-related expenses are reimbursable. Upon completion of travel, please complete and submit the itemized expense report with appropriate original receipts for any taxis, airport fees, etc. Reimbursement for food is made at the Government allowable rate. The current rate for Meals and Incidentals (M&IE) in the Washington, DC area is $51.75 per travel day and $69 per non-travel day (if applicable). Rates are subject to change. Reimbursement will not exceed the current allowable rate in effect at the time of actual travel. Receipts for meals and incidental expenses are not required. Please contact Susan Kerin if you need assistance with these forms or have any questions.

Ground Transportation In Rockville, MD: Unless you specifically requested ground transportation assistance, you are responsible for arranging your ground transportation to the Multinational DSMB meeting from the

Multinational DSMB Member Factsheet – November 8, 2017 Page 2 of 4 airport or train station. The Ronald Reagan Washington National Airport serves the Washington, DC area and is approximately a 31-minute drive to the Hilton Washington DC/Rockville Hotel and an additional 2 minutes to Fishers Lane.

Please visit the following link for additional information: http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc- rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html

From Ronald Reagan Washington National Airport, you may reach the Hilton Washington DC/Rockville Hotel and Fishers Lane the following ways:

. Bendey Transportation: Follow the ground transportation signs to exit the airport. Bendey Transportation services all three Washington, DC area airports. Please notify Jennifer Adona for prepaid transportation service with Bendey Transportation.

. By Taxi: Follow the ground transportation signs to exit the airport. Taxis are located just outside the baggage claim area. The cost is approximately $50-$70 one-way to the Hilton Washington DC/Rockville Hotel.

. By Super Shuttle: Super Shuttle Service vans and town cars are available by following the ground transportation signs to exit the airport just outside of the baggage claim area. You may contact them at 1.800.258.3826 or make a reservation on-line www.supershuttle.com. The rate is approximately $29.00 each way to the hotel and there is a cost of $10.00 for each additional person. No reservations are required for pickup from the airport; however, any transport requests from the hotel back to either airport must be made at least 24 hours in advance.

. By Metro: Please visit the following link for additional metro information: http://www.wmata.com/rail/.

The Washington, DC Metrorail system has an elevated Metrorail station connected to the concourse level of terminals B and C at Ronald Reagan Washington National Airport. The station is accessible via elevators. Take the Yellow line towards Fort Totten to the Gallery Place/ Chinatown Metro Station. Then take the Red line toward Shady Grove to the Twinbrook Metro Station. The hotel is located across the West parking lot at the Twinbrook Metro Station.

Fishers Lane is approximately 0.56 miles or a 13-minute walk from the Twinbrook Metro Station. Exit the station and walk southeast on Chapman, turn left onto walkway (Parklawn Dr). Proceed east and turn left onto Twinbrook Pkwy. Turn right onto Fishers Lane and the building will be at the end of the street on the left.

. By Car: To reach the Hilton Washington DC/Rockville Hotel from Ronald Reagan Washington National Airport, take the George Washington Parkway North 12 miles to the Capital Beltway (I-495, North) toward Maryland. Proceed approximately five miles and keep left to take the I-270 spur North via exit 38 toward Rockville/Frederick. Take exit 4A to Montrose Road. Montrose Road turns into Montrose Parkway. Continue on Montrose Parkway for 1.5 miles. Turn left onto MD- 355 N/Rockville Pike. Continue on MD-355 N/Rockville Pick for 0.7 miles and the Hotel will be on the right.

. From the Hotel to Fishers Lane via Bendey Transportation Shuttle: The Hilton Washington DC/Rockville Hotel does not provide shuttle service to the Fishers Lane building. As a result, we have contracted Bendey Transportation to provide prepaid roundtrip shuttle service for DSMB meeting participants from the Hilton Washington DC/Rockville Hotel to the Fishers Lane building. Bendey Transportation will not be making multiple trips after his departure from the pick-up site. Therefore, on Wednesday, November 8th, please ensure you board the

Multinational DSMB Member Factsheet – November 8, 2017 Page 3 of 4 shuttle in a timely manner at 8:30AM in the morning. Otherwise, please make alternate arrangements for your roundtrip transportation to and from the meeting from the hotel.

Climate: The weather in Washington, DC in November will be cool, with the average temperature ranging from 58 Fahrenheit or 14 Celsius during the day, to 41 Fahrenheit or 5 Celsius during the evening; however, the hotel is climate controlled.

Parking: The Hilton Washington DC/Rockville Hotel offers parking at a daily rate of $15 per day. Public parking is located at 5635 Fishers Lane, approximately a 1- minute walk to 5601 Fishers Lane. Start going east on Twinbrook Pkwy toward Chapman Ave, then turn right on Fishers lane. Make the first left turn to access the parking garage. You may park in the garage at a daily rate of $7.00.

Important Deadlines: September 10, 2017 – Deadline to return honorarium form and current CV. Upon registration or no later than September 27th – Deadline to submit Conflict of Interest Form

Contact Information: For agenda-related questions, please contact:

Delta Saint-Vil [C], DSMB Project Manager Workforce Operations, Communications and Reporting Branch Division of AIDS, NIAID/NIH Kelly Government Solutions Phone: 240.292.4653 Mobile: 240.274.9520 Fax: 240.627.3467 E-mail: [email protected]

Jessica Santos [C], Program Analyst Workforce Operations, Communications and Reporting Branch Division of AIDS, NIAID/NIH Columbus Technologies and Services, Inc. Phone: 240.292.4701 Fax: 240.627.3110 E-mail: [email protected]

For logistical or travel-related questions and to make any special accessibility requests (e.g., sign interpretation, wheelchair ramp access, etc.), please contact:

Jennifer Adona Capital Consulting Corporation Phone: 301.468.6013 Mobile: 301.221.7222 Fax: 301.881.1734 E-mail: [email protected]

Multinational DSMB Member Factsheet – November 8, 2017 Page 4 of 4