National Institute of Allergy & Infectious Diseases, NIH

DAIDS Multinational Data and Safety Monitoring Board

Clinical Trials Review Meeting

April 26, 2017

Logistical Fact Sheet forDSMB 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: 240.292.4653

Fax: 240.627.3467

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, April 26, 2017

9:00 a.m.-9:15 a.m. EDTAdministrative Session: (CLOSED)

9:15 a.m.-11:15 a.m. EDTHVTN 703/HPTN 081: FULL REVIEW

11:15 a.m.-11:30 a.m. EDTBREAK

11:30 a.m.-12:30 p.m. EDT HVTN 704/HPTN 085: FULL REVIEW

12:30 p.m.-1:30 p.m. EDTLUNCH

1:30 p.m.-2:30 p.m. EDTHVTN 704/HPTN 085: FULL REVIEW CONTD.

2:30 p.m.-3:30 p.m. EDT NICHD-P1081: SAFETY REVIEW

3:30 p.m.-3:45 p.m. EDTBREAK

3:45 p.m.-4:15 p.m. EDTNICHD-P1081: SAFETY REVIEW CONTD.

4:15 p.m.-4:45 p.m. EDTWRHI 060/ADVANCE: PROGRESS UPDATE

4:45 p.m.-5:30 p.m. EDTSSAT 062: SAFETY REVIEW

5:30 p.m.-6:15 p.m. EDTWRHI 052: SAFETY REVIEW

6:15 p.m.-6:30 p.m. EDT 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 March 29, 2017. Please date the CV.

Immigration

Information:Travel to Washington, DC may require you to have a valid passport anddepending 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

Travel Arrangements: Capital Consulting Corporation, a contractor to NIAID HIV/AIDS 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 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.

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:Bethesda Marriott (Pooks Hill)

5151 Pooks Hill Road

Bethesda, MD 20814

Telephone: 301.897.9400
Fax: 301.897.0192

A single sleeping room will be reserved in your name at the Bethesda Marriott (Pooks Hill). 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 Adonawithin 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 permeeting 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

InRockville, MD: Unless you specifically requested ground transportation assistance, you are responsible for arranging your ground transportation to the Multinational DSMB meeting from the airport or train station. The Ronald Reagan Washington National Airportserves the Washington, DC area and is approximately a 25-minute drive to the Bethesda Marriott (Pooks Hill)and an additional 10 minutes to Fishers Lane.

Please visit the following link for additional information:

From Ronald Reagan Washington National Airport, you may reach theBethesda Marriott (Pooks Hill)and Fishers Lane.

  • 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 theBethesda Marriott (Pooks Hill).
  • 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 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:

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 Medical Center Station. The hotel is located 1.5 miles north of the Metro Station. Please visit the following link for additional metro information

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 Bethesda Marriott (Pooks Hill)from Ronald Reagan Washington National Airport, take the George Washington Parkway North 12 miles to the Capital Beltway (I-495, North) toward Maryland. Take exit 34 South. Turn right at traffic light onto Pooks Hill Road. Hotel will be on the right.
  • From the Hotel to Fishers Lane via Bendey Transportation Shuttle:The Bethesda Marriott (Pooks Hill)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 Bethesda Marriott (Pooks Hill)to the Fishers Lane building. Bendey Transportation will not be making multiple trips after his departure from the pick-up site. Therefore, on Wednesday, April 26th please ensure you board the shuttle in a timely manner at 8:30 AM in the morning and at 6:30 PM following the meeting.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 mild, with the average temperature ranging from 65 Fahrenheit or 17 Celsius during the day, to 45 Fahrenheit or 7 Celsius during the evening; however, the hotel is climate controlled.

Parking:The Bethesda Marriott (Pooks Hill) offers parking at a daily rate of $16 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:March 29, 2017–Deadline to return honorarium form and current CV.

Upon registration or no later than February 22, 2017– 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:

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:

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:

Multinational DSMB Member Factsheet – April 26, 2017Page 1 of 4