Logistical Support Services for NIAID and Data and Safety Monitoring Board (DSMB) Meeting Support
Synopsis: Small Business Sources Sought Notice Number: 75N93022R00007 Title: Logistical Support Services for NIAID and Data and Safety Monitoring Board (DSMB) Meeting Support This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541990 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $15.0 million. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government. Interested parties are expected to review this Notice and the draft Statement of Work to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk. Background: Logistical Support Services The purpose of this contract is to assist the National Institute of Allergy and Infectious Disease (NIAID) with Logistical Support Service. In order to achieve the NIAID’s goals of facilitating research and improving methods for the prevention, diagnosis and treatment of infectious and immune mediated diseases; and to assist in the dissemination of research results, NIAID requires diverse administrative and logistical support. Due to the dynamic nature of the work conducted by the NIAID, it is necessary to have a support mechanism in place that is flexible, responsive, and timely in order to accommodate changing priorities. Additionally, changes in public health priorities, Congressional emphasis, and changes resulting from ongoing research will impact the administrative and logistical support needs of the institute. In some areas of required logistical support, it is not possible to anticipate the exact work that will be required by the contractor in a given year. The technical requirements outlined below reflect those unknowns as there are base requirements as well as indefinite delivery/indefinite quantity contract task areas. Data and Safety Monitoring Board (DSMB) Meeting Support The mission of the Division of Acquired Immunodeficiency Syndrome (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is to ensure an end to the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic by supporting research that can lead to the development of therapies, vaccines, and prevention strategies. NIH policy requiring independent data and safety monitoring boards (DSMB) for all multicenter Phase III trials has existed since 1979; the most recent restatement was issued in 1998 (NIH Policy for Data and Safety Monitoring, NIH Guide Notice 98-084). In light of the related responsibility for monitoring assigned to local Institutional Review Boards (IRB) by federal regulation (45 CFR 46), NIH added a requirement in 1999 that local IRBs be notified of the outcome of all DSMB reviews, even when no major change has been recommended, to document that data and safety monitoring is occurring as expected (Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials, NIH Guide Notice 99-107). These NIH policies do not address implementation matters, leaving those to individual Institutes and Centers; various approaches are in use. As a result, the NIAID has issued its own policy on basic principles for DSMB operations. DAIDS monitors safety and efficacy of multicenter randomized clinical trials primarily tough standing DSMBs. DAIDS considers standing boards to be both more effective and easier to manage than boards established separately for each new trial. Purpose and Objectives: The objectives include: Logistical Support Services Develop Conference Plans and Policies Providing Planning, Technical, and Logistical Support: Graphics Support Operational Logistical Support Data and Safety Monitoring Board (DSMB) Meeting Support This contract will provide logistical and administrative support for activities associated with the convening of multiple DAIDS DSMB meetings in both domestic and international locations. The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small business concerns that are interested in and capable of performing the work described herein. On behalf of NIAID, the NIH does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this SBSS Notice, the NIAID may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Small Business Sources Sought Notice or the NIAID’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Project Requirements: Logistical Support Services Indefinite Delivery/Indefinite Quantity Task Order Areas: Work required within the following task areas will issued to the contractors via task orders. Each task order will provide the specific details and requirements necessary for completion of the work. Each area will have a minimum and maximum number of hours that can be utilized in a single contract year. Task Area I: Meeting and Conference Support A). Develop Conference Plans and Policies: The rapid expansion and evolving nature of infectious and immune-mediated diseases related research necessitates holding a wide range of domestic and international meetings and conferences each year. The contractor will receive task orders which describe the specific conference or meeting which requires contractor support. In coordination with the Project Officer and Task Order Leader, the contractor will review the task request, identify requirements, identify appropriate pre-meeting materials and produce necessary planning documents and timelines. The contractor shall determine staffing needs to achieve program objectives, which may include identifying outside consultants or subcontractors. The contractor shall participate in frequent and necessary planning meetings with the Project Officer and Task Order leaders. Specifically, the contractor shall be able to provide the following as necessary per each task order: Drafts of all technical meeting materials with minimum errors (no more than tee) for review by the Project Officer and Task Leaders. After review and feedback by NIAID staff, the Contractor shall prepare final technical materials and produce sufficient copies for the conference/meeting participants. Pre-meeting materials such as notebooks and background briefing materials. It is estimated that there will be 3-4 pre-meeting notebooks prepared, varying from 50-200 pages each. A high quality tape-recording system and a meeting reporter to ensure the preparation of high-quality transcripts. Secretarial support at meetings to type, proofread, and copy materials from one session for discussion at following sessions. Prepare meeting minutes for all meetings, including weekly planning meetings, action items, summaries or proceedings, which may be highly scientific and narrowly focused or address broad areas of NIAID research, in final publishing form. B). Providing Planning, Technical, and Logistical Support: It is estimated that support services will be required for approximately 20-40 domestic and international scientific meetings, conferences, and workshops per year. Specifically, the contractor shall be able provide the following as necessary: Assistance in Selecting Participants: For all meetings and conferences, the Project Officer or Task Leader will provide the contractor with a list of potential participants. Final selection of the conference participants shall be made by the Project Officer. The Contractor shall contact all potential participants and determine availability for participation. The Contractor shall provide the Project Officer with a list of conference attendees: names, titles, organizations, addresses, and telephone numbers. Site Selection and Reservation: The Contractor shall arrange for and reserve meeting space at the N IH, if available and suitable, to meet the requirements for each meeting. In the event that NIH pace is not available or suitable, the Contractor shall recommend a number of site/facility combinations in the Washington D.C. metropolitan area, preferably within a 10 mile radius of the main NIH campus in Bethesda, MD. In selecting meeting site other than NIH, the Contractor shall provide the PO/TL at least tee (3) possible sites for lodging and/or meeting space. The Contractor shall provide appropriate cost comparisons when submitting recommendations to the PO for selecting hotel and meeting space. The contractor will select hotels that will provide meeting rooms free-of-charge, and that will set aside a block of rooms for attendees at preferred rates. Other considerations in recommending a meeting site shall include: accessibility and convenience to transportation and parking; adequate number of meeting, breakout, and sleeping rooms available on desired dates; meeting rooms adequate in terms of size, lighting, ventilation, and locations; meeting rooms and some sleeping rooms that meet Federal requirements for accessibility to handicapped participants; and a restaurant or catering capability available to handle the expected number of participants In the event that the meeting is to be held other than at NIH or other than the Washington D.C. metropolitan area, the Contractor shall submit to the Project Officer tee (3) site selection recommendations, along with cost comparisons for the meeting location as specified by the Project Officer in accordance with the considerations listed in (b) above. Following selection and approval of the meeting site by the Project Officer, the Contractor shall negotiate a contract with the selected facility that will provide the best value to the government in meeting the requirements of the NIAID meeting/conference mission. The contractor shall ensure adequate parking and make parking arrangements for all meetings or conferences at the NIH or at other selected sites. The contractor shall assure that meeting space is handicapped accessible in accordance with the Americans with Disabilities Act (ADA). Meeting Participant Communication and Travel: Provide to eligible meeting participants, as identified by the PO, and honorarium and reimbursement for travel and per diem expenses (allowed by the Government travel regulations), including economy airfare, train fare, or the Government’s mileage rate for travel by automobile. Prepare all necessary paperwork associated with meeting participant reimbursement procedures, and develop reimbursement procedures for use by meeting participants identified by the PO as eligible for honorarium, travel, and per diem expenses. These services may also be provided when NIAID reimburses for honorarium, travel, and per diem expenses. It is estimated that honorarium, travel, and per diem will be provided for 3-5 meetings of 10-12 non-government participants per year. The contactor shall electronically contact participants to inform them of, and later confirm, each meeting’s location and dates, and to secure the necessary paperwork to confirm their participation, travel dates, and needed accommodations. The contractor shall provide participants with travel confirmations no alter than 7 days prior to the meeting start date including airfare, ground transportation and/or hotel reservation. The contractor shall regularly and systematically remind non-registered attendees to register, without sending reminders to those participants who have already registered. The contractor shall maintain and be able to report to the PO the number of attendees registered for an upcoming meeting from previous meetings and be able to search for specific participants and participant categories. The contractor shall use the latest technology, such as individual bar coding, to expedite the registration process for meetings with 200 or more attendees. The contractor shall provide sign language interpreters if applicable. The contractor shall provide post-conference services including fiscal management, public relations, preparation and submission of the conference proceedings/summaries, and the mailing of thank you letters to the conference speakers. According to the timetable established for the specific meeting task order, the contractor shall prepare, reproduce, and distribute to the attendees by mail prior to the meeting necessary advance materials to include but not limited to: letter of invitation; agenda; itineraries; travel guide information including directions and maps from local airports and points of interest, subway information, parking, taxi fares, limousine service information, and hotel reservation information including addresses, telephone numbers, and rates for suggested hotels; briefing materials; pamphlets; and other background materials provided by the NIAID. The contractor shall draft the letter of invitation and agenda and provide all other related materials. Drafts of necessary advance materials shall require approval by the task leader or project officer prior to mailing. The contractor shall confirm receipt by attendees of advance materials prior to meeting. For meetings requiring presentations by participants, the contractor shall prepare and distribute to presenters (selected by NIAID) a schedule and instructions for preparing and submitting presentations, manuscripts, and reports. The contractor shall coordinate and confirm receipt of these materials, manuscripts, and reports and submit to the PO for review according to the timetable established for the specific meeting task order. Meeting Room Arrangements The contractor shall: arrange for the set-up of meeting rooms, including breakout rooms if required, accounting for details including audio visual equipment, the number and arrangement of chairs and tables, meeting breaks, light refreshments, meals, etc. meet with appropriate hotel staff prior to the meeting to review the requirements for the meeting room arrangements and to ensure that all needs are met. provide, as requested by the PO, a meeting room coordinator who shall attend specified meetings and provide meeting support services to include: set-up of tables, name cards, arrangements of visual aids; provision of pencils, pens, writing pads; ensure availability of grease pens, markers, chalk, flipcharts, blackboards, pointers, etc.; scheduled coffee breaks; and operation of audiovisual equipment. provide, as requested by the PO, audiovisual equipment (such as slide projectors, overhead projectors, etc.) This can be acquired tough the conference facility or from the contractor’s own equipment. However, the contractor should utilize whichever method is the most economical for the government. The contractor shall have back-up should the primary equipment malfunction. NIAID will not provide funds for the purchase, lease, or maintenance of contractor property. be responsible for investigating and resolving hotel/meeting reservation confirmation issues. be responsible for ensuring that attrition charges are not incurred. Registration Fees and Materials The contractor shall: Provide for the charge and collection of participant registration fees, if appropriate, to cover the costs of conference luncheons or dinners, or other appropriate costs. The amount and procedures for collection of conference registration fees are subject to PO approval and shall be established in the specific meeting task order proposal. Provide registration materials and services to include: name tags, programs, schedules and background materials. Registration materials shall be organized in folders or binders. Arrange for or provide a registration desk and message center services and staff. C). Graphics Support: The contractor shall provide graphic, design, and production for all meeting and conference support materials, including but not limited to conference posters, banner displays, pamphlets, brochures, folders, signage, and abstract books. The contractor’s graphics software must be compatible with NIAID graphics software, unless specifically accepted by the Project Officer. D). Inventory of Meeting Materials: The contractor shall maintain an inventory of meeting materials as needed for the NIAID contract. The contractor shall develop a shipment record which will be completed as the contractor receives materials. This form will include the name of the item, the item number assigned, the quantity received, the location of the item and the condition upon receipt. The contractor shall provide a report of each material usage, to include but not limited to, the item name and number, purpose for use, quantity and dates of removal. The contractor will provide a report twice a year of all materials in inventory. Task Area II: Operational Logistical Support The contractor shall provide support for operational logistics in support of NIAID analysis projects requested by the task leader. Specific requirements for services, deliverables and schedule will be includes in the task order request. Presently, NIAID is using Office 2003 with the expectation of upgrading to the Office 2007 suite within the next tee to six months. The contractor will be required to provide electronic documents and products in formats that are compatible with the software platform in use that the time by the NIAID. Data and Safety Monitoring Board (DSMB) Meeting Support Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, below. Specifically, the Contractor shall perform the following tasks: DOMESTIC & INTERNATIONAL DSMB MEETINGS 1) Assist with the following as needed: a. Coordinate DSMB activities (logistical planning of meetings) b. Secure venue and lodging arrangements for DSMB meetings c. Secure travel and ground transportation arrangements for DSMB members and Ad Hoc experts, if required. d. The Government shall pay for visa processing, if required by a member. e. Complete travel documents (Expense Reports) 2) Venue Search and Selection a. If a government facility is not available for the DSMB meeting in the DC metropolitan area, the Contractor shall begin seeking lodging and/or venue quotes from vendors at least six (6) months prior to the meeting. b. Quotes shall be based on the specific needs of the DSMB meeting, and may include consideration of the following: i. Availability of sleeping accommodations for DSMB members and ad hoc medical/scientific experts. ii. Availability of two meeting rooms for each DSMB meeting that accommodate the meeting room specifications and are not within hearing range of each other, as required iii. Availability for close proximity of onsite food, beverage, and catering iv. Availability of onsite technical support for: LCD projector with screen Laptop computer Microphones and other audio visual (A/V) equipment as needed Conference phone and outside line Podium with microphone, as needed Registration desk with outside telephone line and electricity Internet connection-High-speed or wireless access in registration area and sleeping rooms Onsite business center with copying privileges Other requirements as needed c. At least six (6) months prior to the DSMB meeting, or as directed by the COR, the Contractor shall forward to the COR for review and approval at least tee vendor quotes from hotels, which meet government requirements (e.g., the HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and meeting Space, Food, Promotional Items, and Printing and Publications). 3) Final Travel Details and Ground Transportation Arrangements a. At least two weeks prior to a DSMB meeting, the Contractor shall provide final travel details to the COR for review and approval. b. Arrange ground transportation for meeting participants, as needed. c. All airfare that is not economy class requires prior approval by the COR. 4) DSMB Member Reimbursement a. Non-government DSMB members shall be reimbursed for lodging, meals and incidental travel expenses in accordance with the Federal Travel Regulation (FTR) no later than thirty (30) calendar days after the meeting. b. Non-government DSMB members should receive an honorarium payment as directed by the COR per meeting day. Honorarium shall be paid no later than thirty (30) calendar days after the meeting. DSMB members who are employees of the United States Government shall not receive an honorarium for service on the DSMB. 5) DSMB Documents a. Prior to each meeting, upon request of the COR, the Contractor shall submit the Logistics Factsheet along with the final version of the Travel Spreadsheet no later than thirty (30) calendar days after each meeting, the Contractor shall complete member travel reimbursements and honorariums and submit the Trip Report to the COR. Documents for travelers will be provided to travelers before they travel, so no documents will be made in-country for international travel. 6) Site Visits a. During a scheduled international DSMB meeting, the Contractor may be requested to make travel arrangements (e.g., flight and ground transportation) for DSMB members and ad hoc scientific/medical experts to attend a clinical study site visit. b. At least two weeks prior to a DSMB meeting/clinical study site visit, the Contractor shall provide final travel details to the COR for review and approval. DSMB TELECONFERENCE (SCHEDULED AND AD HOC) DSMB Member Reimbursement Non-government DSMB members shall receive an honorarium payment as directed by the COR per meeting day. Honorarium shall be paid no later than thirty (30) calendar days after the meeting. DSMB members who are employees of the United States Government shall not receive an honorarium for service on the DSMB. OTHER REPORTS AND DELIVERABLES Travel Spreadsheet The Contractor shall maintain and submit a travel spreadsheet for each meeting and provide to the COR, as requested. Details may include such items as: Traveler’s Name Airline and Flight Number Arrival Date Departure Date Number of Nights in the Hotel Confirmation Number Hotel Name Reimbursement Date of Issuance Honoraria Date of Issuance Logistics Factsheet The Contractor shall submit a logistics factsheet to the COR for review and approval upon selection of the meeting venue. The logistics factsheet may include items such as: Meeting Location Security Requirements Tentative Agenda Immigration Information Travel Arrangements Personal Travel Hotel Information Honorarium Meals Expense Reimbursement Ground Transportation Climate Parking Important Deadlines Contract Information MEETINGS and TELECONFERENCES Meetings The Contractor shall be available to attend face to face meetings with the COR at least once a quarter or as needed to review the overall progress of venue and travel arrangements for meeting planning. Teleconferences The Contractor shall be available for bi-weekly teleconferences or as needed with the COR to review the overall progress of the contract. Other Important Considerations: Copies of the Draft Statements of Work (SOW), for the Logistical Support Services and Data and Safety Monitoring Board (DSMB) Meeting Support requirements which are subject to revisions, are attached. Capability Statement/Information Sought: Respondents must be qualified and prepare tailored capability statements for all areas in the attached draft Statement of Work. The capability statements will be evaluated based on the information provided in relation to the project requirement and current capability. Information Submission Instructions: Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed ten (10) single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the firm’s ability to perform the aspects of the notice described above and in the draft SOW. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concern's name, point of contact, address and DUNS number. All proprietary information should be marked as such. Required Business Information: DUNS. Company Name. Company Address. Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/SAM/pages/public/index.jsf. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to both Marvin Barnett, Contract Specialist, at Marvin.Barnett@nih.gov; Kristel Ruch, Contract Specialist, Kristel.Ruch@nih.gov; and Mary Muir, Contracting Officer, mary.muir@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify 75N93022R00007. Facsimile responses will not be accepted. Delivery Point: All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Marvin Barnett: Marvin.Barnett@nih.gov and to Kristel Ruch: Kristel.Ruch@nih.gov in PDF format by Tuesday, March 15, 2022 at 2:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. No calls or facsimile transmissions will be accepted. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Contracting Office Address: 5601 Fishers Lane Rockville, MD 20852 Primary Point of Contact: Marvin Barnett Contract Specialist Email: Marvin.Barnett@nih.gov Phone: 301-761-7833 Second Point of Contact: Kristel Ruch Contract Specialist Email: Kristel.Ruch@nih.gov Phone: 301-594-8181
75N93022R00007 Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases
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