Attachment_A_-_Statement_of_Work.pdf

STATEMENT OF WORK (SOW)

CBER TRANSCRIPTION SERVICES

BACKGROUND

The Center for Biologics Evaluation and Research (CBER), Division of Scientific Advisors and Consultants (DSAC) works closely with CBER's Review Offices in the planning of advisory committee (AC) meetings by providing administrative and technical support for the meetings.

These AC meetings are utilized by the Agency to obtain independent, expert and technical advice on complex public health issues.

Additionally, as part of the Center's advisory committee program, DSAC works closely with CBER's Associate Director for Research and key staff members to provide administrative and technical support for the review and evaluation of research being performed by CBER's research scientists.

OBJECTIVES

The Division of Scientific Advisors and Consultants (DSAC) has a reoccurring requirement for Transcription services to facilitate CBER’s scientific advisory committee meetings. Transcription services are required to provide high quality technical/medical recording and transcribing for dissemination as authorized by the Food and Drug Administration.

NUMBER OF MEETINGS (ESTIMATED):

Ordering Period

Period of Performance Est. # of 1-Day Meetings

Est. # of 2-day Meetings

1 08/20/2018 - 08/19/2019 23 10

2 08/20/2019 - 08/19/2020 23 10

SCOPE

A one (1) day meeting produces approximately 300, and no more than 500, transcribed pages.

For each (2) day meeting, it is expected to produce no more than 1000 transcribed pages.

Meetings will be tentatively held from 8:30 am – 5:00 pm Eastern Time (ET). Should a meeting require two days to complete, day two will be held from 8:30 am to 2:30 pm. Should the meeting end after 5:00pm on the first day or 2:30 pm on the second day, no additional charges for transcription services shall be incurred by the FDA.

TASKS/DELIVERABLES

Requirements tailored to a specific office need will be the focus of each Request for Task Order Quotation (RFTOQ) issued under the contract, including specific deliverables and schedules for the deliverables. Each RFTOQ will include the specific Center requirements, performance standards, and a quality assurance approach. The period of performance of each task order will be established upon the issuance of the order. Deliverables are to be determined upon the issuance of each task order. Transcription services shall be provided by the transcription company for the transcription related deliverables for the meeting

Transcription Services: IDIQ Requisition 1192532

1) DRAFT TRANSCRIPTS:

Shall be sent electronically via Email as an MS WORD document within eight (8) business days after completion of the meeting by 5:00 p.m. Eastern Standard Time.

In addition, the contractor is required to provide the following:

1.1 Printed bound Final transcript shall be in MS WORD (Font size not less than Times

New Roman 12 point) with lines and pages numbered

1.2 Printed Final* condensed version with key word index, 4 per page, one-sided in MS

WORD

1.3 Audio CD shall be 508 Compliant

2) TRANSCRIPT REVISION:

2.0 After the first delivery of the Draft Transcript via email, the contractor is required to go through the following error correction process prior to delivery of the FINAL Transcript.

2.1 The Designated Federal Officer (DFO) (defined at award) will review the Draft

Transcript, provided by the contractor for any typographical and factual errors e.g.

spelling of scientific terms, names of meeting participants, and any missing discussion based on audio recording provided by the contractor.

2.2 DFO will return the Draft Transcript with red line marked-up tracked changes within five (5) business days to the contractor.

2.3 The contractor will incorporate the requested edits and return the second Draft Transcript to the DFO within four (4) business days for re-checking.

2.4 DFO retains the right to re-send requested changes for incorporation into the transcript if the first request to the transcription company is not satisfactorily addressed. The revised transcript version will be considered the FINAL transcript with included disclaimer and will be delivered electronically within 1 business day of addressing the revisions and shall be 508 compliant.

2.5 Final Transcript as a printed bound copy shall be delivered within three (3) business days after electronic delivery of the Final Transcript. The DFO will electronically receive via email the Final Transcript with disclaimer.

DELIVERY

Delivery of Final Transcript with disclaimer –The front page of Final Transcript must include the following disclaimer: “This transcript appears as received from the commercial transcribing service after inclusion of minor corrections to typographical and factual errors recommended by the DFO”. Transcription services shall be provided by the transcription company for the transcription related deliverables for the meeting.

DELIVERABLE CONTRACTOR DFO

Meeting TBD TBD

Draft Transcripts Eight (8) business days Review five (5) business days

Transcript Revision (Second Draft)

Within four (4) business days Review and Concurrence 2 business days

Final Transcript Delivered electronically within 1 business day

Final Acceptance 1 business day

Bound Copy and Audio CD (508 Compliant) of Final Transcript

VIA EXPRESS MAIL within 3 business days.

Email Receipt and Acceptance within 2 business days.

The contractor shall deliver bound copy of Final Transcript via express mail with disclaimer to:

FDA/CBER/OM/DSAC

Attn: TBD FDA White Oak Campus 10903 New Hampshire Ave., Bldg. 71, Rm 6340 (6th floor) Silver Spring, MD 20993

GOVERNMENT-FURNISHED PROPERTY, MATERIAL, EQUIPMENT, OR INFORMATION (GFP,

GFM, GFE, OR GFI)

No GFP, GFM, GFE, or GFI will be provided under this contract.

SECURITY

The transcriber will enter as a visitor at White Oak Campus, Building 31. The Contractor shall provide services to support the hours of the conference. The Contractor shall be familiar with building security enforcement at the FDA White Oak Campus. Security at the meeting location is strictly enforced, and the technicians must know how and when to enter the building to ensure they arrive on time for proper setup prior to the meeting.

TRAVEL

Travel will not be compensated for this requirement. All meetings are local.

SPECIAL REQUIREMENTS

The contractor shall provide the name of the transcriber to the assigned committee management specialist one (1) business day prior to the meeting.

The transcriber shall be in the room for setup 45 minutes prior to the start of the meeting to set-up the equipment. Upon arriving, the transcriber shall contact the technical point of contact (will be notified at time of award).

Transcriber is required to stay until the meeting ends even if the meeting goes beyond the scheduled end time.

Prior to arrival, the Transcription Service Contractor must complete all required security documentation (provided by the COR after award), have been approved by FDA for access to

“Privileged Information,” and must be certified as being capable to receive and protect such information per the requirements set forth in 21 CFR 20.90 (Disclosure to Contractor).

PLEASE NOTE: If the DFO accepts the draft transcript as originally provided by the contractor without any revisions, the disclaimer will state: “This transcript has not been edited or corrected, but appears as received from the commercial transcribing service. Accordingly, the Food and Drug Administration makes no representation as to its accuracy.”

PLACE OF PERFORMANCE

10903 New Hampshire Ave, Silver Spring, MD 20993

PERIOD OF PERFORMANCE

The period of performance for this indefinite delivery indefinite quantity (IDIQ) contract consists of a two (2)-year (24-month) ordering period, commencing as stated in the IDIQ award.