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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 24, 2018 FBO #6118
SOLICITATION NOTICE

R -- Writing and Editing Services for Protocol Summaries, Protocol Consents and Scientific Manuscript

Notice Date

8/22/2018
 

Notice Type

Presolicitation
 

NAICS

561410 — Document Preparation Services
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
 

ZIP Code

20892-5480
 

Solicitation Number

18-006026
 

Archive Date

9/21/2018
 

Point of Contact

Christopher D. Lauver, Phone: 3014965650
 

E-Mail Address

christopher.lauver@nih.gov
(christopher.lauver@nih.gov)
 

Small Business Set-Aside

N/A
 

Description

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Office of Communications and Media Relations (OCMR), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to: VECTOR Technical Resources, Inc. 1577 Spring Hill Road, Suite 220 Vienna, VA, 22182-2223, UNITED STATES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 561410 with a Size Standard of $15,000,000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-99-1, July 16, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Writing and Editing Services for Protocol Summaries, Protocol Consents and Scientific Manuscript 2. Background Information: The National Institutes of Health (NIH) is the nation's foremost federally funded biomedical research institution which comprises 27 institutes and centers. The NIH Clinical Center (CC) is the 200-bed clinical research hospital where the institutes and centers carry out early-phase clinical research studies in Bethesda, Maryland. The CC is the setting for the NIH intramural clinical research program. Research participants are admitted to the CC or seen in its outpatient clinics for the sole purpose of participating in clinical research trials. The CC admits patients from all over the world for clinical trials and natural history studies. The CC accommodates about 10,000 new patients and 100,000 outpatient visits a year. There are about 1,600 clinical research protocols in progress. 3. Purpose or Objective: The FDA Modernization Act of 1997 stipulates that information about all NIH-funded clinical trials must be on an accessible online database and they must be written in understandable lay language. To comply with this legislation, the CC has a requirement for a contractor with extensive experience and demonstrated skill in (1) editing complex protocol documents into plain language that can be easily understood by the general public; (2) using plain language standards to write summaries of complex protocol documents that are easily understood by the general public; and (3) editing scientific manuscripts from NIH scientists and investigators for medical and scientific journals or for lay publications. 4. Period of Performance: A base period of one year beginning on or around 09/27/2018 and four option periods of one year. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) Independently and not as an agent of the Government, Contractor will furnish all necessary services, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform all tasks in this requirement. All work under this requirement will be monitored and technically coordinated by employee(s) of the CC Office of Protocol Services or the Office of Communications and Media Relations. The majority of the work will be performed remotely at the Contractor's site. Specific Tasks 1. The contractor will produce approximately 200 protocol summaries and lay titles in plain, lay language annually according to requirements below. The summaries and lay titles will be drawn from final and approved protocol and consent documents provided by the CC. 2. The contractor will edit protocol consent documents into easily understandable lay language according to requirements below. 3. The contractor will edit scientific manuscripts from NIH scientists and investigators for scientific and lay audiences as needed. 4. The contractor will not maintain copies in any format of government documents after finished work has been accepted by the government. Under this contract, it is expected that 90% of the work will involve writing protocol summaries. About 10% of the work will involve editing free-standing consent documents and/or scientific manuscripts. The summaries, lay titles, protocols and their associated consent documents will be transferred from NIH to vendor and returned by vendor to NIH using the CC's FTP mechanism. Other documents will be transferred in Microsoft Word format via email or in hard copy via mail. Protocol summaries/lay titles will be completed and returned by the contractor within three (3) business days after the contractor receives the original documents. Final documents will be delivered during weekdays only to the vendor and to the government. A document's length and complexity may affect turnaround times, and if additional time is needed to complete writing and editing, the contractor must notify the CC within one (1) business day of receipt and agree to an alternative delivery timeframe, not to exceed six (6) business days. The lay title for protocol summaries is limited to 300 characters including spaces and the summary to 5000 characters, including spaces. The contractor must proofread all written and edited documents so that documents contain no errors such as, grammatical errors, or typos. A CC subject matter expert will review documents before final distribution. If the above errors are found on more than three (3) documents a month, this contract will be terminated. The contractor must determine and follow specific style guides for writing and editing. Reading level for protocol summaries and consents will be at an 8th grade level. The contractor will assess reading level by using a commonly accepted tool, typically the Flesch-Kincaid Grade Level score associated with Microsoft Word. The protocol summaries must not include certain symbols. Text alternatives that the contractor will use are: Tabs Accents β=beta sign a=alpha sign γ=Gamma sign ζ=Zeta sign • Bullets @ at sign & and © ≤ less than or equal to ≥ greater than or equal to µ= micro †= cross º = Degree Subscripts Superscripts Naϊve - replace ϊ with i Backward E = possible existent The following symbols should not be used in the lay title: & ampersand { open bracket } close bracket | pipe + plus sign ± plus and minus With or without More or less %Percentage ~ guiggle ^ hat \ backslash.. chains = General quality measures, as set forth below, will be applied to each work product received from the contractor. Accuracy: Work Products shall be accurate in presentation, technical content, and adherence to accepted elements of style. Clarity: Work Products shall be clear, concise, and relevant. Consistency to Requirements: All work products must satisfy the requirements below. File Editing: All text and diagrammatic files shall be editable by the Government. Format: Work Products shall be submitted in hard copy (where applicable) and in media mutually agreed upon prior to submission. Hard copy formats shall follow any specified instructions. Timelines: Work Products shall be submitted on or before the due date specified or submitted in accordance with a later scheduled date determined by the Government. The government will review, for completeness, preliminary or draft documentation that the contractor submits, and may return it to contractor for correction. Absence of any comments by the Project Officer will not relieve the contractor of the responsibility for complying with the requirements of this work statement. The contractor shall not construe any letter of acknowledgment of receipt material as a waiver of review, or as an acknowledgment that the material is in conformance with this work statement. Any approval given during preparation of the documentation, or approval for shipment shall not guarantee the final acceptance of the completed documentation. Contractor Qualifications The contractor will have the following qualifications: • Demonstrated experience writing protocol summaries and lay titles for Internet posting on clinicaltrials.gov and editing protocol consent documents • Extensive experience writing and editing about complex medical topics • Extensive experience editing materials written by clinical researchers • At a minimum, degree in English, journalism, health communications or a closely related field • Demonstrated ability to follow plain language guidelines as outlined under "Clear Communications: An NIH Health Literacy Initiative," http://www.nih.gov/clearcommunication/plainlanguage.htm • Demonstrated ability to write and edit documents that meet requirements for posting on the National Library of Medicine's clinicaltrials.gov website, http://clinicaltrials.gov/ Government responsibilities The CC will: • Provide final documents for the contractor to summarize or to edit. • Specify FTP instructions • Approve any extensions to established deadlines for all work products • Detail any special requirements for work products Reporting Requirements and Deliverables/ Contractor will: • Provide a list of all products produced, time spent on each product itemized by charges for completion. This deliverable is required monthly as an attachment to the invoice. • Receive and return work products in the manner specified in this contract • Produce materials according to timelines established in this contract Inspection and Acceptance Requirements • Work will be accepted only if it meets requirements and timelines established in this contract. • A subject matter expert will review documents before final distribution. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION Protocol summaries and consents are critical to NIH Clinical Center's research mission and the skill set to develop these documents is highly specialized. These documents translate highly technical language into a format understandable to the general public, particularly patients who enroll in clinical studies at the NIH. A break in service would negatively affect recruitment of patient partners in research. This project is a continuation of a current award. The incumbent vendor is Vector Technical Resources, Inc. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 6, 2018, 1:00 PM Eastern time and must reference solicitation number 18-006026. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-006026/listing.html)
 

Place of Performance

Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN05051369-W 20180824/180822231505-78b93ec48ee95c79ab659b2f2d65dd41 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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