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Protocol Writing Services

General Information

Document Type:PRESOL
Posted Date:Aug 30, 2017
Category: Mechanical Power Transmission Equipment
Set Aside:N/A

Contracting Office Address

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

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 THE NATIONAL INSTITUTES OF HEALTH (NIH), CLINICAL CENTER (CC), OFFICE OF PURCHASING AND CONTRACTS (OPC) ON BEHALF OF THE OFFICE OF PROTOCOL SERVICES T, CLINICAL CENTER (CC) AT THE NATIONAL INSTITUTES OF HEALTH (NIH) INTENDS TO NEGOTIATE AND AWARD A CONTRACT WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION TO VECTOR RESOURCES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE THE INTENDED PROCUREMENT IS CLASSIFIED UNDER NAICS CODE 541990 WITH A SIZE STANDARD OF 15.0 MILLION OF DOLLARS. REGULATORY AUTHORITY THE RESULTANT CONTRACT WILL INCLUDE ALL APPLICABLE PROVISIONS AND CLAUSES IN EFFECT THROUGH THE FEDERAL ACQUISITION CIRCULAR (FAC) 2005-95-1, JANUARY 19, 2017 THIS ACQUISITION IS CONDUCTED UNDER THE PROCEDURES AS PRESCRIBED IN FAR SUBPART 13.106-1 SIMPLIFIED ACQUISITION PROCEDURES. 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-SIMPLIFEID ACQUISITION PROCEDURES ARE EXEMPT FROM THE REQUIREMENTS OF FAR PART 6-COMPETITION REQUIREMENTS. GENERAL INFORMATION 1. TITLE- PROTOCOL WRITING SERVICES 2. BACKGROUND INFORMATION: THE CLINICAL CENTER AT THE NATIONAL INSTITUTES OF HEALTH (NIH) IN BETHESDA, MARYLAND, IS THE NATIONS LARGEST HOSPITAL DEVOTED ENTIRELY CLINICAL RESEARCH. IT IS A NATIONAL RESOURCE THAT MAKES IT POSSIBLE TO RAPIDLY TRANSLATE SCIENTIFIC OBSERVATIONS AND LABORATORY DISCOVERIES INTO NEW APPROACHES FOR DIAGNOSING, TREATING, AND PREVENTING DISEASE. APPROXIMATELY 1,500 STUDIES ARE IN PROGRESS AT THE NIH CLINICAL CENTER. APPROXIMATELY, HALF OF THE STUDIES ARE THE FIRST TESTS OF NEW DRUGS OR MEDICAL TREATMENTS IN HUMANS. THE REST ARE NATURAL HISTORY STUDIES WHICH INCLUDE MANY RARE DISEASES. THESE LONG-TERM STUDIES LEAD TO A BETTER UNDERSTANDING OF HOW DISEASES DEVELOP AND RESULT IN IMPROVEMENTS IN PREVENTION AND TREATMENT. NATIONAL INSTITUTE OF HEALTH -FUNDED CLINICAL TRIALS MUST BE ON ACCESSIBLE ONLINE DATABASE AND THEY MUST WRITTEN IN UNDERSTANDABLE LANGUAGE. TO COMPLY WITH THIS LEGISLATION, THE CLINICAL CENTER (CC) HAS A REQUIREMENT FOR CONTRACTOR WITH EXTENSIVE EXPERIENCE AND DEMONSTRATE SKILL IN EDITING SCIENTIFIC MANUSCRIPT FROM NIH SCIENTIST AND INVESTIGATION FOR MEDICAL AND SCIENTIFIC JOURNALS OR PUBLICATIONS. THE CONTRACTOR WILL FURNISH ALL NECESSARY SERVICES, MATERIALS, EQUIPMENT AND FACILITIES AS NEEDED DELIVERY DATE: AFTER CONTRACT AWARD. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) Vendor will provide Specific Task As follows: 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 CCs 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 documents 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 CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION THE INTENDED SOLE SOURCE IS THE ONLY KNOWN SOURCE TO MEET THE TECHNICAL NEEDS OF THE WRITING AND EDITING SERVICES. 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 09, 2017, 12:00 PM EASTERN TIME AND MUST REFERENCE SOLICITATION NUMBER 17-010671. RESPONSES MAY BE SUBMITTED ELECTRONICALLY TO PRISCILLA ABALOS CONTRACTING SPECIALIST AT PRISCILLA.ABALOS@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."

Original Point of Contact

POC Priscilla S. Abalos, Phone: 3015943879

Place of Performance

Address:
National Institute of Health, Clinical Center, Office of Communication and media relations, bldg. 10, Room 1-4553, Bethesda, Maryland, 20892, United States
20892,
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