SOLICITATION NOTICE
R -- Writing and Editing Services for Protocol Summaries, Protocol Consents and Scientific Manuscripts
- Notice Date
- 7/17/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 561320
— Temporary Help 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
- P-13-007113-1
- Archive Date
- 8/21/2013
- Point of Contact
- Deborah G Culpepper, Phone: 301-402-1928, Susan Nsangou, Phone: 3014969351
- E-Mail Address
-
dculpepper@cc.nih.gov, susan.nsangou@nih.gov
(dculpepper@cc.nih.gov, susan.nsangou@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-68 effective June 26, 2013. This acquisition will be processed under FAR Part 12, Simplified Acquisition Procedures (SAP), and Acquisition of Commercial Items. The Solicitation Number for this acquisition is P-13-007113-1 and is being issued as a Request for Quotation (RFQ). Background Information The National Institutes of Health (NIH) is the nation's foremost federally funded biomedical research institution. It comprises 27 institutes and centers. The NIH Clinical Center (CC) is the 240-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 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 1,500 clinical research protocols in progress. Purpose and Objectives for the Procurement 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 NIH CC has a requirement for a contractor with extensive experience and demonstrated skill in editing complex protocol documents into plain language that can be easily understood by the general public; using plain language standards to write summaries of complex protocol documents that are easily understood by the general public; and editing scientific manuscripts for medical and scientific journals or for lay publications. Contractor Requirements 1. The contractor will produce approximately 300 lay titles in plain, lay language during the contract period according to requirements below. The summaries will be drawn from final and approved protocol and consent documents provided by the CC. 2. Contractor will edit protocol consents documents into easily understandable lay language according to requirements below. 3. Contractor will edit scientific manuscripts for scientific and lay audiences as needed. 4. Contractor will not maintain copies 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 scientific manuscripts. For the writing of summaries and lay titles, protocols and their associated consent documents will be transferred from NIH to vendor and returned by vendor to NIH using the Clinical Center'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 vendor within three business days after the vendor receives the original documents. Final documents will be delivered weekdays only. A document's length and complexity may affect turnaround times, and if additional time is needed to complete writing and editing, contractor must notify NIH within one business day of receipt and agree to an alternative delivery timeframe, not to exceed six business days. The lay title for protocol summaries is limited to 300 characters including spaces and the summary to 5000 characters, including spaces. Vendor must proofread all written and edited documents so that documents contain no errors in fact, errors of omission, grammatical errors, or typos. Subject matter expert will review documents before final distribution. If errors are found on more than three documents a month, this contract will be Terminated for Cause as prescribe in FAR clause 52.212-4. Vendor must determine and follow specific style guides for writing and editing. Reading level for protocol summaries and consents will be at 8th grade. Vendor 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 vendor 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 n-3 = omega 3 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 = n- before numeral to signify fatty acid terminology Vendor will also provide editing for approximately 20 scientific manuscripts and scientific presentations by CC physicians and scientists, which are prepared for submission to various scientific journals. Contractor Qualifications The contractor shall have the following qualifications: • Demonstrated experience writing protocol summaries and lay titles for Internet posting on clinicaltrials.gov and editing protocol consent documents • Demonstrated experience writing and editing about complex medical and health topics for lay audiences • Demonstrated 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 vendor to base summaries 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/Program Management and Control Requirements Vendor will: • Provide a list of all products produced, time spent on each product itemized by charges for completion. Receipt is required on the last business day of each month under this contact. • 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. • Subject matter expert will review documents before final distribution. If errors are found on more than three documents a month, this contract will be terminated. General quality measures, as set forth below, will be applied to each work product received from the contractor under this statement of work. 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 of this SOW. 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. Timeliness: Work Products shall be submitted on or before the due date specified in this SOW or submitted in accordance with a later scheduled date determined by the Government. The government will review, for completeness, preliminary or draft documentation that Contractor submits, and may return it to Contractor for correction. Absence of any comments by the Contract Officer Representative (COR) will not relieve Contractor of the responsibility for complying with the requirements of this work statement. 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 EVALUATION CRITERIA listed in order of importance: 1. Demonstrated expertise in writing summaries of clinical research protocols in plain, easily understandable lay language following the style dictated by clinicaltrials.gov.2. Demonstrated expertise in editing clinical research protocol consent documents into plain, easily understandable lay language. 3. Demonstrated experience and skill editing complex medical and scientific documents for publication in scientific journals. 4. Vendor must demonstrate knowledge of technical/medical subject matter and knowledge of scientific and medical terminology The price quoted shall be evaluated for price reasonableness. A best value analysis will be performed. Instructions Addendum to FAR 52.212-1, the offerors are to provide the following: 1. Provide proof of this expertise, including five examples for evaluation under item 1. 2. Provide proof of this expertise, including five examples for evaluation under item 2. 3. Provide two examples for evaluation under item 3. 4. Provide proof of knowledge under item 4. PERIOD OF PERFORMANCE The period of performance will be one year from the date of the award with up to four (1) option year(s). Questions regarding this combined synopsis/solicitation must be received in writing by this office no later than July 23, 2013. All questions and answers will be posted in this solicitation by July 30, 2013. Offerors may submit a completed FAR 52.212-3, or cite their Rpresentaons and Certifications on SAM.gov. The Government intends to make a single award based upon best value to the Government. Facsimile submissions are not authorized and collect calls will not be accepted. Submit offers to the attention, Deborah Culpepper, dculpepper@cc.nih.gov. Please reference the solicitation number P-13-007113-1 on your offer. The following Provisions and Clauses apply: FAR 52.212-1 Instruction to Offerors-/Commercial Items (FEB 2012); FAR 52.212-2 Evaluation - Commercial Items (Jan 1999) (Additional Evaluation criteria set forth in the combined synopsis/solicitation; FAR 212-3, Offeror Representations and Certifications - Commercial Items (DEC 2012); FAR 52.212-4 Contract Terms and Conditions Commercial Items (FEB 2012), FAR 52.217-8 Option To Extend Services (NOV 1999); FAR 219-6 Notice of Total Small Business Set-Aside (NOV 2011); FAR 52.219.28 Post Award Small Business Program Representation (APR 2012); FAR 52.227-14 RIGHTS IN DATA - General (Dec 2007), and FAR 52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/P-13-007113-1/listing.html)
- Record
- SN03119791-W 20130719/130718010447-37b6c92586295a2f2c13c4e0cfc8ec20 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |