Combined_solicitation-_synopsis_revised.pdf.pdf

PDF 100 KB Posted

Attached to
DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES
Solicitation number
HHS-NIH-NIDA-SSSA-CSS-15-106
Issued by

About this file

Revised combined solicitation synopsis

View the file

Other files

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

HHS-NIH-NIDA-SSSA-CSS-15-106

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED.

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. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

The Solicitation Number for this acquisition is HHS-NIH-NIDA-(SSSA)-CSS-15-106 and is being issued as a Request for Proposal (RFP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-81 effective March 10, 2015. This acquisition is a small business set aside.

The North American Industry Classification System (NAICS) Code for this procurement is 541690 and the Small Business Size Standard is 14.0 million dollars; Other Scientific and Technical Consulting Services.

STATEMENT OF OBJECTIVES

The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the Blueprint Neurotherapeutics Network and possibly other NIH neuroscience-focused drug discovery and development programs.

• Regulatory Affairs

• Phase I Clinical Pharmacology

• Business Development

• Electrophysiology Assay Development

• Medical Writing

STATEMENT OF WORK

Each consulting contract will be specific to one or more areas of expertise as outlined in this Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise.

Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts.

Contract consultants will be expected to provide feedback and guidance on projects to the NIH and to Blueprint LDT members through conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects.

Revised 5-11-2015 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm%23P282_47557

The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the IND and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and five projects remain active. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program.

General Requirements

Consultants may serve on Blueprint LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. Consultants may be asked to serve as co-chairs of LDTs.

A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role.

A teleconference call with all consultants is held twice per month to discuss programmatic issues of broad interest.

The following attachments are provided to assist you in preparing your proposal responding to this solicitation.

Attachment No. 1: Statement of Work Attachment No. 2: Invoice Instructions Attachment No. 3: Security Clauses

The following Provisions and Clauses apply to this RFP:

FAR 52.212-1 Instruction to Offerors-/Commercial Items (FEB 2012

FAR 52.212-2 Evaluation – Commercial Items (Jan 1999),

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(End of provision)

The following factors shall be used to evaluate offer;

EVALUATION CRITERIA

Mandatory Evaluation Criteria

The solicitation contains the following mandatory qualification criteria specific to each discipline:

1. Regulatory Affairs

• An advanced degree (Master’s or PhD) in a scientific discipline is required.

• 5 years’ experience in the pharmaceutical or other related industry is required.

Revised 04-16-2015

• 3 years hands-on Regulatory Affairs experience in the pharmaceutical industry dealing with drugs, biologics, medical devices, and/or combination products

• Experience writing, editing, reviewing, and overseeing multiple IND filings and other regulatory documents.

2. Phase I Clinical Pharmacology

• An advanced degree in a scientific discipline is required (MD or PhD).

• 5 years’ experience in the pharmaceutical or other related industry with responsibility for early clinical trials is required.

• 3 years hands-on Phase I clinical experience in the pharmaceutical industry dealing both in-house and outsourced trials.

3. Business Development

• Bachelor's degree in life science, physical science, or related discipline; advanced degree preferred

• At least 10 years of business development experience in the pharmaceutical or related industry

• Working knowledge of the drug discovery and development industry

• Experience facilitating start-up company formation and negotiating partnering agreements

4. Electrophysiology Assay Development

• An advanced degree in a scientific discipline is required

• 10 years of experience in the pharmaceutical or other related industry is required

• Demonstrated electrophysiology expertise is required

• Experience inventing high throughput cellular screening systems is required

• Proven ability to take on a leadership role in a virtual, cross-functional team environment

5. Medical Writing

• An advanced degree (Master’s or PhD) in a scientific discipline is required.

• A minimum of 5 years of direct regulatory and medical writing experience.

• Experience with writing, editing, reviewing, and oversight of regulatory submissions, including but not limited to INDs, IBs, clinical protocols, and FDA response letters.

The mandatory qualification criterion establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer in order for your proposal to be considered any further for award.

Technical Evaluation Criteria

Proposals will be scored based on the following three (3) technical evaluation criteria.

Professional Experience in Drug Development –50 points

Offerors shall be evaluated based on hands-on and management experience in drug discovery and development projects, explicitly applicable to the corresponding discipline description listed in the statement of work.

Evaluations shall be based on demonstrated expertise and experience in executing and managing drug development tasks, particularly for nervous system conditions. Broad experience across the entire drug discovery and development process is especially desired.

Reviewers shall consider the Offerors’ years of experience, breadth of expertise, and track record in drug development projects that go through to the clinic. Examples of measures of success include preparation of successful IND, CTA, NDA, and MA applications, as well as publications, patents, and work on drugs brought to market. In addition, experiences showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources shall be considered as signs of a strong track record in drug development.

Education and Qualifications in Drug Development – 30 points

Offerors shall be evaluated for a combination of advanced education, board certifications, and other advanced expertise explicitly applicable to the corresponding discipline description listed in the statement of work. Evaluations shall be based on the Offerors’ in-depth understanding of the drug development process, including regulatory procedures and guidelines where relevant, especially in small molecule drug development for CNS indications.

Experience with Collaborative Teams – 20 points

Offerors shall be evaluated based on previous experience working with multi-disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered as illustrations of collaborative work.

Individual consultants and consulting companies that meet the Small Business size standard identified for this requirement are invited to apply to this solicitation.

Total Possible Points - 100

Potential Award without Discussions

The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary.

FAR 52.212-4 Contract Terms and Conditions Commercial Items (FEB 2012), FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive

Orders—Commercial Items (Sept 2013).

The following clauses are applicable to this requirement and they are listed by reference:

52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate 1 (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

52.219-6, Notice of Total Business Set-Aside (Nov 2011) (15 U.S.C. 644).

52.223-18, Encouraging Contractor policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

FAR 52.222.17, Non-displacement of Qualified Workers (May 2014).

The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract in full text, to implement provisions of law or Executive orders applicable to acquisitions of commercial items.

52.217-5 Evaluation of Options (JULY 1999)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). (End of provision)

52.217-6 Option for Increased Quantity. (MAR 1998)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within the current period of performance. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of clause) https://acquisition.gov/far/current/html/Subpart%2017_2.html%23wp1078150

FAR 52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days from the expiration of the current contract period of performance.

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within the current period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires.

The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

Information Security is Applicable to this requirement and the following information is required for RFP preparedness.

1. SECURITY CATEGORIZATION OF FEDERAL INFORMATION AND

INFORMATION SYSTEMS (FIPS 199 Assessment)

a. Information Type:

[ ] Administrative, Management and Support Information:

[ x ] Mission Based Information:

b. Security Categories and Levels (SCL)

Confidentiality Level: [ ] Low [x ] Moderate [ ] High Integrity Level: [ ] Low [x ] Moderate [ ] High Availability Level: [ ] Low [x ] Moderate [ ] High

Overall Level: [ ] Low [ x ] Moderate [ ] High

This contract will entail the following position sensitivity levels:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[x ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

Prospective Offeror Non-Disclosure Agreement

[ x] Offerors WILL NOT require access to sensitive information in order to prepare an offer.

[ ] Offerors WILL require access to sensitive information in order to prepare an offer.

[ x] Systems Security Plan (SSP) is NOT required.

SOLICITATION – STATEMENT OF WORK/REPORTS/DELIVERABLE PROVISIONS

INFORMATION SECURITY AND PHYSICAL ACCESS REPORTING REQUIREMENTS

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

ROSTER OF EMPLOYEES REQUIRING SUITABILITY INVESTIGATIONS

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract.

IT SECURITY PLAN (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements for Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800- 53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

IT RISK ASSESSMENT (IT-RA)

Information Technology Resources, the contractor shall submit the IT-RA within thirtydays after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800- 30, Risk Management Guide for Information Technology Systems, and any

FIPS 199 ASSESSMENT

Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

IT SECURITY CERTIFICATION AND ACCREDITATION (IT-SC&A)

Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

REPORTING OF NEW AND DEPARTING EMPLOYEES

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

CONTRACTOR – EMPLOYEE NON-DISCLOSURE AGREEMENT(s)

The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf

VULNERABILITY SCANNING REPORTS

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, the vulnerability scanning report may be included as part of the Technical Progress Report.

Otherwise, this report shall be submitted under separate cover on a monthly basis.

SOLICITATION – SPECIAL CONTRACT REQUIREMENTS PROVISIONS

INFORMATION AND PHYSICAL ACCESS SECURITY

Information and Physical Access Security is applicable to this solicitation and the following information is provided to assist in proposal preparation.

HHS-CONTROLLED FACILITIES AND INFORMATION SYSTEMS SECURITY

Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

STANDARD FOR SECURITY CONFIGURATIONS, HHSAR 352.239-70, (January

2010)

The Contractor shall configure its computers that contain HHS data with the applicable Federal Desktop Core Configuration (FDCC) (see http://nvd.nist.gov/fdcc/index.cfm ) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level.

STANDARD FOR ENCRYPTION LANGUAGE, HHSAR 352.239-71, (January 2010)

The Contractor shall use Federal Information processing Standard (FIPS) 140-2- compliant encryption (Security) Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004).

SECURITY REQUIREMENT FOR FEDERAL INFORMATION

TECHNOLOGY RESOURCES, HHSAR 352.239-72, (January 2010)

Applicability. This clause applies whether the entire contract or order (hereafter "contract"), or portion thereof, includes information technology resources or services in which the Contractor has physical or logical (electronic) access to, or operates a Department of Health and Human Services (HHS) system containing, information that directly supports HHS' mission. The term "information technology (IT)", as used in this clause, includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services) and related resources. This clause does not apply to national security systems as defined in

FISMA.

INFORMATION SECURITY TRAINING

In addition to any training covered under paragraph (e) of HHSAR 352.239-72, the contractor shall comply with the below training:

PERSONNEL SECURITY RESPONSIBILITIES

In addition to any personnel security responsibilities covered under HHSAR 52.239-72, the contractor shall comply with the below personnel security responsibilities:

LOSS AND/OR DISCLOSURE OF PERSONALLY IDENTIFIABLE INFORMATION

(PII) - NOTIFICATION OF DATA BREACH

The Contractor shall report all suspected or confirmed incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH Incident Response Team (IRT) via email ( IRT@mail.nih.gov ) within one hour of discovering the incident. The Contractor shall follow up with IRT by completing and submitting one of the applicable two forms below within three (3) work days of incident discovery:

VULNERABILITY SCANNING REQUIREMENTS

Revised 04-16-2015 http://nvd.nist.gov/fdcc/index.cfm mailto:IRT@mail.nih.gov

This acquisition requires the Contractor to host an NIH webpage or database.

Contracting Officer’s Representative

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

To be determined at the time of award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements;

(3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COR designation.

Post Award evaluation of Contractor Performance

a) Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted at the time of the annual evaluation. Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation.

The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations Contractor responses and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b) Electronic Access to Contractor Performance evaluations

Contractors that have internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address: hhtp://oamp.od.nih./OD/CPS/cps.asp. The registration process requires the Contractor to identify an individual that will serve as a primary point of contact and who will be authorized access to the evaluations for review and comment. In addition, the Contractor will be required to identify an alternate contact that will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

Reporting Matters Involving Fraud, Waste and Abuse

Anyone who becomes aware of the existence or apparent fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector general’s Office in writing or the Inspector general’s hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is Htips@os.dhhs.gov and the mailing address is:

Office of the Inspector general Department of Health and Human Services

TIPS HOTLINE

PO Box 23489 Washington, DC 20026

ADDITIONAL PROPOSAL INSTRUCTIONS:

Full text copies of the representations and certifications for the other cited provisions and clauses may be obtained online at the NCI website at http://amb.nci.nih.gov.

The following instructions will establish the format and contents of Offers. Special attention is directed to the Fixed Price for technical and business offers to be submitted in accordance with these instructions.

1 Contract Type and General Clauses

It is contemplated that a requirements contract will be awarded. Any resultant contract shall include the clauses applicable to the selected offerors organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract.

2 Authorized Official and Submission of Offers

The offer must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this COMBINED

SOLICITATION\SYNOPSIS.

Your offer shall be submitted as follows:

1. Electronic – emailed to farrin.stanton@nih.gov

Offers will be typewritten, paginated, reproduced on letter size paper and will be legible in all required copies. To expedite the offer evaluation, all documents required for responding to the Solicitation should be placed in the following order:

I. COVER PAGE

Include Solicitation title, number, name of organization, identification of the offer part, specify which Consultant discipline in the SOW the offeror is responding to, and indicate whether the offer is an original or a copy

II. TECHNICAL OFFER

mailto:Htips@os.dhhs.gov http://amb.nci.nih.gov/ mailto:farrin.stanton@nih.gov

It is recommended that the technical offer consist of a cover page, a table of contents, and the information requested in the Technical Offer Instructions.

III. BUSINESS OFFER

It is recommended that the business offer consist of a cover page, a table of contents, and the information requested in the Business Offer Instructions.

3 Separation of Technical and Business Offers

The offer must be prepared in two parts: a "Technical Offer", and a "Business Offer" (maybe contained in one binder with two separate sections). Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The technical offer may include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offerors understanding of the project may be evaluated, but should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any)., and total costs.

The technical offer should disclose your technical approach\expertise in as much detail as possible, including, but not limited to, the specific discipline(s) you are submitting for, should clearly demonstrate the offerors capabilities, knowledge, and corporate capability and experience related to supply the services as described in the Statement of Work. The technical offer should be in as much detail as is considered necessary to provide straightforward, concise delineation of the approach the offeror will use for accomplishing the work and how the project is to be managed and staffed. Stating that the offeror understands and will comply with the

NOTE: THE TECHNICAL OFFER AND OTHER INFORMATION RELATED TO HOW

THE OFFEROR(S) DIRECTLY RELATES TO THE SCOPE OF WORK IN THIS

SOLICITATION AND SHALL NOT EXCEED 50 SINGLE-SIDED PAGES.

Pages in excess of the limitation may neither be read or evaluated. Each page of the technical offer must be numbered sequentially. Offerors are encouraged to limit the overall size of the technical offer, inclusive of appendices

Past Performance Information

a) Offerors shall submit the following information as part of their BUSINESS offer.

A list of the last three ( 3) contracts completed during the past three (3) years and ALL CONTRACTS currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns.

Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a major subcontract is defined as a subcontract that exceeds $500,000.

Include the following information for each contract or subcontract:

1. Name of Contracting Organization

2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)

3. Contract Type

4. Total Contract Value

5. Description of Requirement

6. Contracting Officer's Name and Telephone Number

7. Program Manager's Name and Telephone Number

8. North American Industry Classification System (NAICS) Code

The Offeror may provide information on problems encountered on the identified contracts and the offerors corrective actions.

b) The Government is not required to contact all references provided by the offeror.

Basic Cost/Price Information

The business offer must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services. This information shall include a current financial statement of the firm responding.

The cost information should be submitted on the SF 1449 that is attached to this solicitation.

The Offeror must submit with its proposal;

Please note that Offerors must either complete FAR 52.212-3, Offerors Representation and Certifications – Commercial Items (Aug 2009) or provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management Applications (SAM) with their technical/business proposal submission.

Questions regarding this combined synopsis/so licitation must be received in this office by April 30, 2015. Offers must be received by 10:00 AM. (EST) May 18, 2015.

Submit offers electronically AND hardcopies :

National Institutes of Health

National Institute on Drug Abuse Station Support/ Simplified Acquisition Building 31, Room 1B59 Bethesda, MD 20892 Ms. Farrin Stanton Contract Specialist farrin.stanton@nih.gov

Please reference the solicitation number HHS-NIH-NIDA-(SSSA)-CSS-15-106 on your offer.

Facsimile submissions are not authorized and collect calls will not be accepted.

Revised 04-16-2015 mailto:farrin.stanton@nih.gov

52.217-6 Option for Increased Quantity. (MAR 1998)
SOLICITATION – STATEMENT OF WORK/REPORTS/DELIVERABLE PROVISIONS
ROSTER OF EMPLOYEES REQUIRING SUITABILITY INVESTIGATIONS
IT SECURITY PLAN (IT-SP)
IT RISK ASSESSMENT (IT-RA)
FIPS 199 ASSESSMENT
IT SECURITY CERTIFICATION AND ACCREDITATION (IT-SC&A)
REPORTING OF NEW AND DEPARTING EMPLOYEES
The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:
CONTRACTOR – EMPLOYEE NON-DISCLOSURE AGREEMENT(s)
VULNERABILITY SCANNING REPORTS
SOLICITATION – SPECIAL CONTRACT REQUIREMENTS PROVISIONS
HHS-CONTROLLED FACILITIES AND INFORMATION SYSTEMS SECURITY
STANDARD FOR SECURITY CONFIGURATIONS, HHSAR 352.239-70, (January
STANDARD FOR ENCRYPTION LANGUAGE, HHSAR 352.239-71, (January 2010)
SECURITY REQUIREMENT FOR FEDERAL INFORMATION TECHNOLOGY RESOURCES, HHSAR 352.239-72, (January 2010)
INFORMATION SECURITY TRAINING
PERSONNEL SECURITY RESPONSIBILITIES
LOSS AND/OR DISCLOSURE OF PERSONALLY IDENTIFIABLE INFORMATION (PII) - NOTIFICATION OF DATA BREACH
VULNERABILITY SCANNING REQUIREMENTS

File details come from the government source that posted it. Updated .