RFP NIH-NIAID-DAIDS-00-14

Request for Proposal No.:	NIH-NIAID-DAIDS-00-14
OMB #:	0990-0115
Issue Date:	Friday, April 9, 1999
Issued By:	Paul D. McFarlane, NIAID, NIH Contracts Management Branch Solar Building, Room 3C07 6003 Executive Boulevard, MSC 7610 Bethesda, Maryland 20892-7610
Point of Contact:	Jacqueline C. Holden, Contracting Officer
Purchase Authority:	Public Law 92-218 as amended
Small Business Set-Aside:	Yes, SIC Code 8731
Just In Time:	No
Offer Expiration Date:	Offers will be valid for 120 days unless a different period is specified by the Offeror on the form entitled "Proposal Summary and Data Record, NIH 2043".
Proposal Due Date:	Friday, June 11, 1999, 4:00 P.M EST

Ladies and Gentlemen:

You are invited to submit a proposal in accordance with the requirements of this RFP (NIH-NIAID-DAIDS-00-14) entitled "Resynthesis of Therapeutic Agents for Treatment of Infectious Diseases" The Government anticipates that one (1) cost reimbursement, completion type contract will be awarded for a period of seven (7) years as a result of this RFP.

This RFP will utilize the National Institute of Allergy and Infectious Diseases' (NIAID) Contract Review On-line (CRON) system. Offerors must submit their proposals ELECTRONICALLY. In addition to your electronic submission, Offerors must submit the signed originals of their technical and business proposals along with one (1) full duplicate copy of each, both in HARDCOPY.

NIAID'S CRON system is expected to save the paper and postage costs which the mailing of multiple copies of a standard RFP proposal imposes on the offeror. This approach will also allow us to conduct a technical review based on electronic availability of proposals which will save money that would otherwise be spent shipping proposals out to reviewers and for travel and per diem to bring in reviewers for the Technical Review meetings. We hope this will prove to be convenient to offerors, technical reviewers and the Government. Adequate security for electronic transmission will be provided by using a dedicated server with access restricted through passwords.

Please note that the electronic copy of your proposal will need to be submitted in Adobe Acrobat portable document format (PDF). An official authorized to bind your organization must sign the hardcopy of your proposal.

The documents included with this electronic RFP package are as follows:

Attachments:

1. Introduction, Background and Work Statement, dated April 9, 1999
2. Reporting Requirements and Deliverables, dated April 9, 1999
3. Evaluation Factors for Award, dated April 9, 1999
4. Specific RFP Instructions and Provisions, dated April 9, 1999
5. Applicable RFP References, dated April 9, 1999
6. How to Prepare and Submit an Electronic Proposal, dated April 9, 1999

In addition to the information provided in this document (i.e., The Streamlined RFP), there are five (5) other referenced documents in the Streamlined RFP References that must be retrieved, in whole or in part, in order to submit a proposal. The applicable portions of these referenced documents are explained in Attachment E, Applicable RFP References of this RFP.

If you are unable to download any of the applicable documents, please contact Jacqueline C. Holden, Contracting Officer, by phone, fax or e-mail numbers/address listed below.

Your attention is further directed to the "Proposal Intent Response Sheet" contained in Attachment D of this document. Please complete this form and return it to this office via fax or E-mail on or before Friday, May 7, 1999. This will allow us to expedite preparations for the electronic submission and review of proposals.

Questions concerning any areas of uncertainty which, in your opinion, require clarification or correction must be furnished in writing to Jacqueline C. Holden, Contracting Officer at the Internet electronic mail address jh55b@nih.gov or by fax at 301/402-0972. Ms. Holden's phone number is 301-496-7119. Your questions should be received no later than Friday, May 7, 1999 and marked "Offeror's Questions, RFP NIH-NIAID-DAIDS-00-14."

If you have any additional questions or concerns regarding this RFP, or the electronic transmission of proposals, please contact the above listed individual. Collect calls will NOT be accepted.

Sincerely,

/s/

Paul D. McFarlane
Contracting Officer
Contracts Management Branch
National Institute of Allergy and Infectious Diseases, NIH

Attachments: A - E

Prior to evaluation in clinical trials most experimental agents require chemical resynthesis, pharmaceutical analysis, and dosage formulation to ensure products that are of sufficient quantity and quality to permit proper testing in humans. The DAIDS currently utilizes contracts to fulfill its needs in these areas. The purpose of this RFC is to re-compete one of these contracts (N01-AI-55256) that was awarded to Starks Associates, Inc. for resynthesis of potential therapeutic agents for treatment of infectious diseases.

WORK STATEMENT

Independently and not as an agent of the Government, the Contractor shall furnish all services, qualified personnel, materials, equipment and facilities not otherwise provided by the Government under the terms of this contract as needed to perform the work described below.

[GENERAL NOTE TO OFFEROR: Attachment (1) to this work statement, entitled, "Confidentiality of Information" sets forth an intended Advance Understanding for this effort. It requires the Contractor and all subcontractors to maintain the confidentiality of proprietary data provided to them during the conduct of this effort. Further, data generated under the resultant contract shall not be submitted for publication or public presentation until first reviewed by the Project Officer, NIAID. This NIAID review shall be accomplished within 60 calendar days. Attachment (2) to this work statement provides an example of a typical "Screening Agreement" which may be signed between the NIAID and suppliers of certain compounds to be utilized during the conduct of this effort. The Contractor shall be responsible for reading and understanding this document's content and intent as regards this proposed contract.]

Specifically, the Contractor shall:

1. Resynthesize on a small-scale (0.01 - 10 g/batch) compounds (approximately 40/yr) as designated by the Project Officer. Provide samples of synthetic intermediates to NIAID as requested by the Project Officer. The Government shall identify the target materials and provide synthetic methods when available. When no synthetic method is provided by the Project Officer, the Contractor shall perform literature searches of chemical resources such as on-line databases and propose one for the Project Officer's approval prior to starting work.

[NOTE 1 TO OFFEROR: In responding to this RFP, the offerors are to describe the experience of their proposed staff and the organization in the resynthesis of chemicals, and the facilities available to the offerors for meeting the requirements of the Work Statement. The Principal Investigator should be trained at the Ph.D. level in organic chemistry and have at least five years experience in chemical scale up synthesis. The technical staff should have at least a B.S. in chemistry and at least three years of experience in chemical resynthesis.]

2. Provide synthetic routes for the preparation of, and synthesize 10- 1000 g batches of potential anti-infective agents (approximately 5/yr) selected by the Project Officer. Prior to proceeding with scale-up synthesis, the Contractor shall provide for the Project Officer's review and approval a written synthetic method and cost estimate.

[NOTE 2 TO OFFEROR: The contractor shall manufacture pharmaceutical materials in compliance with current Good Manufacturing Practices (GMP) regulations. The proposal shall describe specific examples of products manufactured by the offeror under GMP regulations]

[NOTE 3 TO OFFEROR: At the present time it is not possible to identify specific candidate compounds or the approximate ratio of small to large-scale batches. However, offerors shall anticipate that individual requests for synthesis will usually be for a compound from one of a variety of relatively simple chemical classes (e.g. heterocyclic or carbocyclic), but which will require diverse capabilities in organic synthesis.

For the purpose of preparing a budget, assume the synthesis of a total of 45 known organic or organometallic compounds per year, including twenty in 100 mg amounts, twenty of 5-10 gram amounts, four compounds in 250 gram amounts, and one 1 kg in quantity.]

3. Provide for each compound synthesized: (a) a summary of the synthetic process including scheme, all materials used and amount, overall yield, solubility, estimation of purity, etc.; (b) an analytical data sheet that includes infrared, NMR, and ultraviolet spectra, melting point, elemental analysis, chromatographic behavior, and when requested, MS and/or 13C NMR; and (c) a Material Safety Data Sheet as required by the Occupational Safety and Health Administration.
4. As requested by the Project Officer, acquire, through purchase or donation, approximately five compounds per year for efficacy testing against opportunistic pathogens (e.g., Pneumocystis carinii, Mycobacterium avium complex, Toxoplasma gondii, etc) associated with AIDS.

[NOTE 4 TO OFFEROR: It is the intent of the Government that the synthesis effort, and not acquisition, will be the major emphasis of this award. For the purposes of preparing a budget, assume that the acquisition task will be approximately 5% of the total effort. The acquired compounds would be for the purpose of testing for efficacy against opportunistic pathogens (e.g. Pneumocystis carinii, Mycobacterium avium complex, Toxoplasma gondii, etc.) associated with AIDS. These compounds shall be acquired through purchase or donations through contacts with pharmaceutical and chemical companies, academic laboratories, or other sources known to the Contractor. Because of the sensitive nature of obtaining donations of compounds for testing against disease organisms, the Offeror shall fully document the corporate experience and the experience of assigned staff in this type of work.

The Offeror shall propose a mechanism by which this effort would be accomplished, including potential sources of such donations, proposed staff, and a proposal for maintaining confidentiality of information between the contractor, the drug sponsor, and the Government. Other compounds to be acquired may include agents (e.g. oligonucleotides, polypeptides, radiolabelled compounds, cytokines, etc.) for which synthesis expertise or equipment may not be available at the Contractor.]

5. Deliver synthesized or acquired compounds to the NIAID in amounts and within the time frame specified by the Project Officer. Compounds are to be packaged, and shipped under appropriate conditions to the AIDS Reference and Reagents Repository, National Institute of Allergy and Infectious Diseases, c/o McKesson Bioservices, 621 Lofstrand Lane, Rockville, MD 20850.
6. Communicate effectively with the Project Officer.

• Establish electronic communication with the Project Officer sufficient to support exchange of e-mail and the submission of data files and reports when requested.
• Provide periodic updates of project status, to be scheduled after contract award, via telephone or e-mail.
• Submit project plans, project reports, and annual reports in a timely fashion in accordance with the Reporting Requirements and Deliverables section incorporated into this contract.
• Meet with the Project Officer annually.

7. Ensure an orderly transition of contract-related materials to a successor Contractor.

1. No later than three (3) months prior to the expiration date of the contract, the Contractor shall provide to the Project Officer,

• a complete record of all successful syntheses assigned during the period of award, all records of unsuccessful synthesis, and any other data and information that were generated during the award period
• protocols detailing ongoing studies anticipated to be uncompleted by the expiration date
• plans for the shipping of materials to the successor site
2. If requested to do so, by the expiration date of the contract, the following shall be transferred to a site designated by the Contracting Officer:

• Equipment and property, including drug samples, chemicals, and other supplies, purchased with contract funds or otherwise furnished by the Government
• An inventory listing of all items transferred. This listing shall accompany the delivery of items and a separate copy shall be provided to the Project Officer
• Copies of laboratory notebooks and files containing data generated during the award period

Certain information and data provided to the Contractor shall require confidential treatment. All information supplied by the Project Officer should be assumd to be proprietary unless specifically identified in writing by the Project Officer as non-proprietary. Proprietary information provided by the Project Officer may not be revealed without written permission, because such revelations may violate Confidentiality Agreements or other agreements between the NIAID and the provider of the therapeutic agent or jeopardize patent claims. Confidentiality will be protected by an Advance Understanding to be included in the resulting contract as follows:

Therapeutic agents and other reagents provided by/through the Government for use under this contract shall be restricted to contract-related studies and further shall not be released to any other investigators without written approval of the Project Officer.

WORK STATEMENT
ATTACHMENT (2)

1. The SUPPLIER may supply products, patented or un-patented, to the DIVISION which may proceed to screen and test for possible treatment for AIDS and associated opportunistic infections including tuberculosis. These products are to be used for screening and testing as anti-viral, anti-bacterial, anti-fungal, anti-parasitic, immunomodulating, and biological modifying agents with potential for the treatment of AIDS and associated infections, and for no other purpose.

   Using protocols evaluated and approved mutually by the DIVISION and the SUPPLIER, the products will be screened by one or more of the DIVISION's contract testing laboratories, or in any other testing laboratories which may from time to time be added to the DIVISION's portfolio but in any event will not be placed in the laboratories of any company in the pharmaceutical or chemical industries without the SUPPLIER's written permission.

2. In order to facilitate records keeping and handling of confidential materials, the DIVISION utilizes the following procedures:

   1. The SUPPLIER shall forward to the DIVISION the products to be tested together with data sheets in duplicate for each product, giving pertinent available data as to chemical constitution, solubility, toxicity, previous biological efficacy and any precautions which need to be followed in handling, storing, and shipping.

   2. It is clearly understood that no data about the products and the results of the testing will be kept in files open to the public either by the DIVISION, the testing laboratories, or the data processing activities. Only those employees directly engaged in the operation of the DIVISION will have access to the files of information regarding source and nature of confidential materials and results of testing, except as required pursuant to the Freedom of Information Act, 5 U.S.C.552.

   3. Whenever possible the SUPPLIER will be given the choice of the DIVISION's contract testing laboratories, although at present there is no preference; and it is understood that the DIVISION reserves the right to send the SUPPLIER's products to another screening contractor if the need arises. It is furthermore understood that the contracts between the DIVISION and the testing laboratories will contain provisions to safe guard the SUPPLIER's rights under this Agreement.

   4. Because the DIVISION's screening effort will be accomplished in collaboration with the DIVISION's scientific staff and academic collaborators, as well as the SUPPLIER's own staff, the DIVISION will work in concert to assure rapid ongoing communications of screening data to the SUPPLIER, and the SUPPLIER will in turn use its best efforts to keep the DIVISION informed on the SUPPLIER's own ongoing concomitant studies.

3. Although the SUPPLIER recognizes that the interchange of information is generally desirable in the field of treatment for AIDS, it is mutually understood that the SUPPLIER, in voluntarily supplying appropriately marked information deemed proprietary, including product and information regarding this product hereunder, is entitled to protection for any such technical information it may furnish.

1. It is understood and agreed to, subject to applicable law, that the SUPPLIER shall retain all rights to those compounds or products in which the SUPPLIER has a proprietary interest. The SUPPLIER understands that contractors have the right to elect to retain title to inventions made under NIAID-supported contracts [37 CFR 401.14(b)]. The SUPPLIER deserves the right to reach an agreement with these contractors concerning the disposition of these intellectual property rights. The DIVISION agrees to notify the SUPPLIER of the names of the contractors prior to submitting compounds or products to them. Subject notwithstanding, to the provision that, with respect only to those drugs which have been determined by means of the various screening and testing processes to possess such significant activity (strong potential to be scheduled for clinical trial by the DIVISION, using mutually approved protocols), the Government shall have a royalty-free, irrevocable, nonexclusive license for clinical trials under any patent which the SUPPLIER may have or obtain on such compound or product or on a process for use of such compound or product, to manufacture and/or use by or for the Government the invention(s) claimed by the patent(s) only for medical research purposes related to or connected with the treatment of AIDS and associated infections including tuberculosis.

2. The DIVISION agrees that the publication of biological data on products provided by the SUPPLIER is worthwhile and shall be encouraged. Specifically:

1. With regard to screening results on compounds in which the SUPPLIER has a proprietary interest, and that the DIVISION deems significant for the research on therapies for AIDS and associated infections including tuberculosis, the SUPPLIER agrees that the DIVISION may publish or otherwise publicly disclose such results after a period of 6 months from the date of final reporting of screening and testing results to the SUPPLIER in order for patent applications to be filed. The DIVISION will consult with the SUPPLIER prior to publication within this period on screening and testing results.
2. For all other compounds, the SUPPLIER will consult with the DIVISION prior to publishing screening data along with the available biological and physical data; such consent shall not be unreasonably withheld.
3. In no case will the DIVISION publish information identifying the SUPPLIER as the source of the compound without written approval.

3. As soon as tests are completed and reported to the DIVISION, the SUPPLIER will receive from the DIVISION a full report including all screening data. The products scheduled for clinical trial, referred to herein, shall be designated by the DIVISION, and the aforementioned report will specify the compounds so selected. The DIVISION shall be consulted whenever the SUPPLIER desires to include screening data in a publication, and appropriate credit shall be given to the U.S. Public Health Service.

The DIVISION is confident that this agreement will lay the basis for mutually satisfactory cooperation in the field and in the treatment of AIDS and associated diseases.

In agreeing to the above, the SUPPLIER signs below, as well as the attached duplicate of this agreement, and returns both to the DIVISION for countersignature. One original will be returned for the SUPPLIER's files.

The Contractor shall submit technical progress reports covering the work accomplished during each reporting period. These should be factual and be prepared in accordance with the following format (refer to paragraph E, Technical Report Distribution, for distribution and submission requirements):

1. Project Reports: Upon delivery of synthesized compounds, the contractor shall submit three copies of a report for each compound. The report shall provide a narrative description of the synthetic procedures, materials used, and yields for each step. The report shall also include a schematic of the synthesis scheme and a data sheet that summarized the analytical results including: solubility, melting point, ultraviolet spectra, infrared spectra, NMR spectra, elemental analysis, and chromatographic behavior. A copy of the Material Safety Data Sheet also shall be included.
2. Quarterly Reports: The contractor shall submit every three months three copies of a report that describes work completed, and uncompleted tasks elucidating difficulties encountered and attempted proposed solutions. This may include a listing of project requests for the reporting period.
3. Final Report: The contractor shall submit three copies of a final report which documents and summarizes the results of the entire contract period. The final report shall be submitted by the expiration date of the contract.

If the contractor is unable to deliver the reports specified above within the period of performance because of unforeseen difficulties, not withstanding the excercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons therefore.

4. Report Format
:

1. All reports shall contain a title page, which includes
:

1. Contract number and title
2. Type of report (Project, Annual, or Final)
3. Period of performance being reported
4. Contractor's name and address
5. Author(s)
6. Date of submission

2. Project Reports minimally shall include the following information
:

1. A brief introduction describing the assigned task
2. Methodology of techniques used
3. Schemes of the reaction steps
4. Description of experimental procedures, physical properties and analytical data

3. Quarterly and Final Reports shall not include detailed copies of material previously submitted in Project Reports. They shall contain a cummulative list of submitted Project Reports, briefly summarize work performed during the reporting period, and include a description of current technical or admistrative problems encountered, their resolution, or the proposed corrective action.

5. Technical Reports Distribution
:

Copies of the technical reports shall be submitted as follows:

Type of Report	No. of Copies	Addressee
Project	2	Project Officer (P.O.) Drug Development and Clinical Sciences Branch Division of AIDS, NIAID National Institutes of Health Solar Building, Room 3C04 6003 Executive Boulevard. Bethesda, MD 20892 (US Mail) or Rockville, MD 20852 (Fed Ex)
	1	Contracting Officer Contract Management Branch Division of Extramural Activities, NIAID National Institutes of Health Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 (US mail) or Rockville, MD 20852 (Fed Ex)
Quarterly	2 1	Same as P.O. above Same as C.O. above
Final	2 1	Same as P.O. above Same as C.O. above

Selection of an offeror for contract award will be based on an evaluation of proposals against two factors. The factors in order of importance are technical and cost. Although technical factors are of paramount consideration in the award of the contract, cost/price are also important to the overall contract award decision. In accordance with FAR 15.305, proposals will be subject to a cost realism analysis by the Government. Offerors are advised that the award will be made to the offeror whose proposal provides the best overall value to the Government.

The evaluation will be based on the demonstrated capabilities of the prospective contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.

PROPOSALS WILL BE JUDGED SOLELY ON THE WRITTEN MATERIAL PROVIDED BY THE OFFERORS.

TECHNICAL EVALUATION CRITERIA

1. Technical Approach (40 POINTS)

The scientific soundness of the approach, and awareness of potential problems, as exhibited in the discussion of: a) approaches to economical scale-up of the synthesis of compounds; including an example of preparation of a known complex molecule, including problems encountered and proposed solutions to such problems (10 pts) b) plans for monitoring the synthetic processes and characterizing the final products and key intermediates with respect to identity and purity (10 pts); and c) plans for acquisition of chemicals for testing against infectious diseases relevant to AIDS and for delivery of compounds to NIAID (10 pts); and d) plans for communicating effectively with the Project Officer, ensuring that confidential data and therapeutic agents are secure from an unauthorized access, and effecting an orderly transition to a successor contractor (10 pts) .

2. Personnel Qualifications and Availability( 30 POINTS)

Principal Investigator: Relevance and quality of training experience and scientific accomplishments in synthetic organic chemistry, in modification of synthetic routes for large scale chemical syntheses, and in directing a project of similar scope and complexity. The Principal Investigator's documented availability for adequate time to direct this project will also be evaluated (15 pts).

Relevance and quality of training and experience, and documented availability, of other staff in relation to their proposed roles. Recent examples of pertinent accomplishments in developing feasible synthetic methods for chemicals and in the scale up syntheses of bulk pharmaceuticals and reference standards will be considered (15 pts).

3. Facilities, Resources and Equipment(15 POINTS)

Adequacy, safety, suitability and documented availability of the facilities, space (provide floor plan) and appropriate equipment to synthesize, package and ship compounds on the scale requested (100 mg-1000 g), and of the analytical equipment to characterize the identity of compounds and reference standards; availability of literature resources, including on-line search capability.

4. Experience and Capabilities of the Organization(15 POINTS)

The documented experience of the organization in: preparatory scale up synthesis of pharmaceuticals; meeting State and Federal regulations with respect to safety; waste disposal; proven capability to manufacture pharmaceutical materials in compliance with Current Good Manufacturing Practice regulations (GMP); preparation of Material Safety Data Sheets; acquisition of drugs for testing by the U.S. Government; and adhering to Federal, State and local regulations pertaining to packaging and shipment of chemicals.

TOTAL: 100 POINTS

SPECIFIC RFP INSTRUCTIONS AND PROVISIONS

NOTICE TO OFFERORS: This attachment contains proposal instructions and information that are specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. References to additional, more general information, and forms regarding proposal preparation are contained in Attachment E, "Applicable RFP References".

1. NUMBER AND TYPE OF AWARD(S)

It is anticipated that one (1) award will be made from this solicitation on/about January 3, 2000.

It is anticipated that the award from this solicitation will be a cost reimbursement completion type contract with a seven (7) year performance period, and that incremental funding will be used.

2. ESTIMATE OF EFFORT

It is expected that one completion type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the seven year total effort to be approximately 2,450%, (350% per year). This estimate is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.

As further assistance, it is estimated that the above total labor effort is constituted as follows:

Labor Category	Annual Effort	7-Year Total
Principal Investigator	25%	175%
Other Professional	250%	1,750%
Technical Support	50%	350%
Support Staff	25%	175%
TOTAL	350%	2,450%

These percentages are based on a 12 month calendar year.

3. SIC CODE AND SIZE STANDARD

Note: The following information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS, FAR 52.219-1:

1. The standard industrial classification (SIC) code for this acquisition is 8731.

(1) The small business size standard is 500 Employees.

(2) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

4. SERVICE OF PROTEST (AUG 1996) - FAR 52.233-2

1. Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Hand-Carried Address:

Brenda J. Velez, Chief, Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

Mailing address (U.S.) Postal Service

Brenda J. Velez, Chief, Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.

The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

5. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

AN OFFEROR SHALL PLACE THIS NOTICE ON TOP OF EACH COPY OF ITS TECHNICAL PROPOSAL.

"This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices that the submitter places on this proposal shall also be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be made only to the extent authorized by, and in accordance with, the procedures in HHSAR paragraph 315.608-72."

(For information regarding authorized restrictive notices, offerors should refer to the "Confidentiality of Proposals" section, Item F.6, of the STANDARD RFP INSTRUCTIONS AND PROVISIONS, General Instructions.)

6. SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUG 1997)

(a)  To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration, and other agencies at the Federal, State, and local levels (Federal, State and local regulatory/enforcement agencies.)

(b)  Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officers, determines to be reasonably necessary. If compliance with such additional safety measures results in an increase or decrease in the cost or time required of performance of any part of work under this contract, an equitable adjustment will be made in accordance with the applicable "Changes" Clause as set forth in the contract.  

(c)  The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contact and all violations for which the Contractor has been cited by any Federal, State, or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.  

(d)  If the Contractor fails or refuses to comply promptly with the Federal, State, or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.

(e)  The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.

7. PROPOSAL INTENT RESPONSE SHEET

RFP No.: NIH-NIAID-DAIDS-00-14

RFP Title: "Resynthesis of Therapeutic Agents for Treatment of Infectious Diseases"

Please review the attached Request for Proposals. Furnish the information requested below and return this page by Friday, May 7, 1999. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

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[ ] DO INTEND TO SUBMIT A PROPOSAL

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:

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Company/Institution Name: ______________________________________

Address: _______________________________________________________
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________

Project Director's Name: ________________________________________

Title: _________________________________________________________

Signature/Date: ________________________________________________

Telephone Number and E-mail Address: ___________________________

Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants):

_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________

(Continue list on a separate page if necessary)

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RETURN TO:

CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
Attn: Jacqueline C. Holden, Contracting Officer
RFP NIH-NIAID-DAIDS-00-14
FAX# 301/402-0972

Email jh55b@nih.gov

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ATTACHMENT E

RFP NIH-NIAID-DAIDS-00-14
APRIL 9, 1999

APPLICABLE RFP REFERENCES

This section identifies the items found in the RFP Web directory entitled RFP REFERENCES that are applicable to this RFP.  

1. The entire file entitled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as otherwise may be modified by the inclusion of an item from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS".
2. The following items are applicable from the file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS:"

• LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS OF PROPOSALS, PHS 352.215-10

3. The following items/files are applicable from the subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS":

Applicable to Technical Proposal

• Technical Proposal Cover Sheet
• Technical Proposal Cost Information
• Summary of Current and Proposed Activities

Applicable to Business Proposal

• Proposal Summary and Data Record, NIH-2043
• Business Proposal Cost Information
• Disclosure of Lobbying Activities, OMB Form SF-LLL
• Excel cost spreadsheet (Template provided)

To Become Contract Attachments

• Invoice/Financing Requests Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1, May 1997
• Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16), Apr. 1984
• Form NIH 2706 (Financial Report) and Instructions for Completing Form NIH 2706 Note: Financial reports are not always required. This will be discussed during negotiations.

Other-to be submitted as directed by Contracting Officer

• Certificate of Current Cost or Pricing Data, NIH-1397

4. The "Representations and Certifications" are applicable.
5. The "Sample Contract Format-General" is applicable.

HOW TO PREPARE AND SUBMIT AN ELECTRONIC PROPOSAL

1. ABOUT NIAID'S CONTRACT REVIEW ON-LINE (CRON) system

   The National Institute of Allergy and Infectious Diseases is using RFP NIH-NIAID-DAIDS-00-14 to test the Contract Review On-Line (CRON) system developed by the NIAID. Proposals in response to this Request for Proposal (RFP) will be submitted electronically over the Internet. Adequate security will be provided by using a dedicated server with access restricted through passwords. Following the initial phase of electronic submission by the offerors, proposals will be forwarded to the selected technical reviewers where they will be read and evaluated electronically. The technical review is designed so that a face-to-face meeting is not required. Instead technical reviewers will access proposals through the Internet. Final Revised Proposals (FRPs) will also be submitted and reviewed electronically.

   This electronic acquisition approach will save the government and, hence, the taxpayer the costs of travel and per diem for the reviewers, and of shipping proposals to the reviewers.

   Offerors will be spared the cost of copying and shipping proposals, which can be a significant expense. This approach should also reduce the staff time needed to process an action through to award. We anticipate that the savings in staff time will be much greater than the savings in postage and paper costs.

2. ELECTRONIC SUBMISSION INSTRUCTIONS

1. GENERAL --- To submit a proposal electronically under this RFP, Offerors will need to prepare the proposal on a word processor or spreadsheet program (for the cost portions) and convert them to Adobe Acrobat Portable Document Format (PDF). THE TECHNICAL PROPOSAL AND BUSINESS PROPOSAL MUST BE CONTAINED ON SEPARATE FILES. Further, to expedite the file transferring process, the two files must be named using the following DOS naming convention:

• Technical Proposal: c:\rfp____\techprop.pdf
• Business Proposal: c:\rfp____\busiprop.pdf

2. Approximately TWO weeks prior to the due date of proposals, all offerors will be provided with specific electronic access information and electronic proposal transmission instructions. For this reason, it is imperative that all offerors who are intending to submit a proposal in response to this RFP contact the Contracting Officer identified in this RFP and complete and submit the attached Proposal Intent Form by FRIDAY, MAY 7, 1999.

NOTE: There is no limit to the size (MB) of the two electronic PDF files to be submitted; however, the size of the technical proposal is limited to the page limitation language outlined below. For purposes of assessing compliance with the page count, technical proposals will be viewed using the print function of the Adobe Acrobat Reader, Version 3.0.

3. ADDITIONAL SUGGESTIONS --- Do not embed sound or video (e.g., MPEG) files into the proposal documents. The evaluation system will not incorporate a capability to read these files. Graphics which are embedded into documents should be kept as simple as possible. Complex graphics require longer periods for the computers used in the evaluation system to draw, and redraw these figures and scrolling through the document is slowed significantly. Suggestions include:

• Limit colors to 256 colors at 1024 x 768 resolution; avoid color gradients.
• Simplify the color palette used in creating figures.
• Be aware of how large these graphics files become. Large files are discouraged.
• Limit scanned images as much as possible.

4. PAGE LIMITS -- The narrative portion of the Technical Proposal is limited to fifty (50) pages. Pages in excess of the maximum will be deleted and will not be read or evaluated. Offerors are encouraged to limit the overall size of the Technical Proposal, inclusive of appendices, attachments, etc. Please note that no page limit has been placed on the contents of the Business Proposal.

Type density and size must be 10 to 12 points. If constant spacing is used, there should be no more than 15 cpi, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be set to 1 inch around.

Technical Proposal and Business Proposal preparation instructions along with proposal table of contents are detailed below.

3. TECHNICAL PROPOSAL INSTRUCTIONS

1. GENERAL --- The entire technical proposal, except as noted below in the "Technical Proposal Table of Contents", is to be submitted electronically. The STANDARD RFP INSTRUCTIONS AND PROVISIONS provide more detail on the TECHNICAL PROPOSAL requirements.
2. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT

(NOTE: Instructions to offerors are indicated in parentheses or as footnotes.)

1. TECHNICAL PROPOSAL COVER SHEET .............................. Page 1
2. TECHNICAL PROPOSAL TABLE OF CONTENTS ................ Page 2
3. SUMMARY OF OBJECTIVES AND METHODS (Abstract)*... Page 3
4. TECHNICAL PLAN (Refer to Technical Proposal Instructions located in the Standard RFP Instructions and Provisions.)

STATEMENT OF WORK

1.Objectives ........................................ Page 4
2. Approach ......................................... _____
3. Methods ........................................... _____
4. Schedule ........................................... _____

PERSONNEL (List by name, title, department and organization, and detail each person's qualifications and role in the Project.)

Provide narrative for:

1. Principal Investigator/Project Director
2. Other Investigators
3. Additional Personnel, (e.g., technical support, subcontractors,consultants)

(Note: For key personnel, include 2 page biosketch/resume and the form entitled "Summary of Current and Proposed Activities.") -- Page ____

5. FACILITIES/RESOURCES AND DIRECT COSTS (List/describe all equipment, facilities and other resources available for this project; attach "Technical Proposal Cost Information" form, and marked laboratory/clinical space floor plan in Item 6.)-- Page ____
6. OTHER CONSIDERATIONS (Provide brief narrative of any unique arrangements, safety procedures in place, animal welfare issues, human subject and minority and gender issues, etc.)-- Page ____
7. HUMAN SUBJECTS, PARTICIPATION OF CHILDREN AND MINORITY AND GENDER ISSUES NOT OTHERWISE ADDRESSED (IF APPLICABLE) -- Page ____  
8. VERTEBRATE ANIMALS (IF APPLICABLE) -- Page ____
9. "Technical Proposal Cost Information" summary spreadsheet -- Page ____
10. LITERATURE CITED -- Page ____  
11. APPENDICES** (Protocols, policy manuals, etc. for above Technical Plan; list each Appendix; Appendices must be clear and legible, and easily located.)

  * State the proposal's broad, long-term objectives and specific aims. Describe concisely the research design and methods for achieving these goals. DO NOT EXCEED ONE PAGE in providing the abstract. Identify the RFP number, institution, and Principal Investigator on the abstract.

** HARDCOPY SUBMISSION OF APPENDICES: The following items are excluded from our electronic submission requirement and will not be subject to page limitations. Instead all Offerors must submit ten (10) paper copies of the information.

• Complete SOPs; any other pertinent policy manuals; any letters of collaboration from other investigators; non-scannable figures or data.

4.  BUSINESS PROPOSAL INSTRUCTIONS

1. GENERAL --- THE ENTIRE BUSINESS PROPOSAL IS TO BE SUBMITTED ELECTRONICALLY. There are no page limits with the business proposal. The STANDARD RFP INSTRUCTIONS AND PROVISIONS provide more detail on the BUSINESS PROPOSAL requirements.

Following proposal submission and review, additional information will be requested by the Contracting Officer from all offerors that comprise the competitive range. The format of your BUSINESS PROPOSAL is detailed in the "Business Proposal Table of Contents", below.

With the Business Proposal, please submit Form NIH-2043, "Proposal Summary and Data Record." Note that in addition to telephone and fax numbers, the INTERNET addresses of both the Principal Investigator and the responsible business representative are to be included on the form.

2. ESCALATION. Due to the National Institute of Allergy and Infectious Diseases' current budget restrictions, it is recommended that any proposed annual increase in costs for inflation be limited to no more than 3% of total costs per year. Final inflation increases will be subject to the negotiation process taking into consideration the most current consumer price index (CPI).
3. BUSINESS PROPOSAL TABLE OF CONTENTS

1. Proposal Summary and Data Record, NIH-2043
2. Business Proposal Cost Information and cost spreadsheets which include an itemized cost element breakdown, for each year of the contract. Cost elements on these spreadsheets include (as applicable): Direct Labor, Fringe Benefits, Materials, Subcontracts, Travel, Equipment, ODC, Raw Materials, Purchased Parts, Indirect Costs, Fee/Profit.

[Note: We have included a template cost spreadsheet in Microsoft Excel. Offerors are requested to complete this spreadsheet and include it with their business proposal. This spreadsheet can replace the cost sheets that you ordinarily provide. It is our hope that this spreadsheet will provide you with a useful tool, allow us to more easily understand your cost proposal, and eliminate our need to recreate your spreadsheets. This spreadsheet template is a new approach, and we would appreciate any feedback you could give us about it.]

3. Business Plan - the business plan has the following components:

• A narrative of the BASIS of costs proposed; do not provide documentation with initial proposal
• Qualification of the Offeror - This includes: General Experience, Organizational Experience Related to the RFP, Performance History, Pertinent Contracts and Grants
• Property, Equipment, Facilities to be dedicated to this work
• Royalties, Financial Capacity, Subcontractors

4. Representations and Certifications
5. Other Forms/Information:

• Disclosure of Lobbying Activities, OMB Form SF-LLL

5. PACKAGING AND DELIVERY OF THE PROPOSAL

[Note: Listed below are delivery instructions for the submission of the paper copies of your proposal. Instructions for your electronic submission are described above in Electronic Submission Instructions.]

Shipment and marking shall be as indicated below:

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

"RFP NIH-NIAID-DAIDS-00-14
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

NUMBER OF COPIES

The number of hard copies required of each part of your proposal is specified below.

Technical Proposal (In addition to the electronic submission): Signed original (and if appropriate to your proposal) ten (10) copies of SOPs, pertinent manuals, non-scannable figures or data, and letters of collaboration/intent.

Business Proposal (In addition to the electronic submission): Signed original and one copy.

PAPER/HARD-COPIES TO

If hand delivered or via delivery service

Jacqueline C. Holden, Contracting Officer
Contract Management Branch
NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, Maryland 20852

If using U.S. Postal Service:

Jacqueline C. Holden, Contracting Officer
Contract Management Branch
NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, Maryland 20892-7610

NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.

NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the Rockville, Maryland address. Any package sent to the Rockville address via this service will be held at a local post office for pick-up. THE GOVERNMENT IS NOT RESPONSIBLE FOR PICKING UP ANY MAIL AT A LOCAL POST OFFICE. If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal," in accordance with PHSAR 352.215-10, Late Proposals, Modifications of Proposals and Withdrawals of Proposals (NOV 1986).

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