PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

Representations, Certifications, and Other Statements of Offerors or Quoters (Negotiated).

1. REPRESENTATIONS AND CERTIFICATIONS

The Representations and Certifications required by this particular acquisition can be accessed electronically from the INTERNET at the following URL:

http://rcb.cancer.gov/rcb-internet/forms/rcneg.pdf

If you are unable to access this document electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST COMPLETE THE REPRESENTATIONS AND CERTIFICATIONS AND SUBMIT THEM AS PART OF THE BUSINESS SECTION OF YOUR TECHNICAL PROPOSAL.

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. SOLICITATION DEFINITIONS

A Master Agreement Announcement (MAA) is a notice inviting potentially qualified sources to submit their approaches, qualifications and experience to perform research and development studies, support or evaluation studies in a particular scientific/technical area.

A Master Agreement (MA) is the instrument issued to sources who responded to a MAA, and who were judged to be qualified to compete for future orders issued under the general project area or areas defined in the MA.

A Request for Proposals (RFP) is the solicitation document issued to MA Holders inviting them to compete for the specific study, Research & Development, resource support or evaluation project or projects described in the RFP.

A Contract is a bilateral award document issued to the MA Holder who successfully competed for the requirement(s) described in a RFP.

b. SIC CODE AND SIZE STANDARD

Note: The following information is to be used by the offeror in preparing its Representations and Certifications (See Section K of this RFP), specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATION, FAR Clause 52.219-1.

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

(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.

THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the Federal Acquisition Regulation (FAR) requires in every solicitation, (except for foreign acquisitions) the inclusion of the Standard Industrial Classification (SIC) Code and corresponding size standard which best describes the nature of the requirement in the solicitation.

c. TYPE OF CONTRACT AND NUMBER OF AWARD(S)

A Master Agreement will be awarded to each Technically Acceptable offeror responding to this MAA. It is anticipated that award will be made on or about May 31, 2000 through May 30, 2005.

The Master Agreements awarded from this MAA will not be funded. After award, the Master Agreement holders will be invited to compete on appropriate Contracts as they are issued.

Individual Contracts will be issued on either a cost reimbursement or fixed price basis, whichever is deemed appropriate by the Contracting Officer.

d. COMMITMENT OF PUBLIC FUNDS

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid.

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

Offerors shall direct all communications to the attention of the Contract Specialist/Contracting Officer cited on the face page of this MAA or the Contracting Officer cited in the SERVICE OF PROTEST paragraph contained in this section of the MAA. Communications with other officials may compromise the competitiveness of this procurement and result in cancellation of the requirement.

f. RELEASE OF INFORMATION

MA selection and award information will be disclosed to offerors in accordance with regulations applicable to negotiated procurements. Prompt written notice will be given to unsuccessful offerors as they are eliminated from the competition, and to all offerors following award.

g. COMPARATIVE IMPORTANCE OF PROPOSALS

You are advised that for MAs, the technical evaluation will be the sole determination if an offeror is selected for award. All technically acceptable proposals will receive an MA award.

h. PREPARATION COSTS

This MAA does not commit the Government to pay for the preparation and submission of a proposal.

i. SERVICE OF PROTEST (AUGUST 1996) - FAR 52.233-2

(a) 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:


Sharon A. Miller
Contracting Officer
Research Contracts and Acquisition Branch
National Cancer Institute
EPS, Room 620
6120 EXECUTIVE BLVD MSC 7224
BETHESDA MD 20892-7224

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

(End of Provision)

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

Notwithstanding the procedures contained in the provision of this solicitation entitled Late Submissions, Modifications, and Withdrawals of Proposals, a proposal received after the date specified for receipt may be considered if it offers significant cost or technical advantages to the Government, and it was received before proposals were distributed for evaluation, or within five calendar days after the exact time specified for receipt, whichever is earlier.

(End of provision)

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

INTRODUCTION

The following instructions will establish the acceptable minimum requirements for the format and contents of proposals. Special attention is directed to the requirements for technical and business proposals to be submitted in accordance with these instructions.

(1) MA Type and General Clauses

It is contemplated that Contracts awarded under this MA may be either cost reimbursement or fixed price type (See General Information). Any resultant MA shall include the clauses applicable to the selected offeror's organization and type(s) of Contracts expected to be awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed MA.

(2) Authorized Official and Submission of Proposal

The proposal 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 MAA. Your proposal shall be submitted in the number of copies, to the addressees, and marked as indicated in ATTACHMENT 3, entitled, "Packaging and Delivery of Proposal," PART III, SECTION J, hereof. Proposals will be typewritten, paginated, and reproduced on letter size paper and will be legible in all required copies. To expedite the proposal evaluation, all documents required for responding to the MAA should be placed in the following order:

I. COVER PAGE

Include MAA title, number, name or organization, identification of the proposal part, and indicate whether the proposal is an original or a copy.

II. TECHNICAL PROPOSAL

It is recommended that the technical proposal consist of a cover page, a table of contents, and the information requested in SECTION J, LIST OF ATTACHMENTS ; TECHNICAL PROPOSAL INSTRUCTIONS; and ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS SPECIFIC TO THIS SOLICITATION.

III. BUSINESS PROPOSAL

The information requested in the Business Proposal Instructions should be included in your Technical Proposal and separately identified. Since no MAO is being awarded at this time, and there are no funds associated with the MAO, no cost information will be required with the business portion of your proposal.

IV. SAMPLE CONTRACT/REQUEST FOR PROPOSAL

The Sample Contract/RFP response (both technical and direct cost information) should be included in your Technical Proposal and separately identified.

(3) Proposal Summary and Data Record (NIH-2043)

The Form NIH-2043 is attached for your future information in responding to actual contract RFP's. [NOT APPLICABLE TO THIS SUBMISSION SINCE-- NO COST PROPOSAL IS REQUIRED.]

(4) Technical Proposal and Business Information

The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions. For the SAMPLE CONTRACT/RFP, the technical proposal must include direct cost and resources information, such as labor hours and categories, materials, subcontracts, travel, etc., and associated costs so that the offeror's understanding of the project may be evaluated (see ATTACHMENT entitled, "TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF LABOR AND DIRECT COSTS". However, the technical proposal should not include cost or pricing data relating to individual salary rates or amounts, indirect cost rates or amounts, fee amounts (if any), and total costs. Because your proposal will be reviewed by non-Government reviewers, we request that you DO NOT include confidential financial information of your company at this time.

(5) Alternate Proposals

You may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the Statement of Work. Such proposals may be considered if overall performance would be improved or not compromised and if they are in the best interests of the Government. Alternative proposals, or deviations from any requirements of this MAA shall be clearly identified.

(6) Confidentiality of Proposals--HHSAR 352.215-12, Restriction on Disclosure and Use of Data (April 1984)

The proposal submitted in response to this MAA may contain data (trade secrets; business data, e.g., commercial information, financial information, and cost and pricing data; and technical data) which the offeror, including its prospective subcontractor(s), does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any data may be so restricted; provided, that the Government determines that the data is not required to be disclosed under the Freedom of Information Act, 5 U.S.C. 552, as amended, and the offeror marks the cover sheet of the proposal with the following legend, specifying the particular portions of the proposal which are to be restricted in accordance with the conditions of the legend. The Government's determination to withhold or disclose a record will be based upon the particular circumstances involving the record in question and whether the record may be exempted from disclosure under the Freedom of Information Act.

Unless disclosure is required by the Freedom of Information Act, 5 U.S.C. 552, as amended, (the Act) as determined by Freedom of Information (FOI) Officials of the Department of Health and Human Services, data contained in the portions of this proposal which have been specifically identified by page number, paragraph, etc. by the offeror as containing restricted information shall not be used or disclosed except for evaluation purposes.

The offeror acknowledges that the Department may not be able to withhold a record (data, document, etc.) nor deny access to a record requested pursuant to the Act, and that the Department's FOI officials must make that determination. The offeror hereby agrees that the Government is not liable for disclosure if the Department has determined that disclosure is required by the Act.

If a MA is awarded to the offeror as a result of, or in connection with, the submission of this proposal; the Government shall have the right to use or disclose the data to the extent provided in the MA. Proposals not resulting in a MA remain subject to the Act.

The offeror also agrees that the Government is not liable for disclosure or use of unmarked data and may use or disclose the data for any purpose, including the release of the information pursuant to requests under the Act.

The data subject to this restriction are contained in pages (insert page numbers, paragraph designations, etc., or other identification).

In addition, the offeror should mark each page of data it wishes to restrict with the following legend:

"Use of disclosure of data contained in this page is subject to the restriction on the cover sheet of this proposal."

NOTE: Offerors are cautioned that proposals submitted with restrictive legends or statements differing in substance from the above legend may not be considered for award. The Government reserves the right to reject any proposal submitted with a nonconforming legend.

(7) Evaluation of Proposals

The Government will evaluate technical proposals in accordance with the criteria set forth in PART IV, SECTION M, of this MAA. These criteria include criteria for the SAMPLE CONTRACT/RFP.

(8) Master Agreement Award

(a) The Government will award MAs resulting from this solicitation to all responsible offerors whose offer has been deemed technically acceptable.

(b) The Government may reject any or all offers, if such action is in the public interest, and waive informalities and minor irregularities in offers received.

(c) The Government may award a MA on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the offeror's best terms from a technical and business standpoint.

(d) The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may be submitted for quantities/task areas less than those specified. The Government reserves the right to make an award for a quantity/task area(s) less than the quantity/task area(s) offered, unless the offeror specifies otherwise in the offer.

(e) Before the offer's specified expiration time, the Government may accept an offer (or part of an offer, as provided in paragraph (d) above), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Negotiations conducted after receipt of an offer do not constitute a rejection or counter offer by the Government.

(f) Neither business data submitted with an offer, nor representations concerning facilities or financing, will form a part of the resulting MA. However, if the resulting MA contains a clause providing for price reduction for defective cost or pricing data, the price of a subsequently awarded CONTRACT will be subject to reduction if cost or pricing data furnished is incomplete, inaccurate, or not current.

(g) It is understood that your proposal will become part of the official file.

(9) Use of the Metric System of Measurement

It is the policy of the Department of Health and Human Services to support the Federal transition to the metric system and to use the metric system of measurement in all procurement, grants, and other business related activities unless such use is impracticable or is likely to cause significant inefficiencies.

The offeror is encouraged to prepare their proposal using either "Hard Metric," "Soft Metric," or "Dual Systems" of measurement. The following definitions are provided for your information:

Hard Metric - The replacement of a standard inch-pound size with an accepted metric size for a particular purpose. An example of size substitution might be: selling or packaging liquids by the liter instead of by the pint or quart (as for soft drinks), or instead of by the gallon (as for gasoline).

Soft Metric - The result of a mathematical conversion of inch-pound measurements to metric equivalents for a particular purpose. The physical characteristics are not changed.

Dual Systems - The use of both inch-pound and metric systems. For example, an item is designed, produced, and described in inch-pound values with soft metric values also shown for information or comparison purposes.

(10) Human Subjects

The following notice is applicable when contract performance is expected to involve risk to human subjects:

Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (SEPTEMBER 1985)

a) Copies of the Department of Health and Human Services (Department) regulations for the protection of human subjects, 45 CFR Part 46, are available from the Office for Protection from Research Risks (OPRR), National Institutes of Health, Bethesda, Maryland 20892. The regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the Department.

b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. The regulations extend to the use of human organs, tissue and body fluids from individually identifiable human subjects as well as to graphic, written or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR, Part 46.

c) Activities in which the only involvement of human subjects will be in one or more of the categories set forth in 45 CFR 46.101(b)(1-6) are exempt from coverage.

d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal. The Public Health Service will make a final determination of whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the proposal. In doubtful cases, prior consideration with OPRR, (telephone: 301-496-7041), is recommended.

e) In accordance with 45 CFR, Part 46, prospective Contractors being considered for award shall be required to file with OPRR an acceptable Assurance of Compliance with the regulations, specifying review procedures and assigning responsibilities for the protection of human subjects. The initial and continuing review of a research project by an institutional review board shall assure that the rights and welfare of the human subjects involved are adequately protected, that the risks to the subjects are reasonable in relation to the potential benefits, if any, to the subjects and the importance of the knowledge to be gained, and that informed consent will be obtained by methods that are adequate and appropriate. Prospective Contractors proposing research that involves human subjects shall be contacted by OPRR and given detailed instructions for establishing an institutional review board and filing an Assurance of Compliance.

f) It is recommended that OPRR be consulted for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects.

(11) Privacy Act

The Privacy Act of 1974 (P.L. 93-579) requires that a Federal agency advise each individual whom it asks to supply information, the authority which authorizes the solicitation, whether disclosure is voluntary or mandatory, the principal purpose or purposes for which the information is intended to be used, the uses outside the agency which may be made of the information, and the effects on the individual, if any, of not providing all or any part of the requested information.

The NIH is requesting the information called for in this MAA pursuant to the authority provided by Sec. 301(g) of the Public Health Service Act, as amended, and P.L. 92-218, as amended.

Providing the information requested is entirely voluntary. The collection of this information is for the purpose of conduction an accurate, fair and adequate review prior to a discussion as to whether to award a MA.

Failure to provide any or all of the requested information may result in a less than adequate review.

In addition, the Privacy Act of 1974 (P.L. 93-579, Sec. 7) requires that the following information be provided when individuals are requested to disclose their social security number.

Provisions of the social security number is voluntary. Social security numbers are requested for the purpose of accurate and efficient identification, referral, review and management of NIH contracting programs. Authority for requesting this information is provided by Section 305 and Title IV of the PHS Act, as amended.

The information provided by you may be routinely disclosed for the following purposes:

-- to the cognizant audit agency and the General Accounting Office for auditing.

-- to the Department of Justice as required for litigation.

-- to respond to congressional inquiries.

-- to qualified experts, not within the definition of Department employees, for opinions as a part of the review process.

(12) Selection of Offerors

(a) The acceptability of the scientific and technical portion of each MA proposal will be evaluated by the Technical Evaluation Panel (TEP). The TEP will evaluate each proposal in strict conformity with the evaluation criteria of the MAA utilizing point scores and written critiques. The TEP may suggest that the Contracting Officer request clarifying information from an offeror.

(b) The business information in each MAA proposal will be subjected to a business/management analysis, etc. [No Separate Business or Cost Proposal is requested.]

(c) Each responsible offeror submitting a technically acceptable proposal will be awarded a Master Agreement. However, the Government reserves the right to make no awards to this solicitation. This MAA may be amended or canceled as necessary to meet NCI requirements.

(13) Small Business Subcontracting Plan

If a contract awarded under the MA exceeds a total estimated cost of $500,000 for the entire period of performance of the contract, the apparent successful offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan", FAR Clause 52.219-9, incorporated herein by reference in the Solicitation.

ATTACHMENT 11 entitled "SMALL BUSINESS SUBCONTRACTING PLAN," contained in SECTION J of this MAA, is an example of such a plan.

(a) This provision does not apply to small business concerns.

(b) The term "subcontract" means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government MA Holder or MA Holders subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements/purchase orders for supplies and services such as equipment purchase, copying services, and travel services.

(c) The offeror understands that:

(1) No contract will be awarded unless and until an acceptable plan is negotiated with the Contracting Officer which plan will be incorporated into the contract, as a material part thereof.

(2)An acceptable plan must, in the determination of the Contracting Officer, provide the maximum practicable opportunity for small business concerns and small business concerns owned and controlled by socially and economically disadvantaged persons to participate in the performance of the contract.

(3) If a subcontracting plan acceptable to the Contracting Officer is not negotiated within the time limits prescribed by the contracting activity and such failure arises out of causes within the control and with the fault or negligence of the offeror, the offeror shall be ineligible for an award. The Contracting Officer shall notify the MA Holder in writing of the reasons for determining a subcontracting plan unacceptable early enough in the negotiation process to allow the MA Holder to modify the plan within the time limits prescribed.

(4) Prior compliance of the offeror with other such subcontracting plans under previous contracts will be considered by the Contracting Officer in determining the responsibility of the offeror for award of a subsequent contract.

(5) It is the offeror's responsibility to develop a satisfactory subcontracting plan with respect to both small business concerns and small business concerns owned and controlled by socially and economically disadvantaged individuals and women-owned small business concerns and that each such aspect of the offeror's plan will be judged independent of the other.

(6) The offeror will submit, as required by the Contracting Officer, subcontracting reports in accordance with the instructions thereon, and as further directed by the Contracting Officer. Subcontractors will also submit these reports to the Government's Contracting Officer or as otherwise directed, with a copy to the MA Holders designated small and disadvantaged business liaison.

d) Each plan must contain the following:

(1) Goals, expressed in terms of percentages of total planned subcontracting dollars, for the use of small, small disadvantaged, and women-owned small business concerns as subcontractors.

(2) A statement of total dollars planned to be subcontracted. A statement of total dollars to be subcontracted to each of the following type of small business concerns: small, small disadvantaged, and women-owned small businesses.

(3) A description of the principal types of supplies and services to be subcontracted with an identification of which supplies and services are expected to be subcontracted to small, small disadvantaged, and/or women-owned small business concerns.

(4) A description of the method used to develop the subcontracting goals.

(5) A description of the method used to identify potential sources for solicitation purposes.

(6) A statement as to whether or not indirect costs were included in establishing subcontracting goals. If they were, a description of the method used to determine the proportionate share of indirect costs to be incurred with small, small disadvantaged and women-owned small business concerns.

(7) The name of the individual employed by the offeror who will administer the offeror's subcontracting program and a description of his/her duties.

(8) A description of the efforts the offeror will make to assure that small, small disadvantaged and women-owned small business concerns have an equitable chance to compete for subcontracts.

(9) Assurances that the offeror will include in all subcontracts the contract clause "Utilization Small Business Concerns", FAR 52.219-8. Assure that all subcontractors, other than small businesses, in excess of $500,000 adopt a plan similar to the plan agreed upon by the offeror.

(10) Assurances that the offeror (and any required subcontractors) will cooperate in studies or surveys asrequired and submit required reports (SF 294 and SF 295) to the Government.

(11) List the types of records the offeror will maintain to demonstrate procedures that have been adopted to comply with the requirement and goals in the plan, including establishing source lists. Also, the offeror shall describe its efforts to locate small, small disadvantaged, and women-owned small business concerns and award subcontracts to them.

For additional information about each of the above elements required to be contained the subcontracting plan, see FAR Clause 52.219-9, Small Business Subcontracting Plan and the Sample Subcontracting Plan which is provided as an Attachment to this RFP in SECTION J.

(14) Inclusion of Women and Minorities in Research Involving Human Subjects

It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), [(this was reprinted to correct typesetting errors from Federal Register dated March 9, 1994 (FR 59 11146-11151)], and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Offerors may obtain copies from these sources or from the contact person listed in the RFP.

Unless otherwise specified in this solicitation, the Government has determined that the work set forth herein does not involve a gender specific study or a single or limited number of minority population groups. Therefore, the NCI believes that the inclusion of women and minority populations is appropriate for this project. (See Section M of this RFP for more information about evaluation factors for award.)

(15) Inclusion of Children in Research Involving Human Subjects

It is NIH policy that children (defined below) must be included in all human subjects research, including, but not limited to, clinical trials, conducted under a contract funded by the NIH, unless there are scientific or ethical reasons not to include them. For the purposes of this policy, contracts involving human subjects include categories that would otherwise be exempt from the DHHS Policy for Protection of Human Research Subjects (sections 101(b) and 401(b) of 45 CFR 46), such as surveys, evaluation of educational interventions, and studies of existing data or specimens that should include children as participants. This policy applies to both domestic and foreign research contracts.

For purposes of this policy, a child is defined as an individual under the age of 21 years.

Inclusion of children as participants in research must be in compliance with all applicable subparts of 45 CFR 46 as well as other pertinent laws and regulations whether or not such research is otherwise exempted from 45 CFR 46. Therefore, any proposals must include a description of plans for including children, unless the offeror presents clear and convincing justification for an exclusion. In the technical proposal, the offeror should create a section titled "Participation of Children." This section should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research. The RFP will contain a review criterion addressing the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification of exclusion.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on theInclusion of Children as Participants in Research Involving Human Subjects" which was published in the NIH Guide for Grants and Contracts on March 6, 1998 and is available at the following URL address: 

http://www.nih.gov/grants/guide/notice-files/not98-024.html

Offerors may also obtain copies from the contact person listed in the RFP.

(16) Reimbursement of Costs for Independent Research and Development Projects (Commercial Organizations Only)

The primary purpose of the Public Health Service (PHS) is to support and advance independent research within the scientific community. This support is provided in the form of contracts and grants totaling approximately 7 billion dollars annually. PHS has established effective, time tested and well recognized and accepted procedures for stimulating and supporting this independent research by selecting from multitudes of proposals those research projects most worthy of support within the constraints of its appropriations. The reimbursement of independent research and development costs not incidental to product improvement, through the indirect cost mechanism, would circumvent this competitive process.

To ensure that all research and development projects receive similar and equal consideration, all offerors may compete for direct funding for independent research and development projects they consider worthy of support by submitting those projects to the appropriate Public Health Service grant and/or contract office for review. Since these projects may be submitted for direct funding, the successful offeror agrees that no costs for any independent research and development project, including applicable indirect costs, will be claimed under any contract resulting from this solicitation.

(17) Salary Rate Limitation in Fiscal Year 2000

Offerors are advised that pursuant to P.L. 106-113, no NIH Fiscal Year 2000 (October 1, 1999 - September 30, 2000) funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses). This does not preclude the offeror from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The salary rate limitation set by P.L. 106-113 applies only to Fiscal Year 2000 funds, however, salary rate ceilings for subsequent years may be included in future DHHS appropriation acts. Multi-year contracts awarded pursuant to this solicitation may be subject to unilateral modifications by the Government if an individual's annual salary exceeds any salary rate ceiling established in future appropriations acts. The Executive Schedule, Level II* annual salary rate limit also applies to individuals proposed under subcontracts. P.L. 106-113 states in pertinent part:

"None of the funds appropriated in this Act for the National Institutes of Health and the Substance Abuse, and Mental Health Services Administration shall be used to pay the salary of an individual through a grant or extramural mechanism at a rate in excess of Executive Level II."

*This rate may change periodically. For your information, the rate can be found at:

http://www.opm.gov/oca/98TABLES/exec_ses/html/98EXCSCH.HTM

(18) Institutional Responsibility Regarding Conflicting Interests of Investigators

EACH INSTITUTION MUST:

(a) Maintain an appropriate written, enforced policy on conflict of interest that complies with 42 CFR Part 50 Subpart F and/or 45 CFR Part 94 as appropriate and inform each investigator of the Institution's policy, the Investigator's reporting responsibilities, and the applicable regulations. If the Institution carries out the NIH funded research through subgrantees, contractors or collaborators, the Institution must take reasonable steps to ensure that Investigators working for such entities comply with the regulations, either by requiring thoseinvestigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with the regulations.

(b) Designate an Institutional official(s) to solicit and review financial disclosure statements from each Investigator who is planning to participate in NIH-funded research.

(c) Require that by the time an application/proposal is submitted to the NIH each investigator who is planning to participate in the NIH-funded research has submitted to the designated official(s) a listing of his/her known Significant Financial Interests (and those of his/her spouse and dependent children): (i) that would reasonably appear to be affected by the research for which the NIH funding is sought; and (ii) in entities whose financial interests would reasonably appear to be affected by the research. All financial disclosures must be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.

(d) Provide guidelines consistent with the regulations for the designated official(s) to identify conflicting interests and take such actions as necessary to ensure that such conflicting interests will be managed, reduced, or eliminated.

(e) Maintain records, identifiable to each award, of all financial disclosures and all actions taken by the institution with respect to each conflicting interest for: (1) in the case of grants, at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR Part 74.53(b) and (2) in the case of contracts, 3 years after final payment or, where applicable, for the other time period specified in 48 CFR Part 4 Subpart 4.7, Contract Records Retention.

(f) Establish adequate enforcement mechanisms and provide for sanctions where appropriate.

(g) Certify, in each application/proposal for funding to which the regulations applies, that:

1) there is in effect at the Institution a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests with respect to all research projects for which funding is sought from the NIH;

2) prior to the Institution's expenditure of any funds under the award, the Institution will report to the awarding component the existence of a conflicting interest (but not the nature of the interest or other details) found by the Institution and assure that the interest has been managed, reduced or eliminated in accord with the regulations; and for any interest that the Institution identifies as conflicting subsequent to the expenditure of funds after award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on a temporary basis within sixty days of that identification;

3) the Institution agrees to make information available, upon request, to the awarding component regarding all conflicting interests identified by the Institution and how those interested have been managed, reduced, or eliminated to protect the research from bias; and

4) the Institution will otherwise comply with the regulations.

Institutional Management of Conflicting Interests

(a) The designated official(s) must: (1) review all financial disclosures; and (2) determine whether conflict of interest exists, and if so, determine what actions should be taken by the Institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interests include, but are not limited to:


(i) public disclosure of significant financial interests;
(ii) monitoring of research by independent reviewers;
(iii) modification of the research plan;
(iv) disqualification of the Investigator(s) from participation in all or a portion of the research funded by the awarding component;
(v) divestiture of significant financial interests; or
(vi) severance of relationships that create actual or potential conflicts of interests.

(b) An Institution may require the management of other conflicting financial interests in addition to those described in paragraph (a) of this section, as the Institution deems appropriate.

(19) ROTC Access and Federal Military Recruiting on Campus

Section 514 of the FY 1997 Appropriations Act prohibits NIH from providing contract funds to educational institutions that the Secretary of Defense determines have a policy or practice (regardless of when implemented ) that either prohibits, or in effect prevents (1) the maintaining, establishing, or operation of a unit of the Senior Reserve Officer Training Corps at the covered education entity; or (2) a student at the covered educational entity from enrolling in a unit of the Senior Reserve Officer Training Corps at another institution of higher education.

Further, contract funds may not be provided to educational institutions that have a policy or practice that prohibits or prevents (1) entry to campuses, or access to students (who are 17 years of age or older) on campuses, for purposes of Federal military recruiting; or (2) access by military recruiters for purposes of Federal military recruiting to information pertaining to students (who are 17 years of age or older) enrolled at the covered educational entity.

(20) Solicitation Provisions Incorporated by Reference, FAR 52.252-1 (February 1998)

This Solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.arnet.gov/far/.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1):

a) Submission of Offers in the English Language, FAR Clause 52.214-34, (April 1991).

b) Submission of Offers in U.S. Currency, FAR Clause 52.214-35, (April 1991).

c) Order of Precedence-Uniform Contract Format, FAR Clause 52.215-8, (October 1997).

d) Preaward On-Site Equal Opportunity Compliance Evaluation, (Over $10,000,000), FAR Clause 52.222-24, (February 1999).

e) Facilities Capital Cost of Money, FAR Clause 52.215-16, (October 1997).

b. TECHNICAL PROPOSAL INSTRUCTIONS

A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical proposal should reflect a clear understanding of the nature of the work being undertaken. The technical proposal must include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks.

(1) Technical Discussions

The technical discussion included in the technical proposal should respond to the items set forth below:

a) Statement of Work

(1) Objectives

State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.

(2) Approach

Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed.

(3) Methods

Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate.

(4) Management of a Master Agreement Project.

Once a Master Agreement is awarded, it is the Government's intent to issue a Request for Proposal (RFP) for contract award(s). It is important that direct lines of communication between the Government and MA Holder exist. The MA Holder must be able to respond quickly to these RFPs. Coordination of several ongoing contract projects may be necessary during the duration of the MA. Describe how you propose to manage a project of this nature. If you have any experience with this type of project or projects which require a similar type management you should so state.

(5) Schedule

When a sample contract is provided for evaluation purposes or as appropriate, provide a schedule for completion of the work and delivery of items specified in the statement of work. Performance or delivery schedules shall be indicated for phases or segments, as applicable, as well as for the overall program. Schedules shall be shown in terms of calendar months from the date of authorization to proceed or, where applicable, from the date of a stated event, as for example, receipt of a required approval by the Contracting Officer.

b) Personnel

Describe the experience and qualifications of personnel who will be assigned for direct work on this program. Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.

(1) Principal Investigator/Project Director

List the name of the Principal Investigator/Project Director responsible for overall implementation of the Contracts issued under this Master Agreement and will be the key contact for technical aspects of the program. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded MAO. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. If the Principal Investigator proposed for this MAA is committed in excess of 100% of his/her time the proposal must include appropriate explanations.

(2) Other Investigators

List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.

(3) Additional Personnel

List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include:

-The specific items or expertise they will provide.

-Their availability to the project and the amount of time anticipated.

-Willingness to act as a consultant.

-How rights to publications and patents will be handled.

(4) Resumes

Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

(2) Summary of Related Activities

Complete this form, which is included as an ATTACHMENT to this solicitation, and include it in all copies of the Technical Proposal.

(3) Technical Evaluation

Proposals will be technically evaluated in accordance with the factors, weights, and order of relative importance as described in the Technical Evaluation Criteria (Section M.., hereof).

(4) Additional Technical Proposal Information

a) Proposals which merely offer to conduct a program in accordance with the requirements of the Government's scope of work will not be eligible for award. The offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives.

b) The technical evaluation is conducted in accordance with the weighted technical evaluation criteria by an initial review panel. This evaluation produces a numerical score (points) which is based upon the information contained in the offeror's proposal only.

(c) YOUR TECHNICAL PROPOSAL MUST INCLUDE A SEPARATE SECTION FOR YOUR RESPONSE TO THE SAMPLE CONTRACT/RFP.

(d) Information provided by the Offeror in any Table must also be discussed in the text.

(e) Study all the Evaluation Criteria carefully, and make sure that details in the Technical Proposal cover everything noted in the Criteria. Insufficient information may result in the proposal being judged to be unacceptable.

(5) Other Considerations

Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:

a) Any agreements and/or arrangements with subcontractor(s). Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship.

b) Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.

c) Equipment and unusual operating procedures established to protect personnel from hazards associated with this project.

d) Other factors you feel are important and support your proposed research.

e) Recommendations for changing reporting requirements if such changes would be more compatible with the offeror's proposed schedules.

(6) Technical Proposal Cost Information

The offeror shall submit a detailed breakdown of direct costs for use in assessing their understanding of the technical proposal for the Sample Contract. Offerors shall use the format in the form entitled, "Technical Proposal Cost Information/Summary of Labor & Direct Costs," and furnish a breakdown by cost elements shown below.

(a) As appropriate, cost breakdowns shall be provided for the following cost elements:

(1) Direct Labor

Provide a time-phased (e.g. monthly, quarterly, etc.) breakdown of labor hours and total labor cost by appropriate category. Hours for all personnel shall be shown, but only the total labor cost shall be shown. No individual salaries shall be provided.

(2) Materials

Provide a list of the materials and quantities of materials proposed to complete the SAMPLE CONTRACT and the basis for pricing (vendor quotes, invoice prices, etc.)

(3) Subcontracted Items

Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the MA Holder. For each subcontract over $500,000, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.806.

(4) Raw Materials

Consists of material in a form or state that requires further processing. Provide priced quantities of items required for the proposal.

(5) Purchased Parts

Includes material items not covered above. Provide priced quantities of items required for the proposal.

(6) Fringe Benefits

Include fringe benefits in direct labor costs if they are directly charged. If they are indirectly charged, make a statement to this effect but do not include an amount.

(7) Indirect Costs

Do not include Indirect Cost information.

(8) Special Equipment

If direct charge, list any equipment proposed including description, price, quantity, total price, purchase or lease, and the basis for pricing. (See also, Business Proposal Instructions.)

(9) Travel

Provide the cost of travel including destination, duration, purpose, per diem, transportation, and the bases for prices.

(10) Other Costs - List all other costs not otherwise included in the categories described above (e.g., computer services, consultant services) and provide bases for pricing.

c. ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS SPECIFIC TO THIS SOLICITATION

PLEASE NOTE: A complete application package requires responses to both this Master Agreement Announcement/Request for Proposal (MAA/RFP) and the SAMPLE CONTRACT/REQUEST FOR PROPOSAL (Sample Contract/RFP). The proposal should contain separately identifiable sections addressing the MAA/RFP and the Sample Contract/RFP requirements. The offeror's proposal should include a Table of Contents.

The offeror should document in writing that the necessary expertise and experience are available to meet the following requirement. The offeror should also demonstrate in writing a complete understanding of the purposes and requirements of this work. Proposals submitted in response to this RFP should address each item described below.

1) Accurate knowledge of the population at risk - Provide: (1) size of population, (2) sex breakdown of population, (3) age breakdown of population, (4) ethnic minority breakdown of population [if the population is homogenous, so state], and (5) source of population information.

2) Accurate computerized enumeration of all incident cases of cancer in the population - List sources of incident cancer cases (e.g., hospitals [both public and private] including pathology laboratories, hematology laboratories, surgery departments [both in-patient and out-patient], radiotherapy departments, oncology clinics, outpatient clinics, autopsy services, medical records departments [discharge summaries, etc.]; private pathology laboratories; private hematology laboratories; private out-patient surgery centers; private radiotherapy centers; private oncology practices; physician's offices; death certificates) and provide an assessment of their compliance in reporting cancer cases to the registry. State whether participation is voluntary or mandatory. If mandatory, describe the relevant legislation. If voluntary, describe the source of authority to collect data. If available, provide measures of data completeness, including the percentage of cases registered on the basis of death certificate only and the mortality / incidence ratio. Indicate and explain any major gaps in coverage of this population by the cancer registry. Provide information on how up-to-dateis the computerized enumeration of incident cancer cases.

3) Correct and reproducible classification and coding of all cancer cases - List information recorded for each cancer case (e.g., registry ID, name; address; sex; race; date of birth; place of birth; primary and/or last occupation; vital status; date of death or date last known to be alive; date of diagnosis of the primary cancer; age at diagnosis of the primary cancer; anatomical site, histological type, and behavior of the primary cancer; coding system [e.g., ICD-O]; basis of diagnosis; histologic verification of diagnosis; clinical stage and grade; treatment). Describe quality control measures in obtaining, entering, and editing data. Explain procedures for detecting duplicates (i.e., reports from multiple sources for the same patient and/or report of a second cancer at the same site in the same patient years after report of the first cancer). Describe procedures to distinguish a new second primary cancer from a metastasis or a recurrence. If available, provide measures of data quality, including percentage of cases verified histologically.

4) A description of general procedures for routine case followup. For example, describe if the followup is active [registry contacts hospital or physician], passive [registry relies on receiving notification of patient's death], or a combination of active and passive.

5) A description of case followup through computer linkage with other registries. List other registries, such as death, emigration, or population registries, that are linked with the cancer registry on a regular basis to follow up incident cancer cases.

6) Submission of basic data about the registry. List year registry started, the years for which population-based data are available, the total number of cancer diagnoses available, and the number of incident cancer diagnoses added each year. Submit the most recent five year incidence data broken down by sex and age (and race, if appropriate). If registry is listed in "Cancer Incidence in Five Continents", copy and submit registry information from most recent volume. If the registry is part of the SEER Program, so state.

7) Provision of security assurances. Give details regarding the following: (1) maintenance of data in a secure environment / use of safeguards to maintain confidentiality, (2) protection of human subjects, and (3) inclusion of minorities, women, and children in the study population, as appropriate.

8) Information on the experience and qualifications of key registry personnel. Include pertinent peer-reviewed publications, as well as descriptions of the roles and personnel played in relevant studies for which they had major responsibility.

9) Documentation of significant research studies utilizing registry data. Attach selected reprints of any previously published peer-reviewed studies using data from the cancer registry in which record-linkage procedures were employed.

OPTIONAL - Capability to Provide Additional Services

10) Experience with linkage to other population-based registries. List registries that have been linked to the cancer registry in the past, such as hospital inpatient registries, outpatient clinics, family registries, birth registries, exposure registries, pharmaceutical registries, or census data.

11) Access to biological specimens for histologic evaluation or biochemical analysis. Describe the registry's experience with collection or analysis of biological specimens. Document procedures that have been used to deal safety with biological specimens. Comment on the feasibility of shipping specimens to NCI for review, and if this is possible, describe how the specimens would be transported. If it is not feasible to ship specimens to NCI, describe the credentials of local laboratories that the registry would recommend for performing histologic review or biochemical analysis.

d. BUSINESS PROPOSAL INSTRUCTIONS

[To be included as a separate section of your Technical Proposal.]

(1) Qualifications of the Offeror

You are requested to submit a summary of your General Experience, Organizational Experience Related to this MAA, Performance History, Pertinent Contracts, Master Agreements and Contracts.

(a) General Experience

General Experience is defined as general background, experience and qualifications of the offeror. A discussion of proposed present facilities which can be devoted to future Contracts may be appropriate.

(b) Organizational Experience Related to this MAA

Organizational experience is defined as the accomplishment of work, either past or on-going which is comparable or related to the effort required by this MAA. This includes overall offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this MAA.

(c) Performance History

Performance history is defined as meeting the objectives within delivery and cost schedules on efforts, either past or on-going, which are comparable or related to the effort required by this MAA.

(d) Pertinent Contracts, Master Agreements and Contracts

Pertinent contracts, Master Agreements and Contracts is defined as a listing of each related Contract, MA or CONTRACT completed within the last three years or currently in process. The listing should include: (1) the MA or Contract/MAO number; (2) Contracting Agency; (3) Contract/MAO dollar value; (4) Dates MA/Contract/MAO began and ended (or ends); (5) brief description of MA/Contract/MAO work; (6) explanation of relevance of work to this MAA; (7) actual delivery and cost performance versus delivery and cost agreed to in the Contracts/MAOs.

(e) Pertinent Grants

List pertinent grants performed for the Government that involved similar or related work to that called for in this MAA. Include the grant number, involved agency, names of the grant specialist and the Science Administrator, identification of the work, and when performed.

You are cautioned that omission or an inadequate or inaccurate response to this MAA requirement could have a negative effect on the overall selection process. Experience and past performance are factors which are relevant to the ability of the offerors to perform and while not an evaluation factor they are considered in the source selection process as an indicator of your responsibility to perform this work.

(2) Other Administrative Data

a) Property

(1) It is HHS policy that MA Holders will provide all equipment and facilities necessary for performance of Contracts. Exception may be granted to furnish Government-owned property, or to authorize purchase with MAO funds, only when approved by the Contracting Officer. If the offeror is proposing that the Government provide any equipment, other than that specified under Government Furnished Property in the MAA, the proposal must include comprehensive justification which includes:

(a) An explanation that the item is for a special use essential to the direct performance of the MA/Contracts and the item will be used exclusively for the purpose. Office equipment such as desks, office machines, etc., will not be provided under a MAO except under very exceptional circumstances.

(b) No practical or economical alternative exists (e.g., rental, capital investment) that can be used to perform the work.

(2) The offeror shall identify Government-owned property in its possession and/or contractor titled property acquired from Federal funds, which they propose to use in the performance of any prospective Contracts.

(3) The management and control of any Government property shall be in accordance with HHS Publication entitled, Contractor's Guide for Control of Government Property, (1990), a copy of which will be provided upon request.

b) Submission of Electronic Funds Transfer Information with Offer, FAR Clause 52.232-38, (May 1999)

The offeror shall provide, with its offer, the following information that is required to make payment by electronic funds transfer (EFT) under any contract that results from this solicitation. This submission satisfies the requirement to provide EFT information under paragraphs (b)(1) and (j) of the clause at 52.232-34, Payment by Electronic Funds Transfer--Other than Central Contractor Registration.

(1) The solicitation number (or other procurement identification number).

(2) The offeror's name and remittance address, as stated in the offer.

(3) The signature (manual or electronic, as appropriate), title, and telephone number of the offeror's official authorized to provide this information.

(4) The name, address, and 9-digit Routing Transit Number of the offeror's financial agent.

(5) The offeror's account number and the type of account (checking, savings, or lockbox).

(6) If applicable, the Fedwire Transfer System telegraphic abbreviation of the offeror's financial agent.

(7) If applicable, the offeror shall also provide the name, address, telegraphic abbreviation, and 9-digit Routing Transit Number of the correspondent financial institution receiving the wire transfer payment if the offeror's financial agent is not directly on-line to the Fedwire and, therefore, not the receiver of the wire transfer payment.

c) Financial Capacity

The offeror shall indicate if it has the necessary financial capacity, working capital, and other resources to perform the contract without assistance from any outside source. If not, indicate the amount required and the anticipated source.

d) Incremental Funding

It is possible that a contract awarded under an MA from this solicitation may be incrementally funded.

An incrementally funded cost-reimbursement contract is a contract in which the total work effort is to be performed over a multiple year period and funds are allotted, as they become available, to cover discernible phases or increments of performance. The incremental funding technique allows for contracts to be awarded for periods in excess of one year even though the total estimated amount of funds expected to be obligated for the contract are not available at the time of the contract award. If this requirement is specified elsewhere in this RFP, the offeror shall submit a cost proposal for each year. In addition, the following provisions are applicable:

Sufficient funds are not presently available to cover the total cost of the complete multiple year project described in this solicitation. However, it is the Government's intention to negotiate and award a contract using the incremental funding concepts described in the clause entitled "Limitation of Funds." Under that clause, which will be included in the resultant contract, initial funds will be obligated under the contract to cover an initial period of performance. Additional funds are intended to be allotted from time to time, to the contract by contract modification, up to and including the full estimated cost of the contract, to accomplish the entire project. While it is the Government's intention to progressively fund this contract over the entire period of performance up to and including the full estimated cost, the Government will not be obligated to reimburse the Contractor for costs incurred in excess of the periodic allotments, nor will the Contractor be obligated to perform in excess of the amount allotted.

The "Limitation of Funds" clause to be included in the resultant contract shall supersede the "Limitation of Cost" clause found in the General Clauses.

e) Facilities Capital Cost of Money, FAR 52.215-16, (October 1997)

(This is applicable if you are a commercial organization.)

(a) Facilities capital cost of money [(see FAR 15.408(h)] will be an allowable cost under the contemplated contract, if the criteria for allowability in subparagraph 31.205-10(a)(2) of the Federal Acquisition Regulation are met. One of the allowability criteria requires the prospective Contractor to propose facilities capital cost of money in its offer.

(b) If the prospective Contractor does not propose this cost, the resulting contract will include the clause Waiver of Facilities Capital Cost of Money.

(End of Provision)

If the offeror elects to claim this cost, the offeror shall specifically identify or propose it in the cost proposal for the contract by checking the appropriate box below.

[ ] The prospective MA Holder has specifically identified or proposed facilities capital cost of money in its cost proposal and elects to claim this cost as an allowable cost under future Contracts. Submit Form CASB-CMR (see FAR 31.205-10).

[ ] The prospective MA Holder has not specifically identified or proposed facilities capital cost of money in its proposal and elects not to claim it as an allowable cost under future Contracts.

(3) Subcontractors

If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:

a) Willingness to perform as a subcontractor for specific duties (list duties).

b) What priority the work will be given and how it will relate to other work.

c) The amount of time and facilities available to this project.

d) Information on their cognizant field audit offices.

e) How rights to publications and patents are to be handled.

f) A complete cost proposal in the same format as the offeror's cost proposal.

(4) Proposer's Annual Financial Report

A copy of the organization's most recent annual report must be submitted as part of the business proposal.

(5) Representations and Certifications

One copy of the Representations and Certifications attached as Section K shall be completed and be signed by an official authorized to bind your organization. Additionally, a completed copy of the Representations and Certifications shall be submitted from any proposed subcontractor.

(6) Travel Costs/Travel Policy

a) Travel Costs - Commercial

In accordance with Title II, section 201 of the Federal Civilian Employee and Contractor Travel Expense Act of 1985 (Public Law 99-234), costs for lodging, meals, and incidental expenses incurred by Contractor personnel shall be considered to be reasonable and allowable to the extent they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulations, General Services Administration (GSA). Therefore, if travel costs are applicable and proposed by offerors, please be advised that they shall be calculated using the per diem rate schedule as established by GSA. Reimbursement of travel costs under any contract awarded from this RFP shall be in accordance with FAR 31.205-46.

b) Travel Policy

One copy of the offeror's (and any proposed subcontractor's) written travel policy shall be included in the business proposal (original only). If an offeror (or any proposed subcontractor) does not have a written travel policy, the offeror shall so state.

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL INFORMATION AND TECHNICAL EVALUATION CRITERIA

The technical proposal will receive paramount consideration in selecting MA Holders for this acquisition. The evaluation will be based on the demonstrated capabilities of prospective MA Holders in relation to the needs of the project as set forth in the MAA. The merits of each proposal will be evaluated carefully, based on responsiveness to the MAA and the thoroughness and feasibility of the technical approach taken. Offerors must submit information sufficient to evaluate their proposals based on the detailed evaluation criteria listed below.

Listed below are technical evaluation criteria. The evaluation criteria are used by the technical evaluation panel to evaluate the technical proposals for both the MA and the SAMPLE CONTRACT/RFP. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. The responses to the technical evaluation criteria for the MAA/RFP will be evaluated as Criteria A and will be given the weight of 60 points. The responses to the technical evaluation criteria for the SAMPLE CONTRACT/RFP will be evaluated as Criteria B and will be given the weight of 40 points. The section evaluated under Criteria C is optional and points from that section will not be combined with those for Criteria A and B.

NOTE: Keep in mind that an Extramural Technical Evaluation Panel (TEP) must review each MAA/RFP response using only the Technical Evaluation Criteria and the material submitted in your proposal. NCI scientists who may have worked with your registry in the past cannot contribute to this review process. Thus, you must not assume that the review committee has knowledge of your past performance or your capabilities without documentation in this response.

	Weight
CRITERIA A -- QUALIFICATION AS A POPULATION-BASED CANCER REGISTRY (MAA/RFP Response)	60 Points
Cancer Registry Coverage - 40 Points
1. How well has the offeror shown an accurate knowledge of the population at risk? Of the registry's complete coverage of the population?
2. How well has the registry demonstrated the completeness of ascertainment of incident cancer cases in the population? How up-to-date is the registry's computerization of incident cancer cases?
3. How valid and reproducible is the registry's classification and coding of all cancer cases? How clearly has the registry defined criteria to determine when a second cancer will be considered a new primary?
4. How satisfactory are the general procedures used by the registry for case follow-up?
5. How complete is the registry's followup of individuals through linkage with registries of death and emigration, and with population registries?
6. How responsive was the registry to the request for detailed five-year cancer incidence data? How well did the registry demonstrate complete and long-term accumulation of cancer incidence data?
7. How adequate were the registry's assurances of (1) maintenance of data in a secure environment/use of safeguards to maintain confidentiality, (2) protection of human subjects, and (3) inclusion of minorities, women, and children in the study population provided, as appropriate?
Personnel, Registry, and Record Linkage Experience - 20 Points
8. How satisfactory are the experience and qualifications of registry personnel?
9. How successfully has the cancer registry used registry data and record-linkage procedures, as documented by publication in peer-reviewed scientific journals?
CRITERIA B - TECHNICAL APPROACH IN RESPONSE TO SAMPLE CONTRACT/RFP (Refer to Technical Evaluation Criteria for Sample Contract/RFP)	40 Points
TOTAL (Criteria A and Criteria B)	100 Points
CRITERIA C -- OPTIONAL
Capability to Provide Additional Services	25 Points
1. How extensive is the list of population-based registries that could be linked successfully to the cancer registry, e.g., hospital inpatient registries, outpatient clinics, pharmaceuticals, census data, family linkage, birth registries, exposure registries?
2. What is the quality of the registry's access to biological specimens for histologic review or biochemical analysis? How well do they demonstrate safe procedures for handling biological specimens? If they indicate a willingness to ship specimens to NCI, how adequate are their arrangements for transporting specimens? If they are unwilling to ship specimens, what is the quality of the laboratories they propose for performing histologic review or biochemical analysis?

RESEARCH CONTRACTS AND ACQUISITION BRANCH NATIONAL CANCER INSTITUTE REQUEST FOR PROPOSAL NUMBER NO1-CP-01003-13 Return to the Table of Contents

PACKAGING AND DELIVERY OF THE PROPOSAL

Your proposal shall be organized as specified in Section L.2., "Instructions to Offerors" - General 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 NO.NO1-CP-01003-13.

TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

NUMBER OF COPIES

PLEASE NOTE - THE TECHNICAL PROPOSAL SHALL BE SENT IN SPLIT SHIPMENTS TO TWO LOCATIONS. PLEASE READ THE FOLLOWING INFORMATION CAREFULLY.

A.	TECHNICAL PROPOSAL ONLY
	ORIGINAL* AND 3 COPIES TO:
	If hand-delivered or delivery service	If using U.S. Postal Service
	Sharon A. Miller Contracting Officer Research Contracts and Acquisition Branch National Cancer Institute Executive Plaza South, Room 620 6120 Executive Boulevard Rockville, Maryland 20852	Sharon A. Miller Contracting Officer Research Contracts and Acquisition Branch National Cancer Institute Executive Plaza South, Room 620 6120 EXECUTIVE BLVD MSC 7224 BETHESDA MD 20892-7224
	15 COPIES TO:
	If hand-delivered or delivery service	If using U.S. Postal Service
	Michael Shatarsky Special Review Referral and Resources Branch National Cancer Institute 6116 Executive Boulevard, Room 8055 Rockville, Maryland 20852-7405	Michael Shatarsky Special Review Referral and Resources Branch National Cancer Institute 6116 EXECUTIVE BLVD MSC 7405, Rm 8055 BETHESDA MD 20892-7405

B .	BUSINESS PROPOSAL**

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.
**SINCE NO MAO WILL BE AWARDED AS A RESULT OF THIS MAA SOLICITATION, NO BUSINESS PROPOSAL IS REQUIRED, ONLY A TECHNICAL COST PROPOSAL IS REQUIRED TO BE SUBMITTED AS PART OF THE TECHNICAL PROPOSAL (SEE ATTACHMENT #2).
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."