RFP--Working Document.doc

10-250-SOL-00079DM

HEALTH AND HUMAN SERVICES

HEALTH RESOURCES AND SERVICES ADMINISTRATION

REQUEST FOR PROPOSAL

SECTION A - TABLE OF CONTENTS

SECTION

DESCRIPTION

A

Table of Contents

B

Supplies or Services and Prices/Costs

C

Description/Specification/Work Statement

D

Packaging and Marking

E

Inspection and Acceptance

F

Deliverables or Performance

G

Contract Administration Data

H

Special Contract Requirements

I

Contract Clauses

J

List of Attachments

K

Representations, Certifications and

Other Statements of Offerors

L

Instructions, Conditions, and Notices to Offerors

M

Evaluation Factors for Award

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 PURPOSE OF CONTRACT

The purpose of this contract is to provide for the collection and maintenance of genetically diverse, high-quality umbilical cord blood units (CBU) for inclusion in the National Cord Blood Inventory (NCBI). CBU collected under this contract are to be made available through the C.W. Bill Young Cell Transplantation Program (hereafter referred to as the Program) for patients in need of blood stem cell transplantation. The contract also requires that some CBU not suitable for clinical use be made available for peer-reviewed research.

B.1 (a). BACKGROUND AND NEED The Stem Cell Therapeutic and Research Act of 2005 (Public Law 109-129) establishes the infrastructure for the C.W. Bill Young Cell Transplantation Program and requires the Secretary to enter into contracts with cord blood banks for the collection and maintenance of genetically diverse, high-quality umbilical cord blood units. Umbilical cord blood has been shown to contain a high concentration of blood stem cells; this offers the potential for another source of hematopoietic reconstitution in patients who lack a matched sibling or unrelated adult donor. Research indicates that blood stem cells from cord blood may result in successful transplants with a less perfect match in tissue type between the donor and recipient than is the case for adult donors. Cord blood offers a chance of survival for patients who lack a suitably tissue-matched relative and who cannot, in the clinically appropriate timeframe, find an adequately matched unrelated adult donor through the C.W. Bill Young Cell Transplantation Program or through other adult donor registries worldwide. Patients from some minority populations, especially African-American patients, have a lower probability of finding a matched unrelated adult donor because of the greater diversity in their tissue types. Consequently, with a recruitment strategy designed to ensure genetic diversity, these patients are especially likely to benefit from additional cord blood units.

B.2 PRICE

a. In consideration of the satisfactory performance of the services that are described in detail in the Statement of Work at Attachment A and Contract Section F.2, the Contractor shall be compensated as follows:

Line

Item

Price Total

Price

1Not Separately Priced, these services are included in the base unit and option collection prices.

2Optional funding for additional units (up to the specified number) may be exercised at HRSA’s discretion if sufficient funds are available.

3If a different unit price, previous race/ethnicity targets must be achieved prior to receiving reimbursement at the new rate.

4The race/ethnicity distribution of these CBU to be negotiated separately.

[Note to Offeror: Offerors should be prepared to negotiate discounted prices. The unit prices may be below the unit cost, and may vary from bank to bank. Prices also may differ based on the Race/Ethnicity of the CBU if justified in the Offeror’s proposal (in which case the structure of the table above will be modified). HRSA anticipates that the final negotiated price for Caucasian non-Hispanic units will be lower than for other units. A Fixed Price amount will be established in the award document.]

b. The Cord Blood Units delivered shall conform to the following Race/Ethnicity specifications.

Number of NCBI CBU Delivered

AI/AN*

B/AA*

Asian*

NH/PI*

White (non-Hispanic)

White (Hispanic)

Multi-race*%

Total

#If the Options for Years 2 and 3 are exercised.

*Hispanic or non-Hispanic ethnicity.

%Two or more broad races (i.e., AI/AN, B/AA, Asian, NH/PI, or White). Note that Hispanic is not a race and cannot, in conjunction with any single broad race category, move a unit into the Multi-race category.

c. The price for services fulfilling the requirements of this contract is a firm fixed price of__________.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 Statement of Work Independently, and not as an agent of the Government, the contractor shall furnish all personnel, material, facilities, services, and equipment as needed to perform the Statement of Work set forth at Attachment A and made part of this document.

C.2 Incorporation of Contractors Proposal It is understood and agreed that the Contractor shall, in meeting the requirements of this contract, perform the work in accordance with the Contractors proposal to the Health Resources and Services Administration dated _____________ , provided however, that to the extent that any provisions of the articles of this contract are in conflict or inconsistent with any provisions of said proposal, the provisions of the articles of this contract shall be controlling and shall supersede the provisions of said proposal.

SECTION D - PACKAGING AND MARKING

D.1 (For this solicitation, there are no clauses in this section).

SECTION E - INSPECTION AND ACCEPTANCE

52.246-4 Inspection of Services-Fixed-Price (Aug 1996)

(a) Definition. "Services," as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may-

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may-

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

SECTION F - DELIVERIES OR PERFORMANCE

F.1 Period of Performance The Period of Performance for Line Item No. 1 will be 3-years from the effective date of the contract. The period of performance for Line Items 4-8 will be 3-years from the date on which the option is exercised. The Period of Performance for Line Items No. 2 and 3 will be 10-years from the effective date of the contract. The total contract Period of Performance will be 10-years from the effective date of the contract.

F.2 Articles or Services to be Furnished and/or Delivery Schedule

a. All deliverable items are subject to the review and approval of the Project Officer. The Contractor shall submit deliverables in accordance with the Statement of Work. Deliverables that are required to be delivered to the Project Officer shall be submitted to the offices listed below:

INSERTED AT TIME OF AWARD

b. All deliverable reports are to carry at the top of the first page the following information:

Contract number

Deliverable item number

Deliverable item delivery due date

Date of submission

c. The Contractor shall meet with, make presentations to and/or submit the following items to the Contracting Officer Technical Representative (COTR) in the format specified below. The Contractor shall submit deliverables in accordance with the following schedule:

SCHEDULE OF DELIVERABLES

Schedule of Reports and Deliverables

Deliverable:

Item Description

CBU Collections

NCBI CBU Characteristics

Non-NCBI CBU Characteristics

Research CBU

CBU Released for Transplant

Information regarding the progress of the contract: transferring of NCBI units, receipt of transferred NCBI units, changes that may impact progress of the contract.

Serious adverse events

When invoicing HRSA for CBU that were collected more than 4-months prior to the invoice date, a summary note indicating the reason(s) for the delay(s).

Annually First progress report due within 90-days of EDOC, then monthly thereafter for the duration of NCBI reimbursement; then annually for the duration of the contract.

The monthly report is due no later than 30-days after the last day of the reporting period.

Paper format 2 copies; electronic format 2 copies.

Paper format 2 copies; electronic format 2 copies.

No later than 45-days after the end of the 10-year contract term.

All submissions, with the exception of vouchers must be in electronic format, unless a paper format is specified. 2 copies of each deliverable must be submitted (one in PDF and the other in MS Word, Excel, Access or other format as agreed to by the COTR).

F.3 CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text:

52.242-15 Stop-Work Order. (AUG 1989) -- Alternate I

APR 1984

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 Designation of Contracting Officer Technical Representative (COTR) The person(s) identified below is hereby designated as the COTR for this contract. The responsibility of the COTR is to ensure that the Government's technical objectives are met. To this end, the COTR will provide necessary information, direction, coordination, et cetera, within the contractual work description. Issuance of changes which affect the articles, terms or conditions of this contract will be accomplished through the Contracting Officer who is the only party authorized to bind the Government to contract:

Contracting Officer Technical Representative (COTR):

INSERTED AT TIME OF AWARD

The Government may unilaterally change its designated COTR (s).

G.2 Key Personnel Pursuant to the Key Personnel clause (HHSAR 352.242-70) referenced in SECTION I of this contract, the following individual(s) is (are) considered to be essential to the work being performed under this contract:

Project Director:

INSERTED AT TIME OF AWARD

Laboratory Director:

INSERTED AT TIME OF AWARD

Medical Director:

INSERTED AT TIME OF AWARD.

Coordinator

INSERTED AT TIME OF AWARD

The clause cited above contains a requirement for review and approval by the Contracting Officer of written request for change of Key Personnel reasonably in advance of diverting any of these individuals. Receipt of written request at least thirty (30) days prior to a proposed change is considered reasonable.

The person identified above as Project Director shall direct the necessary work and services toward fulfillment of the contractual requirements.

G.3 Submission of Invoices and Place of Payment No more often than monthly, the Contractor may submit an invoice for payment based on the quantity of units delivered and compliance with the Schedule of Deliverables. Units must meet the Specifications set forth in the Statement of Work, be reported on Tables 1 and 2 of the Collection Progress Reports, and must be registered with the CBCC. The information submitted on the vouchers will be verified with data from the CBCC.

Invoices must contain and be accompanied by the same tabular information as the Progress Report for CBU Collections.

If the Contractor also holds a previously awarded NCBI contract, invoices under this contract must not contain units that could be invoiced under the other contract. That is, if a Race/Ethnicity target from the previously awarded contract has not been met, the Contractor may not include units from that Race/Ethnicity category on invoices under this contract.

b. Submit invoices as follows to expedite payment:

Send one invoice copy to the Government COTR whose name and address appear in subsection G.1. Send the original and two copies of all invoices directly to the Contracting Officer at the address listed below:

HHS/HRSA/OMPS/DPM

Attn: Daniel E. Matusiewicz

5600 Fishers Lane Room 13A19

Rockville, Maryland 20857

Finance point of contact:

Ms. Van Le

301-443-2284

c. Invoices shall reflect, at a minimum:

Paying office and address

Invoice Number

Date of Invoice

Contract Number and Date

Payee's name and address

Description of goods or services, quantity, unit price of units delivered during the invoice period

Cumulative amount

Invoices must contain the same tabular information as the Progress Report for CBU Collections at Tables 1 and 2 in Attachment B.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 Clearance/Production of Information Products/Services A. The Department of Health and Human Service's Office of the Assistant Secretary for Public Affairs requires clearance for any external publication, audiovisual, exhibit, or public affairs service produced for or by HRSA through this contract as a deliverable -an external publication is one of which 50 copies or more are to distributed outside HHS-. This clearance, which takes approximately 4 weeks, is obtained by the project officer through HRSA’s Office of Communications.

B. It is the policy of DHHS that DHHS must be prominently and dominantly identified as the primary publisher/producer, to include use of the DHHS logo, on all communication materials, including those produced by contractors. This requirement may be satisfied by displaying the DHHS logo on the back cover of a publication. The Health Resources and Services Administration's (HRSA) logo must be displayed in a position of prominence second only to DHHS as the identifier on all communication materials produced on behalf of HRSA, whether by Agency staff, contractors, or other entities. Communication materials are any and all documents and presentations intended for audiences outside the Agency, including but not limited to:

* fact sheets, newsletters, brochures, flyers

* press releases, advisories, other media materials

* exhibits, posters

* summaries, monographs, proceedings

* slides, overhead transparencies, posters

* audio and videotapes, films

* Internet publications

Internal Publications -not more than 50 copies are to be distributed outside HHS- are excepted from this requirement. Where appropriate, the words Division of Transplantation shall be included below the HRSA logo. Only the Agency Administrator may grant an exception to the policy.

C. Title 44 of the U.S. Code requires that the printing of any publication developed under this contract shall be done by the Government Printing Office. Printing shall be coordinated through the Project Officer.

H.2 Rights in Data/Publication

The Contractor shall state on reports and publications required by this contract that data and analyses contained in the report or publication have been supplied by the Contractor, that the authors alone are responsible for reporting and interpretation and that all or part of the data used to compile these publications were collected pursuant to a contract with the Depart of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation. Where there has been a substantial contribution by HRSA staff in the initial analysis or in the writing of the report or publication, those staff shall be included as authors. The Contractor must not publish or disseminate data or information from this project without providing an advanced copy to the COTR for review, comment and approval.

The Contractor shall provide any and all data collected by the Contractor to the Federal Government upon request, including data that contain patient-identifiable, donor-identifiable, bank-identifiable, or transplant-center identifiable information.

H.3 Printing and Duplicating The printing of government documents must be accomplished through the Government Printing Office or its field printing plants, unless otherwise approved by the congressional Joint Committee on Printing (JCP). Contractors and grantees are not intended to be prime or substantial sources of printing for government agencies. Contractors may prepare copy, illustrative material, forms, etc. and/or camera ready copy for the purpose of producing publications.

Regarding the use of private funds for printing, the regulations state that when appropriated funds are used to create information for publication, the printing of that information cannot be made available to a private publisher for publication without prior approval of the JCP.

H.4 Electronic and Information Technology Accessibility

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by P.L. 105-220 under Title IV (Rehabilitation Act Amendments of 1998) and the Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards (36 CFR Part 1194) require that all EIT acquired must ensure that:

1. Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities; and

2. Members of the public with disabilities seeking information or services from an agency have access to and use of information and data that is comparable to the access to and use of information and data by members of the public who are not individuals with disabilities.

This requirement includes the development, procurement, maintenance, and/or use of EIT products/services; therefore, any proposal submitted in response to this must demonstrate compliance with the established EIT Accessibility Standards. Further information about Section 508 is available via the Internet at http://www.section508.gov.

H.5 Consequence of Inability to Meet Certain Requirements

If, for any reason, the Contractor cannot fulfill the storage and distribution requirements of this contract, or if the Contractor cannot meet, throughout the contract Performance Period, the requirements of this contract regarding participation in the Cord Blood Coordinating Center, and regarding listing and distributing cord blood units through the Coordinating Center, the Contractor must transfer at no cost to the Government all HRSA-reimbursed NCBI cord blood units (including any NCBI cord blood units previously transferred from other cord blood banks to the Contractor), together with all associated samples and documentation, to another qualified cord blood bank approved by HRSA. The purpose of this provision is to ensure the continued availability of these units through the Program and to clarify transfer responsibilities of banked units as defined in FAR 52.249-8(e).

SECTION I - CONTRACT CLAUSES

52.202-1 Definitions

JUL 2004

52.203-3 Gratuites

APR 1984

52.203-5 Covenant Against Contingent Fees

APR 1984

52.203-6 Restrictions on Subcontractor Sales to the Government

SEP 2006

52.203-7 Anti-Kickback Procedures

JUL 1995

52.203-8 Cancellation, Rescission, and Recovery of

Funds for Illegal or Improper Activity

JAN 1997

52.203-10 Price or Fee Adjustment for Illegal or Improper Activity

JAN 1997

52.203-12 Limitation on Payments to Influence

Certain Federal Transactions

SEP 2007

52.204-7 Central Contractor Registration

APR 2008

52.204-4 Printing/Copying Double-Sided on

Recycled Paper

AUG 2000

52.209-6 Protecting the Governments Interest When

Subcontracting with Contractors Debarred, Suspended or Proposed for Debarment

52.215-2 Audit and Records - Negotiation

JUN 1999

52.215-8 Order of Precedence - Uniform Contract

Format

OCT 1997

52.215-10 Price Reduction for Defective Cost or

Pricing Data

52.215-12 Subcontractor Cost or Pricing Data

OCT 1997

52.215-15 Pension Adjustments and Asset Reversions

OCT 2004

52.215-18 Revision or Adjustment of Plans for

Postretirement Benefits (PRB) Other

Than Pensions

JUL 2005

52.215-19 Notification of Ownership Changes.

(a) The Contractor shall make the following notifications in writing:

(1) When the Contractor becomes aware that a change in its ownership has occurred, or is certain to occur, that could result in changes in the valuation of its capitalized assets in the accounting records, the Contractor shall notify the COTR within 30 days.

(2) The Contractor shall also notify the COTR within 30 days whenever changes to asset valuations or any other cost changes have occurred or are certain to occur as a result of a change in ownership.

(b) The Contractor shall--

(1) Maintain current, accurate, and complete inventory records of assets and their costs;

(2) Provide the COTR or designated representative ready access to the records upon request;

(3) Ensure that all individual and grouped assets, their capitalized values, accumulated depreciation or amortization, and remaining useful lives are identified accurately before and after each of the Contractor's ownership changes; and

(4) Retain and continue to maintain depreciation and amortization schedules based on the asset records maintained before each Contractor ownership change.

(c) The Contractor shall include the substance of this clause in all subcontracts under this contract that meets the applicability requirement of FAR 15.408(k).

52.217-7 Option for Increased Quantity -

Separately Priced Line Item

MAR 1989

(within 30 days)

52.217-8 Option to Extend Services

NOV 1999

52.217-9 Option to Extend the Term of the

Contract

MAR 2000

(within 30 days)

(intent to extend at least 60 days)

(shall not exceed 3 years)

52.219-8 Utilization of Small Business Concerns

May 2004 52.222-2 Payment of Overtime Premiums

JUL 1990

52.222-3 Convict Labor

JUN 2003

52.222-21 Prohibition of Segregated Facilities

FEB 1999

52.222-26 Equal Opportunity

MAR 2007

52.222-35 Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era

52.222-36 Affirmative Action for Workers with

Disabilities

JUN 1998

52.222-37 Employment Reports on Disabled Veterans and Veterans of the Vietnam Era

52.222-39 Notification of Employee Rights Concerning

Payment of Union Dues or Fees

DEC 2004

52.223-5 Pollution Prevention and Right to

Know Information

AUG 2003

52.223-6 Drug-Free Workplace

MAY 2001

52.223-10 Waste Reduction Program

AUG 2000

52.223-13 Certification of Toxic Chemical Release

Reporting

52.223-14 Toxic Chemical Release Reporting

52.225-1 Buy American Act - Supplies

JUN 2003

52.225-13 Restrictions on Certain Foreign Purchases

FEB 2006

52.226-1 Utilization of Indian Organizations and Indian-Owned Economic Enterprises

JUN 2000

52.227-1 Authorization and Consent

DEC 2007

52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement

DEC 2007

52.227-14 Rights in Data - General

Dec 2007 52.230-2 Cost Accounting Standards

APR 1998

52.230-3 Disclosure and Consistency of Cost

Accounting Practices

APR 1998

52.230-6 Administration of Cost Accounting

Standards

MAE 2008

52.232-1 Payments

APR 1984

52.232-8 Discounts for Prompt Payment

FEB 2002

52.232-9 Limitation on Withholding of Payments

APR 1984

52.232-12 Advance Payments

MAR 2001

52.232-17 Interest

JUN 1996

52.232-23 Assignment of Claims

JAN 1986

52.232-25 Prompt Payment

OCT 2003

52.232-33 Payment by Electronic Funds Transfer-

Central Contractor Registration

OCT 2003

52.233-1 Disputes

JUL 2002

52.233-3 Protest after Award

AUG 1996

52.237-3 Continuity of Services

JAN 1991

52.242-13 Bankruptcy

JUL 1995

52.243-1 Changes - Fixed Price

AUG 1987

52.244-2 Subcontracts. (AUG 1998)

(e) If the Contractor has an approved purchasing system, the Contractor nevertheless shall obtain the Contracting Officer's written consent before placing the following subcontracts: [ ]

(k) Paragraphs (d) and (f) of this clause do not apply to the following subcontracts, which were evaluated during negotiations: [ ]

52.244-5 Competition in Subcontracting.

DEC 1996

52.244-6 Subcontracts for Commercial Items

MAR 2007

52.246-25 Limitation of Liability--Services

FEB 1997

52.248-1 Value Engineering

FEB 2000

52.249-2 Termination for Convenience of the

Government (Fixed Price)

MAY 2004

52.249-8 Default (Fixed-Price Supply and Service)

APR 1984

52.249-14 Excusable Delays

APR 1984

52.253-1 Computer Generated Forms

JAN 1991

52.252-2 Clauses Incorporated by Reference. (FEB 1998) This contract incorporates one or more clauses 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. Also, the full text of a clause may be accessed electronically at this/these address(es):

http:www.arnet.gov/far

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATIONS

352.202-1 Definitions

JAN 2006

352.224-70 Confidentiality of information

JAN 2006

352.228-7 Insurance - Liability to third persons

DEC 1991

352.242-73 Withholding of contract payments

JAN 2006

352.233-71 Litigation and claims

352.242-74 Final decisions on audit findings

APR 1984

352.270-1 Accessibility of meetings, conferences, and seminars to persons with disabilities

JAN 2001

352.242-70 Key personnel

352.227-70 Publication and publicity

352.201-70 Paperwork Reduction Act

The HHS clauses may be obtained electronically at www.hhs.gov/oamp, under Division of Acquisition Policies, Acquisition Policies, HHSAR, or upon request, from the Contracting Officer.

SECTION J - LIST OF ATTACHMENTS

J.1 The following attachments are made part of this solicitation:

Attachment Title

Pages A

Statement of Work

B

Collection Progress Reports

C

Summary Tables

D

Business Proposal Tables

E

Disclosure of Lobbying Activities 2

SF-LLL

F

Past Performance Questionnaire and Letter

G

Cost Proposal Format 2

H

Certificate of Current Cost or Pricing Data

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR QUOTERS K.1 The Offeror makes the following Representations and Certifications as part of its proposal.

RFP No.____________________________________

(Name of organization)

(Signature of authorized individual) (Date)

(Type name of individual authorized to negotiate on behalf of the organization)

TIN No. ____________________________________

DUNS No.____________________________________

Note: The penalty for making false statements in offers is prescribed in 18 U.S.C. 1001.

K.2. The Offeror certifies that it has registered at www.ccr.gov , as required by FAR clause 52.204-7.

K.3 The Offeror certifies that under NAICS Code 621991, it qualifies as a (check all that apply)

ADVANCE \d 4 ___Small business concern

___Small Disadvantaged Business Concern

___Small Disadvantaged Business Concern (8a Participant)

___Women-owned small business concern

___Veteran-owned small business concern

___Service-disabled veteran-owned small business concern

___HUBZone small business

K.4 52.204-8 Annual Representations and Certifications (JAN 2005)

(a)(1) If the clause at 52.204-7, Central Contractor Registration, is included in this solicitation, paragraph (b) of this provision applies.

(2) If the clause at 52.204-7 is not included in this solicitation, and the Offeror is currently registered in CCR, and has completed the ORCA electronically, the Offeror may choose to use paragraph (b) instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

[ ] (i) Paragraph (b) applies.

[ ] (ii) Paragraph (b) does not apply and the Offeror has completed the individual representations and certifications in the solicitation.

(b) The Offeror has completed the annual representations and certifications electronically via the Online Representations and Certifications Application (ORCA) website at http://orca.bpn.gov. After reviewing the ORCA database information, the Offeror verifies by submission of the offer that the representations and certifications currently posted electronically have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [Offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause # Title Date Change

K. 5. 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. (SEPT 2005)

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR

QUOTERS

L.1 PROPOSAL INSTRUCTIONS: FORMAT AND CONTENTS

A.

GENERAL INSTRUCTIONS

1.

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

2.

Business and technical proposals shall be submitted separately and clearly labeled "Business Proposal" and "Technical Proposal". Each of the proposals shall be separate and complete in itself so that evaluation of one may be accomplished independently of evaluation of the other. Volume I shall include a statement indicating whether or not any exceptions are taken to the terms and conditions of the RFP as part of the proposal transmittal letter. Any exceptions taken shall include identification of the specific paragraphs and rationale for each exception. Exceptions shall also be noted in the proposal, at the location of the exception. The proposal shall be submitted in volumes as outlined below:

Volume I Executive Summary & Technical Proposal as outlined in Paragraph B below

Volume II

Business Proposal including Administrative & Proposed Contractual

Documents, Section K of this Solicitation (Representations, Certifications, and Other Statements of Offeror), Rate Agreements, Salary

Documentation, etc.

3.

Proposals shall be single spaced and shall be printed on 8.5 x 11 inch paper containing text no smaller than 12 pitch/10 point. Each page shall be numbered and each volume shall be tabbed to correspond to the Table of Contents. Offerors may include 11 x 17 inch foldouts only to display graphics, flow charts, organizational charts, or drawings.

4.

Where data/information appears in one part, it does not have to be repeated in any other part. However, it shall be cross referenced by indicating the specific location including the volume and page number as a minimum. The clarity, relevance, and conciseness of the proposal is important, not the length.

5.

No cost or pricing data shall be included in either the Executive Summary or Technical Proposal. Conversely, no technical or management information shall be contained in the cost proposal except for basic cross referencing purposes. However, resource information, such as data concerning labor hours and categories, materials, subcontracts, etc., must be contained in the technical proposal so that your understanding of the scope of the work may be evaluated. It must disclose your technical approach in sufficient detail to provide a clear and concise presentation that includes, but is not limited to, the requirements of the technical proposal instructions.

6.

The proposal must be signed by an official authorized to bind your organization. The following quantities are required:

Technical Proposal:

Hard Copies-one original and eight copies

Compact Disc-nine copies

Business Proposal:

Hard copies-one original and three copies

Compact Disc-four copies

Submit to:

HHS/HRSA/OAFM/DPM

Attn: Daniel Matusiewicz

5600 Fishers Lane, Room 13A-19

Rockville, Maryland 20857 Ref: 10-250-00079DM 7.

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. These proposals may be considered if they are in the best interest of the Government. Alternate proposals, or deviations from any requirements of this RFP, must be clearly identified.

8.

The Government will evaluate proposals in accordance with the evaluation criteria set forth in Section M of this request for proposals.

9.

It is understood that your proposal will become part of the official contract file.

10.

The RFP does not commit the Government to pay any cost for the preparation and submission of a proposal. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition.

11.

Understanding of this requirement must be demonstrated by more than a reiteration of the Statement of Work (SOW). Descriptions by the offeror such as, “the offeror understands” or “can and will comply with all requirements of the SOW” alone, or phrases such as "Standard procedures will be employed" or "well known techniques will be used" will be considered insufficient.

12.

The Technical Proposal should not exceed 20 pages, excluding any attachments and resumes. Supplementary information further demonstrating the offeror’s capability to perform this statement of work, such as published reports, may be submitted outside of this page limit; however, the Technical Proposal itself must provide a sufficient basis for evaluation by the Government, without need to refer to such supplementary information. Contractors are requested to use double-sided printing for the entire Technical Proposal including attachments, resumes and supplementary material. The information must be keyed to each task and subtask in the Statement of Work.

B.

TECHNICAL PROPOSAL INSTRUCTIONS

To facilitate proposal evaluations, the offeror shall submit as a part of the proposal, a separate enclosure entitled "Technical Proposal." The data and information should be keyed to each paragraph of the Technical Proposal requirements as outlined below and should address how each task in the Statement of Work will be accomplished. Under no circumstances is any cost to be shown in the Technical Proposal; however, unpriced details of labor hours and other direct cost shall be included.

1. Proposals which merely offer to conduct a program in accordance with the requirement of the Government's Statement of Work will not be eligible for award. You must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives.

2. 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. You must explain how the management and coordination of consultant and/or subcontractor efforts will be accomplished.

3. The technical proposal must include a list of names and proposed duties of the professional personnel, consultants, and key subcontractor employees assigned to the project. Their resumes should be included and should contain information on education, background, recent experience, and specific scientific or technical accomplishments.

4. The technical proposal must contain a discussion of present or proposed facilities and equipment which will be used in the performance of the contract.

5. The proposal shall fully describe the proposed technical approach to meet each of the requirements specified under the Description and Statement of Work.

6. Offerors must address in their technical proposal how they will fulfill the Mandatory Requirements, and the Technical Requirements, as set forth below:

a. MANDATORY REQUIREMENTS

Proposals not meeting the mandatory requirements specified below will not be evaluated for consideration under this solicitation.

1. The organization must establish that it and any of its Subcontractors are located within the 50 states or Puerto Rico, and the units supplied are of U.S. or Puerto Rican origin.

2. The Offeror must be fully accredited by an established program for cord blood bank accreditation (i.e., AABB or the Foundation for the Accreditation of Cellular Therapy (FACT)) on or before the closing date for this solicitation. On or before the closing date for this solicitation, the Offeror must provide proof of having satisfied this requirement.

3. The organization must demonstrate an established program of public cord blood banking with a minimum inventory of 500 public CBU that were collected by the Offeror and are suitable for unrelated donor transplantation. Offerors must have an active public cord blood collection program and provide evidence that the bank has maintained proficiency in collecting and storing high quality CBU suitable for unrelated donor transplants and is prepared to begin the collections proposed by the bank without delay. Evidence of collecting and storing, on average over the past 3-months, at least as many units as the Offeror proposes to collect and store per month in the first year of the contract would be helpful in this regard, especially with respect to minority units. CBU suitable for unrelated donor transplants meet all requirements of the FDA for cord blood units intended for use in unrelated transplantation, any similar State or local legal requirements that apply to the bank, the listing requirements of the Cord Blood Coordinating Center, and the requirements of the organization by which the bank is accredited.

Offerors which are principally engaged in private banking (i.e., collecting and storing cord blood units for family use) may apply if they also have an established program of public cord blood banking which meets the requirements of the RFP.

Award(s) will be made to prime contractors. Organizations interested in only performing specific identified tasks within the Statement of Work and not the entire Statement of Work, may not apply independently under this solicitation, but may do so as subcontractors to applicant offerors.

Organizations previously awarded an NCBI contract may submit proposals and be considered for new contracts under this solicitation. However, because the authorizing law includes a preference for new awardees, the Technical Proposal evaluation factors in Section M.4. include 5 points for organizations which have not previously been awarded an NCBI contract.

b. REQUIRED SUPPLEMENTARY INFORMATION (These items do not count toward the technical proposal page limits. Note that although this supplementary information is required, the technical proposal alone should provide a sufficient basis for evaluation by the Government, without need to read such supplementary information):

1) The Offeror must complete the summary tables contained in Attachment C.

2) The Offeror must provide evidence of accreditation, including expiration date of current accreditation, from an established program for cord blood bank accreditation (i.e., AABB or the Foundation for the Accreditation of Cellular Therapy, FACT). The Offeror must provide a copy of the findings from its most recent accreditation inspection and/or assessment including its response back to the accrediting organization(s) regarding any non-conformities and/or deficiencies.

3) If applicable, the Offeror must provide a letter of ongoing commitment of resources for the cord blood bank program from the parent organization. The letter should commit to support the program for at least the 10-year period of the NCBI contracts.

4) The Offeror must submit verification of FDA registration/listing/licensure or an exemption from this requirement. If the FDA has inspected the Offeror in the past 24-months, the Offeror must include a copy of the inspection report and any reports submitted to the FDA as a result of that inspection. The Offeror must describe any corrective actions that were taken as a result of the inspection.

5) The Offeror must provide the SOP table of contents that includes the date of implementation and date of last revision of the established standard operating procedures that ensure the operation of a quality CBB.

6) The Offeror must attach a copy of the SOP(s) currently in use for CBU processing.

7) The Offeror must attach a copy of the SOP(s) currently in use for the cryopreservation process.

8) The Offeror must include a copy of the current informed consent document in use at each of the proposed collection hospitals and describe any changes that will be implemented for NCBI collections, including the timeline for full implementation of any changes.

9) The Offeror must provide resumes and/or letters of intent detailing the training and experience of professional staff assigned to this contract. Similar information must be provided for technical staff (e.g., processing technicians).

10) Offerors should demonstrate the appropriateness of time proposed for each staff member and consultant for each task (per person-loading matrix).

11) The Offeror must include evidence of liability insurance and other relevant insurance such as insurance against loss of inventory.

12) The Offeror must provide a copy of the written agreements with collection sites in which the Offeror proposes to collect CBU for the NCBI or a timeline for having such agreements in place.

13) The Offeror must include a proposed schedule, by month, for the number of NCBI CBU to be collected and stored in each of the broad race/ethnic categories indicated in Table B.2.b. (for the first 3-years of the contract). This information must be submitted in the technical volume without cost/price information as well as in the business volume with cost/price information.

c. TECHNICAL REQUIREMENTS:

1. Corporate Capability and Experience:

a. The Offeror must demonstrate organizational capability to satisfactorily carry out the 10-year term of this contract recognizing that Federal funding will be provided for no more than 3-years from the date of award. The Offeror must provide evidence of financial viability including a description of its business plan and any letters of commitment regarding financial or other support from a parent organization, if applicable.

b. The Offeror must describe a plan to achieve ongoing financial self-sufficiency of CBB operations after the limited period of HRSA support, as expected by the Congress.

c. The Offeror must describe its relevant experience for this contract including, but not limited to: donor education; donor recruitment; establishing and maintaining collection facility relationships; types of collection models used; training of collection staff and other bank staff; collection and storage of CBU; establishing a genetically diverse (race/ethnicity) inventory including encouraging donations from a genetically diverse group of donors; making CBU available for transplantation (e.g., listing, facilitating search requests, typing and matching experience, reservation practices, distribution of CBU and associated samples), and; collection of data from transplant centers on CBU product characteristics and patient outcomes. Offerors should describe past performance as it relates to setting and achieving goals (e.g., funding goals set by the NMDP or contractual goals with HRSA) for the collection and banking of CBU, especially minority CBU. HRSA is particularly interested in selecting banks demonstrating a superior ability (based on historical performance) to collect and bank large numbers of CBU from underrepresented populations, especially African-Americans. The Technical Proposal evaluation factors in Section M.4.include up to 5 points for Offerors with a history of success in banking CBU from these populations.

d. The Offeror must have obtained all required Federal and State licenses including: Biological License Application (BLA) or investigational new drug applications (INDs) as required by the FDA; certifications; registrations; and, other requirements to operate and maintain a public cord blood bank. The Offeror must state whether a BLA or IND for cord blood operations has been submitted to and/or approved by the FDA. If a BLA has not been submitted, the Offeror must describe its intent and timeline for BLA submission. If NCBI CBU will be collected under the Offeror’s existing IND, the Offeror must describe the applicable IND.

e. The Offeror must have documented plans and ability to comply with all Federal safety guidelines and regulations for collecting, processing, storing (maintaining cryopreserved CBU and associated sample inventory), retrieving, minimizing exposure to potential CBU warming events (as defined in the SOW of this solicitation), and shipping CBU.

f. The Offeror must thoroughly describe its public banking performance regarding for the past 12-months and, at a minimum describe: the number of units collected and stored; characteristics of units collected and banked (including racial and ethnic diversity); collection sites; and, number of units released for transplant

g. The Offeror must describe how it reinforces with transplant centers their obligation to…