Attachment-1-LTRC-CC_Additional_Information.pdf

NHLBI Lung Tissue Research Consortium (LTRC) Attachment 1 Clinical Centers

Attachment 1

Additional Information Specific to Solicitation NHLBI-HR-16-07

• Section B - Brief Description of Supplies or Services Page 2

• Section C - Statement of Work and Reporting Requirements Page 2

• Section F – Deliveries or Performance Page 5

• Section L – Instructions, Conditions, and Notices to Offerors Page 6

• Section L - Additional technical proposal instructions Page 6

a. General Description of the Program and Desired Results

b. Background Information

c. LTRC Committees

d. Estimated Level of Effort

e. Page and Formatting Limitations

f. Sample Technical Proposal Table of Contents

g. Travel

h. Offerors Must Address in Their Technical Proposal

• Section L - Additional business proposal instructions Page 11

a. Sample Business Proposal Table of Contents

b. Offeror’s Identification and Assurance Numbers

c. Cost Proposal Excel Workbook

• Section M - Evaluation Factors for Award Page 12

• Packaging and Delivery of Proposal Page 19

• Proposal Intent Response Sheet Page 20

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractors will support the Lung Tissue Research Consortium (LTRC), which is a network of centers cooperating to harvest and process lung tissue specimens for use in scientific studies of the etiology and pathogenesis of lung diseases, especially chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis. Contractors will also select biospecimens for high throughput assays to generate omics data for inclusion in the LTRC dataset. The LTRC will prepare collections of specimens, linked to data from the donor subjects, for widespread distribution to investigators for use in their research.

Clinical Centers (CCs) will recruit and enroll specimen donor subjects; perform clinical testing of donor subjects; extract data from the patients’ medical records; obtain lung tissues and other biospecimens and perform initial processing of these specimens; and transmit clinical data, computed tomography (CT) image data, and biological specimens to centralized facilities of the LTRC. In addition, the CCs will participate with other LTRC investigators in planning omics analyses of selected biospecimens and analyzing those data.

SECTION C – STATEMENT OF WORK AND REPORTING REQUIREMENTS

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below. The Contractor shall deliver the items specified in ARTICLE C.2. to the destination indicated in

ARTICLE F.1.

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract.

Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

c. The Section 508 applicable Electronic and Information Technology (EIT) Accessibility Standards throughout this Statement of Work are as follows and can be found at the following:

http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards

Subpart B - Technical Standards

• Software Applications and Operating Systems (1194.21)

• Web-based Intranet and Internet Information and Applications (1194.22)

• Video and Multimedia Products (1194.24) Subpart C - Functional Performance Criteria

• Functional Performance Criteria (1194.31) Subpart D - Information, Documentation, and Support

• Information, Documentation, and Support (1194.41) http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/sec508/guide/1194.21.htm http://www.access-board.gov/sec508/guide/1194.22.htm http://www.access-board.gov/sec508/guide/1194.24.htm

d. The Program schedule is estimated to be as follows:

• Task Area A – Subject Characterization and Tissue Procurement (36 months) The Task Area will be for 36 months (3 years) and will include approximately 3 sequential and severable task orders, each requiring approximately twelve (12) months for completion. Each task order will involve enrollment and phenotyping of approximately 33 donor subjects according to the LTRC Protocol; collection of biospecimens; transfer of data and biospecimens to other centers of the LTRC; and participation in study-wide activities, such as training sessions and Steering Committee teleconferences that are necessary to ensure the continuity and quality of LTRC functions. The Task Area will include Task Order 001, which will be awarded concurrently with the base IDIQ contract.

Task Area A – Subject characterization and tissue procurement.

1. Obtain and maintain Institutional Review Board (IRB) approval for CC activities described in the LTRC Protocol Manual, and any amendments thereto.

2. The Principal Investigator shall have expertise in pulmonary diseases and shall participate fully in the activities of the Steering Committee (SC). The SC will monitor operations of the LTRC, consider modifications and updates of the LTRC Protocol as needed to accomplish the general aims of the LTRC, and submit recommended modifications to the Protocol Review Committee (PRC) for review.

3. Obtain and maintain training of appropriate staff in LTRC protocols and procedures, including: 1) administration of questionnaires, performance of clinical testing, extraction of clinical data from medical records, data entry, and transmission of clinical data to the LTRC Data Coordinating Center; 2) imaging procedures and transmission of CT scans to the LTRC Radiology Center; and 3) collection, processing, and shipping of specimens to the LTRC Tissue Repository.

4. In accordance with the LTRC Protocol, the CC contractor shall identify potential donor subjects, obtain their informed consent, and collect screening data necessary to determine eligibility for participation. Recruit and enroll the number of donor subjects prescribed.

Perform clinical testing and collect donor subject data as specified in the LTRC Manual of Operations and transmit the data to the responsible LTRC center. Retain hard copy originals of data collection forms in a secure archive.

5. Procure biological specimens from enrolled donor subjects. Perform initial specimen processing. Transmit processed biological specimens to the LTRC Tissue Repository.

6. Acquire CT images in accordance with the LTRC protocol, de-identify the images, and transmit to the LTRC Radiology Center.

7. Perform quality control and quality assurance activities.

8. Report adverse events (consistent with NHLBI/NIH policies).

9. Provide reports of any radiographic or pathological abnormalities noted by the LTRC Radiology Center and/or LTRC Tissue Repository to the donor subjects’ primary care physicians. Inform the LTRC Data Coordinating Center when notification is accomplished.

10. Identify any problems with existing LTRC procedures and any difficulties that may interfere with LTRC objectives. Devise strategies to improve procedures and overcome difficulties.

11. In collaboration with other LTRC investigators, develop detailed plans for the creation of an omics data set based on LTRC biospecimens and phenotypic data. These plans will include selections of specific donor subjects, biospecimen types, and analysis platforms.

12. In collaboration with other LTRC investigators, carry out data analyses and prepare manuscript(s) reporting study results. Submit manuscript(s) for publication.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the individuals, as specified within ARTICLE F.1. of this contract.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

In addition to those reports required by other terms of the contract, the contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE F.1. DELIVERABLES of this contract. [Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

a. Annual Progress Reports: The annual technical reports, in a narrative form, shall be concise and informational. They shall include but not be limited to: a cover page which includes the contractor’s name and address, the contract number, the name of the Principal Investigator; a description of overall progress, current problems which may impede performance, and proposed corrective actions; and activities planned for the next reporting period. The report shall also address administrative matters and staffing changes. An annual technical report will not be due when the final report is due.

b. Annual Invention Reports: See Article C.3. of the solicitation.

c. Phenotyping data for human subjects: Data obtained from enrolled subjects in accordance with the LTRC Protocol shall be sent to the DCC.

d. CT image data for human subjects: X-ray CT image data obtained from enrolled subjects in accordance with the LTRC Protocol shall be sent to the Radiology Center.

e. Biospecimens: Biospecimens obtained from enrolled subjects in accordance with the

LTRC Protocol shall be sent to the Tissue Repository.

f. Final technical report: This report shall include a summation of the work performed and results achieved for the entire contract period of performance. The report shall be in sufficient detail to describe comprehensively the results achieved.

http://www.hhs.gov/web/508/index.html

g. Summary of Salient Results: The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

h. Information Security Reporting Requirements: The contractor shall submit reports as required by the Information Security Article in Section H of this solicitation.

i. Section 508 Annual Reports: The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

SECTION F – DELIVERIES OR PEFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the contract shall be deemed to occur upon performance of the work described in the Statement of Work ARTICLE in Section C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

A. The items specified below, as described in SECTION C, ARTICLE C.2., will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. Destination, within Consignees Premises (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Deliver to: Delivery Schedule Reference

(1) Annual Progress Reports

Contracting Officer’s Representative (COR) and Contracting Officer

On or before:

12/15/2016; 12/15/2017

Article C.2.

(2) Annual Invention Reports

COR and Contracting Officer

In accordance with Article C.3.

Article C.3.

(3) Phenotypic Study Data

LTRC DCC In accordance with LTRC Manual of Operations and Protocol

LTRC Manual of Operations and Protocol

(4) CT Images LTRC Radiology Center

In accordance with LTRC Manual of Operations and Protocol

LTRC Manual of Operations and Protocol http://www.hhs.gov/web/508/contracting/technology/vendors.html

(5) Biospecimens LTRC Tissue Repository

In accordance with LTRC Manual of Operations and Protocol

LTRC Manual of Operations and Protocol

(6) Summary of Salient Results

COR and Contracting Officer

On or before contract expiration date

Article C.2.

(7) Final Technical Report

COR and Contracting Officer

On or before contract expiration date

Article C.2.

(8) Information Security Reporting

Contracting Officer

In accordance with Section H of the Solicitation.

Section H of the Solicitation

(9) Section 508 Annual Report

Contracting Officer

Annually: Within 30 days of the contract’s anniversary date

Section H of the Solicitation

Copies of deliverables shall be sent to the following addresses:

Addressee: Item Quantity Contracting Officer’s Representative National Heart, Lung, and Blood Institute 1-2 1 Each Division of Lung Diseases 6-7 1 Each Rockledge 2 Building, Room 10142 6701 Rockledge Drive, MSC 7952 Bethesda, MD 20892-7952

Contracting Officer National Heart, Lung, and Blood Institute 1-2 1 Each Office of Acquisitions 6-9 1 Each Rockledge 2 Building, Room 6016 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

Data Coordinating Center (To be determined) 3 1 Each

Radiology Center (To be determined) 4 1 Each

Tissue Repository (To be determined) 5 1 Each

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

a. General Description of the Program and Desired Results

The Lung Tissue Research Consortium (LTRC) is a network of centers cooperating to harvest and process lung tissue specimens for use in scientific studies of the etiology and pathogenesis of lung diseases, especially chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis. The LTRC prepares collections of specimens, linked to clinical data describing the donor subjects, for widespread distribution to investigators for use in their research. This program will consist of: 1) Clinical Centers (CCs); 2) a Tissue Repository (TR); 3) a Radiology Center (RC); and 4) a Data Coordinating Center (DCC).

The CCs will enroll subjects, perform extensive clinical phenotyping, and obtain biospecimens. The TR will process tissues and prepare specimen collections in accordance with investigator requests. The RC will perform quantitative analyses and archiving of high resolution chest computed tomography (CT) images. The DCC will manage the study and a central database, provide data quality assurance, coordinate the review and approval of requests for tissues and data, and provide for omics analyses of selected biospecimens.

b. Background Information Chronic diseases of the lung are a major cause of death and disability among Americans.

Some of these diseases are highly prevalent. For example, chronic obstructive pulmonary disease (COPD) affects over 15 million people in this country and is now the third leading cause of death. Other lung diseases are less common but are very severe. For example, idiopathic pulmonary fibrosis has a prevalence of approximately 28 cases per 100,000 and is associated with 50-70% mortality at 5 years after diagnosis. Chronic pulmonary diseases tend to be: 1) associated with an inflammatory process in the lungs; 2) progressive; 3) inadequately controlled by current therapies; and 4) poorly understood in terms of pathogenetic mechanisms. Research is needed that will foster the development of novel therapeutic approaches for these conditions.

Since recognition of pathways and mechanisms involved in pathogenesis can lead to the identification of causative agents and therapeutic targets, an important avenue of research regarding chronic lung diseases is characterization of cellular and molecular abnormalities that correlate with disease presence, severity, and outcome. Powerful tools of genomics and molecular histopathology are now available that allow studies of inflammatory cell types, gene expression, protein content, cellular phenotype, and microbial and viral infection with exquisite sensitivity and high spatial resolution. These research approaches offer unprecedented opportunities for defining the roles of specific cells and molecular pathways in pulmonary diseases.

Unfortunately, application of state-of-art methods to lung disease research is often limited by the availability of tissue specimens. Although human lung tissues can be obtained from excisions of lung lobes for possible cancer, lung volume reduction surgeries, lung transplantations, and video-assisted thoracic surgical lung biopsies, considerable expertise, expense, and effort are required for recruitment and clinical characterization of lung tissue donor subjects, lung tissue collection, and specimen processing. These difficulties limit the ability of many researchers, particularly basic scientists, to perform human research related to pulmonary diseases. The LTRC was established in 2004 to enable mechanistic and translational studies of lung diseases through centralized donor subject recruitment / characterization and tissue collection / processing according to standard protocol.

Hallmarks of this program include extensive subject phenotyping, a wide variety of biospecimen preparations, and excellent specimen quality. This acquisition will continue operations of the LTRC. The LTRC website is http://www.ltrcpublic.com/index.htm.

c. LTRC Committees The Steering Committee (SC), consisting of the NHLBI Contracting Officer’s Representative (COR), the Principal Investigators from each participating center, and a SC http://www.ltrcpublic.com/index.htm

Chair to be appointed by NHLBI, will work together to monitor study progress, recommend changes and update the LTRC Protocol as needed, and design plans for omics analyses of selected biospecimens. The Steering Committee will meet once in the first year and conduct teleconferences as needed. Each participating center will have one vote on issues pertaining to the LTRC.

A Protocol Review Committee (PRC), appointed by the NHLBI, will make recommendations to the NHLBI regarding changes to the LTRC protocol. The PRC will also evaluate research proposals involving LTRC specimens and clinical data. The PRC will conduct teleconferences as needed.

An Observational and Study Monitoring Board (OSMB) will be established to monitor overall progress, data outcomes, and patient safety. The Board will periodically evaluate LTRC procedures and progress, review results for adverse events and unanticipated problems, and advise the NHLBI when changes should be made. The Board will meet twice per year by teleconference and hold additional teleconferences as needed. Responsibilities of OSMBs appointed by the NHLBI can be found at: http://www.nhlbi.nih.gov/funding/ethics.htm

d. Estimated Level of Effort The Government considers the types of personnel and estimated levels of effort identified below to be required for successful completion of the Clinical Center objectives. Effort is shown as a percentage of FTE (full-time equivalent) labor. The personnel and levels of effort listed below are for information only and are not to be considered restrictive for proposal purposes. The levels were formulated by NHLBI staff based on prior operations of the LTRC.

Labor Category (Core) Labor

Principal Investigator 10%

Co-Investigator 5%

Clinical Coordinator 20%

Tissue Tech 20%

Total: 55%

Labor Category (Protocol) Labor

Principal Investigator 3%

Co-Investigator 0%

Clinical Coordinator 15%

Radiology Tech. 15%

Data Entry/Admin. 15%

Lab Tech/Tissue 15%

Total: 63% http://www.nhlbi.nih.gov/funding/ethics.htm

Core Labor will provide baseline support for CC infrastructure and staff. Protocol Labor will be reimbursed using a capitated system that will take into account the number of donor subjects enrolled, the completion of protocol procedures, and the quality of sample and data obtained from each enrolled donor subject. For proposal purposes, it is sufficient for offerors to estimate Protocol Cost and Core Costs, including labor, travel, and other costs.

See Section J, Cost Proposal Template, of the solicitation for other cost assumptions.

Note: Offerors shall ensure that the Principal Investigator and all other personnel proposed will not be committed on Federal grants and contracts for more than a total of 100% of their time. If the situation arises where it is determined that a proposed individual is committed for more than 100% of his or her time, the Government will require action on the part of the offeror to adjust the time commitment.

e. Page and Formatting Limitations The Technical Plan (objectives, approach, methods, and schedule) of the technical proposal shall not exceed 20 single-sided pages or 10 double-sided pages. This page limitation does not include the cover sheet, table of contents, abstract, personnel, facilities, equipment and resources, summary of related activities, technical proposal cost summary, protection of human subjects, data sharing plan, target enrollment report, information security, HHS Section 508 product assessment template, and appendices. Appendices shall not exceed a total of 50 single-sided pages or 25 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated. Each page of the technical proposal must be numbered sequentially. Offerors are encouraged to limit the overall size of the technical proposal, inclusive of appendices, attachments, etc. Although no page limit has been placed on the business proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be no less than ½ inch around, exclusive of headers and footers.

f. Sample Technical Proposal Table of Contents

1. Cover Page Page 1

Cover page should include: RFP Title and Number, Name of Organization, Name of Principal Investigator, Address, and Telephone Number.

2. Table of Contents Page 2

3. Abstract/Project Objectives Page 3

4. Technical Plan/Statement of Work Page 4-#

The Technical Plan shall not exceed 20 single-sided pages or 10 double-sided pages.

Pages in excess of the limitation will be deleted and will be neither read nor evaluated.

(1) Objectives Page #

(2) Approach Page #

(3) Methods Page #

(4) Schedule Page #

5. Personnel

(1) List of All Personnel in the Project Including Subcontractors, Consultants/ collaborators, by Name, Title, Department and Organization Page #

(2) Provide narrative for Principal Investigator and Other Investigators of expertise and qualifications Page #

(3) Other Staff (Coordinator, Technician,…) Page # [Note: Include a resume/CV/biosketch for PI and co-investigators in the Appendices]

(4) Leadership Plan, if applicable Page #

6. Facilities, Equipment, and Other Resources Page # Describe all facilities, equipment and other resources available for this project.

7. Summary of Related Activities Page #

8. Technical Proposal Cost Summary Page #

9. Protection of Human Subjects Page #

10. Targeted Enrollment Report Page #

11. Data Sharing Plan Page #

12. HHS Section 508 Product Assessment Template Page #

13. Information Security Page #

14. Appendices Page # Appendices shall not exceed a total of 50 single-sided pages or 25 double-sided pages.

g. Travel The Steering Committee will meet in person once during the first year. For the purpose of estimating costs, offerors may assume that this meeting will last one day; be held in Bethesda, MD; and be attended by 2 investigators from each of the CCs.

h. Offerors Must Address in Their Technical Proposal: In order to document capabilities to perform the Statement of Work, ensure efficient modification of the LTRC protocol as needed, and expedite re-initiation of LTRC operations, offerors must address the following:

1. Demonstrate access to donor subjects and the ability to obtain appropriate lung tissue specimens from at least 33 patients per year undergoing lobectomy for suspected lung cancer who have not been previously diagnosed with chronic lung disease. Provide detailed plans for identification and recruitment of donor subjects. Identify the expected numbers of potential tissue donor subjects by gender and racial/ethnic minority status.

Document previous success in obtaining lung tissue specimens for research purposes from surgical patients.

2. It is expected that the Principal Investigator (PI) will be an established investigator who has clinical expertise in caring for patients with pulmonary disease and has participated in multi-center clinical studies. The proposed PI should have leadership experience and be available to participate in Steering Committee activities. Document the prior experience of proposed scientific personnel in enrolling donor patients and directing the harvest and processing of human lung tissue specimens for research purposes.

Document prior experience of proposed scientific personnel as participants in multi-center clinical research studies, especially those involving standardized procedures, data transfer to a central coordinating center, and defined quality assurance procedures.

Describe the qualifications and experience of the PI, proposed investigators, and key staff as related to their capability to successfully fulfill the requirements of this acquisition.

3. Describe proposed procedures for clinical characterization of donor subjects in accordance with the LTRC Protocol (available at http://www.ltrcpublic.com), including methods for obtaining data from medical records, administering questionnaires, and http://www.ltrcpublic.com/ performing laboratory tests (e.g., pulmonary function testing, chest CT imaging).

Describe plans for effective interactions with the Data Coordinating Center to transmit and validate clinical data, with the Radiology Center to transmit CT image data, and with the Tissue Repository to process and transmit biological specimens.

4. Provide detailed plans for assuring the protection and privacy of human research subjects. Provide documentation of an Office of Human Research Protections– approved assurance (e.g., a Federal Wide Assurance).

5. Provide letters of commitment from surgeons and pathologists involved in the clinical care of potential donor subjects documenting their willingness to cooperate with the harvest and rapid processing of lung tissues for research purposes.

6. Provide a detailed description of surgical/clinical/laboratory facilities available to conduct the Statement of Work. The description should identify resources to 1) process tissue specimens prior to their transfer to the Tissue Repository, 2) obtain research CT scans and transmit CT images electronically to the Radiology Center, and 3) perform clinical testing, administer questionnaires, and transmit data electronically to the Data Coordinating Center.

7. Describe the administrative structure of the proposed Clinical Center.

8. Describe any institutional commitments that will be provided if selected for award.

9. Provide any other information needed to allow reviewers to judge the capability of the offeror to accomplish the Statement of Work of a Clinical Center.

10. Note: In order to maintain the integrity and utility of the tissue specimens, expedited transport to the Tissue Repository will be required. Offerors must address plans for packaging and shipping tissue specimens so they are received at the Tissue Repository within 24 hours of shipment. For proposal purposes, it should be assumed that the Tissue Repository will be located in the continental United States.

ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

a. Sample Business Proposal Table of Contents

1. Proposal Summary and Data Record, NIH-2043 ....................................Page 1

2. Offeror's Points of Contact and Identification and Assurance Numbers Page 2

3. Breakdown of Proposed Estimated Costs (Excel Workbook) .................Page 3

4. A written justification of each cost element proposed ..............................Page #-#

5. Certificate of Current Cost or Pricing Data ……………………………......Page #-#

6. Disclosure of Lobbying Activities, OMB Form SF-LLL .............................Page #-#

7. Qualifications of the Offeror......................................................................Page #-#

a. General Experience

b. Organizational Experience Related to the RFP

c. Performance History

d. Pertinent Contracts

e. Pertinent Grants

8. Other Administrative Data...........................................................................Page #-#

9. SAM Representations & Certifications, including NIH Reps and Certs......Page #-#

10. Annual Financial Report……………………………………...……………..Page #-#

11. Travel Policy………………………………………………………………….Page #-#

b. Offeror’s Identification and Assurance Numbers Provide the following:

• Federal Employer Identification Number (EIN)

• Data Universal Numbering System (DUNS) Number

• Human Subjects Federal Wide Assurance (FWA) Number

c. A detailed cost breakdown shall be submitted using the Excel spreadsheet posted with this solicitation. Email a copy of the completed Excel spreadsheet to the Contracting Officer identified on Page 1 of the RFP. The file should not be password protected.

SECTION M - EVALUATION FACTORS FOR AWARD

GENERAL

Selection of an offeror for contract award will be based on an evaluation of proposals against four factors. The factors in order of importance are: technical, cost, and past performance.

Although technical factors are of paramount consideration in the award of the contract, past performance, and cost/price are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

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

a. TECHNICAL EVALUATION CRITERIA

The evaluation criteria are used by the Technical Evaluation Panel when reviewing the technical proposals. The criteria below are listed in relative importance with weights assigned for evaluation purposes.

No. Criterion Points

1. Capability for Donor Subject Recruitment: Access to lung tissue specimens from 33 patients per year, based on the documented frequency of lung lobectomy surgical procedures at the CC site(s) in patients without prior diagnosis of lung disease other than cancer. Documented characteristics of available patient population with regard to medical diagnoses and gender and ethnic/minority status. Documented willingness of thoracic surgeons and pathologists to cooperate with the harvest and rapid processing of lung tissues for research purposes. Demonstrated ability to carry out the rapid harvest and processing of lung tissues for research purposes, with documented biospecimen quality. Documented success in prior studies in the recruitment of subjects for clinical research studies of lung diseases.

2. Personnel: Documented leadership ability, training, expertise, experience, and availability of the Principal Investigator for directing the proposed Clinical Center (CC). Qualifications of other proposed investigator(s), and overall integration of the investigative team. Training and expertise of proposed personnel required for administration of questionnaires, laboratory testing, and biospecimen collection and processing.

Demonstrated expertise of the Principal Investigator and proposed staff in the causes, pathogenesis, progression, treatment, diagnosis, and heterogeneity of COPD and interstitial fibrotic lung disease, as needed to define phenotypes of these diseases in clinical research studies.

3. Facilities and Organization: Availability and adequacy of the facilities and resources necessary to carry out the proposed activities of the CC. Adequacy of the organizational and administrative structure of the proposed CC. Institutional commitment to the CC.

Total: 100

This study involves human subjects. NIH policy requires that women and members of minority groups and their subpopulations and children must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification is provided with respect to the health of the subjects or the purpose of the research. Where inclusion of women, minority populations, and/or children is not feasible, a detailed rationale and justification for exclusion of each group from the study population must be addressed in the technical proposal. The NHLBI will review the rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research. If the rationale is not considered acceptable by the Government and the proposal is included in the competitive range, the offeror will be afforded an opportunity to further discuss and/or clarify its position during discussions and/or propose in its Final Proposal Revisions the inclusion of women, minorities and/or children. If the exclusion rationale is still considered unacceptable by the Government after discussions, the offeror’s proposal may not be considered further for award.

OTHER EVALUATION CRITERIA

b. Cost/Price Evaluation

Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404.

Cost Realism: The specific elements of each offeror(s) proposed costs are realistic when the proposed cost elements are evaluated and found to: 1) be realistic for the work to be performed; 2) reflect a clear understanding of the requirements; and 3) be consistent with the unique methods of performance and materials described in the offeror(s) technical proposal.

Cost Realism will be evaluated only on the offeror(s) inputs which the Government will use to determine the most probable cost to perform the contract in a manner consistent with the offeror's proposal. Cost realism analysis will be conducted in accordance with FAR 15.404- 1(d). The result of the cost realism analysis will be considered in making the best value tradeoff decision.

c. Past Performance

Offerors' past performance information will be evaluated prior to establishment of the competitive range. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable.

The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

The government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance.

The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer.

The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance.

The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.

d. Evaluation of Data Sharing Plan

The offeror's plan for the sharing of final research data shall be assessed for appropriateness and adequacy.

If your proposal does not include a plan or if the plan in your proposal is considered "unacceptable," and the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify your data sharing plan during discussions and in your Final Proposal Revision (FPR).

If your data sharing plan is still considered "unacceptable" by the Government after discussions, your proposal may not be considered further for award.

e. Human Subject Evaluation

This research project involves human subjects. NIH Policy requires:

i. Protection of Human Subjects from Research Risks The offeror's proposal must address the involvement of human subjects and protections from research risk relating to their participation, or provide sufficient information on the research subjects to allow a determination by NHLBI that a designated exemption is appropriate.

If you claim that this research should be considered exempt from coverage by the Federal Regulations at 45 CFR 46, the proposal should address why you believe it is exempt, and under which exemption it applies.

The reviewers will evaluate the proposal with regard to four issues: Risks to Human Subjects, Adequacy of Protection Against Risks, Potential Benefits of the Proposed Research to the Subjects and Others, and Importance of the Knowledge to be Gained.

See Section L for a complete discussion of what is required to be addressed for each of these issues. Based on the response to this criterion, this section of the proposal may be rated "unacceptable" (i.e., concerns are identified as to the protections described against risk to human subjects or no discussion is found regarding protections against risk to human subjects) or "acceptable." If the reviewers find that this portion of the proposal is "unacceptable" they will provide a narrative supporting their finding.

If the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to address the concerns raised by the reviewers. You will be able to further discuss and/or clarify your position until submission of your Final Proposal Revision (FPR). Once discussions are closed with the submission of your FPR, if your proposed plan for the protection of human subjects from research risks is still found to be unacceptable, then your proposal may not be considered further for award.

ii. Women and Minorities

Women and members of minority groups and their subpopulations must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. In addition, for NIH-Defined Phase III clinical trials, all proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to detect significant differences in intervention effect (see NIH Guide http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht m , Definitions - Significant Difference) by sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable, unless the Government has specified that this solicitation http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm involves a sex/gender specific study or a single or limited number of minority population groups. The proposal also must include one of the following plans:

Plans to conduct valid analysis to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR

Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups (representation of sex/gender and/or racial/ethnic groups as subject selection criterion is not required; however, inclusion and analyses are encouraged), OR

Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.

Also, the proposal must address the proposed outreach programs for recruiting women and minorities as participants.

Reviewers will consider the areas covered here and in Section L of the solicitation in narrative form in their evaluation. Some of the issues they will evaluate include:

whether the plan proposed includes minorities and both genders in adequate representation how the offeror addresses the inclusion of women and members of minority groups and their subpopulations in the development of a proposal that is appropriate to the scientific objectives of the solicitation the description of the proposed study populations in terms of sex/gender and racial/ethnic groups and the rationale for selection of such subjects if exclusion is proposed, that the rationale is appropriate with respect to the health of the subjects and/or to the purpose of the research.

In addition, for gender exclusion, the reviewers will examine the rationale to determine if it is because:

• the purpose of the research constrains the offeror's selection of study participants by gender (e.g., uniquely valuable stored specimens or existing datasets are single gender; very small numbers of subjects are involved; or

• overriding factors dictate selection of subjects); or

• gender representation of specimens or existing datasets cannot be accurately determined, and this does not compromise the scientific objectives of the research.

For minority group exclusion, the reviewers will examine the rationale to determine if those minority groups are excluded because:

• inclusion of those groups would be inappropriate with respect to their health; or

• inclusion of those groups would be inappropriate with respect to the purpose of the research.

For NIH-defined Phase III clinical trials, reviewers will also consider whether there is an adequate description of plans to conduct analyses to detect significant differences of clinical or public health importance in intervention effect(s) by sex/gender and/or racial ethnic subgroups when the intervention effect(s) is expected in the primary analyses, or if there is an adequate description of plans to conduct valid analyses of the intervention effect in subgroups when the intervention effect(s) is not expected in the primary analyses.

If you determine that inclusion of women and minority populations is not feasible, you must submit a detailed rationale and justification for exclusion of one or both groups from the study population with the technical proposal. The Government will review the rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research

Based on the evaluation of the response to this criterion, this section of the proposal may be rated "unacceptable" (i.e., no discussion can be found regarding the proposed gender/minority inclusion plans, or concerns are identified as to the gender or minority representation, or the proposal does not adequately address limited representation of one gender or minority; or the plan is not in accordance with NIH policy guidelines) or "acceptable." See Section L of the solicitation for the requirements of women/minorities inclusion. If the reviewers find that this portion of the proposal is "unacceptable" they will provide a narrative supporting their finding.

If the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to address the concerns raised by the reviewers. You will be able to further discuss and/or clarify your position until submission of your Final Proposal Revision (FPR). Once discussions are closed with the submission of your FPR, if your proposed plan for the inclusion/exclusion of women and minorities is still found to be unacceptable, then your proposal may not be considered further for award.

iii. Children

Children (i.e. individuals under the age of 21) must be included in all human subject research unless there are clear and compelling reasons not to include them.

Your proposal must include a description of plans for including children. If you plan to exclude children from the required research, your proposal must present an acceptable justification for the exclusion. If you determine that exclusion of a specific age range of child is appropriate, your proposal must also address the rationale for such exclusion.

Also, the plan must include a description of the expertise of the investigative team for dealing with children at the ages included, of the appropriateness of the available facilities to accommodate the children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose/objective of the solicitation. Also, see Section L of the solicitation for further specific requirements on inclusion of children.

Based on the reviewers' evaluation of the offeror's response, this section of the proposal may be rated "unacceptable" (i.e., no discussion can be found regarding the proposed inclusion plans for children; or concerns are identified as to the offeror's response regarding the inclusion of children; or the plan is not in accordance wit h NIH policy guidelines) or "acceptable." If the reviewers find that this portion of the proposal is "unacceptable" they will provide a narrative supporting their finding.

If the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to address the concerns raised by the reviewers. You will be able to further discuss and/or clarify your position until submission of your Final Proposal Revision (FPR). Once discussions are closed with the submission of your FPR, if your proposed plan for the inclusion of children is still found to be unacceptable, then your proposal may not be considered further for award.

f. Evaluation of Electronic and Information Technology Accessibility – Section 508

The offeror's proposal must demonstrate compliance with the "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports.

If your proposal does not include a completed HHS "Section 508 Product Assessment Template" (hereafter referred to as the "Template") which demonstrates that EIT products and services proposed support applicable Section 508 accessibility standards, or, if the completed "Template" included in your proposal is considered "noncompliant," and the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify the "Template" during discussions and in your Final Proposal Revision (FPR). If your "Template" is still considered "noncompliant" by the Government after discussions, your proposal may not be considered further for award.

ADDITIONAL PROPOSAL INSTRUCTIONS

Packaging and Delivery of the Proposal:

DUE DATE: 3:00 p.m. local time on February 16, 2015.

Proposals not received at the place and time specified in the solicitation will be considered late and will be handled in accordance with HHSAR clause 352.215-70 (Late…