Attachment-1-LTRC_DCC_Additional_Information.pdf

NHLBI Lung Tissue Research Consortium (LTRC) Attachment 1 Data Coordinating Center

Additional Information Specific to Solicitation NHLBI-HR-16-04

• 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 6

• Section L – Instructions, Conditions, and Notices to Offerors Page 8

• Section L - Additional business proposal instructions Page 8

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/ Honoraria

h. Offerors Must Address in Their Technical Proposal

• Section L - Additional business proposal instructions Page 13

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 14

• Packaging and Delivery of Proposal Page 18

• Proposal Intent Response Sheet Page 19

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.

The Data Coordinating Center (DCC) will operate a repository for LTRC data and provide overall management, oversight, and administrative support for the LTRC. The DCC will train Clinical Center personnel regarding data forms completion and data entry and will have primary responsibility for data quality control and assessment. The DCC will conduct site visits as needed to assure that LTRC protocol procedures are followed. The DCC will arrange for meetings of LTRC committees and boards and will prepare reports for the committees and boards and the NHLBI summarizing study progress and status. The DCC will have primary responsibility for planning omics analyses and performing or obtaining high throughput omics analyses of selected biospecimens. The DCC will implement procedures whereby investigators apply for LTRC resources; the applications are reviewed by the Protocol Review Committee and the NHLBI; and tissues and data are granted to applicants whose requests are approved.

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, Article C.2., of the contract, and by direction of the Contracting Officer's Representative (COR).

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

• Task Area A - Coordinating activities of the program and managing study data. (48 months)

• Task Area B - High-throughput assays of biospecimens and processing the data obtained. (30 months)

• Task Area C - Publication of study results and preparation of final dataset. (12 months)

Task Area A – Coordinating Activities of the Program and Managing Study Data The contractor will accomplish the tasks described below through multiple, fully funded, severable task orders throughout the contract period. This Task Area will include Task Order 001, which will be awarded concurrently with the base IDIQ contract. It is anticipated that each task order will be for twelve (12) months.

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

2. The Principal Investigator 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. Provide training for LTRC Clinical Center personnel involved in data collection, forms completion, and data entry. Certify LTRC Clinical Center personnel who demonstrate proficiency in the approved data collection techniques.

4. Update as needed LTRC data collection forms and informed consent documents for use by the LTRC Clinical Centers and the DCC. Update the LTRC Protocol and Manual of Operations to describe proposed and approved modifications to the LTRC protocol and procedures.

5. Develop and maintain a public and private web site that includes: 1) a description of LTRC objectives, organization, and procedures, 2) the LTRC Protocol, 3) data collection forms, 4) a description of specimens and specimen collections available for distribution to researchers, 5) descriptions of research projects for which LTRC specimens or data have been provided, including the project title, the name of the Principal Investigator, and the project description provided by the applicant, 6) references to publications from research studies that have utilized LTRC resources, 7) procedures and forms for requesting LTRC specimens, specimen collections, clinical data, and data analyses, 8) a link to the NHLBI public web site, and 9) LTRC contact information.

The public website designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at:

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

The Section 508 applicable Electronic and Information Technology (EIT) Accessibility Standards throughout this Statement of Work are as follows:

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)

6. In accordance with the LTRC Protocol, the DCC contractor shall develop and/or maintain computer systems and software needed for transfer of clinical data from the LTRC Clinical Centers and External Contributors to the DCC and for the storage, retrieval, and statistical analysis of these data. The computer systems and software shall meet the requirements 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 of Section 508 of the Rehabilitation Act. More information is available on the Web at:

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

7. Assist the LTRC Clinical Centers in transferring clinical and phenotypic data to the DCC.

Perform quality control/quality assurance tests and report results to the NHLBI and Observational and Study Monitoring Board (OSMB).

8. Develop and maintain a database of LTRC clinical, phenotypic, and CT image data received from the LTRC centers, implementing procedures for backup that will minimize possibilities of data loss. The electronic database designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at:

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

9. Serve as the representative of the Steering Committee to convey recommendations for modification of the LTRC Protocol to the PRC and OSMB for review and comment.

10. Coordinate the submission of applications for LTRC resources, review of these applications by the PRC and NHLBI, and delivery of tissues, data, and CT images to applicants whose requests are approved.

11. Prepare data sets and collections of CT images in electronic form for distribution to investigators for approved studies as authorized by the NHLBI, ensuring that study subjects cannot be re-identified using the data provided.

12. Plan, make arrangements for, and provide ongoing support for the meetings and teleconferences of the SC, PRC, and OSMB. Prepare and distribute minutes of the SC meetings.

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

Task Area B – Omics Assays of Biospecimens and Processing the Data Obtained The contractor shall accomplish the tasks described below through a single, fully funded, non-severable task order that is expected to begin in year 2 of the contract period.

1. 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.

2. Obtain approval of plans for biospecimen analyses from the PRC and NHLBI, including any subcontracting arrangements.

3. Perform the required analyses. Biospecimen analyses shall not proceed until written approval has been provided by the Contracting Officer.

4. Incorporate the omics data obtained through these analyses into the LTRC dataset for distribution to investigators.

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/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

Task Area C – Publication of Study Results and Preparation of Final Dataset The contractor will accomplish the tasks described below through a single, fully funded, non-severable task order that is expected to be issued in year 4 of the contract period.

1. In collaboration with other LTRC investigators, finalize data analysis and prepare manuscript(s) reporting study results. Submit manuscript(s) for publication.

2. Prepare final limited access data set. The data set shall include data with full documentation, prepared in accordance with NHLBI policies available at:

http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.htm.

3. Transfer all LTRC data to a repository identified by the NHLBI before the end of the contract period, together with coding information linking the data to tissues and CT images.

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. Final Technical Report: This report shall include a summation of the work performed and results achieved for the entire contract period of performance. This report shall be in sufficient detail to describe the results achieved and include final data on sex/gender and race/ethnicity on each trial. Peer reviewed publications are sufficient to describe research results.

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

c. 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.

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

e. Site Visit Reports: As described in the LTRC Protocol.

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

g. 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."

h. Manual of Operations: This manual and any amendment thereto shall describe all operating procedures of the Network.

i. LTRC Protocol Manual: The Protocol and amendments thereto developed by the SC and approved by the PRC shall include, but not be limited to, a) the purpose of the protocol, b) number of subjects participating, c) detailed description, d) protocol procedures, and e) possible risks of participation.

j. Abstracts and Manuscripts: Citations to all abstracts and manuscripts shall be posted on the LTRC public and private web sites in accordance with the LTRC Manual of Operations.

k. Report of Progress and Performance: In accordance with the LTRC Manual of Operations

l. SC Meeting Minutes: The minutes shall be prepared and posted on the private LTRC website for SC members and NHLBI no later than 30 calendar days after each meeting.

m. LTRC Data Set: The data set shall be submitted in accordance with the NHLBI Limited

Access Data Set Clause and NHLBI policy described at: https://biolincc.nhlbi.nih.gov/submit_data/

n. Public and Private LTRC Website: In accordance with the LTRC Manual of Operations.

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 http://www.hhs.gov/web/508/contracting/technology/vendors.html https://biolincc.nhlbi.nih.gov/submit_data/ following items in accordance with the stated delivery schedule.

A. The items specified below, as described in the Reporting Requirements Article in

SECTION C of this contract 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;

12/15/2018

Article C.2.

(2) Abstracts and Manuscripts

COR and Contracting Officer

In accordance with LTRC Manual of Operations

LTRC Manual of Operations

(3) Annual Invention Report

Contracting Officer In accordance with Article C.3.

Article C.3.

(4) Final Technical Report

COR and Contracting Officer

On or before contract expiration date

Article C.2.

(5) Summary of Salient Results

COR and Contracting Officer

On or before contract expiration date

Article C.2.

(6)

Report of Progress and Performance

COR and OSMB Members

In accordance with LTRC Manual of Operations

LTRC Manual of Operations

(7) Manual of Operations and amendments

COR and Contracting Officer

Thirty (30) days after major revision.

Task Area A, Item 4.

(8) LTRC Protocol Manual

COR, Contracting Officer, Clinical Centers, Tissue Repository, Radiology Center

Thirty (30) days after major revision.

Statement of Work, Task Area A, item 2.

(9) Site Visit Reports COR and Contracting Officer

Thirty (30) days after site visit.

Article C.2.

(10) SC Meeting Minutes

COR, Contracting Officer, Clinical Centers, Tissue Repository, Radiology Center

Thirty (30) days after each SC meeting

Statement of Work, Task Area A, item 12.

(11) Public and Private LTRC websites

In accordance with LTRC Manual of Operations

Within two (2) months of contract award.

Statement of Work, Task Area A, item 5.

(12) Information Security Reporting

Contracting Officer In accordance with Section H of the Solicitation.

Section H of the Solicitation

(13) Section 508 Annual Report

COR and Contracting Officer

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

Section H of the Solicitation

(14) LTRC Dataset To Be Specified At contract closeout Statement of Work, Task Area C, item 3.

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 4 - 10 1 Each Rockledge 2 Building, Room 10142 13 1 Each 6701 Rockledge Drive, MSC 7952 Bethesda, MD 20892-7952

Contracting Officer National Heart, Lung, and Blood Institute 1 - 5 1 Each Office of Acquisitions 7 - 10 1 Each Rockledge 2 Building, Room 6016 12 - 13 1 Each 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

Clinical Centers (To be determined) 8 & 10 1 Each

Tissue Repository (To be determined) 8 & 10 1 Each

Radiology Center (To be determined) 8 & 10 1 Each

OSMB Members (To be determined) 6 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 Chair to be appointed by NHLBI, will work together to monitor study progress, recommend http://www.ltrcpublic.com/index.htm changes and update the LTRC Protocol as needed, and design plans for omics analyses of selected biospecimens. The SC 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 Data Coordinating Center objectives.

The personnel and labor hours listed below are for information purposes only and are not to be considered restrictive for proposal purposes. The hours were formulated by NHLBI staff based on prior operations of the LTRC. Commercial organizations should propose labor hours and not level of effort.

Labor Category Labor Hours

Principal Investigator 520 Biostatistician 520 Programmer 1,040 Data Coordinator 728 Project Coordinator 728 Administrative Asst. 416

Total: 3,952

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 http://www.nhlbi.nih.gov/funding/ethics.htm resources, summary of related activities, technical proposal cost summary, data sharing plan, protection of human subjects, 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 with a brief description of their role in the Project Including

Subcontractors, Consultants/ collaborators, by Name, Title, Department and Organization Page #

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

(3) Other Staff (Project Manager, Programmer,…) 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. Data Sharing Plan Page #

10. Protection of Human Subjects Page #

11. Information Security Page #

12. HHS Section 508 Product Assessment Template Page #

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

g. Travel/ Honoraria The DCC will plan, obtain meeting rooms, coordinate and make arrangements, and provide support for the meetings and teleconferences of LTRC committees and boards.

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 the Steering Committee Chair, 4 investigators/staff from the DCC, 2 from the TR, 2 from the RC, 2 from each of 4 CCs, and 2 from the NHLBI. The DCC will pay an honorarium of $200 per meeting to the Steering Committee Chair, and $50 per teleconference.

DCC personnel will conduct site visits of all other contractors during the first year.

Additional site visits will be conducted as needed in subsequent years to ensure compliance with the LTRC protocol and data management procedures. For proposal purposes, offerors may assume that the other contractors will be located in the central U.S. (e.g., in St. Louis), that 2 DCC staff will travel to the site visits, and that there will be a total of 6 site visits during the first year, 1 site visit in Year 2, and 1 in Year 3.

Honoraria Per Year Meeting Type Cost Number of

Meetings Total Members

OSMB $100 2 6

PRC Concept Review

$100 12 3

PRC Expedited Review

$50 36 3

SC Chair Meeting $200 1 1 SC Chair Teleconference

$50 11 1

h. Offerors Must Address in Their Technical Proposal: In order to document capabilities to perform the Statement of Work, assure continuity of LTRC operations, and expedite potential modifications of the LTRC protocol, offerors’ proposals must address the following:

1. Provide the names, degrees, training, qualifications, experience, role in project, and effort for each individual proposed. Describe the qualifications and experience of the Principal Investigator, co-investigators, statisticians, programmers, and other key staff as related to their capability to successfully fulfill the requirements of this acquisition. Specifically, document the capability, training, expertise, experience, and availability of the Principal Investigator as related to directing the proposed Data Coordinating Center (DCC). Document the experience of staff in performing the functions of study coordination, data management, generation of reports, and user support. Document the familiarity of professional and support staff with the vocabulary, procedures, and diseases involved in activities of the LTRC by describing previous experience managing lung disease clinical research programs.

Document the training, expertise, and availability of proposed personnel for study coordination and data management.

2. Describe proposed plans for data collection, transfer, error checking, quality control, storage, backup, and querying, including plans for incorporating existing LTRC data into the database. Describe in detail plans and proposed systems for remote data entry, including the computer systems and software proposed for use by the Clinical Centers. Describe in detail plans for the transfer of CT image sets from the Radiology Center to the DCC, for archiving these images, and for distributing them to external investigators in electronic form. Describe in detail any proposed improvements or modifications to data management procedures currently implemented by the LTRC (protocol accessible at http://www.ltrcpublic.com).

3. Describe in detail proposed methods for assuring the privacy of data on human research subjects.

4. Describe plans for creating and maintaining a public website to facilitate requests for LTRC resources from external investigators. Also, describe plans for ensuring that the public website meets the requirements of Section 508 of the Rehabilitation Act.

More information regarding Section 508 is available on the Web at:

http://www.access-board.gov/508.htm

5. Describe plans for training personnel of LTRC CCs in data forms completion and data entry.

6. Describe plans for arranging and coordinating meetings and activities of the Steering Committee, Protocol Review Committee (PRC), and Observational Study Monitoring Board (OSMB), including preparation of study reports, meeting room and telephone arrangements, logistical support, honoraria, reimbursements, and preparation of minutes.

7. Describe expertise for and experience in managing omics and other high-dimensionality biological data. Describe in detail plans for assaying LTRC biospecimens and incorporating omics data into the LTRC dataset.

8. Describe the facilities and resources, including computer systems that are available to perform the Statement of Work. Provide an Information Systems Security Plan in accordance with the Federal Information Security Management Act of 2002 (P.L.

107-347).

9. Describe in detail the organizational and administrative structure of the proposed

DCC.

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

11. Provide documentation of an Office of Human Research Protections-approved institutional assurance (e.g., an FWA).

12. Provide any other information needed to allow reviewers to judge the capability of the offeror to accomplish the Statement of Work of the Data Coordinating Center.

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 #-# http://www.ltrcpublic.com/ http://www.access-board.gov/508.htm

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, past performance and Small Disadvantaged Business (SDB) participation. Although technical factors are of paramount consideration in the award of the contract, past performance, cost/price and SDB participation are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are approximately equal to 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. Personnel: Documented capability, training, expertise, experience, and availability of the Principal Investigator for directing the proposed Data Coordinating Center (DCC). Relevant experience and expertise of the proposed statistician(s). Value of expertise provided by other proposed investigators. Experience of key personnel in research studies involving pulmonary terminology, procedures, and diseases. Training and expertise of proposed personnel for multi-center clinical study coordination, data management including omics data, web site creation and maintenance, and processing requests for LTRC resources from investigators.

2. Merit of Proposed Plans and Capability for Operating the Data Coordinating Center: Capabilities of the planned center as a whole for managing a multi-center clinical research study, including coordination, oversight, data management, analysis, and communications. Merit of proposed plans for data quality control and assessment. Adequacy of proposed plans for ensuring the confidentiality of study data and the privacy of human subjects.

Merit of proposed plans for training personnel; transferring, storing, and querying study data; developing and maintaining Section 508 study websites; managing committees; processing requests from investigators for LTRC resources; and preparing reports of study progress and status. Merit and feasibility of proposed plans for analyzing LTRC biospecimens and incorporating omics data into the LTRC dataset. Access to an IRB with appropriate expertise.

3. Facilities and Organization: Availability and adequacy of the facilities and resources, including computer systems, necessary to perform the Statement of Work. Adequacy of the organizational and administrative structure of the proposed DCC.

Total: 100

Although this study involves human subjects, subject enrollment will not be performed at the DCC. Hence, NIH policies regarding inclusion of women and members of minority groups and their subpopulations and children will not be a consideration for selection of the DCC contractor.

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. 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. 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. See pages 76 – 77 of the RFP for further details.

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.

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 Proposals and Revisions). Your proposal shall be organized as specified in Section L.2., "Instructions to Offerors".

Shipment and marking shall be as indicated below.

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

"RFP NO. NHLBI-HR-16-04, NHLBI LTRC Data Coordinating Center, TO BE OPENED BY

AUTHORIZED GOVERNMENT PERSONNEL ONLY"

NUMBER OF COPIES:

Technical Proposal: Original and Twenty (20) Copies Business Proposal: Original and Five (5) Copies Technical & Business Proposal: Two (2) electronic copies as a text-readable PDF file on CD Excel Cost Proposal: Email to bredowsa@nhlbi.nih.gov

IF HAND-DELIVERED:

Office of Scientific Review, Division of Extramural Research Activities National Heart, Lung, and Blood Institute Rockledge 2, Room 7195

6701 ROCKLEDGE DR MSC 7924

BETHESDA, MD 20817

IF USING U.S. POSTAL SERVICE:

Office of Scientific Review, Division of Extramural Research Activities National Heart, Lung, and Blood Institute Rockledge 2, Room 7195

6701 ROCKLEDGE DR MSC 7924

BETHESDA, MD 20892-7924

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

mailto:bredowsa@nhlbi.nih.gov

PROPOSAL INTENT RESPONSE SHEET

RFP No.: NHLBI-HR-16-04

TITLE OF RFP: NHLBI LTRC Data Coordinating Center

If you intend to submit a proposal, please furnish the information requested below and return this page by January 16, 2015. Your expression of intent is not binding but will assist us in planning for proposal evaluation.

COMPANY/INSTITUTION NAME:

ADDRESS:

TELEPHONE NUMBER:

E-MAIL ADDRESS:

PROPOSED STAFF

Please provide the following for each proposed key personnel for the project:

Name (Last, First, MI)

Title Proposed Role on the Project

COLLABORATING INSTITUTIONS AND INVESTIGATORS:

Please provide the following for each proposed subcontractor or consultant:

Name (Last, First, MI)

Title Institution Name Proposed Role on the Project

Please fax or mail to:

Office of Scientific Review National Institutes of Health, NHLBI Attention: Dr. Valerie Prenger 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924

FAX (301) 480-0730