BAA-NHLBI-HC-10-15.pdf

BAA No. NHLBI-HC-10-15

Studying Community Programs to Reduce Childhood Obesity

Note to Offerors

Proposals will be accepted by the National Heart, Lung, and Blood Institute (NHLBI) in accordance with the requirements of Broad Agency Announcement (BAA) Number NHLBI-HC- 10-15 entitled: Studying Community Programs to Reduce Childhood Obesity. The purpose of the BAA is to fund one nationwide study of communities that will examine programs and policies that are occurring around the nation regarding childhood obesity. Only one contract award will be made, which will be to a Research Coordinating Center. Because the purpose is to examine existing programs and policies, the BAA will not provide funding for interventions. Several Frequently Asked Questions (FAQs) are shown at the end of this document, and an updated FAQ document will be provided periodically.

A BAA is a general announcement of an agency’s research interest and constitutes a solicitation. The intent of a BAA is to encourage the submission of creative and innovative approaches to specific research areas identified by the Government.

A proposal submitted in response to this BAA must present detailed technical and business proposals designed to meet the Research and Technical Objectives described in Attachment 3.

The specific work requirements and performance specifications are to be developed by the Offeror and not by the Government.

Proposals received as a result of this BAA will be evaluated by a peer review group, also known as a Scientific Evaluation Panel (SEP), in accordance with the Evaluation Criteria specified in SECTION M, EVALUATION FACTORS FOR AWARD. All the competing proposals are ranked on the basis of their respective program relevance and scientific merit. An Order of Merit Ranking is established by the Contracting Officer.

Negotiations are conducted with those offerors selected from the Order of Merit Ranking based on their scientific merit and those specific considerations set forth in the solicitation under SECTION M (i.e. technical merit, importance to agency programs, availability of funds, past performance, and small business participation). You will be notified if your proposal has been selected for negotiations approximately five-six (5-6) months after receipt of proposals. During negotiations, offerors will have an opportunity to revise their proposals in response to questions and comments provided by the Government. At the conclusion of negotiations, those offerors selected for negotiations are allowed the opportunity to submit a Final Proposal Revision (FPR).

Please note that if your proposal is selected for negotiations, it does not guarantee that it will be selected for contract award.

After receipt of the FPRs, offerors will be notified if their proposal is selected for award. One award is anticipated. The award is expected to be made on or about August 1, 2010. The NHLBI anticipates the total estimated contract award will be about $27,250,000 for the entire five (5) year period of performance.

It is important to read this solicitation in its entirety. The following points are highlighted for your convenience:

Pre-Proposal Conference

A pre-proposal conference in the form of a webinar will be held with prospective offerors around the first week in October 2009. Information regarding the webinar, i.e., time and weblink, will be announced via Fedbiz Opps and the NIH Guide. For those who will not be able to attend the live webinar, the webinar will be recorded and will be available for later viewing. The webinar will be held for the purpose of providing information concerning the Government's requirements which may be helpful in the preparation of proposals and for answering any questions which you have regarding this solicitation. The success of this type of webinar depends largely on the lead-time available to the Government in connection with questions submitted by offerors. Therefore, you are requested to send the Contracting Officer written questions concerning any areas of uncertainty which, in your opinion, require clarification or correction, in sufficient time to be received on or before September 28th, 2009 to the following address or by email (preferred):

Mailing Address:

Kristiane E. Cooper Office of Acquisitions National Heart, Lung, and Blood Institute National Institutes of Health Two Rockledge Center, MSC 7902 6701 Rockledge Drive Bethesda, MD 20892-7902

E-Mail:

cooperke@nhlbi.nih.gov

A set of questions and answers will be posted via an electronic amendment so that all prospective offerors may have similar information whether or not they attend the live webinar.

This information is also provided in the Solicitation under SECTION L, Item 1.e., of the Solicitation.

INQUIRIES:

Inquiries may be submitted at any time to Kristiane E. Cooper at 301-435-0345 or cooperke@nhlbi.nih.gov. However, in order to plan for the Pre-Proposal Conference, it would be appreciated if questions could be submitted by September 28, 2009. Please be sure to review the FAQ’s included as part of this document in case your question has already been addressed.

LETTER OF INTENT:

If you intend to submit a proposal, please complete the Proposal Intent Response Sheet, Attachment 2, by October 19, 2009. Note that if you do not submit a Proposal Intent Sheet, you can still submit a proposal; however, this information is used for purposes of planning the scientific technical evaluation, therefore every effort to submit the form by the required date is appreciated.

PROPOSAL DUE DATE:

Proposals must be received by 4:00 (EST) on November 18, 2009 at the address specified, and the number of copies specified, in Attachment 1, Packaging and Delivery of Proposal.

RESEARCH AND TECHNICAL OBJECTIVES

Proposals submitted in response to this BAA should be in support of the Research and Technical Objectives included as Attachment 3 to this Solicitation. Technical and business proposals must both be included, which are designed to accomplish the Research and Technical Objectives. The specific work requirements and performance specifications are to be developed by the Offeror and not the Government.

SUMMARY OF SOLICITATON SECTIONS:

Please note that the term RFP may be used in some places instead of BAA.

1. SECTIONS A THROUGH I (pages 1-36)

The information provided in Sections A through I represents what may be in the resulting contract. It is not an exact replica because some of the information will need to be tailored to your organization and your proposal. It is provided for your information, so you will understand the type of terms and conditions that will be in any resulting contract.

2. SECTION J (page 37-38)

This section contains a listing of all the attachments to the BAA.

3. SECTION K (page 39)

This section contains Representations and Certifications that must be completed online and submitted with your proposal.

4. SECTION L (pages 40-84)

This section contains instructions to assist you in the preparation of your proposal. It contains general information and instructions, as well as specific preparation instructions for both the technical and business proposals. The technical and business proposals should follow the format outlined in these sections. Some additional items to note regarding the technical and business proposals are as follows:

a. TECHNICAL PROPOSAL

Your proposal must address the Research and Technical Objectives identified in Attachment 3.

Your proposal must include the attachments identified in SECTION J: TECHNICAL

PROPOSAL ATTACHMENTS.

Attachment 5 includes a link to the technical proposal cost summary (http://www.niaid.nih.gov/contract/forms.htm) that is required to be submitted with the technical proposal.

b. BUSINESS PROPOSAL:

Your proposal must include the attachments identified in SECTION J: BUSINESS

PROPOSAL ATTACHMENTS.

Attachment 10 includes a link for the breakdown of total estimated costs (http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls) that is required to be submitted with your business proposal.

5. SECTION M (pages 85-89)

This section contains the evaluation criteria on which your proposal will be evaluated.

a. Your technical proposal must address how human subjects will be protected from risk.

See Section L, Technical Proposal Instructions, for additional Information.

b. Your technical proposal must address the inclusion of women, minorities and children in your research. If the inclusion of women, minorities and children is not appropriate for your research, a justification should be included. See Section L - Technical Proposal for additional instructions.

c. Evaluation of Data Sharing Plan. Your technical proposal must include a data sharing plan. See Section L - Technical Proposal Instructions for additional information.

d. Technical Evaluation Criteria – Your technical proposal will be scored by peer-review based on the criteria in this section.

Frequently Asked Questions (FAQs)

BAA, NHLBI-HC-10-15

“Studying Community Programs to Reduce Childhood Obesity” August 18, 2009

1. I’ve never heard of a Broad Agency Announcement (BAA); what is it?

A Broad Agency Announcement (BAA) is a type of Funding Opportunity Announcement that is used by the government when an objective has been identified, but the specific approaches are to be defined by the offeror, not by the government as would be the case in a traditional contract Request for Proposals (RFP). A BAA results in a contract that requires specific deliverables and a Statement of Work. In the case of a BAA, a Statement of Work is proposed by offerors.

The BAA mechanism was selected for this study because we want scientific experts outside of the government to propose the Statement of Work, which should meet the objectives identified in the Research and Technical Objectives (Attachment 3). Since the BAA funds a contract, it has reporting requirements, deliverables, and regulations as for other government contracts. The NHLBI contracts web page has more information on the contracts process, http://www.nhlbi.nih.gov/crg/contracts.php or see the definition of a BAA at http://www.nhlbi.nih.gov/crg/glossary.php#contract

2. I have seen another Funding Opportunity Announcement from the NHLBI for childhood obesity research. Is this solicitation related or different?

Two other NHLBI funding announcements currently address childhood obesity, in partnership with other Institutes and Centers; however, their objectives differ, as follows:

1) This BAA, “Studying Community Programs to Reduce Childhood Obesity”, will fund one study to evaluate the impact and results of efforts already under way in communities around the nation regarding programs and policies for childhood obesity; therefore, this BAA will not fund interventions.

Only one award will be made to a Research Coordinating Center to define the methodology to be used, in collaboration with the NHLBI and other partners, and to implement and analyze the study.

2) There are two NHLBI RFAs entitled “Childhood Obesity Prevention and Treatment Research Consortium.” One of these RFAs will fund randomized trials to test effects of novel interventions for childhood obesity prevention or treatment; that RFA will fund about four studies (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-10-004.html). The other RFA will fund a coordinating unit for that research program (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-10- 005.html).

3. I’m interested in studying childhood obesity issues, but my idea does not match this BAA concept or the RFAs mentioned above. Are there other opportunities for funding?

Additional funding opportunities are available from NIH Institutes, the Robert Wood Johnson Foundation, the Centers for Disease Control, and other sources. NIH funding opportunities can be found in the NIH Guide for Grants and Contracts at http://grants.nih.gov/grants/guide/ . Other current obesity-related NIH announcements are at http://grants.nih.gov/grants/guide/pa-files/PA-09-141.html and http://grants.nih.gov/grants/guide/pa-files/PA-09-124.html. Also, a major source of NIH funding is through unsolicited, investigator-initiated grant applications (see http://grants.nih.gov/grants/guide/parent_announcements.htm ). Other relevant funding information can be found at the website for the National Collaborative on Childhood Obesity Research (NCCOR) at http://www.nccor.org/ .

4. How many studies will this BAA fund?

The intent is to fund only one study, where a nationwide sample of communities will be identified, data obtained, and analyses conducted. Only one award will be made, which will be to a Research

Coordinating Center. The study will be designed through a collaborative effort with the funded Research Coordinating Center, the NHLBI, and the several partners, with input from community representatives, based on the successful offeror’s proposed, peer-reviewed Statement of Work.

5. How will “children” be defined for this study? What ages are of interest?

The NIH defines a child as an individual under the age of 21 years. However, for the purposes of this study, we envision the focus being on children and adolescents that are the target of most of the current childhood obesity programs and policies. Offerors can propose specific ages, with justification, but we anticipate ages from preschool through high school.

6. How many participants will the study enroll?

This study will not enroll a cohort of individuals, but rather will enroll communities. Information about policies and programs will be collected, and information will also be gathered from residents within the selected communities. The number and type of residents within each community needed to obtain various types of information will be determined during protocol development based on the successful offerors proposed Statement of Work. The main analyses are anticipated to be at the community level. Offerors will need to propose statistical or design approaches to handling the hierarchical, nested data structure.

7. My community has a great program addressing youth obesity. How can my community be involved? Can my community obtain funding for additional programming efforts? Can my community obtain funding for evaluation activities?

This solicitation will not fund community programs because the purpose is to assess what is already going on in communities around the nation. The intent is to identify a nationwide sample of communities with a range of programming and policies relevant to childhood obesity – from none, to some, to a lot. Some communities that have no relevant programs or policies should be included.

Eligibility criteria for communities will be defined and finalized during protocol development between the successful offeror, NHLBI, and other study partners. We are not identifying specific communities at this time.

Also, the purpose is not to evaluate specific programs, but to identify characteristics of programs and policies that are associated with success, in order to inform future programs and policies for childhood obesity control. The study will employ common measurements in all study communities, and analyses will be planned to enable comparisons across types and characteristics of community programs and policies. Therefore, evaluation funding for specific programs will not be available through this BAA.

8. If selected, how will the communities be reimbursed for any data they may need to collect, and what will the communities get out of being involved?

It is expected that data collection approaches will be centrally organized and implemented, so communities will not have to use their own resources for data collection. For example, methods could be similar to national surveys, or data from nationally-available data sources such as Geographic Information Systems (GIS) could be used. Surveys or other data collection specifically for this study will be conducted by the Research Coordinating Center or its subcontractors, which will have personnel and resources needed for obtaining study data.

It is also envisioned that representatives of the selected communities will be engaged and informed throughout the study timeline. The intent is to establish two-way communication and to provide information back to communities in a useful, timely, and respectful manner. It is expected that results of this study will be quite useful to local communities around the nation, whether selected or not.

9. How is “community” defined for this project, and how many communities should be recruited?

“Community” can be defined in a variety of ways including geographic location and catchment areas.

Communities of people can be defined culturally, socially, politically, or in other ways. It is up to the offeror to propose and justify one or more definition of “community” to be used in this study. It is anticipated that a well-articulated concept of a “local geographic area” may be a strong candidate for the primary definition. It is recognized that some types of communities may be nested within others, and these types of issues should be addressed by the offeror.

The number of communities to be included in this study will be finalized during protocol development based on the Statement of Work proposed by the successful offeror. No minimum or maximum number of communities has been identified at this time, but the goal is to recruit a sufficient number of communities to provide a diverse representation geographically, ethnically, and programmatically.

Communities with a range of programs and policies related to childhood obesity should be included, including communities without specific programs or policies, to enable relevant comparisons. Offerors should propose sampling and recruitment strategies, along with a rationale for inclusion and exclusion criteria.

10. What sort of expertise is needed for this study?

This BAA will fund one Research Coordinating Center, which will need a multi-disciplinary team with expertise relevant to assessment of community programs and policies for childhood obesity control, including study design and relevant data collection activities and analysis. Relevant expertise may include community-based participatory evaluation research, physical activity, nutrition, behavioral and social science, public health, statistics, communications, quantitative and qualitative analysis techniques, preventive medicine, relevant technology, community engagement, and/or other relevant areas.

Of particular importance is expertise and demonstrated leadership in high-quality research methods that will enable appropriate data collection and analyses for assessing associations at the community level between specific characteristics of programs and policies and various measures of success, such as diet and physical activity behaviors of youth or community trends in obesity. The successful offeror will also provide evidence that the expertise needed to implement the proposed Statement of Work is available. See Evaluation Criteria section of the BAA, Section M.

11. This BAA describes negotiation and a collaborative effort. How will the process work?

The cover letter to the BAA describes the funding process, including peer-review, negotiations, and selection. After award, the successful Research Coordinating Center will work with the project team, which is led by NHLBI but also includes staff from other NIH Institutes and Offices, the CDC, and the Robert Wood Johnson Foundation. Staff members from these organizations include scientists experienced in similar or related types of research projects. The successful SOW will be used as a basis for collaborative development of the study protocol with the project team. After approval by an external NHLBI-appointed Protocol Review Committee, the protocol becomes part of the contract.

Collaborative efforts between the successful offeror and the project team also include developing study procedures, monitoring study implementation, establishing approaches to analyses, and preparation and authorship of scientific publications and presentations.

12. What is the difference between the budgetary information required for the technical and business proposals?

Budgetary information in the technical proposal is requested to enable reviewers to assess how well the Statement of Work proposed by the offeror matches the proposed budget. Budgetary information in the technical proposal does not contain details such as salaries. Salary and other details are included only in the business proposal, as required by contracting regulations and processes.

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

NHLBI-BAA-HC-10-15

3. Issue Date:

August 18, 2009

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Studying Community Programs to Reduce Childhood Obesity

6. ISSUED BY:

Office of Acquisitions National Heart, Lung and Blood Institute National Institutes of Health Rockledge Building Two 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 4:00 p.m. local time on November 18, 2009. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. THE OFFICIAL POINT OF RECEIPT FOR THE PURPOSE OF DETERMINING TIMELY DELIVERY IS

THE ADDRESS PROVIDED FOR THE OFFICE OF ACQUISITIONS AS STATED IN ATTACHMENT 1,

"PACKAGING AND DELIVERY OF THE PROPOSAL." IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR CLAUSE 352.215-70, ENTITLED, "LATE PROPOSALS, AND REVISIONS" LOCATED IN SECTION L.1. OF

THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. http:// www.ccr.gov

11. FOR INFORMATION CALL: Kristiane E. Cooper

PHONE: 301-435-0345

e-MAIL: cooperke@nhlbi.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Kristiane E. Cooper Contracting Officer Office of Acquisitions National Heart, Lung, and Blood Institute http://www.ccr.gov http://www.ccr.gov

RFP Number : NHLBI-BAA-HC-10-15

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. PERFORMANCE BASED ACQUISITION

e. PRE-PROPOSAL CONFERENCE

f. Total Estimated Cost

g. BRAND NAME OR EQUAL

h. COMMITMENT OF PUBLIC FUNDS

i. COMMUNICATIONS PRIOR TO CONTRACT AWARD

j. RELEASE OF INFORMATION

k. PREPARATION COSTS

l. SERVICE OF PROTEST

m. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Uniform Resource Locators (URLs) in Contract Proposals

6. Page and Formatting Limitations

7. Alternate Proposals

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8. Evaluation of Proposals

9. Potential Award Without Discussions

10. Use of the Metric System of Measurement

11. Standards for Privacy of Individually Identifiable Health Information

12. Privacy Act - Treatment of Proposal Information

13. Selection of Offerors

14. Institutional Responsibility Regarding Conflicting Interests of Investigators

15. ROTC Access and Federal Military Recruiting on Campus

16. Past Performance Information

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

5. Instructions to Offerors Regarding Protection of Human Subjects

6. Required Education in the Protection of Human Research Participants

7. Inclusion of Women and Minorities in Research Involving Human Subjects

8. Inclusion of Children in Research Involving Human Subjects

9. Research Involving Prisoners as Subjects

10. Research Involving Human Fetal Tissue

11. Research Involving Recombinant DNA Molecules (including Human Gene Transfer Research)

12. Human Embryonic Germ Cell (HEGC) Research

13. Human Embryonic Stem Cell (HESC) Research

14. Obtaining and Disseminating Biomedical Research Resources

15. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Cost and Pricing Data

3. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

4. Salary Rate Limitation in Fiscal Year 2009

5. Small Business Subcontracting Plan

6. HUBZone Small Business Concerns

7. Extent of Small Disadvantaged Business Participation

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. HUMAN SUBJECT EVALUATION

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3. EVALUATION OF DATA SHARING PLAN

4. TECHNICAL EVALUATION CRITERIA

5. NON-TECHNICAL EVALUATION CRITERIA

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this solicitation is to support a nationwide scientific study of community-level efforts to identify characteristics of community programs and policies that may help reduce childhood obesity rates. Relevant programs and policies may address educational, behavioral, environmental, and/or other activities aimed at influencing energy balance in youth through diet and physical activity. One Research Coordinating Center (RCC) will be funded, which will work in partnership with members of the National Collaborative on Childhood Obesity Research (NCCOR) -representing the NIH, Robert Wood Johnson Foundation, and CDC - to design and implement the research. The goal is to inform public-health practice and policy by identifying community approaches that may work best for reducing childhood obesity rates. The study will also help identify future research directions

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. Research and Technical Objectives

a. Independently and not as an agent of the Government, the Contractor shall be required to 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, dated August 18, 2009, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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 Technical Representative (COTR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

Technical Progress Reports

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 1 hard copy of these reports will be required as follows:

a) Protocol including all draft versions and amendments. Amendment to the protocol should be included in semi-annual reports, posted immediately on the website and included in OSMB reports.

The protocol and all revisions to the protocol shall be incorporated into the statement of work by reference.

b) Manual of Procedures (MOP) including all draft versions and amendments. Amendments to the MOP should be included in the semi-annual reports and posted immediately on the website.

The MOP shall include a data analysis plan, which includes sample size and power calculations, specific statistical tests to be used, a discussion of how missing data will be handled, and any plans for stratification or subgroup analyses. The MOP shall include include a dissemination plan and materials. The MOP and all revisions to the MOP shall be incorporated into the statement of work by reference.

c) Semiannual progress reports with the first one due 6 months after the effective date of the contract.

This report will detail the progress of the entire contract work for the previous 6 months and includes:

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1) A description of all contract supported staffing for the reporting period, with names, position titles, FTE levels, and type of work performed and any relevant administrative changes (e.g., staffing changes) and 2) A description of activities including development of study protocol and methods, recruitment of communities and participants into the study, data collection process and entry process, and research activities completed.

d) A final technical report, to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved, including recommendations and conclusions based on the data obtained in the study. The Final Report shall be submitted on or before the last day of the contract performance period in accordance with the deliverables of this contract set forth below.

e) Phase I Report. This document shall include protocol and methods development, database development, and OMB clearance.

f) Phase II Report. This document shall include the identification and engagement of communities, data collection and data entry.

g) Phase III Report. This document shall include data analysis, reporting, and dissemination.

h) Quality control (QC) reports, which are concise and summarize the quality of performance for data collection and measurement or interpretation. These will be due as specified in the protocol and MOP.

i) Minutes of meetings and conference calls, such as OSMB, Steering Committee, and subcommittee meetings and calls.

j) Agendas and related materials shall be available 30 days before the OSMB meeting. Minutes of meetings and conference call will be available within 2 weeks after the meeting, with the exception of draft OSMB minutes, which are due as soon as possible following the meeting.

k) Abstracts and manuscripts in advance of submission to journals or conferences. Reprints or PDFs of abstracts and manuscripts, which shall be submitted after publication.

l) Dataset and Documentation: A complete, clean dataset, edited and processed for full anonymity and for potential release to other investigators, is to be provided to the NHLBI at the study conclusion.

Inclusion of raw data that has been processed into summary information shall be discussed with the Project Officer and the NHLBI contact for the Data Repository prior to submission. Data prepared for release shall not contain personal identifiers. The contractor shall coordinate preparation of the data with the NHLBI to ensure confidentiality. The data shall be submitted on CD-ROM, or other mutually agreed upon data medium that includes complete electronic documentation and data. The dataset should be consistent with the existing data release policy at the beginning of the study. The contractor shall produce clear documentation for the dataset that allows for use by investigators not familiar with the dataset. The documentation must be included as a dataset in the storage medium, and study investigators may be expected to answer questions regarding dataset characteristics, format, and content. Ancillary study data (not funded under this contract) are not required to be included in the public use dataset, though the data may be included if agreed upon by the ancillary study investigator, or if the Steering Committee establishes policy requiring that the ancillary study data be treated in a similar approach as the dataset for this study.

m) Quarterly Financial Status Reports (NIH 2706).

n) Development and maintenance of a study website for investigators, study participants, and the general public.

o) 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.

2. Annual Technical Progress Report for Clinical Research Study Populations

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The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract. The first report shall be due on or before the 15th calendar day after the contract anniversary date. Thereafter, the report shall be due on or before the 15th day following each reporting period. The final report shall be due on the last day of the contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. The Guidelines may be found at the following website:

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

Include a description of the plans to conduct analyses, as appropriate, by sex/gender and/or racial/ ethnic groups in the clinical trial protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender and race/ethnicity.

b. Technical Progress Reports Containing Interim Study Data

1. Legend for Technical Progress Reports Containing Interim Study Data

It is recommended that the Contractor incorporate the following legend on the cover of technical progress reports and reports containing study data that are prepared for use by all working committees in their monitoring of the trial. Working committees include but are not limited to the Observational Safety Monitoring Board (OSMB), Steering Committee and Executive Committee.

"The data, if any, contained in this report/deliverable are preliminary and may contain unvalidated findings.

These data are not intended for public use. Public use of these data could create erroneous conclusions which, if acted upon, could threaten public health or safety."

2. Use of Interim Study Data

Interim data used in technical progress reports and other reports developed for the purpose of study monitoring are not intended for public use. Premature release of such data could result in interpretations that prove to be unreliable or invalid once the study is completed and the full context for the data is known.

Unreliable or invalid interpretations can threaten public health and safety by leading the public and medical practitioners to pursue inappropriate measures. In addition, an interpretation of the interim data that is contrary to study protocol could cause participants to drop out of treatment groups. This could prevent completion of the study. A secondary consequence, not in terms of public health and safety, but one that is important in its own right, is that premature release of the data can lead to financial loss to the Government, since any funds spent on a trial that does not answer the questions posed by the study would be devalued.

In consideration of the above, interim data shall be used only for internal study monitoring purposes with the exception of publications and presentations approved in accordance with the programmatic protocol and study procedures.

c. Other Reports/Deliverables

1. Source Code and Object Code http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

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Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

2. Information Security Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. (Reference subparagraph c.(2) of the INFORMATION SECURITY Article in SECTION H of this contract.)

b. Information Security Training Report

The Contractor shall maintain a listing by name and title of each employee (including subcontractors) working under this contract that has completed the NIH required information security training. Any additional security training completed by Contractor/ Subcontractor staff shall be included on this listing. [The listing of completed training shall be included in the first technical progress report. (See Article C.2.a. Technical Progress Reports.) Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report.] (Reference subparagraph d. of the INFORMATION SECURITY Article in SECTION H of this contract.)

c. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Technical Representative (COTR) and Contracting Officer within five business days of staffing changes for positions that require suitability determinations as follows (Reference subparagraph f. of the INFORMATION SECURITY Article in SECTION H of this contract.):

(1) New Employees: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

(2) Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract.

All documentation shall be made available to the COTR and/or Contracting Officer upon request

d. Contractor - Employee Non-Disclosure Agreement(s)

The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and

- 10 -subcontractor employee who may have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/security/Nondisclosure.pdf.

(Reference subparagraph g.of the INFORMATION SECURITY Article in SECTION H of this contract.)

e. Self Assessment & Information Security Plan Reporting

(1) NIST SP 800-53 Self-Assessment (Reference subparagraph h. of the INFORMATION SECURITY Article in SECTION H of this contract.)

The contractor shall annually update and resubmit its Self-Assessment required by NIST SP 800-53, Recommended Security Controls for Federal Information Systems to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer. ( http://csrc.nist.gov/publications - under Special Publications).

The Contractor's annual update to its Self-Assessment Questionnaire shall include similar information for any subcontractor that performs under the SOW to (1) develop a Federal information system(s) at the Contractor's/Subcontractor's facility, or (2) host and/or maintain a Federal information system(s) at the Contractor's/Subcontractor's facility.

(2) Information System Security Plan (Reference subparagraph i. of the INFORMATION SECURITY Article in SECTION H of this contract.)

The Contractor's draft ISSP submitted with its proposal shall be finalized in coordination with the COTR no later than 90 calendar days after contract award.

Following approval of its draft ISSP, the Contractor shall update and resubmit its ISSP to the COTR every three years or when a major modification has been made to its internal system. The Contractor shall use the current ISSP template in Appendix A of NIST SP 800-18, Guide to Developing Security Plans for Federal Information Systems. ( http:// csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf ).

The Contractor shall include similar information for any subcontractor performing under the SOW with the Contractor whenever the submission of an ISSP is required.

3. Section 508 Annual Report

The contractor shall submit an annual Section 508 report for technology accessibility in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. Instructions for completing the report are available at: http://508.hhs.gov/.

4. Multiple Principal Investigators Leadership Plan The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

.All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 2207, MSC 7987, Bethesda, Maryland 20892-7987 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

http://ocio.nih.gov/security/Nondisclosure.pdf http://csrc.nist.gov/publications http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf http://508.hhs.gov/

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The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health National Heart, Lung, and Blood Institute Office of Acquisitions Rockledge Building Two 6701 Rockledge Drive, Room TBD Bethesda, Maryland 20892- 7902

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, TBD is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

TBD

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article…