BAA_NIHAI2013174.pdf

Broad Agency Announcement

No. BAA-NIAID-DMID-NIHAI2013174

Title: DEVELOPMENT OF VACCINE FORMULATIONS EFFECTIVE AGAINSTNIAID

PRIORITY PATHOGENS

Issue Date: July 8, 2013

Due Date: October 2, 2013 - 3:30 p.m. Local Time

Issuing Office: Office of Acquisitions, Division of Microbiology and Infectious Diseases, DEA, NIAID, NIH, 6700-B Rockledge Drive, room 3214, MSC 7612, Bethesda, Maryland 20892-7612

Contact Point/Contract Specialist: Andrew Cherry, cherryan@niaid.nih.gov 301-402-

Contracting Officer: Aileene Mitchell Ford, aileene.mitchellford@nih.gov, 301- 496-

Set-Aside: No

It is requested that you send an early electronic mail message to the Contract Specialist if you intend to respond to this BAA. In your message, please indicate the name of the organization, address, telephone number, and include the name of the Principal Investigator, plus a short description of the scientific fields encompassed by the response.

I. INTRODUCTION

You are invited to submit a proposal in accordance with the requirements of this BROAD AGENCY ANNOUNCEMENT (BAA). The BAA is governed by Federal Acquisition Regulation (FAR) 6.102 and FAR 35.016, as well as the NIH Policy Manual, Manual Chapter 6035, Broad Agency Announcements.

A BAA may be used as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding, and that part of development not related to the development of a specific system or hardware procurement. BAAs are general in nature - identifying areas of research interest - and shall only be used when meaningful proposals with varying technical/scientific approaches can be reasonably anticipated.

Offers submitted in response to this BAA must present detailed technical and business proposals designed to meet the Research and Technical Objectives described herein. The Statement of Work (SOW), including the specific technical requirements and performance specifications, shall be developed and proposed by the offeror, not the Government.

Since they are not submitted in accordance with a common SOW issued by the Government, proposals are NOT evaluated against each other. Instead, Research and Technical Objectives are provided in the BAA that describe the research areas in which the Government is interested.

Proposals received in response to the BAA will be evaluated in accordance with Evaluation Factors for Award specified in Section VIII of this document.

BAA-NIAID-DMID-NIHAI2013174

Multiple awards are anticipated. The amount of resources made available under this BAA will depend on the quality of the proposals received and the availability of funds. The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this BAA. The Government also reserves the right to conduct discussions, if it is later determined to be necessary. Additionally, the Government reserves the right to accept proposals in their entirety or to select only portions of proposals for award.

In the event the National Institute of Allergy and Infectious Diseases (NIAID) decides to award only portions of a proposal, negotiations may be opened with that offeror. The Government reserves the right to fund proposals in phases with options for continued work at the end of one or more of the phases.

NIAID estimates that three (3) to five (5) contracts may be issued for an aggregate total cost (direct and indirect costs combined) of up to $ 19 million for all awards during the first phase. The total funding (direct and indirect costs combined) for all awards reserved for this program is approximately $95 million for a five-year period of performance. Awards are expected to be made on or about 08/13/2014. It is anticipated that the total costs for each award may vary depending upon the scope and capacity of the technical objectives of the award. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research.

The total period of performance comprised of a base period and options proposed by an offeror should not exceed five (5) years.

II. BACKGROUND AND TECHNICAL OBJECTIVES

A. Background

Research supported and conducted by NIAID, National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, with the exception of the human immunodeficiency virus (HIV). This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which are funded through a variety of research grants and contracts. The NIAID also has a mission to advance the development of new medical countermeasures (MCM) against the biological agents that are most likely to be used in a terror attack on civilian populations.

The NIAID has been conducting and supporting much of the research and development for biodefense with defined research priority and agenda against select Category A, B, and C bio threat agents (http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/research/pages/cata.aspx).

The current NIAID’s Strategic Plan for Biodefense Research http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/documents/biosp2007.pdf establishes a strategy for developing new and improved medical countermeasures against a broad array of biological threats, emerging and re-merging infectious diseases, including pathogens and toxins. The NIAID’s plan supports the national biodefense strategy and reflects the Institute’s partnerships with the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and Department of Homeland Security.

The HHS PHEMCE coordinates interagency efforts aiming to optimize NIAID’s preparedness for public health emergencies with respect to the creation, stockpiling, and use of medical countermeasures. Led by the Assistant Secretary for Preparedness Response (ASPR), HHS, PHEMCE consists of NIH, Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC), along with ex officio participation from other federal agencies. PHEMCE

Implementation Plan for Threats Chemical, Biological, Radiological, and Nuclear (CBRN) (http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx) sets the current priorities for medical countermeasure development against advanced, enhanced, and emerging threats and advanced agents.

B. Program Objectives

The NIAID is interested in supporting the development of promising therapeutic and prophylactic vaccine product candidates for emerging and biodefense threats to protect the American public.

C. Technical Objectives

The primary objective of this BAA is to support the advanced development of candidate products which consist of a vaccine component in combination with a technology component (a dry formulation technology) to increase stability and minimize cold chain or preservative requirements. These products will likely be used in post-event settings following the intentional release of NIAID Category A, B and C Priority Pathogens or in response to naturally occurring outbreaks of infectious diseases caused by NIAID Category A, B and C Priority Pathogens (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx). Only candidate products against NIAID Category A, B and C Priority Pathogens are eligible under this solicitation.

Proposals with multiple candidate products using the same vaccine component will be considered, however, proposals with one candidate product are preferred. If more than one candidate product is proposed, a down-select to a single candidate product is required as part of the statement of work

(SOW).

The dry formulation technology must demonstrate enhanced stability of a vaccine compared to liquid formulation and advancement of vaccine development strategies. Examples of dry formulations may include, but are not limited to, lyophilization, spray drying, foam drying, nanoparticles, dry powders, microneedle patches and other emerging drying technologies. Note that simply drying of an existing liquid vaccine formulation (final drug product under clinical evaluation or licensed vaccine) is not considered to advance the current state of technology.

The candidate product may include (but are not required to include) adjuvants. If the proposed candidate product includes an adjuvant, ideally, enhancement of the immune response (enhanced immunogenicity, decreased time or reduced number of immunizations to achieve protective antibodies and/or increased efficacy) should be demonstrated in an animal model. Anticipated benefits may include production of a protective immune response with 1-2 doses of vaccine.

In this setting, simplicity and efficiency of dry formulation vaccine delivery to, and the effectiveness in, large numbers of patients are also key considerations. Thus, a delivery platform may be included as part of the proposed vaccine candidate. Anticipated benefits may include decreased manpower and time required to prepare and administer the vaccine, and increased compliance among vaccine recipients.

Eligible candidate products include a vaccine component comprised of an agent(s) identified as NIAID Category A, B and C Priority Pathogens in combination with a dry formulation technology. If available, supporting information on the candidate product must be provided and may include immunogenicity or efficacy data, safety and toxicology data, development status and manufacturing capabilities, human safety data in general or associated with known adverse events for the product class, the Regulatory pathway/strategy and FDA feedback. When applicable, candidate products may also include an adjuvant that enhances the immune response (i.e., enhanced immunogenicity, decreased time or reduced number or immunizations to achieve protective antibodies and/or increased efficacy). Adjuvants will be supported as components of the candidate product. Novel delivery platforms that reduce logistical requirements may be components of the candidate product to be developed as well. Cross-cutting dry formulation technologies applicable to more than one vaccine component are also of interest. The requirements for vaccine and technology components are described below.

1. Vaccine Component - The vaccine component is the antigen or immunogen of the candidate product. The vaccine component must satisfy the below criteria for consideration. The offeror shall provide sufficient information to demonstrate that the source of the vaccine component meets the following criteria:

a. Immunogenicity and efficacy in an animal model;

b. Completion of current cGMP manufacturing, including production of a Bulk Drug

Substance (BDS) and Final Drug Product (FDP), as well as lot characterization, release and stability testing using qualified assays;

c. Undergone Good Laboratory Practices (GLP) non-clinical studies for toxicology, as appropriate; and

d. Completed a Phase 1 clinical trial for safety and immunogenicity and demonstrate results that support further clinical development at the time of proposal submission.

2. Technology Component - The technology component is the dry formulation technology

(also referred to as a solid formulation technology) in the proposed candidate product.

The offeror shall provide sufficient information to demonstrate that the technology component meets the following criteria:

a. Increases duration of stability of a vaccine;

b. Minimizes the need for cold chain or preservative requirements; and

c. Advances the current knowledge and strategies for vaccine development; methods may include lyophilization, spray drying, foam drying, nanoparticles, dry powders, microneedle patches and other emerging drying technologies.

The proposed candidate product may include an adjuvant and or delivery platform and, if applicable, the requirements are described below:

3. Adjuvant may be included if provided that the following criteria are demonstrated:

a. An enhanced immune response (enhanced immunogenicity, decreased time or reduced number of immunizations to achieve protective antibodies and/or increased efficacy) with proof of concept efficacy data in animal models with the proposed vaccine component/adjuvant combination as compared to the vaccine component alone,

b. Feasibility of attaining a safety profile that meets all existing FDA requirements,

c. Completion of cGMP manufacturing, and

d. Completion of a Phase 1 clinical trial and safety and immunogenicity results that support further clinical development.

4. Delivery platform may be included if provided that the following criteria are demonstrated:

a. Designed to achieve a more rapid or enhanced immune response, or

b. Reduce logistical requirements (decrease manpower and time required to prepare and administer the vaccine, and increase compliance among vaccine recipients).

Contracts awarded under this BAA will support:

Development and updating of the Product Development Plan for the candidate product, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken.

Manufacturing and formulation process development.

Manufacturing, characterization and release of pilot lot cGMP material.

Real time and accelerated vaccine stability testing over the duration of the contract.

Conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies, combination product approvals and multivalent immunogenicity and interference studies, as needed.

Development, qualification and, where necessary, validation of all assays and reagents needed to support product development.

Development, submission, and sponsorship of an Investigational New Drug (IND)/combination product application, including compliance with all regulatory requirements.

Design, conduct, completion, and analysis of a Phase 1 or Phase 2 clinical trial of the candidate product in normal healthy volunteers.

The provision of clinical and non-clinical samples from all studies to NIAID and, for clinical trials, obtaining future use consent from volunteers for their samples.

The delivery to the NIAID of cGMP final container candidate product (amount to be negotiated) and all necessary supporting documentation/letters of cross-reference to allow the NIAID to perform subsequent clinical trials or any other Government purpose.

Contracts awarded under this BAA will not support:

Development and evaluation of the safety and efficacy of individual vaccine components without an associated dry formulation technology that advances vaccine development strategies;

Development of vaccines using simple lyophilization techniques on existing liquid vaccine formulations (final drug product or licensed vaccines)

The design and conduct of clinical trials for vaccine components without a dry formulation technology;

The design and conduct of Phase 3 trials; or Development of devices or diagnostics.

Organizations responding to this BAA will have documented expertise in product development, including regulatory submissions, to advance the development and evaluation of candidate products against biological threats identified as NIAID Category A, B and C Priority Pathogens (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx) or 2012 HHS PHEMCE Strategy and Implementation Plan (http://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx) and shall complete and submit the Summary of Related Activities form from the following website (http://oamp.od.nih.gov/contracts/rfps/summact.htm)

III. GENERAL PROPOSAL INSTRUCTIONS AND INFORMATION

A. Proposals must be in TWO parts

The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal." Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The Technical Proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions and total cost for the work. See http://oamp.od.nih.gov/contracts/rfps/techcst5.htm. Proposals should attempt to be direct and concise in presenting information which clearly describes the proposed project. Offerors should realize that the clarity of the presentation is important in communicating their project ideas to reviewers, and that a concise and well formulated proposal is usually more effective in that respect than a voluminous proposal that lacks effective distillation of ideas.

B. Proposal Submission

1) Receipt Date

The deadline for receipt of proposals submitted in response to this announcement is:

3:30 PM Local Time October 2, 2013

2) Paper Copies, Discs (i.e., CD or DVD), and Online Submission

A. Paper Copies

1. Submit the original and five 5 copies of each proposal. The Principal

Investigator and a corporate official authorized to bind the offeror must sign the original. The 5 copies of the proposal may be photocopies of the original.

2. Include BAA title and number, name of organization, DUNS number, proposal part (Technical or Business), and identify if the proposal is an original or a copy, and date of proposal.

3. In addition to the paper submissions, proposers are also encouraged to submit two CD-ROMs containing a PDF (Adobe Acrobat) copy of the entire proposal (Technical and Business) and an electronic copy. This does not replace the paper copies but is in addition to them. By signing the proposal, the offeror certifies that, as part of the offer, the information in the paper copy is exactly the same as that which is contained on the electronic media.

B. Discs – Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. The Business Proposal must be comprised of the following two files:

a. The first file must be a PDF of your Business Proposal, with all attachments, including file entitled “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet.”

http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls

b. The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. This must include a detailed task-linked budget. Budget will be linked to tasks down to a level that the offeror considers reasonable and manageable but will also facilitate cost accountability and proper Contractor and government oversight and management of cost/performance issues. Any reference to Period or Year should be replaced with your proposed appropriate Task number (1, 2, 3, 4, etc.). In addition, the estimated period of performance of proposed Tasks should be incorporated as well. The estimated period of performance for each Task listed in this spreadsheet should match your proposed Gantt chart. Forms and/or documents requiring signature(s) may be scanned and merged into the Business Proposal PDF file. The second file must be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” in its original Excel format, not PDF.

http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls

3. A separate Disc must be submitted for the Technical Proposal and Business Proposal. Offerors who submit both Technical and Business Proposals on the same Disc will be required to resubmit the proposals on separate Discs.

4. Each of the proposals, Technical and Business, must be separate and complete in itself, so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

5. File naming convention: It is required that the filenames for both your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the BAA number, the type of proposal, and the date of the proposal, (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical_Date.pdf Business Proposal: XYZ Company_NIHAI2012001_Business_Date.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business_Date.xlsx

C. Online Submission of Electronic Proposals

Note: In addition to paper copies and discs, offerors are required to submit an electronic copy of proposals online through the NIAID electronic Contract Proposal Submission (eCPS) website at: https://ecps.niaid.nih.gov A. eCPS PROPOSAL SUBMISSION PROCESS

1. Internet access and an email-address are required.

2. An NIH eRA Commons account is required.

3. If you do not already have an eRA Commons account, your

Business Official, or authorized representative designated by your Business Official, must register for an eRA Commons account at least four (4) weeks prior to the proposal due date. The eRA Commons Online Registration is available at https://commons.era.nih.gov/commons/registration/registrationI nstructions.jsp

4. Log into eCPS with your eRA Commons password and username to upload your proposal at: https://ecps.niaid.nih.gov

5. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at https://ecps.niaid.nih.gov/Home/HowTo

3) Binding and Packaging of Proposal

Send all copies of a proposal in the same package. Do not use special bindings or covers. If stapled, staple the pages in the upper left corner of each proposal.

4) Contracting Officers and Addresses for Mailing or Delivery of Proposals

PAPER COPIES and CD-ROM to:

If Hand Delivery of Express Service If Using U.S. Postal Service Andrew Cherry Contract Specialist National Institutes of Health, DHHS Office of Acquisitions, NIAID 6700-B Rockledge Drive, Room 3110 Bethesda, Maryland 20817-1824

Andrew Cherry Contract Specialist National Institutes of Health, DHHS Office of Acquisitions, NIAID 6700-B Rockledge Drive, Room 3110 Bethesda, Maryland 20892-7612

In addition to the address cited above, mark each package as follows:

“BAA-NIAID-DMID-NIH-AI-2013174 TO BE OPENED BY AUTHORIZED GOVERNMENT

PERSONNEL ONLY”

NOTE: All material sent to this office by Federal Express should be sent to the Hand Delivery address.

NOTE: The U.S. Postal Service’s “Express Mail” does not deliver to the Hand Delivery (20817 zip code) address. Any package sent to the Hand Delivery address via the U.S. Postal Service will be held at a local post office for pick-up. THE GOVERNMENT WILL NOT PICK UP ANY MAIL AT ANY POST OFFICE. If a proposal is not received at the place, date, and time specified herein, it will be considered a “late proposal,” in accordance with FAR 15.208, Submission, Modification, Revision, and Withdrawal of Proposals and FAR 52.215-1(c)(3), Instructions to Offerors-Competitive Acquisition.

Offerors are responsible for submitting proposals, and any revisions thereto, so as to reach the Government office designated in the BAA by the time specified in the BAA or subsequent amendments thereto.

Any proposal or revision received at the offices designated above after the exact time specified for receipt is “late” and will not be considered unless it is received before award is made, and

a. There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government’s control prior to the time set for receipt of offers; or

b. It is the only proposal received.

Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the BAA, and urgent Government requirements preclude amendment of the BAA, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

Any and all pages, including revisions, to proposals that result in the proposal exceeding the stated page limitations will not be considered.

C. Formatting, Number of Copies, and Page Limitations

The Technical Proposal shall not exceed 150 pages. Pages in excess of this limitation will be deleted and will be neither read nor evaluated. Type size must be legibly 10 to 12 points. Each page of the Technical Proposal must be numbered sequentially. 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.

Use your usual word processing and spreadsheet programs to prepare and format the technical and business proposals. If documents are submitted using Adobe .pdf, the document should be submitted using a .pdf searchable format.

• Type size must be legibly 10 to 12 points.

• Type spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

• Print margins must be at least one inch on each edge of the paper.

• Print setup should be double-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe).

The use of links to internet web site addresses (URLs) to direct readers to alternate sources of information within the proposal are prohibited. Any links provided in a proposal will not be reviewed or considered.

Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

Number of copies and applicable page limitations for paper copies, discs, and proposals submitted online through eCPS:

1. Total page count does not include: Title and Back Page; Table of Contents;

Section Dividers that do not contain information other than title of Section.

2. Pages that are 2-sided will count as two pages.

3. Pages in excess of the limitations stated herein will be removed from the proposal and will not be considered.

NUMBER OF COPIES AND APPLICABLE PAGE LIMITATIONS

Document Number of Copies Page Limits

Technical Proposal

PAPER

One (1) unbound SIGNED ORIGINAL.

Five (5) unbound COPIES

DISC (i.e., CD or DVD) One (1) Disc containing one electronic copy of the Technical (including all Attachments)

ONLINE (using the eCPS website) One (1) electronic copy of the Technical Proposal (including all Attachments)

Not to Exceed 150 pages (inclusive of all Attachments)

Business Proposal

PAPER

One (1) unbound SIGNED ORIGINAL.

Five (5) unbound COPIES

DISC (i.e., CD or DVD) One (1) Disc containing two files, as instructed in section III.A.2)B. above.

ONLINE (using the eCPS website) One (1) submission containing two files, as instructed below.

1. One (1) electronic PDF copy of the Business

Proposal (with all Attachments including the PDF rendering of the Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet (http://oamp.od.nih.gov/Division/DFAS /spshexcl.xls).

2. One (1) electronic Cost Proposal Excel Workbook entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook. Microsoft Excel 2007 version or later is required.

N/A

D. NAICS Code and Size Standard

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

(1) The North American Industry Classification System (NAICS) code for this acquisition is 541712.

(2) The small business size standard is 500 employees.

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

E. Restriction on disclosure and use of data

(1) The proposal submitted in response to this request may contain data [trade secrets;

business data (e.g., commercial information, financial information, cost and pricing data);

and technical data] which the offeror, including its prospective Subcontractor(s), does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any data may be so restricted; provided, that the Government determines that the data is not required to be disclosed under the Freedom of Information Act, 5 U.S.C.

552, as amended, and the offeror marks the cover sheet of the proposal with the following statements, specifying the particular portions of the proposal which are to be restricted:

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

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

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

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

(2) In addition, the offeror must mark each page of data it wishes to restrict with the following statement: "Use or disclosure of data contained on this page is subject to the restriction on the cover sheet of this proposal or quotation."

(3) Offerors are cautioned that proposals submitted with restrictive statements or statements differing in substance from those cited above may not be considered for award.

The Government reserves the right to reject any proposal submitted with a nonconforming statement(s).

F. Communications Prior to Contract Award

Offerors shall direct all communications to the attention of the Contract Specialist cited at the beginning of this announcement. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.

G. Release of Information

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

H. Preparation Costs

The Government will not pay for the preparation and submission of proposals.

I. Promoting Efficient Spending

On September 21, 2011, the Office of Management and Budget issued Memorandum M-11-

35 , entitled, "Eliminating Conference Spending and Promoting Efficiency in Government," emphasizing the President's priority to ensure that the Government operates with the utmost efficiency and eliminates unnecessary or wasteful spending. This was followed by the Executive Order on Delivering an Efficient, Effective, and Accountable Government ( EO 13576 ) and the Executive Order on Promoting Efficient Spending ( EO

13589 ). On June 24, 2013, the Department of Health and Human Services (DHHS) issued the memorandum "HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items, and Printing, and Publications"

(See http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html ).

In support of these directives, the Contracting Officer shall not authorize the contractor to conduct any conferences or meetings until the appropriate conference approval/waiver has been approved by the IC EO, NIH Director or HHS Deputy Secretary as applicable in accordance with the NIH Policy Memorandum Implementation Guidance of the HHS Efficient Spending Policy, date June 24, 2013. See http://oamp.od.nih.gov under Efficient Spending Policy.

Any contract awarded as a result of this BAA will:

o Specifically prohibit the use of contract funds for the provision of food for meals, light refreshments and beverages for any NIH funded meeting or conference; and o Limit the procurement of meeting space, promotional items, printing and publications for meetings

J. Service of Protest (September 2006) - FAR 52.233-2

(1) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Aileene Mitchell Ford Contracting Officer, Division of Microbiology and Infectious Diseases Branch National Institute of Allergy and Infectious Diseases DEA, Office of Acquisitions 6700-B Rockledge Drive Room3113, MSC 7612 Bethesda, MD 20892-7612

(2) The copy of any protest shall be received in the office designated above within one (1) day of filing a protest with the GAO.

K. Institutional Responsibility Regarding Conflicting Interests of Investigators

45 CFR Part 94 promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research to be performed under NIH contracts will be biased by any conflicting financial interest of an Investigator. The Institution shall comply with all requirements of 45 CFR Part 94 at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=9f130b6d2d48bb73803ca91ce943be3a;rgn=div5;view=text;node=45%3A1.

0.1.1.53;idno=45;cc=ecfr

L. Limitations on Use of Appropriated Funds

The Department of Health and Human Services Appropriation Act limits the use of appropriated funds on NIH grant, cooperative agreement, and contract awards as specified below. It is anticipated that these statutory provisions will continue in subsequent fiscal years and be incorporated into any award documents. If selected for negotiations, you will be provided all specific limitations concerning appropriated funds applicable at the time of negotiations.

1) Salary Limitations

(a) Pursuant to the current and applicable HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual through this contract at a rate in excess the Federal Executive Schedule Level II in effect on the date an expense is incurred.

(b) For purposes of the salary rate limitation, the terms "direct salary," "salary," and

"institutional base salary" have the same meaning and are collectively referred to as "direct salary" in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract.

Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs).

Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with Federal funds.

(c) The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish contract or order funding.

(d) See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and prior periods.

(End of clause) See the following Web site for Executive Schedule rates of pay:

http://www.opm.gov/oca/ .

(For current year rates, click on Salaries and Wages / Executive Schedule / Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages / select Another Year at the top of the page / Executive Schedule / Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

2) Restriction on Distribution of Sterile Needles

"None of the funds contained in this Act may be used to distribute any needle or syringe for the purpose of preventing the spread of blood borne pathogens in any location that has been determined by the local public health or local law enforcement authorities to be inappropriate for such distribution."

3) Restriction on Abortions

“(a) None of the funds appropriated under this Act, and none of the funds in any trust fund to which funds are appropriated in this Act, shall be expended for any abortion. (b) None of the funds appropriated in this Act, and none of the funds in any trust to which funds are appropriated in this Act, shall be expended for health benefits coverage that includes coverage of abortions. (c) The term “health benefits coverage” means the package of services covered by a managed care provider or organization pursuant to a contract or other arrangement.”

4) Ban on Funding of Human Embryo Research

“(a) The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).” The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

5) Limitation on Use of Funds for Promotion of Legalization of Controlled Substances

"(a) None of the funds made available in this Act may be used for any activity that promotes the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established by section 202 of the Controlled Substances Act except for normal and recognized executive-congressional communications. (b) The limitation in subsection (a) shall not apply when there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage."

6) Dissemination of False or Deliberately Misleading Scientific Information

“None of the funds made available in this Act may be used to disseminate scientific information that is deliberately false or misleading.”

7) Restriction on Employment of Unauthorized Alien Workers

The Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

"(3) Definition of unauthorized alien.- As used in this section, the term 'unauthorized alien' means, with respect to the employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or

(B) authorized to be so employed by this Act or by the Attorney General."

8) NIH Public Access Requirement

“The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, that the NIH shall implement the policy in a manner consistent with copyright law.”

Further information on the implementation of NIH’s Public Access Requirement is available in NIH Guide Notice NOT-OD-08-033 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 08-033.html) published on January 11, 2008.

M. DUNS Number

Prior to award of a contract, the Contractor will be required to provide a Data Universal Numbering System (DUNS) number. A DUNS number may be obtained immediately, at no charge, by calling Dun and Bradstreet at 1-866-705-5711 or via the Internet at https://eupdate.dnb.com/requestoptions/government/ccrreg/. The Contractor must also be registered in the Central Contractor Registry (CCR) prior to award of a contract. Registration can be made via the Internet at http://www.ccr.gov. If you have a DUNS number, it is recommended that the proposal provide the DUNS number.

IV. UNIFORM ASSUMPTIONS

For the purposes of estimating costs and preparing the technical proposal, the following POST-AWARD requirements will apply to all awards made under this BAA.

Offerors are instructed to address responsibility for complying with the following requirements in your proposed SOW. Offerors are NOT required to submit documentation to address these post-award requirements in their technical proposals. Instructions for submitting documentation associated with post-award requirements will be provided during negotiations.

A. Audits: Assume three (3) independent audits per year for the duration of the contract period of performance.

B. Purchase of Equipment: Costs will NOT be allowed for the purchase of any equipment, hardware, or software.

C. Alterations and Renovations: Costs will NOT be allowed for any facility construction, alterations, or renovations.

D. Programmatic Presentations and Reviews

In performance of the work, offerors are expected to attend the following reviews:

1. Post Award Contract Initiation Review

In preparing the proposal, offerors should include costs for attendance at one (1) Post Award Contract Initiation Review. Offerors should assume a one-day review will be conducted at/near Washington, D.C. or at the Contractor site and attendance should include all Key Personnel and all Key Subcontractor personnel.

2. Annual Contract Reviews

In preparing the proposal, offerors should include costs for annual contract reviews.

These reviews are anticipated to be held at the Contractor’s facility and a location at/near Washington D.C. on an alternating-year basis. The reviews are anticipated to be one-day reviews. Offerors should include costs for the attendance of the Key Personnel, members of the External Advisory Group, and Key Subcontractor personnel.

A report of the Post Award Contract Initiation Review and Annual Contract Reviews shall be prepared by the Contractor and submitted within twenty-one (21) calendar days following the date of the reviews. These reports shall include the slide presentations and all other review materials, as well as summaries of all discussions. Minutes of regular, as well as ad hoc, teleconferences and reviews shall be provided by the Contractor within two (2) business days following the date of the teleconference or review.

V. Reporting Requirements

In performance of the work, the following reporting requirements should be assumed:

A. Monthly Progress Report

This report shall include a description of the technical activities and results during the reporting period and the activities planned for the ensuing reporting period, and shall include a budget summary for costs incurred and quantify the accomplishment of work for the monthly reporting period for the base period and each option and milestone. The obligated funding and the cost incurred will be presented in correlation with percent completion of the activities under the base, option and/or milestone. Performance issues, and any risks to the program should be identified as well as any risk mitigation plans.

The format of the monthly report will be finalized as soon as possible upon contract award.

B. Annual Progress Report

This report includes a summation of the technical activities and results for the performance year covered. An Annual Progress Report will not be required for the period when the Final Report is due.

C. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October 2001, applies. 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.

D. Final and Draft Reports

This report is to include a summation of the work performed and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. An annual report will not be required for the period when the Final Report is due. The Contractor shall submit, with the Final Report, a summary (not to exceed 250 words) of salient results achieved during the performance of the contract.

E. Product Development Plan and Statement of Work

The Contractor shall be required to develop and update the Product Development Plan and the SOW to incorporate the progress from the effective date of the contract. The Contractor shall submit an updated Product Development Plan and SOW for review within sixty (60) calendar days of the effective date of the contract and prior to initiation of product development activities, unless otherwise negotiated with the Contracting Officers

Representative (COR) and the Contracting Officer. This updated Product Development Plan shall include:

1. Clearly defined goals, product development stages and product development activities.

2. Activities by fiscal year, Go/No Go criteria and deliverables. A Sample Product Overview Table and Sample Gantt Chart are provided in Attachment 1 and Attachment 2, respectively.

3. Quantitative and qualitative criteria and associated data elements for assessing the scientific merit and feasibility of moving to the next stage of product development.

4. A detailed timeline for each stage covering the initiation, conduct and completion of product development activities and a task-linked budget (a budget linked to each major activity). The SOW shall include a description of the studies to be performed within each stage of the project. The Contractor shall also be required to submit a revised Product Development Plan and associated SOW when a change to the approved plans is requested.

NOTE: for purposes of this BAA:

The Product Development Plan describes the critical path for the proposed product candidate toward eventual licensure and identifies the decision points/gates for progress of the product candidate.

The SOW describes the activities to be performed within the five (5) year term of award in order to implement the Product Development Plan and advance the product through phase I testing.

Note: Contract activities would be divided into manageable, with duration no longer than two years preferably less than one year, tasks. Initial funding would be for the Base Period only. Funding of subsequent tasks would be funded by Options. Each Option would be fully funded when exercised and will be dependent on successful completion of critical Milestones, including USG acceptance of associated deliverables when applicable. The critical predecessor activities should constitute Go/No Go criteria for successor activities. The contract task-linked budget would be aligned with the Base Period, Options and associated tasks identified in the Product Development Plan and associated Gantt chart.

6. Audit Reports

Within thirty (30) calendar days of completion of an audit related to conformance to FDA regulations and guidance, including adherence to GLP, GMP or GCP guidelines, the Contractor shall provide copies of the audit report and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

7. Draft and Final Clinical Trial Protocols

The NIAID has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in the NIAID-funded clinical trials.

Therefore, as described in the…