DevofTxBAADMID071712RevisedperPolicyFINAL.pdf

Broad Agency Announcement

No. NIH-AI-2012149

Title: DEVELOPMENT OF THERAPEUTIC MEDICAL COUNTERMEASURES FOR

BIODEFENSE AND EMERGING INFECTIOUS DISEASES

Issue Date: July 15, 2012

Due Date: October 1, 2012 - 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

Contracting Officer: Charles Jackson, Charles.Jackson@nih.gov, 301-451-

Contact Point/Contract Specialist: Kathy M. Fetterman, fettermanka@niaid.nih.gov, 301-402-4598

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, 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 authorized by Federal Acquisition Regulation

(FAR) 6.102 and further described in 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. BAA’s 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. The

Statement of Work, including the specific technical requirements and performance specifications, is developed and proposed by the offeror, not the Government.

Proposals are NOT evaluated against each other since they are not submitted in accordance with a common Statement of Work issued by the Government. Instead, Research and mailto:Charles.Jackson@nih.gov mailto:fettermanka@niaid.nih.gov

Technical Objectives are provided in the BAA that describes the research areas in which the

Government is interested. Proposals received in response to the BAA are evaluated in accordance with Evaluation Factors for Award specified in Section VIII of this document.

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 solicitation, and to make awards without discussions with proposers. 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 NIAID desires 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 one or more contracts may be issued for an aggregate total cost

(direct and indirect costs combined) of up to $18.5 million for all awards during the first non-severable phase. Awards are expected to be made on or about 06/01/2013. 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 the National Institute of Allergy and Infectious

Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human

Services (DHHS), strive 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 biothreat agents

(http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/research/pages/cata.aspx).

The current NIAID’s Strategic Plan for Biodefense Research

(http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/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.

http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/research/pages/cata.aspx http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.htm http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.pdf

The HHS PHEMCE coordinates interagency effort aiming to optimize our 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.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html) 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 biodefense therapeutic and prophylactic (vaccine) candidates/products with the eventual goal of stockpiling these medical countermeasures and associated technologies to protect the American public.

C. Technical Objectives

The objective of this solicitation is to support the development of candidate therapeutic products for use in post-event settings following the intentional release of the NIAID

Category A, B, and C biothreat agents or in response to naturally occurring outbreaks of infectious diseases caused by the NIAID Category A, B, and C pathogens

(http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx).

Only agents identified as the NIAID Category A, B and C Priority Pathogens are eligible as proposed candidates/products for this solicitation.

This BAA solicitation focuses on supporting the development of promising biodefense therapeutic candidates/products. One category of products being solicited are those with broad spectrum therapeutic activity against viruses or bacterial pathogens. This solicitation also focuses on supporting development of promising anti-toxins as biodefense therapeutic candidates/products, particularly small molecule therapeutics with anti-toxin activity. The research and development activities supported through this BAA will allow candidate therapeutic countermeasures to progress through the product development pipeline toward licensure by the FDA.

Broad spectrum activity is a characteristic that enables a particular product to mitigate biological threats across a range or class of agents. There are a number of traditional threats for which effective treatments are either non-existent, of limited usefulness, or vulnerable to both naturally emerging and intentionally engineered antibacterial and antiviral resistance. A limited number of anti-infectives with broad spectrum activity directed at common, invariable, and essential components of different classes of microbes could potentially be effective against both traditional and non-traditional threats. This approach would allow a small number of drugs to replace dozens of pathogen-specific drugs for emergency use. Additionally, strategies to overcome bacterial and viral drug resistance could extend the clinical utility of existing broad spectrum anti-infectives and have immediate benefits. Moreover, broad spectrum treatments directed towards host targets have the potential to be effective against one or more diseases. For instance, targeting host receptors and cellular processes to treat infections can directly prevent or treat diseases. These approaches could provide clinical utility when used alone or in combination with conventional anti-infectives.

For the purposes of this BAA, the ideal broad spectrum therapeutic candidate is defined as a single agent that meets the following three criteria/definitions:

http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx

1) A drug (synthetic or natural product) or a biological product (e.g. monoclonal antibody or a recombinant protein) intended for use in the cure, mitigation, or treatment; AND

2) A single agent with demonstrated activity in appropriate in vitro assays and in vivo models against more than one selected bacterial or viral pathogen ; AND

3) An agent that will have completed evaluation in a Phase 1 clinical trial within the 5-year contract period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following

International Conference on Harmonization (ICH) Guidelines on Structure and

Content of Clinical Study Reports E3

(http://www.pharmacontract.ch/support/su_ich_liste.htm).

Toxins are poisonous substances, especially protein, produced by living cells or organisms that are capable of causing or exacerbating disease when introduced into the body tissues.

While bacteria that produce toxins may often be eliminated by the use of antibiotics during an infection, disease may still occur or may progress because of the presence of toxins produced by the pathogen. In addition, toxins may be isolated and themselves be introduced into body tissues and thereby cause disease and death, as in the case of ricin.

Treatments are needed to target specific toxins in order to cure or mitigate disease caused by those toxins.

For the purposes of this BAA, the ideal anti-toxin therapeutic candidate is a single agent, preferably a small molecule, meeting the following criteria/definitions:

1) An agent intended for use in the cure, mitigation or treatment; AND

2) An agent that has demonstrated activity against a specific toxin in an in vivo model of disease; AND

3) An agent that will have completed evaluation in a Phase 1 clinical trial within the 5-year contract period of performance. Phase 1 clinical trial completion is defined as completion of a Final Clinical Study Report following International Conference on

Harmonization (ICH) Guidelines on Structure and Content of Clinical Study Reports

E3 (http://www.pharmacontract.ch/support/su_ich_liste.htm).

Therapeutics supported under this BAA are specified as the following classes:

Broad spectrum anti-bacterial: Therapeutic with activity against one of the following bacterial pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazekii AND in addition, activity against one other NIAID Category A, B and C bacterial threat agent.

Broad spectrum anti-viral: Therapeutic with activity against one of the following viral pathogens: Ebola virus, Marburg virus, Variola major, Dengue virus, Venezuelan encephalitis virus, Western Equine encephalitis virus, and Eastern Equine encephalitis virus AND, in addition, activity against one other NIAID Category A, B and C viral threat agent.

Influenza antiviral agents: Therapeutics active against multiple influenza A subtypes directed at either viral or host targets.

Anti-toxins supported under this BAA are specified as the following: A therapeutic agent, particularly a small molecule, with activity against one of the following toxins:

http://www.pharmacontract.ch/support/su_ich_liste.htm http://www.pharmacontract.ch/support/su_ich_liste.htm

Botulinum neurotoxin, Staphylococcus enterotoxin B, Bacillus anthracis Protective

Antigen, Lethal Factor or Edema Factor, and ricin toxin.

Offerors are encouraged to apply state-of-art and innovative technological approaches and platforms in the development of the proposed candidates. State-of-art and innovative technological approaches refer to capabilities, such as temperature stabilization or delivery method, that can be engineered into a wide array of existing and candidate products to enhance the product performance. Technological platforms, on the other hand, are standardized methods that can be used to significantly reduce the time and cost required to bring medical countermeasures to licensure.

Contracts awarded under this BAA will not support:

Basic research and discovery of new candidates/products.

Refinement of a lead series to identify a lead candidate.

Development of devices or diagnostics.

Development of candidates/products that have not demonstrated activity in a relevant animal model of disease.

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 Top Priority Biological Threats in the HHS, 2007 PHEMCE Implementation Plan

(https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.as pxhttp://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html) 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. Proposal Submission

1) Receipt Date

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

3:30 PM Local Time

October 1, 2012

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

A. Paper Copies

Submit the original and 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.

In addition to the paper submissions, proposers are also encouraged to submit two CD-ROM’s 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. The paper copy is the http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/pages/cata.aspx https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx https://www.medicalcountermeasures.gov/BARDA/PHEMCE/enterprise/strategy/strategy.aspx http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html http://oamp.od.nih.gov/contracts/rfps/summact.htm official copy for recording timely receipt of proposals. 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 the Solicitation Section J, Attachment entitled “Breakdown of Proposed Estimated Costs (plus Fee) with

Excel Spreadsheet.” The Business 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 and merged into the Business Proposal PDF file.

b. The second file must be the “Breakdown of Proposed Estimated

Costs (plus Fee) with Excel Spreadsheet” in its original Excel format, not PDF.

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 solicitation number, and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf

Excel Workbook: XYZ Company_NIHAI2012001_Business.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 http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls 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 weeks prior to the proposal due date. The eRA Commons

Online Registration is available at https://commons.era.nih.gov/commons/registration/registrationIns tructions.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

Kathy Fetterman

Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 6700-B Rockledge Drive, Room 3214, MSC Bethesda, Maryland 20817

Kathy Fetterman

Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 6700-B Rockledge Drive, Room 3214, MSC Bethesda, Maryland 20892-7612

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

“BAA-NIAID-DMID-NIH-AI-2012149 TO BE OPENED BY AUTHORIZED GOVERNMENT

PERSONNEL ONLY”

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

Carried Address.

NOTE: The U.S. Postal Service’s “Express Mail” does not deliver to the hand carried

(20817 zip code) address. Any package sent to this address via this service will be held at a local post office for pick-up. THE GOVERNMENT IS NOT RESPONSIBLE FOR

PICKING UP ANY MAIL AT A LOCAL 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.

https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp https://ecps.niaid.nih.gov/ https://ecps.niaid.nih.gov/Home/HowTo

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

Any proposal, modification or revision received at the offices designated below 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 solicitation, and urgent Government requirements preclude amendment of the solicitation, 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 of modifications or revisions to proposals that result in the proposal exceeding the stated page limitations will not be considered.

B. Formatting, Number of Copies, and Page Limitations

The Technical Proposal shall not exceed 100 single-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated. Each page of the

Technical Proposal must be numbered sequentially. 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 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 single-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 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 this limitation 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 Proposal

(including all Attachments)

ONLINE (using the eCPS website)

One (1)electronic copy of the Technical

Proposal (including all Attachments)

Not to Exceed

100 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 II.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).

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

C. 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.

D. Restriction on disclosure and use of data (January 2007) – FAR 52.215-1

(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).

E. Communications Prior to Contract Award

Offerors shall direct all communications to the attention of the Contract Specialist or

Contracting Officer 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.

F. 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.

G. Preparation Costs

This BAA does not commit the Government to pay for the preparation and submission of a proposal.

H. 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 January 3, 2012, 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 NIH issued a January 30, 2012, Memorandum, entitled, "NIH Guidance Related to the HHS Policies on Promoting Efficient Spending:

Use of Appropriated Funds for Conferences, Conference Grants and Meetings, Food, Promotional Items, and Printing and Publications." (See http://oamp.od.nih.gov/ )

Any contract awarded as a result of this solicitation 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

I. Service of Protest (September 2006) - FAR 52.233-2 http://www.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-35.pdf http://www.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-35.pdf http://www.whitehouse.gov/the-press-office/2011/06/13/executive-order-delivering-efficient-effective-and-accountable-governmen http://www.whitehouse.gov/the-press-office/2011/11/09/executive-order-promoting-efficient-spending http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html http://oamp.od.nih.gov/

(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:

Charles H. Jackson, Jr.

Contracting Officer

Office of Acquisitions

National Institute of Allergy and

Infectious Diseases

DEA, Office of Acquisitions

6700-B Rockledge Drive

Room 3156, MSC 7612

Bethesda, Maryland 20892-7612

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

J. 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%3

A1.0.1.1.53;idno=45;cc=ecfr

K. 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).

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 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 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

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

L. 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.

M. 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.

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 these requirements in the proposed Statement of Work for the Technical Proposal. 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: Cost will NOT be allowed for the purchase of any equipment, hardware, or software under this contract.

C. Alterations and Renovations: Cost will NOT be allowed for any facility construction, alterations, or renovations under this contract.

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

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.

http://www.ccr.gov/ http://oamp.od.nih.gov/contracts/rfps/techcst5.htm

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 or 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.

3. External Advisory Group Reviews

After contract award and in consultation with the Contracting Officer

Representative (COR) and the Contracting Officer, the Contractor will establish an

External Advisory Group with the relevant expertise to critically evaluate technical progress in achieving product development objectives and established timelines. It is anticipated that the External Advisory Group will consist of approximately 3-5 members. The membership of the External Advisory Group will be proposed by the Contractor and approved by the COR and Contracting Officer post-award. The specific roles and duties of the External Advisory Group members will be defined by the Contractor and approved by the COR.

Compensation for this role will be provided by the Contractor with contract funds as approved by the Contracting Officer and will be commensurate with the specific roles and duties assigned to the members. The Contractor will have the

External Advisory Group consulting agreements in place within six months of the effective date of the contract.

Reports of all reviews and communications with the External Advisory Group or its individual members will be documented and submitted to the COR and

Contracting Officer. Documentation of such reviews/communications will be provided within twenty-one (21) calendar days and will include a summary of the discussions and copies of slide presentations.

NOTE: DO NOT identify or propose External Advisory Group members in the technical or business proposal. Do not contact specific individuals regarding service on the External Advisory Group in advance of contract award.

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 during the monthly reporting period for the base period and each option and milestone. The funding level will be presented in correlation with percent completion of the activities under the base, option and/or milestone.

B. Annual Progress Report

This report includes a summation of the technical activities and results for the entire contract period 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 under this contract.

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 Work Plan

The Contractor shall be required to update the Product Development Plan and the

Work Plan to incorporate the progress from the effective date of the contract. The

Contractor shall submit an updated Product Development Plan and Work Plan for review within thirty (30) calendar days of the effective date of the contract and prior to initiation of product development activities, unless otherwise negotiated with the COR and the Contracting Officer. This updated Product Development

Plan shall include:

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

2. Go/No Go decision gates.

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 budget linked to each stage. The Work Plan 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

Work Plan when a change to the approved plans is requested.

NOTE: for purposes of this BAA:

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

The Work Plan describes the studies to be performed at each stage of the project within the 5 year term of award in order to implement the

Product Development Plan and advance the product through phase I testing.

5. Milestone Completion/Decision Gate Report

A Decision Gate Report shall be submitted when the Contractor has completed a stage of product development and has reached a Go/No Go decision point, as defined in the Work Plan for the Implementation…