BAA-NIAID-DMID-NIH-AI-2014028.pdf

Broad Agency Announcement

No. BAA-NIAID-DMID-NIH-AI-2014028

Title: Targeted Clinical Research to Address Select Viral Infections

Issue Date: December 15, 2014

Due Date: May 12, 2015

Issuing Office: Office of Acquisitions, Division of Microbiology and

Infectious Diseases, DEA, NIAID, NIH, 5601 Fishers Lane, Room 3D32, MSC 9821, Bethesda, MD 20892-9821

Contracting Officer: George W. Kennedy, kennedyg@niaid.nih.gov

Contact Point/ Contract Specialist: Swee Teo, teosl@niaid.nih.gov

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 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 describes 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.

mailto:kennedyg@niaid.nih.gov mailto:teosl@niaid.nih.gov

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, and to make awards without discussions with offerors. 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 to five contracts may be issued for a total cost (direct and indirect costs combined) of up to $6.3 million in Fiscal Year 2016 for all awards during the first non-severable phase. Awards are expected to be made on or about May 1, 2016. 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 of infectious, immunologic, and allergic diseases that threaten the health and lives of millions of humans. 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.

Rare and/or emerging viral diseases typically are associated with significant morbidity and mortality and economic costs worldwide. A rare (or orphan) disease is generally considered to have a prevalence of fewer than 200,000 affected individuals in the United States.

Emerging viral diseases can be defined as infections that have newly appeared in a population, or have existed but are rapidly increasing in incidence in that population or geographic range.

Although many of the disease syndromes (conditions and manifestations) caused by viruses in general are relatively benign and self-limited in the normal host, they are often much more severe in a variety of special populations of patients, e.g., immunocompromised individuals, the elderly, pregnant women, or children and neonates. The study of serious rare or emerging viral infections in these populations provides unique and special challenges and treatment options are frequently sparse. Consequently, the development of effective therapies or therapeutic strategies for rare viral diseases or viral diseases in special populations remains a significant unmet medical need. The pharmaceutical industry is focused primarily on the development of therapies for chronic viral infections, such as HIV, hepatitis B, hepatitis C or therapies for acute viral illnesses that are usually self-limited, but may affect large numbers of people, such as influenza or the common cold. Whereas, the development of therapies for rare and/or emerging viral diseases has not been an industry priority due to potentially limited markets, high development costs and/or because knowledge on the natural history of the illness is limited. Natural history studies that focus on understanding the range of manifestations, disease progression, disease presentation in various populations and the establishment of biomarkers of clinical progression and correlates of clinical outcome are being recognized as critical to facilitate effective product development programs and overcome issues that have led to stalled or failed product development strategies.

B. Technical Objectives

The overall objective of this solicitation is to support/advance the development of therapeutic strategies for rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations. The NIAID is aware that many of these diseases, and the patient populations that are most affected, may not be amenable to traditional product development/common clinical trial methodologies. Thus, the evaluation of the natural history, as well as the use of alternative and innovative research methods and clinical trial design strategies, is encouraged, where appropriate and valid. A variety of clinical study approaches will be considered responsive including natural history studies, retrospective analysis of existing data (either in patient records or other patient data registries), and interventional clinical trials. Adaptive clinical trial designs

(http://www.fda.gov/downloads/Drugs/.../Guidances/ucm201790.pdf) or other alternative clinical trial designs with adaptive features are encouraged, when appropriate. The assessment of laboratory surrogate markers for clinical response, enhanced use of existing therapies, evaluation of new therapeutic drugs and the development of resistance to important antiviral drugs are important aspects, and may be included in any study proposed.

For the purposes of this BAA, the targeted patient populations are those for which there is a significant unmet medical need for therapeutic options for rare/emerging viral diseases that are not being addressed by the pharmaceutical industry or other significant clinical initiatives. Targeted populations include children (neonates through adolescents); the elderly, transplant recipients, and pregnant women. Studies in the general population may be considered for select rare and/or emerging diseases (see below).

Natural history studies are defined as those that evaluate the contemporary clinical course of the viral disease in a target patient population, with the goal of providing data to design interventional clinical trials. Important aspects include evaluation of a disease’s incidence, variability in patients, causes of morbidity and mortality, and response to standard of care.

Studies that focus primarily on immunologic changes associated with disease progression will not be considered.

The following are some examples of research areas of interest:

In pediatric subjects, viral diseases that are considered to be rare would include, but are not limited to: congenital cytomegalovirus (CMV), serious enteroviral diseases, Epstein-Barr virus (EBV) infections, neonatal herpes virus infections, and serious flavivirus or filovirus infections. However, diseases such as influenza in pediatric patients would not be considered rare.

http://www.fda.gov/downloads/Drugs/.../Guidances/ucm201790.pdf

Viral infections are increasing in incidence in transplant patients, as immunosuppressive therapies improve in potency. Epstein Barr virus (EBV), human herpesvirus-6 (HHV-6) and adenovirus infections are a few examples of infections following transplantation. Norovirus infections are posing an increased risk for serious outcomes in vulnerable populations, such as the elderly and transplant recipients. Viral infections of the nervous system, specifically viral encephalitis (various viral etiologies), are examples of rare diseases with significant morbidity in the general population. Finally emerging diseases such as serious flavivirus, lassa fever virus, and chikungunya virus infections, remain, to date, rare in the US, but have the potential to cause significant morbidity/mortality. In these cases, international studies may be necessary.

For the purposes of this BAA, eligible clinical trials/studies include:

Interventional trials of safety and effectiveness for treatments for rare and/or emerging viral diseases (non-HIV) of medical importance in targeted patient populations and under-served by the pharmaceutical industry (Phase I [except first in human studies], Phase II or Phase IV are allowable);

Natural history studies of the rare and/or emerging viral diseases to assist in the design of treatment trials with useful endpoints;

Validation of biomarkers or surrogate markers of clinical responses and safety in antiviral therapy for the purposes of designing future clinical therapeutic studies;

Validation of diagnostic tests for predicting clinical response to therapy;

Proof of principle studies to further product development;

Exposure/exposure-response studies (using pharmacokinetic and pharmacokinetic

/pharmacodynamic approaches) to optimize therapies;

Assessment of the emergence of resistance to antiviral therapies; or

Analysis of existing databases or patient charts.

Contracts awarded under this BAA will NOT support:

Surveillance studies;

Transmission studies;

Studies of vaccines;

Studies designed primarily to evaluate the immunologic changes associated with the viral disease;

Studies designed to evaluate immunosuppressive regimens in transplant patients;

First in human (FIH) interventional trials;

Phase III studies;

HIV studies or studies of other infections in HIV patients;

Studies for viral illnesses for which there are effective marketed therapeutics or substantial pharmaceutical industry investment in development of therapies, such as influenza, hepatitis C or hepatitis B.

NOTE: Organizations responding to this BAA must have documented expertise in clinical research and clinical research in the patient population proposed or in the type of study proposed, and demonstrated knowledge of applicable regulatory guidelines.

III. GENERAL PROPOSAL INSTRUCTIONS AND INFORMATION

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/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-

Summ.pdf). Proposals should be direct and concise in presenting information which clearly describes the proposed project. Offerors should realize that a concise and well formulated proposal is usually more effective to communicate project ideas to reviewers versus a voluminous proposal that lacks effective distillation of ideas.

A. Proposal Submission

1. Receipt Date

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

May 12, 2015, 3:30 PM EST

2. Proposal Submission

a. The National Institute of Allergy and Infectious Diseases (NIAID) currently requires proposals to be submitted via two methods:

1) Online

2) Disc (CD or DVD)

Notes:

Submission of proposals by facsimile or e-mail is not acceptable.

Online and disc proposals must be exactly the same.

3. Online Submission of Electronic Proposals

a. eCPS PROPOSAL SUBMISSION PROCESS

1) Offerors are required to submit an electronic copy of proposals online through the NIAID electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov/.

2) Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/NIAID/Home/howto.

3) Please note that creating an account to submit can take up to three (3) business days. Please register early to allow enough time for the registration process.

4. DISCS (i.e., CD or DVD)

a. Delivery Instructions http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf https://ecps.nih.gov/ https://ecps.nih.gov/NIAID/Home/howto

If Hand Delivery or Express Service If using U.S. Postal Service

Mr. George Kennedy

Contracting Officer

Office of Acquisitions, DEA, NIAID, NIH

5701 Fishers Lane, Room 3D32 MSC

9821, Rockville, MD 20852-9821

Mr. George Kennedy

Contracting Officer

Office of Acquisitions, DEA, NIAID, NIH

5701 Fishers Lane, Room 3D32 MSC

9821, Bethesda, MD 20892-9821

1) Mark each package with the following items:

The solicitation number: BAA-NIAID-DMID-NIH-AI-2014028

“TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY”

2) All material sent to this office by courier should be sent to the Hand

Delivery or Express Service address.

3) The U.S. Postal Service's "Express Mail" does not deliver to the hand delivered (20852 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.

4) Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal”, in accordance with

FAR Clause 52.215-1 Instructions to Offerors – Competitive

Acquisition.

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”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx). The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx signature(s) may be scanned and merged into the Business

Proposal PDF file.

b) The remaining file(s) must be the “Breakdown of Proposed

Estimated Costs (plus Fee) with Excel Spreadsheet” in its original

Excel format, not PDF. Multiple Excel files may be included, as necessary.

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) 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_NIHAI2014028_Technical_Date.pdf

Business Proposal: XYZ Company_NIHAI2014028_Business_Date.pdf

Excel Workbook: XYZ Company_NIHAI2014028_Business_Date.xlsx

5. Formatting, Number of Copies, and Page Limitations

a. Formatting for discs and proposals submitted online through eCPS:

1) Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information;

2) Font size must be 10 to 12 points;

3) Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text;

4) Margins must be at least one-inch on all sides;

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

b. Number of copies and applicable page limitations:

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 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 ONLINE (using the eCPS website)

One (1) electronic copy of the Technical Proposal

(including all Attachments)

DISC (i.e., CD or DVD)

One (1) Disc containing one electronic copy of the

Technical Proposal (including all Attachments)

Not to Exceed

75 pages

(inclusive of all

Attachments except CVs)

Business Proposal ONLINE (using the eCPS website)

One (1) submission containing two files, as instructed below.

a. 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/sites/default/files/DGS

/contracting-forms/spshexcl_dec2012.xlsx).

b. One (1) Electronic Cost Proposal Excel Workbook

See a. above - Breakdown of Proposed Estimated

Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook. Microsoft Excel 2007 version or later is required.

DISC (i.e., CD or DVD)

One (1) Disc containing two files, as instructed in Section

III.A above.

N/A

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

Code and corresponding size standard which best describes the nature of the requirement in the solicitation.

C. 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 are 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).

D. 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.

E. 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.

F. Preparation Costs

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

G. 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://www.hhs.gov/asfr/ogapa/acquisition/policies/promoting-efficient-conference-spending-policy-12-16-2013.html).

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.

H. 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:

George W. Kennedy, Contracting Officer

Division of Microbiology and Infectious Diseases Branch

National Institute of Allergy and Infectious Diseases

DEA, Office of Acquisitions

5601 Fishers Lane, Room 3D32, MSC 9821 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/

Bethesda, MD 20892-9821

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

I. Restriction on Pornography on Computer Networks

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

J. Gun Control

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

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://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=c868ce44081bdf3d09de55d230c9b5b7&r=PART&n=45y1.0.

1.1.51#45:1.0.1.1.51.0.19.4

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.

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=c868ce44081bdf3d09de55d230c9b5b7&r=PART&n=45y1.0.1.1.51#45:1.0.1.1.51.0.19.4 http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=c868ce44081bdf3d09de55d230c9b5b7&r=PART&n=45y1.0.1.1.51#45:1.0.1.1.51.0.19.4 http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=c868ce44081bdf3d09de55d230c9b5b7&r=PART&n=45y1.0.1.1.51#45:1.0.1.1.51.0.19.4

(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.

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

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.

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. Site Visit: Assume five (5) independent site visits through 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

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.

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.

E. Clinical Protocol and Supporting Documents Development

In the performance of the work of developing the final clinical protocol and subsequent revisions to that protocol, offerors should expect the following:

A protocol team that includes representatives from DMID/NIAID

Protocol standards as outlined in http://www3.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch

Final protocol approval from DMID/NIAID no sooner than 3-6 months after the initial protocol team meeting; typically 2-3 revisions may be required.

DMID/NIAID safety oversight of interventional studies (see:

http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Pages

/safetyoversight.aspx)

F. Clinical Protocol Implementation and Support Services requirements

1. The contractor shall plan to attend 1-2 meetings by teleconference with the

Contracting Officer’s Representative (COR) and DMID clinical oversight personnel per month to discuss specific study related issues.

http://www3.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Pages/safetyoversight.aspx http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Pages/safetyoversight.aspx

2. The contractor shall set up a study initiation meeting to provide training on the protocol for all clinical research sites prior to opening the study for enrollment.

3. The contractor and each participating clinical research site shall undergo an initial site assessment to ensure the adequacy of clinical research facilities, equipment and operating procedures, as well as appropriate training of clinical staff with respect to the conduct of human subjects research. Initial clinical site assessments will be conducted by DMID staff and/or DMID-designated entities (DMID-Clinical Research

Management). The contractor shall make all relevant study personnel, documentation, facilities and equipment available for such assessments and shall implement any COR-approved corrective actions resulting from such assessments.

V. Reporting Requirements

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

1. Semi-annual Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for ensuring reporting period. The initial report will be submitted for the first full six months of the contract performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of six full calendar months. A semi-annual report will not be required for the period when an Annual Progress Report is due.

2. 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.

3. Post Award Contract Initiation and Annual Contract Reviews

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.

4. Meetings and Teleconference Minutes

Minutes of regular, as well as ad hoc, meetings and teleconferences shall be provided by the Contractor within two (2) business days following the date of the meeting or teleconference.

5. 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 of Salient Results (not to exceed 250 words) achieved during the performance of the contract.

6. Draft and Final Clinical Protocols

The Contractors shall develop all necessary draft and final full Clinical Protocols in accordance with DMID clinical research policies, templates and requirements as specified at:

http://www3.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/ and coordinate protocol development activities with the COR. DMID final protocol approval will be required before implementation of any clinical research.

7. Draft and Final Clinical Research Supporting Documents

The Contractor shall be required to develop and submit to DMID for review and approval any documents necessary to support the conduct of the clinical research. Examples of documents that may be needed include, but are not limited to: patient consent forms; case report forms, documents to support the conduct of the study such as study manuals (procedures); a formal statistical analysis plan (for interventional clinical trials). The types of documents needed will be dependent of the type of research proposed (i.e. interventional clinical trial or natural history clinical research).

8. Draft and Final Clinical Study Reports

Upon completion of the clinical study/trial, a Draft Clinical Study Report should be prepared within one hundred twenty (120) calendar days after the database lock, as outlined in the data analysis plan, and submitted to the COR for review. A

Final Clinical Study Report shall be submitted to the COR within thirty (30) calendar days of finalization of the report after the draft reports have been reviewed. At least one round of revision and resubmission for final approval is to be expected. The Clinical Study Reports shall include a complete description of the experimental design, protocol, methods, reagents, data analysis, and conclusions of studies as outlined by DMID or the FDA in the ICH E3 Guideline for

Industry: Structure and Content of Clinical Study Reports, depending on the type of study (interventional vs. non interventional)

(http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy

/E3/E3_Guideline.pdf).

9. Human Subject IRB Annual Report (Form 9OMB No 09900-263)

Within thirty (30) calendar days of each anniversary date of the effective contract award, submit Human Subject Annual Report to the COR and Contracting Officer

(CO).

10. Clinical trial registration

The Contractor shall be responsible for registering the trial and posting of data in compliance with current Federal law with regards to clinical trials, unless otherwise negotiated with the COR and CO. http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering http://www3.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/ http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhoIsResponsibleForRegistering

11. Other Reports

Copies of other documents generated under the BAA may include draft and final annual reports for IND submissions, DMSB/SMC reports, and other study status reports. These will be negotiated post award and will be dependent on the type of study proposed.

B. Delivery Schedule

Delivery of other reports and deliverables will be proposed by the offerors in their technical proposal. They will be developed further after receipt of proposals as a result of finalization of the SOW and other terms and conditions of any resultant contract during negotiations.

C. Post-Award Requirements

Please note that 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.

1. Clinical Protocol Implementation Requirements

a. Contractors must ensure that the clinical research is conducted in accordance with all Federal regulations, the NIAID Clinical Terms of Award

(http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf) and, the International

Conference on Harmonization ICH-E6-GCP guidelines

(http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html). During negotiations further DMID guidance will be provided regarding requirements for the conduct of clinical trials.

b. Following DMID approval of the clinical protocol, the contractor shall secure

Institutional Review Board (IRB) approval and submit to the COR, or the COR’s designee, copies of all Essential Documentation, as defined by the ICH-E6-GCP

(http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html, to conduct the final, COR approved, clinical trial for all participating clinical sites.

c. For interventional studies, the contractor is not expected to serve as the

Investigational New Drug/Investigational Device Exemption (IND/IDE) sponsor.

For those trials where an IND/IDE submission is required, DMID will serve as the

IND/IDE sponsor and will assume responsibility for all required IND/IDE submissions. The necessity for an IND/IDE filing will be determined post-award.

If an IND/IDE is necessary, the contractor shall be responsible for:

assisting the COR and the DMID Office of Regulatory Affairs (ORA) as needed in preparing IND/IDE applications and amendments, pre-IND/IDE submission http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html briefing materials, and other documents for submission to regulatory agencies;

participating in meetings and teleconferences with officials of the U.S. Food and

Drug Administration (FDA); and assisting in responding to FDA comments, questions and requests for additional information relative to IND/IDE applications/studies.

2. Clinical Research Support Services

The DMID/NIAID stratifies clinical research according to resources required to adequately ensure the safety of subjects. Research is stratified into three broad resource allocation categories: Low risk, medium risk and high risk.

NIAID defines high-risk clinical trials as those that have one or more of the following attributes:

involves a non-routine intervention, that is, an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;

involves administration of an unlicensed product; or involves administration of a licensed product for an unapproved indication.

For high-risk clinical trials under DMID-held INDs, DMID will provide the data management, clinical site monitoring and regulatory document review. The contractor shall be responsible for the administrative oversight of the study, managing document development and ensuring compliance of sites with study requirements and DMID oversight. The contractor shall also be responsible for assisting the COR and his/her designees in scheduling study initiation activities, planning agendas and distributing study-specific materials, including Final

Protocols and protocol-related documents, to participating clinical research site personnel. The contractor shall instruct the sites on protocol-specific requirements and procedures. The contractor shall interact and cooperate with other DMID contractors responsible for the data management system, clinical site monitoring and essential regulatory document review.

For medium and low risk studies or for high risk studies that do not require an

IND, the COR will determine, on a study-specific basis, the types of study initiation activities that may be required prior to protocol implementation. Such determinations will be based on an assessment of protocol risk, the characteristics of individual participating clinical research sites, and/or other protocol-related features. Study initiation activities shall be conducted via meetings, videoconferences or teleconferences as determined by the COR in consultation with the Principal Investigator. The contractor shall be responsible for assisting the COR and his/her designees in scheduling study initiation activities and developing study-specific materials; planning agendas and distributing study-specific materials, including Final Protocols and protocol-related documents, to participating clinical research site personnel; and making presentations on protocol-specific requirements and procedures. The Contractor shall interact and cooperate with other DMID contractors providing clinical research support or safety oversight.

Clinical site and study monitoring visits during the conduct of interventional clinical trials will be conducted by DMID staff and/or DMID Clinical Research

Operations Management Support (DMID-CROMS) contractors. Clinical site and study monitoring for non-interventional studies are the responsibility of the contractor.