Amendment_No._1_-_.pdf

AMENDMENT OF SOLICITATION

Solicitation Number: PHS 2015-1 Amendment Number: 1

AMENDMENT ONE (1)

Issued by:

National Institute of Allergy and Infectious Diseases (NIAID) Office of Acquisitions 6700-B Rockledge Drive, Suite 300 Bethesda, MD 20892

Solicitation Number:

PHS 2015-1

Date of Solicitation Issuance:

08/15/2014

Date of Amendment No.1 Issuance:

09/11/2014

Number of Pages:

6 Pages

Attachments:

PHS 2015-1 – Amendment 1

NIAID Point of Contact:

Tiffany Chadwick, Contract Specialist George Kennedy, Contracting Officer Email: tiffany.chadwick@nih.gov Email: kennedyg@mail.nih.gov Phone: 301-435-0699 Phone: 301-451-2607

The hour and date specified for receipt of Offers remains unchanged, 4:30 PM Eastern Prevailing Time on November 5, 2014.

mailto:tiffany.chadwick@nih.gov mailto:kennedyg@mail.nih.gov

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment.

FAILURE OF YOUR ACKNOWLEDEMENT TO BE RECEIVED AT THE PLACE

DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE

SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

Purpose of Solicitation Amendment:

The purpose of this amendment is to provide corrections and revisions to Sections 3.1, 3.2, 6.4, 8.3, 9, 10, and 12 of the subject solicitation.

Accordingly, Solicitation PHS 2015-1 is revised as follows:

Section 3.1 General Definitions, Direct to Phase II, is revised to read as follows:

Direct to Phase II. A new pilot authority under P.L. 112-81 that allows NIH to issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development, if the small business had performed the Phase I stage-type of research through other funding sources (non SBIR/STTR). Certain NIH topics will allow Direct to Phase II SBIR proposals in this solicitation.

Section 3.2 Definitions (Relating to R&D), is revised to add the following definition:

Investigational Device Exemption (IDE). An IDE is a regulatory submission that permits clinical investigation of devices. This investigation is exempt from some regulatory requirements. The term “IDE” stems from the description in 21Code of Federal Regulations

(CFR) 812.1.

Section 6.4 Award Decisions, is revised to read as follows:

For proposals recommended for award, the awarding component considers the following:

1. Ratings resulting from the scientific/technical evaluation process;

2. Areas of high program relevance;

3. Program balance (i.e., balance among areas of research);

4. Availability of funds, and.

5. Cost/Price

The government anticipates that prospective offerors will develop unique proposals in response to the topics of research set forth in this solicitation. The agency is not under any obligation to fund any proposal or make any specific number of contract awards in a given research topic area. The agency may also elect to fund several or none of the proposals received within a given topic area. SBIR contract projects do not require establishing a competitive range but an order of merit ranking and cost analysis is performed before reaching source selection decisions

Section 8.3 Fast Track and Direct to Phase II Proposal Instructions (NIH Only), Item 4, Paragraph (C) Research Plan for Phase II (FAST TRACK or Direct to Phase II) Research Plan, is revised to add Item 9, as follows:

9) Subcontractors/Consultants. Involvement of a university or other subcontractors or consultants in the project may be appropriate and is permitted. If such involvement is intended, it should be described in detail and identified in the cost proposal. In addition, supported by appropriate letters from each individual confirming his/her role in the project must be included. Small business concerns must perform a minimum of one half for Phase II of the research and/or analytical effort (i.e., total contract price less profit/fee) conducted under the resulting contract. The Contracting Officer must approve deviations from this requirement in writing after consultation with the agency SBIR Program Manager/Coordinator.

Section 9, Summary of HHS Components Anticipated Number of Awards, is revised as follows:

HHS Components Anticipated No. of Awards Anticipated Time of Award

National Institutes of Health (NIH) National Cancer Institute (NCI) 20-31

Scientific and Technical Merit Review: March-May 2015 Anticipated Award Date: August- September 2015

National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS)

4-8

Scientific and Technical Merit Review: March-May 2015 Anticipated Award Date: September

National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI)

Scientific and Technical Merit Review: February-April 2015 Anticipated Award Date: July- September 2015

National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID)

4-7

Scientific and Technical Merit Review: March 2015 Anticipated Award Date: August

National Institutes of Health (NIH) National Institute on Drug Abuse

(NIDA)

3-4

Scientific and Technical Merit Review: March 2015 Anticipated Award Date: August

Centers for Disease Control and Prevention (CDC)

1-2

Scientific and Technical Merit Review: May-June 2015

HHS Components Anticipated No. of Awards Anticipated Time of Award

Center for Global Health (CGH) Anticipated Award Date: August

Centers for Disease Control and Prevention (CDC) National Center for Chronic Disease Prevention and Health Promotion

(NCCDPHP)

Review: May-June 2015 Anticipated Award Date: August

Centers for Disease Control and Prevention (CDC) National Center for Emerging Zoonotic and Infectious Diseases

(NCEZID)

Review: May-June 2015 Anticipated Award Date: August

Centers for Disease Control and Prevention (CDC) National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention

(NCHHSTP)

Review: May-June 2015 Anticipated Award Date: August

Centers for Disease Control and Prevention (CDC) National Center for Immunization and Respiratory Diseases (NCIRD)

Review: May-June 2015 Anticipated Award Date: August

Section 10, Contracting Officers and Addresses for Delivery of Contract Proposals, is revised as follows:

The information provided for the NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS) is revised from

Mr. Bryan Jones, Phone: 301-594-1852, E-mail: bryan.jones@nih.gov to

Mr. Sean Dalenberg, Contracting Officer Office of Acquisitions

NIDA COAC

6701 Democracy Blvd, Suite 1084 Bethesda, MD 20892-4874*

*Change the zip code to 20817 if hand-delivered or delivered by an express or other courier service to the NCATS.

The office title provided for the NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) is revised from

Review Branch Division of Extramural Research Activities National Heart, Lung, and Blood Institute to

Office of Scientific Review Division of Extramural Research Activities National Heart, Lung, and Blood Institute

The acronyms used to identify Centers provided for the CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) are revised as follows

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION

(NCCDPHP)

NATIONAL CENTER FOR EMERGING ZOONOTIC AND INFECTIOUS DISEASES (NCEZID)

NATIONAL CENTER FOR HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES (NCIRD)

Section 12 Component Instructions and Technical Topic Descriptions, is revised to correct the following Topic numbers:

National Center for Advancing Translational Sciences (NCATS)

Exploring the Potential of CRISPR/CAS Genome-editing Tools, is revised from Topic number 007 to 009

Assay Development for High-Throughput Screening of Chemicals of Toxicological Concern, is revised from Topic number 009 to 010

Simple and Robust Reaction Progress Analyzer, is revised from Topic number 341 to

Online Real Time Metals Analysis at Low ppm Level, is revised from Topic number 342 to 012

National Heart, Lung, and Blood Institute (NHLBI), Limited Amount of Award, is revised to read as follows:

Limited Amount of Award

For budgetary, administrative, or programmatic reasons, the NHLBI may not fund a proposal and does not intend to fund proposals for more than the budget listed for each topic.

National Institute of Allergy and Infectious Diseases (NIAID)

Simple, Inexpensive Unit for Removing Cells from Small Amounts of Blood in Resource-Limited Settings, is revised from Topic number 031 to 032

Centers for Disease Control and Prevention (CDC)

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Multiplex Assay for Simultaneous Detection of Hepatitis and Other Viruses, is revised from Topic number 032 to 044

Improved Antibody Preparation for Post-Exposure Prophylaxis Against Hepatitis A, is revised from Topic number 033 to 045

National Center for Immunization and Respiratory Diseases (NCIRD)

Thermostable Dry Vaccine Formulation for Microneedle Administration, is revised from Topic number 027 to 029

Thermostable Oral Vaccines to Combat Enteric Diseases, is revised from Topic 029 to 030

The revised solicitation: “PHS 2015-1 – Amendment One”, is attached hereto, incorporating the revisions identified above.

End of Amendment 1