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Division of Microbiology & Infectious Diseases: Regulatory Affairs Support

Solicitation Number: NIAID-DMID-NIHAI2014004
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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NIAID-DMID-NIHAI2014004
:
Solicitation
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Added: Mar 19, 2014 2:16 pm
Type of Requirement:
Re-competition (HHSN272200800069C)

Current Contractor:
SAIC
5202 Presidents Court
Suite 110
Frederick, MD 21703

Contracting Office Address:
Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3223, MSC 7612, Bethesda, MD, 20892-7612

Duration of contract
:
1 Year Base Period plus 6 Additional Option Years

If Options will be included, describe Options
:

- Option Periods
   6 one-year Option Periods.

- Option Quantities
   4 Option Quantities for each contract period, to increase the level of effort.

Total Small Business Set-Aside
This solicitation is reserved exclusively for small business concerns, pursuant to FAR 19.502-2 Total Small Business Set-Asides.  The NAICS Code is 541711 with a size standard of 500 employees.

Anticipated award date
:
07/01/15

Presolicitation Notice Information


Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases, has a requirement for regulatory assistance for a broad spectrum of DMID research activities poised for regulatory approval or licensure.

Description
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), strives to understand, treat and ultimately prevent the myriad of 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 other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which is funded through a variety of research grants and contracts.

Developing and testing new vaccines and therapies have historically been a major focus of the research supported by the DMID. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., avian influenza and West Nile Virus), as well as those supporting the evaluation of the safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). In order to ensure that the development, testing and manufacture of products evaluated under DMID-supported clinical research are executed with a rigor that will support licensure by the Food and Drug Administration (FDA), DMID supports an infrastructure to provide regulatory assistance in the development and testing of these products.

Currently, DMID sponsors approximately 100 Investigational New Drug Applications (INDs) or Master Files (MFs) which span more than 200 clinical trials. This includes both multicenter trials and single center studies, and encompasses Phase 1, 2, and 3 clinical trials performed at both domestic and foreign sites. DMID files approximately 10-20 new INDs each year, and in this capacity, serves as the official IND sponsor and liaisons with the FDA with respect to all regulatory requirements. Currently, the DMID IND portfolio is comprised of approximately 75% vaccine and other biologic (monoclonal) INDs, 20% drug INDs, and 5% MFs. DMID is also the sponsor of an open Investigational Device Exemption application (IDE) and supports interaction with the FDA for studies that support 501(k) filings.

The purpose of this solicitation is to provide scientific, regulatory, technical, project management, and administrative assistance for a broad spectrum of DMID research activities poised for regulatory approval or licensure.


It is anticipated that a single cost-reimbursement, Level of Effort type contract will be awarded with a one-year base period of performance beginning on or about 07/01/2015 and the inclusion of 6 one-year option periods. The Government estimates that the Level of Effort will be 28,252 labor hours, inclusive of subcontractors and consultants, for the base period and for each one-year option period. Additionally, each contract period will contain 4 option quantities totaling another potential 28,252 labor hours.


Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 04/03/2014, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

Added: Apr 17, 2014 10:48 am Modified: Jun 10, 2014 4:01 pmTrack Changes
Amendment 1 - The purpose of Amendment Number One is to: (1) update the FedBizOpps Response Date to reflect the due date for proposals as set forth in Section A of the Solicitation; and, (2) to revise the Issue Date in Section A, Item 3. of the Solicitation to 04/17/2014.

Amendment 2 - The purpose of Amendment Number Two is to respond to questions received regarding this solicitation and to provide a final date for the submission of questions.
Added: Jul 14, 2014 3:04 pm
Amendment 3 - The purpose of Amendment Number Three is to respond to further questions received regarding this solicitation.
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Solicitation 1

Type:
Solicitation
Posted Date:
April 17, 2014
Description: Solicitation - Request for Proposals NIAID-DMID-NIHAI2014004 - "Division of Microbiology & Infectious Diseases: Regulatory Affairs Support"

Amendment 1

Type:
Mod/Amendment
Posted Date:
April 17, 2014
Description: Amendment 1

Amendment 2

Type:
Mod/Amendment
Posted Date:
June 10, 2014
Description: Amendment No. 2 - NIAID-DMID-NIHAI2014004

Amendment 3

Type:
Mod/Amendment
Posted Date:
July 14, 2014
Description: Amendment 3 - NIAID-DMID-NIHAI2014004
:
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612
:
Tiffany Chadwick,
Contract Specialist
Phone: 301-435-0699
:
George Kennedy,
Team Lead
Phone: 301-451-2607