SOURCES SOUGHT
A -- Biological Testing Facility
- Notice Date
- 3/13/2014
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-CDDB-2014-14
- Archive Date
- 9/30/2014
- Point of Contact
- Gilberto Perez-Rosa, Phone: 3014519698, Timni Mahase, Phone: 301-435-8867
- E-Mail Address
-
gilberto.perez-rosa@nih.gov, timni.mahase@nih.gov
(gilberto.perez-rosa@nih.gov, timni.mahase@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: This is a Research and Development ( R & D) Sources Sought notice. This is NOT a solicitation for proposals. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks capability statements from interested and qualified potential sources for the NICHD Biological Testing Facility (BTF). The NI H, NICHD is the lead Federal agency that fulfills a unique role in bridging the discovery of contraceptive targets to the development and approval of the contraceptive products. The studies at the BTF will encompass discovery and optimization of compounds as anti-fertility agents. The BTF fulfills a unique role in bridging the discovery of contraceptive targets to the development and approval of the contraceptive products. The primary objective is to provide a state-of-the-art facility and the capability and capacity to carry out biological safety and efficacy evaluations of new entities with the goal of satisfying the regulatory requirements necessary to be able to introduce the new entities into clinical trials. In addition, the BTF has an important role in enriching and providing the pre-clinical support services necessary to make progress toward the development of high quality, safe and effective male and female contraceptive products. This initiative will provide overall project management and the capabilities to support all phases of preclinical development of contraceptives, including process and product development, clinical lot production, formulation, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications. The contractor will : 1. Assist in identifying products that are ready for development and production by assembling information on experimental anti-fertility agents and/or therapies; 2. Identify potential subcontractors with the capability and interest in producing clinical product lots and to issue and administer subcontracts for the production of products; 3. Perform all preclinical testing of the products necessary for Investigation New Drug (IND) application, either in-house or via subcontracts, and to compile and submit these data in the form of a formal IND submission to the FDA; and 4. Provide information management and IND preparation and filing support as part of their in-house activities as required by the FDA. Overall Areas of Expertise 1) Preclinical Services: a. Efficacy Evaluation Services b. Safety and Toxicology Evaluation and ADME Profiling Services c. Formulation Services d. GMP facilities for product preparation, stability and product release of steroids and other biological compounds to be used in clinical studies e. Animal care and maintenance services 2) General Services : a. Project Planning, Initiation, Implementation and Management b. Database, Data, Document, Product, Specimen/Reagent and Inventory Management. c. Receive, Format, Store, Ship and Record Compounds/Products and Biological Agents d. System Security Plan (SSP) Responses: Capability statements in response to t h is announcement should be no longer than 15 pages inclusive o f al l material. Response s wil l b e evaluate d o n th e basi s of experience, expertise, and capabilities in the areas c i te d above. The anticipated contract type will be a cost reimbursement IDIQ with a base year o f one year and five option years. The RFP is anticipated to be posted on or about April 30, 2014 on FedBi z Opp s (FBO ) w ebsite: h t tp://www.fedbizopps.gov. Dis c laime r an d Importan t Notes : Thi s no t ice does not obligate the Government to award a contract or otherwise p ay for the information provided in the response. The Gov e rnment reserves the right to use inf o rmation provided b y respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this n otice should ensure that its response is compl e te and s u fficiently detailed to all o w th e governmen t t o determine the organization's qualifications to perfor m th e work. Respondent s a r e advise d tha t th e Governmen t i s unde r no o bligation to acknowledge receipt of the information received or provide feedback to respondents with respect to a ny i nformation submitted. After a review of the respon s es received, a pre-solicitation synopsis and solicitation ma y b e publishe d i n Federa l Busines s O pportunities. However, responses to this notice will not be considered a dequate respons e s to a solicitation. CONFIDIENTIALITY : N o proprietary, c lassified, confidential, or sensitive information should be included in your response. Th e governmen t reserve s th e righ t t o us e an y non-proprietary technical information in any resultant s oli c i t at i on(s). Businesses that believe they possess the capabilities necess a ry to undertake this proje c t s hould submit electronic c opies in addition to two (2) hard copies of their capab i lit y statement, addressin g t h e a rea s above. Pleas e limit response s t o fiftee n (15 ) page s o r less. An y p ropriet a ry i n formation should be so marked. Written capability s tatements should be received by the C ontractin g Office r b y n o late r tha n 2:0 0 P M Easter n T im e o n Marc h 31, 2 014. Capability statements m u st iden t if y th e busines s statu s o f th e organizatio n (i.e. educ ational institution, non- p rofit, large business, small business, 8 (a), or other corporate or non - corporat e entity). Informatio n submitte d shoul d b e pertinen t and s pecific in the technical area u nder consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific wor k previousl y performe d o r bein g performe d an d an y in-house research and developm en t effort ; (2 ) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may b e assigned as princi p al investigator and/or project officer: (3) Facilitie s : A v ailability and description of special facilitie s require d t o perfor m i n th e technica l area s under consideration, and a st atemen t regardin g industrial s ecurity clearance. Any other specific and pertinent infor m ation as pertains to this pa r ticular area of procurement that would enhance our consideration and evaluation of the information submitted. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. Inquiries s hould be directed to: Timni Mahase, Contractin g Officer, DHHS/NIH, N at ional Institute o f Child H ealt h an d Huma n Development, 6 100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda MD 2089 2 -7510, Rockville, MD 20852 (for o vernight/express/courier service), telephone: 301-435-8867, email: mahaset@mail.nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-CDDB-2014-14/listing.html)
- Place of Performance
- Address: Agency: Department of Health and Human Services, Office: National Institutes of Health, Location: National Institute of Child Health and Human Development, Bethesda, Maryland, 20892-7510, United States
- Zip Code: 20892-7510
- Zip Code: 20892-7510
- Record
- SN03309892-W 20140315/140313235004-9702d00b0f1aba27a774389bf4ce753f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |