SOURCES SOUGHT
R -- Scientific Consulting Services
- Notice Date
- 2/14/2013
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(DE)-2013-071-JML
- Archive Date
- 3/9/2013
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
learj@nhlbi.nih.gov
(learj@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice No.: NHLBI-CSB-(DE)-2013-071-JML Title: Laboratory Support Services This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The purpose of this SS is to identify qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB] that are interested in and capable of providing scientific consulting and support services to the National Institute of Dental and Craniofacial Research (NIDCR), Division of Intramural Research (DIR) in accordance with the below information. The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this Sources Sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible small business concerns [particularly Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB)] under the North American Industry Classification System (NAICS) code 541690 with a size standard $14.0M. Based on the responses received from this SOURCES SOUGHT announcement, the proposed acquisition may be solicited as a Total Small Business Set-Aside. All eligible small business concerns responding to this Sources Sought Announcement must have the capabilities to provide the services as stated below. Background The Molecular Physiology and Therapeutics Branch (MPTB), Division of Intramural Research (DIR), National Institute of Dental and Craniofacial Research (NIDCR) has a need for the services of an expert who can advise the institute on the preparation and submission of an IND for our AAVhAQP1 gene therapy trial as a treatment for ionizing radiation (IR)-induced parotid gland hypofunction. Contractor Requirements: Task 1 - Initial Review and Gap Analysis: The contractor shall review and provide comments on non-clinical and CMC data/information, and proposed clinical protocol to assess readiness for Pre-IND meeting and IND submission. Task 2 - Pre-IND (Type B) Meeting Support: The contractor shall develop a Pre-IND meeting strategy and request a Pre-IND meeting with the FDA at the appropriate time. The contractor shall guide NIDCR in development of a Pre-IND package including the following as appropriate: -Nonclinical section that contains summary of the pharmacology and toxicology studies completed to support use of product in proposed clinical trial; -CMC section outlining the detailed description of the final product, product components, the manufacturing process and test methods and product characterization; and, -Draft clinical protocol or protocol synopsis. The contractor shall review the Pre-IND information package prepared by NIDCR. The contractor shall prepare a required number of Pre-IND meeting package copies for submission to FDA. The contractor shall review the FDA preliminary comments in advance of the Pre-IND meeting. The contractor shall conduct rehearsal with NIDCR staff and attend the Pre-IND meeting and provide meeting minutes (if applicable). The contractor shall participate in a debriefing meeting. The contractor shall provide analysis of meetings to include: 1) potential impact(s) on initial projected IND submission timeline; and 2) suggested changes to proposed CMC information, clinical protocol, or additional pharmacology / toxicology data, if any, requested by the Agency. Task 3 - IND Preparation and Review: The contractor shall outline appropriate content and format for the original IND based on information obtained during the Pre-IND meeting. The contractor shall review and edit IND sections prepared by NIDCR and participate in teleconferences as needed. Task 4 - IND Document Preparation: The contractor shall format final IND section documents; create pdf file(s) mimicking the final package for review by NIDCR; compile all final documents into an organized submission with labeled tabbed section dividers as needed; create three copies, at the minimum, for FDA and one copy for NIDCR archives in FDA specified binders; and, provide all finalized source documents via Central Desktop or on media following submission. Task 5 - Preparation of RAC Submission: The contractor shall assist in preparation of NIH, RAC submission including Appendix M, abstracts, draft protocol, and draft informed consent document; provide help with formulation of response to RAC review comments and questions; conduct preparation for RAC meeting (if full RAC review is required); and, attend RAC meeting, provide analysis, and follow-up to meeting recommendations. Government Responsibilities: Not applicable Reporting Requirements and Deliverables: The contractor shall provide monthly itemized invoices to NIDCR. Inspection and Acceptance Requirements: Not applicable Period of Performance The proposed period of performance will be twelve (12) months from date of contract award. Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 10 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above and in the draft SOW. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Jonathan Lear, Contract Specialist, at learj@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), by February 22, 2013 12:00PM, EST. All responses must be received by the specified due date and time in order to be considered.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(DE)-2013-071-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health/NIDCR, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02988073-W 20130216/130214234446-5bff3f80896db539c5cc7149eb13712e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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