SOURCES SOUGHT
R -- Subject Matter Expert/Consultant to the Center of Veterinary Medicine (CVM)
- Notice Date
- 10/31/2014
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1138367
- Archive Date
- 11/25/2014
- Point of Contact
- Tammy L. Wright, Phone: 2404027587, Jamie Whitt, Phone: 240-402-7627
- E-Mail Address
-
tammy.wright@fda.hhs.gov, james.whitt@fda.hhs.gov
(tammy.wright@fda.hhs.gov, james.whitt@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This Request for Information (RFI) is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), HUBzone, Disadvantaged, Veteran - owned, or Women-owned) that can perform the described work in compliance with NAICS code 541690 - Other Scientific and Technical Consulting Services. This information is being sought for acquisition planning purposes only, and shall not be construed as an Invitation for Bid (IFB), a Request for Proposal (RFP), a Request for Quote (RFQ), Solicitation, or an indication that the Government will contract for the items or services described herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted in response to this notice. The Government will not reimburse respondents for any costs associated with submission of the information being requested or reimburse expenses incurred to interested parties for response to this SOURCES SOUGHT NOTICE. Any responses received will NOT be used as a proposal. No official solicitation currently exists in connection to this RFI. If in the future an official solicitation is released, there is no guarantee that sources identified in the RFI will be utilized. **** NO QUESTIONS WILL BE ENTERTAINED **** The Food and Drug Administration (FDA), Office of Acquisition and Grant Services (OAGS), Division of Acquisition Operations (DAO), is seeking to identify Small Businesses with capabilities or prior experience in providing professional services such as consultation, advisory, or project management, as it relates to the execution of mandates of the Minor Use Minor Species (MUMS) Animal Health Act of 2004. The contractor may provide substantive direction, collaboration, and advice for the development and issuance of regulations, evaluation of comments to public dockets, and related preparation of guidance for industry for the implementation of the MUMS Animal Health Act of 2004. The contractor may represent a variety of critical public health issues facing CVM. Specific activities anticipated under this effort may include, but are not limited to, participation in strategic planning, management or scientific evaluation activities, meeting both internal and public, and other regulatory systems and science venues as may be determined by CVM. The responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Responses should be no more than fifteen (15) pages long (Letter size (8 ½ x11) with no less than one (1) inch margins in Times New Roman font size of 11 or larger). A copy of the company's capability statement may also be accepted as supplemental information, but not as a replacement of the responses to the below questions). The anticipated period of performance is one (1) twelve (12) month base period of performance and four (4) twelve (12) month option periods of performance. After review of the responses received, a pre-solicitation synopsis and/or formal solicitation may be published on the Federal Business Opportunities website (www.fbo.gov). Responses to this notice must respond to the following questions: 1. Company name, address, CAGE code, and DUNS 2. Point of contact information - name, phone number, and email address 3. Is your business a small business under the NAICS code? 4. Does your firm qualify as a small disadvantaged business? 5. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small Business Act. 6. Are you considered a certified HUBZone firm? 7. Are you considered a woman-owned or operated business? 8. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business? 9. Describe your knowledge and experience with the new animal drug approval process and the requirements that are imposed post approval. 10. Describe your knowledge of the Food, Drug, and Cosmetic (FD&C) Act and the MUMS Animal Health Act of 2004 11. Describe your knowledge of veterinary medicine and husbandry practices regarding a wide range of minor species and medical considerations related to rare diseases in the major species as addressed in the MUMS Animal Health Act of 2004. 12. Describe your proven capability to draft documents for review and approval. 13. Describe your knowledge of the regulations for determining a statutory "small number" of animals. 14. Describe your knowledge of statutes governing other agencies such as Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the National Environmental Policy Act (NEPA). 15. Describe your experience with chemistry and systems associated with the manufacture of new animal drugs 16. Describe your knowledge of precedents and policies guiding product labeling as it relates to the Indexing of new products. 17. Describe your knowledge of the MUMS drug approval and indexing process, biotechnology issues related to new animal drug approval product labeling, Drug Efficacy Study Implementation finalization, and generic new animal drugs. Responses must be received in writing, by no later than November 10, 2014 - 4:30 PM, Eastern Time. This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this notice shall be emailed to Tammy Wright at tammy.wright@fda.hhs.gov or mailed to the Department of Health and Human Services (DHHS), U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS), 5630 Fishers Lane, Room 2079, Rockville, MD 20857, Attn: Tammy Wright. No solicitation is currently available. Responses to this sources sought synopsis will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Reference No. 1138367
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1138367/listing.html)
- Place of Performance
- Address: Department of Health and Human Services (DHHS), U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS), 5630 Fishers Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN03563227-W 20141102/141031234021-794701dd6af1b94da7be6355c719d473 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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