SOLICITATION NOTICE
65 -- RFP 2018-N-67814 - Pharmaceutical Repack and Relabel - RFP 2018-N-67814
- Notice Date
- 7/30/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 561910
— Packaging and Labeling Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2018-N-67814
- Archive Date
- 9/7/2018
- Point of Contact
- David A. Smythe, Phone: 7704882782
- E-Mail Address
-
kuz4@cdc.gov
(kuz4@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- QCU Requirements - 2018-N-67814 RFP 2018-N-67814 A.1 Purpose This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. A.1.2 Solicitation Number The solicitation number is 2018-N-67814 and is being issued as a request for proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-99. A.1.3 NAICS Code The associated North American Industrial Classification System (NAICS) code for this procurement is 561910 - Packaging and Labeling Services with a small business size standard of $11 million. THIS IS A FULL AND OPEN COMPETITION. Offerors must be registered in the System for Award Management (SAM) at http://www.sam.gov, in order to be considered for award. A.1.4 Type of Contract This combined synopsis solicitation notice is a request for competitive proposals. This requirement is for pharmaceutical repackaing and relabeling services and may result in the award of one or more Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) contracts. The term of the resulting IDIQ contract(s) shall be five (5) years from the effective date of the IDIQ contract(s) A Government review of its requirements and the corresponding discounts for this IDIQ contract will be performed annually. A.1.5 Performance Review A Government review of performance will be performed annually through CPARS. CPARS is the Contractor Performance Assessment Reporting System that reports to the Past Performance Information Retrieval System (PPIRS) which provides timely and relevant information on Contractor performance for use in source selection. The anticipated Period of Performance for this requirement is September 1, 2018 thru August 31, 2023. A.2. Attachment A - QCU Requirements - 2018-N-67814 Attached to this notice is a listing of the various pharmaecuetical Quality Control requirements required by the government. A.2.1 Summary of Key Factors The Contractor, as an independent organization and not an agent of the Government, shall be responsible for providing the necessary expertise and trained staff; a fully operational, licensed, and secure facility; equipment, labor, and materials required to receive, stage, and re-package/re-label bulk pharmaceuticals as well as have the required warehouse space to temporarily hold and be able to ship and receive large quantities of government owned pharmaceuticals. In addition, the contractor shall have the ability to perform these services 24 hours a day, 7 days a week, and 365 days a year (24/7) should an emergency event take place in which these services were needed. All repackaging/relabeling of products must be in compliance with the Code of Federal Regulations (CFR) listed in Title 21 and the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended and implemented regulations. Specifically the parts relevant to this service, in which human drug products are packaged, labeled, held, stored and distributed. To violate any section of the FD&C Act and the CFR is to violate the laws governing the purity, safety, and efficacy of food and drugs, medical devices and cosmetics. The DSNS program and the products included in this program support the Country in a response to national emergencies. See section C.3. A.2.2 Shipping and Transportation The government will hold responsibility for transportation arrangements and costs involved in getting government owned bulk products to the contractor's facility, and for the pick-up of finished government owned repackaged/relabeled products, except the government reserves the right to request delivery and transport in the Request for Task Order Proposal (RFTOP). See Section C.4.2.8 A.2.3 FDA Registration/Licensure Contractor shall be responsible to maintain an FDA registered repacking/relabeling facility and must be registered under Section 5 10 of the FD&C Act (21 U.S.C.360) and must have applicable licenses for packaging and relabeling through contract performance period. All necessary permits and licenses required by Federal, State, and Local authorities shall be acquired before contract award and maintained by the Contractor for the life of the contract. This includes DEA, DOT, EPA, FDA, OSHA and individual State regulations. The Contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the COR and Contracting Officer for retention in the contract file. See Section C.4.3 A.3 Key Dates All questions/inquiries must be submitted to the contracting officer via electronic mail (e-mail) not later than August 6, 2018 Noon EST. Inquiries submitted via telephone will be re-directed to an e-mail submission. Submit offers and/or any questions to the attention of David Smythe at dsmythe@cdc.gov. Questions will be answered by COB August 9, 2018 and responses will be posted to FBO. Proposals are due on August 23, 2018 5:00pm EST. Offerors who fail to complete and submit the requirements of this combined synopsis/solicitation may be considered non-responsive. Proposals received prior to the RFP closing date and time (August 23, 2018 5:00pm EST) will be considered by the CDC. Late proposals will only be accepted or rejected in accordance FAR 15.208. See L.2.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2018-N-67814/listing.html)
- Record
- SN05012567-W 20180801/180730230808-87ac563ca991d9596de475b9c65df3eb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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