SOURCES SOUGHT
65 -- Pharmaceutical Relabeling Request for Information (RFI) - Specifications
- Notice Date
- 11/9/2009
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- 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
- 2010-Q-11853
- Archive Date
- 12/15/2009
- Point of Contact
- Christine N Godfrey, Phone: 404-639-7496, Vivian S Hubbs, Phone: (770) 488-2647
- E-Mail Address
-
cnp9@cdc.gov, vhubbs@cdc.gov
(cnp9@cdc.gov, vhubbs@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Sample Label Agency: Centers for Disease Control and Prevention (CDC) Action: Pharmaceutical Relabeling Request for Information (RFI) Background On behalf of state and local public health agencies, the Centers for Disease Control and Prevention (CDC), Division of Strategic National Stockpile (SNS) is seeking to identify Food and Drug Administration (FDA) registered re-labeling companies with the capability to re-label government owned (Federal, State and Local Government Public Health Agencies) unit-of-use bottles of antiviral drugs with extended expiry dating. Description This is a request for information only. It is not a request for proposals and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government which includes Federal, State, and Local and will not be returned. The following outlines the requirements needed for relabeling and recasing government owned unit of use bottles: 1. Contractor shall be registered under Section 510 of the FD&C Act (21 U.S.C. §360) 2. Contractor shall have experience and expertise in FDA approved re-labeling programs for human drugs 3. Contractor's procedures shall conform to applicable United States Food and Drug Administration (FDA) laws, regulations and requirements, including those governing Current Good Manufacturing Practices (cGMP) that prevent misbranding or adulteration of government owned products of government owned products 4. Contractor shall be able to accept multiple shipments of various quantities of government owned pharmaceuticals for relabeling and repackaging in accordance with the performance specifications 5. Contractor shall use pharmacy grade labels to re-label government owned pharmaceuticals and shall comply with all applicable regulatory requirements. 6. The contractor shall be responsible for attaching the new labeling to each applicable product container and ensuring a complete and accurate reconciliation and documentation of each lot of labelers used in the re-labeling process to prevent the inadvertent mislabeling of any product. The contractor shall be responsible to ensure complete labeling consistency between the outer and inner labeling for each product. 7. Upon completion of re-packaging the contractor shall be responsible for re-labeling the outer cartons and inner units with complete, accurate and documented reconciliation for each lot to ensure uniform labeling consistency between outer and inner labeling for each product to prevent the inadvertent mislabeling of any product. Response Data obtained from this RFI will be used by Federal, State and Local Governments in refining the acquisition strategy for the procurement of relabeling services. Interested organizations that have candidate services are invited to submit a written response to CDC. To facilitate a response, the unit of use bottle and label dimensions are as follows. Also please see the attachment for a sample. Bottle: Description: Plastic (HDPE), Square, 90cc (2oz) Dimensions: wall thickness: 0.021" at center panel; weight: 10.5 g ± 0.8g; overflow capacity 93.00cc ± 3.0cc Label: 4"x 1-7/16" ± 1/32" (linear width 1-9/16"); corner radius: 1/16" typical (see attached PDF) As a minimum, submitted information should include: a) A description of the respondent's approach to design and procedures detailing each step in the relabeling and recasing process These policies and procedures must conform to applicable United States Food and Drug Administration (FDA) laws, regulations and requirements, including those governing Current Good Manufacturing Practices (cGMP) that prevent misbranding or adulteration of government owned products shall become part of any resultant contracts(s), and made available to the government upon its request. b) A description of the expected challenges in executing these functions and achieving these objectives, and the manner in which the respondent's solution addresses these challenges; c) A description of the technologies supporting the proposed approach; d) A description of the critical success factors for achieving success in execution of the functions and achievement of the objectives; and e) A listing of the categories of prices and estimates of those prices on a per-unit basis with and without pick-up and delivery provided by the contractor, if readily available for commercial products or services, or an indication of the price estimate for products or services that are not readily available commercially. REMINDER: This is not a request for proposals. Supporting cost data is not required nor requested. Any pricing data provided, including estimates, is informational only and will be used to help formulate and refine the Government Cost Estimate for this requirement. This is an aspect of market research only. Providing pricing information is optional. f) Point of Contact information including name, direct phone number, and email address. Information submitted to CDC will be shared with State and Local Governments. Any questions regarding this request should be submitted electronically to the Contracting Officer by 12:00 p.m. (noon) Monday, November 16, 2009 at cgodfrey@cdc.gov. Information should be submitted by 12:00 p.m. (noon) on Monday, November 30, 2009. Responses should be limited to 12 pages, are preferred in electronic format, and can be e-mailed to the attention of the Contracting Officer: Christine Godfrey, Phone 404-639-7496, email cgodfrey@cdc.gov. If the Contracting Officer isn't available, please call the Team Leader, Vivian Hubbs. Contractors who responded to the original RFI 2009-Q-11513 issued July 09, 2009 need not respond to this requirement. Original Point of Contact Christine Godfrey, Contract Specialist, Phone (404) 639-7496, Fax (404) 639-2095, Email cgodfrey@cdc.gov Vivian Hubbs, Contract Specialist, Phone (770) 488-2647, Fax (770) 488-2670, Email vhubbs@cdc.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2010-Q-11853/listing.html)
- Place of Performance
- Address: Various, United States
- Record
- SN02000891-W 20091111/091109235126-d08ae693e94e6148bff9ef82e144fa70 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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