75N98019R00005.pdf
PDF 265 KB Posted
- Attached to
- Drug Formulation and Manufacturing Program Federal contract opportunity
- Solicitation number
- 75N98019R00005
About this file
This document provides details on a federal contract opportunity for drug formulation and manufacturing services. The National Institutes of Health Clinical Center Pharmacy Department, Office of Research Support and Compliance, and Office of Logistics and Acquisition Operations are partnering to establish multiple award ID/IQ contracts to develop and manufacture dosage forms of small molecule drug candidates for preclinical studies, Investigational New Drug enabling research, and clinical trials. Services include conducting all manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug compounds. Contractors must maintain technical capabilities, minimum resources, and organizational compliance with FDA, WHO, and ICH cGMP standards as applicable. The NAICS code is 325412 for pharmaceutical preparation manufacturing with a size standard of 1,250 employees. This is a partial small business set-aside with proposals due April 25, 2019.
Amendment 00001
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 75N98019R00005_Amendment_0002.pdf | ||
| sectionk_june2017.pdf | ||
| Q&A.pdf | ||
| Quality_Agreement_template.pdf | ||
| Proposal_Intent_Response_Form.pdf | ||
| 75N98019R00005.pdf | ||
| DFMC_Final.pdf | ||
| Sample_Task_Order.pdf |
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Text version
(x)
75N98019R00005 x x
1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT
THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
x
Rockville, MD 20852-3804
OD/OLAO-OA
6011 Executive Blvd Office of Administration Office of Logistics and National Institutes of Health
03/29/20190001
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
FACILITY CODE CODE
10B. DATED (SEE ITEM 13)
10A. MODIFICATION OF CONTRACT/ORDER NO.
9B. DATED (SEE ITEM 11)
9A. AMENDMENT OF SOLICITATION NO.
CODE
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY
PAGE OF PAGES
4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)
1. CONTRACT ID CODE
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
03/08/2019
CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
D. OTHER (Specify type of modification and authority) appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
E. IMPORTANT: Contractor is not, is required to sign this document and return __________________ copies to the issuing office.
ORDER NO. IN ITEM 10A.
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
As a result of this Amendment, Section L.2.a.3 of the Request for proposal is revised as follows:
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)
15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED
(Signature of person authorized to sign) (Signature of Contracting Officer)
ROBERT J. BURDETTE
STANDARD FORM 30 (REV. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
NSN 7540-01-152-8070
Previous edition unusable
Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .
3. PROPOSAL SUBMISSION INFORMATION
The following instructions will establish the acceptable minimum requirements for the format and contents of proposals. Special attention is directed to the requirements for technical and business proposals to be submitted in accordance with these instructions.
The proposal must use Time New Roman 12-point font, and will not utilize multiple columns on sheet. Except for the Schedule of Prices, font size no smaller than Times New Roman 10 point will be acceptable for tables and graphs. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Graphic resolution must be consistent with the purpose of the data presented. Price proposal tables shall be submitted in Microsoft Excel with formula included. The Contracting Officer must be provided unlocked documents or if password protected, each document's password.
All pages shall contain the phrase: "SOURCE SELECTION INFORMATION - See FAR 2.101 and 3.104".
Questions regarding the solicitation shall be submitted via email to Robert.Burdette@nih.gov no later than 5:00PM local time on 4 April 2019.
In order to prepare for source selection activities, the Government requests that vendors who intend to submit offers for this acquisition complete the attached proposal intent response sheet (Attachment
1) and submit to the email address above by 5:00PM local time on 4 April 2019. Failure to submit the proposal intent response sheet is not grounds for rejection of the offeror’s proposal.
The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. Each Offeror shall appoint and list a single point of contact for negotiations and contract administration once the contract is awarded. Offers will be valid for 180 days unless a different period is specified by the offeror on the cover page of the Business Proposal.
Proposals shall be submitted via email to Robert.Burdette@nih.gov no later than 11:00AM local time on 25 April 2019.
Creating and Naming Files:
1. Create one PDF file of your Technical Proposal, including all attachments. The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.
2. Create one PDF file of your Business Proposal, including all attachments:The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable.
Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.
3. Create one PDF file per subcontractor for subcontractor sealed submission, including all attachments:The Sealed submission should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Sealed Submission PDF file.
4. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).
Examples: Technical Proposal: XYZCompany_NIHOD201800024_Technical.pdf
Business Proposal: XYZCompany_NIHOD201800024_Business.pdf
Excel Workbook: XYZCompany_NIHOD201800024_Business.xlsx mailto:Robert.Burdette@nih.gov mailto:Robert.Burdette@nih.gov mailto:CMSSDA@od.nih.gov mailto:CMSSDA@od.nih.gov mailto:CMSSDA@od.nih.gov mailto:CMSSDA@od.nih.gov
Subcontractor Sealed Submission:
XYZCompany_NIHOD201800024_ABCCompany
Volume Page Limitation (Additional
Pages will not be evaluated) Volume I - Technical Proposal
Appendix I - CV
Appendix II - Letter of Commitment (Personnel)
20 pages (does not include Curriculum Vitae(CV))
24 pages
N/A
Volume II - Business Proposal N/A
This solicitation consists of two parts, sterile dosage forms and non-sterile dosage forms. Offerors must submit separate proposals for each part. The Government will evaluate each separately.
| 2019-03-29T15:08:56-0400 | |
| Robert J. Burdette -S |
File details come from the government source that posted it. Updated .