AMENDMENT OF SOLICITATION NO.: RFPN01DA-11-8899 AMENDMENT NO.: 01 EFFECTIVE DATE: April 7, 2011 ISSUED BY: National Institute on Drug Abuse, NIH NIDA R&D Contracts Management Branch 6001 Executive Boulevard Room 4211, MSC 9559 Bethesda, Maryland 20892-9559 Point of Contact: Nicole Bennett, Contract Specialist NAME AND ADDRESS OF CONTRACTOR: To All Offerors The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of Offers is NOT extended. Offerors must acknowledge receipt of this amendment on each copy of the offer submitted. FAILURE OF YOUR ACKNOWLEDGMENT 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 Fax or E-mail or letter, provided each submittal makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. All other terms and conditions of the RFP remain unchanged. DESCRIPTION OF AMENDMENT (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) PURPOSE: To amend RFP and to respond to questions submitted under the RFP. Unless specifically noted below, all specifications remain unchanged. ----------------------------------------------------------------------------------- QUESTION 1: Confirm the drug product supplies are only dry product formulations (capsules, tablets, soft gel capsules) and no Sterile Injectables for Phase I or Phase II. ANSWER 1: No injectable manufacture is included in Task 5. Each active drug may have 1-2 strengths, not 1-6 strengths. The timeline specified for manufacture and release testing, labeling and packaging is NIDA's requirement. Point "E" under Task 5 is not in error. Please refer to the Statement of Work for other questions listed. QUESTION 2: Is the timeline of 8 weeks for manufacture of Phase III tablet supplies compressed verses industry turnaround times? ANSWER 2: The timeline specified under Task 7 is NIDA's requirement. Point "E" under Task 7 in the Statement of Work is not an error. QUESTION 3: For Task 8, are any of the IV dosage forms requiring manufacture lyophilized sterile powder formulations? ANSWER 3: No lyophilized dosage form was mentioned in the Statement of Work. The number of drugs for injectable dosage form was not defined in the Statement of work. This should not affect the preparation of the proposal. Point "E" under Task 7 is not in error. QUESTION 4: Critical questions about Clinical trial study design required by our vendors to construct quotes are : - 4A. Study Design for proposed Phase I, II, or III clinical trials for each Option Year? 4B. Number of Studies planned for Phase I, Phase II and Phase III? - 4B. Number of Studies planned for Phase I, Phase II and Phase III? - 4C. Number of Protocols envisioned for Phase I, II or III clinical trials for each Option Year? - 4D. Number Sites planned for each clinical trial proposed for Phase I, II and III ? - 4E. Number Patients per site & # of Treatment Groups envisioned for each clinical trial proposed for Phase I II and III? - 4F. Do the Phase I or Phase II trials require clinical supplies that are blinded, open label, randomized, or double blinded ? - 4G. Do the Phase III trials require blinded supplies, comparator supplies and randomization? - 4H. What is the duration of each trial planned for Phase I, II, and III ? ANSWER 4: Information is not needed to respond to RFP. Please remember FAR Clause 52.219-14 'Limitation on Subcontracting' is applicable under this solicitation, and this clause requires that at least fifty (50) percent of the cost of contract performance incurred for personnel be expended by employees of the small business firm. QUESTION 5: Questions on the Specific Tasks section for Tasks 5,7,8 and Task 9 are: - 5A. Is there a study design or protocol available for Phase I and Phase II trials? Could we obtain a copy? - 5B. What are the duration of the trials planned for Phase I and Phase II? This duration drives the number of clinical supplies that need to be prepared and is also a critical factor to obtain an estimate for Packaging/Labeling. - 5C. What is the # of Patients planned for each trial in Phase I and in Phase II? - 5D. What is the target number of sites planned for each trial in Phase I and Phase II? - 5E. Point "E" under Task 5 mentions distribution to Pre-Clinical investigators. Is this an error? ANSWER 5: Information is not needed to respond to RFP. QUESTION 6: Task 7 Mfg of Drug Product for Phase III Clinical Trials (mainly tablets or capsules) - Do the Phase III trials require blinded supplies, placebo supplies, IV supplies - What is the duration of each trial planned for Phase III - Do the durations and enrollment targets predict the need for Resupply throughout the Phase III trial? - Point "E" under Task 7 concerning distribution is different than verbiage under Task 5 E for distribution for Phase I/II supplies. Is there a typo in this point e for Task 7. Phase III trial supply distribution can be quite complex and usually involves distribution from a vendor to a clinical trial site or depots for distribution to investigators. ANSWER 6: Information is not needed to respond to RFP. QUESTION 7: Task 8 Mfg of Injections: - 7A. How many different IV drug products could require manufacture? (Cocaine, Methamphetamine are mentioned, and the phrase 'and others'. Do we have a quantity defined or predicted for 'and others'. Answer 7: Information is not needed to respond to RFP. QUESTION 8: Point "E" under Task 8 also indicates distribution to 'preclinical'/clinical investigators. Is the preclinical a typo? Answer 8: No.
