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Research and Analysis of Clinical Pharmacology of Tobacco Products

Solicitation Number: SSN12201011
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Location: Office of Acquisitions and Grants Services
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SSN12201011
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Solicitation
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Added: Dec 21, 2011 5:25 am
TITLE: Research and Analyses of Clinical Pharmacology of Tobacco Products
OPDIV : FDA, Center for Tobacco Products (CTP)

Background: This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of a clinical pharmacology study from initiation and conduct of the study through the data analyses phase and preparation of the final reports.


History: The primary function of the Food and Drug Administration ("FDA" hereinafter) is to promote public health associated with the use of foods, dietary supplements, cosmetics, drugs tobacco, and other products under its jurisdiction. FDA's Center for Tobacco Products ("CTP" hereinafter), implements PL 111-31 and H.R. 1256, Family Smoking Prevention and Tobacco Control Act, which was signed into law on June 22, 2009. The Contractor will provide scientific support necessary to assist in the implementation of this law under the Federal Food, Drug, and Cosmetic Act. Specifically, the contractor will assist FDA by evaluating the pharmacologic properties and safety of tobacco products. The manufacturers of some of the emerging tobacco products (dissolvable tobacco products, e-cigarettes, little cigars, hookahs, etc.) have direct or implied claims that their health risks are less than those of traditional cigarettes. These potentially modified risk tobacco products (MRTPs) have been on the market for too short a time for assessment of the validity of these claims. Since the tobacco products are not regulated as drugs, their pharmacologic and harmful effects have not been evaluated by FDA.


An in-house literature review of the clinical and clinical pharmacology information for a one of the new tobacco products (dissolvable in the mouth) revealed that this information is very sparse. In fact, none of the clinical studies of the pharmacokinetics and pharmacodynamics of the dissolvable tobacco products was prospectively designed (i.e. used an appropriate population of people; adequate sample size; assessed several meaningful biomarkers of exposure and response during the adequate length of time post-dose). There is no clear picture of the absorption, distribution and elimination of nicotine, its pharmacologically active derivatives after the administration of the dissolvable tobacco lozenges, pellets, and/or strips. Moreover, the pharmacokinetics and harmful effect of toxic compounds found in tobacco, such as nitrosamines, polyunsaturated and/or fluorinated hydrocarbons, heavy metals and volatile compounds in human biologic fluids, are not properly characterized for DTPs. The relationship between the biomarkers of exposure and response are not established for DTPs.


The dissolvable tobacco lozenges are composed from the milled tobacco leafs and several ingredients with the functions of binding, protection of degradation, coating, taste making and flavoring. Together with the other flavors (cinnamon, vanilla, etc.) some products contain menthol as a direct addition as well as a part of the natural products (i.e. peppermint) extracts. Since it is well known that menthol in general influences the buccal absorption, it is important to evaluate the effect of menthol on absorption of nicotine and other components of the dissolvable tobacco products, including nitrosamines.


The Office of Science Center for Tobacco Products (CTP), therefore, plans to initiate a series of clinical pharmacology studies of the tobacco products. The first pilot study will be performed with the dissolvable tobacco products (DTPs), followed by full size studies of DTPs, e-cigarettes, little cigars, and hookahs. The information acquired in these studies will fill the gap of knowledge of clinical pharmacology of these products.


The primary objectives of this IDIQ contract are to evaluate the pharmacokinetics and pharmacodynamics of nicotine, its metabolites, as well as tobacco specific toxic compounds after the administration of the tobacco products (dissolvable tobacco products, e-cigarettes, little cigars, hookahs) and to compare the bioavailability of nicotine after administration of these tobacco products with the conventional cigarettes and to evaluate effect of menthol additive in some of these products on the nicotine pharmacokinetics.


In order to fulfill these tasks, the Government is proposing to perform a series of clinical pharmacology studies.


For each task, the constractor shall screen and select participants, administer the tobacco products, collect data and perform data analyses, which includes but is not limited to, subject evaluation, laboratory tests, computer-assisted-self-administered interviewing, specimen collection, assay of the specified compounds in human blood and urine, non-compartmental pharmacokinetic and pharmacodynamics data analyses. Data collected under this mechanism will inform FDA on the nature and the impact of the use of dissolvable tobacco products on the public health which will have an impact on policies and regulations with respect to the dissolvable tobacco products, as well as risk communications regarding the use of tobacco products.


3. SCOPE


Contractor tasks shall include, but not be limited to:


A. Establish and validate the assay methodology for the compounds of interest.


B. Perform the series of studies to evaluate the pharmacokinetics and pharmacodynamics of nicotine and all compounds of interest after the administration of dissolvable tobacco products, e-cigarettes, little cigars, hookahs, etc. The measurements on nitrosamines in urine will be performed until their concentrations will reach a minimum detectable level.

The contractor's activities shall include but not be limited to the following:
• Recruit the candidates; assess their inclusion and exclusion criteria, evaluate the drop out rate in order to achieve sufficient number of evaluable subjects for the appropriate data analyses;
• Select the clinical research facility to perform the study;
• Provide physicians, laboratory technicians and other staff to perform the screening and laboratory tests, to collect specimen samples, to assay the biologic samples.
• Perform assay validation for the compounds of interest in human blood, plasma and urine;
• Take all necessary measures to ensure and maintain the confidentiality of data.
• Analyze pharmacokinetic and pharmacodynamic data.
• Provide the intermediate as well as final data reports.


F. Upon request from the COR, the contractor shall deliver interim raw data as well as the results of the data analyses in SAS transport (.xpt) format and a written report to the Government by a specified date during the testing period.


G. Provide other technical and research assistance as needed and specified by the Government, which may include but shall not be limited to the following:
• Conduct literature reviews
• Develop, design, and review research protocols, instruments, and questionnaires
• Provide in-depth analysis of primary or secondary research data
• Prepare Information Collection Requests (ICR) for OMB approval
• Compose research reports and review manuscripts for peer-reviewed journals


NAICS Code: 541990
Contractor Requirements: Contractors must respond to all of the following points, by indicating your experience and capability:


1. To perform the full scope of pharmacokinetic and pharmacodynamic data analyses.
2. To recruit and identify staff (key personnel) with the expertise to utilize the clinical study methodology, establishment and validation of assay of chemicals in the human biologic fluids and interpretation of results (e.g. clinicians, nurses, laboratory technicians, data managers, pharmacokineticists, statisticians).
3. Demonstrate experience in performing a clinical pharmacology study, including but not limited to recruitment of male and female candidates and assessment of their inclusion or exclusion in the study, selecting a clinical research facility which is equipped to perform the study, ensuring .
4. To identify and recruit physicians, nurses, laboratory technicians and other staff with the necessary capability and experience to perform the screening and laboratory tests, to collect specimen samples and to assay the biologic samples.


Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email to Ann Argaman, Contract Specialist ann.argaman@fda.hhs.gov. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. Please address each in order listed above.


Teaming Arrangements: All teaming arrangements shall include the above-cited information for each entity on the proposed team. Teaming arrangements are encouraged.


Responses must be submitted not later than January 5, 2012. Capability statements will not be returned and will not be accepted after the due date.


This is not an invitation for bid, request for proposal or other solicitation and in no way obligates FDA to award a contract. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes.


Please provide the follow Business information:


1. DUNS Number
2. Company Name
3. Company Address.
4. Company Point of Contact, phone number and email address
5. Type of company under NAICS, as validated via the Central Contractor Registration (CCR). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the CCR located at http://www.ccr.gov/index.asp.
6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.);
7. Current GSA Schedules appropriate to this Sources Sought
8. Current Government Wide Agency Contracts (GWACs)
9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses.
10. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit.


All capability statements can be submitted via e-mail, facsimile, or regular mail to the point of contact listed below. Responses shall be limited to 10 pages
Responses must be submitted no later than January 5, 2012


Documentation should be sent to:

US Food and Drug Administration
Office of Acquisition and Grants Services
5630 Fishers Lane, Room 2118
Rockville, Maryland 20857
Attn: Ann Argaman Contract Specialist


 

Added: Apr 25, 2012 6:16 am
Note: This is a presolicitation notice in advance of the Request for Proposal 12-223-SOL-00028 issuance and the Government is not committed to award a contract pursuant to this announcement. This RFP will be available electronically and may be accessed through the Internet at the Federal Business Opportunities website at http://www.fedbizopps.gov. No paper copies will be available. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet site for any possible solicitation amendment that may be issued by the Government.
Added: Apr 25, 2012 9:19 am
THE PURPOSE OF THIS AMENDMENT IS TO CLARIFY THAT THIS NOTICE REPRESENTS THE FORMAL POSTING OF RFP NO. 12-223-SOL-00028.  OFFERORS ARE REMINDED THAT THEY ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND  AMENDMENTS AND FOR ROUTINELY CHECKING THE INTERNET SITE FOR ANY POSSIBLE SOLICITATION AMENDMENT THAT MAY BE ISSUED BY THE GOVERNMENT.
Added: May 14, 2012 10:54 am Modified: May 23, 2012 9:03 amTrack Changes
The purpose of this amendment is to provide the following responses to vendor questions:

Amendment No. 0002

The following responses are provided to vendor questions received:


1) Question: In addition to the products outlined on page 2 of the solicitation (dissolvable tobacco products, cigarillos, e-cigarettes), what additional products will be characterized during the duration of this IDIQ?


Government Response: The current IDIQ focuses on the identified products. Currently, products of interest are limited to orally dissolvable or inhaled products If another product is identified as of interest, FDA would work with the Contractor to ensure a good fit for that particular task order and the IDIQ contract would be appropriately modified.


2) Question: What are the primary technologies of the modified risk tobacco products (i.e., buccal spray, nasal spray, sublingual, heated tobacco, chewing gum, vaporizers, etc.) that will be studied under this IDIQ?


Government Response: The products identified under the current solicitation include a multiple of routes of exposure, including buccal and inhalation.


3) Question: Do you anticipate the utilization of a comparator (i.e., a cigarette or other nicotine replacement) in some or all of these studies?


Government Response: Yes.


4) Question: Can you share with us your vision for the full set of PD assessments?


Government Response: As stated in the RFP, it is anticipated that all assessments will typically include measurement of tobacco-related compounds in saliva, blood and/or plasma. What is measured, and using what matrix, will depend on the product being tested which cannot be fully identified at this time.


5) Question: Is there a comprehensive list of exactly what compounds and metabolites need to be assayed and in what specific matrix (urine, saliva, plasma) they are to be analyzed?


Government Response No. As with the specific matrix, details will depend on the product being tested. FDA will work with the Contractor and provide additional information in specific task orders.


6) Are there documents specifying the methodology to be used for each assay with required LLOQ's, concentration ranges, etc.?


FDA will work with the Contractor on methodologies as appropriate for individual task orders.


7) Question: Under which regulatory requirements do these assays need to be performed (CLIA, GMP, GLP)?


Government Response: CLIA


 Amendment No. 0003
The purpose of this amendment is to provide responses to vendor questions:


1. Question: Will proposing clinical trial study designs, or biospecimen collection, processing or analysis methodologies, in response to the opportunity, prohibit the offeror from: a) proposing the same or similar designs and/or methodologies in response to Federal Government sponsored grant opportunities, and b) receiving similar levels of peer and administrative review, whether or not some or all of the designs and/or methodologies are later incorporated into Task Orders funded by this contract?
Government Response: No


If the answer to the first question is no, we have the following follow-up question.


2) Question: Will clinical data, biospecimens, associated data and analysis results funded by this opportunity and generated by the contractor, using funding provided by the Federal Government, be available to the contractor for tobacco research grant opportunities sponsored by the Federal Government?
Government Response: No.


3. Question: FDA's answer to question 7 (May 14, 2012) states that CLIA requirements will apply to the assays required by the RFP. Is it sufficient for the analytical laboratory that performs the analyses for tobacco-related analytes in biological media to follow CLIA requirements, or must the laboratory be CLIA certified?


We offer this observation: although the analytical work described in this RFP will be performed on specimens of human origin, this work appears to be research-related rather than "... testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health." It would appear that CLIA regulations should not apply to the analyses described in the RFP.


Government Response: The study description includes "human subjects study with multiple blood draws following controlled exposure to a TP with....measurement of physiological responses during exposure." This statement acknowledges that laboratory monitoring is necessary to ensure human safety against the potential for toxic exposures and adverse events. Therefore, clinical decision-making is exercised based on these laboratory results and CLIA certification.


Additionally, this amendment changes the contract specialist from Dawn Rabunsky to Ms. Kathleen Marsden. Any questions should be directed to Ms. Marsden at kathleen.marsden@fda.hhs.gov telephone number 301-827-9361.


 


 

Added: Jun 12, 2012 1:50 pm
Amendment Number 004 (June 12, 2012).

The purpose of this amendment is to provide the following responses to vendor questions:

1)  QUESTION:  P. 4 of the RFP states that the pricing schedules for the categories shall contain loaded hourly rates for each labor category and shall be fully burdened to include wages, indirect costs (including local travel), fringe benefits, overhead, general and administrative, and profit. P.2 Section 1.3. Overview of Pricing Schedules states that task orders may be Fixed Price, Time & Materials, or Labor Hour contract types. May the offeror provide separate category rate schedules for each contract type?

GOVERNMENT RESPONSE:  Yes; however, the Government may follow-up with clarifying questions, if necessary, after proposals are received.

2)  QUESTION:  The ID/IQ Pricing Tables on p. 3 of the RFP do not allow for Other Direct Costs (ODCs) such as non-local travel, purchased materials and services, subject incentives, subcontractors, etc. However, p. 42 states the offeror shall also provide pricing for any applicable ODCs as well as non local travel. Is it the intent of the Government for ODCs to be proposed on a task-by-task basis and not at the ID/IQ level? If we are to propose ODCs at the ID/IQ level, should they be proposed as a separate line item as shown on p. 42?

GOVERNMENT RESPONSE:  Please propose ODCs on a task-by-task basis

3)  QUESTION:  P. 41 Section 11.6.2 Pricing Approach states that the Offeror shall use the following pricing templates for the submission of their pricing proposals: FDA IDIQ Pricing.xls: The Offeror shall use Sample 1 below and this pricing template for the submission of their IDIQ pricing schedule. Would the government please provide the Excel pricing template?

GOVERNMENT RESPONSE:  There is no actual template - the sample is simply a sample. Offerors may use whatever format they feel is most informative.

4)  QUESTION:  The instructions under 11.6 Volume 3 - Business Proposal pp. 41-42 state that Table 1 should be used to for the submission of the ID/IQ pricing schedule. Table 1 has a column for Estimated Hours. Is that column to be completed for the ID/IQ level or only for Task Order -1?

GOVERNMENT RESPONSE:  Task Order One

5)  QUESTION:  "Alternative Line Items": The RFP on page 4 states that additional labor categories may be added through modifications. As the contractor shall provide a firm-fixed price per labor category proposal for the IDIQ period of performance of this contract, the RFP also states on page 41, the Offeror may also propose additional labor categories if deemed necessary and appropriate for the work to be performed on the IDIQ proposal, in addition to proposing additional labor categories on Task Order 1 as stated in 11.6.3, may the Offeror propose additional labor categories on the IDIQ pricing schedule?

GOVERNMENT RESPONSE:  Yes; however, the Government may follow-up with clarifying questions, if necessary, after proposals are received.

6)  QUESTION:  Section 7.9 requires a Confidentiality Agreement to be signed by each employee/subcontractor employee prior to accessing Government information. Would FDA please clarify that FORM FDA 3398 is sufficient for this purpose?

GOVERNMENT RESPONSE:  Yes, the FDA 3398 is sufficient for this purpose.

7)  QUESTION:  The ‘Reports and Deliverables' table in Section 5.2 on page 8 of the solicitation does not seem to accommodate for what can be a lengthy OMB approval process or FDA's Research Involving Human Subjects Committee (RIHSC) approval process in the timeline. Please clarify.

GOVERNMENT RESPONSE:  FDA understands that this can be a lengthy process. The timeline may be modified to accommodate OMB requirements.

8)  QUESTION:  Is the subject opportunity required to receive approval from FDA's Research Involving Human Subjects Committee (RIHSC)?

GOVERNMENT RESPONSE:  This is not the responsibility of the Contractor.

9)  QUESTION:  Please clarify whether one or separate business volumes are required for the ID/IQ and the Task Order.

GOVERNMENT RESPONSE:  Please submit separate business proposal volumes for the ID/IQ and the Task Order.

10)  QUESTION:  Please confirm whether CVs in the appendix need to adhere to the font size and margin requirements of the technical proposal.

GOVERNMENT RESPONSE:  CVs do not need to adhere to the font size and margin requirements; however, please limit them to 2 pages each.

11)  Would FDA consider staggering the due date for this opportunity in consideration of the multiple FDA RFPs released with the exact same due date?

GOVERNMENT RESPONSE:  The proposal due date is extended to June 29, 2012.

12)  QUESTION:  Section 7.9 requires a Confidentiality Agreement to be signed by each employee/subcontractor employee prior to accessing Government information. Would FDA please clarify that FORM FDA 3398 is sufficient for this purpose?

GOVERNMENT RESPONSE:  Repeated question (please see #6 above).

13)  QUESTION:  Please confirm if deliverables must be in SAS or is a file that has been translated by another software program into a SAS transport (.xpt) format sufficient.

GOVERNMENT RESPONSE:  As long as the data can be manipulated/analyzed by FDA using SAS, the .xpt format is acceptable

14)  QUESTION:  Can the FDA please clarify if biospecimen samples can be shipped internationally for analysis purposes?

GOVERNMENT RESPONSE:  Yes, this is acceptable.


15)  QUESTION:  Section 12.8 Subcontracting Plan contains directions to include dollars and percentages for each socio-economic category. Under an IDIQ where the exact nature and dollar value of the tasks to be issued is unknown initially, the ability to express dollars is extremely challenging. Would FDA allow the offeror to express subcontracting goals in terms of percentages only in the subcontracting plan?

GOVERNMENT RESPONSE:  Yes

16)  QUESTION:  Because we are not diagnosing, treating or preventing any tobacco-related conditions, is a CLIA certified laboratory absolutely required for analysis of biological samples?

GOVERNMENT RESPONSE:  The RFP has the study description as a "human subjects study with multiple blood draws following controlled exposure to a TP with....measurement of physiological responses during exposure." This statement acknowledges that laboratory monitoring is necessary to ensure human safety against the potential for toxic exposures and adverse events. Therefore, clinical decision-making is exercised based on these laboratory results. CLIA certification is needed.

17)  QUESTION:  Can you please clarify if data collection for the Task Order needs to be conducted in a CLIA certified clinical site?

GOVERNMENT RESPONSE:  Yes, data collection needs to be conducted in a CLIA certified clinical site.


Additionally, the proposal due date is hereby extended from Friday, June 15, 2012 to Friday, June 29, 2012, 1:00 pm ET.

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Solicitation 1

Type:
Solicitation
Posted Date:
April 25, 2012
Description: RFP 12-223-SOL-00028 for Research and Analysis of Clinical Pharmacology Products

Amendment 1

Type:
Mod/Amendment
Posted Date:
May 8, 2012
Description: Amendment No. 1 to RFP 12-223-SOL-00028
:
5630 Fishers Lane, Room 2129
Rockville, Maryland 20857-0001
:
[to be specified in each task order]

United States
:
Dawn Rabunsky,
Contact Specialist-Team Leader
Phone: 301-827-7062
Fax: 301-827-7151
:
Dawn Rabunsky,
Contact Specialist-Team Leader
Phone: 301-827-7062
Fax: 301-827-7151