SOURCES SOUGHT
B -- Evaluation of Tobacco Use and Cardiovascular Diseases
- Notice Date
- 8/10/2012
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- RFQ1104678
- Archive Date
- 8/30/2012
- Point of Contact
- Beth A. Goldberg, Phone: 3018277153
- E-Mail Address
-
beth.goldberg@fda.hhs.gov
(beth.goldberg@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: Sources Sought Release Date: August 10, 2012 Response Date: August 15, 2012 at 1:00 pm EDT via email to beth.goldberg@fda.hhs.gov Contracting Office Address: Food and Drug Administration, 5630 Fisher Lane, Rockville, Maryland 20857; Attn: Beth Goldberg, Contract Specialist Description of Services/Supplies: Evaluation of Tobacco Use and Cardiovascular Diseases This is a Sources Sought (SS) to identify the capabilities of the marketplace of all interested parties. This information is being sought for information and planning purposes only and shall not be construed as an invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items or services herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any response received will not be used as a proposal. No official solicitation currently exists in connection to this Sources Sought. If in the future an official solicitation is released, there is no guarantee that sources responding to this notice will be included on the source list. **NO QUESTIONS WILL BE ENTERTAINED** 1. BACKGROUND The Family Smoking Prevention and Tobacco Control Act granted FDA authority to regulate tobacco products including conventional cigarettes, smokeless tobacco, cigars, and pipe tobacco products. The mission of the Center for Tobacco Products (CTP) is to protect public health by issuing and enforcing tobacco product regulations and educating the public about the dangers of tobacco use. CTP is responsible for setting performance standards, reviewing premarket applications for new and modified-risk tobacco products (MRTPs), requiring new warning labels, and establishing/enforcing advertising restrictions. Tobacco products contain thousands of toxic constituents. Cigarette smoking is associated with increased risk of acute cardiovascular diseases such as acute myocardial infarction, sudden death, and stroke. Cigarette smoking also accelerates atherosclerosis, produces premature atherosclerosis, aggravates angina pectosis, rethrombosis after thrombolysis, and restenosis after coronary bypass surgery or angioplasty. There are three cigarette smoke constituents that are regarded as potential contributors to cardiovascular disease: exhaled carbon monoxide or blood carboxyhemoglobin, nicotine/cotinine, and oxidant chemicals. Various forms of smokeless tobacco products are used by individuals of all ages. Epidemiological evidence suggests that smokeless tobacco may be associated with a lower risk of cardiovascular disease than cigarette smoking, though long-term smokeless product use was associated with a modest risk of fatal myocardial infarction and fatal stroke. It is currently not known whether and how individuals with mild cardiovascular diseases change tobacco product use in response to new tobacco policies. In addition, factors that predict the use pattern of tobacco products, including newly emerging tobacco products, and the associations between tobacco use and tobacco toxicant exposure and disease and behavioral outcomes, are unclear. To address these questions, FDA CTP staff developed the following research studies. This study will generate original findings that will provide FDA/CTP reviewers with up to date knowledge regarding the impact of tobacco products that are currently on the market on public health, including disease outcomes such as tobacco-associated cardiovascular diseases. This knowledge will assist CTP in developing the scientific basis for guidance documents and review criteria, and guide FDA reviewers in making evidence-based decisions on future tobacco product submissions. 2. OBJECTIVES The purpose of this contract is to provide FDA with the required resources to conduct a study with subjects that meet the objectives and specifications detailed below. The ultimate objectives of the study are: 1) To evaluate whether and how individuals with mild cardiovascular diseases (such as coronary artery disease and hypertension) change tobacco product use in response to new policies related to tobacco products; 2) To analyze the associations between tobacco use and various health outcomes, and 3) To evaluate the associations between tobacco use and behavioral outcomes 3. DESCRIPTION/SPECIFICATIONS/WORK STATEMENT Project Overview The contractor will conduct epidemiological studies to examine tobacco use patterns in a representative nationwide sample of patients with mild cardiovascular diseases using an existing database. The contractor will also evaluate the associations between the use of various tobacco products and outcomes such as tobacco toxicant exposure and various health/behavioral outcomes. The contractor will perform statistical analyses, submit analysis reports, and assist the FDA in writing manuscripts for peer-reviewed journals. 4. SCOPE OF WORK Contractor tasks shall include: A. A current and existing database that: 1. contains information on tobacco current and former use (including cigarettes, smokeless, cigar, pipes, and etc) and cardiovascular diseases. 2. includes at least 200 known nation-wide (including at least 20 states) clinical sites/practices that treat cardiovascular patients. 3. contains at least 10,000 individuals with mild cardiovascular diseases who have current or former tobacco use information. B. Conduct two types of epidemiological studies to address the study objectives. Analyses shall be compared before vs. after the initiation of various federal policies related to tobacco use. Examples of FDA tobacco policies include: adding graphic health warning labels to U.S. cigarette packages; removing misleading brand descriptors from packages, and; changes in menthol cigarette regulations. 1. Descriptive Epidemiology: Examine tobacco use patterns (e.g., type of tobacco product use including dual use and duration of use in patients, and changes in tobacco use over time such as before and after the implementation of policies related to tobacco use) in a representative nationwide sample of patients with mild cardiovascular diseases. In addition to the overall analysis, stratified analyses according to the following factors will be conducted. • By cardiac condition history • By cardiac event history • By race/ethnicity • By sex • By region • By age (young adults vs. adults) 2. Analytical Epidemiology: The study aim is to evaluate the associations between tobacco use [coded as yes/no and by type (e.g., cigarette, cigars, pipe, and smokeless)], and tobacco toxicant exposure and various health/behavioral outcomes. In addition, predictors of tobacco use will be evaluated. Data will be analyzed as follows: (1) Evaluate the associations between social/demographic factors and different types of tobacco use. (2) Evaluate the associations between tobacco use and a history of cardiac events, by race and sex. (3) Evaluate the associations between tobacco use and biomarkers of tobacco exposure, by race and sex, including: • urine nicotine equivalent (NE) for nicotine uptake • Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL) and total N'-nitrosonornicotine and its glucuronides (total NNN) for the uptake of tobacco-specific nitrosamines • Non tobacco-specific biomarkers that could be considered include 1-HOP for polycyclic aromatic hydrocarbons (PAH) exposure, urinary cadmium, etc. (4) Evaluate the associations between tobacco use and health outcomes, by race and sex. Health outcomes will include: - cardiovascular diseases - mortality if linked to the National Death Index (NDI) - progression/prognosis of cardiovascular disease -intermediate disease outcomes (5) Evaluate the associations between tobacco use and behavioral outcomes, by race and sex. Behavioral outcomes will include: -use of the cessation services -cessation (6) Evaluate the associations between tobacco cessation on the prognosis of patients with cardiovascular disease, by race and sex. C. Provide technical and research assistance as described below: 1. Assist in writing and reviewing manuscripts for peer-reviewed journals 2. Assist in preparing the Information Collection Requests (ICR) for OMB approval as needed 5. DELIVERABLES AND PERFORMANCE All reports required under this contract shall be submitted electronically to the COR in Microsoft Word compatible format and in hard copy. All other deliverables shall he specified for each task. Table 1. Reports and deliverables Deliverable Quantity Delivery date after Contract Award 1. Methodology report: In collaboration with FDA, the contractor will develop report formats, inclusion/exclusion criteria, standardized definitions and relevant outcome metrics, and statistical methods to be used in the study. The contractor will submit a draft summary report on the methodology, which shall include, but is not limited to the following: a. background and purpose of the study b. study population (including but not limited to inclusion/exclusion criteria, subject selection methods, and time frame of study subject selection) c. comparison groups (including definition of each group) d. sample size (subject and site) e. exposure and outcome definitions and methods of ascertainment f. duration of follow-up g. data collection methods h. statistical analysis plan (including but not limited to methods for how the associations between exposure and outcome variables will be assessed, methods for control for potential confounding factors, and statistical software packages to be used). i. data preparation and processing procedures. 1 Draft methodology report due 3 months from award date 2. Methodology report (revised): The contractor will revise the methodology report upon receiving FDA's comments, and submit the revised methodology report. 1 Months 4- 5 from award date. FDA will comment on the report within 14 business days upon receiving the report. 3. Teleconference and Meeting Minutes: The contractor shall schedule monthly teleconferences, prepare agendas, and draft meeting minutes. At these meetings, the contractor shall provide updates of study progress, discuss issues related to the task performance, and discuss refinements of the study methods as needed. 24 Monthly 4. Quarterly Progress Reports: The contractor shall submit quarterly progress reports describing the progress of the study to date, noting all technical areas in which effort is being directed and indicating the status of work within the specified tasks. 8 Due 3, 6, 9, and 12 months from award date. 5. Analysis report: The contractor shall submit analysis reports that cover the work performed during the first 9 months and first 18 months of the contract performance period. These reports shall be in sufficient detail to describe comprehensively the results achieved. The contractor should also submit the original analysis files (output) in STATA or SAS format for FDA to review. 2 Due 9 months from the award date. Specific dates for the analysis reports may be revised by FDA if appropriate. The COR will review the draft report within 20 business days after receipt. A final version will be delivered if revisions are needed. 6. Manuscript: The contractor will assist FDA writing up a manuscript(s) for publication in peer-reviewed journals. 2 Drafts are due 12 months after award date. PERIOD OF PERFORMANCE: One year from date of award with one option year period. Capability Statement Format and Instructions: Part A. Capability and Technical Experience - Viable parties should submit a capability statement describing adequate experience in the following areas: 1. Technical understanding and approach 2. Relevant experience 3. Personnel qualifications 4. Management plan and schedule Part B. Size of Business - Please provide your business size and submit a copy (‘s) of any documentation such as letters of certifications to indicate the firm status such as 8-A certification. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activates of your company, your affiliates, your team members and affiliates of your team member which create either a conflict of interest or the appearance of a conflict of interest Part D. Cost Estimate - Please provide a cost estimate for the prospective services to be conducted under the potential study for method of analysis. Cost should consist of the type of personnel need, hourly rate/days and material estimated per option year.
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