MODIFICATION
A -- Clinical Research Support Services
- Notice Date
- 3/1/2005
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Environmental Health Sciences, Research Contracts Branch, DERT P.O. Box 12874, 79 T.W. Alexander Dr, Bldg 4401, RTP, NC, 27709
- ZIP Code
- 27709
- Solicitation Number
- NIH-ES-05-02
- Response Due
- 3/1/2005
- Archive Date
- 3/16/2005
- Point of Contact
- Vondia Malone, Contract Specialist, Phone 919-541-0428, Fax 919-541-2712, - PHIL JONES, Supervisory Contracting Officer, Phone 919-541-0426, Fax 919-541-2712,
- E-Mail Address
-
malonev@niehs.nih.gov, jonesp@niehs.nih.gov
- Description
- The National Institute of Environmental Health Science (NIEHS) is seeking offers to provide support to Principal Investigators (PIs) in the Office of Clinical Research (OCR) and Division of Intramural Research (DIR) at the NIEHS for various types of clinical research studies and interventional clinical trials. Examples of observational studies to be covered by this contract are case report and case series, case-control, cross-sectional, and prospective and retrospective cohort studies. Interventional studies to be covered by this contract are: 1) efficacy trials of new treatments, new combinations of drugs, new approaches to surgery or radiation therapy; 2) prevention trials using various therapies, diet and lifestyle changes, vitamins, minerals, and methods to minimize potentially toxic exposures; 3) diagnostic trials aimed at developing better tests or procedures for diagnosing a particular disease or condition; and 4) quality of life trials to explore ways to improve comfort or quality of life of individuals with a certain disease or lifestyle by modifying risk factors. Observational and interventional clinical research involves carrying out many complex study tasks, all of which will be supported by this contract. The design and implementation of each clinical research projects will be the responsibility of the Task Leader initiating the study, but advice may be sought from the NIEHS Project Officers, Contractor or a contracted panel of experts. The extent of the Contractor's involvement with any given study may vary depending on the study design and support available in-house, through collaborators or other contracts. For example, the Contractor might carry out only the surveillance and recruitment phase of a study, or only develop and administer study questionnaires. Alternatively, the Contractor might only be involved in the treatment or sample collection phase of a study. Some studies will require medical support for the initial subject evaluation, diagnoses, treatments, and follow-up care and this will involve providing medical personnel and facilities and/or interacting with medical personnel at other facilities including physician?s practices, clinics, and hospitals. The medical institutions may be local or distant, and thus require travel by Contract personnel and/or study participants. The Contractor might be required to coordinate activities with various reference laboratories, medical clinics or other institutions, and collaborators with NIEHS personnel. Finally, all studies and/or tasks supported by this contract will be conducted according to all relevant federal guidelines and regulations. Therefore, the Contractor will have knowledge and experience of all relevant guidelines and regulations for using human beings in research studies, e.g. 45 CFR 46 or the DHHS Common Rule, and those regulations for patient confidentiality such as the Health Insurance Portability and Accountability Act of 1966 (HIPAA). It is anticipated that a contract will be awarded with a base period of performance of four years with options to extend the period of performance up to a total of ten years. Also, the solicitation will include, along with other evaluation criteria, a mandatory qualification criteria that must be met that is geographic restriction that the offeror(s) shall for the duration of the period of performance have existing or demonstrate ability to establish offices, equipment and technical facilities, including laboratory facilities within 30 minutes driving time of the NIEHS, Research Triangle Park, NC 27709. Established offices and facilities must occur within 60 days of contract award. Frequent discussions and consultations with NIEHS Project Officer necessitate that the Contractor be in close proximity to minimize the expense to the Government and increase communications. The anticipated release date of the solicitation is sometime during the 2nd and 3rd week of January 2005. The NAICS code is 541710. See Numbered Note 26. This modification is made to add Amendment 1. The purpose of the amendment is to provide clarifications and answers to questions received from interested parties. The hour and date specified for receipt of offers is not extended. The information from pages 2 - 4 are provided below. Question 1. ?Paragraphs l and p of the organizational evaluation criteria, RFP pages 70-71, are duplicates. However no criteria are given regarding biostatistical experience. May we assume that one of these paragraphs should represent criteria on biostatistical experience?? Answer: Paragraph l. on RFP page 70 and paragraph p. beginning on page 70 and continuing on page 71 are duplicates; therefore, paragraph p. is deleted in its entirety. The 30 points associated with paragraph p. are redistributed as follows: On RFP page 69: Paragraph g. - points for this criteria are increased by 5 from 30 to 35. Paragraph h. - points for this criteria are increased by 5 from 30 to 35. Also, the words ?(assuming general content is identified by a NIEHS PI)? are deleted. Paragraph i. - points for this criteria are increased by 10 from 20 to 30. On RFP page 70: Paragraph n. - points for this criteria are increased by 5 from 20 to 25. Paragraph o. - points for this criteria are increased by 5 from 20 to 25. Biostatistical experience will be evaluated against the criteria in paragraph b. under STAFF: QUALIFICATION OF KEY AND OTHER PERSONNEL on RFP page 71 and the Statement of Work, Attachment 1. Question 2. ?Please provide additional guidance for estimating other direct costs (ODCs) for the overall contract (as opposed to the model study). If each offeror estimates ODCs based on their own assumptions about the studies to be conducted over the 10-year period, how will the Government compare the cost estimates? Also, estimating ODCs for this period of time will result in lengthy business proposals detailing estimated costs (e.g., patient recruitment costs, treatment costs, laboratory analyses, setting up field offices) for numerous studies for the 10-year period. For purposes of the bid, could the Government provide a standard amount (e.g., $100,000 per year) that each offeror should include as ODC costs for the overall contract?? Answer: It is not possible to completely determine in advance the clinical research support needs, or the nature and number of studies to be conducted over the anticipated period of performance of ten years. Nor is it possible to accurately include all work assignments, tasks, and issues that need to be addressed. In year 1, you may consider costs for establishing a facility in the RTP area, initial start-up equipment, e.g., computers, refrigerators, freezers, telephones, etc. Also, consider costs for starting two new major studies each year of the ten years and that an average study will last three years. Between new and ongoing studies, you may estimate the costs for 2, 4, and 6 major studies in years 1, 2, and 3, and then you may estimate providing support for 6 major studies each year for years 4 through 10. Similarly, the level of effort for various personnel will increase incrementally over the first three years and then plateau as the steady state level of the total studies is reached. Both clinical observational studies and clinical trials can require diagnoses. You may consider estimates for diagnostic fees for 600 patients in year 1, 900 patients in year 2, and 1,200 patients in years 3 through 10. Additionally, we have provided guidance for estimating refrigerator and freezer requirements and maintenance and repair thereof on pages 8 and 9 of the Statement of Work, Attachment 1 to the RFP. Guidance for estimating travel costs is provided on pages 12 and 13 of the Statement of Work. An estimate of the level of effort broken down by year and labor category is provided in Attachment 2 of the RFP. Please refer to paragraph a. GENERAL under SECTION M - EVALUATION FACTORS FOR AWARD, RFP page 63, where it states that costs are important factors for consideration in award decisions; however, technical factors are paramount. Question 3. ?On page 36 of the RFP, the ?important Note to Offerors? states that paragraphs 9 through 14 should be addressed in the technical proposal. 3.a Paragraph 14 on page 39 is not relevant to human subject risk. Was the reference to ?paragraphs 9 through 13'? 3.b Under which evaluation criteria will points be assigned to the discussions required by the ?Important Note to Offerors? on page 36, and by Section M.b (Human Subject Evaluation)?? Answer: First, on RFP page 36, paragraph (1) beginning with ?Once you reach.....? is corrected to read as paragraph (10). Now, to answer 3.a. - No, the reference is not to paragraphs (9) through (14). The reference should be to paragraphs (9) and (10); therefore, the ?Important Note to Offerors? is corrected to read as follows: ?IMPORTANT NOTE TO OFFERORS: Paragraphs (9) and (10) shall be addressed in a SEPARATE SECTION of the Technical Proposal entitled, ?HUMAN SUBJECTS.?? Now, to answer 3.b. - Offeror?s proposals regarding human subjects will be evaluated according to paragraph b. entitled HUMAN SUBJECT EVALUATION beginning on RFP page 63. Human subject evaluation will be treated as a stand alone factor and the evaluation thereof will be independent of the technical evaluation. Question 4. ?On page 72 of the RFP, the description of the qualifications of the Study Monitor/Clinical Research Associate are those of the Laboratory Technician. Can we assume the correct qualification are those shown in item 2 on page 23 of the SOW?? Answer: Yes, you are correct. Paragraph f. on RFP page 72 is corrected to read: ?f. Study Monitor/Clinical Research Associate (CRA) - The Study Monitor/CRAs should work closely with the Study Managers and contract personnel to oversee the progress and conduct of clinical research study and ensure the scientific integrity of the data collected. CRAs should be responsible for reviewing data to ensure the rights, safety, and well-being of study subjects are maintained. Study Monitors/CRAs should have at a minimum, a B.S. or B.A. degree, or the equivalent in a health care or science background (e.g., nurse, medical technologist, or physical therapist) and at least 2 years of CRA experience.? Question 5. ?In paragraph two on page 22 of the SOW, it states that ?4 clinical research studies will be initiated during year 1.? However, on page 25, it states that the level of effort is based on starting 2 studies each year. Please clarify the number of studies to be started in year 1.? Answer: Two studies will be initiated during year 1; therefore, the number ?4" in the 4th line of the 2nd paragraph on page 22 of the Statement of Work, Attachment 1, is corrected to read ?2.?
- Record
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