SOURCES SOUGHT
A -- Hormone Therapy and Cognitive Aging in Older and Younger Postmenopausal Women: Continuation Study of WHIMS-ECHO and WHIMS-Y
- Notice Date
- 4/29/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(AG)-SBSS-10-127
- Point of Contact
- Teresa A. Baughman, Phone: (301) 443-1193, Sara Mclaurin, Phone: 301-443-9154
- E-Mail Address
-
baughmat@nida.nih.gov, mclaurinsm@mail.nih.gov
(baughmat@nida.nih.gov, mclaurinsm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. BACKGROUND The Women's Health Initiative (WHI) randomized clinical trials of hormone therapy (HT) were designed to determine whether HT had beneficial effects on health outcomes, especially cardiovascular health, in postmenopausal women. Women without uteri were randomly assigned to take one daily tablet containing either conjugated equine estrogens (CEE), 0.625 mg (Premarin, Wyeth Pharmaceuticals), or a matching placebo (also provided by Wyeth Pharmaceuticals), and women with uteri were randomly assigned to take one daily tablet containing either CEE, 0.625 mg, and medroxyprogesterone acetate (MPA), 2.5 mg, (Prempro, Wyeth Pharmaceuticals) or a matching placebo (also provided by Wyeth Pharmaceuticals). The WHI Memory Study (WHIMS) was an ancillary study (conducted with private funding) to the WHI and investigated the effects of CEE-containing HT on risk of probable dementia and any cognitive impairment and on changes in global cognition over time. WHIMS included 7,450 WHI participants enrolled at 39 of the 40 WHI clinical sites who were age 65 and older. Because WHIMS did not include detailed cognitive assessments of women without cognitive impairment, the WHI Study of Cognitive Aging (WHISCA) was designed as an ancillary study to WHIMS to assess memory and other domain-specific cognitive functions in women free of dementia. WHISCA included 2,305WHIMS participants at 14 clinical sites and was conducted under contract number N01-AG-9-2115. The WHI and ancillary WHIMS and WHISCA studies were stopped earlier than planned for both the combination therapy (CEE+MPA in 2002) and CEE-Alone (in 2004) because these treatments increased health risks and did not protect against coronary heart disease. Although study medications were discontinued, follow-up assessments continued in WHIMS and WHISCA as well as the main WHI trials. WHIMS and WHISCA were designed to test the hypothesis, suggested by results of observational studies, that HT had beneficial effects on maintenance of cognitive health in older post-menopausal women, reducing the risk for dementia and protecting against age-associated memory loss. Contrary to expectations, WHIMS showed that HT increased the risk for probable dementia and was associated with poorer global cognition, and WHISCA showed that CEE+MPA treatment was associated with poorer verbal memory over time and that CEE-Alone did not improve verbal memory. The WHIMS and WHISCA protocols have transitioned from face-to-face to less costly and more efficient centrally based and validated telephone interviews to assess cognitive functioning. The WHIMS Epidemiology of Cognitive Health Outcomes (WHIMS-ECHO) continues through 2010 as part of the current WHI extension follow-up, with the WHIMS components funded by (N01-WH-4-4221), and includes assessments previously performed through WHIMS and WHISCA evaluations. Up to 3,900 women are expected to participate in the WHIMS-ECHO study. In addition, the new Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) is underway (funded by N01-WH-4-4221). In this study, the telephone-based WHIMS ECHO protocol is used to assess the long-term impact of random assignment to postmenopausal hormone therapy among women who were 50-54 years of age at the time they were initially enrolled into the WHI hormone trials. Hormone therapy continues to be widely prescribed for the treatment of menopausal symptoms. Further, there remains a strong belief among basic and clinical scientists that HT begun during the peri- or immediate post-menopausal periods may bestow cognitive benefits and that the cognitive harm associated with HT in the post-menopausal woman occurs only when there is some pre-existing, sub-clinical disease and/or the aging brain is more vulnerable to the possible negative effects of hormones. WHIMS-Y takes advantage of the rich WHI cohort by adding critical information on the clinical treatment of early post-menopausal women and on potential mechanisms of action for how HT may affect cognition. Thus, by the end of the current WHIMS extension period (N01-WH-4-4221), cognitive data will be available for a large portion of the women who participated in the WHI HT, with longitudinal cognitive data on the women who were 65 and older at the beginning of WHI as well as an initial and follow-up assessment for women who were 50-54 at baseline. The proposed continuation of WHIMS-ECHO and WHIMS-Y offers a unique opportunity to gain further insights into the antecedents of cognitive decline or stability, and further clarify the contributions of vascular disease in dementia. The ability to advance science by a systematic study of the predictors of decline or stability of cognitive health will be greatly enhanced by longer follow-up for up to 19 years. As the participants grow older, the proportion with cognitive impairment or dementia is expected to increase rapidly. Feasibility and cost will be explored with the offeror during negotiations. PURPOSE AND OBJECTIVES There are 2 objectives of this contract: Objective 1 - Continued surveillance of the WHIMS-ECHO cohort. The purpose of this objective is to investigate the long-term effects of HT on dementia risk and cognitive function in older postmenopausal women. This includes: a) Enhance statistical power to identify predictors of cognitive decline and cognitive resilience; b) Continue assessment of the adverse effects of postmenopausal hormone therapy on cognition as these women pass through the risk period for accelerated cognitive decline and impairment; and, c) Continue to serve as a national resource on which to build ancillary studies in collaboration with the greater scientific community. Objective 2 - Continued surveillance of the WHIMS-Y cohort. The purpose of this objective is to investigate the long-term effects of early treatment with HT on cognitive health. This includes: a) To determine the later impact of HT when administered to younger, more recently menopausal women; b) To determine whether these effects differ from the adverse effects observed in older postmenopausal women; and, c) To investigate mid-life predictors of cognitive decline and resilience. PROJECT REQUIREMENTS The Contractor shall coordinate the WHIMS-ECHO and WHIMS-Y data collection, including recruitment and scheduling of study participants, administration and scoring of the telephone assessment battery, determination and adjudication of diagnoses of probable dementia and mild cognitive impairment, and data entry and transfer. The Contractor also shall maintain close contact with the main WHI study and assessment schedule to ensure that relevant demographic and clinical variables are available or continue to be collected for WHIMS-ECHO and WHIMS-Y. The Contractor shall: 1) Maintain a high level of cooperation and coordination with WHI Investigators, the WHI Clinical Coordinating Center (CCC), and the Contracting Officer's Technical Representative (COTR); 2) Provide equipment, where needed for test administration; 3) Train and supervise staff in the administration and scoring of the tests and other evaluation instruments; 4) Develop and validate procedures for central adjudication of diagnoses of dementia and mild cognitive impairment; 5) Perform computer data entry and transfer of data to the COTR; 6) Maintain the WHIMS web site; 7) Provide biostatistical and other support for data analysis, manuscript development, and preparation; and, 8) Coordinate the close-out of the study. The Contractor shall develop or adapt informed consent materials for continued participation in WHIMS-ECHO and WHIMS-Y. The Contractor shall obtain appropriate institutional review board approvals from participating sites and shall provide copies of such to the COTR. The Contractor shall identify, recruit, and obtain informed consent for eligible WHIMS-ECHO and WHIMS-Y participants from ongoing study participants. Participant recruitment shall be conducted so as to ensure minority representation. The Contractor or their designate at the participating sites shall schedule enrolled participants. Data collection and scoring shall be performed by trained and certified test administrators. The Contractor shall advise the COTR in writing of any modifications to the telephone assessment battery. The initial and modified procedures shall be approved prior to implementation in writing by the COTR. The telephone assessment battery shall consist of the following procedures: 1) Telephone Interview for Cognitive Status-modified (TICS-m); 2) East Boston Memory Test (EBMT); 3) Oral Trail Making Test (OTMT) - Parts A & B; 4) Verbal Fluency-Animals (VF-A); 5) Digit Span Test (DST); 6) California Verbal Learning Test (Immediate and Delayed Recall); 7) Dementia Questionnaire (DQ); 8) Geriatric Depression Scale (GDS) - Short Form; and 9) Insomnia Rating. Data to be generated by this contract are the raw and scored test results of the WHIMS-ECHO and WHIMS-Y assessments. Copies of the data shall be transmitted electronically to the NIA at 6-month intervals. All data shall be maintained by the Contractor under controlled and secure conditions for the duration of the contract period. Upon completion of the contract, all data collected under this contract will remain the property of the NIH. The Contractor shall accumulate and maintain appropriate data files, maintain confidentiality and security of data files, revise current data collection forms as necessary, collect, edit, store, analyze and report on WHIMS data, prepare limited access datasets, and provide frozen tapes and documentation at the request of and as directed by the COTR and also at the contract expiration date. REPORTS/DELIVERABLES (1) Project Plan - a plan which shall include the final sites for the data collection, projected recruitment goals for each site, the racial/ethnic breakdown for the projected recruitment, and an outline of issues requiring further discussion. (2) Semi-Annual Technical Progress Reports - a report which includes a listing of the numbers of participants recruited and assessed for the entire sample and at each site for the WHIMS-ECHO and WHIMS-Y samples. Information on age and racial/ethnic distributions shall be included. A breakdown of missing or invalid data for telephone assessments shall also be provided. (3) Annual Technical Progress Reports - a report that summarizes the activities completed in the preceding twelve (12) month period. The Contractor shall include copies of annual institutional review board approvals. (4) Final Report - summarize the activities and accomplishments for the entire contract period of performance. In addition, the Final Report shall include a Summary (not to exceed 250 words) of Salient Results achieved during the period of performance. (5) Report of Unexpected Adverse Event - a report of an unexpected adverse event, observed at any stage of the study, which would jeopardize the progress of the study. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is from 3/1/11 through 2/28/16. OTHER IMPORTANT CONSIDERATIONS The North American Industry Classification System (NAICS) Code 541712 with a size standard of 500 employees is being contemplated. CAPABILITY STATEMENT/INFORMATION SOUGHT Respondents to this notice must provide, as part of their responses, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (4) any other information that may be helpful in developing or finalizing the OPDIV's acquisition requirement. INFORMATION SUBMISSION INSTRUCTIONS Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) responses should be received no later than May 13, 2010 at 2:00 PM Local Time; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to baughmat@mail.nih.gov The original statements mailed using the U.S. Postal Service should be sent to ATTN: Sara McLaurin, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Contracting Office Address: Contracts Management Branch 6001 Executive Blvd, Rm 8154, MSC 9661 Bethesda, Maryland 20892-9661 Primary Point of Contact.: Teresa A. Baughman, Contracting Officer baughmat@mail.nih.gov Phone: (301) 443-1193 Fax: (301) 443-0501
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