MODIFICATION
A -- Feasibility of Establishing a National Twin Registry and Three Disease Specific Registries as Resources for Investigations of Genetic Susceptibility and Environmental Influences in Complex Diseases
- Notice Date
- 2/6/2004
- Notice Type
- Modification
- 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-04-03
- Response Due
- 4/16/2004
- Point of Contact
- Velvet Torain, Contract Specialist, Phone 919-541-0400, Fax 919-541-2712,
- E-Mail Address
-
torain@niehs.nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS), NATIONAL INSTITUTES OF HEALTH, INTENDS TO SOLICIT PROPOSALS FOR THE PURPOSE OF DETERMINING THE FEASIBILITY OF ESTABLISHING A NATIONAL TWIN REGISTRY AND THREE DISEASE SPECIFIC REGISTRIES AS RESOURCES FOR INVESTIGATIONS OF GENETIC SUSCEPTIBILITY AND ENVIRONMENTAL INFLUENCES IN COMPLEX DISEASE. THE MAJOR PURPOSE IS TO STUDY THE FEASIBILITY AND COST OF ESTABLISHING A UNITED STATES NATIONAL TWIN REGISTRY. A SECOND MAJOR PURPOSE IS TO INVESTIGATE THE FEASIBILITY AND COST OF ESTABLISHING THREE INDIVIDUAL, DISEASE-SPECIFIC REGISTRIES FOR TWINS WITH TYPE 1 DIABETES MELLITUS (DM), MULTIPLE SCLEROSIS (MS), AND SYSTEMIC LUPUS ERYTHEMATOSUS (SLE). THIS WILL INVOLVE RESEARCHING RELEVANT ISSUES AND MAKING A RECOMMENDATION FOR ACTION BASED ON THE FINDINGS OF THE RESEARCH. PREVIOUS TWIN STUDIES HAVE ALREADY DEMONSTRATED THE USEFULNESS OF THIS TYPE OF FAMILY DESIGN IN ETIOLOGICAL INVESTIGATIONS. THE USE OF TWINS CAN SIGNIFICANTLY ENHANCE THE STATISTICAL POWER OF A GENETIC STUDY BY EXPLOITING THE UNIQUE DEGREE OF SHARING (BOTH GENETIC AND ENVIRONMENTAL) AMONG TWINS. COMPARISON OF CONCORDANCE RATES FOR A TRAIT OR DISEASE AMONG MONOZYGOTIC (MS) AND DIZGOTIC (DZ) TWINS ALLOW FOR A DETERMINATION OF WHETHER THE RISK OF DEVELOPING THAT CONDITION IS DUE TO HEREDITARY SHARED OR NONSHARED ENVIRONMENTAL FACTORS, OR SOME COMBINATION OF THESE. THE CONTRACTOR SHALL PERFORM THE MAJOR TASKS AS FOLLOWS: (1) PROVIDE CURRENT DEMOGRAPHIC STATISTICS OF TWINS IN THE UNITED STATES BY CONDUCTING COMPREHENSIVE QUANTITATIVE ANALYSIS OF THE CURRENT POPULATION OF TWINS IN THE US AND STRATIFY THEM INTO DEMOGRAPHIC SUBGROUPS BASED ON THEIR ZYGOSITY, AGE, SEX, RACE/ETHNICITY, SES, URBAN LIVING CATEGORIES, GEOGRAPHIC LOCATION WITHIN THE US, ETC. THIS WILL HELP TO IDENTIFY SUB-POPULATIONS WITH CONSISTENTLY LOW RATES OF RESEARCH PARTICIPATION WHOM MAY REQUIRE SPECIAL RECRUITMENT AND RETENTION CONSIDERATIONS. (2) PROVIDE IN-DEPTH CURRENT DEMOGRAPHIC STATISTICS OF TWINS IN THE U.S. THAT ARE AFFECTED BY TYPE 1 DIABETES, MULTIPLE SCLEROSIS, OR SYSTEMIS LUPUS ERYTHEMATOSUS. AS PART OF THIS TASK INVESTIGATE AND DESCRIBE THE PROPORTIONS OF US TWINS WITH THESE CONDITIONS THAT ARE CURRENTLY ENROLLED IN EXISTING TWIN REGISTRIES AND/OR PARTICIPATING IN TWIN RESEARCH PROGRAMS CONDUCTED BY REGISTRIES, ACADEMIC, OR OTHER RESEARCH INSTITUTIONS. (3) EVALUATE THE ETHICAL, LEGAL AND SOCIAL ISSUES THAT WOULD BE ENCOUNTERED IN ESTABLISHING AND OPERATING A NATIONAL AND THREE DISEASE SPECIFIC REGISTRIES. THE CONTRACTOR SHALL DISCUSS LEGISLATION SUCH AS THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY (HIPAA) AND THE PRIVACY ACTS AND HOW HEY MIGHT AFFECT ESTABLISHING THESE REGISTRIES OR DISSEMINATING PROTECTED HEALTH INFORMATION IN THE FUTURE, AND HOW THESE ISSUES RELATE TO SPECIAL POPULATIONS INCLUDING CHILDREN, SUBJECTS WITH DIMINISHED CAPACITY, WOMEN, MINORITIES, ETC. (4) ESTIMATE WHAT PROPORTIONS OF US TWINS DESCRIBED IN TASKS 1 AND 2 ABOVE WOULD LIKELY BE WILLING TO ENROL IN A TWIN REGISTRY AND PARTICIPATE IN REGISTRY SPONSORED RESEARCH PROGRAMS. THE CONTRACTOR SHOULD RECOMMEND VARIOUS ASCERTAINMENT AND RECRUITMENT METHODS DESIGNED TO MAXIMIZE RECRUITMENT OF THE GENERAL US TWIN POPULATION, AS WELL AS SPECIAL ASCERTAINMENT AND RECRUITMENT METHODS THAT MIGHT BE NEEDED FOR SUBGROUPS WITH HISTORICALLY LOW RECRUITMENT RATES (MINORITIES, NON-ENGLISH SPEAKING, WOMEN, RURAL GEOGRAPHIC LOCATIONS, LOW SES GROUPS, ETC.) (5) COMPARE THE FEASIBILITY AND CHARACTERISTICS OF A NATIONAL POPULATION-BASED TWIN REGISTRY TO ALTERNATIVES FOR CREATING TWIN RESOURCES FOR FUTURE STUDIES. IF SUCH A NATIONAL REGISTRY IS NOT DEEMED FEASIBLE, THE CONTRACTOR SHALL CONCEIVE, RESEARCH AND EVALUATE ALTERNATIVE OPTIONS OF CREATING US TWIN RESOURCES FOR FUTURE STUDIES. (6) COMPARE THE FEASIBILITY AND CHARACTERISTICS OF THE THREE DISEASE-SPECIFIC TWIN REGISTRIES FOR TYPE 1 DM, MS, AND SLE TO ALTERNATIVES FOR CREATING RESOURCES OF TWINS WITH THESE CONDITIONS FOR FUTURE STUDIES. BASED ON THE DATA COLLECTED IN TASK 2,3, AND 4, THE CONTRACTOR SHALL EVALUATE THE FEASIBILITY OF ESTABLISHING THREE NATIONAL, POPULATION-BASED TWIN REGISTRIES FOR TWIN AFFECTED WITH TYPE 1 DM, MS, AND SLE. (7) MEET AND DISCUSS WITH THE NIEHS PROJECT OFFICERS AND A PANEL OF EXPERTS THE VARIOUS ALTERNATIVES FOR CREATING TWIN RESOURCES. ONCE TASK 1-6 ARE COMPLETED, THE CONTRACTOR SHALL COMPOSE A COMPREHENSIVE REPORT LISTING AND DISCUSSING HOW THE DATA COLLECTED IN TASKS 1-4 AND THEIR WILLINGNESS TO PARTICIPATE IN THE NIEHS-SPONSORED PROGRAMS MIGHT AFFECT THE FEASIBILITY OF ESTABLISHING A NATIONAL POPULATION-BASED AND THREE DISEASE-SPECIFIC REGISTRIES. (8) OUTLINE METHODS REQUIRED FOR ESTABLISHING, OPERATING AND MAINTAINING A NATIONAL, POPULATION-BASED TWIN REGISTRY AND/OR ALTERNATIVE OPTIONS FOR CREATING TWIN RESOURCES. THIS SHOULD INCLUDE SPECIAL RECRUITMENT PROCEDURES FOR WOMEN AND SUB-POPULATIONS WITH HISTORICALLY LOW RESEARCH PARTICIPATION RATES THAT MIGHT BE NEEDED TO ACHIEVE REPRESENTATIVE PROPORTIONS OF MINORITY SUBGROUPS. (9) OUTLINE METHODS REQUIRED FOR ESTABLISHING, OPERATING AND MAINTAINING THE NATIONAL REGISTRIES FOR TWINS WITH TYPE 1 DM, MS, SLE AND/OR ALTERNATIVE OPTIONS FOR CREATING AFFECTED TWIN RESOURCES. FOR EACH CONDITION, THE CONTRACTOR SHALL DEVISE SURVEILLANCE PROGRAMS TO IDENTIFY BOTH INCIDENT AND PREVALENT CASES. (10) ANALYZE THE POTENTIAL CURRENT AND PROJECTED COSTS ASSOCIATED WITH ESTABLISHING AND MAINTAINING A NATIONAL POPULATION-BASED TWIN REGISTRY AND THREE, INDIVIDUAL DISEASE-SPECIFIC REGISTRIES, OR ALTERNATIVE OPTIONS FOR CREATING U.S. TWINS RESOURCES. THESE ANALYSES SHALL INCLUDE THE COSTS OF OPERATING SUCH REGISTRIES ON A YEARLY BASIS FOR THE NEXT 5 YEARS. THE ESTIMATED PERIOD OF PERFORMANCE IS EIGHTEEN (18) MONTHS. THE GOVERNMENT ESTIMATES THAT APPROXIMATELY 5,772 DIRECT LABOR HOURS MAY BE REQUIRED TO COMPLETE THIS PROJECT. THE NORTH AMERICAN INDUSTRY CLASSIFICATION CODE (NAICS) IS 541710. THIS IS A TOTAL SMALL BUSINESS SET-ASIDE OF WHICH THE SIZE STANDARD IS 500 EMPLOYEES OR LESS. THE ANTICIPATED RELEASE DATE OF THE RFP IS FEBRUARY 27, 2004 WITH PROPOSALS DUE BY APRIL 16, 2004. INTERESTED ORGANIZATIONS MAY MAKE REQUEST VIA TELEFAXED, OR E-MAILED TO THE POINTS OF CONTACT LISTED BELOW. ELECTRONIC COPIES OF THE FED BIX OPPS SYNOPSIS AND RFP WILL BE MADE AVAILABLE ON THE INTERNET AT HTTP://WWW.NIEHS.NIH.GOV/DERT/RCB/RFP.HTM ON OR ABOUT MARCH 5, 2004. GOVERNMENT-WIDE NUMBERD NOTE 26 NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (06-FEB-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 22-APR-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIEHS/NIH-ES-04-03/listing.html)
- Record
- SN00794359-F 20050424/050422213203 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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