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RFP TABLE OF CONTENTS
NOTICE TO OFFERORS.............................................................................................................................6
PART I - THE SCHEDULE...........................................................................................................................7
SOLICITATION.......................................................................................................................................8
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.......................................................................9
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES.................................................................9
ARTICLE B.2. PRICES/COSTS.....................................................................................................................9
ARTICLE B.4. ESTIMATED COST - COST SHARING...................................................................................11
ARTICLE B.5. ESTIMATED COST - OPTION..............................................................................................12
ARTICLE B.6. ESTIMATED COST - AWARD TERM....................................................................................13
ARTICLE B.7. ESTIMATED COST PLUS AWARD FEE.................................................................................14
ARTICLE B.8. ESTIMATED COST PLUS AWARD FEE.................................................................................16
ARTICLE B.9. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT, HHSAR 352.232-71 (July 2013)
...............................................................................................................................................................19
ARTICLE B.11. CANCELLATION CEILING..................................................................................................24
ARTICLE B.14. OPTION PRICES...............................................................................................................33
ARTICLE B.15. PROVISIONS APPLICABLE TO DIRECT COSTS...................................................................34
ARTICLE B.16. ADVANCE UNDERSTANDINGS.........................................................................................34
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT.........................................................35
ARTICLE C.1. [DESCRIPTION-SPECIFICATION-WORKSTATEMENT-STATEMENT OF WORK].....................35
ARTICLE C.2. REPORTING REQUIREMENTS............................................................................................35
ARTICLE C.3. INVENTION REPORTING REQUIREMENT..........................................................................46
SECTION D - PACKAGING, MARKING AND SHIPPING...........................................................................48
ARTICLE D.1. PACKAGING.......................................................................................................................48
ARTICLE D.2. MARKING..........................................................................................................................48
ARTICLE D.3. SHIPPING..........................................................................................................................48
SECTION E - INSPECTION AND ACCEPTANCE.......................................................................................49
SECTION F - DELIVERIES OR PERFORMANCE.......................................................................................53
ARTICLE F.1. PERIOD OF PERFORMANCE...............................................................................................53
ARTICLE F.2. PERIOD OF PERFORMANCE...............................................................................................53
ARTICLE F.3. DELIVERIES.........................................................................................................................54
ARTICLE F.4. DELIVERIES.........................................................................................................................55
ARTICLE F.5. TIME OF DELIVERY.............................................................................................................56
ARTICLE F.6. TIME OF DELIVERY.............................................................................................................56
ARTICLE F.7. DESIRED AND REQUIRED TIME OF DELIVERY....................................................................57
ARTICLE F.8. LEVEL OF EFFORT...............................................................................................................58
ARTICLE F.9. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998).....................59
SECTION G - CONTRACT ADMINISTRATION DATA................................................................................61
ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)..........................................................61
ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)......................................................62
1 RFP Handbook
ARTICLE G.3. WORK ASSIGNMENT PROCEDURES..................................................................................62
ARTICLE G.4. METHOD OF ORDERING...................................................................................................64
ARTICLE G.5. TASK ORDER PROCEDURE.................................................................................................66
ARTICLE G.6. EQUITABLE ADJUSTMENTS DUE TO CHANGES.................................................................68
ARTICLE G.7. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL
REPORT..................................................................................................................................................70
ARTICLE G.8. INVOICE SUBMISSION......................................................................................................78
ARTICLE G.9. CONTRACT FINANCIAL REPORT........................................................................................86
ARTICLE G.10. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR
52.232-40 (December 2013)..................................................................................................................87
ARTICLE G.11. INDIRECT COST RATES....................................................................................................88
ARTICLE G.12. GOVERNMENT PROPERTY..............................................................................................88
ARTICLE G.13. ON-SITE CONTRACTOR ACCESS TO GOVERNMENT PROPERTY......................................88
ARTICLE G.14. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE.....................................89
SECTION H - SPECIAL CONTRACT REQUIREMENTS..............................................................................91
ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006).....................91
ARTICLE H.2. HUMAN SUBJECTS............................................................................................................92
ARTICLE H.3. HUMAN SUBJECTS............................................................................................................92
ARTICLE H.4. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS......92
ARTICLE H.5. DATA AND SAFETY MONITORING IN CLINICAL TRIALS.....................................................93
ARTICLE H.6. DATA AND SAFETY MONITORING IN CLINICAL TRIALS AND EPIDEMIOLOGICAL STUDIES
...............................................................................................................................................................94
ARTICLE H.7. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN
CLINICALTRIALS.GOV..............................................................................................................................97
ARTICLE H.8. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS
CLINICALTRIALS.GOV..............................................................................................................................97
ARTICLE H.9. HIV ANTIRETROVIRAL TREATMENT TRIALS......................................................................98
ARTICLE H.10. HUMAN MATERIALS.......................................................................................................98
ARTICLE H.11. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)..........................................99
ARTICLE H.12. RESEARCH INVOLVING HUMAN FETAL TISSUE...............................................................99
ARTICLE H.13. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES
(Including Human Gene Transfer Research)..........................................................................................99
ARTICLE H.14. HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH..................................................100
ARTICLE H.15. HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH..................................................101
ARTICLE H.16. HUMAN EMBRYONIC STEM CELL (hESC) RESEARCH....................................................101
ARTICLE H.17. DATA SHARING IN GENOME-WIDE ASSOCIATION STUDIES (GWAS)............................101
ARTICLE H.18. SHARING HeLa CELL WHOLE GENOME SEQUENCE DATA AND FAMILY
ACKNOWLEDGEMENT..........................................................................................................................102
ARTICLE H.19. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING
FROM NIH-FUNDED RESEARCH...........................................................................................................102
ARTICLE H.20. NEEDLE DISTRIBUTION.................................................................................................103
2 RFP Handbook
ARTICLE H.21. ACKNOWLEDGEMENT OF FEDERAL FUNDING.............................................................103
ARTICLE H.22. RESTRICTION ON ABORTIONS......................................................................................103
ARTICLE H.23. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH...............................103
ARTICLE H.24. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED
SUBSTANCES........................................................................................................................................104
ARTICLE H.25. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION................104
ARTICLE H.26. MULTIPLE PRINCIPAL INVESTIGATORS..........................................................................104
ARTICLE H.27. PRIVACY ACT, HHSAR 352.224-70 (January 2006)........................................................104
ARTICLE H.28. EVALUATION PROJECTS................................................................................................105
ARTICLE H.29. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)..............105
ARTICLE H.30. ANIMAL WELFARE........................................................................................................106
ARTICLE H.31. INTRODUCTION OF RODENTS AND RODENT PRODUCTS.............................................107
ARTICLE H.32. INTRODUCTION OF RODENTS AND RODENT PRODUCTS - NIEHS................................107
ARTICLE H.33. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES.................108
ARTICLE H.34. OMB CLEARANCE.........................................................................................................108
ARTICLE H.35. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS..................................108
ARTICLE H.36. GUN CONTROL.............................................................................................................108
ARTICLE H.37. CERTIFICATION OF FILING AND PAYMENT OF TAXES....................................................108
ARTICLE H.38. OPTION PROVISION......................................................................................................109
ARTICLE H.39. AWARD TERM...............................................................................................................109
ARTICLE H.40. AWARD OPTION...........................................................................................................112
ARTICLE H.41. SUBCONTRACTING PROVISIONS..................................................................................115
ARTICLE H.42. LIMITATIONS ON SUBCONTRACTING - SBIR.................................................................116
ARTICLE H.43. INFORMATION AND PHYSICAL ACCESS SECURITY........................................................117
ARTICLE H.44. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b)
(January 2010).....................................................................................................................................132
ARTICLE H.45. COMMUNICATIONS MATERIALS AND SERVICES..........................................................133
ARTICLE H.46. STORAGE FACILITY REQUIREMENTS AND CERTIFICATION...........................................134
ARTICLE H.47. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL....................134
ARTICLE H.48. FULL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-3 (October 2008)....135
ARTICLE H.49. FULL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-3 (October 2008) with
ALTERNATE I (October 2008)...............................................................................................................136
ARTICLE H.50. PARTIAL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-4 (October 2008)
.............................................................................................................................................................137
ARTICLE H.51. PARTIAL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-4 (October 2008)
with ALTERNATE I (October 2008).......................................................................................................139
ARTICLE H.52. CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH..................................................140
ARTICLE H.53. CONFIDENTIALITY OF INFORMATION...........................................................................140
ARTICLE H.54. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF
INTEREST..............................................................................................................................................141
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ARTICLE H.55. PUBLICATION AND PUBLICITY......................................................................................144
ARTICLE H.56. REVIEW OF MANUSCRIPTS...........................................................................................144
ARTICLE H.57. NHLBI DATA REPOSITORY OF EPIDEMIOLOGY AND CLINICAL TRIALS..........................144
ARTICLE H.58. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN.........................................145
ARTICLE H.59. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE..................................145
ARTICLE H.60. INSURANCE...................................................................................................................146
ARTICLE H.61. HEALTH AND SAFETY PLAN...........................................................................................147
ARTICLE H.62. SECURITY......................................................................................................................159
ARTICLE H.63. OTHER ON-SITE............................................................................................................164
ARTICLE H.64. WORK BY THE GOVERNMENT......................................................................................179
ARTICLE H.65. PERFORMANCE REQUIREMENTS.................................................................................180
ARTICLE H.66. CONTRACTOR FURNISHED ITEMS................................................................................182
ARTICLE H.67. PARTNERING.................................................................................................................183
ARTICLE H.68. CONTRACTOR QUALITY CONTROL (CQC) PROGRAM...................................................184
ARTICLE H.69. DESIGN BUILD CONTRACT - ORDER OF PRECEDENCE..................................................185
ARTICLE H.70. EMERGENCY TASK ORDER PROCEDURES.....................................................................188
ARTICLE H.71. YEAR 2000 COMPLIANCE..............................................................................................188
ARTICLE H.72. INTELLECTUAL PROPERTY OPTION TO COLLABORATOR..............................................190
ARTICLE H.73. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES....................191
ARTICLE H.74. SHARING RESEARCH DATA............................................................................................192
ARTICLE H.75. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS.........193
ARTICLE H.76. HIGHLY PATHOGENIC AGENTS......................................................................................194
ARTICLE H.77. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391).....................................195
ARTICLE H.78. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES...........195
ARTICLE H.79. GOVERNMENT CONTROL OVER UNDELIVERED AND/OR UNPUBLISHED RECORDS AND
DATA.....................................................................................................................................................195
ARTICLE H.80. CONSTITUTION DAY......................................................................................................196
ARTICLE H.81. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD........................................197
ARTICLE H.82. REGISTRATION FEES FOR CONFERENCES, WORKSHOPS AND MEETINGS....................197
ARTICLE H.83. REGISTRATION FEES FOR NIH SPONSORED SCIENTIFIC, EDUCATIONAL, AND RESEARCH-
RELATED CONFERENCES......................................................................................................................198
ARTICLE H.84. GUIDELINES FOR INCLUSION OF WOMEN, MINORITIES, AND PERSONS WITH
DISABILITIES IN NIH-SUPPORTED CONFERENCES................................................................................199
ARTICLE H.85. USE OF FUNDS FOR PROMOTIONAL ITEMS.................................................................200
PART II - CONTRACT CLAUSES..............................................................................................................201
SECTION I - CONTRACT CLAUSES.......................................................................................................201
ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES.....................................................................204
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES...................................................................................216
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT....................................250
4 RFP Handbook
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