KAIVA STRATEGIES, LLC

LABOR HOUR AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) OFFICE OF NEW DRUGS (OND) - HEALTH SCIENCE SUPPORT CONTRACTING OFFICER'S REPRESENTATIVE (COR) SHILA NDEH SHILA.NDEH@FDA.HHS.GOV TEL: 301-796-8347 CONTRACTING SPECIALIST

1-YEAR, LABOR HOUR (LH) TYPE TASK ORDER FOR FDA, OFBA FOR BUDGET AND ACQUISITION LIAISON SUPPORT. MODIFICATION P00001 TO: 1) REVISE THE SOW TO ADD TASKS, 2) REVISE THE LABOR HOUR MIX (LABOR CATEGORIES AND HOURS) FOR TASK 1 AND TASK 4, 3) REVISE THE K

1-YEAR BASE PERIOD, LABOR HOUR (LH) TYPE TASK ORDER FOR THE FOOD AND DRUG ADMINISTRATION (FDA) AND THE OFFICE OF THE COMMISSIONER (OC) TO PROCURE CORRESPONDENCE ANALYST, PUBLIC HEALTH PROGRAM SPECIALIST, AND MANAGEMENT AND PROGRAM ANALYST SERVICES.

1-YEAR, LABOR HOUR (LH) TYPE TASK ORDER FOR U.S. FOOD AND DRUG ADMINISTRATION (FDA), OFFICE OF FINANCE, BUDGET, AND ACQUISITIONS (OFBA) FOR BUDGET AND ACQUISITION LIAISON SUPPORT

LABOR HOUR AWARD FOOD AND DRUG ADMINISTRATION - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) - OST LOGISTICS AND SUPPLY CHAIN SME SUPPORT CONTRACTING SPECIALIST KIMBERLY W. DAVIS TEL: (703) 587-7126 KIMBERLY.DAVIS@FDA.HHS.GOV CONTRACT

1-YEAR BASE WITH TWO (2) OPTION YEARS, TIME AND MATERIALS (TM) TYPE TASK ORDER TO FOR THE FOOD AND DRUG ADMINISTRATION (FDA) AND THE OFFICE OF CENTER FOR DRUG EVALUATION AND RESEARCH (CDER).

BILATERAL MODIFICATION TO INCREASE THE LEVEL OF EFFORT FOR THE OPTION PERIOD.

BASE PERIOD AND THREE (3) OPTION PERIODS, LABOR HOUR (LH) TYPE TASK ORDER TO PROCURE ADDITIVE MANUFACTURING OF MEDICAL PRODUCTS CORE FACILITY SUPPORT FOR THE FOOD AND DRUG ADMINISTRATION (FDA), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) AND OF

NEW TASK ORDER, 3 YEAR (BASE AND 2 OPTION YEARS) FOR OFFICE OF THE COMMISSIONER (OC) RESEARCH AND POLICY SUPPORT SERVICES

OCS CONNECT SERVICES

DIRECT 8(A) AWARD OF 2-YEAR, LABOR HOUR (LH) TYPE CONTRACT FOR FOOD INGREDIENT AND FOOD CONTACT MATERIALS SUPPORT FOR THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN, OFFICE OF FOOD ADDITIVE SAFETY (OF

PUBLIC MEETING SUPPORT

FIRM FIXED PRICE & LABOR HOUR AWARD OFFICE OF COMPUTATIONAL SCIENCE (OCS) REGULATORY REVIEW SUPPORT COR: KIMBERLY MILLER TEL: (301)796-1071 KIMBERLY.MILLER4@FDA.HHS.GOV CS: KIMBERLY W. DAVIS TEL: (703) 587-7126 KIMBERLY.DAVIS@FDA.HHS.GOV

BILATERAL MODIFICATION TO REDUCE THE LEVEL OF EFFORT FOR THE OPTION PERIOD AND TO EXERCISE THE OPTION PERIOD.

DIRECT 8(A) AWARD OF 5-YEAR, LABOR HOUR TYPE CONTRACT TO KAIVA STRATEGIES, LLC TO PROVIDE EXPERT SUPPORT SERVICES FOR THE FOOD AND DRUG ADMINISTRATION (FDA) CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN) STANDARDS OF IDENTITY PROGRAM.

OFFICE OF INSPECTIONS AND INVESTIGATIONS? (OII), OFFICE OF TRAINING, EDUCATION, AND DEVELOPMENT (OTED), TECHNICAL AND LEARNING MANAGEMENT SYSTEM (LMS) SUPPORT

THE OBJECTIVE OF THIS CONTRACT IS TO ACQUIRE CONTRACTOR TO PROVIDE SERVICES TO SUPPORT CFSAN SSAS SCIENTIFIC MESSAGING.

PURCHASE ORDER FOR PROPERTY MANAGEMENT SUPPORT SERVICES TO SUPPORT THE CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN).

BASE PERIOD AND THREE (3) OPTION PERIODS, LABOR HOUR (LH) TYPE TASK ORDER TO PROCURE REGULATORY SUPPORT IN THE RESEARCH AND DOCUMENTATION OF DATA AND INFORMATION TO SUPPORT THE REVIEW OF ABBREVIATED NEW DRUG APPLICATIONS FOR THE FDA'S CENTER FOR

EOI::ENDING RADICAL AND WASTEFUL GOVERNMENT DEI PROGRAMS AND PREFERENCING (JANUARY 20, 2025)::EOI NOTICE OF TERMINATION FOR CONVENIENCE

LABOR HOUR AWARD FOOD AND DRUG ADMINISTRATION - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) - OST LOGISTICS AND SUPPLY CHAIN SME SUPPORT CONTRACTING SPECIALIST KIMBERLY W. DAVIS TEL: (703) 587-7126 KIMBERLY.DAVIS@FDA.HHS.GOV CONTRACT

BILATERAL MODIFICATION TO REDUCE THE LEVEL OF EFFORT FOR OPTION PERIOD 1 AND TO EXERCISE OPTION PERIOD 1.

DIRECT 8(A) AWARD OF 2-YEAR, LABOR HOUR (LH) TYPE CONTRACT FOR FOOD INGREDIENT AND FOOD CONTACT MATERIALS SUPPORT FOR THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN, OFFICE OF FOOD ADDITIVE SAFETY (OF

THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HEREBY INTENDS TO PROCURE PREVENTIVE CONTROL SUPPORT SERVICES THROUGH A DIRECT 8(A) AWARD OF A SINGLE, LABOR-HOUR (LH) TYPE CONTRACT CONSISTING OF ONE (1), 12-MONTH BASE PERIOD AND (4) OPTION PERIODS.

NCSTLTPHIW PUBLIC HEALTH INFRASTRUCTURE SUPPORT

HELP DESK AND USER SUPPORT

THE OFFICE OF THE CENTER DIRECTOR REQUIRES THE SERVICES OF ONE FULL-TIME MANAGEMENT ANALYST TO SUPPORT THE ADMINISTRATIVE OPERATIONS WITH DAY-TO-DAY ADMINISTRATIVE TASKS. THE CONTRACTOR SHALL PROVIDE SUPPORT TO SEVERAL SENIOR LEADERSHIP STAFF INCLUDI

LABOR HOUR AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) OFFICE OF NEW DRUGS (OND) - HEALTH SCIENCE SUPPORT NOTICE TO PROCEED WAS ISSUED ON 06/17/2025 EFFECTIVE 06/19/2025. CONTRACTING OFFICER'S REPRESENTATIVE (COR) SHILA NDEH

TASK ORDER FOR TWO CONSULTANTS AND ONE PROJECT MANAGER

DIRECT 8(A) AWARD OF (1) BASE PERIOD AND (4) OPTION PERIODS, TIME & MATERIALS (T&M) TYPE CONTRACT TO KAIVA STRATEGIES, LLC FOR PROFESSIONAL SERVICES TO SUPPORT FDA OFFICE OF WOMEN'S HEALTH SCIENCE RELATED ACTIVITIES, OFFICE INFORMATION

DIRECT 8(A) AWARD OF 3-YEAR, LABOR HOUR TYPE CONTRACT TO KAIVA STRATEGIES, LLC TO PROVIDE TECHNICAL SUPPORT FOR THE OFFICE OF FOOD ADDITIVE SAFETY (OFAS)/ DIVISION OF SCIENCE AND TECHNOLOGY

TO PROVIDE THE CDRH?S OFFICE OF THE CENTER DIRECTOR (OCD) AND THE CVM WITH THE PROFESSIONAL SUPPORT SERVICES OF A SME IX TO PROVIDE SUPPORT RELATED TO THE MDUFA, ADUFA, AND AGDUFA. THE SME IX SHALL SUPPORT THE EXISTING USER FEE ACTS AND ASSIST FDA LE

PROFESSIONAL, ADMINISTRATIVE, AND CONSULTING SERVICES (PACS) TASK ORDER FOR TRAVEL COORDINATOR

CORRECT POP END DATE OF FULLY TERMINATED, 1-YEAR, TIME AND MATERIALS (T&M) TYPE TASK ORDER FOR PROJECT MANAGEMENT SUPPORT SERVICES FOR THE FDA'S CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), OFFICE OF PHARMACEUTICAL QUALITY (OPQ).

1-YEAR, FIRM-FIXED PRICE (FFP) TYPE TASK ORDER FOR U.S. FOOD AND DRUG ADMINISTRATION (FDA), HUMAN FOODS PROGRAM (HFP) FACILITIES SUPPORT SERVICES.

DIRECT 8(A) AWARD OF A 1-YEAR, LABOR-HOUR (LH) TYPE CONTRACT FOR REGULATORY SUPPORT FOR THE GENERIC DRUG PROGRAM IN THE RESEARCH AND DOCUMENTATION OF DATA AND INFORMATION TO SUPPORT THE REVIEW OF ABBREVIATED NEW DRUG APPLICATIONS FOR THE U.S. FOOD AN

UEI: HCWKVFGBPA64 LABOR HOUR AWARD CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) OFFICE OF NEW DRUGS (OND) - WRITER/EDITOR SUPPORT SERVICES COR: NIKISHA REID PHONE: 240-402-9741, NIKISHA.REID@FDA.HHS.GOV

1-YEAR, TIME AND MATERIALS (T&M) TYPE TASK ORDER FOR PROJECT MANAGEMENT SUPPORT SERVICES FOR THE FDA'S CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), OFFICE OF PHARMACEUTICAL QUALITY (OPQ).

THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HEREBY INTENDS TO PROCURE PROJECT MANAGEMENT SUPPORT SERVICES THROUGH A DIRECT 8(A) AWARD OF A SINGLE, LABOR-HOUR (LH) TYPE CONTRACT CONSISTING OF ONE (1), 12-MONTH BASE PERIOD AND NO OPTION PERIODS.

CDRH PROFESSIONAL AND TECHNICAL SUPPORT SERVICES

ADMINISTRATIVE SUPPORT FOR THE OFFICE OF FOOD SAFETY, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION

DIRECT 8(A) AWARD OF 3-YEAR, TIME & MATERIALS TYPE CONTRACT TO KAIVA TO PROVIDE TPLC ADVISORY PROGRAM (TAP) FOR THE CDRH

DIRECT 8(A) AWARD OF 5-YEAR, LABOR HOUR TYPE CONTRACT TO KAIVA STRATEGIES, LLC TO PROVIDE EXPERT SUPPORT SERVICES FOR THE FOOD AND DRUG ADMINISTRATION (FDA) CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN) STANDARDS OF IDENTITY PROGRAM.

DIRECT 8(A) AWARD OF (1) 12-MONTH BASE PERIOD AND (4) 12-MONTH OPTION PERIODS, TIME & MATERIALS (T&M) TYPE CONTRACT TO KAIVA STRATEGIES, LLC FOR PROFESSIONAL SERVICES TO SUPPORT FDA OFFICE OF WOMEN'S HEALTH SCIENCE RELATED ACTIVITIES, OF

DIRECT 8(A) AWARD OF A 1-YEAR, LABOR-HOUR (LH) TYPE CONTRACT FOR REGULATORY SUPPORT FOR THE GENERIC DRUG PROGRAM IN THE RESEARCH AND DOCUMENTATION OF DATA AND INFORMATION TO SUPPORT THE REVIEW OF ABBREVIATED NEW DRUG APPLICATIONS FOR THE U.S. FOOD AN

THE OBJECTIVE OF THIS CONTRACT IS TO ACQUIRE CONTRACTOR TO PROVIDE SERVICES TO SUPPORT CFSAN SSAS SCIENTIFIC MESSAGING.

THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HEREBY INTENDS TO PROCURE SUBJECT MATTER EXPERT AND TECHNICAL EXPERT STRATEGIC PLANNING SERVICES FOR THE FDA'S CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN) VIA A DIRECT 8(A) AWARD OF A SINGLE,

DIRECT 8(A) AWARD OF A 1-YEAR BASE PERIOD AND TWO (2) OPTION PERIODS, LABOR-HOUR (LH) STAND-ALONE CONTRACT FOR PROFESSIONAL SERVICES SUPPORT FOR CENTER FOR DRUG EVALUATION AND RESEARCH (CDER).

DIRECT 8(A) AWARD OF A 5-YEAR, FIRM-FIXED PRICE (FFP) WITH A BASE AND (4) OPTION PERIOD YEARS PURCHASE ORDER FOR PROPERTY MANAGEMENT SUPPORT SERVICES TO SUPPORT THE CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN).

FY 24 ODT ECTD 4 IMPLEMENTATION GUIDE