Attachment 16 - TE 16 - Applicable Regulations and Manuals.docx
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- Solicitation number
- N6264521R0057
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This document contains a combined synopsis and solicitation for non-personal services in support of the Navy Bloodborne Infection Management Center. The solicitation seeks proposals for infectious disease testing services and will result in an award of an indefinite delivery, indefinite quantity single award task order contract with a five-year ordering period. Proposals are due by 2:00 pm eastern time on November 17, 2021 and shall be submitted to the specified email address. The requirement is competed under full and open competition with a NAICS code of 621511 for medical laboratories and a business size standard of $35 million. The solicitation number is N6264521R0057 and is being conducted by the Department of the Navy Naval Supply Systems Command.
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TECHNICAL EXHIBIT 16
APPLICABLE REGULATIONS AND MANUALS
5 U.S.C. § 552 Freedom of Information Act
5 U.S.C. § 552A Privacy Act
21 CFR Chapter I Food and Drugs - Food And Drug Administration, Department Of Health And Human Services
42 CFR Part 72 Interstate Shipment Of Etiologic Agents
45 CFR Part 160,162,164 HIPAA Rules
49 CFR Part 171 Transportation - Research And Special Programs Administration, Department Of Transportation - General Information, Regulations, And Definitions
CHCS Specifications of Data-Sharing and User Interfaces to the Composite Health Care System (CHCS)
CHCS CHCS Policy and Procedures CCB-34 - Design Change Process
DFARS 252.227-7013 Rights in Technical Data - Noncommercial Items
DoDD 5000.I Defense Acquisition
DoD 5000.2-R Mandatory Procedures For Major Defense Acquisition Programs (MDAPS) And Major Automated Information System (MAIS) Acquisition Program
DoDD 5200.1-R DoD Information Security Program
DoDD 5200.2-R DoD Personnel Security Program
DoD 5200.8-R Physical Security Program
DoD 5200.28-M ADP Security Manual
DoD 5200.28-STD Department Of Defense Trusted Computer System Evaluation Criteria
DoDD 5200.28 Security Requirements For Automated Information Systems (AISS)
DoD 5400.11-R DoD Privacy Act Issuance
DoDI 5200.40 DoD Information Technology Security Certification And Accreditation Process (DITSCAP)
DoDD 6485.01 Human Immunodeficiency Virus (HIV)in Military Service Members
FIPS 140-1 Security Requirements For Cryptographic Modules
IEEE/BIA 12207V Information Technology-Software Lifecycle Processes
Military Health System (MHS) Y2K Management Plan
MHS Information Exchange Architectural Framework
MHS Health Area Standards Profile
MHS Standard Communications Architecture
MHS Standard Security Architecture
MHS Functional Area Model-Data (FAM-D)
MHS Functional Area Model-Activity (FAM-A)
NAVSO Pub 5239.15 Control Access Protection (CAP) Guidebook
NBS SP500-153 Guide to Auditing for Controls and Security: A System Development Life-Cycle Approach
Public Law 104-191 Health Insurance Portability and Accountability Act of I996
SAIC Doc D2-VADS-100 CHCS Interface Control Document for the Laboratory Interoperability Program
SAIC Doc GS-NHIV-I002 Interface Control Document (ICD) for the CHCS/HML Interface.
SECNAVINST 5211.5D Department Of The Navy Privacy Act (PA) Program
SECNAVINST 5300.30 (series) Management Of Human Immunodeficiency (HIV), Hepatitis B and Hepatitis C Virus Infection In The Navy And Marine Corps (27 December 2018)
TAFIM Department of Defense Technical Architecture Framework for Information Management (TAFIM) Version 3.0 (30 April 1996)
Web Content Accessibility Workforce Investment Act of 1998, Section 508, Electronic and Information Technology
7950.1M Tricare System Manual
DoDD 8500.01E Information Assurance
DoDD 5200.2 Personnel Security Program
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