American Domestic Bioterrorism Program - Regulations, Rules and Guidance Documents

New section added to main post.

I added a new section to the main post today.

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U.S. DOMESTIC BIOTERRORISM PROGRAM - ENABLING REGULATIONS, RULES & GUIDANCE DOCUMENTS

• 2011/01 - FDA Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products (19 pages)

• 2014/08/19 - FDA Guidance: Decisions for Investigational Device Exemption Clinical Investigations (19 pages)

• 2015/08 - FDA Guidance: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products. (19 pages)

• 2016/06/21 - HHS Clinicial Trials Registration and Results Final Rule. 81 FR 64981 (177 pages)

• 2017/01/19 - Federal Policy for the Protection of Human Subjects Final Rule. 82 FR 7149. (126 pages) Joint rule by 16 federal agencies, subsequently adopted by other agencies. Revised 1991 Common Rule, which had been developed based on 1947 Nuremberg Code and 1978 Belmont Report.

• 2017/01/19 - HHS Control of Communicable Diseases Final Rule 82 FR 6890. (89 pages)

• 2017/01 - FDA Guidance: Emergency Use Authorization of Medical Products and Related Authorities. (49 pages)

• 2017/07 - FDA Guidance: IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects (8 pages)

• 2017/08 - FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (17 pages)

• 2018/06/19 - Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period Final Rule. 83 FR 28497 (24 pages)

• 2021/04/02 - Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination (14 pages)

• 2021/07/06 - DOJ Opinion: Whether Section 564 of the Food, Drug, and Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency Use Authorization (18 pages)

• 2021/09 - FDA Guidance: Real-World Data - Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (39 pages)

• 2021/11 - FDA Guidance: Real-World Data - Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (17 pages)

• 2021/11/17 - HHS Possession, Use, and Transfer of Select Agents and Toxins—Addition of SARS–CoV/SARS–CoV–2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS–CoV–2 To Incorporate Nucleic Acids Coding for SARS–CoV Virulence Factors to the HHS List of Select Agents and Toxins. Interim Final Rule. 86 FR 64075 (7 pages)

• 2022/02/07 - Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination. Update to 4/2/21 version. (46 pages)

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I’ve skimmed all of these documents to confirm that they’re evidence from the public record (Congressional Record, Federal Register) to support criminal prosecution of sitting and former Congress members, presidents and Health and Human Services secretaries for treason, including acts of bioterrorism conducted pursuant to ‘public health’ pretexts. I haven’t done close-reads or analysis yet.

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St. Pius V. 1504-1572.