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Before the
United States of America
Food and Drug Administration

In the Matter of the A-H1N1-09 “Swine Flu” Vaccines

} FDA Docket No. FDA-2009-P-0418
} PETITION
} With Request for Emergency Relief:
} Temporary Stay of all Pending
} “Swine Flu” Vaccine Approvals

To: Dockets Management Branch
Food and Drug Administration
Room 1061 HFA-305
5630 Fishers Lane
Rockville, MD 20852

Dated: August 17, 2009 – rev.1.01 (08.23.09)

Pursuant to the Constitution of the United States of America, First Amendment, Right to Petition for Redress of Grievances, the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), 21 C.F.R. 10.20 and 10.30 (Citizens Petition) and, to the extent applicable, 21 C.F.R. 10.35, to amend the FDA’s rules respecting the safety, effectiveness and availability of vaccines said to be useful for swine flu (A-H1N1-09), the undersigned Petitioners PETITION the Unites States, to wit:

Introduction

1. This Petition is brought before the Executive Authority of the United States of America, mindful of the President’s call for transparency in government and science-based decision-making. This Revision 1.01 of the Petition has been modified in form to meet the terms of applicable portions of 21 C.F.R. 10.20 – 35. Petitioners, however, note that this Petition is grounded in the Constitutional Right to Petition which may not be “abridged” by Government and therefore any regulatory requirements are subordinate to that primary source of authority for this Petition. In so far as any of the Petitioners are protected under the RFRA, all rights are reserved under the Religious Freedom Restoration Act of 1993 (RFRA – P.L. 103-141).

The Petitioners therefore have included Addendum 1.1 in this Petition to address the formal requirements of Section 10.30: A. Action requested; B. Statement of Grounds; C. Environmental Impact/Exemption and D. Economic Impact. Furthermore, in so far as Sec. 10.35 (Stay of Actions) may apply, the Petitioners have included Addendum 1.2 to this Petition to address the formal requirements of Section 10.35: A. Decision Involved and B. Action Requested. Finally, Petitioners append to this Petition actual copies of non-governmental Citations referenced in Appendix B, which has been further amended to meet the “unfavorable representative data” requirement of the Sec. 10.30 Certification format.

2. Petitioners are several nongovernmental organizations involved in health care civil rights and several individuals who are adversely impacted by the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) actions referred to in this Petition, and all persons who join in this Petition hereafter.

3. This Petition is submitted to request specific action by the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) (the Federal Agencies) within the scope of the mandated duties thereof, in order to exhaust administrative remedies.

4. The primary purpose of the Petition is to seek emergency actions with regard to the imminent Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) granting of various drug-interest commercial applications or approval and widespread use of various so-called “H1N1” “A-H1N1-09” or “Swine Flu” vaccines (herein, the Vaccines).

5. The Vaccine Approvals are being treated as emergency drug approvals, but are being sought without even minimal science-based safety testing or testing for clinical efficacy in preventing disease, and with the inclusion of dangerous adjuvants, including Mercury, and squalene, which has never been heretofore approved as a vaccine adjuvant. Legal immunity has been granted a priori to the manufactures, the Federal Government and its agents in the event of harm or death from these vaccines.

6. a. As one example, within the past two weeks, the British Neurological Surveillance Unit (BNSU) warned of “the Government’s concern about releasing a vaccine of unknown safety.” and has alerted its members to be on the alert for an up to 8-fold increase in Guillain-Barre Syndrome (GBS) due to the Vaccines that are the subject of this Petition.

http://www.dailymail.co.uk/news/article-1206807/Swine-flu-jab-link-killer-nerve-disease-Leaked-letter-reveals-concern-neurologists-25-deaths-America.html#ixzz0OJSgKn4b

b. The United States government has paid nearly two billion dollars to the families of individuals who have been killed or maimed by vaccines as part the Vaccine Injury Compensation Program. A massive increase in the use of vaccines such as the swine flu vaccine that is the subject of this petition will be likely to significantly increase the number of individuals harmed by vaccines.

See: http://www.usdoj.gov/civil/torts/const/vicp/about.htm

Redress Sought

7. (a) The first action sought is an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in imminent peril of irreparable harm if the Temporary Stay is not granted immediately.

(b) Additionally, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, requiring strong warnings to the public, as mandated by the United States Supreme Court in another context, Thompson v. Western States Medical Center – 535 U.S. 357, 2002:

“If the First Amendment means anything, it means that regulating speech must be a last – not first – resort. … We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.”

“Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown.”

The warning should therefore read: “This Vaccine has not undergone FDA safety or efficacy testing and its risks are unknown in all age groups. This Vaccine contains ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.”

The warning should further advise that should the recipient experience an adverse event or death from the vaccine, the vaccine manufacturers, government and government agencies have no liability, and the National Vaccine Injury Compensation Program does not currently provide for possible compensation to victims of the Vaccines.

(c) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to engage in a vigorous public information campaign, interleaved with their promotion of the Vaccines, and given equal prominence in type face, media announcements, web presence and other methods of public information used to promote the Vaccines, stating that the Vaccines contain ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected. And, further that should the recipient experience an adverse event or death from the vaccine, the vaccine manufacturers, government and government agencies have no liability, and the National Vaccine Injury Compensation Program does not currently provide for possible compensation to victims of the Vaccines.

(d) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health, that these uninsurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.

(e) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.

Legal Basis for Relief

8. As an Executive Department Agency, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must “Take Care that the Laws be faithfully executed” (Article II, Section3, United States Constitution).

9. This Petition is grounded in fundamental principles of inalienable right, law and equity.

10. The primary legal basis for submitting this Petition to the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is the First Amendment to the Constitution of the United States: “Congress shall make no law…abridging… the right of the people… to petition the Government for a redress of grievances.” Additionally, the First Amendment Freedom of Speech, requiring transparency in government, as well as Fourth, Fifth, Ninth, Tenth and Fourteenth Amendments impact the arguments herein.

11. Petitioners also cite: the World Medical Association 1964 Declaration of Helsinki. See: http://www.wma.net/e/policy/b3.htm. This Declaration has the force of International Law, to which the United States is a party, and it clearly forbids experimental medication or medication without fully informed consent, as does United States law, for example, 42 U.S.C. 289(a).

12. The United Nations Universal Declaration of Human Rights – Article 12 – “No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honor and reputation. Everyone has the right to the protection of the law against such interference or attacks.” See: http://www.un.org/en/documents/udhr/ and the Geneva Conventions: Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of Non-International Armed Conflicts (Protocol II) – Article 17.-Prohibition of forced movement of civilians:

“1. The displacement of the civilian population shall not be ordered for reasons related to the conflict unless the security of the civilians involved or imperative military reasons so demand.
Should such displacements have to be carried out, all possible measures shall be taken in order that the civilian population may be received under satisfactory conditions of shelter, hygiene, health, safety and nutrition.

2. Civilians shall not be compelled to leave their own territory for reasons connected with the conflict.”

See: http://www2.ohchr.org/english/law/protocol2.htm

13. Current law and regulations provide for involuntary Provisional Quarantine, with removal, following refusal of persons to submit to vaccination with the untested, uninsurable, non-voluntary “informed consent” Vaccines. The Agency regulations should be amended to provide for voluntary Self-Shielding, Self-Quarantine and Self-Isolation as permitted alternatives.

14. Bivens v. Six Unknown-Named Agents of Fed. Bureau of Narcotics, 403 U.S. 388, 396-397, (1971); Carison v. Green, 466 U.S. 14, 18-19 (1980). – These cases construe “42 USC § 300aa-31” with its “more likely than not” evidentiary burden and its Daubert v. Merrell Dow Pharmaceuticals, Inc, 509 U.S. 579, 113 S.Ct 2786, 2797 (1993), prohibition against expert opinion reliance upon poor quality and flawed data, the surviving good quality data shows the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is statutorily required to reject the Vaccines approval since it “more likely than not” caused numerous neurological and immune system pandemics (e.g., autism, neurological disorders, autoimmune disorders, etc). Since the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) know of this linking data and intentionally exposed the public to these serous risks of harm, while attempting to hide/alter the data that showed the harm, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) also violated the 14th Amendment’s “Constitutional Safety Guarantees.” Under these egregious and horrifying circumstances, both Sec. 300aa-31 and a 28 USC § 1331 “Bivens Action” would authorize injunctive relief, and where warranted, damages.

15. Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), in which the Supreme Court of the United States, prior to the establishment of the Food, Drugs and Cosmetics Act revisions that established Federal pre-emption of drug approvals, gave deference to the Supreme Court of Massachusetts in an involuntary vaccination matter, also contains clear language authorizing Federal intervention in circumstances that are clearly present with regard to the Vaccines involved in this Petition.

“It is easy, for instance, to suppose the case of an adult who is embraced by the mere words of the act, but yet to subject whom to vaccination in a particular condition of his health or body, would be cruel and inhuman in the last degree. We are not to be understood as holding that the statute was intended to be applied to such a case, or, if it was so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned. “All laws,” this court has said, “should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression or absurd consequence. It will always, therefore, be presumed that the legislature intended exceptions to its language which would avoid results of that character. The reason of the law in such cases should prevail over its letter.” United States v. Kirby, 7 Wall. 482; Lau Ow Bew v. United States, 144 U.S. 47, 58. Until otherwise informed by the highest court of Massachusetts we are not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”

16. The Acts establishing the authority of the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) being herein petitioned are also a legal basis for the Petition. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) exist to protect the public, within the limits established by the Constitution of the United States of America. However, Article 16 of the original enabling legislation that created the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) indicates, in effect, that a primary purpose is to promote, protect and promulgate the pharmaceutical industry.

17. Petitioners note the statute in the derogation of the common law and Constitutional limitations, establishing certain exemptions from liability of Vaccine Injuries, 42 USC 300aa-16 (and the Vaccine Injury Compensation Program, there under). This law is further cited as a law that must be strictly construed in favor of patients, guardians, parents and children even if such construction is against the economic interests of the drug industry and other persons exempt there under.

18. Petitioners note that, given the exceptional exemption given to both manufactures of the Vaccines and employees of the Federal Agencies and their designees which purports to eliminate the possibility of redress through the Courts by the public in the event that individuals suffer irreversible harm or death, it is especially important that careful notification and protection be offered to the public in the face of instructions or compulsions to accept the use of the Vaccines which contain ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.

19. The total amount that the Vaccine Injury Compensation Program has paid in compensation since its 1989 founding is $1,884,145,255.29, however, this program does not currently list the Vaccines as being ones for which compensation under this program may be had.

See: http://www.hrsa.gov/Vaccinecompensation/statistics_report.htm

20. Basic common law principles prohibit forced acquiescence under duress and limited or intentionally distorted information, as exemplified by the United States Supreme Court decision in the case of Thompson v Western States Medical Centers – 535 U.S. 357 (2002). The Petitioners note with concern that FDA regulation permits a choice under duress upon limited and distorted information such that those refusing the Vaccines in a Pandemic Emergency situation face incarceration/quarantine under Provisional Quarantine regulations in violation of the prohibitions mentioned above against forced acquiescence under duress and limited or intentionally distorted information.

21. Additionally, the Statutes authorizing the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) contain general provisions that support the actions requested in this petition. Federal Law includes provisions that grant the responsible persons in the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) broad authority to promulgate rules and regulations “necessary to carry out the Act[s].”

22. The Food, Drug and Cosmetics Act (FD&C Act) Mission Statement requires that “…(B) human and veterinary drugs are safe and effective…” (21 USC §393(b)(2)). The Act had been amended repeatedly, to require that no drug be approved unless it is proven “safe and effective.”

This clear legal requirement is explained by the Agency on its web site:

“In October 1962, Congress passed the Kefauver-Harris Drug Amendments to the Federal FD&C Act. Before marketing a drug, firms now had to prove not only safety, but also provide substantial evidence of effectiveness for the product’s intended use. Temple says, “That evidence had to consist of adequate and well-controlled studies, a revolutionary requirement.”

“Also critically, the 1962 amendments required that the FDA specifically approve the marketing application before the drug could be marketed, another major change.” The Kefauver-Harris Drug Amendments also asked the Secretary to establish rules of investigation of new drugs, including a requirement for the informed consent of study subjects. The amendments also formalized good manufacturing practices, required that adverse events be reported, and transferred the regulation of prescription drug advertising from the Federal Trade Commission to the FDA.”

See: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm

23. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should issue the actions requested herein as an Interim Final Rule without first completing Notice and Comment, Risk Assessment, and Cost-Benefit Analysis. Additionally, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should not issue the drug-industry requested vaccine approvals as an emergency matter.

24. Under ordinary circumstances, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must comply with procedural requirements under the Administrative Procedures Act (APA) and the specific Acts authorizing the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC), including the use of notice-and-comment rulemaking and the completion of a risk assessment and cost-benefit analysis before issuance of a new rule. However, both Acts provide for exceptions to those requirements for circumstances such as those present here (with regard to the Petitioners herein, but not with regard to the drug-industry applications), where the continuation of current policy (the emergency approval of the Vaccines) would constitute an imminent threat to public safety and any delay in the policy-making the Petitioners herein would be contrary to the public interest.

25. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should only avail itself of those statutory exceptions with regard with Petitioner’s request herein and promulgate the requested policies while first providing the public with reasonable notice under these circumstances and an opportunity for comment and before completing a full risk assessment and cost-benefit analysis. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should first adopt the policy as an “interim-final rule,” which would become binding upon publication (or within a time certain; for example, a week after publication) and subsequently provide for public comment and complete its risk assessment and cost-benefit analysis. If such a time period is provided for public comment and the completion of risk assessment and cost-benefit analysis, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should make no declaration, take no action, approve no product or Vaccine related to this situation during such period.

26. The Requested Actions of Petitioners herein satisfy the “good cause” exception to the Administrative Procedure Act’s (APA) requirement for notice and comment, while the application of that exception should not apply to the Vaccine applications.

27. The Administrative Procedures Act (APA) provides that full notice-and-comment rulemaking is not required when an agency “for good cause finds (and incorporates the finding and a brief statement of the reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. Section 553(b)(B) The good cause exception “is an important safety valve to be used where delay would do real harm.” United States Steel v EPA, 595 F.2d207, 214 (5th Cir. 1979). According to the legislative history of the provision, “impracticable” means a situation in which the due and required execution of the agency functions would be unavoidably prevented by its undertaking public rule-making proceedings.” S. Rep. No. 752, 79thCong., 1st Sess., at 16 (1945). It has been held, determining “impracticality” requires analysis in practical terms of the particular statutory-agency setting and the reasons why agency action could not await notice and comment. American Transfer & Storage Company v. ICC, 719 F. 2d 1283, 1295 (5th Cir. 1983).

28. The same urgency which motivates the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with excessive rapidly and inappropriate zeal, in the light of an alleged pandemic threat (declared despite the mild nature of the supposed pandemic disease) should motivate the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with the measures proposed by Petitioners herein to protect both the public’s welfare and their right to fully informed consent and transparency.

29. Below are listed three of numerous instances in which courts have upheld an agency’s decision to invoke the “good cause” exception and issue a rule without providing notice and comment where a delay would threaten public safety or the environment. See: Hawaii Helicopter Operators Ass’n v. FAA, 51 F.3d 212, 24 (9th Cir. 1995) (good cause exception satisfied in view of “the threat to public safety reflected in an increasing number of helicopter accidents”); Northern Arapahoe Tribe v. Hodel, 808 F.2d741, 750-52 (10th Cir. 1987) (good cause exception satisfied in view of urgent need for hunting regulations where herds were threatened with extinction); Northwest Airlines v. Goldschmidt, 645 F2d 1309, 1321 (8th Cir. 1981) (good cause exception satisfied in view of urgent need to allocate landing slots at major airport).

30. The rationale underlying those decisions is that compliance with time-consuming procedural requirements would “do real harm” by delaying implementation of urgently needed policies to safeguard public health. Swine Flu causes a disease of low virulence and pathogenicity so that the need for current Agency displays of overwhelming haste in their approval is not present, but the Vaccines contain never-before-approved adjuvants and known toxins so that the need for caution in their approval is very much present. Clearly, the exigent circumstances necessary to satisfy the Administrative Procedures Act’s (APA’s) good cause exception are present with regard to Petitioner’s concerns as set forth in the Factual Basis for Relief. They are not present with regard to the Vaccine approval applications. On the contrary, such approval would harm the public health.

Factual Basis for Relief

31. Vaccinations cause well-known and foreseeable harm. Autism, neurological damage, Guillian Barré syndrome, post vaccination Encephalitis, asthma, coma, juvenile ALS, adult ALS, oil-in-water adjuvant-induced poly arthritis, dermatitis, fibromyalgia, fatigue, malaise, death and other known consequences of vaccine injury are not generally reversible and the present danger from the Vaccines to children and adults is so great that the “good cause” exception referenced above is well warranted in this case. Consumers are being defrauded while children and others are being irreversibly damaged. Once a child collapses into autism, for example, there is a virtually irreversible path which the child and family follow, often leading to eventual institutionalization. These are, in most cases, preventable tragedies. The probable harm is immediate and irreparable.

32. In order to redress the perceived harm, there are several procedural matters that should be addressed by Agency Rule or Court interpretation. These are the need for:

(1) Clear and prominent Warnings as specified elsewhere herein,
(2) Due-process compliant procedures for opting out of involuntary vaccinations,
(3) Sound information to support informed consent if the vaccination is truly voluntary, and
(4) Due-process compliant procedures required to involuntarily isolate or quarantine any person who refuses to take an involuntary vaccine, or for anyone who for voluntary reasons refuses to take a vaccine.

33. Medical ethics, United States law regarding medical experimentation and treatment, and international legal standards require nothing less. These international legal standards are among the international standards the Agency pledged to harmonize to in a notice published in the Federal Register of October 11, 1995 (60 FR 53078), “FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines…”

See: http://www.cfsan.fda.gov/~lrd/fr970707.html

34. Similarly, if the H1N1 “Swine Flu” vaccination results are similar to the 1976 “Swine Flu” vaccination panic, hundreds will die (more than are alleged to have died from the 2009 “Swine Flu”) and hundreds of thousands or more will be injured. If the Vaccines, with their squalene adjuvant, are as deadly as the experimental squalene Anthrax Vaccine mandated for United States soldiers during the First Gulf War, hundreds of thousands will be hospitalized due to vaccine adverse reactions with tragic consequences to them and enormous preventable financial burdens on the healthcare system.

35. The Petitioners append to this Petition further supporting materials as Appendix B – these address:

1. Epidemics Timeline – Andrew Maniotis, Ph.D
2. Voluntary vs Mandatory – Rima E. Laibow, MD
3. Legal Article: Basis for Injunction – Kent R. Holcome
4. Your Right to Self Shield – Ralph Fucetola, JD
5. Access to Representative Data Unfavorable to Petitioners

Actions Requested from Food and Drug Administration (FDA)
and/or the Centers for Disease Control (CDC)

36. Therefore the Petitioners request the following redress of grievances:

(a) The first action sought is an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in immanent peril of irreparable harm if the Temporary Stay is not granted immediately.

(b) Additionally, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, requiring strong warnings to the publics of each age groups, geographic location and any other relevant demographics, that a process be developed for individuals to opt out of any mandatory program and that clear instructions be given on the risk and benefits of the vaccine:

“This Vaccine has not undergone adequate FDA safety or efficacy testing and its risks are unknown in all age groups. This Vaccine contains ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.” Additionally, there is no legal mechanism, such as the VICP, which will provide compensation for those who may be foreseen to be injured by the Vaccines.

(c) Furthermore, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that the Vaccines not be subject to any legal mandate requiring their use by any class of persons in order for such persons to receive government services, or to work in particular employments, or to travel or to attend any public places or for any other purpose.

(d) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that these uninsurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.

(e) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.

Wherefore the undersigned certifies that to the best of his knowledge and belief the factual statements made herein are true, complete and not intentionally misleading.

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the Petitioner which are unfavorable to the petition.

August 17, 2009 (Rev.1.01 – 08.23.09)

Initial Petitioners Listed on Appendix A

By:
Ralph Fucetola JD
Natural Solutions Foundation Trustee, on behalf of all Petitioners

Express Mail: EO 964 064 326 US – 0144 4000 0332 0857
Revision by email to: [redacted]@fda.hhs.gov

Appendixes

Appendix A – Signatories

Gary Null, PhD – Human Nutrition & Public Health Science
New York, New York 10024

Dr. Tedd Koren, DC – Foundation for Health Choice
Hatfield, PA 19440

Albert N. Stubblebine III – (Maj Gen. US Army Ret.) President
Natural Solutions Foundation
Maryville, Missouri 64468

Rev. Dr. Robert H. Sorge – Pastor of Abunda Life Center
Asbury Park, New Jersey 07712

Rev. Kathy A. Greene, BARA – Chair of LifeSpirit Center
Newton, New Jersey 07860

Alan Phillips, J.D., VaccineRights.com
Chapel Hill, NC 27515-3473

Karen Horbatt – President – Institute for Health Research
Summit, NJ 07901-1826

Appendix B – Articles

1. Andrew Maniotis, Ph.D – How to Predict an Epidemic Timeline
http://drrimatruthreports.com/?p=3198

2. Rima E. Laibow, MD – Truth and the Ministry of Lies
http://drrimatruthreports.com/?p=3279

3. Kent R. Holcome – Basis for Injunction
http://www.medicalveritas.com/man1925_1936.pdf

4. Ralph Fucetola JD: Your Right to Self Shield
http://drrimatruthreports.com/?p=2752

5. Unfavorable Data:

21 C.F.R. 10.30 includes a form of Certification, as used in this Petition, which requires Petitioners to set forth “representative data and information known to the petitioner which are unfavorable to the petition” In fulfillment of this requirement, Petitioners cite the Government’s own web site on Vaccine Safety which includes a representative sample of opinions contrary to those of Petitioners:

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm133806.htm

———————————–

Addendum 1.01

Requirements under 21 C.F.R. 10.30 (Citizens Petition)

A. Action requested

The Petitioners request the five specific actions set forth in Paragraph 36 of the Petition.

B. Statement of Grounds

The Legal and Factual Statement of Grounds is found in Paragraphs 8 through 35 of the Petition.

C. Environmental Impact/Exemption

The impact of the granting of the five specific relief actions requested herein will not have any measurable effect on the current environment. This Petition should therefore be exempt under 21 C.F.R. 25.31 (Human drugs and biologics).

D. Economic Impact

This decision will impact the economy as follows:

1. May limit upside profit potential of the vaccine makers and others who will profit from the sale of uninsured, un-tested-for-safety and unproven vaccines to the public.
2. Will reduce the cost to the economy of the lost productivity and other costs of persons who will suffer foreseeable harm from the vaccines.
3. Since the effectiveness of the vaccines are not proven, it cannot be determined what economic benefit may occur from any alleged immunization effect.

Addendum 1.02

Requirements under 21 C.F.R. 10.35 (Stay of Action)

A. Decision Involved

The Center for Biological Evaluation and Research (CBER) pending “Swine Flu”- A-H1N1-09 Vaccine Approvals under the Public Health Service Act, Biological Products:

Section 351(d) (Section 262 of Consolidated Title 21): “Licenses for the maintenance of establishments for the propagation or manufacture and preparation of products described in Subsection A of this Section may be issued only upon a showing that the establishment and the products licenses desired standards, designed to assure the continued safety, purity, and potency of such products, prescribed in regulations, and licenses for new products may be issued only upon a showing that they meet such standards.”

B. Action Requested.

Per Paragraph 36 (a) of the Petition: “an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in immanent peril of irreparable harm if the Temporary Stay is not granted immediately. ”