Federal Legislation
AVFCA Bills Supported and Opposed
Table of Contents
2023 SB 499 (Menjivar): Cool Schools Act
A Voice for Choice Advocacy is the Sponsor of the 2023 Cools Schools Act
Bill Description: SB 499 has two parts:
1. Would require all schoolsites, at the earliest possible time or, at the latest, the next time resurfacing or replacement of outdoor surfaces is required, to replace low specific heat surfaces, such as cement, asphalt, brick, pebbles, sand, aggregates, rubber, and synthetic turf, with high specific heat surfaces, such as cool pavement technologies, natural grass, shrubs, trees, wood chips, or other natural systems that mitigate heat and pollution, as provided. The bill would require all schoolsite decision making personnel involved in the replacement or resurfacing of outdoor surfaces at a schoolsite to be trained in extreme heat mitigation measures.
2. This bill would, on or before January 1, 2025, require all schoolsites, as defined, to develop an extreme heat action plan, as specified, and, by January 1, 2027, to begin implementation of their extreme heat action plan. The bill would require the plan to include installing or planting (1) shade trees or mini-forests, positioned on schoolsites where pupils can access them during the school day, (2) school garden infrastructure and plantings, and (3) coniferous tree barriers between the schoolsite and any adjacent high-polluting streets or commercial projects.
(https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240SB499)
Ask of Legislators: To support SB 499, The 2023 Cool Schools Act
Current Status: Will be heard by the Senate Education Committee on Wednesday, March 22, 2023 and has also been referred to Senate Human Services Committee. Notice of the hearing is given at least 72 hours in advance.
Take Action on SB 499 TODAY!
Meet
with your Senator, in person, at their local district office and ask them to support SB 499
Upload
a letter of support to the Legislative Portal
Add
your organization to AVFCA’s SB 499 support coalition, to be part of the official support materials
Educate
local public School Board members, individual Board of Supervisors, and other organizations and ask them to support SB 499
Further Information
1) Make an appointment TODAY to meet with your CA Senator and their staff to ask them to support SB 499
- -Not sure who that is – enter your address here: https://findyourrep.legislature.ca.gov/ (Note: No need to contact your Senator yet)
- Not sure how to set up a meeting and build a trusted relationship with your legislators – watch this webinar: https://youtu.be/NGwnwAcJJZ4. Be sure to mention you are a constituent.
- Not sure what to say – print out and use the AVFCA resources (coming soon)
2) Submit a letter of support to the Legislative Portal, as an individual and on behalf of any organization you represent, and encourage other organizations to do the same:
– Write a brief letter in your own words asking the Senate Education and Human Services Committees to Support SB 499. This does not need to be more than a few sentences stating “I Support SB 499 bill because ….”. Make sure your letter is polite, to the point, and sounds convincing. Remember you are trying to sway the legislators to vote the way you want them to, not alienate them. If you can write on behalf of an organization or company, be sure to put your letter on a letterhead and sign it, so that it gets recognized.
– Create an account or sign in at https://calegislation.lc.ca.gov/Advocates/
– Click “Submit a letter” and enter the bill number (SB 499), and follow the instructions to upload your letter to Senate Education and Human Services Committees.
3) Sign your organization on to AVFCA’s SB 499 support materials
As the sponsor of SB 499, A Voice for Choice Advocacy is gathering a coalition of concerned organizations throughout California to support SB 499, AB 246 and AB 99 through the 2023 legislative process. Please sign your organization on to our letters by completing the form https://avoiceforchoiceadvocacy.org/avfca-2023-organization-bill-support/ here: to show your organization’s support to increase the health of our environment and decrease toxics, which in turn will impact people’s physical and mental health positively.
By completing this form A Voice for Choice Advocacy will add your organization to a support letter submitted to each bill’s author, the CA Legislative Committees through which these bills will pass, as well as to legislators voting on the bill. You are welcome to add your organizations support to any or all of these bills.
4) Meet and educate organization leaders to gain their support of SB 499
One of the key ways legislators are swayed to vote on a bill, is by seeing lots of organizations supporting a bill. Therefore reach out and meet with individual school board members, individual board of supervisors, and other organization leaders to encourage them to support SB 499 and take the steps above.
Other 2023 CA Bill Information
AVFCA 2023 Organization Bill SupportAVFCA Educational Resources AB 6592023 CA Legislation2023 AB 659 (Aguiar-Curry): College HPV Vaccine Mandate
CDC Update of MMR and MMRV Vaccine Information Statements – Public Comment
The CDC is updating the MMR and MMRV Vaccine Information Sheets (VIS).
These are required by the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) which states:
“The information in such materials shall be based on available data and information, shall be presented in understandable terms and shall include:
(1) a concise description of the benefits of the vaccine,
(2) a concise description of the risks associated with the vaccine,
(3) a statement of the availability of the National Vaccine Injury Compensation Program, and
(4) such other relevant information as may be determined by the Secretary
The public comment on the changes to the MMR and MMRV Vaccine Information Sheets can be made until December 19, 2016, by clicking here. https://www.regulations.gov/docket?D=CDC-2016-0094
TAKE ACTION TODAY:
Submit your public comment by midnight EDT, December 19, 2016, by clicking here. https://www.regulations.gov/docket?D=CDC-2016-0094. A Voice For Choice Advocacy recommends drafting comments in a word document and then cutting and pasting when submitting online as there is a limited amount to time to comment before the session times out. You can use the sections and comments below to support your comments.
The CDC has clear instructions for the comments to be taken into consideration so be sure to follow them:
– Identify you are referring to Docket No. CDC-2016-0094
– Be specific and reference particular sections.
– Provide supporting documents and data.
– Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. Our comments can make a difference. HHS/CDC state they will carefully consider and address all comments submitted and may revise the content of the rule as appropriate at the final rulemaking stage. HHS/CDC will publish a final rule after the comment period that reflects any content changes made as a result of comments received.
AVFCA Analysis and Comments on Changes to MMR and MMRV Vaccine Information Statements:
The VIS for MMR and MMRV are very similar and so our comments apply to both, unless stated otherwise. If you wish to see the specific changes made to the two VIS statements you can click here for the MMR VIS and here for the MMRV VIS. The most important suggestion AVFCA has is that a link to the full package insert be added to the VIS. Overall – the statements are mostly the same, but there are some sentences that are not consistent across the two VIS, such as the disease descriptions in Section 1.
Specific Section comments: Section 1.
Taken out: Before vaccines, these diseases were very common in the United States.
Replaced with: Vaccination programs have made these diseases much less common in the U.S. But if we stopped vaccinating, these diseases could return and cause a lot of people to become ill.
Comment: Take out the second sentence. This is fearmongering, hypothetical and speculative. Disease is increasing among the vaccinated populations currently.
The disease descriptions differ in the MMR vs MMRV VIS. For example, but not limited to:
MMR VIS
Measles
Measles virus causes fever, cough, runny nose, and red, watery eyes, followed by rash
Measles can lead to ear infection, pneumonia, brain damage, and death.
MMRV VIS
Measles
Causes rash, cough, runny nose, eye irritation, fever.
Can lead to ear infection, pneumonia, brain damage, and death.
Comment: Make two VIS statements consistent in wording. The MMR looks to have been updated but the MMRV has not.
Mumps
Taken out: “sterility” in disease description
Replaced with: “death”
Comment: Sterility is a more common side effect from the mumps disease than death so if death is included then sterility should be as well.
General Section 1 Comment: For all disease descriptions – including death for these in the US is not appropriate as death from measles, mumps rubella or varicella is (or was when they were more prevalent) extremely rare in the US. (Understood that globally that may be different, but this VIS should only refer to the US as that is where it will be used). It is misleading and fearmongering to say that these diseases lead to death, here in the US where this VIS will be used.
General Section 1 Comment: These should give the likelihood of getting each of these disease side effects in US today, so the consumer can do a risk/benefit evaluation.
Section 2.
Comment: The Proquad (MMRV) package insert reads:
Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with M-M-R® II and VARIVAX® administered separately. (5.1, 6.1, 6.3)
This is mentioned in Section 4, but should be mentioned here when the options are given. Consumers should be made aware that there is a higher risk of severe side effects using the MMRV vs the MMR and V separately.
Comment: Both VIS updated to read “There are no known risks to getting MMRV/MMR vaccine at the same time as other vaccines.”
However the ProQuad (MMRV) package insert reads:
Tuberculin testing should be administered anytime before, simultaneously with, or at least 4 to 6 weeks after ProQuad. (7.4)
ProQuad may be administered concomitantly with Haemophilus influenzae type b conjugate vaccine and/or hepatitis B vaccine at separate injection sites. (7.5)
ProQuad may be administered concomitantly with pneumococcal 7-valent conjugate vaccine and/or hepatitis A vaccine (inactivated) at separate injection sites. (7.5)
The MMRV vaccine has not been advised with vaccines other than these and although the statement is accurate it is omitting the fact that only a few vaccines may be administered at the same time.
And the MMRII package insert reads:
Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.
The MMR vaccine has not been advised with these two vaccines and the statement should be updated to reflect this.
Comment: Both MMRV and MMR VIS state that a second dose can be administered 3 months or 28 days after the first dose if necessary.
Neither Package insert nor the CDC pink book states that the second dose can be given in 28days or 3 months.
https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/a/age-interval-table.pdf
http://www.immunize.org/technically-speaking/20120301.asp
Comment: The MMRII package insert reads:
Following vaccination, antibodies associated with protection can be measured by neutralization assays, HI, or ELISA (enzyme linked immunosorbent assay) tests.
Titer testing should be mentioned on the VIS so that consumers are aware that a titer test could be used to determine if a second dose is necessary.
Section 3.
Taken out: Anyone who has ever had a life-threatening allergic reaction to the antibiotic neomycin, or any other component of MMR vaccine, should not get the vaccine. Tell your doctor if you have any severe allergies.
Comment: Neomycin is still used in the production of MMRII and Proquad. This reference should be added back in. A link to the excipient list should be included here or somewhere on the sheet, so that customers know where to look for ingredients. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf
Section 4.
Inserted: Getting MMRV/MMR vaccine is much safer than getting measles, mumps, rubella, or chickenpox disease.
Comment: Need reference to research that shows this as if you look at VAERS or the compensation given by VCIP it is contrary to this. Need to give the relative risk of getting each disease in the US and death vs vaccine side effects and death in the US if you claim this.
Removed: Likelihood of side effects happening, e.g. (about 1 child out of 5).
Comment: Add these numbers back in and also add them for the likelihood in Section 1 for the US/
General Section 4 Comment: Death is not included in the side effects anywhere. It is as common as the death from the actual disease in the US. If you have death mentioned in Section 1 then it should be mentioned here, or taken out in both places. Otherwise it is fearmongering and unbalanced
Section 5.
Comment: The side effects mentioned in this section, e.g hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness, have not been mentioned in Section 4 as side effects. Should be consistent.
Section 7.
Inserted: Ask your healthcare provider. He or she can give you the vaccine package insert or suggest other sources of information.
Comment: The vaccine package insert link should be added to sheet so that customers have it handy if they wish to read it. http://www.immunize.org/fda/#var[:]
21st Century Cures Act HR34 (was HR6) – AVFCA Objects
On December 13th, 2017 President Obama signed the 21st Century Cures Act which passed both the House and the Senate nearly unanimously. There were 5 Senators who stood up against big Pharma:
Elizabeth Warren – MA
Jeff Merkley -OR
Ron Wyden – OR
Mike Lee -UT
Bernie Sanders -VT
Although 1000s of calls were made legislators did not listen to their constituents. Why? Because these legislators were bought. Over the last two years 1400+ lobbyists and $525+ million influenced their vote. These legislators are BOUGHT. Each and every one of them has had two years’ worth of wheeling and dealing, horse-trading and funds being put in their bank account. They also each had their “wish” amendment or section added in so they are all invested. This is how our legislature works these days. We the people have a week to undo the work that has been done for the past two years. If we want to make a change we need to wake up more people so that there are more people in these fights. We need all of the health freedom groups to come together and fight together on all these issues, even if they are not the primary issue for that person/group. That is what we need to do while we are playing in their sandpit, but at the same time we need to build our own sandpit and share the truth so that people find our sandpit more appealing.
So what do we do now? We get off the bus! We vote with our dollars and feet and quit going to traditional medical doctors and using traditional medical care except in temporary rare acute times such as accidents, broken bones, stitches, etc. The power of the consumer is amazing and we need to show them that we are not OK with what they are pedaling. We need to boycott the Pharma industry and the industries that support them. Emergency drugs or hospital visits are one thing, but the fact that the average number of drugs a senior takes in this country is 13 is a problem. The fact that the US consumers 75% of the pharma drugs globally is a problem. The fact that we are one of two countries in the world that allow TV advertising for Pharma drugs is a problem. These companies are not going to stop and the legislature is not going to stop until we either get the money out of politics or lessen the size and power of these Pharma corporations. The big corporations just have too much lobbying power right now. So go out and talk about your Chiropractors, Acupuncturists, Naturopaths, Homeopaths etc. to your friends and family and share the issues with this bill. Talk about the chronic addiction to fix it pills this country has. Open their eyes because most are asleep.
ACTION NEEDED:
- Tweet/Facebook and call the 5 no votes and thank them for standing up against Big Pharma (.@SenWarren.@SenSanders.@SenJeffMerkley .@RonWyden .@SenMikeLee). You can retweet AVFCA’s tweet (https://twitter.com/avoiceforchoice/status/806616233034424320)
Sanders (202) 224-5141
Warren (202) 224-4543
Merkley (202) 224-3753
Lee (202) 224-5444
Wyden (202) 224-5244 - Then vote with your Dollars and educate others so they can know why they should be concerned about our government’s and the Big Pharma’s influence.
Legislative Details: On November 30th 2016, the House of Representatives passed the 21st Century Cures Act (HR34) nearly unanimously (392-Yay; 26 Nay) (https://www.govtrack.us/congress/votes/114-2016/h592), and on December 7th 2016 it passed the Senate also nearly unanimously (95-Yay; 5 Nay) The 21st Century Cures Act legislation was originally passed in the house last year on July 10, 2015 as HR 6. After passing the house in 2015, the legislation stalled. Many of the provisions of HR 6 were broken up into several smaller bills, but over the Thanksgiving holiday, the legislation was quickly reassembled into a new version including some sections from HR 6 and adding some new sections, amending them all onto bill HR 34. HR 34 was originally a bill that only addressed “Tsunami Warning, Education, and Research”.
A few legislators spoke out against it. They include:
Rep Rosa DeLauro
Sen Elizabeth Warren
Rep Jim McDermott
Sen Bernie Sanders
Sen Jeff Merkley
Bill Details: Although this is coveted as a wonderful bill that is needed in the US so that drugs and medical devices can be fast tracked, if you read the nearly 1000 pages it is clear this is dangerous bill that is has the best interests of the Pharmaceutical industry at heart, NOT its consumers. Over 1400 lobbyists were involved in the creation of this bill. “The 21st Century Cures Act is a drug company stockholder’s dream and a consumer’s worst nightmare,” said Barbara Loe Fisher, NVIC Co-founder and President. “Making experimental drugs quickly available for the sick and dying, who voluntarily choose to use them, is one thing but Congress should not be greasing the skids to license experimental vaccines that government will recommend and legally require healthy children and adults to use. It is a prescription for disaster.”
Here are some of the issues with this bill:
Informed Consent (or lack thereof) in HR34: The 21st Century Cures Act would no longer requires the informed consent of the subjects for medical devices or drugs. All patients receiving treatment by any medical doctor may be, WITHOUT THEIR KNOWLEDGE, enrolled in a clinical trial for drugs and devices as long as there is “minimal risk” to the patient and the practitioner, and as long as there are “safeguards”. This means that the person being given the drug or having the medical device used on them does NOT have to be informed that they are entered into the clinical trial or of the adverse side effects or risks. This provision makes no sense logically, or scientifically, and is dangerous. We use clinical trials not only to study the efficacy of drugs and devices, but also to determine their safety profiles. Under the 21st Century Act, no clinical trial can proceed unless the safety profiles are known. The effect of this act is to leave “safety” to guesswork and rationalization, and to allow the medical establishment to assess harm in drugs and devices in a manner in which (1) the patients are not informed that they are in a clinical trial, and (2) they have no right to say “No” to being part of an experiment. If they are harmed during the trial, they cannot know that they should sue because any ill effect of the experimental drug or device cannot be traced to the experiment. This allows the medical establishment to experiment on the population with impunity. The act does not specify “minimal risk”. (This is probably one of the ones that resonates most with staffers)
Vaccines in HR34: The 21st Century Cures Act would fast track the approval of all vaccines, and shields drug companies and vaccine administrators from liability for fetal injuries and deaths caused by vaccines marketed for and given to pregnant woman. It also allows the approval of drugs by the FDA vaccines “with the least BURDENSOME means.” Drugs should require the MOST rigorous testing, not the least burdensome means.
Health Information Privacy (or lack thereof) in HR34: The 21st Century Cures Act would allow the government to access and use your private health information and records without your authorization.
Big Brother for Disability Care in HR34: The 21st Century Cures Act would create big brother mechanisms in (IHSS) In Home Supportive Services for home care providers with the creation of the electronic visit verification system.
Electric shock “therapy” in HR34: The 21st Century Cures Act would fast track Electric shock “therapy” as a cure for maladaptive behaviors and seizures.
Reduced Funding of NIH and FDA in HR34: The 21st Century Cures Act would trade temporary additional funding for the National Institutes of Health and the FDA for permanent weakening of the FDA’s approval process.
Removes Requirement to Report Payments to Physicians: The 21st Century Cures Act would remove the requirement that manufacturers of medical products report payments to physicians for certain “educational” activities.
Prescription Drug Price Increases : The 21st Century Cures Act would likely increase prescription drug prices and make them less accessible to lower income patients.
CDC surveillance of neurological diseases: The 21st Century Cures Act would increase surveillance of neurological diseases and with the question of what would they do with that information and how would it negatively influence laws in the future.
HR34: 21st Century Cures Act in the media and related articles
“David Hilzenrath at the Project on Government Oversight (POGO) reports that at least 39 of 42 patient advocacy groups who participated in discussions with the FDA over agency review processes for prescription drugs received funding from pharmaceutical companies. And at least 15 have representatives of drug or biotechnology companies on their governing boards.
“Kaiser Health News reviewed the lobbying records filed by the Pharmaceutical Researchers and Manufacturers of America, the trade group representing drug makers, and found the industry group spend up to $24.7 million lobbying on the bill. (On some of the lobbyists’ disclosure forms, multiple healthcare laws are listed, and it was not clear how the industry’s lobbyists divided their time.) The mega-drug maker AbbVie — which manufacturers Humira, one of the most lucrative pharmaceuticals marketed for multiple uses — spent up to $7.7 million. The U.S. Chamber of Commerce spent up to $136.5 million.
The bill also had support from the US. Oil and Gas Association — which spent $293,000 on lobbying — since some of the new funding for research would come from selling oil crude from the Strategic Petroleum Reserve.” http://www.ibtimes.com/political-capital/new-healthcare-law-win-lobbyists-drug-companies-2453329
http://www.fiercepharma.com/pharma/elizabeth-warren-21st-century-cures-bill-it-s-extortion
National Vaccine Information Center (NVIC) Calls 21st Century Cures Act “A Wolf in Sheep’s Clothing” and Urges Presidential Veto to Protect Public Health | Business Wire http://ow.ly/7epQ306W4Ku
https://www.facebook.com/vaccineinfo/posts/10154708664460891
21st Century Cures Act Eliminates Vaccine Safety Science
http://nvicadvocacy.org/members/Home/AnnouncementDetails.aspx?itemid=799&Page=True
House lawmakers passed the biggest health reform bill since the Affordable Care Act
House approves the 21st Century Cures Act, sending landmark bill to Senate
U.S. House Passes 21st Century Cures Legislation | Health IT
http://www.cnn.com/2015/12/09/opinions/das-prescription-drugs-costs/
http://www.nbcnews.com/health/health-news/cures-act-congress-heavily-influenced-lobbyists-n689531
http://www.foxnews.com/opinion/2016/12/02/medical-cures-in-21st-century.html
More bill specific info from the NVIC Advocacy Page.
To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes
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US |
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Title: |
To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes |
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HR 34 |
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Stance: |
OPPOSE |
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Action Required: |
Contact your US Senators and US Congressman and tell them to oppose HR6 |
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Status: |
Reworked and amended, scheduled for a vote in US House 11/30/16 |
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Description: |
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UPDATE: 11/30/2016 – The 21st Century Cures Act debate can be watched here – http://houselive.gov/MediaPlayer.php?view_id=23&event_id=92
UPDATE: 11/29/2016 – A reworked version of HR 6, The 21th Century Cures Act, was released over the Thanksgiving holiday weekend by Rep. Fred Upton, R-Mich., and Sen. Lamar Alexander, R-Tenn, according to this news article from US News . The US House plans to vote on this bill on Wednesday, Nov. 30, 2016.
Text of the new version is available here – http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf
This new version still contains many of the sections of concern that were in the original version outlined in Barbara Loe Fisher’s commentary from 7/21/15, Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science .
UPDATE: 9/14/2016 HR 6 has not moved since passing the US House and being referred in the Senate to the Committee on Health, Education, Labor, and Pensions.
HR 6 is a federal bill that has passed the US House and is now in the US Senate assigned to the Senate Committee on Health, Education, Labor and Pensions Committee.
http://www.senate.gov/general/committee_membership/committee_memberships_SSHR.htm – Senate HELP Committee information
The bill is sponsored by Rep. Fred Upton (R) from Michigan and has 230 cosponsors. https://www.congress.gov/bill/114th-congress/house-bill/6/cosponsors
https://www.congress.gov/bill/114th-congress/house-bill/6/actions – status and history for HR 6
The title of this bill is An Act To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
This legislation includes a section that would fast track newly licensed vaccines for approval by the ACIP (Advisory Committee on Immunization Practices). The ACIP makes recommendations for the use of vaccines, then states follow by requiring them or mandating them.
In her commentary, Barbara Loe Fisher says:
The 21st Century Cures Act is being sold as a way for the FDA to quickly license experimental pharmaceutical products for people suffering with rare or life threatening diseases, whether or not those products have been adequately tested.26 However, greasing the FDA licensure skids to make experimental drugs available for the sick and dying, who voluntarily choose to use them, is one thing, while greasing the skids to bum rush experimental vaccines to licensure that government will legally require healthy children and adults to buy and use, is something quite different.27 28 29 30 31
Nearly every single vaccine that the pharmaceutical industry creates and the FDA licenses for child use is eventually recommended for all children and mandated by state governments for daycare and school entry.32 33 34 35 36And, now, many adults are being brought into the vaccine mandate net as well.37 38 39
The 21st Century Cures Act is a prescription for disaster. Vaccine research, development and fast tracking should not be a part of it.
Watch and read Barbara Loe Fisher’s full commentary on this legislation, Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science. http://www.nvic.org/NVIC-Vaccine-News/July-2015/21st-century-cures-act-eliminates-good-science.aspx
Read NVIC’s press release here – http://www.enhancedonlinenews.com/news/eon/20150722006035/en/Vaccines/vaccination/CDC
HR 6 adds the following new laws:
Full text of HR 6, vaccine section begins on page 162 – https://www.congress.gov/114/bills/hr6/BILLS-114hr6rfs.pdf
subtitle H—Vaccine Access, Certainty, and Innovation
SEC. 2141. Timely review of vaccines by the Advisory Committee on Immunization Practices.
Section 2102(a) of the Public Health Service Act (42 U.S.C. 300aa–2(a)) is amended by adding at the end the following:
“(10) ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.—
“(A) STANDARD PERIODS OF TIME FOR MAKING RECOMMENDATIONS.—Upon the licensure of any vaccine or any new indication for a vaccine, the Director of the Program shall direct the Advisory Committee on Immunization Practices, at its next regularly scheduled meeting, to consider the use of the vaccine.
“(B) EXPEDITED REVIEW PURSUANT TO REQUEST BY SPONSOR OR MANUFACTURER.—If the Advisory Committee does not make recommendations with respect to the use of a vaccine at the Advisory Committee’s first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee, at the request of the sponsor of the vaccine, shall make such recommendations on an expedited basis.
“(C) EXPEDITED REVIEW FOR BREAKTHROUGH THERAPIES AND FOR USE DURING PUBLIC HEALTH EMERGENCIES.—If a vaccine is designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act, and is licensed under section 351 of this Act, the Advisory Committee shall make recommendations with respect to the use of the vaccine on an expedited basis.
“(D) DEFINITION.—In this paragraph, the terms ‘Advisory Committee on Immunization Practices’ and ‘Advisory Committee’ mean the advisory committee on immunization practices established by the Secretary pursuant to section 222, acting through the Director of the Centers for Disease Control and Prevention.”.
SEC. 2142. Review of processes and consistency of ACIP recommendations.
(a) Review.—The Director of the Centers for Disease Control and Prevention shall conduct a review of the process used by the Advisory Committee on Immunization Practices to evaluate consistency in formulating and issuing recommendations pertaining to vaccines.
(b) Considerations.—The review under subsection (a) shall include assessment of—
(1) the criteria used to evaluate new and existing vaccines;
(2) the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to the review and analysis of scientific and economic data, including the scientific basis for such approach; and
(3) the extent to which the processes used by the working groups of the Advisory Committee on Immunization Practices are consistent among groups.
(c) Stakeholders.—In carrying out the review under subsection (a), the Director of the Centers for Disease Control and Prevention shall solicit input from vaccine stakeholders.
(d) Report.—Not later than 18 months after the date of enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress and make publicly available a report on the results of the review under subsection (a), including recommendations on improving the consistency of the process described in such subsection.
(e) Definition.—In this section, the term “Advisory Committee on Immunization Practices” means the advisory committee on immunization practices established by the Secretary of Health and Human Services pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention.
SEC. 2143. Meetings between CDC and vaccine developers.
Section 310 of the Public Health Service Act (42 U.S.C. 242o) is amended by adding at the end the following:
“(c)(1) In this subsection, the term ‘vaccine developer’ means a nongovernmental entity engaged in—
“(A)(i) the development of a vaccine with the intent to pursue licensing of the vaccine by the Food and Drug Administration; or
“(ii) the production of a vaccine licensed by the Food and Drug Administration; and
“(B) vaccine research.
“(2)(A) Upon the submission of a written request for a meeting by a vaccine developer, that includes a valid justification for the meeting, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall convene a meeting of representatives of the vaccine developer and experts from the Centers for Disease Control and Prevention in immunization programs, epidemiology, and other relevant areas at which the Director (or the Director’s designee), for the purpose of informing the vaccine developer’s understanding of public health needs and priorities, shall provide the perspectives of the Centers for Disease Control and Prevention and other relevant Federal agencies regarding—
“(i) public health needs, epidemiology, and implementation considerations with regard to a vaccine developer’s potential vaccine profile; and
“(ii) potential implications of such perspectives for the vaccine developer’s vaccine research and development planning.
“(B) In addition to the representatives specified in subparagraph (A), the Secretary may, with the agreement of the vaccine developer requesting a meeting under such subparagraph, include in such meeting representatives of—
“(i) the Food and Drug Administration; and
“(ii) the National Vaccine Program.
“(C) The Secretary shall convene a meeting requested with a valid justification under subparagraph (A) not later than 120 days after receipt of the request for the meeting.
“(3)(A) Upon the submission of a written request by a vaccine developer, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall provide to the vaccine developer any age-based or other demographically assessed disease epidemiological analyses or data that—
“(i) are specified in the request;
“(ii) have been published;
“(iii) have been performed by or are in the possession of the Centers;
“(iv) are not a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code; and
“(v) do not contain individually identifiable information.
“(B) The Secretary shall provide analyses requested by a vaccine manufacturer under subparagraph (A) not later than 120 calendar days after receipt of the request for the analyses.
“(4) The Secretary shall promptly notify a vaccine developer if—
“(A) the Secretary becomes aware of any significant change to information that was—
“(i) shared by the Secretary with the vaccine developer during a meeting under paragraph (2); or
“(ii) provided by the Secretary to the vaccine developer in one or more analyses under paragraph (3); and
“(B) the change to such information may have implications for the vaccine developer’s vaccine research and development.”.
CDC Notice of Proposed Rulemaking on Control of Communicable Disease – AVFCA Objects
“With its Notice of Proposed Rulemaking (NPRM) in the Federal Register on Aug. 15, 2016,
the Centers for Disease Control and Prevention (CDC) has moved to dramatically expand the power of the U.S. government over the lives of the American people.”
~ National Vaccine Information Center, September 27, 2016.
The CDC put out a Notice of Proposed Rulemaking (NPRM) for Control of Communicable Disease (Docket #: CDC 2016 0068) with comments due by midnight EDT, October 14, 2016. A Voice for Choice Advocacy strongly opposes the CDC’s proposed rules and seeks for the CDC to withdraw the NPRM for Control of Communicable Disease. The NPRM attempts to increase police power over citizens in time of public health emergencies. Through the extensive laws currently in place the CDC already has broad rulemaking authority to prevent the introduction, transmission, and spread of communicable diseases in interstate and foreign countries into the U.S., and its broad powers to apprehend persons moving across interstate borders and entering the U.S. from international locations regarding a certain and specific number of communicable diseases. Therefore these proposed rules would be an overreaching and dangerous threat to personal liberties and the health of the people of the USA.
CDC Notice of Proposed Rulemaking on Control of Communicable Disease (Docket #: CDC 2016 0068) can be found by clicking here. A pdf of the full 88 pages of the Notice can be found by clicking here. National Health Freedom Action’s Response to the CDC’s Notice of Proposed Rulemaking for Control of Communicable Disease, written by Diane Miller, JD, which outlines the NPRM in great detail can be found by clicking here. Because it is so extensive and so long A Voice for Choice Advocacy is sharing the extracted sections that affect health freedoms, including forced vaccination, with comments which can be found by clicking here. These can be used by individuals when giving comment directly to the CDC on this NPRM.
Related articles and comments by organizations and individuals can be found by clicking here.
TAKE ACTION TODAY:
- Submit your public comment by midnight EDT, October 14, 2016, by clicking here. A Voice For Choice Advocacy recommends drafting comments in a word document and then cutting and pasting when submitting online as there is a limited amount to time to comment before the session times out. You can use the sections and comments found by clicking here to support your comments.
The CDC has clear instructions for the comments to be taken into consideration so be sure to follow them:
– Identify you are referring to Docket No. CDC-2016-0068
– Be specific and reference particular sections.
– Provide supporting documents and data.
– Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. Our comments can make a difference. HHS/CDC state they will carefully consider and address all comments submitted and may revise the content of the rule as appropriate at the final rulemaking stage. HHS/CDC will publish a final rule after the comment period that reflects any content changes made as a result of comments received. - Call to request an extension on the comment period. Call (404) 498 1600. Let the operator know that you are calling to request an extension on docket number, CDC 2016 0068. You will be transferred to the CDC Info line. Again state you are requesting an extension on docket number, CDC 2016 0068. You will need to give your name, email, and phone number (do not make that stop you – be brave). On your behalf the representative should create an “Escalation Request” that will be forwarded to a “Subject Matter Expert”. That person will forward to “The Program” and the “The Program” will contact you within NO timeframe, the order in which received for which you MUST explain that “Time is Of the Essence”.
- Call and email YOUR Congress member (find contact info at http://www.house.gov/representatives/find/) and ask them to stop the CDC’s proposal from being enacted. Then ask YOUR Congress member to request THEY contact the Energy and Commerce Committee Members (https://energycommerce.house.gov/about-ec/energy-commerce-committee-members) on your behalf, because the Energy and Commerce Committee is CDC’s Oversight Committee. Find a sample letter, written by NVIC, to your legislators by clicking here.
Congress, through the Congressional Review Act (CRA) (5 U.S.C. Chapter 8), may review and choose to reject new regulations issued by Federal agencies. The CRA requires Federal agencies to submit all new final rules to both the House and Senate. After submission, Congress may begin a process to reconsider and vote to overturn the rule. Most legislators are probably not even aware of the proposed regulation. - Share this alert with family and friends TODAY.
Health Freedom Related Sections of CDC Notice of Proposed Rulemaking on Control of Communicable Disease
CDC Notice of Proposed Rulemaking (NPRM) on Control of Communicable Disease (Docket #: CDC 2016 0068) can be found by clicking here. A pdf of the full 88 pages of the Notice can be found by clicking here. Because it is so extensive and so long A Voice for Choice Advocacy is sharing the extracted sections that affect health freedoms, including forced vaccination, with comments which can be found on each below. (Credit given to an amazing activist for putting this together). These can be used when giving public comment on this NPRM by clicking here.
Page 54232-33: Section 361 (42 U.S.C. 264) is divided into five subsections, (a)-(e). subsection (a) does not seek to limit the types of communicable diseases for which regulations may be enacted, but rather applies to all communicable diseases that may impact human health. Section 361(a) (42 U.S.C. 264(a)) further authorizes the Secretary to promulgate and enforce a variety of public health regulations to prevent the spread of these communicable diseases including: Inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures. In contrast, section 361(b) (42 U.S.C. 264(b)) authorizes the “apprehension, detention, or conditional release” of individuals for the purpose of preventing the introduction, transmission, and spread of a limited subset of communicable diseases, specifically those communicable diseases specified in an Executive Order of the President, upon recommendation of the Secretary in consultation with the Surgeon General. HHS/CDC refers to this limited subset of communicable diseases as “quarantinable communicable diseases” because these are the communicable disease for which by statute quarantine, isolation, or conditional release are authorized. Section 361(c) (42 U.S.C. 264(c)) states that, except as provided in subsection (d), regulations regarding apprehension, detention, examination, or conditional release shall only be applicable to individuals coming into a state or U.S. territory from a foreign country or U.S. territory. 42 U.S.C. 264(c). Thus, subsection (c) provides the basis for the quarantine, isolation, or conditional release of individuals arriving into the United States from foreign countries for the purposes of preventing the introduction, transmission, and spread of quarantinable communicable diseases (as specified by Executive Order) while subsection (d) provides the statutory basis for interstate quarantine, isolation, and conditional release measures.
COMMENT: The CDC should not be making regulations on communicable diseases other than those on the quarantinable communicable diseases. Limiting the list of communicable diseases allows for the democratic decision of diseases to be added. Leaving the list unlimited, as proposed, leaves to much interpretation without feedback and too much power for the CDC/public health department. Measles, chicken pox, and the basic influenza should not be included in additional regulations of any kind. The communicable diseases the CDC wants to regulate should not be left open for them to add any disease that they want to add, such as Zika. Only the previous Executive Order quarantinable diseases such as Ebola, MERS, and TB should be included in CDC regulations. Also, regarding fumigating contaminated areas, this needs to be clarified that poison fumes, such as bug spray, will NOT be sprayed when humans are in the area.
Page 54233: Section 361 Subsection (d) states that regulations may provide for the apprehension and examination of any individual “reasonably believed to be infected with a communicable disease in a qualifying stage.” 42 U.S.C. 264(d)(1). As defined by this subsection, a “qualifying stage” means that the communicable disease is in “a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals” or “a communicable stage.” 42 U.S.C. 264(d)(2). The subsection further states that if upon examination any such individual is found to be infected, he or she may be detained for such time and in such manner as may be reasonably necessary
COMMENT: Using a precommunicable stage to apprehend people is unacceptable and inappropriate. This could include any person in the world since we are all walking around getting exposed to other people. This is removing personal liberties. This part should be taken out of the rules.
COMMENT: Using a precommunicable stage to apprehend people is unacceptable and inappropriate. This could include any person in the world since we are all walking around getting exposed to other people. This is removing personal liberties. This part should be taken out of the rules.
Page 54233: Section 311 authorizes the Secretary to accept state and local assistance in the enforcement of quarantine rules and regulations and to assist states and their political subdivisions in the control of communicable diseases.
COMMENT: There should be no regulations for diseases not deemed quarantinable by executive order such as measles.
Page 54234: .B Historical Background for This Rulemaking: The 2005 proposal also stated that “provisional quarantine” could last up to 3 business days. CDC received public comments that the term “provisional quarantine” was inconsistent with public health practice and that relying on “business days” which by definition excludes weekends and holidays was inappropriate. In response, the current proposal does not use the term “provisional quarantine,” but rather uses the term “apprehension” which is a statutory term used in section 361 of the Public Health Service Act (42 U.S.C. 264(c) and (d)(1)), and is defined in this proposal as “the temporary taking into custody of an individual or group for purposes of determining whether Federal quarantine, isolation, or conditional release is warranted.” Furthermore, as explained in the preamble text explaining the use of the term “apprehension,” based on past experience, HHS/CDC believes that the service of a written order for quarantine, isolation, or conditional release can generally be accomplished within 24-48 hours of an apprehension.
COMMENT: As in the 2005 rules, a time frame needs to be set. Leaving no frame for the time of being apprehended and detained is unacceptable. An absolute set time from of 24 hours needs to be set…..”generally can be accomplished” is not acceptable when you are talking about apprehending people against their will. Also apprehending people in the United States of America is against the Constitution. These are law-abiding people who have not committed a crime and who are being apprehended against their will with no way out. The former term “provisional quarantine” needs to be put back in and the term “apprehend” needs to be removed. As stated in other areas of the proposal, the CDC has NEVER in 50 years needed to use the forced quarantine. All people have voluntarily agreed and no Federal Order has needed to be issued. WHY does the CDC think that there is a reason to create stricter rules when they have never needed to use the “looser” rules before. That makes no sense.
Page 54236: IV. Rationale for Notice of Proposed Rulemaking: A third and historically more common example is measles. Measles is a highly contagious, acute viral illness that can lead to serious complications such as pneumonia, encephalitis, and even death. Although not a quarantinable communicable disease, every case of measles in the United States is considered a public health emergency because of its extremely high transmissibility….Importations from other countries where measles remains endemic continue to occur, which can lead to clusters of measles cases in the United States in pockets of unvaccinated persons.
COMMENT: Actually many of the measles cases in the United States have occurred in vaccinated people including the outbreak at Disneyland California. This false statement needs to be removed. Measles is not a quarantinable disease and people should NOT be tracked for having measles. That is against their freedom of privacy and Constitutional rights. Remove this from the proposal.
Page 54236: IV. Rationale for Notice of Proposed Rulemaking: Given the grave consequences for mortality and morbidity of introducing and spreading these diseases, a strengthening of this reporting requirement via mandatory reporting according to the revised definition of an ill person, as described in this NPRM, is essential. This is validated by several recent instances of individuals traveling interstate while symptomatic with MERS, Ebola, Lassa fever, and measles.
COMMENT: Measles should be taken off this list, it should not be included with Ebola. Neither measles or varicella should be included in these rules.
Page 54236: IV. Rationale for Notice of Proposed Rulemaking: The proposed updated definition of “ill person” also includes a provision for the CDC Director to revise the symptom definition as needed in response to a newly identified communicable disease; this will greatly enhance HHS/CDC’s ability to respond rapidly to emerging public health threats.
COMMENT: There should be no option to change these rules to update symptom definition in the future. If changes are needed, then a new proposal for the public needs to be given before the change. Basically leaving the option to add and change definitions as needed, with no one in the public having input, gives too much free reign for the CDC to do whatever they want against the peoples’ will.
Page 54237: In certain circumstances, HHS/CDC has allowed people contagious with or exposed to serious communicable diseases to travel interstate if this can be done in a manner that does not expose the public (e.g., by private vehicle). However, the needs of the individual to engage in travel must be carefully weighed against the public health risk due to the potential lack of public health oversight, especially during travel over long distances or crossing multiple states. For this reason, during the 2014-2016 Ebola epidemic, HHS/CDC recommended against long-distance travel by private vehicle for people with certain types of exposures to Ebola. State and local public health authorities, relying on their own legal processes, enforced these recommendations by imposing their own movement restrictions on individuals potentially exposed to Ebola. While HHS/CDC could similarly impose movement restrictions for individuals reasonably believed to be infected with a quarantinable communicable disease through the issuance of a Federal order for isolation, quarantine, or conditional release, codifying in regulation a separate, formal process to issue interstate travel permits for individuals subject to controlled movement allows for greater transparency and public understanding of what actions HHS/CDC may take to condition an individual’s travel on the observance of public health measures to assure the safety of other travelers and communities.
COMMENT: The CDC should not be adding these stricter movement rules. The movement rules were left up the Federal Executive Order, which the CDC acknowledges they have never had to use, so why add this where there is already an option to have it happen by Executive Order as needed, not whenever the CDC feels like it. Remove this strict portion.
Page 54237: Table for required data elements of public health interest:
Address while in the United States (number and street, city, state, and zip code), except that U.S. citizens and lawful permanent residents will provide address of permanent residence in the U.S. (number and street, city, state, and zip code; as applicable)(18)X
Primary contact phone number to include country code X
Secondary contact phone number to include country codeXEmail Address X
Seat or Cabin Number X
COMMENT: phone number and email address should not be added to collected passenger information
Page 54238: A. Updates to Part 70:
§ 70.1 General Definitions Apprehension: In certain circumstances, the individual may remain apprehended pending confirmation that he or she is not infected or not reasonably believed to be infected with a quarantinable communicable disease. If it is necessary to issue the individual a Federal order for quarantine, isolation, or conditional release, the individual will remain apprehended pending the service of the written order. The factors that may give rise to an order for quarantine, isolation, or conditional release are discussed in detail in the preamble section discussing the definition of “reasonably believed to be infected, as applied to an individual.” Based on past experience, HHS/CDC believes that a written Federal order may be served to an individual within 24-48 hours of an apprehension. These timeframes are merely offered as guidance and HHS/CDC believes that the facts and circumstances of each case will dictate the expected length of an apprehension. Generally, however, HHS/CDC does not expect that the typical public health apprehension will last longer than 72 hours. It is not HHS/CDC’s intent through this definition to allow for extended apprehensions absent the issuance of a Federal order for quarantine, isolation, or conditional release. HHS/CDC requests public comment concerning the expected apprehension period (no longer than 72 hours), and whether there are any public concerns with the absence of a specific maximum apprehension period in the regulation.
COMMENT: A time frame must be given. People cannot be held for an unlimited amount of time against their will. Using the term “generally” not longer than 72 hours is not binding by any means. Keep the original language of “provisional quarantine” and 3 day limit.
Page 54239: Conditional Release: HHS/CDC is proposing to define conditional release to mean “surveillance” as that term is proposed in 42 CFR 71.1 and update the definition to include public health supervision through in-person visits by a public health official (or designee), telephone, or through electronic or internet-based monitoring as that term is defined. Surveillance under § 71.1 is currently defined as temporary supervision by a public health official (or designee) of an individual or group, who may have been exposed to a quarantinable communicable disease, to determine the risk of disease spread. HHS/CDC is proposing to expand the definition of conditional release to clarify that it may include electronic or internet-based monitoring in addition to in-person visits by a public health official or telephone reporting by the individual under a conditional release order. A proposed definition for electronic or internet-based monitoring has been included as part of this proposal and is discussed below. In general, such monitoring may include electronic or internet-based systems, such as video chat and voice calls from computers, tablets and mobile devices. This language is intended to be broad and would apply to any new or existing technologies that would allow for the public health supervision and monitoring of an individual under a conditional release order.
Electronic or Internet-Based Monitoring: HHS/CDC has proposed a definition for “electronic or internet-based monitoring” that defines this term as referring to mechanisms or technologies allowing for the temporary public health supervision of an individual under conditional release, including electronic mail, SMS texts, video conference or webcam technologies, integrated voice-response systems, entry of information into a web-based forum, wearable tracking technologies, and other mechanisms or technologies as determined by the Director or supervising health authority. HHS/CDC specifically solicits comment regarding whether this proposed definition is sufficiently broad to apply to any new or existing technologies that would allow for the public health supervision and monitoring of an individual under a conditional release order. HHS/CDC also solicits comment regarding whether the proposed definition raises any privacy implications for an individual who is reasonably believed to be infected with a quarantinable communicable disease and who is subject to a conditional release order.
COMMENT: This does raise privacy implications for an individual. The CDC is proposing to force the person to wear trackable devices. Many electronic devices emit dangerous EMF rays and should not be worn directly on the body. Also using a webcam to video and view the person around their home is an invasion of privacy. There should be no portion of this proposal that allows for more ways to track the individual to be added. A new public forum for any additions to the a proposal is needed at that time.
Page 54239: Ill Person Definition: However, HHS/CDC is also including a provision in this NPRM to allow it to include additional signs and symptoms of illness in case our understanding of the recognizable symptoms of communicable diseases of public health concern, such as Ebola, may change or to respond to communicable diseases that may emerge as future concerns. Notice of such additional signs and symptoms will be published in the Federal Register.
Skin rash: This term means that the individual has areas on the skin with multiple red bumps
Persistent cough: This term means that the cough is frequent and severe enough that it catches the attention of the crewmember, or the individual or another passenger voices concern about it. Persistent cough, along with fever, may indicate the traveler has pertussis/whooping cough
COMMENT: The new definition of an ill person is too open, especially for the addition of skin rash and persistent cough. The CDC admits that none of the travelers that had Ebola and flew to spread it to other countries has no signs of illness. This new definition appears geared more toward non-quarantinable diseases such as measles, chickenpox, and whooping cough. In fact the proposal mentions those three diseases specifically when it is defining an ill person even though it states the new ill person definition is aimed to catch those with Ebola. Measles, varicella, and whooping cough are NOT diseases that are “quarantinable”. What is the CDC trying to do with this new definition? It appears that they are more concerned with getting airlines to turn on people who have NON-quarantinable diseases versus Ebola. The former definition of ill person needs to be maintained and this new definition needs removed. Additionally this updated definition if going to include those with seasonal allergy coughs, general cold coughs and fever, and those with ecezema and bug bites that are itching and oozing from being scratched.
Page 54241: Medical reviewer means a physician, nurse practitioner, or similar medical professional qualified in the diagnosis and treatment of infectious diseases who is appointed by the HHS Secretary or CDC Director to conduct a medical review. The medical reviewer may be an HHS or HHS/CDC employee, but only if the employee differs from the HHS/CDC official who issued the Federal order for quarantine, isolation, or conditional release. The medical reviewer’s role will be to review the medical or other evidence presented, make medical or scientific findings of fact, and issue a recommendation to the CDC Director concerning whether the quarantine, isolation, or conditional release should be continued, rescinded, or modified. The medical reviewer and the medical representative will be different individuals
COMMENT: The medical reviewer should not be an employee of the CDC. This can represent a conflict of interest. The CDC employed physician may continue a quarantine for fear of being reprimanded by the CDC employer if he releases the person sooner than expected. An independent contractor should be used as the medical reviewer.
Page 54241: Public Health Emergency: Under section 361(d) of the Public Health Service Act, in order to authorize the quarantine, isolation, or conditional release of any individual traveling interstate, CDC must reasonably believe that an individual is infected with a communicable disease in a qualifying stage. 42 U.S.C. 264(d)(1). As defined by this subsection, a “qualifying stage” means that the communicable disease is in “a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals” or “a communicable stage.” 42 U.S.C. 264(d)(2). While the phrase “public health emergency” also appears under section 319 of the Public Health Service Act (42 U.S.C. 247d(a)), the use of the same phrase in both sections 319 and 361(d)(2) are not necessarily synonymous. Accordingly, HHS/CDC felt it was important to define “public health emergency” as used under section 361(d)(2) to provide the public with a clear understanding of HHS/CDC’s authority for interstate quarantine, isolation or conditional release. Public health emergency as used in this part means any communicable disease event as determined by the CDC Director with either documented or significant potential for regional, national, or international communicable disease spread or that is highly likely to cause death or serious illness if not properly controlled; or any communicable disease event described in a declaration by the Secretary pursuant to § 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)); or any communicable disease event the occurrence of which is notified to the World Health Organization, in accordance with Articles 6 and 7 of the International Health Regulations, as one that may constitute a Public Health Emergency of International Concern; or any communicable disease event the occurrence of which is determined by the Director-General of the World Health Organization, in accordance with Article 12 of the International Health Regulations, to constitute a Public Health Emergency of International Concern; or any communicable disease event for which the Director-General of the World Health Organization, in accordance with Articles 15 or 16 of the International Health Regulations, has issued temporary or standing recommendations for purposes of preventing or promptly detecting the occurrence or reoccurrence of the communicable disease. HHS/CDC specifically requests public comment on this definition and its utility in identifying communicable diseases that “would be likely to cause a public health emergency if transmitted to other individuals” under 42 U.S.C. 264(d)(2)(B).
COMMENT: In my opinion this is one of the worst portions of this proposal. It appears to allow the CDC to quarantine, isolate, and conditional release of almost anyone with a communicable disease such as chickenpox or measles. The “would be likely to cause a public health emergency if transmitted to other individuals” needs to be removed. Only qualified quarantinable diseases under Federal Order should be included in this proposal. No other communicable diseases should be involved in this or have any updated rules. This leaves the CDC wide open to taking individuals freedom, privacy, and movement