HR-4701 Original
&
Subsequent Bill Drafts
Working behind the scenes, some people, unbeknownst to others, approached Congressman Chris Gibson (NY) to get a Lyme bill introduced in the House.
Eventually, others in the Lyme Community were provided a copy of the bill and as a result the language was adjusted to make it at least not completely harmful to Lyme patients and their doctors (LDA). It was not of the quality, or as helpful and protective as Congressman Chris Smith's original Lyme bill, however, people in the background continued to push Congress to get a bill so it had to be addressed.
May 21, 2014- Original Bill- HR-4701
Sponsor: Congressman Chris Gibson (NY)
Co-sponsors: Congressmen Courtney, Peterson, Smith (NJ), Wolf (VA) and Barletta.
June 19, 2014- Substitute bill in the form of an amendment submitted at the last hour by House Democrats (of which Frank Pallone-NJ is one) on the Health Subcommittee without the rest of the subcommittee members supposedly knowing the original had been switched to a new substitute bill.
The Lyme bill was discussed in the Health Subcommittee, approved and passed forward per protocol to the House Energy and Commerce Committee. However, the version that passed was the substitute bill, not the original, yet somehow it was approved and signed by the Sponsor (Chris Gibson- NY). ???
Question- Was someone (bill sponsor) not paying attention in order to allow this to happen? It is a BIG deal and does not give anyone confidence in this particular legislative bill process.
July 3, 2014- The next substitute bill was not acceptable via patient advocate groups. This is the new version of the substitute bill draft proposed by Congress on this date. It is basically the same language as the previous substitute bill, with some spicing up and flowering of the wording to make it appear it was designed to be better than before. It wasn't.
Question- Did they think we would not notice the "newer" version was basically the same as the previous bill? Attempting to trick or pull the wool over the eyes of the patients is not acceptable, and is made worse when it is done by the sponsor of the bill.
July 15, 2014- Latest draft, also not accepted by patient advocates. The draft of this bill was proposed by Congressman Chris Gibson on this date.
July 23, 2014- Next draft offered to Lyme patient advocacy groups, who voted on recommending the bill be moved forward during a rushed, late night conference call, without being provided benefit of a little "time" (overnight) to consider the newest language, the other advocate's input, and the bill's pros or cons.
There were 13 individuals and 10 Lyme groups represented in this process.
# of People
3 from NY
3 from NJ
2 from CA
1 from PA
1 from MD
1 from RI
1 from MN
1 from MI
#of Groups
2 from NY
2 from NJ
1 from CA
1 from PA
1 from MD
1 from RI
1 from MN
1 from MI
VOTING 7/24/14- Three group's representatives were not on the call(s) and did not participate in the final vote; 5 group's reps voted to move forward with the bill (2-NJ, 1-NY, 1-CA, 1-RI) and 2 group's reps voted against moving forward.
For the Record- 7/25/14: The Lyme Disease Education & Support Groups of Maryland representative, Lucy Barnes, voted to NOT move forward with the bill.
July 23, 2014 version of HR-4701
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AMENDMENT IN THE NATURE OF A SUBSTITUTE TO H.R. 4701
OFFERED BY Ml. llllll
Strike all after the enacting clause and insert the following:
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øSECTION 1. SHORT TITLE. This Act may be cited as the ‘‘Tick-Borne Disease
Research Accountability and Transparency Act of 2014’’.¿
øSEC. 2. LYME DISEASE AND OTHER TICK-BORNE DIS-
EASES.
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following new part:¿
ø‘‘PART W—LYME DISEASE AND OTHER TICK- BORNE DISEASES¿
ø‘‘SEC. 399OO. RESEARCH. ø‘‘(a) IN GENERAL.—The Secretary shall conduct or
support epidemiological, basic, translational, and clinical research regarding Lyme disease and other tick-borne dis- eases.¿
ø‘‘(b) BIENNIAL REPORTS.—The Secretary shall en- sure that each biennial report under section 403 includes information on actions undertaken by the National Insti-
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tutes of Health to carry out subsection (a) with respect to Lyme disease and other tick-borne diseases, including an assessment of the progress made in improving the out- comes of Lyme disease and such other tick-borne dis- eases.¿
ø‘‘SEC. 399OO–1. WORKING GROUP. ø‘‘(a) ESTABLISHMENT.—The Secretary shall estab-lish a permanent working group, to be known as the Inter- agency Lyme and Tick-Borne Disease Working Group (in this section and section 399OO–2 referred to as the ‘Working Group’), to review all efforts within the Depart- ment of Health and Human Services concerning Lyme dis- ease and other tick-borne diseases to ensure interagency coordination, minimize overlap, and examine research pri- orities.¿
ø‘‘(b) RESPONSIBILITIES.—The Working Group shall—¿
ø‘‘(1) not later than 24 months after the date of enactment of this part, and every 24 months thereafter, develop or update a summary of—¿
ø‘‘(A) ongoing Lyme disease and other tick-borne disease research related to causes, prevention, treatment, surveillance, diagnosis, duration of illness, intervention, and access to
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services and supports for individuals with Lyme disease or other tick-borne diseases;¿
ø‘‘(B) advances made pursuant to such re- search;¿
ø‘‘(C) the engagement of the Department of Health and Human Services with persons that participate at the public meetings required by paragraph (5); and¿
ø‘‘(D) the comments received by the Work- ing Group at such public meetings and the Sec- retary’s response to such comments;¿
ø‘‘(2) ensure that a broad spectrum of scientific viewpoints is represented in each such summary;¿
ø‘‘(3) monitor Federal activities with respect to Lyme disease and other tick-borne diseases;¿
ø‘‘(4) make recommendations to the Secretary regarding any appropriate changes to such activities; and¿
ø‘‘(5) ensure public input by holding annual
public meetings that address scientific advances, re- search questions, surveillance activities, and emerg- ing strains in species of pathogenic organisms.¿
ø‘‘(c) MEMBERSHIP.—¿
ø‘‘(1) IN GENERAL.—The Working Group shall be composed of a total of 14 members as follows:¿
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ø‘‘(A) FEDERAL MEMBERS.—Seven Fed- eral members, consisting of one or more rep- resentatives of each of—¿
ø‘‘(i) the Office of the Assistant Sec- retary for Health;¿
ø‘‘(ii) the Food and Drug Administra- tion;¿
ø‘‘(iii) the Centers for Disease Con- trol and Prevention;¿
ø‘‘(iv) the National Institutes of Health; and¿
ø‘‘(v) such other agencies and offices of the Department of Health and Human Services as the Secretary determines ap- propriate.¿
ø‘‘(B) NON-FEDERAL PUBLIC MEMBERS.—
Seven non-Federal public members, consisting of representatives of the following categories:¿
ø‘‘(i) Physicians and other medical providers with experience in diagnosing and treating Lyme disease and other tick-
borne diseases.¿
ø‘‘(ii) Scientists or researchers with
expertise.¿
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ø‘‘(iii) Patients and their family mem- bers.¿
ø‘‘(iv) Nonprofit organizations that advocate for patients with respect to Lyme disease and other tick-borne diseases.¿
ø‘‘(v) Other individuals whose exper- tise is determined by the Secretary to be beneficial to the functioning of the Work- ing Group.¿
ø‘‘(2) APPOINTMENT.—The members of the Working Group shall be appointed by the Secretary, except that of the non-Federal public members under paragraph (1)(B)—¿
ø‘‘(A) one shall be appointed by the Speak- er of the House of Representatives; and¿
ø‘‘(B) one shall be appointed by the Ma- jority Leader of the Senate.¿ ‘‘
(3) DIVERSITY OF SCIENTIFIC PERSPEC-TIVES.—In making appointments under paragraph (2), the Secretary, the Speaker of the House of Rep- resentatives, and the Majority Leader of the Senate shall ensure that the non-Federal public members of the Working Group represent a diversity of scientific perspectives.
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ø‘‘(4) TERMS.—The non-Federal public mem- bers of the Working Group shall each be appointed to serve a 4-year term and may be reappointed at the end of such term.¿
ø‘‘(d) MEETINGS.—The Working Group shall meet
as often as necessary, as determined by the Secretary, but not less than twice each year.¿
ø‘‘(e) REPORTING.—Not later than 24 months after the date of enactment of this part, and every 24 months thereafter, the Working Group—¿
ø‘‘(1) shall submit a report on its activities, in- cluding an up-to-date summary under subsection (b)(1) and any recommendations under subsection (b)(4), to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate;¿
ø‘‘(2) shall make each such report publicly available on the website of the Department of Health and Human Services; and¿
ø‘‘(3) shall allow any member of the Working Group to include in any such report minority views.¿
ø‘‘SEC. 399OO–2. STRATEGIC PLAN. ‘‘Not later than 3 years after the date of enactment
of this section, and every 5 years thereafter, the Secretary
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shall submit to the Congress a strategic plan, informed by the most recent summary under section 399OO– 1(b)(1), for the conduct and support of Lyme disease and tick-borne disease research, including—¿
ø‘‘(1) proposed budgetary requirements;¿
ø‘‘(2) a plan for improving outcomes of Lyme disease and other tick-borne diseases, including progress related to chronic or persistent symptoms and chronic or persistent infection and co-infec- tions;¿
ø‘‘(3) a plan for improving diagnosis, treat- ment, and prevention;¿
ø‘‘(4) appropriate benchmarks to measure progress on achieving the improvements described in paragraphs (2) and (3); and¿
ø‘‘(5) a plan to disseminate each summary under section 399OO–1(b)(1) and other relevant in- formation developed by the Working Group to the public, including health care providers, public health departments, and other relevant medical groups.’’.¿
Amend the title so as to read: ‘‘A bill to provide for research with respect to Lyme disease and other tick- borne diseases, and for other purposes.’’.
◊
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