2014 HR 4701

See Brief History and Drafts of HR- 4701

By Clicking Here

Update- July 26, 2014

In a final vote by patient advocacy group leaders to support and try to move the latest and final version of HR-4701 forward through the next committee (House- Energy & Commerce) or not move it forward, your volunteer Maryland legislation patient advocate voted "no" for various reasons.

However, the bill IS supported by some patient groups and it WILL be moving forward because the "yes" votes prevailed.

The bill is currently on the Energy and Commerce Committee schedule to be discussed next week on Tuesday and/or Wednesday (July 29/30, 2014).

More information here- http://energycommerce.house.gov/press-release/look-ahead-committee-announces-hearing-and-vote-schedule-week-july-28

Please read the letter below.

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7/26/14

Open Letter to Maryland Lyme patients, doctors and group leaders.

Click here to read.

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PRIOR ACTIONS

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ATTENTION!

Lyme Disease Support Group Leaders &

Other Groups Concerned About Lyme Disease

Please Act Now!

Congress is moving a bill that takes away your voice!

IMMEDIATE ACTION NEEDED

OPPOSE- The June 19, 2014 Substitute Amendment

Referred to as the June 19, 2014

"Amendment in the nature of a substitute to HR 4701”

To be added to the national letter to Congress requesting this bill not be moved forward, please click here and sign up your group. This needs to be completed by July 7, 2014 at 10:00 AM.

This dangerous June 19, 2014 Substitute Amendment passed through the health committee and was signed by some members who didn't notice a last minute switch had been made. It could be brought up for a vote before the full Energy & Commerce committee any time now. It needs to be stopped!

The national Lyme Disease Association, LymeDisease.org and other Lyme disease advocacy groups across the country want Congress to know:

• We DO NOT want this bill to be moved forward
• It hurts Lyme patients. It takes away a seat at the table for input from patients, researchers and treating physicians in government decision-making on how Lyme & tick-borne diseases research dollars are spent.
• It takes away input on decisions about the direction of patient diagnosis and treatment research from patients and treating physicians.

The original bill, HR 4701, that Congressman Gibson submitted, provided:

Patients with a seat at the table

Transparency in government

Open meetings

Balanced representation

Accountability

The revised bill “Amendment in the nature of a substitute to HR 4701"

Sidelines patients

Permits secret meetings

Permits the government agencies to continue to operate without oversight

POSITION: It’s disappointing and shameful that the House Energy & Commerce Health Subcommittee pulled the rug out from under Lyme disease patient constituencies by throwing aside legislation that could have received support from the Lyme community, and instead passed a substitute amendment designed in part by the NIH that will cause more harm than good.

HISTORY of LYME BILLS: For decades, Lyme disease patients, advocates, treating physicians, and many researchers have pushed for federal legislation that would unshackle Lyme disease from entrenched biases that have been holding back progress on the science of Lyme. This legislation has been blocked by some members in Congress for many years.

The Lyme community was then chagrined to learn that a vector-borne diseases (VBD) bill was going to be introduced and passed through the House instead of the other pieces of patient-vetted legislation. The community’s fear was that the language of the VBD was too diluted and would be harmful to Lyme disease patients.

In a sincere effort to cooperate with House and Committee leadership, members of the Lyme community worked tirelessly to improve the language of the VBD bill to ensure that it would be helpful to Lyme stakeholders. The resulting bill – HR 4701 – was strengthened to ensure it provide meaningful benefit to Lyme and other TBD stakeholders.

WHAT WE WANTED: The original HR 4701, as introduced, created an advisory committee that would operate under the decades old Federal Advisory Committee Act (FACA), which stresses transparency and accountability. Congress passed FACA, because many believed that too much of the government functioned behind closed doors and did not sufficiently represent the public interest.

FACA requires committee membership “to be fairly balanced in terms of the points of view represented and the functions to be performed.”

Under this original HR 4701, working groups/advisory committees would provide a seat at the table for experienced physicians, non-federal scientists, and patients and family members, and advocates. Any existing VBD working groups also would be required to operate under FACA.

WHAT NIH & MEMBERS OF CONGRESS SUBSTITUTED: The June 19, 2014 “Amendment in the nature of a substitute to HR 4701,” which was passed recently by the Health subcommittee, simply institutionalizes the existing HHS internal Lyme disease and other TBD working groups status quo.

The only members of the working group are HHS government employees- no patients, advocates, private physicians or non-federal researchers will be working group members, although it permits the committee to “consult with” outside parties.

The HHS working group also is not under FACA─ its meetings, papers, records, minutes, etc. may be kept under wraps. A single public meeting, before the issuance of a report every five years, does not provide a reasonable level of public input and transparency and occurs after the committee deliberative work is done.

It is disgraceful that the substitute bill retains the words “Accountability and Transparency” in the title because the bill makes great efforts to purge itself of those attributes.

IMMEDIATE ACTION NEEDED

OPPOSE THE JULY 19, 2014 SUBSTITUTE AMENDMENT

"Amendment in the nature of a substitute to HR 4701”

To be added to the national letter to Congress

Please Click HERE and enter your group's information.

THANK YOU!

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More Information

To See Video of the Passing of the Amended Bill (16 minutes)- Click Here

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Original Bill Text

(Replaced NJ Congressman Smith's Lyme Bill)

H.R.4701 -- Vector-Borne Disease Research Accountability and Transparency Act of 2014 (Introduced in House - IH)

HR 4701 IH

113th CONGRESS

2d Session

H. R. 4701

To provide for scientific frameworks with respect to vector-borne diseases.

IN THE HOUSE OF REPRESENTATIVES

May 21, 2014

Mr. GIBSON (for himself, Mr. COURTNEY, Mr. PETERSON, Mr. SMITH of New Jersey, Mr. WOLF, and Mr. BARLETTA) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To provide for scientific frameworks with respect to vector-borne diseases.

• Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

• This Act may be cited as the `Vector-Borne Disease Research Accountability and Transparency Act of 2014'.

SEC. 2. SCIENTIFIC FRAMEWORK FOR VECTOR-BORNE DISEASES.

• Subpart 6 of part C of title IV of the Public Health Service Act (42 U.S.C. 285f et seq.) is amended by adding at the end the following:

`SEC. 447D. SCIENTIFIC FRAMEWORK FOR VECTOR-BORNE DISEASES.

• `(a) Development of Scientific Framework for Vector-Borne Diseases-
  • `(1) IN GENERAL- For each vector-borne disease identified under subsection (b), the Directors shall develop a scientific framework for the conduct or support of research on such vector-borne disease.
  • `(2) CONTENTS- The scientific framework with respect to a vector-borne disease shall include the following:
    • `(A) CURRENT STATUS-
      • `(i) COMPREHENSIVE REVIEW OF THE LITERATURE- A summary of findings from the current literature in the areas of--
        • `(I) the prevention, diagnosis, and treatment of acute and chronic vector-borne disease;
        • `(II) the fundamental environmental and biologic process that regulate acute and chronic vector-borne disease; and
        • `(III) the epidemiology of acute and chronic vector-borne disease.
      • `(ii) NUMBER OF INCIDENCES INTERNATIONALLY- An assessment of the incidence of acute and chronic vector-borne disease reported internationally.
      • `(iii) SCIENTIFIC ADVANCES- The identification of relevant and diverse emerging scientific areas, and promising scientific advances, in basic, translational, and clinical science relating to the areas described in subclauses (I) and (II) of clause (i).
      • `(iv) RESEARCHERS- A description of the availability of individuals who--
        • `(I) conduct scientific research in the areas described in clause (i); and
        • `(II) represent a diversity of scientific perspectives relevant to such areas.
      • `(v) COORDINATED RESEARCH INITIATIVES- The identification of the types of initiatives and partnerships for the coordination of intramural and extramural research of the National Institutes of Health and the Centers for Disease Control and Prevention in the areas described in clause (i) with research of the relevant national research institutes, Federal agencies, and non-Federal public and private entities in such areas.
      • `(vi) RESEARCH RESOURCES- The identification of public and private resources, such as patient registries, that are available to facilitate research relating to each of the areas described in clause (i).
    • `(B) IDENTIFICATION OF RESEARCH QUESTIONS- The identification of research questions relating to basic, translational, and clinical science in the areas described in subclauses (I) and (II) of subparagraph (A)(i) that have not been adequately addressed with respect to acute or chronic vector-borne disease.
    • `(C) RECOMMENDATIONS- Recommendations for appropriate actions that should be taken to advance research in the areas described in subparagraph (A)(i) and to address the research questions identified in subparagraph (B), as well as for appropriate benchmarks to measure progress on achieving such action, including the following:
      • `(i) RESEARCHERS- Ensuring adequate availability of individuals described in subparagraph (A)(iv).
      • `(ii) COORDINATED RESEARCH INITIATIVES- Promoting and developing initiatives and partnerships described in subparagraph (A)(v).
      • `(iii) RESEARCH RESOURCES- Developing additional public and private resources described in subparagraph (A)(vi) and strengthening existing resources.
  • `(3) TIMING-
    • `(A) INITIAL DEVELOPMENT AND SUBSEQUENT UPDATE- For each vector-borne disease identified under subsection (b)(1), the Directors shall--
      • `(i) develop a scientific framework under this subsection not later than 18 months after the date of the enactment of this section; and
      • `(ii) review and update the scientific framework not later than 5 years after its initial development.
    • `(B) OTHER UPDATES- The Directors may review and update each scientific framework developed under this subsection as necessary.
  • `(4) PUBLIC NOTICE- With respect to each scientific framework developed under this subsection, not later than 30 days after the date of completion of the framework, the Directors shall--
    • `(A) submit such framework to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
    • `(B) make such framework publicly available on the Internet Web site of the Department of Health and Human Services.
• `(b) Identification of Vector-Borne Diseases-
  • `(1) IN GENERAL- Not later than 6 months after the date of the enactment of this section, the Directors shall identify 2 or more bacterial or parasitic vector-borne diseases that each have a high incidence domestically.
  • `(2) TREATING TICK-BORNE DISEASES AS A SINGLE VECTOR-BORNE DISEASE- For purposes of identifying vector-borne diseases under this subsection and developing scientific frameworks for such diseases under subsection (a), tick-borne diseases, including Lyme disease and other tick-borne diseases that are known to be transmitted by ticks to humans in the United States, shall be treated as a single vector-borne disease.
  • `(3) ADDITIONAL VECTOR-BORNE DISEASES- Subject to paragraph (2), the Directors may, at any time, identify other vector-borne diseases for purposes of this section. In identifying a vector-borne disease pursuant to the previous sentence, the Directors may consider additional metrics of progress against such type of vector-borne disease.
• `(c) Working Groups-
  • `(1) IN GENERAL- For each vector-borne disease identified under subsection (b), the Directors shall convene a working group in accordance with the Federal Advisory Committee Act. The Directors (or their designees) shall participate in the meetings of each such working group.
  • `(2) MEMBERS- Each working group convened under this subsection shall be comprised of the following members:
    • `(A) One or more representatives of each of the following:
      • `(i) The National Institutes of Health.
      • `(ii) The Centers for Disease Control and Prevention.
      • `(iii) Other agencies or offices of the Department of Health and Human Services, as determined appropriate by the Directors.
      • `(iv) Other Federal agencies, as determined appropriate by the Directors.
    • `(B) One or more representatives of each of the following categories:
      • `(i) Physicians with experience in diagnosing and treating stages or manifestations of the relevant vector-borne disease.
      • `(ii) Non-Federal scientists or researchers with expertise, and representing a diversity of perspectives, regarding the science pertaining to vector-borne diseases.
      • `(iii) Patients and their family members.
      • `(iv) Nonprofit organizations that advocate for patients by promoting education, services, or research.
      • `(v) Other individuals whose expertise is determined by the Directors to be beneficial to the functioning of the working group.
    • `(C) One individual appointed by the Speaker of the House of Representatives.
    • `(D) One individual appointed by the Majority Leader of the Senate.
  • `(3) FACA SUNSET INAPPLICABLE- Section 14(a) of the Federal Advisory Committee Act (5 U.S.C. App.; relating to termination of advisory committees) shall not apply to a working group convened under paragraph (1).
  • `(4) OTHER WORKING GROUPS- If the Directors, in addition to convening the working groups required by this subsection, choose to continue any working group on any vector-borne disease in existence on the date of enactment of the Vector-Borne Disease Research Accountability and Transparency Act of 2014, any such working group is deemed to be an advisory committee subject to the Federal Advisory Committee Act.
• `(d) Public Hearings-
  • `(1) IN GENERAL- The Directors shall, within 60 days after identifying a vector-borne disease under section (b), and annually thereafter, convene public forums--
    • `(A) to seek public input on the development of the scientific framework for such vector-borne disease under this section and progress in addressing related chronic conditions; and
    • `(B) to identify, and seek public input on, potential emerging strains in species of pathogenic organisms.
  • `(2) PARTICIPANTS- The participants at the forums convened under this subsection shall be researchers, physicians, patients, and other members of the public.
• `(e) Reporting-
  • `(1) BIENNIAL REPORTS- The Directors shall ensure that each biennial report under section 403 includes information on actions undertaken to carry out each scientific framework developed under subsection (a) with respect to a vector-borne disease, including the following:
    • `(A) Information on research grants awarded by the National Institutes of Health and the Centers for Disease Control and Prevention for research relating to such vector-borne disease.
    • `(B) An assessment of the progress made in improving outcomes.
  • `(2) ADDITIONAL ONE-TIME REPORTS-
    • `(A) FRAMEWORKS- For each vector-borne disease identified under subsection (b)(1), the Directors shall, not later than 6 years after the initial development of a scientific framework for such disease under subsection (a), submit a report to the Congress on the effectiveness of the framework (including the update required by subsection (a)(3)(A)(ii)) in improving the prevention, detection, diagnosis, and treatment of such disease.
    • `(B) TOTAL NUMBER OF WORKING GROUPS- Not later than 1 year after the date of enactment of this section, the Directors shall submit a report to the Congress identifying the total number of working groups convened under this section.
• `(f) Recommendations for Exception Funding- The Directors shall consider each relevant scientific framework developed under subsection (a) when making recommendations for exception funding for grant applications.
• `(g) Definition- In this section:
  • `(1) The term `Directors' means the Director of NIH and the Director of the Centers for Disease Control and Prevention acting jointly.
  • `(2) The term `vector-borne disease' means an infection transmitted to humans or other animals by ticks, mosquitoes, or fleas, such as Lyme disease.'.

http://thomas.loc.gov/cgi-bin/query/z?c113:H.R.4701:

COSPONSORS(16), BY DATE [order is left to right]: (Sort: alphabetical order)

H.R.4701

Latest Title: Vector-Borne Disease Research Accountability and Transparency Act of 2014

Sponsor: Rep Gibson, Christopher P. [NY-19] (introduced 5/21/2014) Cosponsors(16)

Latest Major Action: 5/23/2014 Referred to House subcommittee. Status: Referred to the Subcommittee on Health.

ALL ACTIONS:

AMENDED AND SUBSTITUTED WITH THE FOLLOWING BILL

June 19, 2014 @ 3:24 PM

AMENDMENT IN THE NATURE OF A SUBSTITUTE TO H.R. 4701

OFFERED BY M___. _____________

Strike all after the enacting clause and insert the following:

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Vector-Borne Disease Research Accountability and Transparency Act of 2014’’.

SEC. 2. RESEARCH REGARDING LYME DISEASE AND OTHER

VECTOR-BORNE DISEASES.

Subpart 6 of part C of title IV of the Public Health Service Act (42 U.S.C. 285f et seq.) is amended by adding at the end the following:

‘‘SEC. 447D. RESEARCH REGARDING LYME DISEASE AND OTHER VECTOR-BORNE DISEASES.

‘‘(a) IN GENERAL.—In carrying out section 446, the Director of the Institute shall conduct or support basic, translational, and clinical research regarding Lyme Dis- ease and other vector-borne diseases.

‘‘(b) BIENNIAL REPORTS.—The Director of NIH shall ensure that each biennial report under section 403 includes information on actions undertaken 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 outcomes of Lyme Disease and such other tick-borne diseases.’’.

SEC. 3. LYME AND TICK-BORNE DISEASES WORKING GROUP.

Part P of title III of the Public Health Service Act 7 (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

‘‘SEC. 399V–6. LYME AND TICK-BORNE DISEASES WORKING GROUP.

‘‘(a) IN GENERAL.—For the purpose described in subsection

(b), the Secretary shall continue to maintain, as a permanent working group, the Department of Health and Human Services Lyme and Tick-borne Diseases Working Group (in this section referred to as the ‘Working Group’).

‘‘(b) PURPOSE.—The purpose of the Working Group shall be to review programs and activities (including research and surveillance, policy updates, and events) relating to Lyme Disease and other tick-borne diseases across all agencies and offices of the Department of Health and Human Services to ensure coordination and collaboration of such programs and activities.

‘‘(c) MEMBERSHIP.—The members of the Working Group shall consist of—

‘‘(1) the Commissioner of Food and Drugs (or the Commissioner’s designee);

‘‘(2) the Director of the Centers of Disease Control and Prevention (or the Director’s designee);

‘‘(3) the Director of the National Institutes of Health (or the Director’s designee); and

‘‘(4) such other officials and employees of the Department of Health and Human Services as the Secretary determines appropriate.

‘‘(d) CONSULTATION.—In carrying out the purpose described in subsection (b), the Working Group shall— ‘‘

(1) consult with one or more representatives of each of the categories of— ‘‘

(A) physicians and other clinicians with experience in diagnosing and treating Lyme Disease and other tick-borne diseases;

‘‘(B) non-Federal scientists or researchers with appropriate expertise;

‘‘(C) patients and their family members;

‘‘(D) nonprofit organizations that advocate for patients by promoting education, services, or research; and

‘‘(E) other individuals whose expertise is determined by the Secretary to be beneficial; and

‘‘(2) hold a public meeting before the issuance

of each report under subsection (e) and in each such meeting address, with respect to Lyme Disease and other tick-borne diseases—

‘‘(A) scientific advances;

‘‘(B) research questions on basic, translational, and clinical research;

‘‘(C) surveillance activities; and

‘‘(D) emerging strains.

‘‘(e) PROGRESS REPORT AND PLAN.—

‘‘(1) INITIAL REPORT.—Not later than 24 months after the date of enactment of the Vector- Borne Disease Research Accountability and Trans- parency Act of 2014, the Secretary shall, with re- spect to Lyme Disease and other tick-borne diseases, prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a progress report including the following:

‘‘(A) A description of the activities of the Working Group.

‘‘(B) A description of scientific advances related to Lyme Disease and other tick-borne diseases, including new scientific findings in the areas of prevention, diagnosis, and treatment of Lyme Disease and other tick-borne diseases.

‘‘(C) Research questions relating to basic, translational, and clinical science on prevention,

diagnosis, and treatment.

‘‘(D) An assessment of the progress made in improving outcomes of Lyme Disease and other tick-borne diseases.

‘‘(E) A summary of current surveillance activities.

‘‘(F) A description of engagement by the Department of Health and Human Services with the categories of people listed in subsection (d)(1).

‘‘(G) A summary of the comments received at, and of the Department’s response to, the public meetings required by subsection (d)(2).

‘‘(H) Recommendations for appropriate ac- tions to advance research questions, improve surveillance, and identify appropriate bench- marks to measure progress on achieving such actions.

‘‘(I) A strategic plan for implementing such recommendations.

‘‘(2) UPDATES.—Every 5 years after the submission of the initial progress report under paragraph (1), the Secretary shall submit an updated version of such report to the committees referred to in such paragraph.’’.

Amend the long title to read as follows: ‘‘A bill to provide for research with respect to Lyme Disease and other vector-borne diseases, and for other purposes.’’.

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