/  H.R. 6 - 21st Century Cures Act

H.R. 6 - 21st Century Cures Act

Bill Text

  • Rules Committee Print 114-22 PDF XML

    Showing text based on H.R. 6 as ordered reported by the Committee on Energy and Commerce. 
            ::  Section-by-Section Summary as provided by the Committee on Energy and Commerce  PDF
            ::  Summary of Major Changes as provided by the Committee on Energy and Commerce PDF

  • Text of H.R. 6 PDF XML

    21st Century Cures Act (as introduced)

  • H. Rept. 114-190 Part I PDF

    Report from the Committee on Energy and Commerce

Rule Information

COMMITTEE ACTION:
REPORTED BY VOICE VOTE on Wednesday, July 8, 2015.

FLOOR ACTION ON H. RES. 350: 
Agreed to by record vote of 244-183, after ordering the previous question by record vote of 242-185, on Thursday, July 9, 2015. 

MANAGERS: Burgess/McGovern

1. Structured rule.

2. Provides one hour of general debate equally divided and controlled by the chair and ranking minority member of the Committee on Energy and Commerce.

3. Waives all points of order against consideration of the bill.

4. Provides that an amendment in the nature of a substitute consisting of the text of Rules Committee Print 114-22 shall be considered as adopted and the bill, as amended, shall be considered as read.

5. Waives all points of order against provisions in the bill, as amended.

6. Makes in order only those further amendments printed in the Rules Committee report. Each such amendment may be offered only in the order printed in the report, may be offered only by a Member designated in the report, shall be considered as read, shall be debatable for the time specified in the report equally divided and controlled by the proponent and an opponent, shall not be subject to amendment, and shall not be subject to a demand for division of the question.

7. Waives all points of order against the amendments printed in the report.

8. Provides one motion to recommit with or without instructions.

Amendments

#Version #Sponsor(s)PartySummaryStatus
26Version 1Adams (NC)DemocratDirects five percent of the funds allocated for the NIH and Cures Innovation Fund to Historically Black Colleges and Universities for biomedical research. Submitted
29Version 1Brat (VA), McClintock (CA), Garrett (NJ), Stutzman (IN), Perry (PA)RepublicanReforms the NIH and Cures Innovation Fund to make it a discretionary spending program. Made In Order
14Version 1Castro (TX)DemocratEnsures that the Council for 21st Century Cures include coordination with minority health organizations to ensure that the discovery, development and delivery of innovative cures and treatments help address minority health disparities and patient needs. Submitted
19Version 1Castro (TX)DemocratEnsures underrepresented individuals, such as women and minorities, are included in the Supporting Young Emerging Scientists Report. Made In Order
28Version 2Castro (TX)DemocratRevised Requires the Director of the NIH, in coordination with the Director of USCIS, to submit a report to Congress detailing the retention of nonimmigrant NIH grant recipients. The report would provide the total number of those who remain in the United States and those who leave the United States after their training.Submitted
33Version 1Collins (GA)RepublicanLate Withdrawn Adds a section clarifying that pharmacy reimbursement levels would stay comparable on the state and federal level after enactment. Clarifying section does not change the intent of the legislationWithdrawn
2Version 1Fitzpatrick (PA)RepublicanStrikes Subtitle M which eases medical device safety regulations.Submitted
3Version 1Fitzpatrick (PA)RepublicanDirects the Government Accountability Office to investigate and issue a report on the Food and Drug Administration's (FDA) implementation of medical device safety reporting regulations, focusing on reporting problems involving power morcellators.Submitted
4Version 1Fitzpatrick (PA)RepublicanExpresses a sense of Congress that the Food and Drug Administration, in coordination with the medical device industry, should prioritize and expedite the development of a robust post-market medical device surveillance system that can quickly identify and remove dangerous medical devices from market.Submitted
5Version 1Fitzpatrick (PA)RepublicanExpresses a sense of Congress that the Food and Drug Administration should review medical device safety reporting regulations and, in cooperation with appropriate law enforcement agencies, thoroughly investigate any instance in which safety reporting requirements were violated.Submitted
6Version 1Fitzpatrick (PA)RepublicanExpresses a sense of Congress that any medical device that is approved by the Food and Drug Administration be sufficiently evaluated for risk and patient safety, including any medical device approved through the 510(k) process.Submitted
7Version 1Fitzpatrick (PA)RepublicanProhibits finding a new medical device substantially equivalent (under the 510(k) process) to a predicate device if the predicate has been removed from the market by the Secretary of Health and Human Services or determined to be misbranded or adulterated by judicial order. Also permits the FDA to reject a claim of substantial equivalency for a medical device whose predicate has been corrected or removed from the market by its sponsor.Submitted
8Version 1Fitzpatrick (PA)RepublicanExpresses a sense of Congress that recording Unique Device Identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for post-market surveillance purposes.Made In Order
9Version 1Fitzpatrick (PA)RepublicanStrikes Sec. 2221 which would allow medical device companies to have their quality system certified by a third party instead of the FDA.Submitted
20Version 1Gosar (AZ)RepublicanStrikes Section 2151 from the bill which is the section that allows the FDA to grant a 6 month extension of marketing exclusivity if an existing drug is approved to treat a rare disease.Submitted
1Version 2Griffith (VA), Harris (MD), Blumenauer (OR), Farr (CA)Bi-PartisanRevised Reschedules marijuana, and its derivatives including cannabidiol, under a new 1-R schedule that would better facilitate credible research on its safety and efficacy as a medical treatment. Marijuana could then be rescheduled further after this research is completed. The amendment also includes a sense of Congress that the National Institutes of Health, in consultation with the Drug Enforcement Administration, should be studying the benefits and risks of the drug to treat diseases such as cancer, epilepsy, glaucoma, and post-traumatic stress disorder (PTSD.)Submitted
15Version 1Jackson Lee (TX)DemocratDirects the Secretary of Health and Human Services to conduct outreach to Historically Black Colleges and Universities; Hispanic Serving Institutions; Native American Colleges; and rural Colleges to ensure that health professionals from underrepresented populations are aware of research opportunities under this Act.Made In Order
17Version 1Jackson Lee (TX)DemocratDirects the Secretary of Health and Human Services to conduct outreach to underrepresented populations are educated on the benefits of medical research. Submitted
18Version 1Jackson Lee (TX)DemocratWithdrawn Directs the Secretary of Health and Human Services to provide a report to Congress on addressing research capacity during times of public health emergencies as determined under section 319 of the Public Health Service Act.Withdrawn
24Version 1Jackson Lee (TX)DemocratDirects the Secretary of Health and Human Services to report to Congress priorities if any that are placed on finding treatments for deadly diseases, degenerative diseases, and debilitating conditions; and make recommendations on the classification of such research for continuity of research purposes. Submitted
25Version 1Jackson Lee (TX)DemocratDirects the Secretary of Health and Human Services to produce a report to Congress on efforts undertaken to recruit researchers from underrepresented populations and to ensure that health professionals from underrepresented populations are aware of research opportunities under this Act. Submitted
36Version 2Jackson Lee (TX)DemocratLate Revised The Jackson Lee Amendment provides for a clinical trial program and outreach effort to increase interest on the part of researchers to investigate effective early detection, treatment options and cures for Lupus, Triple Negative Breast Cancer, and Sickle Cell Disease.Submitted
27Version 1King, Steve (IA)RepublicanRepeals penalties relating to meaningful EHR use by Medicare-eligible professionals. The amendment would provide a rebate to eligible professionals during the period beginning on January 1, 2015. Submitted
11Version 1Lee, Barbara (CA), Schakowsky (IL), Clarke (NY)DemocratStrikes the provision that applies any policy riders included in the annual LHHS Appropriations Bill to NIH funds in H.R. 6. Also strikes the provision that applies any policy riders applied to the FDA in the annual Agriculture Appropriations bill to FDA funding in H.R. 6. Made In Order
16Version 1Maloney, Carolyn (NY)DemocratProvides that on page 68, after line 12, insert the following: Subtitle I – Feminine Hygiene Product Safety, directs NIH to conduct or support research on dioxin and other potentially harmful components of feminine hygiene products.Submitted
10Version 1Pingree (ME), Rohrabacher (CA)Bi-PartisanAllows for the personal importation of safe and affordable drugs from approved pharmacies in Canada. Submitted
35Version 2Polis (CO)DemocratLate Revised Directs the Food and Drug Administration to issue a report on the risks and benefits associated with a two-tiered approval process that would permit certain medical devices to provisionally come to market if they have demonstrated safety but not efficacy.Made In Order
22Version 1Schakowsky (IL), Welch (VT)DemocratAdds a new section requiring drug manufacturers seeking FDA approval to disclose the costs of research and development for that particular drug, as well as how much was funded by NIH. Also requires the Secretary of HHS make this information public.Submitted
23Version 2Schakowsky (IL)DemocratRevised Increases mandatory funding for the NIH Innovation Fund. Strikes provisions providing additional exclusivity to drug manufacturers and additional Medicare payments for DISARM drugs.Submitted
21Version 3Slaughter (NY)DemocratRevised Directs the CDC to conduct a study to determine how the additional payments are affecting the development of drug resistance. Made In Order
12Version 1Smith, Christopher (NJ)RepublicanAdds hydrocephalus as a condition included in the National Neurological Disease Surveillance System established by the bill. Submitted
30Version 1Stivers (OH)RepublicanLate Requires CMS to cover medical devices which are less expensive than those which are currently covered.Submitted
31Version 1Stivers (OH)RepublicanLate Requires CMS to accelerate review of coverage and reimbursement of breakthrough medical devices for cancer treatment.Submitted
34Version 4Welch (VT)DemocratLate Revised Closes loopholes that inhibit the development of generic drugs, which has been informally estimated by CBO to save approximately $2.35 billion. A portion of these savings would be used to restore funding to the NIH Innovation Fund to the committee-passed level of $2 billion per year, while the remaining savings would be designated for the spending reduction account. Submitted
13Version 2Young (IN), Harris (MD)RepublicanRevised Creates authority within NIH to conduct a prize program. The intent of the program would be to incentivize health innovation by offering competitors the chance to win a prize for creating breakthrough research and technology.Made In Order