Hearing Information
Meeting Information
Wednesday, July 8, 2015 - 3:00pm in H-313 The Capitol View Announcement »
Amendment Deadline
Tuesday, July 7, 2015 - 3:00pm View Announcement »
Wednesday, July 8, 2015 - 3:00pm in H-313 The Capitol View Announcement »
Tuesday, July 7, 2015 - 3:00pm View Announcement »
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
21st Century Cures Act (as introduced)
H. Rept. 114-190 Part I PDF
Report from the Committee on Energy and Commerce
Rule PDF
H. Res. 350 PDF
H. Rept. 114-193 PDF
# | Version # | Sponsor(s) | Party | Summary | Status |
---|---|---|---|---|---|
26 | Version 1 | Adams (NC) | Democrat | Directs five percent of the funds allocated for the NIH and Cures Innovation Fund to Historically Black Colleges and Universities for biomedical research. | Submitted |
29 | Version 1 | Brat (VA), McClintock (CA), Garrett (NJ), Stutzman (IN), Perry (PA) | Republican | Reforms the NIH and Cures Innovation Fund to make it a discretionary spending program. | Submitted |
14 | Version 1 | Castro (TX) | Democrat | Ensures 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 |
19 | Version 1 | Castro (TX) | Democrat | Ensures underrepresented individuals, such as women and minorities, are included in the Supporting Young Emerging Scientists Report. | Submitted |
28 | Version 2 | Castro (TX) | Democrat | Revised 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 |
33 | Version 1 | Collins (GA) | Republican | Late Withdrawn Adds a section clarifying that pharmacy reimbursement levels would stay comparable on the state and federal level after enactment. Clarifying section does not change the intent of the legislation | Withdrawn |
2 | Version 1 | Fitzpatrick (PA) | Republican | Strikes Subtitle M which eases medical device safety regulations. | Submitted |
3 | Version 1 | Fitzpatrick (PA) | Republican | Directs 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 |
4 | Version 1 | Fitzpatrick (PA) | Republican | Expresses 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 |
5 | Version 1 | Fitzpatrick (PA) | Republican | Expresses 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 |
6 | Version 1 | Fitzpatrick (PA) | Republican | Expresses 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 |
7 | Version 1 | Fitzpatrick (PA) | Republican | Prohibits 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 |
8 | Version 1 | Fitzpatrick (PA) | Republican | Expresses 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. | Submitted |
9 | Version 1 | Fitzpatrick (PA) | Republican | Strikes Sec. 2221 which would allow medical device companies to have their quality system certified by a third party instead of the FDA. | Submitted |
20 | Version 1 | Gosar (AZ) | Republican | Strikes 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 |
1 | Version 2 | Griffith (VA), Harris (MD), Blumenauer (OR), Farr (CA) | Bi-Partisan | Revised 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 |
15 | Version 1 | Jackson Lee (TX) | Democrat | Directs 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. | Submitted |
17 | Version 1 | Jackson Lee (TX) | Democrat | Directs the Secretary of Health and Human Services to conduct outreach to underrepresented populations are educated on the benefits of medical research. | Submitted |
18 | Version 1 | Jackson Lee (TX) | Democrat | 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. | Submitted |
24 | Version 1 | Jackson Lee (TX) | Democrat | Directs 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 |
25 | Version 1 | Jackson Lee (TX) | Democrat | Directs 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 |
36 | Version 2 | Jackson Lee (TX) | Democrat | Late 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 |
27 | Version 1 | King, Steve (IA) | Republican | Repeals 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 |
11 | Version 1 | Lee, Barbara (CA), Schakowsky (IL), Clarke (NY) | Democrat | Strikes 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. | Submitted |
16 | Version 1 | Maloney, Carolyn (NY) | Democrat | Provides 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 |
10 | Version 1 | Pingree (ME), Rohrabacher (CA) | Bi-Partisan | Allows for the personal importation of safe and affordable drugs from approved pharmacies in Canada. | Submitted |
35 | Version 2 | Polis (CO) | Democrat | Late 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. | Submitted |
22 | Version 1 | Schakowsky (IL), Welch (VT) | Democrat | Adds 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 |
23 | Version 2 | Schakowsky (IL) | Democrat | Revised Increases mandatory funding for the NIH Innovation Fund. Strikes provisions providing additional exclusivity to drug manufacturers and additional Medicare payments for DISARM drugs. | Submitted |
21 | Version 3 | Slaughter (NY) | Democrat | Revised Directs the CDC to conduct a study to determine how the additional payments are affecting the development of drug resistance. | Submitted |
12 | Version 1 | Smith, Christopher (NJ) | Republican | Adds hydrocephalus as a condition included in the National Neurological Disease Surveillance System established by the bill. | Submitted |
30 | Version 1 | Stivers (OH) | Republican | Late Requires CMS to cover medical devices which are less expensive than those which are currently covered. | Submitted |
31 | Version 1 | Stivers (OH) | Republican | Late Requires CMS to accelerate review of coverage and reimbursement of breakthrough medical devices for cancer treatment. | Submitted |
34 | Version 4 | Welch (VT) | Democrat | Late 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 |
13 | Version 1 | Young (IN), Harris (MD) | Republican | 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. | Submitted |