hyperdemocracy/usc-billstatus huggingface dataset:
To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes.

Bill: 114-hr-2416
Sponsor: Rep. Burgess, Michael C. [R-TX-26]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation
Government information and archives
Health information and medical records

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to evaluate the potential use of evidence from clinical experience to support the approval of a new indication for an approved drug and to support post-approval study requirements.
 
&quot;Evidence from clinical experience&quot; means data from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.
 
Before implementing the program, the FDA must establish a draft framework for the program that describes current sources of data from clinical experience, gaps in current data collection activities, standards and methodologies for collection and analysis of data from clinical experience, and priority areas, remaining challenges, and potential pilot opportunities that the program will address.
 The FDA must use the program to inform guidance to industry on the collection and use of evidence from clinical experience.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
Foreign Medical School Accountability Fairness Act of 2015

Bill: 114-hr-2417
Sponsor: Rep. Burgess, Michael C. [R-TX-26]
Introduced: 2015-05-19 in the House
Policy area: Education
Subjects: Education programs funding
Government lending and loan guarantees
Medical education
Student aid and college costs

Summary:
action_date: 2015-05-19
text: 

Foreign Medical School Accountability Fairness Act of 2015

 
This bill amends the Higher Education Act of 1965 to require all foreign medical schools to meet minimum requirements for percentage of foreign students and for percentage of students passing exams administered by the Educational Commission for Foreign Medical Graduates in order for students to be eligible for William D. Ford Federal Direct Loans. (Currently, the Department of Education may establish alternative standards and certain clinical training programs are grandfathered.)
 
Students continue to be eligible for a loan if, on the date of enactment of this Act, they are enrolled in a foreign medical school that loses eligibility as a result of this Act. 


Legislative actions:
action_date: 2015-11-16
text: Referred to the Subcommittee on Higher Education and Workforce Training.
action_date: 2015-05-19
text: Referred to the House Committee on Education and the Workforce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
Fuel Choice for American Prosperity and Security Act of 2015

Bill: 114-hr-2418
Sponsor: Rep. Dold, Robert J. [R-IL-10]
Introduced: 2015-05-19 in the House
Policy area: Energy
Subjects: Air quality
Climate change and greenhouse gases
Energy efficiency and conservation
Hybrid, electric, and advanced technology vehicles
Manufacturing
Motor fuels
Motor vehicles
Oil and gas

Summary:
action_date: 2015-05-19
text: 

Fuel Choice for American Prosperity and Security Act of 2015

 
 Revises requirements for calculating the average fuel economy for automobile manufacturers.
 
Prescribes requirements to calculate the average fuel economy for a manufacturer of a fuel choice enabling vehicle to be the average fuel economy determined for an automobile manufacturer, plus 4 miles per gallon.
 
Defines &quot;fuel choice enabling vehicle&quot; to mean an automobile that:
 
 
 operates on natural gas, hydrogen, propane, or biodiesel;
 
is a flexible fuel vehicle;
 
is a plug-in electric drive vehicle;
 
is propelled solely by a fuel cell that produces power without the use of petroleum or petroleum-based fuel; or
 
is propelled solely by something other than an internal combustion engine that operates on something other than petroleum-based fuel.
 


Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Energy and Power.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Public Health Services Act to reauthorize funding for the National Institutes of Health.

Bill: 114-hr-2419
Sponsor: Rep. Barton, Joe [R-TX-6]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Department of Health and Human Services
Health programs administration and funding
Medical research
National Institutes of Health (NIH)
Research administration and funding

Summary:
action_date: 2015-05-19
text: 
This bill amends the Public Health Service Act to reauthorize the National Institutes of Health through FY2018.


Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To reduce administrative burdens on researchers.

Bill: 114-hr-2420
Sponsor: Rep. Barton, Joe [R-TX-6]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Department of Health and Human Services
Health programs administration and funding
Medical research
National Institutes of Health (NIH)
Research administration and funding

Summary:
action_date: 2015-05-19
text: 
This bill directs the National Institutes of Health (NIH) to reduce the administrative burdens of researchers funded by the NIH.


Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Public Health Service Act to increase accountability at the National Institutes of Health.

Bill: 114-hr-2421
Sponsor: Rep. Barton, Joe [R-TX-6]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Congressional oversight
Department of Health and Human Services
Executive agency funding and structure
Federal officials
Government studies and investigations
Medical research
National Institutes of Health (NIH)
Research administration and funding

Summary:
action_date: 2015-05-19
text: 
This bill amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to appoint the directors of the national research institutes and national centers (excluding the National Cancer Institute) instead of the Secretary of Health and Human Services (HHS). Directors appointed by the Director of NIH have five-year terms.
 
This bill amends the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 to remove a provision that makes appropriations available for compensation of consultants or individual scientists appointed for limited periods of time to the Public Health Service.
 
Before a national research institute or national center awards a grant for a research project (R-series grant) the director of the institute or center must review and approve the award, taking into consideration the mission and priorities of the institute or center and whether other agencies are funding projects to accomplish the same goal.
 HHS must enter an arrangement with the National Academy of Medicine (formerly known as the Institute of Medicine) under which a study is completed on the extent to which federally funded biomedical research is duplicative and recommendations are made on preventing such duplication.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment.

Bill: 114-hr-2422
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Health technology, devices, supplies
Product safety and quality

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety.
 
Device manufacturers are allowed to make changes to a device without submitting to the FDA the 30-day notice required for manufacturing changes or a premarket approval supplement if their quality system has been certified by an accredited person.
 
An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified.
 
Periodic reports by device manufacturers must describe any changes made to a device without submission of the 30-day notice or the premarket approval supplement. 
 
Certifications accepted by the FDA remain in effect for two years.
 The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence.

Bill: 114-hr-2423
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation
Health technology, devices, supplies
Scientific communication

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to define &ldquo;valid scientific evidence&rdquo; to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.


Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.

Bill: 114-hr-2424
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Government employee pay, benefits, personnel management
Government studies and investigations
Health technology, devices, supplies
Product safety and quality

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the &quot;least burdensome appropriate means&quot; concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process.
 When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards.

Bill: 114-hr-2425
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Government employee pay, benefits, personnel management
Health technology, devices, supplies
Performance measurement
Product safety and quality

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.)
 The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.

Bill: 114-hr-2426
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Government information and archives
Health technology, devices, supplies
Product safety and quality

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.)
 Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.

Bill: 114-hr-2427
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Advisory bodies
Drug safety, medical device, and laboratory regulation
Health technology, devices, supplies
Product safety and quality

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel.
 
The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to the device and at least one member who is knowledgeable about the technology of the device.
 The person whose device is under review may designate a representative (who may be accompanied by experts) to participate in panel meetings.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

Bill: 114-hr-2428
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Health technology, devices, supplies

Summary:
action_date: 2015-05-19
text: 
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.
 Within 18 months of enactment of this Act, the FDA must define &ldquo;probable benefit&rdquo; for these devices.

Legislative actions:
action_date: 2015-05-22
text: Referred to the Subcommittee on Health.
action_date: 2015-05-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
Student Loan Tax Debt Relief Act

Bill: 114-hr-2429
Sponsor: Rep. McDermott, Jim [D-WA-7]
Introduced: 2015-05-19 in the House
Policy area: Taxation
Subjects: Income tax exclusion
Student aid and college costs

Summary:
action_date: 2015-05-19
text: 

Student Loan Tax Debt Relief Act

 
Amends the Internal Revenue Code to expand the exclusion from gross income of income attributable to the discharge of student loan indebtedness to include indebtedness discharged pursuant to income-contingent and income-based repayment plans.


Legislative actions:
action_date: 2015-05-19
text: Referred to the House Committee on Ways and Means.
action_date: 2015-05-19
text: Sponsor introductory remarks on measure. (CR E751)
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
America's Red Rock Wilderness Act

Bill: 114-hr-2430
Sponsor: Rep. Lowenthal, Alan S. [D-CA-47]
Introduced: 2015-05-19 in the House
Policy area: Public Lands and Natural Resources
Subjects: Land transfers
Utah
Water use and supply
Wilderness and natural areas, wildlife refuges, wild rivers, habitats

Summary:
action_date: 2015-05-19
text: 

America's Red Rock Wilderness Act

 
 Designates specified lands in the following areas of Utah as components of the National Wilderness Preservation System: (1) Great Basin, (2) Grand Staircase-Escalante, (3) Moab-La Sal Canyons, (4) Henry Mountains, (5) Glen Canyon, (6) San Juan-Anasazi, (7) Canyonlands Basin, (8) San Rafael Swell, and (9) Book Cliffs and Uinta Basin. 
 
Sets forth administrative requirements for: (1) the exchange of state-owned lands within such areas, (2) federal reservation of water rights, (3) measurement of setbacks for roads with wilderness, (4) authorized livestock grazing, and (5) withdrawal of such lands from disposition under certain public land laws.

Legislative actions:
action_date: 2015-06-10
text: Referred to the Subcommittee on Federal Lands.
action_date: 2015-06-02
text: Sponsor introductory remarks on measure. (CR H3651-3652)
action_date: 2015-05-19
text: Referred to the House Committee on Natural Resources.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House
On-the-Job Training Tax Credit Act of 2015

Bill: 114-hr-2431
Sponsor: Rep. Aguilar, Pete [D-CA-31]
Introduced: 2015-05-19 in the House
Policy area: Taxation
Subjects: Employment and training programs
Income tax credits

Summary:
action_date: 2015-05-19
text: 

On-the-Job Training Tax Credit Act of 2015

 
 Amends the Internal Revenue Code to allow employers who employ not more than 500 full-time employees during the taxable year an on-the-job training tax credit equal to the lesser of: 50% of the job training program expenditures for a full-time employee participating in a qualified training program, or $5,000. 
 
Defines &quot;qualified training program&quot; as a written plan of study and training that is either: (1) an apprenticeship program registered and certified with the Department of Labor under the National Apprenticeship Act; (2) a program licensed, registered, or certified by the workforce investment board or apprenticeship agency or council of a state or administered in compliance with state apprenticeship laws; (3) a program conducted by a vocational or technical education school, community college, industrial or trade training organization, or labor organization; (4) a program which conforms to apprentice training programs developed or administered by an employer trade group or committee; or (5) an industry-sponsored or -administered program which is clearly identified and commonly recognized. 
 
Terminates such credit after 2017.


Legislative actions:
action_date: 2015-05-21
text: Sponsor introductory remarks on measure. (CR H3544)
action_date: 2015-05-19
text: Referred to the House Committee on Ways and Means.
action_date: 2015-05-19
text: Introduced in House
action_date: 2015-05-19
text: Introduced in House