Congressional Bills
H.R. 6 (Engrossed in House)
335 sections
- PreambleTo accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
- PreambleTo accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
- PreambleTo accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
- PreambleTo accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
- Sec. 1Short title; table of contents
- Sec. 1Short title; table of contents
- Sec. 1Short title; table of contents
- Sec. 1Short title; table of contents
- Sec. 2NIH and Cures Innovation Fund
- Sec. 2NIH and Cures Innovation Fund
- Sec. 1001National Institutes of Health reauthorization
- Sec. 1001National Institutes of Health reauthorization
- Sec. 1001National Institutes of Health reauthorization
- Sec. 1001National Institutes of Health reauthorization
- Sec. 1002Prize competitions
- Sec. 1002NIH Innovation Fund
- Sec. 1002Prize competitions
- Sec. 1002NIH Innovation Fund
- Sec. 1021NIH research strategic plan
- Sec. 1021NIH research strategic plan
- Sec. 1021NIH research strategic plan
- Sec. 1021NIH research strategic plan
- Sec. 1022Increasing accountability at the National Institutes of Health
- Sec. 1022Increasing accountability at the National Institutes of Health
- Sec. 1022Increasing accountability at the National Institutes of Health
- Sec. 1022Increasing accountability at the National Institutes of Health
- Sec. 1023Reducing administrative burdens of researchers
- Sec. 1023Reducing administrative burdens of researchers
- Sec. 1023Reducing administrative burdens of researchers
- Sec. 1023Reducing administrative burdens of researchers
- Sec. 1024Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements
- Sec. 1024Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements
- Sec. 1024Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements
- Sec. 1024Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements
- Sec. 1025NIH travel
- Sec. 1025NIH travel
- Sec. 1025NIH travel
- Sec. 1025NIH travel
- Sec. 1026Other transactions authority
- Sec. 1026Other transactions authority
- Sec. 1026Other transactions authority
- Sec. 1026Other transactions authority
- Sec. 1027NCATS phase IIB restriction
- Sec. 1027NCATS phase IIB restriction
- Sec. 1027NCATS phase IIB restriction
- Sec. 1027NCATS phase IIB restriction
- Sec. 1028High-risk, high-reward research
- Sec. 1028High-risk, high-reward research
- Sec. 1028High-risk, high-reward research
- Sec. 1028High-risk, high-reward research
- Sec. 1029Sense of Congress on increased inclusion of underrepresented communities in clinical trials
- Sec. 1029Sense of Congress on increased inclusion of underrepresented communities in clinical trials
- Sec. 1029Sense of Congress on increased inclusion of underrepresented communities in clinical trials
- Sec. 1041Improvement of loan repayment programs of the National Institutes of Health
- Sec. 1041Improvement of loan repayment programs of National Institutes of Health
- Sec. 1041Improvement of loan repayment programs of the National Institutes of Health
- Sec. 1041Improvement of loan repayment programs of the National Institutes of Health
- Sec. 1042Report
- Sec. 1042Report
- Sec. 1042Report
- Sec. 1042Report
- Sec. 1061Capstone award
- Sec. 1061Capstone award
- Sec. 1061Capstone award
- Sec. 1061Capstone award
- Sec. 1081National pediatric research network
- Sec. 1081National Pediatric Research Network
- Sec. 1081National pediatric research network
- Sec. 1081National pediatric research network
- Sec. 1082Global pediatric clinical study network sense of Congress
- Sec. 1082Global Pediatric Clinical Study Network Sense of Congress
- Sec. 1082Global pediatric clinical study network sense of Congress
- Sec. 1082Global pediatric clinical study network sense of Congress
- Sec. 1083Appropriate age groupings in clinical research
- Sec. 1083Appropriate age groupings in clinical research
- Sec. 1083Appropriate age groupings in clinical research
- Sec. 1083Appropriate age groupings in clinical research
- Sec. 1101Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials
- Sec. 1101Sharing of data generated through NIH-funded research
- Sec. 1101Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials
- Sec. 1101Sharing of data generated through NIH-funded research
- Sec. 1102Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials
- Sec. 1102Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials
- Sec. 1121Clinical trial data system
- Sec. 1121Clinical Trial Data System
- Sec. 1121Clinical trial data system
- Sec. 1121Clinical trial data system
- Sec. 1122National neurological diseases surveillance system
- Sec. 1122National neurological diseases surveillance system
- Sec. 1122National neurological diseases surveillance system
- Sec. 1122National neurological diseases surveillance system
- Sec. 1123Data on natural history of diseases
- Sec. 1123Data on natural history of diseases
- Sec. 1123Data on natural history of diseases
- Sec. 1123Data on natural history of diseases
- Sec. 1124Accessing, sharing, and using health data for research purposes
- Sec. 1124Accessing, sharing, and using health data for research purposes
- Sec. 1124Accessing, sharing, and using health data for research purposes
- Sec. 1124Accessing, sharing, and using health data for research purposes
- Sec. 1141Council for 21st Century Cures
- Sec. 1141Council for 21st Century Cures
- Sec. 1141Council for 21st Century Cures
- Sec. 1141Council for 21st Century Cures
- Sec. 2001Development and use of patient experience data to enhance structured risk-benefit assessment framework
- Sec. 2001Development and use of patient experience data to enhance structured risk-benefit assessment framework
- Sec. 2001Development and use of patient experience data to enhance structured risk-benefit assessment framework
- Sec. 2001Development and use of patient experience data to enhance structured risk-benefit assessment framework
- Sec. 2021Qualification of drug development tools
- Sec. 2021Qualification of drug development tools
- Sec. 2021Qualification of drug development tools
- Sec. 2021Qualification of drug development tools
- Sec. 2022Accelerated approval development plan
- Sec. 2022Accelerated approval development plan
- Sec. 2022Accelerated approval development plan
- Sec. 2022Accelerated approval development plan
- Sec. 2041Precision medicine guidance and other programs of Food and Drug Administration
- Sec. 2041Precision medicine guidance and other programs of Food and Drug Administration
- Sec. 2041Precision medicine guidance and other programs of Food and Drug Administration
- Sec. 2041Precision medicine guidance and other programs of Food and Drug Administration
- Sec. 2061Broader application of Bayesian statistics and adaptive trial designs
- Sec. 2061Broader application of Bayesian statistics and adaptive trial designs
- Sec. 2061Broader application of Bayesian statistics and adaptive trial designs
- Sec. 2061Broader application of Bayesian statistics and adaptive trial designs
- Sec. 2062Utilizing evidence from clinical experience
- Sec. 2062Utilizing evidence from clinical experience
- Sec. 2062Utilizing evidence from clinical experience
- Sec. 2062Utilizing evidence from clinical experience
- Sec. 2063Streamlined data review program
- Sec. 2063Streamlined data review program
- Sec. 2063Streamlined data review program
- Sec. 2063Streamlined data review program
- Sec. 2081Sense of Congress
- Sec. 2081Sense of Congress
- Sec. 2081Sense of Congress
- Sec. 2081Sense of Congress
- Sec. 2082Expanded access policy
- Sec. 2082Expanded access policy
- Sec. 2082Expanded access policy
- Sec. 2082Expanded access policy
- Sec. 2083Finalizing draft guidance on expanded access
- Sec. 2083Finalizing draft guidance on expanded access
- Sec. 2083Finalizing draft guidance on expanded access
- Sec. 2083Finalizing draft guidance on expanded access
- Sec. 2101Facilitating dissemination of health care economic information
- Sec. 2101Facilitating dissemination of health care economic information
- Sec. 2101Facilitating dissemination of health care economic information
- Sec. 2101Facilitating dissemination of health care economic information
- Sec. 2102Facilitating responsible communication of scientific and medical developments
- Sec. 2102Facilitating responsible communication of scientific and medical developments
- Sec. 2102Facilitating responsible communication of scientific and medical developments
- Sec. 2102Facilitating responsible communication of scientific and medical developments
- Sec. 2121Approval of certain drugs for use in a limited population of patients
- Sec. 2121Approval of certain drugs for use in a limited population of patients
- Sec. 2121Approval of certain drugs for use in a limited population of patients
- Sec. 2121Approval of certain drugs for use in a limited population of patients
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 2122Susceptibility test interpretive criteria for microorganisms
- Sec. 2123Encouraging the development and use of DISARM drugs
- Sec. 2123Encouraging the development and use of new antimicrobial drugs
- Sec. 2123Encouraging the development and use of DISARM drugs
- Sec. 2123Encouraging the development and use of new antimicrobial drugs
- Sec. 2141Timely review of vaccines by the Advisory Committee on Immunization Practices
- Sec. 2141Timely review of vaccines by the Advisory Committee on Immunization Practices
- Sec. 2141Timely review of vaccines by the Advisory Committee on Immunization Practices
- Sec. 2141Timely review of vaccines by the Advisory Committee on Immunization Practices
- Sec. 2142Review of processes and consistency of ACIP recommendations
- Sec. 2142Review of processes and consistency of ACIP recommendations
- Sec. 2142Review of processes and consistency of ACIP recommendations
- Sec. 2142Review of processes and consistency of ACIP recommendations
- Sec. 2143Meetings between CDC and vaccine developers
- Sec. 2143Meetings between CDC and vaccine developers
- Sec. 2143Meetings between CDC and vaccine developers
- Sec. 2143Meetings between CDC and vaccine developers
- Sec. 2151Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition
- Sec. 2151Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition
- Sec. 2151Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition
- Sec. 2151Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition
- Sec. 2152Reauthorization of rare pediatric disease priority review voucher incentive program
- Sec. 2152Reauthorization of rare pediatric disease priority review voucher incentive program
- Sec. 2152Reauthorization of rare pediatric disease priority review voucher incentive program
- Sec. 2152Reauthorization of rare pediatric disease priority review voucher incentive program
- Sec. 2161Grants for studying the process of continuous drug manufacturing
- Sec. 2161Grants for studying the process of continuous drug manufacturing
- Sec. 2161Grants for studying the process of continuous drug manufacturing
- Sec. 2161Grants for studying the process of continuous drug manufacturing
- Sec. 2162Re-exportation among members of the European Economic Area
- Sec. 2162Re-exportation among members of the European Economic Area
- Sec. 2162Re-exportation among members of the European Economic Area
- Sec. 2162Re-exportation among members of the European Economic Area
- Sec. 2181Enhancing combination products review
- Sec. 2181Enhancing combination products review
- Sec. 2181Enhancing combination products review
- Sec. 2181Enhancing combination products review
- Sec. 2201Priority review for breakthrough devices
- Sec. 2201Priority review for breakthrough devices
- Sec. 2201Priority review for breakthrough devices
- Sec. 2201Priority review for breakthrough devices
- Sec. 2221Third-party quality system assessment
- Sec. 2221Third-party quality system assessment
- Sec. 2221Third-party quality system assessment
- Sec. 2221Third-party quality system assessment
- Sec. 2222Valid scientific evidence
- Sec. 2222Valid scientific evidence
- Sec. 2222Valid scientific evidence
- Sec. 2222Valid scientific evidence
- Sec. 2223Training and oversight in least burdensome appropriate means concept
- Sec. 2223Training and oversight in least burdensome appropriate means concept
- Sec. 2223Training and oversight in least burdensome appropriate means concept
- Sec. 2223Training and oversight in least burdensome appropriate means concept
- Sec. 2224Recognition of standards
- Sec. 2224Recognition of standards
- Sec. 2224Recognition of standards
- Sec. 2224Recognition of standards
- Sec. 2225Easing regulatory burden with respect to certain class I and class II devices
- Sec. 2225Easing regulatory burden with respect to certain class I and class II devices
- Sec. 2225Easing regulatory burden with respect to certain class I and class II devices
- Sec. 2225Easing regulatory burden with respect to certain class I and class II devices
- Sec. 2226Advisory committee process
- Sec. 2226Advisory committee process
- Sec. 2226Advisory committee process
- Sec. 2226Advisory committee process
- Sec. 2227Humanitarian device exemption application
- Sec. 2227Humanitarian device exemption application
- Sec. 2227Humanitarian device exemption application
- Sec. 2227Humanitarian device exemption application
- Sec. 2228CLIA waiver study design guidance for in vitro diagnostics
- Sec. 2228CLIA waiver study design guidance for in vitro diagnostics
- Sec. 2228CLIA waiver study design guidance for in vitro diagnostics
- Sec. 2228CLIA waiver study design guidance for in vitro diagnostics
- Sec. 2241Health software
- Sec. 2241Health software
- Sec. 2241Health software
- Sec. 2241Health software
- Sec. 2242Applicability and inapplicability of regulation
- Sec. 2242Applicability and inapplicability of regulation
- Sec. 2242Applicability and inapplicability of regulation
- Sec. 2242Applicability and inapplicability of regulation
- Sec. 2243Exclusion from definition of device
- Sec. 2243Exclusion from definition of device
- Sec. 2243Exclusion from definition of device
- Sec. 2243Exclusion from definition of device
- Sec. 2261Protection of human subjects in research; applicability of rules
- Sec. 2261Protection of human subjects in research; applicability of rules
- Sec. 2261Protection of human subjects in research; applicability of rules
- Sec. 2261Protection of human subjects in research; applicability of rules
- Sec. 2262Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions
- Sec. 2262Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions
- Sec. 2262Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions
- Sec. 2262Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions
- Sec. 2263Alteration or waiver of informed consent for clinical investigations
- Sec. 2263Alteration or waiver of informed consent for clinical investigations
- Sec. 2263Alteration or waiver of informed consent for clinical investigations
- Sec. 2263Alteration or waiver of informed consent for clinical investigations
- Sec. 2281Silvio O. Conte Senior Biomedical Research Service
- Sec. 2281Silvio O. Conte Senior Biomedical Research Service
- Sec. 2281Silvio O. Conte Senior Biomedical Research Service
- Sec. 2281Silvio O. Conte Senior Biomedical Research Service
- Sec. 2282Enabling FDA scientific engagement
- Sec. 2282Enabling FDA scientific engagement
- Sec. 2282Enabling FDA scientific engagement
- Sec. 2282Enabling FDA scientific engagement
- Sec. 2283Reagan-Udall Foundation for the Food and Drug Administration
- Sec. 2283Reagan-Udall Foundation for the Food and Drug Administration
- Sec. 2283Reagan-Udall Foundation for the Food and Drug Administration
- Sec. 2283Reagan-Udall Foundation for the Food and Drug Administration
- Sec. 2284Collection of certain voluntary information exempted from Paperwork Reduction Act
- Sec. 2284Collection of certain voluntary information exempted from Paperwork Reduction Act
- Sec. 2284Collection of certain voluntary information exempted from Paperwork Reduction Act
- Sec. 2284Collection of certain voluntary information exempted from Paperwork Reduction Act
- Sec. 2285Hiring authority for scientific, technical, and professional personnel
- Sec. 2285Hiring authority for scientific, technical, and professional personnel
- Sec. 2285Hiring authority for scientific, technical, and professional personnel
- Sec. 2301Exempting from sequestration certain user fees of Food and Drug Administration
- Sec. 2301Exempting from sequestration certain user fees of Food and Drug Administration
- Sec. 2301Exempting from sequestration certain user fees of Food and Drug Administration
- Sec. 2321Sense of Congress
- Sec. 2321Sense of Congress
- Sec. 3001Ensuring interoperability of health information technology
- Sec. 3001Ensuring interoperability of health information technology
- Sec. 3001Ensuring interoperability of health information technology
- Sec. 3001Ensuring interoperability of health information technology
- Sec. 3021Telehealth services under the Medicare Program
- Sec. 3021Telehealth services under the Medicare program
- Sec. 3021Telehealth services under the Medicare Program
- Sec. 3021Telehealth services under the Medicare program
- Sec. 3041Exempting from manufacturer transparency reporting certain transfers used for educational purposes
- Sec. 3041Exempting from manufacturer transparency reporting certain transfers used for educational purposes
- Sec. 3041Exempting from manufacturer transparency reporting certain transfers used for educational purposes
- Sec. 3041Exempting from manufacturer transparency reporting certain transfers used for educational purposes
- Sec. 3061Treatment of certain items and devices
- Sec. 3061Treatment of certain items and devices
- Sec. 3061Treatment of certain items and devices
- Sec. 3061Treatment of certain items and devices
- Sec. 3081Improvements in the Medicare local coverage determination (LCD) process
- Sec. 3081Improvements in the Medicare local coverage determination (LCD) process
- Sec. 3081Improvements in the Medicare local coverage determination (LCD) process
- Sec. 3081Improvements in the Medicare local coverage determination (LCD) process
- Sec. 3101Medicare pharmaceutical and technology ombudsman
- Sec. 3101Medicare pharmaceutical and technology ombudsman
- Sec. 3101Medicare pharmaceutical and technology ombudsman
- Sec. 3101Medicare pharmaceutical and technology ombudsman
- Sec. 3121Medicare site-of-Service price transparency
- Sec. 3121Medicare site-of-Service price transparency
- Sec. 3121Medicare site-of-Service price transparency
- Sec. 3121Medicare site-of-Service price transparency
- Sec. 3141Programs to prevent prescription drug abuse under Medicare parts C and D
- Sec. 3141Programs to prevent prescription drug abuse under Medicare parts C and D
- Sec. 3141Programs to prevent prescription drug abuse under Medicare parts C and D
- Sec. 3141Programs to prevent prescription drug abuse under Medicare parts C and D
- Sec. 4001Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates
- Sec. 4001Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates
- Sec. 4001Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates
- Sec. 4002Excluding authorized generics from calculation of average manufacturer price
- Sec. 4002Excluding authorized generics from calculation of average manufacturer price
- Sec. 4002Medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other Medicare imaging payment provision
- Sec. 4003Medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other Medicare imaging payment provision
- Sec. 4003Medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other Medicare imaging payment provision
- Sec. 4003Implementation of Office of Inspector General recommendation to delay certain Medicare prescription drug plan prepayments
- Sec. 4004Treatment of infusion drugs furnished through durable medical equipment
- Sec. 4004Treatment of infusion drugs furnished through durable medical equipment
- Sec. 4005Extension and expansion of prior authorization for power mobility devices (PMDs) and accessories and prior authorization audit limitations
- Sec. 4005Extension and expansion of prior authorization for power mobility devices (PMDs) and accessories and prior authorization audit limitations
- Sec. 4006Civil monetary penalties for violations related to grants, contracts, and other agreements
- Sec. 4006Civil monetary penalties for violations related to grants, contracts, and other agreements
- Sec. 4041SPR drawdown
- Sec. 4041SPR drawdown
- Sec. 4041Cures Innovation Fund
- Sec. 4061Lyme disease and other tick-borne diseases
- Sec. 4061Lyme disease and other tick-borne diseases
- Sec. 4061SPR drawdown
- Sec. 4062Outreach to historically black colleges and universities
- Sec. 4062Outreach to historically black colleges and universities
- Sec. 4081Lyme disease and other tick-borne diseases