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Recent Public Laws Page

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In addition to legislative proposals pending in the current Congress, this page provides summaries of recent cancer-related legislation that has passed in both the House and Senate and has been signed into law by the President.

Select public laws with direct relevance to NCI research efforts are summarized below.

Henrietta Lacks Enhancing Cancer Research Act of 2019 (Public Law No: 116-291)

Further Consolidated Appropriations Act, 2020, P.L. 116-94, Sec. 603 Minimum age of sale of tobacco products 

  • Language raising the federal minimum age to purchase tobacco products from 18 to 21 was included in several pieces of legislation introduced in the 116th Congress, including the Tobacco to 21 Act (S.1258, H.R. 2411) and the Tobacco-Free Youth Act (S. 1541). Provisions from the Tobacco-Free Youth Act were included in P.L. 116-94 as Section 603, “Minimum age of sale of tobacco products.”
  • The legislation amends Section 906(d) of the Federal Food, Drug, and Cosmetic Act by raising the federal minimum age for sale of tobacco products from 18 to 21 years of age. 
  • The law applies to sales of all tobacco products including cigarettes, smokeless tobacco, hookah tobacco, cigars, pipe tobacco, and electronic nicotine delivery systems. 
  • The President signed the bill on 12/20/19 and the law raising the minimum age to 21 became effective immediately. 
  • Read the full bill text on Congress.gov (Sec. 603)

Childhood Cancer STAR (Survivorship, Treatment, Access, Research) Act (Public Law No: 115-180)

  • This law (signed into law on 6/05/2018) authorizes NCI to support and expand collection of biospecimens from children, as well as adolescents and young adults (AYAs), diagnosed with cancer to build upon biorepositories and biospecimen research already underway with NCI support. The bill encourages that these efforts focus on cancer types/subtypes (and their recurrences) for which current treatments are least effective and occur within the context of clinical trials.
  • The law also authorizes NIH, with guidance from the NCI Director and in coordination with ongoing research activities, to continue to conduct and support pediatric cancer survivorship research and includes an emphasis on studying late effects of pediatric cancer treatment, as well as disparities in outcomes and barriers to follow-up care.
  • Other provisions specific to NIH and NCI include requiring that at least one member of the presidentially appointed National Cancer Advisory Board be knowledgeable in pediatric oncology; reaffirming reporting requirements for NIH in addressing pediatric oncology research within congressional reporting, including its annual Pediatric Research Initiative Report to Congress; and expressing the sense of Congress that the NCI Director should ensure that all applicable study sections, committees, advisory groups, and panels at NCI should include one or more qualified pediatric oncologists, as appropriate.
  • The law also authorizes HHS, through the Centers of Disease Control and Prevention, to award grants to state cancer registries to expand surveillance infrastructure to track the epidemiology of cancer in children and AYAs.
  • Additional provisions in the law focused on pediatric cancer survivorship encourage the HHS Secretary to establish pilot programs to evaluate model systems for monitoring and caring for pediatric cancer survivors, and to conduct efforts to identify best practices for pediatric cancer survivorship care. The law also directs HHS to conduct a review of activities related to workforce development for health care providers who treat pediatric cancer patients and survivors.
  • Read the full bill text on Congress.gov.

Implementation:

NCI is currently supporting implementation of several Childhood Cancer STAR Act provisions that are directed toward the Institute. As encouraged in Section 202 of the STAR Act, in addition to continuing to conduct and support childhood, adolescent, and young adult (AYA) cancer survivorship research, NCI is also expanding support in this area for new research projects, as described in more detail below. NCI is also working to enhance biospecimen collection, biobanking, and related resources for childhood and AYA cancers, with an emphasis on those cancer types and subtypes for which treatments are least effective, as specifically encouraged in Section 101 of the STAR Act. NCI convened a meeting on 05/13/2019 with more than 50 representatives from across the childhood cancer research and advocacy communities, focused on challenges and opportunities in this field. More information about the meeting proceedings, including presentations and discussion, is available here in the "Enhancing Biobanking for Childhood Cancers Meeting Minutes". The Institute has identified several additional efforts to enhance biospecimen collection and biobanking across its childhood cancer research programs, as described in more detail below.

  • New biospecimen research projects: NCI is supporting several new projects in FY2020 and FY2021 through the Children’s Oncology Group (COG) to focus attention to rare cancer subtypes that are currently underrepresented in NCI-supported biorepositories, as well as tumor types with a high risk of treatment failure. NCI also recently initiated a new 5-year grant to support the COG Biorepository. This ongoing support is being funded in addition to NCI’s investment in STAR Act biobanking projects.
    • COG – Rare Tumor Populations Biobanking: For rare cancers for which COG does not have open clinical trials, tumor tissue collection options are limited. This program expanded in FY2021 and supports tumor tissue and blood collection for specific groups of patients for which current tumor tissue collection is lacking or inadequate, with priority for tumor types with high risk of treatment failure. This initiative also collaborates closely with the Childhood Cancer Data Initiative (CCDI) to analyze tumor tissue to obtain a clinically relevant molecular profiling through the CCDI Molecular Characterization Protocol. The data helps this Protocol support characterization of tumors for rare cancers, Central Nervous System (CNS) tumors as well as soft tissue sarcomas.

    • COG – Tumor Specimens from Patients at Relapse: An important impediment to understanding mechanisms of treatment failure for childhood solid tumors is the limited numbers of paired specimens from both diagnosis and relapse that are available for researchers to study. Specimens at relapse are critical for evaluating biological changes between diagnosis and relapse that can lead to the identification of mechanisms of treatment failure and to the development of strategies for circumventing these mechanisms. One area of focus is the collection of relapse specimens from children with rhabdomyosarcoma.

    • COG – Rapid Autopsy Specimen Collection: NCI and COG continue to work with patient organizations to support rapid autopsy collection of tumor samples from children and AYAs who have died of their disease. Foundations and families within the pediatric brain tumor community have been leaders in such programs, and we hope to learn from their experiences to expand this model to other childhood cancers. We are incredibly grateful to these parents and caregivers, who amidst unimaginable grief and loss, contribute to future research to help other families.

    • COG – Pediatric MATCH Diagnostic Specimen Collection: This effort collects diagnostic samples for children and AYAs who have already submitted samples at relapse through NCI’s Pediatric MATCH Trial and enables molecular characterization to identify the changes in gene mutations and gene expression that occur between diagnosis and relapse. This in-depth characterization aims to inform development of more relevant treatments.

    • CCSS Biobanking I –  Specimen Collection of Subsequent Cancers: The development of subsequent malignant neoplasms (SMN) is associated with significant morbidity and mortality for survivors of childhood cancer. The CCSS has prioritized collection of SMN somatic tissue specimens (tissue blocks, scrolls, slides) from survivors with confirmed cases of subsequent malignancies. The results help design treatment protocols and interventions that will result in an increase in survival, while minimizing harmful late effects. This research is also used to develop and expand programs for early detection and prevention of late effects in children and adolescent cancer survivors.

    • CCSS Biobanking II –  Specimen Collection to Study Chronic Health Conditions: This project will enhance the CCSS as a resource for future biologic and genetic evaluations to better understand the causes of chronic health conditions in survivors of childhood cancer.

  • New survivorship research projects: NCI issued a new request for applications (RFA) in March 2020, titled “Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors”, which builds upon a previous RFA, RFA-CA-19-033, to continue to address survivorship research areas emphasized in the STAR Act. Ten projects were funded in FY 2021, with additional projects set to be funded in FY 2022. These efforts aim to improve care and health-related quality of life for childhood and AYA cancer survivors, through mechanistic, observational, and intervention research projects that focus on six key domains: (1) disparities in survivor outcomes; (2) barriers to follow-up care; (3) impact of familial, socioeconomic, and other environmental factors on survivor outcomes; (4) indicators for long-term follow-up needs related to risk for late effects, recurrence, and subsequent cancers; (5) risk factors and predictors of late/long-term effects of cancer treatment; and (6) development of targeted interventions to reduce the burden of cancer for pediatric/AYA survivors. More information about each project is provided in the tables below.

RFA-CA-20-027/028: Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors 

Project Title, Principal Investigator, Institution, Grant Type

Target Population Topic Area

Predicting and Preventing Chemotherapy-Induced Cardiotoxicity in African American Children 

PI: Drs. Paul W Burridge and Yadav Sapkota (Northwestern University at Chicago), R01

African American, doxorubicin-treated childhood cancer survivors

Cardiotoxicity

Bridging Information Divides and Gaps to Ensure Survivorship: The BRIDGES Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship 

PI: Dr. Nina S Kadan-Lottick (Yale University), R01

Childhood cancer survivors and primary care providers

Follow-up care

Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Cancer Survivors 

PI: Dr. Bradley Jay Zebrack (University of Michigan at Ann Arbor), R01

Non-Hodgkin’s lymphoma and Hodgkin’s lymphoma survivors

Social determinants of health

SALSA – Study of Active Lifestyle Activation 

PI: Dr. Eric Jessen Chow (Fred Hutchinson Cancer Research Center), R01

Childhood cancer survivors

Cardiovascular disease

Individual, Cultural, and Area-Based Factors Associated with Survivorship Care Among Asian/Asian American Childhood Cancer Survivors 

PI: Drs. Kimberly Ann Miller and Joel E Milam (University of Sothern California), R01

Asian and Asian American Childhood cancer survivors

Follow-up care

Optimization of a mHealth Physical Activity Promotion Intervention with Mindful Awareness for Adolescent and Young Adult Cancer Survivors 

PI: Drs. Siobhan Marie Phillips and David Victorson (Northwestern University at Chicago), R01

Childhood and AYA cancer survivor

Quality of life

Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors 

PI: Drs. Carolyn Lauckner and Laurie Mclouth (University of Kentucky), R21

Rural AYA cancer survivors

Alcohol consumption

Treatment-Specific Genetic Risk Scores for Late Effects Prediction in Childhood, Adolescent, and Young Adult Cancer Survivors 

PI: Drs. Cindy Im and Yan Yuan (University of Alberta), R21

Childhood cancer survivors

Risk for chronic conditions

Remote Monitoring of Cardiac Function in Childhood Cancer Survivors 

PI: Dr. Saro Armenian (Beckman Research Institute/City of Hope), R21

Anthracycline-exposed, long-term childhood cancer survivors

Cardiac dysfunction

Caregiving For Young Adults with Cancer in Latino Families: Understanding Healthcare Engagement and Family Wellbeing

PI: Dr. Michael A Hoyt (University of California-Irvine), R21

Latino AYA cancer survivors and their families and providers

Caregiving

RFA-CA-19-033: Improving outcomes for Pediatric, Adolescent, and Young Adult Cancer Survivors 

Project Title, Principal Investigator, Institution, Grant Type

Tumor Types Late/Long Term Effect(s)

Using Information Technology to Improve Outcomes for Children Living with Cancer 

PI: Dr. Jin-Shei Lai (Northwestern University at Chicago), U01

All

Disease and treatment-related symptoms

A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among AYA Childhood Cancer Survivors  

PI: Dr. Nina Kadan-Lottick (Yale University), U01

All

Sedentary behavior

Utility Of Memantine In Preventing Cognitive Dysfunction In Children Receiving Cranial Radiotherapy

PI: Dr. Nadia Laack (Mayo Clinic), U01

Primary brain tumors

Cognitive dysfunction after cranial radiotherapy 

A web-based patient-reported symptom monitoring and self-management portal for AYA breast cancer survivors

PI: Dr. Ann Partridge (Dana-Farber), U01

Breast cancer

Symptoms, unmet needs, concerns

Telehealth based exercise intervention to improve functional capacity in survivors of childhood cancer with significantly limited exercise tolerance 

PI: Dr. Kirsten Ness (St. Jude), U01

All

Reduced exercise capacity, impaired physical dysfunction

An INteractive Survivorship Program to Improve Healthcare REsources [INSPIRE] for Adolescent and Young Adult (AYA) Cancer Survivors

PI: Dr. Karen Syrjala (Fred Hutchinson), U01

All

Emotional distress; adherence

Implementation of a Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors receiving Follow-Up Care in Pediatric Oncology Practices: A Cluster-Randomized Trial

PI: Dr. Wendy Landier (University of Alabama), U01

All

Elevated risk of HPV-related complications & malignancies 

  • Collaboration with the Agency for Healthcare Research and Quality (AHRQ): NCI entered into an Inter-Agency Agreement with AHRQ to support its work to implement Section 203 of the STAR Act, focused on identifying best practices in survivorship care, through AHRQ Evidence Reviews on Childhood Cancer Survivorship.
  • Ongoing survivorship research efforts: NCI continues its longstanding investment in the Childhood Cancer Survivor Study, which NCI’s Board of Scientific Advisors approved in June 2020 for another 5-year funding period (FY2023-27). The Institute also continues to support a diverse portfolio of survivorship research through investigator-initiated research projects and NCI’s intramural research program.
  • NCI support to NCI-designated Cancer Centers: NCI also supported several grant supplemental awards to NCI-designated Cancer Centers, to conduct research to understand and address organizational factors that contribute to disparities in outcomes among childhood cancer survivors.

Additionally, NCI advisory boards, groups, and committees continue to include pediatric oncologists, scientists with pediatric expertise, and patient advocates, as encouraged in Sections 111 and 112 of the STAR Act. For example:

NCI will also continue to report on childhood cancer research efforts, as directed in Section 121 of the STAR Act, including through the annual NIH Pediatric Research Initiative Report to Congress, as well as the NIH Triennial Report. NCI also reports on activities across its childhood and AYA cancer research portfolio on its website through several pages focused on childhood cancer research and resources for patients and families, and through the Cancer Currents Blog.

FDA Reauthorization Act of 2017 (Public Law No: 115-52)

The FDA Reauthorization Act of 2017 (FDARA) amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products. H.R. 2430 was introduced by Rep. Greg Walden (R-OR) on 5/16/2017 and was signed into law on 8/18/2017, becoming Public Law No: 115-52.

Section 504 of FDARA, The Research to Accelerate Cures and Equity (RACE) for Children Act

The RACE for Children Act was introduced as stand-alone legislation in both the House and Senate, and key provisions of the bill were included in FDARA as Section 504, Development of drugs and biological products for pediatric cancers. These provisions amend current study requirements under the Pediatric Research Equity Act (PREA) so that requirements for pediatric studies are based on relevant molecular targets rather than the current requirements, based on cancer site of origin. Additionally, the provisions amend PREA by ending the exemption of PREA obligations for cancer drugs with orphan designations if the molecular target of their drug is relevant to a pediatric cancer.

Implementation:

The Act includes two provisions specifically relevant to NCI, and NCI collaborates with FDA’s Oncology Center of Excellence Pediatric Oncology Program to implement these provisions:

  • The Act directed the HHS Secretary to consult with both FDA and NCI to develop a list of relevant molecular targets. The Act describes this as "a list of molecular targets considered, on the basis of data the Secretary determines to be adequate, to be substantially relevant to the growth and progression of a pediatric cancer, and that may trigger the requirements under this section."
  • The Act also directed the HHS Secretary to consult with FDA and NCI and in convening a public meeting within one year after the Act is signed into law to solicit feedback from physicians, researchers, patients, and other stakeholders regarding various aspects of implementation, including development of the list of relevant molecular targets.

Applicable FDA guidance, relevant meeting information, as well as the pediatric Relevant Molecular Target List developed through this collaboration are available here on the FDA website.

21st Century Cures Act, P.L. 114-255 (H.R. 6/H.R. 34)

On 12/13/2016, President Obama signed the 21st Century Cures Act (“Cures”) into law. The nearly 1,000-page bill passed the House 392-26 and the Senate by a vote of 94-5. Key provisions for NIH aim to coordinate policies relating to early career investigators, improve loan repayment programs, and streamline procedural requirements for attendance at scientific meetings. Cures reauthorizes the NIH for FY2018-FY2020 at the following levels:

  • $34,851,000,000 for FY 2018
    • $35,585,871,000 for FY 2019
    • $36,472,442,775 for FY 2020

    In addition, Cures creates a $4.8 billion "NIH Innovation Account."  The funds in the Innovation Account support these specific projects:

    • Precision Medicine Initiative -- $1.45 billion over the next 10 years
    • Beau Biden Cancer Moonshot -- $1.8 billion over the next seven years
    • BRAIN Initiative -- $1.511 million over the next 10 years
    • Regenerative Medicines -- $30 million over the next four years

    Beau Biden Cancer Moonshot: One of the key features of the NIH Innovation Account is the Beau Biden Cancer Moonshot.  This provision of the law was renamed via a joint amendment introduced by Senate Majority Leader Mitch McConnell (R-KY) and Senate Minority Leader Harry Reid (D-NV), in honor of Vice President Joe Biden's son Beau, who passed away from cancer in 2015.  The $1.8 billion for the Cancer Moonshot was authorized to be appropriated as follows:

    • $300 million for FY 2017
    • $300 million for FY 2018
    • $400 million for FY 2019
    • $195 million for FY 2020
    • $195 million for FY 2021
    • $194 million for FY 2022
    • $216 million for FY 2023

    Per the Cures statute, the purpose of the Cancer Moonshot funding is: To support cancer research, such as the development of cancer vaccines, the development of more sensitive diagnostic tests for cancer, immunotherapy and the development of combination therapies, and research that has the potential to transform the scientific field, that has inherently higher risk, and that seeks to address major challenges related to cancer.

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