Recent Public Laws

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

• This law 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 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 identify best practices pediatric cancer survivorship care. The bill would also require HHS to conduct a review of activities related to workforce development for health care providers who treat pediatric cancer patients and survivors.
• The President signed the bill into law on June 5, 2018.
• Read the full bill text on Congress.gov.

FDA Reauthorization Act of 2017 Public Law No: 115-52 (H.R. 2430 / S. 934)

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. The Act includes several provisions relevant to NCI as described below:

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 earlier this year, 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.

The Act includes two provisions specifically relevant to NCI, and NCI is currently coordinating with the FDA to begin planning and implementation of these efforts:

• The Act directs 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 directs 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.

Additional Background and Implementation: Implementation of the provisions described above is underway. Representatives from FDA, NIH/NCI, the patient advocacy community, academia, and industry participated in an informal public meeting on 2/20/18 to discuss several considerations to define the best approaches for the creation of a list of molecular targets considered substantially relevant in pediatric cancers. FDA, in consultation with NCI, will be hosting a public meeting, as required under the law, on April 20 to review molecular target lists. Additionally, the Pediatric Subcommittee of the FDA Oncologic Drugs Advisory Committee will review and provide comment on the list at their June 18-19, 2018 meeting. The RACE for Children Act was originally introduced as H.R. 1231 by Reps. McCaul (R-TX), Duffy (R-WI), and Clarke (D-NY) on February 27, 2017, and as S. 456 Sens. Bennet (D-CO), Rubio (R-FL), Van Hollen (D-MD), and Gardner (R-CO) on February 27, 2017.

Enhanced Clinical Trial Design Act of 2017

The Enhanced Clinical Trial Design Act of 2017 was also introduced as stand-alone legislation in the Senate. The bill aims to expand patient access to experimental treatments in clinical trials, including by providing updated guidance on eligibility criteria. Several aspects of this bill are relevant to NCI and were included in the FDA Reauthorization Act of 2017 as well.

• The Act requires the FDA and the NIH to convene a public meeting to discuss clinical trial criteria, including: barriers to participation, alternative clinical trial designs, and potential impact of changes to clinical trial inclusion and exclusion criteria.
• The Secretary is required to issue a public report on the topics discussed at the meeting as well as guidance documents regarding eligibility criteria for clinical trials.
• In addition, the Secretary is required to issue guidance to streamline the institutional review board (IRB) review process for individual pediatric and adult patient expanded access protocol and how the IRBs may facilitate the use of the protocols.

Additional Background and Implementation: Implementation of the provisions described above are underway, and FDA is supporting a public meeting on 4/16/18 to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials, their potential impact on patient access to investigational drugs, and how they might facilitate the enrollment of a diverse patient population. The Enhanced Clinical Trial Design Act of 2017 was originally introduced as S. 1048 by Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on 5/4/2017.

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

• On December 13, 2016, President Obama signed the 21^st 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.
• Read the full bill text on Congress.gov.

Breast Cancer Commemorative Coin Act, P.L. 114-148 (H.R. 2722/S.2185)

• The bill aims to establish a Breast Cancer Awareness Commemorative Coin by requiring the Secretary of the Treasury to mint up to 50,000 $5 gold coins (to be sold for $35 per coin), up to 400,000 $1 silver coins (to be sold for $10 per coin), and up to 750,000 half-dollar coins (to be sold for $5 per coin) in 2018. Once the cost of design and issuance of the coins is covered, the surcharge would be paid to the Breast Cancer Research Foundation to further research funded by the organization.
• Rep. Carolyn Mahoney (D-NY) introduced H.R. 2722 on 6/10/2015. The bill was referred to the Committees on Financial Services; and the Budget. S.2722 was introduced by Sen. Heidi Heitkamp (D-ND) and referred to the Committee on Banking, Housing, and Urban Affairs on 10/20/15.
• The House passed H.R. 2722 on 7/15/2015 after it was amended to remove Susan G. Komen as a co-recipient after a number of Republican Members of the House objected to the organization’s support for breast cancer screening services provided by Planned Parenthood. The Senate passed the bill on 4/19/2016. The President signed the bill into law (P.L. 114-148) on 4/29/2016.
• Read the full bill text on Congress.gov.

Child Nicotine Poisoning Prevention Act of 2015, P.L. 114-116 (S.142/H.R. 1375/H.R.3243)

• The bill would require the Consumer Product Safety Commission to promulgate a rule to require child safety packaging for liquid nicotine containers.
• The law shall not be construed to limit or otherwise affect the authority of the Secretary of Health and Human Services to regulate, issue guidance, or take action regarding the manufacture, marketing, sale, distribution, importation, or packaging, including child-resistant packaging, of nicotine, liquid nicotine, liquid nicotine containers, electronic cigarettes, electronic nicotine delivery systems or other similar products.
• Sen. Bill Nelson (D-FL) introduced S. 142 on 1/8/2015 and the bill was referred to the Committee on Commerce, Science, and Transportation. Rep. Elizabeth Esty (D-CT) introduced H.R. 1375 on 3/16/15 and the bill was referred to Rep. Susan Brooks (R-IN) introduced H.R. 3243 on 7/28/2015 and the bill was referred to the Committee on Energy and Commerce.
• The Senate passed S. 142 on 12/10/2015, and the House passed the bill on 1/11/2016. The President signed the bill into law (P.L. 114-116) on 1/28/2016.
• Read the full bill text on Congress.gov

Breast Cancer Research Stamp Reauthorization Act of 2015, P.L. 114-99 (S.1170/H.R. 2191)

• The bill would extend the authority of the U.S. Postal Service to issue a semipostal to raise funds for breast cancer research through 2019. Seventy percent of the net proceeds from the Breast Cancer Research Stamp surcharge go to the National Institutes of Health for breast cancer research and 30 percent to the Department of Defense for the same purpose.
• Rep. Jackie Speier (D-CA) introduced H.R. 2191 on 4/30/2015. The bill was referred to the Committees on Armed Services; Energy and Commerce; and Oversight and Government Reform. Sen. Dianne Feinstein (D-CA) introduced S. 1170 on 4/30/2015. The bill was referred to the Committee on Homeland Security and Governmental Affairs.
• The Senate passed S. 1170 by Unanimous Consent on 9/22/2015 and the House passed it on 12/1/2015. The President signed the bill into law (P.L. 114-99) on 12/11/15.
• Read the full bill text on Congress.gov

Early Act Reauthorization of 2014, P.L. 113-265 (H.R. 5185/S. 2655; 113th Congress)

• The bill aims to reauthorize the Young Women’s Breast Health Education and Awareness Requires Learning Young (EARLY) Act of 2009 for a period of 5 years. The EARLY Act was originally signed into law as section 10413 of the Patient Protection and Affordable Care Act (Public Law 111-148) on 3/23/10.
• Consistent with the original law, the reauthorization proposes to increase awareness of breast cancer risks in young women (15 – 39 years old) and to provide support for those diagnosed with breast cancer.
• The reauthorization would direct CDC to continue implementation of the EARLY Act provisions signed into law in 2010 and does not include new provisions. The bill would direct the CDC to continue to conduct a national evidence-based education campaign to increase public awareness regarding breast cancer in young women, especially regarding risks faced by ethnic and cultural groups. Additionally, the bill would direct the CDC, in consultation with HRSA, to continue an education campaign to increase awareness among physicians and other health care professionals of risk factors, risk reduction strategies, early diagnosis and treatment of breast cancer in young women.
• The bill would also direct the CDC to continue to conduct prevention research on breast cancer in younger women; continue to support research aimed at measuring their awareness of the disease; and continue the activities of its Advisory Committee on Breast Cancer in Young Women.
• The bill would authorize $9 M for each fiscal year from 2015 through 2019. Reps. Debbie Wasserman Schultz (D-FL) and Renee Ellmers (R-NC) introduced H.R. 5185 on 7/24/2014, and Sens. Amy Klobuchar (D-MN) and David Vitter (R-LA) introduced S. 2655 on 7/24/14. H.R. 5185 was referred to the Committee on Energy and Commerce, and S.2655 was referred to the Committee on Health, Education, Labor, and Pensions. The House passed H.R. 5185 on 12/9/14 by voice vote and the Senate passed it by unanimous consent on 12/15/14. The President signed it into law (P.L. 113-265) on 12/18/2014.
• Read the full bill text on Congress.gov

Sunscreen Innovation Act, P.L. 113-195 (H.R. 4250/S. 2141, 113th Congress)

• The bills aim to accelerate FDA review and approval of sunscreens with new active ingredients. FDA’s Center for Drug Evaluation and Research would be required to complete its review of eligible applications within 300 days of the request being filed. If the center did not act within that time, the request would be transferred to the FDA Commissioner for review within 60 days.
• Provisions in the bills are specific to FDA, and NCI would not have any responsibility for implementation.
• H.R. 4250 was originally introduced by Rep. Ed Whitfield (R-KY) on 3/13/14, and Jack Reed (D-RI) and Johnny Isakson (R-GA) introduced a companion bill, S. 2141 on the same date. The Senate passed S. 2141 on 9/17/14, agreeing to the measure by Unanimous Consent. The House passed S. 2141 by unanimous consent on 11/13/14. The President signed it into law (P.L. 113-195) on 11/26/2014.
• Read the full bill text on Congress.gov

Gabriella Miller Kids First Research Act, P.L. 113-94 (H.R.2019, 113^th Congress)

• This law amends the Internal Revenue Code to eliminate taxpayer financing of political party conventions and to reprogram savings to provide for a 10-year pediatric research initiative administered through the National Institutes of Health Common Fund.
  • The bill calls for funds for political conventions currently in accounts maintained by national committees of political parties to be transferred to a fund in the Treasury to be known as the “10-Year Pediatric Research Initiative Fund” in the amount of $12.6 million per year for fiscal years 2014-2023.
  • The funds are to be made available to NIH Common Fund “in such amounts as are provided in advance in appropriation Acts.”
  • Effect of the law is limited to identifying a specific source of funds and authorizing an appropriation to the NIH Common Fund. By itself, the law does not actually provide any funds to NIH.
  • As pointed out by Reps. Nita Lowey (D-NY) and Rosa DeLauro (D-CT) (Ranking Members of the House Appropriations Committee and Labor-HHS Appropriations Subcommittee, respectively), in order for NIH to receive such funds, Congressional Appropriators must include a specific appropriation of funds in the Labor-HHS Appropriations Act each year. If this does not happen, the funds remain in the Treasury “10-Year Pediatric Research Initiative Fund” indefinitely. Reps. Lowey and DeLauro also noted that the appropriations needed to make these funds available would be fully subject to the spending caps in place under the Budget Control Act, and to the budget resolution spending allocations to the Appropriations Committee and Labor-HHS Subcommittee. This means that an increase in appropriations to NIH by the “10-Year Pediatric Research Initiative Fund” would need to be offset by a reduction elsewhere in the Labor-HHS-Education bill.
• H.R. 2019 was introduced by Rep. Gregg Harper on 5/16/13, as the Kids First Research Act, and was renamed in honor of Gabriella Miller, a 10-year-old girl from Virginia who passed away in October 2013 due to a pediatric brain tumor, Diffuse Intrinsic Pontine Glioma.
• H.R. 2019 was referred to the House Energy and Commerce Committee, Subcommittee on Health, as well as the House Committees on Administration, and Ways and Means. The bill did not proceed through mark up and was not passed out of committee. On 12/11/13, the House passed the bill under suspension of the rules, in a vote of 295-103. On 3/11/13, the Senate passed the bill by unanimous consent. The President signed the bill into law on 4/4/14.
• Read the full bill text on Congress.gov
• Learn about the implementation of the Gabriella Miller Kids First research Act and the NIH Common Fund’s Gabriella Miller Kids First Research Program

Recalcitrant Cancer Research Act of 2012, P.L. 112-239 (S. Amdt. 3180 to S. 3254/H.R. 4310, 112^th Congress)

• Initially, bills were introduced on 2/16/11 as the Pancreatic Cancer Research and Education Act (H.R. 733/S. 362). These bills were specific to pancreatic cancer and included provisions that would: require NCI to establish a pancreatic cancer initiative; require HHS to establish an Interdisciplinary Pancreatic Cancer Coordinating Committee with authority to make recommendations regarding the prioritization and award of NIH research grants relating to pancreatic cancer; require NCI and CDC to develop a communication tool kit for patients and their families focused on pancreatic cancer issues.
• Prior to consideration by the House Energy and Commerce Committee, H.R. 733 was modified. In action by the Health Subcommittee, on 9/11/12, an amendment was approved that replaced the original bill with new text and the title was changed to the Recalcitrant Cancer Research Act.
• The bill, as amended would require NCI to develop a scientific framework to conduct and support research for “recalcitrant cancers,” defined initially as cancers with a five-year survival rate of less than 20 percent and estimated to cause at least 30,000 deaths per year in the United States. Pancreatic cancer and a grouping of four types of lung cancer would qualify under this definition.
• For each recalcitrant cancer, NCI is directed to convene a working group of Federal and non-Federal entities to provide expertise and assistance in developing the scientific framework. The frameworks are to be completed within 18 months of enactment, then submitted to Congress and made publicly available on the HHS website within 30 days. The Act calls for review and update to these frameworks not later than five years after initial development, and one-time reports on the effectiveness of each framework not later than six years after initial development.
• The bill requires that actions undertaken to carry out each scientific framework be reported in the NIH Biennial report, with an assessment of progress made in improving outcomes for recalcitrant cancers.
• The bill further states that the NCI Director “shall consider each relevant scientific framework when making recommendations for exception funding for grant applications.”

Major Legislative Actions:

• H.R. 733, titled the Pancreatic Cancer Research and Education Act, was introduced by Rep. Anna Eshoo (D-CA) on 2/16/11 and was referred to the House Committee on Energy and Commerce, Subcommittee on Health.
• S. 362, titled the Pancreatic Cancer Research and Education Act, was introduced by Sen. Sheldon Whitehouse (D-RI) on 2/16/11 and was referred to the Committee on Health, Education, Labor, and Pensions.
• H.R. 733 as amended, titled the Recalcitrant Cancer Research Act, was passed by the House on 9/19/12 and was received in the Senate on 9/20/12.
• S. 3566 was introduced by Sen. Tom Harkin on 9/19/12. This bill, including the new text of H.R. 733, titled the Recalcitrant Cancer Research Act, replaced S. 362.
• Sen. Sheldon Whitehouse (D-RI), offered the Recalcitrant Cancer Research Act as an amendment to the Defense Authorization Act of 2013 (S. Amdt. 3180 to S. 3254 / H.R. 4310). The amendment passed the Senate on 11/29/12, and was included in the final bill, H.R. 4310, which passed the House on 12/20/12 and the Senate on 12/21/12. The President signed the bill into law on 1/2/13 (P.L. 112-239).

Implementation:

The NCI is meeting the requirements of the RCRA and has already delivered to Congress “scientific framework” reports on both pancreatic ductal adenocarcinoma (PDAC) and small cell lung cancer (SCLC), two cancer types meeting the criteria for cancers as defined in the RCRA. Reports to NCI’s Clinical and Translational Research Advisory Committee (CTAC) at regular intervals will inform the public of progress on PDAC and SCLC (read the November 2015 update and report; read the March 2015 update; read the November 2014 update). This approach, it should be noted, is not unique to these cancer types: workshops to identify scientific opportunities relevant to many types of cancer occur as part of NCI's standard practices.

The scientific framework for PDAC was completed and delivered to Congress in February 2014. NCI is addressing the recommendations made in that report, including the relationship between PDAC and diabetes mellitus of recent onset; biomarker and imaging studies of pancreatic cysts to identify those at high risk of PDAC; and new immunotherapies. NCI has also begun the RAS Initiative to develop new ways to treat cancers, including PDAC, that are commonly driven by mutations in the RAS gene family. One of the three RAS genes is often mutated in pancreatic, lung, and colorectal cancers, as well as several other cancer types, yet methods for treating such tumors have been difficult to produce. NCI is also investing in the training of the next generation of RAS experts and has joined with the Pancreatic Cancer Action Network to support two training fellowships focused on a type of RAS mutation relevant to pancreatic cancer.

The scientific framework for small cell lung cancer (SCLC) was completed and delivered to Congress in June 2014. The NCI is currently pursuing several research efforts in support of the initiatives recommended in the framework. These include optimizing the collection of tumor tissue specimens representing distinct phases of SCLC (from initial diagnosis to disease recurrence following radio-chemotherapy); developing new tumor models (conditionally-reprogrammed cell lines, patient-derived xenografts, and genetically-engineered mouse models) that reflect the phases of SCLC found in the clinic; expanding comprehensive genomic profiling studies of SCLC specimens; investigating new diagnostic approaches for populations at high risk of developing SCLC; focusing therapeutic development efforts on specific molecular vulnerabilities of SCLC; and investigating the mechanisms underlying both the high initial rate of response to primary SCLC therapy and the rapid emergence of drug and radiation resistance following completion of treatment.