The publication is reproduced in full below:
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. PADILLA (for himself and Mrs. Feinstein):
S. 4439. A bill to take certain Federal land located in Siskiyou County, California, and Humboldt County, California, into trust for the benefit of the Karuk Tribe, and for other purposes; to the Committee on Indian Affairs.
Mr. PADILLA, Mr. President, I rise to introduce the Katimiin and Ameekyaaraam Sacred Lands Act to place roughly 1,000 acres of sacred lands currently under Federal ownership into trust for the benefit of the Karuk Tribe.
The Karuk have lived in and conducted ceremonies on these sacred lands known as Katimiin for centuries, and this bill would promote the longevity of the Tribe's culture and traditions.
Our bill would transfer 1,031 acres of Federal land known as Katimiin from the U.S. Forest Service to the Interior Department to place those lands into trust for the Karuk Tribe. Doing so would allow the Karuk to access Katimiin for use during their ancestral ceremonies without interruption and exercise better stewardship over their sacred lands for generations to come.
As our Nation works to correct historic injustices, it is important that we promote Tribal sovereignty and the continuation of Tribal culture. These sacred lands, located in Humbolt and Siskiyou Counties, are central to Karuk culture, religion, and identity, and serve as the Tribe's center of the universe and site of the Pikyavish world renewal ceremony.
Currently, the Karuk have a special use permit from the Forest Service to access the land for prayers and ancestral ceremonies. However, in recent years, the Tribe has struggled to access the site and conduct their sacred ceremonies privately without interruption. Placing these lands into trust would allow the Karuk to provide better public notice of ceremonies, preserve traditional practices, and protect the land's rich natural beauty, a core tenant of the Tribe's identity.
I thank Senator Feinstein for introducing this legislation with me in the Senate and Congressman Huffman for championing this effort in the House of Representatives. I also thank the Karuk Tribe, including Chairman Attebery, for leading this important effort. I look forward to working with my colleagues to enact this bill as quickly as possible.
______
By Ms. COLLINS (for herself and Mr. Kaine):
S. 4446. A bill to modernize the process of accelerated approval of a drug for a serious or life-threatening disease or condition; to the Committee on Health, Education, Labor, and Pensions.
Ms. COLLINS, Mr. President, I rise to introduce the Modernizing the Accelerated Approval Pathway Act with my colleague from Virginia, Senator Tim Kaine. The Food and Drug Administration's accelerated approval pathway has long had broad bipartisan support and is an important tool that provides early access to treatments for patients with serious and life-threatening conditions for which there is an unmet need, like Alzheimer's disease, Duchenne muscular dystrophy, and many cancers.
FDA grants accelerated approval based on substantial evidence that a surrogate end point is reasonably likely to predict a clinical benefit. In other words, therapies have to meet the same ``substantial evidence'' standard as traditional approval, but they can rely on a surrogate end point that predicts a clinical benefit rather than measuring that clinical benefit directly. For example, a study might measure viral load as a surrogate end point for survival in HIV or tumor size in oncology.
This can considerably shorten the time required before a product receives FDA approval. Clinical outcomes can take significantly more time to manifest than a surrogate end point, and in the meantime, patients go without treatments while studies are being conducted. Sponsors are still required to complete postmarket studies for their accelerated approval products, which are designed to confirm the clinical benefit with goals of converting an accelerated approval into a traditional approval. A review of accelerated approval drugs approved between 1992 and 2016 concluded that 76.5 percent were converted to traditional approval.
The accelerated approval pathway has served us well over the decades since it was created in response to outcry over unmet patient need during the HIV/AIDS crisis. More than 250 new therapies have received accelerated approval, with 65 percent of those therapies treating cancer indications and just over 40 percent treating rare diseases or conditions. We need, however, to make sure that we update this pathway so that it remains flexible in our current scientific environment and can continue to enable access to treatments for patients with serious and life-threatening conditions who are desperate for a treatment or cure.
It is well known that use of the accelerated approval pathway is inconsistent across FDA. Some therapeutic areas, like oncology, have vast experience and success using the pathway. In fact, about 85 percent of accelerated approvals between 2010 and 2020 were for oncology indications. In other areas, like neurological diseases, it is infrequently used. Patient communities are deeply frustrated by what they view as underutilization of the tool and feel it has created disparities given that the urgency of finding a cure is one shared by all patients with diseases for which there is no treatment or cure, regardless of which bureaucratic office leads drug review for their particular disease. The Government Accountability Office has found that these inconsistencies are due in part to a lack of familiarity with the tools of accelerated approval in certain FDA centers and divisions. Our bill would correct this by establishing a council of senior FDA leadership to ensure consistent and appropriate use of the accelerated approval pathway across and within FDA centers and divisions.
Although a number of rare disease therapies have been good candidates for accelerated approval, there can also be challenges to using the pathway. Sometimes a disease is so rare or heterogeneous that developers need to study a small subset of the population in order to demonstrate a treatment effect. Our bill would clarify that real-world evidence--data from patient registries, electronic health records, medical claims, and observational studies--can be used to augment or support appropriate post approval studies. This approach may yield meaningful and timely evidence that adds context to other data and helps us understand how a product works in the real world and across the entire population for a disease.
Some have criticized the timeliness of confirmatory trials, which are sometimes delayed by operational or ethical challenges. FDA and drug developers are often rushing to agree on a confirmatory trial structure late in the review structure, and in those cases they may not be able to benefit from expert input or feasibility analyses. This can create untenable expectations regarding timelines or, in a worst case scenario, result in drug developers pursuing a flawed study that is not appropriately designed to confirm clinical benefit. Our bill would clarify that FDA may require confirmatory trials to be underway prior to approval and that FDA can specify the conditions for those studies, which may include enrollment targets, study protocol, milestones, and a target date for study completion. Our bill also outlines expedited procedures for withdrawing an accelerated approval if a confirmatory trial fails to confirm the clinical benefit.
Finally, we need to make it clearer how much progress an accelerated approval product has made toward confirming its clinical benefit. Our bill would require that developers of drugs approved under accelerated approval submit to FDA a report of the progress they have made on required confirmatory trials every 180 days. It would also require that if FDA does not require postapproval studies for an accelerated approval product, the Agency must publish an explanation on its website as to why such a study is not appropriate or necessary.
Our bill has support from the Juvenile Diabetes Research Foundation, American Cancer Society Cancer Action Network, Parent Project for Muscular Dystrophy, EveryLife Foundation for Rare Diseases, Alzheimer's Association, National MS Society, American Academy of Neurology, National Organization of Rare Diseases, and the Haystack Project. I thank Health, Education, Labor, and Pensions Committee Chairman Murray and Ranking Member Burr for including it in their FDA Safety and Landmark Advancements Act, which was favorably reported out of the HELP Committee this week. I encourage my colleagues to support that bill when it is considered on the Senate floor.
______
By Mr. REED (for himself and Mr. Moran):
S. 4448. A bill to authorize a pilot program to expand and intensify surveillance of self-harm in partnership with State and local public health departments, to establish a grant program to provide self-harm and suicide prevention services in hospital emergency departments, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.
Mr. REED. Mr. President, as we all know too well, rates of suicide have risen to epidemic levels in the United States, with suicide now the 10th leading cause of death in the country. On average, there are 130 suicides every day, roughly 1 every 11 minutes. These are staggering statistics behind which there are tragic stories of loss. That is why I am joining Senator Moran to introduce the Suicide Prevention Act.
Our bipartisan, bicameral bill would provide new resources to help turn the tide on this disturbing trend. It would authorize new funding for the Centers for Disease Control and Prevention, CDC, partner with State and local health departments to improve surveillance of suicide attempts and other incidences of self-harm. Data collection efforts regarding suicide often occur years after the fact, which limits the ability of State and local health departments, as well as community organizations, to recognize trends early and intervene. CDC has already begun some of this work as a pilot program, but the Suicide Prevention Act would expand these efforts and enhance data collection so we can respond to new trends quickly and save lives.
We know that emergency healthcare providers are often at the frontlines of responding to suicide attempts. Approximately 37 percent of individuals without a previous history of mental health or substance abuse who die by suicide make an emergency department visit within the year before their death. According to the Suicide Prevention Resource Center, the risk of suicide is greatest within a month of discharge from the hospital. To help ensure our emergency healthcare professionals have the tools to respond, the bill would also authorize funding for a grant program within the Substance Abuse and Mental Health Services Administration, SAMHSA, to help better train emergency department staff to implement suicide prevention strategies, screen at-
risk patients, and refer patients to appropriate followup care. The legislation would also require SAMHSA to develop best practices for such programs, so that healthcare providers are able to provide their patients with the best possible care and advice.
Nationwide, suicide rates have skyrocketed over the last decade. In 2020, nearly 46,000 Americans lost their lives to suicide. That same year, there were 1.2 million suicide attempts. We must renew our efforts on suicide prevention and take a holistic approach. In addition to the Suicide Prevention Act, we must reauthorize the Garrett Lee Smith Memorial Act, which I am working with Senator Murkowski to do. Despite the troubling national trend, programs under this law have contributed to declines in the youth suicide rates in my home State of Rhode Island over the last decade.
We must also invest in the National Suicide Prevention Lifeline and the new nationwide three-digit 9-8-8 number, which is scheduled to go live this summer. Senator Moran and I have teamed up on the National Suicide Prevention Lifeline Improvement Act that will increase funding for the Lifeline and make key improvements, such as enhance texting capability.
Today, I am pleased to have the opportunity to partner with Senator Moran once again by introducing the Suicide Prevention Act. This bill is one more step Congress can take to combat the mental health and suicide crisis in our country. I look forward to working with Senator Moran and advocates in Rhode Island and across the country to make a difference in addressing this epidemic.
______
By Mr. CORNYN (for himself, Mr. King, Mr. Sasse, and Mrs.
Gillibrand):
S. 4456. A bill to prohibit certain former employees of the intelligence community from providing certain services to governments of countries that are state sponsors of terrorism, the People's Republic of China, and the Russian Federation, and for other purposes; to the Select Committee on Intelligence.
Mr. CORNYN. Mr. President, I ask unanimous consent to print my bill for introduction in the Congressional Record. The bill prohibits certain former employees of the intelligence community from providing certain services to governments of countries that are state sponsors of terrorism, the People's Republic of China and the Russian Federation.
There being no objection, the text of the bill was ordered to be printed in the Record, as follows:
S. 4456
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. PROHIBITION ON EMPLOYMENT WITH GOVERNMENTS OF
CERTAIN COUNTRIES.
(a) In General.--Title III of the National Security Act of 1947 (50 U.S.C. 3091 et seq.) is amended by inserting after section 304 the following:
``SEC. 305. PROHIBITION ON EMPLOYMENT WITH GOVERNMENTS OF
CERTAIN COUNTRIES.
``(a) Definitions.--In this section:
``(1) Covered employee.--The term `covered employee', with respect to an employee occupying a position within an element of the intelligence community, means an officer or official of an element of the intelligence community, a contractor of such an element, a detailee to such an element, or a member of the Armed Forces assigned to such an element that, based on the level of access of a person occupying such position to information regarding sensitive intelligence sources or methods or other exceptionally sensitive matters, the head of such element determines should be subject to the requirements of this section.
``(2) Former covered employee.--The term `former covered employee' means an individual who was a covered employee on or after the date of enactment of this section and is no longer a covered employee.
``(3) State sponsor of terrorism.--The term `state sponsor of terrorism' means a country the government of which the Secretary of State determines has repeatedly provided support for international terrorism pursuant to--
``(A) section 1754(c)(1)(A) of the Export Control Reform Act of 2018 (50 U.S.C. 4813(c)(1)(A));
``(B) section 620A of the Foreign Assistance Act of 1961
(22 U.S.C. 2371);
``(C) section 40 of the Arms Export Control Act (22 U.S.C. 2780); or
``(D) any other provision of law.
``(b) Prohibition on Employment and Services.--No former covered employee may provide services relating to intelligence, the military, or internal security to--
``(1) the government of a country that is a state sponsor of terrorism, the People's Republic of China, or the Russian Federation;
``(2) a person or entity that is directed and controlled by a government described in paragraph (1).
``(c) Training and Written Notice.--The head of each element of the intelligence community shall--
``(1) regularly provide to the covered employees of the element training on the prohibition in subsection (b); and
``(2) provide to each covered employee of the element before the covered employee becomes a former covered employee written notice of the prohibition in subsection (b).
``(d) Limitation on Eligibility for Access to Classified Information.--A former covered employee who knowingly and willfully violates subsection (b) shall not be considered eligible for access to classified information (as defined in the procedures established pursuant to section 801(a) of this Act (50 U.S.C. 3161(a))) by any element of the intelligence community.
``(e) Criminal Penalties.--A former employee who knowingly and willfully violates subsection (b) shall be fined under title 18, United States Code, or imprisoned for not more than 5 years, or both.
``(f) Application.--Nothing in this section shall apply to--
``(1) a former covered employee who continues to provide services described in subsection (b) that the former covered employee first began to provide before the date of the enactment of this section;
``(2) a former covered employee who, on or after the date of the enactment of this section, provides services described in subsection (b) to a person or entity that is directed and controlled by a country that is a state sponsor of terrorism, the People's Republic of China, or the Russian Federation as a result of a merger, acquisition, or similar change of ownership that occurred after the date on which such former covered employee first began to provide such services;
``(3) a former covered employee who, on or after the date of the enactment of this section, provides services described in subsection (b) to--
``(A) a government that was designated as a state sponsor of terrorism after the date on which such former covered employee first began to provide such services; or
``(B) a person or entity directed and controlled by a government described in subparagraph (A).''.
(b) Annual Reports.--Not later than March 31 of each year through 2032, the Director of National Intelligence shall submit to the congressional intelligence committees a report on any violations of subsection (b) of section 305 of the National Security Act of 1947, as added by subsection (a) of this section, by former covered employees (as defined in subsection (a) of such section 305).
(c) Clerical Amendment.--The table of contents immediately preceding section 2 of the National Security Act of 1947 (50 U.S. C. 3002) is amended by inserting after the item relating to section 304 the following new item:
``Sec. 305. Prohibition on employment with governments of certain countries.''.
____________________
SOURCE: Congressional Record Vol. 168, No. 106
The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.
Senators' salaries are historically higher than the median US income.
Alerts Sign-up