FDA CTP & NIH News

As stewards of taxpayer funds, NIH must deliver results that matter to the public. Today, I’m pleased to announce that NIH is moving toward a unified strategy that aligns our priorities and funding approaches to fulfill this commitment. Through this strategy, we will better leverage the synergistic missions of each NIH Institute and Center to fund the most meritorious science, address urgent health needs, and sustain a robust biomedical research workforce.

A central pillar of this approach is balancing scientific opportunity with mission-critical objectives. NIH is sharpening its focus on chronic health issues that affect Americans, including chronic childhood diseases and nutrition. We are also prioritizing next-generation tools such as artificial intelligence, alternative testing models, and real-world data platforms.

To rebuild public trust, NIH is enhancing oversight of funded research abroad and reinforcing its commitment to responsible stewardship of taxpayer dollars. We will expand support for replication studies and strengthen our capacity to advance groundbreaking science. At the same time, NIH remains dedicated to fostering open, competitive, and accountable science and supporting investigators as they pursue innovative, and sometimes controversial, questions grounded in rigorous methodology.

A core function of NIH Institutes and Centers is to assess scientific merit within the context of NIH’s broader strategic goals and develop appropriate research funding plans accordingly. In an environment where NIH receives more meritorious applications than it can fund, this review process is increasingly critical. To that end, NIH will empower its Institutes, Centers and Offices to make funding decisions that reflect agency and institute priorities, scientific opportunity, program balance, workforce needs, and other core principles that will be consistently applied across the agency.

Taxpayer dollars are a finite resource, entrusted to NIH officials to invest in the nation’s future. By transparently establishing priorities and aligning our goals, we aim to demonstrate to the American public that we take this commitment seriously—and that we are doing all we can to honor their trust.

Jay Bhattacharya, M.D., Ph.D.
Director, NIH

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health®

Priorities: 

This document has been prepared in furtherance of the NIH Director’s responsibility to provide the overall direction of NIH, to establish and implement general policies respecting the management and operation of NIH programs and activities, and to coordinate and oversee the operation of NIH’s institutes, centers, and offices. See 42 U.S.C. § 282(b)(1) & (2). Please note that this is not an exhaustive list of all agency priorities. This document is intended to clarify specific issues that currently require additional guidance. NIH continues to support projects across the full spectrum of biomedical research topics. Through an executive order on Gold-Standard Science and the Make America Healthy Again Commission Report, the President has directed the NIH to close critical research gaps and guide efforts to better combat chronic disease in America and improve the health of all Americans through gold-standard science. To meet these requirements and fulfill our mission, NIH is prioritizing research in the following areas:

Training future biomedical scientists:

NIH training programs should focus on training future physicians and scientists to lead American preeminence in biomedical research in the 21stcentury. Programs should allow trainees to design and conduct the highest quality scientific studies. Importantly, these programs should be based on merit, follow civil rights law, and not discriminate against anyone. NIH and the institutions we support must also uphold safe, equal, and healthy working and learning conditions conducive to high-quality research and free inquiry.

Replication and reproducibility:

Replicable, reproducible, and generalizable research must serve as the basis for truth in biomedical science. The “publish or perish” culture favors the promotion of only favorable results, and replication work is little valued or rewarded. NIH is prioritizing research that produces robust, reproducible results. We are exploring various mechanisms to support scientists focused on replication work, to publish negative findings, and to elevate replication research.

Real-World Data Platform:

NIH is establishing a robust and secure national infrastructure to integrate and link data from various real-world sources consistent with a deep respect for individual privacy rights. This new Real-World Data Platform will provide advanced computational analysis resources for investigators across numerous research areas, including neurodevelopmental disorders and chronic diseases.

Artificial intelligence:

Artificial intelligence breakthroughs provide exciting new possibilities for science and medicine, but require careful, rigorous research to fulfill their promise. The NIH will develop an AI Strategic Plan to enhance transparency in AI models, develop replication standards for AI use in research, and expedite the research, development, and translation of AI discoveries to benefit patients. The plan will consider strategic architecture, high-impact AI use cases, new opportunities to use AI for agency operations, and best practices for validating AI in healthcare delivery.

Nutrition:

NIH will champion initiatives rigorously exploring the role of poor diets in causing common chronic conditions and the identification of healthy diets that can prevent and better manage these conditions. We will prioritize projects focusing on the role of maternal and infant dietary exposures on health outcomes across the lifespan. NIH will also work to initiate long-term studies to understand the impacts of certain foods and diets on obesity and insulin resistance in children.

Furthering our understanding of autism:

NIH is supporting initiatives to understand the etiology and the treatment and care needs of the broad spectrum of people with autism. The new autism data science initiative will support investigators in identifying and addressing data gaps in scientific understanding of the etiology of autism and commonly co-occurring conditions. Activities supported will include creating new data resources and integrating existing data resources into state-of-the-art analyses on autism etiology. The program aims to develop knowledge to improve health outcomes for people on the autism spectrum.

Alternative testing models:

NIH is establishing the Office of Research Innovation, Validation, and Application under the Division of Program Coordination, Planning, and Strategic Initiatives, to develop, validate, and scale the use of human-biology-based new approach methodologies (NAMs) to complement animal models and enhance investigations. This office will coordinate with NIH institutes, centers, and offices to explore and prioritize ways to reduce our reliance on animal testing to advance technologies that improve translation to humans. Accordingly, all new funding opportunities that include support for animal models will also incorporate language on the consideration of NAMs. The office will serve as a hub for interagency collaboration and expand funding opportunities and infrastructure for non-animal approaches.

Promoting research focused on scientifically valid, measurable health outcomes:

NIH will continue to support research that advances the health of all Americans, regardless of their age, race, ethnicity, sex, sexual orientation, or other characteristics. To conduct meaningful biomedical research, scientists must consider both individual and external factors that influence health outcomes, guided by the needs of the specific research question. Some relevant personal characteristics may include demographic indicators such as race and sex, while some contextual factors, like environmental exposures and socioeconomic conditions (e.g., poverty), may also be scientifically significant. Any distinctions made in study design must be directly relevant to the health outcomes under investigation. NIH will support scientifically rigorous research that considers these factors when they are scientifically justified and aligned with the study’s objectives.

In contrast to research that considers race or ethnicity when scientifically justified (described in the paragraph above), research based on ideologies that promote differential treatment of people based on race or ethnicity, rely on poorly defined concepts or on unfalsifiable theories, does not follow the principles of gold-standard science. Such studies divert resources away from projects that advance the health and longevity of all Americans, including minority populations. The NIH will always prioritize gold-standard science.

Investigators must employ specific and measurable concepts in health disparities research. For example, redlining and housing discrimination are clearly defined practices that can measurably impact the health of minority populations. The NIH will support scientifically rigorous research programs that explore such causes as one reason among many for poor health outcomes for Americans.

However, broad or subjective claims—such as attributing worse health outcomes in a particular population to poorly measured factors like systemic racism—should not be presented as established background facts without clearly defining measurable variables that are part of the research question.

Relatedly, research involving participant volunteers should be based on appropriate population descriptors and categories that use precise language to define participant attributes, comparator group attributes, and to whom the study findings apply. Research based on overly broad and scientifically imprecise goals is of low value and off-mission.

Shifting to solution-oriented approaches in health disparities research:

NIH has invested substantially in health disparities research, focusing mainly on identifying and documenting worse health outcomes for minority populations. The field has made significant progress in mapping the breadth and depth of differences in health outcomes across populations, but this research has not always translated into measurable improved health for minority populations.

Going forward, the NIH will prioritize research that goes beyond measuring health disparities to focusing on solution-oriented approaches. This includes actively testing, advancing, scaling, and implementing innovative evidence-based interventions and treatments that address poor health outcomes.

Improving oversight of NIH funds going to foreign research institutions:

The NIH will continue to support research collaborations with institutions and scientists outside the U.S. Many critical breakthroughs that improve the health of Americans have resulted from global partnerships, so foreign scientific research collaborations often have clear scientific value. However, we must take action to ensure better oversight of our funding abroad.

All NIH institutes, centers, and offices should consider whether there is a scientific justification for conducting a research program at a foreign site rather than a domestic one. The NIH should prefer the latter over the former when scientifically justified. We should also consider whether each project involving foreign collaboration will likely lead to better health for Americans, since American taxpayers fund NIH research.

We must also assess risks to national security, biosecurity, and waste, abuse, or fraud at foreign sites where NIH has substandard or no oversight. To address this goal, we have established a new award structure for foreign collaboration. Foreign institutions receiving funds for work on a funded project will henceforth be considered independent awards linked to the parent project. This system will allow the NIH to directly track funds awarded to all foreign components receiving NIH funding and hold all institutions receiving NIH funding to grant terms and conditions regardless of where they are in the world.

Ensuring evidence-based health care for children and teenagers identifying as transgender:

The state of the scientific literature regarding optimal care and support approaches for children and teenagers identifying as transgender and those diagnosed with gender dysphoria is described in the recent HHS review of treatment for pediatric gender dysphoria. In accordance with these data, there are clearly more promising avenues of research that can be taken to improve the health of these populations than to conduct studies that involve the use of puberty suppression, hormone therapy, or surgical intervention to treat gender dysphoria, gender identity disorder, or gender incongruence in minors. By contrast, research that aims to identify and treat the harms these therapies and procedures have potentially caused to minors diagnosed with gender dysphoria, gender identity disorder, or gender incongruence, and how to best address the needs of these individuals so that they may live long, healthy lives is more promising.

Implementing advances in HIV/AIDS research:

Ending the HIV epidemic in the United States remains a key priority. For more than 40 years, NIH support has enabled significant advances in antiretroviral therapies, transforming the landscape of care and prevention approaches. Recent breakthroughs in simpler-to-take treatments and long-acting prophylactics, and many other recent breakthroughs, provide us with the technological tools needed to finally win this long battle. To take advantage of this opportunity, the NIH will support implementation science and other research directions to improve the uptake of and access to existing medical and behavioral interventions that can significantly limit and eventually eradicate HIV infection from the United States. Research on HIV/AIDS prevention, treatment, and cure will continue as needed to support this goal.

An updated Harmonized Dataset containing data from all available waves (1992 through 2023) of the Tobacco Use Supplement to the Current Population Survey (TUS-CPS) is now available on the TUS-CPS website. This single dataset provides a more robust data source, allowing for increased sample size and improved tracking of trends over time. Harmonized variables cover a wide range of topics, including, but not limited to, cigarette and e-cigarette use, workplace and home smoking restrictions, attitudes toward smokefree rules, advice to quit by physician/dentist, health perceptions and beliefs, and other tobacco product use. See the updated fact sheet for additional information on the TUS-CPS harmonized dataset. 

A new User Guide is also available. This document provides detailed information about the construction of the harmonized dataset, offers guidance on using the dataset to conduct weighted analyses, and presents examples of weighted analyses using SAS.  

For general questions about the TUS-CPS, contact us at ncidccpsbrpadvances@mail.nih.gov.

The Wave 7.5 Special Collection Restricted-Use Files from the Population Assessment of Tobacco and Health (PATH) Study are now available from NIH’s National Institute on Drug Abuse and FDA’s Center for Tobacco Products . These Wave 7.5 files contain questionnaire data from youth (12-17 years old) and young adults (18-22 years old) collected between April 2023 and December 2023. Researchers are encouraged to submit a request to obtain data access. 

The PATH Study is a household-based, nationally representative, longitudinal study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. 

In addition to these newly released data files, researchers may continue to request access to the Wave 1-Wave 7 Restricted-Use Files and Biomarker Restricted-Use Files. Data and documentation from the Public-Use Files are also available for download with updated Master Linkage Files.

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com.

NIH’s National Institute on Drug Abuse and FDA’s Center for Tobacco Products are announcing the release of the Wave 7 Public-Use File from the Population Assessment of Tobacco and Health (PATH) Study. These Wave 7 files contain questionnaire data collected between January 2022 and April 2023.

The Public-Use Files are available for download. Additionally, the Master Linkage Files have each been updated to reflect the current availability of biospecimens in the Biospecimen Access Program.

Researchers are also encouraged to apply for access to the Restricted-Use Files and Biomarker Restricted-Use Files. In addition, the Biospecimen Access Program webpage  provides information on how to access the urine, serum, plasma, and genomic DNA collected from adult PATH Study participants during Wave 1 (2013 – 2014) and urine collected during Wave 2 (2014 – 2015), Wave 3 (2015-2016), Wave 4 (2016-2018),Wave 5 (2018-2019), and Wave 7 (2022-2023).

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com. 

Today, FDA posted additional regulatory science policy memos related to the agency’s review of premarket applications. This release includes thirteen memos developed between 2020 and 2023 that describe the process and prioritization methods used to conduct filing and review of PMTAs for flavored e-cigarettes and other PMTAs, as well as the bases to support specific actions related to environmental assessments.

In April, FDA resumed the posting of regulatory science policy memos. This is now the fourth batch of released memos in 2024, and including those posted today, FDA has released a total of 26 memos. The release of these latest memos reflects the center’s commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation. Visit the FDA website to read more about FDA’s actions in response to the evaluation.

Read the Full Statement

NIH’s National Institute on Drug Abuse and FDA’s Center for Tobacco Products are announcing the release of the Wave 7 Biomarker Restricted-Use File (BRUF) from the Population Assessment of Tobacco and Health (PATH) Study. This release is the first to include biomarker data from Wave 7, which were collected between January 2022 and April 2023. Researchers may apply for access to the Biomarker Restricted-Use Files (BRUF). 

In addition, the Wave 1 BRUF has been updated to include expanded samples from Wave 1 adults who had former experimental use or long-term former use of any tobacco product. The Restricted-Use and Public-Use Master Linkage Files have been updated to reflect the new files and the current availability of biospecimens in the Biospecimen Access Program. 

Researchers are encouraged to apply for access to the Restricted-Use Files. Public-Use Files are also available for download. In addition, the Biospecimen Access Program webpage provides information on how to access the urine, serum, plasma, and genomic DNA collected from adult PATH Study participants during Wave 1 (2013 – 2014) and urine collected during Wave 2 (2014 – 2015), Wave 3 (2015-2016), Wave 4 (2016-2018),Wave 5 (2018-2019), and Wave 7 (2022-2023).

In addition, the PATH Study has posted a new training video entitled “Modelling with the PATH Study Data – Survival Analysis” available in the PATH Study playlist.

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com.

On Monday, October 21, from 9 a.m. to 4:30 p.m. EDT, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) will host a joint public meeting entitled, “Advancing Smoking Cessation: FDA and NIH Priorities.” The focus of the meeting is on advancing innovation of smoking cessation products to help both adults and youth.

The meeting will feature presentations and panel discussions on several smoking cessation-focused topics, including:

• Clinical and community perspectives
• Promising target areas for development
• Regulatory paths forward

The meeting will include an opportunity for public comment on several topics related to cessation.

The meeting is free, and can be attended virtually or in-person at the FDA’s White Oak campus in Silver Spring, Maryland. Additional information about the meeting, including specific questions for which public comment is being sought, is found in the Federal Register notice announcing the meeting. Deadlines for registration, including for public comment, are as follows:

• In-person registration is required by October 15, 2024, while virtual registration is open through 9:00 a.m. EDT on the day of the meeting.
• Registration to speak in-person during the public comment portion of the meeting is required by October 1 at 5:00 p.m. EDT. Please note that public comments during the meeting will only be accepted in person and not virtually. Every effort will be made to accommodate as many speakers as possible; however, speaking spots are limited and not guaranteed.
• Written comments must be submitted by November 21, 2024 via the meeting's public docket on Regulations.gov [Docket No. FDA-2024-N-4085].

Tobacco product use remains the single most preventable cause of disease, disability and death in the United States, and each year, an estimated 480,000 Americans die prematurely from smoking or from exposure to second-hand smoke. The U.S. Department of Health and Human Services (HHS) Framework to Support and Accelerate Smoking Cessation includes a stated goal to promote ongoing and innovative research in the area of cessation. The FDA and NIH’s joint October meeting is in support of these efforts, as the Department advances our collective efforts to improve the nation’s health.

NIH’s National Institute on Drug Abuse (NIDA) and NIH and FDA’s Center for Tobacco Products (CTP) are announcing the availability of the adult and youth/parent Location Characteristics Restricted Use Files from Wave 1 (2013) through Wave 5 (2019) of the Population Assessment of Tobacco and Health (PATH) Study. 

These newly-released variables characterize a respondent's neighborhood of residence as one of four basic locale types: City, Suburban, Town, or Rural. Providing an enhanced measure of a respondent’s location as more urban or rural improves the ability of researchers to understand relationships between tobacco use behaviors, health equity, and community characteristics. Researchers may apply for access to the RUF at https://doi.org/10.3886/ICPSR36231.

In addition, the PATH Study Biomarker Restricted-Use Files (RUF) have been updated to include additional panel assays from Wave 4 and Wave 5, which can be accessed at https://doi.org/10.3886/ICPSR36840. The PATH Study Restricted-Use Files (RUF) have been updated to include Wave 7 state identifier, state design, and Tobacco Universal Product (UPC) data. The Restricted-Use and Public-Use Master Linkage Files have each been updated to reflect the new RUF files and the current availability of biospecimens in the Biospecimen Access Program. Master Linkage Files can be accessed at https://doi.org/10.3886/ICPSR38008.

Members of the research community are encouraged to apply for access to the Restricted-Use Files through https://doi.org/10.3886/ICPSR36231 and Biomarker Restricted-Use Files at https://doi.org/10.3886/ICPSR36840. Public-Use Files are also available for download at https://doi.org/10.3886/ICPSR36498. In addition, the Biospecimen Access Program webpage at http://bit.ly/2wBFOtc provides information on how to access the urine, serum, plasma, and genomic DNA (gDNA) collected from adult PATH Study participants during Wave 1 (2013 – 2014) and urine collected during Wave 2 (2014 – 2015), Wave 3 (2015-2016), Wave 4 (2016-2018), and Wave 5 (2018-2019).

The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. It was launched in 2011 to inform the FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. Questions regarding accessing the PATH Study can be sent to NAHDAP@icpsr.umich.edu. 

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com (not to be used for questions about statistical analysis or analytic guidance).

The NIH’s Office of Science Policy, through an NIH-wide collaboration, has developed and releasedInformed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language.  This resource presents general points to consider, instructions for use, and optional sample language for the research community. This resource will best be used to inform research teams and Institutional Review Board (IRB) members who are planning, reviewing, or conducting research that studies or uses digital health technologies.

On June 10, in partnership with the Clinical Data Interchange Standards Consortium (CDISC), FDA’s Center for Tobacco Products (CTP) released the Tobacco Implementation Guide – a new resource for stakeholders to use to help facilitate tobacco product research and scientific review. The resource–which includes data standards that can help optimize scientific accuracy and review efficiency–was created by a multidisciplinary team from CTP, tobacco industry stakeholders, and CDISC, and included public/community review.

CTP awarded a grant to CDISC to expedite the development of data standards and terminologies to facilitate tobacco research, scientific review, and information exchange. Specifically, CDISC created the Tobacco Implementation Guide to serve as a comprehensive resource for the collection, analysis, and exchange of tobacco product data for submissions to CTP, including tobacco product applications and research findings. Examples of tobacco product application submissions include Premarket Tobacco Product Applications (PMTAs), Substantial Equivalence (SE) reports, and Modified Risk Tobacco Product (MRTP) applications, and examples of research include epidemiology studies, toxicology reports, and behavioral studies.

This initial version of the Guide implements several data models, including Clinical Data Acquisition Standards Harmonization, Study Data Tabulation Model, and Analysis Data Model.

Comments and feedback to this guide can help inform future updates to the Tobacco Implementation Guide. CDISC posts public review comments and resolutions to ensure transparency and show implementers how comments were addressed.

The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) today announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. 

Along with the FDA and the Justice Department, the task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth. Additional agencies may join the task force in the coming weeks and months. 

“Enforcement against illegal e-cigarettes is a multi-pronged issue that necessitates a multi-pronged response,” said Dr. Brian King, director of the FDA’s Center for Tobacco Products. “This ‘All Government’ approach – including the creation of this new Task Force – will bring the collective resources and experience of the federal government to bear on this pressing public health issue.”   

NIH’s National Institute on Drug Abuse (NIDA) and NIH and FDA’s Center for Tobacco Products (CTP) announce the release of the Wave 7 Restricted-Use File (RUF) from the Population Assessment of Tobacco and Health (PATH) Study.  Wave 7 files contain data collected between January 2022 and April 2023, including questionnaire data, tobacco Universal Product Code (UPC) data, and state identifier data. Researchers may apply for access to the RUF at https://doi.org/10.3886/ICPSR36231.

In addition, the PATH Study Biomarker Restricted-Use Files (BRUF) have been updated to include additional assays from Wave 4 and Wave 5. The PATH Study Restricted-Use Files (RUF) have been updated to include Wave 6 Ever/Never reference data for all participants, which can be accessed at https://doi.org/10.3886/ICPSR36231. The Restricted-Use and Public-Use Master Linkage Files have each been updated to reflect the new RUF files and the current availability of biospecimens in the Biospecimen Access Program. Master Linkage Files can be accessed at https://doi.org/10.3886/ICPSR38008.

Members of the research community are encouraged to apply for access to the Restricted-Use Files through https://doi.org/10.3886/ICPSR36231 and Biomarker Restricted-Use Files at https://doi.org/10.3886/ICPSR36840. Public-Use Files are also available for download at https://doi.org/10.3886/ICPSR36498. In addition, the Biospecimen Access Program webpage at http://bit.ly/2wBFOtc provides information on how to access the urine, serum, plasma, and genomic DNA (gDNA) collected from adult PATH Study participants during Wave 1 (2013 – 2014) and urine collected during Wave 2 (2014 – 2015), Wave 3 (2015-2016), Wave 4 (2016-2018), and Wave 5 (2018-2019).

The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. Questions regarding accessing the PATH Study can be sent to NAHDAP@icpsr.umich.edu. 

Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com (not to be used for questions about statistical analysis or analytic guidance).