Findings

Congress finds the following: (1)Human papillomavirus (in this section referred to as HPV) is the most common sexually transmitted infection in the United States, with a significant proportion of HPV-related cancers, particularly oropharyngeal cancers, occurring among men. (2)There is currently no HPV diagnostic test for men that is approved by the Food and Drug Administration, creating a critical gap in public health surveillance, prevention, and treatment. (3)The National Academies of Sciences, Engineering, and Medicine, in its 2023 report titled National Cancer Control Efforts Should Address the System, Not Its Individual Parts, emphasized the importance of coordinated, system-wide strategies for cancer prevention. (4)Expanding HPV detection efforts to include men would promote gender equity in cancer prevention and enhance national cancer control and public health outcomes. (5)The absence of a standardized HPV diagnostic test for men contributes to sustained transmission pathways and delayed detection that directly impact women’s health outcomes, including cervical cancer incidence, thereby reinforcing inequities in cancer prevention.

NIH study and report on development of standardized, noninvasive HPV test for men

(a)

Study

The Director of NIH shall, not later than 24 months after the date of the enactment of this Act, conduct a comprehensive study on the development of a standardized, noninvasive test for HPV in men. (b)

Consultation; coordination

The Director of NIH shall conduct the study under subsection (a)— (1)in consultation with the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, the Administrator of the Health Resources and Services Administration, and the National Academy of Medicine; (2)in consultation with scientific and clinical experts, public health agencies, and relevant research institutions; and (3)in coordination with the President of the National Academy of Medicine. (c)

Elements

In conducting the study under subsection (a), the Director of NIH shall— (1)assess the current state of development, scientific knowledge, and research gaps related to standardized, noninvasive tests for HPV in men; (2)explore potential approaches and methodologies for noninvasive HPV testing in men, including evaluation of multi-site testing (such as testing of oral, pharyngeal, anal, and penile and urine testing); (3)provide considerations for future implementation, including advancing research to improve understanding of HPV-related cancer risk in men, potential pilot studies or population-level testing protocols, and identify areas where further research could inform public health strategies; (4)assess the feasibility of conducting pilot and implementation studies related to such tests in men across diverse populations (including high-risk and underserved communities) and across multiple sites affected by HPV (including testing of oral, pharyngeal, anal, and penile sites and urine testing); (5)develop recommendations for interagency coordination to facilitate regulatory approval of such tests, community-based screening of HPV in men, and equitable access to such tests through the Food and Drug Administration and the Health Resources and Services Administration; and (6)conduct such other pilot and feasibility studies as the Secretary determines appropriate to complete the study under subsection (a). (d)

Interagency working group

The Director of the National Institutes of Health shall establish an interagency working group, which shall include representatives from the Food and Drug Administration, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and the National Academy of Medicine, to ensure that throughout the period of the study under this section, the study is implemented by coordinating among scientific, regulatory, and community implementation pathways. (e)

Report

Not later than 30 months after the date of enactment of this Act, the Director of NIH shall submit to Congress a report describing— (1)the findings and conclusions of the Director based on the study; (2)recommendations for developing and implementing a standardized, noninvasive test for HPV in men; and (3)interagency strategies for integrating HPV testing into national cancer prevention and health equity initiatives. (f)

Definitions

In this section: (1)

Director of NIH

The term Director of NIH means the Director of the National Institutes of Health. (2)

HPV

The term HPV means the human papillomavirus. (3)

Study

The term study means the study referred to in subsection (a). (g)

Funding

To carry out this section, the Director of NIH shall use funds appropriated or otherwise made available to the Director of NIH for each of fiscal years 2026 through 2030.