Closing the HPV Testing Gap Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8939 Introduced in House (IH)]

<DOC>

119th CONGRESS
  2d Session
                                H. R. 8939

To direct the Director of the National Institutes of Health to conduct
    a study and submit to Congress a report on the development of a
 standardized, noninvasive test for HPV in men, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 20, 2026

 Mrs. McIver (for herself, Mr. Carter of Louisiana, Mr. Menendez, and
 Mr. Veasey) introduced the following bill; which was referred to the
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

To direct the Director of the National Institutes of Health to conduct
    a study and submit to Congress a report on the development of a
 standardized, noninvasive test for HPV in men, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Closing the HPV Testing Gap Act''.

SEC. 2. 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.

SEC. 3. 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.
                                 <all>