US Codex
Pub. L.
Notes

Title VI — Advancing Technologies for Medical Countermeasures

116th Congress · Approved Jun 24, 2019 · 133 Stat. 905

TITLE VI Advancing Technologies for Medical Countermeasures

SEC. 601. Administration of Countermeasures.

Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d–7e(c)(4)(D)(iii)) is amended by striking “ and platform technologies” and inserting “ platform technologies, technologies to administer countermeasures, and technologies to improve storage and transportation of countermeasures”.

SEC. 602. Updating Definitions of Other Transactions.

Section 319L (42 U.S.C. 247d–7e) is amended—
(1)
in subsection (a)(3), by striking “ , such as” and all that follows through “ Code”; and
(2)
in subsection (c)(5)(A)—
(A)
in clause (i), by striking “ under this subsection” and all that follows through “ Code” and inserting “ (as defined in subsection (a)(3)) under this subsection”; and
(B)
in clause (ii)—
(i)
by amending subclause (I) to read as follows:

“(I) In general.—To the maximum extent practicable, competitive procedures shall be used when entering into transactions to carry out projects under this subsection.”

; and

(ii)
in subclause (II)—
(I)
by striking “ $20,000,000” and inserting “ $100,000,000”;
(II)
by striking “ senior procurement executive for the Department (as designated for purpose of section 16(c) of the Office of Federal Procurement Policy Act (41 U.S.C. 414(c)))” and inserting “ Assistant Secretary for Financial Resources”; and
(III)
by striking “ senior procurement executive under” and inserting “ Assistant Secretary for Financial Resources under”.

SEC. 603. Medical Countermeasure Master Files.

(a)
In General.— The purpose of this section (including section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b)) is to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support the development of such products, and through clarifying the authority to cross-reference to data and information previously submitted to the Secretary of Health and Human Services (referred to in this section as the “Secretary”), including data and information submitted to medical countermeasure master files or other master files.
(b)
Medical Countermeasure Master Files.— Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 565A the following:

“SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES.

“(a) Applicability of Reference.—

“(1) In general.—A person may submit data and information in a master file to the Secretary with the intent to reference, or to authorize, in writing, another person to reference, such data or information to support a medical countermeasure submission (including a supplement or amendment to any such submission), without requiring the master file holder to disclose the data and information to any such persons authorized to reference the master file. Such data and information shall be available for reference by the master file holder or by a person authorized by the master file holder, in accordance with applicable privacy and confidentiality protocols and regulations.

“(2) Reference of certain master files.—In the case that data or information within a medical countermeasure master file is used only to support the conditional approval of an application filed under section 571, such master file may be relied upon to support the effectiveness of a product that is the subject of a subsequent medical countermeasure submission only if such application is supplemented by additional data or information to support review and approval in a manner consistent with the standards applicable to such review and approval for such countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

“(b) Medical Countermeasure Master File Content.—

“(1) In general.—A master file under this section may include data or information to support—

“(A) the development of medical countermeasure submissions to support the approval, licensure, classification, clearance, conditional approval, or authorization of one or more security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products; and

“(B) the manufacture of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products.

“(2) Required updates.—The Secretary may require, as appropriate, that the master file holder ensure that the contents of such master file are updated during the time such master file is referenced for a medical countermeasure submission.

“(c) Sponsor Reference.—

“(1) In general.—Each incorporation of data or information within a medical countermeasure master file shall describe the incorporated material in a manner in which the Secretary determines appropriate and that permits the review of such information within such master file without necessitating resubmission of such data or information. Master files shall be submitted in an electronic format in accordance with sections 512(b)(4), 571(a)(4), and 745A, as applicable, and as specified in applicable guidance.

“(2) Reference by a master file holder.—A master file holder that is the sponsor of a medical countermeasure submission shall notify the Secretary in writing of the intent to reference the medical countermeasure master file as a part of the submission.

“(3) Reference by an authorized person.—A person submitting an application for review may, where the Secretary determines appropriate, incorporate by reference all or part of the contents of a medical countermeasure master file, if the master file holder authorizes the incorporation in writing.

“(d) Acknowledgment of and Reliance Upon a Master File by the Secretary.—

“(1) In general.—The Secretary shall provide the master file holder with a written notification indicating that the Secretary has reviewed and relied upon specified data or information within a master file and the purposes for which such data or information was incorporated by reference if the Secretary has reviewed and relied upon such specified data or information to support the approval, classification, conditional approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product. The Secretary may rely upon the data and information within the medical countermeasure master file for which such written notification was provided in additional applications, as applicable and appropriate and upon the request of the master file holder so notified in writing or by an authorized person of such holder.

“(2) Certain applications.—If the Secretary has reviewed and relied upon specified data or information within a medical countermeasure master file to support the conditional approval of an application under section 571 to subsequently support the approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product, the Secretary shall provide a brief written description to the master file holder regarding the elements of the application fulfilled by the data or information within the master file and how such data or information contained in such application meets the standards of evidence under subsection (c) or (d) of section 505, subsection (d) of section 512, or section 351 of the Public Health Service Act (as applicable), which shall not include any trade secret or confidential commercial information.

“(e) Rules of Construction.—Nothing in this section shall be construed to—

“(1) limit the authority of the Secretary to approve, license, clear, conditionally approve, or authorize drugs, biological products, or devices pursuant to, as applicable, this Act or section 351 of the Public Health Service Act (as such applicable Act is in effect on the day before the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019), including the standards of evidence, and applicable conditions, for approval under the applicable Act;

“(2) alter the standards of evidence with respect to approval, licensure, or clearance, as applicable, of drugs, biological products, or devices under this Act or section 351 of the Public Health Service Act, including, as applicable, the substantial evidence standards under sections 505(d) and 512(d) or this Act and section 351(a) of the Public Health Service Act; or

“(3) alter the authority of the Secretary under this Act or the Public Health Service Act to determine the types of data or information previously submitted by a sponsor or any other person that may be incorporated by reference in an application, request, or notification for a drug, biological product, or device submitted under sections 505(i), 505(b), 505(j), 512(b)(1), 512(b)(2), 512(j), 564, 571, 520(g), 515(c), 513(f)(2), or 510(k) of this Act, or subsection (a) or (k) of section 351 of the Public Health Service Act, including a supplement or amendment to any such submission, and the requirements associated with such reference.

“(f) Definitions.—In this section:

“(1) The term ‘master file holder’ means a person who submits data and information to the Secretary with the intent to reference or authorize another person to reference such data or information to support a medical countermeasure submission, as described in subsection (a).

“(2) The term ‘medical countermeasure submission’ means an investigational new drug application under section 505(i), a new drug application under section 505(b), or an abbreviated new drug application under section 505(j) of this Act, a biological product license application under section 351(a) of the Public Health Service Act or a biosimilar biological product license application under section 351(k) of the Public Health Service Act, a new animal drug application under section 512(b)(1) or abbreviated new animal drug application under section 512(b)(2), an application for conditional approval of a new animal drug under section 571, an investigational device application under section 520(g), an application with respect to a device under section 515(c), a request for classification of a device under section 513(f)(2), a notification with respect to a device under section 510(k), or a request for an emergency use authorization under section 564 to support—

“(A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or

“(B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

“(3) The terms ‘qualified countermeasure’, ‘security countermeasure’, and ‘qualified pandemic or epidemic product’ have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act.”

(c)
Stakeholder Input.— Not later than 18 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall solicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the Food and Drug Administration can advance the use of tools and technologies to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, including through reliance on cross-referenced data and information contained within master files and submissions previously submitted to the Secretary as set forth in section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).
(d)
Guidance.— Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products. The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act.

SEC. 604. Animal Rule Report.

(a)
Study.— The Comptroller General of the United States shall conduct a study on the application of the requirements under subsections (c) and (d) of section 565 of the of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) (referred to in this section as the “animal rule”) as a component of medical countermeasure advanced development under the Biomedical Advanced Research and Development Authority and regulatory review by the Food and Drug Administration. In conducting such study, the Comptroller General shall examine the following:
(1)
The extent to which advanced development and review of a medical countermeasure are coordinated between the Biomedical Advanced Research and Development Authority and the Food and Drug Administration, including activities that facilitate appropriate and efficient design of studies to support approval, licensure, and authorization under the animal rule, consistent with the recommendations in the animal rule guidance, issued pursuant to section 565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(c)) and entitled “Product Development Under the Animal Rule: Guidance for Industry” (issued in October 2015), to resolve discrepancies in the design of adequate and well-controlled efficacy studies conducted in animal models related to the provision of substantial evidence of effectiveness for the product approved, licensed, or authorized under the animal rule.
(2)
The consistency of the application of the animal rule among and between review divisions within the Food and Drug Administration.
(3)
The flexibility pursuant to the animal rule to address variations in countermeasure development and review processes, including the extent to which qualified animal models are adopted and used within the Food and Drug Administration in regulatory decisionmaking with respect to medical countermeasures.
(4)
The extent to which the guidance issued under section 565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(c)), entitled, “Product Development Under the Animal Rule: Guidance for Industry” (issued in October 2015), has assisted in achieving the purposes described in paragraphs (1), (2), and (3).
(b)
Consultations.— In conducting the study under subsection (a), the Comptroller General of the United States shall consult with—
(1)
the Federal agencies responsible for advancing, reviewing, and procuring medical countermeasures, including the Office of the Assistant Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, and the Department of Defense;
(2)
manufacturers involved in the research and development of medical countermeasures to address biological, chemical, radiological, or nuclear threats; and
(3)
other biodefense stakeholders, as applicable.
(c)
Report.— Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study conducted under subsection (a) and recommendations to improve the application and consistency of the requirements under subsections (c) and (d) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) to support and expedite the research and development of medical countermeasures, as applicable.
(d)
Protection of National Security.— The Comptroller General of the United States shall conduct the study and issue the assessment and report under this section in a manner that does not compromise national security.

SEC. 605. Review of the Benefits of Genomic Engineering Technologies and Their Potential Role in National Security.

(a)
Meeting.—
(1)
In general.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall convene a meeting to discuss the potential role advancements in genomic engineering technologies (including genome editing technologies) may have in advancing national health security. Such meeting shall be held in a manner that does not compromise national security.
(2)
Attendees.— The attendees of the meeting under paragraph (1)—
(A)
shall include—
(i)
representatives from the Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration; and
(ii)
representatives from academic, private, and nonprofit entities with expertise in genome engineering technologies, biopharmaceuticals, medicine, or biodefense, and other relevant stakeholders; and
(B)
may include—
(i)
other representatives from the Department of Health and Human Services, as the Secretary determines appropriate; and
(ii)
representatives from the Department of Homeland Security, the Department of Defense, the Department of Agriculture, and other departments, as the Secretary may request for the meeting.
(3)
Topics.— The meeting under paragraph (1) shall include a discussion of—
(A)
the current state of the science of genomic engineering technologies related to national health security, including—
(i)
medical countermeasure development, including potential efficiencies in the development pathway and detection technologies; and
(ii)
the international and domestic regulation of products utilizing genome editing technologies; and
(B)
national security implications, including—
(i)
capabilities of the United States to leverage genomic engineering technologies as a part of the medical countermeasure enterprise, including current applicable research, development, and application efforts underway within the Department of Defense;
(ii)
the potential for state and non-state actors to utilize genomic engineering technologies as a national health security threat; and
(iii)
security measures to monitor and assess the potential threat that may result from utilization of genomic engineering technologies and related technologies for the purpose of compromising national health security.
(b)
Report.— Not later than 270 days after the meeting described in subsection (a) is held, the Assistant Secretary for Preparedness and Response shall issue a report to the congressional committees of jurisdiction on the topics discussed at such meeting, and provide recommendations, as applicable, to utilize innovations in genomic engineering (including genome editing) and related technologies as a part of preparedness and response activities to advance national health security. Such report shall be issued in a manner that does not compromise national security.

SEC. 606. Report on Vaccines Development.

Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing efforts and activities to coordinate with other countries and international partners during recent public health emergencies with respect to the research and advanced research on, and development of, qualified pandemic or epidemic products (as defined in section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d)). Such report may include information regarding relevant work carried out under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)(E)), through public-private partnerships, and through collaborations with other countries to assist with or expedite the research and development of qualified pandemic or epidemic products. Such report shall not include information that may compromise national security.

SEC. 607. Strengthening Mosquito Abatement for Safety and Health.

(a)
Reauthorization of Mosquito Abatement for Safety and Health Program.— Section 317S (42 U.S.C. 247b–21) is amended—
(1)
in subsection (a)(1)(B)—
(A)
by inserting “ including programs to address emerging infectious mosquito-borne diseases,” after “ subdivisions for control programs,”; and
(B)
by inserting “ or improving existing control programs” before the period at the end;
(2)
in subsection (b)—
(A)
in paragraph (1), by inserting “ , including improvement,” after “ operation”;
(B)
in paragraph (2)—
(i)
in subparagraph (A)—
(I)
in clause (ii), by striking “ or” at the end;
(II)
in clause (iii), by striking the semicolon at the end and inserting “ , including an emerging infectious mosquito-borne disease that presents a serious public health threat; or”; and
(III)
by adding at the end the following:

“(iv) a public health emergency due to the incidence or prevalence of a mosquito-borne disease that presents a serious public health threat;”

; and

(ii)
by amending subparagraph (D) to read as follows:

“(D)

(i) is located in a State that has received a grant under subsection (a); or

“(ii) that demonstrates to the Secretary that the control program is consistent with existing State mosquito control plans or policies, or other applicable State preparedness plans.”

(C)
in paragraph (4)(C), by striking “ that extraordinary” and all that follows through the period at the end and inserting the following:

“(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver; or

“(ii) the geographical area covered by a political subdivision or consortium for a grant under paragraph (1) has an extreme mosquito control need due to—

“(I) the size or density of the potentially impacted human population;

“(II) the size or density of a mosquito population that requires heightened control; or

“(III) the severity of the mosquito-borne disease, such that expected serious adverse health outcomes for the human population justify the waiver.”

; and

(D)
by amending paragraph (6) to read as follows:

“(6) Number of grants.—A political subdivision or a consortium of political subdivisions may not receive more than one grant under paragraph (1).”

; and

(3)
in subsection (f)—
(A)
in paragraph (1) by striking “ for fiscal year 2003, and such sums as may be necessary for each of fiscal years 2004 through 2007” and inserting “ for each of fiscal years 2019 through 2023”;
(B)
in paragraph (2), by striking “ the Public Health Security and Bioterrorism Preparedness and Response Act of 2002” and inserting “ this Act and other medical and public health preparedness and response laws”; and
(C)
in paragraph (3)—
(i)
in the paragraph heading, by striking “ 2004” and inserting “ 2019”; and
(ii)
by striking “ 2004,” and inserting “ 2019,”.
(b)
Epidemiology-Laboratory Capacity Grants.— Section 2821 (42 U.S.C. 300hh–31) is amended—
(1)
in subsection (a)(1), by inserting “ , including mosquito and other vector-borne diseases,” after “ infectious diseases”; and
(2)
in subsection (b), by striking “ 2010 through 2013” and inserting “ 2019 through 2023”.