Title VII — Miscellaneous Provisions

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

TITLE VII Miscellaneous Provisions

SEC. 701. Reauthorizations and Extensions.

(a)

Veterans Affairs.— Section 8117(g) of title 38, United States Code, is amended by striking “ 2014 through 2018” and inserting “ 2019 through 2023”.

(b)

Vaccine Tracking and Distribution.— Section 319A(e) (42 U.S.C. 247d–1(e)) is amended by striking “ 2014 through 2018” and inserting “ 2019 through 2023”.

(c)

Temporary Reassignment.— Section 319(e)(8) (42 U.S.C. 247d(e)(8)) is amended by striking “ 2018” and inserting “ 2023”.

(d)

Strategic Innovation Partner.— Section 319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is amended by striking “ 2022” and inserting “ 2023”.

(e)

Limited Antitrust Exemption.—

(1)

In general.— Section 405 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417; 42 U.S.C. 247d–6a note) is amended—

(A)

in subsection (a)(1)(A)—

(i)

by striking “ Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’)” and inserting “ Secretary”;

(ii)

by striking “ of the Public Health Service Act (42 U.S.C. 247d–6b)) (as amended by this Act”;

(iii)

by striking “ of the Public Health Service Act (42 U.S.C. 247d–6a)) (as amended by this Act”; and

(iv)

by striking “ of the Public Health Service Act (42 U.S.C. 247d–6d)”;

(B)

in subsection (b), by striking “ 12-year” and inserting “ 17-year”;

(C)

by redesignating such section 405 as section 319L–1; and

(D)

by transferring such section 319L–1, as redesignated, to the Public Health Service Act (42 U.S.C. 201 et seq.), to appear after section 319L of such Act (42 U.S.C. 247d–7e).

(2)

Conforming amendments.—

(A)

Table of contents.— The table of contents in section 1(b) of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417) is amended by striking the item related to section 405.

(B)

Reference.— Section 319L(c)(4)(A)(iii) (42 U.S.C. 247d–7e) is amended by striking “ section 405 of the Pandemic and All-Hazards Preparedness Act” and inserting “ section 319L–1”.

(f)

Inapplicability of Certain Provisions.— Subsection (e)(1) of section 319L (42 U.S.C. 247d–7e(e)(1)) is amended—

(1)

by amending subparagraph (A) to read as follows:

“(A) Nondisclosure of information.—

“(i) In general.—Information described in clause (ii) shall be deemed to be information described in section 552(b)(3) of title 5, United States Code.

“(ii) Information described.—The information described in this clause is information relevant to programs of the Department of Health and Human Services that could compromise national security and reveal significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against chemical, biological, radiological, or nuclear threats, and is comprised of—

“(I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c);

“(II) information pertaining to the location security, personnel, and research materials and methods of high-containment laboratories conducting research with select agents, toxins, or other agents with a material threat determination under section 319F–2(c)(2); or

“(III) security and vulnerability assessments.”

(2)

by redesignating subparagraph (C) as subparagraph (D);

(3)

by inserting after subparagraph (B) the following:

“(C) Reporting.—One year after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and annually thereafter, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclosure, as well as the nature of any request under section 552 of title 5, United States Code that was denied using such authority.”

; and

(4)

in subparagraph (D), as so redesignated, by striking “ 12” and inserting “ 17”.

SEC. 702. Location of Materials in the Stockpile.

Subsection (d) of section 319F–2 (42 U.S.C. 247d–6b) is amended to read as follows:

“(d) Disclosures.—No Federal agency may disclose under section 552 of title 5, United States Code any information identifying the location at which materials in the stockpile described in subsection (a) are stored, or other information regarding the contents or deployment capability of the stockpile that could compromise national security.”

SEC. 703. Cybersecurity.

(a)

Strategy for Public Health Preparedness and Response to Cybersecurity Threats.—

(1)

Strategy.— Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall prepare and submit to the relevant committees of Congress a strategy for public health preparedness and response to address cybersecurity threats (as defined in section 102 of Cybersecurity Information Sharing Act of 2015 (6 U.S.C. 1501)) that present a threat to national health security. Such strategy shall include—

(A)

identifying the duties, functions, and preparedness goals for which the Secretary is responsible in order to prepare for and respond to such cybersecurity threats, including metrics by which to measure success in meeting preparedness goals;

(B)

identifying gaps in public health capabilities to achieve such preparedness goals; and

(C)

strategies to address identified gaps and strengthen public health emergency preparedness and response capabilities to address such cybersecurity threats.

(2)

Protection of national security.— The Secretary shall make such strategy available to the Committee on Health, Education, Labor, and Pensions of the Senate, the Committee on Energy and Commerce of the House of Representatives, and other congressional committees of jurisdiction, in a manner that does not compromise national security.

(b)

Coordination of Preparedness for and Response to All-Hazards Public Health Emergencies.— Subparagraph (D) of section 2811(b)(4) (42 U.S.C. 300hh–10(b)(4)) is amended to read as follows:

“(D) Policy coordination and strategic direction.—Provide integrated policy coordination and strategic direction, before, during, and following public health emergencies, with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan described in section 504(a)(6) of the Homeland Security Act of 2002 (6 U.S.C. 314(a)(6)), or any successor plan; and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 228(c) of the Homeland Security Act of 2002 (6 U.S.C. 149(c)), including public health emergencies or incidents related to cybersecurity threats that present a threat to national health security.”

SEC. 704. Strategy and Report.

Not later than 14 days after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Assistant Secretary for Preparedness and Response and the Assistant Secretary for the Administration on Children and Families or other appropriate office, and in collaboration with other departments, as appropriate, shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and other relevant congressional committees—

(1)

a formal strategy, including interdepartmental actions and efforts to reunify children with their parents or guardians, in all cases in which such children have been separated from their parents or guardians as a result of the initiative announced on April 6, 2018, and due to prosecution under section 275(a) of the Immigration and Nationality Act (8 U.S.C. 1325(a)), if the parent or guardian chooses such reunification and the child—

(A)

was separated from a parent or guardian and placed into a facility funded by the Department of Health and Human Services;

(B)

as of the date of the enactment of this Act, remains in the care of the Department of Health and Human Services; and

(C)

can be safely reunited with such parent or guardian; and

(2)

a report on challenges and deficiencies related to the oversight of, and care for, unaccompanied alien children and appropriately reuniting such children with their parents or guardians, and the actions taken to address any challenges and deficiencies related to unaccompanied alien children in the custody of the Department of Health and Human Services, including deficiencies identified and publicly reported by Congress, the Government Accountability Office, or the inspectors general of the Department of Health and Human Services or other Federal departments.

SEC. 705. Technical Amendments.

(a)

Public Health Service Act.— Title III (42 U.S.C. 241 et seq.) is amended—

(1)

in paragraphs (1) and (5) of section 319F–1(a) (42 U.S.C. 247d–6a(a)), by striking “ section 319F(h)” each place such term appears and inserting “ section 319F(e)”; and

(2)

in section 319K(a) (42 U.S.C. 247d–7d(a)), by striking “ section 319F(h)(4)” and inserting “ section 319F(e)(4)”.

(b)

Public Health Security Grants.— Section 319C–1(b)(2) (42 U.S.C. 247d–3a(b)(2)) is amended—

(1)

in subparagraph (C), by striking “ individuals,,” and inserting “ individuals,”; and

(2)

in subparagraph (F), by striking “ make satisfactory annual improvement and describe” and inserting “ makes satisfactory annual improvement and describes”.

(c)

Emergency Use Instructions.— Subparagraph (A) of section 564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(e)(2)) is amended by striking “ subsection (a)(1)(C)(i)” and inserting “ subsection (a)(1)(C)”.

(d)

Products Held for Emergency Use.— Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b) is amended—

(1)

in subparagraph (B), by inserting a comma after “ 505”; and

(2)

in subparagraph (C), by inserting “ or section 564A” before the period at the end.

(e)

Transparency.— Section 507(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) is amended—

(1)

by striking “ Nothing in” and inserting the following:

“(A) In general.—Nothing in”

(2)

by inserting “ or directing” after “ authorizing”;

(3)

by striking “ disclose any” and inserting

“(i) any”

(4)

by striking the period and inserting “ ; or”; and

(5)

by adding at the end the following:

“(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act, any information that the Secretary determines has a significant potential to affect national security.

“(B) Public acknowledgment.—In the case that the Secretary, pursuant to subparagraph (A)(ii), does not make information publicly available, the Secretary shall provide on the internet website of the Food and Drug Administration an acknowledgment of the information that has not been disclosed, pursuant to subparagraph (A)(ii).”

Title VII — Miscellaneous Provisions