(a) Short title.—This Act may be cited as the “Protecting Pandemic and All-Hazards Preparedness Act of 2023” or the “Protecting PAHPA Act of 2023”.

(b) Table of contents.—The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

(a) Public health workforce.—Section 2802(a)(3) of the Public Health Service Act (42 U.S.C. 300hh–1(a)(3)) is amended by striking “In 2022, the” and inserting “The”.

(b) Medical and public health community preparedness goal.—Section 2802(b)(8)(A) of the Public Health Service Act (42 U.S.C. 300hh–1(b)(8)(A)) is amended by inserting before the semicolon the following: “, including by protecting against cybersecurity threats”.

(c) Cybersecurity resiliency of health care delivery systems.—Section 2802(b) of the Public Health Service Act (42 U.S.C. 300hh–1(b)) is amended by adding at the end the following:

“(11) CYBERSECURITY RESILIENCY OF HEALTH CARE DELIVERY SYSTEMS.—Strengthening the ability of States, local communities, Tribal communities, and territorial entities to protect against, mitigate, or otherwise address the impact of cybersecurity risks or cybersecurity attacks that affect public health through mechanisms (including awards of grants or cooperative agreements under section 319C–2) that encourage hospitals and other facilities involved in the delivery of health care items and services to use recognized security practices meeting or exceeding the approaches promulgated under section 405(d) of the Cybersecurity Act of 2015.”.

Section 2811(f)(2)(A) of the Public Health Service Act (42 U.S.C. 300hh–10(f)(2)(A)) is amended by striking “$250,000,000 for each of fiscal years 2019 through 2023” and inserting “$327,991,000 for each of fiscal years 2024 through 2028”.

(a) Authorization of appropriations.—Section 319C–2(j)(1)(A) of the Public Health Service Act (42 U.S.C. 247d–3b(j)(1)(A)) is amended—

(1) by striking “is authorized to be appropriated” and inserting “are authorized to be appropriated”; and

(2) by inserting “ and $500,000,000 for each of fiscal years 2024 through 2028” before the period at the end.

(b) Sunset.—Section 319C–2(j)(1)(B)(iii) of the Public Health Service Act (42 U.S.C. 247d–3b(j)(1)(B)(iii)) is amended by striking “2023” and inserting “2028”.

(a) Guidelines.—Section 319C–3(b)(3) of the Public Health Service Act (42 U.S.C. 247d–3c(b)(3)) is amended by striking “the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (including any amendments made by such Act)” and inserting “the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the PREVENT Pandemics Act (title II of division FF of Public Law 117–328), and the Protecting Pandemic and All-Hazards Preparedness Act of 2023”.

(b) Demonstration project for regional health care preparedness and response systems.—Section 319C–3(e)(2) of the Public Health Service Act (42 U.S.C. 247d–3c(e)(2)) is amended by striking “2023” and inserting “2028”.

(a) Vendor-Managed inventory and warm-Based surge capacity contracts and cooperative agreements with clinical laboratories.—Section 319F–2(a)(5)(A) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(5)(A)) is amended—

(1) by inserting after “contracts or cooperative agreements with vendors, which may include manufacturers or distributors of medical products,” the following: “as well as clinical laboratories,”; and

(2) in clause (ii), by striking “domestic manufacturing capacity” and inserting “domestic manufacturing and laboratory capacity”.

(b) Authorization of appropriations.—

(1) IN GENERAL.—Section 319F–2(f) of the Public Health Service Act (42 U.S.C. 247d–6b(f)) is amended—

(A) in paragraph (1), by striking “$610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023” and inserting “$1,963,000,000 for each of fiscal years 2024 through 2028”;

(B) by striking paragraph (2); and

(C) by striking “Authorization of appropriations” and all that follows through “For the purpose of carrying out subsection (a), there are authorized to be appropriated” and inserting “Authorization of appropriations.—For the purpose of carrying out subsection (a), there is authorized to be appropriated”.

(2) PILOT PROGRAM TO SUPPORT STATE MEDICAL STOCKPILES.—Section 319F–2(i)(9) of the Public Health Service Act (42 U.S.C. 247d–6b(i)(9)) is amended by striking “2024” and inserting “2028”.

The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by inserting after section 319F–5 of such Act (42 U.S.C. 247d–6f) the following:

(a) Medical countermeasures for viral threats with pandemic potential.—Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amended—

(1) in subparagraph (D)—

(A) in clause (ii), by striking “; and” and inserting a semicolon;

(B) by redesignating clause (iii) as clause (v); and

(C) by inserting after clause (ii) the following:

“(iii) the identification and development of platform manufacturing technologies needed for advanced development and manufacturing of medical countermeasures for viral families which have significant potential to cause a pandemic;

“(iv) advanced research and development of flexible medical countermeasures against priority respiratory virus families and other respiratory viral pathogens with a significant potential to cause a pandemic, with both pathogen-specific and pathogen-agnostic approaches; and”; and

(2) in subparagraph (F)—

(A) in clause (ii), by striking “; and” at the end and inserting a semicolon;

(B) in clause (iii), by striking the period and inserting “; and”; and

(C) by adding at the end the following:

“(iv) priority virus families and other viral pathogens with a significant potential to cause a pandemic.”.

(b) Authorization of appropriations.—Section 319L(d)(2) of the Public Health Service Act (42 U.S.C. 247d–7e(d)(2)) is amended by striking “$611,700,000 for each of fiscal years 2019 through 2023” and inserting “$950,000,000 for each of fiscal years 2024 through 2028”.

(c) Inapplicability of certain provisions sunset.—Section 319L(e)(1)(D) of the Public Health Service Act (42 U.S.C. 247d–7e(e)(1)(D)) is amended by striking “on the date that is 17 years after the date of enactment of the Pandemic and All-Hazards Preparedness Act” and inserting “on October 1, 2028”.

Section 319L–1(b) of the Public Health Service Act (42 U.S.C. 274d–7f(b)) is amended by striking “at the end of the 17-year period that begins on the date of enactment of this Act” and inserting “on October 1, 2028”.

(a) In general.—Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall complete a review of—

(1) the Supply Chain Control Tower Program (in this section referred to as the “SCCT Program”) under the Administration for Strategic Preparedness and Response of the Department of Health and Human Services; and

(2) any related efforts of the Administration for Strategic Preparedness and Response—

(A) to create supply chain visibility into inventory, capacity, and distribution flow of certain products critical to preparedness and response efforts;

(B) to provide insights into demand forecasting and modeling of certain products critical to preparedness and response efforts; or

(C) to inform preparedness and response efforts by targeting distribution and coordinating supply with demand for certain products critical to preparedness and response efforts.

(b) Issues.—The review under this section shall include examination of—

(1) the data being collected and maintained pursuant to the SCCT Program;

(2) how the Department of Health and Human Services, acting through the Administration for Strategic Preparedness and Response, uses such data to provide supply chain visibility and address actual or potential supply gaps;

(3) the extent to which such data is provided and shared with end users, including States, localities, Territories, Tribes, and industry partners;

(4) the frequency and cadence of data reporting and sharing by and among States, localities, Territories, Tribes, and industry partners;

(5) information related to the type and number of States, localities, Territories, Tribes, and industry partners participating in the SCCT Program;

(6) the process by which States, localities, Territories, Tribes, and industry partners voluntarily choose to participate in the SCCT Program; and

(7) any inefficiencies, deficiencies, or challenges related to the application or operation of the SCCT Program.

(c) Report to Congress.—Not later than the deadline described in subsection (a) for the completion of the review under this section, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the results of such review.

(a) In general.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall conduct and complete a review examining the efforts of the Secretary of Health and Human Services to ensure that the United States is prepared to rapidly produce qualified countermeasures (as defined in section 319F–1 of the Public Health Service Act (42 U.S.C. 247d–6a)) in the event of a public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 274d).

(b) Contents.—The review conducted under subsection (a) shall include a review of—

(1) the efforts described in such subsection, including the Secretary’s efforts to transition from the Centers for Innovation and Advanced Drug Manufacturing program to any new efforts, including the National Biopharmaceutical Manufacturing Partnership and Industrial Base Expansion Connect;

(2) the progress made toward the implementation of such efforts; and

(3) the planning within the Department of Health and Human Services to assess risks and challenges associated with advanced development and manufacturing of qualified countermeasures.

(c) Report to Congress.—Not later than 1 year after completing the review under subsection (a), the Comptroller General of the United States shall submit to the Congress a report containing—

(1) the results of the review; and

(2) the Comptroller General’s recommendations for ensuring that the United States is prepared to rapidly produce qualified countermeasures in the event of a public health emergency.

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the Office for Civil Rights of the Department of Health and Human Services, shall issue guidance on how to develop or modify State and local crisis standards of care for use during an emergency period (as defined in section 1135(g)(1) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)) so as to bring such standards of care into compliance with the nondiscrimination requirements of section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794).

(a) In general.—Section 319I(a) of the Public Health Service Act (42 U.S.C. 247d–7b) is amended by striking “Not later than 12 months after the date of enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall link existing State verification systems to maintain” and inserting “The Secretary shall continue to maintain”.

(b) Authorization of appropriations.—Section 319I(k) of the Public Health Service Act (42 U.S.C. 247d–7b(k)) is amended by striking “2019 through 2023” and inserting “2024 through 2028”.

Section 1291(g) of the Public Health Service Act (42 U.S.C. 300d–91(g)) is amended by striking “2019 through 2023” and inserting “2024 through 2028”.

(a) National Advisory Committee on Children and Disasters.—Subsection (g) of section 2811A of the Public Health Service Act (42 U.S.C. 300hh–10b) is amended to read as follows:

“(g) Sunset.—

“(1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2028.

“(2) EXTENSION OF COMMITTEE.—Not later than October 1, 2027, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.”.

(b) National Advisory Committee on Seniors and Disasters.—Section 2811B of the Public Health Service Act (42 U.S.C. 300hh–10c) is amended—

(1) in subsection (d)—

(A) in paragraph (1), by striking “in consultation with such other heads of agencies as appropriate, shall appoint not more than 17 members” and inserting “in consultation with such other Secretaries as may be appropriate, shall appoint not more than 23 members”;

(B) by redesignating paragraph (2) as paragraph (3);

(C) by amending paragraph (3), as so redesignated—

(i) in the paragraph heading, by striking “Required members” and inserting “Required Federal members”;

(ii) in the matter preceding subparagraph (A), by striking “and non-Federal members,”;

(iii) by striking subparagraphs (J) and (K); and

(iv) by redesignating subparagraph (L) as subparagraph (J);

(D) by inserting after paragraph (1) the following new paragraph:

“(2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—

“(A) at least 4 non-Federal health care providers with expertise in geriatric medical disaster planning, preparedness, response, or recovery;

“(B) at least 3 representatives of State, local, Tribal, or territorial agencies with expertise in geriatric disaster planning, preparedness, response, or recovery; and

“(C) at least 4 non-Federal professionals with training in gerontology, including social workers, scientists, human services specialists, or other non-medical professionals, with experience in disaster planning, preparedness, response, or recovery among other adults.”; and

(E) by adding at the end the following new paragraphs:

“(4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees serving on the date of enactment of the Preparing for All Hazards and Pathogens Reauthorization Act, or appointees who are initially appointed after such date of enactment, in order to provide for a staggered term of appointment for all members.

“(5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not more than 3 terms on the Advisory Committee, and not more than 2 of such terms may be served consecutively.”; and

(2) in subsection (g)—

(A) in paragraph (1), by striking “2023” and inserting “2028”; and

(B) in paragraph (2), by striking “2022” and inserting “2027”.

(c) National Advisory Committee on Individuals with Disabilities.—Section 2811C of the Public Health Service Act (42 U.S.C. 300hh–10d) is amended—

(1) by redesignating subsections (c) through (g) as subsections (d) through (h), respectively;

(2) by inserting after subsection (b) the following new subsection:

“(c) Additional duties.—The Advisory Committee may provide advice and recommendations to the Secretary with respect to individuals with disabilities, and medical and public health grants and cooperative agreements, as applicable to preparedness and response activities under this title and title III.”;

(3) in subsection (d), as so redesignated—

(A) in paragraph (1), by striking “in consultation with such other heads of agencies and departments as appropriate, shall appoint not more than 17 members” and inserting “in consultation with such other Secretaries as may be appropriate, shall appoint not more than 23 members”;

(B) by redesignating paragraph (2) as paragraph (3);

(C) by amending paragraph (3), as redesignated—

(i) in the paragraph heading, by striking “Required members” and inserting “Required Federal members”;

(ii) in the matter preceding subparagraph (A), by striking “and non-Federal members,”;

(iii) by striking subparagraph (K) and inserting the following:

“(K) Representatives of such other Federal agencies as the Secretary determines necessary to fulfill the duties of the Advisory Committee.”; and

(iv) by striking subparagraphs (L) and (M);

(D) by inserting after paragraph (1) the following new paragraph:

“(2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—

“(A) at least 4 non-Federal health care professionals with expertise in disability accessibility before, during, and after disasters, medical and mass care disaster planning, preparedness, response, or recovery;

“(B) at least 3 representatives from State, local, Tribal, or territorial agencies with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities; and

“(C) at least 4 individuals with a disability with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.”; and

(E) by adding at the end the following new paragraphs:

“(4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees serving on the date of enactment of the Preparing for All Hazards and Pathogens Reauthorization Act, or appointees who are initially appointed after such date of enactment, in order to provide for a staggered term of appointment for all members.

“(5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not more than 3 terms on the Advisory Committee, and not more than 2 of such terms may be served consecutively.”; and

(4) in subsection (g)—

(A) in paragraph (1), by striking “2023” and inserting “2028”; and

(B) in paragraph (2), by striking “2022” and inserting “2027”.

(a) Elimination of sunset of authority To make certain appointments for National Disaster Medical System.—Section 2812(c)(4) of the Public Health Service Act (42 U.S.C. 300hh–11(c)(4)) is amended—

(1) by striking “(A) In general.—If the Secretary determines” and inserting “If the Secretary determines”; and

(2) by striking subparagraph (B).

(b) Authorization of appropriations.—Section 2812(g) of the Public Health Service Act (42 U.S.C. 300hh–11(g)) is amended by striking “$57,400,000 for each of fiscal years 2019 through 2023” and inserting “$96,904,000 for each of fiscal years 2024 through 2028”.

Section 2813(i) of the Public Health Service Act (42 U.S.C. 300hh–15(i)) is amended by striking “2019 through 2023” and inserting “2024 through 2028”.

(a) Authorization of appropriations.—Section 319C–1(h)(1)(A) of the Public Health Service Act (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking “$685,000,000 for each of fiscal years 2019 through 2023” and inserting “$1,000,000,000 for each of fiscal years 2024 through 2028”.

(b) Elimination of deadwood.—Section 319C–1(h) of the Public Health Service Act (42 U.S.C. 247d–3a(h)) is amended—

(1) by striking paragraphs (4) and (5); and

(2) by redesignating paragraphs (6) and (7) as paragraphs (4) and (5).

(a) Study.—Section 319D(a)(4) of the Public Health Service Act (42 U.S.C. 247d–4(a)(4)) is amended by striking “Not later than June 1, 2022, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2013 through 2018” and inserting “Not later than June 1, 2027, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2021 through 2026”.

(b) Authorization of appropriations.—Section 319D(h) of the Public Health Service Act (42 U.S.C. 247d–4(h)) is amended—

(1) in paragraph (1), by striking “$25,000,000 for each of fiscal years 2022 and 2023” and inserting “$40,000,000 for each of fiscal years 2024 through 2028”; and

(2) in paragraph (2), by striking “2022 and 2023” and inserting “2024 through 2028”.

Section 319A(e) of the Public Health Service Act (42 U.S.C. 247d–1(e)) is amended by striking “2019 through 2023” and inserting “2024 through 2028”.

Section 351A(m) of the Public Health Service Act (42 U.S.C. 262a(m)) is amended by striking “2027” and inserting “2028”.

Section 317S(f) of the Public Health Service Act (42 U.S.C. 247b–21(f)) is amended—

(1) in paragraph (1), by striking “2019 through 2023” and inserting “2024 through 2028”; and

(2) by striking paragraph (3).

Section 2821(b) (42 U.S.C. 300hh–31(b)) is amended by striking “2019 through 2023” and inserting “2024 through 2028”.

(a) Designation of public health data standards.—Section 2823(a)(2) of the Public Health Service Act (42 U.S.C. 300hh–33(a)(2)) is amended by adding at the end the following:

“(D) SELECTION OF DATA AND TECHNOLOGY STANDARDS.—The standards designated as described in subparagraph (A) may include standards to improve—

“(i) the exchange of electronic health information for—

“(I) electronic case reporting;

“(II) syndromic surveillance;

“(III) reporting of vital statistics; and

“(IV) reporting test orders and results electronically, including from laboratories;

“(ii) automated electronic reporting to relevant public health data systems of the Centers for Disease Control and Prevention; and

“(iii) such other uses as the Secretary determines appropriate.

“(E) CONSIDERATIONS.—Standards designated under this paragraph shall include standards and implementation specifications necessary to ensure the appropriate capture, exchange, access, and use of information regarding race, ethnicity, sex (including sexual orientation and gender identity), disability status, veteran status, housing status, age, functional status, and other elements.”.

(b) Improving information sharing and availability of public health data.—Section 310B of the Public Health Service Act (42 U.S.C. 242u) is amended to read as follows:

(c) Public Health Information Sharing and Availability Advisory Committee.—Part A of title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following:

(d) Improving public health data collection.—

(1) IN GENERAL.—The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall award grants, contracts, or cooperative agreements to eligible entities for purposes of identifying, developing, or disseminating best practices in the collection of electronic health information and the use of designated data standards and implementation specifications—

(A) to improve the quality and completeness of data, including demographic data, collected, accessed, or used for public health purposes; and

(B) to address health disparities and related health outcomes.

(2) ELIGIBLE ENTITIES.—To be eligible to receive an award under this subsection an entity shall—

(A) be a health care provider, academic medical center, community-based organization, State, local governmental entity, Indian Tribe or Tribal organization (as such terms are defined in section 4 of the Indian Self Determination and Education Assistance Act (25 U.S.C. 5304)), Urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603)), or other appropriate public or private nonprofit entity, or a consortia of any such entities; and

(B) submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.

(3) ACTIVITIES.—Entities receiving awards under this subsection shall use such award to develop and test best practices for training health care providers to use standards and implementation specifications that assist in the capture, access, exchange, and use of electronic health information, including demographic information, disability status, veteran status, housing status, functional status, and other data elements. Such activities shall, at a minimum, include—

(A) improving, understanding, and using data standards and implementation specifications;

(B) developing or identifying methods to improve communication with patients in a culturally and linguistically appropriate manner, including to better capture information related to demographics of such individuals;

(C) developing methods for accurately categorizing and recording patient responses using available data standards;

(D) educating providers regarding the utility of such information for public health purposes and the importance of accurate collection and recording of such data; and

(E) other activities, as the Secretary determines appropriate.

(4) REPORTING.—

(A) REPORTING BY AWARD RECIPIENTS.—Each recipient of an award under this subsection shall submit to the Secretary a report on the results of best practices identified, developed, or disseminated through such award.

(B) REPORT TO CONGRESS.—Not later than 1 year after the completion of the program under this subsection, the Secretary shall submit a report to Congress on the success of the best practices developed under such program, opportunities for further dissemination of such best practices, and recommendations for improving the capture, access, exchange, and use of information to improve public health and reduce health disparities.

(5) NONDUPLICATION OF EFFORTS.—The Secretary shall ensure that the activities and programs carried out under this subsection are free of unnecessary duplication of effort.

(6) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $10,000,000 for each of fiscal years 2024 through 2026 to carry out this subsection.

(e) Information collection.—Section 319D(a) of the Public Health Service Act (42 U.S.C. 247d–4(a)) is amended by adding at the end the following:

“(5) INFORMATION COLLECTION.—Subchapter I of chapter 35 of title 44, United States Code, shall not apply to information collection by the Centers for Disease Control and Prevention, including the Agency for Toxic Substances and Disease Registry, that are part of investigations, research, surveillance, or evaluations undertaken for public health purposes under any available authority.”.

(a) Report to Congress.—Section 319(e)(6) of the Public Health Service Act (42 U.S.C. 247d(e)(6)) is amended by striking “Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Comptroller General of the United States shall” and inserting “Not later than 4 years after the date of enactment of the Protecting PAHPA Act of 2023, the Comptroller General of the United States shall”.

(b) Sunset.—Section 319(e)(8) of the Public Health Service Act (42 U.S.C. 247d(e)(8)) is amended by striking “2023” and inserting “2028”.

Section 317F(c)(2) of the Public Health Service Act (42 U.S.C. 247b–7(c)(2)) is amended by striking “2019 through 2023” and inserting “2024 through 2028”.

(a) In general.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after section 506L of such Act (21 U.S.C. 356l) the following new section:

(b) Prohibited act.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 3503(a)(1)(A) of division FF of Public Law 117–328, is amended by inserting at the end the following new subsection:

“(jjj) The failure to comply with any order issued under section 506M.”.

(c) Penalties.—Subsection (b) of section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by inserting at the end the following:

“(9) If a manufacturer of a life-saving drug fails to submit data and information as required under section 506M(b)(1), fails to conduct or submit the data and information generated by studies as required under section 506M(b)(2), or fails to make a labeling change as required under section 506M(c), such manufacturer shall be subject to a civil penalty of not more than $10,000 for the first day on which the violation occurs and not more than $10,000 for each subsequent day on which the violation is not corrected.”.

(a) In general.—Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)(3)) is amended—

(1) in subparagraph (A), by adding “or (2)” after “paragraph (1)”; and

(2) by adding at the end the following:

“(C) Each report submitted pursuant to subparagraph (A) with respect to a drug shall—

“(i) include additional information as may be specified by the Secretary in regulation or guidance regarding the supply chain for such drug, such as—

“(I) the identity of the respective suppliers of each active pharmaceutical ingredient, active pharmaceutical ingredient intermediate, and in-process material used in such manufacture, preparation, propagation, compounding, or processing of the drug; and

“(II) the respective amounts of such drug that were manufactured, prepared, propagated, compounded, or processed using an active pharmaceutical ingredient, active pharmaceutical ingredient intermediate, and in-process material from each such identified supplier; and

“(ii) be submitted more frequently than annually, in accordance with a reporting schedule as may be specified by the Secretary in such regulation or guidance, but not more frequently than 4 times per year.

“(D) Any additional information specified in regulation or guidance pursuant to subparagraph (C) shall be a required element of reports under this paragraph not earlier than 6 months after the date on which such regulation or guidance is issued in final form (and in no event shall the absence of any regulation or guidance issued under subparagraph (C) affect the requirement to report as described in subparagraph (A)).”.

(b) Conforming amendment.—Section 510(j)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 510(j)(3)(B)) is amended by striking “subparagraph (A)” and inserting “this paragraph”.

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended—

(1) in paragraph (b)—

(A) by striking “(b) If in a package” and inserting “(b)(1) If in a package”;

(B) by striking “a label containing (1) the name and place” and inserting “a label containing—

“(A) the name and place”;

(C) by striking “or distributor; and (2) an accurate statement” and inserting “or distributor; and

“(B) an accurate statement”;

(D) by striking “under clause (2) of this paragraph” and inserting “under this clause”; and

(E) by inserting at the end the following:

“(2) (A) Subject to clause (C), if it is a drug, including an active pharmaceutical ingredient, unless it bears a label containing the name and place of business, and unique facility identifier of the original manufacturer of such drug or active pharmaceutical ingredient, except that the Secretary may provide, by regulation, for reasonable variations in the implementation of such labeling requirements.

“(B) Subject to clause (C), if it is a drug that is an active pharmaceutical ingredient, unless any accompanying certificate of analysis contains the name and place of business, and unique facility identifier of the original manufacturer of the active pharmaceutical ingredient.