§247d–1 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Secretary may track the first distribution of vaccines the federal government buys during an influenza or other pandemic by working with vaccine makers, wholesalers, and distributors that agree to help. The Secretary must promote communication between State, local, and tribal public health officials and those companies about how to get seasonal flu vaccine out. That communication must include the Secretary’s estimates of high‑priority groups in each area so officials can act during shortages or supply problems. Any distribution data given to the Secretary or its contractors must stay private under laws that protect trade secrets and privacy (for example, 5 U.S.C. 552(b)(4); 18 U.S.C. 1832 and 1833; and HIPAA rules). The data cannot be shared with other manufacturers or used to give a company a market advantage without its consent. The Secretary must write guidelines, with input from companies and health departments, to keep information confidential while letting health officials use it to reach high‑priority groups during pandemics or shortages. Congress authorized $30,800,000 for each of fiscal years 2019 through 2023 for this work, and the Secretary must report on implementation as part of the National Health Security Strategy.

Title 42, §247d–1

The Public Health and Welfare — Source: USLM XML via OLRC

(a)The Secretary, together with relevant manufacturers, wholesalers, and distributors as may agree to cooperate, may track the initial distribution of federally purchased influenza vaccine in an influenza pandemic, or other federally purchased vaccine to address another pandemic. Such tracking information shall be used to inform Federal, State, local, and tribal decision makers during an influenza pandemic or other pandemic.

(b)The Secretary shall promote communication between State, local, and tribal public health officials and such manufacturers, wholesalers, and distributors as agree to participate, regarding the effective distribution of seasonal influenza vaccine. Such communication shall include estimates of high priority populations, as determined by the Secretary, in State, local, and tribal jurisdictions in order to inform Federal, State, local, and tribal decision makers during vaccine shortages and supply disruptions.

(c)The information submitted to the Secretary or its contractors, if any, under this section or under any other section of this chapter related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in section 552(b)(4) of title 5, and subject to the penalties and exceptions under section 1832 and 1833 of title 18 relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer, wholesaler, or distributor shall be disclosed without its consent to another manufacturer, wholesaler, or distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage.

(d)The Secretary, in order to maintain the confidentiality of relevant information and ensure that none of the information contained in the systems involved may be used to provide proprietary advantage within the vaccine market, while allowing State, local, and tribal health officials access to such information to maximize the delivery and availability of vaccines to high priority populations, during times of influenza pandemics or other pandemics, vaccine shortages, and supply disruptions, in consultation with manufacturers, distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a) and (b).

(e)There are authorized to be appropriated to carry out this section, $30,800,000 for each of fiscal years 2019 through 2023.

(f)As part of the National Health Security Strategy described in section 300hh–1 of this title, the Secretary shall provide an update on the implementation of subsections (a) through (d).

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (c), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–328, § 2232(1), inserted “, or other federally purchased vaccine to address another pandemic” after “in an influenza pandemic” and “or other pandemic” after “during an influenza pandemic”. Subsec. (d). Pub. L. 117–328, § 2232(2), inserted “or other pandemics” after “influenza pandemics”. 2019—Subsec. (e). Pub. L. 116–22 substituted “2019 through 2023” for “2014 through 2018”. 2013—Subsec. (e). Pub. L. 113–5 substituted “$30,800,000 for each of fiscal years 2014 through 2018” for “such sums for each of fiscal years 2007 through 2011”. 2006—Pub. L. 109–417 amended section catchline and text generally, substituting provisions relating to vaccine tracking and distribution for provisions relating to establishment of capacities to combat threats to public health. 2002—Subsec. (a)(1). Pub. L. 107–188 substituted “five years” for “10 years”.

§247d–1 Vaccine tracking and distribution