3.0.0 7989 2022-12-29T17:18:49Z 2022-12-29T17:18:49Z House HR 2022-06-08 117 [Congressional Record Volume 168, Number 98 (Wednesday, June 8, 2022)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. SCHRIER:H.R. 7989.Congress has the power to enact this legislation pursuantto the following:Article I[Page H5409]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2022-06-08T14:01:35Z Protecting Infants from Formula Shortages Act of 2022 117 4256 S 2022-05-18 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS 2022-06-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2022-06-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2022-06-08 Introduced in House IntroReferral 1000 9 Library of Congress S001216 Rep. Schrier, Kim [D-WA-8] Kim Schrier D WA 8 N H001081 Rep. Hayes, Jahana [D-CT-5] Jahana Hayes D CT 5 2022-06-08 True W000797 Rep. Wasserman Schultz, Debbie [D-FL-23] Debbie Wasserman Schultz D FL 23 2022-06-08 True B001300 Rep. Barragan, Nanette Diaz [D-CA-44] Nanette Barragan D CA Diaz 44 2022-06-28 False Health Administrative law and regulatory procedures Business records Child health Department of Health and Human Services Emergency medical services and trauma care Food industry and services Food supply, safety, and labeling Government information and archives Government studies and investigations Industrial facilities Infectious and parasitic diseases Manufacturing Nutrition and diet Health 00 2022-06-08 Introduced in House 2022-06-16T13:32:38Z Protecting Infants from Formula Shortages Act of 2022

This bill imposes requirements on manufacturers of infant formula and medical foods for individuals with inborn errors of metabolism.

A manufacturer of such a food must notify the Food and Drug Administration (FDA) of any circumstance that is likely to lead to a meaningful disruption of the U.S. supply of the food, including a discontinuance or interruption of manufacturing. The manufacturer must submit the notification at least six months prior to the cause of the disruption or, if that is not possible, as soon as practicable. The FDA must provide the Department of Agriculture and appropriate organizations information about the cause of the disruption.

The FDA must inform a person (an individual or entity) of their failure to comply with these notification requirements. If the failure continues for a certain time period, the person shall be subject to fines, imprisonment, or both.

During a public health emergency, the FDA may impose additional conditions for such notifications and designate additional categories of food that are subject to the notification requirements.

The bill also requires each manufacturer of such a food to develop and maintain a redundancy risk management plan that identifies and evaluates risks for each manufacturing establishment for the food.

]]> Protecting Infants from Formula Shortages Act of 2022 Display Title Protecting Infants from Formula Shortages Act of 2022 Short Title(s) as Introduced Protecting Infants from Formula Shortages Act of 2022 Introduced in House IH Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to prevent food shortages, including shortages of infant formula and certain medical foods. Introduced in House IH Introduced in House 2022-06-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr7989ih/xml/BILLS-117hr7989ih.xml 2022-06-08 Referred to the House Committee on Energy and Commerce. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.