The Secretary shall publish a list on the website of the Department of Health and Human Services providing information on how to identify appropriate substitutes for infant formula products in shortage that are relied upon by infants and other individuals with inborn errors of metabolism or other serious health conditions.
Not later than 60 days after December 29, 2022, the Secretary shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph as the “National Academies”) to examine and report on challenges in supply, market competition, and regulation of infant formula in the United States.
The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after December 29, 2022, complete such study and submit a report on the results of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
Promptly after a submission under paragraph (1) is received, the Secretary shall provide such submission, together with the information specified in subparagraph (B), in a 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.
Not later than 7 days after receiving a written communication from a manufacturer of infant formula containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufacturing of an infant formula impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide a substantive response to such communication concerning the sufficiency of the proposed corrective actions.
The Secretary shall ensure timely communication with a manufacturer of infant formula following an inspection of a facility engaged in the manufacturing of infant formula for consumption in the United States. If a reinspection of a manufacturer of an infant formula is required to ensure that such manufacturer completed any remediation actions or addressed any deficiencies, the Secretary shall reinspect such facility in a timely manner. The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an infant formula.
Not later than 6 months after December 29, 2022, and not less than once per calendar year thereafter, the Secretary shall conduct inspections, including unannounced inspections, of the facilities (including foreign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(A)), in accordance with a risk-based approach and ensure timely and effective internal coordination and alignment among the Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition. In meeting the inspection requirements under this subsection, the Secretary may rely on inspections conducted by foreign regulatory authorities, under arrangements or agreements, and conducted by State agencies under contract, memoranda of understanding, or any other obligation.
The Secretary, in consultation with the Secretary of Agriculture and other heads of relevant departments and agencies, shall develop and issue, not later than 90 days after December 29, 2022, a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and information they need.