,,ii #aagth ,,congress #b;d ,session ,s4 #dbef ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #ah 7legislative day1 ,may #ag71 #bjbb,mr4 ,casey 7for himself1 ,mr4 ,brown1 ,ms4 ,duckworth1 ,mrs4 ,gillibrand1 and ,ms4 ,warren7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to prevent food shortages1 including shortages of infant formula and certain medical foods4 #a4 ,short title ,this ,act may be cited as the ,protecting ,infants from ,formula ,shortages ,act of #bjbb4 #b4 ,discontinuance or interruption in the production of essential sources of nutrition 7a7 ,discontinuance or interruption in the production of essential food ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #dab 7#ba ,u4,s4,c4 #cej;a7 the following new section3 #dab;,a4 ,discontinuance or interruption in the production of food1 including infant formula and certain medical foods for inborn errors of metabolism 7a7 ,in general ,a manufacturer of an essential source of nutrition shall notify the ,secretary1 in accordance with subsection 7b71 of a permanent discontinuance in the manufacture of such food or an interruption of the manufacture of an essential source of nutrition or any other circumstance that is likely to lead to a meaningful disruption in the supply of such food in the ,united ,states1 and the reasons for such discontinuance or interruption4 7b7 ,timing ,except as provided in subsection 7g71 a notice required under subsection 7a7 shall be submitted to the ,secretary-- 7#a7 at least #f months prior to the date of the discontinuance or interruption2 or 7#b7 if compliance with paragraph 7#a7 is not possible1 as soon as practicable4 7c7 ,distribution ,to the maximum extent practicable1 the ,secretary shall distribute1 to the ,secretary of ,agriculture and to appropriate organizations1 as determined by the ,secretary1 through such means as the ,secretary determines appropriate1 information on the discontinuance or interruption of the manufacture of an essential source of nutrition1 or other circumstance1 reported under subsection 7a74 7d7 ,confidentiality ,nothing in this section authorizes the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7e7 ,failure ,to meet requirements ,if a person fails to submit information required under subsection 7a7 in accordance with subsection 7b7-- 7#a7 the ,secretary shall issue to such person a letter that-- 7,a7 informs such person of the failure to comply2 7,b7 describes the basis for noncompliance2 and 7,c7 requires the person to comply not later than #cj calendar days after the date on which the letter was issued2 7#b7 not later than #cj calendar days after the issuance of a letter under paragraph 7#a71 the person who receives such letter shall submit to the ,secretary a written response to such letter that provides the information required under subsection 7a72 and 7#c7 not later than #de calendar days after the issuance of a letter under paragraph 7#a71 the ,secretary shall make such letter and any response to such letter under paragraph 7#b7 available to the public on the website of the ,food and ,drug ,administration1 with appropriate redactions made to protect information described in subsection 7d71 except that1 if the ,secretary determines that the letter under paragraph 7#a7 was issued in error or1 after review of such response1 the person had a reasonable basis for not notifying as required under subsection 7a71 the requirements of this paragraph shall not apply4 7f7 ,regulations 7#a7 ,in general ,not later than #a year after the date of enactment of the ,protecting ,infants from ,formula ,shortages ,act of #bjbb1 the ,secretary shall promulgate regulations regarding the requirements under this section4 7#b7 ,contents ,such regulations-- 7,a7 shall include a list of each category of food for which a manufacturer is required to notify the ,secretary in accordance with subsection 7a72 and 7,b7 may-- 7i7 designate foods not otherwise defined as an essential source of nutrition1 giving special consideration to foods-- 7,i7 upon which individuals with certain diseases or conditions may be particularly reliant2 or 7,,ii7 that are administered under medical supervision2 7ii7 designate additional categories of foods for which the ,secretary determines notification described in subsection 7a7 is appropriate during a public health emergency declared under section #cai of the ,public ,health ,service ,act2 and 7iii7 prescribe additional conditions on the timing and manner of such notifications as are reasonable and appropriate during such a public health emergency4 7g7 ,order ,during a public health emergency declared under section #cai of the ,public ,health ,service ,act1 the ,secretary may order any manufacturer of an essential source of nutrition to provide notification required by this section4 ,such order may-- 7#a7 impose additional conditions on the timing and manner of notification as are reasonable and appropriate in light of the circumstances of the public health emergency2 and 7#b7 designate additional categories of food for which the ,secretary determines notification is appropriate during the public health emergency4 7h7 ,risk management plans ,each manufacturer of an essential source of nutrition shall develop1 maintain1 and1 as appropriate1 implement a redundancy risk management plan that identifies and evaluates risks to the supply of the food1 as applicable1 for each establishment in which such food is manufactured4 ,a risk management plan under this subsection-- 7#a7 may identify and evaluate risks to the supply of more than one food1 or food category1 manufactured at the same establishment2 and 7#b7 shall be subject to inspection and copying by the ,secretary pursuant to section #gjd or at the request of the ,secretary4 7i7 ,definitions ,in this section3 7#a7 ,essential source of nutrition ,the term essential source of nutrition means-- 7,a7 an infant formula2 7,b7 a food that-- 7i7 meets the definition of medical food in section #e7;b7 of the ,orphan ,drug ,act2 and 7ii7 is intended for use by individuals with-- 7,i7 certain inborn errors of metabolism2 or 7,,ii7 other conditions requiring a medical food1 as determined by the ,secretary in guidance issued under subsection 7f72 or 7,c7 a food so designated pursuant to subsection 7f74 7#b7 ,meaningful disruption ,the term meaningful disruption-- 7,a7 means a change in production that is reasonably likely to lead to a reduction in the supply of an essential source of nutrition by a manufacturer that is more than negligible and affects the ability of the manufacturer to fulfill contractual obligations or meet expected demand for its product2 and 7,b7 does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time4 4 7b7 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following new subsection3 7fff7 ,the failure to provide information as required under section #dab;,a after receipt of a letter from the ,secretary under subsection 7e7 of such section4 4 #c4 ,remote records assessment for essential sources of nutrition 7a7 ,factory inspection ,section #gjd7;a77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77;,a77 is amended in the first sentence by inserting or the manufacturing1 processing1 packing1 or holding of an essential source of nutrition 7as defined in section #dab;,a7 after processing of a drug4 7b7 ,regulations ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall promulgate regulations describing circumstances in which the ,secretary may issue requests for records or other information in advance of1 or in lieu of1 an inspection pursuant to section #gjd7;a77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a71 processes for responding to such requests electronically or in physical form1 and factors the ,secretary may consider in evaluating whether such records are provided within a reasonable timeframe1 within reasonable limits1 and in a reasonable manner1 accounting for resource and other limitations that may exist1 including for small businesses4