【正文】 iew of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. SEC. 102. DEFINITIONS. Section 735 (21 . 379g) is amended (1) in the matter before paragraph (1), by striking ``For purposes of this subchapter39。 FINDING. (a) Short NOTE: 21 USC 301 note. title may be cited as the ``Prescription Drug User Fee Amendments of 202139。 risk evaluation and mitigation strategies. Sec. 902. Enforcement. Sec. 903. No effect on withdrawal or suspension of approval. Sec. 904. Benefitrisk assessments. Sec. 905. Active postmarket risk identification and analysis. Sec. 906. Statement for inclusion in directtoconsumer advertisements of drugs. Sec. 907. No effect on veterinary medicine. Sec. 908. Authorization of appropriations. Sec. 909. Effective date and applicability. Subtitle BOther Provisions to Ensure Drug Safety and Surveillance Sec. 911. Clinical trial guidance for antibiotic drugs. Sec. 912. Prohibition against food to which drugs or biological products have been added. Sec. 913. Assuring pharmaceutical safety. Sec. 914. Citizen petitions and petitions for stay of agency action. Sec. 915. Postmarket drug safety information for patients and providers. Sec. 916. Action package for approval. Sec. 917. Risk munication. Sec. 918. Referral to advisory mittee. Sec. 919. Response to the institute of medicine. Sec. 920. Database for authorized generic drugs. Sec. 921. Adverse drug reaction reports and postmarket safety. TITLE XFOOD SAFETY Sec. 1001. Findings. [[Page 121 STAT. 825]] Sec. 1002. Ensuring the safety of pet food. Sec. 1003. Ensuring efficient and effective munications during a recall. Sec. 1004. State and Federal Cooperation. Sec. 1005. Reportable Food Registry. Sec. 1006. Enhanced aquaculture and seafood inspection. Sec. 1007. Consultation regarding geically engineered seafood products. Sec. 1008. Sense of Congress. Sec. 1009. Annual report to Congress. Sec. 1010. Publication of annual reports. Sec. 1011. Rule of construction. TITLE XIOTHER PROVISIONS Subtitle AIn General Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees. Sec. 1102. Priority review to encourage treatments for tropical diseases. Sec. 1103. Improving geic test safety and quality. Sec. 1104. NIH Technical amendments. Sec. 1105. Severability clause. Subtitle BAntibiotic Access and Innovation Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. Sec. 1112. Orphan antibiotic drugs. Sec. 1113. Exclusivity of certain drugs containing single enantiomers. Sec. 1114. Report. TITLE IPRESCRIPTION NOTE: Prescription Drug User Fee Amendments of 2021. DRUG USER FEE AMENDMENTS OF 2021 SEC. 101. SHORT TITLE。 statements。 finding. Subtitle AFees Related to Medical Devices Sec. 211. Definitions. Sec. 212. Authority to assess and use device fees. Sec. 213. Reauthorization。 conforming amendment. TITLE IIMEDICAL DEVICE USER FEE AMENDMENTS OF 2021 Sec. 201. Short title。 finding. Sec. 102. Definitions. Sec. 103. Authority to assess and use drug fees. Sec. 104. Fees relating to advisory review of prescriptiondrug television advertising. Sec. 105. Reauthorization。. SEC. 2. TABLE OF CONTENTS. The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. TITLE IPRESCRIPTION DRUG USER FEE AMENDMENTS OF 2021 Sec. 101. Short title。 [110th Congress Public Law 85] [From the . Government Printing Office] [DOCID: f:] [[Page 121 STAT. 823]] Public Law 11085 110th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the userfee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. NOTE: Sept. 27, 2021 [. 3580] Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, NOTE: Food and Drug Administration Amendments Act of 2021. SECTION 1. NOTE: 21 USC 301 note. SHORT TITLE. This Act may be cited as the ``Food and Drug Administration Amendments Act of 202139。39。 references in title。 reporting requirements. Sec. 106. Sunset dates. Sec. 107. Effective date. Sec. 108. Savings clause. Sec. 109. Technical amendment。 references in title。 reporting requirements. Sec. 214. Savings clause. Sec. 215. Additional authorization of appropriations for postmarket safety information. Sec. 216. Effective date. Sec. 217. Sunset clause. Subtitle BAmendments Regarding Regulation of Medical Devices Sec. 221. Extension of authority for third party review of premarket notification. Sec. 222. Registration. Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and pounded by registrants。 acpanying disclosures. Sec. 224. Electronic registration and listing. S