United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2022_register executive 2022-06-28 article Proposed Rules D09002ee1c7a3d7a8 D09002ee1c7a3d852 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. 87 FR 38313 https://www.govinfo.gov/app/details/FR-2022-06-28/2022-13309 2022-13309 fr28jn22-23 RIN 0910-AH62 4164-01-P Docket No. FDA-2021-N-0862 https://www.govinfo.gov/app/details/FR-2022-06-28/2022-13309 https://www.govinfo.gov/content/pkg/FR-2022-06-28/html/2022-13309.htm https://www.govinfo.gov/content/pkg/FR-2022-06-28/pdf/2022-13309.pdf Drugs Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Confidential Business Information 19 p. 38313 38331 87 FR 38313 Title 21 Part 201 21 CFR Part 201 Title 21 Part 314 21 CFR Part 314 RIN 0910-AH62 Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Federal Register Vol. 87, Issue PRORULE 2022-13309 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2022-10-26 Docket No. FDA-2021-N-0862 4164-01-P 2022-13309 Proposed rule.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.

Either electronic or written comments on the proposed rule must be submitted by October 26, 2022. Submit comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by July 28, 2022. With regard to the proposed rule: Chris Wheeler, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993-0002, 301- 796-0151, Chris.Wheeler@fda.hhs.gov. Drugs Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Confidential Business Information Nonprescription Drug Product With an Additional Condition for Nonprescription Use, Chris.Wheeler@fda.hhs.gov PRAStaff@fda.hhs.gov http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm https://www.brookings.edu/events/exploring-implications-of-the-nonprescription-drug-safe-use-regulatory-expansion-nsure-initiative-on-reimbursement-and-access https://www.brookings.edu/events/innovative-technologies-and-nonprescription-medications-addressing-undertreated-diseases-and-conditions-through-technology-enabled-self-care https://www.brookings.edu/events/nonprescription-medications-with-conditions-of-safe-use-as-a-novel-solution-for-undertreated-diseases-or-conditions https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.jrpp.net/text.asp?2016/5/3/149/185706 https://www.reginfo.gov/public/do/PRAMain https://www.regulations.gov reginfo.gov www.XYZCompany.com Vol. 87, no. 123 Office of the Federal Register, National Archives and Records Administration 2022-06-28 continuing daily deposited born digital 378 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-06-28 P0b002ee1b6264048 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28jn22 https://www.govinfo.gov/app/details/FR-2022-06-28 https://www.govinfo.gov/content/pkg/FR-2022-06-28/pdf/FR-2022-06-28.pdf https://www.govinfo.gov/content/pkg/FR-2022-06-28/xml/FR-2022-06-28.xml fdlp 38265 38632 DGPO 2022-06-28 2024-05-29 FR-2022-06-28 machine generated eng FR FR-2022-06-28 87 123