SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients), and the Advanced Manufacturing Technologies Designation Program

OMB Control Number 0910-0139—Revision

This information collection supports statutory and regulatory requirements that govern the manufacture, processing, packing, or holding of finished pharmaceuticals, including active pharmaceutical ingredients (APIs). Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with CGMP regulations. FDA is responsible for enforcing the FD&C Act as well as related statutes, including the Public Health Service Act. Congress enacted these laws to ensure that covered products meet applicable requirements regarding the safety, identity and strength, and the quality and purity characteristics they purport or are represented to possess and are labeled with adequate warnings and instructions for use.

The pharmaceutical or drug quality-related regulations appear in several parts of Title 21 Code of Federal Regulations (CFR) (Food and Drugs), including sections in parts 1 through 99, 200 through 299, 300 through 499, 600 through 7 99, and 800 through 1299. The regulations enable a common understanding of the regulatory process by describing requirements to be followed by drug manufacturers, applicants, and FDA. The information collection also supports regulations codified under parts 610 and 680 (21 CFR parts 610 and 680), which reference certain CGMP regulations in part 211 (see §§  610.12(g), 610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f)). The information collection requirements help FDA ensure compliance with applicable requirements and meet its public health protection responsibilities.

The information collection also includes FDA's Center for Drug Evaluation and Research's (CDER) Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) and Circular A-119 by the Office of Management and Budget (OMB) have established Federal Government policies to improve the internal management of the executive branch by directing agencies to use voluntary consensus standards developed or adopted by a standards developing organization—rather than Government-unique standards—except where these standards are inconsistent with applicable law or otherwise impractical. The guidance document entitled, “ CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality ” (July 2023), outlines justifications for why a standard may be recognized wholly, partly, or not at all. (The guidance document is available for download from our website at: CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality | FDA.) The guidance document also communicates that interested parties may request recognition of a standard. We intend on finalizing the guidance document upon OMB approval of the attendant information collection.

The information collection also covers activities associated with FDA's Advanced Manufacturing Technologies (AMT) Designation Program, as provided for in section 506L of the FD&C Act (21 U.S.C. 356l) and added by section 3213 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). The guidance document entitled, Advanced Manufacturing Technologies Designation Program, (December 2024), communicates the statutory goals, scope, and framework of the AMT program. The guidance document is available for download from our internet site at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​advanced-manufacturing-technologies-designation-program.

We are revising the information collection to remove activities and burden attributable to medical gas requirements. Through rulemaking on ( printed page 29969) June 18, 2024, (89 FR 51738) (RIN 0910-AC53), current good manufacturing practice requirements applicable to medical gas are now established in 21 CFR parts 213 and 230 and accounted for under OMB control number 0910-0906.

In the Federal Register of February 20, 2026 (91 FR 8249), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although three comments were received, the comments were not responsive to the four collection of information topics solicited.

FDA estimates the burden of this collection of information as follows:

Our estimated burden for the information collection reflects a decrease of 396,293 hours and 639,491 responses annually, resulting from removal of burden attributable to information collection for medical gas requirements. We have otherwise retained currently approved estimates, noting that the AMT activity element has been inadvertently omitted from our burden summary table that appears at www.reginfo.gov.

91 FR 29968