Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information

OMB Control Number 0910-0045—Extension

This information collection supports implementation of requirements related to drug establishment registration and listing governed by section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), including registrant reporting under section 510(j)(3) of the FD&C Act with respect to listed drugs. Agency regulations implementing drug establishment and registration provisions are found in part 207 (21 CFR part 207) and include reporting and recordkeeping requirements. Agency guidance addressing reporting and recordkeeping provided for by section 510 of the FD&C Act is also addressed in this information collection. All Agency guidance documents are issued consistent with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time. To search available FDA guidance documents, visit the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

Respondents to the collection of information are domestic establishments that manufacture, repack, relabel, or salvage a drug, or an animal feed bearing or containing a new animal drug, and foreign establishments that manufacture, repack, relabel, or salvage a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. As set forth in the regulations governing drug establishment registration and listing, when operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments. Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed. Drug listing information gives FDA a current inventory of drugs manufactured, repacked, relabeled, or salvaged for commercial distribution. Data reported by registrants under section 510(j)(3) of the FD&C Act on the number of listed drugs they annually manufacture, prepare, propagate, compound or process provide FDA with a more comprehensive picture of the drug supply chain, which can inform operational decisions and support the Agency's efforts to reduce drug shortage risk. All these types of information facilitate implementation and enforcement of the FDC Act and are used for many important public health purposes.

While there are 10,480 establishments currently registered with FDA, registration and listing data is subject to frequent fluctuation as a result of the volume of activity. Consistent with provisions in § 207.61, except as provided in § 207.65, all information submitted under part 207 must be transmitted to FDA in an electronic format by using our electronic drug registration and listing system, in a form that we can process, review, and archive. For more information regarding FDA's Electronic Drug Registration and Listing System (eDRLS), including “Latest News” updates, we encourage respondents to visit our website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/electronic-drug-registration-and-listing-system-edrls. To assist respondents in complying with electronic submission requirements related to drug establishment registration and drug listing under section 510 of the FD&C Act, we issued the guidance document entitled “Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing” (June 2009) (available at https://www.fda.gov/media/71146/download ). Updated daily, we also maintain a registration database that includes a publication of currently registered establishments on our website at https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.

Since our last evaluation of the collection of information, there have been modifications to certain reporting and recordkeeping requirements under section 510 of the FD&C Act resulting from amendments made by the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136). Relevant to the information collection described herein, section 510(j) of the FD&C Act was amended to include the following information collection activities:

• Section 510(j)(3) of the FD&C Act, as added by the CARES Act, requires that registrants under section 510 of the FD&C Act must annually report the amount of each listed drug that they manufactured, prepared, propagated, compounded, or processed (hereinafter manufactured) for commercial distribution. Section 510(j)(3) of the FD&C Act also authorizes FDA to require that registrants report this information electronically, and to require that registrants report this information at the time a public health emergency is declared. To provide guidance on the submission of the reporting required under section 510(j)(3) of the FD&C Act, we issued the guidance document entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act” (February 2024) (available at https://www.fda.gov/media/175933/download ). In addition to supporting FDA's response to drug shortages, this guidance on reporting under section 510(j)(3) also facilitates FDA's access to information useful in making decisions regarding the appropriate level of drug facility surveillance.
• The guidance document entitled “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products” (March 2011) (available at https://www.fda.gov/media/120092/download ) is intended to encourage manufacturers of drug and therapeutic biological products, and any raw materials and components used in those products, to develop a written Emergency Plan (Plan) for maintaining an adequate supply of medically necessary drug products during an emergency that results in high employee absenteeism; that guidance discusses the elements that should be covered by such a Plan. The guidance also recommends respondents notify FDA's Center for Drug Evaluation and Research (CDER) when activating or deactivating a Plan.
• As we continue to receive similar information regarding animal drug shortages, we developed and issued the guidance document “Reporting and Mitigating Animal Drug Shortages” (Center for Veterinary Medicine GFI #271) (May 2023) (available at https://www.fda.gov/media/137722/download ) intended to assist respondents in notifying FDA about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of animal drugs.
• The Secretary may issue an order under section 510(j)(3)(B) of the FD&C Act to exempt certain biological products or categories of biological products regulated under section 351 of the Public Health Service Act (42 U.S.C. 242) from some or all of the reporting requirements established in section 510(j)(3)(A) of the FD&C Act, if the Secretary determines that applying such reporting requirements to those products (or product categories) is not necessary to protect the public health, We most recently revised the information collection to reflect reporting exemptions via such an order pertaining to: (1) blood and blood components for transfusion and (2) cell and gene therapy products, where one lot treats a single patient, as announced in the Federal Register of April 13, 2023 (88 FR 22454) (April 2023 final order).

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