Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2026-06719 · Docket No. FDA-2026-N-2431

Summary

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with general FDA administrative practices and procedures, including requests for formal hearings.

Dates

Either electronic or written comments on the collection of information must be submitted by June 8, 2026.

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. Administrative Practices and Procedures; Formal Hearings—21 CFR Parts 10, 12-16, and 19 OMB Control Number 0910-0191—Extension This information collection supports Food and Drug Administration (FDA, the agency, us or we) regulations found in 21 CFR part 10, 21 CFR parts 12 through 16, and 21 CFR part 19 (21 CFR 10, 12-16, and 19), which implement general provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The regulations were promulgated in accordance with the Administrative Procedures Act and establish administrative practice and procedures to give instructions to those conducting business with FDA. Regulations in part 10 (21 CFR part 10) describe general administrative practices and include content and format instructions on submitting information to the agency, petitions for agency action, and other topics such as the public calendar. Regulations in 21 CFR parts 12 through 16 cover formal evidentiary, public, and regulatory hearings. We also account for burden associated with waiver requests under 21 CFR part 10.19. Unless a waiver, suspension, or modification submitted under § 10.19 (21 CFR 10.19) is granted by the Commissioner of Food and Drugs (the Commissioner), the regulations in 21 CFR part 10 apply to all petitions, hearings, and other administrative proceedings and activities conducted by FDA. Although we have not received requests under § 10.19, to reflect the attendant burden resulting from submitting such a request, we provide an estimate of 1 response and 1 burden hour annually, as reflected in Question-12 of this supporting statement. Also, because most information associated with regulations in parts 12-16 is obtained during the conduct of an official administrative action as described under 5 CFR 1320.4, we only include burden associated with initiating hearings pursuant to the applicable regulations. The information collection also includes activities and burden associated with general meeting requests and correspondence submitted under section 10.65 (21 CFR 10.65), as well and general submissions associated with section 10.115—which provides for public participation in the development of agency guidance documents through requests to our Dockets Management Staff. Although most submissions and attendant burden associated with recommendations found in FDA guidance documents is accounted for in topic-specific and approved ICRs, here we account for burden associated with general public submissions as described in § 10.115(f)(3). The information collection also includes burden associated with recommendations discussed in the guidance document entitled, “ Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act. ” The guidance document communicates FDA's interpretation of section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(q)): Petitions and Civil Actions Regarding Approval of Certain Applications. The guidance identifies and discusses submission elements including certification, as well as verification of supplemental information. It also addresses the relationship between the review of petitions and pending ANDAs, 505(b)(2) applications, and 351(k) applications for which a decision on approvability has not yet made. The information collection also includes burden associated with requests for FDA speakers. FDA receives thousands of requests each year from trade associations and industry-based groups for speakers to participate in external meetings, conferences, and workshops. To facilitate the processing of these requests and determine participation, we have designated contacts throughout the agency and have developed web-based request templates which can be found on our website at https://www.fda.gov/training-and-continuing-education/contacts-requesting-fda-speaker. We estimate the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 10.19—request for waiver, suspension, or modification of requirements 2 1 2 1 2 10.30 and 10.31—citizen petitions and petitions related to ANDAs 2 certain NDAs, 3 or certain BLAs 4 330 1 330 24 7,920 10.33—administrative reconsideration of action 13 1 13 10 130 10.35—administrative stay of action 28 1 28 10 280 10.65—meetings and correspondence 18 1 18 5 90 10.85—requests for Advisory opinions 3 1 3 16 48 10.115(f)(3)—submitting draft guidance proposals 1 1 1 4 4 12.22—Filing objections and requests for a hearing on a regulation or order 15 1 15 20 300 12.45—Notice of participation 1 1 1 3 3 External requests for FDA speakers 3,900 1 3,900 0.17 (10 minutes) 663 Total 4,311 9,440 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Abbreviated New Drug Applications. 3 New Drug Applications. 4 Biologics License Applications. Based on submissions to FDA's Division of Dockets Management since our last evaluation of the information collection, we have adjusted burden estimates associated with the individual activities that correspond to the applicable provisions. As a result, the information collection reflects an increase of 3,080 annual burden hours. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-06719 Filed 4-6-26; 8:45 am]