Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings

Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings

DATES:

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

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."

Instructions: All submissions received must include the Docket No. FDA-2026-N-2431 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings." Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies in total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

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:

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.