Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Good Manufacturing Practices for Positron Emission Tomography Drugs

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs

DATES:

Either electronic or written comments on the collection of information must be submitted by November 24, 2025.

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-2025-N-3656 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs-21 CFR part 212." 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 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.

Current Good Manufacturing Practices for Positron Emission Tomography Drugs-21 CFR Part 212

OMB Control Number 0910-0667-Extension

This information collection implements statutory and regulatory requirements that govern positron emission tomography (PET) drugs. FDA has promulgated regulations in 21 CFR part 212 establishing current good manufacturing practice (CGMP) intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. While regulations in 21 CFR part 212, subpart A set forth general provisions, additional requirements are established in 21 CFR part 212 as follows:

Subpart B-Personnel and Resources-212.10

Subpart C-Quality Assurance-212.20

Subpart D-Facilities and Equipment-212.30

Subpart E-Control of Components, Containers, and Closures-212.40

Subpart F-Production and Process Controls-212.50

Subpart G-Laboratory Controls-212.60-212.61

Subpart H-Finished Drug Product Controls and Acceptance-212.70-212.71

Subpart I-Packaging and Labeling-212.80

Subpart J-Distribution-212.90

Subpart K-Complaint Handling-212.100

Subpart L-Records-212.110

Records must be maintained at the PET drug production facility or another location that is reasonably accessible to responsible officials of the production facility and to employees of FDA designated to perform inspections. All records, including those not stored at the inspected establishment, must be legible, stored to prevent deterioration or loss, and readily available for review and copying by FDA employees. All records and documentation referenced in this part must be maintained for a period of at least 1 year from the date of final release, including conditional final release, of a PET drug product.

The regulations contain what we believe are the minimum standards for quality production of PET drugs at all types of PET drug production facilities. These CGMP requirements are designed according to the unique characteristics of PET drugs, including their short half-lives and because most PET drugs are produced at locations close to the patients to whom the drugs are administered. We have also taken into account that time spent on recording procedures, processes, and specifications may be somewhat higher in the year in which records are first established and correspondingly lower in subsequent years, when only updates and revisions will be required.

We have also issued Agency guidance entitled, "PET Drugs-Current Good Manufacturing Practice (CGMP)," (December 2009), available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pet-drug-products-current-good-manufacturing-practice-cgmp. The guidance document communicates FDA's thinking concerning compliance with the CGMP regulations. The guidance document addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.

Respondents to the information collection include are PET production facilities, including academic or hospital facilities as well as commercial facilities.

We estimate the burden of the collection of information as follows:

Our estimated burden for the information collection reflects an overall increase of 14,348 hours and a corresponding increase of 12,851 records. We attribute this adjustment to an increase in our estimate of the number of small firms due to new facilities.