Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-3656]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments (including recommendations) on the collection of information by January 28, 2026.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to

https://www.reginfo.gov/public/do/PRAMain.

Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0667. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,

PRAStaff@fda.hhs.gov.

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 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.

In the

Federal Register

of September 25, 2025 (90 FR 46218), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Table 1—Estimated Annual Recordkeeping Burden

1

Required recordkeeping activity; 21 CFR 212

Number of

recordkeepers

Records per

recordkeeper

Total

annual

records

Average burden

per record

Total

hours

Academia, Small Firms, & High-Risk Component Manufacture Records

76

~824.26

62,644

~.81 (50 minutes)

50,862

Corporate Firm Records

91

~1,447.10

131,686

~.35 (21 minutes)

45,728

External Control Testing Laboratory Records

23

145

3,335

~.67 (40 minutes)

2,243

Total

197,665

98,833

1

There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Disclosure Burden

Notifications required under 21 CFR 212.70

Number of

respondents

Number of

disclosures per

respondent

Total annual

disclosures

Average

burden per

disclosure

Total

hours

Sterility Testing Failures

11

3

33

2.5

83

1

There are no capital costs or operating and maintenance costs associated with this collection of information.

2

Totals have been rounded to the nearest whole number.

3

Two reports are sent to FDA per incident, and one notification is sent to the receiving site.

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.

Brian Fahey,

Associate Commissioner for Legislation.

[FR Doc. 2025-23859 Filed 12-23-25; 8:45 am]

BILLING CODE 4164-01-P