Notice2025-23859
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
Primary source
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Published
December 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
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[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Pages 60726-60727]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23859]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#0f5f5d4e5c7b6e69694f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="e6b6b4a7b592878080a6808287c88e8e95c8818990">[email protected]</span></a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pet-drug-products-current-good-manufacturing-practice-cgmp">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pet-drug-products-current-good-manufacturing-practice-cgmp</a>. The guidance document communicates
[[Page 60727]]
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\
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Total
Required recordkeeping activity; Number of Records per annual Average burden per record Total
21 CFR 212 recordkeepers recordkeeper records hours
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Academia, Small Firms, & High- 76 ~824.26 62,644 ~.81 (50 minutes)......... 50,862
Risk Component Manufacture
Records.
Corporate Firm Records.......... 91 ~1,447.10 131,686 ~.35 (21 minutes)......... 45,728
External Control Testing 23 145 3,335 ~.67 (40 minutes)......... 2,243
Laboratory Records.
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Total....................... .............. ............ 197,665 .......................... 98,833
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Disclosure Burden
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Number of
Notifications required under Number of disclosures per Total annual Average burden Total
21 CFR 212.70 respondents respondent disclosures per disclosure hours
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Sterility Testing Failures... 11 3 33 2.5 83
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\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
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