[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Pages 46218-46220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-18620]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-3656]
Agency Information Collection Activities; Proposed Collection;
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 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 collection of information under FDA's
current good manufacturing practice (CGMP) regulations for positron
emission tomography (PET) drug products. PET is
[[Page 46219]]
a medical imaging modality involving the use of a unique type of
radiopharmaceutical drug product.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 24, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 24, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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
[[Page 46220]]
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:
Table 1--Estimated Annual Recordkeeping Burden\1\
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Number of Records per Total annual
Required recordkeeping activity; 21 CFR 212 recordkeepers recordkeeper records Average burden per record Total hours
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Academia, Small Firms, & High-Risk Component 76 ~824.26 62,644 ~.81 (50 minutes)............. 50,862
Manufacture Records.
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
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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 21 CFR 212.70 Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18620 Filed 9-24-25; 8:45 am]
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