Notice2026-03773
Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing.
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Published
February 25, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 (the 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 the information collection requirements relating to the reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations in manufacturing, and Forms FDA 3486 and 3486A.
Full Text
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<title>Federal Register, Volume 91 Issue 37 (Wednesday, February 25, 2026)</title>
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[Federal Register Volume 91, Number 37 (Wednesday, February 25, 2026)]
[Notices]
[Pages 9287-9289]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03773]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0027]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations and Human Cells, Tissues, and Cellular and Tissue-Based
Product Deviations in Manufacturing.
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
(the 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 the information collection
requirements relating to the reporting of biological product deviations
and human cells, tissues, and cellular and tissue-based product (HCT/P)
deviations in manufacturing, and Forms FDA 3486 and 3486A.
DATES: Submit either electronic or written comments on the collection
of information by April 27, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 27, 2026. 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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="http://www.regulations.gov">http://www.regulations.gov</a>
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,
[[Page 9288]]
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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.
[Insert docket number xxxxx] for '' Agency Information Collection
Activities; Proposed Collection; Comment Request; Biological Products:
Reporting of Biological Product Deviations and Human Cells, Tissues,
and Cellular and Tissue-Based Deviations in Manufacturing; Forms FDA
3486 and 3486A.'' 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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: <a href="http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#cd9d9f8c9eb9acabab8daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="27777566745346414167414346094f4f5409404851">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.
Biological Products: Reporting of Biological Product Deviations and
Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations
in Manufacturing; Forms FDA 3486 and 3486A (OMB Control Number 0910-
0458)--Extension
Under section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), all biological products, including human blood and blood
components, offered for sale in interstate commerce must be licensed
and meet standards, including those prescribed in the FDA regulations,
designed to ensure the continued safety, purity, and potency of such
products. In addition, under section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or possessions or from foreign countries into the States or
possessions. Further, the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351) provides that drugs and devices (including human
blood and blood components) are adulterated if they do not conform with
current good manufacturing practice (CGMP) assuring that they meet the
requirements of the FD&C Act. Establishments manufacturing biological
products, including human blood and blood components, must comply with
the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts
211, 606, and 820)) and current good tissue practice (CGTP) regulations
(part 1271 (21 CFR part 1271)) as appropriate. FDA regards biological
product deviation (BPD) reporting and HCT/P deviation reporting to be
an essential tool in its directive to protect public health by
establishing and maintaining surveillance programs that provide timely
and useful information.
Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer
who holds the biological product license, for other than human blood
and blood components, and who had control over a distributed product
when the deviation occurred, to report to the Center for Biologics
Evaluation and
[[Page 9289]]
Research (CBER) or to the Center for Drugs Evaluation and Research
(CDER) as soon as possible but at a date not to exceed 45 calendar days
after acquiring information reasonably suggesting that a reportable
event has occurred. Section 606.171, in brief, requires licensed
manufacturers of human blood and blood components, including Source
Plasma, unlicensed registered blood establishments, and transfusion
services, who had control over a distributed product when the deviation
occurred, to report to CBER as soon as possible but at a date not to
exceed 45 calendar days after acquiring information reasonably
suggesting that a reportable event has occurred. Similarly, Sec.
1271.350(b), in brief, requires HCT/P establishments that manufacture
non-reproductive HCT/Ps described in Sec. 1271.10 to investigate and
report to CBER all HCT/P deviations relating to a distributed HCT/P
that relates to the core CGTP requirements, if the deviation occurred
in the establishment's facility or in a facility that performed a
manufacturing step for the establishment under contract, agreement or
other arrangement. Form FDA 3486 is used to submit BPD reports and HCT/
P deviation reports.
Respondents to this collection of information are (1) Licensed
manufacturers of biological products other than human blood and blood
components, (2) licensed manufacturers of blood and blood components
including Source Plasma, (3) unlicensed registered blood
establishments, (4) transfusion services, and (5) establishments that
manufacture non-reproductive HCT/Ps regulated solely under section 361
of the PHS Act as described in Sec. 1271.10. The number of respondents
and total annual responses are based on the BPD reports and HCT/P
deviation reports FDA received in fiscal year (FY) 2024. The number of
licensed manufacturers and total annual responses under Sec. 600.14
include the estimates for BPD reports submitted to both CBER and CDER.
Based on the information from industry, the estimated average time to
complete a deviation report is 2 hours, which includes a minimal one-
time burden to create a user account for those reports submitted
electronically. The availability of the standardized report form, Form
FDA 3486, and the ability to submit this report electronically to CBER
(CDER does not currently accept electronic filings) further streamlines
the report submission process.
CBER has developed a Web-based addendum to Form FDA 3486 (Form FDA
3486A) to provide additional information when a BPD report has been
reviewed by FDA and evaluated as a possible recall. The additional
information requested includes information not contained in the Form
FDA 3486 such as: (1) Distribution pattern; (2) method of consignee
notification; (3) consignee(s) of products for further manufacture; (4)
additional product information; (5) updated product disposition; and
(6) industry recall contacts. This information is requested by CBER
through email notification to the submitter of the BPD report. This
information is used by CBER for recall classification purposes. CBER
estimates that 5 percent of the total BPD reports submitted to CBER
would need additional information submitted in the addendum. CBER
further estimates that it would take between 10 to 20 minutes to
complete the addendum. For calculation purposes, CBER is using 15
minutes.
Activities such as investigating, changing standard operating
procedures or processes, and follow up are currently required under 21
CFR parts 211, (approved under OMB control number 0910-0139), 606
(approved under OMB control number 0910-0116), 820 (approved under OMB
control number 0910-0073) and 1271 (approved under OMB control number
0910-0543) and, therefore, are not included in the burden calculation
for the separate requirement of submitting a deviation report to FDA.
We estimate the burden of this collection of information as
follows:
Estimated Annual Reporting Burden\1\
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Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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600.14 Reporting of product deviations by licensed 3486 70 7.186 503 2.0 10,060
manufacturers..........................................
606.171 Reporting of product deviations by licensed 3486 2,455 6.630 16,278 2.0 32,556
manufacturers, unlicensed registered blood
establishments and transfusion services................
1271.350(b) Reporting requirements (human cells tissues 3486 86 2.465 212 2.0 424
and cellular and tissue-based products)................
1271.350(b) CBER addendum report........................ \2\ 3486A 127 6.50 825 0.25 206.25
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Total............................................... .............. .............. .............. 17,818 .............. 43,246.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of the number of respondents ((2,455 + 86 x 0.05 = 127) and total annual responses to CBER ((16,278 + 212) x 0.05 = 825).
Our estimated burden for the information collection reflects an
overall increase of approximately 13,602.95 hours and a corresponding
increase of 2,383 responses. We attribute this adjustment to an
increase in the number of product deviations we received in FY 2024
from licensed manufacturers, unlicensed registered blood establishments
and transfusion services under Sec. 606.171. This is likely due to the
issuance of the revised guidance document titled, ``Biological product
Deviation Reporting for Blood and Plasma Establishments'' (85 FR 14682;
March 13, 2020), which provided blood and plasma establishments with
revised recommendations related to BPD reporting.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03773 Filed 2-24-26; 8:45 am]
BILLING CODE P
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