Notice2022-13086
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
June 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 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 87 Issue 117 (Friday, June 17, 2022)</title>
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[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36512-36514]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13086]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0545]
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, Agency, or we) 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 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 August 16, 2022.
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 August 16, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://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, 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="https://www.regulations.gov">https://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.
FDA-2009-N-0545 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="https://www.regulations.gov">https://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="https://www.regulations.gov">https://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
[[Page 36513]]
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="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/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="https://www.regulations.gov">https://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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#de8e8c9f8daabfb8b89eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="efbfbdaebc9b8e8989af898b8ec187879cc1888099">[email protected]</span></a>.
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.
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 Research (CBER) or to the Center for Drug 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 (21 CFR 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) (21 CFR 1271.350(b)), in brief,
requires HCT/P establishments that manufacture non-reproductive HCT/Ps
described in Sec. 1271.10 (21 CFR 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) 2021. 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
[[Page 36514]]
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 3 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 and 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
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:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR section; activity FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
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600.14; Reporting of product deviations by licensed 3486 103 6.864 707 2 1,414
manufacturers..........................................
606.171; Reporting of product deviations by licensed 3486 2,008 6.883 13,821 2 27,642
manufacturers, unlicensed registered blood
establishments, and transfusion services...............
1271.350(b); HCT/P deviations........................... 3486 80 2.575 206 2 412
Web-based Addendum...................................... \2\ 3486A 66 6.69 442 0.25 110.5
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Total............................................... .............. .............. .............. 15,176 .............. 29,578.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Three percent of the number of respondents ((2,008 + 103 + 80) x 0.03 = 66) and total annual responses to CBER ((13,821 + 707 + 206) x 0.03 = 442).
Our estimated burden for the information collection reflects an
overall decrease of approximately 65,014 hours and a corresponding
decrease of 34,152 responses. We attribute this adjustment to a
decrease in the number of deviation reports we received in FY 2021 from
licensed manufacturers and unlicensed registered blood establishments
under Sec. 606.171. This is likely due to our issuance of the revised
guidance document entitled ``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. The revised guidance provided a less
burdensome policy for reporting BPDs that is consistent with public
health and eliminated the reporting of post donation information (PDI)
events as BPD reports because these reports were no longer unexpected
or unforeseeable. Given the substantial number of PDI reports FDA has
received, the Agency is aware that these events occur, and the
submission of additional PDI reports to FDA is unlikely to facilitate
the identification of manufacturing or safety issues.
Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13086 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P
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