Notice2023-00013
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 88 Issue 4 (Friday, January 6, 2023)</title>
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[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1074-1075]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00013]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0545]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 February 6, 2023.
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 0910-0458. Also include the FDA docket
number found in brackets in the heading of this document.
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#4e1e1c0f1d3a2f28280e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="cf9f9d8e9cbbaea9a98fa9abaee1a7a7bce1a8a0b9">[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.
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 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 human cells, tissues, and
cellular and tissue-based product (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-
[[Page 1075]]
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
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 followup 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.
In the Federal Register of June 17, 2022 (87 FR 36512), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
21 CFR section; activity FDA form Number of responses per annual Average burden per response Total
No. respondents respondent responses hours
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600.14; Reporting of product deviations by 3486 103 6.864 707 2..................................... 1,414
licensed manufacturers.
606.171; Reporting of product deviations by 3486 2,008 6.883 13,821 2..................................... 27,642
licensed 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 (15 minutes)..................... 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: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00013 Filed 1-5-23; 8:45 am]
BILLING CODE 4164-01-P
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