Notice2024-05222
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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
March 12, 2024
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 89 Issue 49 (Tuesday, March 12, 2024)</title>
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[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17858-17859]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05222]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3847]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Experience
Reporting for Licensed Biological Products; and General Records
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 April 11, 2024.
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 0910-0308. 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#eebebcafbd9a8f8888ae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="36666477654257505076505257185e5e4518515940">[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.
Adverse Experience Reporting for Licensed Biological Products; and
General Records--21 CFR Part 600
OMB Control Number 0910-0308--Extension
This information collection helps support implementation of
statutory and regulatory authorities that govern adverse experience
reporting. Under the Public Health Service Act (PHS Act) (42 U.S.C.
262), FDA may only approve a biologics license application for a
biological product that is safe, pure, and potent. When a biological
product is approved and enters the market, the product is introduced to
a larger patient population in settings different from clinical trials.
New information generated during the postmarketing period offers
further insight into the benefits and risks of the product, and
evaluation of this information is important to ensure its safe use.
Regulations implementing adverse experience reporting (AER)
requirements applicable to biological products are codified in part 600
(21 CFR part 600). Regulations applicable to combination products
subject to regulations in part 600 are found in part 4 (21 CFR part
4)--Regulation of Combination Products. The collections of information
are intended to enable FDA to take actions necessary for the protection
of the public health in response to reports of adverse experiences
related to biologics licensed under any provision of section 351 of the
PHS Act.
To assist respondents with the reporting provisions of the
information collection, FDA has created both paper-based and electronic
forms. Information may be submitted electronically through MEDWATCH or
the Vaccine Adverse Experience Reporting System (VAERS). AER reports
are filed using the MEDWATCH Form FDA-3500A (approved under OMB control
numbers 0910-0291 and 0910-0645) or the VAERS-1. Both versions of the
forms and instructions are available from the internet at <a href="https://vaers.hhs.gov">https://vaers.hhs.gov</a>. The forms may also be downloaded, completed, and
submitted to the Agency by mail or facsimile.
For operational efficiency, on March 20, 2023, we requested, and
OMB has approved, the addition of burden attributable to provisions set
forth in part 4, subpart B, previously included in OMB control number
0910-0834. When information regarding an event that involves a death or
serious injury, or an adverse event, associated with the use of the
combination product is received by the product sponsor, the information
must be provided to the other constituent part applicant(s) no later
than 5 calendar days after receipt under Sec. 4.103. Relatedly, Sec.
4.104 explains how and where to submit reports.
In the Federal Register of September 28, 2023 (88 FR 66856), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment regarding our
estimate of 28 hours per response for periodic adverse experience
reports. The comment suggested we lower that estimate but provided no
data or explanation in support of the proposed reduction. While we have
therefore made no adjustment in our burden estimate, we encourage
further comment regarding a basis for assessing burden for the scope of
information collection activity covered by the applicable regulations
and associated forms.
Respondents: Respondents to this collection of information are
manufacturers of biological products (including blood and blood
[[Page 17859]]
components) and any person whose name appears on the label of a
licensed biological product.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden--Biological Products \1\
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Number of Average burden
21 CFR Section; activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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600.80(c)(1), 600.80(d), and 109 3,806.95 414,958 1 414,958
600.80(e); postmarketing 15-
day Alert Reports............
600.82; notification of 23 1.435 33 2 66
discontinuance or
interruption in manufacturing
600.80(c)(2); Periodic Adverse 109 3,697 402,973 28 11,283,244
Experience Reports...........
600.81; distribution reports.. 172 5.727 985 1 985
600.80(h)(2), 600.81(b)(2), 35 1.886 66 1 66
and 600.90; waiver requests..
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Total..................... ............... ............... .............. .............. 11,699,319
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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 Reporting Burden--Biological Products \1\
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Average burden
Number of Numbers of Total annual per
21 CFR Section; activity recordkeepers records per records recordkeeper Total hours
recordkeeper (in hours)
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600.12 \2\; Maintenance of 131 40.145 5,259 32 168,288
Records......................
600.12(b)(2); Recall Records.. 216 3.4028 735 24 17,640
600.80(c)(1) and 600.80(k); 109 7,503.95 817,931 1 817,931
AER Records..................
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Total..................... ............... ............... .............. .............. 1,003,859
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The recordkeeping requirements in Sec. 610.18(b) are included in the estimate for Sec. 600.12.
Table 3--Estimated Annual Reporting Burden--Combination Products \1\
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Number of Average burden
21 CFR Section; activity Number of disclosures per Total annual per disclosure Total hours
respondents respondents disclosures (in hours)
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4.102, 4.103, 4.104, 4.105; 11 18 198 0.35 (21 69
Postmarketing Safety minutes).
Reporting for Combination
Products, including
associated reports and
sharing information with
other constituent part
applicants.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden for this information collection has changed since the
last OMB approval. The reporting and recordkeeping burden has increased
mostly due to an increase in the number of AER reports submitted to FDA
and the associated recordkeeping with these reports. We have also added
burden we believe attributable to post marketing safety reporting and
attendant recordkeeping and disclosures, as required under part 4,
subpart B.
Dated: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05222 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P
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