[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66856-66858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3847]
Agency Information Collection Activities: Proposed Collection;
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 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 the proposed extension of the collection of
information applicable to required adverse experience reporting for
licensed biological products, and general records associated with the
manufacture and distribution of biological products.
DATES: Submit either electronic or written comments on the collection
of information by November 27, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 27, 2023. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 27, 2023 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:
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-2023-N-3847 for ``Adverse Experience Reporting for Licensed
Biological Products; and General Records.'' 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
[[Page 66857]]
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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
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 https://vaers.hhs.gov/. 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.
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.
[[Page 66858]]
Table 2--Estimated Annual Reporting Burden--Biological Products \1\
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Average burden
Number of Number 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
21 CFR section; activity Number of disclosures per Total annual Average burden per Total
respondents respondents disclosures disclosure (in hours) hours
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4.102, 4.103, 4.104, 4.105; 11 18 198 0.35 (21 minutes).... 69
Postmarketing Safety
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: September 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21252 Filed 9-27-23; 8:45 am]
BILLING CODE 4164-01-P