[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:
    <bullet> 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.
    <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-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.
    <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 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, 
<a href="/cdn-cgi/l/email-protection#5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="5e0e0c1f0d2a3f38381e383a3f7036362d70393128">[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.

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\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
   21 CFR section; activity        Number of      responses per    Total annual    per response     Total hours
                                  respondents       respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
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..
                               ---------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                                                  Average burden
                                   Number of        Number of      Total annual         per
   21 CFR section; activity      recordkeepers     records per        records      recordkeeper     Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
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..................
                               ---------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
  21 CFR section; activity       Number of     disclosures per   Total annual     Average burden per     Total
                                respondents      respondents      disclosures   disclosure (in hours)    hours
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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


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