[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17858-17859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 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.
    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..
                               ---------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                                                  Average burden
                                   Number of        Numbers 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                      Average burden
   21 CFR Section; activity       Number of     disclosures per   Total annual    per disclosure    Total hours
                                 respondents       respondents     disclosures      (in hours)
----------------------------------------------------------------------------------------------------------------
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