[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78694-78696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-3208]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Records and Reports Concerning Experiences With 
Approved New Animal Drugs: Adverse Event Reports

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 adverse event reporting by FDA on new 
animal drugs and product manufacturing defects.

DATES: Either electronic or written comments on the collection of 
information must be submitted by February 21, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 21, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received 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

[[Page 78695]]

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-2022-N-3208 for ``Records and Reports Concerning Experiences with 
Approved New Animal Drugs: Adverse Event Reports.'' 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 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, 10A-12M, 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.

Records and Reports Concerning Experiences With Approved New Animal 
Drugs: Adverse Event Reports

OMB Control Number 0910-0284--Extension

    This information collection supports statutory and regulatory 
requirements governing reporting associated with certain animal drug 
products. With regard to adverse events and product/manufacturing 
defects associated with approved new animal drugs, section 512(l) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l)) 
requires applicants with approved new animal drug applications (NADAs) 
and abbreviated new animal drug applications (ANADAs) to establish and 
maintain records and reports of data relating to experience with uses 
of such drug, or with respect to animal feeds bearing or containing 
such drug, to facilitate a determination under section 512(e) as to 
whether there may be grounds for suspending or withdrawing approval of 
the NADA or ANADA under section 512(e) or 512(m)(4).
    In 2020, FDA amended Sec.  514.80 (21 CFR 514.80) to require 
electronic submission of certain postmarketing safety reports for 
approved new animal drugs and to provide a procedure for requesting a 
temporary waiver of the requirement. We, therefore, retain use of 
certain paper-based forms. Section 514.80 requires applicants and 
nonapplicants to keep records of and report to us data, studies, and 
other information concerning experience with new animal drugs for each 
approved NADA and ANADA. Following complaints from animal owners or 
veterinarians, or following their own detection of a problem, 
applicants or nonapplicants are required to submit adverse event 
reports and product/manufacturing defect reports under Sec.  
514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) on 
Form FDA 1932.
    The information collection includes electronic submission of 
adverse event reports and product/manufacturing defect reports under 
Sec.  514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and 
(C) using Form FDA 1932.
    The information collection also includes submissions under Sec.  
514.80(d)(2), by an applicant or nonapplicant requesting, in writing, a 
temporary waiver of the electronic submission requirements. The initial 
request may be by telephone or email to CVM's Division of 
Pharmacovigilance and Surveillance, with prompt written follow-up 
submitted as a letter to the application(s). FDA will grant waivers

[[Page 78696]]

on a limited basis for good cause shown. If FDA grants a waiver, the 
applicant or nonapplicant must comply with the conditions for reporting 
specified by FDA upon granting the waiver.
    Description of Respondents: Respondents to this collection of 
information are applicants and nonapplicants as defined in 21 CFR 
514.3. Respondents include individuals and the private sector (for-
profit businesses).
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                           Number of
              21 CFR section                 FDA form      Number of     responses per   Total annual       Average burden per response      Total hours
                                               No.        respondents     respondent       responses
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Medicated feed reports, 510.301(a) and             N/A               8               1               8  .25 (15 minutes)...................            2
 (b).
Submission of postmarketing safety                1932              85            1249          98,639  1..................................       98,639
 reports under Sec.   514.80(b)(1),
 (2)(i) and (ii), (3), and (4)(iv)(A) and
 (C).
Voluntary reporting FDA Form 1932a for           1932a             106               1             106  1..................................          106
 the public.
514.80(b)(4) Periodic Drug Experience             2301              79              20           1,582  16.................................       25,312
 Reports.
514.80(b)(5)(i) Special Drug Experience           2301              78             215          16,790  2..................................       33,580
 Reports.
514.80(b(5)(ii) Advertisement and                 2301              38             192           7,282  2..................................       14,564
 Promotional labeling.
514.80(b)(5)(iii) Distributor's                   2301              22               2              36  2..................................           72
 Statements.
514.80(d)(2).............................          N/A               1               1               1  1..................................            1
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    Total................................  ...........  ..............  ..............  ..............  ...................................      172,276
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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 Recordkeeping Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Recordkeeping, 510.301 \2\......               8               1               8               4              32
Recordkeeping, 21 U.S.C. 360b(1)              79        1,575.14         124,436              14       1,742,104
 and 514.80(e) \3\..............
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    Total.......................  ..............  ..............  ..............  ..............       1,742,136
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This estimate includes all recordkeeping by licensed medicated feed manufacturers under Sec.   510.301.
\3\ This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs
  under Sec.   514.80(e).

    Upon review of the information collection, we have adjusted our 
estimated burden to reflect an overall increase of 136,029.75 hours and 
1,677,019 responses/records, annually.

    Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27817 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P


