Document ID: FDA-2022-N-3208-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
Posted Date: 2023-04-28T04:00Z

[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26318-26320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08999]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 May 30, 2023.

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

[[Page 26319]]

control number for this information collection is 0910-0284. 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.

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 (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 the 
Center for Veterinary Medicine's Division of Pharmacovigilance and 
Surveillance, with prompt written followup submitted as a letter to the 
application(s). FDA will grant waivers 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).
    In the Federal Register of December 22, 2022 (87 FR 78694) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received it was not 
responsive to any of the four information collection topics solicited 
in our notice.
    FDA estimates 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 No.      Number of     responses per   Total annual      Average burden per response      Total hours
                                                          respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated feed reports, 510.301(a) and             N/A               8               1               8  0.25 (15 minutes)...............               2
 (b).
Submission of postmarketing safety                1932              85           1,249          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                      2301              78             215          16,790  2...............................          33,580
 Experience 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
                                       -----------------------------------------------------------------------------------------------------------------
    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
                21 CFR section                     Number of      records per    Total annual       Average burden per recordkeeping        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping, 510.301 \2\....................               8               1               8  4.......................................              32

[[Page 26320]]

 
Recordkeeping, 21 U.S.C. 360b(1) and 514.80(e)              79        1,575.14         124,436  14......................................       1,742,104
 \3\.
                                               ---------------------------------------------------------------------------------------------------------
    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: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08999 Filed 4-27-23; 8:45 am]
BILLING CODE 4164-01-P