Notice2023-08999
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 82 (Friday, April 28, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26318-26320]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08999]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#77272536240316111137111316591f1f0459101801"><span class="__cf_email__" data-cfemail="9dcdcfdccee9fcfbfbddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a>.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 28, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.