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
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 a...
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
( printed 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,
PRAStaff@fda.hhs.gov.
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 § 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 § 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 § 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 § 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
21 CFR section
FDA form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Medicated feed reports, 510.301(a) and (b)
N/A
8
1
8
0.25 (15 minutes)
2
Submission of postmarketing safety reports under § 514.80(b)(1), (2)(i) and (ii), (3) , and (4)(iv)(A) and (C)
1932
85
1,249
98,639
1
98,639
Voluntary reporting FDA Form 1932a for the public
1932a
106
1
106
1
106
514.80(b)(4) Periodic Drug Experience Reports
2301
79
20
1,582
16
25,312
514.80(b)(5)(i) Special Drug Experience Reports
2301
78
215
16,790
2
33,580
514.80(b)(5)(ii) Advertisement and Promotional labeling
2301
38
192
7,282
2
14,564
514.80(b)(5)(iii) Distributor's Statements
2301
22
2
36
2
72
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.
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 § 510.301.
3
This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs under § 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.
Use this for formal legal and research references to the published document.
88 FR 26318
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“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,” thefederalregister.org (April 28, 2023), https://thefederalregister.org/documents/2023-08999/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-records-a.