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Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written or electronic comments on the collection of information by June 4, 2003.
The Office of Management and Budget (OMB) is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be electronically mailed to Start Printed Page 23727 firstname.lastname@example.org or faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA, FAX 202-395-6974.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.End Further Info End Preamble Start Supplemental 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 Experience With Approved New Animal Drugs— (OMB Control Number 0910-0284)
Description: This final rule amends the provisions of the animal drug regulations concerning requirements for recordkeeping and reports concerning experience with approved new animal drugs. The information contained in the reports required by this rule enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy. The reporting requirements include: (1) A report that provides information on product and manufacturing defects that may result in serious adverse drug events within 3 days of becoming aware the defect exists (§ 514.80(b)(1) (21 CFR 514.80(b)(1))); (2) a report that provides information on serious and unexpected adverse drug events and a followup report on such events (§ 514.80(b)(2)); (3) a summary report of increased frequency of adverse drug experiences (§ 514.80(b)(4)(v)); (4) a report from nonapplicants, such as distributors, to applicants providing information on adverse drug experiences (§ 514.80(b)(3)); (5) a periodic report with information on distribution, labeling, manufacturing or controls changes, new laboratory studies, and all adverse events in the reporting period (§ 514.80(b)(4)); (6) other reports that include special drug experience reports; and (7) reports for advertising and promotional labeling, and reports for distributor statements (§ 514.80(b)(5)). These reports must be kept for 5 years (§ 514.80(e)).
The final rule strengthens the current reporting system by requiring periodic reports every 6 months for the first 2 years following initial approval of an application rather than just for the first year following initial approval. The increased burden on applicants amounts to one additional periodic report. While greater than the reporting burden in the previous rule, this burden is less than that of the proposed rule which would have required quarterly periodic reports for 3 years following initial approval.
All periodic reports must be submitted with Form FDA 2301, “Transmittal of Periodic Reports and Promotional Materials for New Animal Drugs” (OMB control number 0910-0012). Adverse drug experience reports must be submitted on Form FDA 1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report” (OMB control number 0910-0012).
In the Federal Register of February 4, 2002 (67 FR 5046), FDA invited comments on the interim final rule and the information collection requirements. Only one comment received pertained to information collection. That comment stated that the requirements under “Multiple Applications” do not appear to decrease but may increase the burden on the applicant. In particular, the comment questioned the requirement under § 514.80(c)(4) and requested clarification. The comment also voiced concern about an increased reporting burden due to the increasing number of approved applications for combinations of drugs for use in feeds since the implementation of the Animal Drug Availability Act of 1996. Further complicating the reporting issue is that frequently there are nonapplicants involved in the marketing of these combinations. The comment stated that with the exception of “promotion literature,” there is rarely any other information to be reported, suggesting that the “promotion literature” be submitted to the application held by either party, i.e., the nonapplicants or applicant, and not the application approved for the use of the combination of drugs.
In response, FDA notes that the provision of the regulation in question is currently codified under § 510.300(b)(4)(ii). The current regulation and the proposal in the interim final rule are similar. There is no increase of the reporting burden. It is not the intention of FDA for the implementation of § 514.80(c) to be different from the current requirement under § 510.300(b)(4)(ii). There is no additional reporting burden than that already covered under § 514.80(b)(4). Section 514.80(c) is not an additional information collection, i.e., in addition to § 514.80(b)(4); it is an administrative tool for industry to use to submit common information only once to FDA. Only information specific to a particular new animal drug application (NADA)/abbrieviated new animal drug application (ANADA) that is not common to all the applications must be included in the report for that particular NADA/ANADA; for example, labeling. With regard to the comment that there is an increased reporting burden due to the Animal Drug Availability Act of 1996, increased reporting is due to the increased number of approved applications. FDA consequently believes that this is a reasonable reporting requirement.
Description of Respondents: Applicant respondents are sponsors of approved NADAs and ANADAs. Nonapplicant respondents are those, other than the applicant, involved in manufacturing, processing, packing, labeling, or distributing new animal drugs.
FDA estimates the burden of this collection of information as follows:
|21 CFR Section/Title/FDA Form No.||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|514.80(b)(2)(i)/Original 15-day Alert Report/Form FDA 1932||190||55.26||12,283||1||12,283|
|514.80(b)(1)/3-day Field Alert Report/Form FDA 1932||190||0.32||95||1||95|
|514.80(b)(2)(ii)/Followup 15-day Alert Report/Form FDA 1932||190||17.90||6,007||1||6,007|
|514.80(b)(3)/Nonapplicant Report/Form FDA 1932||340||2.94||1,000||1||1,000|
|514.80(b)(4)/Periodic Drug Experience Report/Form FDA 2301, and 514.80(c) Multiple Applications2||190||7.11||1,226||11||13,486|
|Start Printed Page 23728|
|514.80(b)(4)(v)/Summary Report of Increased Frequency of Adverse Drug Experience||190||1.58||300||2||600|
|514.80(b)(5)(i)/Special Drug Experience Report/Form FDA 2301||190||0.13||25||2||50|
|514.80(b)(5)(ii)/Advertising and Promotional Materials Report/Form FDA 2301||190||2.11||772||2||1,544|
|514.80(b)(5)(iii)/Distributor's Statement Report/Form FDA 2301||530||0.14||56||2||112|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
|2 The reporting burden for § 514.80(b)(4)(iv)(A) is included in the reporting burden for § 514.80(b)(2)(i).|
|21 CFR Section||No. of Respondents||Annual Frequency of Response||Total Annual Responses||Hours per Response||Total Hours|
|1 Burden estimates were separated between Form FDA 1932 and Form FDA 2301 to reflect the difference in estimates for “Hours per Respondent” required.|
|2 Recordkeeping estimates for § 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932.|
|3 Recordkeeping estimates for § 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301.|
Forms FDA 1932 and FDA 2301 for this collection of information are currently approved under OMB control number 0910-0012 and will not change due to implementation of this regulation. The reporting and recordkeeping burden estimates in this document are based on the submission of reports to the Division of Surveillance, Center for Veterinary Medicine. The total annual response numbers are based on the 2000 fiscal year submission of reports to the Division of Surveillance, Center for Veterinary Medicine. The numbers in
tables 1 and 2 of this document are total burden associated with this regulation. Section 514.80(b)(3) and (b)(4)(v) are new information collection requirements over the current requirements.Start Signature
Dated: April 28, 2003.
Assistant Commissioner for Policy.
[FR Doc. 03-10932 Filed 5-2-03; 8:45 am]
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