Source: https://www.federalregister.gov/documents/2017/07/18/2017-14995/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2017-08-17 04:08:46
Document Index: 491992107

Matched Legal Cases: ['art 225', 'art 225', 'art 225', 'art 225', 'art 225', 'art 225', 'art 225']

Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
This document has a comment period that ends in 1 day. (08/17/2017) Submit a formal comment
82 FR 32848
32848-32851 (4 pages)
Docket No. FDA-2010-N-0601
2017-14995
FDA-2010-N-0601
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225
OMB Control Number 0910-0152—Extension
https://www.federalregister.gov/d/2017-14995 https://www.federalregister.gov/d/2017-14995
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0152. Also include the FDA docket number found in brackets in the heading of this document.
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.Start Printed Page 32849
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21 CFR part 225). Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act. Under part 225, a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), labels, and product distribution.
This information is needed so that FDA can monitor drug usage and possible misformulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled. In addition, FDA will use the cGMP criteria in part 225 to determine whether or not the systems and procedures used by manufacturers of medicated feeds are adequate to assure that their feeds meet the requirements of the FD&C Act as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter or because of carcinogenic concerns. Conversely, a license is not required and the recordkeeping requirements are less demanding for those medicated feeds for which FDA has determined that the drugs used in their manufacture need less control. Respondents to this collection of information are commercial feed mills and mixer-feeders.
In the Federal Register of October 17, 2016 (81 FR 71508), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one letter in response to the notice, which contained multiple comments. One comment was generally supportive of the recordkeeping provisions of part 225. Another comment suggested that we should collect data from manufacturers of medicated feed, and described several benefits of having this information. Our regulations in part 225 require recordkeeping to document procedures required during the manufacturing process to assure that proper quality control is maintained. The regulations do not require manufacturers to submit this information to us on a routine basis but, rather, to make the information available to us upon inspection. To the extent that the comments recommend changes to our cGMP regulations for medicated feed, which can only be accomplished by rulemaking, the comments were outside the scope of the four collection of information topics on which the notice requested comments and will not be discussed in this document.
Table 1—Estimated Annual Recordkeeping Burden
[Registered Licensed Commercial Feed Mills] 1
225.42(b)(5) through (b)(8), requires records of receipt, storage, and inventory control of medicated feeds 877 260 228,020 1 228,020
225.58(c) and (d), requires records of the results of periodic assays for medicated feeds that are in accord with label specifications and also those medicated feeds not within documented permissible assay limits 877 45 39,465 .50 (30 minutes) 19,732.5
225.80(b)(2), requires that verified medicated feed label(s) be kept for 1 year 877 1,600 1,403,200 .12 (7 minutes) 168,384
225.102(b)(1), requires records of Master Record Files and production records for medicated feeds 877 7,800 6,840,600 .08 (5 minutes) 547,248
225.110(b)(1) and (b)(2), requires maintenance of distribution records for medicated feeds 877 7,800 6,840,600 .02 (1 minute) 136,812
225.115(b)(1) and (b)(2), requires maintenance of complaint files by the medicated feed manufacturer 877 5 4,385 .12 (7 minutes) 526.2
Total 1,100,722.7
Start Printed Page 32850
[Registered Licensed Mixer-Feeders] 1
225.42(b)(5) through (b)(8), requires records of receipt, storage, and inventory control of medicated feeds 100 260 26,000 .15 (9 minutes) 3,900
225.58(c) and (d), requires records of the results of periodic assays for medicated feeds that are in accord with label specifications and also those medicated feeds not within documented permissible assay limits 100 36 3,600 .50 (30 minutes) 1,800
225.80(b)(2), requires that verified medicated feed label(s) be kept for 1 year 100 48 4,800 .12 (7 minutes) 576
225.102(b)(1) through (b)(5), requires records of Master Record Files and production records for medicated feeds 100 260 26,000 .40 (24 minutes) 10,400
Total 16,676
Table 3—Estimated Annual Recordkeeping Burden
[Nonregistered Unlicensed Commercial Feed Mills] 1
225.142, requires procedures for identification, storage, and inventory control (receipt and use) of Type A medicated articles and Type B medicated feeds 4,186 4 16,744 1 16,744
225.158, requires records of investigation and corrective action when the results of laboratory assays of drug components indicate that the medicated feed is not in accord with the permissible assay limits 4,186 1 4,186 4 16,744
225.180, requires identification, storage, and inventory control of labeling in a manner that prevents label mix-ups and assures that correct labels are used for medicated feeds 4,186 96 401,856 .12 (7 minutes) 48,223
225.202, requires records of formulation, production, and distribution of medicated feeds 4,186 260 1,088,360 .65 (39 minutes) 707,434
Total 789,145
Table 4—Estimated Annual Recordkeeping Burden
[Nonregistered Unlicensed Mixer-Feeders] 1
225.142, requires procedures for identification, storage, and inventory control (receipt and use) of Type A medicated articles and Type B medicated feeds 3,400 4 13,600 1 13,600
225.158, requires records of investigation and corrective action when the results of laboratory assays of drug components indicate that the medicated feed is not in accord with the permissible assay limits 3,400 1 3,400 4 13,600
225.180, requires identification, storage, and inventory control of labeling in a manner that prevents label mix-ups and assures that correct labels are used for medicated feeds 3,400 32 108,800 .12 (7 minutes) 13,056
225.202, requires records of formulation, production, and distribution of medicated feeds 3,400 260 884,000 .33 (20 minutes) 291,720
Start Printed Page 32851
Total 331,976
We based our estimate of the time required for record preparation and maintenance on our communications with industry. We derived additional information needed to calculate the total burden hours (i.e., number of recordkeepers, number of medicated feeds being manufactured, etc.) from our records and experience. The burden has not changed since the last OMB approval.
[FR Doc. 2017-14995 Filed 7-17-17; 8:45 am]