[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32848-32851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14995]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0601]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Current Good 
Manufacturing Practice Regulations for Medicated Feeds

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) 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: Fax written comments on the collection of information by August 
17, 2017.

ADDRESSES: 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 [email protected]. 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.

FOR FURTHER INFORMATION CONTACT: 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, 
[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.

[[Page 32849]]

Current Good Manufacturing Practice Regulations for Medicated Feeds--21 
CFR Part 225

OMB Control Number 0910-0152--Extension

    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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Recordkeeping Burden
                                                     [Registered Licensed Commercial Feed Mills] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR Section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8), requires                    877             260         228,020  1.........................................         228,020
 records of receipt, storage, and inventory
 control of medicated feeds.
225.58(c) and (d), requires records of the               877              45          39,465  .50 (30 minutes)..........................        19,732.5
 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.
225.80(b)(2), requires that verified                     877           1,600       1,403,200  .12 (7 minutes)...........................         168,384
 medicated feed label(s) be kept for 1 year.
225.102(b)(1), requires records of Master                877           7,800       6,840,600  .08 (5 minutes)...........................         547,248
 Record Files and production records for
 medicated feeds.
225.110(b)(1) and (b)(2), requires                       877           7,800       6,840,600  .02 (1 minute)............................         136,812
 maintenance of distribution records for
 medicated feeds.
225.115(b)(1) and (b)(2), requires                       877               5           4,385  .12 (7 minutes)...........................           526.2
 maintenance of complaint files by the
 medicated feed manufacturer.
                                                                                                                                         ---------------
    Total...................................  ..............  ..............  ..............  ..........................................     1,100,722.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 32850]]


                                                     Table 2--Estimated Annual Recordkeeping Burden
                                                         [Registered Licensed Mixer-Feeders] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR Section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8), requires                    100             260          26,000  .15 (9 minutes)...........................           3,900
 records of receipt, storage, and inventory
 control of medicated feeds.
225.58(c) and (d), requires records of the               100              36           3,600  .50 (30 minutes)..........................           1,800
 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.
225.80(b)(2), requires that verified                     100              48           4,800  .12 (7 minutes)...........................             576
 medicated feed label(s) be kept for 1 year.
225.102(b)(1) through (b)(5), requires                   100             260          26,000  .40 (24 minutes)..........................          10,400
 records of Master Record Files and
 production records for medicated feeds.
                                                                                                                                         ---------------
    Total...................................  ..............  ..............  ..............  ..........................................          16,676
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                     Table 3--Estimated Annual Recordkeeping Burden
                                                  [Nonregistered Unlicensed Commercial Feed Mills] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR Section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142, requires procedures for                       4,186               4          16,744  1.........................................          16,744
 identification, storage, and inventory
 control (receipt and use) of Type A
 medicated articles and Type B medicated
 feeds.
225.158, requires records of investigation             4,186               1           4,186  4.........................................          16,744
 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.
225.180, requires identification, storage,             4,186              96         401,856  .12 (7 minutes)...........................          48,223
 and inventory control of labeling in a
 manner that prevents label mix-ups and
 assures that correct labels are used for
 medicated feeds.
225.202, requires records of formulation,              4,186             260       1,088,360  .65 (39 minutes)..........................         707,434
 production, and distribution of medicated
 feeds.
                                                                                                                                         ---------------
    Total...................................  ..............  ..............  ..............  ..........................................         789,145
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                     Table 4--Estimated Annual Recordkeeping Burden
                                                      [Nonregistered Unlicensed Mixer-Feeders] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR Section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142, requires procedures for                       3,400               4          13,600  1.........................................          13,600
 identification, storage, and inventory
 control (receipt and use) of Type A
 medicated articles and Type B medicated
 feeds.
225.158, requires records of investigation             3,400               1           3,400  4.........................................          13,600
 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.
225.180, requires identification, storage,             3,400              32         108,800  .12 (7 minutes)...........................          13,056
 and inventory control of labeling in a
 manner that prevents label mix-ups and
 assures that correct labels are used for
 medicated feeds.
225.202, requires records of formulation,              3,400             260         884,000  .33 (20 minutes)..........................         291,720
 production, and distribution of medicated
 feeds.
                                                                                                                                         ---------------

[[Page 32851]]

 
    Total...................................  ..............  ..............  ..............  ..........................................         331,976
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14995 Filed 7-17-17; 8:45 am]
 BILLING CODE 4164-01-P