82 FR 32848 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 136 (July 18, 2017)

Page Range		32848-32851
FR Document		2017-14995
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.
Federal Register, Volume 82 Issue 136 (Tuesday, July 18, 2017)
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32848-32851]
From the Federal Register Online  [www.thefederalregister.org]
[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
32848 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
records per burden per Total hours
Harmonisation; guidance for industry recordkeepers records
recordkeeper recordkeeping

Section 5.0—Quality Management (including sections
5.0.1 to 5.0.7)—Developing a Quality Management Sys-
tem .................................................................................... 1,457 1 1,457 60 87,420
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
responses per burden per Total hours
Harmonisation; guidance for industry respondents responses
respondent response

Section 5.0.7—Risk Reporting—Describing the Quality
Management Approach Implemented in a Clinical Trial
and Summarizing Important Deviations From the
Predefined Quality Tolerance Limits and Remedial Ac-
tions Taken in the Clinical Study Report ......................... 1,457 4.6 6,702 3 20,107
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
records per burden per Total hours
Harmonisation; guidance for industry recordkeepers records
recordkeeper recordkeeping

Section 5.0—Quality Management (including 5.0.1 to
5.0.7)—Developing a Quality Management System ........ 218 1 218 60 13,080
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
Number of Average
E6(R2) Good clinical practice; International Council for Number of Total annual
responses per burden per Total hours
Harmonisation; guidance for industry responses responses
respondent response

Section 5.0.7—Risk Reporting—Describing the Quality
Management Approach Implemented in a Clinical Trial
and Summarizing Important Deviations From the
Predefined Quality Tolerance Limits and Remedial Ac-
tions Taken in the Clinical Study Report ......................... 218 3.69 804 3 2,413
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: July 12, 2017. ACTION: Notice. include the FDA docket number found
Anna K. Abram, in brackets in the heading of this
Deputy Commissioner for Policy, Planning, SUMMARY: The Food and Drug document.
Legislation, and Analysis. Administration (FDA) is announcing
[FR Doc. 2017–14999 Filed 7–17–17; 8:45 am] that a proposed collection of FOR FURTHER INFORMATION CONTACT: Ila
BILLING CODE 4164–01–P
information has been submitted to the S. Mizrachi, Office of Operations, Food
Office of Management and Budget and Drug Administration, Three White
(OMB) for review and clearance under Flint North, 10A63, 11601 Landsdown
DEPARTMENT OF HEALTH AND the Paperwork Reduction Act of 1995. St., North Bethesda, MD 20852, 301–
HUMAN SERVICES DATES: Fax written comments on the 796–7726, PRAStaff@fda.hhs.gov.
collection of information by August 17, SUPPLEMENTARY INFORMATION: In
Food and Drug Administration 2017. compliance with 44 U.S.C. 3507, FDA
[Docket No. FDA–2010–N–0601] ADDRESSES: To ensure that comments on has submitted the following proposed
the information collection are received, collection of information to OMB for
Agency Information Collection
OMB recommends that written
sradovich on DSK3GMQ082PROD with NOTICES

Activities; Submission for Office of review and clearance.
comments be faxed to the Office of
Management and Budget Review;
Information and Regulatory Affairs,
Comment Request; Current Good
OMB, Attn: FDA Desk Officer, FAX:
Manufacturing Practice Regulations for
202–395–7285, or emailed to oira_
Medicated Feeds
submission@omb.eop.gov. All
AGENCY: Food and Drug Administration, comments should be identified with the
HHS. OMB control number 0910–0152. Also

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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices 32851

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
[Nonregistered Unlicensed Mixer-Feeders] 1

Number of
Number of Total annual Average burden per
21 CFR Section records per Total hours
recordkeepers records recordkeeping
recordkeeper

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 Coast Guard Federal Safety Advisory intended voyage. In 2010, USCG
required for record preparation and Committees, industry stakeholders and announced policy accepting some
maintenance on our communications agency partners, the Coast Guard electronic publications in lieu of paper
with industry. We derived additional updated its original policy on electronic publications.4 NVIC 01–16 change 1
information needed to calculate the total charts and publications. Navigation and does not substantively change this
burden hours (i.e., number of Vessel Inspection Circular (NVIC) 01–16 USCG publication policy, but rather
recordkeepers, number of medicated change 1 is revised to focus on the consolidates information.
feeds being manufactured, etc.) from our equivalency determination for charts, Additionally, NVIC 01–16 change 1
records and experience. The burden has publications and, newly added, also provides guidance to marine
not changed since the last OMB navigation functions. It only accepts inspectors regarding how to identify
approval. certain electronic charts as described. It approved and/or appropriate electronic
Dated: July 12, 2017.
requires vessels that operate offshore to charts, display systems, position
display charts on certain systems. It information and electronic publications.
Anna K. Abram,
describes the minimum performance Finally, this Circular recommends
Deputy Commissioner for Policy, Planning, requirements for equipment receiving
Legislation, and Analysis.
practices that vessel owners and
position information and restates our operators should consider when
[FR Doc. 2017–14995 Filed 7–17–17; 8:45 am]
policy on electronic navigation navigating with the assistance of
BILLING CODE 4164–01–P publications. electronics.
Title 33 of the Code of Federal This Circular is not a substitute for
Regulations requires ‘‘currently applicable legal requirements, nor is it
DEPARTMENT OF HOMELAND corrected marine charts’’ of a large itself a rule. It does not provide
SECURITY enough scale and with enough detail to equivalence for the purposes of SOLAS
make safe navigation possible. In 2002, certificates. Mariners are responsible to
Coast Guard the Coast Guard authorized U.S. flagged safely navigate and follow applicable
[Docket No. USCG–2017–0692] SOLAS-compliant vessels to use an regulatory requirements.
Electronic Chart Display and Dated: July 10, 2017.
Equivalency Determination for ‘‘Marine Information System (ECDIS) in lieu of
Charts,’’ ‘‘Charts,’’ or ‘‘Maps,’’ RADM Paul F. Thomas,
paper charts.1 That policy did not apply
‘‘Publications,’’ and Navigation to the U.S. flagged vessels engaged Assistant Commandant for Prevention Policy,
Functions—Notice of Availability of U.S. Coast Guard.
solely on domestic voyages. Therefore,
Navigation and Vessel Inspection [FR Doc. 2017–15056 Filed 7–17–17; 8:45 am]
the Coast Guard is publishing an
Circular 01–16 Change 1 equivalency to address electronic chart BILLING CODE 9110–04–P

carriage on those vessels.
AGENCY: Coast Guard, DHS. Title 33 of the CFR 164 also requires
ACTION: Notice of availability. that some vessels fix their position 2 and DEPARTMENT OF HOMELAND
other vessels fix and plot their SECURITY
SUMMARY: The Coast Guard (USCG) is
announcing, the availability of position.3 The USCG recognizes the
Federal Emergency Management
Navigation and Vessel Inspection benefit of real-time positioning data, Agency
Circular (NVIC) 01–16 change 1. The and that it can provide greater
situational awareness than what could [Internal Agency Docket No. FEMA–4320–
NVIC provides that display of certain DR; Docket ID FEMA–2017–0001]
electronic charts and publications will be achieved using paper charts.
meet—as an equivalency—the ‘‘marine Therefore, USCG is announcing an
equivalency to fixing and plotting. Title Tennessee; Major Disaster and Related
charts,’’ ‘‘charts,’’ ‘‘maps,’’ or Determinations
‘‘publications’’ carriage requirements 33 of the CFR, along with the
and provides for an equivalency for International Convention of Safety of AGENCY: Federal Emergency
position fixing and plotting. USCG Life at Sea (SOLAS) Chapter V Management Agency, DHS.
intends, by this policy, to provide a path Regulation 27, also requires currently ACTION: Notice.
for U.S. flagged vessels to replace paper corrected editions of, or applicable
charts and most hard copy publications currently corrected extracts from, SUMMARY: This is a notice of the
if so desired. nautical publications necessary for the Presidential declaration of a major
sradovich on DSK3GMQ082PROD with NOTICES

disaster for the State of Tennessee
FOR FURTHER INFORMATION CONTACT: 1 67 Federal Register 53382 as amended by 69
(FEMA–4320–DR), dated June 23, 2017,
Please address questions or feedback Federal Register 42192, Carriage of Navigation and related determinations.
concerning this policy to LCDR Equipment for Ships on International Voyages.
DATES: Effective Date: June 23, 2017.
Matthew Walter, telephone 202–372– 2 33 CFR 164.11 & 164.78—Self-propelled vessels

1565 or email cgnav@uscg.mil. 1600 or more gross tons and towing vessels 12
meters or more in length. 4 CG–543 Policy Letter 10–05 canceled and
SUPPLEMENTARY INFORMATION: In 3 33 CFR 164.11—Self-propelled vessels 1600 or replaced by Navigation and Vessel Inspection
response to recommendations from more gross tons. Circular 01–16.

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Document Created: 2018-10-24 11:25:22
Document Modified: 2018-10-24 11:25:22
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by August 17, 2017.
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]
FR Citation		82 FR 32848
82 FR 32848 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 136 (July 18, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
