Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 41594-41596 [2020-14797]

Download as PDF 41594 Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices Our estimated burden for the information collection reflects an overall increase of 40 hours and a corresponding increase of one response/ record. We attribute this adjustment to an increase in the number of submissions we received over the last few years. collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0152. Also include the FDA docket number found in brackets in the heading of this document. Dated: July 6, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2020–14880 Filed 7–9–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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: Submit written comments (including recommendations) on the collection of information by August 10, 2020. 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 SUMMARY: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St. North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. 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 (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 March 4, 2020 (85 FR 12790), we published a 60day notice requesting public comment on the proposed collection of information. No comments were received. 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 recordkeepers jbell on DSKJLSW7X2PROD with NOTICES 21 CFR section 225.42(b)(5) through (8) requires records of receipt, storage, and inventory control of medicated feeds. 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. 225.80(b)(2) requires that verified medicated feed label(s) be kept for 1 year. 225.102(b)(1) through (5), requires records of Master Record Files and production records for medicated feeds. 225.110(b)(1) and (2) requires maintenance of distribution records for medicated feeds. VerDate Sep<11>2014 18:28 Jul 09, 2020 Jkt 250001 PO 00000 Frm 00080 Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 825 260 214,500 1 .......................... 825 45 37,125 0.50 (30 minutes) 825 1,600 1,320,000 0.12 (7 minutes) .. 158,400 825 7,800 6,435,000 0.08 (5 minutes) .. 514,800 825 7,800 6,435,000 0.02 (1 minute) .... 128,700 Fmt 4703 Sfmt 4703 E:\FR\FM\10JYN1.SGM 10JYN1 214,500 18,562.50 41595 Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED COMMERCIAL FEED MILLS) 1— Continued Number of recordkeepers 21 CFR section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 225.115(b)(1) and (2) requires maintenance of complaint files by the medicated feed manufacturer. 825 5 4,125 0.12 (7 minutes) .. 495 Total ........................................................................ ........................ ........................ ........................ ............................. 1,035,457.50 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED MIXER/FEEDERS) 1 Number of recordkeepers 21 CFR section 225.42(b)(5) through (8) requires records of receipt, storage, and inventory control of medicated feeds. 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. 225.80(b)(2) requires that verified medicated feed label(s) be kept for 1 year. 225.102(b)(1) through (5) requires records of Master Record Files and production records for medicated feeds. Total ........................................................................ 1 There Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 100 260 26,000 0.15 (9 minutes) .. 3,900 100 36 3,600 0.50 (30 minutes) 1,800 100 48 4,800 0.12 (7 minutes) .. 100 260 26,000 0.40 (24 minutes) 10,400 ........................ ........................ ........................ ............................. 16,676 576 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 recordkeepers 21 CFR section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours 225.142 requires procedures for identification, storage, and inventory control (receipt and use) of Type A medicated articles and Type B medicated feeds. 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. 225.180 requires identification, storage, and inventory control of labeling in a manner that prevents label mixups and assures that correct labels are used for medicated feeds. 225.202 requires records of formulation, production, and distribution of medicated feeds. 4,186 4 16,744 1 .......................... 16,744 4,186 1 4,186 4 .......................... 16,744 4,186 96 401,856 0.12 (7 minutes) .. 48,223 4,186 260 1,088,360 0.65 (39 minutes) 707,434 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 recordkeepers jbell on DSKJLSW7X2PROD with NOTICES 21 CFR section 225.142 requires procedures for identification, storage, and inventory control (receipt and use) of Type A medicated articles and Type B medicated feeds. 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. VerDate Sep<11>2014 18:28 Jul 09, 2020 Jkt 250001 PO 00000 Frm 00081 Number of records per recordkeeper Average burden per recordkeeper Total annual records Total hours 3,400 4 13,600 1 .......................... 13,600 3,400 1 3,400 4 .......................... 13,600 Fmt 4703 Sfmt 4703 E:\FR\FM\10JYN1.SGM 10JYN1 41596 Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED MIXER/FEEDERS) 1—Continued Number of recordkeepers 21 CFR section Average burden per recordkeeper Total annual records Total hours 225.180 requires identification, storage, and inventory control of labeling in a manner that prevents label mixups and assures that correct labels are used for medicated feeds. 225.202 requires records of formulation, production, and distribution of medicated feeds. 3,400 32 108,800 0.12 (7 minutes) .. 13,056 3,400 260 884,000 0.33 (20 minutes) 291,720 Total ........................................................................ ........................ ........................ ........................ ............................. 331,976 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects a decrease of 65,265.20 hours. We attribute this adjustment to a decrease in the number of respondents for Registered Licensed Commercial Feed Mills. Medicated Feed Mill licensing is voluntary. Firms may withdraw if they go out of business or if they change the source of the drug and a license is not required. Dated: July 2, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–14797 Filed 7–9–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0598] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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: Submit written comments (including recommendations) on the collection of information by August 10, 2020. 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. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Number of records per recordkeeper VerDate Sep<11>2014 18:28 Jul 09, 2020 Jkt 250001 Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0154. 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, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, 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. Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR part 226 OMB Control Number 0910–0154— Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including Type A medicated articles. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Statutory requirements for cGMPs for Type A medicated articles have been codified in part 226 (21 CFR part 226). Type A medicated articles that are not manufactured in accordance with these regulations are considered adulterated PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 under section 501(a)(2)(B) of the FD&C Act. Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under 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), and product distribution. The required records are used by both the respondents and FDA. The records are used by manufacturers of Type A medicated articles to verify that appropriate control measures have been maintained, or that appropriate corrective actions were taken if the control measures were not maintained. Such verification activities are essential to ensure that the cGMP system is working as planned. We review the records during the conduct of periodic plant inspections. This information is needed so that we can monitor drug usage and possible misformulation of Type A medicated articles. The information could also prove useful to us in investigating product defects when a drug is recalled. In addition, we will use the cGMP criteria in part 226 to determine whether or not the systems used by manufacturers of Type A medicated articles are adequate to ensure that their medicated articles meet the requirements of the FD&C Act as to safety and also meet the article’s claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act. In the Federal Register of February 21, 2020 (85 FR 10170), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41594-41596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14797]


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

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, Health and Human Services (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: Submit written comments (including recommendations) on the 
collection of information by August 10, 2020.

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 control number for 
this information collection is 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, 10A-12M, 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.

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 (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 March 4, 2020 (85 FR 12790), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 (8) requires records of               825             260         214,500  1.......................................         214,500
 receipt, storage, and inventory control of
 medicated feeds.
225.58(c) and (d) requires records of the                  825              45          37,125  0.50 (30 minutes).......................       18,562.50
 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 medicated              825           1,600       1,320,000  0.12 (7 minutes)........................         158,400
 feed label(s) be kept for 1 year.
225.102(b)(1) through (5), requires records of             825           7,800       6,435,000  0.08 (5 minutes)........................         514,800
 Master Record Files and production records
 for medicated feeds.
225.110(b)(1) and (2) requires maintenance of              825           7,800       6,435,000  0.02 (1 minute).........................         128,700
 distribution records for medicated feeds.

[[Page 41595]]

 
225.115(b)(1) and (2) requires maintenance of              825               5           4,125  0.12 (7 minutes)........................             495
 complaint files by the medicated feed
 manufacturer.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................    1,035,457.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                  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 (8) requires records of               100             260          26,000  0.15 (9 minutes)........................           3,900
 receipt, storage, and inventory control of
 medicated feeds.
225.58(c) and (d) requires records of the                  100              36           3,600  0.50 (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 medicated              100              48           4,800  0.12 (7 minutes)........................             576
 feed label(s) be kept for 1 year.
225.102(b)(1) through (5) requires records of              100             260          26,000  0.40 (24 minutes).......................          10,400
 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 and            4,186               1           4,186  4.......................................          16,744
 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, and            4,186              96         401,856  0.12 (7 minutes)........................          48,223
 inventory control of labeling in a manner
 that prevents label mixups and assures that
 correct labels are used for medicated feeds.
225.202 requires records of formulation,                 4,186             260       1,088,360  0.65 (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  recordkeeper       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 and            3,400               1           3,400  4.......................................          13,600
 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.

[[Page 41596]]

 
225.180 requires identification, storage, and            3,400              32         108,800  0.12 (7 minutes)........................          13,056
 inventory control of labeling in a manner
 that prevents label mixups and assures that
 correct labels are used for medicated feeds.
225.202 requires records of formulation,                 3,400             260         884,000  0.33 (20 minutes).......................         291,720
 production, and distribution of medicated
 feeds.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         331,976
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects a 
decrease of 65,265.20 hours. We attribute this adjustment to a decrease 
in the number of respondents for Registered Licensed Commercial Feed 
Mills. Medicated Feed Mill licensing is voluntary. Firms may withdraw 
if they go out of business or if they change the source of the drug and 
a license is not required.

    Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14797 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P


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