Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 6620-6621 [2011-2548]

Download as PDF 6620 Federal Register / Vol. 76, No. 25 / Monday, February 7, 2011 / Notices for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: January 31, 2011. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2011–2551 Filed 2–4–11; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES [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, HHS. ACTION: FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7651, Juanmanuel.vilela@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 Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910–0152)—Extension Food and Drug Administration AGENCY: 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. ADDRESSES: Notice. 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 March 9, 2011. SUMMARY: 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 manufacture 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 mixerfeeders. In the Federal Register of November, 29, 2010 (75 FR 73101), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments. 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 Annual frequency per recordkeeping 225.42(b)(5) through (b)(8) ................................................ 225.58(c) and (d) ............................................................... 225.80(b)(2) ....................................................................... 225.102(b)(1) ..................................................................... 225.110(b)(1) and (b)(2) .................................................... 225.115(b)(1) and (b)(2) .................................................... 1,004 1,004 1,004 1,004 1,004 1,004 260 45 1,600 7,800 7,800 5 261,040 45,180 1,606,400 7,831,200 7,831,200 5,020 Total ............................................................................ ........................ ........................ ........................ emcdonald on DSK2BSOYB1PROD with NOTICES 21 CFR section 1 There Total annual records Hours per record 1 .5 .12 .08 .015 .12 261,040 22,590 192,768 626,496 117,468 602 .......................... 1,220,964 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 17:16 Feb 04, 2011 Jkt 223001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\07FEN1.SGM Total hours 07FEN1 6621 Federal Register / Vol. 76, No. 25 / Monday, February 7, 2011 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN [Registered licensed mixer-feeders] 1 Number of recordkeepers Annual frequency per recordkeeping 225.42(b)(5) through (b)(8) ................................................ 225.58(c) and (d) ............................................................... 225.80(b)(2) ....................................................................... 225.102(b)(1) ..................................................................... 100 100 100 100 260 36 48 260 26,000 3,600 4,800 26,000 .15 .5 .12 .4 3,900 1,800 576 10,400 Total ............................................................................ ........................ ........................ ........................ .......................... 16,676 21 CFR section 1 There Total annual records Hours per record Total hours 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 Annual frequency per recordkeeping .............................................................................. .............................................................................. .............................................................................. .............................................................................. 8,000 8,000 8,000 8,000 4 1 96 260 32,000 8,000 768,000 2,080,000 1 4 .12 .65 32,000 32,000 92,160 1,352,000 Total ............................................................................ ........................ ........................ ........................ .......................... 1,508,160 21 CFR section 225.142 225.158 225.180 225.202 1 There Total annual records Hours per record Total hours 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 Annual frequency per recordkeeping .............................................................................. .............................................................................. .............................................................................. .............................................................................. 45,000 45,000 45,000 45,000 4 1 32 260 180,000 45,000 1,440,000 11,700,000 1 4 .12 .33 180,000 180,000 172,800 3,861,000 Total ............................................................................ ........................ ........................ ........................ .......................... 4,393,800 21 CFR section 225.142 225.158 225.180 225.202 1 There Hours per record Total hours are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the times required for record preparation and maintenance is based on Agency communications with industry. Other information needed to finally calculate the total burden hours (i.e., number of recordkeepers, number of medicated feeds being manufactured, etc.) is derived from Agency records and experience. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0536] Dated: February 1, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension [FR Doc. 2011–2548 Filed 2–4–11; 8:45 am] AGENCY: BILLING CODE 4160–01–P emcdonald on DSK2BSOYB1PROD with NOTICES Total annual records HHS. ACTION: Food and Drug Administration, Notice. 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. SUMMARY: VerDate Mar<15>2010 17:16 Feb 04, 2011 Jkt 223001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 Fax written comments on the collection of information by March 9, 2011. DATES: 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 0910–0557. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6620-6621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2548]

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

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 March
9, 2011.

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 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.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@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 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 manufacture 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 November, 29, 2010 (75 FR 73101), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Recordkeeping Burden
[Registered licensed commercial feed mills] \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)..... 1,004 260 261,040 1 261,040
225.58(c) and (d)............... 1,004 45 45,180 .5 22,590
225.80(b)(2).................... 1,004 1,600 1,606,400 .12 192,768
225.102(b)(1)................... 1,004 7,800 7,831,200 .08 626,496
225.110(b)(1) and (b)(2)........ 1,004 7,800 7,831,200 .015 117,468
225.115(b)(1) and (b)(2)........ 1,004 5 5,020 .12 602
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,220,964
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

[[Page 6621]]

Table 2--Estimated Annual Recordkeeping Burden
[Registered licensed mixer-feeders] \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)..... 100 260 26,000 .15 3,900
225.58(c) and (d)............... 100 36 3,600 .5 1,800
225.80(b)(2).................... 100 48 4,800 .12 576
225.102(b)(1)................... 100 260 26,000 .4 10,400
-------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.142......................... 8,000 4 32,000 1 32,000
225.158......................... 8,000 1 8,000 4 32,000
225.180......................... 8,000 96 768,000 .12 92,160
225.202......................... 8,000 260 2,080,000 .65 1,352,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,508,160
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.142......................... 45,000 4 180,000 1 180,000
225.158......................... 45,000 1 45,000 4 180,000
225.180......................... 45,000 32 1,440,000 .12 172,800
225.202......................... 45,000 260 11,700,000 .33 3,861,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,393,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The estimate of the times required for record preparation and
maintenance is based on Agency communications with industry. Other
information needed to finally calculate the total burden hours (i.e.,
number of recordkeepers, number of medicated feeds being manufactured,
etc.) is derived from Agency records and experience.

Dated: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2548 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P

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