Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, 35357-35358 [2014-14473]
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Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices
35357
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Instrument
Estimated Total Annual Burden Hours: ....................................................
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–14460 Filed 6–19–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
22:31 Jun 19, 2014
Jkt 232001
Number of
responses per
respondent
Average
burden hours
per response
........................
........................
........................
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 July 21,
2014.
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 0910–0620. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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.
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species
21 CFR Part 516—(OMB Control
Number 0910–0620)—(Extension)
Description: The Minor Use and
Minor Species Animal Health Act of
2004 (MUMS Act) amended the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) to authorize FDA to establish
new regulatory procedures intended to
make more medications legally available
to veterinarians and animal owners for
the treatment of minor animal species
(species other than cattle, horses, swine,
chickens, turkeys, dogs, and cats), as
well as uncommon diseases in major
animal species.
The MUMS Act created three new
sections to the FD&C Act (sections 571,
572, and 573), and this final rule
implements section 572 of the FD&C Act
(21 U.S.C. 360ccc–1), which provides
for an index of legally marketed
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Total burden
hours
378
unapproved new animal drugs for minor
species. Participation in any part of the
MUMS program is optional so the
associated paperwork only applies to
those who choose to participate. The
final rule specifies, among other things,
the criteria and procedures for
requesting eligibility for indexing and
for requesting addition to the index as
well as the annual reporting
requirements for index holders.
Under subpart C of part 516, § 516.119
provides requirements for naming a
permanent-resident U.S. agent by
foreign drug companies, and § 516.121
provides for informational meetings
with FDA. Section 516.123 provides
requirements for requesting informal
conferences regarding Agency
administrative actions and § 516.125
provides for investigational use of new
animal drugs intended for indexing.
Provisions for requesting a
determination of eligibility for indexing
can be found under § 516.129 and
provisions for subsequent requests for
addition to the index can be found
under § 516.145. A description of the
written report required in § 516.145 can
be found under § 516.143. Under
§ 516.141 are provisions for drug
companies to nominate a qualified
expert panel as well as the panel’s
recordkeeping requirements. This
section also calls for the submission of
a written conflict of interest statement to
FDA by each proposed panel member.
Index holders are able to modify their
index listing under § 516.161 or change
drug ownership under § 516.163.
Requirements for records and reports
are under § 516.165.
Description of Respondents:
Pharmaceutical companies that sponsor
new animal drugs.
In the Federal Register of April 7,
2014 (79 FR 19094), FDA 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\20JNN1.SGM
20JNN1
35358
Federal Register / Vol. 79, No. 119 / Friday, June 20, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
516.119
516.121
516.123
516.125
516.129
516.141
516.143
516.145
516.161
516.163
516.165
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total Hours
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
2
30
3
2
30
20
20
20
1
1
10
1
2
1
3
2
1
1
1
1
1
2
2
60
3
6
60
20
20
20
1
1
20
1
4
8
20
20
16
120
20
4
2
8
2
240
24
120
1200
320
2400
400
4
2
160
Total ..............................................................................
........................
........................
........................
........................
4,872
1 There
is no capital or operating and maintenance cost associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
516.141 ................................................................................
516.165 ................................................................................
30
10
2
2
60
20
2 0.5
1
30
20
Total ..............................................................................
........................
........................
........................
........................
50
1 There
is no capital or operating and maintenance cost associated with this collection of information.
2 30 minutes.
Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
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.
[Docket No. FDA–2004–N–0193]
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–14473 Filed 6–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 July 21,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
22:31 Jun 19, 2014
Jkt 232001
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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 that they
E:\FR\FM\20JNN1.SGM
20JNN1
]]>Agencies
[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35357-35358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14473]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Index of Legally
Marketed Unapproved New Animal Drugs for Minor Species
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 July
21, 2014.
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 0910-0620.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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.
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
21 CFR Part 516--(OMB Control Number 0910-0620)--(Extension)
Description: The Minor Use and Minor Species Animal Health Act of
2004 (MUMS Act) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) to authorize FDA to establish new regulatory procedures
intended to make more medications legally available to veterinarians
and animal owners for the treatment of minor animal species (species
other than cattle, horses, swine, chickens, turkeys, dogs, and cats),
as well as uncommon diseases in major animal species.
The MUMS Act created three new sections to the FD&C Act (sections
571, 572, and 573), and this final rule implements section 572 of the
FD&C Act (21 U.S.C. 360ccc-1), which provides for an index of legally
marketed unapproved new animal drugs for minor species. Participation
in any part of the MUMS program is optional so the associated paperwork
only applies to those who choose to participate. The final rule
specifies, among other things, the criteria and procedures for
requesting eligibility for indexing and for requesting addition to the
index as well as the annual reporting requirements for index holders.
Under subpart C of part 516, Sec. 516.119 provides requirements
for naming a permanent-resident U.S. agent by foreign drug companies,
and Sec. 516.121 provides for informational meetings with FDA. Section
516.123 provides requirements for requesting informal conferences
regarding Agency administrative actions and Sec. 516.125 provides for
investigational use of new animal drugs intended for indexing.
Provisions for requesting a determination of eligibility for indexing
can be found under Sec. 516.129 and provisions for subsequent requests
for addition to the index can be found under Sec. 516.145. A
description of the written report required in Sec. 516.145 can be
found under Sec. 516.143. Under Sec. 516.141 are provisions for drug
companies to nominate a qualified expert panel as well as the panel's
recordkeeping requirements. This section also calls for the submission
of a written conflict of interest statement to FDA by each proposed
panel member. Index holders are able to modify their index listing
under Sec. 516.161 or change drug ownership under Sec. 516.163.
Requirements for records and reports are under Sec. 516.165.
Description of Respondents: Pharmaceutical companies that sponsor
new animal drugs.
In the Federal Register of April 7, 2014 (79 FR 19094), FDA
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:
[[Page 35358]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total Hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
516.119......................... 2 1 2 1 2
516.121......................... 30 2 60 4 240
516.123......................... 3 1 3 8 24
516.125......................... 2 3 6 20 120
516.129......................... 30 2 60 20 1200
516.141......................... 20 1 20 16 320
516.143......................... 20 1 20 120 2400
516.145......................... 20 1 20 20 400
516.161......................... 1 1 1 4 4
516.163......................... 1 1 1 2 2
516.165......................... 10 2 20 8 160
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,872
----------------------------------------------------------------------------------------------------------------
\1\ There is no capital or operating and maintenance cost associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
516.141......................... 30 2 60 \2\ 0.5 30
516.165......................... 10 2 20 1 20
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 50
----------------------------------------------------------------------------------------------------------------
\1\ There is no capital or operating and maintenance cost associated with this collection of information.
\2\ 30 minutes.
Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14473 Filed 6-19-14; 8:45 am]
BILLING CODE 4160-01-P
