Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, 75481-75482 [2010-30335]
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75481
Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices
TABLE 1—TOTAL ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Physician survey—pretest ...................................................
Physician survey—main study .............................................
Consumer experiment—pretest ...........................................
Consumer experiment—main study ....................................
Annual
frequency
per response
100
600
200
2,500
Total annual
responses
1
1
1
1
100
600
200
2,500
Total ..............................................................................
1 There
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.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the burden hours associated with
indexing of legally marketed
unapproved new animal drugs for minor
species.
DATES: Submit either electronic or
written comments on the collection of
information by February 1, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
SUMMARY:
VerDate Mar<15>2010
16:09 Dec 02, 2010
Jkt 223001
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
33
198
50
625
906
docket number found in brackets in the
heading of this document.
[FR Doc. 2010–30385 Filed 12–2–10; 8:45 am]
ACTION:
.33
.33
.25
.25
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Hours per
response
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species—
21 CFR Part 516 (OMB Control Number
0910–0620)—Extension
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 added three new
sections to the FD&C Act (sections 571,
572, and 573 (21 U.S.C. 360ccc, 360ccc–
1, and 360ccc–2, respectively)). The
final rule (72 FR 69108, December 6,
2007) implements section 572 of the
FD&C Act, 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 the new subpart C of part 516
(21 CFR part 516, subpart C), § 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
E:\FR\FM\03DEN1.SGM
03DEN1
75482
Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices
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.
FDA estimates the burden of this
collection of information as follows:
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
Annual
frequency
per response
Total annual
responses
Hours 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
1,200
320
2,400
400
4
2
160
Total ..............................................................................
........................
........................
........................
........................
4,872
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Annual
frequency per
recordkeeper
516.141 ................................................................................
516.165 ................................................................................
30
10
2
2
60
20
0.5
1
30
20
Total ..............................................................................
........................
........................
........................
........................
50
21 CFR Section
1 There
addresses the United States
Pharmacopeia (USP) General Chapter
<467> Residual Solvents that applies to
both human and veterinary drugs and to
compendial and non-compendial drug
products. This document answers
questions regarding CVM’s
implementation of USP <467> Residual
Solvents.
[FR Doc. 2010–30335 Filed 12–2–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by February 1, 2011.
DATES:
Food and Drug Administration
[Docket No. FDA–2010–D–0566]
Draft Guidance for Industry on
Residual Solvents in Animal Drug
Products; Questions and Answers;
Availability
Food and Drug Administration,
mstockstill on DSKH9S0YB1PROD with NOTICES
HHS.
ACTION:
Hours per
recordkeeper
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Total annual
records
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry #211 entitled ‘‘Residual
Solvents in Animal Drug Products;
Questions and Answers.’’ The draft
questions and answers (Q&A) guidance
SUMMARY:
VerDate Mar<15>2010
16:09 Dec 02, 2010
Jkt 223001
Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sudesh Kamath, Center for Veterinary
Medicine (HFV–145), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8260, email: sudesh.kamath@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 1, 2008, the USP
implemented a requirement for the
control of residual solvents in drug
products marketed in the United States.
Once implemented, the requirement,
USP General Chapter <467> Residual
Solvents, became a statutory
requirement under section 501(b) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 351(b)).
FDA is announcing the availability of
a draft guidance for industry #211
entitled ‘‘Residual Solvents in Animal
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75481-75482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30335]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the burden hours associated
with indexing of legally marketed unapproved new animal drugs for minor
species.
DATES: Submit either electronic or written comments on the collection
of information by February 1, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Index of Legally Marketed Unapproved New Animal Drugs for Minor
Species--21 CFR Part 516 (OMB Control Number 0910-0620)--Extension
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 added three new sections to the FD&C Act (sections
571, 572, and 573 (21 U.S.C. 360ccc, 360ccc-1, and 360ccc-2,
respectively)). The final rule (72 FR 69108, December 6, 2007)
implements section 572 of the FD&C Act, 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 the new subpart C of part 516 (21 CFR part 516, subpart C),
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
[[Page 75482]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per Total hours
respondents response responses 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 1,200
516.141......................... 20 1 20 16 320
516.143......................... 20 1 20 120 2,400
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 are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeper records recordkeeper
----------------------------------------------------------------------------------------------------------------
516.141......................... 30 2 60 0.5 30
516.165......................... 10 2 20 1 20
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: November 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30335 Filed 12-2-10; 8:45 am]
BILLING CODE 4160-01-P
