Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals, 51821-51822 [E8-20578]
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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by November 4, 2008:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations and
Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lllll,
Room C4–26–05,
7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Dated: August 29, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–20686 Filed 9–4–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Extralabel Drug
Use in Animals
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 October 6,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0325. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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.
Extralabel Drug Use in Animals—21
CFR part 530 (OMB Control Number
0910–0325)—Extension
Under part 530 (21 CFR Part 530), a
veterinarian is permitted to prescribe
the extralabel use of approved new
animal drugs. Section 530.22 (b) of the
implementing regulations permits FDA,
if it finds there is a reasonable
51821
probability that the extralabel use of an
animal drug may present a risk to the
public health, to: (1) Establish a safe
level for a residue from the extralabel
use of the drug, and (2) require the
development of an analytical method for
the detection of residues above that
established safe level. To date, FDA has
not established a safe level for a residue
from the extralabel use of any new
animal drug and therefore has not
required the development of analytical
methodology. However, the agency
believes that there may be instances
when analytical methodology will be
required. Thus, FDA is estimating the
reporting burden based on two methods
being required annually. The
requirement to establish an analytical
method may be fulfilled by any
interested person. The agency believes
that the sponsor of the drug will be
willing to develop the method in most
cases. Alternatively, FDA, the sponsor,
and perhaps a third party may
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs, State, or
Federal government, or individuals.
In the Federal Register of June 3, 2008
(73 FR 31693), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
530.22(b)
mstockstill on PROD1PC66 with NOTICES
1 There
Annual Frequency
per Response
2
Total Annual
Responses
1
Hours per
Response
2
4,160
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
18:40 Sep 04, 2008
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Total Hours
8,320
51822
Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices
Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–20578 Filed 9–4–08; 8:45 am]
Fax written comments on the
collection of information by October 6,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0363. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0474] (formerly
Docket No. 2005N–0210)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Veterinary Feed
Directive
AGENCY:
FOR FURTHER INFORMATION CONTACT:
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.
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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.
Veterinary Feed Directive—21 CFR Part
558 (OMB Control Number 0910–
0363)—Extension
With passage of the Animal Drug
Availability Act, Congress enacted
legislation establishing a new class of
restricted feed use drugs called
Veterinary Feed Directive (VFD) drugs.
The VFD class of drugs may be
distributed without involving State
pharmacy laws. Although controls on
the distribution and use of VFD drugs
are similar to controls for prescription
drugs regulated under section 503(f) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 503(f)), the implementing
VFD regulation under section 558.6 (21
CFR 558.6) is tailored to the unique
circumstances relating to the
distribution of medicated feeds. The
content of the VFD is spelled out in the
regulation. All distributors of medicated
feed containing VFD drugs must notify
FDA of their intent to distribute, and the
distribution records of all medicated
feeds containing VFD must be
maintained. The VFD regulation ensures
the protection of the public health while
enabling animal producers to obtain and
use needed drugs as efficiently and costeffectively as possible.
In the Federal Register of June 5, 2008
(73 FR 32029), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
558.6(a)(3) through (a)(5)
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
15,000
25
375,000
.25
93,750
300
1
300
.25
75
20
1
20
.25
5
558.6(d)(2)
1,000
5
5,000
.25
1,250
514..1(b)(9)
1
1
1
3.00
3
558.6(d)(1)(i) through (d)(1)(iii)
558.6(d)(1)(iv)
Total
1 There
16,321
95,083
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
558.6(c)(1) through (c)(4)
112,500
10
1,125,000
.0167
18,788
558.6(e)(1) through (e)(4)
5,000
75
375,000
.0167
6,263
Total
mstockstill on PROD1PC66 with NOTICES
1 There
117,500
25,051
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
18:40 Sep 04, 2008
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PO 00000
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Fmt 4703
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05SEN1
]]>Agencies
[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51821-51822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20578]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0312]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Extralabel Drug Use
in Animals
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 October
6, 2008.
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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0325. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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.
Extralabel Drug Use in Animals--21 CFR part 530 (OMB Control Number
0910-0325)--Extension
Under part 530 (21 CFR Part 530), a veterinarian is permitted to
prescribe the extralabel use of approved new animal drugs. Section
530.22 (b) of the implementing regulations permits FDA, if it finds
there is a reasonable probability that the extralabel use of an animal
drug may present a risk to the public health, to: (1) Establish a safe
level for a residue from the extralabel use of the drug, and (2)
require the development of an analytical method for the detection of
residues above that established safe level. To date, FDA has not
established a safe level for a residue from the extralabel use of any
new animal drug and therefore has not required the development of
analytical methodology. However, the agency believes that there may be
instances when analytical methodology will be required. Thus, FDA is
estimating the reporting burden based on two methods being required
annually. The requirement to establish an analytical method may be
fulfilled by any interested person. The agency believes that the
sponsor of the drug will be willing to develop the method in most
cases. Alternatively, FDA, the sponsor, and perhaps a third party may
cooperatively arrange for method development. The respondents may be
sponsors of new animal drugs, State, or Federal government, or
individuals.
In the Federal Register of June 3, 2008 (73 FR 31693), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
530.22(b) 2 1 2 4,160 8,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 51822]]
Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20578 Filed 9-4-08; 8:45 am]
BILLING CODE 4160-01-S
