Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008, 7272-7274 [2010-3029]
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7272
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Section of the Federal
Food, Drug,
and Cosmetic Act
No. of
Respondents
Annual Frequency
per Response
Total Annual
Respondents
Hours per
Response
Total Hours
520(m)(6)(A)(iii)
1
1
1
100
100
520(m)(6)(C)
5
1
5
100
500
Total
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
1,250
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the
number of original HDE applications
that the Center for Devices and
Radiological Health (CDRH) received for
the period October 1, 2004, through
September 30, 2007. During that time,
CDRH received 16 original HDE
applications or about 5 per year.
FDA estimates that for each year,
CDRH will receive five HDE
applications and that three of these
applications will be indicated for
pediatric use. One HDE holder will
notify the agency that the number of
devices distributed in the year has
exceeded the ADN and five HDE holders
will petition to have the ADN modified
due to additional information on the
number of individuals affected by the
disease of condition.
The draft guidance refers also to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 803 have been approved under
OMB control number 0910–0437; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814, subparts A, B, and C, have
been approved under OMB control
number 0910–0231; the collection of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; the collections of
information in 21 CFR part 814, subpart
H, have been approved under OMB
control number 0910–0332; and the
collection of information requirements
in 21 CFR 10.30 have been approved
under OMB control number 0910–0183.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3030 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
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Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0512]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Antimicrobial
Animal Drug Distribution Reports
Under Section 105 of the Animal Drug
User Fee Amendments of 2008
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 22,
2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Antimicrobial Animal Drug
Distribution Reports Under Section 105
of the Animal Drug User Fee
Amendments of 2008.’’ 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, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 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.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Antimicrobial Animal Drug
Distribution Reports Under Section 105
of the Animal Drug User Fee
Amendments of 2008—(OMB Control
Number 0910–NEW)—Extension
Section 105 of the Animal Drug User
Fee Amendments of 2008 (ADUFA)
amended section 512 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360b) to require that the
sponsor of each new animal drug that
contains an antimicrobial agent submit
an annual report to FDA on the amount
of each antimicrobial active ingredient
in the drug that is sold or distributed for
use in food-producing animals,
including information on any
distributor-labeled product. The
legislation was enacted to address the
problem of antimicrobial resistance, and
to help ensure that FDA has the
necessary information to examine safety
concerns related to the use of antibiotics
in food-producing animals (154
Congressional Record H7534).
Each report must specify: (1) The
amount of each antimicrobial active
ingredient by container size, strength,
and dosage form; (2) quantities
distributed domestically and quantities
exported; and (3) a listing of the target
animals, indications, and production
classes that are specified on the
approved label of the product.
The first report must be submitted not
later than March 31, 2010. The report
must cover the period of the preceding
calendar year and include separate
information for each month of the
calendar year. The reports required
under section 105 of ADUFA are
required to be separate from periodic
drug experience reports that are
required under § 514.80(b)(4) (21 CFR
§ 514.80(b)(4) (OMB Control No. 0910–
0284).
In the Federal Register of October 26,
2009 (74FR 55046), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received comments
from two organizations. Both
commenters supported the information
collection and stated that the data to be
collected would be useful in addressing
E:\FR\FM\18FEN1.SGM
18FEN1
7273
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
the problem of antimicrobial resistance.
However, both comments suggested that
more extensive measures are necessary
to address this problem. For example,
one of the comments stated that the
practical utility of the data would be
broadened in conjunction with a larger
federal monitoring effort requiring
manufacturers to report uses of their
products in all food animal products,
which would involve collecting data
from end users such as veterinarians
and animal owners. The other comment
stated that the information collection
would not be sufficient to show how
much of each class of antimicrobial is
sold for use in different types of food
animals, and recommended that FDA
collect distribution data on medicated
feeds for this purpose because feeds are
specific to animal species and class. The
comment also recommended that FDA
require all data to be submitted through
a Web-based application directly into a
form created by FDA, and that FDA
create a publically accessible database
that allows searches by drug class, dose
form, and marketing status. FDA has
considered the comments, but at this
time we have decided to only require
the submission of information that is
expressly required to be submitted by
section 512(l)(3) of the act. We are
pursuing notice and comment
rulemaking to codify these
requirements, during which time we
will assess any additional data
requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FD&C Act
Section 512(l)(3)
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Hours
Capital
Cost
Annual Reports for
Sponsors with Active Applications
29
6.7
194
80
15,520
Annual Reports for
Sponsors with Inactive Applications
23
4.0
92
1
92
Total
1 There
15,612
$107,880
$107,880
are no operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
FD&C Act
Section 512(l)(3)
No. of
Respondents
All Applicants
Annual Frequency of
Recordkeeping
34
Total Annual
Records
1
Hours per
Record
34
2
Total
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
Total Hours
68
68
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden estimates,
including the total number of annual
responses, are based on the number of
sponsors and approved applications for
antimicrobial drug products in foodproducing animals. The annual
frequency of responses was calculated
as the total annual responses divided by
the number of respondents.
The agency arrived at the estimates
for reporting as follows: There are 34
sponsors with approved applications for
antimicrobial drugs for food-producing
animals. There are 29 animal drug
manufacturers with 194 approved
applications for antimicrobial drugs for
food-producing animals for which the
drugs are being actively marketed
(active applications). Additionally, there
are 93 approved applications for
antimicrobial drugs for food-producing
animals for which the drugs are not
being marketed (inactive applications),
owned by 23 animal drug
manufacturers.
Regarding the reporting burden
associated with the collection of
information, FDA believes that the large
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14:39 Feb 17, 2010
Jkt 220001
majority of the burden will be incurred
by industry in the first year in which
reporting is required to design a report
that meets the requirements of section
512(l)(3) of the act. The agency has
estimated this burden at 80 hours per
applicant with active applications. The
agency has factored into this estimate
the time it will take industry to identify
and locate the necessary information
within existing records, and to develop
a report that complies with section
512(l)(3) of the act. Once this has been
accomplished, FDA believes that the
process for producing reports in
subsequent years will essentially be
automated, and that it will take
approximately 3 hours to run a report
that satisfies the act’s requirements. For
sponsors of approved applications that
are inactive (i.e., the approved drug is
not being marketed), the sponsor would
only have to submit a report stating that
the drug is not being marketed, which
FDA estimates will take approximately
1 hour.
FDA has developed a form to report
the information required by section
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
512(l)(3) of the act. FDA plans to make
the form available to animal drug
manufacturers through FDA’s Web site,
however, use of the form would be
entirely voluntary. The form contains
various fields for information, including
the drug manufacturer’s name, NADA
number, active ingredient name,
National Drug Code number, container
size, potency, and the number of units
sold by month.
The animal drug manufacturers can
meet the statutory requirements by
submitting their information in paper
format using either the FDA-provided
form or one of their own design or by
designing their own electronic form
whose results could be submitted to the
agency on a compact disc or on paper.
The cost to animal drug sponsors for
gathering the necessary information for
report design and preparation or for
completing FDA’s form in the first year
of reporting is $107,880 (29 active
sponsors x 80 hours x $46.50 per hour
= $107,880). This is a one-time cost for
a computer or mathematic employees to
design and prepare a report that satisfies
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7274
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
the statutory requirements of section
512(l)(3) of the act.1 For subsequent
years, the preparation of the report
should take approximately 3 hours.
Thus, the total cost in subsequent years
would be $139.50.
Regarding the recordkeeping burden
associated with this collection of
information, FDA believes that most of
the necessary information for the annual
report required to be submitted under
section 512(l)(3) of the act is already
collected and maintained by animal
drug manufacturers under existing
requirements.
Animal drug manufacturers are
already required to maintain
distribution records for their drug
products to comply with FDA’s current
good manufacturing practice regulations
under § 211.196 (21 CFR § 211.96) (OMB
Control No. 0910–0139), and to comply
with regulations for periodic drug
experience reports under
§ 514.80(b)(4)(i) (OMB Control No.
0910–0284). Therefore, FDA believes
that manufacturers of animal drugs
already possess the computers, software,
and additional equipment necessary to
collect and maintain the necessary
records and to make reports.
Section 512(l)(3) of the act differs
from § 514.80(b)(4)(i) in that it requires
that records include separate
information for each month of the
calendar year. Under § 211.196 (OMB
Control No. 0910–0139), manufacturers
currently are required to maintain
distribution records that include the
dosage form and date the drug is
distributed. Additionally, FDA believes
that manufacturers already keep
detailed records of the dates when
antimicrobial drugs are distributed for
marketing and recall purposes from
which monthly reports can be prepared
as part of their usual and customary
practice. However, FDA estimates an
additional hourly burden required by
section 512(l)(3) of the act as shown in
table 2 of this document.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
[FR Doc. 2010–3029 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
1 BLS Occupation Employment and Wages, May
2006, by occupation, for all industries (https://
www.bls.gov). Wage ($46.50) includes mean hourly
wage of $33.22 for Standard Occupational
Classification 15–0000, computer and mathematics
occupations, all industries; we add 40 percent to
account for benefits.
VerDate Nov<24>2008
16:37 Feb 17, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0390] (formerly
Docket No. 2004N–0503)
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Consultation Procedures: Foods
Derived From New Plant Varieties
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
FDA’s consultation procedures for foods
derived from new plant varieties,
including the information collection
provisions in the guidance entitled
‘‘Consultation Procedures: Foods
Derived From New Plant Varieties,’’ and
in Form FDA 3665 entitled ‘‘Final
Consultation For Food Derived From a
New Plant Variety (Biotechnology Final
Consultation),’’ which developers may
use to prepare the final consultation in
a standard format.
DATES: Submit written or electronic
comments on the collection of
information by April 19, 2010.
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
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. In the Federal
Register of November 24, 2004 (69 FR
68379), FDA published a previous 60day notice requesting public comment
on this proposed collection of
information. FDA is publishing this
notice to update comments. Comments
previously submitted to the Division of
Dockets Management do not need to be
resubmitted because all such comments
that are responsive to the comment
request will be summarized and
responded to in the Information
Collection Request, i.e. 30-day notice,
submitted to OMB.
Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties
Since 1992, when FDA issued its
Statement of Policy: Foods Derived from
New Plant Varieties (the 1992 policy)
(57 FR 22984, May 29, 1992), FDA has
encouraged developers of new plant
varieties, including those varieties that
are developed through biotechnology, to
consult with FDA during the plant
development process to discuss possible
scientific and regulatory issues that
might arise. In the 1992 policy, FDA
explained that, under the Federal Food,
Drug, and Cosmetic Act (the act),
developers of new foods (in this
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]]>Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7272-7274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3029]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0512]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Antimicrobial Animal
Drug Distribution Reports Under Section 105 of the Animal Drug User Fee
Amendments of 2008
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
22, 2010.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910--NEW and
title ``Antimicrobial Animal Drug Distribution Reports Under Section
105 of the Animal Drug User Fee Amendments of 2008.'' 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, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 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.
Antimicrobial Animal Drug Distribution Reports Under Section 105 of the
Animal Drug User Fee Amendments of 2008--(OMB Control Number 0910-
NEW)--Extension
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA)
amended section 512 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360b) to require that the sponsor of each new animal
drug that contains an antimicrobial agent submit an annual report to
FDA on the amount of each antimicrobial active ingredient in the drug
that is sold or distributed for use in food-producing animals,
including information on any distributor-labeled product. The
legislation was enacted to address the problem of antimicrobial
resistance, and to help ensure that FDA has the necessary information
to examine safety concerns related to the use of antibiotics in food-
producing animals (154 Congressional Record H7534).
Each report must specify: (1) The amount of each antimicrobial
active ingredient by container size, strength, and dosage form; (2)
quantities distributed domestically and quantities exported; and (3) a
listing of the target animals, indications, and production classes that
are specified on the approved label of the product.
The first report must be submitted not later than March 31, 2010.
The report must cover the period of the preceding calendar year and
include separate information for each month of the calendar year. The
reports required under section 105 of ADUFA are required to be separate
from periodic drug experience reports that are required under Sec.
514.80(b)(4) (21 CFR Sec. 514.80(b)(4) (OMB Control No. 0910-0284).
In the Federal Register of October 26, 2009 (74FR 55046), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from two
organizations. Both commenters supported the information collection and
stated that the data to be collected would be useful in addressing
[[Page 7273]]
the problem of antimicrobial resistance. However, both comments
suggested that more extensive measures are necessary to address this
problem. For example, one of the comments stated that the practical
utility of the data would be broadened in conjunction with a larger
federal monitoring effort requiring manufacturers to report uses of
their products in all food animal products, which would involve
collecting data from end users such as veterinarians and animal owners.
The other comment stated that the information collection would not be
sufficient to show how much of each class of antimicrobial is sold for
use in different types of food animals, and recommended that FDA
collect distribution data on medicated feeds for this purpose because
feeds are specific to animal species and class. The comment also
recommended that FDA require all data to be submitted through a Web-
based application directly into a form created by FDA, and that FDA
create a publically accessible database that allows searches by drug
class, dose form, and marketing status. FDA has considered the
comments, but at this time we have decided to only require the
submission of information that is expressly required to be submitted by
section 512(l)(3) of the act. We are pursuing notice and comment
rulemaking to codify these requirements, during which time we will
assess any additional data requirements.
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
FD&C Act Section 512(l)(3) Respondents per Response Responses Response Total Hours Capital Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors with Active 29 6.7 194 80 15,520 $107,880
Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors with Inactive 23 4.0 92 1 92 ..............
Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 15,612 $107,880
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
FD&C Act
Section No. of Annual Frequency of Total Annual Hours per Record Total Hours
512(l)(3) Respondents Recordkeeping Records
----------------------------------------------------------------------------------------------------------------
All Applicants 34 1 34 2 68
----------------------------------------------------------------------------------------------------------------
Total 68
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The reporting burden estimates, including the total number of
annual responses, are based on the number of sponsors and approved
applications for antimicrobial drug products in food-producing animals.
The annual frequency of responses was calculated as the total annual
responses divided by the number of respondents.
The agency arrived at the estimates for reporting as follows: There
are 34 sponsors with approved applications for antimicrobial drugs for
food-producing animals. There are 29 animal drug manufacturers with 194
approved applications for antimicrobial drugs for food-producing
animals for which the drugs are being actively marketed (active
applications). Additionally, there are 93 approved applications for
antimicrobial drugs for food-producing animals for which the drugs are
not being marketed (inactive applications), owned by 23 animal drug
manufacturers.
Regarding the reporting burden associated with the collection of
information, FDA believes that the large majority of the burden will be
incurred by industry in the first year in which reporting is required
to design a report that meets the requirements of section 512(l)(3) of
the act. The agency has estimated this burden at 80 hours per applicant
with active applications. The agency has factored into this estimate
the time it will take industry to identify and locate the necessary
information within existing records, and to develop a report that
complies with section 512(l)(3) of the act. Once this has been
accomplished, FDA believes that the process for producing reports in
subsequent years will essentially be automated, and that it will take
approximately 3 hours to run a report that satisfies the act's
requirements. For sponsors of approved applications that are inactive
(i.e., the approved drug is not being marketed), the sponsor would only
have to submit a report stating that the drug is not being marketed,
which FDA estimates will take approximately 1 hour.
FDA has developed a form to report the information required by
section 512(l)(3) of the act. FDA plans to make the form available to
animal drug manufacturers through FDA's Web site, however, use of the
form would be entirely voluntary. The form contains various fields for
information, including the drug manufacturer's name, NADA number,
active ingredient name, National Drug Code number, container size,
potency, and the number of units sold by month.
The animal drug manufacturers can meet the statutory requirements
by submitting their information in paper format using either the FDA-
provided form or one of their own design or by designing their own
electronic form whose results could be submitted to the agency on a
compact disc or on paper. The cost to animal drug sponsors for
gathering the necessary information for report design and preparation
or for completing FDA's form in the first year of reporting is $107,880
(29 active sponsors x 80 hours x $46.50 per hour = $107,880). This is a
one-time cost for a computer or mathematic employees to design and
prepare a report that satisfies
[[Page 7274]]
the statutory requirements of section 512(l)(3) of the act.\1\ For
subsequent years, the preparation of the report should take
approximately 3 hours. Thus, the total cost in subsequent years would
be $139.50.
---------------------------------------------------------------------------
\1\ BLS Occupation Employment and Wages, May 2006, by
occupation, for all industries (https://www.bls.gov). Wage ($46.50)
includes mean hourly wage of $33.22 for Standard Occupational
Classification 15-0000, computer and mathematics occupations, all
industries; we add 40 percent to account for benefits.
---------------------------------------------------------------------------
Regarding the recordkeeping burden associated with this collection
of information, FDA believes that most of the necessary information for
the annual report required to be submitted under section 512(l)(3) of
the act is already collected and maintained by animal drug
manufacturers under existing requirements.
Animal drug manufacturers are already required to maintain
distribution records for their drug products to comply with FDA's
current good manufacturing practice regulations under Sec. 211.196 (21
CFR Sec. 211.96) (OMB Control No. 0910-0139), and to comply with
regulations for periodic drug experience reports under Sec.
514.80(b)(4)(i) (OMB Control No. 0910-0284). Therefore, FDA believes
that manufacturers of animal drugs already possess the computers,
software, and additional equipment necessary to collect and maintain
the necessary records and to make reports.
Section 512(l)(3) of the act differs from Sec. 514.80(b)(4)(i) in
that it requires that records include separate information for each
month of the calendar year. Under Sec. 211.196 (OMB Control No. 0910-
0139), manufacturers currently are required to maintain distribution
records that include the dosage form and date the drug is distributed.
Additionally, FDA believes that manufacturers already keep detailed
records of the dates when antimicrobial drugs are distributed for
marketing and recall purposes from which monthly reports can be
prepared as part of their usual and customary practice. However, FDA
estimates an additional hourly burden required by section 512(l)(3) of
the act as shown in table 2 of this document.
Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3029 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S
