Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, 75475-75477 [2010-30316]
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Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices
contact: nationalconversation@cdc.gov
or Julie Fishman at 770–488–0629.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–30165 Filed 12–2–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–437]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of currently
approved collection; Title of
Information Collection: Psychiatric Unit
Criteria Work Sheet and Supporting
Regulations 412.25 and 412.27; Use:
Certain hospital units are excluded from
the Medicare Prospective Payment
System (PPS). The exclusion of units is
not optional on the part of the provider
but is required by section 1886(d)(1)(B)
of the Social Security Act. That section
excludes psychiatric hospitals,
rehabilitation hospitals, hospitals whose
inpatients are predominantly
individuals under 18 years of age
(children’s hospitals), and psychiatric
and rehabilitation units which are a
distinct part of a hospital.
CMS proposes to continue the current
process of performing initial
verifications and annual reverifications
to determine that psychiatric units
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AGENCY:
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continue to comply with the regulatory
criteria at 42 CFR 412.25 and 42 CFR
412.27 of the PPS regulations. These
regulations state the criteria that distinct
part units must meet for exclusion.
If, as a result of the regular survey
process a hospital is certified as a
psychiatric hospital by the State survey
agency (SA), then it automatically
satisfies the regulatory criteria for
exclusion. Thus, no additional
verification is required for psychiatric
hospitals. Some verification is needed,
however, to ensure that other types of
hospitals and units meet the criteria for
exclusion.
Consequently, CMS instructed the
Fiscal Intermediaries (FIs) and SAs to
perform certain verification activities,
beginning in October 1983 when PPS
was implemented. CMS originally
developed the CMS–437 as SA
Worksheet for verifying exclusions from
PPS for psychiatric units.
Since April 9, 1994, PPS-excluded
psychiatric units already excluded from
the PPS have met CMS’s annual
requirement for PPS-exclusion by selfattesting that they remain in compliance
with the PPS exclusion criteria. Under
the current procedure, all psychiatric
units applying for first-time exclusion
are surveyed by the SAs. The SAs also
perform surveys to investigate
complaint allegations and conduct
annual sample reverification surveys on
5 percent of all psychiatric units.
The aforementioned exclusions
continue to exist and thus CMS
proposes to continue to use the Criteria
Worksheet, Forms CMS–437 for
verifying first-time exclusions from the
PPS, for complaint surveys, for its
annual 5 percent validation sample, and
for facility self-attestation. These forms
are related to the survey and
certification and Medicare approval of
the PPS-excluded units. Form Number:
CMS–437 (OMB#: 0938–0358);
Frequency: Annually; Affected Public:
Private sector businesses or other forprofits; Number of Respondents: 1,333;
Total Annual Responses: 1,333; Total
Annual Hours: 333. (For policy
questions regarding this collection
contact Kelley Leonette at 410–786–
6664. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
PO 00000
Frm 00025
Fmt 4703
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75475
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by February 1, 2011:
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, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: November 24, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–30367 Filed 12–2–10; 8:45 am]
BILLING CODE 4120–01–P
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.
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.
SUMMARY:
E:\FR\FM\03DEN1.SGM
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75476
Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices
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
DATES:
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), § 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
mstockstill on DSKH9S0YB1PROD with NOTICES
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 ..............................................................................
1
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
................................................................................
........................
........................
........................
........................
4,872
There are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of
recordkeepers
21 CFR Section
Annual frequency per
recordkeeper
Total annual
records
Hours per
recordkeeper
Total hours
516.141 ................................................................................
516.165 ................................................................................
30
10
2
2
60
20
0.5
1
30
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.
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0266]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Study of Clinical
Efficacy Information in Professional
Labeling and Direct-to-Consumer Print
Advertisements for Prescription Drugs
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 January 3,
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910-new and title
‘‘Study of Clinical Efficacy Information
in Professional Labeling and Direct-toConsumer (DTC) Print Advertisements
for Prescription Drugs.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
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In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. Study of Clinical
Efficacy Information in Professional
Labeling and Direct-to-Consumer (DTC)
Print Advertisements for Prescription
Drug—(OMB Control Number 0910–
New)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 903(b)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and
other FDA-regulated products in
carrying out the provisions of the FD&C
Act.
FDA regulations require that an
advertisement that makes claims about
a prescription drug include a ‘‘fair
balance’’ of information about the
benefits and risks of the advertised
product, in terms of both content and
presentation (21 CFR 202.1(e)(5)(ii)). In
past research FDA has focused primarily
on the risk component of the riskbenefit ratio. In the interest of
thoroughly exploring the issue of fair
balance, however, the presentation of
effectiveness, or benefit, information is
equally important.
The FD&C Act requires that
manufacturers, packers, and distributors
(sponsors) who advertise prescription
human and animal drugs, including
biological products for humans, disclose
in advertisements certain information
about the advertised product’s uses and
risks.1 By its nature, the presentation of
this risk information is likely to evoke
active trade-offs by consumers, i.e.,
comparisons with the perceived risks of
not taking treatment, and comparisons
with the perceived benefits of taking a
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–30316 Filed 12–2–10; 8:45 am]
1 For prescription drugs and biologics, the FD&C
Act requires advertisements to contain ‘‘information
in brief summary relating to side effects,
contraindications, and effectiveness’’ (21 U.S.C.
352(n)).
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
treatment.2 Since FDA has an interest in
fostering safe and proper use of
prescription drugs, an activity that
engages both risks and benefits, an indepth understanding of consumers’
processing of this information is central
to this regulatory task.
Research and guidance to sponsors on
how to present benefit and efficacy
information in prescription drug
advertisements is limited. For example,
‘‘benefit claims,’’ broadly defined,
appearing in advertisements are often
presented in general language that does
not inform patients of the likelihood of
efficacy and are often simply variants of
an ‘‘intended use’’ statement. In a
content analysis of DTC advertising,3
the researchers classified the
‘‘promotional techniques’’ used in the
advertisements. Emotional appeals were
observed in 67 percent of the ads while
vague and qualitative benefit
terminology was found in 87 percent of
the ads. Only 9 percent contained data.
For risk information, however, half the
advertisements used data to describe
side-effects, typically with lists of sideeffects that generally occurred
infrequently.
FDA regulations require that
prescription drug advertisements that
make (promotional) claims about a
product also include risk information in
a ‘‘balanced’’ manner (21 CFR
202.1(e)(5)(ii)), both in terms of the
content and presentation of the
information. This balance applies to
both the front (aka ‘‘display’’) page of an
advertisement, as well as the brief
summary page. However, beyond the
‘‘balance’’ requirement limited guidance
and research exists to direct or
encourage sponsors to present benefit
claims that are informative, specific,
and reflect clinical effectiveness data.
The purpose of this project is to: (1)
Understand how physicians process
clinical efficacy information and how
2 See Schwartz, L., S. Woloshin, W. Black, et al.,
‘‘The Role of Numeracy in Understanding the
Benefit of Screening Mammography,’’ Annals of
Internal Medicine, 127(11), 966–72, 1997.
3 Woloshin, S. and L. Schwartz, ‘‘Direct to
Consumer Advertisements for Prescription Drugs:
What Are Americans Being Told,’’ Lancet, 358,
1141–46, 2001.
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75475-75477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30316]
-----------------------------------------------------------------------
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.
[[Page 75476]]
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 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.
[[Page 75477]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. 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. 2010-30316 Filed 12-2-10; 8:45 am]
BILLING CODE 4160-01-P
