Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, 14405-14407 [2011-6055]
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Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices
approval expires on February 28, 2014.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6091 Filed 3–15–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2011–6092 Filed 3–15–11; 8:45 am]
BILLING CODE 4160–01–P
[Docket No.FDA–2011–N–0085]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Cooperative Manufacturing
Arrangements for Licensed Biologics
Food and Drug Administration
BILLING CODE 4160–01–P
AGENCY:
Food and Drug Administration
[Docket No. FDA–2010–N–0468]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Patent Term Restoration, Due
Diligence Petitions, Filing, Format, and
Content of Petitions
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Focus Groups About Drug Products,
as Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Focus Groups About Drug Products, as
Used by the Food and Drug
Administration’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Patent Term Restoration, Due Diligence
Petitions, Filing, Format, and Content of
Petitions’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In the
Federal Register of January 12, 2011 (76
FR 2127), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0233. The
approval expires on February 28, 2014.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
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SUPPLEMENTARY INFORMATION:
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FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In the
Federal Register of July 9, 2010 (75 FR
39541), the Agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0677. The
approval expires on July 31, 2012. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6093 Filed 3–15–11; 8:45 am]
BILLING CODE 4160–01–P
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Food and Drug Administration,
HHS.
[Docket No. FDA–2010–N–0122]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
14405
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 proposed extension of the collection
of information concerning the guidance
for industry on cooperative
manufacturing arrangements for
licensed biologics.
DATES: Submit either electronic or
written comments on the collection of
information by May 16, 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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr,
PI50–400B, Rockville, MD 20850, 301–
796–3794,
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
SUMMARY:
E:\FR\FM\16MRN1.SGM
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Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices
jlentini on DSKJ8SOYB1PROD with NOTICES
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.
Guidance For Industry: Cooperative
Manufacturing Arrangements for
Licensed Biologics—(OMB Control
Number 0910–0629—Extension)
The guidance document provides
information concerning cooperative
manufacturing arrangements applicable
to biological products subject to
licensure under section 351 of the
Public Health Service Act (42 U.S.C.
262). The guidance addresses several
types of manufacturing arrangements
(i.e., short supply arrangements, divided
manufacturing arrangements, shared
manufacturing arrangements, and
contract manufacturing arrangements)
and describes certain reporting and
recordkeeping responsibilities,
associated with these arrangements,
including the following: (1) Notification
of all important proposed changes to
production and facilities, (2)
notification of results of tests and
investigations regarding or possibly
impacting the product, (3) notification
of products manufactured in a contract
facility, and (4) standard operating
procedures as follows:
1. Notification of All Important
Proposed Changes to Production and
Facilities
Each licensed manufacturer in a
divided manufacturing arrangement or
shared manufacturing arrangement must
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notify the appropriate FDA Center
regarding proposed changes in the
manufacture, testing, or specifications of
its product, in accordance with § 601.12
(21 CFR 601.12). In the guidance, we
recommend that each licensed
manufacturer that proposes such a
change should also inform other
participating licensed manufacturer(s)
of the proposed change.
For contract manufacturing
arrangements, we recommend that the
contract manufacturer should share
with the license manufacturer all
important proposed changes to
production and facilities (including
introduction of new products or at
inspection). The license holder is
responsible for reporting these changes
to FDA § 601.12).
2. Notification of Results of Tests and
Investigations Regarding or Possibly
Impacting the Product
In the guidance, we recommend the
following for contract manufacturing
arrangements:
• The contract manufacturer should
fully inform the license manufacturer of
the results of all tests and investigations
regarding or possibly having an impact
on the product; and
• The license manufacturer should
obtain assurance from the contractor
that any FDA list of inspectional
observations will be shared with the
license manufacturer to allow
evaluation of its impact on the purity,
potency, and safety of the license
manufacturer’s product.
3. Notification of Products
Manufactured in a Contract Facility
In the guidance, we recommend for
contract manufacturing arrangements
that a license manufacturer cross
reference a contract manufacturing
facility’s Master Files only in
circumstances involving certain
proprietary information of the contract
manufacturer, such as a list of all
products manufactured in a contract
facility. In this situation, the license
manufacturer should be kept informed
of the types or categories of all products
manufactured in the contract facility.
4. Standard Operating Procedures
In the guidance, we (FDA) remind the
license manufacture that the license
manufacturer assumes responsibility for
compliance with the applicable product
and establishment standards (21 CFR
600.3(t)). Therefore, if the license
manufacturer enters into an agreement
with a contract manufacturing facility,
the license manufacturer must ensure
that the facility complies with the
applicable standards. An agreement
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between a license manufacturer and a
contract manufacturing facility normally
includes procedures to regularly assess
the contract manufacturing facility’s
compliance. These procedures may
include, but are not limited to, review
of records and manufacturing deviations
and defects, and periodic audits.
For shared manufacturing
arrangements, each manufacturer must
submit a separate biologics license
application (BLA) describing the
manufacturing facilities and operations
applicable to the preparation of that
manufacturer’s biological substance or
product (21 CFR 601.2(a)). In the
guidance, we state that we expect the
manufacturer that prepares (or is
responsible for the preparation of) the
product in final form for commercial
distribution to assume primary
responsibility for providing data
demonstrating the safety, purity, and
potency of the final product. We also
state that we expect the licensed
finished product manufacturer to be
primarily responsible for any postapproval obligations, such as
postmarketing clinical trials, additional
product stability studies, complaint
handling, recalls, postmarket reporting
of the dissemination of advertising and
promotional labeling materials as
required under § 601.12(f)(4) and
adverse experience reporting. We
recommend that the final product
manufacturer establish a procedure with
the other participating manufacturer(s)
to obtain information in these areas.
Description of Respondents: The
recordkeeping and reporting
recommendations described in this
document affect the participating
licensed manufacturer(s), final product
manufacturer(s), and contract
manufacturer(s) associated with
cooperative manufacturing
arrangements.
Burden Estimate
We believe that the information
collection provisions in the guidance do
not create a new burden for
respondents. We believe the reporting
and recordkeeping provisions are part of
usual and customary business practices.
Licensed manufacturers would have
contractual agreements with
participating licensed manufacturers,
final product manufacturers, and
contract manufacturers, as applicable
for the type of cooperative
manufacturing arrangement, to address
all these information collection
provisions.
The guidance also refers to previously
approved collections of information
found in FDA regulations at parts 201,
207, 211, 600, 601, 606, 607, 610, 660,
E:\FR\FM\16MRN1.SGM
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Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices
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801, 803, and 807, 809, and 820 (21 CFR
parts 201, 207, 211, 600, 601, 606, 607,
610, 660, 801, 803, 807, 809, and 820).
The collections of information in
§§ 606.121, 606.122, and 610.40 have
been approved under OMB Control No.
0910–0116; § 610.2 has been approved
under OMB Control No. 0910–0206;
§§ 600.12(e) and 600.80 have been
approved under OMB Control No.
0910–0308; §§ 601.2(a), 601.12, 610.60
through 610.65, 610.67, 660.2(c),
660.28(a) and (b), 660.35(a), 660.35(c)
through (g), 660.35(i) through (m),
660.45, and 660.55(a) and (b) have been
approved under OMB Control No.
0910–0338; §§ 803.20, 803.50, and
803.53 have been approved under OMB
Control No. 0910–0437; and §§ 600.14
and 606.171 have been approved under
OMB Control No. 0910–0458. The
current good manufacturing practice
regulations for finished pharmaceuticals
(part 211) have been approved under
OMB Control No. 0910–0139;
§§ 820.181 and 820.184 have been
approved under OMB Control No.
0910–0073; the establishment
registration regulations (parts 207, 607,
and 807) have been approved under
OMB Control Nos. 0910–0045, 0910–
0052, and
0910–0387; and the labeling regulations
(parts 201, 801, and 809) have been
approved under OMB Control Nos.
0910–0537, 0910–0572, and 0910–0485.
VerDate Mar<15>2010
18:34 Mar 15, 2011
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Dated: February 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–6055 Filed 3–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0109]
Exchange of Letters Between Dr.
Murray M. Lumpkin, Deputy
Commissioner, International
Programs, Food and Drug
Administration and Mr. Martin
Heraghty, Assistant Secretary General,
Department of Agriculture, Fisheries
and Food of Ireland Concerning
Certification Requirements for
Caseins, Caseinates, and Mixtures
Thereof Exported From Ireland to the
United States
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is providing
notice of exchange of letters between Dr.
Murray M. Lumpkin, Deputy
Commissioner, International and
Special Programs, FDA and Mr. Martin
Heraghty, Assistant Secretary General,
Department of Agriculture, Fisheries
and Food (DAFF), concerning
certification requirements for caseins,
SUMMARY:
PO 00000
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14407
caseinates, and mixtures thereof
exported from Ireland to the United
States.
The mutual goals of FDA and DAFF
in establishing certification
requirements for caseins, caseinates,
and mixtures thereof exported from
Ireland to the United States are to assure
that contaminated products will not be
imported into the United States and to
minimize the need for extensive FDA
audit sampling of these products from
Ireland. DAFF and FDA have a history
of cooperation on this issue and it is,
therefore, desirable that the two
Agencies continue to cooperate to
maintain and improve consumer
protection.
The agreement became effective
November 10, 2010.
FOR FURTHER INFORMATION CONTACT:
David P. Kelly, Office of International
Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 3404, Silver Spring,
MD 20993–0002, 301–796–8373, Fax:
301–595–7941.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and understandings between FDA and
others shall be published in the Federal
Register, the Agency is publishing
notice of this agreement.
DATES:
Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Pages 14405-14407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6055]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2011-N-0085]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Cooperative Manufacturing
Arrangements for Licensed Biologics
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 proposed extension of the
collection of information concerning the guidance for industry on
cooperative manufacturing arrangements for licensed biologics.
DATES: Submit either electronic or written comments on the collection
of information by May 16, 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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr,
PI50-400B, Rockville, MD 20850, 301-796-3794,
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
[[Page 14406]]
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.
Guidance For Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics--(OMB Control Number 0910-0629--Extension)
The guidance document provides information concerning cooperative
manufacturing arrangements applicable to biological products subject to
licensure under section 351 of the Public Health Service Act (42 U.S.C.
262). The guidance addresses several types of manufacturing
arrangements (i.e., short supply arrangements, divided manufacturing
arrangements, shared manufacturing arrangements, and contract
manufacturing arrangements) and describes certain reporting and
recordkeeping responsibilities, associated with these arrangements,
including the following: (1) Notification of all important proposed
changes to production and facilities, (2) notification of results of
tests and investigations regarding or possibly impacting the product,
(3) notification of products manufactured in a contract facility, and
(4) standard operating procedures as follows:
1. Notification of All Important Proposed Changes to Production and
Facilities
Each licensed manufacturer in a divided manufacturing arrangement
or shared manufacturing arrangement must notify the appropriate FDA
Center regarding proposed changes in the manufacture, testing, or
specifications of its product, in accordance with Sec. 601.12 (21 CFR
601.12). In the guidance, we recommend that each licensed manufacturer
that proposes such a change should also inform other participating
licensed manufacturer(s) of the proposed change.
For contract manufacturing arrangements, we recommend that the
contract manufacturer should share with the license manufacturer all
important proposed changes to production and facilities (including
introduction of new products or at inspection). The license holder is
responsible for reporting these changes to FDA Sec. 601.12).
2. Notification of Results of Tests and Investigations Regarding or
Possibly Impacting the Product
In the guidance, we recommend the following for contract
manufacturing arrangements:
The contract manufacturer should fully inform the license
manufacturer of the results of all tests and investigations regarding
or possibly having an impact on the product; and
The license manufacturer should obtain assurance from the
contractor that any FDA list of inspectional observations will be
shared with the license manufacturer to allow evaluation of its impact
on the purity, potency, and safety of the license manufacturer's
product.
3. Notification of Products Manufactured in a Contract Facility
In the guidance, we recommend for contract manufacturing
arrangements that a license manufacturer cross reference a contract
manufacturing facility's Master Files only in circumstances involving
certain proprietary information of the contract manufacturer, such as a
list of all products manufactured in a contract facility. In this
situation, the license manufacturer should be kept informed of the
types or categories of all products manufactured in the contract
facility.
4. Standard Operating Procedures
In the guidance, we (FDA) remind the license manufacture that the
license manufacturer assumes responsibility for compliance with the
applicable product and establishment standards (21 CFR 600.3(t)).
Therefore, if the license manufacturer enters into an agreement with a
contract manufacturing facility, the license manufacturer must ensure
that the facility complies with the applicable standards. An agreement
between a license manufacturer and a contract manufacturing facility
normally includes procedures to regularly assess the contract
manufacturing facility's compliance. These procedures may include, but
are not limited to, review of records and manufacturing deviations and
defects, and periodic audits.
For shared manufacturing arrangements, each manufacturer must
submit a separate biologics license application (BLA) describing the
manufacturing facilities and operations applicable to the preparation
of that manufacturer's biological substance or product (21 CFR
601.2(a)). In the guidance, we state that we expect the manufacturer
that prepares (or is responsible for the preparation of) the product in
final form for commercial distribution to assume primary responsibility
for providing data demonstrating the safety, purity, and potency of the
final product. We also state that we expect the licensed finished
product manufacturer to be primarily responsible for any post-approval
obligations, such as postmarketing clinical trials, additional product
stability studies, complaint handling, recalls, postmarket reporting of
the dissemination of advertising and promotional labeling materials as
required under Sec. 601.12(f)(4) and adverse experience reporting. We
recommend that the final product manufacturer establish a procedure
with the other participating manufacturer(s) to obtain information in
these areas.
Description of Respondents: The recordkeeping and reporting
recommendations described in this document affect the participating
licensed manufacturer(s), final product manufacturer(s), and contract
manufacturer(s) associated with cooperative manufacturing arrangements.
Burden Estimate
We believe that the information collection provisions in the
guidance do not create a new burden for respondents. We believe the
reporting and recordkeeping provisions are part of usual and customary
business practices. Licensed manufacturers would have contractual
agreements with participating licensed manufacturers, final product
manufacturers, and contract manufacturers, as applicable for the type
of cooperative manufacturing arrangement, to address all these
information collection provisions.
The guidance also refers to previously approved collections of
information found in FDA regulations at parts 201, 207, 211, 600, 601,
606, 607, 610, 660,
[[Page 14407]]
801, 803, and 807, 809, and 820 (21 CFR parts 201, 207, 211, 600, 601,
606, 607, 610, 660, 801, 803, 807, 809, and 820). The collections of
information in Sec. Sec. 606.121, 606.122, and 610.40 have been
approved under OMB Control No. 0910-0116; Sec. 610.2 has been approved
under OMB Control No. 0910-0206; Sec. Sec. 600.12(e) and 600.80 have
been approved under OMB Control No. 0910-0308; Sec. Sec. 601.2(a),
601.12, 610.60 through 610.65, 610.67, 660.2(c), 660.28(a) and (b),
660.35(a), 660.35(c) through (g), 660.35(i) through (m), 660.45, and
660.55(a) and (b) have been approved under OMB Control No. 0910-0338;
Sec. Sec. 803.20, 803.50, and 803.53 have been approved under OMB
Control No. 0910-0437; and Sec. Sec. 600.14 and 606.171 have been
approved under OMB Control No. 0910-0458. The current good
manufacturing practice regulations for finished pharmaceuticals (part
211) have been approved under OMB Control No. 0910-0139; Sec. Sec.
820.181 and 820.184 have been approved under OMB Control No. 0910-0073;
the establishment registration regulations (parts 207, 607, and 807)
have been approved under OMB Control Nos. 0910-0045, 0910-0052, and
0910-0387; and the labeling regulations (parts 201, 801, and 809) have
been approved under OMB Control Nos. 0910-0537, 0910-0572, and 0910-
0485.
Dated: February 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6055 Filed 3-15-11; 8:45 am]
BILLING CODE 4160-01-P
