Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking, 69447-69449 [2010-28441]
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<![CDATA[
69447
Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices
Estimated Total Annual Burden
Hours: 51,845.88
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information;
(c) the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 8, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–28447 Filed 11–10–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Community-Based Family
Resource and Support Grants (Name
changed to Child Abuse Prevention
Program—OIS notified 6/2007).
OMB No.: 0970–0155.
Description: The Program Instruction,
prepared in response to the enactment
of the Community-Based Grants for the
Prevention of Child Abuse and Neglect
(administratively known as the
Community Based Child Abuse
Prevention Program, (CBCAP), as set
forth in Title II of Public Law 108–36,
Child Abuse Prevention and Treatment
Act Amendments of 2003, and in the
process of reauthorization, provides
direction to the States and Territories to
accomplish the purposes of (1)
supporting community-based efforts to
develop, operate, expand, and where
appropriate to network, initiatives
aimed at the prevention of child abuse
and neglect, and to support networks of
coordinated resources and activities to
better strengthen and support families to
reduce the likelihood of child abuse and
neglect, and; (2) fostering an
understanding, appreciation, and
knowledge of diverse populations in
order to be effective in preventing and
treating child abuse and neglect. This
Program Instruction contains
information collection requirements that
are found in (Pub. L. 108–36) at sections
201; 202; 203; 205; 206; 207; and
pursuant to receiving a grant award. The
information submitted will be used by
the agency to ensure compliance with
the statute, complete the calculation of
the grant award entitlement, and
provide training and technical
assistance to the grantee.
Respondents: State Governments.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
mstockstill on DSKH9S0YB1PROD with NOTICES
Application .......................................................................................................
Annual Report ..................................................................................................
Estimated Total Annual Burden
Hours: 3,328.
In compliance with the requirements
of section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
VerDate Mar<15>2010
17:23 Nov 10, 2010
Jkt 223001
52
52
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 8, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–28445 Filed 11–10–10; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Number of
responses
per respondent
Average
burden hours
per response
1
1
Total burden
hours
40
24
2,080
1,248
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0555]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Device Tracking
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
SUMMARY:
E:\FR\FM\12NON1.SGM
12NON1
69448
Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
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
information collection requirements for
the tracking of medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by January 11, 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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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.
In preparing this notice, the agency
reviewed a comment that was posted in
response to the 60-day notice of
February 5, 2008 (73 FR 6729) (Docket
No. FDA–2008–N–0050). FDA
transitioned to the Federal Dockets
Management System (FDMS) in January
2008, and this comment was not posted
to the docket until after the closing of
the comment period. The comment
responded to item 1 (whether the
information collection is necessary) and
item 3 (how to enhance quality of ICR).
With regard to item 1, the comment
emphasized the importance of medical
device tracking and supported the
information collection request in full.
With regard to item 3, the comment said
that implementing the unique device
identification provision (UDI) of the
Food and Drug Administration
Modernization Act (FDAMA) would go
a long way in enhancing medical device
tracking, and the agency is currently
undertaking this effort.
Medical Devices; Device Tracking—21
CFR Part 821 (OMB Control Number
0910–0442)—Extension
Section 211 of the Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) became
effective on February 19, 1998. FDAMA
amended the previous medical device
tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(e)(1) and (e)(2)) and were
added by the Safe Medical Devices Act
of 1990 (SMDA) (Pub. L. 101–629).
Unlike the tracking provisions under
SMDA which required tracking of any
medical device meeting certain criteria,
FDAMA allows FDA discretion in
applying tracking provisions to medical
devices meeting certain criteria, and
provides that tracking requirements for
medical devices can be imposed only
after FDA issues an order. In the Federal
Register of February 8, 2002 (67 FR
5943), FDA issued a final rule which
conformed existing tracking regulations
to changes in tracking provisions
effected by FDAMA under part 821 (21
CFR part 821).
Section 519(e)(1) of the act, as
amended by FDAMA, provides that
FDA may require by order, that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary), use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
obligations of persons other than device
manufacturers, e.g., distributors; records
and inspection requirements; (4)
confidentiality; and (5) record retention
requirements.
Respondents for this collection of
information are medical device
manufacturers, importers, and
distributors of tracked implants or
tracked l/s-l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
CFR section
821.1(d) ................................................................................
821.2 and 821.30(e) ............................................................
821.25(a) ..............................................................................
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17:23 Nov 10, 2010
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Frm 00053
Annual
frequency per
response
1
1
12
Fmt 4703
Sfmt 4703
Total annual
responses
1
1
1
E:\FR\FM\12NON1.SGM
1
1
12
12NON1
Hours per
response
Total hours
1
1
76
1
1
912
69449
Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Annual
frequency per
response
Number of
respondents
CFR section
Total annual
responses
Hours per
response
Total hours
821.25(d) ..............................................................................
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
915
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
Annual
frequency of
recordkeeping
821.25(b) ..............................................................................
821.25(c)2 ............................................................................
821.25(c)(3) ..........................................................................
12
12
12
46,260
1
1,124
555,120
12
13,488
1
63
1
555,120
756
13,488
Total ..............................................................................
........................
........................
........................
........................
569,364
CFR section
1
2
Total annual
records
Hours per
record
Total hours
There are no capital costs or operating and maintenance costs associated with this collection of information.
One time burden.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1
Number of
respondents
21 CFR section
Annual
frequency of
disclosure
Total annual
disclosures
Hours per
disclosure
Total hours
821.30(a) and (b) .................................................................
821.30(c) and (d) .................................................................
17,000
17,000
1
1
17,000
17,000
1
1
17,000
17,000
Total Hours ...................................................................
........................
........................
........................
........................
34,000
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSKH9S0YB1PROD with NOTICES
The annual hourly burden for
respondents involved with medical
device tracking is estimated to be
604,279 hours per year. The burden
estimates cited in tables 1, 2, and 3 of
this document are based on the number
of device tracking orders issued in the
last 3 years.
This regulation also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by Office of
Management and Budget under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). The collections of
information found in 21 CFR 821.2(b),
821.25(e), and 821.30(e) have been
approved under OMB control number
0910–0183.
Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–28441 Filed 11–10–10; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:23 Nov 10, 2010
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0319]
Draft Guidance for Industry and Food
and Drug Administration Staff on Dear
Health Care Provider Letters:
Improving Communication of
Important Safety Information;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry and FDA staff entitled ‘‘Dear
Health Care Provider Letters: Improving
Communication of Important Safety
Information.’’ Dear Health Care Provider
(DHCP) Letters are correspondence—
usually in the form of a mass mailing
from the manufacturer or distributor of
a human drug or biologic, or from
FDA—intended to alert physicians and
other health care providers to important
new information about a marketed drug
or biological product. This draft
guidance provides recommendations on
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
when to use a DHCP letter, the types of
information to include in a DHCP letter,
how to organize that information, and
formatting techniques to make the
information more accessible. The draft
guidance is intended to improve the
quality of DHCP letters to make them
more effective communication tools for
new information about marketed
products.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by January 11,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach, and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
E:\FR\FM\12NON1.SGM
12NON1
]]>Agencies
[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Pages 69447-69449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28441]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0555]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Device Tracking
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
[[Page 69448]]
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 information
collection requirements for the tracking of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by January 11, 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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.
In preparing this notice, the agency reviewed a comment that was
posted in response to the 60-day notice of February 5, 2008 (73 FR
6729) (Docket No. FDA-2008-N-0050). FDA transitioned to the Federal
Dockets Management System (FDMS) in January 2008, and this comment was
not posted to the docket until after the closing of the comment period.
The comment responded to item 1 (whether the information collection is
necessary) and item 3 (how to enhance quality of ICR). With regard to
item 1, the comment emphasized the importance of medical device
tracking and supported the information collection request in full. With
regard to item 3, the comment said that implementing the unique device
identification provision (UDI) of the Food and Drug Administration
Modernization Act (FDAMA) would go a long way in enhancing medical
device tracking, and the agency is currently undertaking this effort.
Medical Devices; Device Tracking--21 CFR Part 821 (OMB Control Number
0910-0442)--Extension
Section 211 of the Food and Drug Administration Modernization Act
(FDAMA) (Pub. L. 105-115) became effective on February 19, 1998. FDAMA
amended the previous medical device tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360i(e)(1) and (e)(2)) and were added by the Safe
Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629). Unlike the
tracking provisions under SMDA which required tracking of any medical
device meeting certain criteria, FDAMA allows FDA discretion in
applying tracking provisions to medical devices meeting certain
criteria, and provides that tracking requirements for medical devices
can be imposed only after FDA issues an order. In the Federal Register
of February 8, 2002 (67 FR 5943), FDA issued a final rule which
conformed existing tracking regulations to changes in tracking
provisions effected by FDAMA under part 821 (21 CFR part 821).
Section 519(e)(1) of the act, as amended by FDAMA, provides that
FDA may require by order, that a manufacturer adopt a method for
tracking a class II or III medical device, if the device meets one of
the three following criteria: (1) The failure of the device would be
reasonably likely to have serious adverse health consequences, (2) the
device is intended to be implanted in the human body for more than 1
year (referred to as a ``tracked implant''), or (3) the device is life-
sustaining or life-supporting (referred to as a ``tracked l/s-l/s
device'') and is used outside a device user facility.
Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary), use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
obligations of persons other than device manufacturers, e.g.,
distributors; records and inspection requirements; (4) confidentiality;
and (5) record retention requirements.
Respondents for this collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
821.1(d)........................ 1 1 1 1 1
821.2 and 821.30(e)............. 1 1 1 1 1
821.25(a)....................... 12 1 12 76 912
[[Page 69449]]
821.25(d)....................... 1 1 1 1 1
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
CFR section Number of frequency of Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
821.25(b)....................... 12 46,260 555,120 1 555,120
821.25(c)\2\.................... 12 1 12 63 756
821.25(c)(3).................... 12 1,124 13,488 1 13,488
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 569,364
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency of Total annual Hours per Total hours
respondents disclosure disclosures disclosure
----------------------------------------------------------------------------------------------------------------
821.30(a) and (b)............... 17,000 1 17,000 1 17,000
821.30(c) and (d)............... 17,000 1 17,000 1 17,000
-------------------------------------------------------------------------------
Total Hours................. .............. .............. .............. .............. 34,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The annual hourly burden for respondents involved with medical
device tracking is estimated to be 604,279 hours per year. The burden
estimates cited in tables 1, 2, and 3 of this document are based on the
number of device tracking orders issued in the last 3 years.
This regulation also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information found in 21 CFR 821.2(b), 821.25(e), and 821.30(e) have
been approved under OMB control number 0910-0183.
Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28441 Filed 11-10-10; 8:45 am]
BILLING CODE 4160-01-P
