Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds, 73101-73103 [2010-29928]
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73101
Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices
NOTIFICATION PROCEDURE:
For purpose of notification, the
subject individual should write to the
system manager who will require the
system name, and the retrieval selection
criteria (e.g., Provider number, SSN,
etc.).
Provider Enrollment, Chain, and
Ownership System (PECOS) and the
National Plan & Provider Enumeration
System (NPPES).
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
RECORD ACCESS PROCEDURE:
[FR Doc. 2010–29952 Filed 11–26–10; 8:45 am]
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2)).
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORD SOURCE CATEGORIES:
Information in the National Level
Repository will be populated from other
CMS systems of records, including the
Proposed Information Collection
Activity; Comment Request
Title: Evaluation of Pregnancy
Prevention Approaches and Teen
Pregnancy Prevention Evaluation.
OMB No.: 0970–0360.
Description: The Administration for
Children and Families (ACF), the Office
of the Assistant Secretary for Planning
and Evaluation (ASPE), and the Office
of the Assistant Secretary for Health
(ASH), 13.5. Department of Health and
Human Services (HHS), are proposing a
data collection activity to be undettaken
by two related studies—the Evaluation
of Pregnancy Prevention Approaches
study and the Teen Pregnancy
Prevention Evaluation. Both studies are
sponsored by ASH and will use the
same data collection instruments; ACF
is facilitating the Evaluation of
Pregnancy Prevention Approaches,
while ASPE is facilitating the Teen
Pregnancy Prevention Evaluation.
These two studies will assess the
effectiveness of a range of programs
designed to prevent or reduce sexual
risk behavior and pregnancy among
older adolescents. Knowing what types
of programs are effective will enhance
programmatic decisions by
policymakers and practitioners.
The proposed activity involves the
collection of information from
observations of program activities and
interviews with a range of experts and
persons involved with programs about
various aspects of existing prevention
programs and topics the experts view as
important to address through
evaluation. These data will be used to
help enhance decisions about the types
of programs to be evaluated in the
studies.
Respondents: Researchers and policy
experts, program directors, program
staff, or school administrators.
ANNUAL BURDEN ESTIMATES
Annual number of respondents
Instrument
mstockstill on DSKH9S0YB1PROD with NOTICES
Discussion Guide for Use with Researchers and Policy Experts ...................
Discussion Guide for Use with Program Directors ..........................................
Discussion Guide for Use with Program Staff .................................................
Focus Group Discussion Guide for Use with Program Participants ...............
Discussion Guide for Use with School Administrators ....................................
Estimated Total Annual Burden
Hours: 920.
In compliance with the requirements
of section 3506(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 Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. E-mail address:
OPREinfocollection@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
17:57 Nov 26, 2010
Jkt 223001
Dated: November 22, 2010.
Steven Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2010–29917 Filed 11–26–10; 8:45 am]
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Average burden hours per
response
Estimated annual burden
hours
1
2
1
1
1
1
2
2
1.5
1
30
120
120
450
200
30
30
60
300
200
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.
BILLING CODE 4184–01–M
Number of responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0601]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Medicated Feeds
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
SUMMARY:
E:\FR\FM\29NON1.SGM
29NON1
73102
Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices
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 recordkeeping requirements for
manufacturers of medicated animal
feeds.
DATES: Submit either electronic or
written comments on the collection of
information by January 28, 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.
Current Good Manufacturing Practice
Regulations for Medicated Feeds—21
CFR Part 225 (OMB Control Number
0910–0152)—Extension
Under section 501 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 351), FDA has the
statutory authority to issue current good
manufacturing practice (cGMP)
regulations for drugs, including
medicated feeds. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease, or growth
promotion and feed efficiency. Statutory
requirements for cGMPs have been
codified under part 225 (21 CFR part
225). Medicated feeds that are not
manufactured in accordance with these
regulations are considered adulterated
under section 501(a)(2)(B) of the FD&C
Act. Under part 225, a manufacturer is
required to establish, maintain, and
retain records for a medicated feed,
including records to document
procedures required during the
manufacturing process to assure that
proper quality control is maintained.
Such records would, for example,
contain information concerning receipt
and inventory of drug components,
batch production, laboratory assay
results (i.e., batch and stability testing),
labels, and product distribution.
This information is needed so that
FDA can monitor drug usage and
possible misformulation of medicated
feeds to investigate violative drug
residues in products from treated
animals and to investigate product
defects when a drug is recalled. In
addition, FDA will use the cGMP
criteria in part 225 to determine
whether or not the systems and
procedures used by manufacturers of
medicated feeds are adequate to assure
that their feeds meet the requirements of
the FD&C Act as to safety and also that
they meet their claimed identity,
strength, quality, and purity, as required
by section 501(a)(2)(B) of the FD&C Act.
A license is required when the
manufacture of a medicated feed
involves the use of a drug or drugs that
FDA has determined requires more
control because of the need for a
withdrawal period before slaughter or
because of carcinogenic concerns.
Conversely, a license is not required and
the recordkeeping requirements are less
demanding for those medicated feeds
for which FDA has determined that the
drugs used in their manufacture need
less control. Respondents to this
collection of information are
commercial feed mills and mixerfeeders.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED COMMERCIAL FEED MILLS) 1
No. of recordkeepers
Annual frequency per
recordkeeping
225.42(b)(5) through (b)(8) ................................................
225.58(c) and (d) ...............................................................
225.80(b)(2) .......................................................................
225.102(b)(1) .....................................................................
225.110(b)(1) and (b)(2) ....................................................
225.115(b)(1) and (b)(2) ....................................................
1,004
1,004
1,004
1,004
1,004
1,004
260
45
1,600
7,800
7,800
5
261,040
45,180
1,606,400
7,831,200
7,831,200
5,020
Total ............................................................................
........................
........................
........................
mstockstill on DSKH9S0YB1PROD with NOTICES
21 CFR Section
1
Total annual
records
Hours per
record
1
.5
.12
.08
.015
.12
261,040
22,590
192,768
626,496
117,468
602
..........................
1,220,964
There are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
17:57 Nov 26, 2010
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E:\FR\FM\29NON1.SGM
Total hours
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73103
Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSED MIXER-FEEDERS) 1
No. of recordkeepers
Annual frequency per
recordkeeping
225.42(b)(5) through (b)(8) ................................................
225.58(c) and (d) ...............................................................
225.80(b)(2) .......................................................................
225.102(b)(1) .....................................................................
100
100
100
100
260
36
48
260
26,000
3,600
4,800
26,000
.15
.5
.12
.4
3,900
1,800
576
10,400
Total ............................................................................
........................
........................
........................
..........................
16,676
21 CFR Section
1 There
Total annual
records
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED COMMERCIAL FEED MILLS) 1
No. of recordkeepers
Annual frequency per
recordkeeping
..............................................................................
..............................................................................
..............................................................................
..............................................................................
8,000
8,000
8,000
8,000
4
1
96
260
32,000
8,000
768,000
2,080,000
1
4
.12
.65
32,000
32,000
92,160
1,352,000
Total ............................................................................
........................
........................
........................
..........................
1,508,160
21 CFR Section
225.142
225.158
225.180
225.202
1 There
Total annual
records
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED MIXER-FEEDERS) 1
No. of recordkeepers
Annual frequency per
recordkeeping
..............................................................................
..............................................................................
..............................................................................
..............................................................................
45,000
45,000
45,000
45,000
4
1
32
260
180,000
45,000
1,440,000
11,700,000
1
4
.12
.33
180,000
180,000
172,800
3,861,000
Total ............................................................................
........................
........................
........................
..........................
4,393,800
21 CFR Section
225.142
225.158
225.180
225.202
1 There
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the times required for
record preparation and maintenance is
based on Agency communications with
industry. Other information needed to
finally calculate the total burden hours
(i.e., number of recordkeepers, number
of medicated feeds being manufactured,
etc.) is derived from Agency records and
experience.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0600]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fee Cover Sheet, Form 3546
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2010–29928 Filed 11–26–10; 8:45 am]
ACTION:
BILLING CODE 4160–01–P
mstockstill on DSKH9S0YB1PROD with NOTICES
Total annual
records
SUMMARY:
VerDate Mar<15>2010
17:57 Nov 26, 2010
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
Jkt 223001
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
notice. This notice solicits comments on
burden hours necessary to complete
FDA Form 3546, Animal Drug User Fee
Act (ADUFA) Cover Sheet.
DATES: Submit either electronic or
written comments on the collection of
information by January 28, 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
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73101-73103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29928]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0601]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Medicated Feeds
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
[[Page 73102]]
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
recordkeeping requirements for manufacturers of medicated animal feeds.
DATES: Submit either electronic or written comments on the collection
of information by January 28, 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.
Current Good Manufacturing Practice Regulations for Medicated Feeds--21
CFR Part 225 (OMB Control Number 0910-0152)--Extension
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue
current good manufacturing practice (cGMP) regulations for drugs,
including medicated feeds. Medicated feeds are administered to animals
for the prevention, cure, mitigation, or treatment of disease, or
growth promotion and feed efficiency. Statutory requirements for cGMPs
have been codified under part 225 (21 CFR part 225). Medicated feeds
that are not manufactured in accordance with these regulations are
considered adulterated under section 501(a)(2)(B) of the FD&C Act.
Under part 225, a manufacturer is required to establish, maintain, and
retain records for a medicated feed, including records to document
procedures required during the manufacturing process to assure that
proper quality control is maintained. Such records would, for example,
contain information concerning receipt and inventory of drug
components, batch production, laboratory assay results (i.e., batch and
stability testing), labels, and product distribution.
This information is needed so that FDA can monitor drug usage and
possible misformulation of medicated feeds to investigate violative
drug residues in products from treated animals and to investigate
product defects when a drug is recalled. In addition, FDA will use the
cGMP criteria in part 225 to determine whether or not the systems and
procedures used by manufacturers of medicated feeds are adequate to
assure that their feeds meet the requirements of the FD&C Act as to
safety and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the FD&C
Act.
A license is required when the manufacture of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required and the recordkeeping requirements are less demanding for
those medicated feeds for which FDA has determined that the drugs used
in their manufacture need less control. Respondents to this collection
of information are commercial feed mills and mixer-feeders.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills) \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)..... 1,004 260 261,040 1 261,040
225.58(c) and (d)............... 1,004 45 45,180 .5 22,590
225.80(b)(2).................... 1,004 1,600 1,606,400 .12 192,768
225.102(b)(1)................... 1,004 7,800 7,831,200 .08 626,496
225.110(b)(1) and (b)(2)........ 1,004 7,800 7,831,200 .015 117,468
225.115(b)(1) and (b)(2)........ 1,004 5 5,020 .12 602
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,220,964
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 73103]]
Table 2--Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders) \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)..... 100 260 26,000 .15 3,900
225.58(c) and (d)............... 100 36 3,600 .5 1,800
225.80(b)(2).................... 100 48 4,800 .12 576
225.102(b)(1)................... 100 260 26,000 .4 10,400
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 16,676
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Commercial Feed Mills) \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.142......................... 8,000 4 32,000 1 32,000
225.158......................... 8,000 1 8,000 4 32,000
225.180......................... 8,000 96 768,000 .12 92,160
225.202......................... 8,000 260 2,080,000 .65 1,352,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,508,160
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Mixer-Feeders) \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
225.142......................... 45,000 4 180,000 1 180,000
225.158......................... 45,000 1 45,000 4 180,000
225.180......................... 45,000 32 1,440,000 .12 172,800
225.202......................... 45,000 260 11,700,000 .33 3,861,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,393,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimate of the times required for record preparation and
maintenance is based on Agency communications with industry. Other
information needed to finally calculate the total burden hours (i.e.,
number of recordkeepers, number of medicated feeds being manufactured,
etc.) is derived from Agency records and experience.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29928 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P
