Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals, 47794-47796 [2020-17197]
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47794
Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0133. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Temporary Marketing Permit
Applications—21 CFR 130.17(c) and (i)
OMB Control Number 0910–0133—
Extension
Section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341) (FD&C
Act) directs FDA to issue regulations
establishing definitions and standards of
identity for food. Under section 403(g)
of the FD&C Act (21 U.S.C. 343(g)), a
food that is subject to a definition and
standard of identity prescribed by
regulation is misbranded if it does not
conform to such definition and standard
of identity. Section 130.17 (21 CFR
130.17) provides for the issuance by
FDA of temporary marketing permits
that enable the food industry to test
consumer acceptance and measure the
technological and commercial feasibility
in interstate commerce of experimental
packs of food that deviate from
applicable definitions and standards of
identity. Section 130.17(c) enables the
Agency to monitor the manufacture,
labeling, and distribution of
experimental packs of food that deviate
from applicable definitions and
standards of identity. The information
so obtained can be used in support of
a petition to establish or amend the
applicable definition or standard of
identity to provide for the variations.
Section 130.17(i) specifies the
information that a firm must submit to
FDA to obtain an extension of a
temporary marketing permit.
Description of Respondents:
Respondents to this collection of
information include private sector
businesses including institutional and/
or industrial customers and food
industry members such as
manufacturers, packers, or distributors
desiring to apply for a temporary
marketing permit or permit extension.
In the Federal Register of April 16,
2020 (85 FR 21247), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
Number of
responses
per
respondent
Total annual
responses
Total hours
130.17(c); Request for temporary marketing permit ...........
130.17(i); Request to extend marketing permit ...................
13
1
2
2
26
2
25
2
650
4
Total ..............................................................................
........................
........................
........................
........................
654
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 31, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–17168 Filed 8–5–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 reporting
requirements associated with extralabel
drug use in animals.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by October 5, 2020.
DATES:
jbell on DSKJLSW7X2PROD with NOTICES
Average
burden
per response
(in hours)
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extralabel Drug
Use in Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:13 Aug 05, 2020
Jkt 250001
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 5,
2020. The https://www.regulations.gov
ADDRESSES:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 5, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
E:\FR\FM\06AUN1.SGM
06AUN1
Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2008–N–0312 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Extralabel Drug Use in Animals.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
VerDate Sep<11>2014
17:13 Aug 05, 2020
Jkt 250001
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
47795
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.
Extralabel Drug Use for Animals—21
CFR 530
OMB Control Number 0910–0325—
Extension
The Animal Medicinal Drug Use
Clarification Act of 1994 (Pub. L. 103–
396) allows a veterinarian to prescribe
the extralabel use of approved new
animal drugs. Also, it permits FDA, if it
finds that there is a reasonable
probability that the extralabel use of an
animal drug may prevent the risk to the
public health, to establish a safe level
for a residue from the extralabel use of
the drug, and to require the
development of an analytical method for
the detection of residues above that
established safe level (21 CFR
530.22(b)). Although to date, we have
not established a safe level for a residue
from the extralabel use of any new
animal drug and, therefore, have not
required the development of analytical
methodology, we believe that there may
be instances when analytical
methodology will be required. We are,
therefore, estimating the reporting
burden based on two methods being
required annually. The requirement to
establish an analytical method may be
fulfilled by any interested person. We
believe that the sponsor of the drug will
be willing to develop the method in
most cases. Alternatively, FDA, the
sponsor, and perhaps a third party may
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs; State,
Federal, and/or State Agencies;
academia; or individuals.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\06AUN1.SGM
06AUN1
47796
Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Part
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
530.22(b); Submission(s) of Analytical Method ...................
2
1
2
4,160
8,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17197 Filed 8–5–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1207]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Establishing and
Maintaining a List of U.S.
Manufacturers/Processors of Feed
Additives, Premixes, Compound Feed,
Distillers’ Dried Grains, and Distillers’
Dried Grains with Solubles for Use
with Animals with Interest in Exporting
to The People’s Republic of China
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by September
8, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0884. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Establishing and Maintaining a List of
U.S. Manufacturers/Processors of Feed
Additives, Premixes, Compound Feed,
Distillers’ Dried Grains, and Distillers’
Dried Grains with Solubles for Use with
Animals with Interest in Exporting to
The People’s Republic of China OMB
Control Number 0910–0884
This information collection request
allows FDA to include respondents who
are U.S. manufacturers/processors of
feed additives, premixes, compound
feed, distillers’ dried grains, and
distillers’ dried grains with solubles
(hereinafter, ‘‘manufacturers/
processors’’ of ‘‘covered products’’) on a
list of those who wish to export their
products to The People’s Republic of
China (China). On January 15, 2020, the
United States and China entered into an
Economic and Trade Agreement (the
Agreement) which, among other things,
will streamline the procedures for, and
improve the efficiencies of, the
exportation of U.S. covered products to
China. These provisions of the
Agreement are intended to facilitate
trade between the two countries to
better meet the demand for U.S. animal
feed products in China and to promote
the development of animal husbandry
in China. Since the timing of the
Agreement did not allow for publication
of a 60-day notice under the PRA in
advance of its implementation, FDA
requested and OMB granted emergency
review under 5 CFR 1320.13 of a new
information collection request.
In the Federal Register of April 16,
2020 (85 FR 21242), subsequent to
implementation under the emergency
clearance, we published a 60-day notice
requesting public comment on the
proposed collection of information. No
comments were received.
Respondents: Manufacturing/
processing facilities of covered products
interested in exporting animal feed to
China.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section; activity
§ 1.101(b)(1); Request for list placement to export to
China—data elements demonstrating that product meets
the foreign purchaser’s specifications ..............................
jbell on DSKJLSW7X2PROD with NOTICES
1 There
Number of
responses per
respondent
450
Total annual
responses
1
450
Average
burden per
response
0.083
Total hours
38
are no capital costs or operating and maintenance costs associated with this collection of information.
We have revised our burden table. In
the 60-day notice published on April 16,
2020, the burden table identified types
of respondents. Here we are clarifying
that the information being collected is a
VerDate Sep<11>2014
17:13 Aug 05, 2020
Jkt 250001
request from those respondents to be
placed on a list. By requesting to be
placed on the list, respondents agree to
disclose data elements, as agreed upon
by the U.S. government and China, that
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
demonstrate the product meets
acceptable entry criteria. Since
establishing the collection, we have 197
facilities on the list to date. There were
fewer emails received, as some of the
E:\FR\FM\06AUN1.SGM
06AUN1
]]>Agencies
[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47794-47796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0312]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Extralabel Drug Use in Animals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 reporting requirements
associated with extralabel drug use in animals.
DATES: Submit either electronic or written comments on the collection
of information by October 5, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 5, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 5, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or
[[Page 47795]]
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2008-N-0312 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Extralabel Drug Use in Animals.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Extralabel Drug Use for Animals--21 CFR 530
OMB Control Number 0910-0325--Extension
The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L.
103-396) allows a veterinarian to prescribe the extralabel use of
approved new animal drugs. Also, it permits FDA, if it finds that there
is a reasonable probability that the extralabel use of an animal drug
may prevent the risk to the public health, to establish a safe level
for a residue from the extralabel use of the drug, and to require the
development of an analytical method for the detection of residues above
that established safe level (21 CFR 530.22(b)). Although to date, we
have not established a safe level for a residue from the extralabel use
of any new animal drug and, therefore, have not required the
development of analytical methodology, we believe that there may be
instances when analytical methodology will be required. We are,
therefore, estimating the reporting burden based on two methods being
required annually. The requirement to establish an analytical method
may be fulfilled by any interested person. We believe that the sponsor
of the drug will be willing to develop the method in most cases.
Alternatively, FDA, the sponsor, and perhaps a third party may
cooperatively arrange for method development. The respondents may be
sponsors of new animal drugs; State, Federal, and/or State Agencies;
academia; or individuals.
FDA estimates the burden of this collection of information as
follows:
[[Page 47796]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
530.22(b); Submission(s) of Analytical Method...................... 2 1 2 4,160 8,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17197 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P
