Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms, 57621-57623 [2015-24228]
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Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–24270 Filed 9–23–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3155]
Interim Results of Study of Workload
Volume and Full Costs Associated
With Review of Biosimilar Biological
Product Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the interim results of a
study of the workload volume and full
costs associated with the process for the
review of biosimilar biological product
applications (interim report). This study
was conducted by an independent
consulting firm, and it fulfills FDA’s
statutory requirement under the first
authorization of the Biosimilar User Fee
Act of 2012 (BsUFA), which enables
FDA to collect user fees for the review
of biosimilar biological applications for
fiscal years 2013 to 2017. This notice
solicits comments on the interim report.
DATES: The interim report will be
released on September 24, 2015, and
will be available at https://www.fda.gov/
downloads/ForIndustry/UserFees/
BiosimilarUserFeeActBsUFA/
UCM459686.pdf. Submit either
electronic or written comments on the
interim report by October 26, 2015.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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Jkt 235001
Submit electronic
comments on the interim report to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mark Ascione, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1150,
Silver Spring, MD 20993–0002, 301–
796–7652, FAX: 301–847–8443.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
The Patient Protection and Affordable
Care Act of 2010 (Pub. L. 111–148)
amended the Public Health Service Act
to create an abbreviated licensure
pathway for biological products that are
demonstrated to be ‘‘biosimilar’’ to or
‘‘interchangeable’’ with an FDAlicensed biological product. The Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by BsUFA (Title
IV of the Food and Drug Administration
Safety and Innovation Act, Pub. L. 112–
144), authorizes FDA to assess and
collect fees for biosimilar biological
products from October 2012 through
September 2017. FDA uses these fees to
expedite the review process for
biosimilar biological products.
Biosimilar biological products represent
an important public health benefit, with
the potential to offer life-saving or lifealtering benefits at reduced cost to the
patient. BsUFA facilitates the
development of safe and effective
biosimilar products for the American
public.
As part of BsUFA, FDA is required to
contract with an independent
accounting or consulting firm to study
the workload volume and full costs
associated with the process for the
review of biosimilar biological product
applications. This notice solicits
comments on the interim report, and the
final report is due no later than
September 30, 2016. The interim report
is described in section 744I(d) of the
FD&C Act (21 U.S.C. 379j–53(d)) (https://
uscode.house.gov/
view.xhtml?req=granuleid:U.S.C.prelim-title21-section379j53&num=0&edition=prelim), as
amended by the Food and Drug
Administration Safety and Innovation
Act enacted in 2012.
II. Comments
FDA is issuing this notice to request
public comment on the interim report.
Interested persons may submit either
electronic comments to https://
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57621
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
The interim report can be accessed at
https://www.fda.gov/downloads/
ForIndustry/UserFees/
BiosimilarUserFeeActBsUFA/
UCM459686.pdf.
Dated: September 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–24227 Filed 9–23–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–1837]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic User
Fee Payment Request Forms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 26,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
title Electronic User Fee Payment
Request Forms. Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
SUMMARY:
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57622
Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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.
Electronic User Fee Payment Request
Forms—(OMB Control Number 0910—
NEW)
The Government Paperwork
Elimination Act (GPEA) (Pub. L. 105–
277, title XVII), was signed into law on
October 21, 1998. GPEA requires
Federal Agencies to allow individuals or
entities that deal with the Agencies the
option to submit information or transact
business with the Agency electronically,
when practicable, and to maintain
records electronically, when practicable.
Its goal is to encourage Agencies to
incorporate technologically improved
respondent reporting, as this process
typically lowers the burden on the
respondent. GPEA allows FDA to collect
information relating to a user fee
payment refund request and transfer
request.
Form FDA 3913, User Fee Payment
Refund Request, is designed to provide
the minimum necessary information for
FDA to review and process a user fee
payment refund. The information
collected includes the organization,
contact, and payment information. The
information is used to determine the
reason for the refund, the refund
amount, and who to contact if there are
any questions regarding the refund
request. A submission of the User Fee
Payment Refund Request form does not
guarantee that a refund will be issued.
FDA estimates an average of 0.40 hours
per response, including the time to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete and review the
collection of information. The estimated
hours are based on past FDA experience
with the user fee payment refund
request.
In fiscal year 2014, approximately
1,741 user fee refunds were processed
for cover sheets and invoices including
27 for Animal Drug User Fee Act, 5 for
Animal Generic Drug User Fee Act, 3 for
Biosimilar Drug User Fee Act, 1 for a
Center for Tobacco Products Civil
Money Penalties, 216 for Export
Certificate Program, 79 for Freedom of
Information Act requests, 523 for
Generic Drug User Fee Amendments,
539 for Medical Device User Fee
Amendments, 266 for Mammography
inspection fee, 81 for Prescription Drug
User Fee Act, and 1 for a Tobacco
product fee.
Form FDA 3914, User Fee Payment
Transfer Request, is designed to provide
the minimum necessary information for
FDA to review and process a user fee
payment transfer request. The
information collected includes payment
and organization information. The
information is used to determine the
reason for the transfer, how the transfer
should be performed, and who to
contact if there are any questions
regarding the transfer request. A
submission of the User Fee Payment
Transfer Request form does not
guarantee that a transfer will be
performed. FDA estimates an average of
0.25 hours per response, including the
time to review instructions, search
existing data sources, gather and
maintain the data needed, and complete
and review the collection of
information. FDA estimated hours are
based on past FDA experience with the
user fee payment transfer request.
In fiscal year 2014, approximately
1,291 user fee payment transfers were
processed for cover sheets and invoices
including 21 for Animal Drug User Fee
Act, 2 for Animal Generic Drug User Fee
Act, 544 for Generic Drug User Fee
Amendments, 627 for Medical Device
User Fee Amendments, and 97 for
Prescription Drug User Fee Act.
Respondents for the electronic request
forms include domestic and foreign
firms (including pharmaceutical,
medical device, etc.). Specifically,
refund request forms target respondents
who submitted a duplicate payment or
overpayment for a user fee cover sheet
or invoice. Respondents may also
include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
to be re-applied to another cover sheet
or invoice (transfer of funds).
The electronic user fee payment
request forms will streamline the refund
and transfer processes, facilitate
processing, and improve the tracking of
requests. The burden for this collection
of information is the same for all
customers (small and large
organizations). The information being
requested or required has been held to
the absolute minimum required for the
intended use of the data. Customers will
be able to request a user fee payment
refund and transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit a user fee payment
refund and transfer request.
In the Federal Register of June 26,
2015 (80 FR 36822), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
User Fee Payment Refund Request—Form FDA
3913.
User Fee Payment Transfer Request—Form FDA
3914.
1,700
1
1,700
0.40 (24 minutes) ......
680
1,700
1
1,700
0.25 (15 minutes) ......
425
Total ..................................................................
........................
........................
........................
....................................
1105
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
Dated: September 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–24228 Filed 9–23–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1939]
Use of Investigational Tobacco
Products; Draft Guidance for Industry
and Investigators; 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 investigators entitled ‘‘Use
of Investigational Tobacco Products.’’
The draft guidance, when finalized, will
describe FDA’s current thinking
regarding the definition of
‘‘investigational tobacco product’’ and
will discuss the kind of information
FDA intends to consider in making
enforcement decisions regarding the use
of investigational tobacco products until
regulations governing the use of
investigational tobacco products become
effective or FDA provides written notice
of its intent to change its enforcement
policy.
SUMMARY:
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 by November 23, 2015.
Submit either electronic or written
comments on the proposed collection of
information by November 23, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the draft guidance
may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance, including comments on
the proposed collection of information,
to https://www.regulations.gov. Submit
written comments on the draft guidance,
including comments on the proposed
tkelley on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:45 Sep 23, 2015
Jkt 235001
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:
With regard to the draft guidance:
Laura Rich or Deirdre Jurand, Center for
Tobacco Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002, 1–
877–287–1373, CTPRegulations@
fda.hhs.gov, laura.rich@fda.hhs.gov, or
Deirdre.Jurand@fda.hhs.gov.
With regard to the proposed collection
of information: FDA PRA Staff, Office of
Operations, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14526, Silver Spring, MD 20993–
0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and
investigators entitled ‘‘Use of
Investigational Tobacco Products.’’ This
draft guidance, when finalized, will
describe FDA’s current thinking
regarding the definition of
‘‘investigational tobacco product’’ and
will discuss the kind of information
FDA intends to consider in making
enforcement decisions regarding the use
of investigational tobacco products until
regulations governing the use of
investigational tobacco products become
effective or FDA provides written notice
of its intent to change its enforcement
policy. It is intended to provide
guidance not only to persons who
currently intend to submit study
information to FDA, but to all persons
who conduct ‘‘nonclinical laboratory
studies,’’ as that term is used in the draft
guidance, and ‘‘clinical investigations,’’
as that term is used in the draft
guidance, using investigational tobacco
products.
The draft guidance also discusses that
for clinical investigations, a sponsor (as
defined in the guidance) may submit
information regarding a proposed use of
an investigational tobacco product to
FDA for review prior to enrolling
subjects. As discussed in the guidance,
FDA encourages this type of voluntary
submission because it will allow FDA to
work with a sponsor to help ensure that
the factors FDA considers in making
enforcement decisions are appropriately
accounted for. FDA has created a form
to assist sponsors in submitting
information. While use of the form is
voluntary, it will help ensure that
PO 00000
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57623
complete information is provided for
FDA’s consideration and will facilitate
FDA’s processing and review. A copy of
the form is attached as Appendix A to
this guidance.
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Pub. L. 111–
31) (Tobacco Control Act) into law. The
Tobacco Control Act amends the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) and grants FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health
generally and to reduce tobacco use by
minors.
To introduce or deliver for
introduction into interstate commerce a
new tobacco product, there must be in
effect a marketing authorization order
issued by FDA for the tobacco product
under section 910(c)(1)(A)(i) of the
FD&C Act (21 U.S.C. 387j(c)(1)(A)(i))
unless, in brief:
• A substantial equivalence order
under section 910(a)(2)(A)(i) of the
FD&C Act is in effect for the tobacco
product;
• FDA has granted a request for an
exemption of the tobacco product from
the requirement to obtain a substantial
equivalence order and the manufacturer
has made the required submission
under section 905(j)(1)(A)(ii) of the
FD&C Act and waited 90 days before
introducing its product to the market; or
• The manufacturer has submitted a
substantial equivalence report in
accordance with section 910(a)(2)(B) of
the FD&C Act and there is no order
finding that the tobacco product is not
substantially equivalent.
To introduce or deliver for
introduction into interstate commerce a
modified risk tobacco product, there
must be in effect an order under section
911(g) of the FD&C Act (21 U.S.C.
387k(g)) and the applicant must satisfy
any applicable premarket review
requirements under section 910 of the
FD&C Act.
Further, a tobacco product must
conform in all respects with applicable
tobacco product standards established
under section 907 of the FD&C Act (21
U.S.C. 387g).
Persons intending to file submissions
with FDA to demonstrate that a tobacco
product meets the criteria for marketing
set forth in section 910 or 911 of the
FD&C Act, and other researchers seeking
to study tobacco products, may need to
conduct or sponsor studies involving
tobacco products that do not have
marketing authorization or that do not
comply with an applicable tobacco
product standard.
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57621-57623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24228]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1837]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic User Fee
Payment Request Forms
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
26, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the title Electronic User Fee
Payment Request Forms. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455
[[Page 57622]]
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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.
Electronic User Fee Payment Request Forms--(OMB Control Number 0910--
NEW)
The Government Paperwork Elimination Act (GPEA) (Pub. L. 105-277,
title XVII), was signed into law on October 21, 1998. GPEA requires
Federal Agencies to allow individuals or entities that deal with the
Agencies the option to submit information or transact business with the
Agency electronically, when practicable, and to maintain records
electronically, when practicable. Its goal is to encourage Agencies to
incorporate technologically improved respondent reporting, as this
process typically lowers the burden on the respondent. GPEA allows FDA
to collect information relating to a user fee payment refund request
and transfer request.
Form FDA 3913, User Fee Payment Refund Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment refund. The information collected includes the
organization, contact, and payment information. The information is used
to determine the reason for the refund, the refund amount, and who to
contact if there are any questions regarding the refund request. A
submission of the User Fee Payment Refund Request form does not
guarantee that a refund will be issued. FDA estimates an average of
0.40 hours per response, including the time to review instructions,
search existing data sources, gather and maintain the data needed, and
complete and review the collection of information. The estimated hours
are based on past FDA experience with the user fee payment refund
request.
In fiscal year 2014, approximately 1,741 user fee refunds were
processed for cover sheets and invoices including 27 for Animal Drug
User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar
Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money
Penalties, 216 for Export Certificate Program, 79 for Freedom of
Information Act requests, 523 for Generic Drug User Fee Amendments, 539
for Medical Device User Fee Amendments, 266 for Mammography inspection
fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product
fee.
Form FDA 3914, User Fee Payment Transfer Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment transfer request. The information collected includes
payment and organization information. The information is used to
determine the reason for the transfer, how the transfer should be
performed, and who to contact if there are any questions regarding the
transfer request. A submission of the User Fee Payment Transfer Request
form does not guarantee that a transfer will be performed. FDA
estimates an average of 0.25 hours per response, including the time to
review instructions, search existing data sources, gather and maintain
the data needed, and complete and review the collection of information.
FDA estimated hours are based on past FDA experience with the user fee
payment transfer request.
In fiscal year 2014, approximately 1,291 user fee payment transfers
were processed for cover sheets and invoices including 21 for Animal
Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for
Generic Drug User Fee Amendments, 627 for Medical Device User Fee
Amendments, and 97 for Prescription Drug User Fee Act.
Respondents for the electronic request forms include domestic and
foreign firms (including pharmaceutical, medical device, etc.).
Specifically, refund request forms target respondents who submitted a
duplicate payment or overpayment for a user fee cover sheet or invoice.
Respondents may also include firms that withdrew an application or
submission. Transfer request forms target respondents who submitted
payment for a user fee cover sheet or invoice and need that payment to
be re-applied to another cover sheet or invoice (transfer of funds).
The electronic user fee payment request forms will streamline the
refund and transfer processes, facilitate processing, and improve the
tracking of requests. The burden for this collection of information is
the same for all customers (small and large organizations). The
information being requested or required has been held to the absolute
minimum required for the intended use of the data. Customers will be
able to request a user fee payment refund and transfer online at https://www.fda.gov/forindustry/userfees/default.htm. This electronic
submission is intended to reduce the burden for customers to submit a
user fee payment refund and transfer request.
In the Federal Register of June 26, 2015 (80 FR 36822), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
User Fee Payment Refund Request--Form FDA 1,700 1 1,700 0.40 (24 minutes)......................... 680
3913.
User Fee Payment Transfer Request--Form FDA 1,700 1 1,700 0.25 (15 minutes)......................... 425
3914.
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 1105
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 57623]]
Dated: September 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24228 Filed 9-23-15; 8:45 am]
BILLING CODE 4164-01-P
