Proposed Collection; 60-Day Comment Request: NIH Information Collection Forms To Support Genomic Data Sharing for Research Purposes (OD), 75120-75122 [2015-30465]
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Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices
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Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
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• Confidential Submissions—To
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‘‘THIS DOCUMENT CONTAINS
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provide this information on the cover
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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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Policy and Regulations Staff (HFV–6),
Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Dragan Momcilovic, Center for
Veterinary Medicine (HFV–226), Food
and Drug Administration, 7519 Standish
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Pl., Rockville, MD 20855, 240–402–
5944, dragan.momcilovic@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry #233
entitled ‘‘Veterinary Feed Directive
Common Format Questions and
Answers.’’
In 1996, Congress enacted the Animal
Drug Availability Act (ADAA) to
facilitate the approval and marketing of
new animal drugs and medicated feeds.
In passing the ADAA, Congress created
a new regulatory category for certain
animal drugs used in or on animal feed
called VFD drugs. VFD drugs are new
animal drugs intended for use in or on
animal feed which are limited to use
under the professional supervision of a
licensed veterinarian. FDA published
final regulations at § 558.6 (21 CFR
558.6) implementing the VFD-related
provisions of the ADAA in 2000. On
June 3, 2015 (80 FR 31707), FDA
published a VFD final rule that revised
those VFD regulations and introduced
clarifying changes to specified
definitions.
During the latest rulemaking process,
FDA received a few comments
requesting the Agency to require a
uniform VFD format. We declined this
request because we thought that
requiring a specific format would be too
prescriptive. However, we acknowledge
that a common VFD format would help
clients, veterinarians, and distributors
(including feed mills) quickly identify
relevant information on the VFD.
We are issuing this draft guidance to
recommend a common VFD format. In
the draft guidance, we use the term
‘‘VFD’’ to refer to the form used to
convey the VFD order. This draft
guidance describes the requirements in
§ 514.1(b)(9) (21 CFR 514.1(b)(9)) for
sponsor submission of a VFD to FDA as
part of the application process for
approval of a new animal drug for use
in or on animal feed as a VFD drug, as
well as the required and optional
information to be included on the VFD.
This draft guidance provides examples
that illustrate how a common VFD
format might appear and how some of
the information on the VFD may be
prepopulated by a sponsor.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Veterinary Feed
Directive Common Format Questions
and Answers.’’ It does not establish any
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rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in § 514.1 have been
approved under OMB control number
0910–0032. The collections of
information in § 558.6 have been
approved under OMB control number
0910–0363.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: November 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–30411 Filed 11–30–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request: NIH Information Collection
Forms To Support Genomic Data
Sharing for Research Purposes (OD)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Office of the Director, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
SUMMARY:
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Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices
methodology and assumptions used; (3)
The quality, utility, and clarity of the
information to be collected; and (4)
Minimization of the burden of the
collection of information from those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dina N. Paltoo, Ph.D.,
MPH, Director, Genetics, Health, and
Society Program, Office of Clinical
Research and Bioethics Policy, Office of
Science Policy, 6705 Rockledge Drive,
Suite 750, Bethesda, MD 20892 or call
non-toll-free number 301–496–9838 or
Email your request, including your
address to: GDS@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: National
Institutes of Health Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes—
0925–0670—Expiration Data 03/31/
2016—Revision—Office of the Director
(OD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: Sharing research data
supports the NIH mission and is
essential to facilitate the translation of
DATES:
research results into knowledge,
products, and procedures that improve
human health. The NIH has
longstanding policies to make a broad
range of research data, including
genomic data, publicly available in a
timely manner from the research
activities that it funds. Genomic
research data sharing is an integral
element of the NIH mission as it
facilitates advances in our
understanding of factors that influence
health and disease, while also providing
opportunities to accelerate research
through the power of combining large
and information-rich datasets. To
promote robust sharing of human and
non-human data from a wide range of
large-scale genomic research and
provide appropriate protections for
research involving human data, the
National Institutes of Health (NIH)
issued the NIH Genomic Data Sharing
Policy (GDS Policy). Human genomic
data submissions and controlled-access
are managed through a central data
repository, the database of Genotypes
and Phenotypes (dbGaP) which is
administered by the National Center for
Biotechnology Information (NCBI), part
of the National Library of Medicine at
NIH.
Under the GDS Policy, all
investigators who receive NIH funding
to conduct large-scale genomic research
are expected to register studies with
human genomic data in dbGaP, no
matter which NIH-designated data
repository will maintain the data. As
part of the registration process,
investigators must provide basic study
information such as the type of data that
will be submitted to dbGaP, a
description of the study, and an
institutional assurance (i.e. Institutional
Certification) of the data submission
which delineates any limitations on the
secondary use of the data (e.g., data
cannot be shared with for-profit
companies, data can be used only for
research of particular diseases).
Investigators interested in using
controlled-access data for secondary
research must apply through dbGaP and
be granted permission from the relevant
NIH Data Access Committee(s). As part
of the application process, investigators
and their institutions must provide
information such as a description of the
proposed research use of controlledaccess datasets that conforms to any
data use limitations, agree to the
Genomic Data User Code of Conduct,
and agree to the terms of access through
a Data Use Certification agreement.
Requests to renew data access and
reports to close out data use are similar
to the initial data access request,
requiring sign-off by both the requestor
and the institution, but also ask for
information about how the data have
been used, and about publications,
presentations, or intellectual property
based on the research conducted with
the accessed data as well as any data
security issues or other data
management incidents.
The NIH has developed online forms,
available through dbGaP, in an effort to
reduce the burden for researchers and
their institutional officials to complete
the study registration, data submission,
data access, and renewal and closeout
processes.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,505.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of form
Number of
responses per
respondent
Average
time per
response
(in hours)
Total annual
burden hour
Study Registration and Data Submission
Investigator Submitting Data ...........................................................................
Institutional Official to Certify ...........................................................................
150
150
1
1
1
30/60
150
75
633
633
2
2
45/60
30/60
950
633
2
2
15/60
18/60
317
380
Initial Data Access Request
Investigator Requesting Data ..........................................................................
Signing Official to Certify .................................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Renewal and Close-out of Data Access
Investigator Requesting Data ..........................................................................
Signing Official to Certify .................................................................................
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Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices
Dated: November 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015–30465 Filed 11–30–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
tkelley on DSK3SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts and Continuous Submissions.
Date: December 3, 2015.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Chee Lim, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4128,
Bethesda, MD 20892, 301–435–1850,
limc4@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cardiovascular Sciences.
Date: December 9, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Lawrence E Boerboom,
Ph.D., Chief, CVRS IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4130, MSC 7814,
Bethesda, MD 20892, (301) 435–8367,
boerboom@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
VerDate Sep<11>2014
23:35 Nov 30, 2015
Jkt 238001
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cardiovascular Sciences.
Date: December 9–10, 2015.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kimm Hamann, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118A,
MSC 7814, Bethesda, MD 20892, 301–435–
5575, hamannkj@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neuropharmacology and Channels.
Date: December 11, 2015.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Mary Custer, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4148,
MSC 7850, Bethesda, MD 20892, (301) 435–
1164, custerm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship
Review.
Date: December 11, 2015.
Time: 11:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Raj K Krishnaraju, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190,
Bethesda, MD 20892, 301–435–1047,
kkrishna@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 24, 2015.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–30351 Filed 11–30–15; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine Drug
Testing for Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908);
September 30, 1997 (62 FR 51118);
April 13, 2004 (69 FR 19644); November
25, 2008 (73 FR 71858); December 10,
2008 (73 FR 75122); and on April 30,
2010 (75 FR 22809).
A notice listing all currently HHScertified laboratories and IITFs is
published in the Federal Register
during the first week of each month. If
any laboratory or IITF certification is
suspended or revoked, the laboratory or
IITF will be omitted from subsequent
lists until such time as it is restored to
full certification under the Mandatory
Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
Internet at https://www.samhsa.gov/
workplace.
FOR FURTHER INFORMATION CONTACT:
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room 7–
1051, One Choke Cherry Road,
Rockville, Maryland 20857; 240–276–
2600 (voice), 240–276–2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were initially
developed in accordance with Executive
Order 12564 and section 503 of Pub. L.
100–71. The ‘‘Mandatory Guidelines for
Federal Workplace Drug Testing
Programs,’’ as amended in the revisions
listed above, requires strict standards
that laboratories and IITFs must meet in
order to conduct drug and specimen
SUMMARY:
E:\FR\FM\01DEN1.SGM
01DEN1
]]>Agencies
[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75120-75122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30465]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request: NIH Information
Collection Forms To Support Genomic Data Sharing for Research Purposes
(OD)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the Office of the Director, the
National Institutes of Health (NIH) will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited to address one or more of the following points:
(1) Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the
[[Page 75121]]
methodology and assumptions used; (3) The quality, utility, and clarity
of the information to be collected; and (4) Minimization of the burden
of the collection of information from those who are to respond,
including the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Dina N.
Paltoo, Ph.D., MPH, Director, Genetics, Health, and Society Program,
Office of Clinical Research and Bioethics Policy, Office of Science
Policy, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 or call
non-toll-free number 301-496-9838 or Email your request, including your
address to: GDS@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: National Institutes of Health Information
Collection Forms to Support Genomic Data Sharing for Research
Purposes--0925-0670--Expiration Data 03/31/2016--Revision--Office of
the Director (OD), National Institutes of Health (NIH).
Need and Use of Information Collection: Sharing research data
supports the NIH mission and is essential to facilitate the translation
of research results into knowledge, products, and procedures that
improve human health. The NIH has longstanding policies to make a broad
range of research data, including genomic data, publicly available in a
timely manner from the research activities that it funds. Genomic
research data sharing is an integral element of the NIH mission as it
facilitates advances in our understanding of factors that influence
health and disease, while also providing opportunities to accelerate
research through the power of combining large and information-rich
datasets. To promote robust sharing of human and non-human data from a
wide range of large-scale genomic research and provide appropriate
protections for research involving human data, the National Institutes
of Health (NIH) issued the NIH Genomic Data Sharing Policy (GDS
Policy). Human genomic data submissions and controlled-access are
managed through a central data repository, the database of Genotypes
and Phenotypes (dbGaP) which is administered by the National Center for
Biotechnology Information (NCBI), part of the National Library of
Medicine at NIH.
Under the GDS Policy, all investigators who receive NIH funding to
conduct large-scale genomic research are expected to register studies
with human genomic data in dbGaP, no matter which NIH-designated data
repository will maintain the data. As part of the registration process,
investigators must provide basic study information such as the type of
data that will be submitted to dbGaP, a description of the study, and
an institutional assurance (i.e. Institutional Certification) of the
data submission which delineates any limitations on the secondary use
of the data (e.g., data cannot be shared with for-profit companies,
data can be used only for research of particular diseases).
Investigators interested in using controlled-access data for
secondary research must apply through dbGaP and be granted permission
from the relevant NIH Data Access Committee(s). As part of the
application process, investigators and their institutions must provide
information such as a description of the proposed research use of
controlled-access datasets that conforms to any data use limitations,
agree to the Genomic Data User Code of Conduct, and agree to the terms
of access through a Data Use Certification agreement. Requests to renew
data access and reports to close out data use are similar to the
initial data access request, requiring sign-off by both the requestor
and the institution, but also ask for information about how the data
have been used, and about publications, presentations, or intellectual
property based on the research conducted with the accessed data as well
as any data security issues or other data management incidents.
The NIH has developed online forms, available through dbGaP, in an
effort to reduce the burden for researchers and their institutional
officials to complete the study registration, data submission, data
access, and renewal and closeout processes.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 2,505.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of form Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Study Registration and Data Submission
----------------------------------------------------------------------------------------------------------------
Investigator Submitting Data.................... 150 1 1 150
Institutional Official to Certify............... 150 1 30/60 75
----------------------------------------------------------------------------------------------------------------
Initial Data Access Request
----------------------------------------------------------------------------------------------------------------
Investigator Requesting Data.................... 633 2 45/60 950
Signing Official to Certify..................... 633 2 30/60 633
----------------------------------------------------------------------------------------------------------------
Renewal and Close-out of Data Access
----------------------------------------------------------------------------------------------------------------
Investigator Requesting Data.................... 633 2 15/60 317
Signing Official to Certify..................... 633 2 18/60 380
----------------------------------------------------------------------------------------------------------------
[[Page 75122]]
Dated: November 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-30465 Filed 11-30-15; 8:45 am]
BILLING CODE 4140-01-P
