Defense Federal Acquisition Regulation Supplement; DoD Voucher Processing (DFARS Case 2011-D054), 9617-9618 [2012-3659]
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Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Proposed Rules
comments regarding this document. It is
only necessary to submit one set of
comments. Identify comments with the
docket number found in the 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.
XX. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site address, but FDA is not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register.)
1. Schiano, T.D., ‘‘Clinical Management of
Hepatic Encephalopathy,’’ vol. 30, pp.
10S–15S, Pharmacotherapy, 2010.
2. Blozan, C.F. and S.A. Tucker, ‘‘Premarket
Notifications: The First 24,000,’’ pp. 59–
69, Medical Device & Diagnostic
Industry, 1986.
3. Geiger, D.R., ‘‘FY 2003 and FY 2004 Unit
Costs for the Process of Medical Device
Review,’’ (https://www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDeviceUserFeeand
ModernizationActMDUFMA/ucm
109216.pdf), September 2005.
List of Subjects in 21 CFR Part 876
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 876 be amended as follows:
PART 876—GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for 21 CFR
part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Section 876.5870 is amended by
revising paragraphs (b) and (c) to read
as follows:
§ 876.5870
system.
Sorbent hemoperfusion
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(b) Classification. (1) Class II (special
controls) when the device is intended
for the treatment of poisoning and drug
overdose. The special controls for this
device are:
(i) The device should be demonstrated
to be biocompatible;
(ii) Performance data to demonstrate
the mechanical integrity of the device
(e.g., tensile, flexural, and structural
strength), including testing for the
possibility of leaks, ruptures, release of
particles, and/or disconnections;
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(iii) Performance data to demonstrate
device sterility and shelf life;
(iv) Bench performance data to
demonstrate device functionality in
terms of substances, toxins, and drugs
removed by the device, and the extent
that these are removed when the device
is used according to its labeling;
(v) Summary of clinical experience
with the device that discusses and
analyzes device safety and performance,
including a list of adverse events
observed during the testing;
(vi) Labeling controls, including
appropriate warnings, precautions,
cautions, and contraindications
statements to alert and inform users of
proper device use and potential clinical
adverse effects, including blood loss,
platelet loss, leukopenia, hemolysis,
hypotension, clotting, metabolic
disturbances, and loss of vital nutrients
and substances; Labeling
recommendations must be consistent
with the performance data obtained for
the device, and must include a list of
the drugs the device has been
demonstrated to remove, and the extent
for removal/depletion; and
(vii) For those devices that
incorporate electrical components,
appropriate analysis and testing to
validate electrical safety and
electromagnetic compatibility.
(2) Class III (premarket approval)
when the device is intended for the
treatment of hepatic coma and
metabolic disturbances.
(c) Date premarket approval
application (PMA) or notice of
completion of product development
protocol (PDP) is required. A PMA or
notice of completion of a PDP is
required to be filed with FDA on or
before [date 90 days after date of
publication of the final rule in the
Federal Register], for any sorbent
hemoperfusion system indicated for
treatment of hepatic coma or metabolic
disturbances that was in commercial
distribution before May 28, 1976, or that
has, on or before [date 90 days after date
of publication of the final rule in the
Federal Register], been found to be
substantially equivalent to any sorbent
hemoperfusion device indicated for
treatment of hepatic coma or metabolic
disturbances that was in commercial
distribution before May 28, 1976. Any
other sorbent hemoperfusion system
device indicated for treatment of hepatic
coma or metabolic disturbances shall
have an approved PMA or declared
completed PDP in effect before being
placed in commercial distribution.
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9617
Dated: February 14, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2012–3810 Filed 2–16–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 242
RIN 0750–AH52
Defense Federal Acquisition
Regulation Supplement; DoD Voucher
Processing (DFARS Case 2011–D054)
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Proposed rule; clarification.
AGENCY:
DoD is clarifying the rule
published on January 19, 2012,
proposing to amend the Defense Federal
Acquisition Regulation Supplement
(DFARS) to update DoD’s voucher
processing procedures and better
accommodate the use of Wide Area
WorkFlow to process vouchers.
DATES: Comments on the proposed rule
published January 19, 2012, at 77 FR
2682, continue to be accepted until
March 19, 2012.
FOR FURTHER INFORMATION CONTACT: Mr.
Mark Gomersall, Defense Acquisition
Regulations System, OUSD (AT&L)
DPAP (DARS), Room 3B855, 3060
Defense Pentagon, Washington, DC
20301–3060. Telephone 703–602–0302;
facsimile 703–602–0350.
SUPPLEMENTARY INFORMATION: DoD is
clarifying the proposed rule published
on January 19, 2012 (77 FR 2682), which
proposes to revise requirements for
approving interim vouchers. Interim
vouchers that are selected using riskbased sampling methodologies will be
reviewed and approved by the contract
auditors for provisional payment and
sent to the disbursing office after the
pre-payment review. Interim vouchers
not selected for a pre-payment review
will be considered acceptable for
payment and will be sent directly to the
disbursing office. All interim vouchers
are subject to an audit of actual costs
incurred after payment. The sampling
process will be accomplished largely
within the Wide Area WorkFlow
system.
The rule proposes to revise the
requirements for approving interim
vouchers by replacing the direct
submission process currently referenced
SUMMARY:
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Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Proposed Rules
at DFARS 242.803(b)(i)(C) with a riskbased sampling process. The proposed
risk-based sampling process is a more
effective and efficient approach. It
allows for the evaluation of selected
interim vouchers on a pre-payment
basis in lieu of the current direct
submission authorization, which does
not allow for the pre-payment
evaluation of higher risk interim
vouchers. It is anticipated that the
revised process will provide a more
comprehensive sample of all vouchers
and an enhanced oversight of higher
risk vouchers, while allowing a more
efficient processing of the vouchers not
selected for pre-payment review.
List of Subjects in 48 CFR Part 242
Government procurement.
Ynette R. Shelkin,
Editor, Defense Acquisition Regulations
System.
[FR Doc. 2012–3659 Filed 2–16–12; 8:45 am]
BILLING CODE 5001–06–P
This finding is available on
the Internet at https://
www.regulations.gov at Docket Number
FWS–R8–ES–2012–0001. Supporting
documentation we used in preparing
this finding is available for public
inspection, by appointment, during
normal business hours at the U.S. Fish
and Wildlife Service, Klamath Falls Fish
and Wildlife Office, 1936 California
Avenue, Klamath Falls, CA 97601.
Please submit any new information,
materials, comments, or questions
concerning this finding to the above
street address.
FOR FURTHER INFORMATION CONTACT:
Laurie Sada, Field Supervisor, Klamath
Falls Fish and Wildlife Office (see
ADDRESSES), by telephone at 541–885–
2507, or by facsimile to 541–885–7837.
If you use a telecommunications device
for the deaf (TDD), please call the
Federal Information Relay Service
(FIRS) at 800–877–8339.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Background
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–R8–ES–2012–0001;
4500030113]
Endangered and Threatened Wildlife
and Plants; 90-Day Finding on a
Petition To List the Thermophilic
Ostracod as Endangered or
Threatened
Fish and Wildlife Service,
Interior.
ACTION: Notice of 90-day petition
finding.
AGENCY:
We, the U.S. Fish and
Wildlife Service, announce a 90-day
finding on a petition to list the
thermophilic ostracod (Potamocypris
hunteri) as endangered or threatened
under the Endangered Species Act of
1973, as amended (Act). Based on our
review, we find that the petition does
not present substantial information
indicating that listing the thermophilic
ostracod may be warranted. Therefore,
we are not initiating a status review in
response to this petition. We ask the
public to submit to us any new
information that becomes available
concerning the status of, or threats to,
the thermophilic ostracod or its habitat
at any time.
DATES: The finding announced in this
document was made on February 17,
2012.
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Section 4(b)(3)(A) of the Act (16
U.S.C. 1531 et seq.) requires that we
make a finding on whether a petition to
list, delist, or reclassify a species
presents substantial scientific or
commercial information indicating that
the petitioned action may be warranted.
We are to base this finding on
information provided in the petition,
supporting information submitted with
the petition, and information otherwise
available in our files. To the maximum
extent practicable, we are to make this
finding within 90 days of our receipt of
the petition, and publish our notice of
the finding promptly in the Federal
Register.
Our standard for substantial scientific
or commercial information within the
Code of Federal Regulations (CFR) with
regard to a 90-day petition finding is
‘‘that amount of information that would
lead a reasonable person to believe that
the measure proposed in the petition
may be warranted’’ (50 CFR 424.14(b)).
If we find that substantial scientific or
commercial information was presented,
we are required to promptly conduct a
species status review, which we
subsequently summarize in our
12-month finding.
Petition History
On March 8, 2011, we received a
petition dated March 4, 2011, from
Chris Zinda (Friends of Hunter’s Hot
Springs) and Drs. Brendan Bohannan
and Richard Castenholz (University of
Oregon) requesting that the
thermophilic ostracod (Potamocypris
hunteri) be listed as endangered or
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threatened under the Act. The petition
clearly identified itself as such and
included the requisite identification
information for the petitioner, as
required by 50 CFR 424.14(a). In a May
4, 2011, letter to the petitioner, we
responded that we had reviewed the
information presented in the petition
and determined that issuing an
emergency regulation temporarily
listing the species under section 4(b)(7)
of the Act was not warranted. We also
stated that we were required to
complete a significant number of listing
and critical habitat actions in Fiscal
Year 2011 pursuant to court orders,
judicially approved settlement
agreements, and other statutory
deadlines, but that we had secured
funding for Fiscal Year 2012 and
anticipated publishing a finding in the
Federal Register in 2012. This finding
addresses the petition.
Evaluation of Listable Entity
Section 3(16) of the Act defines the
term ‘‘species’’ to include ‘‘any
subspecies of fish or wildlife or plants,
and any distinct population segment of
any species of vertebrate fish or wildlife
which interbreeds when mature.’’
Entities that meet the Act’s definition of
a ‘‘species’’ can be considered for listing
under the Act and are, therefore,
referred to as ‘‘listable entities.’’ Listable
entities can then be listed if they are
determined to meet the definition of an
endangered species or a threatened
species. Prior to making a determination
of whether the petition presents
substantial information to indicate
whether listing may be warranted, we
must address the question of whether
the petition presents substantial
information to indicate whether the
petitioned thermophilic ostracod may
be a listable entity. We may consider the
petitioned ostracod to be a listable
entity if information submitted with the
petition or in our files indicates that
treatment of this ostracod as a listable
entity may be warranted. Based on the
information presented in the petition
and information in our files, there is a
considerable amount of uncertainty
regarding the taxonomy of this entity.
The following paragraphs present our
evaluation of whether Potamocypris
hunteri may be a listable entity.
Wickstrom and Castenholz (1973, p.
1063) reported finding what they
considered to be a new undescribed
species of Potamocypris at Hunter’s Hot
Springs (Hunter’s) in southeastern
Oregon. The Latin name Potamocypris
hunteri was coined in a footnote in
1973, but not accompanied by a formal
description (Wickstrom and Castenholz
1973, p. 1064). Wickstrom and
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]]>Agencies
[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Proposed Rules]
[Pages 9617-9618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3659]
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DEPARTMENT OF DEFENSE
Defense Acquisition Regulations System
48 CFR Part 242
RIN 0750-AH52
Defense Federal Acquisition Regulation Supplement; DoD Voucher
Processing (DFARS Case 2011-D054)
AGENCY: Defense Acquisition Regulations System, Department of Defense
(DoD).
ACTION: Proposed rule; clarification.
-----------------------------------------------------------------------
SUMMARY: DoD is clarifying the rule published on January 19, 2012,
proposing to amend the Defense Federal Acquisition Regulation
Supplement (DFARS) to update DoD's voucher processing procedures and
better accommodate the use of Wide Area WorkFlow to process vouchers.
DATES: Comments on the proposed rule published January 19, 2012, at 77
FR 2682, continue to be accepted until March 19, 2012.
FOR FURTHER INFORMATION CONTACT: Mr. Mark Gomersall, Defense
Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), Room 3B855,
3060 Defense Pentagon, Washington, DC 20301-3060. Telephone 703-602-
0302; facsimile 703-602-0350.
SUPPLEMENTARY INFORMATION: DoD is clarifying the proposed rule
published on January 19, 2012 (77 FR 2682), which proposes to revise
requirements for approving interim vouchers. Interim vouchers that are
selected using risk-based sampling methodologies will be reviewed and
approved by the contract auditors for provisional payment and sent to
the disbursing office after the pre-payment review. Interim vouchers
not selected for a pre-payment review will be considered acceptable for
payment and will be sent directly to the disbursing office. All interim
vouchers are subject to an audit of actual costs incurred after
payment. The sampling process will be accomplished largely within the
Wide Area WorkFlow system.
The rule proposes to revise the requirements for approving interim
vouchers by replacing the direct submission process currently
referenced
[[Page 9618]]
at DFARS 242.803(b)(i)(C) with a risk-based sampling process. The
proposed risk-based sampling process is a more effective and efficient
approach. It allows for the evaluation of selected interim vouchers on
a pre-payment basis in lieu of the current direct submission
authorization, which does not allow for the pre-payment evaluation of
higher risk interim vouchers. It is anticipated that the revised
process will provide a more comprehensive sample of all vouchers and an
enhanced oversight of higher risk vouchers, while allowing a more
efficient processing of the vouchers not selected for pre-payment
review.
List of Subjects in 48 CFR Part 242
Government procurement.
Ynette R. Shelkin,
Editor, Defense Acquisition Regulations System.
[FR Doc. 2012-3659 Filed 2-16-12; 8:45 am]
BILLING CODE 5001-06-P
