Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Proposed Rules 9617 

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,’’ (http://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 Sorbent hemoperfusion 

system. 

* * * * * 

(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; 

(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. 

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) 

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 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 

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9618 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 

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 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of 90-day petition 

finding. 

SUMMARY: 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. 

ADDRESSES: This finding is available on 

the Internet at http:// 

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: 

Background 

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 

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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