Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29487 

privileges to furnish telemedicine 

services under an agreement with the 

hospital, the criteria for determining 

privileges and the procedure for 

applying the criteria are also subject to 

the requirements in § 482.12(a)(8) and 

§ 482.22(a)(3). 

* * * * * 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

4. The authority citation for part 485 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

5. Section 485.616 is amended by 

adding a new paragraph (c) to read as 

follows: 

§ 485.616 Condition of participation: 

Agreements. 

* * * * * 

(c) Standard: Agreements for 

credentialing and privileging of 

telemedicine physicians and 

practitioners. (1) The governing body of 

the CAH must ensure that, when 

telemedicine services are furnished to 

the CAH’s patients through an 

agreement with a distant-site (as defined 

at section 1834(m)(4)(A) of the Act) 

hospital, the agreement specifies that it 

is the responsibility of the governing 

body of the distant-site hospital to meet 

the following requirements with regard 

to its physicians or practitioners 

providing telemedicine services: 

(i) Determine, in accordance with 

State law, which categories of 

practitioners are eligible candidates for 

appointment to the medical staff. 

(ii) Appoint members of the medical 

staff after considering the 

recommendations of the existing 

members of the medical staff. 

(iii) Assure that the medical staff has 

bylaws. 

(iv) Approve medical staff bylaws and 

other medical staff rules and 

regulations. 

(v) Ensure that the medical staff is 

accountable to the governing body for 

the quality of care provided to patients. 

(vi) Ensure the criteria for selection 

are individual character, competence, 

training, experience, and judgment. 

(vii) Ensure that under no 

circumstances is the accordance of staff 

membership or professional privileges 

in the hospital dependent solely upon 

certification, fellowship or membership 

in a specialty body or society. 

(2) When telemedicine services are 

furnished to the CAH’s patients through 

an agreement with a distant-site (as 

defined at section 1834(m)(4)(A) of the 

Act) hospital, the CAH’s governing body 

or responsible individual may choose to 

rely upon the credentialing and 

privileging decisions made by the 

governing body of the distant-site 

hospital regarding individual distantsite physicians or practitioners. The 

CAH’s governing body or responsible 

individual must ensure that the 

following provisions are met: 

(i) The distant-site hospital providing 

telemedicine services is a Medicareparticipating hospital. 

(ii) The individual distant-site 

physician or practitioner is privileged at 

the distant-site hospital providing the 

telemedicine services, which provides a 

current list of the distant-site 

physician’s or practitioner’s privileges; 

(iii) The individual distant-site 

physician or practitioner holds a license 

issued or recognized by the State in 

which the CAH is located; and 

(iv) With respect to a distant-site 

physician or practitioner granted 

privileges by the CAH, the CAH has 

evidence of an internal review of the 

distant-site physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site hospital such 

information for use in the periodic 

appraisal of the individual distant-site 

physician or practitioner. At a 

minimum, this information must 

include all adverse events that result 

from the telemedicine services provided 

by the distant-site physician or 

practitioner to the CAH’s patients and 

all complaints the CAH has received 

about the distant-site physician or 

practitioner. 

6. Section 485.641 is amended by— 

A. Republishing paragraph (b)(4)(i). 

B. Revising paragraphs (b)(4)(ii) and 

(iii). 

C. Adding a new paragraph (b)(4)(iv). 

The additions and revisions read as 

follows: 

§ 485.641 Condition of participation: 

Periodic evaluation and quality assurance 

review 

* * * * * 

(b) * * * 

(4) The quality and appropriateness of 

the diagnosis and treatment furnished 

by doctors of medicine or osteopathy at 

the CAH are evaluated by— 

(i) One hospital that is a member of 

the network, when applicable; 

(ii) One QIO or equivalent entity; 

(iii) One other appropriate and 

qualified entity identified in the State 

rural health care plan; or 

(iv) In the case of distant-site 

physicians and practitioners providing 

telemedicine services to the CAH’s 

patients under an agreement between 

the CAH and a distant-site (as defined 

at section 1834(m)(4)(A) of the Act) 

hospital, the distant-site hospital. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). (Catalog of Federal 

Domestic Assistance Program No. 93.778, 

Medical Assistance Program) 

Dated: May 20, 2010. 

Marilyn Tavenner, 

Acting Administrator and Chief Operating 

Officer, Centers for Medicare & Medicaid 

Services. 

Approved: May 21, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–12647 Filed 5–21–10; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 578 

[Docket No. NHTSA–2010–0066] 

Reports, Forms and Record Keeping 

Requirements, Agency Information 

Collection Activity Under OMB Review 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), DOT. 

ACTION: Notice of proposed extension, 

without change, of a currently approved 

collection of information. 

SUMMARY: Before a Federal agency can 

collect certain information from the 

public, the agency must receive 

approval from the Office of Management 

and Budget (‘‘OMB’’). Under procedures 

established by the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.), 

before seeking OMB approval, Federal 

agencies must solicit public comment 

on proposed collections of information, 

including extensions and reinstatements 

of previously approved collections. In 

compliance with the Paperwork 

Reduction Act of 1995, this notice 

describes one collection of information 

for which NHTSA intends to seek OMB 

approval. 

DATES: Comments must be submitted on 

or before July 26, 2010. 

ADDRESSES: You may submit comments 

to the docket number identified in the 

heading of this document by any of the 

following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
29488 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 

online instructions for submitting 

comments. 

• Mail: Docket Management Facility, 

M–30, U.S. Department of 

Transportation, West Building, Ground 

Floor, Rm. W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery or Courier: West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., between 

9 a.m. and 5 p.m. Eastern Time, Monday 

through Friday, except Federal holidays. 

• Fax: (202) 493–2251. 

Regardless of how you submit your 

comments, please be sure to mention 

the docket number of this document and 

cite OMB Clearance No. 2127–0609, 

‘‘Criminal Penalty Safe Harbor 

Provision.’’ 

You may call the Docket at 202–366– 

9322. 

Note that all comments received will 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. Please 

see the Privacy Act discussion below. 

Privacy Act: Anyone is able to search 

the electronic form of all comments 

received into any of our dockets by the 

name of the individual submitting the 

comment (or signing the comment, if 

submitted on behalf of an association, 

business, labor union, etc.). You may 

review DOT’s complete Privacy Act 

Statement in the Federal Register 

published on April 11, 2000 (65 FR 

19477–78). 

FOR FURTHER INFORMATION CONTACT: For 

questions please contact Mr. John Piazza 

in the Office of the Chief Counsel at the 

National Highway Traffic Safety 

Administration, telephone (202) 366– 

9511. Please identify the relevant 

collection of information by referring to 

OMB Clearance Number 2127–0609 

‘‘Criminal Penalty Safe Harbor 

Provision’’. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995, 

before an agency submits a proposed 

collection of information to OMB for 

approval, it must publish a document in 

the Federal Register providing a 60-day 

comment period and otherwise consult 

with members of the public and affected 

agencies concerning each proposed 

collection of information. The OMB has 

promulgated regulations describing 

what must be included in such a 

document. Under OMB’s regulations (at 

5 CFR 1320.8(d)), an agency must ask 

for public comment on the following: 

(i) Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(ii) the accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; 

(iii) how to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(iv) how to minimize the burden of 

the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of responses. 

In compliance with these 

requirements, NHTSA asks public 

comment on the following proposed 

extension, without change, of a 

currently approved collection of 

information: 

Criminal Penalty Safe Harbor Provision 

Type of Request—Extension, without 

change, of a currently approved 

collection. 

OMB Clearance Number—2127–0609. 

Form Number—This collection of 

information uses no standard forms. 

Requested Expiration Date of 

Approval—Three (3) years from the date 

of approval of the collection. 

Summary of the Collection of 

Information—Each person seeking safe 

harbor protection from criminal 

penalties under 49 U.S.C. 30170 related 

to an improper report or failure to report 

is required to submit the following 

information to NHTSA: (1) A signed and 

dated document that identifies (a) each 

previous improper report and each 

failure to report as required under 49 

U.S.C. 30166, including a regulation, 

requirement, request or order issued 

thereunder, for which protection is 

sought and (b) the specific predicate 

under which the improper or omitted 

report should have been provided; and 

(2) the complete and correct information 

that was required to be submitted but 

was improperly submitted or was not 

previously submitted, including 

relevant documents that were not 

previously submitted to NHTSA or, if 

the person cannot do so, provide a 

detailed description of that information 

and/or the content of those documents 

and the reason why the individual 

cannot provide them to NHTSA. See 49 

U.S.C. 30170(a)(2) and 49 CFR 578.7. 

See also, 66 FR 38380 (July 24, 2001) 

(safe harbor final rule) and 65 FR 81414 

(Dec. 26, 2000) (safe harbor interim final 

rule). 

Description of the Need for the 

Information and Use of the 

Information—This information 

collection was mandated by Section 5 of 

the Transportation Recall Enhancement, 

Accountability, and Documentation Act, 

codified at 49 U.S.C. 30170(a)(2). The 

information collected will provide 

NHTSA with information the agency 

should have received previously and 

will also promptly provide the agency 

with correct information to do its 

analyses, such as, for example, 

conducting tests or drawing conclusions 

about possible safety-related defects. 

NHTSA anticipates using this 

information to help it to accomplish its 

statutory assignment of identifying 

safety-related defects in motor vehicles 

and motor vehicle equipment and, when 

appropriate, seeking safety recalls. 

Description of the Likely Respondents, 

Including Estimated Number and 

Proposed Frequency of Response to the 

Collection of Information—This 

collection of information applies to any 

person who seeks a ‘‘safe harbor’’ from 

potential criminal liability for 

knowingly and willfully acting with the 

specific intention of misleading the 

Secretary by an act or omission that 

violates section 1001 of title 18 with 

respect to the reporting requirements of 

49 U.S.C. 30166, regarding a safetyrelated defect in motor vehicles or 

motor vehicle equipment that caused 

death or serious bodily injury to an 

individual. Thus, the collection of 

information applies to the 

manufacturers, and any officers or 

employees thereof, who respond or have 

a duty to respond to an information 

provision requirement pursuant to 49 

U.S.C. 30166 or a regulation, 

requirement, request or order issued 

thereunder. 

We believe that there will be very few 

criminal prosecutions under section 

30170, given its elements. Since the safe 

harbor related rule has been in place, 

the agency has not received any reports. 

Accordingly, it is not likely to be a 

substantial motivating force for a 

submission of a proper report. We 

estimate that no more than one such 

person a year would invoke this new 

collection of information, and we do not 

anticipate receiving more than one 

report a year from any particular person. 

Estimate of the Total Annual 

Reporting and Recordkeeping Burdens 

Resulting From the Collection of 

Information—2 hours. 

As stated before, we estimate that no 

more than one person a year would be 

subject to this collection of information. 

Incrementally, we estimate that on 

average it will take no longer than two 

hours for a person to compile and 

submit the information we are requiring 

to be reported. Therefore, the total 

burden hours on the public per year is 

estimated to be a maximum of two 

hours. 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules 29489 

Since nothing in the rule requires 

those persons who submit reports 

pursuant to this rule to keep copies of 

any records or reports submitted to us, 

recordkeeping costs imposed would be 

zero hours and zero costs. 

Authority: 44 U.S.C. 3506; delegation of 

authority at 49 CFR 1.50. 

Issued on: May 21, 2010. 

O. Kevin Vincent, 

Chief Counsel. 

[FR Doc. 2010–12664 Filed 5–25–10; 8:45 am] 

BILLING CODE 4910–59–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 223 

[Docket No. 090324348–9655–01] 

RIN 0648–XO28 

Listing Endangered and Threatened 

Species: Completion of a Review of the 

Status of the Oregon Coast 

Evolutionarily Significant Unit of Coho 

Salmon; Proposal to Promulgate Rule 

Classifying Species as Threatened 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule. 

SUMMARY: We, the National Marine 

Fisheries Service (NMFS), propose to 

affirm the Endangered Species Act 

(ESA) status for the Oregon Coast (OC) 

Evolutionarily Significant Unit (ESU) of 

coho salmon (Oncorhynchus kisutch) by 

promulgating a rule that will supersede 

our February 11, 2008, listing 

determination for this ESU. This 

proposal will also serve as our 

announcement of the outcome of a new 

review of the status of this ESU and 

request for public comment on the 

proposal to promulgate the OC coho 

salmon ESU listing determination. On 

February 11, 2008, we listed the OC 

coho salmon ESU as threatened, 

designated critical habitat, and issued 

final protective regulations under 

section the Endangered Species Act 

(ESA) (February 11, 2008). The ESA 

listing status of the OC coho salmon 

ESU has been controversial and has 

attracted litigation in the past. This 

listing determination is the result of a 

settlement agreement. This new listing 

determination will supersede our 

February 11, 2008, listing determination 

for this ESU. Our February 11, 2008, 

determination establishing protective 

regulations under the ESA and 

designating critical habitat for this ESU 

will remain in effect. 

DATES: Information and comments on 

this proposal must be received by July 

26, 2010. A public hearing will be held 

promptly if any person so requests by 

July 12, 2010. Notice of the location and 

time of any such hearing will be 

published in the Federal Register not 

less than 15 days before the hearing is 

held. 

ADDRESSES: You may submit comments 

identified by 0648–XO28 by any of the 

following methods: 

• Electronic Submissions: Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Submit written comments to 

Chief, Protected Resources Division, 

Northwest Region, National Marine 

Fisheries Service, 1201 NE Lloyd Blvd., 

Suite 1100, Portland, OR 97232. 

Instructions: All comments received 

are a part of the public record and will 

generally be posted to http:// 

www.regulations.gov without change. 

All Personal Identifying Information (for 

example, name, address, etc.) 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit Confidential Business 

Information or otherwise sensitive or 

protected information. We will accept 

anonymous comments (enter ‘‘N/A’’ in 

the required fields if you wish to remain 

anonymous). Attachments to electronic 

comments will be accepted in Microsoft 

Word, Excel, WordPerfect, or Adobe 

PDF file formats only. Information about 

the OC coho salmon ESU can be 

obtained via the Internet at: http:// 

www.nwr.noaa.gov/ or by submitting a 

request to the Assistant Regional 

Administrator, Protected Resources 

Division, Northwest Region, NMFS, 

1201 NE Lloyd Blvd., Suite 1100, 

Portland, OR 97232. 

FOR FURTHER INFORMATION CONTACT: For 

further information regarding this 

proposal, contact Eric Murray, NMFS, 

Northwest Region, (503) 231–2378; or 

Marta Nammack, NMFS, Office of 

Protected Resources, (301) 713–1401. 

SUPPLEMENTARY INFORMATION: 

Previous Federal ESA Actions Related 

to Oregon Coast Coho Salmon 

We first proposed to list the OC coho 

salmon ESU as threatened under the 

ESA in 1995 (60 FR 38011; July 25, 

1995). Since then, we have completed 

several status reviews for this species, 

and its listing classification has changed 

between threatened and not warranted 

for listing a number of times. A 

complete history of this ESU’s listing 

status can be found in our February 11, 

2008, final rule (73 FR 7816), classifying 

this ESU as a threatened species. 

To summarize that history, on July 25, 

1995 we first proposed to list the ESU 

as threatened (60 FR 38011). We 

withdrew that proposal in response to 

the State of Oregon’s proposed 

conservation measures as described in 

the Oregon Plan for Salmon and 

Watersheds (62 FR 24588; May 6, 1997). 

On June 1, 1998, the U.S. District Court 

for the District of Oregon found that our 

determination to not list the OC coho 

salmon ESU was arbitrary and 

capricious (Oregon Natural Resources 

Council v. Daley, 6 F. Supp. 2d 1139 (D. 

Or. 1998)). The Court ruled that our 

decision gave too much weight to 

conservation measures with an 

uncertain likelihood of implementation. 

On August 10, 1998, we issued a final 

rule listing the OC coho ESU as 

threatened (63 FR 42587). In 2001, the 

U.S. District Court in Eugene, Oregon, 

set aside the 1998 threatened listing of 

the OC coho salmon ESU (Alsea Valley 

Alliance v. Evans, 161 F. Supp. 2d 1154, 

(D. Or. 2001)). The Court ruled that our 

failure to include certain hatchery fish 

as part of the ESU was not consistent 

with the ESA. Subsequently, we 

announced that we would conduct an 

updated status review of 27 West Coast 

salmonid ESUs, including the OC coho 

salmon ESU (67 FR 6215, February 11, 

2002; 67 FR 48601, July 25, 2002). 

To aid us in these reviews, we 

convened a team of Federal scientists, 

known as a biological review team 

(BRT). For the OC coho salmon ESU, 

NMFS concluded that this ESU was not 

in danger of extinction, but was likely 

to become endangered in the foreseeable 

future. The BRT noted considerable 

scientific uncertainty regarding the 

future viability of this ESU given 

unknowns about ocean conditions for 

coho salmon survival (Good et al., 

2005). They also stated that there is 

uncertainty about whether current 

freshwater habitats are of sufficient 

quality and quantity to support the then 

recent high abundance levels and 

sustain populations during future 

downturns in ocean conditions. 

Considering the BRT’s scientific 

findings and our assessment of risks and 

benefits from artificial propagation 

programs included in the ESU, efforts 

being made to protect the species, and 

the five factors listed under section 

4(a)(1) of the ESA, we proposed to list 

this ESU as threatened (69 FR 33102; 

June 14, 2004). In the June 2004 

proposed rule, we noted that Oregon 

was initiating a comprehensive 

assessment of the viability of the OC 

coho salmon ESU and of the adequacy 


wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1