56588 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 

2 73 FR 34750. 

3 Staff’s labor cost estimates are based on recent 

data from the Bureau of Labor and Statistics found 

here: (http://www.bls.gov/news.release/pdf/ 

ocwage.pdf). 

to lengthy delays due to heightened 

security precautions. 

The FTC Act and other laws the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives, 

whether filed in paper or electronic 

form. Comments received will be 

available to the public on the FTC 

website, to the extent practicable, at 

www.ftc.gov. As a matter of discretion, 

the FTC makes every effort to remove 

home contact information for 

individuals from the public comments it 

receives before placing those comments 

on the FTC website. More information, 

including routine uses permitted by the 

Privacy Act, may be found in the FTC’s 

privacy policy at (http://www.ftc.gov/ 

ftc/privacy.shtm). 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be addressed to Jock K. Chung, 

Attorney, Division of Enforcement, 

Bureau of Consumer Protection, Federal 

Trade Commission, NJ-2122, 600 

Pennsylvania Avenue, N.W., 

Washington, D.C. 20580, (202) 326- 

2984. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act (‘‘PRA’’), 44 

U.S.C. 3501-3520, federal agencies must 

obtain approval from OMB for each 

collection of information they conduct 

or sponsor. On June 18, 2008, the FTC 

sought comment on the information 

collection requirements pertaining to 

the Commission’s Amplifier Rule (OMB 

Control Number 3084-0105).2 No 

comments were received. Pursuant to 

the OMB regulations that implement the 

PRA (5 CFR Part 1320), the FTC is 

providing this second opportunity for 

public comment while seeking OMB 

approval to extend the existing 

paperwork clearance for the 

Commission’s Amplifier Rule. All 

comments should be filed as prescribed 

in the ADDRESSES section above, and 

must be received on or before October 

29, 2008. 

The Amplifier Rule assists consumers 

by standardizing the measurement and 

disclosure of power output and other 

performance characteristics of 

amplifiers in stereos and other home 

entertainment equipment. The Rule also 

specifies the test conditions necessary to 

make the disclosures that the Rule 

requires. 

Estimated annual hours burden: 450 

hours (300 testing-related hours; 150 

disclosure-related hours). 

The Rule’s provisions require affected 

entities to test the power output of 

amplifiers in accordance with a 

specified FTC protocol. The 

Commission staff estimates that 

approximately 300 new amplifiers and 

receivers come on the market each year. 

High fidelity manufacturers routinely 

conduct performance tests on these new 

products prior to sale. Because 

manufacturers conduct such tests, the 

Rule imposes no additional costs except 

to the extent that the FTC protocol is 

more time-consuming than alternative 

testing procedures. In this regard, a 

warm-up (‘‘precondition’’) period that 

the Rule requires before measurements 

are taken may add approximately one 

hour to the time testing would 

otherwise entail. Thus, staff estimates 

that the Rule imposes approximately 

300 hours (1 hour x 300 new products) 

of added testing burden annually. 

In addition, the Rule requires 

disclosures if a manufacturer makes a 

power output claim for a covered 

product in an advertisement, 

specification sheet, or product brochure. 

This requirement does not impose any 

additional costs on manufacturers 

because, absent the Rule, media 

advertisements, as well as manufacturer 

specification sheets and product 

brochures, would contain a power 

specification obtained using an 

alternative to the Rule-required testing 

protocol. The Rule, however, also 

requires disclosure of harmonic 

distortion, power bandwidth, and 

impedance ratings in manufacturer 

specification sheets and product 

brochures that might not otherwise be 

included. 

Staff assumes that manufacturers 

produce one specification sheet and one 

brochure each year for each new 

amplifier and receiver. The burden of 

disclosing the harmonic distortion, 

bandwidth, and impedance information 

on the specification sheets and 

brochures is limited to the time needed 

to draft and review the language 

pertaining to the aforementioned 

specifications. Staff estimates the time 

involved for this task to be a maximum 

of fifteen minutes for each new 

specification sheet and brochure for a 

total of 150 hours ([300 new products x 

1 specification sheet) + (300 new 

products x 1 brochure)] x 15 minutes). 

The total annual burden imposed by 

the Rule, therefore, is approximately 

450 burden hours for testing and 

disclosures. 

Estimated annual cost burden: 

$19,000, rounded to the nearest 

thousand.3

Generally, electronics engineers 

perform the testing of amplifiers and 

receivers. Staff estimates a labor cost of 

$12,300 for such testing (300 hours for 

testing x $41 per hour). Staff assumes 

advertising or promotions managers 

prepare the disclosures contained in 

product brochures and manufacturer 

specification sheet and estimates a labor 

cost of $6,600 (150 hours for disclosures 

x $44 per hour). Accordingly, staff 

estimates the total labor costs associated 

with the Rule to be approximately 

$19,000 per year, rounded to the nearest 

thousand ($12,300 for testing + $6,600 

for disclosures). 

The Rule imposes no capital or other 

non-labor costs because its requirements 

are incidental to testing and advertising 

done in the ordinary course of business. 

William Blumenthal, 

General Counsel. 

[FR Doc. E8–22811 Filed 9–26–08: 8:45 am] 

[BILLING CODE 6750–01–S] 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2895–FN] 

Medicare and Medicaid Programs; 

Approval of Det Norske Veritas 

Healthcare, Inc. for Deeming Authority 

for Hospitals 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to approve Det Norske Veritas 

Healthcare, Inc. (DNVHC) for 

recognition as a national accreditation 

program for hospitals seeking to 

participate in the Medicare or Medicaid 

programs. 

DATES: Effective Date: This final notice 

is effective September 26, 2008 through 

September 26, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

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Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 56589 

services in a hospital provided certain 

requirements are met. The regulations 

specifying the Medicare conditions of 

participation (CoPs) for hospitals are 

located at 42 CFR part 482. These 

conditions implement section 1861(e) of 

the Social Security Act (the Act), which 

specifies services covered as hospital 

care and the conditions that a hospital 

program must meet in order to 

participate in the Medicare program. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to the activities relating 

to the survey and certification of 

facilities are at 42 CFR part 488. 

Generally, in order to enter into a 

provider agreement, a hospital must first 

be certified by a State survey agency as 

complying with the conditions set forth 

in the statute and part 482 of the 

regulations. Then, the hospital is subject 

to routine surveys by a State survey 

agency to determine whether it 

continues to meet the Medicare 

requirements. 

There is, however, an alternative to 

State compliance surveys. Certification 

by a nationally recognized accreditation 

program can substitute for ongoing State 

review. Section 1865(a)(1) of the Act (as 

amended by section 125(a) of the 

Medicare Improvements for Patients and 

Providers Act of 2008, Public Law 110– 

275, July 15, 2008) (MIPPA)) provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization that 

all applicable Medicare conditions are 

met or exceeded, we may ‘‘deem’’ those 

provider entities as having met the 

requirements. Accreditation by an 

accreditation organization is voluntary 

and is not required for Medicare 

participation. 

If an accreditation organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, a 

provider entity accredited by the 

national accrediting body’s approved 

program may be deemed to meet the 

Medicare conditions. A national 

accreditation organization applying for 

approval of deeming authority under 

part 488, subpart A must provide us 

with reasonable assurance that the 

accreditation organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

II. Deeming Applications Approval 

Process 

Section 1865(a)(3)(A) of the Act (as 

amended) provides a statutory time 

table to ensure that our review of 

deeming applications is conducted in a 

timely manner. The Act provides us 

with 210 calendar days after the date of 

receipt of a complete application, with 

any documentation necessary to make a 

determination, to complete our survey 

activities and application review 

process. Within 60 days of receiving a 

complete application, we must publish 

a notice in the Federal Register that 

identifies the national accreditation 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

an approval or denial of the application. 

III. Provisions of the Proposed Notice 

and Response to Comments 

On April 25, 2008, we published a 

proposed notice in the Federal Register 

(73 FR 22420) announcing DNVHC’s 

request for approval as a deeming 

organization for hospitals. In the 

proposed notice, we detailed our 

evaluation criteria. Under section 

1865(a)(2) of the Act (as amended) and 

our regulations at § 488.4 (Application 

and reapplication procedures for 

accreditation organizations), we 

conducted a review of DNVHC’s 

application in accordance with the 

criteria specified by our regulation, 

which include, but are not limited to the 

following: 

• An onsite administrative review of 

DNVHC’s (1) corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and, (5) survey review and decisionmaking process for accreditation; 

• A comparison of DNVHC’s hospital 

accreditation standards to our current 

Medicare hospital CoPs; and, 

• A documentation review of 

DNVHC’s survey processes to: 

Æ Determine the composition of the 

survey team, surveyor qualifications, 

and DNVHC’s ability to provide 

continuing surveyor training; 

Æ Compare DNVHC’s processes to 

those of State survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

Æ Evaluate DNVHC’s procedures for 

monitoring providers or suppliers found 

to be out of compliance with DNVHC 

program requirements. The monitoring 

procedures are used only when DNVHC 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d); 

Æ Assess DNVHC’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner; 

Æ Establish DNVHC’s ability to 

provide us with electronic data and 

reports necessary for effective validation 

and assessment of DNVHC’s survey 

process; 

Æ Determine the adequacy of staff 

and other resources; 

Æ Review DNVHC’s ability to 

provide adequate funding for 

performing required surveys; 

Æ Confirm DNVHC’s policies with 

respect to whether surveys are 

announced or unannounced; and, 

Æ Obtain DNVHC’s agreement to 

provide us with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey as we may require, including 

corrective action plans. 

In accordance with former section 

1865(b)(3)(A) of the Act, (now section 

1865(a)(3)(A) of the Act), the April 25, 

2008 proposed notice also solicited 

public comments regarding whether 

DNVHC’s requirements met or exceeded 

the Medicare CoPs for hospitals. We 

received 33 public comments in 

response to our proposed notice. 

The majority of commenters 

expressed support for DNVHC’s 

application for hospital deeming 

authority. Many of these commenters 

stated that it is important for hospitals 

to have alternatives for accreditation. 

Other commenters specifically voiced 

support for DNVHC’s integration of the 

Medicare CoPs and the ISO 9001 quality 

management systems. These 

commenters stated that DNVHC’s 

accreditation program provides 

hospitals with a unique, refreshing 

approach to ensure compliance with the 

Medicare requirements and facilitates 

continuous improvement. 

Comment: One commenter stated that 

it would be inappropriate to issue 

DNVHC exclusive deeming authority to 

certify hospitals using the ISO 9001 

standards and the Medicare CoPs. 

Response: As a CMS approved 

national accreditation organization, 

DNVHC does not have exclusive 

deeming authority for hospitals based 

on a program that integrates the ISO 

9001 standards and the Medicare 

hospital CoPs. Any accreditation 

organization that can demonstrate that 

its accreditation program meets or 

exceeds the Medicare requirements can 

apply for deeming authority. CMS’ 

application process for deeming 

authority is outlined in the Code of 

Federal Regulations at § 488.4. 

Comment: One commenter stated that 

although he agrees with DNVHC’s 

premise, he believes that a single, 

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56590 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 

standardized, regulatory approach to 

healthcare is necessary. 

Response: The Medicare CoPs are the 

minimum health and safety 

requirements that all hospitals must 

meet to participate in the Medicare 

program and serves as a single, 

standardized federal regulatory 

approach. Accreditation by an 

accreditation organization is voluntary 

and is not required for Medicare 

participation. A hospital may opt for 

routine surveys by a State survey agency 

to determine whether it meets the 

Medicare requirements. 

Comment: One commenter stated that 

it is CMS’ responsibility to review 

DNVHC’s application thoroughly to 

ensure DNVHC will meet the intent of 

the regulations. This commenter also 

expressed concerns related to a 

potential conflict of interest issue as 

DNVHC currently provides Joint 

Commission readiness consulting 

services to prepare hospitals for a Joint 

Commission accreditation survey. 

Response: All deeming applications 

are reviewed in accordance with the 

requirements at § 488.4 and § 488.8 to 

ensure that the applicant’s accreditation 

program meets or exceeds Medicare’s 

requirements. In terms of the conflict of 

interest issue raised by the commenter, 

DNVHC has provided a written 

statement as part of its application that 

this consultative service will be 

discontinued when DNVHC is approved 

as a nationally recognized accreditation 

organization for hospitals. 

IV. Provisions of the Final Notice 

A. Differences Between DNVHC’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared DNVHC’s hospital 

accreditation requirements and survey 

process with the Medicare hospital CoPs 

and survey process as outlined in the 

State Operations Manual (SOM). Our 

review and evaluation of DNVHC’s 

deeming application, which were 

conducted as described in section III of 

this final notice, yielded the following: 

• DNVHC modified its policies 

related to the effective date of 

participation in Medicare for new 

providers in accordance with 

requirements at § 489.13; 

• DNVHC modified its policies 

regarding time frames for sending and 

receiving a required plan of correction, 

and the required elements of an 

approved plan of correction in 

accordance with section 2728 of the 

SOM; 

• DNVHC developed and conducted 

training for its surveyors to ensure that 

all deficiencies cited contain a 

regulatory reference, a clear and 

detailed description of the deficient 

practice and relevant finding; 

• In accordance with § 488.3(a) and 

Appendix A of the SOM, DNVHC 

modified its policies to ensure that all 

off-campus provider based locations, 

satellite locations and services provided 

at remote locations that are under the 

hospital’s CCN number will be surveyed 

at least once every three years; 

• To meet the Medicare requirements 

at § 488.20(a) and § 488.28(a), DNVHC 

developed a policy regarding our 

requirements for submission of a plan of 

correction by the hospital and the 

completion of an onsite follow-up 

survey to determine compliance with 

Medicare CoPs after citing condition 

level noncompliance during a 

recertification survey; 

• DNVHC developed a policy 

regarding condition level 

noncompliance identified during an 

initial certification survey for 

participation in Medicare in accordance 

with section 2005A2 of the SOM; 

• DNVHC modified its policies 

regarding complaint investigation 

activities with appropriate licensing 

bodies and ombudsmen programs in 

accordance with the requirements at 

§ 488.4(a)(6); 

• DNVHC amended its interpretive 

guidance and surveyor tool to include 

the survey methods its surveyors would 

use to determine compliance with the 

requirements at § 482.12(f)(2), 

§ 482.23(a), and § 482.23(c)(1); 

• DNVHC amended its interpretive 

guidance and surveyor tools to meet the 

requirements at § 482.13(c)(3), 

§ 488.22(c)(3), § 482.23(c)(3), 

§ 482.24(c)(1)(iii), § 482.25(b)(2)(i), 

§ 482.25(b)(6), § 482.25(b)(7), 

§ 482.30(b)(3)(i), § 482.43(e), 

§ 482.45(a)(1), § 482.51(a), § 482.52, 

§ 482.53(b), § 482.54, § 482.54(a), and 

§ 482.56; 

• DNVHC added language to its 

standards, and interpretive guidance to 

address the requirements at 

§ 482.13(e)(9), § 482.30, and 

§ 482.30(b)(1)(ii)(A)–(B); 

• DNVHC amended its policies by 

eliminating recommendations referred 

to as ‘‘opportunities for improvement’’ 

from the written survey findings to meet 

the requirements at § 488.28(a) and 

Section 2726 of the SOM. 

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we have determined that 

DNVHC’s requirements for hospitals 

meet or exceed our requirements. 

Therefore, we approve DNVHC as a 

national accreditation organization for 

hospitals that request participation in 

the Medicare program, effective 

September 26, 2008 through September 

26, 2012. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and record 

keeping requirements. Consequently, it 

need not be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 35). 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplemental Medical Insurance 

Program) 

Dated: August 21, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E8–22585 Filed 9–25–08; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Child Care and Development 

Fund Plan for States/Territories for FFY 

2010–2011 (ACF–118). 

OMB No.: 0970–0114. 

Description: The Child Care and 

Development Fund (CCDF) Plan (the 

Plan) for States and Territories is 

required from each CCDF Lead agency 

in accordance with Section 658E of the 

Child Care and Development Block 

Grant Act of 1990, as amended (Pub. L. 

101–508, Pub. L. 104–193, and 42 U.S.C. 

9858). The implementing regulations for 

the statutorily required Plan are set forth 

at 45 CFR 98.10 through 98.18. The 

Plan, submitted on the ACF–118, is 

required biennially, and remains in 

effect for two years. The Plan provides 

ACF and the public with a description 

of, and assurance about, the States or 

the Territories child care program. The 

ACF–118 is currently approved through 

June 30, 2009, making it available to 

States and Territories needing to submit 

Plan Amendments through the end of 

the FY 2009 Plan Period. However, in 

July 2009, States and Territories will be 

required to submit their FY 2010–2011 

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