Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 28057 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Independent 

Renal Dialysis Facility Cost Report and 

supporting regulations 42 CFR 413.20 

and 42 CFR 413.24; Form No.: CMS–

265–94 (OMB# 0938–0236); Use: 

Providers of services participating in the 

Medicare program are required under 

sections 1815(a), 1833(e), 1861(v)(1)(A) 

and 1881(b)(2)(B) of the Social Security 

Act to submit annual information to 

achieve reimbursement for health care 

services rendered to Medicare 

beneficiaries. The Form CMS 265–94 

cost report is needed to determine the 

amount of reasonable cost due to the 

providers for furnishing medical 

services to Medicare beneficiaries. 

The data collected will be used for the 

following additional purposes: (a) 

Determination of reimbursement rates 

for renal dialysis treatments, selfdialysis training, and other reasonable 

and medically necessary services 

rendered in connection with these 

treatments; (b) justification of requests 

for adjustments or exceptions in the 

reimbursements rates; and, (c) 

accumulation of data for overall 

evaluation. Worksheet B, Worksheet C 

and Worksheet D have been modified to 

implement provisions of the Medicare 

Prescription Drug Improvement and 

Modernization Act of 2003. On 

Worksheet B, the allocation of 

Administrative and General cost to 

Separately Billable Drugs was 

eliminated. On Worksheet C, two 

columns were sub-divided to identify 

services before, on or after 4/1/2005. A 

line was added to Worksheet D to report 

bad debts for dual eligible beneficiaries. 

None of these changes request new 

information; rather, the changes require 

reporting of data in greater detail than 

was previously reported. Frequency: 

Reporting—Annually; Affected Public: 

Business or other for-profit, Not-forprofit institutions; Number of 

Respondents: 4,885; Total Annual 

Responses: 4,885; Total Annual Hours: 

957,460. 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Participating Physician or Supplier 

Agreement; Form No.: CMS–460 (OMB# 

0938–0373); Use: The CMS–460 is the 

agreement a physician, supplier or their 

authorized official signs to participate in 

Medicare Part B. By signing the 

agreement to participate in Medicare, 

the physician, supplier or their 

authorized official agrees to accept the 

Medicare-determined payment for 

Medicare covered services as payment 

in full and to charge the Medicare Part 

B beneficiary no more than the 

applicable deductible or coinsurance for 

the covered services. For purposes of 

this explanation, the term a supplier 

means any person or entity that may bill 

Medicare for Part B services (e.g. DME 

supplier, nurse practitioner, supplier of 

diagnostic tests) except a Medicare 

provider of services (e.g. hospital), 

which must participate to be paid by 

Medicare for covered care. 

There are additional benefits 

associated with payment for services 

paid under the Medicare fee schedule. 

Payments made under the Medicare fee 

schedule for physician services to 

participating physicians and suppliers 

are based on 100 percent of the 

Medicare fee schedule amount, while 

the Medicare fee schedule payment for 

physician services by nonparticipating 

physicians and suppliers is based on 95 

percent of the fee schedule amount. 

Physicians and suppliers who do not 

participate in Medicare are subject to 

limits on their actual charges for 

unassigned claims for physician 

services. These limits, known as 

limiting charges, cannot exceed 115 

percent of the non-participant fee 

schedule, which is set at 95 percent of 

the full fee schedule amount. In 

addition, if a physician or supplier does 

not accept assignment on a claim for 

Medicare payment, the physician or 

supplier must collect payment from the 

beneficiary. If the physician or supplier 

accepts assignment on the claim, 

Medicare pays its share of the payment 

directly to the physician or supplier, 

resulting in faster and more certain 

payment. Frequency: Reporting, Other—

when starting a new business; Affected 

Public: Business or other for-profit; 

Number of Respondents: 6000; Total 

Annual Responses: 6000; Total Annual 

Hours: 1500. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

or faxed within 30 days of this notice 

directly to the OMB desk officer: OMB 

Human Resources and Housing Branch, 

Attention: Carolyn Lovett, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Fax Number: 

(202) 395–6974. 

Dated: May 10, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–9473 Filed 5–17–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Income Withholding for 

Support (IWO) (Formerly: Order to 

Withhold Income for Child Support and 

Notice of an Order to Withhold Income 

for Child Support). 

OMB No.: 0970–0154. 

Description: Pub. L. 104–193, The 

Personal Responsibility and Work 

Opportunity Reconciliation Act 

(PRWORA) of 1996, Section 324, 

requires the Federal Office of Child 

Support Enforcement (OCSE) to develop 

a standardized form to collect child 

support payments from an obligor’s 

employer. The form, which promotes 

standardization and is used for title IV–

D and non-IV–D cases that require 

income withholding, expires 5/31/2007, 

and the Administration for Children and 

Families is taking this opportunity to 

revise the form and its instructions. 

Overall, the language and format of 

the form have been edited, modified, 

and made easier to read and 

comprehend. The two-page form 

provides a detailed legal description of 

the established order, support amounts, 

and remittance information an employer 


pwalker on PROD1PC71 with NOTICES
28058 Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 

needs to withhold payments from an 

obligor who owes child support. One of 

the new fields on the form is for the 

attachment of lump sum payments by 

employers. This addition allows the 

issuing entity to instruct the employer 

with respect to the attachment and 

remittance of lump sum payments. 

Fields for child’s name and date of birth 

have been moved to the front of the 

form, allowing the employer community 

to easily identify who the form is for 

and to avoid implementation of 

duplicate orders. Other changes that 

have enhanced the form include: A 

simplified title, clear identification of 

who is sending the form, and 

modifications to allow the employer to 

easily report employee terminations. 

The electronic IWO (e-IWO) allows 

States to transmit IWOs electronically 

and employers to notify States 

electronically regarding the status of 

IWOs. 

Respondents: States, Territories, 

Tribes, and Courts. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Income Withholding for Support (IWO) ........................................................... 58 206,897 .0017 20,400 

ELECTRONIC Income Withholding for Support .............................................. 20 60,000 .0008 960 

IWO—Submitted Manually .............................................................................. 1,800 1,321 .0840 199,735 

Estimated Total Annual Burden 

Hours: 221,095. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202–

395–6974, Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: May 15, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–2479 Filed 5–17–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0166] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Draft Guidance for Industry on Target 

Animal Safety for Veterinary 

Pharmaceutical Products, VICH GL43, 

Request for Comments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability for comments of a draft 

guidance document for industry (#185) 

entitled ‘‘Draft Guidance for Industry on 

Target Animal Safety for Veterinary 

Pharmaceutical Products,’’VICH GL43. 

This draft guidance has been developed 

for veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). This draft VICH guidance 

document has been developed as a 

harmonized standard to aid in 

development of mutually acceptable 

target animal safety (TAS) studies for 

the relevant governmental regulatory 

bodies. 

DATES: Submit written or electronic 

comments on the draft guidance by June 

18, 2007, to ensure their adequate 

consideration in preparation of the final 

document. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Communications Staff (HFV–12), 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 request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Comments should be identified with the 

full title of the draft guidance and the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Laura Hungerford, Center for Veterinary 

Medicine, (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6439, email: laura.hungerford@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote the 

international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 


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