10766 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 

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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received at the address below, no 

later than 5 p.m. on May 8, 2007. CMS, 

Office of Strategic Operations and 

Regulatory Affairs, Division of 

Regulations Development—B, Attention: 

William N. Parham, III, Room C4–26–

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: March 2, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–4235 Filed 3–8–07; 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: Evaluation of the Mentoring 

Children of Prisoners (MCP) Program. 

OMB No.: New Collection. 

Description: The Promoting Safe and 

Stable Families Amendments, as 

reauthorized (2006), amended Title IV–

B of the Social Security Act (42 U.S.C. 

629–629e) providing funding for 

nonprofit agencies that recruit, screen, 

train, and support mentors for children 

with an incarcerated parent or parents. 

The Family and Youth Services Bureau 

(FYSB) of the Administration for 

Children and Families, United States 

Department of Health and Human 

Services, administers the Mentoring 

Children of Prisoners (MCP) program. 

The MCP program provides children of 

prisoners with caring adult mentors, 

supporting one-to-one mentoring 

relationships. Research in other 

populations has shown that such 

relationships can lead to reductions in 

risk behaviors and improvements in 

academic, behavioral and psychological 

outcomes in children and youth. 

Although the MCP program was 

developed based on research 

documenting the efficacy of mentoring 

as a general intervention strategy, it is 

not yet known whether or not this 

particular intervention yields positive 

outcomes for the children of prisoners 

population. Little is known about how 

mentoring relationships work for these 

youth, and how effective mentoring 

relationships for children of prisoners 

differ from effective mentoring 

relationships for other youth. In 

addition, little is known about children 

of prisoners in general and thus a survey 

of MCP program youth has the potential 

to provide important data about this 

relatively unstudied population. 

The evaluation and data collection 

proposed in this notice are to fulfill the 

statutory requirement under Section 8, 

subsection h(1) of the Child and Family 

Services Improvement Act of 2006, as 

amended, that the Secretary of the 

Department of Health and Human 

Services evaluate outcomes of the MCP 

program and report to Congress on the 

findings. The proposed data collections 

will support a study of the MCP 

program that measures the program’s 

child outcomes and compares these 

outcomes in similar programs. The data 

collection also will provide general 

information about youth in the program. 

Finally, the study will include an 

administrative survey of grantees 

participating in the study. The proposed 

study will include baseline and followup surveys (to be administered 

approximately 12 months apart) of 

youth ages 9–16 in the MCP program 

and will compare changes in key 

behaviors for program youth against 

changes in behaviors of similar youth 

not enrolled in mentoring programs. By 

comparing changes for youth in the 

MCP program against changes for youth 

not in the program, we will be able to 

determine if MCP youths’ behaviors are 

closer to the norm for their age group at 

follow-up than at program intake. If 

MCP youths’ behaviors and outcomes 

are shown to improve relative to other 

groups, the MCP program has 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 10767 

demonstrated the potential for positive 

impacts. The survey also will include 

some general informational questions 

about youth in the study so that HHS, 

policy makers, and practitioners can 

have a greater understanding of the life 

circumstances of these youth and of 

some of the challenges they may face. 

The youth surveys will focus on 

measuring both attitudinal and 

behavioral changes in areas targeted by 

the MCP program including attitudes 

towards and performance in school; 

relationships with parents, peers and 

teachers; self-esteem; and engagement in 

a variety of risk behaviors, including 

alcohol and drug use and physical 

violence. They also will include 

questions about the living situations of 

youth in the study, their relationships 

with both incarcerated and nonincarcerated caregivers, and their 

relationships with other supportive 

adults in their communities. 

The administrative survey of grantees 

will include questions about the 

programmatic structure of each grantee. 

It will provide information about 

variations in program administration, 

mentor activities, and youth served. 

Respondents: Mentoring Children of 

Prisoners (MCP) grantees and non-MCP 

mentoring organizations. 

Annual Burden Estimates: 

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden 

hours per response 

Total burden 

hours 

Student Baseline Survey. ............................................................................ 625 1 .5 312 .5 

Student follow-up Survey. ............................................................................ 500 1 .5 250 

Grantee Survey ............................................................................................ 72 1 1 72 

Estimated Total Annual Burden 

Hours: 634.5. 

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 ACF. 

Dated: March 5, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–1101 Filed 3–8–07; 8:45 am] 

BILLING CODE 4184–07–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0301] 

Guidance for Industry: Animal Drug 

User Fees; Fees Exceed Costs Waiver/ 

Reduction; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance for industry 

(#183) entitled ‘‘Guidance for Industry: 

Animal Drug User Fees; Fees Exceed 

Costs Waiver/Reduction.’’ This 

guidance explains the procedures FDA 

expects to use to evaluate waiver 

requests under the fees exceed costs 

waiver provision of the Animal Drug 

User Fee Act of 2003 (ADUFA). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

to the Communications Staff (HFV–12), 

Center for Veterinary Medicine (CVM), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the guidance document 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 

guidance document and the docket 

number found in the heading of this 

document. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Dave Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 17, 

2006 (71 FR 47502), FDA published the 

notice of availability of the draft 

guidance entitled ‘‘Guidance for 

Industry: Animal Drug User Fees; Fees 

Exceed Costs Waiver and Reductions’’

giving interested persons until October 

31, 2006, to submit comments. FDA 

received no comments. 

ADUFA (Public Law 108–130) 

amended the Federal Food, Drug, and 

Cosmetic Act (the act) and requires the 

FDA to assess and collect user fees for 

certain applications, products, 

establishments, and sponsors. It also 

requires the agency to grant a waiver 

from or a reduction of those fees in 

certain circumstances. 

This guidance explains the 

procedures FDA expects to use to 

evaluate waiver requests under the fees 

exceed costs waiver provision of 

ADUFA. These procedures may be 

modified in the future as FDA gains 

more experience with waiver requests. 

To qualify for waiver consideration, a 

written request to the agency for a 

waiver/reduction, including under the 

fees exceed costs waiver provision, must 

be submitted no later than 180 days 

after the fee is due (section 740(i) of the 

act (21 U.S.C. 379j–12(i))). 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the topic. The 

document does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. 

Alternative approaches may be used as 

long as they satisfy the requirements of 

the applicable statutes and regulations. 


jlentini on PROD1PC65 with NOTICES