Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 55851 

• Develops, evaluates and maintains 

policies, regulations, and instructions 

that define the scope of benefits and 

payment amounts for: 

1. Hospitals for inpatient services 

under the inpatient prospective 

payment system and the long-term care 

hospital prospective payment system; 

2. Inpatient services in hospitals and 

units excluded from the prospective 

payment systems; 

3. Physicians and non-physician 

practitioners; 

4. Hospital outpatient departments, 

comprehensive outpatient rehabilitation 

facilities and ambulatory surgical 

centers; 

5. Clinical laboratory services; 

6. Ambulance services; 

7. Prescription drugs and blood, blood 

products and hemophilia clotting factor; 

and 

8. Telemedicine services, rural health 

clinics, and federally-qualified health 

centers. 

• Formulates CMS policy for 

development, analysis, and 

maintenance of new and revised 

medical codes and medical 

classification systems (including ICD–9– 

CM, Healthcare Common Procedure 

Coding System, Diagnosis Related 

Groups, and Ambulatory Payment 

Classifications) and develops common 

medical coding standards and policy. 

• Participates in the development and 

evaluation of proposed legislation 

pertaining to assigned subject areas. 

• Coordinates with the Office of 

Clinical Standards and Quality on 

coverage issues in assigned areas. 

• Develops, evaluates, and reviews 

regulations, manuals, program 

guidelines, and instructions required for 

the dissemination of program policies to 

program contractors and the health care 

field. 

• Identifies, studies and makes 

recommendations for modifying 

Medicare policies to reflect changes in 

beneficiary health care needs, program 

objectives, and the health care delivery 

system. 

• Develops, evaluates and maintains 

policies, regulations, and instructions 

that define the scope of benefits and 

payment amounts for skilled nursing 

facilities, home health agencies, 

hospice, durable medical equipment, 

orthotics, prosthetics and supplies. 

• Develops and evaluates national 

Medicare policies and principles for 

applying limitations to the costs of 

skilled nursing facilities and home 

health agencies. Develops criteria for 

exceptions to the cost limitations for 

skilled nursing facilities. Reviews and 

makes decisions on requests for such 

exceptions. 

• Analyzes payment data, develops, 

maintains and updates payments rates 

for End Stage Renal Disease services and 

Program of All-Inclusive Care for the 

Elderly sites. 

• Manages designation process for 

Medicare organ transplant centers, 

organ procurement organizations and 

for hospitals seeking out-of-service-area 

waivers. 

• Develops, issues and administers 

the specifications, requirements, 

methods, standards, policies, 

procedures and budget guidelines for 

Medicare claims processing related 

activities, including detailed definitions 

of the relative responsibilities of 

providers, contractors, CMS, other thirdparty payers and the beneficiaries of the 

Medicare program. 

• Develops and releases the coding 

and pricing databases and software for 

physician, laboratory, Skilled Nursing 

Facility, Home Health, Inpatient, 

Outpatient and supplier services in the 

Medicare claims processing standard 

systems. 

• Develops policies related to the 

integration of health care services, 

including policies on ownership and 

referral arrangements, business 

relationships and conflict of interest. 

• Serves as the CMS lead for 

management, oversight, budget and 

performance issues relating to Medicare 

carriers, fiscal intermediaries, and 

MACs. 

• Functions as CMS liaison for all 

Medicare carrier, fiscal intermediary, 

and MAC program issues and, in close 

collaboration with the regional offices 

and other CMS components, coordinates 

Agency-wide contractor activities. 

• Manages contractor instructions, 

workload, and change management 

process. 

• Manages and oversees Medicare 

contractor provider inquiry, outreach, 

and education activities including 

specifying Budget Performance 

Requirements, allocating and managing 

budget dollars across contractors, 

evaluating supplemental budget 

requests, issuing program instructions 

and participating in contractor 

performance evaluation activities. 

• In conjunction with the CMS 

program area experts, develops training 

programs and materials, and training 

tools to educate providers, physicians, 

suppliers and Medicare contractor 

provider education staff on new 

initiatives and changes to the Medicare 

program. 

• Develops national provider/ 

supplier education products and 

training tools for Medicare contractors 

as well as for provider education 

provided directly by CMS. 

• Supports communication between 

CMS and the provider/supplier 

community through facilitation of 

‘‘open door’’ and Participating 

Physician Advisory Committee 

meetings, other listening sessions and 

promotes awareness of Agency 

initiatives by sponsoring exhibit 

programs at industry conferences. 

• Develops system requirements and 

computer software for select portions of 

Medicare FFS claims processing 

systems. 

• Develops and implements Medicare 

FFS program requirements for provider 

billing and for claims processing 

systems. 

• Implements the Medicare Health 

Support Program. 

Dated: September 18, 2008. 

James W. Weber, 

Acting Director, Office of Operations 

Management, Centers for Medicare & 

Medicaid Services. 

[FR Doc. E8–22690 Filed 9–25–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0514] 

Draft Guidance for Industry on End-ofPhase 2A Meetings; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘End-of-Phase 2A 

Meetings.’’ This draft guidance provides 

information on end-of-phase 2A 

(EOP2A) meetings for sponsors of 

investigational new drug applications 

(INDs) who seek guidance on employing 

clinical trial simulation and quantitative 

modeling of prior knowledge (e.g., drug, 

disease, placebo) to design trials for 

better dose response estimation, dose 

selection, and other appropriate issues. 

This draft guidance is intended to 

further FDA initiatives directed at 

identifying opportunities to facilitate 

the development of innovative medical 

products and to improve the quality of 

drug applications through early 

meetings with sponsors. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 


jlentini on PROD1PC65 with NOTICES
55852 Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 

written or electronic comments on the 

draft guidance by November 25, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Robert Powell, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4526, 

Silver Spring, MD 20993–0002, 301– 

796–1589 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘End-of-Phase 2A Meetings.’’ This draft 

guidance will meet one of the 

performance goals agreed to under the 

September 27, 2007, reauthorization of 

the Prescription Drug User Fee Act 

(PDUFA IV). Under section XI of the 

PDUFA IV Performance Goals, 

Expediting Drug Development, FDA 

agreed to publish by the end of fiscal 

year 2008 a draft guidance on end-ofphase 2A meetings (see section XI.A.4 at 

http://www.fda.gov/oc/pdufa4/ 

pdufa4goals.html). This draft guidance 

is intended to facilitate early meetings 

(referred to as end-of-phase 2A meetings 

or EOP2A meetings) between FDA and 

sponsors who seek interaction or 

guidance related to the use of 

quantitative drug development methods 

(i.e., exposure-response, 

pharmacokinetic/pharmacodynamic 

(PK/PD) modeling, drug-disease 

modeling, genomic analysis) to inform 

drug development and regulatory 

decisions. The draft guidance provides 

recommendations to IND sponsors on 

the following topics: 

• Objectives of an EOP2A meeting, 

• Possible topics for discussion at 

EOP2A meetings, 

• Useful information for an EOP2A 

meeting package, and 

• Timing of EOP2A meetings. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on end-of-phase 2A meetings. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 and 

the guidance on ‘‘Formal Meetings With 

Sponsors and Applicants for PDUFA 

Products’’ have been approved under 

OMB control numbers 0910–0014 and 

0910–0429, respectively. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: September 22, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22669 Filed 9–25–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2008–M–0207, FDA– 

2008–M–0243, FDA–2008–M–0244, FDA– 

2008–M–0283, FDA–2008–M–0335, FDA– 

2008–M–0311, FDA–2008–M–0342, FDA– 

2008–M–0378] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in Table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4010. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 


jlentini on PROD1PC65 with NOTICES