Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 49683 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 7, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E8–18971 Filed 8–21–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1405–N] 

Medicare Program; Medicare Provider 

Feedback Group Town Hall Meeting—

September 22, 2008 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

annual Medicare Provider Feedback 

Group (MPFG) Town Hall meeting. This 

meeting is open to all Medicare fee-forservice (FFS) providers and suppliers 

that participate in the Medicare 

program, including physicians, 

hospitals, home health agencies, thirdparty billers, and interested parties, to 

present their individual views and 

opinions on selected FFS Medicare 

topics. In addition, we will be soliciting 

input on how we can improve 

communications to better serve the 

Medicare providers and suppliers. 

DATES: Meeting Date: The Town Hall 

meeting announced in this notice will 

be held on Monday, September 22, 2008 

from 2 p.m. to 4 p.m. EDT. 

ADDRESSES: Meeting Location: The 

Town Hall meeting will be held in the 

main auditorium of the central building 

of the Centers for Medicare and 

Medicaid Services, 7500 Security 

Boulevard, Baltimore, MD 21244. The 

meeting will also be available by 

teleconference. 

FOR FURTHER INFORMATION CONTACT: 

Colette Shatto, (410) 786–6932. You 

may also send inquiries about this 

meeting via e-mail to 

MFG@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Since 2005, CMS has held four 

Medicare Provider Feedback Group 

(MPFG) Town Hall meetings. The 

purpose of these meetings is to capture 

individual provider and supplier 

feedback on relevant Fee-For-Service 

(FFS) Medicare policy and operational 

issues. These meetings allow us to 

further advance our efforts to strengthen 

the Medicare program and enhance our 

relationship with providers and 

suppliers. The meetings also provide a 

venue to allow us to continue a process 

of communication with individual 

providers and suppliers through the 

following year. 

II. Meeting Format and Agenda 

The meeting will begin with an 

overview of the goals and objectives of 

the MPFG efforts to gather feedback 

from individual Medicare providers and 

suppliers. This meeting will be held onsite at CMS and by teleconference. The 

meeting agenda and discussion 

materials will be available to download 

by September 19, 2008. These materials 

can be located at http:// 

www.cms.hhs.gov/center/provider.asp. 

The feedback provided during this 

meeting will assist us as we evaluate 

FFS Medicare policy, operational issues, 

and CMS’ provider and supplier 

communication activities. Topics to be 

discussed include, but are not limited 

to, 5010 (possible next version of 

HIPAA standards for claims and other 

transactions), Medicare Administrative 

Contract Transitions, and Recovery 

Auditing. 

There will be a question and answer 

session that offers meeting participants 

an opportunity to provide feedback on 

how CMS services physicians, providers 

and suppliers, as well as make 

suggestions on how this process can be 

improved. Time for participants to ask 

questions or provide feedback will be 

limited according to the number of 

registered participants; however, written 

submissions will be accepted. 

Individuals who wish to provide written 

feedback should e-mail that feedback to 

Colette Shatto at MFG@cms.hhs.gov. 

Written feedback will be accepted 

through September 30, 2008. 

Consideration will be given to 

feedback received on the topics 

discussed at the meeting, but written 

responses will not be provided. The 

meeting is open to the public, but onsite attendance is limited to space 

available. Registered participants from 

the meeting will be included in the 

MPFG and may be contacted throughout 

the year for follow-up meetings to solicit 

additional opinions or clarify any issues 

that may arise from the September 22, 

2008 meeting. 

III. Registration Instructions 

The Division of Provider Relations 

and Evaluations, Provider 

Communications Group, Center for 

Medicare Management is coordinating 

the meeting registration. While there is 

no registration fee, individuals, 

providers, and suppliers must register to 

participate both on-site and by 

teleconference. Individuals must 

complete the on-line registration located 

at http://registration.intercall.com/go/ 

cms2. 

The on-line registration system will 

capture contact information and 

practice characteristics (for example, 

names, e-mail addresses, and provider, 

and supplier types). Registration will be 

open beginning August 29, 2008 and 

will close on September 17, 2008. 

Registration after 5 p.m. EDT on 

September 17, 2008 will not be 

accepted. 

The on-line registration system will 

generate a confirmation page to indicate 

the completion of your registration. 

Participants should print this page as 

his or her registration receipt. 

Teleconference instructions will be 

issued as part of the confirmation page 

once participants have registered 

through the on-line registration 

instrument. If seating capacity has been 

reached for on-site participants, 

notification will be sent that the meeting 

has reached capacity; however, those 

wishing to participate may still do so by 

teleconference. 

IV. Security, Building, and Parking 

Guidelines 

Because this meeting will be located 

on Federal property, for security 

reasons, any persons wishing to attend 

this meeting must register by 5 p.m. 

EDT on September 17, 2008. Individuals 

who have not registered by the 

registration deadline will not be allowed 

to enter the building to attend the 

meeting or attend the meeting by 

teleconference. Seating capacity is 

limited to the first 250 registrants. 

The on-site check-in for visitors will 

be held from 12:30 p.m. to 1:30 p.m. 

EDT. Participants should allow 

sufficient time to go through the 

security checkpoints. It is suggested that 

participants arrive at 7500 Security 

Boulevard no later than 1:30 p.m. EDT 

in order to arrive promptly at the 

meeting by 2 p.m. 

Security measures will include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. In addition, 

all persons entering the building must 

pass through a metal detector. All items 

brought to the building, whether 

personal or for the purpose of 

demonstration or to support a 

presentation, are subject to inspection. 

In order to gain access to the building, 

participants will be required to show a 

government-issued photo identification 

(for example, driver’s license, or 


jlentini on PROD1PC65 with NOTICES
49684 Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 

passport), and must be listed on an 

approved security list before persons are 

permitted entrance. Persons not 

registered in advance will not be 

permitted into the CMS building and 

will not be permitted to attend the 

meeting. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for the purpose 

of presentation. 

Individuals requiring sign language 

interpretation or other special 

accommodation must contact the 

Designated Federal Officer specified in 

the FOR FURTHER INFORMATION CONTACT

section of this notice by September 17, 

2008. 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program) 

Dated: August 19, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E8–19564 Filed 8–21–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0419] 

Draft Guidance for Industry on Acute 

Bacterial Exacerbations of Chronic 

Bronchitis in Patients With Chronic 

Obstructive Pulmonary Disease: 

Developing Antimicrobial Drugs for 

Treatment; 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 ‘‘Acute Bacterial 

Exacerbations of Chronic Bronchitis in 

Patients With Chronic Obstructive 

Pulmonary Disease: Developing 

Antimicrobial Drugs for Treatment.’’

The purpose of this draft guidance is to 

assist clinical trial sponsors and 

investigators in the development of 

antimicrobial drugs for the treatment of 

acute bacterial exacerbations of chronic 

bronchitis in patients with chronic 

obstructive pulmonary disease (ABECB–

COPD). The agency’s thinking in this 

area has evolved in recent years, and 

this draft guidance, when finalized, will 

inform sponsors of the changes in our 

recommendations. In addition, it will 

fulfill a statutory requirement enacted in 

the Food and Drug Administration 

Amendments Act of 2007 (FDAAA) to 

publish such a guidance. 

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 

written or electronic comments on the 

draft guidance by November 20, 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: 

Steven Gitterman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6134, 

Silver Spring, MD 20993–0002, 301–

796–1600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Acute Bacterial Exacerbations of 

Chronic Bronchitis in Patients With 

Chronic Obstructive Pulmonary Disease: 

Developing Antimicrobial Drugs for 

Treatment.’’ The purpose of this draft 

guidance is to assist clinical trial 

sponsors and investigators in the 

development of antimicrobial drugs for 

the treatment of ABECB–COPD. This 

guidance revises the draft guidance 

regarding ABECB published in 1998. 

Section 911 of FDAAA (Public Law 

110–85) adds section 511 to the Federal 

Food, Drug, and Cosmetic Act that 

directs the Secretary of Health and 

Human Services to ‘‘issue guidance for 

the conduct of clinical trials with 

respect to antibiotic drugs, including 

antimicrobials to treat * * * acute 

bacterial exacerbation of chronic 

bronchitis.’’

The design of ABECB clinical trials 

was discussed at a meeting of the AntiInfective Drugs Advisory Committee on 

February 19, 2002, and an IDSA/ 

PhRMA/FDA workshop on November 

19 and 20, 2002. In addition, other 

advisory committee meetings have 

focused on the development of specific 

drugs for this indication. As a result of 

these public discussions, as well as 

review of applications at FDA, the 

agency’s thinking in this area has 

evolved in recent years, and this draft 

guidance informs sponsors of the 

changes in our recommendations. 

Specifically, this draft guidance 

recommends that ABECB–COPD clinical 

trials be designed as superiority rather 

than noninferiority trials, and discusses 

some possible study designs that might 

be employed in an ABECB–COPD trial 

designed to show superiority. This draft 

guidance discusses patient-reported 

outcome instruments for assessing 

clinical response, and the use of time to 

resolution of symptoms as a possible 

approach to assessing the primary 

endpoint in clinical studies. 

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 developing drugs for the treatment of 

ABECB–COPD. 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. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information that 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 have been approved under 

OMB control number 0910–0014; the 

collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001; and 

the collections of information referred to 

in the guidance ‘‘Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees’’ have been 

approved under OMB control number 

0910–0581. 

III. 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 


jlentini on PROD1PC65 with NOTICES