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Draft Guidance for Industry on Acute 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availability of a draft guidance for 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The purpose of this draft guidance is to 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this draft guidance, when finalized, will 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
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 49685 

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. 

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: August 13, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19490 Filed 8–21–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0447] 

Achieving a Future Vision at the 2008 

Parenteral Drug Association and the 

Food and Drug Administration Joint 

Regulatory Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

meeting: Achieving a Future Vision at 

the 2008 Parenteral Drug Association 

and the Food and Drug Administration 

Joint Regulatory Conference. The topics 

to be discussed are: FDA’s 

Pharmaceutical Inspectorate and the 

Global Harmonization Task Force; Trans 

Atlantic initiative; Product 

development; and legacy products; 

Supply chain; Combination products; 

and Recall root causes. 

Date and Time: The meeting will be 

held on September 8 through 12, 2008, 

7 a.m. to 6. 

Location: The meeting will be held at 

Renaissance Hotel, 999 9th St., NW., 

Washington, DC 20001. 

Contact: Wanda Neal-Ballard, 

Parenteral Drug Association, PDA 

Global Headquarters, Bethesda Towers, 

4350 East West Hwy., Suite 200, 

Bethesda, MD 20814 or by telephone on 

301–986–0293, ext. 111. 

Registration and Meeting Information: 

See PDA Web site, www.pda.org/ 

pdafda2008 or contact Wanda NealBallard on 301–986–0293, ext. 111. 

From now until August 25, 2008, 

registration fees are as follows: 

$1,600.00 for Members, $2,000.00 for 

Non-members, $615.00 for Government/ 

Health Authority/Academic and 

$230.00 for Students. After August 25, 

2008, registration fees are as follows: 

$1,800.00 for Members, $2,200.00 for 

Non-members, $700.00 for Government/ 

Health Authority/Academic and 

$260.00 for Students. 

If you need special accommodations 

due to a disability, please contact 

Wanda Neal-Ballard at least 7 days in 

advance. 

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19491 Filed 8–21–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; California Health Interview 

Survey Cancer Control Module (CHIS–

CCM) 2009 (NCI) 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: California 

Health Interview Survey Cancer Control 

Module (CHIS–CCM) 2009. Type of 

Information Collection Request: New. 

Need and Use of Information Collection: 

The NCI has sponsored four Cancer 

Control Modules in the California 

Health Interview Survey (CHIS), and 

will be sponsoring a fifth to be 

administered in 2009. CHIS is a 

telephone survey that collects 

population-based, standardized healthrelated data to assess California’s 

progress in meeting Healthy People 

2010 objectives for the nation and the 

state. The CHIS sample is designed to 

provide statistically reliable estimates 

statewide, for California counties, and 

for California’s ethnically and racially 

diverse population. Initiated by the 

UCLA Center for Health Policy 

Research, the California Department of 

Health Services, and the California 

Public Health Institute, the survey is 

funded by a number of public and 

private sources. It was first administered 

in 2001 to 55,428 adults and 

subsequently in 2003 to 42,043 adults, 

in 2005 to 43,020 adults, and in 2007 to 

48,150 adults. These adults are a 

representative sample of California’s 

non-institutionalized population living 

in households. CHIS 2009, the fifth biannual survey, is planned for 

administration to 55,000 adult 

Californians. This study will allow NCI 

to examine patterns and trends in 

cancer screening and follow-up, as well 

as to study other cancer-related topics 

such as tobacco control, diet, physical 

activity, and obesity. Additionally, CHIS 

is designed to be comparable to the 

National Health Interview Survey 

(NHIS) data in order to conduct 

comparative analyses. CHIS provides 

enhanced estimates for cancer risk 

factors and screening among racial/ 

ethnic minority populations. Frequency 

of Response: Once. Affected public: 

Individuals or households. Types of 

Respondents: U.S. adults and 

adolescents (persons 12 years of age and 

older). The total annual burden hours 

requested are 3,276.94 (see Table A). 

The annualized cost to respondents is 

estimated at: $55,071.88. There are no 

Capital Costs, Operating Costs, and/or 

Maintenance Costs to report. 

TABLE A—ANNUALIZED BURDEN ESTIMATES FOR CHIS 2009 

Type of respondent Form type Number of 

respondents 

Frequency 

of response 

Average 

time per 

response 

(hours) 

Annual hour 

burden 

Adults ........................................................ Adult Pilot ................................................. 75 1 8/60 10.00 

.............................................................. Adult Survey ............................................. 24,000.00 1 8/60 3,200.00 


jlentini on PROD1PC65 with NOTICES