48080 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

Dated: September 14, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–22646 Filed 9–18–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0514] 

Guidance for Industry on End-of-Phase 

2A Meetings; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘End-of-Phase 2A Meetings.’’ 

This guidance provides information on 

end-of-phase 2A (EOP2A) meetings for 

sponsors of investigational new drug 

applications (INDs). The purpose of an 

EOP2A meeting is to facilitate 

interaction between FDA and sponsors 

who seek guidance related to clinical 

trial design employing clinical trial 

simulation and quantitative modeling of 

prior knowledge (e.g., drug, disease, 

placebo), designing trials for better dose 

response estimation and dose selection, 

and other related issues. This guidance 

is intended to further FDA initiatives 

directed at identifying opportunities to 

facilitate the development of innovative 

medical products and improve the 

quality of drug applications through 

early meetings with sponsors. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this 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 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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jogarao Gobburu, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3186, 

Silver Spring, MD 20993–0002, 301– 

796–2460. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Endof-Phase 2A Meetings.’’ This 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 EOP2A 

meetings and to complete the final 

guidance within 1 year of the close of 

the public comment period (see http:// 

www.fda.gov/ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

ucm119243.htm at section XI.A). 

FDA has a long-standing interest in 

defining dose or exposure-response 

relationships for the effectiveness and 

safety of new drugs. Accurate doseresponse information is important for 

understanding how patients should take 

drugs to maximize desirable effects and 

minimize undesirable effects. Dose 

selection for phase 2 and phase 3 

studies is a challenge in many drug 

development programs and poor choice 

may lead to trial failure. Improving early 

dose selection may increase the 

likelihood of future trial success. FDA 

recognizes trial planning may be 

improved by clinical trial simulations 

that employ quantitative models of drug 

exposure-response, placebo effect, and 

disease progression. This guidance on 

EOP2A meetings is intended to 

encourage the best use of this science to 

facilitate the exploration of trial design 

alternatives to increase the likelihood 

for successful trials. 

In the Federal Register of September 

26, 2008 (73 FR 55851), FDA announced 

the availability of a draft guidance of the 

same title. In response to public 

comments on the draft version, the 

guidance has been revised to clarify the 

following topics: (1) The type of 

information that should be submitted 

with the meeting request and the 

background package and (2) the role of 

the Office of New Drugs in preparing for 

and conducting EOP2A meetings. 

This 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 roles of modelbased drug development together with 

early interaction between FDA and 

industry to improve late phase clinical 

trial success. 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. 

III. Paperwork Reduction Act of 1995 

This 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/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: September 16, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22623 Filed 9–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 48081 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Childhood 

Obesity ARRA CR. 

Date: October 2, 2009. 

Time: 10 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Ann A. Jerkins, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6154, 

MSC 7892, Bethesda, MD 20892. 301–435– 

4514. jerkins@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Arthritis, 

Connective Tissue and Skin (ACTS), Small 

Business Applications. 

Date: October 7, 2009. 

Time: 8:30 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Aftab A. Ansari, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4108, 

MSC 7814, Bethesda, MD 20892. 301–594– 

6376. ansaria@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 14, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–22587 Filed 9–18–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PCMB 

Member SEP. 

Date: September 30, 2009. 

Time: 9 a.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Barbara Whitmarsh, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2206, 

MSC 7890, Bethesda, MD 20892, (301) 435– 

4511, whitmarshb@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflicts: GMPB. 

Date: October 2, 2009. 

Time: 12 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Patricia Greenwel, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2178, 

MSC 7818, Bethesda, MD 20892, 301–435– 

1169, greenwep@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 11, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–22435 Filed 9–18–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number NIOSH–187] 

Proposed Enhancements to 

Occupational Health Surveillance Data 

Collection Through the Healthcare 

Personnel Safety (HPS) Component of 

the National Healthcare Safety Network 

(NHSN) 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of public meeting and 

availability for public comment. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting and 

request for public comment on proposed 

enhancements to occupational health 

surveillance data collection through the 

Healthcare Personnel Safety (HPS) 

Component of the National Healthcare 

Safety Network (NHSN). 

Public Comment Period: Comments 

must be received by October 21, 2009. 

Public Meeting Date and Time: 

November 16, 2009, 1 p.m.–5 p.m. and 

November 17, 2009, 8 a.m.–5 p.m. 

Place: Sheraton Cincinnati Airport 

Hotel, 2826 Terminal Drive, Hebron, 

Kentucky 41048, (859) 371–6166. 

Purpose of Meeting: To obtain public 

comment on the content and conduct of 

enhancements to occupational health 

surveillance data collection through the 

Healthcare Personnel Safety (HPS) 

Component of the National Healthcare 

Safety Network (NHSN). Special 

emphasis will be placed on discussion 

of the content of the data collection 

forms. 

Status: The forum will include 

scientists and representatives from 

industry, labor, and other stakeholders, 

and is open to the public. Attendance is 

limited only by the space available. The 

meeting room will accommodate 

approximately 60 people. Interested 

parties should contact Ahmed Gomaa at 

agomaa@cdc.gov or (513) 841–4337, or 

mstockstill on DSKH9S0YB1PROD with NOTICES