45468 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

King, Sr., Center for Drug 

Evaluation and Research (HFD–

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002,301–

796–1242; or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–1),Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852–1448, 

301–827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In June 2008, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘Q4B Evaluation and 

Recommendation of Pharmacopoeial 

Texts for Use in the ICH Regions; Annex 

4C: Microbiological Examination of 

Non-Sterile Products: Acceptance 

Criteria for Pharmaceutical Preparations 

and Substances for Pharmaceutical Use 

General Chapter’’ should be made 

available for public comment. The draft 

guidance is the product of the Q4B 

Expert Working Group of the ICH. 

Comments about this draft will be 

considered by FDA and the Q4B Expert 

Working Group. 

The draft guidance provides the 

specific evaluation results from the ICH 

Q4B process for the Microbiological 

Examination of Non-Sterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter 

harmonization proposal originating 

from the three-party PDG. This draft 

guidance is in the form of an annex to 

the core ICH Q4B guidance. Once 

finalized, the annex will provide 

guidance to assist industry and 

regulators in the implementation of the 

specific topic evaluated by the ICH Q4B 

process. 

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 this topic. 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 on the draft guidance. 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. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/cder/guidance/index.htm, 

or http://www.fda.gov/cber/ 

guidelines.htm. 

Dated: July 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17865 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Committee on Rural 

Health and Human Services; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

that the following committee will 

convene its fifty-ninth meeting. 

Name: National Advisory Committee on 

Rural Health and Human Services. 

Dates and Times: September 24, 2008, 9 

a.m.–4:30 p.m.; September 25, 2008, 8:45 

a.m.–5:30 p.m.; September 26, 2008, 8:15 

a.m.–10 a.m. 

Place: Madden’s on Gull Lake, 11266 Pine 

Beach Peninsula, Brainerd, MN 56401, 

Phone: 800–642–5363. 

Status: The meeting will be open to the 

public. 

Purpose: The National Advisory 

Committee on Rural Health and Human 

Services provides advice and 

recommendations to the Secretary with 

respect to the delivery, research, 

development and administration of health 

and human services in rural areas. 

Agenda: Wednesday morning, at 9 a.m., 

the meeting will be called to order by the 

Chairperson of the Committee, the Honorable 

David Beasley. The first presentation will be 

an overview of rural Minnesota. The 

Committee will hear presentations on the 

three chosen Subcommittee topics. The first 

panel will focus on Workforce and 

Community Development. Jay Fonkert, with 

the Minnesota Office of Rural Health and 

Primary Care, and Valerie DeFor, Director of 

the Healthcare Education Industry 

Partnership, are confirmed speakers. The 

second panel of speakers will lead a 

discussion on Serving At-Risk Children with 

a representative from the Minnesota Early 

Childhood Comprehensive System. The final 

panel for the day is on the Medical Home 

Model, with Scott Leitz, Assistant 


dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45469 

Commissioner of the Minnesota Department 

of Health, as a confirmed speaker. After the 

panel discussions, the Committee Chair will 

give an overview of the site visits. The 

Wednesday meeting will close at 4:30 p.m. 

Tuesday morning, at 8:45 a.m., the 

Committee will break into Subcommittees 

and depart to the site visits. The Workforce 

and Community Development Subcommittee 

will learn about the Bridges to Excellence 

Program and a cross-training program for 

paramedics in Crosby, Minnesota. The 

Serving At-Risk Children Subcommittee will 

learn about child welfare, family support and 

prevention initiatives in rural Minnesota. 

The Medical Home Subcommittee will visit 

a medical home model at Lakewood Health 

System in Staples, Minnesota. Transportation 

to the site visits will not be provided to the 

public. At 4 p.m. the Subcommittees will 

arrive back at Madden’s on Gull Lake for 

Subcommittee meetings. The Committee as a 

whole will reconvene at 4:45 p.m. There will 

be a review of the site visits and action items 

will be developed for the Committee 

members and staff. The meeting will be 

adjourned at 5:30 p.m. 

The final session will be convened on 

Friday morning, at 8:15 a.m. Those available 

from the Committee will meet to discuss 

topic ideas for the next report. The Friday 

meeting will adjourn at 10 a.m. 

For Further Information Contact: Anyone 

requiring information regarding the 

Committee should contact Jennifer Chang, 

MPH, Executive Secretary, National Advisory 

Committee on Rural Health and Human 

Services, Health Resources and Services 

Administration, Parklawn Building, Room 

9A–55, 5600 Fishers Lane, Rockville, MD 

20857, Telephone (301) 443–0835, Fax (301) 

443–2803. 

Persons interested in attending any portion 

of the meeting should contact Michele PrayGibson, Office of Rural Health Policy 

(ORHP), Telephone: (301) 443–0835. The 

Committee meeting agenda will be posted on 

ORHP(s Web site: http:// 

www.ruralhealth.hrsa.gov. 

Dated: July 29, 2008. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E8–17850 Filed 8–4–08; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Advisory Environmental 

Health Sciences Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting 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: National Advisory 

Environmental Health Sciences Council. 

Date: September 9–10, 2008. 

Open: September 9, 2008, 8:30 a.m. to 1 

p.m. 

Agenda: Discussion of program policies 

and issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Closed: September 9, 2008, 1 p.m. to 5 p.m. 

Agenda: To review and evaluate 

programmatic and personnel issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Closed: September 10, 2008, 8:30 a.m. to 12 

p.m. 

Agenda: To review and evaluate 

programmatic and personnel issues. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Contact Person: Dennis R. Lang, PhD., 

Acting Director, Division of Extramural 

Research and Training, Nat. Inst. of 

Environmental Health Sciences, National 

Institutes of Health, P.O. Box 12233/EC–

3431, 79 Alexander Drive, Research Triangle 

Park, NC 27709, (919) 541–7729, 

lang4@niehs.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.niehs.nih.gov/dert/c-agenda.htm, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: July 28, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–17728 Filed 8–4–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting 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: National Institute on 

Drug Abuse Special Emphasis Panel: 

MIDARP. 

Date: August 19, 2008. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852. 

(Telephone Conference Call). 

Contact Person: Nadine Rogers, PhD., 

Scientific Review Administrator, Office of 

Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Boulevard, Bethesda, 

MD 20892–8401, 301–402–2105, 

rogersn2@nida.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. 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health HHS) 

Dated: July 29, 2008. 

Jennifer Spaeth 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–17819 Filed 8–4–08; 8:45 am] 

BILLING CODE 4140–01–M 


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