Federal Register / Vol. 75, No. 44 / Monday, March 8, 2010 / Notices 10487 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0006] 

International Conference on 

Harmonisation; Guidance on S9 

Nonclinical Evaluation for Anticancer 

Pharmaceuticals; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘S9 

Nonclinical Evaluation for Anticancer 

Pharmaceuticals.’’ The guidance was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance provides 

recommendations for nonclinical 

studies for the development of 

pharmaceuticals, including both drugs 

and biotechnology derived products, 

intended to treat patients with advanced 

cancer. The recommendations describe 

the type and timing of nonclinical 

studies to support an investigational 

new drug application (IND) and the 

submission of a new drug application 

(NDA) or biologics license application 

(BLA). The guidance is intended to 

provide information on internationally 

accepted recommendations for 

nonclinical studies to facilitate the 

development of anticancer 

pharmaceuticals. 

DATES: Submit written or electronic 

comments on agency guidance at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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, or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448. Send two self-addressed adhesive 

labels to assist the office in processing 

your requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 301–827–1800. 

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: 

Regarding the guidance: John K. 

Leighton, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave, Bldg. 22, rm. 2204, Silver Spring, 

MD 20993–0002, 301–796–2330; or 

Mercedes Serabian, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 Rockville 

Pike, Rockville, MD 20852–1448, 301– 

827–5377. 

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 the Federal Register of February 

17, 2009 (74 FR 7445), FDA published 

a notice announcing the availability of 

a draft guidance entitled ‘‘S9 

Nonclinical Evaluation for Anticancer 

Pharmaceuticals.’’ The notice gave 

interested persons an opportunity to 

submit comments by April 20, 2009. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the guidance was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in 

October, 2009. 

The guidance provides guidance on 

recommendations for nonclinical 

studies for the development of 

pharmaceuticals, including both drugs 

and biotechnology derived products, 

intended to treat patients with advanced 

cancer. The recommendations describe 

the type and timing of nonclinical 

studies to support an IND and the 

submission of an NDA or BLA. 

In response to comments received on 

the draft guidance, the guidance was 

revised to provide clarification of the 

following topics: (1) The intended 

patient population covered by the 

guidance, (2) inclusion of recovery 

groups for general toxicology studies, (3) 

additional nonclinical studies to 

support clinical dosing schedule 

changes, and (4) when impurities 

should be qualified. The guidance was 

revised to address the following 

additional topics: (1) Inclusion of 

electrocardiographic measurements as 

part of general toxicology studies, (2) 

the study design for reproduction 

toxicology assessment for 

biopharmaceuticals, (3) assessment of 

the safety of pharmaceutical 

combinations, and (4) photosafety 

assessments. 

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 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) either electronic or written 

comments on the guidance. Submit a 


srobinson on DSKHWCL6B1PROD with NOTICES
10488 Federal Register / Vol. 75, No. 44 / Monday, March 8, 2010 / Notices 

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. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: March 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4841 Filed 3–5–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; ‘‘Modeling Immunity for 

Biodefense’’. 

Date: April 6–7, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Doubletree Hotel Bethesda 

(Formerly Holiday Inn Select), 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Paul A. Amstad, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIAID/NIH/DHHS, 6700B Rockledge Drive, 

MSC 7616, Bethesda, MD 20892–7616, 301– 

402–7098, pamstad@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Regulatory T cells in 

Autoimmune and Inflammatory Diseases. 

Date: April 30, 2010. 

Time: 11 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, 3118, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Sujata Vijh, PhD, Scientific 

Review Officer, Scientific Review Program, 

Division of Extramural Activities, NIAID/ 

NIH/DHHS, 6700B Rockledge Drive, MSC 

7616, Bethesda, MD 20892, 301–594–0985, 

vijhs@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 2, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–4836 Filed 3–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; 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: National Human 

Genome Research Institute Special Emphasis 

Panel; NHGRI MAP Review Teleconference 

Spring 2010. 

Date: March 23, 2010. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NHGRI Twinrook Library, 5635 

Fishers Lane, Suite 4076, Rockville, MD 

20852 (Telephone Conference Call). 

Contact Person: Keith McKenney, PhD, 

Scientific Review Officer, NHGRI, 5635 

Fishers Lane, Suite 4076, Bethesda, MD 

20814, 301–594–4280, 

mckenneyk@mail.nih.gov. 

Name of Committee: National Human 

Genome Research Institute Special Emphasis 

Panel; LRP 2010 Teleconference. 

Date: April 7, 2010. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NHGRI Twinbrook Library, 5635 

Fishers Lane, Suite 4076, Rockville, MD 

20852 (Telephone Conference Call). 

Contact Person: Keith McKenney, PhD, 

Scientific Review Officer, NHGRI, 5635 

Fishers Lane, Suite 4076, Bethesda, MD 

20814, 301–594–4280, 

mckenneyk@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: March 1, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–4839 Filed 3–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 13, 2010, from 8 a.m. to 

5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Anuja Patel, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, FAX: 301–

827–6776, e-mail: Anuja.Patel@fda.hhs.

gov, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 301–451–2539. Please call 


srobinson on DSKHWCL6B1PROD with NOTICES