9906 Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices 

Cell Substrates and Other Biological 

Starting Materials Used in the 

Production of Viral Vaccines for the 

Prevention and Treatment of Infectious 

Diseases,’’ dated September 2006. FDA 

received numerous comments on the 

draft guidance and those comments 

were considered as the guidance was 

finalized. In addition, editorial changes 

were made to improve clarity. The 

guidance announced in this notice 

finalizes the draft guidance dated 

September 2006, and replaces 

information specific to viral vaccines for 

the prevention and treatment of 

infectious diseases contained in the 

1993 document entitled ‘‘Points to 

Consider in the Characterization of Cell 

Lines Used to Produce Biologicals.’’ The 

guidance is also intended to supplement 

recommendations on the production of 

viral vaccines for the prevention and 

treatment of infectious diseases, 

provided in the International 

Conference on Harmonisation (ICH) 

guidance documents entitled ‘‘Q5A Viral 

Safety Evaluation of Biotechnology 

Products Derived from Cell Lines of 

Human or Animal Origin’’dated 

September 1998 (63 FR 51074; 

September 24, 1998) and ‘‘Q5D 

Derivation and Characterisation of Cell 

Substrates Used for Production of 

Biotechnological/Biological Products’’ 

(63 FR 50244; September 21, 1998). 

For the production of biological 

products not covered under this 

guidance, we recommend that you refer 

to the ‘‘Points to Consider in the 

Characterization of Cell Lines Used to 

Produce Biologicals,’’ dated 1993. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’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. Paperwork Reduction Act 

The 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). Most of the collections of 

information to which the guidance 

refers are covered by 21 CFR part 601 

(BLAs (biologics license application)) 

and part 312 (INDs (investigational new 

drugs)), and were approved under OMB 

Control No. 0910–0338 and 0910–0014, 

respectively. For the remaining 

referenced collections of information, 

those in 21 CFR 640.3 and 640.63 have 

been approved under OMB Control 

Number 0910–0116; those in 21 CFR 

part 211, including § 211.160(b), have 

been approved under OMB Control 

Number 0910–0139; and those in 21 

CFR part 58 have been approved under 

OMB Control No. 0910–0119. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) elecronic 

or written comments regarding the 

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. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

http://www.fda.gov/cber/guidelines.htm 

or http://www.regulations.gov. 

Dated: March 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4553 Filed 3–3–10; 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 

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, Program 

Project: Computational Resource Review. 

Date: March 24–26, 2010. 

Time: 6:30 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Estancia La Jolla Hotel & Spa, 9700 

N. Torrey Pines Road, La Jolla, CA 92037. 

Contact Person: Raymond Jacobson, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5858, 

MSC 7849, Bethesda, MD 20892. 301–996– 

7702. jacobsonrh@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Program 

Project: Opiate Drug Abuse and CNS 

Vulnerability to HIV. 

Date: March 25–26, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive,Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: Robert Freund, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3200, 

MSC 7848, Bethesda, MD 20892. 301–435– 

1050. freundr@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Fellowships: AIDS Predoctoral and 

Postdoctoral. 

Date: March 30–31, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: Hilary D. Sigmon, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5216, 

MSC 7852, Bethesda, MD 20892. (301) 594– 

6377. sigmonh@csr.nih.gov. 

(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: February 25, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–4487 Filed 3–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices 9907 

amended (5 U.S.C. App.), 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 of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Immunobiology of 

Xenotransplantation. 

Date: March 22–23, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard at Marriott, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Jay Bruce Sundstrom, PhD, 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, Room 

3119, 6700B Rockledge Drive, MSC–7616, 

Bethesda, MD 20892–7616, 301–496–7042, 

sundstromj@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: February 24, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–4476 Filed 3–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

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, Tooth 

Development and Mineralization, 

Date: March 24, 2010. 

Time: 2 p.m. to 5 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: Priscilla B. Chen, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4104, 

MSC 7814, Bethesda, MD 20892. (301) 435– 

1787. chenp@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Developmental Pharmacology. 

Date: March 31–April 1, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: Janet M. Larkin, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1102, 

MSC 7840, Bethesda, MD 20892. 301–806– 

2765. larkinja@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Fellowships: Physiology and Pathobiology of 

Musculoskeletal, Oral, and Skin Systems 

(F10B). 

Date: March 31, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Ritz-Carlton, Washington DC, 

1150 22nd Street, NW., Washington, DC 

20037. 

Contact Person: Abdelouahab Aitouche, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4222, 

MSC 7812, Bethesda, MD 20892. 301–435– 

2365. aitouchea@csr.nih.gov. 

(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) 

Dated: February 25, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–4486 Filed 3–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

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 Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Development of Blood Donor Tests for the 

Presence of Human Babesia Microorganisms. 

Date: March 16, 2010. 

Time: 1:15 p.m. to 4 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: Youngsuk Oh, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7182, 

Bethesda, MD 20892–7924. 301–435–0277. 

yoh@mail.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Patient Oriented Research Career 

Enhancement Awards. 

Date: March 17–18, 2010. 

Time: 8 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ritz-Carlton, 1150 22nd Street NW., 

Washington, DC 20037. 

Contact Person: Mark Roltsch, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7192, 

Bethesda, MD 20892–7924. 301–435–0287. 

roltschm@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Catheter for Delivering High Intensity 

Focused Ultrasound for Transluminal and 

Endocavitary Intervention. 

Date: March 18, 2010. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: Youngsuk Oh, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7182, 

Bethesda, MD 20892–7924. 301–435–0277. 

yoh@mail.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Research Demonstration and Dissemination 

Projects. 

Date: March 24, 2010. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

mstockstill on DSKH9S0YB1PROD with NOTICES