Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices 9905 

is subject to debarment if FDA finds that 

he ‘‘has been convicted of—* * * a 

misdemeanor under Federal law’’ and 

that ‘‘the type of conduct which served 

as the basis for such conviction 

undermines the process for the 

regulation of drugs.’’ FDA has made both 

findings, and Holland does not dispute 

either finding. Section 306 contains no 

requirement that a conviction be 

finalized on appeal before it subjects an 

individual to debarment. In fact, under 

306(l)(1)(A), ‘‘a person is considered to 

have been convicted of a criminal 

offense—* * * when a judgment of 

conviction has been entered against the 

person * * * regardless of whether 

there is an appeal pending.’’ Moreover, 

under 306(d)(3), Holland may apply to 

FDA to have the debarment order 

withdrawn if his conviction is reversed. 

It is therefore clear from section 306 that 

a pending appeal for a conviction does 

not preclude FDA’s reliance on that 

conviction for debarment. 

III. Findings and Order 

Therefore, the Acting Chief Scientist 

and Deputy Commissioner, under 

section 306(b)(2)(B)(i)(I) of the act and 

under authority delegated to him, finds 

(1) that Holland has been convicted of 

a misdemeanor under Federal law for 

conduct relating to the development or 

approval of a drug product or otherwise 

relating to the regulation of a drug 

product under the act and (2) that the 

type of conduct which served as the 

basis for that conviction undermines the 

process for the regulation of drugs. FDA 

has considered the relevant factors 

listed in section 306(c)(3) of the act and 

determined that a debarment of 5 years 

is appropriate. 

As a result of the foregoing findings, 

Holland is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under section 

505, 512, or 802 of the act (21 U.S.C. 

355, 360b, or 382), or under section 351 

of the Public Health Service Act (42 

U.S.C. 262), effective (see DATES) (see 21 

U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) 

and 21 U.S.C. 321(dd)). Any person 

with an approved or pending drug 

product application who knowingly 

uses the services of Holland, in any 

capacity during his period of 

debarment, will be subject to civil 

money penalties. If Holland, during his 

period of debarment, provides services 

in any capacity to a person with an 

approved or pending drug product 

application, he will be subject to civil 

money penalties. In addition, FDA will 

not accept or review any abbreviated 

new drug applications submitted by or 

with the assistance of Holland during 

his period of debarment. 

Any application by Holland for 

termination of debarment under section 

306(d) of the act should be identified 

with Docket No. FDA–2009–N–0205 

and sent to the Dockets Management 

Branch (see ADDRESSES). All such 

submissions are to be filed in four 

copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). Publicly 

available submissions may be seen in 

the Dockets Management Branch 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Publicly available submissions may 

be seen in the Dockets Management 

Branch between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: January 22, 2010. 

Jesse L. Goodman, 

Acting Chief Scientist and Deputy 

Commissioner for Science and Public Health. 

[FR Doc. 2010–4449 Filed 3–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0223] (formerly 

2006D–0383) 

Guidance for Industry: 

Characterization and Qualification of 

Cell Substrates and Other Biological 

Materials Used in the Production of 

Viral Vaccines for Infectious Disease 

Indications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Characterization 

and Qualification of Cell Substrates and 

Other Biological Materials Used in the 

Production of Viral Vaccines for 

Infectious Disease Indications,’’ dated 

February 2010. The guidance document 

provides recommendations to 

manufacturers of viral vaccines for the 

characterization and qualification of cell 

substrates, viral seeds, and other 

biological materials used for the 

production of viral vaccines for human 

use. The guidance announced in this 

notice finalizes the draft guidance 

entitled ‘‘Guidance for Industry: 

Characterization and Qualification of 

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, and 

replaces the information specific to viral 

vaccines for the prevention and 

treatment of infectious diseases that the 

agency provided in the 1993 document 

entitled ‘‘Points to Consider in the 

Characterization of Cell Lines Used to 

Produce Biologicals.’’ 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic or written 

comments on the guidance. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Paul 

E. Levine, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Characterization and 

Qualification of Cell Substrates and 

Other Biological Materials Used in the 

Production of Viral Vaccines for 

Infectious Disease Indications,’’ dated 

February 2010. The guidance document 

provides manufacturers of viral vaccines 

with recommendations for the 

characterization and qualification of cell 

substrates, viral seeds, and other 

biological materials used for the 

production of viral vaccines for human 

use. The recommendations in the 

guidance may be used to support a 

Biologics License Application or an 

application for an Investigational New 

Drug. 

In the Federal Register of September 

29, 2006 (71 FR 57547), FDA announced 

the availability of the draft guidance 

entitled ‘‘Guidance for Industry: 

Characterization and Qualification of 

mstockstill on DSKH9S0YB1PROD with NOTICES

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