54926 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 

that it is seeking pharmaceutical 

companies to participate in a pilot 

program involving the submission of 

CMC information consistent with a new 

pharmaceutical quality assessment 

system. The Office of New Drug 

Chemistry (ONDC) in the Office of 

Pharmaceutical Science, Center for Drug 

Evaluation and Research, is establishing 

a modern, risk-based pharmaceutical 

quality assessment system, as described 

in a September 2004 White Paper, 

‘‘ONDC’s New Risk-Based 

Pharmaceutical Quality Assessment 

System’’ (http://www.fda.gov/cder/gmp/ 

gmp2004/ondc_reorg.htm). The pilot 

program will provide additional 

information for ONDC to use in 

implementing the new quality 

assessment system. The pilot program 

will provide participating 

pharmaceutical companies an 

opportunity to submit critical CMC 

information that demonstrates their 

understanding of quality by design, 

product knowledge, and process 

understanding of the drug substance 

and drug product at the time of 

submission of an NDA. The pilot 

program will also enable the public and 

regulated industry to provide feedback 

that will assist FDA in developing 

guidance for industry on the new 

quality assessment system. 

The July 14, 2005 (70 FR 40719), 

notice provided deadlines related to the 

submission of certain information 

related to the pilot program. To ensure 

inclusive and relevant results from the 

pilot program, this notice extends the 

deadlines as follows: Requests to 

participate in the pilot program to 

March 31, 2006, from October 31, 2005, 

and submission of eligible New Drug 

Applications (NDA) to March 31, 2007, 

from December 31, 2006. This notice 

also extends the comment period on the 

pilot program to March 31, 2007, from 

December 31, 2006. See the process 

section (II.B) in the July 14, 2005 (70 FR 

40719) notice for instructions on 

submitting requests to participate in the 

pilot program. All requests to 

participate in the pilot program, both 

written and electronic, should be 

marked confidential. 

II. Comments 

Interested persons may submit written 

comments on this pilot program to the 

Division of Dockets Management (see 

ADDRESSES). Two copies of any 

comments are to be submitted, except 

that individuals may submit one 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. 

While detailed information on 

participating NDAs will not be publicly 

available, names of participating 

applicants will be made public. 

Dated: September 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18515 Filed 9–16–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–02–1000] 

Memorandum of Understanding 

Between the Food and Drug 

Administration, Center for Biologics 

Evaluation and Research, and the 

National Institutes of Health, National 

Institute of Neurological Disorders and 

Stroke 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between the Food 

and Drug Administration, Center for 

Biologics Evaluation and Research 

(FDA/CBER), and the National Institutes 

of Health, National Institute of 

Neurological Disorders and Stroke (NIH/ 

NINDS). The purpose of this MOU is to 

provide a framework for coordination 

and collaborative efforts between these 

two entities, which are both 

components of the Department of Health 

and Human Services. This MOU also 

provides the principles and procedures 

by which information sharing between 

FDA/CBER and NIH/NINDS units shall 

take place. 

DATES: The agreement became effective 

February 12, 2002. 

FOR FURTHER INFORMATION CONTACT: For 

FDA/CBER: Kimberly Benton, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, WOC1/rm. 209N, 

Rockville, MD 20852, 301–827–5102. 

For NIH/NINDS: Robert Finkelstein, 

Extramural Research, Neuroscience 

Center, National Institutes of Health, 

6001 Executive Blvd., rm. 2143, 

Bethesda, MD 20892, 301–496–9248. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: September 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 

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[FR Doc. 05–18514 Filed 9–16–05; 8:45 am] 

BILLING CODE 4160–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–05–3000] 

Memorandum of Understanding 

Between the Food and Drug 

Administration and the Veterans 

Health Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the Veterans Health Administration 

(VHA). The purpose of this MOU is to 

extend an existing formal collaboration 

between FDA and VHA for the purpose 

of developing and implementing 

terminology standards for medication 

information. 

DATES: The agreement became effective 

June 28, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Randy Levin, Health and Regulatory 

Data Standards (HFD–001), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

5411. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: September 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 


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