[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54925-54926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18515]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0262]


Submission of Chemistry, Manufacturing, and Controls Information 
in a New Drug Application Under the New Pharmaceutical Quality 
Assessment System; Extension of Application and Comment Deadlines

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice to extend application and comment deadlines.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
extension in the deadlines for submitting requests to participate in 
and comment on a pilot program involving the submission of chemistry, 
manufacturing, and controls (CMC) information consistent with the new 
pharmaceutical quality assessment system.

DATES: Submit written requests to participate in the pilot program by 
March 31, 2006. Submit eligible new drug applications (NDAs) by March 
31, 2007. Submit written or electronic comments on the pilot program by 
March 31, 2007.

ADDRESSES: Submit written requests to participate in the pilot program 
and comments on the pilot program to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic requests to participate in and 
comments on the pilot program to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Michael Folkendt, Center for Drug 
Evaluation and Research (HFD-800), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5918, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 14, 2005 (70 FR 40719), FDA 
announced

[[Page 54926]]

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