[Federal Register Volume 72, Number 71 (Friday, April 13, 2007)]
[Notices]
[Pages 18660-18661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0525]


Supplements and Other Changes to an Approved Application; Public 
Meeting; Reopening of Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

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SUMMARY:  The Food and Drug Administration (FDA) is reopening until May 
18, 2007, the comment period for a notice of public meeting that 
published in the Federal Register of January 5, 2007 (72 FR 574). In 
the notice, FDA announced a February 7, 2007, meeting to solicit input 
on issues that the agency should consider if it decides to propose 
revisions to its regulations regarding chemistry, manufacturing, and 
controls (CMC) supplements and other changes to approved marketing 
applications for human drugs. FDA is reopening the comment period in 
light of continued public interest in this topic.

DATES:  Submit written or electronic comments by May 18, 2007.

ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug

[[Page 18661]]

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: David J. Cummings, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, rm. 3525, Rockville, MD 20993-0002, 301-796-
2400, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On February 7, 2007, FDA held a public meeting to solicit comments 
on issues that FDA should consider if it decides to propose revisions 
to Sec.  314.70 (21 CFR 314.70) regarding CMC supplements and other 
changes to approved marketing applications for human drugs. In the 
notice announcing the public meeting (72 FR 574), FDA stated that 
current Sec.  314.70 categorizes postapproval CMC changes and their 
associated reporting requirements without consideration of the 
applicant's risk management activities or internal quality systems and 
practices; therefore, Sec.  314.70 reflects a rules-based, or 
prescriptive, approach to regulating postapproval manufacturing 
changes. Current Sec.  314.70 may create regulatory burdens and costs 
that discourage beneficial manufacturing changes and may not support a 
desirable level of innovation, modernization, and flexibility for the 
industry as described in FDA's pharmaceutical current good 
manufacturing practices for the 21st century initiative (CGMP 
Initiative). Consistent with the agency's risk-based approach to 
regulating pharmaceutical manufacturing described in the CGMP 
Initiative, FDA is considering possible revisions to Sec.  314.70 to 
allow for more manufacturing changes to be made without prior FDA 
approval using a firm's internal change control system and to allow for 
consideration of risk-based approaches based on manufacturing process 
understanding, including prior knowledge of similar products, and 
overall quality systems to provide an enhanced risk-based approach to 
the CMC regulatory process.
    Interested persons were given until March 7, 2007, to submit 
written or electronic comments to the agency related to the focus of 
the public meeting. As a result of continued public interest, FDA is 
reopening the comment period until May 18, 2007, to allow interested 
persons additional time to submit comments.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments related to this topic 
(see DATES). All relevant data and information should be submitted with 
the written comments. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one copy. Comments are to be identified with Docket No. 2006N-
0525. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6985 Filed 4-12-07; 8:45 am]
BILLING CODE 4160-01-S