80 FR 31050 - Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 104 (June 1, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.'' The purpose of this guidance is to provide applicants of new drug applications, abbreviated new drug applications, and biologic license applications with FDA's current thinking on established conditions (i.e., the chemistry, manufacturing, and controls (CMC) information in a submission that would require reporting to FDA if changed for approved drug and biologic products, per the current regulations). This guidance also describes those sections of a common technical document formatted application that typically contain information that meets the definition of established conditions, and provides considerations for managing changes to established conditions over the life cycle of an approved product.

[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31050-31051]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1659]


Established Conditions: Reportable Chemistry, Manufacturing, and 
Controls Changes for Approved Drug and Biologic Products; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Established 
Conditions: Reportable CMC Changes for Approved Drug and Biologic 
Products.'' The purpose of this guidance is to provide applicants of 
new drug applications, abbreviated new drug applications, and biologic 
license applications with FDA's current thinking on established 
conditions (i.e., the chemistry, manufacturing, and controls (CMC) 
information in a submission that would require reporting to FDA if 
changed for approved drug and biologic products, per the current 
regulations). This guidance also describes those sections of a common 
technical document formatted application that typically contain 
information that meets the definition of established conditions, and 
provides considerations for managing changes to established conditions 
over the life cycle of an approved product.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 31, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002; or to the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research (CBER), Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-
7800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.
    Submit electronic comments on the draft guidance 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: Ashley Boam, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-2400; or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Established Conditions: Reportable CMC Changes for Approved 
Drug and Biologic Products.'' The current regulations for drugs and 
biologics require applicants with approved drug or biologic products to 
notify FDA about each change in each condition established in the 
approved application beyond the variations already provided for in the 
application (see 21 CFR 314.70) or each change in the product, 
production process, quality controls, equipment, facilities, 
responsible personnel, or labeling established in the approved license 
application (see 21 CFR 601.12). FDA guidance documents clarify the 
recommended reporting mechanism (i.e., supplement, annual report) for 
postapproval CMC changes. This draft guidance has been developed to 
address the lack of clarity with respect to what CMC information in an 
application constitutes an established condition.
    A better understanding of which elements of the CMC information 
constitute established conditions to FDA and where in an application 
these are generally expected to be described will allow for a more 
effective postapproval submission strategy (e.g., effective use of risk 
management

[[Page 31051]]

principles in the International Conference on Harmonisation (ICH) Q9, 
and knowledge management as defined in ICH Q10) by the regulated 
industry. This will also provide the FDA pathways to better regulate 
postapproval changes by utilizing more flexibility and risk-based 
principles, as envisioned by the pharmaceutical product quality 
initiatives laid out in FDA's ``Pharmaceutical Current Good 
Manufacturing Practices (cGMPs) for the 21st Century--A Risk Based 
Approach'' (see http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Established 
Conditions: Reportable CMC Changes for Approved Drug and Biologic 
Products.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act

    This guidance refers to previously approved collections of 
information that 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). The collections of information in 21 CFR parts 211, 314, and 601 
have been approved under OMB control numbers 0910-0139, 0910-0001, and 
0910-0338, respectively.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: May 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13104 Filed 5-29-15; 8:45 am]
 BILLING CODE 4164-01-P