80_FR_31154 80 FR 31050 - Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Availability

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Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Availability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

Page Range31050-31051
FR Document2015-13104

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.''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 Issue 104 (Monday, June 1, 2015) 
[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Controls Changes for Approved Drug and Biologic Products; Draft 
Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Established 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

31050 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices to the Division of Freedom of the Internet at http://www.reginfo.gov/ Development, Center for Biologics Information (ELEM–1029), Food and public/do/PRAMain. Evaluation and Research (CBER), Food Drug Administration, 12420 Parklawn Dated: May 21, 2015. and Drug Administration, 10903 New Dr., Element Bldg., Rockville, MD Leslie Kux, Hampshire Ave., Bldg. 71, Rm. 3128, 20857. Silver Spring, MD 20993–0002. Send Associate Commissioner for Policy. Dated: May 26, 2015. one self-addressed adhesive label to [FR Doc. 2015–13064 Filed 5–29–15; 8:45 am] Leslie Kux, assist the office in processing your BILLING CODE 4164–01–P requests. The draft guidance may also be Associate Commissioner for Policy. obtained by mail by calling CBER at 1– [FR Doc. 2015–13063 Filed 5–29–15; 8:45 am] 800–835–4709 or 240–402–7800. See BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND the SUPPLEMENTARY INFORMATION section HUMAN SERVICES for electronic access to the draft Food and Drug Administration guidance document. DEPARTMENT OF HEALTH AND Submit electronic comments on the HUMAN SERVICES [Docket No. FDA–2015–D–1659] draft guidance to http:// Food and Drug Administration www.regulations.gov. Submit written Established Conditions: Reportable comments to the Division of Dockets [Docket No. FDA–2005–N–0161] Chemistry, Manufacturing, and Management (HFA–305), Food and Drug Controls Changes for Approved Drug Administration, 5630 Fishers Lane, Rm. Agency Information Collection and Biologic Products; Draft Guidance 1061, Rockville, MD 20852. Activities; Announcement of Office of for Industry; Availability Management and Budget Approval; FOR FURTHER INFORMATION CONTACT: Current Good Manufacturing Practices AGENCY: Food and Drug Administration, Ashley Boam, Center for Drug for Blood and Related Regulations for HHS. Evaluation and Research, Food and and Blood Components; and ACTION: Notice. Drug Administration, 10903 New Requirements for Donor Testing, Hampshire Ave., Silver Spring, MD SUMMARY: The Food and Drug 20993, 301–796–2400; or Stephen Donor Notification, and ‘‘Lookback’’ Administration (FDA) is announcing the Ripley, Center for Biologics Evaluation AGENCY: Food and Drug Administration, availability of a draft guidance for and Research, Food and Drug HHS. industry entitled ‘‘Established Administration, 10903 New Hampshire ACTION: Notice. Conditions: Reportable CMC Changes Ave., Bldg. 71, Rm. 7301, Silver Spring, for Approved Drug and Biologic MD 20993, 240–402–7911. SUMMARY: The Food and Drug Products.’’ The purpose of this guidance SUPPLEMENTARY INFORMATION: Administration (FDA) is announcing is to provide applicants of new drug that a collection of information entitled, applications, abbreviated new drug I. Background ‘‘Current Good Manufacturing Practices applications, and biologic license FDA is announcing the availability of for Blood and Related Regulations for applications with FDA’s current a draft guidance for industry entitled and Blood Components; and thinking on established conditions (i.e., ‘‘Established Conditions: Reportable Requirements for Donor Testing, Donor the chemistry, manufacturing, and CMC Changes for Approved Drug and Notification, and ‘Lookback’ ’’ has been controls (CMC) information in a Biologic Products.’’ The current approved by the Office of Management submission that would require reporting regulations for drugs and biologics and Budget (OMB) under the Paperwork to FDA if changed for approved drug require applicants with approved drug Reduction Act of 1995. and biologic products, per the current or biologic products to notify FDA about FOR FURTHER INFORMATION CONTACT: FDA regulations). This guidance also each change in each condition PRA Staff, Office of Operations, Food describes those sections of a common established in the approved application and Drug Administration, 8455 technical document formatted beyond the variations already provided Colesville Rd., COLE–14526, Silver application that typically contain for in the application (see 21 CFR Spring, MD 20993–0002, PRAStaff@ information that meets the definition of 314.70) or each change in the product, fda.hhs.gov. established conditions, and provides production process, quality controls, SUPPLEMENTARY INFORMATION: On March considerations for managing changes to equipment, facilities, responsible 11, 2015, the Agency submitted a established conditions over the life personnel, or labeling established in the proposed collection of information cycle of an approved product. approved license application (see 21 entitled, ‘‘Current Good Manufacturing DATES: Although you can comment on CFR 601.12). FDA guidance documents Practices for Blood and Related any guidance at any time (see 21 CFR clarify the recommended reporting Regulations for and Blood Components; 10.115(g)(5)), to ensure that the Agency mechanism (i.e., supplement, annual and Requirements for Donor Testing, considers your comment on this draft report) for postapproval CMC changes. Donor Notification, and ‘Lookback’ ’’ to guidance before it begins work on the This draft guidance has been developed OMB for review and clearance under 44 final version of the guidance, submit to address the lack of clarity with U.S.C. 3507. An Agency may not either electronic or written comments respect to what CMC information in an conduct or sponsor, and a person is not on the draft guidance by July 31, 2015. application constitutes an established required to respond to, a collection of ADDRESSES: Submit written requests for condition. information unless it displays a single copies of the draft guidance to the A better understanding of which Lhorne on DSK2VPTVN1PROD with NOTICES currently valid OMB control number. Division of Drug Information, Center for elements of the CMC information OMB has now approved the information Drug Evaluation and Research, Food constitute established conditions to collection and has assigned OMB and Drug Administration, 10001 New FDA and where in an application these control number 0910–0116. The Hampshire Ave., Hillandale Building, are generally expected to be described approval expires on May 31, 2018. A 4th Floor, Silver Spring, MD 20993– will allow for a more effective copy of the supporting statement for this 0002; or to the Office of postapproval submission strategy (e.g., information collection is available on Communication, Outreach and effective use of risk management VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1

Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices 31051 principles in the International Information/default.htm, or http:// amended, to ‘‘promote rural health care Conference on Harmonisation (ICH) Q9, www.regulations.gov. services outreach by expanding the and knowledge management as defined Dated: May 26, 2015. delivery of health care services to in ICH Q10) by the regulated industry. Leslie Kux, include new and enhanced services in This will also provide the FDA rural areas.’’ The purpose of the 3-year Associate Commissioner for Policy. pathways to better regulate postapproval Benefits Counseling Program is to changes by utilizing more flexibility and [FR Doc. 2015–13104 Filed 5–29–15; 8:45 am] expand outreach, education, and risk-based principles, as envisioned by BILLING CODE 4164–01–P enrollment efforts to eligible uninsured the pharmaceutical product quality and newly insured individuals and initiatives laid out in FDA’s families in rural communities. ‘‘Pharmaceutical Current Good DEPARTMENT OF HEALTH AND The overarching goals of this grant Manufacturing Practices (cGMPs) for the HUMAN SERVICES funding are to coordinate and conduct 21st Century—A Risk Based Approach’’ innovative outreach activities through a Health Resources and Services (see http://www.fda.gov/Drugs/ strong consortium in order to: (1) Administration DevelopmentApprovalProcess/ Identify and enroll uninsured Manufacturing/QuestionsandAnswerson Agency Information Collection individuals and families who are CurrentGoodManufacturingPracticesc Activities: Proposed Collection: Public eligible for public health insurance, GMPforDrugs/UCM071836). Comment Request such as Medicare, Medicaid, and the This draft guidance is being issued Children’s Health Insurance Program, consistent with FDA’s good guidance AGENCY: Health Resources and Services and qualified health plans offered practices regulation (21 CFR 10.115). Administration, HHS. through Health Insurance Marketplaces The draft guidance, when finalized, will ACTION: Notice. and/or private health insurance plans in represent the current thinking of FDA rural communities and (2) educate the on ‘‘Established Conditions: Reportable SUMMARY: In compliance with the newly insured individuals and families CMC Changes for Approved Drug and requirement for opportunity for public in rural communities about their health Biologic Products.’’ It does not establish comment on proposed data collection insurance benefits, help connect them to any rights for any person and is not projects (section 3506(c)(2)(A) of the primary care and preventive services to binding on FDA or the public. You can Paperwork Reduction Act of 1995), the which they now have access, and help use an alternative approach if it satisfies Health Resources and Services them retain their health insurance the requirements of the applicable Administration (HRSA) announces coverage. statutes and regulations. plans to submit an Information Need and Proposed Use of the Collection Request (ICR), described Information: For this program, II. Comments below, to the Office of Management and performance measures were drafted to Interested persons may submit either Budget (OMB). Prior to submitting the provide data to the program and to electronic comments regarding this ICR to OMB, HRSA seeks comments enable HRSA to provide aggregate document to http://www.regulations.gov from the public regarding the burden program data required by Congress or written comments to the Division of estimate, below, or any other aspect of under the Government Performance and Dockets Management (see ADDRESSES). It the ICR. Results Act (GPRA) of 1993. These is only necessary to send one set of DATES: Comments on this Information measures cover the principal topic areas comments. Identify comments with the Collection Request must be received no of interest to the Federal Office of Rural docket number found in brackets in the later than July 31, 2015. Health Policy (FORHP), including: (a) heading of this document. Received Access to care; (b) population ADDRESSES: Submit your comments to comments may be seen in the Division demographics; (c) staffing; (d) paperwork@hrsa.gov or mail the HRSA of Dockets Management between 9 a.m. consortium/network; (e) sustainability; Information Collection Clearance and 4 p.m., Monday through Friday, and and (f) benefits counseling process and Officer, Room 10–29, Parklawn will be posted to the docket at http:// outcomes. Several measures will be Building, 5600 Fishers Lane, Rockville, www.regulations.gov. used for the Benefits Counseling MD 20857. Program. All measures will speak to III. Paperwork Reduction Act FOR FURTHER INFORMATION CONTACT: To FORHP’s progress toward meeting the This guidance refers to previously request more information on the goals set. approved collections of information that proposed project or to obtain a copy of Likely Respondents: The respondents are subject to review by the Office of the data collection plans and draft will be recipients of the Rural Outreach Management and Budget (OMB) under instruments, email paperwork@hrsa.gov Benefits Counseling Program grant the Paperwork Reduction Act of 1995 or call the HRSA Information Collection funding. (44 U.S.C. 3501–3520). The collections Clearance Officer at (301) 594–4306. Burden Statement: Burden in this of information in 21 CFR parts 211, 314, SUPPLEMENTARY INFORMATION: When context means the time expended by and 601 have been approved under submitting comments or requesting persons to generate, maintain, retain, OMB control numbers 0910–0139, information, please include the disclose or provide the information 0910–0001, and 0910–0338, information request collection title for requested. This includes the time respectively. reference. needed to review instructions; to Information Collection Request Title: develop, acquire, install and utilize IV. Electronic Access Rural Outreach Benefits Counseling technology and systems for the purpose Lhorne on DSK2VPTVN1PROD with NOTICES Persons with access to the Internet Program Measures OMB No. 0915– of collecting, validating and verifying may obtain the document at either XXXX—New. information, processing and http://www.fda.gov/Drugs/Guidance Abstract: The Rural Outreach Benefits maintaining information, and disclosing ComplianceRegulatoryInformation/ Counseling Program (Benefits and providing information; to train Guidances/default.htm, http:// Counseling Program) is authorized by personnel and to be able to respond to www.fda.gov/BiologicsBloodVaccines/ section 330A(e) of the Public Health a collection of information; to search GuidanceComplianceRegulatory Service (PHS) Act (42 U.S.C. 254c(e)), as data sources; to complete and review VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1


Document Created: 2015-12-15 15:19:04
Document Modified: 2015-12-15 15:19:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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.
ContactAshley 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.
FR Citation80 FR 31050 
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