81 FR 23303 - Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 76 (April 20, 2016)

Page Range		23303-23304
FR Document		2016-09137

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.'' This document is a revised version of a draft guidance that published in February 2003 entitled ``Comparability Protocols: Chemistry, Manufacturing, and Controls Information.'' A related draft guidance entitled ``Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information,'' that published in September 2003, was withdrawn on May 6, 2015. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). By using a CP, manufacturers who fall within the scope of this guidance will not have to submit commercial- scale CMC information on postchange products to FDA before making the proposed change. This draft guidance is intended to establish a framework to promote manufacturing of quality drug products.

Federal Register, Volume 81 Issue 76 (Wednesday, April 20, 2016)

[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23303-23304]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-09137]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0973]

Comparability Protocols for Human Drugs and Biologics: Chemistry,
Manufacturing, and Controls Information; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Comparability
Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and
Controls Information.'' This document is a revised version of a draft
guidance that published in February 2003 entitled ``Comparability
Protocols: Chemistry, Manufacturing, and Controls Information.'' A
related draft guidance entitled ``Comparability Protocols--Protein Drug
Products and Biological Products--Chemistry, Manufacturing, and
Controls Information,'' that published in September 2003, was withdrawn
on May 6, 2015.
The revised draft guidance provides recommendations to human drug
and biologics manufacturers on implementing a chemistry, manufacturing,
and controls (CMC) postapproval change(s) through the use of a
comparability protocol (CP). By using a CP, manufacturers who fall
within the scope of this guidance will not have to submit commercial-
scale CMC information on postchange products to FDA before making the
proposed change. This draft guidance is intended to establish a
framework to promote manufacturing of quality drug products.

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 June 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Comments

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-0973 for ``Comparability Protocols for Human Drugs and
Biologics: Chemistry, Manufacturing, and Controls Information.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Stephen Moore, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 21, Rm.
2012, 10903 New Hampshire Ave.,

[[Page 23304]]

Silver Spring, MD 20993-0002, 301-796-7579 or Stephen Ripley, Center
for Biologics Evaluation and Research, Food and Drug Administration,
Bldg. 71, Rm. 7268, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Comparability Protocols for Human Drugs and Biologics:
Chemistry, Manufacturing, and Controls Information.'' This draft
guidance is a revised version of a draft guidance that published in
February 2003 entitled ``Comparability Protocols: Chemistry,
Manufacturing, and Controls Information.'' A related draft guidance
entitled ``Comparability Protocols--Protein Drug Products and
Biological Products--Chemistry, Manufacturing, and Controls
Information,'' which published in September 2003, was withdrawn on May
6, 2015 (80 FR 26059).
The revised draft guidance provides recommendations to holders of
applications for human drugs and biologics on implementing a chemistry,
manufacturing, controls (CMC) postapproval change(s) through the use of
a comparability protocol (CP). The revised draft guidance applies to
new drug applications (NDAs), abbreviated new drug applications
(ANDAs), or biologics license applications (BLAs) regulated by the
Center for Drug Evaluation and Research (CDER) or the Center for
Biologics Evaluation and Research (CBER) or supplements following 21
CFR 314.70 or 21 CFR 601.12.
On February 25, 2003 (68 FR 8772), FDA announced the availability
of the first draft version of this guidance. The public comment period
closed on June 25, 2003. A number of comments were received, which the
Agency considered carefully as it prepared this revised draft guidance.
We revised the guidance for the following reasons:
To provide more flexibility regarding filing procedures
for a notification of change in a condition established in an approved
application.
To include current pharmaceutical quality concepts.
To add an appendix to address commonly asked questions.
This revised draft guidance provides recommendations to human drug
manufacturers on implementing CMC postapproval change(s) through the
use of a CP. By using an approved CP, manufacturers whom fall within
the scope of this guidance will not have to submit commercial-scale CMC
information on postchange products to FDA before making the proposed
changes. The draft guidance is intended to establish a framework to
promote manufacturing of quality drug products by employing the
following:
Effective use of knowledge and understanding of the
product and manufacturing process.
A robust control strategy.
Risk management activities over a product's life cycle.
An effective pharmaceutical quality system.
This draft guidance incorporates the modern regulatory concepts
stated in the guidance for industry entitled ``PAT--A Framework for
Innovative Pharmaceutical Development, Manufacturing, and Quality
Assurance,'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf) the
Pharmaceutical Current Good Manufacturing Practices for the 21st
Century Initiative (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836), the Critical Path Initiative (http://www.fda.gov/scienceresearch/specialtopics/criticalpathinitiative/default.htm), and
the quality by design principles described in the guidance for industry
entitled ``Q8(R2) Pharmaceutical Development'' (http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm073507.pdf). In publishing this draft guidance, FDA is communicating
its expectations and support for the described approach.
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 Agency's current thinking on
comparability protocols for applications regulated in CDER and CBER as
described previously. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This draft guidance contains information collection provisions 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
collection of information requested in the draft guidance is covered
under FDA regulations 21 CFR 314.50, 314.70, and 314.81(b)(2) for human
drugs and 21 CFR 601.2 and 601.12 for biologics. The collection of
information is approved under the following OMB Control Numbers: 0910-
0001 for human drugs and 0910-0338 for biologics.

III. 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.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

Dated: April 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09137 Filed 4-19-16; 8:45 am]
BILLING CODE 4164-01-P

23304 Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices

Silver Spring, MD 20993–0002, 301– scope of this guidance will not have to regulations 21 CFR 314.50, 314.70, and
796–7579 or Stephen Ripley, Center for submit commercial-scale CMC 314.81(b)(2) for human drugs and 21
Biologics Evaluation and Research, information on postchange products to CFR 601.2 and 601.12 for biologics. The
Food and Drug Administration, Bldg. FDA before making the proposed collection of information is approved
71, Rm. 7268, 10903 New Hampshire changes. The draft guidance is intended under the following OMB Control
Ave., Silver Spring, MD 20993–0002, to establish a framework to promote Numbers: 0910–0001 for human drugs
240–402–7911. manufacturing of quality drug products and 0910–0338 for biologics.
SUPPLEMENTARY INFORMATION: by employing the following:
• Effective use of knowledge and III. Electronic Access
I. Background understanding of the product and Persons with access to the Internet
FDA is announcing the availability of manufacturing process. may obtain the document at either
a draft guidance for industry entitled • A robust control strategy. http://www.fda.gov/Drugs/Guidance
‘‘Comparability Protocols for Human • Risk management activities over a ComplianceRegulatoryInformation/
Drugs and Biologics: Chemistry, product’s life cycle. Guidances/default.htm, http://
Manufacturing, and Controls • An effective pharmaceutical quality www.regulations.gov, or http://
Information.’’ This draft guidance is a system. www.fda.gov/BiologicsBloodVaccines/
revised version of a draft guidance that This draft guidance incorporates the GuidanceComplianceRegulatory
published in February 2003 entitled modern regulatory concepts stated in Information/default.htm.
‘‘Comparability Protocols: Chemistry, the guidance for industry entitled
‘‘PAT—A Framework for Innovative Dated: April 14, 2016.
Manufacturing, and Controls
Pharmaceutical Development, Leslie Kux,
Information.’’ A related draft guidance
entitled ‘‘Comparability Protocols— Manufacturing, and Quality Assurance,’’ Associate Commissioner for Policy.
Protein Drug Products and Biological (http://www.fda.gov/downloads/Drugs/ [FR Doc. 2016–09137 Filed 4–19–16; 8:45 am]
Products—Chemistry, Manufacturing, GuidanceComplianceRegulatory BILLING CODE 4164–01–P
and Controls Information,’’ which Information/Guidances/
published in September 2003, was UCM070305.pdf) the Pharmaceutical
withdrawn on May 6, 2015 (80 FR Current Good Manufacturing Practices DEPARTMENT OF HEALTH AND
26059). for the 21st Century Initiative (http:// HUMAN SERVICES
The revised draft guidance provides www.fda.gov/Drugs/Development
recommendations to holders of ApprovalProcess/Manufacturing/ Food and Drug Administration
applications for human drugs and QuestionsandAnswersonCurrentGood [Docket No. FDA–2011–N–0655]
biologics on implementing a chemistry, ManufacturingPracticescGMPforDrugs/
manufacturing, controls (CMC) UCM071836), the Critical Path Initiative Animal Generic Drug User Fee Act;
postapproval change(s) through the use (http://www.fda.gov/scienceresearch/ Stakeholder Consultation Meetings on
of a comparability protocol (CP). The specialtopics/criticalpathinitiative/ the Animal Generic Drug User Fee Act
revised draft guidance applies to new default.htm), and the quality by design Reauthorization; Request for
drug applications (NDAs), abbreviated principles described in the guidance for Notification of Stakeholder Intention
new drug applications (ANDAs), or industry entitled ‘‘Q8(R2) To Participate
biologics license applications (BLAs) Pharmaceutical Development’’ (http://
regulated by the Center for Drug www.fda.gov/ucm/groups/fdagov- AGENCY: Food and Drug Administration,
Evaluation and Research (CDER) or the public/@fdagov-drugs-gen/documents/ HHS.
Center for Biologics Evaluation and document/ucm073507.pdf). In ACTION: Notice; request for notification
Research (CBER) or supplements publishing this draft guidance, FDA is of participation.
following 21 CFR 314.70 or 21 CFR communicating its expectations and
support for the described approach. SUMMARY: The Food and Drug
601.12.
On February 25, 2003 (68 FR 8772), This draft guidance is being issued Administration (FDA or Agency) is
FDA announced the availability of the consistent with FDA’s good guidance issuing this notice to request that public
first draft version of this guidance. The practices regulation (21 CFR 10.115). stakeholders notify FDA of their intent
public comment period closed on June The draft guidance, when finalized, will to participate in periodic consultation
25, 2003. A number of comments were represent the Agency’s current thinking meetings on reauthorization of the
received, which the Agency considered on comparability protocols for Animal Generic Drug User Fee Act
carefully as it prepared this revised draft applications regulated in CDER and (AGDUFA). The statutory authority for
guidance. CBER as described previously. It does AGDUFA expires September 30, 2018.
We revised the guidance for the not create or confer any rights for or on The Federal Food, Drug, and Cosmetic
following reasons: any person and does not operate to bind Act (the FD&C Act) requires that FDA
• To provide more flexibility FDA or the public. An alternative consult with a range of stakeholders—
regarding filing procedures for a approach may be used if such approach including patient and consumer
notification of change in a condition satisfies the requirements of the advocacy groups, veterinary
established in an approved application. applicable statutes and regulations. professionals, and scientific and
• To include current pharmaceutical academic experts—in developing
II. Paperwork Reduction Act of 1995 recommendations for the next AGDUFA
quality concepts.
• To add an appendix to address This draft guidance contains program, and hold discussions with
Lhorne on DSK5TPTVN1PROD with NOTICES

commonly asked questions. information collection provisions that these stakeholders at least once every 4
This revised draft guidance provides are subject to review by the Office of months during FDA’s negotiations with
recommendations to human drug Management and Budget (OMB) under the regulated industry. The purpose of
manufacturers on implementing CMC the Paperwork Reduction Act of 1995 this request for notification is to ensure
postapproval change(s) through the use (44 U.S.C. 3501–3520). The collection of continuity and progress in these regular
of a CP. By using an approved CP, information requested in the draft discussions by establishing consistent
manufacturers whom fall within the guidance is covered under FDA stakeholder representation.

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Document Created: 2016-04-20 01:51:20
Document Modified: 2016-04-20 01:51:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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 June 20, 2016.
Contact		Stephen Moore, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 21, Rm. 2012, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7579 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7268, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002, 240-402-7911.
FR Citation		81 FR 23303

81 FR 23303 - Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 76 (April 20, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration