Document ID: FDA-1995-D-0288-0002
Agency: fda
Document Type: Notice
Title: Chemistry, Manufacturing, and Controls Changes to an Approved
Application: Certain Biological Products; Draft Guidance for Industry;
Availability
Posted Date: 2017-12-22T05:00Z

[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60750-60752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27589]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1995-D-0288 (Formerly Docket No. 95D-0052)]

Chemistry, Manufacturing, and Controls Changes to an Approved 
Application: Certain Biological Products; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Chemistry, 
Manufacturing, and Controls Changes to an Approved Application: Certain 
Biological Products; Draft Guidance for Industry.'' The draft guidance 
is intended to assist applicants and manufacturers of certain licensed 
biological products in determining which reporting category is 
appropriate for a change in chemistry, manufacturing, and controls 
(CMC) information to an approved biologics license application (BLA). 
The draft guidance provides applicants and manufacturers general and 
administrative information on reporting and evaluating changes and 
recommendations for reporting categories based on a tiered-reporting 
system for specific changes. The draft guidance, when finalized, is 
intended to supersede the document entitled ``Guidance for Industry: 
Changes to an Approved Application: Biological Products'' dated July 
1997 (July 1997 guidance).

DATES: Submit either electronic or written comments on the draft 
guidance by March 22, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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

[[Page 60751]]

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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-1995-D-0288 (formerly Docket No. 95D-0052) for ``Chemistry, 
Manufacturing, and Controls Changes to an Approved Application: 
Biological Products.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff 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 Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance 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 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Chemistry, Manufacturing, and Controls Changes to an Approved 
Application: Certain Biological Products; Draft Guidance for 
Industry.'' The draft guidance, when finalized, is intended to assist 
applicants and manufacturers of licensed biological products in 
determining which reporting category is appropriate for a change in CMC 
to an approved BLA as specified in 21 CFR 601.12. The draft guidance 
provides applicants and manufacturers general and administrative 
information on reporting and evaluating changes and recommendations for 
reporting categories based on a tiered-reporting system for specific 
changes under Sec.  601.12.
    FDA issued the July 1997 guidance (62 FR 39904; July 24, 1997) to 
assist applicants in determining which reporting mechanism is 
appropriate for reporting a change to an approved application to reduce 
the burden on manufacturers when reporting changes and to facilitate 
the approval process of the change being made. We are updating the July 
1997 guidance to accommodate advances in manufacturing and testing 
technology and to clarify the FDA's current thinking on assessing 
reportable changes. The updated guidance applies to certain biological 
products licensed under the Public Health Service Act (PHS Act), 
including in vitro diagnostics licensed under BLAs. This draft guidance 
applies to all manufacturing locations, including contract locations. 
The following biological products are not within the scope of this 
guidance: Whole blood, blood components, source plasma, and source 
leukocytes. This draft guidance also does not apply to human cells, 
tissues, and cellular and tissue-based products regulated solely under 
section 361 of the PHS Act (42 U.S.C. 264), as described in 21 CFR part 
1271; specified biotechnology and specified synthetic biological 
products; and biosimilar biological products subject to licensure under 
section 351(k) of the PHS Act. The draft guidance, when finalized, is 
intended to supersede the July 1997 guidance.
    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 ``Chemistry, 
Manufacturing, and Controls Changes to an Approved Application: Certain 
Biological 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information 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 part 210 and

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21 CFR part 211 have been approved under OMB control number 0910-0139; 
the collections of information in 21 CFR 601.12 have been approved 
under OMB control numbers 0910-0338, and the collections of information 
in 21 CFR part 820 have been approved under OMB control number 0910-
0073.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27589 Filed 12-21-17; 8:45 am]
 BILLING CODE 4164-01-P