
[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Pages 37232-37233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16718]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2802]


Chemistry, Manufacturing, and Controls Postapproval Manufacturing 
Changes for Specified Biological Products To Be Documented in Annual 
Reports; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``CMC 
Postapproval Manufacturing Changes for Specified Biological Products To 
Be Documented in Annual Reports.'' This draft guidance provides 
recommendations to holders of biologics license applications (BLAs) for 
specified products regarding the types of changes to be documented in 
annual reports. Specifically, the draft guidance describes chemistry, 
manufacturing, and controls (CMC) postapproval manufacturing changes 
that the Agency generally considers to have a minimal potential to have 
an adverse effect on the identity, strength, quality, purity, or 
potency of the product as they may relate to the safety or 
effectiveness of the product. Under FDA regulations, such minor changes 
in the product, production process, quality controls, equipment, 
facilities, or responsible personnel must be documented by applicants 
in an annual report.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 10, 2017.

ADDRESSES: You may submit comments 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 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-2017-D-2802 for ``CMC Postapproval Manufacturing Changes for 
Specified Biological Products To Be Documented in Annual Reports.'' 
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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and

[[Page 37233]]

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.
    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, 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 that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Michail Alterman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4245, Silver Spring, MD 20993, 240-402-
9355; or Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``CMC Postapproval Manufacturing Changes for Specified 
Biological Products To Be Documented in Annual Reports.'' Applicants 
must notify the Agency of a change to an approved BLA in accordance 
with all statutory and regulatory requirements--including section 506A 
of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
356a) and 21 CFR 601.12. Section 506A of the FD&C Act provides 
requirements for making and reporting manufacturing changes to an 
approved application or license and for distributing a drug product 
made with such changes. Under Sec.  601.12, each post-approval change 
in the product, production process, quality controls, equipment, 
facilities, or responsible personnel established in an approved BLA is 
categorized into one of three reporting categories:
     Major change: Applicants must submit and receive FDA's 
approval of a supplement to the BLA before the product produced with 
the manufacturing change is distributed.
     Moderate change: Applicants must submit a supplement at 
least 30 days before the product is distributed or, in some cases, the 
product may be distributed immediately upon FDA's receipt of the 
supplement.
     Minor change: Applicants may proceed with the change but 
must notify FDA of the change in an annual report.
    This draft guidance provides recommendations for changes that 
generally should be documented in an annual report. It discusses the 
contents of an annual report notification and lists examples of 
postapproval manufacturing changes for BLAs that FDA generally 
considers to have a minimal potential to have an adverse effect on the 
identity, strength, quality, purity, or potency of the product as they 
may relate to the safety or effectiveness of the product and, 
therefore, generally should be documented in an annual report.
    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 CMC 
postapproval manufacturing changes for specified biological products to 
be documented in annual reports. 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. The Paperwork Reduction Act of 1995

    This draft guidance 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 Sec.  601.12 have been approved under OMB 
control number 0910-0338.

III. Electronic Access

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

    Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16718 Filed 8-8-17; 8:45 am]
 BILLING CODE 4164-01-P


