[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]
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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Reports; Draft Guidance for Industry; Availability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.
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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the availability of a draft guidance for industry entitled ``CMC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 This draft guidance provides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 Specifically, the draft guidance describes chemistry,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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 10, 2017.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]
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