Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry; Availability, 37232-37233 [2017-16718]
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Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
agencies, industry, and external
perspectives and experiences with
structured benefit-risk assessment. This
public meeting will have discussion
sessions focusing on the entire drug
development life cycle, including
premarket drug review and postmarket
safety surveillance. The format of the
meeting consists of a series of
presentations on topics related to
structured assessment of benefits and
risks, followed by a discussion on those
topics with invited panelists and
audience members.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Meeting Attendance and
Participation
ACTION:
sradovich on DSK3GMQ082PROD with NOTICES
Dated: August 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16720 Filed 8–8–17; 8:45 am]
BILLING CODE 4164–01–P
17:00 Aug 08, 2017
[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Reports; Draft Guidance for Industry;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.
Notice of availability.
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announcing the availability of a draft
guidance for industry entitled ‘‘CMC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draft guidance provides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Specifically, the draft guidance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.
SUMMARY:
Registration: If you wish to attend this
meeting, visit https://
fdabenefitrisk.eventbrite.com. Please
register by September 11, 2017. If you
are unable to attend the meeting in
person, you can register to view a live
webcast of the meeting. You will be
asked to indicate in your registration if
you plan to attend in person or via the
webcast. Seating will be limited, so
early registration is recommended.
Registration is free and will be on a
first-come, first-served basis. However,
FDA may limit the number of
participants from each organization
based on space limitations. Registrants
will receive confirmation once they
have been accepted. Onsite registration
on the day of the meeting will be based
on space availability.
If you need special accommodations
because of a disability, please contact
Graham Thompson (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
forindustry/userfees/prescriptiondrug
userfee/ucm378861.htm.
VerDate Sep<11>2014
Food and Drug Administration
Jkt 241001
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
E:\FR\FM\09AUN1.SGM
09AUN1
Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
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 § 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.
I. Background
sradovich on DSK3GMQ082PROD with NOTICES
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/201523389.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:
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 § 601.12 have been
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,
VerDate Sep<11>2014
17:00 Aug 08, 2017
Jkt 241001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
37233
approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meetings Announcement for the
Physician-Focused Payment Model
Technical Advisory Committee
Required by the Medicare Access and
CHIP Reauthorization Act of 2015
(MACRA)
ACTION:
Notice of public meetings.
This notice announces the
next meeting of the Physician-Focused
Payment Model Technical Advisory
Committee (hereafter referred to as ‘‘the
Committee’’) which will be held in
Washington, DC. This meeting will
include voting and deliberations on
proposals for physician-focused
payment models (PFPMs) submitted by
members of the public. All meetings are
open to the public.
DATES: The PTAC meeting will occur on
the following dates:
• Thursday—Friday, September 7–8,
2017, from 9:00 a.m. to 5:00 p.m. ET.
Please note that times are subject to
change. If the times change, registrants
will be notified directly via email.
ADDRESSES: The September 7–8, 2017
meeting will be held at the Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Washington, DC, 20201.
FOR FURTHER INFORMATION CONTACT: Ann
Page, Designated Federal Official, at the
Office of Health Policy, Assistant
Secretary for Planning and Evaluation,
U.S. Department of Health and Human
Services, 200 Independence Ave. SW.,
Washington, DC 20201, (202) 690–6870.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Purpose
The Physician-Focused Payment
Model Technical Advisory Committee
(‘‘the Committee’’) is required by the
E:\FR\FM\09AUN1.SGM
09AUN1
Agencies
[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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://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