82 FR 37232 - Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 152 (August 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 152 (August 9, 2017)
| Page Range | 37232-37233 | |
| FR Document | 2017-16718 |
[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)] [Notices] [Pages 37232-37233] From the Federal Register Online [www.thefederalregister.org] [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and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.'' This draft guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to be documented in annual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 Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that the Agency generally considers to have a minimal potential to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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 10, 2017.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.thefederalregister.org/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
![37232 Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices
agencies, industry, and external DEPARTMENT OF HEALTH AND comment does not include any
perspectives and experiences with HUMAN SERVICES confidential information that you or a
structured benefit-risk assessment. This third party may not wish to be posted,
public meeting will have discussion Food and Drug Administration such as medical information, your or
sessions focusing on the entire drug [Docket No. FDA–2017–D–2802]
anyone else’s Social Security number, or
development life cycle, including confidential business information, such
premarket drug review and postmarket Chemistry, Manufacturing, and as a manufacturing process. Please note
safety surveillance. The format of the Controls Postapproval Manufacturing that if you include your name, contact
meeting consists of a series of Changes for Specified Biological information, or other information that
Products To Be Documented in Annual identifies you in the body of your
presentations on topics related to
Reports; Draft Guidance for Industry; comments, that information will be
structured assessment of benefits and
Availability posted on https://www.regulations.gov.
risks, followed by a discussion on those • If you want to submit a comment
topics with invited panelists and AGENCY: Food and Drug Administration, with confidential information that you
audience members. HHS. do not wish to be made available to the
III. Meeting Attendance and ACTION: Notice of availability. public, submit the comment as a
Participation written/paper submission and in the
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
Registration: If you wish to attend this Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’).
meeting, visit https:// announcing the availability of a draft
Written/Paper Submissions
fdabenefitrisk.eventbrite.com. Please guidance for industry entitled ‘‘CMC
register by September 11, 2017. If you Postapproval Manufacturing Changes Submit written/paper submissions as
for Specified Biological Products To Be follows:
are unable to attend the meeting in • Mail/Hand delivery/Courier (for
person, you can register to view a live Documented in Annual Reports.’’ This
draft guidance provides written/paper submissions): Dockets
webcast of the meeting. You will be Management Staff (HFA–305), Food and
asked to indicate in your registration if recommendations to holders of biologics
license applications (BLAs) for specified Drug Administration, 5630 Fishers
you plan to attend in person or via the Lane, Rm. 1061, Rockville, MD 20852.
products regarding the types of changes
webcast. Seating will be limited, so
to be documented in annual reports. • For written/paper comments
early registration is recommended. Specifically, the draft guidance submitted to the Dockets Management
Registration is free and will be on a describes chemistry, manufacturing, and Staff, FDA will post your comment, as
first-come, first-served basis. However, controls (CMC) postapproval well as any attachments, except for
FDA may limit the number of manufacturing changes that the Agency information submitted, marked and
participants from each organization generally considers to have a minimal identified, as confidential, if submitted
based on space limitations. Registrants potential to have an adverse effect on as detailed in ‘‘Instructions.’’
the identity, strength, quality, purity, or Instructions: All submissions received
will receive confirmation once they
potency of the product as they may must include the Docket No. FDA–
have been accepted. Onsite registration 2017–D–2802 for ‘‘CMC Postapproval
on the day of the meeting will be based relate to the safety or effectiveness of the
product. Under FDA regulations, such Manufacturing Changes for Specified
on space availability. Biological Products To Be Documented
minor changes in the product,
If you need special accommodations in Annual Reports.’’ Received
production process, quality controls,
because of a disability, please contact equipment, facilities, or responsible comments will be placed in the docket
Graham Thompson (see FOR FURTHER personnel must be documented by and, except for those submitted as
INFORMATION CONTACT) at least 7 days applicants in an annual report. ‘‘Confidential Submissions,’’ publicly
before the meeting. viewable at https://www.regulations.gov
DATES: Although you can comment on
Transcripts: Please be advised that as or at the Dockets Management Staff
any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday
soon as a transcript of the public 10.115(g)(5)), to ensure that the Agency through Friday.
meeting is available, it will be accessible considers your comment on this draft • Confidential Submissions—To
at https://www.regulations.gov. It may guidance before it begins work on the submit a comment with confidential
be viewed at the Dockets Management final version of the guidance, submit information that you do not wish to be
Staff (see ADDRESSES). A link to the either electronic or written comments made publicly available, submit your
transcript will also be available on the on the draft guidance by October 10, comments only as a written/paper
internet at https://www.fda.gov/ 2017. submission. You should submit two
forindustry/userfees/prescriptiondrug ADDRESSES: You may submit comments copies total. One copy will include the
userfee/ucm378861.htm. as follows: information you claim to be confidential
Dated: August 3, 2017. with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Anna K. Abram,
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Deputy Commissioner for Policy, Planning, Agency will review this copy, including
following way:
Legislation, and Analysis.
• Federal eRulemaking Portal: the claimed confidential information, in
[FR Doc. 2017–16720 Filed 8–8–17; 8:45 am]
https://www.regulations.gov. Follow the its consideration of comments. The
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Staff. If you do not wish your name and
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![Federal Register / Vol. 82, No. 152 / Wednesday, August 9, 2017 / Notices 37233
contact information to be made publicly and Cosmetic Act (the FD&C Act) (21 approved under OMB control number
available, you can provide this U.S.C. 356a) and 21 CFR 601.12. Section 0910–0338.
information on the cover sheet and not 506A of the FD&C Act provides
III. Electronic Access
in the body of your comments and you requirements for making and reporting
must identify this information as manufacturing changes to an approved Persons with access to the internet
‘‘confidential.’’ Any information marked application or license and for may obtain the draft guidance at either
as ‘‘confidential’’ will not be disclosed distributing a drug product made with http://www.fda.gov/Drugs/Guidance
except in accordance with 21 CFR 10.20 such changes. Under § 601.12, each ComplianceRegulatoryInformation/
and other applicable disclosure law. For post-approval change in the product, Guidances/default.htm, http://
more information about FDA’s posting production process, quality controls, www.fda.gov/BiologicsBloodVaccines/
of comments to public dockets, see 80 equipment, facilities, or responsible GuidanceComplianceRegulatory
FR 56469, September 18, 2015, or access personnel established in an approved Information/default.htm, or https://
the information at: https://www.gpo.gov/ BLA is categorized into one of three www.regulations.gov.
fdsys/pkg/FR-2015-09-18/pdf/2015- reporting categories: Dated: August 3, 2017.
23389.pdf. • Major change: Applicants must
Anna K. Abram,
Docket: For access to the docket to submit and receive FDA’s approval of a
supplement to the BLA before the Deputy Commissioner for Policy, Planning,
read background documents or the Legislation, and Analysis.
electronic and written/paper comments product produced with the
[FR Doc. 2017–16718 Filed 8–8–17; 8:45 am]
received, go to https://www.regulations manufacturing change is distributed.
.gov and insert the docket number, • Moderate change: Applicants must BILLING CODE 4164–01–P
found in brackets in the heading of this submit a supplement at least 30 days
document, into the ‘‘Search’’ box and before the product is distributed or, in
some cases, the product may be DEPARTMENT OF HEALTH AND
follow the prompts and/or go to the HUMAN SERVICES
Dockets Management Staff, 5630 Fishers distributed immediately upon FDA’s
Lane, Rm. 1061, Rockville, MD 20852. receipt of the supplement.
• Minor change: Applicants may Meetings Announcement for the
Submit written requests for single Physician-Focused Payment Model
copies of the draft guidance to the proceed with the change but must notify
FDA of the change in an annual report. Technical Advisory Committee
Division of Drug Information, Center for Required by the Medicare Access and
This draft guidance provides
Drug Evaluation and Research, Food CHIP Reauthorization Act of 2015
recommendations for changes that
and Drug Administration, 10001 New (MACRA)
generally should be documented in an
Hampshire Ave., Hillandale Building,
annual report. It discusses the contents ACTION: Notice of public meetings.
4th Floor, Silver Spring, MD 20993–
of an annual report notification and lists
0002 or to the Office of Communication,
examples of postapproval SUMMARY: This notice announces the
Outreach and Development, Center for
manufacturing changes for BLAs that next meeting of the Physician-Focused
Biologics Evaluation and Research,
FDA generally considers to have a Payment Model Technical Advisory
Food and Drug Administration, 10903
minimal potential to have an adverse Committee (hereafter referred to as ‘‘the
New Hampshire Ave., Bldg. 71, Rm.
effect on the identity, strength, quality, Committee’’) which will be held in
3128, Silver Spring, MD 20993–0002.
purity, or potency of the product as they Washington, DC. This meeting will
Send one self-addressed adhesive label
may relate to the safety or effectiveness include voting and deliberations on
to assist that office in processing your
of the product and, therefore, generally proposals for physician-focused
requests. See the SUPPLEMENTARY
should be documented in an annual payment models (PFPMs) submitted by
INFORMATION section for electronic
report. members of the public. All meetings are
access to the draft guidance document. This draft guidance is being issued open to the public.
FOR FURTHER INFORMATION CONTACT: consistent with FDA’s good guidance
Michail Alterman, Center for Drug DATES: The PTAC meeting will occur on
practices regulation (21 CFR 10.115). the following dates:
Evaluation and Research, Food and The draft guidance, when finalized, will
Drug Administration, 10903 New • Thursday—Friday, September 7–8,
represent the current thinking of FDA 2017, from 9:00 a.m. to 5:00 p.m. ET.
Hampshire Ave., Bldg. 51, Rm. 4245, on CMC postapproval manufacturing
Silver Spring, MD 20993, 240–402– Please note that times are subject to
changes for specified biological change. If the times change, registrants
9355; or Stephen Ripley, Center for products to be documented in annual
Biologics Evaluation and Research, will be notified directly via email.
reports. It does not establish any rights
Food and Drug Administration, 10903 ADDRESSES: The September 7–8, 2017
for any person and is not binding on
New Hampshire Ave., Bldg. 71, Rm. meeting will be held at the Hubert H.
FDA or the public. You can use an
7301, Silver Spring, MD 20993–0002, Humphrey Building, 200 Independence
alternative approach if it satisfies the
240–402–7911. Avenue SW., Washington, DC, 20201.
requirements of the applicable statutes
SUPPLEMENTARY INFORMATION: and regulations. FOR FURTHER INFORMATION CONTACT: Ann
Page, Designated Federal Official, at the
I. Background II. The Paperwork Reduction Act of Office of Health Policy, Assistant
FDA is announcing the availability of 1995 Secretary for Planning and Evaluation,
a draft guidance for industry entitled This draft guidance refers to U.S. Department of Health and Human
‘‘CMC Postapproval Manufacturing previously approved collections of Services, 200 Independence Ave. SW.,
sradovich on DSK3GMQ082PROD with NOTICES
Changes for Specified Biological information found in FDA regulations. Washington, DC 20201, (202) 690–6870.
Products To Be Documented in Annual These collections of information are SUPPLEMENTARY INFORMATION:
Reports.’’ Applicants must notify the subject to review by the Office of
Agency of a change to an approved BLA Management and Budget (OMB) under I. Purpose
in accordance with all statutory and the Paperwork Reduction Act of 1995 The Physician-Focused Payment
regulatory requirements—including (44 U.S.C. 3501–3520). The collections Model Technical Advisory Committee
section 506A of the Federal Food, Drug, of information in § 601.12 have been (‘‘the Committee’’) is required by the
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Document Created: 2017-08-09 02:18:14
Document Modified: 2017-08-09 02:18:14
| 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 October 10, 2017. | |
| 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. | |
| FR Citation | 82 FR 37232 |
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