Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability, 76117-76119 [2024-20924]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices
Accreditation Commission for Health
Care, Incorporated’s (ACHC’s) term of
approval for their HHA accreditation
program expires February 24, 2025.
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of a national accrediting
organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide us with the necessary
data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, a description
of the nature of the request, and
provision of at least a 30-day public
comment period. We have 210 days
from the receipt of a complete
application to publish notice of
approval or denial of the application.
The purpose of this proposed notice
is to inform the public of ACHC’s
request for continued CMS approval of
its HHA accreditation program. This
notice also solicits public comment on
whether ACHC’s requirements meet or
exceed the Medicare conditions of
participation (CoPs) for HHAs.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Evaluation of Deeming Authority
Request
ACHC submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its HHA
accreditation program. This application
was determined to be complete on July
29, 2024. Under section 1865(a)(2) of the
Act and our regulations at § 488.5
(Application and re-application
procedures for national accrediting
organizations), our review and
evaluation of ACHC will be conducted
in accordance with, but not necessarily
limited to, the following factors:
• The equivalency of ACHC’s
standards for HHAs as compared with
CMS’ HHA CoPs.
• ACHC’s survey process to
determine the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
VerDate Sep<11>2014
17:12 Sep 16, 2024
Jkt 262001
++ The comparability of ACHC’s
processes to those of state agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited HHAs.
++ ACHC’s processes and procedures
for monitoring HHAs found out of
compliance with ACHC’s program
requirements. These monitoring
procedures are used only when ACHC
identifies noncompliance. If
noncompliance is identified through
validation reviews or complaint
surveys, the state survey agency
monitors corrections as specified at
§ 488.9(c).
++ ACHC’s capacity to report
deficiencies to the surveyed HHAs and
respond to the HHA’s plan of correction
in a timely manner.
++ ACHC’s capacity to provide us
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of ACHC’s staff and
other resources, and its financial
viability.
++ ACHC’s capacity to adequately
fund required surveys.
++ ACHC’s policies with respect to
whether surveys are announced or
unannounced, to ensure that surveys are
unannounced.
++ ACHC’s policies and procedures
to avoid conflicts of interest, including
the appearance of conflicts of interest,
involving individuals who conduct
surveys or participate in accreditation
decisions.
++ ACHC’s agreement to provide us
with a copy of the most current
accreditation survey together with any
other information related to the survey
as we may require (including corrective
action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is reporting, recordkeeping or thirdparty disclosure requirements.
Consequently, there is no need for
review by the Office Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35).
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this notice. Upon completion of our
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
76117
evaluation, including evaluation of
comments received because of this
notice, we will publish a final notice in
the Federal Register summarizing our
response to comments and announcing
the result of our evaluation.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Chyana Woodyard, who is
the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–21014 Filed 9–16–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1492]
Chemistry, Manufacturing, and
Controls Technical Section Filing
Strategies; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #227
entitled ‘‘Chemistry, Manufacturing,
and Controls (CMC) Technical Section
Filing Strategies.’’ This draft guidance
provides recommendations to sponsors
submitting CMC data submissions to
new animal drug applications. This
guidance describes the options for
soliciting early input from the Center for
Veterinary Medicine (CVM) and the
process for submission of components
of the CMC technical section.
DATES: Submit either electronic or
written comments on the draft guidance
by November 18, 2024 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:
SUMMARY:
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,
E:\FR\FM\17SEN1.SGM
17SEN1
76118
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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–
2014–D–1492 for ‘‘Chemistry,
Manufacturing, and Controls (CMC)
Technical Section Filing Strategies.’’
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, 240–402–7500.
• 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
VerDate Sep<11>2014
17:12 Sep 16, 2024
Jkt 262001
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
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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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 guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed 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:
Heather Longstaff, Center for Veterinary
Medicine (HFV–147), Food and Drug
Administration, 7500 Standish Pl.,
Rockville MD 20855, 240–402–0651,
Heather.Longstaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
draft GFI #227 entitled ‘‘Chemistry,
Manufacturing, and Controls (CMC)
Technical Section Filing Strategies.’’
This guidance provides
recommendations to sponsors
submitting CMC data submissions to
new animal drug applications. This
draft guidance replaces final GFI #227,
issued September 2015, entitled ‘‘TwoPhased Chemistry, Manufacturing, and
Controls (CMC) Technical Sections.’’
There are several mechanisms to
receive input from CVM prior to
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
submission of the CMC technical
section, as well as various approaches to
submitting the CMC technical section
itself. For review efficiency, CVM
prefers that full CMC information be
provided in a single technical section
submission.
However, there may be instances
when submission of the individual
components of the technical section
(drug product, drug substance, and
facility sterile process validation
information for sterile drug products)
could reduce the overall time to
complete a technical section, and
therefore drug approval. This guidance
describes the options for soliciting early
input from CVM and the process for
submission of components of the CMC
technical section.
This level 1 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 (CMC)
Technical Section Filing Strategies.’’ 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. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 514 have
been approved under OMB control
numbers 0910–0032; the collections of
information in 21 CFR 511.1 have been
approved under OMB control number
0910–0117; and the collections of
information in sections 512(b) and
512(n) of the Federal Food, Drug, and
Cosmetic Act have been approved under
OMB control number 0910–0669.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
E:\FR\FM\17SEN1.SGM
17SEN1
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20924 Filed 9–16–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3924]
Digital Health Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for
Comments—Total Product Lifecycle
Considerations for Generative Artificial
Intelligence-Enabled Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Digital Health Advisory
Committee (the Committee). The general
function of the Committee is to provide
advice and recommendations to FDA on
regulatory issues. The Committee will
discuss total product lifecycle
considerations for Generative Artificial
Intelligence (AI)-enabled devices. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this topic.
DATES: The meeting will be held on
November 20–21, 2024, from 9 a.m. to
6 p.m. eastern time.
ADDRESSES: Holiday Inn Gaithersburg,
Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel’s
telephone number is 301–948–8900.
The hotel’s link can be found at: https://
www.ihg.com/holidayinn/hotels/us/en/
gaithersburg/wasrv/hoteldetail. Answers
to commonly asked questions including
information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–3924.
The docket will close on January 21,
2025. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 21, 2025.
Comments received by mail/hand
delivery/courier (for written/paper
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:12 Sep 16, 2024
Jkt 262001
submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
November 1, 2024, will be provided to
the Committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is canceled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
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–
2024–N–3924 for ‘‘Digital Health
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
76119
comments, those filed in a timely
manner (see ADDRESSES), 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, 240–402–7500.
• 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.’’ FDA
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
contact information 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 the 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5221, Silver Spring,
MD 20993–0002, 301–796–6313,
James.Swink@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76117-76119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1492]
Chemistry, Manufacturing, and Controls Technical Section Filing
Strategies; 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 (GFI) #227 entitled
``Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing
Strategies.'' This draft guidance provides recommendations to sponsors
submitting CMC data submissions to new animal drug applications. This
guidance describes the options for soliciting early input from the
Center for Veterinary Medicine (CVM) and the process for submission of
components of the CMC technical section.
DATES: Submit either electronic or written comments on the draft
guidance by November 18, 2024 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,
[[Page 76118]]
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-2014-D-1492 for ``Chemistry, Manufacturing, and Controls (CMC)
Technical Section Filing Strategies.'' 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, 240-402-7500.
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 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.govinfo.gov/content/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, 240-402-7500.
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 guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
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: Heather Longstaff, Center for
Veterinary Medicine (HFV-147), Food and Drug Administration, 7500
Standish Pl., Rockville MD 20855, 240-402-0651,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft GFI #227 entitled
``Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing
Strategies.'' This guidance provides recommendations to sponsors
submitting CMC data submissions to new animal drug applications. This
draft guidance replaces final GFI #227, issued September 2015, entitled
``Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical
Sections.''
There are several mechanisms to receive input from CVM prior to
submission of the CMC technical section, as well as various approaches
to submitting the CMC technical section itself. For review efficiency,
CVM prefers that full CMC information be provided in a single technical
section submission.
However, there may be instances when submission of the individual
components of the technical section (drug product, drug substance, and
facility sterile process validation information for sterile drug
products) could reduce the overall time to complete a technical
section, and therefore drug approval. This guidance describes the
options for soliciting early input from CVM and the process for
submission of components of the CMC technical section.
This level 1 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 (CMC) Technical Section Filing
Strategies.'' 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. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 514 have been approved under OMB control numbers 0910-
0032; the collections of information in 21 CFR 511.1 have been approved
under OMB control number 0910-0117; and the collections of information
in sections 512(b) and 512(n) of the Federal Food, Drug, and Cosmetic
Act have been approved under OMB control number 0910-0669.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
[[Page 76119]]
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20924 Filed 9-16-24; 8:45 am]
BILLING CODE 4164-01-P
