Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability, 52470-52471 [2024-13796]

Download as PDF 52470 Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices thinking of FDA on ‘‘Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use.’’ 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 number 0910–0032 and the collections of information in 21 CFR part 511 have been approved under OMB control number 0910–0117. 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 Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/animal-veterinary/ guidance-regulations/guidanceindustry, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or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. Dated: June 18, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–13778 Filed 6–21–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES articles. Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed. DATES: Submit either electronic or written comments on the draft guidance by August 23, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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, 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 Food and Drug Administration [Docket No. FDA–2024–D–1202] Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; 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) #292 entitled ‘‘Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles.’’ This draft guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:55 Jun 21, 2024 Jkt 262001 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–D–1202 for ‘‘Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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-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 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices Medicine (HFV–147), Food and Drug Administration, 7500 Standish Place, Rockville MD 20855, 240–402–0651, Heather.Longstaff@fda.hhs. SUPPLEMENTARY INFORMATION: I. Background The FDA is announcing the availability of a draft GFI #292 entitled ‘‘Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles.’’ This draft guidance provides recommendations to sponsors submitting CMC information for Type A medicated articles. Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed. Type A medicated articles are intended solely for use in the manufacture of another Type A medicated article or in the manufacture of a Type B or Type C medicated feed. Because Type A medicated articles are not directly administered to the animal, there are some issues specific to Type A medicated articles that do not apply to other new animal drug dosage forms. These unique considerations are highlighted in this guidance under the relevant Common Technical Document—Quality section headings. 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 Considerations for Type A Medicated Articles.’’ 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. lotter on DSK11XQN23PROD with NOTICES1 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 (21 U.S.C. 360b(b) and 360b(n)) have been approved under OMB control number 0910–0669. VerDate Sep<11>2014 18:55 Jun 21, 2024 Jkt 262001 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/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Dated: June 18, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–13796 Filed 6–21–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–2561] Best Practices for Meeting Management; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ‘‘Best Practices for Meeting Management.’’ This workshop is being conducted to fulfill a commitment to hold a public meeting to discuss best practices for meeting management in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII). The purpose of the public workshop is to discuss issues related to submission of meeting requests, efficient time management, finalizing meeting agenda, development and submission of meeting background packages, and lessons learned from the Coronavirus Disease 2019 (COVID–19) pandemic including the use of virtual meeting platforms. The public workshop will also discuss and share experience and metrics related to specific PDUFA meeting activities associated with the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) meetings in fiscal years (FYs) 2021 through 2023. This will include Type D and Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT) meetings, which began with PDUFA VII in FY 2023. Learnings from the public meeting could inform FDA’s internal process improvement efforts and, as appropriate, be reflected in an update to the ‘‘Best Practices for Communication SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 52471 Between IND [Investigational New Drug Application] Sponsors and FDA During Drug Development’’ guidance. DATES: The public workshop will be held in person and virtually on July 22, 2024, from 9 a.m. to 2 p.m., Eastern Time. Either electronic or written comments on this public workshop must be submitted by August 22, 2024. See the SUPPLEMENTARY INFORMATION section for registration date and information. The public workshop will be held in person at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room, Silver Spring, MD 20993–0002 and virtually using the Zoom platform. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/about-fda/visitorinformation. You may submit comments as follows. 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 August 22, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. ADDRESSES: 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 E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52470-52471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13796]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-1202]


Chemistry, Manufacturing, and Controls Considerations for Type A 
Medicated Articles; 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) #292 entitled 
``Chemistry, Manufacturing, and Controls Considerations for Type A 
Medicated Articles.'' This draft guidance provides recommendations to 
sponsors submitting chemistry, manufacturing, and controls (CMC) 
information for Type A medicated articles. Type A medicated articles 
contain new animal drugs and provide for administration of these drugs 
in animal feed.

DATES: Submit either electronic or written comments on the draft 
guidance by August 23, 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, 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-D-1202 for ``Chemistry, Manufacturing, and Controls 
Considerations for Type A Medicated Articles.'' 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

[[Page 52471]]

Medicine (HFV-147), Food and Drug Administration, 7500 Standish Place, 
Rockville MD 20855, 240-402-0651, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA is announcing the availability of a draft GFI #292 entitled 
``Chemistry, Manufacturing, and Controls Considerations for Type A 
Medicated Articles.'' This draft guidance provides recommendations to 
sponsors submitting CMC information for Type A medicated articles. Type 
A medicated articles contain new animal drugs and provide for 
administration of these drugs in animal feed. Type A medicated articles 
are intended solely for use in the manufacture of another Type A 
medicated article or in the manufacture of a Type B or Type C medicated 
feed. Because Type A medicated articles are not directly administered 
to the animal, there are some issues specific to Type A medicated 
articles that do not apply to other new animal drug dosage forms. These 
unique considerations are highlighted in this guidance under the 
relevant Common Technical Document--Quality section headings.
    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 Considerations for Type A 
Medicated Articles.'' 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 (21 U.S.C. 360b(b) and 360b(n)) 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.

    Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13796 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P

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