Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry; Availability, 65396-65397 [2023-20590]

Download as PDF 65396 Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices guidance provides examples to help guide stakeholders on selecting and requesting the proper meeting type for a given scenario. This draft guidance replaces the draft guidance entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products’’ issued on December 29, 2017 (82 FR 61763). FDA considered comments received on the draft guidance as the guidance was revised. Changes made include the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings, request for clarification/ followup opportunity correspondence, and virtual meetings as a face-to-face meeting. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.’’ 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 under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521). The collections of information in 21 CFR part 312 pertaining to meetings, including ‘‘End-of-phase 2’’ and ‘‘preNDA’’, have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 314 pertaining to formal meetings between sponsors or applicants and FDA have been approved under OMB control number 0910–0001. The collections of information pertaining to formal meetings between the FDA and sponsors or applicants for biological products have been approved under OMB control number 0910–0718. lotter on DSK11XQN23PROD with NOTICES1 III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ regulatory-information/search-fda- VerDate Sep<11>2014 16:40 Sep 21, 2023 Jkt 259001 guidance-documents, or https:// www.regulations.gov. Dated: September 19, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–20592 Filed 9–21–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–3031] Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; 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 entitled ‘‘Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.’’ This draft guidance provides information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in ‘‘PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027’’ (PDUFA VII commitment letter) and ‘‘Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027’’ (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID–19) pandemic. This draft guidance, within the context of approval and licensure decisions by FDA, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, or a BLA to establish that these facilities meet the applicable requirements, including under the Federal Food, Drug, and Cosmetic (FD&C Act) or the Public Health Service Act (PHS Act). SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Submit either electronic or written comments on the draft guidance by November 21, 2023 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: DATES: 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– 2023–D–3031 for ‘‘Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.’’ 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. E:\FR\FM\22SEN1.SGM 22SEN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices • 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 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 (CBER), 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. VerDate Sep<11>2014 16:40 Sep 21, 2023 Jkt 259001 FOR FURTHER INFORMATION CONTACT: Jessica Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4214, Silver Spring, MD 20993–0002, 240– 402–8985; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.’’ This draft guidance provides information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, a BLA, or a supplement to any of these types of applications. As part of the negotiations relating to the reauthorization of BsUFA and PDUFA, FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the COVID–19 pandemic. This draft guidance, within the context of approval and licensure decisions by FDA, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, or a BLA to establish that these facilities meet the applicable requirements, including under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) and either section 505 of the FD&C Act (21 U.S.C. 355) or section 351 of the PHS Act (42 U.S.C. 262). During the pandemic, FDA expanded its use of alternative tools to evaluate drug manufacturing facilities to support regulatory decision making when facility inspections were not feasible. Given the success of these innovative approaches, FDA intends to continue risk-based use of these alternative tools and to apply certain virtual technological capabilities within a specific inspectional context defined within this draft guidance. When used in advance or in lieu of preapproval inspections (PAIs) and prelicense inspections (PLIs) or to support PAIs and PLIs, the appropriate use of these approaches will help FDA maintain operational flexibility to support timely facility evaluations and application decisions. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 65397 represent the current thinking of FDA on ‘‘Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.’’ 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 parts 210 and 211 pertaining to current good manufacturing practice requirements and electronic records and signatures have been approved under OMB control numbers 0910–0139 and 0910–0303, respectively. The collections of information in 21 CFR part 314 pertaining to the submission of NDAs and ANDAs have been approved under OMB control number 0910–0001. The collections of information in 21 CFR part 601 pertaining to BLAs have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: September 19, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–20590 Filed 9–21–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–0917] In-Home Disposal Systems for Opioid Analgesics; Request for Information; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65396-65397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20590]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3031]

Alternative Tools: Assessing Drug Manufacturing Facilities
Identified in Pending Applications; 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
``Alternative Tools: Assessing Drug Manufacturing Facilities Identified
in Pending Applications.'' This draft guidance provides information to
applicants on how FDA intends to use alternative tools to assess
manufacturing facilities identified in a marketing application (i.e., a
new drug application (NDA), an abbreviated new drug application (ANDA),
a biologics license application (BLA), or a supplement to any of these
types of applications). As part of the negotiations relating to the
reauthorization of the Prescription Drug User Fee Act (PDUFA) and the
Biosimilar User Fee Act (BsUFA), as described in ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2023
Through 2027'' (PDUFA VII commitment letter) and ``Biosimilar
Biological Product Reauthorization Performance Goals and Procedures for
Fiscal Years 2023 Through 2027'' (BsUFA III commitment letter), FDA
agreed to issue guidance on the use of alternative tools to assess
manufacturing facilities named in pending applications and to
incorporate best practices from the use of such tools during the
Coronavirus Disease 2019 (COVID-19) pandemic. This draft guidance,
within the context of approval and licensure decisions by FDA,
describes the use of alternative tools to assess manufacturing
facilities identified in an NDA, an ANDA, or a BLA to establish that
these facilities meet the applicable requirements, including under the
Federal Food, Drug, and Cosmetic (FD&C Act) or the Public Health
Service Act (PHS Act).

DATES: Submit either electronic or written comments on the draft
guidance by November 21, 2023 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-2023-D-3031 for ``Alternative Tools: Assessing Drug Manufacturing
Facilities Identified in Pending Applications.'' 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.

[[Page 65397]]

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 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 (CBER), 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: Jessica Dunn, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4214, Silver Spring, MD 20993-0002, 240-
402-8985; or Anne Taylor, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Alternative Tools: Assessing Drug Manufacturing Facilities
Identified in Pending Applications.'' This draft guidance provides
information to applicants on how FDA intends to use alternative tools
to assess manufacturing facilities identified in an NDA, an ANDA, a
BLA, or a supplement to any of these types of applications. As part of
the negotiations relating to the reauthorization of BsUFA and PDUFA,
FDA agreed to issue guidance on the use of alternative tools to assess
manufacturing facilities named in pending applications and to
incorporate best practices from the use of such tools during the COVID-
19 pandemic. This draft guidance, within the context of approval and
licensure decisions by FDA, describes the use of alternative tools to
assess manufacturing facilities identified in an NDA, an ANDA, or a BLA
to establish that these facilities meet the applicable requirements,
including under section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) and either section 505 of the FD&C Act (21 U.S.C. 355) or
section 351 of the PHS Act (42 U.S.C. 262).
During the pandemic, FDA expanded its use of alternative tools to
evaluate drug manufacturing facilities to support regulatory decision
making when facility inspections were not feasible. Given the success
of these innovative approaches, FDA intends to continue risk-based use
of these alternative tools and to apply certain virtual technological
capabilities within a specific inspectional context defined within this
draft guidance. When used in advance or in lieu of preapproval
inspections (PAIs) and prelicense inspections (PLIs) or to support PAIs
and PLIs, the appropriate use of these approaches will help FDA
maintain operational flexibility to support timely facility evaluations
and application decisions.
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 ``Alternative
Tools: Assessing Drug Manufacturing Facilities Identified in Pending
Applications.'' 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 parts 210 and 211 pertaining to current good manufacturing
practice requirements and electronic records and signatures have been
approved under OMB control numbers 0910-0139 and 0910-0303,
respectively. The collections of information in 21 CFR part 314
pertaining to the submission of NDAs and ANDAs have been approved under
OMB control number 0910-0001. The collections of information in 21 CFR
part 601 pertaining to BLAs have been approved under OMB control number
0910-0338.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

Dated: September 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20590 Filed 9-21-23; 8:45 am]
BILLING CODE 4164-01-P

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