Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability, 65395-65396 [2023-20592]

Download as PDF Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Written/Paper Submissions [Docket No. FDA–2017–D–6530] Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.’’ This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of new drug or biological drug products. This draft guidance replaces the guidance ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products’’ issued on December 29, 2017. DATES: Submit either electronic or written comments on the draft guidance by December 21, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: lotter on DSK11XQN23PROD with NOTICES1 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, 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 VerDate Sep<11>2014 16:40 Sep 21, 2023 Jkt 259001 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–6530 for ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.’’ 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-201509-18/pdf/2015-23389.pdf. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 65395 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: Jennifer Mercier, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993–0002, 301– 796–0957; or Anne Taylor, 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 ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.’’ This draft guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products as agreed upon during the Prescription Drug User Fee Act (PDUFA) VII negotiations. The draft guidance describes the different meeting types, formats, and timelines associated with those requests. It also provides industry with the information necessary to have a complete meeting request and background package to help facilitate the meeting to gain useful feedback for product development. The draft E:\FR\FM\22SEN1.SGM 22SEN1 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

Agencies

[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65395-65396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20592]

[[Page 65395]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6530]

Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Prescription Drug User Fee Act Products;
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 ``Formal
Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products.'' This draft guidance outlines the recommendations to
industry on formal meetings between the FDA and sponsors or applicants
relating to the development and review of new drug or biological drug
products. This draft guidance replaces the guidance ``Formal Meetings
Between the FDA and Sponsors or Applicants of PDUFA Products'' issued
on December 29, 2017.

DATES: Submit either electronic or written comments on the draft
guidance by December 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-2017-D-6530 for ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products.'' 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 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: Jennifer Mercier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993-0002, 301-
796-0957; or Anne Taylor, 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 ``Formal Meetings Between the FDA and Sponsors or Applicants
of PDUFA Products.'' This draft guidance outlines the recommendations
to industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of drug or biological drug
products as agreed upon during the Prescription Drug User Fee Act
(PDUFA) VII negotiations. The draft guidance describes the different
meeting types, formats, and timelines associated with those requests.
It also provides industry with the information necessary to have a
complete meeting request and background package to help facilitate the
meeting to gain useful feedback for product development. The draft

[[Page 65396]]

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 ``pre-NDA'', 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.

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, 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. 2023-20592 Filed 9-21-23; 8:45 am]
BILLING CODE 4164-01-P

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