Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment; Revised Draft Guidance for Industry; Availability, 36590-36592 [2023-11899]

Download as PDF 36590 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Notices 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 this 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Ronald Wange, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3342, Silver Spring, MD 20993–0002, 301– 796–1304. SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.’’ The purpose of this guidance is to assist sponsors in the nonclinical safety evaluation of the immunotoxic potential of pharmaceuticals, which for purposes of the guidance is defined to encompass drug products, including small molecule drugs, and oligonucleotides, as well as certain biological products, such as biotechnology-derived therapeutic proteins. Immunotoxicity is any adverse unintended immunosuppression or stimulation, which can be the result of off-target effects or exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators. VerDate Sep<11>2014 17:59 Jun 02, 2023 Jkt 259001 This guidance finalizes the draft guidance entitled ‘‘Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics’’ issued February 20, 2020 (85 FR 9784). FDA considered comments received on the draft guidance as the guidance was finalized. Changes made in the draft guidance in response to public comment were focused on placing this guidance within the appropriate context as it relates to other guidances relevant to the assessment of immunotoxicity. Additionally, the scope was rewritten to better clarify the types of products that were to be considered within or outside of the scope. Although the 2020 draft guidance was issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research, the finalized guidance is being issued by CDER only. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.’’ 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. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: May 31, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–11898 Filed 6–2–23; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–4656] Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment; Revised 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 revised draft guidance for industry entitled ‘‘Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.’’ This draft guidance is intended to revise and replace the current draft guidance for industry entitled ‘‘Interstitial Cystitis/Bladder Pain Syndrome (IC/ BPS): Establishing Effectiveness of Drugs for Treatment’’ issued on December 5, 2019. This draft guidance provides recommendations for drug development programs for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS). DATES: Submit either electronic or written comments on the draft guidance by August 4, 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: 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. E:\FR\FM\05JNN1.SGM 05JNN1 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 • 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– 2019–D–4656 for ‘‘Interstitial Cystitis/ Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.’’ 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 VerDate Sep<11>2014 17:59 Jun 02, 2023 Jkt 259001 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. 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: Jeannie Roule, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993–002, 301–796– 3993. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised draft guidance for industry entitled ‘‘Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.’’ IC/BPS is a complex, poorly understood heterogeneous syndrome of unknown etiology. This draft guidance provides recommendations to assist applicants in developing products intended for treatment of IC/BPS. As with the 2019 draft guidance, this draft guidance incorporates advice FDA received at a December 2017 advisory committee meeting on appropriate patient selection criteria and trial design features, including enrollment criteria and acceptable efficacy endpoints for drugs intended to treat IC/BPS. This draft guidance encourages sponsors to assess dosing strategies, explore multiple efficacy endpoints, and collect safety information during early drug development to inform design strategy and selection of clinically meaningful endpoints for later clinical trials. This draft guidance also provides advice on enrollment criteria, efficacy endpoints, and other considerations for PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 36591 clinical trials to support an IC/BPS indication. This draft guidance provides recommendations based on the Agency’s current thinking on the development of patient-reported outcomes to evaluate patient symptoms to demonstrate a clinically meaningful change with treatment for this condition. This draft guidance revises and provides updates to the draft guidance entitled ‘‘Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment’’ issued on December 5, 2019 (84 FR 66681). FDA considered comments received on the 2019 draft guidance in revising the draft guidance. Changes from the 2019 draft guidance include discussion of early drug development considerations, selection of patient outcomes for development, and clarification of evaluation of Hunner’s lesions. In addition, editorial changes made to improve clarity include revised references to current Agency guidances on patient-reported outcomes and updated clinical considerations. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.’’ 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. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 relating investigational new drug applications, including clinical trial design and study protocols, have been approved under OMB control number 0910–0014. 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/ regulatory-information/search-fda- E:\FR\FM\05JNN1.SGM 05JNN1 36592 Federal Register / Vol. 88, No. 107 / Monday, June 5, 2023 / Notices Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. guidance-documents, or https:// www.regulations.gov. Dated: May 30, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–11899 Filed 6–2–23; 8:45 am] BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–0577] Authorization of Emergency Use of a Drug Product During the COVID–19 Pandemic; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use during the COVID–19 pandemic. FDA has issued an Authorization for the drug product GOHIBIC (vilobelimab) as requested by InflaRx GmbH’s (InflaRx). The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS–CoV–2, causes the illness COVID–19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID–19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. DATES: The Authorization is effective as of April 4, 2023. ADDRESSES: Submit written requests for a single copy of the EUA to the Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:59 Jun 02, 2023 Jkt 259001 Johanna McLatchy, Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, Silver Spring, MD 20993–0002, 301–796–3200 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) allows FDA to strengthen public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives (among other criteria). II. Criteria for EUA Authorization Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50, U.S. Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents; or (B) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 forces; 1 (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F–2 of the Public Health Service (PHS) Act (42 U.S.C. 247d–6b) sufficient to affect national security or the health and security of U.S. citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Under section 564(h)(1) of the FD&C Act, revisions to an authorization shall be made available on FDA’s website. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use in an actual or potential emergency when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, and 360e) or section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable 1 In the case of a determination by the Secretary of Defense, the Secretary of HHS shall determine within 45 calendar days of such determination, whether to make a declaration under section 564(b)(1) of the FD&C Act, and, if appropriate, shall promptly make such a declaration. E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36590-36592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11899]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4656]


Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug 
Development Programs for Treatment; Revised 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 revised draft guidance for industry entitled 
``Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug 
Development Programs for Treatment.'' This draft guidance is intended 
to revise and replace the current draft guidance for industry entitled 
``Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing 
Effectiveness of Drugs for Treatment'' issued on December 5, 2019. This 
draft guidance provides recommendations for drug development programs 
for drugs intended to treat patients with interstitial cystitis/bladder 
pain syndrome (IC/BPS).

DATES: Submit either electronic or written comments on the draft 
guidance by August 4, 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.

[[Page 36591]]

     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-2019-D-4656 for ``Interstitial Cystitis/Bladder Pain Syndrome: 
Establishing Drug Development Programs for Treatment.'' 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. 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: Jeannie Roule, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993-002, 301-
796-3993.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Interstitial Cystitis/Bladder Pain Syndrome: 
Establishing Drug Development Programs for Treatment.'' IC/BPS is a 
complex, poorly understood heterogeneous syndrome of unknown etiology. 
This draft guidance provides recommendations to assist applicants in 
developing products intended for treatment of IC/BPS. As with the 2019 
draft guidance, this draft guidance incorporates advice FDA received at 
a December 2017 advisory committee meeting on appropriate patient 
selection criteria and trial design features, including enrollment 
criteria and acceptable efficacy endpoints for drugs intended to treat 
IC/BPS.
    This draft guidance encourages sponsors to assess dosing 
strategies, explore multiple efficacy endpoints, and collect safety 
information during early drug development to inform design strategy and 
selection of clinically meaningful endpoints for later clinical trials. 
This draft guidance also provides advice on enrollment criteria, 
efficacy endpoints, and other considerations for clinical trials to 
support an IC/BPS indication. This draft guidance provides 
recommendations based on the Agency's current thinking on the 
development of patient-reported outcomes to evaluate patient symptoms 
to demonstrate a clinically meaningful change with treatment for this 
condition.
    This draft guidance revises and provides updates to the draft 
guidance entitled ``Interstitial Cystitis/Bladder Pain Syndrome (IC/
BPS): Establishing Effectiveness of Drugs for Treatment'' issued on 
December 5, 2019 (84 FR 66681). FDA considered comments received on the 
2019 draft guidance in revising the draft guidance. Changes from the 
2019 draft guidance include discussion of early drug development 
considerations, selection of patient outcomes for development, and 
clarification of evaluation of Hunner's lesions. In addition, editorial 
changes made to improve clarity include revised references to current 
Agency guidances on patient-reported outcomes and updated clinical 
considerations.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the current thinking of FDA on 
``Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug 
Development Programs for Treatment.'' 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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 312 relating investigational new drug 
applications, including clinical trial design and study protocols, have 
been approved under OMB control number 0910-0014.

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/regulatory-
information/search-fda-

[[Page 36592]]

guidance-documents, or https://www.regulations.gov.

    Dated: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11899 Filed 6-2-23; 8:45 am]
BILLING CODE 4164-01-P
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