Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Draft Guidance for Industry; Availability, 64229-64230 [2022-23032]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices legal status of the drug product covered by ANDA 083483. An ANDA holder who decides to seek a hearing must file the following: (1) a written notice of participation and request for a hearing (see DATES and ADDRESSES) and (2) the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing (see DATES and ADDRESSES). Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, notice of participation and request for a hearing, the information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in § 314.200 and in 21 CFR part 12. The failure of an ANDA holder to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that ANDA holder not to avail itself of the opportunity for a hearing concerning CDER’s proposal to withdraw approval of the ANDA and constitutes a waiver of any contentions concerning the legal status of the drug product. FDA will then withdraw approval of the ANDA, and the drug product may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved ANDA is subject to regulatory action at any time. A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing (§ 314.200(g)). If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing (§ 314.200(g)(1)). All submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. This notice is issued under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs. VerDate Sep<11>2014 17:07 Oct 21, 2022 Jkt 259001 Dated: October 14, 2022. Patrizia Cavazzoni, Acting Director, Center for Drug Evaluation and Research. [FR Doc. 2022–23034 Filed 10–21–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–2170] Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; 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 ‘‘Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.’’ This draft guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products of all potency groups (referred to in this notice as topical corticosteroids). The draft guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence of topical corticosteroids. When finalized, this guidance will replace FDA’s 1995 guidance for industry of the same name. Revising this guidance will provide clarity for potential ANDA applicants on the appropriate pilot and pivotal studies and other recommendations for pharmacodynamic approach to assess the bioequivalence of topical dermatologic corticosteroids. These recommendations have evolved since the original guidance was issued in 1995. SUMMARY: Submit either electronic or written comments on the draft guidance by December 23, 2022 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:// PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 64229 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– 2022–D–2170 for ‘‘Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.’’ 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 E:\FR\FM\24OCN1.SGM 24OCN1 lotter on DSK11XQN23PROD with NOTICES1 64230 Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices 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. 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: Susan Levine, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993–0002, 240–402–7936, Susan.Levine@fda.hhs.gov. SUPPLEMENTARY INFORMATION: This draft guidance provides recommendations for the study design, method qualification, data analysis, and data reporting for the pilot doseduration vasoconstrictor response study and pivotal vasoconstrictor bioequivalence study used for topical corticosteroids. The draft guidance also discusses considerations and approaches for estimating key study parameters and sample size for the pivotal vasoconstrictor bioequivalence study. 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 ‘‘Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.’’ 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. I. Background 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-fdaguidance-documents, or https:// www.regulations.gov. FDA is announcing the availability of a draft guidance for industry entitled ‘‘Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.’’ This draft guidance is intended to assist applicants who submit ANDAs for topical corticosteroids. This draft guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence of topical corticosteroids. When finalized, this guidance will replace FDA’s 1995 guidance for industry of the same name. VerDate Sep<11>2014 17:07 Oct 21, 2022 Jkt 259001 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 314 have been approved under OMB control number 0910–0001. The collections of information related to current good manufacturing practices have been approved under OMB control number 0910–0139. The collections of information pertaining to controlled correspondence related to generic drug development have been approved under OMB control number 0910–0797. III. Electronic Access Dated: October 18, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–23032 Filed 10–21–22; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–1864] Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug 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 ‘‘Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.’’ This draft guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquidbased and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as ‘‘topical products’’). This draft guidance document provides recommendations for physicochemical and structural (collectively, ‘‘Q3’’) characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)). DATES: Submit either electronic or written comments on the draft guidance by December 23, 2022 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 E:\FR\FM\24OCN1.SGM 24OCN1

Agencies

[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64229-64230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23032]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2170]


Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; 
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 ``Topical 
Dermatologic Corticosteroids: In Vivo Bioequivalence.'' This draft 
guidance is intended to assist applicants who submit abbreviated new 
drug applications (ANDAs) for topical dermatologic corticosteroid 
products of all potency groups (referred to in this notice as topical 
corticosteroids). The draft guidance describes recommendations for an 
in vivo pharmacodynamic approach to demonstrate the bioequivalence of 
topical corticosteroids. When finalized, this guidance will replace 
FDA's 1995 guidance for industry of the same name. Revising this 
guidance will provide clarity for potential ANDA applicants on the 
appropriate pilot and pivotal studies and other recommendations for 
pharmacodynamic approach to assess the bioequivalence of topical 
dermatologic corticosteroids. These recommendations have evolved since 
the original guidance was issued in 1995.

DATES: Submit either electronic or written comments on the draft 
guidance by December 23, 2022 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-2022-D-2170 for ``Topical Dermatologic Corticosteroids: In Vivo 
Bioequivalence.'' 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

[[Page 64230]]

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: Susan Levine, Office of Generic Drugs, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-
0002, 240-402-7936, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Topical Dermatologic Corticosteroids: In Vivo 
Bioequivalence.'' This draft guidance is intended to assist applicants 
who submit ANDAs for topical corticosteroids. This draft guidance 
describes recommendations for an in vivo pharmacodynamic approach to 
demonstrate the bioequivalence of topical corticosteroids. When 
finalized, this guidance will replace FDA's 1995 guidance for industry 
of the same name.
    This draft guidance provides recommendations for the study design, 
method qualification, data analysis, and data reporting for the pilot 
dose-duration vasoconstrictor response study and pivotal 
vasoconstrictor bioequivalence study used for topical corticosteroids. 
The draft guidance also discusses considerations and approaches for 
estimating key study parameters and sample size for the pivotal 
vasoconstrictor bioequivalence study.
    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 ``Topical 
Dermatologic Corticosteroids: In Vivo Bioequivalence.'' 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 314 have been approved under OMB control 
number 0910-0001. The collections of information related to current 
good manufacturing practices have been approved under OMB control 
number 0910-0139. The collections of information pertaining to 
controlled correspondence related to generic drug development have been 
approved under OMB control number 0910-0797.

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

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23032 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.