Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Draft Guidance for Industry; Availability, 4252-4254 [2022-01577]

Download as PDF 4252 Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices is a basis to conclude that an attribute of each approved drug product makes each one medically unsuitable to treat certain patients for their condition, an interpretation that protects patients and the integrity of the drug approval process. The nominations proposing to compound drug products in ready-touse form containing bulk drug substances in one or more FDAapproved drug products do not show that the approved drug product, when not manufactured in the ready-to-use form, is medically unsuitable for certain patients. Nor do the nominations and comments establish that drug products in the relevant concentrations, including ready-to-use products, cannot be prepared from the approved drug products. Rather, they propose to compound a ready-to-use product from bulk drug substances to seek improved efficiency for prescribers or healthcare providers, or to address the possibility that the approved drug might be mishandled by a medical professional, neither of which falls within the meaning of clinical need to compound a drug product using a bulk drug substance. Two comments requested changes to the Interim Policy. These comments are outside the scope of FDA’s bulk drug substance evaluations and decisions that are the subject of this notice. FDA welcomes public comments on its guidance documents that address human drug compounding. We encourage comments on the Interim Policy to be submitted the docket for the guidance, docket number FDA–2015–D– 3539. Comments may be submitted to this docket at any time on https:// www.regulations.gov. lotter on DSK11XQN23PROD with NOTICES1 V. Conclusion For the reasons stated above, we find that there is a clinical need for outsourcing facilities to compound using the bulk drug substances DPCP for topical use only, glycolic acid for topical use only in concentrations up to 70 percent, SADBE for topical use only, and TCA for topical use only and, therefore, we are now including them on the 503B Bulks List. In addition, we find that there is no clinical need for outsourcing facilities to compound using the bulk drug substances diazepam, dipyridamole, dobutamine HCl, dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate, and sodium thiosulfate (except for topical administration), and therefore we are not including these bulk drug substances on the 503B Bulks List. VerDate Sep<11>2014 17:53 Jan 26, 2022 Jkt 256001 VII. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https:// www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. *1. FDA, Guidance for Industry, ‘‘Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act,’’ January 2017 (available at https:// www.fda.gov/media/94402/download). *2. FDA, Guidance for Industry, ‘‘Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act,’’ March 2019 (available at https://www.fda.gov/media/121315/ download). *3. FDA Memorandum to File, Clinical Need for Diphenylcyclopropenone (DPCP) in Compounding Under Section 503B of the FD&C Act, July 2020. *4. FDA Memorandum to File, Clinical Need for Glycolic Acid in Compounding Under Section 503B of the FD&C Act, July 2020. *5. FDA Memorandum to File, Clinical Need for Squaric Acid Dibutyl Ester (SADBE) in Compounding Under Section 503B of the FD&C Act, July 2020. *6. FDA Memorandum to File, ‘‘Clinical Need for Trichloroacetic Acid (TCA) in Compounding Under Section 503B of the FD&C Act,’’ July 2020. 7. Leheta, T. M., A. El Tawdy, R. M. Abdel Hay, and S. Farid, 2011, ‘‘Percutaneous Collagen Induction Versus FullConcentration Trichloroacetic Acid in the Treatment of Atrophic Acne Scars,’’ Dermatologic Surgery, 37(2):207–216. 8. Kumari, R. and D. M. Thappa, 2010, ‘‘Comparative Study of Trichloroacetic Acid Versus Glycolic Acid Chemical Peels in the Treatment of Melasma,’’ Indian Journal of Dermatology, Venereology and Leprology, 76:447, available at https://ijdvl.com/ comparative-study-of-trichloroaceticacid-versus-glycolic-acid-chemical-peelsin-the-treatment-of-melasma/. 9. Nigwekar, S. U., S. M. Brunelli, D. Meade, et al., 2013, ‘‘Sodium Thiosulfate Therapy for Calcific Uremic Arteriolopathy,’’ Clinical Journal of the American Society of Nephrology, 8(7):1162–1170. 10. Generali, J. A. and D. J. Cada, 2015, PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 ‘‘Sodium Thiosulfate: Calciphylaxis,’’ Hospital Pharmacy, 50(11):975–977. 11. Udomkarnjananun, S., K. Kongnatthasate, K. Praditpornsilpa, et al., 2019, ‘‘Treatment of Calciphylaxis in CKD: A Systematic Review and Meta-Analysis,’’ Kidney International Reports, 4(2):231– 244. 12. Schulz, L. T., E. J. Elder, Jr, K. J. Jones, et al., 2010, ‘‘Stability of Sodium Nitroprusside and Sodium Thiosulfate 1:10 Intravenous Admixture,’’ Hospital Pharmacy, 45(10):779–784. *13. FDA Guidance for Industry, Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act, December 2016 (available at https:// www.fda.gov/media/97347/download). 14. Pun, Patrick H. and John P. Middleton, 2017, ‘‘Dialysate Potassium, Dialysate Magnesium, and Hemodialysis Risk,’’ Journal of the American Society of Nephrology, 28: 3441–3451. 15. De Nicola, L., V. Bellizzi, R. Minutolo, et al., 2000, ‘‘Effect of Dialysate Sodium Concentration on Interdialytic Increase of Potassium,’’ Journal of the American Society of Nephrology, 11:2337–2343. Dated: January 21, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–01558 Filed 1–26–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–0092] Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; 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 ‘‘Revising ANDA Labeling Following Revision of the RLD Labeling.’’ This guidance provides recommendations for updating labeling for abbreviated new drug applications (ANDAs) following revisions to the labeling of a reference listed drug (RLD), including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates. This draft guidance revises the guidance for industry entitled ‘‘Revising ANDA Labeling Following Revision of the RLD Labeling’’ issued in April 2000. SUMMARY: E:\FR\FM\27JAN1.SGM 27JAN1 Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices Submit either electronic or written comments on the draft guidance by March 28, 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:// 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’’). lotter on DSK11XQN23PROD with NOTICES1 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–0092 for ‘‘Revising ANDA Labeling Following Revision of the RLD Labeling.’’ 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. VerDate Sep<11>2014 17:53 Jan 26, 2022 Jkt 256001 • 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. 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: Jonathan Hughes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1688, PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 4253 Silver Spring, MD 20993–0002, 301– 796–9291. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Revising ANDA Labeling Following Revision of the RLD Labeling.’’ This guidance provides recommendations for updating labeling for ANDAs following revisions to the labeling of an RLD, including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates. This draft guidance revises the guidance for industry ‘‘Revising ANDA Labeling Following Revision of the RLD Labeling’’ issued in April 2000. Significant changes from the 2000 version include updates to outdated details about how to obtain information on changes to RLD labeling and how to submit revised ANDA labeling to FDA. A generic drug is required to have the same labeling as the RLD, except for changes required because of differences approved under a suitability petition (see section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)) (21 U.S.C. 355(j)(2)(C) and 21 CFR 314.93) or because the generic drug and the RLD are produced or distributed by different manufacturers (see e.g., section 505(j)(2)(A)(v) of the FD&C Act and § 314.94(a)(8)(iv) (21 CFR 314.94(a)(8)(iv))). FDA regulations provide examples of permissible differences in labeling that may result when a proposed generic drug and the RLD are ‘‘produced or distributed by different manufacturers,’’ including the omission of an indication or other aspect of labeling protected by patent or exclusivity and ‘‘labeling revisions made to comply with current FDA labeling guidelines or other guidance’’ (§ 314.94(a)(8)(iv)). An ANDA holder is expected to update its labeling after FDA has approved relevant changes to the labeling for the corresponding RLD. Prompt revision, submission to the Agency, and implementation of revised labeling are important to ensure that the generic drug continues to be as safe and effective as the corresponding RLD. Because the labeling of a generic drug must be the same as the labeling for the RLD, except for permissible differences, the revision should be made at the earliest time possible. In this draft guidance, FDA is providing information on how ANDA applicants and holders should monitor for changes to RLD labeling, procedures for the electronic submission of labeling E:\FR\FM\27JAN1.SGM 27JAN1 4254 Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices updates, information describing the type of submission that should be made to FDA, as well as other considerations for submitting a labeling update to FDA. 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 ‘‘Revising ANDA Labeling Following Revision of the RLD Labeling.’’ 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 part 314 for the submission of ANDAs (including the content and format of ANDAs and supplements and amendments) have been approved under OMB control number 0910–0001 and in part 314 (included under the 21 CFR parts 10 through 16 hearing regulations) for OMB control number 0910–0191. • The collections of information pertaining to the electronic submission of labeling changes have been approved under OMB control number 0910–0045. • The collections of information pertaining to the content and format requirements for human prescription drugs and biological products and the submission of such labeling have been approved under OMB control number 0910–0572. lotter on DSK11XQN23PROD with NOTICES1 III. Electronic Access Persons with access to the internet may obtain the draft guidance at either 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: January 21, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–01577 Filed 1–26–22; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:53 Jan 26, 2022 Jkt 256001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–4337] Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA, Agency, or we) is announcing the following virtual public meeting entitled ‘‘Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.’’ The purpose of the virtual public meeting and the request for comments is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards and electronic submissions initiatives. DATES: The public meeting will be held on April 12, 2022, from 9 a.m. to 1 p.m. Eastern Time, and will take place virtually, held by webcast only. Submit either electronic or written comments on this public meeting by March 22, 2022. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: Registration to attend the meeting and other information can be found at https://www.fda.gov/industry/ prescription-drug-user-fee-amendments/ pdufa-vi-information-technology-goalsand-progress. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 22, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 22, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 • 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– 2018–N–4337 for ‘‘Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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 E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4252-4254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01577]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0092]


Revising Abbreviated New Drug Application Labeling Following 
Revision of the Reference Listed Drug Labeling; 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 ``Revising 
ANDA Labeling Following Revision of the RLD Labeling.'' This guidance 
provides recommendations for updating labeling for abbreviated new drug 
applications (ANDAs) following revisions to the labeling of a reference 
listed drug (RLD), including information on how to identify RLD 
labeling updates and how to submit labeling updates to both unapproved 
and approved ANDAs to conform to RLD labeling updates. This draft 
guidance revises the guidance for industry entitled ``Revising ANDA 
Labeling Following Revision of the RLD Labeling'' issued in April 2000.

[[Page 4253]]


DATES: Submit either electronic or written comments on the draft 
guidance by March 28, 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-0092 for ``Revising ANDA Labeling Following Revision of the 
RLD Labeling.'' 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: Jonathan Hughes, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1688, Silver Spring, MD 20993-0002, 301-
796-9291.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Revising ANDA Labeling Following Revision of the RLD 
Labeling.'' This guidance provides recommendations for updating 
labeling for ANDAs following revisions to the labeling of an RLD, 
including information on how to identify RLD labeling updates and how 
to submit labeling updates to both unapproved and approved ANDAs to 
conform to RLD labeling updates. This draft guidance revises the 
guidance for industry ``Revising ANDA Labeling Following Revision of 
the RLD Labeling'' issued in April 2000. Significant changes from the 
2000 version include updates to outdated details about how to obtain 
information on changes to RLD labeling and how to submit revised ANDA 
labeling to FDA.
    A generic drug is required to have the same labeling as the RLD, 
except for changes required because of differences approved under a 
suitability petition (see section 505(j)(2)(C) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act)) (21 U.S.C. 355(j)(2)(C) and 21 CFR 
314.93) or because the generic drug and the RLD are produced or 
distributed by different manufacturers (see e.g., section 
505(j)(2)(A)(v) of the FD&C Act and Sec.  314.94(a)(8)(iv) (21 CFR 
314.94(a)(8)(iv))). FDA regulations provide examples of permissible 
differences in labeling that may result when a proposed generic drug 
and the RLD are ``produced or distributed by different manufacturers,'' 
including the omission of an indication or other aspect of labeling 
protected by patent or exclusivity and ``labeling revisions made to 
comply with current FDA labeling guidelines or other guidance'' (Sec.  
314.94(a)(8)(iv)).
    An ANDA holder is expected to update its labeling after FDA has 
approved relevant changes to the labeling for the corresponding RLD. 
Prompt revision, submission to the Agency, and implementation of 
revised labeling are important to ensure that the generic drug 
continues to be as safe and effective as the corresponding RLD. Because 
the labeling of a generic drug must be the same as the labeling for the 
RLD, except for permissible differences, the revision should be made at 
the earliest time possible.
    In this draft guidance, FDA is providing information on how ANDA 
applicants and holders should monitor for changes to RLD labeling, 
procedures for the electronic submission of labeling

[[Page 4254]]

updates, information describing the type of submission that should be 
made to FDA, as well as other considerations for submitting a labeling 
update to FDA.
    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 ``Revising 
ANDA Labeling Following Revision of the RLD Labeling.'' 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 part 314 for the 
submission of ANDAs (including the content and format of ANDAs and 
supplements and amendments) have been approved under OMB control number 
0910-0001 and in part 314 (included under the 21 CFR parts 10 through 
16 hearing regulations) for OMB control number 0910-0191.
     The collections of information pertaining to the 
electronic submission of labeling changes have been approved under OMB 
control number 0910-0045.
     The collections of information pertaining to the content 
and format requirements for human prescription drugs and biological 
products and the submission of such labeling have been approved under 
OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either 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: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01577 Filed 1-26-22; 8:45 am]
BILLING CODE 4164-01-P
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