Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 80315-80317 [2023-25485]

Download as PDF Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices Submissions’’ to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Pras Pathmanathan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm 1133, Silver Spring, MD 20993–0002, at 301–796–3490. SUPPLEMENTARY INFORMATION: I. Background CM&S can be used in a variety of ways in medical device applications, including to perform ‘‘in silico’’ (virtual) device testing or to influence algorithms within software embedded in a device. This guidance provides a general riskinformed framework that can be used in the credibility assessment of CM&S used in medical device regulatory submissions. For the purposes of this guidance, CM&S refers to first principles-based (e.g., physics-based or mechanistic) computational models, and not statistical or data-driven (e.g., machine learning or artificial intelligence-based) models. This guidance is intended to help improve the consistency and transparency of the review of CM&S, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S credibility evidence submitted in regulatory submissions A notice of availability of the draft guidance appeared in the Federal Register of December 23, 2021 (86 FR 72969). FDA considered comments received and revised the guidance as appropriate in response to the comments, including revising the categorization of credibility evidence defined in the guidance, clarifying the scope of the guidance, and clarifying how the recommendations in the guidance relate to the framework described in the FDA-recognized standard American Society of Mechanical Engineers V&V 40, ‘‘Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices.’’ 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 ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.’’ 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. Electronic Access Persons interested in obtaining a copy of the guidance may do so by III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in the following table have been approved by OMB: OMB control No. Topic 807, subpart E ................................................................. 814, subparts A through E .............................................. 814, subpart H ................................................................. 812 ................................................................................... 860, subpart D ................................................................. ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. Premarket notification ........................................................................... Premarket approval ............................................................................... Humanitarian Device Exemption ........................................................... Investigational Device Exemption ......................................................... De Novo classification process ............................................................. Q-Submissions and Early Payor Feedback Request Programs for Medical Devices. [FR Doc. 2023–25470 Filed 11–16–23; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] BILLING CODE 4164–01–P Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability khammond on DSKJM1Z7X2PROD with NOTICES downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov and at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download an electronic copy of ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI01500056 and complete title to identify the guidance you are requesting. 21 CFR part; or guidance Dated: November 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft SUMMARY: VerDate Sep<11>2014 18:57 Nov 16, 2023 Jkt 262001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 80315 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0756 product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance. E:\FR\FM\17NON1.SGM 17NON1 80316 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices Submit either electronic or written comments on the draft guidance by January 16, 2024 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’’). khammond on DSKJM1Z7X2PROD with NOTICES 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– 2007–D–0369 for ‘‘Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.’’ 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 18:57 Nov 16, 2023 Jkt 262001 • 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: Christine Le, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 MD 20993–0002, 301–796–2398, PSGQuestions@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s website at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA’s website and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on August 22, 2023 (88 FR 57116). This notice announces draft product-specific guidances, either new or revised, that are posted on FDA’s website. II. Drug Products for Which New Draft Product-Specific Guidances Are Available FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients: TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS Active ingredient(s) Azacitidine Chlorhexidine gluconate Cimetidine Citalopram hydrobromide Deucravacitinib Deutetrabenazine Dextroamphetamine Edaravone Ferric pyrophosphate citrate (multiple reference listed drugs) Fingolimod lauryl sulfate Furosemide Futibatinib Ganaxolone Glycopyrrolate; Neostigmine methylsulfate Halobetasol propionate; Tazarotene E:\FR\FM\17NON1.SGM 17NON1 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80317 1. On page 40849, the following TABLE 1—NEW DRAFT PRODUCT-SPE- Office of Management and Budget under corrections are made: CIFIC GUIDANCES FOR DRUG PROD- the Paperwork Reduction Act of 1995 is • In the second column, the title of not required. UCTS—Continued V. Electronic Access Active ingredient(s) Latanoprost Omidenepag isopropyl Risperidone Semaglutide Tapinarof III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients: 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. Dated: November 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–25485 Filed 11–16–23; 8:45 am] BILLING CODE 4164–01–P TABLE 2—REVISED DRAFT PRODUCT- DEPARTMENT OF HEALTH AND SPECIFIC GUIDANCES FOR DRUG HUMAN SERVICES PRODUCTS Food and Drug Administration Active ingredient(s) khammond on DSKJM1Z7X2PROD with NOTICES Albuterol sulfate Betamethasone acetate; Betamethasone sodium phosphate Budesonide; Formoterol fumarate dihydrate Emtricitabine; Tenofovir alafenamide fumarate Ferumoxytol Fluticasone propionate Fluticasone propionate; Salmeterol xinafoate Fulvestrant Gabapentin Glatiramer acetate Levalbuterol tartrate Mometasone furoate Naltrexone Primidone Semaglutide Sotorasib Soybean oil Tiotropium bromide For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. IV. Paperwork Reduction Act of 1995 FDA tentatively concludes that these draft guidances contain no collection of information. Therefore, clearance by the VerDate Sep<11>2014 18:57 Nov 16, 2023 Jkt 262001 [Docket Nos. FDA–2020–E–2333; FDA– 2020–E–2334; FDA–2020–E–2336; and FDA– 2020–E–2337] Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK INJECTION; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 8, 2022. The document announced the determination of the regulatory review period for ROZLYTREK INJECTION (entrectinib) for purposes of patent extension. The document was published with an incorrect dosage form. This notice corrects the dosage form of the drug product. SUMMARY: FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: Correction In the Federal Register of July 8, 2022 (87 FR 40849), the dosage form for the human drug product ROZLYTREK (entrectinib), NDA 212726, is corrected from ‘‘INJECTION’’ to ‘‘CAPSULES’’ for all instances mentioned in the notice. Specifically, the drug product dosage form is corrected from ‘‘INJECTION’’ to ‘‘CAPSULES’’ in the following locations: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 the document is corrected to read: ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK CAPSULES.’’ • In the second column, the first sentence under the SUMMARY section is corrected to read: ‘‘The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROZLYTREK CAPSULES and is publishing this notice of that determination as required by law.’’ • In the third column, the first sentence under the section Instructions is corrected to read: ‘‘All submissions received must include the Docket Nos. FDA–2020–E–2333; FDA–2020–E–2334; FDA–2020–E–2336; and FDA–2020–E– 2337 for ‘Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK CAPSULES.’’’ 2. On page 40850, the following corrections are made: • In the second column, under section I. Background of the SUPPLEMENTARY INFORMATION section, the third paragraph introduction is corrected to read: ‘‘FDA has approved for marketing the human drug product, ROZLYTREK CAPSULES (entrectinib), NDA 212726, indicated for the treatment of:’’ • In the second and third columns, under section I. Background of the SUPPLEMENTARY INFORMATION section, the last paragraph is corrected to read: ‘‘Subsequent to this approval, the USPTO received patent term restoration applications for ROZLYTREK CAPSULES (U.S. Patent Nos. 8,299,057; 8,673,893; 9,029,356; and 9,085,565) from Genentech, Inc., and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated March 1, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ROZLYTREK CAPSULES represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period.’’ • In the third column, under II. Determination of Regulatory Review Period, the first sentence of the introductory paragraph is corrected to read: ‘‘FDA has determined that the applicable regulatory review period for ROZLYTREK CAPSULES is 1,968 days.’’ • In the third column, under II. Determination of Regulatory Review Period, the second sentence of the third paragraph is corrected to read: ‘‘FDA E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80315-80317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25485]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Product-Specific Guidances; Draft and Revised Draft Guidances 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 additional draft and revised draft product-specific 
guidances. The guidances provide product-specific recommendations on, 
among other things, the design of bioequivalence (BE) studies to 
support abbreviated new drug applications (ANDAs). In the Federal 
Register of June 11, 2010, FDA announced the availability of a guidance 
for industry entitled ``Bioequivalence Recommendations for Specific 
Products'' that explained the process that would be used to make 
product-specific guidances available to the public on FDA's website. 
The guidances identified in this notice were developed using the 
process described in that guidance.

[[Page 80316]]


DATES: Submit either electronic or written comments on the draft 
guidance by January 16, 2024 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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised 
Draft Guidances for Industry.'' 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: Christine Le, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products'' that explained 
the process that would be used to make product-specific guidances 
available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process as a means 
to develop and disseminate product-specific guidances and provide a 
meaningful opportunity for the public to consider and comment on those 
guidances. Under that process, draft guidances are posted on FDA's 
website and announced periodically in the Federal Register. The public 
is encouraged to submit comments on those recommendations within 60 
days of their announcement in the Federal Register. FDA considers any 
comments received and either publishes final guidances or publishes 
revised draft guidances for comment. Guidances were last announced in 
the Federal Register on August 22, 2023 (88 FR 57116). This notice 
announces draft product-specific guidances, either new or revised, that 
are posted on FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are 
Available

    FDA is announcing the availability of new draft product-specific 
guidances for industry for drug products containing the following 
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Azacitidine
Chlorhexidine gluconate
Cimetidine
Citalopram hydrobromide
Deucravacitinib
Deutetrabenazine
Dextroamphetamine
Edaravone
Ferric pyrophosphate citrate (multiple reference listed drugs)
Fingolimod lauryl sulfate
Furosemide
Futibatinib
Ganaxolone
Glycopyrrolate; Neostigmine methylsulfate
Halobetasol propionate; Tazarotene

[[Page 80317]]

 
Latanoprost
Omidenepag isopropyl
Risperidone
Semaglutide
Tapinarof
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances 
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the 
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Albuterol sulfate
Betamethasone acetate; Betamethasone sodium phosphate
Budesonide; Formoterol fumarate dihydrate
Emtricitabine; Tenofovir alafenamide fumarate
Ferumoxytol
Fluticasone propionate
Fluticasone propionate; Salmeterol xinafoate
Fulvestrant
Gabapentin
Glatiramer acetate
Levalbuterol tartrate
Mometasone furoate
Naltrexone
Primidone
Semaglutide
Sotorasib
Soybean oil
Tiotropium bromide
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the current thinking of FDA on, among 
other things, the product-specific design of BE studies to support 
ANDAs. They do not establish any rights for any person and are not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that these draft guidances contain no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

V. 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: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25485 Filed 11-16-23; 8:45 am]
BILLING CODE 4164-01-P

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