Product-Specific Guidances; Revised Draft Guidances for Industry; Availability, 86811-86822 [2024-25391]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices maintained in the most resourceefficient manner. By harmonizing the regulatory requirements in regions around the world, ICH guidelines enhance global drug development, improve manufacturing standards, and increase the availability of medications. For example, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, and standardized marketing application submissions. The six Founding Members of the ICH are the FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. ICH membership continues to expand to include other regulatory authorities and industry associations from around the world (refer to https:// www.ich.org/). ICH works by engaging global regulatory and industry experts in a detailed, science-based, and consensusdriven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry. As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In the Federal Register of February 1, 2023 (88 FR 6750), FDA published a notice announcing the availability of a draft guidance entitled ‘‘M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation.’’ The notice gave interested persons an opportunity to submit comments by April 3, 2023. After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in July 2024. VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 This guidance finalizes the draft guidance issued on February 1, 2023. The final guidance includes clarification on the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered immediate-release solid oral dosage forms. The supplemental questions and answers document provides further clarification and examples of the technical aspects of the main guidance in order to effectively implement the guidance. The internationally harmonized guidance and questions and answers document aim to increase the efficiency of drug development and accelerate the availability of safe and effective orally administered immediate-release solid oral dosage forms. 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 ‘‘M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms’’. The guidance and supplemental questions and answers document 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. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR 314.94 for content and format for BE studies submitted under abbreviated new drug applications have been approved under OMB control number 0910–0001. The collections of information for the implementation of improved quality and integrity of the study data approaches pertaining to good clinical practice have been approved under OMB control number 0910–0014. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatory- PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 86811 information-biologics/biologicsguidances. Dated: October 23, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–25355 Filed 10–30–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Guidances; Revised Draft Guidances 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 additional revised draft product-specific guidances. The draft 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 draft guidances identified in this notice were developed using the process described in that guidance. DATES: Submit either electronic or written comments on the draft guidance by December 30, 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: 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 E:\FR\FM\31OCN1.SGM 31OCN1 86812 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 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: Joseph Kotsybar, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993–0002, 240– 402–1062, PSG-Questions@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. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 23, 2024 (89 FR 68162). This notice announces revised draft product-specific guidances that are being posted on FDA’s website for a subset of immediate-release oral drug products to reflect FDA’s current thinking and to align the bioequivalence recommendations with the recently adopted International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M13A guideline titled ‘‘M13A Bioequivalence for ImmediateRelease Solid Oral Dosage Forms’’ (October 2024). These revised productspecific guidances recommend that ANDA applicants conduct one bioequivalence study for products with a non-high risk of bioinequivalence due to food effect under either fasting or fed condition rather than conducting two bioequivalence studies: one BE study under fasting conditions, and one BE study under fed conditions. Other revisions, including revisions to align the recommendations in these PSGs with the recently adopted M13A guideline and editorial revisions, are incorporated as appropriate. FDA recommends that applicants consult the relevant product-specific guidance, in conjunction with general guidances on bioequivalence, when considering the design and conduct of studies supporting an evaluation of BE for immediate-release solid oral dosage forms. II. 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: E:\FR\FM\31OCN1.SGM 31OCN1 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Abacavir sulfate Abacavir sulfate; Dolutegravir sodium; Lamivudine (multiple reference listed drugs) Abacavir sulfate; Lamivudine Abacavir sulfate; Lamivudine; Zidovudine Abemaciclib Abrocitinib Acalabrutinib Acetaminophen; Aspirin; Caffeine Acetaminophen; Benzhydrocodone hydrochloride Acetaminophen; Butalbital; Caffeine; Codeine phosphate Acetaminophen; Ibuprofen Acetaminophen; Propoxyphene napsylate Acetaminophen; Tramadol hydrochloride Acetazolamide Acetylcysteine Acrivastine; Pseudoephedrine hydrochloride Acyclovir (multiple reference listed drugs) Adagrasib Adefovir dipivoxil Albuterol sulfate Allopurinol; Lesinurad Almotriptan malate Alogliptin benzoate Alogliptin benzoate; Metformin hydrochloride Alogliptin benzoate; Pioglitazone hydrochloride Alosetron hydrochloride Alprazolam (multiple reference listed drugs) Amantadine hydrochloride (multiple reference listed drugs) Ambrisentan Amifampridine phosphate Amiloride hydrochloride Aminocaproic acid Amiodarone hydrochloride Amitriptyline hydrochloride Amitriptyline hydrochloride; Chlordiazepoxide Amlodipine benzoate Amlodipine besylate Amlodipine besylate; Atorvastatin calcium Amlodipine besylate; Benazepril hydrochloride Amlodipine besylate; Celecoxib Amlodipine besylate; Hydrochlorothiazide; Olmesartan medoxomil Amlodipine besylate; Hydrochlorothiazide; Valsartan Amlodipine besylate; Olmesartan medoxomil Amlodipine besylate; Perindopril arginine Amlodipine besylate; Valsartan Amoxicillin (multiple reference listed drugs) Amoxicillin; Clarithromycin; Vonoprazan fumarate Amoxicillin; Clavulanate potassium (multiple reference listed drugs) Amoxicillin; Vonoprazan fumarate Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine saccharate; Dextroamphetamine sulfate Anagrelide hydrochloride Anastrozole Apixaban Apremilast Aripiprazole (multiple reference listed drugs) Armodafinil Aspirin Aspirin; Butalbital; Caffeine; Codeine phosphate Atazanavir sulfate Atazanavir sulfate; Cobicistat Atenolol Atenolol; Chlorthalidone Atomoxetine hydrochloride Atorvastatin calcium (multiple reference listed drugs) Atorvastatin calcium; Ezetimibe Atovaquone (multiple reference listed drugs) Auranofin Avanafil Avatrombopag maleate Axitinib Azilsartan kamedoxomil Azilsartan kamedoxomil; Chlorthalidone VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 86813 86814 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Azithromycin (multiple reference listed drugs) Baclofen (multiple reference listed drugs) Baloxavir marboxil (multiple reference listed drugs) Baricitinib Bedaquiline fumarate Belumosudil mesylate Bempedoic acid Bempedoic acid; Ezetimibe Benazepril hydrochloride Benazepril hydrochloride; Hydrochlorothiazide Benznidazole Berotralstat hydrochloride Bexagliflozin Bicalutamide Binimetinib Bisoprolol fumarate Bisoprolol fumarate; Hydrochlorothiazide Boceprevir Bosentan (multiple reference listed drugs) Bosutinib monohydrate Brexpiprazole Brincidofovir Brivaracetam Bumetanide Bupropion hydrochloride Buspirone hydrochloride Cabotegravir sodium Calcium carbonate; Famotidine; Magnesium hydroxide Canagliflozin Canagliflozin; Metformin hydrochloride Candesartan cilexetil Candesartan cilexetil; Hydrochlorothiazide Capmatinib hydrochloride Carbidopa Carbidopa; Entacapone; Levodopa Carbidopa; Levodopa (multiple reference listed drugs) Carglumic acid Cariprazine hydrochloride Carisoprodol Carvedilol Cefaclor Cefadroxil/cefadroxil hemihydrate Cefdinir (multiple reference listed drugs) Cefditoren pivoxil Cefixime (multiple reference listed drugs) Cefpodoxime proxetil (multiple reference listed drugs) Cefprozil (multiple reference listed drugs) Cefuroxime axetil (multiple reference listed drugs) Celecoxib; Tramadol hydrochloride Cenobamate Cephalexin (multiple reference listed drugs) Ceritinib (multiple reference listed drugs) Cetirizine hydrochloride (multiple reference listed drugs) Cevimeline hydrochloride Chenodiol Chlordiazepoxide hydrochloride Chlordiazepoxide hydrochloride; Clidinium bromide Chlorothiazide Chlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochloride Chlorpheniramine maleate; Ibuprofen; Pseudoephedrine hydrochloride Chlorpromazine hydrochloride Chlorthalidone (multiple reference listed drugs) Chlorzoxazone Cholic acid Cimetidine Cinacalcet hydrochloride Ciprofloxacin Ciprofloxacin hydrochloride Citalopram hydrobromide (multiple reference listed drugs) Clarithromycin (multiple reference listed drugs) Clemastine fumarate (multiple reference listed drugs) Clindamycin hydrochloride VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Clobazam (multiple reference listed drugs) Clomiphene citrate Clomipramine hydrochloride Clonazepam (multiple reference listed drugs) Clonidine hydrochloride Clopidogrel bisulfate Clorazepate dipotassium Cobicistat Cobimetinib fumarate Colchicine (multiple reference listed drugs) Crizotinib Cyclobenzaprine hydrochloride Cycloserine Daclatasvir dihydrochloride Dacomitinib Dantrolene sodium Dapagliflozin Dapagliflozin; Saxagliptin hydrochloride Daprodustat Dapsone Darolutamide Darunavir (multiple reference listed drugs) Dasatinib Deferiprone Deflazacort (multiple reference listed drugs) Delafloxacin meglumine Delavirdine mesylate Desipramine hydrochloride Desloratadine (multiple reference listed drugs) Desmopressin acetate Desogestrel; Ethinyl estradiol (multiple reference listed drugs) Dexamethasone Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride; Serdexmethylphenidate chloride Dextromethorphan hydrobromide; Quinidine sulfate Diazepam Diazoxide Dichlorphenamide Diclofenac Diclofenac potassium (multiple reference listed drugs) Dicyclomine hydrochloride (multiple reference listed drugs) Dienogest; Estradiol valerate Diflunisal Diphenhydramine citrate; Ibuprofen Diphenhydramine hydrochloride Diphenhydramine hydrochloride; Ibuprofen Diphenhydramine hydrochloride; Naproxen sodium Dipyridamole Disopyramide phosphate Disulfiram Dofetilide Dolasetron mesylate Dolutegravir sodium (multiple reference listed drugs) Dolutegravir sodium; Lamivudine Dolutegravir sodium; Rilpivirine hydrochloride Donepezil hydrochloride (multiple reference listed drugs) Doxazosin mesylate Doxepin hydrochloride (multiple reference listed drugs) Doxycycline (multiple reference listed drugs) Doxycycline calcium Doxycycline hyclate (multiple reference listed drugs) Dronedarone hydrochloride Drospirenone Drospirenone; Estetrol Drospirenone; Estradiol Drospirenone; Ethinyl estradiol (multiple reference listed drugs) Drospirenone; Ethinyl estradiol; Levomefolate calcium Droxidopa Duvelisib Elacestrant dihydrochloride Eletriptan hydrobromide Eliglustat tartrate VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 86815 86816 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Eltrombopag olamine (multiple reference listed drugs) Eluxadoline Empagliflozin Empagliflozin; Linagliptin Empagliflozin; Metformin hydrochloride Emtricitabine Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate Emtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarate Emtricitabine; Tenofovir alafenamide fumarate Emtricitabine; Tenofovir disoproxil fumarate Enalapril maleate Enasidenib mesylate Entacapone Eplerenone Eprosartan mesylate Eprosartan mesylate; Hydrochlorothiazide Erdafitinib Ertugliflozin; Metformin hydrochloride Ertugliflozin; Sitagliptin phosphate Erythromycin ethylsuccinate (multiple reference listed drugs) Erythromycin ethylsuccinate; Sulfisoxazole acetyl Escitalopram oxalate (multiple reference listed drugs) Eslicarbazepine acetate Estradiol Estradiol; Norethindrone acetate Estrogens, esterified Eszopiclone Ethacrynic acid Ethambutol hydrochloride Ethinyl estradiol; Ethynodiol diacetate Ethinyl estradiol; Levonorgestrel (multiple reference listed drugs) Ethinyl estradiol; Norethindrone (multiple reference listed drugs) Ethinyl estradiol; Norethindrone acetate (multiple reference listed drugs) Ethinyl estradiol; Norethindrone acetate; Ethinyl estradiol; Ferrous fumarate Ethinyl estradiol; Norgestimate Ethinyl estradiol; Norgestrel Ethionamide Ethosuximide Etodolac (multiple reference listed drugs) Exemestane Ezetimibe Ezetimibe; Simvastatin Ezogabine Famciclovir Famotidine (multiple reference listed drugs) Famotidine; Ibuprofen Febuxostat Fedratinib hydrochloride Fenofibric acid Fenoprofen calcium Fexofenadine hydrochloride (multiple reference listed drugs) Finasteride Finerenone Fingolimod hydrochloride Fingolimod lauryl sulfate Flavoxate hydrochloride Flecainide acetate Flibanserin Fluconazole Flucytosine Fludrocortisone acetate Fluoxetine hydrochloride (multiple reference listed drugs) Fluoxetine hydrochloride; Olanzapine Fluphenazine hydrochloride Flutamide Fluvastatin sodium Fosamprenavir calcium Fosinopril sodium Fosinopril sodium; Hydrochlorothiazide Frovatriptan succinate Furosemide Futibatinib VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Gabapentin (multiple reference listed drugs) Galantamine hydrobromide Ganaxolone Ganciclovir Gefitinib Gemifloxacin mesylate Gilteritinib fumarate Glasdegib maleate Glimepiride Glimepiride; Pioglitazone hydrochloride Glimepiride; Rosiglitazone maleate Glipizide Glipizide; Metformin hydrochloride Glyburide (multiple reference listed drugs) Glyburide; Metformin hydrochloride Granisetron hydrochloride Griseofulvin, microcrystalline; Griseofulvin, microsize Guanfacine hydrochloride Haloperidol Hydralazine hydrochloride; Isosorbide dinitrate Hydrochlorothiazide (multiple reference listed drugs) Hydrochlorothiazide; Irbesartan Hydrochlorothiazide; Lisinopril Hydrochlorothiazide; Losartan potassium Hydrochlorothiazide; Metoprolol tartrate Hydrochlorothiazide; Olmesartan medoxomil Hydrochlorothiazide; Quinapril hydrochloride Hydrochlorothiazide; Spironolactone Hydrochlorothiazide; Triamterene (multiple reference listed drugs) Hydrochlorothiazide; Valsartan Hydrocodone bitartrate; Ibuprofen Hydrocortisone Hydromorphone hydrochloride Hydroxychloroquine sulfate Hydroxyzine pamoate (multiple reference listed drugs) Ibrexafungerp citrate Ibrutinib (multiple reference listed drugs) Ibuprofen (multiple reference listed drugs) Ibuprofen sodium Ibuprofen; Phenylephrine hydrochloride Ibuprofen; Pseudoephedrine hydrochloride (multiple reference listed drugs) Icosapent ethyl Idelalisib Iloperidone Imipramine pamoate Indapamide Indinavir sulfate Indomethacin (multiple reference listed drugs) Irbesartan Isavuconazonium sulfate Isocarboxazid Isosorbide dinitrate (multiple reference listed drugs) Isradipine Istradefylline Ivabradine hydrochloride Ketoconazole Ketoprofen Ketorolac tromethamine Lacosamide Lamivudine (multiple reference listed drugs) Lamivudine; Tenofovir disoproxil fumarate (multiple reference listed drugs) Lamivudine; Zidovudine Lamotrigine (multiple reference listed drugs) Larotrectinib sulfate Lasmiditan succinate Leflunomide Lemborexant Lenalidomide Lesinurad Letermovir Letrozole Letrozole; Ribociclib succinate VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 86817 86818 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Leucovorin calcium Levetiracetam (multiple reference listed drugs) Levocarnitine Levocetirizine dihydrochloride (multiple reference listed drugs) Levofloxacin Levonorgestrel Levorphanol tartrate Linagliptin Linagliptin; Metformin hydrochloride Linezolid (multiple reference listed drugs) Lisdexamfetamine dimesylate (multiple reference listed drugs) Lisinopril Lofexidine hydrochloride Loperamide hydrochloride (multiple reference listed drugs) Loperamide hydrochloride; Simethicone Loratadine (multiple reference listed drugs) Lorazepam Lumateperone tosylate Lurasidone hydrochloride Lusutrombopag Macitentan Maraviroc Maribavir Mavacamten Mecamylamine hydrochloride Medroxyprogesterone acetate Mefenamic acid Megestrol acetate Meloxicam (multiple reference listed drugs) Memantine hydrochloride Mesna Mestranol; Norethindrone Metformin hydrochloride Metformin hydrochloride; Pioglitazone hydrochloride Metformin hydrochloride; Repaglinide Metformin hydrochloride; Sitagliptin phosphate Methazolamide Methenamine hippurate Methimazole Methoxsalen (multiple reference listed drugs) Methsuximide Methylergonovine maleate Methylphenidate hydrochloride (multiple reference listed drugs) Methylprednisolone Methyltestosterone Metoclopramide hydrochloride (multiple reference listed drugs) Metolazone Metoprolol tartrate Metyrosine Mexiletine hydrochloride Midodrine hydrochloride Miglustat Milnacipran hydrochloride Minocycline hydrochloride (multiple reference listed drugs) Minoxidil Mirtazapine (multiple reference listed drugs) Mitapivat sulfate Mobocertinib succinate Modafinil Molindone hydrochloride Montelukast sodium (multiple reference listed drugs) Morphine sulfate Moxidectin Moxifloxacin hydrochloride Mycophenolate mofetil (multiple reference listed drugs) Nabumetone Nadolol Naldemedine tosylate Naltrexone hydrochloride Naproxen (multiple reference listed drugs) Naproxen sodium (multiple reference listed drugs) Naratriptan hydrochloride VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Nateglinide Nebivolol hydrochloride Nebivolol hydrochloride; Valsartan Neratinib maleate Netupitant; Palonosetron hydrochloride Nevirapine (multiple reference listed drugs) Nicardipine hydrochloride Nimodipine Nitisinone (multiple reference listed drugs) Nitrofurantoin Nitrofurantoin, macrocrystalline Nitrofurantoin; Nitrofurantoin, macrocrystalline Norethindrone (multiple reference listed drugs) Norethindrone acetate Nortriptyline hydrochloride Obeticholic acid Olanzapine (multiple reference listed drugs) Olanzapine; Samidorphan l-malate Olmesartan medoxomil Omaveloxolone Omega-3-acid ethyl esters type a Ondansetron Ondansetron hydrochloride Oseltamivir phosphate (multiple reference listed drugs) Osilodrostat phosphate Osimertinib mesylate Ospemifene Oteseconazole Oxaprozin Oxazepam Oxcarbazepine (multiple reference listed drugs) Oxybutynin chloride Oxycodone hydrochloride (multiple reference listed drugs) Oxymetholone Ozanimod hydrochloride Pacritinib citrate Palbociclib Palonosetron hydrochloride Panobinostat lactate Paroxetine hydrochloride Paroxetine mesylate (multiple reference listed drugs) Pemigatinib Penbutolol sulfate Penicillin v potassium Perampanel (multiple reference listed drugs) Perindopril erbumine Perphenazine Phenelzine sulfate Phentermine hydrochloride Pilocarpine hydrochloride Pimavanserin tartrate (multiple reference listed drugs) Pimozide Pindolol Pioglitazone hydrochloride Pirfenidone (multiple reference listed drugs) Piroxicam Pitavastatin calcium Pitavastatin magnesium Pitavastatin sodium Pitolisant hydrochloride Pomalidomide Ponesimod Pramipexole dihydrochloride Prasugrel hydrochloride Pravastatin sodium Praziquantel Prazosin hydrochloride Prednisolone Prednisolone acetate Prednisolone sodium phosphate Pregabalin Primaquine phosphate VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 86819 86820 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued lotter on DSK11XQN23PROD with NOTICES1 Active ingredient(s) Prochlorperazine maleate Promethazine hydrochloride Propafenone hydrochloride Propranolol hydrochloride Propylthiouracil Protriptyline hydrochloride Prucalopride succinate Pyrazinamide Pyridostigmine bromide Pyrimethamine Quetiapine fumarate Quinapril hydrochloride Raloxifene hydrochloride Ramelteon Ramipril (multiple reference listed drugs) Ranitidine hydrochloride (multiple reference listed drugs) Relugolix Repaglinide Reserpine Ribavirin (multiple reference listed drugs) Ribociclib succinate Rifapentine Rilpivirine hydrochloride Rimegepant sulfate Riociguat Risperidone (multiple reference listed drugs) Rivastigmine tartrate Rizatriptan benzoate (multiple reference listed drugs) Roflumilast Rolapitant hydrochloride Ropinirole hydrochloride Rosiglitazone maleate Rosuvastatin calcium Rufinamide (multiple reference listed drugs) Ruxolitinib phosphate Sacubitril; Valsartan Safinamide mesylate Sapropterin dihydrochloride Sarecycline hydrochloride Saxagliptin hydrochloride Selegiline hydrochloride (multiple reference listed drugs) Selexipag Selpercatinib Sertraline hydrochloride (multiple reference listed drugs) Sibutramine hydrochloride Sildenafil citrate (multiple reference listed drugs) Silodosin Simvastatin (multiple reference listed drugs) Simvastatin; Sitagliptin phosphate Siponimod Sitagliptin phosphate Sodium phenylbutyrate (multiple reference listed drugs) Sodium phenylbutyrate; Taurursodiol Sofosbuvir Solifenacin succinate Solriamfetol hydrochloride Sotalol hydrochloride (multiple reference listed drugs) Sotorasib Sparsentan Spironolactone (multiple reference listed drugs) Stavudine Stiripentol (multiple reference listed drugs) Succimer Sulfadiazine Sulfamethoxazole; Trimethoprim (multiple reference listed drugs) Sumatriptan succinate Tadalafil Tafenoquine succinate (multiple reference listed drugs) Tamoxifen citrate Tapentadol hydrochloride Tasimelteon Tecovirimat VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86821 TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued Active ingredient(s) lotter on DSK11XQN23PROD with NOTICES1 Tedizolid phosphate Telbivudine Telithromycin Telotristat etiprate Temazepam Tenofovir alafenamide fumarate Tenofovir disoproxil fumarate (multiple reference listed drugs) Tepotinib hydrochloride Terazosin hydrochloride Terbinafine hydrochloride (multiple reference listed drugs) Terbutaline sulfate Teriflunomide Testosterone undecanoate Tetrabenazine Tetracycline hydrochloride Thioridazine hydrochloride Thiothixene Tiagabine hydrochloride Ticagrelor Ticlopidine hydrochloride Timolol maleate Tivozanib hydrochloride Tizanidine hydrochloride Tofacitinib citrate Tolcapone Tolterodine tartrate Topiramate (multiple reference listed drugs) Toremifene citrate Torsemide (multiple reference listed drugs) Trandolapril Tranylcypromine sulfate Trazodone hydrochloride Triamterene Triazolam Triclabendazole Trimethoprim Trimipramine maleate Ubrogepant Ulipristal acetate Uridine triacetate Ursodiol (multiple reference listed drugs) Valacyclovir hydrochloride Valbenazine tosylate Valganciclovir hydrochloride Valsartan Vandetanib Vardenafil hydrochloride (multiple reference listed drugs) Varenicline tartrate Vericiguat Vibegron Vilazodone hydrochloride Vismodegib Vorapaxar sulfate Vortioxetine hydrobromide Voxelotor (multiple reference listed drugs) Zalcitabine Zaleplon Zidovudine (multiple reference listed drugs) Zileuton Ziprasidone hydrochloride (multiple reference listed drugs) Zolmitriptan (multiple reference listed drugs) Zolpidem tartrate Zonisamide 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. VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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. E:\FR\FM\31OCN1.SGM 31OCN1 86822 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 While these guidances contain no collection of information, they do 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 (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 312 for investigational new drugs have been approved under 0910–0014. The collections of information in 21 CFR part 314 for applications for FDA approval to market a new drug and in 21 CFR part 320 for bioavailability and bioequivalence requirements have been approved under OMB control number 0910–0001. IV. 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-fdaguidance-documents, or https:// www.regulations.gov. Dated: October 24, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–25391 Filed 10–30–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Maternal and Child Health Jurisdictional Survey Instrument for the Title V Maternal and Child Health Block Grant Program Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:18 Oct 30, 2024 Jkt 265001 (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than December 30, 2024. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Joella Roland, the HRSA Information Collection Clearance Officer, at (301) 443–3983. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Maternal and Child Health (MCH) Jurisdictional Survey Instrument for the Title V MCH Block Grant Program, OMB No. 0906–0042—Revision Abstract: The purpose of the Title V MCH Services Block Grant is to improve the health of the nation’s mothers, infants, children, including children with special health care needs, and their families by creating Federal/State partnerships that provide each State/ jurisdiction with needed flexibility to respond to its individual MCH population needs. Unique to the MCH Block Grant is a commitment to performance accountability, while assuring State flexibility. Utilizing a three-tiered national performance measure framework, which includes National Outcome Measures, National Performance Measures, and EvidenceBased and -Informed Strategy Measures, State MCH Block Grant programs report annually on their performance relative to the selected national performance and outcome measures. Such reporting enables the State and Federal program offices to assess the progress achieved in key MCH priority areas and to document MCH Block Grant program accomplishments. By legislation (section 505(a) and 506(a) of title V of the Social Security Act), the MCH Block Grant Application/ Annual Report must be developed by, or in consultation with, the State MCH health agency. In establishing State reporting requirements, HRSA considers the availability of national data from Federal agencies. Data for the National Performance and Outcome Measures are pre-populated for States in the Title V Information System. Such national data PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 sources often do not include data from the title V jurisdiction grantees, with the exception of the District of Columbia. As a result, the eight remaining jurisdictions (i.e., American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, Puerto Rico, the Republic of the Marshall Islands, the Federated States of Micronesia, and U.S. Virgin Islands) have limited access to significant data and MCH indicators, with limited resources for collecting these data. Sponsored by HRSA, the MCH Jurisdictional Survey is designed to produce data on the physical and emotional health of mothers and children under 18 years of age in the following eight jurisdictions—American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, Puerto Rico, the Republic of the Marshall Islands, the Federated States of Micronesia, and U.S. Virgin Islands. More specifically, the MCH Jurisdictional Survey collects information on factors related to the well-being of children, including health status, visits to health care providers, health care costs, and health insurance coverage. In addition, the MCH Jurisdictional Survey collects information on factors related to the well-being of mothers, including health risk behaviors, health conditions, and preventive health practices. Collecting these data will enable the jurisdictions to meet Federal performance reporting requirements and demonstrate the impact of MCH Block Grant funding on MCH outcomes. The MCH Jurisdictional Survey was designed based on informationgathering activities with title V leadership and program staff in the jurisdictions, Federal experts, and organizations with relevant data collection experience. Survey items are based on the National Survey of Children’s Health; the Behavioral Risk Factor Surveillance System; the Youth Behavior Surveillance System; and selected other Federal studies. The Survey is designed as a core questionnaire to be administered across all jurisdictions with a supplemental set of survey questions customized to the needs of each jurisdiction. The MCH Jurisdictional Survey has been conducted annually since 2019, with several modifications to address emerging issues and challenges related to survey questions and methods. The 2022 extension (ICR 202203–0906–002) enhanced the detail in collecting demographic data through race and ethnicity survey questions in response to jurisdictional feedback. Since the E:\FR\FM\31OCN1.SGM 31OCN1

Agencies

[Federal Register Volume 89, Number 211 (Thursday, October 31, 2024)]
[Notices]
[Pages 86811-86822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Product-Specific Guidances; 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 revised draft product-specific 
guidances. The draft 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 draft guidances identified in this notice were developed using the 
process described in that guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by December 30, 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

[[Page 86812]]

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: Joseph Kotsybar, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993-0002, 240-
402-1062, [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 23, 2024 (89 FR 68162).
    This notice announces revised draft product-specific guidances that 
are being posted on FDA's website for a subset of immediate-release 
oral drug products to reflect FDA's current thinking and to align the 
bioequivalence recommendations with the recently adopted International 
Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use M13A guideline titled ``M13A Bioequivalence for 
Immediate-Release Solid Oral Dosage Forms'' (October 2024). These 
revised product-specific guidances recommend that ANDA applicants 
conduct one bioequivalence study for products with a non-high risk of 
bioinequivalence due to food effect under either fasting or fed 
condition rather than conducting two bioequivalence studies: one BE 
study under fasting conditions, and one BE study under fed conditions. 
Other revisions, including revisions to align the recommendations in 
these PSGs with the recently adopted M13A guideline and editorial 
revisions, are incorporated as appropriate. FDA recommends that 
applicants consult the relevant product-specific guidance, in 
conjunction with general guidances on bioequivalence, when considering 
the design and conduct of studies supporting an evaluation of BE for 
immediate-release solid oral dosage forms.

II. 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:

[[Page 86813]]



   Table 1--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Abacavir sulfate
Abacavir sulfate; Dolutegravir sodium; Lamivudine (multiple reference
 listed drugs)
Abacavir sulfate; Lamivudine
Abacavir sulfate; Lamivudine; Zidovudine
Abemaciclib
Abrocitinib
Acalabrutinib
Acetaminophen; Aspirin; Caffeine
Acetaminophen; Benzhydrocodone hydrochloride
Acetaminophen; Butalbital; Caffeine; Codeine phosphate
Acetaminophen; Ibuprofen
Acetaminophen; Propoxyphene napsylate
Acetaminophen; Tramadol hydrochloride
Acetazolamide
Acetylcysteine
Acrivastine; Pseudoephedrine hydrochloride
Acyclovir (multiple reference listed drugs)
Adagrasib
Adefovir dipivoxil
Albuterol sulfate
Allopurinol; Lesinurad
Almotriptan malate
Alogliptin benzoate
Alogliptin benzoate; Metformin hydrochloride
Alogliptin benzoate; Pioglitazone hydrochloride
Alosetron hydrochloride
Alprazolam (multiple reference listed drugs)
Amantadine hydrochloride (multiple reference listed drugs)
Ambrisentan
Amifampridine phosphate
Amiloride hydrochloride
Aminocaproic acid
Amiodarone hydrochloride
Amitriptyline hydrochloride
Amitriptyline hydrochloride; Chlordiazepoxide
Amlodipine benzoate
Amlodipine besylate
Amlodipine besylate; Atorvastatin calcium
Amlodipine besylate; Benazepril hydrochloride
Amlodipine besylate; Celecoxib
Amlodipine besylate; Hydrochlorothiazide; Olmesartan medoxomil
Amlodipine besylate; Hydrochlorothiazide; Valsartan
Amlodipine besylate; Olmesartan medoxomil
Amlodipine besylate; Perindopril arginine
Amlodipine besylate; Valsartan
Amoxicillin (multiple reference listed drugs)
Amoxicillin; Clarithromycin; Vonoprazan fumarate
Amoxicillin; Clavulanate potassium (multiple reference listed drugs)
Amoxicillin; Vonoprazan fumarate
Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine
 saccharate; Dextroamphetamine sulfate
Anagrelide hydrochloride
Anastrozole
Apixaban
Apremilast
Aripiprazole (multiple reference listed drugs)
Armodafinil
Aspirin
Aspirin; Butalbital; Caffeine; Codeine phosphate
Atazanavir sulfate
Atazanavir sulfate; Cobicistat
Atenolol
Atenolol; Chlorthalidone
Atomoxetine hydrochloride
Atorvastatin calcium (multiple reference listed drugs)
Atorvastatin calcium; Ezetimibe
Atovaquone (multiple reference listed drugs)
Auranofin
Avanafil
Avatrombopag maleate
Axitinib
Azilsartan kamedoxomil
Azilsartan kamedoxomil; Chlorthalidone

[[Page 86814]]

 
Azithromycin (multiple reference listed drugs)
Baclofen (multiple reference listed drugs)
Baloxavir marboxil (multiple reference listed drugs)
Baricitinib
Bedaquiline fumarate
Belumosudil mesylate
Bempedoic acid
Bempedoic acid; Ezetimibe
Benazepril hydrochloride
Benazepril hydrochloride; Hydrochlorothiazide
Benznidazole
Berotralstat hydrochloride
Bexagliflozin
Bicalutamide
Binimetinib
Bisoprolol fumarate
Bisoprolol fumarate; Hydrochlorothiazide
Boceprevir
Bosentan (multiple reference listed drugs)
Bosutinib monohydrate
Brexpiprazole
Brincidofovir
Brivaracetam
Bumetanide
Bupropion hydrochloride
Buspirone hydrochloride
Cabotegravir sodium
Calcium carbonate; Famotidine; Magnesium hydroxide
Canagliflozin
Canagliflozin; Metformin hydrochloride
Candesartan cilexetil
Candesartan cilexetil; Hydrochlorothiazide
Capmatinib hydrochloride
Carbidopa
Carbidopa; Entacapone; Levodopa
Carbidopa; Levodopa (multiple reference listed drugs)
Carglumic acid
Cariprazine hydrochloride
Carisoprodol
Carvedilol
Cefaclor
Cefadroxil/cefadroxil hemihydrate
Cefdinir (multiple reference listed drugs)
Cefditoren pivoxil
Cefixime (multiple reference listed drugs)
Cefpodoxime proxetil (multiple reference listed drugs)
Cefprozil (multiple reference listed drugs)
Cefuroxime axetil (multiple reference listed drugs)
Celecoxib; Tramadol hydrochloride
Cenobamate
Cephalexin (multiple reference listed drugs)
Ceritinib (multiple reference listed drugs)
Cetirizine hydrochloride (multiple reference listed drugs)
Cevimeline hydrochloride
Chenodiol
Chlordiazepoxide hydrochloride
Chlordiazepoxide hydrochloride; Clidinium bromide
Chlorothiazide
Chlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochloride
Chlorpheniramine maleate; Ibuprofen; Pseudoephedrine hydrochloride
Chlorpromazine hydrochloride
Chlorthalidone (multiple reference listed drugs)
Chlorzoxazone
Cholic acid
Cimetidine
Cinacalcet hydrochloride
Ciprofloxacin
Ciprofloxacin hydrochloride
Citalopram hydrobromide (multiple reference listed drugs)
Clarithromycin (multiple reference listed drugs)
Clemastine fumarate (multiple reference listed drugs)
Clindamycin hydrochloride

[[Page 86815]]

 
Clobazam (multiple reference listed drugs)
Clomiphene citrate
Clomipramine hydrochloride
Clonazepam (multiple reference listed drugs)
Clonidine hydrochloride
Clopidogrel bisulfate
Clorazepate dipotassium
Cobicistat
Cobimetinib fumarate
Colchicine (multiple reference listed drugs)
Crizotinib
Cyclobenzaprine hydrochloride
Cycloserine
Daclatasvir dihydrochloride
Dacomitinib
Dantrolene sodium
Dapagliflozin
Dapagliflozin; Saxagliptin hydrochloride
Daprodustat
Dapsone
Darolutamide
Darunavir (multiple reference listed drugs)
Dasatinib
Deferiprone
Deflazacort (multiple reference listed drugs)
Delafloxacin meglumine
Delavirdine mesylate
Desipramine hydrochloride
Desloratadine (multiple reference listed drugs)
Desmopressin acetate
Desogestrel; Ethinyl estradiol (multiple reference listed drugs)
Dexamethasone
Dexmethylphenidate hydrochloride
Dexmethylphenidate hydrochloride; Serdexmethylphenidate chloride
Dextromethorphan hydrobromide; Quinidine sulfate
Diazepam
Diazoxide
Dichlorphenamide
Diclofenac
Diclofenac potassium (multiple reference listed drugs)
Dicyclomine hydrochloride (multiple reference listed drugs)
Dienogest; Estradiol valerate
Diflunisal
Diphenhydramine citrate; Ibuprofen
Diphenhydramine hydrochloride
Diphenhydramine hydrochloride; Ibuprofen
Diphenhydramine hydrochloride; Naproxen sodium
Dipyridamole
Disopyramide phosphate
Disulfiram
Dofetilide
Dolasetron mesylate
Dolutegravir sodium (multiple reference listed drugs)
Dolutegravir sodium; Lamivudine
Dolutegravir sodium; Rilpivirine hydrochloride
Donepezil hydrochloride (multiple reference listed drugs)
Doxazosin mesylate
Doxepin hydrochloride (multiple reference listed drugs)
Doxycycline (multiple reference listed drugs)
Doxycycline calcium
Doxycycline hyclate (multiple reference listed drugs)
Dronedarone hydrochloride
Drospirenone
Drospirenone; Estetrol
Drospirenone; Estradiol
Drospirenone; Ethinyl estradiol (multiple reference listed drugs)
Drospirenone; Ethinyl estradiol; Levomefolate calcium
Droxidopa
Duvelisib
Elacestrant dihydrochloride
Eletriptan hydrobromide
Eliglustat tartrate

[[Page 86816]]

 
Eltrombopag olamine (multiple reference listed drugs)
Eluxadoline
Empagliflozin
Empagliflozin; Linagliptin
Empagliflozin; Metformin hydrochloride
Emtricitabine
Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate
Emtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarate
Emtricitabine; Tenofovir alafenamide fumarate
Emtricitabine; Tenofovir disoproxil fumarate
Enalapril maleate
Enasidenib mesylate
Entacapone
Eplerenone
Eprosartan mesylate
Eprosartan mesylate; Hydrochlorothiazide
Erdafitinib
Ertugliflozin; Metformin hydrochloride
Ertugliflozin; Sitagliptin phosphate
Erythromycin ethylsuccinate (multiple reference listed drugs)
Erythromycin ethylsuccinate; Sulfisoxazole acetyl
Escitalopram oxalate (multiple reference listed drugs)
Eslicarbazepine acetate
Estradiol
Estradiol; Norethindrone acetate
Estrogens, esterified
Eszopiclone
Ethacrynic acid
Ethambutol hydrochloride
Ethinyl estradiol; Ethynodiol diacetate
Ethinyl estradiol; Levonorgestrel (multiple reference listed drugs)
Ethinyl estradiol; Norethindrone (multiple reference listed drugs)
Ethinyl estradiol; Norethindrone acetate (multiple reference listed
 drugs)
Ethinyl estradiol; Norethindrone acetate; Ethinyl estradiol; Ferrous
 fumarate
Ethinyl estradiol; Norgestimate
Ethinyl estradiol; Norgestrel
Ethionamide
Ethosuximide
Etodolac (multiple reference listed drugs)
Exemestane
Ezetimibe
Ezetimibe; Simvastatin
Ezogabine
Famciclovir
Famotidine (multiple reference listed drugs)
Famotidine; Ibuprofen
Febuxostat
Fedratinib hydrochloride
Fenofibric acid
Fenoprofen calcium
Fexofenadine hydrochloride (multiple reference listed drugs)
Finasteride
Finerenone
Fingolimod hydrochloride
Fingolimod lauryl sulfate
Flavoxate hydrochloride
Flecainide acetate
Flibanserin
Fluconazole
Flucytosine
Fludrocortisone acetate
Fluoxetine hydrochloride (multiple reference listed drugs)
Fluoxetine hydrochloride; Olanzapine
Fluphenazine hydrochloride
Flutamide
Fluvastatin sodium
Fosamprenavir calcium
Fosinopril sodium
Fosinopril sodium; Hydrochlorothiazide
Frovatriptan succinate
Furosemide
Futibatinib

[[Page 86817]]

 
Gabapentin (multiple reference listed drugs)
Galantamine hydrobromide
Ganaxolone
Ganciclovir
Gefitinib
Gemifloxacin mesylate
Gilteritinib fumarate
Glasdegib maleate
Glimepiride
Glimepiride; Pioglitazone hydrochloride
Glimepiride; Rosiglitazone maleate
Glipizide
Glipizide; Metformin hydrochloride
Glyburide (multiple reference listed drugs)
Glyburide; Metformin hydrochloride
Granisetron hydrochloride
Griseofulvin, microcrystalline; Griseofulvin, microsize
Guanfacine hydrochloride
Haloperidol
Hydralazine hydrochloride; Isosorbide dinitrate
Hydrochlorothiazide (multiple reference listed drugs)
Hydrochlorothiazide; Irbesartan
Hydrochlorothiazide; Lisinopril
Hydrochlorothiazide; Losartan potassium
Hydrochlorothiazide; Metoprolol tartrate
Hydrochlorothiazide; Olmesartan medoxomil
Hydrochlorothiazide; Quinapril hydrochloride
Hydrochlorothiazide; Spironolactone
Hydrochlorothiazide; Triamterene (multiple reference listed drugs)
Hydrochlorothiazide; Valsartan
Hydrocodone bitartrate; Ibuprofen
Hydrocortisone
Hydromorphone hydrochloride
Hydroxychloroquine sulfate
Hydroxyzine pamoate (multiple reference listed drugs)
Ibrexafungerp citrate
Ibrutinib (multiple reference listed drugs)
Ibuprofen (multiple reference listed drugs)
Ibuprofen sodium
Ibuprofen; Phenylephrine hydrochloride
Ibuprofen; Pseudoephedrine hydrochloride (multiple reference listed
 drugs)
Icosapent ethyl
Idelalisib
Iloperidone
Imipramine pamoate
Indapamide
Indinavir sulfate
Indomethacin (multiple reference listed drugs)
Irbesartan
Isavuconazonium sulfate
Isocarboxazid
Isosorbide dinitrate (multiple reference listed drugs)
Isradipine
Istradefylline
Ivabradine hydrochloride
Ketoconazole
Ketoprofen
Ketorolac tromethamine
Lacosamide
Lamivudine (multiple reference listed drugs)
Lamivudine; Tenofovir disoproxil fumarate (multiple reference listed
 drugs)
Lamivudine; Zidovudine
Lamotrigine (multiple reference listed drugs)
Larotrectinib sulfate
Lasmiditan succinate
Leflunomide
Lemborexant
Lenalidomide
Lesinurad
Letermovir
Letrozole
Letrozole; Ribociclib succinate

[[Page 86818]]

 
Leucovorin calcium
Levetiracetam (multiple reference listed drugs)
Levocarnitine
Levocetirizine dihydrochloride (multiple reference listed drugs)
Levofloxacin
Levonorgestrel
Levorphanol tartrate
Linagliptin
Linagliptin; Metformin hydrochloride
Linezolid (multiple reference listed drugs)
Lisdexamfetamine dimesylate (multiple reference listed drugs)
Lisinopril
Lofexidine hydrochloride
Loperamide hydrochloride (multiple reference listed drugs)
Loperamide hydrochloride; Simethicone
Loratadine (multiple reference listed drugs)
Lorazepam
Lumateperone tosylate
Lurasidone hydrochloride
Lusutrombopag
Macitentan
Maraviroc
Maribavir
Mavacamten
Mecamylamine hydrochloride
Medroxyprogesterone acetate
Mefenamic acid
Megestrol acetate
Meloxicam (multiple reference listed drugs)
Memantine hydrochloride
Mesna
Mestranol; Norethindrone
Metformin hydrochloride
Metformin hydrochloride; Pioglitazone hydrochloride
Metformin hydrochloride; Repaglinide
Metformin hydrochloride; Sitagliptin phosphate
Methazolamide
Methenamine hippurate
Methimazole
Methoxsalen (multiple reference listed drugs)
Methsuximide
Methylergonovine maleate
Methylphenidate hydrochloride (multiple reference listed drugs)
Methylprednisolone
Methyltestosterone
Metoclopramide hydrochloride (multiple reference listed drugs)
Metolazone
Metoprolol tartrate
Metyrosine
Mexiletine hydrochloride
Midodrine hydrochloride
Miglustat
Milnacipran hydrochloride
Minocycline hydrochloride (multiple reference listed drugs)
Minoxidil
Mirtazapine (multiple reference listed drugs)
Mitapivat sulfate
Mobocertinib succinate
Modafinil
Molindone hydrochloride
Montelukast sodium (multiple reference listed drugs)
Morphine sulfate
Moxidectin
Moxifloxacin hydrochloride
Mycophenolate mofetil (multiple reference listed drugs)
Nabumetone
Nadolol
Naldemedine tosylate
Naltrexone hydrochloride
Naproxen (multiple reference listed drugs)
Naproxen sodium (multiple reference listed drugs)
Naratriptan hydrochloride

[[Page 86819]]

 
Nateglinide
Nebivolol hydrochloride
Nebivolol hydrochloride; Valsartan
Neratinib maleate
Netupitant; Palonosetron hydrochloride
Nevirapine (multiple reference listed drugs)
Nicardipine hydrochloride
Nimodipine
Nitisinone (multiple reference listed drugs)
Nitrofurantoin
Nitrofurantoin, macrocrystalline
Nitrofurantoin; Nitrofurantoin, macrocrystalline
Norethindrone (multiple reference listed drugs)
Norethindrone acetate
Nortriptyline hydrochloride
Obeticholic acid
Olanzapine (multiple reference listed drugs)
Olanzapine; Samidorphan l-malate
Olmesartan medoxomil
Omaveloxolone
Omega-3-acid ethyl esters type a
Ondansetron
Ondansetron hydrochloride
Oseltamivir phosphate (multiple reference listed drugs)
Osilodrostat phosphate
Osimertinib mesylate
Ospemifene
Oteseconazole
Oxaprozin
Oxazepam
Oxcarbazepine (multiple reference listed drugs)
Oxybutynin chloride
Oxycodone hydrochloride (multiple reference listed drugs)
Oxymetholone
Ozanimod hydrochloride
Pacritinib citrate
Palbociclib
Palonosetron hydrochloride
Panobinostat lactate
Paroxetine hydrochloride
Paroxetine mesylate (multiple reference listed drugs)
Pemigatinib
Penbutolol sulfate
Penicillin v potassium
Perampanel (multiple reference listed drugs)
Perindopril erbumine
Perphenazine
Phenelzine sulfate
Phentermine hydrochloride
Pilocarpine hydrochloride
Pimavanserin tartrate (multiple reference listed drugs)
Pimozide
Pindolol
Pioglitazone hydrochloride
Pirfenidone (multiple reference listed drugs)
Piroxicam
Pitavastatin calcium
Pitavastatin magnesium
Pitavastatin sodium
Pitolisant hydrochloride
Pomalidomide
Ponesimod
Pramipexole dihydrochloride
Prasugrel hydrochloride
Pravastatin sodium
Praziquantel
Prazosin hydrochloride
Prednisolone
Prednisolone acetate
Prednisolone sodium phosphate
Pregabalin
Primaquine phosphate

[[Page 86820]]

 
Prochlorperazine maleate
Promethazine hydrochloride
Propafenone hydrochloride
Propranolol hydrochloride
Propylthiouracil
Protriptyline hydrochloride
Prucalopride succinate
Pyrazinamide
Pyridostigmine bromide
Pyrimethamine
Quetiapine fumarate
Quinapril hydrochloride
Raloxifene hydrochloride
Ramelteon
Ramipril (multiple reference listed drugs)
Ranitidine hydrochloride (multiple reference listed drugs)
Relugolix
Repaglinide
Reserpine
Ribavirin (multiple reference listed drugs)
Ribociclib succinate
Rifapentine
Rilpivirine hydrochloride
Rimegepant sulfate
Riociguat
Risperidone (multiple reference listed drugs)
Rivastigmine tartrate
Rizatriptan benzoate (multiple reference listed drugs)
Roflumilast
Rolapitant hydrochloride
Ropinirole hydrochloride
Rosiglitazone maleate
Rosuvastatin calcium
Rufinamide (multiple reference listed drugs)
Ruxolitinib phosphate
Sacubitril; Valsartan
Safinamide mesylate
Sapropterin dihydrochloride
Sarecycline hydrochloride
Saxagliptin hydrochloride
Selegiline hydrochloride (multiple reference listed drugs)
Selexipag
Selpercatinib
Sertraline hydrochloride (multiple reference listed drugs)
Sibutramine hydrochloride
Sildenafil citrate (multiple reference listed drugs)
Silodosin
Simvastatin (multiple reference listed drugs)
Simvastatin; Sitagliptin phosphate
Siponimod
Sitagliptin phosphate
Sodium phenylbutyrate (multiple reference listed drugs)
Sodium phenylbutyrate; Taurursodiol
Sofosbuvir
Solifenacin succinate
Solriamfetol hydrochloride
Sotalol hydrochloride (multiple reference listed drugs)
Sotorasib
Sparsentan
Spironolactone (multiple reference listed drugs)
Stavudine
Stiripentol (multiple reference listed drugs)
Succimer
Sulfadiazine
Sulfamethoxazole; Trimethoprim (multiple reference listed drugs)
Sumatriptan succinate
Tadalafil
Tafenoquine succinate (multiple reference listed drugs)
Tamoxifen citrate
Tapentadol hydrochloride
Tasimelteon
Tecovirimat

[[Page 86821]]

 
Tedizolid phosphate
Telbivudine
Telithromycin
Telotristat etiprate
Temazepam
Tenofovir alafenamide fumarate
Tenofovir disoproxil fumarate (multiple reference listed drugs)
Tepotinib hydrochloride
Terazosin hydrochloride
Terbinafine hydrochloride (multiple reference listed drugs)
Terbutaline sulfate
Teriflunomide
Testosterone undecanoate
Tetrabenazine
Tetracycline hydrochloride
Thioridazine hydrochloride
Thiothixene
Tiagabine hydrochloride
Ticagrelor
Ticlopidine hydrochloride
Timolol maleate
Tivozanib hydrochloride
Tizanidine hydrochloride
Tofacitinib citrate
Tolcapone
Tolterodine tartrate
Topiramate (multiple reference listed drugs)
Toremifene citrate
Torsemide (multiple reference listed drugs)
Trandolapril
Tranylcypromine sulfate
Trazodone hydrochloride
Triamterene
Triazolam
Triclabendazole
Trimethoprim
Trimipramine maleate
Ubrogepant
Ulipristal acetate
Uridine triacetate
Ursodiol (multiple reference listed drugs)
Valacyclovir hydrochloride
Valbenazine tosylate
Valganciclovir hydrochloride
Valsartan
Vandetanib
Vardenafil hydrochloride (multiple reference listed drugs)
Varenicline tartrate
Vericiguat
Vibegron
Vilazodone hydrochloride
Vismodegib
Vorapaxar sulfate
Vortioxetine hydrobromide
Voxelotor (multiple reference listed drugs)
Zalcitabine
Zaleplon
Zidovudine (multiple reference listed drugs)
Zileuton
Ziprasidone hydrochloride (multiple reference listed drugs)
Zolmitriptan (multiple reference listed drugs)
Zolpidem tartrate
Zonisamide
------------------------------------------------------------------------

    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.

[[Page 86822]]

You can use an alternative approach if it satisfies the requirements of 
the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    While these guidances contain no collection of information, they do 
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 (44 U.S.C. 3501-3521). The collections of information in 21 
CFR part 312 for investigational new drugs have been approved under 
0910-0014. The collections of information in 21 CFR part 314 for 
applications for FDA approval to market a new drug and in 21 CFR part 
320 for bioavailability and bioequivalence requirements have been 
approved under OMB control number 0910-0001.

IV. 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 24, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-25391 Filed 10-30-24; 8:45 am]
BILLING CODE 4164-01-P
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