Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86811 

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draft guidance entitled ‘‘M13A 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. 

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-regulatoryinformation-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. 

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 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: 

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 


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86812 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 

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, 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. 

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: 


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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 


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TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

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 


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TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

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 


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TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

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 


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TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

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 


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TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

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 


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Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86819 

TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

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 


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86820 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 

TABLE 1—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

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 


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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) 

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. 


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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 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: 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 

(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 

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 


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