4252 Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices 

is a basis to conclude that an attribute 

of each approved drug product makes 

each one medically unsuitable to treat 

certain patients for their condition, an 

interpretation that protects patients and 

the integrity of the drug approval 

process. The nominations proposing to 

compound drug products in ready-touse form containing bulk drug 

substances in one or more FDAapproved drug products do not show 

that the approved drug product, when 

not manufactured in the ready-to-use 

form, is medically unsuitable for certain 

patients. Nor do the nominations and 

comments establish that drug products 

in the relevant concentrations, 

including ready-to-use products, cannot 

be prepared from the approved drug 

products. Rather, they propose to 

compound a ready-to-use product from 

bulk drug substances to seek improved 

efficiency for prescribers or healthcare 

providers, or to address the possibility 

that the approved drug might be 

mishandled by a medical professional, 

neither of which falls within the 

meaning of clinical need to compound 

a drug product using a bulk drug 

substance. 

Two comments requested changes to 

the Interim Policy. These comments are 

outside the scope of FDA’s bulk drug 

substance evaluations and decisions 

that are the subject of this notice. FDA 

welcomes public comments on its 

guidance documents that address 

human drug compounding. We 

encourage comments on the Interim 

Policy to be submitted the docket for the 

guidance, docket number FDA–2015–D– 

3539. Comments may be submitted to 

this docket at any time on https://

www.regulations.gov. 

V. Conclusion 

For the reasons stated above, we find 

that there is a clinical need for 

outsourcing facilities to compound 

using the bulk drug substances DPCP for 

topical use only, glycolic acid for 

topical use only in concentrations up to 

70 percent, SADBE for topical use only, 

and TCA for topical use only and, 

therefore, we are now including them 

on the 503B Bulks List. In addition, we 

find that there is no clinical need for 

outsourcing facilities to compound 

using the bulk drug substances 

diazepam, dipyridamole, dobutamine 

HCl, dopamine HCl, edetate calcium 

disodium, folic acid, glycopyrrolate, and 

sodium thiosulfate (except for topical 

administration), and therefore we are 

not including these bulk drug 

substances on the 503B Bulks List. 

VII. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they are also available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

*1. FDA, Guidance for Industry, ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under Section 503B of 

the Federal Food, Drug, and Cosmetic 

Act,’’ January 2017 (available at https:// 

www.fda.gov/media/94402/download). 

*2. FDA, Guidance for Industry, ‘‘Evaluation 

of Bulk Drug Substances Nominated for 

Use in Compounding Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act,’’ March 2019 (available at 

https://www.fda.gov/media/121315/ 

download). 

*3. FDA Memorandum to File, Clinical Need 

for Diphenylcyclopropenone (DPCP) in 

Compounding Under Section 503B of the 

FD&C Act, July 2020. 

*4. FDA Memorandum to File, Clinical Need 

for Glycolic Acid in Compounding 

Under Section 503B of the FD&C Act, 

July 2020. 

*5. FDA Memorandum to File, Clinical Need 

for Squaric Acid Dibutyl Ester (SADBE) 

in Compounding Under Section 503B of 

the FD&C Act, July 2020. 

*6. FDA Memorandum to File, ‘‘Clinical 

Need for Trichloroacetic Acid (TCA) in 

Compounding Under Section 503B of the 

FD&C Act,’’ July 2020. 

7. Leheta, T. M., A. El Tawdy, R. M. Abdel 

Hay, and S. Farid, 2011, ‘‘Percutaneous 

Collagen Induction Versus FullConcentration Trichloroacetic Acid in 

the Treatment of Atrophic Acne Scars,’’ 

Dermatologic Surgery, 37(2):207–216. 

8. Kumari, R. and D. M. Thappa, 2010, 

‘‘Comparative Study of Trichloroacetic 

Acid Versus Glycolic Acid Chemical 

Peels in the Treatment of Melasma,’’ 

Indian Journal of Dermatology, 

Venereology and Leprology, 76:447, 

available at https://ijdvl.com/ 

comparative-study-of-trichloroaceticacid-versus-glycolic-acid-chemical-peelsin-the-treatment-of-melasma/. 

9. Nigwekar, S. U., S. M. Brunelli, D. Meade, 

et al., 2013, ‘‘Sodium Thiosulfate 

Therapy for Calcific Uremic 

Arteriolopathy,’’ Clinical Journal of the 

American Society of Nephrology, 

8(7):1162–1170. 

10. Generali, J. A. and D. J. Cada, 2015, 

‘‘Sodium Thiosulfate: Calciphylaxis,’’ 

Hospital Pharmacy, 50(11):975–977. 

11. Udomkarnjananun, S., K. Kongnatthasate, 

K. Praditpornsilpa, et al., 2019, 

‘‘Treatment of Calciphylaxis in CKD: A 

Systematic Review and Meta-Analysis,’’ 

Kidney International Reports, 4(2):231– 

244. 

12. Schulz, L. T., E. J. Elder, Jr, K. J. Jones, 

et al., 2010, ‘‘Stability of Sodium 

Nitroprusside and Sodium Thiosulfate 

1:10 Intravenous Admixture,’’ Hospital 

Pharmacy, 45(10):779–784. 

*13. FDA Guidance for Industry, Prescription 

Requirement Under Section 503A of the 

Federal Food, Drug, and Cosmetic Act, 

December 2016 (available at https://

www.fda.gov/media/97347/download). 

14. Pun, Patrick H. and John P. Middleton, 

2017, ‘‘Dialysate Potassium, Dialysate 

Magnesium, and Hemodialysis Risk,’’ 

Journal of the American Society of 

Nephrology, 28: 3441–3451. 

15. De Nicola, L., V. Bellizzi, R. Minutolo, et 

al., 2000, ‘‘Effect of Dialysate Sodium 

Concentration on Interdialytic Increase 

of Potassium,’’ Journal of the American 

Society of Nephrology, 11:2337–2343. 

Dated: January 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01558 Filed 1–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0092] 

Revising Abbreviated New Drug 

Application Labeling Following 

Revision of the Reference Listed Drug 

Labeling; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Revising 

ANDA Labeling Following Revision of 

the RLD Labeling.’’ This guidance 

provides recommendations for updating 

labeling for abbreviated new drug 

applications (ANDAs) following 

revisions to the labeling of a reference 

listed drug (RLD), including information 

on how to identify RLD labeling updates 

and how to submit labeling updates to 

both unapproved and approved ANDAs 

to conform to RLD labeling updates. 

This draft guidance revises the guidance 

for industry entitled ‘‘Revising ANDA 

Labeling Following Revision of the RLD 

Labeling’’ issued in April 2000. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices 4253 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 28, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–D–0092 for ‘‘Revising ANDA 

Labeling Following Revision of the RLD 

Labeling.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Hughes, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1688, 

Silver Spring, MD 20993–0002, 301– 

796–9291. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Revising ANDA Labeling Following 

Revision of the RLD Labeling.’’ This 

guidance provides recommendations for 

updating labeling for ANDAs following 

revisions to the labeling of an RLD, 

including information on how to 

identify RLD labeling updates and how 

to submit labeling updates to both 

unapproved and approved ANDAs to 

conform to RLD labeling updates. This 

draft guidance revises the guidance for 

industry ‘‘Revising ANDA Labeling 

Following Revision of the RLD 

Labeling’’ issued in April 2000. 

Significant changes from the 2000 

version include updates to outdated 

details about how to obtain information 

on changes to RLD labeling and how to 

submit revised ANDA labeling to FDA. 

A generic drug is required to have the 

same labeling as the RLD, except for 

changes required because of differences 

approved under a suitability petition 

(see section 505(j)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act)) (21 U.S.C. 355(j)(2)(C) and 21 CFR 

314.93) or because the generic drug and 

the RLD are produced or distributed by 

different manufacturers (see e.g., section 

505(j)(2)(A)(v) of the FD&C Act and 

§ 314.94(a)(8)(iv) (21 CFR 

314.94(a)(8)(iv))). FDA regulations 

provide examples of permissible 

differences in labeling that may result 

when a proposed generic drug and the 

RLD are ‘‘produced or distributed by 

different manufacturers,’’ including the 

omission of an indication or other 

aspect of labeling protected by patent or 

exclusivity and ‘‘labeling revisions 

made to comply with current FDA 

labeling guidelines or other guidance’’ 

(§ 314.94(a)(8)(iv)). 

An ANDA holder is expected to 

update its labeling after FDA has 

approved relevant changes to the 

labeling for the corresponding RLD. 

Prompt revision, submission to the 

Agency, and implementation of revised 

labeling are important to ensure that the 

generic drug continues to be as safe and 

effective as the corresponding RLD. 

Because the labeling of a generic drug 

must be the same as the labeling for the 

RLD, except for permissible differences, 

the revision should be made at the 

earliest time possible. 

In this draft guidance, FDA is 

providing information on how ANDA 

applicants and holders should monitor 

for changes to RLD labeling, procedures 

for the electronic submission of labeling 


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4254 Federal Register / Vol. 87, No. 18 / Thursday, January 27, 2022 / Notices 

updates, information describing the type 

of submission that should be made to 

FDA, as well as other considerations for 

submitting a labeling update to FDA. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Revising ANDA Labeling Following 

Revision of the RLD Labeling.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. 

• The collections of information in 

part 314 for the submission of ANDAs 

(including the content and format of 

ANDAs and supplements and 

amendments) have been approved 

under OMB control number 0910–0001 

and in part 314 (included under the 21 

CFR parts 10 through 16 hearing 

regulations) for OMB control number 

0910–0191. 

• The collections of information 

pertaining to the electronic submission 

of labeling changes have been approved 

under OMB control number 0910–0045. 

• The collections of information 

pertaining to the content and format 

requirements for human prescription 

drugs and biological products and the 

submission of such labeling have been 

approved under OMB control number 

0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: January 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01577 Filed 1–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4337] 

Prescription Drug User Fee Act of 

2017; Electronic Submissions and Data 

Standards; Public Meeting; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the following virtual public 

meeting entitled ‘‘Prescription Drug 

User Fee Act of 2017; Electronic 

Submissions and Data Standards.’’ The 

purpose of the virtual public meeting 

and the request for comments is to 

fulfill FDA’s commitment to seek 

stakeholder input related to data 

standards and the electronic submission 

system’s past performance, future 

targets, emerging industry needs, and 

technology initiatives. FDA will use the 

information from the public meeting as 

well as from comments submitted to the 

docket to provide input into data 

standards and electronic submissions 

initiatives. 

DATES: The public meeting will be held 

on April 12, 2022, from 9 a.m. to 1 p.m. 

Eastern Time, and will take place 

virtually, held by webcast only. Submit 

either electronic or written comments 

on this public meeting by March 22, 

2022. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: Registration to attend the 

meeting and other information can be 

found at https://www.fda.gov/industry/ 

prescription-drug-user-fee-amendments/ 

pdufa-vi-information-technology-goalsand-progress. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before March 22, 2022. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of March 22, 2022. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–4337 for ‘‘Prescription Drug 

User Fee Act of 2017; Electronic 

Submissions and Data Standards.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 


lotter on DSK11XQN23PROD with NOTICES1