Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 25493 

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, 2004. ‘‘Guidance for Industry: Juice 

HACCP Hazards and Controls Guidance 

First Edition; Final Guidance.’’ Available 

at https://www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/Juice/ 

ucm072557.htm. 

2. Codex Alimentarius, 2021. Revision of the 

Code of Practice for the Prevention and 

Reduction of Lead Contamination in 

Foods. 

3. HHS, National Toxicology Program, 2012. 

NTP Monograph on Health Effects of 

Low-Level Lead. Available at: https://

ntp.niehs.nih.gov/ntp/ohat/lead/final/ 

monographhealtheffectslowlevellead_

newissn_508.pdf. 

4. Flannery, B.M., L.C. Dolan, D. HoffmanPennesi, A. Gavelek, et al., 2020. U.S. 

Food and Drug Administration’s Interim 

Reference Levels for Dietary Lead 

Exposure in Children and Women of 

Childbearing Age.’’ Regulatory 

Toxicology and Pharmacology. 110:1–20. 

5. WHO/FAO Joint Expert Committee on 

Food Additives, 2011. Evaluation of 

Certain Contaminants in Food, 73rd 

Report of the World Health 

Organization/Food and Agriculture 

Organization of the United Nations Joint 

Expert Committee on Food Additives. 

WHO Technical Report Series 960. 

Available at https://apps.who.int/iris/ 

bitstream/handle/10665/44515/WHO_

TRS_960_eng.pdf?sequence=1. 

6. Codex Alimentarius, 2021. General 

Standard for Contaminants and Toxins 

in Food and Feed, CXS 193–1995. http:// 

www.fao.org/fao-whocodexalimentarius/sh-proxy/en/?lnk=1&

url=https%253A%252F%252F

workspace.fao.org%252Fsites%252F

codex%252FMeetings%252FCX-735- 

14%252FINFO-DOC%252FCF14_

INF01x.pdf. 

* 7. FDA, 2021. Closer to Zero: Action Plan 

for Baby Foods. Available at https://

www.fda.gov/food/metals-and-yourfood/closer-zero-action-plan-baby-foods. 

* 8. FDA, 2022b. Draft Supporting Document 

for Establishing FDA’s Action Levels for 

Lead in Juice. Available at https://

www.fda.gov. 

Dated: April 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09255 Filed 4–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–1188] 

Determination That Cupric Sulfate 

Injection, Equivalent to 0.4 Milligram 

Copper/Milliliter, Was Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that Cupric Sulfate 

Injection, equivalent to (EQ) 0.4 

milligram (mg) copper/milliliter (mL), 

was not withdrawn from sale for reasons 

of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for Cupric Sulfate 

Injection, EQ 0.4 mg copper/mL, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Kaetochi Okemgbo, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6272, 

Silver Spring, MD 20993–0002, 240– 

825–9944, Kaetochi.Okemgbo@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) Has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

Cupric Sulfate Injection, EQ 0.4 mg 

copper/mL, is the subject of NDA 

019350, held by Abraxis Pharmaceutical 

Products, and initially approved on May 

5, 1987. Cupric Sulfate Injection is 

indicated for use as a supplement to 

intravenous solutions given for total 

parenteral nutrition, to prevent and treat 

copper deficiency. 

In a letter dated April 17, 1995, 

Fujisawa USA, Inc. (the applicant at that 

time), notified FDA that Cupric Sulfate 

Injection, EQ 0.4 mg copper/mL, was 

being discontinued, and requested 

withdrawal of NDA 019350. FDA moved 

the drug product to the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. In the Federal Register of June 21, 

2017 (82 FR 28322), FDA announced 

that it was withdrawing approval of 

NDA 019350, effective June 21, 2017. 

Arent Fox LLP submitted a citizen 

petition dated November 2, 2021 

(Docket No. FDA–2021–P–1188), under 

21 CFR 10.30, requesting that the 

Agency determine whether Cupric 

Sulfate Injection, EQ 0.4 mg copper/mL, 

was withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that Cupric Sulfate Injection, 

EQ 0.4 mg copper/mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that Cupric Sulfate Injection, 

EQ 0.4 mg copper/mL, was withdrawn 

for reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

Cupric Sulfate Injection, EQ 0.4 mg 

copper/mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this drug product was 

not withdrawn from sale for reasons of 

safety or effectiveness. 


lotter on DSK11XQN23PROD with NOTICES1
25494 Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 

Accordingly, the Agency will 

continue to list Cupric Sulfate Injection, 

EQ 0.4 mg copper/mL, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to Cupric Sulfate Injection, EQ 0.4 mg 

copper/mL, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: April 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09238 Filed 4–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0091] 

Crohn’s Disease: Developing Drugs for 

Treatment; 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 ‘‘Crohn’s 

Disease: Developing Drugs for 

Treatment.’’ This draft guidance 

addresses FDA’s current thinking about 

necessary attributes of clinical trials for 

developing drugs for the treatment of 

Crohn’s disease in adults, including 

recommendations for trial population, 

trial design, and efficacy and safety 

considerations. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 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–0091 for ‘‘Crohn’s Disease: 

Developing Drugs for Treatment.’’ 

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, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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: Jay 

Fajiculay, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5353, Silver Spring, 

MD 20993–0002, 301–796–9007, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 


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