71578 Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices 

Dated: October 11, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22843 Filed 10–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–P–3682] 

Determination That ZOFRAN ODT 

(Ondansetron) Orally Disintegrating 

Tablets, 4 Milligrams and 8 Milligrams, 

Were Not Withdrawn From Sale for 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 the Agency) has 

determined that ZOFRAN ODT 

(ondansetron) orally disintegrating 

tablets, 4 milligrams (mg) and 8 mg, 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to these drug 

products, and it will allow FDA to 

continue to approve ANDAs that refer to 

the products as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Veniqua Stewart, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6219, 

Silver Spring, MD 20993–0002, 301– 

796–3267, Veniqua.stewart@

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. 

ZOFRAN ODT (ondansetron) orally 

disintegrating tablets, 4 mg and 8 mg, 

are the subject of NDA 020781, held by 

Sandoz Inc., and initially approved on 

January 27, 1999. ZOFRAN ODT is 

indicated for the prevention of nausea 

and vomiting associated with: highly 

emetogenic cancer chemotherapy, 

including cisplatin greater than or equal 

to 50 mg/m2; initial and repeat courses 

of moderately emetogenic cancer 

chemotherapy; and radiotherapy in 

patients receiving either total body 

irradiation, single high-dose fraction to 

the abdomen, or daily fractions to the 

abdomen. ZOFRAN ODT is also 

indicated for the prevention of 

postoperative nausea and/or vomiting. 

ZOFRAN ODT (ondansetron) orally 

disintegrating tablets, 4 mg and 8 mg, 

are currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Sun Pharmaceutical Industries 

Limited submitted a citizen petition 

dated August 24, 2023 (Docket No. 

FDA–2023–P–3682), under 21 CFR 

10.30, requesting that the Agency 

determine whether ZOFRAN ODT 

(ondansetron) orally disintegrating 

tablets, 4 mg and 8 mg, were 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 ZOFRAN ODT 

(ondansetron) orally disintegrating 

tablets, 4 mg and 8 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that ZOFRAN 

ODT (ondansetron) orally disintegrating 

tablets, 4 mg and 8 mg, were withdrawn 

for reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

ZOFRAN ODT (ondansetron) orally 

disintegrating tablets, 4 mg and 8 mg, 

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 these 

drug products were not withdrawn from 

sale for reasons of safety or 

effectiveness. 

Accordingly, the Agency will 

continue to list ZOFRAN ODT 

(ondansetron) orally disintegrating 

tablets, 4 mg and 8 mg, 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. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to these 

drug products. Additional ANDAs for 

these drug products may also 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 these drug products should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: October 10, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22844 Filed 10–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4067] 

Diabetic Foot Infections: 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 ‘‘Diabetic 

Foot Infections: Developing Drugs for 

Treatment.’’ The purpose of this draft 

guidance is to assist sponsors in the 


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Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices 71579 

clinical development of drugs for the 

treatment of diabetic foot infections 

(DFI) without concomitant bone and 

joint involvement. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 18, 2023 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– 

2023–D–4067 for ‘‘Diabetic Foot 

Infections: 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. 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: 

Mayurika Ghosh, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6219, 

Silver Spring, MD 20993, 301–796– 

4776. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Diabetic Foot Infections: Developing 

Drugs for Treatment.’’ 

The purpose of this draft guidance is 

to assist sponsors in the clinical 

development of drugs for the treatment 

of DFI without concomitant bone and 

joint involvement. Specifically, this 

guidance addresses FDA’s current 

thinking regarding the overall 

development program and clinical trial 

designs for the development of drugs to 

support an indication for treatment of 

DFI. 

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 ‘‘Diabetic Foot Infections: 

Developing Drugs for Treatment.’’ 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. 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 part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR 201.56 and 

201.57 relating to prescription product 

labeling requirements have been 

approved under OMB control number 

0910–0572. 

III. 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. 


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71580 Federal Register / Vol. 88, No. 199 / Tuesday, October 17, 2023 / Notices 

Dated: October 11, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22842 Filed 10–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Rural Health and Economic 

Development Analysis Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Announcing funding 

supplement for Rural Health and 

Economic Development Analysis 

Program. 

SUMMARY: HRSA provided additional 

award funds to the Rural Health and 

Economic Development Analysis 

Program recipient to produce a research 

project that quantifies the relationships 

between health care and economic 

factors in rural communities. 

FOR FURTHER INFORMATION CONTACT: 

Karis Tyner, Federal Office of Rural 

Health Policy, HRSA, at ktyner@

hrsa.gov and (240) 645–5756. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: The 

University of Kentucky. 

Amount of Non-Competitive Award: 

One award for $250,000. 

Project Period: September 1, 2023, to 

August 31, 2024. 

CFDA Number: 93.155. 

Award Instrument: Supplement. 

Authority: Social Security Act section 

711(b) (42 U.S.C. 912(b)). 

TABLE 1—RECIPIENT AND AWARD AMOUNT

Grant No. Award recipient name City, state Supplemental 

award amount 

5 U1ZRH33331 ....................... The University of Kentucky ...................................................... Lexington, KY ......................... $250,000 

Justification: This funding will 

provide a one-time supplement to the 

University of Kentucky via the Rural 

Health and Economic Development 

Analysis Program with a budget period 

of September 2023 through August 

2024. This supplement will allow the 

University of Kentucky to build on past 

and ongoing projects supported by 

HRSA to improve health care in rural 

areas by advancing the knowledge base 

regarding the economic impacts of local 

health care sectors on rural economies. 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–22814 Filed 10–16–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Solicitation of 

Written Comments on Healthy People 

2030 Objectives 

AGENCY: Office of Disease Prevention 

and Health Promotion, Office of the 

Assistant Secretary of Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

solicits written comments from the 

public on the current Healthy People 

2030 objectives, and written comments 

from the public proposing additional 

new core, developmental, or research 

objectives or topics to be included in 

Healthy People 2030. Public comment 

informed the development of Healthy 

People 2030. HHS will provide 

opportunities for public input 

periodically throughout the decade to 

ensure Healthy People 2030 reflects 

current public health priorities and 

public input. The updated set of 

Healthy People 2030 objectives and 

topics will be incorporated on https://

health.gov/healthypeople. This updated 

set will reflect further review and 

deliberation by Federal Healthy People 

topic area workgroups, the Federal 

Interagency Workgroup on Healthy 

People 2030, and other Federal subject 

matter experts. 

DATES: Written comments will be 

accepted through 11:59 p.m. ET, 

November 20, 2023. 

ADDRESSES: Written comments should 

be submitted by email to 

HP2030Comment@hhs.gov. 

FOR FURTHER INFORMATION CONTACT: Erik 

Orta, Office of Disease Prevention and 

Health Promotion, U.S. Department of 

Health and Human Services, 1101 

Wootton Parkway, Suite 420, Rockville, 

MD 20852; Phone: 240–268–0823; 

Email: HP2030@hhs.gov. 

SUPPLEMENTARY INFORMATION: Since 

1980, Healthy People has provided a 

comprehensive set of national health 

promotion and disease prevention 

objectives with 10-year targets aimed at 

improving the health of all. Healthy 

People 2030 objectives present a picture 

of the nation’s health at the beginning 

of the decade, establish national goals 

and targets to be achieved by the year 

2030, and monitor progress over time. 

The U.S. Department of Health and 

Human Services (HHS) is soliciting the 

submission of written comments 

regarding the current Healthy People 

2030 objectives. The public is also 

invited to submit proposals for 

additional new core, developmental, or 

research objectives that meet the criteria 

outlined below. 

Healthy People 2030 is the product of 

an extensive collaborative process that 

relies on input from a diverse array of 

individuals and organizations, both 

within and outside the Federal 

Government, with a common interest in 

improving the nation’s health. Public 

comments were a cornerstone of 

Healthy People 2030’s development. 

During the first phase of planning for 

Healthy People 2030, HHS asked for the 

public’s comments on the initiative’s 

vision, mission, and overarching goals. 

Those comments helped set the 

framework for Healthy People 2030. The 

public was also invited to submit 

comments on proposed Healthy People 

2030 objectives, which helped shape the 

current set of Healthy People 2030 

objectives. HHS most recently solicited 

comments on one new objective during 

the 2022 public comment period from 

October 24, 2022, through December 2, 

2022, and three new proposed 

objectives during the 2021 public 

comment period from December 3, 

2021, through January 10, 2022. These 

new objectives, which were developed 

by Healthy People 2030 subject matter 

experts, meet specific criteria, and 

reflect public input, are now accessible 

on https://health.gov/healthypeople. 

While there are no new objectives 

being proposed at this time, the public 


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