Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 67765 

selected for the pilot. Overall, pilot 

participants will be selected based on 

application readiness (e.g., sponsors 

who demonstrate having the ability to 

move the program forward towards a 

marketing application). 

D. FDA-Sponsor Interactions During the 

START Pilot Program 

If selected for the START Pilot 

Program, sponsors will receive 

enhanced communications with FDA 

review staff. These enhanced 

communications may vary between 

CBER and CDER but will include at a 

minimum an initial meeting to review 

features of the pilot, discuss a pathway 

intended to support a marketing 

application, and to discuss specific 

issues for which a sponsor requests 

enhanced communication with FDA. 

Additional communications will 

include ongoing interactions via email 

or teleconference that take place on a 

scheduled and/or as needed basis as 

agreed upon by the sponsor and FDA. 

III. Paperwork Reduction Act of 1995 

This notice refers to previously 

approved FDA collections of 

information. These 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 have been approved under 

OMB control number 0910–0014 and 

the collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338. 

IV. References 

The following references are on 

display at the Dockets Management Staff 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, 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. 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 FDA Draft Guidance for Industry 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ (September 2023): https://

www.fda.gov/media/172311/download. 

2. FDA Guidance for Industry 

‘‘Providing Regulatory Submissions in 

Electronic Format—Certain Human 

Pharmaceutical Product Applications 

and Related Submissions using the 

eCTD Specifications’’ (February 2020): 

https://www.fda.gov/media/135373/ 

download. 

Dated: September 25, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21235 Filed 9–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0219] 

Human Prescription Drug and 

Biological Products—Labeling for 

Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘‘Dose Banding’’; 

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 final 

guidance for industry entitled ‘‘Human 

Prescription Drug and Biological 

Products—Labeling for Dosing Based on 

Weight or Body Surface Area for Readyto-Use Containers—‘Dose Banding.’ ’’ 

The guidance is intended to assist 

applicants in incorporating dose 

banding information, based on dosing 

information of a previously approved 

drug product that is based on weight or 

body surface area (BSA), into the 

proposed labeling of injectable drug 

products that are the subject of certain 

marketing applications submitted to 

FDA. This guidance finalizes the draft 

guidance of the same title issued on July 

21, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 2, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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–0219 for ‘‘Human Prescription 

Drug and Biological Products—Labeling 

for Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘Dose Banding.’ ’’ 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 


lotter on DSK11XQN23PROD with NOTICES1
67766 Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 

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 this 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Chris Wheeler, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3330, 

Silver Spring, MD 20993–0002, 301– 

796–0151; or Anne Taylor, 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: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Human Prescription Drug and 

Biological Products—Labeling for 

Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘Dose Banding.’ ’’ This 

guidance provides recommendations for 

incorporating dose banding information 

into the labeling of an injectable drug 

product that is seeking approval through 

a new drug application submitted under 

section 505(b) of the FD&C Act (21 

U.S.C. 355(b)), a biologics license 

application submitted under section 

351(a) of the PHS Act (42 U.S.C. 262(a)), 

or a supplement to one of these 

approved applications. The 

recommendations and examples in this 

guidance are relevant to situations in 

which an applicant (1) proposes to 

develop ready-to-use containers with a 

range of different strengths for an 

injectable drug product and (2) seeks to 

incorporate dose banding information 

into the prescribing information based 

on dosing information of a previously 

approved drug product that is based on 

weight or BSA. 

This guidance finalizes the draft 

guidance entitled ‘‘Human Prescription 

Drug and Biological Products—Labeling 

for Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘Dose Banding’ ’’ issued on 

July 21, 2022 (87 FR 43533). FDA 

considered comments received on the 

draft guidance as it developed the final 

guidance. Changes from the draft 

guidance are primarily intended to 

improve clarity. 

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 ‘‘Human 

Prescription Drug and Biological 

Products—Labeling for Dosing Based on 

Weight or Body Surface Area for Readyto-Use Containers—‘Dose Banding.’ ’’ 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 new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by Office of Management Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 201 have been approved 

under OMB control number 0910–0572; 

the collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001; and 

the collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: September 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21558 Filed 9–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Regional Pediatric Pandemic Network 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Announcing supplemental 

funding for Regional Pediatric Pandemic 

Network award recipients in Maryland 

and Ohio. 

SUMMARY: HRSA provided additional 

award funds to the two Regional 

Pediatric Pandemic Network (RPPN) 

Program recipients in Maryland and 

Ohio with periods of performance 

ending in fiscal year 2024. 

FOR FURTHER INFORMATION CONTACT: Sara 

Kinsman, MD, Director, Division of 

Child, Adolescent and Family Health, 

Maternal and Child Bureau, Health 

Resources and Services Administration, 

at SKinsman@hrsa.gov and 301–443– 

2250. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient(s) of the Award: 

The two award recipients of the HRSA 

Regional Pediatric Pandemic Network 

Program are Children’s National 

Medical Center in Maryland, and 

University Hospitals Cleveland Medical 

Center in Ohio, as listed in Table 1. 


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