Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 81421 

translated report is an accurate 

representation of the original GLP study 

report. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Translation of GLP Study Reports: 

Questions and Answers.’’ 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 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 58 for good laboratory 

practice for nonclinical laboratory 

studies have been approved under OMB 

control number 0910–0119. 

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may obtain the draft guidance at https:// 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.regulations.gov, or https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances. 

Dated: November 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25859 Filed 11–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4996] 

Advancing Drug Development for the 

Prevention of Spontaneous Preterm 

Birth; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Advancing Drug 

Development for the Prevention of 

Spontaneous Preterm Birth.’’ The 

meeting will be convened by Duke 

University’s Robert J. Margolis, MD, 

Center for Health Policy (DukeMargolis) and supported by a 

cooperative agreement with FDA. The 

meeting is intended to gather industry, 

family, clinician, researcher, ethicist, 

professional society, and other 

stakeholder input on the impact of 

preterm birth on families and on 

society, as well as on the ethical, 

regulatory, and clinical trial 

considerations surrounding the drug 

development for the prevention of 

spontaneous preterm birth. 

DATES: The public meeting will be held 

on January 23 and 24, 2024, from 1 p.m. 

to 4:30 p.m. Eastern Time each day. See 

the SUPPLEMENTARY INFORMATION section 

for registration information. 

ADDRESSES: The public meeting will be 

held virtually via Zoom. 

FOR FURTHER INFORMATION CONTACT: 

Luke Durocher, Duke-Margolis Center 

for Health Policy, margolisevents@

duke.edu, 202–621–2800; or Christina 

Chang, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–2078. 

SUPPLEMENTARY INFORMATION: 

I. Background Information 

In the United States in 2021, 1 in 

every 10 infants was born prematurely 

(before 37 weeks of pregnancy). Infants 

born too early have higher rates of death 

and disability, resulting in a significant 

public health concern. The exact 

mechanisms and risk factors associated 

with spontaneous preterm birth are not 

fully understood, resulting in a dearth of 

interventions demonstrated to be 

effective and safe. 

FDA endorses an informed and 

balanced approach to gathering data 

supporting the safe and effective use of 

drugs and biological products for the 

prevention of spontaneous preterm 

birth. Currently, there is a significant 

medical need for such therapies, as 

there are no FDA approved therapies for 

reducing the risk of neonatal morbidity/ 

mortality resulting from spontaneous 

preterm birth. Input from this meeting 

will help provide guidance on the 

development of therapies for the 

prevention of spontaneous preterm 

birth. 

II. Topics for Discussion at the Public 

Meeting 

The meeting will allow participants 

(including clinicians, patients, family, 

researchers, ethicists, professional 

societies, and other stakeholders) to 

provide input on key topics, including: 

• The current understanding of 

spontaneous preterm birth, including 

the epidemiology of the condition, 

etiologies, and pathophysiology 

• Ethical and regulatory considerations 

and challenges associated with the 

development of therapeutics for the 

prevention of spontaneous preterm 

birth 

• Impact of preterm birth on families 

and society 

• Assessing efficacy and safety in 

clinical programs for therapeutics for 

spontaneous preterm birth prevention 

• Dose-finding and clinical trial design 

considerations 

For more information on the meeting 

topics and discussion questions, visit 

https://duke.is/g/gde6. Duke-Margolis 

will publish a discussion guide 

outlining background information and 

current thinking on the topic areas to 

this website approximately 2 weeks 

before the meeting date. FDA will also 

post the agenda and other meeting 

materials to this website approximately 

5 business days before the meeting. 

The format of the public meeting will 

consist of a series of presentations, 

panel discussions, and open discussion. 

III. Participating in the Public Meeting 

Registration: To register for the virtual 

public meeting, please visit the 

following website: https://duke.is/g/ 

gde6. Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. 

Registration is free. Persons interested 

in attending this virtual public meeting 

must register. Early registration is 

recommended. Registrants will receive 

confirmation once they have been 

accepted. If you need special 

accommodations due to a disability, 

please contact Luke Durocher, DukeMargolis Center for Health Policy, at 

margolisevents@duke.edu or at 202– 

621–2800. 

Streaming Webcast of the Public 

Meeting: This virtual public meeting 

will be webcast via Zoom and the 

archived video footage will be available 

at the event website. The link for 

registration is the same as above: 

https://duke.is/g/gde6. Registered 

webcast participants will be sent 

technical system requirements in 

advance of the event. It is recommended 

that you review these technical system 

requirements prior to joining the 

streaming webcast of the public 

meeting. Although FDA has verified the 

website addresses in this document, 

please note that websites are subject to 

change over time. 


khammond on DSKJM1Z7X2PROD with NOTICES
81422 Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 

Transcripts: Please be advised that 

transcripts of the public meeting will 

not be available. 

Dated: November 16, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25816 Filed 11–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4965] 

Advancing the Use of Complex 

Innovative Designs in Clinical Trials: 

From Pilot to Practice; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the following public 

workshop entitled ‘‘Advancing the Use 

of Complex Innovative Designs in 

Clinical Trials: From Pilot to Practice.’’ 

The purpose of the public workshop is 

to discuss aspects of complex adaptive, 

Bayesian, and other novel clinical trial 

designs. This workshop is being 

conducted to meet the performance goal 

of convening a public workshop on 

complex innovative design (CID) 

included in the seventh authorization of 

the Prescription Drug User Fee Act 

(PDUFA VII). The workshop may also 

inform a draft guidance on the use of 

Bayesian methodology in clinical trials 

of drugs and biological products. In 

conjunction with the workshop, FDA is 

seeking comments on the use of CID to 

inform regulatory decision making, 

including high-level case examples of 

CIDs and approaches that can advance 

the use of these designs. The public 

workshop will be held on March 5, 

2024, from 9 a.m. to 3:30 p.m. Eastern 

Time. 

DATES: Either electronic or written 

comments on this public workshop 

must be submitted by April 5, 2024. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room, 

Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/about-fda/visitorinformation. The public workshop will 

use an online platform for the webcast. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 5, 2024. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

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– 

2023–N–4965 for ‘‘Advancing the Use of 

Complex Innovative Designs in Clinical 

Trials: From Pilot to Practice; Public 

Workshop; Request for Comments.’’ 

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 

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. 

FOR FURTHER INFORMATION CONTACT: 

Tuan Pham, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 3670, 

Silver Spring, MD 20993–0002, 301– 

348–1595, CID.Meetings@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


khammond on DSKJM1Z7X2PROD with NOTICES