Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5899 

based multi-product, multi-sponsor 

pregnancy registries. 

This current public workshop is part 

of FDA’s commitment to advance 

optimal approaches to efficient 

generation of high-quality human safety 

data for drug products used during 

pregnancy. The purpose of the 

workshop is to discuss current 

challenges in gathering safety data for 

drug and biological products used 

during pregnancy and to discuss 

approaches to optimize and improve 

pregnancy registries with key interested 

parties. 

II. Topics for Discussion at the Public 

Workshop 

The objective of the meeting is to 

discuss the following topics with 

interested parties: 

• Current status of pregnancy 

registries and challenges in gathering 

data regarding the safety of drug and 

biological products used during 

pregnancy. 

• Perspectives from interested parties 

(FDA, academia, industry, healthcare 

providers, and patients) on strategies to 

improve the design and conduct of 

pregnancy registries. 

• Innovative approaches/models to 

facilitate the conduct of pregnancy 

registries, including disease-based 

multi-product, multi-sponsor pregnancy 

registries. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://lu.ma/bod9zouc. 

Persons interested in attending this 

public workshop must register online by 

March 14, 2025, 11:59 p.m. eastern time. 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone number. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Registrants will receive 

confirmation when they have been 

accepted. If time and space permit, 

onsite registration on the day of the 

public workshop will be provided 

beginning at 8:30 a.m. eastern time. We 

will let registrants know if registration 

closes before the day of the public 

workshop. 

If you need special accommodations 

due to a disability, please contact the 

Optimizing Pregnancy Registries 

Workshop Planning Team at 

OPRWorkshop@fda.hhs.gov no later 

than March 14, 2025. 

Virtual Streaming of the Public 

Workshop: This public workshop will 

also be streamed virtually via Zoom. 

Virtual attendees may register at the 

following website to receive the Zoom 

link: https://lu.ma/bod9zouc. Although 

FDA verified the website addresses in 

this document, please note that websites 

are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov (Docket No. FDA– 

2024–N–0001). It also may be viewed at 

the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Notice of this meeting is given 

pursuant to 21 CFR 10.65. 

Dated: January 10, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01164 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–2033] 

Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics; Draft Guidance 

for Industry; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

draft guidance for industry entitled 

‘‘Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics’’ that appeared in 

the Federal Register of December 6, 

2024. In the notice of availability for the 

draft guidance, FDA requested 

comments on the draft guidance. The 

Agency is taking this action in response 

to requests for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the draft guidance for 

industry published December 6, 2024 

(89 FR 97011). Either electronic or 

written comments must be submitted by 

March 6, 2025. 

ADDRESSES: 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 

March 6, 2025. 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– 

2024–D–2033 for ‘‘Expedited Program 

for Serious Conditions—Accelerated 

Approval of Drugs and Biologics.’’ 

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. 


KHAMMOND on DSK9W7S144PROD with NOTICES
5900 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

• 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: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926 or 301– 

796–2500, dat.doan@fda.hhs.gov; James 

Myers, 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; or Paul 

Kluetz, Oncology Center of Excellence, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 22, Rm. 

2223, Silver Spring, MD 20993, 301– 

796–9567, Paul.Kluetz@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 6, 2024, 

FDA published a notice of availability 

with a 60-day comment period to 

request comments on the draft guidance 

for industry entitled ‘‘Expedited 

Program for Serious Conditions— 

Accelerated Approval of Drugs and 

Biologics.’’ The Agency has received 

requests for a 30-day extension of the 

comment period. The requests conveyed 

concern that the current 60-day 

comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the draft 

guidance. 

FDA has considered the requests and 

is extending the comment period for 30 

days, until March 6, 2025. The Agency 

believes that a 30-day extension allows 

adequate time for interested persons to 

submit comments on this draft 

guidance. 

Dated: January 14, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01179 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3595] 

Agency Information Collection 

Activities; Proposed Collection; 

Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification; Withdrawal of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of a notice that was 

published in the Federal Register of 

October 18, 2023. 

DATES: The notice is withdrawn on 

January 17, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Darren Eicken, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, Rm. 6206, 

Silver Spring, MD 20993–0002, 240– 

402–0978. 

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

October 18, 2023 (88 FR 71875), 

‘‘Agency Information Collection 

Activities; Proposed Collection; 

Comment Request: Improving the 

Quality and Representativeness of the 

Treatment Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ FDA requested 

comment on the information collection 

associated with the proposed study 

entitled ‘‘Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ 

Under the Paperwork Reduction Act 

of 1995, Federal Agencies are required 

to publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. 

In the October 18, 2023, Federal 

Register notice, FDA proposed a new 

collection of information. However, 

FDA no longer intends to proceed with 

the proposed study due to 

circumstances and timing surrounding 

the execution of the study. Therefore, 

we are withdrawing the October 18, 

2023 notice. 

Dated: January 13, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01152 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5468] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and Drug 

Administration’s Adverse Event and 

Product Experience Reporting 

Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing an opportunity for 

public comment on the proposed 

collection of certain information by the 

Agency. Under the Paperwork 

Reduction Act of 1995 (PRA), Federal 

Agencies are required to publish notice 

in the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with FDA’s 


KHAMMOND on DSK9W7S144PROD with NOTICES