5898 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

1https://healthpolicy.duke.edu/events/ 

optimizing-use-postapproval-pregnancy-safetystudies. 

2https://www.nichd.nih.gov/about/advisory/ 

PRGLAC. 

2019 public health emergency, we 

revised the Agency guidance document 

to provide recommendations for 

recordkeeping applicable to any 

pandemic, not just influenza, including 

recommendations for planning, 

notification, and documentation for 

continuity of operations for firms that 

report postmarketing adverse events 

during any pandemic. 

For operational efficiency, on March 

20, 2023, OMB approved the addition of 

burden attributable to provisions related 

to postmarketing safety reporting for 

combination products as outlined in 

part 4, subpart B, and previously 

included in OMB control number 0910– 

0834. When information regarding an 

event that involves a death or serious 

injury, or an adverse event, associated 

with the use of a combination product 

that includes a drug product, is received 

by the product sponsor, the information 

must be provided to the other 

constituent part applicant(s) no later 

than 5 calendar days after receipt under 

§ 4.103 (21 CFR 4.103). Relatedly, 21 

CFR 4.104 explains how and where to 

submit reports for combination 

products, and 21 CFR 4.105 provides for 

associated recordkeeping. For 

combination products that are 

administered as drug products with a 

constituent part, adverse event reports 

are submitted to the drug application 

under 21 CFR part 314, and constituent 

applicants are notified of the AER under 

§ 4.103. These provisions are also 

described in the guidance document 

‘‘Postmarketing Safety Reporting for 

Combination Products’’ (July 2019), 

available at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/postmarketingsafety-reporting-combination-products. 

Our estimates of the number of 

respondents and the total annual 

responses are based on reports 

submitted to the Agency. This 

information collection incorporates 

revisions to include the two guidances 

for industry regarding submission of 

adverse event reports (‘‘Postmarketing 

Adverse Event Reporting for Medical 

Products and Dietary Supplements 

During a Pandemic’’ and ‘‘Providing 

Submissions in Electronic Format— 

Postmarketing Safety Reports’’) and 

adjustments to include 15-day alert 

reports from applicants, manufacturers, 

distributors, and packers that were not 

recorded previously in this information 

collection. We also believe adjustments 

in the information collection reflect 

anticipated fluctuations in burden after 

pandemic conditions, adjustments by 

reporters’ and changes in electronic 

reporting methodologies use of updated 

technology including updates and 

redefinitions of reporting software, and 

changes of company business practices 

over time. All reports and followup 

reports must be submitted to FDA in 

electronic format. Waivers of the 

electronic requirements are available. 

As a result of these revisions and 

adjustments, including the additional 

reports, the inclusion of guidance 

document recommendations and the 

consolidation of the burden from OMB 

control number 0910–0834 (previously 

added to this information collection 

March 2023), the total burden hours of 

the information collection have 

increased by 61,614,921 hours and 

2,546,112 responses as compared to the 

previous renewal. While no changes 

have been made to the estimates in the 

60-day notice, due to a clerical error, we 

are clarifying in this notice that the total 

burden hour increase is slightly lower (a 

difference of 198 burden hours and 89 

responses). 

Dated: January 7, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01151 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–0001] 

Optimizing Pregnancy Registries; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Optimizing 

Pregnancy Registries.’’ The purpose of 

the public workshop is to discuss 

challenges in designing and 

implementing pregnancy registries and 

to consider innovative approaches to 

improve the design and conduct of 

pregnancy registries to inform the safety 

of drug and biological products during 

pregnancy. This public workshop is 

being held in collaboration with the 

University of Maryland Center of 

Excellence in Regulatory Science and 

Innovation program. 

DATES: The public workshop will be 

held on March 27, 2025, from 9 a.m. to 

4 p.m. eastern time and on March 28, 

2025, from 9 a.m. to 12 p.m. eastern 

time. 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., Building 

31 Conference Center, the Great Room 

(Room 1503), Silver Spring, MD 20993 

and online. 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. 

FOR FURTHER INFORMATION CONTACT: 

Denise Johnson-Lyles, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Silver Spring, 

MD 20993, 301–796–6169, 

OPRWorkshop@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Historically, pregnant individuals 

have been excluded from drug and 

biological product development. At the 

time of initial approval of a drug or 

biological product, there are generally 

limited data on the safety of the product 

when used during pregnancy. Therefore, 

postapproval pregnancy safety studies 

are needed to evaluate the safety of a 

product in the postapproval setting and 

to inform safety-related product labeling 

and clinical care. 

Under the latest reauthorization of the 

Prescription Drug User Fee Act, FDA 

made a commitment to develop a 

framework describing how to optimally 

use data from different types of 

postapproval pregnancy safety studies. 

On September 18–19, 2023, FDA and 

the Duke-Margolis Institute for Health 

Policy convened a public workshop to 

discuss the design of postapproval 

pregnancy safety studies for drug and 

biological products.1 Participants and 

interested parties discussed ways these 

studies can be optimized and different 

approaches that can be taken to bridge 

knowledge gaps in developing the 

framework. Although data were 

presented that suggest that pregnancy 

registry studies are an important source 

of pregnancy safety information, 

interested parties noted challenges with 

conducting single-drug, single-sponsor 

pregnancy registries, including low 

enrollment and long lag time to study 

completion. Similar to the Pregnant 

Women and Lactating Women 

recommendations,2 interested parties 

identified the need to optimize diseaseVerDate Sep<11>2014 09:31 Jan 17, 2025 Jkt 265001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1

KHAMMOND on DSK9W7S144PROD with NOTICES
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