Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5895 

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 related to the protection of 

human subjects under 21 CFR part 50 

have been approved under OMB control 

number 0910–0130. 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 part 314 have 

been approved under OMB control 

number 0910–0001. 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may obtain the draft guidance at https:// 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: January 10, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01197 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–3112] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Postmarketing 

Adverse Experience Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

18, 2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0230. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Postmarketing Adverse Experience 

Reporting 

OMB Control Number 0910–0230— 

Revision 

This information collection helps 

support provisions found in sections 

201, 502, 505, 701, and 760 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 321, 352, 355, 

371, and 379aa) governing adverse 

experience reporting (AER) and 

associated recordkeeping for FDAregulated drug products. FDA has 

issued applicable regulations in part 4 

and §§ 310.305, 314.80, 314.81, 314.98, 

and 329.100 (21 CFR part 4 and 21 CFR 

310.305, 314.80, 314.81, 314.98, and 

329.100) that implement the statutory 

requirements, identify specific content 

and format elements, and establish 

reporting and retention schedules for 

the required information. Postmarketing 

safety data collection and adverse event 

reporting are critical elements of FDA’s 

monitoring of drugs. For more 

information, please visit https://

www.fda.gov/drugs/surveillance/ 

postmarketing-adverse-event-reportingcompliance-program. 

Respondents to the information 

collection are manufacturers, packers, 

distributors, and applicants of FDAregulated drug and biologic products 

marketed with or without an FDAapproved application, including overthe-counter (OTC) drug products 

marketed without an approved 

application; OTC drug products 

marketed under the OTC Drug 

Monograph Review process (whether 

subject to a final monograph or not); and 

drug products marketed outside the 

monograph system. All reports and 

followup reports must be submitted to 

FDA in electronic format, although 

waivers of the electronic requirements 

are available for good cause. 

Adverse experience reporting for 

products associated with drug 

marketing applications are governed by 

regulations in §§ 314.80, 314.81, and 

314.98. The regulations identify 

required reporting content and format 

elements, as well as establish followup 

reporting requirements and mandatory 

reporting schedules. The regulations 

also establish associated recordkeeping 

and require that written procedures be 

developed for the surveillance, receipt, 

evaluation, and reporting of 

postmarketing adverse experiences to 

FDA. The regulations require reporting 

in an electronic format that FDA can 

process, although temporary waivers 

may be granted on a limited basis for 

good cause. A final guidance for 

industry entitled ‘‘Providing 

Submissions in Electronic Format— 

Postmarketing Safety Reports’’ (April 

2022) is available for general 

information pertaining to electronic 

submission of postmarketing safety 

reports for certain human drugs, 

biological products, and combination 

products. The guidance is available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/providing-submissionselectronic-format-postmarketing-safetyreports. 

We have established and maintain the 

FDA Adverse Event Reporting System 

(FAERS) at https://www.fda.gov/drugs/ 

questions-and-answers-fdas-adverseevent-reporting-system-faers/fdaadverse-event-reporting-system-faerselectronic-submissions. Information 

may be submitted via FDA’s Electronic 

Submissions Gateway or utilizing the 

‘‘Safety Reporting Portal,’’ developed by 

FDA and the National Institutes of 

Health to streamline reporting and 

review of adverse events. 

The primary purpose of FDA’s 

adverse drug experience reporting 

system is to enable identification of 

signals for potentially serious safety 

problems with marketed drugs. 

Although premarket testing discloses a 

general safety profile of a new drug’s 

comparatively common adverse effects, 

the larger and more diverse patient 

populations exposed to the marketed 

product provide the opportunity to 

collect information on rare, latent, and 

long-term effects. Signals are obtained 

from a variety of sources, including 

reports from patients, treating 

physicians, foreign regulatory agencies, 

clinical investigators, and literature. 

Information derived from the adverse 

drug experience reporting system 

contributes directly to increased public 


KHAMMOND on DSK9W7S144PROD with NOTICES
5896 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

health protection because the 

information enables FDA to make 

important changes to the product’s 

labeling (such as adding a new 

warning), to make decisions about risk 

evaluation and mitigation strategies; the 

need for postmarketing studies or 

clinical trials; and, when necessary, to 

initiate removal of a product from the 

market. 

In the Federal Register of September 

23, 2024 (89 FR 77515), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 123

21 CFR section or guidance; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

310.305(c)(5); AERs for prescription products not the subject of a marketing application ......................................... 36 88.8 3,197 1 3,197 

314.80(c)(1); 15-day alerts for approved products .............. 682 1,832.84 1,250,000 1 1,250,000 

314.80(c)(2); periodic reports for approved products .......... 682 1,228.73 838,000 60 50,280,000 

329.100; AERs for non-prescription drug products ............. 312 62.522 19,507 6 117,042 

ICH E2C(R2) Guidance; Periodic safety updates; Applicants w/waiver for an approved application (section 

III.A.) ................................................................................. 471 8.885 4,185 1 4,185 

ICH E2C(R2) Guidance; Periodic safety updates; Applicants w/no waiver for an approved application (section 

III.B.) ................................................................................. 1,115 16.254 18,123 2 36,246 

AER During Pandemic Guidance; notifying FDA when normal reporting is not feasible (section III.C.) ..................... 1 1 1 8 8 

4.103, 4.104, 4.105, 310.305, 314.80, 314.98, 329.100(c); 

Waiver requests from electronic reporting requirements 1 1 1 24 24 

Total .............................................................................. 4 2,618 ........................ 2,133,014 ........................ 51,690,702 

1There are no capital costs associated with this collection. The operating and maintenance costs associated with this collection of information 

are approximately $25,000 annually. 2The reporting burdens for § 310.305(c)(1), (2), and (3), and voluntary reports by healthcare providers received under § 314.80(c)(1)(i) and (ii) 

are covered under OMB control number 0910–0291. 3Totals may not sum due to rounding. 

4Total of unique respondents. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

21 CFR section or guidance section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

310.305; AER records—prescription product not the subject of a marketing application ....................................... 36 88.8 3,197 16 51,152 

314.80(j); AER records—product associated w/marketing 

application ...................................................................... 841 1,814.0606 1,525,625 16 24,410,000 

Postmarket AER for Nonprescription Drug Products 

Guidance; (§ 329.100) .................................................... 312 62.5224 19,507 8 156,056 

AERs During Pandemic Guidance; Continuity of operations planning (section III.B.) ........................................ 100 1 100 50 5,000 

AERs During Pandemic Guidance; documenting conditions and resultant high absenteeism (section III.C.2) .. 350 1 350 8 2,800 

AERs During Pandemic Guidance; documenting AER 

process (section III.C.1.) ................................................ 350 1 350 8 2,800 

4.105; Postmarketing safety recordkeeping for combination products and constituent parts ................................ 11 18 198 0.1 (6 minutes) 19.8 

Total ............................................................................ ........................ ........................ 1,549,327 .......................... 24,627,827.8 

1There are no capital costs associated with this collection of information. There are operating and maintenance costs associated with this collection of information of approximately $22,000 annually. 2Totals may not sum due to rounding. 


KHAMMOND on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5897 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

4.103; Postmarketing Safety reporting for combination 

products—Sharing information with other constituent 

part applicants .................................................................. 11 18 198 0.35 (21 

minutes) 

69.3 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

All applicants who have received 

marketing approval for drug products 

(including combination products that 

are administered as drug products) are 

required to report serious, unexpected 

adverse drug experiences (15-day ‘‘Alert 

reports’’) (§ 314.80(c)(1)(i)), as well as 

followup reports (§ 314.80(c)(1)(ii)) to 

FDA. These include all foreign or 

domestic AERs as well as AERs based 

on information from applicable 

scientific literature and certain reports 

from post marketing studies. Section 

314.80(c)(1)(iii) pertains to AERs 

submitted by nonapplicants. 

For operational efficiency, we have 

adjusted this information collection and 

burden table to include all 15-day alert 

reports submitted by applicants, 

manufacturers, packers, and 

distributors. Voluntary reports from 

healthcare providers are included under 

OMB control number 0910–0291. 

Under § 314.80(c)(2), applicants 

(including combination products that 

are administered as drug products) must 

also provide periodic reports of adverse 

drug experiences. For the reporting 

interval, a periodic report includes 

reports of serious, expected adverse 

drug experiences, all nonserious adverse 

drug experiences, and an index of these 

reports; a narrative summary and 

analysis of adverse drug experiences; an 

analysis of the 15-day Alert reports 

submitted during the reporting interval; 

and a history of actions taken because 

of adverse drug experiences. Under 

§ 314.80(j), applicants must keep

records of all adverse drug experience

reports known to the applicant for 10

years.

For marketed prescription drug 

products without approved new drug 

applications (NDAs) or abbreviated new 

drug applications (ANDAs), 

manufacturers, packers, and distributors 

of these products are required to report 

to FDA serious, unexpected adverse 

drug experiences as well as followup 

reports (§ 310.305(c)). Section 

310.305(c)(5) pertains to the submission 

of followup reports to reports forwarded 

to the manufacturers, packers, and 

distributors by FDA. Under § 310.305(g), 

each manufacturer, packer, and 

distributor shall maintain records of all 

adverse drug experiences required to be 

reported for 10 years. All 15-day Alert 

reports and followup reports must be 

submitted to FDA in electronic format. 

Section 760 of the FD&C Act also 

provides for mandatory safety reporting 

for over-the-counter human drug 

products not subject to applications 

approved under section 505 of the FD&C 

Act (NDAs or ANDAs). These 

requirements apply to all OTC drug 

products marketed without an approved 

application, including those marketed 

under the OTC Drug Monograph Review 

process (whether or not subject to a final 

monograph), those marketed outside the 

monograph system, and including those 

that have been discontinued from 

marketing but for which a report of an 

adverse event was received. Under 

§ 329.100, respondents must submit

reports according to section 760 of the

FD&C Act in an electronic format.

To assist respondents with 

implementation of section 760 of the 

FD&C Act, FDA developed the guidance 

for industry entitled ‘‘Postmarketing 

Adverse Event Reporting for 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application’’ (July, 2009), available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/postmarketing-adverseevent-reporting-nonprescription-humandrug-products-marketed-withoutapproved. The guidance document 

discusses what should be included in a 

serious adverse drug event report 

submitted under section 760(b)(1) of the 

FD&C Act, including how to submit 

these reports and followup reports 

under section 760(c)(2) of the FD&C Act. 

Section 760(e) of the FD&C Act also 

requires that responsible persons 

maintain records of nonprescription 

drug adverse event reports, whether the 

event is serious or not, for a period of 

6 years. FDA’s guidance recommends 

that respondents maintain records of 

efforts to obtain the minimum data 

elements for a report of a serious 

adverse drug event and any followup 

reports. 

In addition, this information 

collection includes an International 

Council for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH) guidance for industry 

entitled ‘‘Providing Postmarketing 

Periodic Safety Reports in the ICH 

E2C(R2) Format (Periodic Benefit-Risk 

Evaluation Report), (November 2016)’’ 

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

regulatory-information/search-fdaguidance-documents/providingpostmarket-periodic-safety-reports-iche2cr2-format-periodic-benefit-riskevaluation. The ICH E2C(R2) guidance 

describes the conditions under which 

applicants may use the ICH E2C(R2) 

Periodic Benefit-Risk Evaluation Report 

format for certain types of adverse event 

reporting. 

FDA regulations in §§ 314.80(c)(2) 

and 600.80(c)(2) require applicants to 

submit postmarketing periodic safety 

reports for each approved application. 

The reports must be submitted quarterly 

for the first 3 years following the U.S. 

approval date and annually thereafter 

and must contain the information 

described in §§ 314.80(c)(2)(ii) and 

600.80(c)(2)(ii) (the information 

collection associated with 21 CFR part 

600—Biological Products, is approved 

under OMB control number 0910–0308). 

The Agency guidance assists 

respondents with satisfying the 

regulatory requirements in an 

alternative format, noting that the 

process differs depending on whether 

an applicable periodic safety update 

report waiver is in place. 

Similarly, this information collection 

accounts for burden that may be 

applicable to the guidance document, 

‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During a 

Pandemic (May 2020),’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/postmarketing-adverseevent-reporting-medical-products-anddietary-supplements-during-pandemic. 

In response to the Coronavirus Disease 


KHAMMOND on DSK9W7S144PROD with NOTICES
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