Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77515 

CMS has contracted with an outside 

vendor to assist in the administration of 

the RDS program; this effort is called the 

RDS Center. Plan Sponsors will apply 

on-line for the retiree drug subsidy by 

logging on to the RDS Secure website. 

42 CFR 423.844 describes the 

requirement for qualified retiree 

prescription drug plans who want to 

receive the retiree drug subsidy. Once 

the Plan Sponsor submits the RDS 

application via the RDS Secure website 

(and a valid initial retiree list) CMS, 

using its contractor, will analyze the 

application to determine whether the 

Plan Sponsor qualifies for the RDS. To 

qualify for the subsidy, the Plan 

Sponsor must show that its coverage is 

as generous as, or more generous than, 

the defined standard coverage under the 

Medicare Part D prescription drug 

benefit. The information within the 

application includes sponsor account 

registration information, plan 

information, benefit options under the 

plan, actuary information and actuarial 

attestation. The RDS center has various 

checks within each section of the 

application. Applications can be denied 

if issues cannot be resolved. Form 

Number: CMS–10170 (OMB control 

number: 0938–0977); Frequency: Yearly; 

Affected Public: Private Sector; Business 

or other for-profits, and Not-for Profits; 

Number of Respondents: 1,245; Number 

of Responses: 1,245; Total Annual 

Hours: 79,680. (For questions regarding 

this collection, contact Ivan Iveljic at 

410–786–3312 or Ivan.iveljic@

cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–21631 Filed 9–20–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2219] 

Progynon Associates, et al.; 

Withdrawal of Approval of Four New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of four new drug applications 

(NDAs) from multiple holders of those 

NDAs. The basis for the withdrawal is 

that these NDA holders have repeatedly 

failed to file required annual reports for 

the identified NDAs. 

DATES: Approval is withdrawn as of 

September 23, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holder of an approved application to 

market a new drug for human use is 

required to submit annual reports to 

FDA concerning its approved 

application in accordance with § 314.81 

(21 CFR 314.81). 

In the Federal Register of May 28, 

2024 (89 FR 46139), FDA published a 

notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of four NDAs 

because the holders of those NDAs had 

repeatedly failed to submit the required 

annual reports for those NDAs. The 

holders of those NDAs did not respond 

to the NOOH. Failure to file a written 

notice of participation and request for 

hearing as required by § 314.200 (21 

CFR 314.200) constitutes an election by 

those holders of the NDAs not to make 

use of the opportunity for a hearing 

concerning the proposal to withdraw 

approval of their NDAs and a waiver of 

any contentions concerning the legal 

status of the drug products. Therefore, 

FDA is withdrawing approval of the 

four applications listed in table 1 of this 

document. 

TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED

Application No. Drug Holder 

NDA 004652 ..... ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg).Progynon Associates, 9300 Wilshire Blvd., Beverly Hills, CA 

90212. 

NDA 013268 ..... WINSTEROID (stanozolol) Tablets, 2 mg ................................ Sterling Winthrop Inc., 90 Park Ave., New York, NY 10016. 

NDA 017455 ..... Copper T Model TCu 200B (copper) Intrauterine Device ........ Duramed Research, Inc., 425 Privet Rd., Horsham, PA 

19044. 

NDA 205003 ..... PRESTALIA (amlodipine besylate/perindopril arginine) Tablets, equivalent to (EQ) 2.5 mg base/3.5mg, EQ 5 mg base/ 

7 mg, and EQ 10 mg base/14 mg.

Adhera Therapeutics, Inc., 224 Holding Ave., Wake Forest, 

NC 27588. 

FDA finds that the holders of the 

NDAs listed in table 1 have repeatedly 

failed to submit reports required by 

§ 314.81. In addition, under § 314.200, 

FDA finds that the holders of the NDAs 

have waived any contentions 

concerning the legal status of the drug 

products. Therefore, under these 

findings, approval of the NDAs listed in 

table 1 and all amendments and 

supplements thereto are hereby 

withdrawn as of September 23, 2024. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21680 Filed 9–20–24; 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; Proposed Collection; 

Comment Request; Postmarketing 

Adverse Experience Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 


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77516 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

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 postmarketing 

reporting and recordkeeping of adverse 

experiences for drug and biological 

products. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 22, 2024. 

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 

November 22, 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– 

2024–N–3112 for ‘‘Postmarketing 

Adverse Experience Reporting.’’ 

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: 

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: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

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 


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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77517 

promulgated 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 

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. 

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. 

4 Total 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 


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I I I 
77518 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued 

21 CFR section or guidance section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average burden per 

recordkeeping Total hours 

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 ...................................................................................................... 3 1,650 ........................ 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. 

3Total of unique respondents. 

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 


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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 

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 61,615,010.1 hours and 

2,546,310 responses as compared to the 

previous renewal. We invite comment 

on our assumptions. 

Dated: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21675 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–N–2030 and FDA– 

2024–N–0972] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 


khammond on DSKJM1Z7X2PROD with NOTICES