Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77519 

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. 


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77520 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control No. Date approval 

expires 

Applications for FDA Approval to Market a New Drug ............................................................................... 0910–0001 8/31/2025 

Regulations Under the Federal Import Milk Act .......................................................................................... 0910–0212 8/31/2027 

Dated: September 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21672 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–2019–E–1081; FDA– 

2019–E–1082; FDA–2019–E–1083; FDA– 

2019–E–1084; FDA–2019–E–1085; and FDA– 

2019–E–1844] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SYMDEKO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for SYMDEKO and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by November 22, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

March 24, 2025. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 Nos. FDA– 

2019–E–1081; FDA–2019–E–1082; 

FDA–2019–E–1083; FDA–2019–E–1084; 

FDA–2019–E–1085; and FDA–2019–E– 

1844 for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; SYMDEKO.’’ 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 § 10.20 (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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 


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