View Information Collection Request (ICR) Package

View ICR - Agency Submission

OMB Control No:	ICR Reference No: 202607-0910-004
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 07/14/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	52,355	0
Time Burden (Hours)	103,819	0
Cost Burden (Dollars)	7,786,425	0

ICR Summary of Burden

	Total Request	Change Due to Agency Discretion
Annual Number of Responses	52,355	52,355
Annual Time Burden (Hours)	103,819	103,819
Annual Cost Burden (Dollars)	7,786,425	7,786,425

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

Annual Cost to Federal Government: $33,333

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Anne Taylor 240 402-5683 anne.taylor@fda.hhs.gov

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.