Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0498	ICR Reference No: 202009-0910-006
Status: Historical Active	Previous ICR Reference No: 202003-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 09/18/2020
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/29/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/16/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	6 Months From Approved	04/30/2021
Responses	19,431	0	19,431
Time Burden (Hours)	30,606	0	30,606
Cost Burden (Dollars)	3,400,425	0	3,400,425

Abstract: Section 801(e)(4) of the Act provides that persons exporting certain FDA-regulated products may request that FDA certify that the products meet the requirements of sections 801(e) or 802 or other requirements of the Act. The Act does not require FDA to issue certificates for food, including animal feeds, food and feed additives, and dietary supplements, or cosmetics. However, since foreign governments may require certificates for these types of products, the agency intends to continue to provide this service as resources permit. Section 801(e)(4) of the Act also provides that FDA may charge a fee of up to $175 if FDA issues a certificate within 20 days of receipt of a complete request for such a certificate. This fee may vary depending on the product type, but it will not exceed $175.

Emergency Justfication: The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted on March 27, 2020. Section 3856 of the CARES Act contained a provision that made the U.S. Food and Drug Administration (FDA) immediately obligated to review and process requests for certifications for devices not exported from the United States. These new certificates will be issued for products that have received FDA marketing authorization, are exempt from 510(k) or are preamendment, and will be shipped from one foreign country to another without entering U.S. commerce. The Food, Drug, and Cosmetic (FD&C) Act anticipates that FDA will issue certifications within 20 days of the establishment’s request for such documentation, and that FDA will collect fees for such certifications, as set forth in section 801(e)(4) of the FD&C Act.

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	19,431	19,431
Annual Time Burden (Hours)	30,606	30,606
Annual Cost Burden (Dollars)	3,400,425	3,400,425

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

Annual Cost to Federal Government: $3,300,000

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. No

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? Yes

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov