[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Page 61279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1996-D-0405]


Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the withdrawal of Compliance Policy Guide Sec. 110.100, 
``Certification for Exports'' (CPG Sec. 110.100), which FDA issued in 
1980. We are taking this action because CPG Sec. 110.100 contains 
information that is either duplicative of other information we have 
published or no longer reflects the Agency's current thinking.

DATES: The withdrawal is effective November 5, 2021.

FOR FURTHER INFORMATION CONTACT: Tiffany Kelley, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-348-1970, [email protected].

SUPPLEMENTARY INFORMATION: FDA originally issued CPG Sec. 110.100 on 
October 1, 1980, in the Agency's Manual of Compliance Policy Guides. 
The CPG was revised periodically but has not been revised since April 
14, 2000.
    Since FDA last revised CPG Sec. 110.100, the Agency issued separate 
guidance for industry on FDA export certification in 2004. FDA revised 
that guidance in 2005, 2019, and, most recently, in August 2021. The 
August 2021 version of the guidance for industry, entitled ``FDA Export 
Certification,'' provides the Agency's current guidance regarding FDA 
issuance of export certification. Persons with access to the internet 
may obtain the guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Although this guidance originally 
complemented the content in CPG Sec. 110.100, changes in the document 
over time have increasingly resulted in CPG Sec. 110.100 containing 
duplicative and outdated information. Thus, FDA is withdrawing CPG Sec. 
110.100 in its entirety.

    Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24234 Filed 11-4-21; 8:45 am]
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