Notice2021-24234
Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance
Primary source
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Published
November 5, 2021
Effective
November 5, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Page 61279]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#3d69545b5b5c5344137658515158447d5b595c1355554e135a524b"><span class="__cf_email__" data-cfemail="5a0e333c3c3b342374113f36363f231a3c3e3b74323229743d352c">[email protected]</span></a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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]
BILLING CODE 4164-01-P
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