In the interest of public service, the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) of the Food and Drug Administration (FDA) hereby informs the Household/Urban Hazardous Substances (HUHS) industry that starting 15 December 2021 and throughout the transitory period provided in the FDA Circular 2021-011 and its subsequent amendments, CCHUHSRR shall be including a Notice of Deficiency (NOD) step in the HUHS product registration process.
A NOD shall be issued once to product registration applications with minor deficiencies to allow the HUHS establishment (applicant) to correct and address said deficiencies within seven (7) calendar days. This, however, does not preclude CCHUHSRR from outright disapproving product registration applications with major deficiencies.
Should you have further inquiries, please contact CCHUHSRR at email@example.com.
For your information and guidance.
Dissemination of this Advisory is hereby requested.