CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR1.1116]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart R - Laboratory Accreditation for Analyses of Foods

FDA Recognition of Accreditation Bodies

Sec. 1.1116 What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?

(a) Notice to FDA of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify FDA of its intention to leave the program, specifying the date on which the relinquishment or expiration will occur. The recognized accreditation body must provide the name and contact information of the custodian who will maintain and make available to FDA the records required by § 1.1124 after the date of relinquishment or the date recognition expires, as applicable. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.

(b) Notice to LAAF-accredited laboratories of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify the laboratories it LAAF accredits of its intention to leave the program, specifying the date on which relinquishment or expiration will occur.

(c) Public notice of voluntary relinquishment or expiration of recognition. FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment or expiration of recognition of an accreditation body.