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GUIDANCE DOCUMENT

Draft Guidance for Industry: Application of the "Solely Engaged" Exemptions in Parts 117 and 507 PDF October 2017

Draft

Not for implementation. Contains non-binding recommendations.

Draft Guidance for Industry: Application of the "Solely Engaged" Exemptions in Parts 117 and 507 PDF

Docket Number:
2017-D-6333

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2017-D-6333.