This guidance is for immediate implementation.
FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(3) without initially seeking prior comment. The Agency has determined that prior public participation is not feasible or appropriate because this guidance presents a less burdensome policy that is consistent with the public health. Although this guidance document is immediately in effect, it remains subject to public comment in accordance with the Agency’s good guidance practices regulation (21 CFR 10.115).
You may submit comments or suggestions at any time. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact Janet Norden, 301-796-1127; Carol Drew, 301-796-8510; (CDER) Ebla Ali Ibrahim, Office of Medical Policy, 301-796-3691; (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010; or (CDRH) Office of Device Evaluation, Clinical Trials Program, 301-796-5640.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.