Waiver requests may be submitted as a part of an original
IND or application for marketing approval, a supplemental
application, or an amendment to an application submitted under 21
CFR Parts 314 and 601.45 The affected application should use the
waiver section of Module 1 in eCTD format and/or include a cover
letter that clearly states that a waiver under 21 CFR 312.120(c) is
being requested. The waiver section or the cover letter should
identify the affected studies and the relevant sections of the
application. If a waiver has already been requested and granted by
FDA, the previously submitted materials that include the waiver
request should be referenced in the cover letter (or in Module 1).
In addition, FDA recognizes that there may be certain
circumstances where, before submitting a waiver request, sponsors
may wish to discuss with FDA concerns regarding their ability to
meet all of the regulatory requirements under 21 CFR 312.120.
Depending on the circumstances, these issues may be discussed
with FDA during a pre-IND or pre-NDA/BLA meeting. For
example, a sponsor who is considering locating sites in a foreign
country where privacy laws would prohibit them from obtaining
IEC member names may wish to discuss their concerns during the
early stages of planning a study.
