On February 29, 2016, the Coalition submitted comments to the FDA on the burdens associated with the PET drug Good Manufacturing Practice (GMP) regulations at 21 CFR part 212. As previously reported, the FDA issued a Federal Notice on December 29, 2015. FDA included in their notice estimates of the recordkeeping and third-party disclosure burdens that are required to comply with the PET GMPs. The notice also describes some of the methodology that the FDA used to develop these estimates. The notice is in response to the Paperwork Reduction Act of 1995, which requires the FDA to estimate the recordkeeping burden required to comply with the PET GMPs.
The Coalition submitted comments on three areas of importance:
- Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility
- The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used
- Ways to enhance the quality, utility, and clarity of the information to be collected