It’s funny. Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document. When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.
That’s right, this morning the FDA published a brief notice announcing that the Office of Management and Budget (OMB) has approved “…a collection of information entitled ‘Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification’…” under the Paperwork Reduction Act of 1995.
That guidance was originally published in draft form back in June of 2014 (see “The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus“) along with a docket to collect public comments. The public comment collection part of the docket was officially closed back in August of 2014, but not before 17 comments were submitted by various stakeholders and others.
Today’s notice says that:
“On September 21, 2015, the Agency submitted a proposed collection of information entitled “Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0806. The approval expires on December 31, 2018.”
I can’t say I totally understand this beyond just what the words mean. We know that the original guidance was only in draft form, not final form, so no one was required to follow it yet anyway, with or without OMB approval.
Maybe this approval is an indication that the FDA is about to publish the final guidance and perhaps the OMB’s approval is necessary before they do. I don’t know. We may see soon enough.
Despite my lack of understanding of the relationship between the OMB and FDA guidance documents, I do have a deep understanding of the DSCSA itself and its implications to the members of the pharma supply chain. I suggest you pick up a copy of my new book, “The Drug Supply Chain Security Act Explained“, the second edition, from CreateSpace.com or Amazon.com.