Delay All Day (or at Least for Six Months)

It’s out it’s out it’s out it’s out it’s oooooouuuuuttttttttttttttttt!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

That was basically the thought bubble in my head when the much anticipated delay of the revisions to the Common Rule for six months finally came out Jan. 17 (It was 4:15 p.m. and our deadline was more than an hour earlier). I didn’t have time to exhale, much less insert commas).

But then I saw this and took a breath:

DATES: This interim final rule is effective on July 19, 2018. This interim final rule delays until July 19, 2018 [ the revised Common Rule ]

Huh? How can the effective date of a rule fall on the last day that it’s actually effective? Was that a typo, I asked folks at the Department of Health and Human Services.

Actually, no.

That’s right.

“We’ll call you very shortly to explain,” folks from the HHS Office for Human Research Protections replied in an email.

It turns out to be some very technical, procedural thing on rulemaking.

Let’s back up for a second. There are two different rules we’re talking about here: One is the actual revisions to the human subject protection regulations known as the Common Rule, which came out Jan. 19, 2017, and were scheduled to go into effect exactly one year later. The other rule is a move to delay the implementation of those changes for six months, which came out Jan. 17 as an interim final rule (which they later refer to as an “IFR”).

The Common Rule revisions weren’t effective when the HHS issued the delay/interim final rule on Jan. 17. “This rule doesn’t actually exist yet,” Jerry Menikoff, director of the HHS Office for Human Research Protections, told me Jan. 17. “So our understanding is the effect of all this, as of January 19, where there would have been a whole new set of Common Rule provisions that went into the Federal Register, that’s not going to exist on January 19.”

So the July 19 effective date is the day “these rules will then enter the Federal Register together with the amendments that this new provision, the IFR, is putting into effect. And therefore from the Federal Register’s viewpoint, that is the date that all of this happens and is meaningful.”

But the big points are:

  • That date is not a typo (I was not the only one who thought so!).
  • The delay to the Common Rule changes starts now and goes to July 19.

If you’re wondering what on earth I’m talking about with this Common Rule stuff, you can stay on top of new developments in health law and regulation, and learn more, by signing up for a free trial to Bloomberg Law.