[Congressional Record (Bound Edition), Volume 153 (2007), Part 18]
[House]
[Page 25429]
[From the U.S. Government Publishing Office, www.gpo.gov]




       CORRECTING TECHNICAL ERRORS IN THE ENROLLMENT OF H.R. 3580

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and agree to 
the concurrent resolution (H. Con. Res. 217) to correct technical 
errors in the enrollment of the bill H.R. 3580.
  The Clerk read the title of the concurrent resolution.
  The text of the concurrent resolution is as follows:

                            H. Con. Res. 217

       Resolved by the House of Representatives (the Senate 
     concurring), That, in the enrollment of the bill H.R. 3580, 
     the Clerk of the House shall make the following corrections:
       (1) In subparagraph (I) of section 402(j)(3) of the Public 
     Health Service Act, as inserted by section 801(a)(2) of the 
     bill:
       (A) In clause (i) of such subparagraph (I), strike ``drugs 
     described in subparagraph (C)'' and insert ``drugs and 
     devices described in subparagraph (C)''.
       (B) In clause (iii) of such subparagraph (I), strike 
     ``drugs described in subparagraph (C)'' and insert ``drugs 
     and devices described in subparagraph (C)''.
       (2) In subparagraph (A) of section 505(q)(1) of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 914(a) of 
     the bill, add at the end the following:

     ``Consideration of the petition shall be separate and apart 
     from review and approval of any application.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Nebraska (Mr. Terry) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, once again I would ask unanimous consent 
that all Members may have 5 legislative days to revise and extend their 
remarks and include extraneous material on the resolution under 
consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, this resolution concerns two errors in the bill, H.R. 
3580, the Food and Drug Administration Amendments of 2007. The bill has 
passed both the House and Senate and is currently in the process of 
being enrolled for delivery to the President.
  The resolution directs the Clerk of the House to correct two errors, 
both of which were made in drafting and inadvertently occurred as we 
all worked under pressure to complete the drafting of H.R. 3580.
  We were under pressure to complete that bill, as you know, before the 
expiration date on September 30 of PDUFA, the Prescription Drug User 
Fee Act. The failure to reauthorize PDUFA in time would have caused the 
Food and Drug Administration to send out notice of employee layoffs.
  I'm aware of no objection to passage of the resolution, and I would 
urge my colleagues to support it.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TERRY. Mr. Speaker, I yield myself as much time as I may consume.
  Mr. Speaker, H.R. 3580, which passed the House last week, was highly 
technical and addressed a number of very complicated FDA policy and 
regulatory matters. I commend the bipartisan Members and the staff who 
worked so hard on the language that passed with such broad support in 
the House. Inevitably, when these complicated matters are addressed, 
some drafting and technical issues need to be revisited in a technical 
corrections bill.
  In the case of the FDA Amendments of 2007, we were especially mindful 
that the funding had to be secured to prevent the layoff of FDA 
reviewers prior to September 30. Given the importance of that deadline 
to protecting the public health, it is inevitable drafting and 
workability issues may need to be revisited. The resolution simply 
corrects two omissions from the text that was approved last week.
  I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, once again I would urge passage of this 
corrections legislation. I have no further requests for time and yield 
back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and agree to the concurrent resolution, H. Con. Res. 217.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the concurrent resolution was agreed to.
  A motion to reconsider was laid on the table.

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