To ensure transparency in Food and Drug Administration user fee agreement negotiations.

1. Adds SEC. 11__. TRANSPARENCY IN FDA USER FEE AGREEMENT NEGOTIATIONS at the end of title XI

   Adds a section

   In S. 3187 · Placed on Calendar Senate

   "(b) Financial Interest.--In this section, the term 'financial interest' means a financial interest under section 208(a) of title 18, United States Code.".

   Inserted: SEC. 11__. TRANSPARENCY IN FDA USER FEE AGREEMENT NEGOTIATIONS.

   Inserted: (a) PDUFA.--Section 736B(d) (21 U.S.C. 379h 2(d)), as amended by section 104, is further amended by adding at the end the following:

   Inserted: "(7) Inclusion of congressional representatives.--Notwithstanding any other provision of this section, Members of Congress or their designated staff may be present at any negotiation meeting conducted under this subsection between the Food and Drug Administration and the regulated industry, if a Member of Congress decides to attend, or have his or her designated staff attend on his or her behalf. Any staff designated under the preceding sentence may be required to comply with applicable confidentiality agreements.".

   Inserted: (b) MDUFA.--Section 738A(b) (21 U.S.C. 379j 1(b)), as amended by section 204, is further amended by adding at the end the following:

   Inserted: "(7) Inclusion of congressional representatives.--Notwithstanding any other provision of this section, Members of Congress or their designated staff may be present at any negotiation meeting conducted under this subsection between the Food and Drug Administration and the regulated industry, if a Member of Congress decides to attend, or have his or her designated staff attend on his or her behalf. Any staff designated under the preceding sentence may be required to comply with applicable confidentiality agreements.".

   Inserted: (c) GDUFA.--Section 744C(d), as added by section 303 of this Act, is amended by adding at the end the following:

   Inserted: "(7) Inclusion of congressional representatives.--Notwithstanding any other provision of this section, Members of Congress or their designated staff may be present at any negotiation meeting conducted under this subsection between the Food and Drug Administration and the regulated industry, if a Member of Congress decides to attend, or have his or her designated staff attend on his or her behalf. Any staff designated under the preceding sentence may be required to comply with applicable confidentiality agreements.".

   Inserted: (d) BSUFA.--Section 744I(e), as added by section 403 of this Act, is amended by adding at the end the following:

   Inserted: "(4) Inclusion of congressional representatives.--Notwithstanding any other provision of this section, Members of Congress or their designated staff may be present at any negotiation meeting conducted under this subsection between the Food and Drug Administration and the regulated industry, if a Member of Congress decides to attend, or have his or her designated staff attend on his or her behalf. Any staff designated under the preceding sentence may be required to comply with applicable confidentiality agreements.".

   Original wording

   At the end of title XI, add the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed