To modify provisions relating to user fees, and for other purposes.

1. 1

   Change 1: Rewrites page 104, line 23 through page 105, line 14

   ReplacesPrinted page

   Removes page 104, line 23 through page 105, line 14 of the printed bill. See that page

   Inserted: (II) the amount equal to one-fifth of the excess amount in item (bb), provided that--

   Inserted: (aa) the amount of the total appropriation for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total appropriation for the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1); and

   Inserted: (bb) the amount of the total appropriations for the process of human drug review at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations for the process of human drug review at the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1).

   Inserted: In making the adjustment under subclause (II) for any fiscal year 2008 through 2012, subsection (c)(1) shall be applied by substituting '2007' for '2008.'

   Original wording

   Beginning on page 104, strike line 23 and all that follows through line 14 on page 105 and insert the following:

2. 2

   Change 2: Adds SEC. __. PROHIBITION ON IMPORTATION FROM A FOREIGN FOOD FACILITY THAT DENIES ACCESS TO FOOD INSPECTORS wherever appropriate

   Adds a section

   Inserted: SEC. __. PROHIBITION ON IMPORTATION FROM A FOREIGN FOOD FACILITY THAT DENIES ACCESS TO FOOD INSPECTORS.

   Inserted: Notwithstanding any other provision of law, no food product may be imported into the United States that is the product of a foreign facility registered under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) that refuses to permit United States inspectors, upon request, to inspect such facility or that unduly delays access to United States inspectors.

   The amendment doesn't say where this goes; the clerk decides.

   Original wording

   At the appropriate place, insert the following:

3. 3

   Change 3: Adds SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES wherever appropriate

   Adds a section

   Inserted: SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES.

   Inserted: Notwithstanding any other provision of this Act, the requirement that the Secretary of Health and Human Services certify that the implementation of the title of this Act relating to the Importation of Prescription Drugs will pose no additional risk to the public's health and safety and will result in a significant reduction in the cost of covered products to the American consumer shall not apply to the requirement that the Secretary require that the packaging of any prescription drug incorporates--

   Inserted: (1) not later than 18 months after the date of enactment of this Act, a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) unique to each package of such drug, applied at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing); and

   Inserted: (2) not later than 24 months after the date of enactment of this Act for the 50 prescription drugs with the highest dollar volume of sales in the United States, based on the calendar year that ends of December 31, 2007, and, not later than 30 months after the date of enactment of this Act for all other prescription drugs--

   Inserted: (A) overt optically variable counterfeit-resistant technologies that--

   Inserted: (i) are visible to the naked eye, providing for visual identification of product authenticity without the need for readers, microscopes, lighting devices, or scanners;

   Inserted: (ii) are similar to that used by the Bureau of Engraving and Printing to secure United States currency;

   Inserted: (iii) are manufactured and distributed in a highly secure, tightly controlled environment; and

   Inserted: (iv) incorporate additional layers of nonvisible convert security features up to and including forensic capability; or

   Inserted: (B) technologies that have a function of security comparable to that described in subparagraph (A), as determined by the Secretary.

   The amendment doesn't say where this goes; the clerk decides.

   Original wording

   At the appropriate place, insert the following:

4. 4

   Change 4: Adds SEC. __. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION wherever appropriate

   Adds a section

   Inserted: SEC. __. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

   Inserted: (a) Findings.--Congress finds the following:

   Inserted: (1) In 2007, there has been an overwhelming increase in the volume of aquaculture and seafood that has been found to contain substances that are not approved for use in food in the United States.

   Inserted: (2) As of May 2007, inspection programs are not able to satisfactorily accomplish the goals of ensuring the food safety of the United States.

   Inserted: (3) To protect the health and safety of consumers in the United States, the ability of the Secretary of Health and Human Services to perform inspection functions must be enhanced.

   Inserted: (b) Heightened Inspections.--The Secretary of Health and Human Services (referred to in this section as the "Secretary") is authorized to, by regulation, enhance, as necessary, the inspection regime of the Food and Drug Administration for aquaculture and seafood, consistent with obligations of the United States under international agreements and United States law.

   Inserted: (c) Report to Congress.--Not later than 90 days after the date of enactment of this Act, the Secretary shall submit to Congress a report that--

   Inserted: (1) describes the specifics of the aquaculture and seafood inspection program;

   Inserted: (2) describes the feasibility of developing a traceability system for all catfish and seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products; and

   Inserted: (3) provides for an assessment of the risks associated with particular contaminants and banned substances.

   Inserted: (d) Partnerships With States.--Upon the request by any State, the Secretary may enter into partnership agreements, as soon as practicable after the request is made, to implement inspection programs regarding the importation of aquaculture and seafood.

   Inserted: (e) Authorization of Appropriations.--There are authorized to be appropriated such sums as may be necessary to carry out this section.

   The amendment doesn't say where this goes; the clerk decides.

   Original wording

   At the appropriate place, insert the following:

5. 5

   Change 5: Adds SEC. __. SENSE OF THE SENATE REGARDING CERTAIN PATENT INFRINGEMENTS wherever appropriate

   Adds a section

   Inserted: SEC. __. SENSE OF THE SENATE REGARDING CERTAIN PATENT INFRINGEMENTS.

   Inserted: (a) Findings.--The Senate makes the following findings:

   Inserted: (1) Innovation in developing life-saving prescription drugs saves millions of lives around the world each year.

   Inserted: (2) The responsible protection of intellectual property is vital to the continued development of new and life-saving drugs and future growth of the United States economy.

   Inserted: (3) In order to maintain the global competitiveness of the United States, the United States Trade Representative's Office of Intellectual Property and Innovation develops and implements trade policy in support of vital American innovations, including innovation in the pharmaceutical and medical technology industries.

   Inserted: (4) The United States Trade Representative also provides trade policy leadership and expertise across the full range of interagency initiatives to enhance protection and enforcement of intellectual property rights.

   Inserted: (5) Strong and fair intellectual property protection, including patent, copyright, trademark, and data protection plays an integral role in fostering economic growth and development and ensuring patient access to the most effective medicines around the world.

   Inserted: (6) There are concerns that certain countries have engaged in unfair price manipulation and abuse of compulsory licensing. Americans bear the majority of research and development costs for the world, which could undermine the value of existing United States pharmaceutical patents and could impede access to important therapies.

   Inserted: (7) There is a growing global threat of counterfeit medicines and increased need for the United States Trade Representative and other United States agencies to use available trade policy measures to strengthen laws and enforcement abroad to prevent harm to United States patients and patients around the world.

   Inserted: (b) Sense of the Senate.--It is the sense of the Senate that--

   Inserted: (1) the United States Trade Representative should use all the tools at the disposal of the Trade Representative to address violations and other concerns with intellectual property, including through--

   Inserted: (A) bilateral engagement with United States trading partners;

   Show 4 more inserted paragraphsShow less

   Inserted: (B) transparency and balance of the annual "Special 301" review and reviews of compliance with the intellectual property requirements of countries with respect to which the United States grants trade preferences;

   Inserted: (C) negotiation of responsible and fair intellectual property provisions as part of bilateral and regional trade agreements; and

   Inserted: (D) multilateral engagement through the World Trade Organization (WTO); and

   Inserted: (2) the United States Trade Representative should develop and submit to Congress a strategic plan to address the problem of countries that infringe upon American pharmaceutical intellectual property rights and the problem of countries that engage in price manipulation.

   The amendment doesn't say where this goes; the clerk decides.

   Original wording

   At the appropriate place, insert the following:

6. 6

   Change 6: Adds SEC. __. CONSULTATION REGARDING GENETICALLY ENGINEERED SEAFOOD PRODUCTS wherever appropriate

   Adds a section

   Inserted: SEC. __. CONSULTATION REGARDING GENETICALLY ENGINEERED SEAFOOD PRODUCTS.

   Inserted: The Commissioner of Food and Drugs shall consult with the Assistant Administrator of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration to produce a report on any environmental risks associated with genetically engineered seafood products, including the impact on wild fish stocks.

   The amendment doesn't say where this goes; the clerk decides.

   Original wording

   At the appropriate place, insert the following:

7. 7

   Change 7: Adds SEC. __. REPORT ON THE MARKETING OF CERTAIN CRUSTACEANS wherever appropriate

   Adds a section

   Inserted: SEC. __. REPORT ON THE MARKETING OF CERTAIN CRUSTACEANS.

   Inserted: Not later than 30 days after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Secretary of Commerce, shall submit to the Health, Education, Labor, and Pensions Committee and the Committee on Commerce, Science, and Transportation of the Senate, a report on the differences between taxonomy of species of lobster in the subfamily Nephropinae, and species of langostino, specifically from the infraorder Caridea or Anomura. This report shall also describe the differences in consumer perception of such species, including such factors as taste, quality, and value of the species.

   The amendment doesn't say where this goes; the clerk decides.

   Original wording

   At the appropriate place, insert the following:

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As printed