[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 10983-10995]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 1008. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       Strike section 252 and insert the following:

     SEC. __. MARIJUANA SMOKED BY PATIENTS.

       (a) Evaluation and Report.--
       (1) Evaluation.--The Secretary of Health and Human Services 
     shall conduct an evaluation of the manufacture, distribution, 
     and use of marijuana in States that have enacted laws 
     legalizing, decriminalizing, or otherwise allowing the use of 
     marijuana for purported medical use to determine--
       (A) whether such activity is taking place in violation of 
     any provision of Federal law for which the Department of 
     Health of Human Services is responsible; and
       (B) whether such marijuana activities are taking place in 
     violation of any provision of the Food, Drug, and Cosmetic 
     Act (21 U.S.C. 301 et seq.) that is designed to ensure the 
     safety and effectiveness of drugs used by the American 
     public.
       (2) Report.--Not later than 90 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to Congress a report concerning the 
     findings of the evaluation conducted under paragraph (1).
       (b) Determination of Effectiveness.--Not later than 30 days 
     after the date of enactment of this Act, the Commissioner of 
     Food and Drugs shall, based on available scientific data, 
     make a determination, and disclose such determination to the 
     general public, concerning--
       (1) whether or not smoked marijuana is a safe or effective 
     treatment for any medical condition; and
       (2) the adverse impact to human health, both physician and 
     mental, as a result of smoking marijuana.
                                 ______
                                 
  SA 1009. Mr. HATCH submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:


[[Page 10984]]

       At the end of title II, insert the following:

              Subtitle __Antibiotic Safety and Innovation

     SEC. 2__. DEVELOPMENT OF ANTIMICROBIALS.

       (a) Incentives for Development of New Antibiotics and New 
     Antibiotic Uses.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), as amended by this Act, is 
     further amended by adding at the end the following:
       ``(r)(1) Notwithstanding any provision of the Food and Drug 
     Administration Modernization Act of 1997 or any other 
     provision of law, a sponsor of a drug that is the subject of 
     an approved application described in paragraph (2) may elect 
     to receive, with respect to the drug--
       ``(A)(i) the 3-year exclusivity period referred to under 
     clauses (iii) and (iv) of subsection (c)(3)(E) and under 
     clauses (iii) and (iv) of subsection (j)(5)(F); and
       ``(ii) the 5-year exclusivity period referred to under 
     subsection (c)(3)(E)(ii) and under subsection (j)(5)(F)(ii); 
     or
       ``(B) a patent term extension under section 156 of title 
     35, United States Code.
       ``(2) An application described under this paragraph is an 
     application for marketing submitted under this section after 
     the date of enactment of this subsection in which--
       ``(A) the drug that is the subject of the application 
     contains an antibiotic drug; and
       ``(B) such antibiotic drug was the subject of an 
     application received by the Secretary under section 507 of 
     this Act (as in effect before November 21, 1997).
       ``(3) Paragraph (1) shall not be construed to entitle a 
     drug that is the subject of an approved application described 
     in paragraph (2) for any market exclusivities or patent 
     extensions other than those exclusivities or extensions 
     described in paragraph (1).''.
       (b) Bioequivalence to Listed Antibiotic Drug.--Section 
     505(j)(8) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355(j)(8)) is amended by adding at the end the 
     following:
       ``(D) Notwithstanding any other provision of this 
     subsection, an oral antibiotic drug that is not intended to 
     be absorbed into the bloodstream shall be considered to be 
     bioequivalent to a listed antibiotic drug only if--
       ``(i) clinical trials do not show a significant difference 
     between the antibiotic drug and the listed antibiotic drug in 
     safety and effectiveness; or
       ``(ii) the Secretary has--

       ``(I) established alternative, scientifically valid methods 
     that are reasonably expected to detect a significant 
     difference between the antibiotic drug and the listed 
     antibiotic drug in safety and effectiveness;
       ``(II) developed the alternative, scientifically valid 
     methods described in subclause (I) through notice and comment 
     rulemaking in accordance with section 553 of title 5, United 
     States Code; and
       ``(III) determined that, based on the alternative, 
     scientifically valid methods described in subclauses (I) and 
     (II), there is no significant difference between the 
     antibiotic drug and the listed antibiotic drug in safety and 
     effectiveness.''.

       (c) Public Meeting.--The Commissioner of Food and Drugs 
     shall convene a public meeting and, if appropriate, issue 
     guidance regarding which serious and life-threatening 
     infectious diseases, such as diseases due to gram-negative 
     bacteria and other diseases due to antibiotic-resistant 
     bacteria, potentially qualify for available grants and 
     contracts under subsection (a) of section 5 of the Orphan 
     Drug Act (21 U.S.C. 360ee(a)) or other incentives for 
     development.
       (d) Grants and Contracts for the Development of Orphan 
     Drugs.--Subsection (c) of section 5 of the Orphan Drug Act 
     (21 U.S.C. 360ee(c)) is amended to read as follows:
       ``(c) For grants and contracts under subsection (a), there 
     are authorized to be appropriated such sums as already have 
     been appropriated for fiscal year 2007, and $35,000,000 for 
     each subsequent fiscal year.''.

     SEC. 2__. ESTABLISHMENT OF ANTIMICROBIAL BREAKPOINTS.

       (a) Definition.--In this section, the term ``antimicrobial 
     breakpoint'' means specific values which characterize 
     bacteria as clinically susceptible, intermediate, or 
     resistant to the drug (or drugs) tested, such as Minimum 
     Inhibitory Concentrations (MICs) or zones of inhibitions.
       (b) Establishment of Breakpoints.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     direct the Commissioner of Food and Drugs to establish and 
     periodically update antimicrobial breakpoints.
       (2) Review and update.--Antimicrobial breakpoints shall be 
     reviewed and updated as necessary pursuant to recommendations 
     from the Antimicrobial Resistance Task Force and in 
     consultation with the Centers for Disease Control and 
     Prevention, or more frequently upon the discretion of the 
     Commissioner of Food and Drugs, but in no case less than once 
     every 5 years.
       (c) Public Availability.--The Secretary shall direct the 
     Commissioner of Food and Drugs to make antimicrobial 
     breakpoints publicly available within 30 days of the date of 
     establishment and any update under this section.
       (d) Advisory Organizations.--The Commissioner of Food and 
     Drugs may contract with an organization or organizations to 
     aid in the establishment of antimicrobial breakpoints under 
     this section in a manner not inconsistent with the Federal 
     Advisory Committee Act (5 U.S.C. App.). The Commissioner of 
     Food and Drugs shall make the final determination regarding 
     establishments of antimicrobial breakpoints under this 
     section.

     SEC. 2__. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING 
                   ENANTIOMERS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S. C. 355), as amended by this subtitle, is amended by 
     adding at the end the following:
       ``(s) Drugs Containing Enantiomers.--For purposes of 
     subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an 
     application is submitted under subsection (b) for a non-
     racemic drug containing as an active ingredient a single 
     enantiomer that is contained in a racemic drug approved in 
     another application under subsection (b), the single 
     enantiomer shall not be considered the same active ingredient 
     contained in the approved racemic drug, if--
       ``(1)(A) the single enantiomer has not been previously 
     approved as an active ingredient except in the approved 
     racemic drug; and
       ``(B) the application submitted under subsection (b) for 
     the drug containing the single enantiomer includes full 
     reports of investigations described in subsection (b)(1)(A) 
     which do not rely on any investigations that are part of the 
     application submitted under subsection (b) for approval of 
     the approved racemic drug; and
       ``(2)(A) the application submitted under subsection (b) for 
     the drug containing the single enantiomer is not submitted 
     for approval of a use--
       ``(i) in a therapeutic area in which the approved racemic 
     drug has been approved; or
       ``(ii) for which any other enantiomer of the racemic drug 
     has been approved; or
       ``(B) in the case of an antibiotic drug, such drug is 
     demonstrated through well-controlled clinical trials to be 
     safe and effective for a use for which the racemic drug has 
     not been approved and for which no other enantiomer of the 
     racemic drug has been previously approved.''.
                                 ______
                                 
  SA 1010. Mr. COCHRAN (for himself, Mr. Carper, Mr. Nelson of 
Nebraska, Mr. Hatch, Mr. Bennett, Mr. Enzi, Mr. Burr, and Mr. Menendez) 
submitted an amendment intended to be proposed to amendment SA 990 
submitted by Mr. Dorgan (for himself, Ms. Snowe, Mr. Grassley, Mr. 
McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders, 
Mr. Whitehouse, and Mrs. McCaskill) to the bill S. 1082, to amend the 
Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; as 
follows:

       At the end of the amendment, add the following:

     SEC. __. PROTECTION OF HEALTH AND SAFETY.

       This title, and the amendments made by this title, shall 
     become effective only if the Secretary of Health and Human 
     Services certifies to Congress that the implementation of 
     this title (and amendments) will--
       (1) pose no additional risk to the public's health and 
     safety; and
       (2) result in a significant reduction in the cost of 
     covered products to the American consumer.
                                 ______
                                 
  SA 1011. Ms. STABENOW (for herself, Mr. Thune, Mr. Lott, Mr. Brown, 
and Mr. Kohl) submitted an amendment intended to be proposed by her to 
the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to 
reauthorize and amend the prescription drug user fee provisions, and 
for other purposes; as follows:

       At the appropriate place, insert the following:

     SEC. __. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY 
                   ACTION.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by this Act, is amended by adding at 
     the end the following:
       ``(r) Citizen Petitions and Petitions for Stay of Agency 
     Action.--
       ``(1) In general.--
       ``(A) No delay of consideration or approval.--
       ``(i) In general.--With respect to a pending application 
     submitted under subsection (b)(2) or (j), if a petition is 
     submitted to the Secretary that seeks to have the Secretary 
     take, or refrain from taking, any form of action relating to 
     the approval of the application, including a delay in the 
     effective date of the application, clauses (ii) and (iii) 
     shall apply.
       ``(ii) No delay of consideration.--The receipt of a 
     petition is not just cause to delay consideration of an 
     application submitted under subsection (b)(2) or (j) and 
     consideration of a petition described in clause (i) shall be 
     separate and apart from the review of an application 
     submitted under either such subsection.
       ``(iii) No delay of approval without determination.--The 
     Secretary shall not delay approval of an application 
     submitted under

[[Page 10985]]

     subsection (b)(2) or (j) while a petition described in clause 
     (i) is reviewed and considered unless the Secretary 
     determines, not later than 30 days after the submission of 
     the petition, that a delay is necessary to protect the public 
     health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A)(iii) 
     that a delay is necessary to protect the public health the 
     following shall apply:
       ``(i) Not later than 5 days after making such 
     determination, the Secretary shall publish on the Internet 
     website of the Food and Drug Administration a detailed 
     statement providing the reasons underlying the determination. 
     The detailed statement shall include a summary of the 
     petition and comments and supplements, the specific 
     substantive issues that the petition raises which need to be 
     considered prior to approving a pending application submitted 
     under subsection (b)(2) or (j), and any clarifications and 
     additional data that is needed by the Secretary to promptly 
     review the petition.
       ``(ii) Not later than 10 days after making such 
     determination, the Secretary shall provide notice to the 
     sponsor of the pending application submitted under subsection 
     (b)(2) or (j) and provide an opportunity for a meeting with 
     appropriate staff as determined by the Commissioner to 
     discuss the determination.
       ``(2) Timing of final agency action on petitions.--
       ``(A) In general.--Notwithstanding a determination made by 
     the Secretary under paragraph (1)(A)(iii), the Secretary 
     shall take final agency action with respect to a petition not 
     later than 180 days of submission of that petition unless the 
     Secretary determines, prior to the date that is 180 days 
     after the date of submission of the petition, that a delay is 
     necessary to protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A) that a 
     delay is necessary to protect the public health the following 
     shall apply:
       ``(i) Not later than 5 days after making the determination 
     under subparagraph (A), the Secretary shall publish on the 
     Internet website of the Food and Drug Administration a 
     detailed statement providing the reasons underlying the 
     determination. The detailed statement should include the 
     state of the review of the petition, the specific outstanding 
     issues that still need to be resolved, a proposed timeframe 
     to resolve the issues, and any additional information that 
     has been requested by the Secretary of the petitioner or 
     needed by the Secretary in order to resolve the petition and 
     not further delay an application filed under subsection 
     (b)(2) or (j).
       ``(ii) Not later than 10 days after making the 
     determination under subparagraph (A), the Secretary shall 
     provide notice to the sponsor of the pending application 
     submitted under subsection (b)(2) or (j) and provide an 
     opportunity for a meeting with appropriate staff as 
     determined by the Commissioner to discuss the determination.
       ``(3) Verifications.--
       ``(A) Petitions for review.--The Secretary shall not accept 
     a petition for review unless it is signed and contains the 
     following verification: `I certify that, to my best knowledge 
     and belief: (a) this petition includes all information and 
     views upon which the petition relies; and (b) this petition 
     includes representative data and/or information known to the 
     petitioner which are unfavorable to the petition. I further 
     certify that the information upon which I have based the 
     action requested herein first became known to the party on 
     whose behalf this petition is filed on or about __________. I 
     received or expect to receive payments, including cash and 
     other forms of consideration, from the following persons or 
     organizations to file this petition: ________. I verify under 
     penalty of perjury that the foregoing is true and correct.', 
     with the date of the filing of such petition and the 
     signature of the petitioner inserted in the first and second 
     blank space, respectively.
       ``(B) Supplemental information.--The Secretary shall not 
     accept for review any supplemental information or comments on 
     a petition unless the party submitting such information or 
     comments does so in written form and that the subject 
     document is signed and contains the following verification: 
     `I certify that, to my best knowledge and belief: (a) I have 
     not intentionally delayed submission of this document or its 
     contents. I further certify that the information upon which I 
     have based the action requested herein first became known to 
     me on or about __________. I received or expect to receive 
     payments, including cash and other forms of consideration, 
     from the following persons or organizations to submit this 
     information or its contents: _____. I verify under penalty of 
     perjury that the foregoing is true and correct.', with the 
     date of the submission of such document and the signature of 
     the petitioner inserted in the first and second blank space, 
     respectively.
       ``(4) Annual report on delays in approvals per petition.--
     The Secretary shall annually submit to the Congress a report 
     that specifies--
       ``(A) the number of applications under subsection (b)(2) 
     and (j) that were approved during the preceding 1-year 
     period;
       ``(B) the number of petitions that were submitted during 
     such period;
       ``(C) the number of applications whose effective dates were 
     delayed by petitions during such period and the number of 
     days by which the applications were so delayed; and
       ``(D) the number of petitions that were filed under this 
     subsection that were deemed by the Secretary under paragraph 
     (1)(A)(iii) to require delaying an application under 
     subsection (b)(2) or (j) and the number of days by which the 
     applications were so delayed.
       ``(5) Exception.--This subsection does not apply to a 
     petition that is made by the sponsor of the application under 
     subsection (b)(2) or (j) and that seeks only to have the 
     Secretary take or refrain from taking any form of action with 
     respect to that application.
       ``(6) Report by inspector general.--The Office of Inspector 
     General of the Department of Health and Human Services shall 
     issue a report not later than 2 years after the date of 
     enactment of this subsection evaluating evidence of the 
     compliance of the Food and Drug Administration with the 
     requirement that the consideration by the Secretary of 
     petitions that do not raise public health concerns remain 
     separate and apart from the review and approval of an 
     application submitted under subsection (b)(2) or (j).
       ``(7) Definition.--For purposes of this subsection, the 
     term `petition' includes any request to the Secretary, 
     without regard to whether the request is characterized as a 
     petition.''.
                                 ______
                                 
  SA 1012. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. AUTHORIZATION OF APPROPRIATIONS FOR THE OFFICE OF 
                   GENERIC DRUGS.

       Notwithstanding section 736(b) of the Federal Food, Drug, 
     and Cosmetic Act (as amended by section 103(b) of this Act), 
     the Secretary of Health and Human Services shall allocate 
     $20,000,000 of the user fees generated by section 736(a) of 
     the Federal Food, Drug, and Cosmetic Act (as amended by 
     section 103(a) of this Act), for each fiscal year beginning 
     with fiscal year 2009 and ending with fiscal year 2012, to 
     the Office of Generic Drugs of the Food and Drug 
     Administration, for the sole purpose of reviewing and 
     approving abbreviated new drug applications.
                                 ______
                                 
  SA 1013. Mr. VITTER submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. OFFICE OF GENERIC DRUGS.

       (a) Findings.--Congress makes the following findings:
       (1) More than $100,000,000,000 in blockbuster brand 
     pharmaceutical products will lose patent protection between 
     April 2007 and 2010. As a result, more applications for 
     generic versions of these products will be filed with the 
     Office of Generic Drugs of the Food and Drug Administration.
       (2) The staff of the Office of Generic Drugs is backlogged. 
     Approximately 800 generic drug applications are pending 
     review as of April 2007.
       (3) The workload of the Office of Generic Drugs has 
     increased by 36 percent since 2004, yet the Office has the 
     same budget and the same number of staff.
       (4) The workload of the Office of Generic Drugs also has 
     increased due to the filing of citizen petitions by brand 
     companies designed to delay generic drug approvals.
       (5) A modest investment in the Office of Generic Drugs, 
     such as $15,000,000, would help to make more affordable 
     medicines available in a timely manner to consumers and 
     public and private health care purchasers, who would save 
     billions of dollars.
       (6) Those savings also would enable the Federal Government 
     to reach more Americans through important health care 
     initiatives, such as Medicare, Medicaid, and programs to 
     improve children's health care, assist the chronically ill, 
     and fight HIV/AIDS.
       (b) Authorization of Appropriations.--Notwithstanding 
     section 736(b) of the Federal Food, Drug, and Cosmetic Act 
     (as amended by section 103(b) of this Act), the Secretary of 
     Health and Human Services shall allocate $20,000,000 of the 
     user fees generated by section 736(a) of the Federal Food, 
     Drug, and Cosmetic Act (as amended by section 103(a) of this 
     Act), for each fiscal year beginning with fiscal year 2009 
     and ending with fiscal year 2012, to the Office of Generic 
     Drugs of the Food and Drug Administration, for the sole 
     purpose of reviewing and approving abbreviated new drug 
     applications.
                                 ______
                                 
  SA 1014. Mr. VITTER submitted an amendment intended to be proposed to

[[Page 10986]]

amendment SA 990 submitted by Mr. Dorgan (for himself, Ms. Snowe, Mr. 
Grassley, Mr. McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, 
Mr. Sanders, Mr. Whitehouse, and Mrs. McCaskill) to the bill S. 1082, 
to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 
amend the prescription drug user fee provisions, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the appropriate place in the amendment, insert the 
     following:

     SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR PRESCRIPTION 
                   DRUGS.

       (a) Required Technologies.--The Secretary of Health and 
     Human Services shall require that the packaging of any 
     prescription drug incorporate--
       (1) radio frequency identification (RFID) tagging 
     technology, or similar trace and track technologies that have 
     an equivalent function;
       (2) tamper-indicating technologies; and
       (3) blister security packaging when possible.
       (b) Use of Technologies.--
       (1) Authorized uses.--The Secretary shall require that 
     technologies described in subsection (a)(1) be used 
     exclusively to authenticate the pedigree of prescription 
     drugs, including by--
       (A) implementing inventory control;
       (B) tracking and tracing prescription drugs;
       (C) verifying shipment or receipt of prescription drugs;
       (D) authenticating finished prescription drugs; and
       (E) electronically authenticating the pedigree of 
     prescription drugs.
       (2) Privacy protection.--The Secretary shall prohibit 
     technologies required by subsection (a)(1) from containing or 
     transmitting any information that may be used to identify a 
     health care practitioner or the prescription drug consumer.
       (3) Prohibition against advertising.--The Secretary shall 
     prohibit technologies required by subsection (a)(1) from 
     containing or transmitting any advertisement or information 
     about prescription drug indications or off-label prescription 
     drug uses.
       (c) Recommended Technologies.--The Secretary shall 
     encourage the manufacturers and distributors of prescription 
     drugs to incorporate into the packaging of such drugs, in 
     addition to the technologies required under subsection (a), 
     overt optically variable counterfeit-resistant technologies 
     that--
       (1) are visible to the naked eye, providing for visual 
     identification of prescription drug authenticity without the 
     need for readers, microscopes, lighting devices, or scanners;
       (2) are similar to technologies used by the Bureau of 
     Engraving and Printing to secure United States currency;
       (3) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (4) incorporate additional layers of non-visible covert 
     security features up to and including forensic capability.
       (d) Standards for Packaging.--
       (1) Multiple elements.--For the purpose of making it more 
     difficult to counterfeit the packaging of prescription drugs, 
     the Secretary shall require manufacturers of prescription 
     drugs to incorporate the technologies described in paragraphs 
     (1), (2), and (3) of subsection (a), and shall encourage 
     manufacturers and distributors of prescription drugs to 
     incorporate the technologies described in subsection (c), 
     into multiple elements of the physical packaging of the 
     drugs, including--
       (A) blister packs, shrink wrap, package labels, package 
     seals, bottles, and boxes; and
       (B) at the item level.
       (2) Labeling of shipping container.--Shipments of 
     prescription drugs shall include a label on the shipping 
     container that incorporates the technologies described in 
     subsection (a)(1), so that members of the supply chain 
     inspecting the packages will be able to determine the 
     authenticity of the shipment. Chain of custody procedures 
     shall apply to such labels and shall include procedures 
     applicable to contractual agreements for the use and 
     distribution of the labels, methods to audit the use of the 
     labels, and database access for the relevant governmental 
     agencies for audit or verification of the use and 
     distribution of the labels.
       (e) Penalty.--A prescription drug is deemed to be 
     misbranded for purposes of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) if the packaging or 
     labeling of the drug is in violation of a requirement or 
     prohibition applicable to the drug under subsection (a), (b), 
     or (d).
       (f) Transitional Provisions; Effective Dates.--
       (1) National specified list of susceptible prescription 
     drugs.--
       (A) Initial publication.--Not later than 180 days after the 
     date of the enactment of this Act, the Secretary shall 
     publish in the Federal Register a list, to be known as the 
     National Specified List of Susceptible Prescription Drugs, 
     consisting of not less than 30 of the prescription drugs that 
     are most frequently subject to counterfeiting in the United 
     States (as determined by the Secretary).
       (B) Revision.--Not less than annually through the end of 
     calendar year 2010, the Secretary shall review and, as 
     appropriate, revise the National Specified List of 
     Susceptible Prescription Drugs. The Secretary may not revise 
     the List to include fewer than 30 prescription drugs.
       (2) Effective dates.--The Secretary shall implement the 
     requirements and prohibitions of subsections (a), (b), and 
     (d)--
       (A) with respect to prescription drugs on the National 
     Specified List of Susceptible Prescription Drugs, beginning 
     not later than the earlier of--
       (i) 1 year after the initial publication of such List; or
       (ii) December 31, 2008; and
       (B) with respect to all prescription drugs, beginning not 
     later than December 31, 2011.
       (3) Authorized uses during transitional period.--In lieu of 
     the requirements specified in subsection (b)(1), for the 
     period beginning on the effective date applicable under 
     paragraph (2)(A) and ending on the commencement of the 
     effective date applicable under paragraph (2)(B), the 
     Secretary shall require that technologies described in 
     subsection (a)(1) be used exclusively to verify the 
     authenticity of prescription drugs.
       (g) Definitions.--In this Act:
       (1) The term ``pedigree''--
       (A) means the history of each prior sale, purchase, or 
     trade of the prescription drug involved to a distributor or 
     retailer of the drug (including the date of the transaction 
     and the names and addresses of all parties to the 
     transaction); and
       (B) excludes information about the sale, purchase, or trade 
     of the drug to the drug consumer.
       (2) The term ``prescription drug'' means a drug subject to 
     section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 353(b)(1)).
       (3) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

                                 ______
                                 
  SA 1015. Mr. HAGEL (for himself and Mrs. Clinton) submitted an 
amendment intended to be proposed by him to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. LUNG CANCER COMPUTED TOMOGRAPHY ASSESSMENT AND 
                   INTERIM QUALITY STANDARDS.

       Not later than 180 days after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall submit 
     to Congress a report that contains--
       (1) an assessment of the number, quality, charges, and 
     capabilities of sites offering computed tomography scanning 
     for the diagnosis of lung cancer;
       (2) interim quality standards for computed tomography 
     scanning for the diagnosis of lung cancer which incorporate 
     the protocol established by the International Early Lung 
     Cancer Action Program and contained in the document dated 
     October 20, 2006 entitled ``International Early Lung Cancer 
     Action Program: Enrollment and Screening Protocol''; and
       (3) recommendations, including legislative recommendations 
     if appropriate, for the establishment of lung cancer 
     diagnostic centers, as practicable, to collect and analyze 
     the data as recommended under the protocol described in 
     paragraph (2) in order to continue and accelerate research 
     into the early detection, diagnosis, and treatment of lung 
     cancer.
                                 ______
                                 
  SA 1016. Mr. SPECTER submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place in the bill, insert the following:

     SEC. __. NATIONAL CENTERS FOR PHARMACEUTICAL INNOVATION.

       Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 371 et seq.) is amended by adding at the end the 
     following:

      ``Subchapter __--Establishment of the National Centers for 
                       Pharmaceutical Innovation

     ``SEC. __1. ESTABLISHMENT OF THE CENTERS.

       ``(a) In General.--The Commissioner of Food and Drugs, in 
     consultation with the Secretary, shall establish through 
     competitive selection not more than 5 university-based 
     National Centers for Pharmaceutical Innovation (referred to 
     in this subchapter as the `Centers').
       ``(b) Purpose of Centers.--The purpose of the Centers is to 
     advance the Food and Drug Administration's Critical Path 
     Initiative, as well as subsequent efforts, to modernize 
     medical pharmaceutical product development by--
       ``(1) designing methodologies to dramatically increase the 
     speed at which new drugs

[[Page 10987]]

     enter the market while significantly reducing the cost of 
     such process;
       ``(2) developing new technological tools to speed the 
     creation of safer, more effective drugs targeted at 
     individuals;
       ``(3) assisting the Food and Drug Administration with drug 
     therapy-monitoring programs to look for adverse consequences 
     utilizing medicines;
       ``(4) expanding the quality and number of professionals 
     trained in translational medicine, translational 
     therapeutics, and the manufacture of pharmaceutical and 
     biotechnology products; and
       ``(5) introducing new technologies to improve the 
     manufacture of pharmaceutical and biotechnology products.

     ``SEC. __2. CRITERIA FOR SELECTION.

       ``The Commissioner of Food and Drugs, in consultation with 
     the Secretary, shall select the Centers from among qualified 
     university or university consortium applicants on the basis 
     of key factors in pharmaceutical product development, safety, 
     and manufacturing technology, including--
       ``(1) whether the applicant has established graduate 
     training programs that integrate the elements of 
     translational therapeutics, including basic and clinical 
     pharmacology, pharmaceutical science, including 
     pharmacokinetic modeling, analytical technologies, genomics 
     and proteomics, pharmacoepidemiology, informatics, and 
     statistics;
       ``(2) demonstration of extensive experience in the 
     development and evaluation of medicines through drug approval 
     to the post-marketing process;
       ``(3) scientific programs in translational therapeutics and 
     pharmaceutical science designed to hasten the personalization 
     of medicine;
       ``(4) proficiencies in pharmaceutical and biotechnology 
     science and engineering, including therapy development and 
     manufacturing; and
       ``(5) other factors that the Commissioner of Food and Drugs 
     determines appropriate.

     ``SEC. __3. AUTHORIZATION OF APPROPRIATIONS.

       ``There are authorized to be appropriated to carry out this 
     subchapter such sums as may be necessary for each of the 
     fiscal years 2008 through 2013.''.
                                 ______
                                 
  SA 1017. Mr. GREGG (for himself and Mr. Coleman) submitted an 
amendment intended to be proposed to amendment SA 990 submitted by Mr. 
Dorgan (for himself, Ms. Snowe,, Mr. Grassley, Mr. McCain, Ms. 
Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders, Mr. 
Whitehouse, and Mrs. McCaskill) to the bill S. 1082, to amend the 
Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       Strike sections 7 and 8 of the amendment and insert the 
     following:

     SEC. 7. INTERNET PHARMACIES.

       (a) Internet Pharmacies.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
     inserting after section 510 the following:

     ``SEC. 511. INTERNET PHARMACIES.

       ``(a) Definitions.--In this section:
       ``(1) Advertising service provider.--The term `advertising 
     service provider' means an advertising company that contracts 
     with a provider of an interactive computer service (as 
     defined in section 230(f) of the Communications Act of 1934 
     (47 U.S.C. 230(f)) to provide advertising on the Internet.
       ``(2) Designated payment system.--
       ``(A) In general.--The term `designated payment system' 
     means a system used by a person described in subparagraph (B) 
     to effect a credit transaction, electronic fund transfer, or 
     money transmitting service that the Board determines, by 
     regulation or order, is regularly used in connection with, or 
     to facilitate restricted transactions.
       ``(B) Persons described.--A person referred to in 
     subparagraph (A) is--
       ``(i) a creditor;
       ``(ii) a credit card issuer;
       ``(iii) a financial institution;
       ``(iv) an operator of a terminal at which an electronic 
     fund transfer may be initiated;
       ``(v) a money transmitting business; or
       ``(vi) a participant in an international, national, 
     regional, or local network constructed primarily to effect a 
     credit transaction, electronic fund transfer, or money 
     transmitting service.
       ``(3) Federal functional regulator.--The term `Federal 
     functional regulator' has the meaning given the term in 
     section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809).
       ``(4) Internet pharmacy.--The term `Internet pharmacy' 
     means a person that offers to dispense or dispenses in the 
     United States a prescription drug through an Internet website 
     in interstate commerce, regardless of whether the physical 
     location of the principal place of business of the Internet 
     pharmacy is in the United States or in another country.
       ``(5) Prescription drug.--The term `prescription drug' 
     means a drug described in section 503(b) that is approved by 
     the Secretary under section 505.
       ``(6) Restricted transaction.--The term `restricted 
     transaction' means a transaction or transmittal, on behalf of 
     a individual who places an unlawful Internet pharmacy request 
     to any person engaged in the operation of an unlicensed 
     Internet pharmacy, of--
       ``(A) credit, or the proceeds of credit, extended to or on 
     behalf of the individual for the purpose of the unlawful 
     Internet request (including credit extended through the use 
     of a credit card);
       ``(B) an electronic fund transfer or funds transmitted by 
     or through a money transmitting business, or the proceeds of 
     an electronic fund transfer or money transmitting service, 
     from or on behalf of the individual for the purpose of the 
     unlawful Internet request;
       ``(C) a check, draft, or similar instrument which is drawn 
     by or on behalf of the individual for the purpose of the 
     unlawful Internet request and is drawn on or payable at or 
     through any financial institution; or
       ``(D) the proceeds of any other form of financial 
     transaction (identified by the Board by regulation) that 
     involves a financial institution as a payor or financial 
     intermediary on behalf of or for the benefit of the 
     individual for the purpose of the unlawful Internet request.
       ``(7) Treating provider.--The term `treating provider' 
     means a health care provider licensed in the United States 
     who is authorized to prescribe medications and who--
       ``(A)(i) performs a documented patient evaluation 
     (including a patient history and physical examination) of an 
     individual, portions of which may be conducted by other 
     health professionals;
       ``(ii) discusses with the individual the treatment options 
     of the individual and the risks and benefits of treatment; 
     and
       ``(iii) maintains contemporaneous medical records 
     concerning the individual; or
       ``(B) provides care to an individual as part of an on-call 
     or cross-coverage arrangement with a health care provider 
     described in subparagraph (A).
       ``(8) Unlawful internet pharmacy request.--The term 
     `unlawful Internet pharmacy request' means the request, or 
     transmittal of a request, made to an unlicensed Internet 
     pharmacy for a prescription drug by mail (including a private 
     carrier), facsimile, telephone, or electronic mail, or by a 
     means that involves the use, in whole or in part, of the 
     Internet.
       ``(9) Unlicensed internet pharmacy.--The term `unlicensed 
     Internet pharmacy' means an Internet pharmacy that is not 
     licensed under this section.
       ``(10) Other definitions.--
       ``(A) Board.--The term `Board' means the Board of Governors 
     of the Federal Reserve System.
       ``(B) Credit; creditor; credit card.--The terms `credit', 
     `creditor', and `credit card' have the meanings given the 
     terms in section 103 of the Truth in Lending Act (15 U.S.C. 
     1602).
       ``(C) Electronic fund transfer.--The term `electronic fund 
     transfer'--
       ``(i) has the meaning given the term in section 903 of the 
     Electronic Fund Transfer Act (15 U.S.C. 1693a); and
       ``(ii) includes any fund transfer covered under article 4A 
     of the Uniform Commercial Code, as in effect in any State.
       ``(D) Financial institution.--The term `financial 
     institution'--
       ``(i) has the meaning given the term in section 903 of the 
     Electronic Transfer Fund Act (15 U.S.C. 1693a); and
       ``(ii) includes a financial institution (as defined in 
     section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
       ``(E) Money transmitting business; money transmitting 
     service.--The terms `money transmitting business' and `money 
     transmitting service' have the meanings given the terms in 
     section 5330(d) of title 31, United States Code.
       ``(b) In General.--An Internet pharmacy may only dispense 
     or offer to dispense a prescription drug to a person in the 
     United States in accordance with this section.
       ``(c) Licensing of Internet Pharmacies.--
       ``(1) In general.--An Internet pharmacy shall be licensed 
     by the Secretary in accordance with this section prior to 
     offering to dispense or dispensing a prescription drug to an 
     individual.
       ``(2) Conditions for licensing.--
       ``(A) Application requirements.--An Internet pharmacy shall 
     submit to the Secretary an application that includes--
       ``(i)(I) in the case of an Internet pharmacy located in the 
     United States, verification that, in each State in which the 
     Internet pharmacy engages in dispensing or offering to 
     dispense prescription drugs, the Internet pharmacy, and all 
     employees and agents of the Internet pharmacy, is in 
     compliance with applicable Federal and State laws regarding--

       ``(aa) the practice of pharmacy, including licensing laws 
     and inspection requirements; and
       ``(bb) the manufacturing and distribution of controlled 
     substances, including with respect to mailing or shipping 
     controlled substances to consumers; or

       ``(II) in the case of an Internet pharmacy whose principal 
     place of business is located outside the United States, 
     verification that--

[[Page 10988]]

       ``(aa) all employees and agents of the Internet pharmacy 
     are in compliance with applicable Federal and State laws 
     regarding the practice of pharmacy, including licensing laws 
     and inspection requirements;
       ``(bb) the Internet pharmacy is in compliance with 
     applicable Federal and State laws regarding the practice of 
     pharmacy, including licensing laws and inspection 
     requirements;
       ``(cc) the Internet pharmacy expressly and affirmatively 
     agrees to provide and maintain an agent for service of 
     process in the United States;
       ``(dd) the Internet pharmacy expressly and affirmatively 
     agrees to be subject to the jurisdiction of the United States 
     and any of its States or territories where it engages in 
     commerce; and
       ``(ee) the Internet pharmacy agrees to affix to each 
     shipping container of drugs to be shipped in the United 
     States such markings as the Secretary determines to be 
     necessary to identify that the shipment is from a licensed 
     Internet pharmacy, which may include anticounterfeiting or 
     track-and-trace technologies;

       ``(ii) verification that the person that owns the Internet 
     pharmacy has not had a license for an Internet pharmacy 
     terminated by the Secretary, and that no other Internet 
     pharmacy owned by the person has had a license under this 
     subsection that has been terminated by the Secretary;
       ``(iii) verification from the person that owns the Internet 
     pharmacy that the person will permit inspection of the 
     facilities and business practices of the Internet pharmacy by 
     the Secretary to the extent necessary to determine whether 
     the Internet pharmacy is in compliance with this subsection;
       ``(iv) in the case of an agreement between a patient and an 
     Internet pharmacy that releases the Internet pharmacy, and 
     any employee or agent of the Internet pharmacy, from 
     liability for damages arising out of the negligence of the 
     Internet pharmacy, an assurance that such a limitation of 
     liability shall be null and void;
       ``(v) verification that the Internet pharmacy expressly and 
     affirmatively agrees to provide the Secretary with the 
     identity of any providers of interactive computer services 
     that provide host services or advertising services for the 
     Internet pharmacy; and
       ``(vi) assurance that the Internet pharmacy will comply 
     with the requirements under subparagraphs (B) and (C).
       ``(B) Identification requirements.--An Internet pharmacy 
     shall post in a clear and visible manner, on each page of the 
     website of the Internet pharmacy or by a link to a separate 
     page, the following information:
       ``(i) The street address, city, ZIP Code or comparable mail 
     code, State (or comparable entity), country, and telephone 
     number of--

       ``(I) each place of business of the Internet pharmacy; and
       ``(II) the name of the supervising pharmacist of the 
     Internet pharmacy and each individual who serves as a 
     pharmacist for purposes of the Internet pharmacy website.

       ``(ii) The names of all States in which the Internet 
     pharmacy and the pharmacists employed by the Internet 
     pharmacy are licensed or otherwise authorized to dispense 
     prescription drugs.
       ``(iii) If the Internet pharmacy makes referrals to, or 
     solicits on behalf of, a health care practitioner or group of 
     practitioners in the United States for prescription 
     services--

       ``(I) the name, street address, city, ZIP Code or 
     comparable mail code, State, and telephone number of the 
     practitioner or group; and
       ``(II) the name of each State in which each practitioner is 
     licensed or otherwise authorized to prescribe drugs.

       ``(iv) A statement that the Internet pharmacy will dispense 
     prescription drugs only after receipt of a valid prescription 
     from a treating provider.
       ``(v) A distinctive tamper resistant seal to identify that 
     the Internet pharmacy is licensed.
       ``(C) Professional services requirements.--An Internet 
     pharmacy shall carry out the following:
       ``(i) Maintain patient medication profiles and other 
     related data in a readily accessible format organized to 
     facilitate consultation with treating providers, caregivers, 
     and patients.
       ``(ii) Conduct prospective drug use reviews before 
     dispensing medications or medical devices.
       ``(iii) Ensure patient confidentiality and the protection 
     of patient identity and patient-specific information, in 
     accordance with the regulations promulgated under section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996.
       ``(iv) Offer interactive and meaningful consultation by a 
     licensed pharmacist to the caregiver or patient before and 
     after the time at which the Internet pharmacy dispenses the 
     drug.
       ``(v)(I) Establish a mechanism for patients to report 
     errors and suspected adverse drug reactions.
       ``(II) Document in the reporting mechanism the response of 
     the Internet pharmacy to those reports.
       ``(III) Submit those reports within 3 days of receipt and 
     the response of the Internet pharmacy to the Food and Drug 
     Administration in a manner determined appropriate by the 
     Secretary.
       ``(vi) Develop a system to inform caregivers and patients 
     about drug recalls.
       ``(vii) Educate caregivers and patients about the 
     appropriate means of disposing of expired, damaged, or 
     unusable medications.
       ``(viii) Assure that the sale of a prescription drug is in 
     accordance with a valid prescription from the treating 
     provider of the individual.
       ``(ix)(I) Verify the validity of the prescription of an 
     individual by using 1 of the following methods:

       ``(aa) If the prescription for any drug other than a 
     controlled substance (as defined in section 102 of the 
     Controlled Substances Act (21 U.S.C. 802)) is received from 
     an individual or the treating provider of the individual by 
     mail (including a private carrier), or from the treating 
     provider of the individual by electronic mail, the validity 
     of the prescription shall be confirmed in accordance with all 
     applicable Federal and State laws.
       ``(bb) If the prescription is for a controlled substance 
     (as defined in section 102 of the Controlled Substances Act), 
     the validity of the prescription shall be confirmed with the 
     treating provider as described in subclause (II).

       ``(II) When seeking verification of a prescription of an 
     individual under subclause (I)(bb), an Internet pharmacy 
     shall provide to the treating provider the following 
     information:

       ``(aa) The full name and address of the individual.
       ``(bb) Identification of the prescription drug.
       ``(cc) The quantity of the prescription drug to be 
     dispensed.
       ``(dd) The date on which the individual presented the 
     prescription to the Internet pharmacy.
       ``(ee) The date and time of the verification request.
       ``(ff) The name of a contact person at the Internet 
     pharmacy, including a voice telephone number, electronic mail 
     address, and facsimile telephone number.

       ``(III) A prescription is verified under subclause (I)(bb) 
     only if 1 of the following occurs:

       ``(aa) The treating provider confirms, by direct 
     communication with the Internet pharmacy, that the 
     prescription is accurate.
       ``(bb) The treating provider informs the Internet pharmacy 
     that the prescription is inaccurate and provides the accurate 
     prescription.

       ``(IV) An Internet pharmacy shall not fill a prescription 
     if--

       ``(aa) a treating provider informs the Internet pharmacy 
     within 72 hours after receipt of a communication under 
     subclause (I)(bb) that the prescription is inaccurate or 
     expired; or
       ``(bb) the treating provider does not respond within that 
     time.

       ``(x) Maintain, for such period of time as the Secretary 
     shall prescribe by regulation, a record of all direct 
     communications with a treating provider regarding the 
     dispensing of a prescription drug, including verification of 
     the prescription.
       ``(3) Licensure procedure.--
       ``(A) Action by secretary.--On receipt of a complete 
     licensing application from an Internet pharmacy under 
     paragraph (2), the Secretary shall--
       ``(i) assign an identification number to the Internet 
     pharmacy;
       ``(ii) notify the applicant of the receipt of the licensing 
     application; and
       ``(iii) if the Internet pharmacy is in compliance with the 
     conditions under paragraph (2), issue a license not later 
     than 60 days after receipt of a licensing application from 
     the Internet pharmacy.
       ``(B) Electronic filing.--
       ``(i) In general.--For the purpose of reducing paperwork 
     and reporting burdens, the Secretary shall require the use of 
     electronic methods of submitting to the Secretary a licensing 
     application required under this section and provide for 
     electronic methods of receiving the applications.
       ``(ii) Authentication.--In providing for the electronic 
     submission of such licensing applications under this section, 
     the Secretary shall ensure that adequate authentication 
     protocols are used to allow identification of the Internet 
     pharmacy and validation of the data as appropriate.
       ``(4) Database.--
       ``(A) In general.--The Secretary shall compile, maintain, 
     and periodically update a database of the Internet pharmacies 
     licensed under this section.
       ``(B) Availability.--The Secretary shall make the database 
     described under subparagraph (A) and information submitted by 
     the licensee under paragraph (2)(B) available to the public 
     on an Internet website and through a toll-free telephone 
     number.
       ``(5) Fees.--
       ``(A) In general.--
       ``(i) Licensing application fee.--The Secretary shall 
     establish a licensing application fee to be paid by all 
     applicants.
       ``(ii) Renewal fee.--The Secretary shall establish a yearly 
     renewal fee to be paid by all Internet pharmacies licensed 
     under this section.
       ``(B) Collection.--
       ``(i) Collection of licensing application fee.--A licensing 
     application fee payable for

[[Page 10989]]

     the fiscal year in which the Internet pharmacy submits a 
     licensing application, as established under subparagraph (C), 
     shall be payable upon the submission to the Secretary of such 
     licensing application.
       ``(ii) Collection of renewal fees.--After the licensing 
     application fee is paid for the first fiscal year of 
     licensure, the yearly renewal fee, as established under 
     subparagraph (C), shall be payable on or before October 1 of 
     each subsequent fiscal year.
       ``(iii) One fee per internet pharmacy.--The licensing 
     application fee and yearly renewal fee shall be paid only 
     once for each Internet pharmacy for a fiscal year in which 
     the fee is payable.
       ``(C) Fee amount.--The amount of the licensing application 
     fee and the yearly renewal fee for an Internet pharmacy shall 
     be determined each year by the Secretary based on the 
     anticipated costs to the Secretary of enforcing the 
     requirements of this section in the subsequent fiscal year.
       ``(D) Annual fee determination.--
       ``(i) In general.--Not later than 60 days before the 
     beginning of each fiscal year beginning after September 30, 
     2007, the Secretary shall determine the amount of the 
     licensing application fee and the yearly renewal fee for that 
     fiscal year.
       ``(ii) Publication of fee amount.--Not later than 60 days 
     before each fiscal year, the Secretary shall publish the 
     amount of the licensing application fee and the yearly 
     renewal fee under this section for that fiscal year and 
     provide for a period of 30 days for the public to provide 
     written comments on the fees.
       ``(E) Use of fees.--The fees collected under this section 
     shall be used, without further appropriation, to carry out 
     this section.
       ``(F) Failure to pay fee.--
       ``(i) Due date.--A fee payable under this section shall be 
     paid by the date that is 30 days after the date on which the 
     fee is due.
       ``(ii) Failure to pay.--If an Internet pharmacy subject to 
     a fee under this section fails to pay the fee by the date 
     specified under clause (i), the Secretary shall not permit 
     the Internet pharmacy to engage in the dispensing of drugs as 
     described under this section until all such fees owed by the 
     Internet pharmacy are paid.
       ``(G) Reports.--Beginning with fiscal year 2008, not later 
     than 60 days after the end of each fiscal year during which 
     licensing application fees are collected under this section, 
     the Secretary shall submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that describes--
       ``(i) implementation of the licensing fee authority during 
     the fiscal year; and
       ``(ii) the use by the Secretary of the licensing fees 
     collected during the fiscal year for which the report is 
     made.
       ``(6) Suspension.--
       ``(A) In general.--If the Secretary determines that an 
     Internet pharmacy is engaged in a pattern of violations of 
     any of the requirements of this Act, the Secretary may 
     immediately order the suspension of the license of the 
     Internet pharmacy.
       ``(B) Appeal of suspension order.--An Internet pharmacy 
     subject to a suspension order under subparagraph (A) may 
     appeal the suspension order to the Secretary. Not later than 
     30 days after an appeal is filed, the Secretary, after 
     providing opportunity for an informal hearing, shall affirm 
     or terminate the order.
       ``(C) Failure to act.--If, during the 30-day period 
     specified in subparagraph (B), the Secretary fails to provide 
     an opportunity for a hearing or to affirm or terminate the 
     order, the order shall be deemed to be terminated.
       ``(D) No judicial review.--An order under this paragraph 
     shall not be subject to judicial review.
       ``(7) Termination of license.--The Secretary may terminate 
     a license issued under this subsection, after notice to the 
     Internet pharmacy and an opportunity for a hearing, and if 
     the Secretary determines that the Internet pharmacy--
       ``(A) has demonstrated a pattern of noncompliance with this 
     section;
       ``(B) has made an untrue statement of material fact in its 
     licensing application; or
       ``(C) is in violation of any applicable Federal or State 
     law relating to the dispensing of a prescription drug.
       ``(8) Renewal evaluation.--
       ``(A) In general.--Before renewing a license of an Internet 
     pharmacy under this subsection, the Secretary shall conduct 
     an evaluation to determine whether the Internet pharmacy is 
     in compliance with this section.
       ``(B) Evaluation of internet pharmacies.--At the discretion 
     of the Secretary and as applicable, an evaluation under 
     subparagraph (A) may include testing of the Internet pharmacy 
     website or other systems through which the Internet pharmacy 
     communicates with consumers, and a physical inspection of the 
     records and premises of the pharmacy.
       ``(9) Contract for operation of program.--
       ``(A) In general.--The Secretary may award a contract under 
     this subsection for the operation of the licensing program.
       ``(B) Term.--The duration of a contract under subparagraph 
     (A) shall not exceed 5 years and may be renewable.
       ``(C) Performance review.--The Secretary shall annually 
     review performance under a contract under subparagraph (A).
       ``(d) Providers of Interactive Computer Services or 
     Advertising Services.--No provider of interactive computer 
     services (as defined in section 230(f) of the Communications 
     Act of 1934 (47 U.S.C. 230(f)) or an advertising service 
     provider shall be liable under this section on account of 
     another person's selling or dispensing of a prescription 
     drug, so long as the provider of the interactive computer 
     service or the advertising service provider does not own or 
     exercise corporate control over such person.
       ``(e) Policies and Procedures Required To Prevent Payments 
     for Unlawful Internet Pharmacy Requests.--
       ``(1) Regulations.--Not later than 180 days after 
     designating a system under subsection (a)(2), the Board shall 
     promulgate regulations that require--
       ``(A) an operator of a credit card system that is a 
     designated payment system, an operator of an international, 
     national, or local network used to effect a credit 
     transaction, electronic fund transfer, or money transmitting 
     service that is a designated payment system, and an operator 
     of any other designated payment system specified by the Board 
     that is centrally managed and is primarily engaged in the 
     transmission and settlement of credit transactions, 
     electronic transfers, or money transmitting services where at 
     least 1 party to the transaction or transfer is an 
     individual; and

       ``(B) in the case of a designated payment system, other 
     than a designated payment system described in subparagraph 
     (A), a person described in subsection (a)(2)(B);

     to establish policies and procedures that are reasonably 
     designed to prevent the introduction of restricted 
     transactions into a designated payment system or the 
     completion of restricted transactions using a designated 
     payment system.
       ``(2) Requirements for policies and procedures.--In 
     promulgating regulations under paragraph (1), the Board 
     shall--
       ``(A) identify types of policies and procedures, including 
     nonexclusive examples, that shall be considered to be 
     reasonably designed to identify and reasonably designed to 
     prevent the introduction of a restricted transaction in a 
     designated payment or the completion of restricted 
     transactions using a designated payment system; and
       ``(B) to the extent practicable, permit any designated 
     payment system, or person described in subsection (a)(2)(B), 
     as applicable, to choose among alternative means of 
     preventing the introduction or completion of restricted 
     transactions.
       ``(3) No liability for blocking or refusing to honor 
     restricted transaction.--
       ``(A) In general.--A designated payment system, or a person 
     described in subsection (a)(2)(B), that is subject to a 
     regulation or an order issued under this subsection, and any 
     participant in such payment system, that--
       ``(i) prevents or otherwise refuses to honor restricted 
     transactions, in an effort to implement the policies and 
     procedures required under this subsection or to otherwise 
     comply with this section, shall not be liable to any party 
     for such action; and
       ``(ii) prevents or otherwise refuses to honor a 
     nonrestricted transaction in an effort to implement the 
     policies and procedures under this subsection or to otherwise 
     comply with this section, shall not be liable to any party 
     for such action.
       ``(B) Compliance with this subsection.--A person described 
     in subsection (a)(2)(B) meets the requirements of this 
     subsection, if any, if the person relies on and complies with 
     the policies and procedures of a designated payment system of 
     which the person is a member or in which the person is a 
     participant, and such policies and procedures of the 
     designated payment system comply with the requirements of the 
     regulations under paragraph (1)(B).
       ``(4) Enforcement.--
       ``(A) In general.--This subsection shall be enforced by the 
     Federal functional regulators and the Federal Trade 
     Commission under applicable law in the manner provided in 
     section 505(a) of the Gramm-Leach-Bliley Act (21 U.S.C. 
     6805(a)).
       ``(B) Factors to be considered.--In considering any 
     enforcement action under this subsection against a payment 
     system or person described in subsection (a)(2)(B), the 
     Federal functional regulators and the Federal Trade 
     Commission shall consider the following factors:
       ``(i) The extent to which the payment system or person 
     knowingly permits restricted transactions.
       ``(ii) The history of the payment system or person in 
     connection with permitting restricted transactions.
       ``(iii) The extent to which the payment system or person 
     has established and is maintaining policies and procedures in 
     compliance with regulations prescribed under this subsection.
       ``(iv) The feasibility that any specific remedy prescribed 
     can be implemented by the payment system or person without 
     substantial deviation from normal business practice.
       ``(v) The costs and burdens the specific remedy will have 
     on the payment system or person.

[[Page 10990]]

       ``(f) Reports Regarding Internet-Related Violations of 
     Federal and State Laws on Dispensing of Drugs.--The Secretary 
     shall, pursuant to the submission of an application meeting 
     criteria prescribed by the Secretary, make an award of a 
     grant or contract to an entity with experience in developing 
     and maintaining systems for the purpose of--
       ``(1) identifying Internet pharmacy websites that are not 
     licensed or that appear to be operating in violation of 
     Federal or State laws concerning the dispensing of drugs;
       ``(2) reporting such Internet pharmacy websites to State 
     medical licensing boards and State pharmacy licensing boards, 
     and to the Attorney General and the Secretary, for further 
     investigation; and
       ``(3) submitting, for each fiscal year for which the award 
     under this subsection is made, a report to the Secretary 
     describing investigations undertaken with respect to 
     violations described in paragraph (1).
       ``(g) Transactions Permitted.--A designated payment system 
     or person subject to a regulation or an order issued under 
     subsection (e) may engage in transactions with licensed and 
     unlicensed Internet pharmacies in connection with 
     investigating violations or potential violations of any rule 
     or requirement adopted by the payment system or person in 
     connection with complying with subsection (e). A person 
     subject to a regulation or an order issued under subsection 
     (e) and the agents and employees of that person shall not be 
     found to be in violation of, or liable under, any Federal, 
     State, or other law for engaging in any such transaction.
       ``(h) Relation to State Laws.--No requirement, prohibition, 
     or liability may be imposed on a designated payment system or 
     person subject to a regulation or an order issued under 
     subsection (e) under the laws of any State with respect to 
     any payment transaction by an individual because the payment 
     transaction involves a payment to an Internet pharmacy.
       ``(i) Timing of Requirements.--A designated payment system 
     or a person subject to a regulation under subsection (e) 
     shall adopt policies and procedures reasonably designed to 
     comply with any regulations required under subsection (e) not 
     later than 180 days after the date on which such final 
     regulations are issued.''.
       (b) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding 
     at the end the following:
       ``(hh)(1) The sale, under section 511, of a drug that is 
     not a prescription drug, the sale of such a prescription drug 
     without a valid prescription from a treating provider, or the 
     ownership or operation of an Internet pharmacy, in violation 
     of section 511.
       ``(2) The representation by advertisement, sales 
     presentation, direct communication (including telephone, 
     facsimile, or electronic mail), or otherwise by an Internet 
     pharmacy, that a prescription drug may be obtained from the 
     Internet pharmacy without a prescription, in violation of 
     section 511.
       ``(3) The advertisement related to a prescription drug 
     through any media including sales presentation, direct 
     communication (including telephone, facsimile, or electronic 
     mail), by an unlicensed Internet pharmacy.
       ``(4) The provision of an untrue statement of material fact 
     in the licensing application of an Internet pharmacy.
       ``(5) For purposes of this subsection, any term used in 
     this subsection that is also used in section 511 shall have 
     the meaning given that term in section 511.''.
       (c) Links to Unlicensed Internet Pharmacies.--Section 302 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) 
     is amended by adding at the end the following:
       ``(c)(1) In the case of a violation of section 511 relating 
     to an unlicensed Internet pharmacy (as defined in such 
     section 511), the district courts of the United States and 
     the United States courts of the territories shall have 
     jurisdiction to order a provider of an interactive computer 
     service to remove, or disable access to, links to a website 
     violating that section that resides on a computer server that 
     the provider controls or operates.
       ``(2) Relief under paragraph (1)--
       ``(A) shall be available only after provision to the 
     provider of notice and an opportunity to appear;
       ``(B) shall not impose any obligation on the provider to 
     monitor its service or to affirmatively seek facts indicating 
     activity violating section 511;
       ``(C) shall specify the provider to which the relief 
     applies; and
       ``(D) shall specifically identify the location of the 
     website to be removed or to which access is to be 
     disabled.''.
       (d) Regulations.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall promulgate interim final regulations to carry 
     out the amendments made by this section.
       (2) Effective date.--The requirement of licensure under 
     section 511 of the Federal Food, Drug, and Cosmetic Act (as 
     added by this section) shall take effect on the date 
     determined by the Secretary of Health and Human Services but 
     in no event later than 90 days after the effective date of 
     the interim final regulations under paragraph (1).
       (e) Penalties.--Section 303 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 333) is amended by adding at the end 
     the following:
       ``(g) Notwithstanding subsection (a), any person who 
     knowingly violates paragraph (1), (2), (3), or (4) of section 
     301(hh) shall be imprisoned for not more than 10 years or 
     fined in accordance with title 18, United States Code, or 
     both.''.
                                 ______
                                 
  SA 1018. Mr. DeMINT (for himself, Mr. Inhofe, Mr. Brownback, Mr. 
Martinez, Mr. Vitter, and Mr. Coburn) submitted an amendment intended 
to be proposed by him to the bill S. 1082, to amend the Federal Food, 
Drug, and Cosmetic Act to reauthorize and amend the prescription drug 
user fee provisions, and for other purposes; as follows:

       In section 214(b)(3)(B) of the bill, insert ``, except with 
     respect to the drug Mifeprex (mifepristone), such assessment 
     shall be submitted 6 months after the applicant is so 
     notified'' before the period at the end.
                                 ______
                                 
  SA 1019. Mr. CASEY (for himself and Mr. Specter) submitted an 
amendment intended to be proposed by him to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. ORPHAN DISEASE TREATMENT IN CHILDREN.

       (a) Finding.--The Senate finds that parents of children 
     suffering from rare genetic diseases known as orphan diseases 
     face multiple obstacles in obtaining safe and effective 
     treatment for their children due mainly to the fact that many 
     Food and Drug Administration-approved drugs used in the 
     treatment of orphan diseases in children may not be approved 
     for pediatric indications.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that the Food and Drug Administration should enter into a 
     contract with the Institute of Medicine for the conduct of a 
     study concerning measures that may be taken to improve the 
     likelihood that Food and Drug Administration-approved drugs 
     that are safe and effective in treating children with orphan 
     diseases are made available and affordable for pediatric 
     indications.
                                 ______
                                 
  SA 1020. Mr. GRASSLEY submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       Strike clause (i) of section 402(j)(3)(A) of the Public 
     Health Service Act, as added by this bill, and insert the 
     following:
       ``(i) In general.--

       ``(I) Requirement.--Not later than 90 days after the date 
     of enactment of the Food and Drug Administration 
     Revitalization Act, for all clinical trials (except as 
     provided in subclause (II)), whether federally or privately 
     funded, conducted to test the safety or efficacy (including 
     comparative efficacy), of any drug or device (including those 
     drugs or devices approved or cleared by the Secretary), the 
     Secretary shall ensure that the registry data bank includes 
     links to results information for such clinical trial--

       ``(aa) not earlier than 30 days after the date of the 
     approval of the drug involved or clearance or approval of the 
     device involved; or
       ``(bb) not later than 30 days after such information 
     becomes publicly available, as applicable.

       ``(II) Exception.--The requirement of subclause (I) shall 
     not apply to phase I clinical investigations conducted to 
     test solely the safety of an unapproved drug or unlicensed 
     biological product, or pilot or feasibility studies conducted 
     to confirm the design and operating specifications of an 
     unapproved or not yet cleared medical device.
       ``(III) Voluntary submission.--A responsible party for a 
     clinical trial that is not an applicable drug clinical trial 
     or an applicable device clinical trial may submit to the 
     Secretary results information for a clinical trial described 
     in subclause (II).
       ``(IV) Expanded registry data bank.--Notwithstanding any 
     other provision of law, the clinical trials described in 
     subclause (I) shall be clinical trials of which the results 
     information with respect to such trials is appropriate for 
     adding to the expanded registry data bank, as described in 
     subparagraph (C).

       At the end section 402(j)(4) of the Public Health Service 
     Act, as added by this bill, insert the following:
       ``(F) Trials conducted outside of the united states.--
       ``(i) In general.--With respect to clinical trials 
     described in clause (ii), the responsible party shall submit 
     to the Secretary the information required under this 
     subsection.

[[Page 10991]]

     The Secretary shall ensure that such information and the 
     results of such clinical trials are made available to the 
     public in a timely manner and as soon as practicable after 
     receiving such information. Failure to comply with this 
     paragraph shall be deemed to be a failure to submit 
     information as required under this subsection, and the 
     appropriate remedies and sanctions under this section shall 
     apply.
       ``(ii) Clinical trial described.--A clinical trial is 
     described in this clause if--

       ``(I) such trial is conducted outside of the United States; 
     and
       ``(II) the data from such trial is--

       ``(aa) submitted to the Secretary as part of an 
     application, including a supplemental application, for a drug 
     or device under section 505, 510, 515, or 520 of the Federal 
     Food, Drug, and Cosmetic Act or for the biological product 
     under section 351 of this Act; or
       ``(bb) used in advertising or labeling to make a claim 
     about the drug or device involved.
       ``(iii) Expanded registry data bank.--Notwithstanding any 
     other provision of law, the clinical trials described in 
     clause (ii) shall be clinical trials of which the results 
     information with respect to such trials is appropriate for 
     adding to the expanded registry data bank, as described in 
     paragraph (3)(C).
                                 ______
                                 
  SA 1021. Mrs. CLINTON submitted an amendment intended to be proposed 
by her to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of the bill, add the following:

     SEC. __. NO SUNSET FOR SECTION 505B.

       Notwithstanding any provision of this Act, an amendment 
     made by this Act, or any other provision of law, section 505B 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) 
     and the authority provided for under such section shall not 
     sunset but shall remain in effect.
                                 ______
                                 
  SA 1022. Mr. DURBIN (for himself, Mr. Enzi, Mr. Kennedy, Mr. Allard, 
Mr. Kohl, Ms. Cantwell, Mr. Schumer, Mr. Biden, Mr. Nelson of Florida, 
and Mr. Casey) proposed an amendment to the bill S. 1082, to amend the 
Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; as 
follows:

       At the end of the bill, insert the following:

                         TITLE __--FOOD SAFETY

     SEC. _01. FINDINGS.

       (a) Findings.--Congress finds that--
       (1) the safety and integrity of the United States food 
     supply is vital to the public health, to public confidence in 
     the food supply, and to the success of the food sector of the 
     Nation's economy;
       (2) illnesses and deaths of individuals and companion 
     animals caused by contaminated food--
       (A) have contributed to a loss of public confidence in food 
     safety; and
       (B) have caused significant economic losses to 
     manufacturers and producers not responsible for contaminated 
     food items;
       (3) the task of preserving the safety of the food supply of 
     the United States faces tremendous pressures with regard to--
       (A) emerging pathogens and other contaminants and the 
     ability to detect all forms of contamination; and
       (B) an increasing volume of imported food from a wide 
     variety of countries; and
       (C) a shortage of adequate resources for monitoring and 
     inspection;
       (4) the United States is increasing the amount of food that 
     it imports such that --
       (A) from 2003 to the present, the value of food imports has 
     increased from $45,600,000,000 to $64,000,000,000; and
       (B) imported food accounts for 13 percent of the average 
     Americans diet including 31 percent of fruits, juices, and 
     nuts, 9.5 percent of red meat and 78.6 percent of fish and 
     shellfish; and
       (5) the number of full time equivalent Food and Drug 
     Administration employees conducting inspections has decreased 
     from 2003 to 2007.

     SEC. _02. ENSURING THE SAFETY OF PET FOOD.

       (a) Processing and Ingredient Standards.--Not later than 18 
     months after the date of enactment of this Act, the Secretary 
     of Health and Human Services (referred to in this title as 
     the ``Secretary''), in consultation with the Association of 
     American Feed Control Officials, and other relevant 
     stakeholder groups, including veterinary medical 
     associations, animal health organizations, and pet food 
     manufacturers, shall by regulation establish--
       (1) processing and ingredient standards with respect to pet 
     food, animal waste, and ingredient definitions; and
       (2) updated standards for the labeling of pet food that 
     includes nutritional information and ingredient information.
       (b) Early Warning Surveillance Systems and Notification 
     During Pet Food Recalls.--Not later than 180 days after the 
     date of enactment of this Act, the Secretary shall by 
     regulation establish an early warning and surveillance system 
     to identify adulteration of the pet food supply and outbreaks 
     of illness associated with pet food. In establishing such 
     system, the Secretary shall--
       (1) use surveillance and monitoring mechanisms similar to, 
     or in coordination with, those mechanisms used by the Centers 
     for Disease Control and Prevention to monitor human health, 
     such as the Foodborne Diseases Active Surveillance Network 
     (FoodNet) and PulseNet;
       (2) consult with relevant professional associations and 
     private sector veterinary hospitals; and
       (3) work with the Health Alert Network and other 
     notification networks to inform veterinarians and relevant 
     stakeholders during any recall of pet food.

     SEC. _03. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS 
                   DURING A RECALL.

       The Secretary shall, during an ongoing recall of human or 
     pet food--
       (1) work with companies, relevant professional 
     associations, and other organizations to collect and 
     aggregate information pertaining to the recall;
       (2) use existing networks of communication including 
     electronic forms of information dissemination to enhance the 
     quality and speed of communication with the public; and
       (3) post information regarding recalled products on the 
     Internet website of the Food and Drug Administration in a 
     consolidated, searchable form that is easily accessed and 
     understood by the public.

     SEC. _04. STATE AND FEDERAL COOPERATION.

       (a) In General.--The Secretary shall work with the States 
     in undertaking activities and programs that assist in 
     improving the safety of fresh and processed produced so that 
     State food safety programs involving the safety of fresh and 
     processed produce and activities conducted by the Secretaries 
     function in a coordinated and cost-effective manner. With the 
     assistance provided under subsection (b), the Secretary shall 
     encourage States to--
       (1) establish, continue, or strengthen State food safety 
     programs, especially with respect to the regulation of retail 
     commercial food establishments; and
       (2) establish procedures and requirements for ensuring that 
     processed produce under the jurisdiction of the State food 
     safety programs is not unsafe for human consumption.
       (b) Assistance.--The Secretary may provide to a State, for 
     planning, developing, and implementing such a food safety 
     program--
       (1) advisory assistance;
       (2) technical assistance, training, and laboratory 
     assistance (including necessary materials and equipment); and
       (3) financial and other assistance.
       (c) Service Agreements.--The Secretary may, under an 
     agreement entered into with a Federal, State, or local 
     agency, use, on a reimbursable basis or otherwise, the 
     personnel, services, and facilities of the agency to carry 
     out the responsibilities of the agency under this section. An 
     agreement entered into with a State agency under this 
     subsection may provide for training of State employees.

     SEC. _05. ADULTERATED FOOD REGISTRY.

       (a) Findings.--Congress makes the following findings:
       (1) In 1994, Congress passed the Dietary Supplement Health 
     and Education Act (P.L. 103-417) to provide the Food and Drug 
     Administration with the legal framework to ensure that 
     dietary supplements are safe and properly labeled foods.
       (2) In 2006, Congress passed the Dietary Supplement and 
     Nonprescription Drug Consumer Protection Act (P.L. 109-462) 
     to establish a mandatory reporting system of serious adverse 
     events for non-prescription drugs and dietary supplements 
     sold and consumed in the United States.
       (3) The adverse event reporting system created under the 
     Dietary Supplement and Nonprescription Drug Consumer 
     Protection Act will serve as the early warning system for any 
     potential public health issues associated with the use of 
     these food products.
       (4) A reliable mechanism to track patterns of adulteration 
     in food would support efforts by the Food and Drug 
     Administration to effectively target limited inspection 
     resources to protect the public health.
       (b) In General.--Chapter IV of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 417. ADULTERATED FOOD REGISTRY.

       ``(a) Definitions.--In this section:
       ``(1) Importer.--The term `importer', with respect to an 
     article of food, means the person who submitted the notice 
     with respect to such article of food under section 801(m).
       ``(2) Responsible party.--The term `responsible party', 
     with respect to an article of food, means any registered food 
     facility under section 415(a), including those responsible 
     for the manufacturing, processing, packaging or holding of 
     such food for consumption in the United States.
       ``(3) Reportable adulterated food.--The term `reportable 
     adulterated food' for purposes of this section means a food 
     that is adulterated or--
       ``(A) presents a situation in which there is a reasonable 
     probability that the use of, or

[[Page 10992]]

     exposure to, a violative product will cause serious adverse 
     health consequences or death as defined in section 7.3(m)(1) 
     of title, Code of Federal Regulations (or any successor 
     regulations); or
       ``(B) meets the threshold established in section 304(h).
       ``(b) Establishment.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this section, the Secretary shall establish 
     within the Food and Drug Administration an Adulterated Food 
     Registry to which instances of reportable adulterated food 
     may be submitted by the Food and Drug Administration after 
     receipt of reports of adulteration, via an electronic portal, 
     from--
       ``(A) Federal, State, and local public health officials;
       ``(B) an importer;
       ``(C) a responsible party; or
       ``(D) a consumer or other individual.
       ``(2) Review by secretary.--The Secretary shall review and 
     determine the validity of the information submitted under 
     paragraph (1) for the purposes of identifying adulterated 
     food, submitting entries to the Adulterated Food Registry, 
     acting under subsection (c), and exercising other existing 
     food safety authorities under the Act to protect the public 
     health.
       ``(c) Issuance of an Alert by the Secretary.--
       ``(1) In general.--The Secretary shall issue an alert with 
     respect to an adulterated food if the Adulterated Food 
     Registry shows that the food--
       ``(A) has been associated with repeated and separate 
     outbreaks of illness or has been repeatedly determined to be 
     adulterated; or
       ``(B) is a reportable adulterated food.
       ``(2) Scope of alert.--An alert under paragraph (1) may 
     apply to a particular food or to food from a particular 
     producer, manufacturer, shipper, growing area, or country, to 
     the extent that elements in subparagraph (A) or (B) of 
     paragraph (1) are associated with the particular food, 
     producer, manufacturer, shipper, growing area, or country.
       ``(d) Submission by a Consumer or Other Individual.--A 
     consumer or other individual may submit a report to the Food 
     and Drug Administration using the electronic portal data 
     elements described in subsection (e). Such reports shall be 
     evaluated by the Secretary as specified in subsection (b)(2).
       ``(e) Notification and Reporting of Adulteration.--
       ``(1) Determination by responsible party or importer.--If a 
     responsible party or importer determines that an article of 
     food it produced, processed, manufactured, distributed, or 
     otherwise handled is a reportable adulterated food, the 
     responsible party shall provide the notifications described 
     under paragraph (2).
       ``(2) Notification of adulteration.--
       ``(A) In general.--Not later than 5 days after a 
     responsible party or importer receives a notification, the 
     responsible party or importer, as applicable, shall review 
     whether the food referenced in the report described in 
     paragraph (1) is a reportable adulterated food.
       ``(B) Notification.--If a determination is made by such 
     responsible party or importer that the food is a reportable 
     adulterated food, such responsible party or importer shall, 
     no later than 5 days after such determination is made, notify 
     other responsible parties directly linked in the supply chain 
     to which and from which the article of reportable adulterated 
     food was transferred.
       ``(3) Submission of reports to the food and drug 
     administration by a responsible party or importer.--The 
     responsible party or importer, as applicable, shall submit a 
     report to the Food and Drug Administration through the 
     electronic portal using the data elements described in 
     subsection (f) not later than 2 days after a responsible 
     party or importer--
       ``(A) makes a notification under paragraph (2)(B); or
       ``(B) determines that an article of food it produced, 
     processed, manufactured, distributed, imported, or otherwise 
     handled is a reportable adulterated food, except that if such 
     adulteration was initiated with such responsible party or 
     importer, was detected prior to any transfer of such article 
     of food, and was destroyed, no report is necessary.
       ``(f) Data Elements in the Registry.--A report submitted to 
     the Food and Drug Administration electronic portal under 
     subsection (e) shall include the following data elements:
       ``(1) Contact information for the individual or entity 
     submitting the report.
       ``(2) The date on which an article of food was determined 
     to be adulterated or suspected of being adulterated.
       ``(3) A description of the article of food including the 
     quantity or amount.
       ``(4) The extent and nature of the adulteration.
       ``(5) The disposition of the article.
       ``(6) Product information typically found on packaging 
     including product codes, use by dates, and names of 
     manufactures or distributors.
       ``(7) Information about the place of purchase or process by 
     which the consumer or other individual acquired the article 
     of adulterated food.
       ``(8) In the case of a responsible party or an importer, 
     the elements required for the registration of food facilities 
     under section 415(a).
       ``(9) The contact information for parties directly linked 
     in the supply chain and notified under subsection (e)(2).
       ``(10) In the case of an importer, the elements required 
     for the prior notice of imported food shipments under section 
     801(m).
       ``(g) Maintenance and Inspection of Records.--The 
     responsible person or importer shall maintain records related 
     to each report received, notification made, and report 
     submitted to the Food and Drug Administration under this 
     section and permit inspection of such records as provided for 
     in section 414. Such records shall also be made available 
     during an inspection under section 704.
       ``(h) Request for Information.--Section 552 of title 5, 
     United States Code, shall apply to any request for 
     information regarding a record in the Adulterated Food 
     Registry.
       ``(i) Homeland Security Notification.--If, after receiving 
     a report under subsection (e), the Secretary suspects such 
     food may have been deliberately adulterated, the Secretary 
     shall immediately notify the Secretary of Homeland Security. 
     The Secretary shall make the data in the Adulterated Imported 
     Food Registry available to the Secretary of Homeland 
     Security.''.
       (c) Definition.--Section 201(ff) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking 
     ``section 201(g)'' and inserting ``sections 201(g) and 417''.
       (d) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331), as amended by this 
     Act, is further amended by adding at the end the following:
       ``(kk) The failure to provide a report as required under 
     section 417(e)(3).
       ``(ll) The falsification a report as required under section 
     417(e)(3).''.
       (e) Suspected Food Adulteration Regulations.--The Secretary 
     shall, within 180 days of enactment of this Act, promulgate 
     regulations that establish standards and thresholds by which 
     importers and responsible parties shall be required and 
     consumers may be able to, under section 417 of the Federal 
     Food, Drug, and Cosmetic Act (as added by this section)--
       (1) report instances of suspected reportable adulteration 
     of food to the Food and Drug Administration for possible 
     inclusion in the Adulterated Food Registry after evaluation 
     of such report; and
       (2) notify, in keeping with subsection (e)(2) of such 
     section 417, other responsible parties directly linked in the 
     supply chain, including establishments as defined in section 
     415(b) of such Act.
       (f) Effective Date.--The requirements of section 417(e) of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), shall become effective 180 days after the 
     date of enactment of this Act.

     SEC. _06. SENSE OF THE SENATE.

       It is the sense of the Senate that--
       (1) it is vital for Congress to provide the Food and Drug 
     Administration with additional resources, authorities, and 
     direction with respect to ensuring the safety of the food 
     supply of the United States;
       (2) additional inspectors are required to improve the Food 
     and Drug Administration's ability to safeguard the food 
     supply of the United States;
       (3) because of the increasing volume of international trade 
     in food products the Secretary of Health and Human Services 
     should make it a priority to enter into agreements with the 
     trading partners of the United States with respect to food 
     safety; and
       (4) the Senate should work to develop a comprehensive 
     response to the issue of food safety.

     SEC. _07. ANNUAL REPORT TO CONGRESS.

       The Secretary shall, on an annual basis, submit to the 
     Committee on Health, Education, Labor, and Pensions and the 
     Committee on Appropriations of the Senate and the Committee 
     on Energy and Commerce and the Committee on Appropriations of 
     the House of Representatives a report that includes, with 
     respect to the preceding 1-year period--
       (1) the number and amount of food products regulated by the 
     Food and Drug Administration imported into the United States, 
     aggregated by country and type of food;
       (2) a listing of the number of Food and Drug Administration 
     inspectors of imported food products referenced in paragraph 
     (1) and the number of Food and Drug Administration 
     inspections performed on such products; and
       (3) aggregated data on the findings of such inspections, 
     including data related to violations of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), and 
     enforcement actions used to follow-up on such findings and 
     violations.

     SEC. _08. RULE OF CONSTRUCTION.

       Nothing in this title (or an amendment made by this title) 
     shall be construed to affect--
       (1) the regulation of dietary supplements under the Dietary 
     Supplement Health and Education Act; or
       (2) the adverse event reporting system for dietary 
     supplements created under the Dietary Supplement and 
     Nonprescription Drug Consumer Protection Act.

[[Page 10993]]



     SEC. _09. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated to carry out this 
     title (and the amendments made by this title) such sums as 
     may be necessary.

                                 ______
                                 
  SA 1023. Mr. DURBIN submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. STUDY ON FOOD INSPECTION AND SAFETY USER FEES.

       (a) In General.--The Secretary of Health and Human Services 
     shall conduct a study to determine the feasibility of 
     instituting a user fee program for food inspections and food 
     safety that incorporates lessons learned from the user fee 
     program for prescription drugs under chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) 
     and that is designed to increase the resources and 
     capabilities of the Food and Drug Administration to safeguard 
     the food supply of the United States.
       (b) Report to Congress.--Not later than 180 days after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services shall submit to Congress a report that--
       (1) describes the findings of the study conducted under 
     subsection (a); and
       (2) includes--
       (A) any recommendations for legislation related to such 
     findings; and
       (B) provides details, with respect to such recommended 
     legislation, regarding--
       (i) the expected revenues for the Food and Drug 
     Administration;
       (ii) the expected costs to the private sector, categorized 
     by industry; and
       (iii) any other relevant information.
                                 ______
                                 
  SA 1024. Mr. SALAZAR submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

     SEC. __. PROHIBITION OF REORGANIZATION PLAN PENDING REVIEW.

       (a) In General.--The Commissioner of Food and Drugs may not 
     implement a reorganization plan that reduces or consolidates 
     the number of laboratory facilities currently in operation 
     within the Office of Regulatory Affairs of the Food and Drug 
     Administration pending a comprehensive review of the 
     reorganization plan by the Comptroller General of the United 
     States to determine--
       (1) the impact of the reorganization on the mission of the 
     Food and Drug Administration to ensure that foods, cosmetics, 
     and medical products are safe, effective, and properly 
     promoted and labeled;
       (2) the projected cost savings; and
       (3) the projected operational efficiencies.
       (b) Report.--Not later than 1 year after the date of 
     enactment of this section, the Comptroller General of the 
     United States shall issue a report on the impact of the 
     reorganization plan described in subsection (a).
                                 ______
                                 
  SA 1025. Mr. SCHUMER (for himself, Mrs. Clinton, Mr. Enzi, Mr. Hatch, 
and Mr. Kennedy) proposed an amendment to the bill S. 1082, to amend 
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the 
prescription drug user fee provisions, and for other purposes; as 
follows:

       At the end of the bill, add the following:

     SEC. __. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON 
                   BIOLOGICS.

       (a) Findings.--The Senate finds the following:
       (1) The Food and Drug Administration has stated that it 
     requires legislative authority to review follow-on biologics.
       (2) Business, consumer, and government purchasers require 
     competition and choice to ensure more affordable prescription 
     drug options.
       (3) Well-constructed policies that balance the needs of 
     innovation and affordability have broad bipartisan support.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that--
       (1) legislation should be enacted to--
       (A) provide the Food and Drug Administration with the 
     authority and flexibility to approve biopharmaceuticals 
     subject to an abbreviated approval pathway;
       (B) ensure that patient safety remains paramount in the 
     system;
       (C) establish a regulatory pathway that is efficient, 
     effective, and scientifically-grounded and that also includes 
     measures to ensure timely resolution of patent disputes; and
       (D) provide appropriate incentives to facilitate the 
     research and development of innovative biopharmaceuticals.
                                 ______
                                 
  SA 1026. Mr. FEINGOLD submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

     SEC. __. PUBLICATION OF ANNUAL REPORTS.

       (a) In General.--The Commissioner on Food and Drugs shall 
     annually submit to Congress and publish on the Internet 
     website of the Food and Drug Administration, a report 
     concerning the results of the Administration's pesticide 
     residue monitoring program, that includes--
       (1) information and analysis similar to that contained in 
     the report entitled ``Food and Drug Administration Pesticide 
     Program Residue Monitoring 2003'' as released in June of 
     2005;
       (2) based on an analysis of previous samples, an 
     identification of products or countries (for imports) that 
     require special attention and additional study (including 
     details on the plans for such additional studies), including 
     in the initial report (and subsequent reports as determined 
     necessary) the results and analysis of the Ginseng Dietary 
     Supplements Special Survey as described on page 13 of the 
     report entitled ``Food and Drug Administration Pesticide 
     Program Residue Monitoring 2003'';
       (3) information on the relative number of interstate and 
     imported shipments of each tested commodity that were 
     sampled, including recommendations on whether sampling is 
     statistically significant, provides confidence intervals or 
     other related statistical information, and whether the number 
     of samples should be increased and the details of any plans 
     to provide for such increase; and
       (4) a description of whether certain commodities are being 
     improperly imported as another commodity, including a 
     description of additional steps that are being planned to 
     prevent such smuggling.
       (b) Initial Reports.--Annual reports under subsection (a) 
     for fiscal years 2004 through 2006 may be combined into a 
     single report, by not later than June 1, 2008, for purposes 
     of publication under subsection (a). Thereafter such reports 
     shall be completed by June 1 of each year for the data 
     collected for the year that was 2-years prior to the year in 
     which the report is published.
       (c) Memorandum of Understanding.--The Commissioner of Food 
     and Drugs, the Administrator of the Food Safety and 
     Inspection Service, and the head of the Agricultural 
     Marketing Service shall enter into a memorandum of 
     understanding to permit inclusion of data in the reports 
     under subsection (a) relating to testing carried out by the 
     Food Safety and Inspection Service and the Agricultural 
     Marketing Service on meat, poultry, eggs, and certain raw 
     agricultural products, respectively.
                                 ______
                                 
  SA 1027. Mr. DURBIN submitted an amendment intended to be proposed by 
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic 
Act to reauthorize and amend the prescription drug user fee provisions, 
and for other purposes; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

                         TITLE __--FOOD SAFETY

     SEC. __. FOOD SAFETY FOR HUMANS AND PETS.

       Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 341 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 417. NOTIFICATION AND RECALL.

       ``(a) Notice to Secretary of Violation.--
       ``(1) In general.--A person that has reason to believe that 
     any food introduced into or in interstate commerce, or held 
     for sale (whether or not the first sale) after shipment in 
     interstate commerce, may be in violation of this Act shall 
     immediately notify the Secretary of the identity and location 
     of the food.
       ``(2) Manner of notification.--Notification under paragraph 
     (1) shall be made in such manner and by such means as the 
     Secretary may require by regulation.
       ``(b) Recall and Consumer Notification; Voluntary 
     Actions.--If the Secretary determines that food is in 
     violation of this Act when introduced into or while in 
     interstate commerce or while held for sale (whether or not 
     the first sale) after shipment in interstate commerce and 
     that there is a reasonable probability that the food, if 
     consumed, would present a threat to public health, as 
     determined by the Secretary, the Secretary shall give the 
     appropriate persons (including the manufacturers, importers, 
     distributors, or retailers of the food) an opportunity to--
       ``(1) cease distribution of the food;
       ``(2) notify all persons--
       ``(A) processing, distributing, or otherwise handling the 
     food to immediately cease such activities with respect to the 
     food; or
       ``(B) to which the food has been distributed, transported, 
     or sold, to immediately cease distribution of the food;
       ``(3) recall the food;
       ``(4) in conjunction with the Secretary, provide notice of 
     the finding of the Secretary--
       ``(A) to consumers to whom the food was, or may have been, 
     distributed; and

[[Page 10994]]

       ``(B) to State and local public health officials; or
       ``(5) take any combination of the measures described in 
     this paragraph, as determined by the Secretary to be 
     appropriate in the circumstances.
       ``(c) Civil and Criminal Penalties.--
       ``(1) Civil sanctions.--
       ``(A) Civil penalty.--Any person that commits an act that 
     violates the notification and recall standards under 
     subsection (b) (including a regulation promulgated or order 
     issued under this Act) may be assessed a civil penalty by the 
     Secretary of not more than $10,000 for each such act.
       ``(B) Separate offense.--Each act described in subparagraph 
     (A) and each day during which that act continues shall be 
     considered a separate offense.
       ``(2) Other requirements.--
       ``(A) Written order.--The civil penalty described in 
     paragraph (1) shall be assessed by the Secretary by a written 
     order, which shall specify the amount of the penalty and the 
     basis for the penalty under subparagraph (B) considered by 
     the Secretary.
       ``(B) Amount of penalty.--Subject to paragraph (1)(A), the 
     amount of the civil penalty shall be determined by the 
     Secretary, after considering--
       ``(i) the gravity of the violation;
       ``(ii) the degree of culpability of the person;
       ``(iii) the size and type of the business of the person; 
     and
       ``(iv) any history of prior offenses by the person under 
     this Act.
       ``(C) Review of order.--The order may be reviewed only in 
     accordance with subsection (d).
       ``(3) Exception.--No person shall be subject to the 
     penalties of this subsection--
       ``(A) for having received, proffered, or delivered in 
     interstate commerce any food, if the receipt, proffer, or 
     delivery was made in good faith, unless that person refuses 
     to furnish (on request of an officer or employee designated 
     by the Secretary)--
       ``(i) the name, address and contact information of the 
     person from whom that person purchased or received the food;
       ``(ii) copies of all documents relating to the person from 
     whom that person purchased or received the food; and
       ``(iii) copies of all documents pertaining to the delivery 
     of the food to that person; or
       ``(B) if that person establishes a guaranty signed by, and 
     containing the name and address of, the person from whom that 
     person received in good faith the food, stating that the food 
     is not adulterated or misbranded within the meaning of this 
     Act.
       ``(d) Judicial Review.--
       ``(1) In general.--An order assessing a civil penalty under 
     subsection (c) shall be a final order unless the person--
       ``(A) not later than 30 days after the effective date of 
     the order, files a petition for judicial review of the order 
     in the United States court of appeals for the circuit in 
     which that person resides or has its principal place of 
     business or the United States Court of Appeals for the 
     District of Columbia; and
       ``(B) simultaneously serves a copy of the petition by 
     certified mail to the Secretary.
       ``(2) Filing of record.--Not later than 45 days after the 
     service of a copy of the petition under paragraph (1)(B), the 
     Secretary shall file in the court a certified copy of the 
     administrative record upon which the order was issued.
       ``(3) Standard of review.--The findings of the Secretary 
     relating to the order shall be set aside only if found to be 
     unsupported by substantial evidence on the record as a whole.
       ``(e) Collection Actions for Failure to Pay.--
       ``(1) In general.--If any person fails to pay a civil 
     penalty assessed under subsection (c) after the order 
     assessing the penalty has become a final order, or after the 
     court of appeals described in subsection (d) has entered 
     final judgment in favor of the Secretary, the Secretary shall 
     refer the matter to the Attorney General, who shall institute 
     in a United States district court of competent jurisdiction a 
     civil action to recover the amount assessed.
       ``(2) Limitation on review.--In a civil action under 
     paragraph (1), the validity and appropriateness of the order 
     of the Secretary assessing the civil penalty shall not be 
     subject to judicial review.
       ``(f) Penalties Paid Into Account.--The Secretary--
       ``(1) shall deposit penalties collected under this section 
     in an account in the Treasury; and
       ``(2) may use the funds in the account, without further 
     appropriation or fiscal year limitation--
       ``(A) to carry out enforcement activities under food safety 
     law; or
       ``(B) to provide assistance to States to inspect retail 
     commercial food establishments, such as an establishment that 
     holds, stores, or transports food or food ingredients, or 
     other food or firms under the jurisdiction of State food 
     safety programs.
       ``(g) Discretion of the Secretary to Prosecute.--Nothing in 
     this section or section 418 requires the Secretary to report 
     for prosecution, or for the commencement of an action, the 
     violation of this Act in a case in which the Secretary finds 
     that the public interest will be adequately served by the 
     assessment of a civil penalty under this section.
       ``(h) Remedies Not Exclusive.--The remedies provided in 
     this section may be in addition to, and not exclusive of, 
     other remedies that may be available.

     ``SEC. 418. MANDATORY RECALL ACTION.

       ``(a) Mandatory Actions.--If a person referred to in 
     section 417(b) refuses to or does not adequately carry out 
     the actions described in that section within the time period 
     and in the manner prescribed by the Secretary, the Secretary 
     shall--
       ``(1) have authority to control and possess the food, 
     including ordering the shipment of the food from a food 
     establishment, such as an establishment that holds, stores, 
     or transports food or food ingredients, to the Secretary--
       ``(A) at the expense of such food establishment; or
       ``(B) in an emergency (as determined by the Secretary), at 
     the expense of the Secretary; and
       ``(2) by order, require, as the Secretary determines to be 
     necessary, the person to immediately--
       ``(A) cease distribution of the food; and
       ``(B) notify all persons--
       ``(i) processing, distributing, or otherwise handling the 
     food to immediately cease such activities with respect to the 
     food; or
       ``(ii) if the food has been distributed, transported, or 
     sold, to immediately cease distribution of the food.
       ``(b) Notification to Consumers by Secretary.--The 
     Secretary shall, as the Secretary determines to be necessary, 
     provide notice of the finding of the Secretary under 
     paragraph (1)--
       ``(1) to consumers to whom the food was, or may have been, 
     distributed; and
       ``(2) to State and local public health officials.
       ``(c) Nondistribution by Notified Persons.--A person that 
     processes, distributes, or otherwise handles the food, or to 
     which the food has been distributed, transported, or sold, 
     and that is notified under section 417(b)(2) or subsection 
     (a)(2)(B) of this section shall immediately cease 
     distribution of the food.
       ``(d) Availability of Records to Secretary.--Each person 
     referred to in section 417 that processed, distributed, or 
     otherwise handled food shall make available to the Secretary 
     information necessary to carry out this subsection, as 
     determined by the Secretary, regarding--
       ``(1) persons that processed, distributed, or otherwise 
     handled the food; and
       ``(2) persons to which the food has been transported, sold, 
     distributed, or otherwise handled.
       ``(e) Informal Hearings on Orders.--
       ``(1) In general.--The Secretary shall provide any person 
     subject to an order under subsection (a) with an opportunity 
     for an informal hearing, to be held as soon as practicable 
     but not later than 2 business days after the issuance of the 
     order.
       ``(2) Scope of the hearing.--In a hearing under paragraph 
     (1), the Secretary shall consider the actions required by the 
     order and any reasons why the food that is the subject of the 
     order should not be recalled.
       ``(f) Post-Hearing Recall Orders.--
       ``(1) Amendment of order.--If, after providing an 
     opportunity for an informal hearing under subsection (e), the 
     Secretary determines that there is a reasonable probability 
     that the food that is the subject of an order under 
     subsection (a), if consumed, would present a threat to the 
     public health, the Secretary, as the Secretary determines to 
     be necessary, may--
       ``(A) amend the order to require recall of the food or 
     other appropriate action;
       ``(B) specify a timetable in which the recall shall occur;
       ``(C) require periodic reports to the Secretary describing 
     the progress of the recall; and
       ``(D) provide notice of the recall to consumers to whom the 
     food was, or may have been, distributed.
       ``(2) Vacation of orders.--If, after providing an 
     opportunity for an informal hearing under subsection (e), the 
     Secretary determines that adequate grounds do not exist to 
     continue the actions required by the order, the Secretary 
     shall vacate the order.
       ``(g) Remedies Not Exclusive.--The remedies provided in 
     this section shall be in addition to, and not exclusive of, 
     other remedies that may be available.''.
                                 ______
                                 
  SA 1028. Mr. ROCKEFELLER (for himself, Mr. Schumer, Mr. Leahy, Mr. 
Kohl, and Ms. Stabenow) submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of the bill, add the following:

     SEC.__. PROHIBITION OF AUTHORIZED GENERICS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by this Act, is further amended by 
     adding at the end the following:
       ``(s) Prohibition of Authorized Generic Drugs.--

[[Page 10995]]

       ``(1) In general.--Notwithstanding any other provision of 
     this Act, no holder of a new drug application approved under 
     subsection (c) shall manufacture, market, sell, or distribute 
     an authorized generic drug, direct or indirectly, or 
     authorize any other person to manufacture, market, sell, or 
     distribute an authorized generic drug.
       ``(2) Authorized generic drug.--For purposes of this 
     subsection, the term `authorized generic drug'--
       ``(A) means any version of a listed drug (as such term is 
     used in subsection (j)) that the holder of the new drug 
     application approved under subsection (c) for that listed 
     drug seeks to commence marketing, selling, or distributing, 
     directly or indirectly, after receipt of a notice sent 
     pursuant to subsection (j)(2)(B) with respect to that listed 
     drug; and
       ``(B) does not include any drug to be marketed, sold, or 
     distributed--
       ``(i) by an entity eligible for exclusivity with respect to 
     such drug under subsection (j)(5)(B)(iv); or
       ``(ii) after expiration or forfeiture of any exclusivity 
     with respect to such drug under such subsection 
     (j)(5)(B)(iv).''.
                                 ______
                                 
  SA 1029. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 138 strike line 5 and all that follows 
     through line 10 on page 142 and insert the following:
       ``(x) specify a process for annual Board review of the 
     operations of the Foundation;
       ``(xi) establish specific duties of the Executive Director; 
     and
       ``(xii) establish specific policies to safeguard the 
     Federal Government's patent rights in inventions made with 
     Federal assistance through the Foundation;
       ``(B) prioritize and provide overall direction to the 
     activities of the Foundation;
       ``(C) evaluate the performance of the Executive Director; 
     and
       ``(D) carry out any other necessary activities regarding 
     the functioning of the Foundation.
       ``(3) Terms and vacancies.--
       ``(A) Term.--The term of office of each member of the Board 
     appointed under paragraph (1)(C) shall be 4 years, except 
     that the terms of offices for the initial appointed members 
     of the Board shall expire on a staggered basis as determined 
     by the ex officio members.
       ``(B) Vacancy.--Any vacancy in the membership of the 
     Board--
       ``(i) shall not affect the power of the remaining members 
     to execute the duties of the Board; and
       ``(ii) shall be filled by appointment by the appointed 
     members described in paragraph (1)(C) by majority vote.
       ``(C) Partial term.--If a member of the Board does not 
     serve the full term applicable under subparagraph (A), the 
     individual appointed under subparagraph (B) to fill the 
     resulting vacancy shall be appointed for the remainder of the 
     term of the predecessor of the individual.
       ``(D) Serving past term.--A member of the Board may 
     continue to serve after the expiration of the term of the 
     member until a successor is appointed.
       ``(4) Compensation.--Members of the Board may not receive 
     compensation for service on the Board. Such members may be 
     reimbursed for travel, subsistence, and other necessary 
     expenses incurred in carrying out the duties of the Board, as 
     set forth in the bylaws issued by the Board.
       ``(e) Incorporation.--The ex officio members of the Board 
     shall serve as incorporators and shall take whatever actions 
     necessary to incorporate the Foundation.
       ``(f) Nonprofit Status.--The Foundation shall be considered 
     to be a corporation under section 501(c) of the Internal 
     Revenue Code of 1986, shall be subject to the provisions of 
     such section, and shall be considered a nonprofit 
     organization for purpose of section 201(i) of title 35, 
     United States Code.
       ``(g) Executive Director.--
       ``(1) In general.--The Board shall appoint an Executive 
     Director who shall serve at the pleasure of the Board. The 
     Executive Director shall be responsible for the day-to-day 
     operations of the Foundation and shall have such specific 
     duties and responsibilities as the Board shall prescribe.
       ``(2) Compensation.--The compensation of the Executive 
     Director shall be fixed by the Board but shall not be greater 
     than the compensation of the Commissioner.
       ``(h) Administrative Powers.--In carrying out this 
     subchapter, the Board, acting through the Executive Director, 
     may--
       ``(1) adopt, alter, and use a corporate seal, which shall 
     be judicially noticed;
       ``(2) hire, promote, compensate, and discharge 1 or more 
     officers, employees, and agents, as may be necessary, and 
     define their duties;
       ``(3) prescribe the manner in which--
       ``(A) real or personal property of the Foundation is 
     acquired, held, and transferred;
       ``(B) general operations of the Foundation are to be 
     conducted; and
       ``(C) the privileges granted to the Board by law are 
     exercised and enjoyed;
       ``(4) with the consent of the applicable executive 
     department or independent agency, use the information, 
     services, and facilities of such department or agencies in 
     carrying out this section;
       ``(5) enter into contracts with public and private 
     organizations for the writing, editing, printing, and 
     publishing of books and other material;
       ``(6) hold, administer, invest, and spend any gift, devise, 
     or bequest of real or personal property made to the 
     Foundation under subsection (i);
       ``(7) enter into such other contracts, leases, cooperative 
     agreements, and other transactions as the Board considers 
     appropriate to conduct the activities of the Foundation, 
     except that Federal rights in patented inventions made with 
     Federal assistance shall be preserved;
       ``(8) modify or consent to the modification of any contract 
     or agreement to which it is a party or in which it has an 
     interest under this subchapter;
       ``(9) take such action as may be necessary to obtain 
     patents and licenses for devices and procedures developed by 
     the Foundation and its employees, except that Federal rights 
     in patented inventions made with Federal assistance shall be 
     preserved;
                                 ______
                                 
  SA 1030. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 171, between lines 18 and 19, insert the following:
       ``(C) Additional certification.--At the time of the 
     submission of an application under section 505 of the Federal 
     Food, Drug, and Cosmetic Act, section 515 of such Act, 
     section 520(m) of such Act or section 351 of the Public 
     Health Service Act, or submission of a report under section 
     510(k) of such Act, such application or submission shall be 
     accompanied by a certification that all applicable 
     requirements of sections 201 through 212 of title 35, United 
     States Code, and any other provision of Federal law relating 
     to Federal rights in patented inventions made with Federal 
     Government assistance, have been met, including, where 
     applicable, the requirement under section 201(f) of such 
     title that the benefits of such inventions be made available 
     to the public on reasonable terms, including price.''.
                                 ______
                                 
  SA 1031. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 171, line 16, insert before the period the 
     following: ``, and that any patent filed or that will be 
     filed contains a statement specifying that the invention was 
     made with Federal Government support and that the Federal 
     Government has certain rights in it, if such a statement is 
     otherwise required by law''.
                                 ______
                                 
  SA 1032. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 156, between lines 2 and 3, insert the following:

       ``(VII) The rights of the Federal Government in the drug or 
     device that is the subject of the clinical trial.''.

                                 ______
                                 
  SA 1033. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill S. 1082, to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize and amend the prescription drug user fee 
provisions, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 145, between lines 11 and 12, insert the following:
       ``(n) Protecting Federal Rights in Patented Inventions 
     Developed With Federal Government Assistance.--Any invention 
     developed by the Foundation or with the funds of the 
     Foundation shall be considered a subject invention for 
     purposes of section 201(e) of title 35, United States 
     Code.''.

     

                          ____________________