[Congressional Record (Bound Edition), Volume 158 (2012), Part 5]
[Senate]
[Pages 7063-7066]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2107. Mr. McCAIN submitted an amendment intended to be proposed by 
him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs for prescription drugs 
and medical devices, to establish user-fee programs for generic drugs 
and biosimilars, and for other purposes; which was ordered to lie on 
the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. SAFE AND AFFORDABLE DRUGS FROM CANADA.

       Chapter VIII of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 381 et seq.), as amended by this Act, is further 
     amended by adding at the end the following:

     ``SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIPTION DRUGS 
                   FROM CANADA.

       ``(a) In General.--Notwithstanding any other provision of 
     this Act, not later than 180 days after the date of enactment 
     of this section, the Secretary shall promulgate regulations 
     permitting individuals to safely import into the United 
     States a prescription drug (other than a controlled 
     substance, as defined in section 102 of the Controlled 
     Substances Act) that--
       ``(1) is purchased from an approved Canadian pharmacy;
       ``(2) is dispensed by a pharmacist licensed to practice 
     pharmacy and dispense prescription drugs in Canada;
       ``(3) is purchased for personal use by the individual, not 
     for resale, in quantities that do not exceed a 90-day supply;
       ``(4) is filled using a valid prescription issued by a 
     physician licensed to practice in the United States; and
       ``(5) has the same active ingredient or ingredients, route 
     of administration, dosage form, and strength as a 
     prescription drug approved by the Secretary under chapter V.
       ``(b) Approved Canadian Pharmacy.--
       ``(1) In general.--In this section, an approved Canadian 
     pharmacy is a pharmacy that--
       ``(A) is located in Canada; and
       ``(B) that the Secretary certifies--

[[Page 7064]]

       ``(i) is licensed to operate and dispense prescription 
     drugs to individuals in Canada; and
       ``(ii) meets the criteria under subsection (c).
       ``(2) Publication of approved canadian pharmacies.--The 
     Secretary shall publish on the Internet Web site of the Food 
     and Drug Administration a list of approved Canadian 
     pharmacies, including the Internet Web site address of each 
     such approved Canadian pharmacy, from which individuals may 
     purchase prescription drugs in accordance with subsection 
     (a).
       ``(c) Additional Criteria.--To be an approved Canadian 
     pharmacy, the Secretary shall certify that the pharmacy--
       ``(1) has been in existence for a period of at least 5 
     years preceding the date of enactment of this section and has 
     a purpose other than to participate in the program 
     established under this section;
       ``(2) operates in accordance with pharmacy standards set 
     forth by the provincial pharmacy rules and regulations 
     enacted in Canada;
       ``(3) has processes established by the pharmacy, or 
     participates in another established process, to certify that 
     the physical premises and data reporting procedures and 
     licenses are in compliance with all applicable laws and 
     regulations, and has implemented policies designed to monitor 
     ongoing compliance with such laws and regulations;
       ``(4) conducts or commits to participate in ongoing and 
     comprehensive quality assurance programs and implements such 
     quality assurance measures, including blind testing, to 
     ensure the veracity and reliability of the findings of the 
     quality assurance program;
       ``(5) agrees that laboratories approved by the Secretary 
     shall be used to conduct product testing to determine the 
     safety and efficacy of sample pharmaceutical products;
       ``(6) has established, or will establish or participate in, 
     a process for resolving grievances and will be held 
     accountable for violations of established guidelines and 
     rules;
       ``(7) does not resell products from online pharmacies 
     located outside Canada to customers in the United States; and
       ``(8) meets any other criteria established by the 
     Secretary.''.
                                 ______
                                 
  SA 2108. Ms. MURKOWSKI (for herself, Mr. Begich, Mr. Merkley, Mr. 
Sanders, Mr. Leahy, and Ms. Cantwell) submitted an amendment intended 
to be proposed by her to the bill S. 3187, to amend the Federal Food, 
Drug, and Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. ANALYSES OF APPLICATION FOR APPROVAL OF 
                   GENETICALLY-ENGINEERED FISH.

       Notwithstanding any other provision of law, approval by the 
     Secretary of Health and Human Services of an application 
     submitted under the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.) for approval of any genetically modified 
     marine or anadromous organism shall not take effect until the 
     date that the Secretary of Commerce, acting through the Under 
     Secretary for Oceans and Atmosphere, approves such 
     application using standards applied by the Under Secretary 
     under the National Environmental Policy Act of 1969 (42 
     U.S.C. 4321 et seq.), which shall include a Regulatory Impact 
     Review required by Executive Order 12866 (58 Fed. Reg. 51735) 
     and Initial Regulatory Flexibility Analyses required under 
     chapter 6 of title 5, United States Code (commonly referred 
     to as the ``Regulatory Flexibility Act'').
                                 ______
                                 
  SA 2109. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. CONDITIONS ON AWARD OF DRUG EXCLUSIVITY.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.) is 
     amended by inserting after section 569C, as added by this 
     Act, the following:

     ``SEC. 569D. CONDITIONS ON AWARD OF DRUG EXCLUSIVITY.

       ``(a) Termination of Exclusivity.--Notwithstanding any 
     other provision of this Act, any period of exclusivity 
     described in subsection (b) granted to a person or assigned 
     to a person on or after the date of enactment of this section 
     with respect to a drug shall be terminated if the person to 
     which such exclusivity was granted or any person to which 
     such exclusivity is assigned--
       ``(1) commits a violation described in subsection (c)(1) 
     with respect to such drug; or
       ``(2) fails to report such a violation as required by 
     subsection (e).
       ``(b) Exclusivities Affected.--The periods of exclusivity 
     described in this subsection are those periods of exclusivity 
     granted under any of the following sections:
       ``(1) Clause (ii), (iii), or (iv) of section 505(c)(3)(E).
       ``(2) Clause (iv) of section 505(j)(5)(B).
       ``(3) Clause (ii), (iii), or (iv) of section 505(j)(5)(F).
       ``(4) Section 505A.
       ``(5) Section 505E.
       ``(6) Section 527.
       ``(7) Section 351(k)(7) of the Public Health Service Act.
       ``(8) Any other provision of this Act that provides for 
     market exclusivity (or extension of market exclusivity) with 
     respect to a drug.
       ``(c) Violations.--
       ``(1) In general.--A violation described in this subsection 
     is a violation of a law described in paragraph (2) that 
     results in--
       ``(A) a criminal conviction of a person described in 
     subsection (a);
       ``(B) a civil judgment against a person described in 
     subsection (a); or
       ``(C) a settlement agreement in which a person described in 
     subsection (a) admits to fault.
       ``(2) Laws described.--The laws described in this paragraph 
     are the following:
       ``(A) The provisions of this Act that prohibit--
       ``(i) the adulteration or misbranding of a drug;
       ``(ii) the making of false statements to the Secretary or 
     committing fraud; or
       ``(iii) the illegal marketing of a drug.
       ``(B) The provisions of subchapter III of chapter 37 of 
     title 31, United States Code (commonly known as the `False 
     Claims Act').
       ``(C) Section 287 of title 18, United States Code.
       ``(D) The Medicare and Medicaid Patient Protection and 
     Program Act of 1987 (commonly known as the `Antikickback 
     Statute').
       ``(E) Section 1927 of the Social Security Act.
       ``(F) A State law against fraud comparable to a law 
     described in subparagraphs (A) through (E).
       ``(d) Date of Exclusivity Termination.--The date on which 
     the exclusivity shall be terminated as described in 
     subsection (a) is the date on which, as applicable--
       ``(1) a final judgment is entered relating to a violation 
     described in subparagraph (A) or (B) of subsection (c)(1); or
       ``(2)(A) a settlement agreement described in subsection 
     (c)(1)(C) is approved by a court order that is or becomes 
     final and nonappealable; or
       ``(B) if there is no court order approving a settlement 
     agreement described in subsection (c)(1)(C), a court order 
     dismissing the applicable case, issued after the settlement 
     agreement, is or becomes final and nonappealable.
       ``(e) Reporting of Information.--A person described in 
     subsection (a) that commits a violation described in 
     subsection (c)(1) shall report such violation to the 
     Secretary no later than 30 days after the date that--
       ``(1) a final judgment is entered relating to a violation 
     described in subparagraph (A) or (B) of subsection (c)(1); or
       ``(2)(A) a settlement agreement described in subsection 
     (c)(1)(C) is approved by a court order that is or becomes 
     final and nonappealable; or
       ``(B) if there is no court order approving a settlement 
     agreement described in subsection (c)(1)(C), a court order 
     dismissing the applicable case, issued after the settlement 
     agreement, is or becomes final and nonappealable.''.
                                 ______
                                 
  SA 2110. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill S. 3187, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and medical devices, to establish user-fee programs 
for generic drugs and biosimilars, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the end of title XI, add the following:

     SEC. 11__. TRANSPARENCY IN NEW DRUG APPLICATIONS.

       (a) General Requirements.--Subchapter A of chapter V (21 
     U.S.C. 351 et seq.), as amended by section 802, is further 
     amended by adding at the end the following:

     ``SEC. 524B. TRANSPARENCY IN DRUG APPLICATIONS TO THE FDA.

       ``(a) Initial Disclosure of Financial Information.--
       ``(1) In general.--A drug application submitted under 
     subsection (b) or (j) of section 505, an application for a 
     biologics license under subsection (a) or (k) of section 351 
     of the Public Health Service Act, an investigational new drug 
     application under section 505(i), an application for an 
     extension of market exclusivity following the completion of 
     pediatric studies under section 505A(c), an application for a 
     priority review voucher under section 524, a request for a 
     designation as an orphan drug under section 526, and any 
     other application to the Food and Drug Administration with 
     respect to approval of a drug or an extension of the market 
     exclusivity of a drug shall include a disclosure to

[[Page 7065]]

     the Secretary of such financial information associated with 
     the research and development of the drug as required by the 
     Secretary, as described in paragraph (2). The Secretary shall 
     make such information public.
       ``(2) Required information.--The financial information 
     provided to the Secretary and made public under paragraph (1) 
     shall include--
       ``(A) the total amount expended for pre-clinical research 
     and for each phase of clinical trials of the drug;
       ``(B) a description of any grant or other economic 
     incentive for research and development of such drug the 
     sponsor receives from private, public, or any other funding 
     source or research institution, including the National 
     Institutes of Health, and the amount obtained from each 
     source; and
       ``(C) such other information, as the Secretary may require.
       ``(3) Research and development defined.--For purposes of 
     this section, `research and development' of a drug shall 
     include identification of chemical compounds, proof of 
     concepts, testing of concepts, and all phases of clinical 
     trials, including failed tests or trials. Research and 
     development of a particular drug does not include the costs 
     of failed drugs other than the drug that is the subject of 
     the application described in paragraph (1).
       ``(b) Subsequent Financial Disclosures.--A sponsor of a 
     drug approved under subsection (b) or (j) of section 505, or 
     a biological product approved under subsection (a) or (k) of 
     section 351 of the Public Health Service Act, on an annual 
     basis during the period during which the sponsor claims 
     market exclusivity with respect to the drug and for 7 years 
     thereafter, shall report to the Secretary the quarterly 
     domestic and global unit sales and sales revenue of the drug.
       ``(c) Public Disclosure of Clinical Trials.--
       ``(1) In general.--The Secretary shall require the sponsor 
     of a drug to register each clinical trial of such drug on the 
     Internet web site of the National Institutes of Health, 
     clinicaltrials.gov (or such successor Internet website 
     developed by the Secretary).
       ``(2) TDP.--In the case of a sponsor that claims test data 
     protection, the sponsor shall register the required 
     information of the related drug with a clinicaltrials.gov 
     identifier supplied by the Secretary.
       ``(d) Disclosure of Numbers of Individuals Participating in 
     Clinical Trials.--A manufacturer or sponsor who submits a 
     request under paragraph (1) shall also submit to the 
     Secretary the following information with respect to clinical 
     trials of the drug, which the Secretary shall make public:
       ``(1) The numbers of individuals participating in each 
     phase of clinical trials, using de-identified data.
       ``(2) A description of each participant's dosage of the 
     drug, using de-identified data.
       ``(3) A description of each participant's results, using 
     de-identified data.''.
       (b) Disclosure of Safety and Effectiveness Data.--Section 
     505(l)(1) (21 U.S.C. 355(l)(1)) is amended, in the matter 
     preceding subparagraph (A), by striking ``, unless 
     extraordinary circumstances are shown''.
                                 ______
                                 
  SA 2111. Mr. BINGAMAN (for himself, Mr. Vitter, Mr. Franken, Mrs. 
Shaheen, Mr. Kohl, Mr. Udall of New Mexico, Mr. Johnson of South 
Dakota, Ms. Klobuchar, Mr. Merkley, and Mr. Sanders) submitted an 
amendment intended to be proposed by him to the bill S. 3187, to amend 
the Federal Food, Drug, and Cosmetic Act to revise and extend the user-
fee programs for prescription drugs and medical devices, to establish 
user-fee programs for generic drugs and biosimilars, and for other 
purposes; which was ordered to lie on the table; as follows:

       In title IX, add at the end the following:

     SEC. 9__. ENSURING THAT VALID GENERIC DRUGS MAY ENTER THE 
                   MARKET.

       (a) 180-Day Exclusivity Period Amendments Regarding First 
     Applicant Status.--
       (1) Amendments to the federal food, drug, and cosmetic 
     act.--
       (A) In general.--Section 505(j)(5)(B) (21 U.S.C. 
     355(j)(5)(B)) is amended--
       (i) in clause (iv)(II)--

       (I) by striking item (bb); and
       (II) by redesignating items (cc) and (dd) as items (bb) and 
     (cc), respectively; and

       (ii) by adding at the end the following:
       ``(v) First Applicant Defined.--As used in this subsection, 
     the term `first applicant' means an applicant--
       ``(I)(aa) that, on the first day on which a substantially 
     complete application containing a certification described in 
     paragraph (2)(A)(vii)(IV) is submitted for approval of a 
     drug, submits a substantially complete application that 
     contains and lawfully maintains a certification described in 
     paragraph (2)(A)(vii)(IV) for the drug; and
       ``(bb) that has not entered into a disqualifying agreement 
     described under clause (vii)(II); or
       ``(II)(aa) for the drug that is not described in subclause 
     (I) and that, with respect to the applicant and drug, each 
     requirement described in clause (vi) is satisfied; and
       ``(bb) that has not entered into a disqualifying agreement 
     described under clause (vii)(II).
       ``(vi) Requirement.--The requirements described in this 
     clause are the following:
       ``(I) The applicant described in clause (v)(II) submitted 
     and lawfully maintains a certification described in paragraph 
     (2)(A)(vii)(IV) or a statement described in paragraph 
     (2)(A)(viii) for each unexpired patent for which a first 
     applicant described in clause (v)(I) had submitted a 
     certification described in paragraph (2)(A)(vii)(IV) on the 
     first day on which a substantially complete application 
     containing such a certification was submitted.
       ``(II) With regard to each such unexpired patent for which 
     the applicant described in clause (v)(II) submitted a 
     certification described in paragraph (2)(A)(vii)(IV), no 
     action for patent infringement was brought against such 
     applicant within the 45 day period specified in paragraph 
     (5)(B)(iii); or if an action was brought within such time 
     period, such an action was withdrawn or dismissed by a court 
     (including a district court) without a decision that the 
     patent was valid and infringed; or if an action was brought 
     within such time period and was not withdrawn or so 
     dismissed, such applicant has obtained the decision of a 
     court (including a district court) that the patent is invalid 
     or not infringed (including any substantive determination 
     that there is no cause of action for patent infringement or 
     invalidity, and including a settlement order or consent 
     decree signed and entered by the court stating that the 
     patent is invalid or not infringed).
       ``(III) If an applicant described in clause (v)(I) has 
     begun commercial marketing of such drug, the applicant 
     described in clause (v)(II) does not begin commercial 
     marketing of such drug until the date that is 30 days after 
     the date on which the applicant described in clause (v)(I) 
     began such commercial marketing.''.
       (B) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) (21 
     U.S.C. 355(j)(5)(D)(i)(IV)) is amended by striking ``The 
     first applicant'' and inserting ``The first applicant, as 
     defined in subparagraph (B)(v)(I),''.
       (2) Applicability.--The amendments made by paragraph (1) 
     shall apply only with respect to an application filed under 
     section 505(j) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)) to which the amendments made by section 
     1102(a) of the Medicare Prescription Drug, Improvement, and 
     Modernization Act of 2003 (Public Law 108 173) apply.
       (b) 180-Day Exclusivity Period Amendments Regarding 
     Agreements to Defer Commercial Marketing.--
       (1) Amendments to federal food, drug, and cosmetic act.--
       (A) Limitations on agreements to defer commercial marketing 
     date.--Section 505(j)(5)(B) (21 U.S.C. 355(j)(5)(B)), as 
     amended by subsection (a), is further amended by adding at 
     the end the following:
       ``(vii) Agreement by first applicant to defer commercial 
     marketing; limitation on acceleration of deferred commercial 
     marketing date.--
       ``(I) Agreement to defer approval or commercial marketing 
     date.--An agreement described in this subclause is an 
     agreement between a first applicant and the holder of the 
     application for the listed drug or an owner of one or more of 
     the patents as to which any applicant submitted a 
     certification qualifying such applicant for the 180-day 
     exclusivity period whereby that applicant agrees, directly or 
     indirectly, (aa) not to seek an approval of its application 
     that is made effective on the earliest possible date under 
     this subparagraph, subparagraph (F) of this paragraph, 
     section 505A, or section 527, (bb) not to begin the 
     commercial marketing of its drug on the earliest possible 
     date after receiving an approval of its application that is 
     made effective under this subparagraph, subparagraph (F) of 
     this paragraph, section 505A, or section 527, or (cc) to both 
     items (aa) and (bb).
       ``(II) Agreement that disqualifies applicant from first 
     applicant status.--An agreement described in this subclause 
     is an agreement between an applicant and the holder of the 
     application for the listed drug or an owner of one or more of 
     the patents as to which any applicant submitted a 
     certification qualifying such applicant for the 180-day 
     exclusivity period whereby that applicant agrees, directly or 
     indirectly, not to seek an approval of its application or not 
     to begin the commercial marketing of its drug until a date 
     that is after the expiration of the 180-day exclusivity 
     period awarded to another applicant with respect to such drug 
     (without regard to whether such 180-day exclusivity period is 
     awarded before or after the date of the agreement).
       ``(viii) Limitation on acceleration.--If an agreement 
     described in clause (vii)(I) includes more than 1 possible 
     date when an applicant may seek an approval of its 
     application or begin the commercial marketing of its drug--
       ``(I) the applicant may seek an approval of its application 
     or begin such commercial marketing on the date that is the 
     earlier of--
       ``(aa) the latest date set forth in the agreement on which 
     that applicant can receive an approval that is made effective 
     under this subparagraph, subparagraph (F) of this paragraph, 
     section 505A, or section 527, or begin

[[Page 7066]]

     the commercial marketing of such drug, without regard to any 
     other provision of such agreement pursuant to which the 
     commercial marketing could begin on an earlier date; or
       ``(bb) 180 days after another first applicant begins 
     commercial marketing of such drug; and
       ``(II) the latest date set forth in the agreement on which 
     that applicant can receive an approval that is made effective 
     under this subparagraph, subparagraph (F) of this paragraph, 
     section 505A, or section 527, or begin the commercial 
     marketing of such drug, without regard to any other provision 
     of such agreement pursuant to which commercial marketing 
     could begin on an earlier date, shall be the date used to 
     determine whether an applicant is disqualified from first 
     applicant status pursuant to clause (vii)(II).''.
       (B) Notification of fda.--Section 505(j) (21 U.S.C. 355(j)) 
     is amended by adding at the end the following:
       ``(11)(A) The holder of an abbreviated application under 
     this subsection shall submit to the Secretary a notification 
     that includes--
       ``(i)(I) the text of any agreement entered into by such 
     holder described under paragraph (5)(B)(vii)(I); or
       ``(II) if such an agreement has not been reduced to text, a 
     written detailed description of such agreement that is 
     sufficient to disclose all the terms and conditions of the 
     agreement; and
       ``(ii) the text, or a written detailed description in the 
     event of an agreement that has not been reduced to text, of 
     any other agreements that are contingent upon, provide a 
     contingent condition for, or are otherwise related to an 
     agreement described in clause (i).
       ``(B) The notification described under subparagraph (A) 
     shall be submitted not later than 10 business days after 
     execution of the agreement described in subparagraph (A)(i). 
     Such notification is in addition to any notification required 
     under section 1112 of the Medicare Prescription Drug, 
     Improvement, and Modernization Act of 2003.
       ``(C) Any information or documentary material filed with 
     the Secretary pursuant to this paragraph shall be exempt from 
     disclosure under section 552 of title 5, United States Code, 
     and no such information or documentary material may be made 
     public, except as may be relevant to any administrative or 
     judicial action or proceeding. Nothing in this paragraph is 
     intended to prevent disclosure to either body of the Congress 
     or to any duly authorized committee or subcommittee of the 
     Congress.''.
       (C) Prohibited acts.--Section 301(e) (21 U.S.C. 331(e)) is 
     amended by striking ``505 (i) or (k)'' and inserting ``505 
     (i), (j)(11), or (k)''.
       (2) Infringement of patent.--Section 271(e) of title 35, 
     United States Code, is amended by adding at the end the 
     following:
       ``(7) The exclusive remedy under this section for an 
     infringement of a patent for which the Secretary of Health 
     and Human Services has published information pursuant to 
     subsection (b)(1) or (c)(2) of section 505 of the Federal 
     Food, Drug, and Cosmetic Act shall be an action brought under 
     this subsection within the 45-day period described in 
     subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the 
     Federal Food, Drug, and Cosmetic Act.''.
       (3) Applicability.--
       (A) Limitations on acceleration of deferred commercial 
     marketing date.--The amendment made by paragraph (1)(A) shall 
     apply only with respect to--
       (i) an application filed under section 505(j) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) to 
     which the amendments made by section 1102(a) of the Medicare 
     Prescription Drug, Improvement, and Modernization Act of 2003 
     (Public Law 108 173) apply; and
       (ii) an agreement described under section 
     505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and Cosmetic 
     Act (as added by subsection (a)(1)) executed after the date 
     of enactment of this Act.
       (B) Notification of fda.--The amendments made by 
     subparagraphs (B) and (C) of paragraph (1) shall apply only 
     with respect to an agreement described under section 
     505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and Cosmetic 
     Act (as added by paragraph (1)(A)) executed after the date of 
     enactment of this Act.
       (c) Technical Amendment.--Section 744B(n), as added by 
     section 302 of this Act, is amended by striking 
     ``505(j)(5)(B)(iv)(II)(cc)'' and inserting 
     ``505(j)(5)(B)(iv)(II)(bb)''.
                                 ______
                                 
  SA 2112. Mr. REID (for Mrs. Boxer (for herself and Mrs. Feinstein)) 
proposed an amendment to the bill H.R. 4849, to direct the Secretary of 
the Interior to issue commercial use authorizations to commercial stock 
operators for operations in designated wilderness within the Sequoia 
and Kings Canyon National Parks, and for other purposes; as follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Sequoia and King Canyon 
     National Parks Backcountry Access Act''.

     SEC. 2. COMMERCIAL SERVICES AUTHORIZATIONS IN WILDERNESS 
                   WITHIN THE SEQUOIA AND KINGS CANYON NATIONAL 
                   PARKS.

       (a) Continuation of Authority.--Until the date on which the 
     Secretary of the Interior (referred to in this Act as the 
     ``Secretary'') completes any analysis and determination 
     required under the Wilderness Act (16 U.S.C. 1131 et seq.), 
     the Secretary shall continue to issue authorizations to 
     provide commercial services for commercial stock operations 
     (including commercial use authorizations and concession 
     contracts) within any area designated as wilderness in the 
     Sequoia and Kings Canyon National Parks (referred to in this 
     section as the ``Parks)'' at use levels determined by the 
     Secretary to be appropriate and subject to any terms and 
     conditions that the Secretary determines to be appropriate.
       (b) Wilderness Stewardship Plan.--Not later than 3 years 
     after the date of enactment of this Act, the Secretary shall 
     complete a wilderness stewardship plan with respect to the 
     Parks.
       (c) Termination of Authority.--The authority of the 
     Secretary to issue authorizations under subsection (a) shall 
     terminate on the earlier of--
       (1) the date on which the Secretary begins to issue 
     authorizations to provide commercial services for commercial 
     stock operations within any areas designated as wilderness in 
     the Parks, as provided in a record of decision issued in 
     accordance with a wilderness stewardship plan completed under 
     subsection (b); or
       (2) the date that is 4 years after the date of enactment of 
     this Act.

                          ____________________