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SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Consumer Access to 
Generic Drugs Act of 2007''.

SEC. 2. UNFAIR AND DECEPTIVE ACTS AND PRACTICES RELATED TO NEW DRUG 
              APPLICATIONS.

    (a) Conduct Prohibited.--It shall be unlawful for any person to 
directly or indirectly be a party to any agreement resolving or 
settling a patent infringement claim in which--
            (1) an ANDA filer receives anything of value; and
            (2) the ANDA filer agrees not to research, develop, 
        manufacture, market, or sell, for any period of time, the drug 
        that is to be manufactured under the ANDA involved and is the 
        subject of the patent infringement claim.
    (b) Exceptions.--Notwithstanding subsection (a)(1), subsection (a) 
does not prohibit a resolution or settlement of a patent infringement 
claim in which the value received by the ANDA filer includes no more 
than--
            (1) the right to market the drug that is to be manufactured 
        under the ANDA involved and is the subject of the patent 
        infringement claim, before the expiration of--
                    (A) the patent that is the basis for the patent 
                infringement claim; or
                    (B) any other statutory exclusivity that would 
                prevent the marketing of such drug; and
            (2) the waiver of a patent infringement claim for damages 
        based on prior marketing of such drug.
    (c) Enforcement.--A violation of subsection (a) shall be treated as 
an unfair and deceptive act or practice and an unfair method of 
competition in or affecting interstate commerce prohibited under 
section 5 of the Federal Trade Commission Act (15 U.S.C. 45). The 
Federal Trade Commission shall enforce this Act in the same manner, by 
the same means, and with the same jurisdiction as though all applicable 
terms and provisions of the Federal Trade Commission Act were 
incorporated into and made a part of this Act.
    (d) Definitions.--In this section:
            (1) Agreement.--The term ``agreement'' means anything that 
        would constitute an agreement for purposes of section 5 of the 
        Federal Trade Commission Act (15 U.S.C. 45).
            (2) Agreement resolving or settling.--The term ``agreement 
        resolving or settling'', in reference to a patent infringement 
        claim, includes any agreement that is contingent upon, provides 
        a contingent condition for, or is otherwise related to the 
        resolution or settlement of the claim.
            (3) ANDA.--The term ``ANDA'' means an abbreviated new drug 
        application for the approval of a new drug under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
            (4) ANDA filer.--The term ``ANDA filer'' means a party that 
        has filed an ANDA with the Food and Drug Administration.
            (5) Patent infringement.--The term ``patent infringement'' 
        means infringement of any patent or of any filed patent 
        application, extension, reissuance, renewal, division, 
        continuation, continuation in part, reexamination, patent term 
        restoration, patent of addition, or extension thereof.
            (6) Patent infringement claim.--The term ``patent 
        infringement claim'' means any allegation made to an ANDA 
        filer, whether or not included in a complaint filed with a 
        court of law, that its ANDA or drug to be manufactured under 
        such ANDA may infringe any patent.

SEC. 3. FTC RULEMAKING.

    The Federal Trade Commission may, by rule promulgated under section 
553 of title 5, United States Code, exempt certain agreements described 
in section 2 if the Commission finds such agreements to be in 
furtherance of market competition and for the benefit of consumers. 
Consistent with the authority of the Commission, such rules may include 
interpretive rules and general statements of policy with respect to the 
practices prohibited under section 2.

SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD UNDER THE FFDCA.

    Section 505(j)(5)(D)(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(5)(D)(i)) is amended--
            (1) in subclause (I)(bb)--
                    (A) by redesignating subitem (CC) as subitem (EE); 
                and
                    (B) by inserting after subitem (BB) the following:

                                                    ``(CC) In a 
                                                declaratory judgment 
                                                action described in 
                                                subitem (AA), a court 
                                                dismisses the action 
                                                for lack of subject 
                                                matter jurisdiction, 
                                                either with or without 
                                                prejudice.

                                                    ``(DD) The 
                                                applicant files with 
                                                the Secretary a 
                                                covenant by the patent 
                                                owner that the patent 
                                                owner will not sue the 
                                                applicant for 
                                                infringement with 
                                                respect to the 
                                                patent.''; and

            (2) in subclause (V), by inserting ``section 2 of the 
        Protecting Consumer Access to Generic Drugs Act of 2007 or'' 
        after ``that the agreement has violated''.

SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS.

    (a) Notice of All Agreements.--Section 1112(c)(2) of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (21 
U.S.C. 3155 note) is amended by--
            (1) striking ``the Commission the'' and inserting ``the 
        Commission (1) the''; and
            (2) inserting before the period at the end the following: 
        ``; and (2) a description of the subject matter of any other 
        agreement the parties enter into within 30 days of an entering 
        into an agreement covered by subsection (a) or (b)''.
    (b) Certification of Agreements.--Section 1112 of such Act is 
amended by adding at the end the following:
    ``(d) Certification.--The Chief Executive Officer or the company 
official responsible for negotiating any agreement required to be filed 
under subsection (a), (b), or (c) shall execute and file with the 
Assistant Attorney General and the Commission a certification as 
follows: `I declare under penalty of perjury that the following is true 
and correct: The materials filed with the Federal Trade Commission and 
the Department of Justice under section 1112 of subtitle B of title XI 
of the Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003, with respect to the agreement referenced in this 
certification: (1) represent the complete, final, and exclusive 
agreement between the parties; (2) include any ancillary agreements 
that are contingent upon, provide a contingent condition for, or are 
otherwise related to, the referenced agreement; and (3) include written 
descriptions of any oral agreements, representations, commitments, or 
promises between the parties that are responsive to subsection (a) or 
(b) of such section 1112 and have not been reduced to writing.'.''.
Protecting Consumer Access to Generic Drugs Act of 2007 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages.

Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers.

Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stop Westward Aquatic Threats Act''.

SEC. 2. AMENDMENT OF NONINDIGENOUS AQUATIC NUISANCE PREVENTION AND 
              CONTROL ACT OF 1990.

    Except as otherwise expressly provided, whenever in this Act an 
amendment or repeal is expressed in terms of an amendment to, or repeal 
of, a section or other provision, the reference shall be considered to 
be made to a section or other provision of Nonindigenous Aquatic 
Nuisance Prevention and Control Act of 1990 (16 U.S.C. 4701 et seq.).

SEC. 3. 100TH MERIDIAN AND WESTWARD PROGRAM.

    Subtitle C (16 U.S.C. 4721 et seq.) is amended by adding at the end 
the following:

``SEC. 1210. 100TH MERIDIAN AND WESTWARD PROGRAM.

    ``(a) Public Information and Education.--The Secretary shall 
coordinate with the States to provide the public with information and 
education on the threat of zebra mussels and other aquatic nuisance 
species and how to prevent their westward advance.
    ``(b) Source States Action Plan.--The Secretary, in consultation 
with the Task Force, shall work with States that contain aquatic 
nuisance species, including zebra mussels, that threaten western States 
to develop and implement a prevention action plan that includes 
inspections of vessels at boat launches and elsewhere.
    ``(c) Movement Across the 100th Meridian.--
            ``(1) Early detection and rapid response.--The Secretary, 
        in consultation with the Task Force, shall seek to prevent 
        westward movement of aquatic nuisance species by monitoring and 
        preventing westward movement of zebra mussels and other aquatic 
        nuisance species across and beyond the 100th meridian, 
        monitoring water bodies, educating boaters leaving waters 
        infected by aquatic nuisance species, and providing rapid 
        response capacity in North Dakota, South Dakota, Nebraska, 
        Kansas, Oklahoma, and Texas.
            ``(2) Check stations.--Under this subsection, the 
        Secretary, in collaboration with the Secretary of 
        Transportation and the States, shall--
                    ``(A) work with States to establish check stations 
                on highways and waterways that cross the 100th 
                meridian, and require that all commercial vessels 
                moving westward across the meridian stop and be checked 
                for zebra mussels and aquatic weeds at such check 
                stations;
                    ``(B) require that contaminated vessels identified 
                at such check stations be cleaned in accordance with 
                protocols developed by the Task Force before being 
                moved across the 100th meridian;
                    ``(C) assess and collect from persons who violate 
                such requirement more than one time a civil penalty of 
                $150 for each violation after the first violation;
                    ``(D) identify and record all vessels that stop at 
                such check stations and the water body most recently 
                visited by each such vessel;
                    ``(E) focus prevention resources on States having 
                the greatest number of contaminated vessels; and
                    ``(F) coordinate implementation of this subsection 
                with appropriate Canadian authorities.
    ``(d) Vector Action Plans.--The Secretary and the Task Force, in 
collaboration with the States and within 18 months after the date of 
the enactment of this subsection, shall--
            ``(1) assess the relative risk of vectors and pathways of 
        westward movement of zebra mussels and other aquatic nuisance 
        species across the 100th meridian and throughout the western 
        States and develop adequate action plans to control each 
        pathway, ranked by priority; and
            ``(2) provide to the Task Force, for distribution to the 
        States, data developed through such assessment.
    ``(e) Lewis and Clark Bicentennial Expedition.--
            ``(1) In general.--The Secretary of the Interior shall 
        ensure that the United States Fish and Wildlife Service and the 
        National Park Service coordinate efforts to implement an action 
        plan to prevent the spread of aquatic nuisance species by 
        vessels and other potential vectors involved in the Lewis and 
        Clark Bicentennial Expedition, including efforts to educate 
        participants in such Expedition by no later than January 1, 
        2003.
            ``(2) Authorization of appropriations.--There are 
        authorized to be appropriated to the Secretary of the Interior 
        to carry out this subsection $100,000 for each of fiscal years 
        2002 through 2005.
    ``(f) Application in Other States.--If the Secretary determines 
that any State (other than those listed in subsection (c)) that is 
located west of the 100th meridian needs to be involved in 
implementation of this section for this section to be effective, the 
Secretary may apply this section in such State.
    ``(g) Evaluation of Effectiveness.--The Secretary shall enter into 
an arrangement with an independent entity under which the entity shall, 
by January 1, 2005, evaluate the effectiveness of the 100th meridian 
and westward program under this section in stopping the westward 
movement of zebra mussels and other aquatic nuisance species across and 
beyond the 100th meridian.
    ``(h) Authorization of Appropriations.--There are authorized to be 
appropriated to the Secretary to carry out this section $5,000,000 for 
each of fiscal years 2003 through 2007.''.

SEC. 4. STATE MANAGEMENT PLANS.

    (a) Grants to States for Development of Management Plans.--Section 
1204(b) (16 U.S.C. 4724(b)) is amended--
            (1) in paragraph (1) by inserting ``make grants to States 
        to develop management plans under this section, including for 
        hiring personnel for such development, and'' after ``at the 
        recommendation of the Task Force,'';
            (2) in paragraph (3)(A) by striking ``each comprehensive 
        management plan implemented with Federal assistance'' and 
        inserting ``implementation of each comprehensive management 
        plan''; and
            (3) in paragraph (3)(B) by striking ``each public facility 
        management plan implemented with Federal assistance'' and 
        inserting ``implementation of each public facility management 
        plan''.
    (b) Authorization of Appropriations.--Section 1301 (16 U.S.C. 4724) 
is amended--
            (1) in subsection (c) by striking ``There are authorized'' 
        and all that follows through ``of which'' and inserting ``For 
        grants to States under section 1204(b) there are authorized to 
        be appropriated to the Director $10,000,000 for each of fiscal 
        years 2003 through 2007, of which up to 20 percent may be 
        available for plan development and of which''; and
            (2) by adding at the end the following:
    ``(f) Funding for Capacity Building by Western Regional Panel.--To 
build capacity and foster the development and implementation of 
comprehensive management plans under section 1204 for States located on 
or west of the 100th meridian there are authorized to be appropriated 
to the Western Regional panel established under section 1203(b) 
$600,000 for each of fiscal years 2003 through 2007.''.
Stop Westward Aquatic Threats Act - Amends the Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990 to direct the Secretary of the Interior to: (1) provide the public with information and education on the threat of zebra mussels and other aquatic nuisance species and how to prevent their westward advance; (2) work with States that contain aquatic nuisance species (including zebra mussels) that threaten western States to develop and implement a prevention action plan that includes inspections of vessels at boat launches and elsewhere (including vessels involved in the Lewis and Clark Bicentennial Expedition); and (3) prevent westward movement of aquatic nuisance species by monitoring and preventing westward movement of zebra mussels and other aquatic nuisance species beyond the 100th meridian, monitoring water bodies, educating boaters leaving waters infected by aquatic nuisance species, and providing rapid response capacity in North Dakota, South Dakota, Nebraska, Kansas, Oklahoma, and Texas.Authorizes the Director of the of the Aquatic Nuisance Species Task Force to make grants to States to develop management plans which identify those areas or activities within the State for which assistance is needed to eliminate or reduce the environmental, public health, and safety risks associated with aquatic nuisance species, particularly the zebra mussel.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``9/11 First Responders History 
Project Act of 2011''.

SEC. 2. FINDINGS; PURPOSE.

    (a) Findings.--Congress finds as follows:
            (1) Over 410,000 people were exposed to the site of the 
        September 11, 2001, terrorist attacks at the World Trade Center 
        (WTC) in New York City, including 50,000 workers from across 
        the Nation who traveled to the site to lend their support.
            (2) Of these over 410,000 people, 91,000 were rescue and 
        recovery workers.
            (3) Post-traumatic stress disorder (PTSD) was one of the 
        major health effects for individuals who responded to the WTC 
        attacks.
            (4) Nineteen percent of adult enrollees (about 71,000 
        people) in the WTC Health Registry report new PTSD symptoms, 4 
        times the rate typically seen in adults in the United States.
            (5) Of the more than 10,000 rescue and recovery workers 
        monitored for a study at the Mount Sinai WTC Consortium over a 
        five-year period from 2002 to 2007, 11% met criteria for 
        probable PTSD, 8.8% had probable depression, 5.0% had probable 
        panic disorder, and 62% had substantial stress reaction.
            (6) According to the Mount Sinai study, the rate of PTSD 
        among responders to the September 11, 2001, terrorist attacks 
        at the WTC is significantly greater than in the general 
        population and is on par with the rate experienced by veterans 
        of the war in Afghanistan. For example, 15.5% of firefighters 
        report probable post-9/11 PTSD and firefighters who worked at 
        Ground Zero lost an average of 12 years of lung function.
    (b) Purpose.--It is the purpose of this Act to create a new 
federally sponsored, authorized, and funded project that will 
coordinate at a national level the collection of video and audio 
recordings of personal histories and testimonials of emergency 
responders and recovery and cleanup workers who responded to the 
September 11, 2001, terrorist attacks that will build upon and 
complement previous and ongoing documentary work on this subject, and 
to assist and encourage local efforts to preserve the memories of such 
individuals so that Americans of all current and future generations may 
hear from them directly and better appreciate the sacrifices they made.

SEC. 3. ESTABLISHMENT OF PROJECT AT LIBRARY OF CONGRESS TO COLLECT 
              VIDEO AND AUDIO RECORDINGS OF HISTORIES OF 9/11 FIRST 
              RESPONDERS.

    (a) Establishment of Project.--Within the limits of available 
funds, the Librarian of Congress (hereafter referred to as the 
``Librarian'') shall establish an oral history project--
            (1) to survey, during the initial phase of the project, 
        collections of audio and video recordings of the reminiscences 
        of 9/11 first responders that are housed in archives, 
        libraries, museums, and other educational institutions, as well 
        as ongoing documentary work, in order to augment and complement 
        these endeavors and avoid duplication of effort;
            (2) to solicit, reproduce, and collect--
                    (A) video and audio recordings of personal 
                histories and testimonials of 9/11 first responders; 
                and
                    (B) visual and written materials (such as letters, 
                diaries, photographs, and ephemera) relevant to the 
                personal histories of individuals;
            (3) to create a collection of the recordings and other 
        materials obtained, and to catalog and index the collection in 
        a manner the Librarian considers appropriate; and
            (4) to make the collection available for public use through 
        the Library of Congress, as well as through such other methods 
        as the Librarian consider appropriate.
    (b) Use of and Consultation With Other Entities.--The Librarian may 
carry out the activities described in subsection (a) through agreements 
and partnerships entered into with other government and private 
entities, and may otherwise consult with interested persons (within the 
limits of available resources) and develop appropriate guidelines and 
arrangements for soliciting, acquiring, and making available recordings 
under the project under this Act.
    (c) Services of Experts and Consultants; Acceptance of Volunteer 
Services; Advance Payments.--In carrying out activities described in 
subsection (a)(1), the Librarian may--
            (1) procure temporary and intermittent services under 
        section 3109 of title 5, United States Code;
            (2) accept and utilize the services of volunteers and other 
        uncompensated personnel and reimburse them for travel expenses, 
        including per diem, as authorized under section 5703 of title 
        5, United States Code; and
            (3) make advances of money and payments in advance in 
        accordance with section 3324 of title 31, United States Code.
    (d) Timing.--As soon as practicable after the enactment of this 
Act, the Librarian shall begin collecting video and audio recordings 
and other materials under subsection (a), and shall attempt to collect 
the first such recordings from the oldest individuals involved.
    (e) Definition.--In this Act, the term ``9/11 first responders'' 
means emergency responders and recovery and cleanup workers who 
responded to the terrorist attacks that occurred on September 11, 2001, 
in New York City, in Shanksville, Pennsylvania, and at the Pentagon 
(including the aftermath of such attacks).

SEC. 4. PRIVATE SUPPORT FOR PROJECT.

    (a) Encouraging Solicitation and Acceptance of Donations.--The 
Librarian of Congress is encouraged to solicit and accept donations of 
funds and in-kind contributions to support activities under section 3.
    (b) Dedication of Funds Provided to Library of Congress.--
Notwithstanding any other provision of law--
            (1) any funds donated to the Librarian of Congress to 
        support the activities of the Librarian under section 3 shall 
        be deposited entirely into an account established for such 
        purpose;
            (2) the funds contained in such account shall be used 
        solely to support such activities; and
            (3) the Librarian of Congress may not deposit into such 
        account any funds donated to the Librarian which are not 
        donated for the exclusive purpose of supporting such 
        activities.

SEC. 5. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated to carry out this Act--
            (1) $250,000 for fiscal year 2012; and
            (2) $150,000 for each of the 4 succeeding fiscal years.

9/11 First Responders History Project Act of 2011 - Requires, within the limits of available funds, the Librarian of Congress to establish an oral history project to: (1) survey collections of audio and video recordings (as well as ongoing documentary work) of the reminiscences of 9/11 first responders housed in archives, libraries, museums, and other educational institutions; (2) solicit, reproduce, and collect video and audio recordings of personal histories and testimonials of 9/11 first responders, and visual and written materials (such as letters, diaries, photographs, and ephemera) relevant to the personal histories of individuals; (3) create a collection, with a catalog and index, of the recordings and other materials obtained; and (4) make the collection available for public use through the Library of Congress (LOC) and other appropriate methods.

Defines "9/11 first responders" as emergency responders and recovery and cleanup workers who responded to the terrorist attacks that occurred on September 11, 2001, in New York City, in Shanksville, Pennsylvania, and at the Pentagon (including the aftermath of such attacks).