SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Paleontological Resources
Preservation Act''.

SEC. 2. DEFINITIONS.

    As used in this Act:
            (1) Casual collecting.--The term ``casual collecting''
        means the collecting of a reasonable amount of common
        invertebrate and plant paleontological resources for non-
        commercial personal use, either by surface collection or the
        use of non-powered hand tools resulting in only negligible
        disturbance to the Earth's surface and other resources. As used
        in this paragraph, the terms ``reasonable amount'', ``common
        invertebrate and plant paleontological resources'' and
        ``negligible disturbance'' shall be determined by the
        Secretary.
            (2) Secretary.--The term ``Secretary'' means the Secretary
        of the Interior with respect to lands controlled or
        administered by the Secretary of the Interior or the Secretary
        of Agriculture with respect to National Forest System Lands
        controlled or administered by the Secretary of Agriculture.
            (3) Federal lands.--The term ``Federal lands'' means--
                    (A) lands controlled or administered by the
                Secretary of the Interior, except Indian lands; or
                    (B) National Forest System lands controlled or
                administered by the Secretary of Agriculture.
            (4) Indian lands.--The term ``Indian Land'' means lands of
        Indian tribes, or Indian individuals, which are either held in
        trust by the United States or subject to a restriction against
        alienation imposed by the United States.
            (5) State.--The term ``State'' means the fifty States, the
        District of Columbia, the Commonwealth of Puerto Rico, and any
        other territory or possession of the United States.
            (6) Paleontological resource.--The term ``paleontological
        resource'' means any fossilized remains, traces, or imprints of
        organisms, preserved in or on the earth's crust, that are of
        paleontological interest and that provide information about the
        history of life on earth, except that the term does not
        include--
                    (A) any materials associated with an archaeological
                resource (as defined in section 3(1) of the
                Archaeological Resources Protection Act of 1979 (16
                U.S.C. 470bb(1)); or
                    (B) any cultural item (as defined in section 2 of
                the Native American Graves Protection and Repatriation
                Act (25 U.S.C. 3001)).

SEC. 3. MANAGEMENT.

    (a) In General.--The Secretary shall manage and protect
paleontological resources on Federal lands using scientific principles
and expertise. The Secretary shall develop appropriate plans for
inventory, monitoring, and the scientific and educational use of
paleontological resources, in accordance with applicable agency laws,
regulations, and policies. These plans shall emphasize interagency
coordination and collaborative efforts where possible with non-Federal
partners, the scientific community, and the general public.
    (b) Coordination.--To the extent possible, the Secretary of the
Interior and the Secretary of Agriculture shall coordinate in the
implementation of this Act.

SEC. 4. PUBLIC AWARENESS AND EDUCATION PROGRAM.

    The Secretary shall establish a program to increase public
awareness about the significance of paleontological resources.

SEC. 5. COLLECTION OF PALEONTOLOGICAL RESOURCES.

    (a) Permit Requirement.--
            (1) In general.--Except as provided in this Act, a
        paleontological resource may not be collected from Federal
        lands without a permit issued under this Act by the Secretary.
            (2) Casual collecting exception.--The Secretary may allow
        casual collecting without a permit on Federal lands controlled
        or administered by the Bureau of Land Management, the Bureau of
        Reclamation, and the Forest Service, where such collection is
        consistent with the laws governing the management of those
        Federal lands and this Act.
            (3) Previous permit exception.--Nothing in this section
        shall affect a valid permit issued prior to the date of
        enactment of this Act.
    (b) Criteria for Issuance of a Permit.--The Secretary may issue a
permit for the collection of a paleontological resource pursuant to an
application if the Secretary determines that--
            (1) the applicant is qualified to carry out the permitted
        activity;
            (2) the permitted activity is undertaken for the purpose of
        furthering paleontological knowledge or for public education;
            (3) the permitted activity is consistent with any
        management plan applicable to the Federal lands concerned; and
            (4) the proposed methods of collecting will not threaten
        significant natural or cultural resources.
    (c) Permit Specifications.--A permit for the collection of a
paleontological resource issued under this section shall contain such
terms and conditions as the Secretary deems necessary to carry out the
purposes of this Act. Every permit shall include requirements that--
            (1) the paleontological resource that is collected from
        Federal lands under the permit will remain the property of the
        United States;
            (2) the paleontological resource and copies of associated
        records will be preserved for the public in an approved
        repository, to be made available for scientific research and
        public education; and
            (3) specific locality data will not be released by the
        permittee or repository without the written permission of the
        Secretary.
    (d) Modification, Suspension, and Revocation of Permits.--
            (1) The Secretary may modify, suspend, or revoke a permit
        issued under this section--
                    (A) for resource, safety, or other management
                considerations; or
                    (B) when there is a violation of term or condition
                of a permit issued pursuant to this section.
            (2) The permit shall be revoked if any person working under
        the authority of the permit is convicted under section 9 or is
        assessed a civil penalty under section 10.
    (e) Area Closures.--In order to protect paleontological or other
resources and to provide for public safety, the Secretary may restrict
access to or close areas under the Secretary's jurisdiction to the
collection of paleontological resources.

SEC. 6. CURATION OF RESOURCES.

    Any paleontological resource, and any data and records associated
with the resource, collected under a permit, shall be deposited in an
approved repository. The Secretary may enter into agreements with non-
Federal repositories regarding the curation of these resources, data,
and records.

SEC. 7. PROHIBITED ACTS; CRIMINAL PENALTIES.

    (a) In General.--A person may not--
            (1) excavate, remove, damage, or otherwise alter or deface
        or attempt to excavate, remove, damage, or otherwise alter or
        deface any paleontological resources located on Federal lands
        unless such activity is conducted in accordance with this Act;
            (2) exchange, transport, export, receive, or offer to
        exchange, transport, export, or receive any paleontological
        resource if, in the exercise of due care, the person knew or
        should have known such resource to have been excavated or
        removed from Federal lands in violation of any provisions,
        rule, regulation, law, ordinance, or permit in effect under
        Federal law, including this Act; or
            (3) sell or purchase or offer to sell or purchase any
        paleontological resource if, in the exercise of due care, the
        person knew or should have known such resource to have been
        excavated, removed, sold, purchased, exchanged, transported, or
        received from Federal lands.
    (b) False Labeling Offenses.--A person may not make or submit any
false record, account, or label for, or any false identification of,
any paleontological resource excavated or removed from Federal lands.
    (c) Penalties.--A person who knowingly violates or counsels,
procures, solicits, or employs another person to violate subsection (a)
or (b) shall, upon conviction, be fined in accordance with title 18,
United States Code, or imprisoned not more than 10 years, or both; but
if the sum of the commercial and paleontological value of the
paleontological resources involved and the cost of restoration and
repair of such resources does not exceed $500, such person shall be
fined in accordance with title 18, United States Code, or imprisoned
not more than one year, or both.
    (d) General Exception.--Nothing in subsection (a) shall apply to
any person with respect to any paleontological resource which was in
the lawful possession of such person prior to the date of the enactment
of this Act.

SEC. 8. CIVIL PENALTIES.

    (a) In General.--
            (1) Hearing.--A person who violates any prohibition
        contained in an applicable regulation or permit issued under
        this Act may be assessed a penalty by the Secretary after the
        person is given notice and opportunity for a hearing with
        respect to the violation. Each violation shall be considered a
        separate offense for purposes of this section.
            (2) Amount of penalty.--The amount of such penalty assessed
        under paragraph (1) shall be determined under regulations
        promulgated pursuant to this Act, taking into account the
        following factors:
                    (A) The scientific or fair market value, whichever
                is greater, of the paleontological resource involved,
                as determined by the Secretary.
                    (B) The cost of response, restoration, and repair
                of the resource and the paleontological site involved.
                    (C) Any other factors considered relevant by the
                Secretary assessing the penalty.
            (3) Multiple offenses.--In the case of a second or
        subsequent violation by the same person, the amount of a
        penalty assessed under paragraph (2) may be doubled.
            (4) Limitation.--The amount of any penalty assessed under
        this subsection for any one violation shall not exceed an
        amount equal to double the cost of response, restoration, and
        repair of resources and paleontological site damage plus double
        the scientific or fair market value of resources destroyed or
        not recovered.
    (b) Petition for Judicial Review; Collection of Unpaid
Assessments.--
            (1) Judicial review.--Any person against whom an order is
        issued assessing a penalty under subsection (a) may file a
        petition for judicial review of the order in the United States
        District Court for the District of Columbia or in the district
        in which the violation is alleged to have occurred within the
        30-day period beginning on the date the order making the
        assessment was issued. Upon notice of such filing, the
        Secretary shall promptly file such a certified copy of the
        record on which the order was issued. The court shall hear the
        action on the record made before the Secretary and shall
        sustain the action if it is supported by substantial evidence
        on the record considered as a whole.
            (2) Failure to pay.--If any person fails to pay a penalty
        under this section within 30 days--
                    (A) after the order making assessment has become
                final and the person has not filed a petition for
                judicial review of the order in accordance with
                paragraph (1); or
                    (B) after a court in an action brought in paragraph
                (1) has entered a final judgment upholding the
                assessment of the penalty,
        the Secretary may request the Attorney General to institute a
        civil action in a district court of the United States for any
        district in which the person if found, resides, or transacts
        business, to collect the penalty (plus interest at currently
        prevailing rates from the date of the final order or the date
        of the final judgment, as the case may be). The district court
        shall have jurisdiction to hear and decide any such action. In
        such action, the validity, amount, and appropriateness of such
        penalty shall not be subject to review. Any person who fails to
        pay on a timely basis the amount of an assessment of a civil
        penalty as described in the first sentence of this paragraph
        shall be required to pay, in addition to such amount and
        interest, attorneys fees and costs for collection proceedings.
    (c) Hearings.--Hearings held during proceedings instituted under
subsection (a) shall be conducted in accordance with section 554 of
title 5, United States Code.
    (d) Use of Recovered Amounts.--Penalties collected under this
section shall be available to the Secretary and without further
appropriation may be used only as follows:
            (1) To protect, restore, or repair the paleontological
        resources and sites which were the subject of the action, or to
        acquire sites with equivalent resources, and to protect,
        monitor, and study the resources and sites. Any acquisition
        shall be subject to any limitations contained in the organic
        legislation for such Federal lands.
            (2) To provide educational materials to the public about
        paleontological resources and sites.
            (3) To provide for the payment of rewards as provided in
        section 11.

SEC. 9. REWARDS AND FORFEITURE.

    (a) Rewards.--The Secretary may pay from penalties collected under
section 9 or 10--
            (1) consistent with amounts established in regulations by
        the Secretary; or
            (2) if no such regulation exists, an amount equal to the
        lesser of one-half of the penalty or $500,
to any person who furnishes information which leads to the finding of a
civil violation, or the conviction of criminal violation, with respect
to which the penalty was paid. If several persons provided the
information, the amount shall be divided among the persons. No officer
or employee of the United States or of any State or local government
who furnishes information or renders service in the performance of his
official duties shall be eligible for payment under this subsection.
    (b) Forfeiture.--All paleontological resources with respect to
which a violation under section 9 or 10 occurred and which are in the
possession of any person, and all vehicles and equipment of any person
that were used in connection with the violation, shall be subject to
civil forfeiture, or upon conviction, to criminal forfeiture. All
provisions of law relating to the seizure, forfeiture, and condemnation
of property for a violation of this Act, the disposition of such
property or the proceeds from the sale thereof, and remission or
mitigation of such forfeiture, as well as the procedural provisions of
chapter 46 of title 18, United States Code, shall apply to the seizures
and forfeitures incurred or alleged to have incurred under the
provisions of this Act.
    (c) Transfer of Seized Resources.--The Secretary may transfer
administration of seized paleontological resources to Federal or non-
Federal educational institutions to be used for scientific or
educational purposes.

SEC. 10. CONFIDENTIALITY.

    Information concerning the nature and specific location of a
paleontological resource the collection of which requires a permit
under this Act or under any other provision of Federal law shall be
exempt from disclosure under section 552 of title 5, United States
Code, and any other law unless the Secretary determines that disclosure
would--
            (1) further the purposes of this Act;
            (2) not create risk of harm to or theft or destruction of
        the resource or the site containing the resource; and
            (3) be in accordance with other applicable laws.

SEC. 11. REGULATIONS.

    As soon as practical after the date of the enactment of this Act,
the Secretary shall issue such regulations as are appropriate to carry
out this Act, providing opportunities for public notice and comment.

SEC. 12. SAVINGS PROVISIONS.

    Nothing in this Act shall be construed to--
            (1) invalidate, modify, or impose any additional
        restrictions or permitting requirements on any activities
        permitted at any time under the general mining laws, the
        mineral or geothermal leasing laws, laws providing for minerals
        materials disposal, or laws providing for the management or
        regulation of the activities authorized by the aforementioned
        laws including but not limited to the Federal Land Policy
        Management Act (43 U.S.C. 1701-1784), the Mining in the Parks
        Act, the Surface Mining Control and Reclamation Act of 1977 (30
        U.S.C. 1201-1358), and the Organic Administration Act (16
        U.S.C. 478, 482, 551);
            (2) invalidate, modify, or impose any additional
        restrictions or permitting requirements on any activities
        permitted at any time under existing laws and authorities
        relating to reclamation and multiple uses of Federal lands;
            (3) apply to, or require a permit for, casual collecting of
        a rock, mineral, or invertebrate or plant fossil that is not
        protected under this Act;
            (4) affect any lands other than Federal lands or affect the
        lawful recovery, collection, or sale of paleontological
        resources from lands other than Federal lands;
            (5) alter or diminish the authority of a Federal agency
        under any other law to provide protection for paleontological
        resources on Federal lands in addition to the protection
        provided under this Act; or
            (6) create any right, privilege, benefit, or entitlement
        for any person who is not an officer or employee of the United
        States acting in that capacity. No person who is not an officer
        or employee of the United States acting in that capacity shall
        have standing to file any civil action in a court of the United
        States to enforce any provision or amendment made by this Act.

SEC. 13. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated such sums as may be
necessary to carry out this Act.

            Passed the Senate July 17, 2003.

            Attest:

                                             EMILY J. REYNOLDS,

                                                             Secretary.

Summary: Paleontological Resources Preservation Act - Directs the Secretaries of the Interior and Agriculture to: (1) manage and protect paleontological resources on Federal land using scientific principles and expertise. And (2) develop plans for inventorying, monitoring, and deriving the scientific and educational use of such resources. Directs the Secretaries to establish a program to increase public awareness about the significance of paleontological resources. Prohibits a person from collecting a paleontological resource from Federal land without a permit issued under this Act by one of the Secretaries. Authorizes the Secretaries to allow casual collecting of common invertebrate and plant paleontological resources for scientific, educational, and recreational uses, without a permit, on certain Federal lands where not inconsistent with laws governing management of such lands and this Act. Recognizes as valid permits issued before enactment of this Act. Sets forth criteria by which the Secretaries may issue permits for paleontological resources. Requires that any paleontological resource and associated records collected under a permit be deposited in an approved repository. Allows the Secretaries to modify, suspend, or revoke a permit under specified circumstances, including if there is a violation of a term or a condition of a permit. Declares that a permit shall be revoked if any person working under the authority of the permit is convicted of a criminal offense under this Act or assessed a civil penalty under this Act. States that the Secretaries may enter into agreements with non-Federal repositories regarding the curation of paleontological resources, data, and records. Prohibits: (1) excavating, removing, or altering a paleontological resource located on Federal lands, except in compliance with this Act. (2) exchanging or receiving such a resource, if the person knew or should have known such resource to have been illegally removed from Federal lands. (3) selling or purchasing a paleontological resource, if the person knew or should have known such resource to have been illegally removed from Federal lands. Or (4) making or submitting false records, accounts, or identification of any paleontological resource excavated or removed from Federal lands. Imposes criminal penalties for violating this Act. Sets forth requirements for the assessment of civil penalties by the Secretaries for violations of any prohibitions contained in regulations or permits issued under this Act. Requires any recovered amounts to be available for use: (1) to protect or restore the paleontological resources and sites which were the subject of the action, or to acquire sites with equivalent resources and to protect, monitor, and study the resources and sites. (2) to provide educational materials to the public about paleontological resources and sites. And (3) as a reward. Allows the Secretaries to pay from penalties collected under this Act a reward to any person who furnishes information leading to the finding of a civil violation, or the conviction of criminal violation, with respect to which the penalty was paid. Provides for the civil or, as appropriate, the criminal forfeiture of all paleontological resources with respect to which a civil or criminal violation occurred, and of all vehicles and equipment that were used in connection with the violation. Allows the Secretary to transfer administration of seized paleontological resources to educational institutions for scientific or educational purposes. Requires that information on the nature and specific location of a paleontological resource that requires a permit under this Act or other Federal law be withheld from the public, including under the Freedom of Information Act, except under specified conditions. Directs the Secretaries to issue such regulations as are appropriate to carry out this Act, while providing opportunities for public notice and comment. Declares that nothing in this Act shall be construed to do certain things, including to: (1) modify any activity under the general mining laws, the mineral or geothermal leasing laws, laws providing for minerals materials disposal, or laws providing for the management or regulation of the activities authorized by the aforementioned laws. (2) modify any activity under existing laws and authorities relating to reclamation and multiple uses of Federal lands. Or (3) alter or diminish the authority of a Federal agency under any other law to provide protection for paleontological resources on Federal lands in addition to the protection provided under this Act. Authorizes appropriations.

A bill to provide for the protection of paleontological resources on Federal lands, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Curecanti National Recreation Area
Boundary Establishment Act of 2010''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Since 1965, the National Park Service has been co-
        managing the Curecanti National Recreation Area under
        agreements with the Bureau of Reclamation.
            (2) The Curecanti National Recreation Area has never been
        legislatively established.
            (3) Public Law 106-76 directed the National Park Service to
        conduct a study to assess the natural, cultural, recreational,
        and scenic resources within and surrounding Curecanti National
        Recreation Area, and to identify and recommend a variety of
        alternatives and tools to protect those resource values and the
        character of the land.
            (4) The Curecanti National Recreation Area includes an
        abundance of natural, historic, and archeological features in a
        setting of canyons, pinnacles, cliffs, and mesas, offering the
        public opportunities for recreation and reflection within its
        scenic landscape.
            (5) The National Park Service, in cooperation with the
        Bureau of Reclamation, completed the Curecanti Resource
        Protection Study/EIS, and prepared a Report to Congress,
        October 2009, which recommends that Congress pass enabling
        legislation for the National Recreation Area.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Map.--The term ``map'' means the map entitled ``Map to
        Establish Curecanti National Recreation Area'', numbered 616/
        100485, and dated March 5, 2010.
            (2) National recreation area.--The term ``national
        recreation area'' means the Curecanti National Recreation Area,
        established in section 4.
            (3) Secretary.--The term ``Secretary'' means the Secretary
        of the Interior.

SEC. 4. CURECANTI NATIONAL RECREATION AREA, COLORADO.

    (a) Establishment.--There is established the Curecanti National
Recreation Area in the State of Colorado, as a unit of the National
Park System, consisting of approximately 51,830 acres, as generally
depicted on the map.
    (b) Conservation Opportunity Area.--There is established a
conservation opportunity area, consisting of approximately 24,300
acres, as generally depicted on the map.
    (c) Availability of Map.--The map shall be on file and available
for public inspection in the appropriate offices of the National Park
Service.

SEC. 5. ADMINISTRATION OF NATIONAL RECREATION AREA.

    (a) In General.--The Secretary shall administer the national
recreation area in accordance with this Act, the cooperative agreements
described in this section, and with laws and regulations generally
applicable to units of the National Park System, including the National
Park Service Organic Act (39 Stat. 535, 16 U.S.C. 1).
    (b) Dam, Power Plant, and Reservoir Management and Operations.--
Nothing in this Act shall affect or interfere with the authority of the
Secretary under--
            (1) the National Reclamation Act (Public Law 57-161; Stat.
        388), as amended and supplemented, to operate the Uncompahgre
        Valley Reclamation Project; or
            (2) Public Law 84-485, as amended and supplemented, to
        operate the Wayne N. Aspinall Unit of the Colorado River
        Storage Project.
    (c) Cooperative Agreements.--
            (1) In general.--The Secretary may enter into, or modify
        existing, management agreements involving the National Park
        Service, the Bureau of Reclamation, the Bureau of Land
        Management, or the Forest Service to manage Federal lands
        within the boundary of the national recreation area.
            (2) State lands.--The Secretary may enter into cooperative
        management agreements for any lands administered by the State
        of Colorado that are within or adjacent to the national
        recreation area, pursuant to the cooperative management
        authority found in section 802(a) of the National Parks Omnibus
        Management Act of 1998 (Public Law 105-391).
    (d) Recreational Activities.--The Secretary shall allow boating,
boating-related activities, hunting, and fishing within the national
recreation area in accordance with applicable Federal and State laws.
The Secretary may designate zones where, and establish periods when, no
boating, hunting, or fishing shall be permitted for reasons of public
safety.
    (e) Conservation Opportunity Area.--Within the boundaries of the
conservation opportunity area established under this Act, the Secretary
is authorized to acquire lands, or interests in lands, including
conservation easements from willing sellers, and to provide technical
assistance to landowners in order to conserve resources and values
identified as important to the national recreation area on lands that
are outside but adjacent to the national recreation area.
    (f) Withdrawal.--Subject to valid existing rights, all Federal
lands within the national recreation area are withdrawn from all forms
of entry, appropriation, or disposal under the public land laws; from
location, entry, and patent under the mining laws; and from disposition
under all laws relating to mineral and geothermal leasing, and all
amendments thereto.
    (g) Grazing.--
            (1) State or private lands.--On State or private lands
        acquired for the national recreation area on which authorized
        grazing is occurring on the date of enactment of this Act, the
        Secretary, in consultation with the lessee, may allow the
        continuation of grazing on the land by the lessee at the time
        of acquisition, subject to applicable law (including
        regulations).
            (2) Federal land.--Where grazing is allowed on land that is
        Federal land on the date of the enactment of this section and
        is located within the boundary of the national recreation area,
        the Secretary is authorized to allow the continuation of such
        grazing unless the Secretary determines that grazing would harm
        the resources or values of the national recreation area.
            (3) Termination of leases.--Nothing in this section shall
        prohibit the Secretary from accepting the voluntary termination
        of leases or permits for grazing within the national recreation
        area.

SEC. 6. ACQUISITION OF PROPERTY AND BOUNDARY MANAGEMENT.

    (a) In General.--The Secretary is authorized to acquire from
willing sellers lands, or interests in lands, within the boundary of
the national recreation area or the conservation opportunity area
necessary for effective management of the national recreation area.
Lands acquired within the conservation opportunity area shall be added
to the national recreation area and the boundary of the national
recreation area shall be adjusted accordingly.
    (b) Acquisition.--Lands identified in subsection (a) may be
acquired by donation, purchase with donated or appropriated funds,
transfer from another Federal agency, or exchange. Lands or interests
in lands owned by the State of Colorado, or a political subdivision
thereof, may only be acquired by donation or exchange.
    (c) Exchanges.--For purposes of management efficiency and expanded
recreational opportunities, the Secretary is authorized to conduct land
exchanges with the Secretary of Agriculture and between the National
Park Service and the Bureau of Land Management.
    (d) Transfer of Administrative Jurisdiction.--The Secretary of
Agriculture and the Bureau of Land Management shall transfer, without
consideration, administrative jurisdiction for lands to be added to the
national recreation area, as shown on the map, to the National Park
Service. The boundary of the Gunnison National Forest shall be modified
to reflect the transfer of administrative jurisdiction from the
Secretary of Agriculture.

SEC. 7. GENERAL MANAGEMENT PLAN.

    (a) In General.--Not later than 3 years after the date on which
funds are made available to carry out this Act, the National Park
Service, in consultation with the Bureau of Reclamation, shall prepare
a general management plan for the national recreation area.
    (b) Inclusions.--The general management plan shall include, at a
minimum--
            (1) measures for the preservation of the resources of the
        national recreation area;
            (2) requirements for the type and extent of development and
        use of the national recreation area;
            (3) identification of visitor carrying capacities for the
        national recreation area; and
            (4) opportunities for involvement by the Bureau of
        Reclamation, the Bureau of Land Management, the Forest Service,
        the State of Colorado, and other local and national entities in
        the formulation of educational and recreational programs for
        the national recreation area and for developing and supporting
        the national recreation area.

Summary: Curecanti National Recreation Area Boundary Establishment Act of 2010 - Establishes a boundary for the Curecanti National Recreation Area in Colorado and designates it as a unit of the National Park System. Establishes a conservation opportunity area within the Recreation Area. Withdraws all federal lands within the Recreation Area from specified public land, mining, and mineral and geothermal leasing laws. Requires the National Park Service (NPS) to develop a general management plan for the Recreation Area.

To establish the boundary of the Curecanti National Recreation Area, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Unshackling Students to Lead, Excel,
Act, Develop, and Serve Act of 2012'' or the ``U.S. LEADS Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Outstanding student loan debt will reach one trillion
        dollars this year.
            (2) In 2008, two-thirds of students graduating with a
        bachelor's degree had outstanding student loan debt.
            (3) In 2010, the average debt owed by college graduates
        paying off student loans was $24,000.
            (4) Of all students who graduated with a 4-year degree in
        2009, only 55.6 percent are working in jobs that require a
        college degree.
            (5) Of all students who graduated with a 4-year degree in
        2009, 22.4 percent are not working.
            (6) The median student loan debt for students who graduated
        from college between 2006 and 2010 is $20,000.
            (7) Average in-State tuition and fees at public 4-year
        institutions of higher education have risen 8.3 percent between
        the 2010-2011 and 2011-2012 academic years.

SEC. 3. INTEREST-FREE DEFERMENT DURING PERIODS WHEN THE NATIONAL
              UNEMPLOYMENT RATE EXCEEDS 7 PERCENT.

    (a) FFEL Subsidized Loan Deferment.--Section 428(b)(1)(M) of the
Higher Education Act of 1965 (20 U.S.C. 1078(b)(1)(M)) is amended--
            (1) by striking ``or'' at the end of clause (iii);
            (2) by adding ``or'' at the end of clause (iv); and
            (3) by adding at the end the following new clause:
                            ``(v) in a case of a borrower who is
                        between the ages of 21 and 25, inclusive, and a
                        recent college student, as defined in section
                        455(f)(5), with respect to loans made under
                        this section to such borrower for a period of
                        enrollment during which the borrower was
                        pursuing a degree described in subparagraph (A)
                        of such section 455(f)(5)--
                                    ``(I) beginning as soon as
                                practicable after the last day of the
                                second consecutive month for which the
                                Bureau of Labor Statistics of the
                                Department of Labor (in this paragraph
                                referred to as the `Bureau') publishes
                                a national unemployment rate that
                                exceeds 7 percent, and ending as soon
                                as practicable after the Bureau
                                publishes a national unemployment rate
                                that is 7 percent or lower, except that
                                such period shall not exceed 5 years;
                                or
                                    ``(II) beginning as soon as
                                practicable after the last day of the
                                second consecutive month for which the
                                Bureau publishes a national
                                unemployment rate for individuals ages
                                21 through 25 years old that exceeds 9
                                percent, and ending as soon as
                                practicable after the Bureau publishes
                                a national unemployment rate for such
                                individuals that is 9 percent or lower,
                                except that such period shall not
                                exceed 5 years.''.
    (b) Treatment of Consolidation Loans.--Section 428C(b)(4)(C)(ii) of
the Higher Education Act of 1965 (20 U.S.C. 1078-3(b)(4)(C)(ii)) is
amended--
            (1) by striking ``or'' at the end of subclause (II);
            (2) by redesignating subclause (III) as subclause (IV);
            (3) by inserting after subclause (II) the following:
                                    ``(III) in the case of a borrower
                                who is between the ages of 21 and 25,
                                inclusive, and a recent college
                                student, as defined in section
                                455(f)(5), by the Secretary, in the
                                case of a consolidation loan made to
                                the borrower for a period of enrollment
                                during which the borrower was pursuing
                                a degree described in subparagraph (A)
                                of such section 455(f)(5) and for which
                                the application is received on or after
                                the date of enactment of the U.S. Leads
                                Act, except that in the case of a
                                deferral under clause (ii) of section
                                428(b)(1)(M), the Secretary shall pay
                                such interest only for a period not in
                                excess of 3 years for which a borrower
                                would be eligible for such a deferral
                                and, in the case of a deferral under
                                clause (v) of such section, for a
                                period not in excess of 5 years for
                                which the borrower would be eligible
                                for such a deferral; or''; and
            (4) in subclause (IV) (as so redesignated by this
        subsection), by striking ``(I) or (II)'' and inserting ``(I),
        (II), or (III)''.
    (c) FFEL Unsubsidized Loan Deferment.--
            (1) In general.--Section 428H(e)(2) of the Higher Education
        Act of 1965 (20 U.S.C. 1078-8(e)(2)) is amended--
                    (A) in subparagraph (A), by inserting ``Except as
                provided in subparagraph (C)'' before ``Interest on'';
                and
                    (B) by adding at the end the following new
                subparagraph:
                    ``(C) In the case of a borrower who is between the
                ages of 21 and 25, inclusive, and a recent college
                student, as defined in section 455(f)(5), interest on
                loans made under this section to the borrower for a
                period of enrollment during which the borrower was
                pursuing a degree described in subparagraph (A) of such
                section 455(f)(5) and for which payments are deferred--
                            ``(i) under clause (i), (iii), or (iv) of
                        section 428(b)(1)(M), for a period of deferment
                        granted to such borrower on or after the date
                        of enactment of the U.S. Leads Act, shall
                        accrue and be paid by the Secretary during any
                        period during which the loans are so deferred;
                            ``(ii) under clause (ii) of section
                        428(b)(1)(M), for a period of deferment granted
                        to such borrower on or after the date of
                        enactment of the U.S. Leads Act, shall accrue
                        and be paid by the Secretary during any period
                        during which the loans are so deferred, not in
                        excess of 3 years; and
                            ``(iii) under clause (v) of section
                        428(b)(1)(M), for a period of deferment granted
                        to such borrower on or after the date of
                        enactment of the U.S. Leads Act, shall accrue
                        and be paid by the Secretary during any period
                        during which the loans are so deferred, not in
                        excess of 5 years.''.
            (2) Conforming amendment.--Section 428(b)(1)(Y)(iii) of the
        Higher Education Act of 1965 (20 U.S.C. 1078(b)(1)(Y)(iii)) is
        amended by inserting ``(other than a deferment under such
        subparagraph granted to a borrower described in section
        428H(e)(2)(C) on or after the date of enactment of the U.S.
        Leads Act)'' after ``of this paragraph''.
    (d) Direct Loan Deferment.--Section 455(f) of the Higher Education
Act of 1965 (20 U.S.C. 1087(f)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) by striking ``or'' at the end of clause
                        (i); and
                            (ii) by adding at the end the following:
                            ``(iii) Federal Direct Unsubsidized
                        Stafford Loan or Federal Direct Consolidation
                        Loan made to a borrower for a period of
                        enrollment during which the borrower was
                        pursuing a degree described in paragraph (5)(A)
                        and the borrower is between the ages of 21 and
                        25, inclusive, and a recent college student, as
                        defined in paragraph (5); or''; and
                    (B) in subparagraph (B)--
                            (i) by inserting ``not described in
                        subparagraph (A)(iii)'' after ``Unsubsidized
                        Stafford Loan''; and
                            (ii) by striking ``subparagraph (A)(ii)''
                        and inserting ``clause (ii) or (iii) of
                        subparagraph (A)'';
            (2) in paragraph (2)--
                    (A) by striking ``or'' at the end of subparagraph
                (C);
                    (B) by striking the period at the end of
                subparagraph (D) and inserting ``; or''; and
                    (C) by adding at the end the following new
                subparagraph:
                    ``(E) in a case of a borrower who is between the
                ages of 21 and 25, inclusive, and a recent college
                student, as defined in paragraph (5), with respect to
                loans made under this part to such borrower for a
                period of enrollment during which the borrower was
                pursuing a degree described in subparagraph (A) of such
                paragraph (5)--
                            ``(i) beginning as soon as practicable
                        after the last day of the second consecutive
                        month for which the Bureau of Labor Statistics
                        of the Department of Labor (in this paragraph
                        referred to as the `Bureau') publishes a
                        national unemployment rate that exceeds 7
                        percent, and ending as soon as practicable
                        after the Bureau publishes a national
                        unemployment rate that is 7 percent or lower,
                        except that such period shall not exceed 5
                        years; or
                            ``(ii) beginning as soon as practicable
                        after the last day of the second consecutive
                        month for which the Bureau publishes a national
                        unemployment rate for individuals ages 21
                        through 25 years old that exceeds 9 percent,
                        and ending as soon as practicable after the
                        Bureau publishes a national unemployment rate
                        for such individuals that is 9 percent or
                        lower, except that such period shall not exceed
                        5 years.''; and
            (3) by adding at the end the following new paragraph:
            ``(5) Definition of recent college student.--For the
        purpose of this subsection, the term `recent college student'
        means a borrower who--
                    ``(A) who has received a baccalaureate degree from
                an institution of higher education within 48 months
                prior to the date of enactment of the U.S. Leads Act;
                and
                    ``(B) who has not previously received any such
                baccalaureate degree.''.

Summary: Unshackling Students to Lead, Excel, Act, Develop, and Serve Act of 2012 or US LEADS Act - Amends title IV of the Higher Education Act of 1965 to allow recent college graduates to defer payment on their student loans under the Federal Family Education Loan (FFEL) and Direct Loan (DL) programs without accruing interest when the national unemployment rate exceeds 7 or the unemployment rate for 21-25 year olds exceeds 9. Limits that deferral period to a maximum of five years. Makes the deferral available only to graduates aged 21-25 who received their first baccalaureate degree within the four years preceding this Act's enactment.

To provide interest-free deferment on unsubsidized student loans made to recent college students during periods when the national unemployment rate is above 7 percent and other periods of deferment.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Quadrennial Energy Review Act of
2011''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) the President's Council of Advisors on Science and
        Technology recommends that the United States develop a
        Government wide Federal energy policy and update the policy
        regularly with strategic Quadrennial Energy Reviews similar to
        the reviews conducted by the Department of Defense;
            (2) as the lead agency in support of energy science and
        technology innovation, the Department of Energy has conducted a
        Quadrennial Technology Review of the energy technology policies
        and programs of the Department;
            (3) the Quadrennial Technology Review of the Department of
        Energy serves as the basis for coordination with other agencies
        and on other programs for which the Department has a key role;
            (4) a Quadrennial Energy Review would--
                    (A) establish integrated, Government wide national
                energy objectives in the context of economic,
                environmental, and security priorities;
                    (B) coordinate actions across Federal agencies;
                    (C) identify the resources needed for the
                invention, adoption, and diffusion of energy
                technologies; and
                    (D) provide a strong analytical base for Federal
                energy policy decisions;
            (5) the development of an energy policy resulting from a
        Quadrennial Energy Review would--
                    (A) enhance the energy security of the United
                States;
                    (B) create jobs; and
                    (C) mitigate environmental harm; and
            (6) while a Quadrennial Energy Review will be a product of
        the executive branch, the review will have substantial input
        from--
                    (A) Congress;
                    (B) the energy industry;
                    (C) academia;
                    (D) nongovernmental organizations; and
                    (E) the public.

SEC. 3. QUADRENNIAL ENERGY REVIEW.

    Section 801 of the Department of Energy Organization Act (42 U.S.C.
7321) is amended to read as follows:

``SEC. 801. QUADRENNIAL ENERGY REVIEW.

    ``(a) Definitions.--In this section:
            ``(1) Director.--The term `Director' means the Director of
        the Office of Science and Technology Policy.
            ``(2) Federal laboratory.--
                    ``(A) In general.--The term `Federal Laboratory'
                has the meaning given the term `laboratory' in section
                12(d) of the Stevenson-Wydler Technology Innovation Act
                of 1980 (15 U.S.C. 3710a(d)).
                    ``(B) Inclusion.--The term `Federal Laboratory'
                includes a federally funded research and development
                center sponsored by a Federal agency.
            ``(3) Interagency working group.--The term `interagency
        working group' means a working group established under
        subsection (b)(1).
            ``(4) Quadrennial energy review.--The term `Quadrennial
        Energy Review' means a comprehensive multiyear examination of
        the energy programs and technologies of the Federal Government
        conducted under this section.
    ``(b) Interagency Working Group.--
            ``(1) Establishment of interagency working group.--
        Beginning on February 1, 2013, and every 4 years thereafter,
        the President shall establish an interagency working group to
        coordinate the Quadrennial Energy Review.
            ``(2) Co-chairpersons.--The Secretary and the Director
        shall be co-chairpersons of the interagency working group.
            ``(3) Membership.--The interagency working group shall be
        comprised of representatives at level I or II of the Executive
        Schedule of--
                    ``(A) the Department of Commerce;
                    ``(B) the Department of Defense;
                    ``(C) the Department of State;
                    ``(D) the Department of the Interior;
                    ``(E) the Department of Agriculture;
                    ``(F) the Department of the Treasury;
                    ``(G) the Department of Transportation;
                    ``(H) the Office of Management and Budget;
                    ``(I) the National Science Foundation;
                    ``(J) the Environmental Protection Agency; and
                    ``(K) such other Federal organizations,
                departments, and agencies that the President considers
                to be appropriate.
    ``(c) Conduct of Review.--Each Quadrennial Energy Review shall be
conducted to provide an integrated view of national energy objectives
and Federal energy policy, including alignment of research programs,
incentives, regulations, and partnerships.
    ``(d) Submission of Quadrennial Energy Review to Congress.--
            ``(1) In general.--Not later than February 1, 2014, and
        every 4 years thereafter, the Secretary, in cooperation with
        the Director, shall publish and submit to Congress a report on
        the Quadrennial Energy Review.
            ``(2) Inclusions.--The report described in paragraph (1)
        shall include, at a minimum--
                    ``(A) an integrated view of short-, intermediate-,
                and long-term objectives for Federal energy policy in
                the context of economic, environmental, and security
                priorities;
                    ``(B) anticipated Federal actions (including
                programmatic, regulatory, and fiscal actions) and
                resource requirements--
                            ``(i) to achieve the objectives described
                        in subparagraph (A); and
                            ``(ii) to be coordinated across multiple
                        agencies;
                    ``(C) an analysis of the prospective roles of
                parties (including academia, industry, consumers, the
                public, and Federal agencies) in achieving the
                objectives described in subparagraph (A), including--
                            ``(i) an analysis, by energy use sector,
                        of--
                                    ``(I) commercial and residential
                                buildings;
                                    ``(II) industry;
                                    ``(III) transportation;
                                    ``(IV) electric power; and
                                    ``(V) agriculture;
                            ``(ii) requirements for invention,
                        adoption, development, and diffusion of energy
                        technologies that are mapped onto each of the
                        energy use sectors; and
                            ``(iii) other research that inform
                        strategies to incentivize desired actions;
                    ``(D) an assessment of policy options to increase
                domestic energy supplies;
                    ``(E) an evaluation of energy storage,
                transmission, and distribution requirements, including
                requirements for renewable energy;
                    ``(F) an integrated plan for the involvement of the
                Federal Laboratories in energy programs;
                    ``(G) portfolio assessments that describe the
                optimal deployment of resources, including prioritizing
                financial resources for energy programs;
                    ``(H) a mapping of the linkages among basic
                research and applied programs, demonstration programs,
                and other innovation mechanisms across the Federal
                agencies;
                    ``(I) an identification of, and projections for,
                demonstration projects, including timeframes,
                milestones, sources of funding, and management;
                    ``(J) an identification of public and private
                funding needs for various energy technologies, systems,
                and infrastructure, including consideration of public-
                private partnerships, loans, and loan guarantees;
                    ``(K) an assessment of global competitors and an
                identification of programs that can be enhanced with
                international cooperation;
                    ``(L) an identification of policy gaps that need to
                be filled to accelerate the adoption and diffusion of
                energy technologies, including--
                            ``(i) Federal tax policies; and
                            ``(ii) the role of Federal agencies as
                        early adopters and purchasers of new energy
                        technologies;
                    ``(M) an analysis of--
                            ``(i) points of maximum leverage for policy
                        intervention to achieve outcomes; and
                            ``(ii) areas of energy policy that can be
                        most effective in meeting national goals for
                        the energy sector; and
                    ``(N) recommendations for executive branch
                organization changes to facilitate the development and
                implementation of Federal energy policies.
    ``(e) Executive Secretariat.--
            ``(1) In general.--The Secretary shall provide the
        Executive Secretariat with the necessary analytical, financial,
        and administrative support for the conduct of each Quadrennial
        Energy Review required under this section.
            ``(2) Cooperation.--The heads of applicable Federal
        agencies shall cooperate with the Secretary and provide such
        assistance, information, and resources as the Secretary may
        require to assist in carrying out this section.''.

Summary: Quadrennial Energy Review Act of 2011 - Amends the Department of Energy Organization Act to direct the President to establish an interagency working group to coordinate the Quadrennial Energy Review to provide an integrated view of national energy objectives and federal energy policy, including alignment of research programs, incentives, regulations, and partnerships. Requires the Secretary of Energy, in cooperation with the Director of the Office of Science and Technology Policy, to report to Congress on the Quadrennial Energy Review, including an integrated view of short-, intermediate-, and long-term objectives for federal energy policy in the context of economic, environmental, and security priorities. Requires the Secretary to provide the Executive Secretariat with the necessary analytical, financial, and administrative support for the conduct of each Quadrennial Energy Review.

A bill to amend the Department of Energy Organization Act to require a Quadrennial Energy Review, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``School Security Improvement Act of
1997''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) independent studies have shown that the safety and
        discipline of students in public school systems are ranked as
        the top 2 concerns of the public with respect to matters
        relating to the administration of public school systems;
            (2) administrators of public school systems must be given
        the resources necessary to ensure that the students and the
        personnel of such systems are provided educational and working
        environments that are safe and orderly; and
            (3) if the misconduct of a student who is a child with a
        disability is not a manifestation of a disability of the
        student, the student should be subject to the same disciplinary
        measures that are provided in the rules or code of conduct of
        an educational entity for a student who is a child without a
        disability, including a disciplinary measure such as a
        cessation of educational services.

SEC. 3. PURPOSES.

    The purposes of this Act are--
            (1) to permit educational entities to use fair disciplinary
        measures against all students, including children with
        disabilities; and
            (2) to require educational entities--
                    (A) to include in the educational record of a
                student who is a child with a disability or a student
                who is a child without a disability a statement of
                disciplinary measures taken against the student; and
                    (B) to transmit the statement with the educational
                record of the student to other educational entities if
                the student transfers from an elementary school or
                secondary school (as the terms are defined in section
                602(c)) to another such school.

SEC. 4. DISCIPLINE OF STUDENTS WHO ARE CHILDREN WITH DISABILITIES.

    (a) Maintenance of Disciplinary Records.--Section 612 of the
Individuals with Disabilities Education Act (20 U.S.C. 1412) is amended
by adding at the end the following:
            ``(8) The State has in effect a State law that requires
        State educational agencies, local educational agencies, and
        intermediate educational units--
                    ``(A) to include in the educational record of a
                child with a disability or a child without a disability
                a statement of any disciplinary measure taken against
                the child that results in an out-of-school suspension
                of more than 10 days or an expulsion from school; and
                    ``(B) in a case in which the child with a
                disability or the child without a disability is
                transferred from an elementary school or secondary
                school (as the terms are defined in section 602(c), or
                section 14101 of the Elementary and Secondary Education
                Act of 1965 (20 U.S.C. 8801), whichever are applicable)
                to another such school (in the State or in another
                State), to transmit the statement with the educational
                record to other educational entities involved with such
                a transfer.
        The statement described in subparagraph (A) for a child with a
        disability or a child without a disability may include a
        description of any behavior engaged in by the child that
        required a disciplinary measure, a description of the
        disciplinary measure taken against the child, and any other
        information that is relevant to the safety of the child and the
        individuals involved with the child.''.
    (b) Disciplinary Measures.--
            (1) Use of disciplinary measures when the behavior of a
        child is not a manifestation of the disability of the child.--
        Part B of the Individuals with Disabilities Education Act (20
        U.S.C. 1411 et seq.) is amended by inserting after section 615
        the following:

``SEC. 615A. USE OF DISCIPLINARY MEASURES WHEN THE BEHAVIOR OF A CHILD
              IS NOT A MANIFESTATION OF THE DISABILITY OF THE CHILD.

    ``(a) In General.--A State educational agency, a local educational
agency, or an intermediate educational unit may use a long-term
disciplinary measure to address the behavior of a child with a
disability that is a violation of the rules or code of conduct of such
an educational entity, if--
            ``(1) the behavior was not a manifestation of the
        disability of the child; and
            ``(2) the long-term disciplinary measure applies to the
        child with a disability to the same extent the long-term
        disciplinary measure applies to a child without a disability
        who engages in the same behavior.
    ``(b) Provision of Educational Services.--In the case of a child
with a disability who engages in behavior that violates the rules or
code of conduct of an educational entity described in subsection (a),
the child shall continue to receive educational services in accordance
with this Act, unless--
            ``(1) the behavior of the child was not a manifestation of
        the disability of the child; and
            ``(2) the policy of the educational entity is to cease
        educational services to any child determined to be engaged in
        such behavior.
    ``(c) Construction.--Nothing in this section shall be construed to
limit the rights provided for children with disabilities under section
615.
    ``(d) Definition.--In this section, the term `long-term
disciplinary measure' means a disciplinary action that is carried out
by an educational entity described in subsection (a) for a period of
more than 10 school days.''.
            (2) Alternative Educational Placement for Threatening
        Behavior.--Section 615(e)(3)(B)(i) of the Individuals with
        Disabilities Education Act (20 U.S.C. 1415(e)(3)(B)(i)) is
        amended by striking ``jurisdiction of such agency,'' and
        inserting ``jurisdiction of such agency or is determined by a
        hearing officer to have been engaged in behavior in such school
        that posed a threat to the safety of individuals involved with
        the child,''.
    (c) Definitions.--Section 602 of the Individuals with Disabilities
Education Act (20 U.S.C. 1401) is amended by adding at the end the
following:
    ``(c) In sections 612(8) and 615A, the term `child without a
disability' means an individual--
            ``(1) who is enrolled in an elementary school or secondary
        school (as the terms are defined in section 14101 of the
        Elementary and Secondary Education Act of 1965 (20 U.S.C.
        8801); and
            ``(2) who is not a child with a disability.''.

SEC. 5. SENSE OF THE SENATE.

    (a) Findings.--Congress finds that--
            (1) when Congress enacted the Individuals with Disabilities
        Education Act (20 U.S.C. 1400 et seq.), Congress made a
        commitment to provide funding for the State grant program under
        the Act at a level of 40 percent of the national average per-
        pupil expenditure; and
            (2) since the enactment of such Act, Congress has only
        funded the State grant program at 7 percent of the national
        average per-pupil expenditure.
    (b) Sense of the Senate.--It is the sense of the Senate that
Congress should follow through on its original funding commitment and
provide funding for the State grant program under the Individuals with
Disabilities Education Act at the level of 40 percent of the national
average per-pupil expenditure.

Summary: School Security Improvement Act of 1997 - Amends the Individuals with Disabilities Education Act (IDEA) to require educational entities to include, in the educational records of students who are children with disabilities and students who are children without disabilities, documentation with regard to disciplinary measures taken against them. Permits the use of long-term disciplinary measures against students who are children with disabilities. Requires continuing provision of educational services to children with disabilities who engage in behavior that violates an educational entity's rules or code of conduct, unless such behavior is not a manifestation of their disabilities, and it is the entity's policy to cease educational services to any child engaged in such behavior. Expresses the sense of the Senate that the Congress should follow through on its original commitment and provide funding for the IDEA State grant program at the level of 40 percent of the national average per-pupil expenditure.

School Security Improvement Act of 1997


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Trials Modernization Act of
2015''.

SEC. 2. CLINICAL TRIAL MODERNIZATION.

    (a) Proposals for Use of Innovative Statistical Methods in Clinical
Protocols for Drugs, Biological Products, and Devices.--Chapter V of
the Federal Food, Drug, and Cosmetic Act is amended by inserting after
section 506F (21 U.S.C. 356f) the following new section:

``SEC. 507. CLINICAL TRIAL MODERNIZATION.

    ``(a) In General.--To promote the efficiency of the development and
regulatory review and approval, licensure, or clearance of drugs,
biological products, and devices and the timely availability of
innovative treatments, the Secretary shall, after providing notice and
an opportunity for public comment, establish and implement a framework
through which--
            ``(1) sponsors of drugs, biological products, or devices
        may submit to the Secretary a proposal for the incorporation of
        adaptive trial designs, Bayesian methods, or other alternative
        statistical methods into proposed clinical protocols and
        marketing applications for drugs, biological products, or
        devices; and
            ``(2) the Secretary will commit to timelines for reviewing
        and providing feedback on proposals so submitted.''.
    (b) Guidance Addressing Use of Adaptive Trial Designs and Bayesian
Methods.--
            (1) In general.--The Secretary of Health and Human
        Services, acting through the Commissioner of Food and Drugs (in
        this subsection referred to as the ``Secretary''), shall--
                    (A) update and finalize the draft guidance
                addressing the use of adaptive trial design for drugs
                and biological products; and
                    (B) issue draft guidance on the use of Bayesian
                methods in the development and regulatory review and
                approval, licensure, or clearance of drugs, biological
                products, and devices.
            (2) Contents.--The guidances under paragraph (1) shall--
                    (A) establish or clarify standards for using
                adaptive trial designs and Bayesian methods in clinical
                trials, including clinical trials that form the primary
                basis for approval, clearance, or licensure of the
                products involved (such as trials that provide
                substantial evidence for the approval of drugs);
                    (B) establish a mechanism for sponsors to obtain
                feedback from the Secretary under section 507, as added
                by subsection (a), on technical issues related to
                modeling and simulations prior to--
                            (i) completion of such modeling or
                        simulations; or
                            (ii) the submission of resulting
                        information to the Secretary;
                    (C) specify the types of quantitative and
                qualitative information required for review; and
                    (D) specify the recommended analysis methodology.
            (3) Public meeting.--Prior to updating or developing the
        guidances required by paragraph (1), the Secretary shall
        consult, through a public meeting to be held no later than 1
        year after the date of enactment of this Act, with stakeholders
        including representatives of regulated industry, academia,
        patient advocacy organizations, and disease research
        foundations.
            (4) Schedule.--The Secretary shall, after providing notice
        and opportunity for public comment, publish--
                    (A) the final guidance required by paragraph (1)(A)
                not later than 6 months after the date of the public
                meeting required by paragraph (3); and
                    (B) the guidance required by paragraph (1)(B) not
                later than 12 months after the date of the public
                meeting required by paragraph (3).
            (5) Review and revision of guidance documents.--Not later
        than 48 months after the date of enactment of this Act, the
        Secretary shall review and, as appropriate, revise the guidance
        documents required by subparagraphs (A) and (B) of paragraph
        (1) to reflect developments in statistical methods that could
        be appropriate for use in clinical trials, including clinical
        trials that--
                    (A) form the primary basis for approval, clearance,
                or licensure of drugs, biological products or devices;
                or
                    (B) provide substantial evidence for the approval
                of drugs.

SEC. 3. EVALUATIONS OF REQUIRED POSTAPPROVAL STUDIES AND CLINICAL
              TRIALS.

    (a) In General.--Section 505(o)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(o)(3)) is amended by adding at the end the
following new subparagraph:
                    ``(G) Evaluations of required postapproval studies
                and clinical trials.--
                            ``(i) In general.--The Secretary shall
                        establish a process under which the Secretary,
                        on the initiative of the Secretary or at the
                        request of a responsible person, shall
                        periodically evaluate a postapproval study or
                        clinical trial required to be conducted under
                        this paragraph to determine whether--
                                    ``(I) the trial or study is no
                                longer scientifically warranted; or
                                    ``(II) the design, or the timelines
                                applicable to the completion of, the
                                study or trial should be renegotiated
                                because of changes in medical practice
                                or the standard of care.
                            ``(ii) Not scientifically warranted.--In
                        the case of a determination under clause (i)(I)
                        that a postapproval study or clinical trial
                        required to be conducted under this paragraph
                        is no longer scientifically warranted, the
                        Secretary shall no longer require the
                        responsible person to conduct the study or
                        trial.
                            ``(iii) Renegotiation.--In the case of a
                        determination under clause (i)(II) that the
                        design, or the timelines applicable to the
                        completion of, a postapproval study or clinical
                        trial required to be conducted under this
                        paragraph should be renegotiated, the Secretary
                        shall enter into negotiations with the
                        responsible person to make such changes as may
                        be necessary to such design or timelines as the
                        Secretary determines are necessary.''.
    (b) Guidance.--Not later than one year after the date of the
enactment of this Act, the Secretary shall issue draft guidance on the
implementation of subparagraph (G) of section 505(o)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)), as added by
subsection (a). Not later than two years after such date of enactment,
the Secretary shall issue final guidance on such implementation.

Summary: Clinical Trials Modernization Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing applications. The FDA is required to issue guidance that establishes or clarifies standards for using alternative statistical methods in clinical trials. The FDA must establish a process under which a post-approval study or clinical trial required by the FDA is periodically evaluated to determine whether the trial or study is no longer scientifically warranted or whether the design should be renegotiated because of changes in medical practice or the standard of care.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Metropolitan Washington Airports Act
Amendments of 1995''.

SEC. 2. FINDINGS.

    Section 6002(7) of the Metropolitan Washington Airports Act of 1986
(49 U.S.C. App. 2451(7)) is amended--
            (1) by inserting ``declining'' after ``perceived''; and
            (2) by striking ``the growing local interest,'' and
        inserting ``the increasing need for local planning and
        management on a metropolitan statistical area basis,''.

SEC. 3. AIRPORTS AUTHORITY.

    (a) Board of Directors.--Section 6007 of the Metropolitan
Washington Airports Act of 1986 (49 U.S.C. App. 2456) is amended by
striking subsections (e), (f), (g), and (h) and inserting the
following:
    ``(e) Board of Directors.--
            ``(1) Appointment.--The Airports Authority shall be
        governed by a board of directors of 11 members as follows:
                    ``(A) 1 member shall be appointed by the Governor
                of Virginia.
                    ``(B) 1 member shall be appointed by the Mayor of
                the District of Columbia.
                    ``(C) 1 member shall be appointed by the Governor
                of Maryland.
                    ``(D) 2 members shall be appointed by the Virginia
                State legislature.
                    ``(E) 2 members shall be appointed by those
                representatives from Virginia local governments who are
                on the Board of Directors of the Metropolitan
                Washington Council of Governments.
                    ``(F) 2 members shall be appointed by those
                representatives from the District of Columbia
                government who are on the Board of Directors of the
                Metropolitan Washington Council of Governments.
                    ``(G) 2 members shall be appointed by those
                representatives from Maryland local governments who are
                on the Board of Directors of the Metropolitan
                Washington Council of Governments.
        The Chairman shall be appointed from among the members by a
        majority vote of the members and shall serve until replaced by
        a majority vote of the members.
            ``(2) Restrictions.--Members (A) shall serve without
        compensation other than reasonable expenses incident to board
        functions, and (B) must reside within the Washington Standard
        Metropolitan Statistical Area.
            ``(3) Terms.--Members shall be appointed for terms of 4
        years.
            ``(4) Required number of votes.--7 votes shall be required
        to approve bond issues and the annual budget.
    ``(f) Airport Noise.--
            ``(1) Balanced environmental protection.--In order to
        protect the public from the impact of aircraft noise and at the
        same time provide for suitable air transportation service to
        the Washington Standard Metropolitan Statistical Area, a
        proposed action of the board of directors which could result in
        a change in the impact of aircraft noise in the vicinity of a
        Metropolitan Washington Airport may not take unless, at least
        60 days before the action is to take effect, the board of
        directors--
                    ``(A) notifies, in writing, the Committee on Noise
                Abatement at National and Dulles Airports of the
                Washington Council of Governments of the action for the
                purpose of allowing such committee the opportunity to
                review, and submit comments on, the action; and
                    ``(B) submits, in writing, to such committee a
                response to any comment of such committee with respect
                to the action within 30 days after the date of receipt
                of such comment.''.

SEC. 4. EFFECTIVE DATE.

    (a) In General.--Except as provided in subsections (b) and (c), the
amendments made by sections 2 and 3 shall take effect on the date of
the enactment of this Act.
    (b) Limitation on Applicability.--Persons appointed as members of
the board of directors of the Metropolitan Washington Airports
Authority on the date of the enactment of this Act shall continue to
serve on such board until their respective terms expire under former
section 6007(e).
    (c) Initial Appointments.--
            (1) Virginia appointments.--The Governor of Virginia shall
        appoint under new section 6007(e)(1)(A) a person to fill the
        vacancy of the first member appointed by the Governor of
        Virginia under former section 6007(e)(1)(A) whose term expires
        after the date of the enactment of this Act. The Virginia State
        legislature shall appoint under new section 6007(e)(1)(D)
        persons to fill the vacancies of the second and third members
        appointed by the Governor under former section 6007(e)(1)(A)
        whose terms expire after such date of enactment.
        Representatives from Virginia local governments shall appoint
        under new section 6007(e)(1)(E) persons to fill the vacancies
        of the fourth and fifth members appointed by the Governor under
        former section 6007(e)(1)(A) whose terms expire after such date
        of enactment.
            (2) District of columbia appointments.--The Mayor of the
        District of Columbia shall appoint under new section
        6007(e)(1)(B) a person to fill the vacancy of the first member
        appointed by the Mayor of the District of Columbia under former
        section 6007(e)(1)(B) whose term expires after the date of the
        enactment of this Act. Representatives from the District of
        Columbia government shall appoint under new section
        6007(e)(1)(F) persons to fill the vacancies of the second and
        third such members appointed by the Mayor under former section
        6007(e)(1)(B) whose terms expire after such date of enactment.
            (3) Maryland appointments.--The Governor of Maryland shall
        appoint under new section 6007(e)(1)(C) a person to fill the
        vacancy of the first member appointed by the Governor of
        Maryland under former section 6007(e)(1)(C) whose term expires
        after the date of the enactment of this Act. Representatives
        from Maryland local governments shall appoint under new section
        6007(e)(1)(G)--
                    (A) a person to fill the vacancy of the second
                member appointed by the Governor under former section
                6007(e)(1)(C) whose term expires after such date of
                enactment; and
                    (B) a person to fill the vacancy of the member
                appointed by the President under former section
                6007(e)(1)(D) when the term of such member expires
                after such date of enactment.
    (d) Definitions.--In this section, the following definitions apply:
            (1) Former section 6007(e).--The term ``former section
        6007(e)'' means section 6007(e) of the Metropolitan Washington
        Airports Act of 1986 as in effect on the day before the date of
        the enactment of this Act.
            (2) New section 6007(e).--The term ``new section 6007(e)''
        means section 6007(e) of the Metropolitan Washington Airports
        Act of 1986, as amended by section 3 of this Act.

Summary: Metropolitan Washington Airports Act Amendments of 1995 - Amends the Metropolitan Washington Airports Act of 1986 to revise congressional findings with respect to the two federally owned airports in the Washington metropolitan area to declare a perceived declining limited need for a Federal role in the management of these airports and increasing need for local planning and management on a metropolitan statistical area basis. Revises the composition of the Board of Directors for the Metropolitan Washington Airports Authority. Repeals the mandate for and authority of a Board of Review of the Airports Authority, thus abolishing it. Prohibits any proposed action of the Board of Directors which could result in a change in the impact of aircraft noise in the vicinity of a Metropolitan Washington Airport unless, at least 60 days before the action is to take effect, it: (1) notifies the Committee on Noise Abatement at National and Dulles Airports of the Washington Council of Governments of the action to allow them an opportunity to review, and submit comments on, such action. And (2) submits to such committee a response to any committee comment with respect to such action. Requires persons appointed as members of the Board upon the enactment of this Act to continue to serve until their original terms expire. Provides for the appointment of persons to fill vacancies on the Board.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National All Schedules Prescription
Electronic Reporting Reauthorization Act of 2010''.

SEC. 2. AMENDMENT TO PURPOSE.

    Paragraph (1) of section 2 of the National All Schedules
Prescription Electronic Reporting Act of 2005 (Public Law 109-60) is
amended to read as follows:
            ``(1) foster the establishment of State-administered
        controlled substance monitoring systems in order to ensure
        that--
                    ``(A) health care providers have access to the
                accurate, timely prescription history information that
                they may use as a tool for the early identification of
                patients at risk for addiction in order to initiate
                appropriate medical interventions and avert the tragic
                personal, family, and community consequences of
                untreated addiction; and
                    ``(B) appropriate law enforcement, regulatory, and
                State professional licensing authorities have access to
                prescription history information for the purposes of
                investigating drug diversion and prescribing and
                dispensing practices of errant prescribers or
                pharmacists; and''.

SEC. 3. AMENDMENTS TO CONTROLLED SUBSTANCE MONITORING PROGRAM.

    Section 399O of the Public Health Service Act (42 U.S.C. 280g-3) is
amended--
            (1) in subsection (a)(1)--
                    (A) in subparagraph (A), by striking ``or'';
                    (B) in subparagraph (B), by striking the period at
                the end and inserting ``; or''; and
                    (C) by adding at the end the following:
                    ``(C) to maintain and operate an existing State-
                controlled substance monitoring program.'';
            (2) by amending subsection (b) to read as follows:
    ``(b) Minimum Requirements.--The Secretary shall maintain and, as
appropriate, supplement or revise (after publishing proposed additions
and revisions in the Federal Register and receiving public comments
thereon) minimum requirements for criteria to be used by States for
purposes of clauses (ii), (v), (vi), and (vii) of subsection
(c)(1)(A).'';
            (3) in subsection (c)--
                    (A) in paragraph (1)(B)--
                            (i) in the matter preceding clause (i), by
                        striking ``(a)(1)(B)'' and inserting
                        ``(a)(1)(B) or (a)(1)(C)'';
                            (ii) in clause (i), by striking ``program
                        to be improved'' and inserting ``program to be
                        improved or maintained''; and
                            (iii) in clause (iv), by striking ``public
                        health'' and inserting ``public health or
                        public safety'';
                    (B) in paragraph (3)--
                            (i) by striking ``If a State that submits''
                        and inserting the following:
                    ``(A) In general.--If a State that submits'';
                            (ii) by inserting before the period at the
                        end ``and include timelines for full
                        implementation of such interoperability''; and
                            (iii) by adding at the end the following:
                    ``(B) Monitoring of efforts.--The Secretary shall
                monitor State efforts to achieve interoperability, as
                described in subparagraph (A).'';
                    (C) in paragraph (5)--
                            (i) by striking ``implement or improve''
                        and inserting ``establish, improve, or
                        maintain''; and
                            (ii) by adding at the end the following:
                        ``The Secretary shall redistribute any funds
                        that are so returned among the remaining
                        grantees under this section in accordance with
                        the formula described in subsection
                        (a)(2)(B).'';
            (4) in the matter preceding paragraph (1) in subsection
        (d), by striking ``In implementing or improving'' and all that
        follows through ``(a)(1)(B)'' and inserting ``In establishing,
        improving, or maintaining a controlled substance monitoring
        program under this section, a State shall comply, or with
        respect to a State that applies for a grant under subparagraph
        (B) or (C) of subsection (a)(1)'';
            (5) in subsections (e), (f)(1), and (g), by striking
        ``implementing or improving'' each place it appears and
        inserting ``establishing, improving, or maintaining'';
            (6) in subsection (f)--
                    (A) in paragraph (1)(B) by striking ``misuse of a
                schedule II, III, or IV substance'' and inserting
                ``misuse of a controlled substance included in schedule
                II, III, or IV of section 202(c) of the Controlled
                Substance Act''; and
                    (B) by adding at the end the following:
            ``(3) Evaluation and reporting.--Subject to subsection (g),
        a State receiving a grant under subsection (a) shall provide
        the Secretary with aggregate data and other information
        determined by the Secretary to be necessary to enable the
        Secretary--
                    ``(A) to evaluate the success of the State's
                program in achieving its purposes; or
                    ``(B) to prepare and submit the report to Congress
                required by subsection (k)(2).
            ``(4) Research by other entities.--A department, program,
        or administration receiving nonidentifiable information under
        paragraph (1)(D) may make such information available to other
        entities for research purposes.'';
            (7) by redesignating subsections (h) through (n) as
        subsections (i) through (o), respectively;
            (8) in subsections (c)(1)(A)(iv) and (d)(4), by striking
        ``subsection (h)'' each place it appears and inserting
        ``subsection (i)'';
            (9) by inserting after subsection (g) the following:
    ``(h) Education and Access to the Monitoring System.--A State
receiving a grant under subsection (a) shall take steps to--
            ``(1) facilitate prescriber use of the State's controlled
        substance monitoring system; and
            ``(2) educate prescribers on the benefits of the system
        both to them and society.'';
            (10) by amending subsection (l), as redesignated, to read
        as follows:
    ``(l) Preference.--Beginning 3 years after the date on which funds
are first appropriated to carry out this section, the Secretary, in
awarding any competitive grant under title V that is related to drug
abuse (as determined by the Secretary) and for which only States or
tribes are eligible to apply, may give preference to eligible States
with applications approved under this section, to eligible States or
tribes with existing controlled substance monitoring programs that meet
minimum requirements under this section, or to eligible States or
tribes that put forth a good faith effort to meet those requirements
(as determined by the Secretary).''.
            (11) in subsection (m)(1), as redesignated, by striking
        ``establishment, implementation, or improvement'' and inserting
        ``establishment, improvement, or maintenance'';
            (12) in subsection (n)(8), as redesignated, by striking
        ``and the District of Columbia'' and inserting ``, the District
        of Columbia, and any commonwealth or territory of the United
        States''; and
            (13) by amending subsection (o), as redesignated, to read
        as follows:
    ``(o) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $15,000,000 for fiscal year
2011 and $10,000,000 for each of fiscal years 2012 and 2013.''.

            Passed the House of Representatives September 23, 2010.

            Attest:

                                            LORRAINE C. MILLER,

                                                                 Clerk.

Summary: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 - Amends the National All Schedules Prescription Electronic Reporting Act of 2005 to include as a purpose of such Act to foster the establishment of state-administered controlled substance monitoring systems in order to ensure that appropriate law enforcement, regulatory, and state professional licensing authorities have access to prescription history information for the purposes of investigating drug diversion and prescribing and dispensing practices of errant prescribers or pharmacists. Amends the Public Health Service Act to revise and update the controlled substance monitoring program, including to: (1) allow grants to be used to maintain and operate existing state controlled substance monitoring programs. (2) require the Secretary of Health and Human Services (HHS) to redistribute any funds that are returned among the remaining grantees. (3) require a state to provide the Secretary with aggregate data and other information to enable the Secretary to evaluate the success of the state's program and to submit a progress report to Congress. And (4) expand the program to include any commonwealth or territory of the United States. Authorizes the Drug Enforcement Administration (DEA) or a state medicaid program or state health department receiving nonidentifiable information from a controlled substance monitoring database to make such information available to other entities for research purposes. Requires a state receiving a grant to: (1) facilitate prescriber use of the state's controlled substance monitoring system. And (2) educate prescribers on the benefits of the system both to them and society. Revises preferences for grants related to drug abuse to authorize the Secretary to give preference to eligible states or tribes that put forth a good faith effort to meet minimum requirements under the controlled substance monitoring program. Authorizes appropriations for FY2011-FY2013.

To amend and reauthorize the controlled substance monitoring program under section 399O of the Public Health Service Act.