In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National High Performance Passenger 
Rail Transportation-Oriented Development Act of 2012''.

SEC. 2. TRANSPORTATION-ORIENTED DEVELOPMENT INITIATIVE.

    (a) Establishment.--The Secretary of Transportation (in this Act 
referred to as the ``Secretary'') shall establish an initiative to 
promote passenger rail operations and transportation-oriented 
development by creating incentives for communities to encourage 
dedicated revenue sources for urban and regional rail corridor 
development.
    (b) Implementation.--The Secretary shall appoint a Planning 
Developer to oversee implementation of this initiative. The Planning 
Developer shall report to the Secretary.
    (c) Coordinating Committee.--The Secretary shall harmonize planning 
requirements and direct coordination and administration of the 
initiative between the Federal Railroad Administration and the Federal 
Transit Administration. The Secretary shall appoint a Transportation-
Oriented Development Coordinating Committee composed of the Planning 
Developer as Chair, the Administrator of the Federal Railroad 
Administration, and the Administrator of the Federal Transit 
Administration.

SEC. 3. FEDERAL INCENTIVES.

    (a) Qualified Projects.--
            (1) Criteria.--The Secretary shall establish criteria for 
        the designation of projects qualified for Federal incentives 
        pursuant to this section and the amendments made by this 
        section.
            (2) Types of projects that may qualify.--Projects that may 
        qualify for Federal incentives pursuant to this section and the 
        amendments made by this section are those that contribute to 
        the generation of revenue by the capture of increasing value 
        from development around station areas, as defined by the 
        Secretary, which are likely to make long-term contributions to 
        rail corridor development funds or similar mechanisms that help 
        finance intercity and urban passenger rail infrastructure or 
        operating expenses. Such commercial development or other 
        projects designated as qualified by the Secretary may generate 
        revenue for transportation-oriented development and rail 
        operations in the region by increasing the tax base, promoting 
        job growth, promoting cost effectiveness, facilitating 
        intermodal connectivity, combining congestion relief with 
        station development, stimulating economic development, or any 
        other appropriate means. The capture of increased value shall 
        be through the establishment of special assessment districts or 
        similar mechanisms, and distribution of revenues shall be 
        through rail corridor development funds or similar mechanisms 
        established within the regions.
            (3) Designated coordinating authority.--The Secretary shall 
        designate a State authority, or regional commission in 
        appropriate regions of the country as defined by the Secretary, 
        that petitions the Secretary to participate in the initiative 
        established under section 2. Such designated entity shall 
        provide for coordination among stakeholders, local governments, 
        and private developers in the defined region, and shall endorse 
        each project of, and be the lead party in, an application for 
        Federal incentives pursuant to this section and the amendments 
        made by this section.
    (b) Railroad Rehabilitation Improvement Financing.--Section 502 of 
the Railroad Revitalization and Regulatory Reform Act of 1976 (45 
U.S.C. 822) is amended--
            (1) in subsection (a)--
                    (A) by striking ``and'' at the end of paragraph 
                (5);
                    (B) by striking the period at the end of paragraph 
                (6) and inserting ``; and''; and
                    (C) by adding at the end the following new 
                paragraph:
            ``(7) persons conducting a qualified project (as defined in 
        section 8 of the National High Performance Passenger Rail 
        Transportation-Oriented Development Act of 2012).''; and
            (2) in subsection (b)(1)--
                    (A) by striking ``and'' at the end of subparagraph 
                (B);
                    (B) by striking the period at the end of 
                subparagraph (C) and inserting ``; or''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(D) conduct a qualified project (as defined by 
                the Secretary under section 3 of the National High 
                Performance Passenger Rail Transportation-Oriented 
                Development Act of 2012.''.
    (c) Transportation Infrastructure Finance.--Section 601(a)(8) of 
title 23, United States Code, is amended--
            (1) by striking ``and'' at the end of subparagraph (C);
            (2) by striking the period at the end of subparagraph (D) 
        and inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(E) a qualified project (as defined by the 
                Secretary under section 3 of the National High 
                Performance Passenger Rail Transportation-Oriented 
                Development Act of 2012).''.
    (d) Application Priority.--In general, Federal applications to the 
Federal Railroad Administration and Federal Transit Administration for 
railroad projects that participate in the transportation-oriented 
development program under this Act shall receive a priority for funding 
in the application decision process.
    (e) Administrative Costs.--For administrative costs to carry out 
this Act, including contracting with and support for the Planning 
Developer and transportation-oriented development initial 
administrative costs of the Federal Railroad Administration and Federal 
Transit Administration for the first 5 years, the Secretary may use 
such funds as necessary which are appropriated for carrying out chapter 
6 of title 23, United States Code.
    (f) Revenue Neutral Program Cost.--The Secretary may establish a 
mechanism whereby amounts used under subsection (e) will be repaid to 
the Secretary for use in carrying out chapter 6 of title 23, United 
States Code. Repayment shall be derived from a small fee to all 
recipients of funding provided under subsection (e). The repayment 
shall commence upon substantial completion of qualified projects.

SEC. 4. TECHNICAL ASSISTANCE.

    (a) National Technical Assistance.--The program established under 
this Act shall provide technical assistance to the States with respect 
to--
            (1) identification of transportation-oriented development 
        opportunities;
            (2) establishment of special assessment districts in 
        regions;
            (3) establishment of rail corridor development funds; and
            (4) expediting Federal, State, and local regulatory 
        approvals.
    (b) States and Regions Outside the Northeast Corridor.--The 
Secretary, through the initiative established by this Act, shall 
provide technical assistance to the States and regions outside the 
Northeast Corridor as identified by the Secretary, and shall provide--
            (1) technical assistance on the establishment of Regional 
        Advisory Committees appropriate to carrying out the purposes of 
        this Act at the regional level; and
            (2) technical assistance at the request of a State or 
        qualified entity provided by the Planning Developer that will 
        identify stations and potential stations within a given region, 
        and conduct a preliminary survey of property available and 
        potentially available, to maximize development and commercial 
        revenue generation to financially support the development of a 
        high performance rail passenger corridor.
    (c) Northeast Corridor.--The Secretary, through the initiative 
established under this Act, shall provide technical assistance to the 
States and entities along the Northeast Corridor as identified by the 
Secretary--
            (1) on the establishment, by the Northeast Corridor 
        Infrastructure and Operations Advisory Commission established 
        under section 24905 of title 49, United States Code, of a 
        Northeast Corridor Transportation-Oriented Development Working 
        Group, which shall--
                    (A) include outside members with expertise in 
                transportation-oriented development;
                    (B) be chaired by the Planning Developer; and
                    (C) advise the Secretary and the Northeast Corridor 
                Infrastructure and Operations Advisory Commission on 
                the ways and means for carrying out the purposes of 
                this Act at the regional level; and
            (2) technical assistance provided by the Planning Developer 
        to the Secretary and identified States and entities, not more 
        than one year after the date of enactment of this Act, that 
        will identify Northeast Corridor stations and potential 
        stations, and conduct a preliminary survey of property 
        available and potentially available, to maximize development 
        and commercial revenue generation to financially support the 
        creation of a true high-speed rail corridor in the Northeast 
        Corridor.

Output: National High Performance Passenger Rail Transportation-Oriented Development Act of 2012 - Directs the Secretary of Transportation (DOT) to establish an initiative to promote passenger rail operations and transportation-oriented development by creating rail projects qualified for federal incentives for communities to encourage dedicated revenue sources for urban and regional rail corridor development.

Amends the Railroad Revitalization and Regulatory Reform Act of 1976 to direct the Secretary to provide direct loans and loan guarantees for qualified rail projects. Authorizes the Secretary to make secured loans, loan guarantees, or lines of credit for such projects.

Directs the Secretary to provide technical assistance to: (1) states to identify transportation-oriented development opportunities, (2) states and regions outside the Northeast Corridor to establish Regional Advisory Committees and identify stations and potential stations within the region to maximize development and commercial revenue generation to support financially the development of a high performance rail passenger corridor, and (3) states and entities along the Northeast Corridor to establish a Northeast Corridor Transportation-Oriented Development Working Group and identify Northeast Corridor stations and potential stations to maximize development and commercial revenue generation to support financially the creation of a true high-speed rail corridor in the Northeast Corridor.


Input: Consider Input: SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.-- This Act may be cited as the ``Tribal Government 
Homeland Security Coordination and Integration Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
Sec. 3. Definitions.
Sec. 4. Office of tribal government homeland security.
Sec. 5. Report to congress.
Sec. 6. Authorization of appropriations.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress finds the following:
            (1) Since the terrorist attacks of September 11, 2001, and 
        the subsequent introduction of weapons grade anthrax into the 
        United States Postal System and Congressional office buildings 
        in Washington, D.C., the President and the Congress have worked 
        closely to respond to the need to rebuild and strengthen the 
        nation's public health, national security, and emergency 
        response systems.
            (2) Based on Article I, section 8 of the United States 
        Constitution, treaties, Federal statutes, and court decisions, 
        the United States has a unique historical and legal 
        relationship with American Indian and Alaska Native people, 
        which serves as the basis for the Federal Government's trust 
        responsibility and obligations. There are currently 558 
        federally-recognized Indian tribes in the United States, with 
        some 40 percent of Indian tribes located in the State of 
        Alaska. Indian tribes have principle responsibility for lands 
        and people within their jurisdiction.
            (3) Despite the government-to-government relationship 
        between Indian tribes and the United States, the United States 
        has failed to include and consult with Indian tribes with 
        regard to homeland security prevention, protection, and 
        response activities planning. Moreover, there are no specific 
        provisions for the Bureau of Indian Affairs or the Indian 
        Health Service to participate in homeland security programs and 
        funding.
            (4) Throughout many areas of the United States, facilities 
        operated, and services, activities and government functions 
        carried out, by Indian tribes, the Bureau of Indian Affairs and 
        the Indian Health Service are the only sources available to 
        provide emergency health services, disaster response, and law 
        enforcement to the tribal and non-tribal community, thus 
        serving the role as ``first responders'' in the event of a 
        terrorist attack.
            (5) To provide for the public health and safety on tribal 
        lands and in the surrounding communities, it is imperative to 
        establish tribal participation in homeland security 
        initiatives. Indian tribes must be included in the national 
        strategy for homeland security and receive an appropriate share 
        of related funding.
            (6) The treatment of Indian tribes as State governments, as 
        appropriate, for developing funding methodologies, planning, 
        consultation, coordination, and for eligibility for grant 
        monies will ensure Indian tribes are adequately prepared to 
        respond to Homeland Security threats.
            (7) Indian tribes shall be treated as State, as 
        appropriate, for purposes of planning, consultation, 
        coordination, eligibility for grant monies and other purposes 
        to improve the United States capacity to prepare, prevent and 
        respond to terrorist activities.
    (b) Purposes.--The purposes of this Act are as follows:
            (1) To establish within the Department of Homeland Security 
        an office known as the Office of Tribal Government Homeland 
        Security.
            (2) To authorize the Secretary of Homeland Security to 
        appoint, in consultation with Indian tribes, a Director of 
        Tribal Government Homeland Security.
            (3) To provide for more effective management of, and 
        accountability for the proper discharge of, the Secretary's 
        trust responsibility to Indian tribes and individual American 
        Indians and Alaska Natives by establishing in the Department of 
        Homeland Security an Office of Tribal Government Homeland 
        Security.
            (4) To integrate and coordinate the efforts of the 
        Department of Homeland Security and Indian tribes to prepare 
        for, prevent, protect against, respond to, and recover from 
        terrorist attacks.
            (5) To provide strategic integration of the Homeland 
        Security activities of Indian tribes that will complement the 
        operational consolidation of the various directorates within 
        the Department.
            (6) To supplement the capacity of the Indian Health Service 
        and the Bureau of Indian Affairs to respond to the homeland 
        security needs of American Indians and Alaska Natives, without 
        jeopardizing the nonsecurity missions of the Indian Health 
        Service and the Bureau of Indian Affairs.
            (7) To serve as an information clearinghouse and to enhance 
        the integration and coordination of Indian tribes and in the 
        activities of the Department of Homeland Security.
            (8) To establish an organizational framework within the 
        Department of Homeland Security through which the Federal 
        Government, Indian tribes, and State and local governments can 
        work effectively and collaboratively on public health and 
        safety, terrorism detection, prevention, response, and 
        protection of critical infrastructure.

SEC. 3. DEFINITIONS.

     In this Act:
            (1) Director.--The term ``Director'' means the Director of 
        the Office of Tribal Government Homeland Security.
            (2) Indian tribe.--The term ``Indian tribe'' has the 
        meaning given that term in section 4(e) of the Indian Self-
        Determination and Education Assistance Act (25 U.S.C. 450b(e)).
            (3) Office.--The term ``Office'' means the Office of Tribal 
        Government Homeland Security established in section 4.
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of Homeland Security.

SEC. 4. OFFICE OF TRIBAL GOVERNMENT HOMELAND SECURITY.

    (a) In General.--
            (1) Establishment.--There is hereby established within the 
        Department of Homeland Security an office to be known as the 
        ``Office of Tribal Government Homeland Security''.
            (2) Director.--The Office shall be headed by a Director, 
        appointed by the Secretary in consultation with Indian tribes, 
        whose title shall be the Director of Tribal Government Homeland 
        Security. The Director shall be equal in pay and authority of 
        an Assistant Secretary.
    (b) Duties of Secretary; Director.--
            (1) Duties of the secretary.--The Secretary shall--
                    (A) ensure the coordination of Federal programs 
                that provide assistance (including financial and 
                technical assistance) to eligible Indian tribes and 
                provide those governments with treatment as State 
                governments, as appropriate, for planning, 
                consultation, and coordination and for eligibility for 
                Federal grant monies and funds to improve capacity and 
                help prepare, prevent, and respond to terrorist 
                activities, and for other related purposes in and near 
                tribal communities;
                    (B) ensure Indian tribes are included in the 
                coordination activities of the Homeland Security 
                Department's Border and Transportation functions in the 
                same manner as State and local law enforcement 
                entities;
                    (C) ensure Indian tribes with jurisdiction over 
                lands adjacent to the Canadian and Mexican borders are 
                adequately prepared to help protect United States 
                borders, territorial waters, waterways, and other 
                transportation systems;
                    (D) ensure the broad spectrum of infrastructure 
                throughout Indian Country, including nuclear and 
                electrical power plants, water and sanitation 
                facilities, agricultural, food processing, oil, timber, 
                and other natural resources is adequately protected 
                against terrorist threats;
                    (E) ensure that Indian tribes are properly equipped 
                to prepare for, prevent, and respond to terrorist 
                activities in the same manner as State and local 
                governments;
                    (F) provide Indian tribes the necessary equipment 
                for detection, protection, and decontamination in 
                emergencies involving weapons of mass destruction;
                    (G) provide Indian tribes with emergency 
                preparedness training and exercise programs and further 
                assistance for any emergency, including natural 
                disasters or disease;
                    (H) include Indian tribes in all facets of 
                research, development, resource assessment, and risk 
                analysis in the same manner as State and local 
                governments; and
                    (I) include Indian tribes, as appropriate, in the 
                coordination of the Homeland Security Department's 
                Immigration and Nationality functions in the same 
                manner as State and local law enforcement entities.
            (2) Duties of the director.--The Director shall--
                    (A) coordinate homeland security activities among 
                Indian tribes and related Federal agencies, including 
                integration and coordination of the efforts of the 
                Department of Homeland Security and Indian tribes to 
                prepare for, prevent, protect against, respond to, and 
                recover from terrorist attacks;
                    (B) provide strategic integration to complement the 
                operational consolidation of the various directorates 
                within the Department of Homeland Security, with 
                respect to Indian tribes;
                    (C) ensure that Indian tribes are included in the 
                gathering and analysis of terrorist threats and other 
                information in the same manner as Federal, State, and 
                local law enforcement entities;
                    (D) serve as the Secretary's key point of contact 
                for Indian tribes in need of assistance and information 
                homeland security grants for purposes of planning, 
                consultation, coordination, eligibility for grant 
                monies and other purposes to improve the United States 
                capacity to prepare, prevent and respond to terrorist 
                activities and to work with Indian tribes and executive 
                agencies in promoting homeland security;
                    (E) serve as the coordinating center intended to 
                facilitate communication between and integration with 
                Indian tribes and other Federal departments that have 
                homeland security responsibilities, including but not 
                limited to health surveillance, emergency preparation 
                and response, border security, critical infrastructure 
                protection, technology, and communication;
                    (F) establish a network through which the Federal 
                Government, Indian tribes, and State and local 
                governments work collaboratively on public health and 
                safety, terrorism detection, prevention, response, and 
                protection of critical infrastructure targets; and
                    (G) establish a mechanism for the distribution of 
                warnings and information to tribal communities.
    (c) Treatment of Indian Tribes as States.--
            (1) In general.--The Secretary shall--
                    (A) treat Indian tribes as States, as appropriate, 
                for the purpose of homeland security consultation, 
                planning, coordination, bioterrorism preparedness, 
                prevention, and response, emergency preparedness and 
                response, border and transportation security, and for 
                other purposes related to protecting the homeland;
                    (B) include Indian tribes in funding methodologies 
                for purposes of allocating any financial resources; and
                    (C) support and facilitate the capacity necessary 
                for the Indian Health Service and Bureau of Indian 
                Affairs to respond to the homeland security needs of 
                American Indians and Alaska Natives, without 
                jeopardizing their non-security missions.
            (2) Discretionary authority.--The Secretary may delegate to 
        such Indian tribes primary responsibility for homeland security 
        activities within its respective jurisdiction.
    (d) Information Sharing.--The Secretary shall provide assistance to 
enhance information technology capabilities of Indian tribes and 
ensure--
            (1) the active participation of Indian tribes in the 
        coordination with Federal, State, and local governments and the 
        private sector as related to Homeland Security activities; and
            (2) provide Indian tribes access to the same type of 
        information being exchanged between Federal, State, and local 
        authorities for the purpose of providing government personnel, 
        agencies, and authorities, with appropriate intelligence 
        information, including warnings, regarding threats posed by 
        terrorism in a timely and secure manner.
    (e) Federal Grants.--
            (1) General eligibility.--Indian tribes shall be eligible 
        to apply for, receive, direct, and supervise any homeland 
        security-related Federal grant programs.
            (2) Authority to award grants.--The Secretary may award 
        grants to Indian tribes for the following purposes:
                    (A) Planning, consultation, and coordination to 
                improve infrastructure, to prevent terrorist 
                activities.
                    (B) Training and education of employees responsible 
                for public health, safety and emergency response 
                activities.
                    (C) Addressing communication gaps and 
                infrastructure needs related to homeland security.
                    (D) Increasing the capacity of Indian tribes to 
                help prepare, prevent, and respond to terrorist 
                activities and other public health and safety 
                emergencies.
                    (E) Development of a comprehensive plan to help 
                prepare, prevent, and respond to terrorist activities 
                and other public health and safety emergencies.
                    (F) Implementation of plans to help prepare, 
                prevent, and respond to terrorist activities and other 
                public health and safety emergencies.
                    (G) The preparation of reports assessing the 
                emergency preparedness of Indian tribes, including an 
                assessment of Indian tribes' coordination with the 
                Department.
                    (H) Such other purposes related to the purposes of 
                this Act the Secretary considers appropriate.
    (f) Technical Assistance.--The Secretary shall--
            (1) directly or by contract, provide Indian tribes with 
        technical assistance in developing, implementing and managing 
        emergency response plans.
            (2) Ensure that legal, financial, and other expertise of 
        the Department of Homeland Security is made fully available in 
        an advisory capacity to Indian tribes to assist in the 
        development, implementation, and management of emergency 
        response plans.
            (3) Provide Department of Homeland Security programs 
        designed to provide legal, accounting, financial, or technical 
        assistance to eligible Indian tribes.
            (4) Facilitate cooperation with the heads of appropriate 
        Federal agencies working on Homeland Security initiatives.
            (5) Any other activity that the Secretary, in consultation 
        with the Director, considers appropriate to carry out this 
        section.
    (g) Assessment.--Not later than 6 months after the date of the 
enactment of this Act, the Secretary shall submit an assessment report 
detailing the baseline readiness of Indian tribes to the Committee on 
Indian Affairs of the Senate and the Committee on Resources of the 
House of Representatives. In addition to an assessment of baseline 
readiness, the report shall contain any legislative recommendations 
necessary to improve coordination and integration of Indian tribes in 
the National Homeland Security Strategy.
    (h) Reporting.--The Secretary shall determine the effectiveness of 
the Office through the preparation of reports assessing the emergency 
preparedness of Indian tribes, including an assessment of Indian 
tribes' coordination with the Department of Homeland Security.
    (i) Prohibition.--The Secretary may not provide assistance under 
this section for any activity related to the operation of a gaming 
activity on Indian lands pursuant to the Indian Gaming Regulatory Act 
(25 U.S.C. 2701 et seq.).

SEC. 5. REPORT TO CONGRESS.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, and annually thereafter, the Secretary, in 
consultation with the Director, shall prepare and submit to the 
Committee on Indian Affairs of the Senate and the Committee on 
Resources of the House of Representatives a report on the operation of 
the Office.
    (b) Contents of Report.--Each report prepared under subsection (a) 
shall include--
            (1) for the period covered by the report, a summary of the 
        activities conducted by the Secretary, in carrying out 
        subsections (b) through (h) of section 4; and
            (2) any recommendations for legislation that the Secretary, 
        in consultation with the Director, determines to be necessary 
        to carry out such sections.

SEC. 6. AUTHORIZATION OF APPROPRIATIONS.

     There are authorized to be appropriated such sums are necessary to 
carry out this Act, to remain available until expended.

Output: Tribal Government Homeland Security Coordination and Integration Act - Establishes the Office of Tribal Government Homeland Security (Office) within the Department of Homeland Security. Requires the Secretary of Homeland Security to appoint a Director to head the Office.

Prescribes the Secretary's and the Director's duties of coordination, infrastructure and equipment readiness, training, and inclusion of Indian tribes in homeland security preparedness. 
 
 Requires the Secretary to treat Indian tribes as states, as appropriate for the purpose of homeland security. Authorizes the Secretary to delegate to Indian tribes primary responsibility for homeland security activities within their respective jurisdictions. Requires the Secretary to integrate the roles of the Bureau of Indian Affairs and Indian Health Services with regard to homeland security. 
 
 Requires the Secretary to provide assistance to enhance information technology capabilities of tribes and ensure the participation of Indian tribes in the coordination with federal, state, and local governments and the private sector as related to Homeland Security activities. 
 
 Declares Indian tribes to be eligible to apply for, receive, direct, and supervise any homeland security-related federal grant program. 
 
 Authorizes the Secretary to award grants to Indian tribes for specified homeland security purposes. 
 
 Requires the Secretary to provide Indian tribes with: (1) technical assistance in developing, implementing, and managing emergency response plans; (2) Department of Homeland Security expertise and programs; (3) the cooperation of the heads of appropriate Federal agencies; and (4) any other activity the Secretary considers appropriate to provide homeland security technical assistance to Indian tribes.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Animal Medicinal Drug Use 
Clarification Act of 1994''.

SEC. 2. UNAPPROVED USES.

    (a) General Rule.--Section 512(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(a)) is amended by adding the following new 
paragraphs at the end:
    ``(4)(A) Except as provided in subparagraph (B), if an approval of 
an application filed under subsection (b) is in effect with respect to 
a particular use or intended use of a new animal drug, the drug shall 
not be deemed unsafe for the purposes of paragraph (1) and shall be 
exempt from the requirements of section 502(f) with respect to a 
different use or intended use of the drug, other than a use in or on 
animal feed, if such use or intended use--
        ``(i) is by or on the lawful written or oral order of a 
    licensed veterinarian within the context of a veterinarian-client-
    patient relationship, as defined by the Secretary; and
        ``(ii) is in compliance with regulations promulgated by the 
    Secretary that establish the conditions for such different use or 
    intended use.
The regulations promulgated by the Secretary under clause (ii) may 
prohibit particular uses of an animal drug and shall not permit such 
different use of an animal drug if the labeling of another animal drug 
that contains the same active ingredient and which is in the same 
dosage form and concentration provides for such different use.
    ``(B) If the Secretary finds that there is a reasonable probability 
that a use of an animal drug authorized under subparagraph (A) may 
present a risk to the public health, the Secretary may--
        ``(i) establish a safe level for a residue of an animal drug 
    when it is used for such different use authorized by subparagraph 
    (A); and
        ``(ii) require the development of a practical, analytical 
    method for the detection of residues of such drug above the safe 
    level established under clause (i).
The use of an animal drug that results in residues exceeding a safe 
level established under clause (i) shall be considered an unsafe use of 
such drug under paragraph (1). Safe levels may be established under 
clause (i) either by regulation or order.
    ``(C) The Secretary may by general regulation provide access to the 
records of veterinarians to ascertain any use or intended use 
authorized under subparagraph (A) that the Secretary has determined may 
present a risk to the public health.
    ``(D) If the Secretary finds, after affording an opportunity for 
public comment, that a use of an animal drug authorized under 
subparagraph (A) presents a risk to the public health or that an 
analytical method required under subparagraph (B) has not been 
developed and submitted to the Secretary, the Secretary may, by order, 
prohibit any such use.
    ``(5) If the approval of an application filed under section 505 is 
in effect, the drug under such application shall not be deemed unsafe 
for purposes of paragraph (1) and shall be exempt from the requirements 
of section 502(f) with respect to a use or intended use of the drug in 
animals if such use or intended use--
        ``(A) is by or on the lawful written or oral order of a 
    licensed veterinarian within the context of a veterinarian-client-
    patient relationship, as defined by the Secretary; and
        ``(B) is in compliance with regulations promulgated by the 
    Secretary that establish the conditions for the use or intended use 
    of the drug in animals.''.
    (b) Other Amendments.--
        (1) Section 301.--Section 301 of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 331) is amended--
            (A) in paragraph (e), by striking ``507(d) or (g),'' and 
        inserting ``507(d) or (g), 512(a)(4)(C),''; and
            (B) by adding at the end the following:
    ``(u) The failure to comply with any requirements of the provisions 
of, or any regulations or orders of the Secretary, under section 
512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).''.
        (2) Section 512(e).--Section 512(e)(1)(A) of the Federal Food, 
    Drug and Cosmetic Act (21 U.S.C. 360b(e)(1)(A)) is amended by 
    inserting before the semicolon the following: ``or the condition of 
    use authorized under subsection (a)(4)(A)''.
        (3) Section 512(l).--Section 512(l)(1) of the Federal Food, 
    Drug, and Cosmetic Act (21 U.S.C. 360b(l)(1)) is amended by 
    striking ``relating to experience'' and inserting ``relating to 
    experience, including experience with uses authorized under 
    subsection (a)(4)(A),''.
    (c) Regulations.--Not later than 2 years after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
promulgate regulations to implement paragraphs (4)(A) and (5) of 
section 512(a) of the Federal Food, Drug, and Cosmetic Act (as amended 
by subsection (a)).
    (d) Effective Date.--The amendments made by this section shall take 
effect upon the adoption of the final regulations under subsection (c).

SEC. 3. MAPLE SYRUP.

    (a) Preemption.--Section 403A(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343-1(a)) is amended--
        (1) in paragraph (1), by inserting at the end the following: 
    ``except that this paragraph does not apply to a standard of 
    identity of a State or political subdivision of a State for maple 
    syrup that is of the type required by sections 401 and 403(g),'';
        (2) in paragraph (2), by inserting at the end the following: 
    ``except that this paragraph does not apply to a requirement of a 
    State or political subdivision of a State that is of the type 
    required by section 403(c) and that is applicable to maple 
    syrup,''; and
        (3) in paragraph (3) by inserting at the end the following: 
    ``except that this paragraph does not apply to a requirement of a 
    State or political subdivision of a State that is of the type 
    required by section 403(h)(1) and that is applicable to maple 
    syrup,''.
    (b) Procedure.--Section 701(e)(1) (21 U.S.C. 371(e)(1)) is amended 
by striking ``or maple syrup (regulated under section 168.140 of title 
21, Code of Federal Regulations).''.







                               Speaker of the House of Representatives.







                            Vice President of the United States and    
                                               President of the Senate.


Output: Animal Medicinal Drug Use Clarification Act of 1994 - Amends the Federal Food, Drug, and Cosmetic Act to allow, on order of a veterinarian:  (1) a new animal drug approved for one use to be used for a different purpose other than a use in or on animal feed; and (2) a new drug approved for human use to be used in animals. 
Specifies that regulations promulgated by the Secretary of Health and Human Services may prohibit particular uses of an animal drug and shall not permit such different use if the labeling of another animal drug that contains the same active ingredient and that is in the same dosage form and concentration provides for such different use. 
Permits the Secretary, upon finding that there is a reasonable probability that a use of an animal drug authorized may present a risk to the public health, to establish a safe level for residue of an animal drug for such different authorized use and require the development of a practical, analytical method for the detection of residues of such drug above the safe level established.  Directs that the use of an animal drug that results in residues exceeding a safe level so established be considered an unsafe use of such drug.  Allows safe levels to be established either by regulation or order. 
Authorizes the Secretary by general regulation to provide access to the records of veterinarians to ascertain any use or intended use authorized that the Secretary has determined may present a risk to the public health.  Specifies that if the Secretary finds, after affording an opportunity for public comment, that a use of an animal drug so authorized presents such a risk or that an analytical method required has not been developed and submitted, the Secretary may by order prohibit any such use. 
Exempts State and local governments from Federal requirements that preempt their authority with respect to nutrition labeling for maple syrup.