[Congressional Record (Bound Edition), Volume 153 (2007), Part 20]
[Senate]
[Pages 27796-27804]
[From the U.S. Government Publishing Office, www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. HATCH (for himself and Mr. Biden):
  S. 2213. A bill to amend title 18, United States Code, to improve 
prevention, investigation, and prosecution of cyber-crime, and for 
other purposes; to the Committee on the Judiciary.
  Mr. HATCH. Mr. President, I rise today to introduce S. 2213, the 
Cyber-Crime Act of 2007. I am joined in this effort by my colleague and 
good friend Senator Biden. This bipartisan legislation makes important, 
appropriate and necessary changes to federal law relating to computer 
fraud.
  Continuous innovation in technology provides remarkable benefits to 
individuals throughout the world. In the United States, the integration 
of computer networks has allowed for increased efficiency of American 
businesses and provided greater access to services and information for 
individuals. The ability of individuals and businesses to store vast 
amounts of data on computer networks has led to innumerable advantages 
including increased productivity and financial savings.
  However, these same networks have proven to be prime targets for 
criminals seeking to utilize malicious computer code for illicit gain. 
Criminals are using viruses to exploit technological weaknesses in 
computer networks. These collections of compromised computers are 
called ``botnets'', and serve as zombie networks which can be remotely 
controlled by an attacker and used for numerous crimes, including 
identity theft and attacks on critical computer systems. Botnets can 
consist of hundreds of thousands of computers, and most victims are 
unaware their computer equipment has been compromised. An underground 
market has developed for these botnets, as criminals are renting these 
compromised networks to carry out different types of attacks. Botnets 
have the ability to grow exponentially and the potential damage from 
these networks grows accordingly.
  Botnets pose a tremendous threat to our national infrastructure, 
economy, and security. Portions of the federal law relating to computer 
crime, written in a pre-Internet era, are inadequate and leave several 
unaddressed loopholes in our criminal code. For example, under current 
federal law a creator of a botnet can only be charged if the financial 
loss to one or more persons during one year passes a certain dollar 
threshold. It can be very difficult to put a price tag on the losses 
experienced by computer users, as it is not easy to calculate how much 
money an individual's time is worth in terms diverted from work or in 
trying to fix a malicious bot. In addition, it is possible for a 
criminal to create large botnets that can be utilized for future denial 
of service attacks and other violations, and still not violate this 
section of law.
  In order to address this, the legislation we offer today modifies the 
Federal criminal code by criminalizing willful damage to 10 or more 
computers

[[Page 27797]]

in any one year period. This change will allow the prosecution of 
criminals who covertly install malicious bots on protected computers 
with the purposes of making a botnet.
  Also, S. 2213, will make other necessary changes to the Federal code, 
including expanding the definition of cyber extortion, and permit law 
enforcement seizure of computer equipment and other property used to 
perpetrate computer crimes. As well, the bill includes a directive to 
the U.S. Sentencing Commission to consider many highly relevant factors 
in its review of appropriate sentences for cyber crime.
  All of the changes contemplated by this legislation, if aggressively 
enforced by law enforcement, will have a positive impact on our 
security. In this information age, it will not take long for potential 
criminals to hear about the new tools available to law enforcement 
personnel and many will be deterred from perpetrating illegal activity 
over the Internet.
  As criminals continue to adapt their tactics to exploit technological 
changes and loopholes in the law, it is imperative that Congress pass 
legislation that allows Federal law enforcement to maintain vigorous 
and tireless efforts in the investigation of cyber crime activity. I am 
confidant that this legislation, once enacted, will provide for the 
tools needed to pursue those who choose to inflict such harm to our 
society.
                                 ______
                                 
      By Mr. INHOFE:
  S. 2214. A bill to establish the Federal Emergency Management Agency 
as an independent agency, and for other purposes; to the Committee on 
Homeland Security and Governmental Affairs.
  Mr. INHOFE. Mr. President, I rise today to introduce the Federal 
Emergency Management Advancement Act of 2007, a bill to establish the 
Federal Emergency Management Agency, FEMA, as an independent agency. 
After a series of winter storms and summer flooding caused extensive 
damage in Oklahoma, the State encountered problems with FEMA as they 
sought disaster assistant due to the levels of bureaucracy and a lack 
of communication. When other natural disasters struck Oklahoma prior to 
the placement of FEMA under Homeland Security, the State did not 
encounter the same bureaucratic delays and other problems. Therefore, I 
support making FEMA an independent agency again in an effort to grant 
FEMA more autonomy by removing that added layer of bureaucracy. 
Additionally, after Oklahoma experienced troubles establishing an 
accurate incident period for the 2007 summer flooding, I have also 
included in my bill language stating that the administrator should give 
deference to State documentation when determining disaster incident 
periods.
  Oklahoma first encountered problems with FEMA and lack of 
communication and information when wildfires ravaged the state in 2005 
and 2006. These devastating wildfires swept through the entire state 
leading to declarations for Public Assistance, Individual Assistance 
and hazard mitigation funding. All 77 counties in the State of Oklahoma 
qualified for Public Assistance while all counties were also eligible 
to apply for the Hazard Mitigation Grant Program. These wildfires were 
wide spread and deadly to my State.
  More recently, Oklahoma encountered severe winter storms with 
devastating results in January 2007. These storms led to prolonged loss 
of power and extensive building damage for many of my constituents. In 
Muskogee County alone, an estimated 16,000 power company customers 
experienced loss of electricity for days at time with temperatures 
remaining below freezing.
  This summer, Oklahoma was hit by heavy rain, tornadoes, and flooding 
from May through September. The State made a number of disaster 
declarations during these periods. While I appreciate these 
declarations and aid, the process it took the state to get to this 
point was filled with unnecessary difficulty. Oklahoma particularly 
struggled with FEMA on the dates of the incident periods which is why I 
have included language in my bill to give deference to the State's 
documentation regarding the dates of such incidents. It makes sense 
that the State would be the one to have the most accurate information 
available regarding the disasters and the cause.
  I believe this is an extremely important bill that will free FEMA 
from additional levels of bureaucracy and allow it to work in a more 
effective manner.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2214

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Federal Emergency Management 
     Advancement Act of 2007''or the ``FEMA Act''.

              TITLE I--FEDERAL EMERGENCY MANAGEMENT AGENCY

     SEC. 101. DEFINITIONS.

       In this title--
       (1) the term ``catastrophic incident'' means any natural 
     disaster, act of terrorism, or other man-made disaster that 
     results in extraordinary levels of casualties or damage or 
     disruption severely affecting the population (including mass 
     evacuations), infrastructure, environment, economy, national 
     morale, or government functions in an area;
       (2) the term ``Director'' means the Director of the Federal 
     Emergency Management Agency;
       (3) the term ``Federal coordinating officer'' means a 
     Federal coordinating officer as described in section 302 of 
     the Robert T. Stafford Disaster Relief and Emergency 
     Assistance Act (42 U.S.C. 5143);
       (4) the term ``interoperable'' has the meaning given the 
     term ``interoperable communications'' under section 
     7303(g)(1) of the Intelligence Reform and Terrorism 
     Prevention Act of 2004 (6 U.S.C. 194(g)(1));
       (5) the term ``National Advisory Council'' means the 
     National Advisory Council established under section 508 of 
     the Homeland Security Act of 2002;
       (6) the term ``National Incident Management System'' means 
     a system to enable effective, efficient, and collaborative 
     incident management;
       (7) the term ``National Response Plan'' means the National 
     Response Plan or any successor plan prepared under section 
     104(b)(6);
       (8) the term ``Nuclear Incident Response Team'' means a 
     resource that includes--
       (A) those entities of the Department of Energy that perform 
     nuclear or radiological emergency support functions 
     (including accident response, search response, advisory, and 
     technical operations functions), radiation exposure functions 
     at the medical assistance facility known as the Radiation 
     Emergency Assistance Center/Training Site (REAC/TS), 
     radiological assistance functions, and related functions; and
       (B) those entities of the Environmental Protection Agency 
     that perform such support functions (including radiological 
     emergency response functions) and related functions; and
       (9) the term ``tribal government'' means the government of 
     any entity described under section 2(10)(B) of the Homeland 
     Security Act of 2002 (6 U.S.C. 101(10)(B)).

     SEC. 102. ESTABLISHMENT OF AGENCY AND DIRECTOR AND DEPUTY 
                   DIRECTOR.

       (a) Establishment.--The Federal Emergency Management Agency 
     is established as an independent establishment in the 
     executive branch as defined under section 104 of title 5, 
     United States Code.
       (b) Director.--
       (1) In general.--The Director shall be the head of the 
     Federal Emergency Management Agency. The Director shall be 
     appointed by the President, by and with the advice and 
     consent of the Senate. The Director shall report directly to 
     the President.
       (2) Qualifications.--The Director shall have significant 
     experience, knowledge, training, and expertise in the area of 
     emergency preparedness, response, recovery, and mitigation as 
     related to natural disasters and other national cataclysmic 
     events.
       (3) Executive schedule position.--Section 5312 of title 5, 
     United States Code, is amended by adding at the end the 
     following:
       ``Director of the Federal Emergency Management Agency.''.
       (4) Principal advisor on emergency management.--
       (A) In general.--The Director is the principal advisor to 
     the President, the Homeland Security Council, and the 
     Secretary of Homeland Security for all matters relating to 
     emergency management in the United States.
       (B) Advice and recommendations.--
       (i) In general.--In presenting advice with respect to any 
     matter to the President, the Homeland Security Council, or 
     the Secretary of Homeland Security, the Director shall, as 
     the Director considers appropriate, inform the President, the 
     Homeland Security Council, or the Secretary, as the case may 
     be, of

[[Page 27798]]

     the range of emergency preparedness, protection, response, 
     recovery, and mitigation options with respect to that matter.
       (ii) Advice on request.--The Director, as the principal 
     advisor on emergency management, shall provide advice to the 
     President, the Homeland Security Council, or the Secretary of 
     Homeland Security on a particular matter when the President, 
     the Homeland Security Council, or the Secretary requests such 
     advice.
       (iii) Recommendations to congress.--After informing the 
     President, the Director may make such recommendations to 
     Congress relating to emergency management as the Director 
     considers appropriate.
       (5) Cabinet status.--The President shall designate the 
     Administrator to serve as a member of the Cabinet in the 
     event of natural disasters, acts of terrorism, or other man-
     made disasters.
       (c) Deputy Director.--
       (1) In general.--The Deputy Director of the Federal 
     Emergency Management Agency shall assist the Director of the 
     Federal Emergency Management Agency. The Deputy Director 
     shall be appointed by the President, by and with the advice 
     and consent of the Senate.
       (2) Qualifications.--The Deputy Director of the Federal 
     Emergency Management Agency shall have significant 
     experience, knowledge, training, and expertise in the area of 
     emergency preparedness, response, recovery, and mitigation as 
     related to natural disasters and other national cataclysmic 
     events.
       (3) Executive schedule position.--Section 5313 of title 5, 
     United States Code, is amended--
       (A) by striking the following:
       ``Administrator of the Federal Emergency Management 
     Agency.'';
     and
       (B) by adding at the end the following:
       ``Deputy Director of the Federal Emergency Management 
     Agency.''.

     SEC. 103. MISSION.

       (a) Primary Mission.--The primary mission of the Federal 
     Emergency Management Agency is to reduce the loss of life and 
     property and protect the Nation from all hazards, including 
     natural disasters, acts of terrorism, and other man-made 
     disasters, by leading and supporting the Nation in a risk-
     based, comprehensive emergency management system of 
     preparedness, protection, response, recovery, and mitigation.
       (b) Specific Activities.--In support of the primary mission 
     of the Federal Emergency Management Agency, the Director 
     shall--
       (1) lead the Nation's efforts to prepare for, protect 
     against, respond to, recover from, and mitigate against the 
     risk of natural disasters, acts of terrorism, and other man-
     made disasters, including catastrophic incidents;
       (2) partner with State, local, and tribal governments and 
     emergency response providers, with other Federal agencies, 
     with the private sector, and with nongovernmental 
     organizations to build a national system of emergency 
     management that can effectively and efficiently utilize the 
     full measure of the Nation's resources to respond to natural 
     disasters, acts of terrorism, and other man-made disasters, 
     including catastrophic incidents;
       (3) develop a Federal response capability that, when 
     necessary and appropriate, can act effectively and rapidly to 
     deliver assistance essential to saving lives or protecting or 
     preserving property or public health and safety in a natural 
     disaster, act of terrorism, or other man-made disaster;
       (4) integrate the Federal Emergency Management Agency's 
     emergency preparedness, protection, response, recovery, and 
     mitigation responsibilities to confront effectively the 
     challenges of a natural disaster, act of terrorism, or other 
     man-made disaster;
       (5) develop and maintain robust Regional Offices that will 
     work with State, local, and tribal governments, emergency 
     response providers, and other appropriate entities to 
     identify and address regional priorities;
       (6) coordinate with the Secretary of Homeland Security, the 
     Commandant of the Coast Guard, the Director of Customs and 
     Border Protection, the Director of Immigration and Customs 
     Enforcement, the National Operations Center, and other 
     agencies and offices in the Department of Homeland Security 
     to take full advantage of the substantial range of resources 
     in that Department;
       (7) coordinate with the Administrator of the Small Business 
     Administration, the Chief of Engineers of the United States 
     Army Corps of Engineers, and the Secretary of Housing and 
     Urban Development to take full advantage of the resources of 
     those departments and agencies;
       (8) provide funding, training, exercises, technical 
     assistance, planning, and other assistance to build tribal, 
     local, State, regional, and national capabilities (including 
     communications capabilities), necessary to respond to a 
     natural disaster, act of terrorism, or other man-made 
     disaster; and
       (9) develop and coordinate the implementation of a risk-
     based, all-hazards strategy for preparedness that builds 
     those common capabilities necessary to respond to natural 
     disasters, acts of terrorism, and other man-made disasters 
     while also building the unique capabilities necessary to 
     respond to specific types of incidents that pose the greatest 
     risk to our Nation.

     SEC. 104. AUTHORITY AND RESPONSIBILITIES.

       (a) In General.--The Director shall provide Federal 
     leadership necessary to prepare for, protect against, respond 
     to, recover from, or mitigate against a natural disaster, act 
     of terrorism, or other man-made disaster, including--
       (1) helping to ensure the effectiveness of emergency 
     response providers to terrorist attacks, major disasters, and 
     other emergencies;
       (2) with respect to the Nuclear Incident Response Team, 
     regardless of whether it is operating as an organizational 
     unit of the Department of Homeland Security, and in 
     consultation with the Secretary of Homeland Security--
       (A) establishing standards and certifying when those 
     standards have been met;
       (B) conducting joint and other exercises and training and 
     evaluating performance; and
       (C) providing funds to the Department of Energy and the 
     Environmental Protection Agency, as appropriate, for homeland 
     security planning, exercises and training, and equipment;
       (3) providing the Federal Government's response to 
     terrorist attacks and major disasters, including--
       (A) managing such response;
       (B) directing the Domestic Emergency Support Team, the 
     National Disaster Medical System, and, in consultation with 
     the Secretary of Homeland Security, the Nuclear Incident 
     Response Team (when that team is operating as an 
     organizational unit of the Department of Homeland Security);
       (C) overseeing the Metropolitan Medical Response System; 
     and
       (D) coordinating other Federal response resources, 
     including requiring deployment of the Strategic National 
     Stockpile, in the event of a terrorist attack or major 
     disaster;
       (4) aiding the recovery from terrorist attacks and major 
     disasters;
       (5) building a comprehensive national incident management 
     system with Federal, State, and local government personnel, 
     agencies, and authorities, to respond to such attacks and 
     disasters;
       (6) consolidating existing Federal Government emergency 
     response plans into a single, coordinated national response 
     plan;
       (7) helping ensure the acquisition of operable and 
     interoperable communications capabilities by Federal, State, 
     local, and tribal governments and emergency response 
     providers;
       (8) assisting the President in carrying out the functions 
     under the Robert T. Stafford Disaster Relief and Emergency 
     Assistance Act (42 U.S.C. 5121 et seq.) and carrying out all 
     functions and authorities given to the Director under that 
     Act;
       (9) carrying out the mission of the Federal Emergency 
     Management Agency to reduce the loss of life and property and 
     protect the Nation from all hazards by leading and supporting 
     the Nation in a risk-based, comprehensive emergency 
     management system of--
       (A) mitigation, by taking sustained actions to reduce or 
     eliminate long-term risks to people and property from hazards 
     and their effects;
       (B) preparedness, by planning, training, and building the 
     emergency management profession to prepare effectively for, 
     mitigate against, respond to, and recover from any hazard;
       (C) response, by conducting emergency operations to save 
     lives and property through positioning emergency equipment, 
     personnel, and supplies, through evacuating potential 
     victims, through providing food, water, shelter, and medical 
     care to those in need, and through restoring critical public 
     services; and
       (D) recovery, by rebuilding communities so individuals, 
     businesses, and governments can function on their own, return 
     to normal life, and protect against future hazards;
       (10) increasing efficiencies, by coordinating efforts 
     relating to preparedness, protection, response, recovery, and 
     mitigation;
       (11) helping to ensure the effectiveness of emergency 
     response providers in responding to a natural disaster, act 
     of terrorism, or other man-made disaster;
       (12) supervising grant programs administered by the Federal 
     Emergency Management Agency;
       (13) administering and ensuring the implementation of the 
     National Response Plan, including coordinating and ensuring 
     the readiness of each emergency support function under the 
     National Response Plan;
       (14) coordinating with the National Advisory Council;
       (15) preparing and implementing the plans and programs of 
     the Federal Government for--
       (A) continuity of operations;
       (B) continuity of government; and
       (C) continuity of plans;
       (16) minimizing, to the extent practicable, overlapping 
     planning and reporting requirements applicable to State, 
     local, and tribal governments and the private sector;
       (17) maintaining and operating within the Federal Emergency 
     Management Agency the National Response Coordination Center 
     or its successor;
       (18) developing a national emergency management system that 
     is capable of preparing

[[Page 27799]]

     for, protecting against, responding to, recovering from, and 
     mitigating against catastrophic incidents;
       (19) assisting the President in carrying out the functions 
     under the national preparedness goal and the national 
     preparedness system and carrying out all functions and 
     authorities of the Director under the national preparedness 
     System;
       (20) carrying out all authorities of the Federal Emergency 
     Management Agency; and
       (21) otherwise carrying out the mission of the Federal 
     Emergency Management Agency as described in section 103.
       (b) All-Hazards Approach.--In carrying out the 
     responsibilities under this section, the Director shall 
     coordinate the implementation of a risk-based, all-hazards 
     strategy that builds those common capabilities necessary to 
     prepare for, protect against, respond to, recover from, or 
     mitigate against natural disasters, acts of terrorism, and 
     other man-made disasters, while also building the unique 
     capabilities necessary to prepare for, protect against, 
     respond to, recover from, or mitigate against the risks of 
     specific types of incidents that pose the greatest risk to 
     the Nation.
       (c) Conflict of Authorities.--If the Director determines 
     that there is a conflict between any authority of the 
     Director under this Act, the amendments made by this Act, or 
     the Robert T. Stafford Disaster Relief and Emergency 
     Assistance Act (42 U.S.C. 5121 et seq.) and any authority of 
     another Federal officer, the Director shall request that the 
     President make such determinations as may be necessary 
     regarding such authorities.

     SEC. 105. REGIONAL OFFICES.

       (a) In General.--There are in the Federal Emergency 
     Management Agency 10 regional offices, as identified by the 
     Director.
       (b) Management of Regional Offices.--
       (1) Regional administrator.--Each Regional Office shall be 
     headed by a Regional Administrator who shall be appointed by 
     the Director, after consulting with State, local, and tribal 
     government officials in the region. Each Regional 
     Administrator shall report directly to the Director and be in 
     the Senior Executive Service.
       (2) Qualifications.--
       (A) In general.--Each Regional Administrator shall be 
     appointed from among individuals who have a demonstrated 
     ability in and knowledge of emergency management and homeland 
     security.
       (B) Considerations.--In selecting a Regional Administrator 
     for a Regional Office, the Director shall consider the 
     familiarity of an individual with the geographical area and 
     demographic characteristics of the population served by such 
     Regional Office.
       (c) Responsibilities.--
       (1) In general.--The Regional Administrator shall work in 
     partnership with State, local, and tribal governments, 
     emergency managers, emergency response providers, medical 
     providers, the private sector, nongovernmental organizations, 
     multijurisdictional councils of governments, and regional 
     planning commissions and organizations in the geographical 
     area served by the Regional Office to carry out the 
     responsibilities of a Regional Administrator under this 
     section.
       (2) Responsibilities.--The responsibilities of a Regional 
     Administrator include--
       (A) ensuring effective, coordinated, and integrated 
     regional preparedness, protection, response, recovery, and 
     mitigation activities and programs for natural disasters, 
     acts of terrorism, and other man-made disasters (including 
     planning, training, exercises, and professional development);
       (B) assisting in the development of regional capabilities 
     needed for a national catastrophic response system;
       (C) coordinating the establishment of effective regional 
     operable and interoperable emergency communications 
     capabilities;
       (D) staffing and overseeing 1 or more strike teams within 
     the region under subsection (f), to serve as the focal point 
     of the Federal Government's initial response efforts for 
     natural disasters, acts of terrorism, and other man-made 
     disasters within that region, and otherwise building Federal 
     response capabilities to respond to natural disasters, acts 
     of terrorism, and other man-made disasters within that 
     region;
       (E) designating an individual responsible for the 
     development of strategic and operational regional plans in 
     support of the National Response Plan;
       (F) fostering the development of mutual aid and other 
     cooperative agreements;
       (G) identifying critical gaps in regional capabilities to 
     respond to populations with special needs;
       (H) maintaining and operating a Regional Response 
     Coordination Center or its successor; and
       (I) performing such other duties relating to such 
     responsibilities as the Director may require.
       (3) Training and exercise requirements.--
       (A) Training.--The Director shall require each Regional 
     Administrator to undergo specific training periodically to 
     complement the qualifications of the Regional Administrator. 
     Such training, as appropriate, shall include training with 
     respect to the National Incident Management System, the 
     National Response Plan, and such other subjects as determined 
     by the Director.
       (B) Exercises.--The Director shall require each Regional 
     Administrator to participate as appropriate in regional and 
     national exercises.
       (d) Area Offices.--The Director shall establish Area 
     Offices as components in the appropriate Regional Office, as 
     determined appropriate by the Director.
       (e) Regional Advisory Council.--
       (1) Establishment.--Each Regional Administrator shall 
     establish a Regional Advisory Council.
       (2) Nominations.--A State, local, or tribal government 
     located within the geographic area served by the Regional 
     Office may nominate officials, including Adjutants General 
     and emergency managers, to serve as members of the Regional 
     Advisory Council for that region.
       (3) Responsibilities.--Each Regional Advisory Council 
     shall--
       (A) advise the Regional Administrator on emergency 
     management issues specific to that region;
       (B) identify any geographic, demographic, or other 
     characteristics peculiar to any State, local, or tribal 
     government within the region that might make preparedness, 
     protection, response, recovery, or mitigation more 
     complicated or difficult; and
       (C) advise the Regional Administrator of any weaknesses or 
     deficiencies in preparedness, protection, response, recovery, 
     and mitigation for any State, local, and tribal government 
     within the region of which the Regional Advisory Council is 
     aware.
       (f) Regional Office Strike Teams.--
       (1) In general.--In coordination with other relevant 
     Federal agencies, each Regional Administrator shall oversee 
     multi-agency strike teams authorized under section 303 of the 
     Robert T. Stafford Disaster Relief and Emergency Assistance 
     Act (42 U.S.C. 5144) that shall consist of--
       (A) a designated Federal coordinating officer;
       (B) personnel trained in incident management;
       (C) public affairs, response and recovery, and 
     communications support personnel;
       (D) a defense coordinating officer;
       (E) liaisons to other Federal agencies;
       (F) such other personnel as the Director or Regional 
     Administrator determines appropriate; and
       (G) individuals from the agencies with primary 
     responsibility for each of the emergency support functions in 
     the National Response Plan.
       (2) Other duties.--The duties of an individual assigned to 
     a Regional Office strike team from another relevant agency 
     when such individual is not functioning as a member of the 
     strike team shall be consistent with the emergency 
     preparedness activities of the agency that employs such 
     individual.
       (3) Location of members.--The members of each Regional 
     Office strike team, including representatives from agencies 
     other than the Department, shall be based primarily within 
     the region that corresponds to that strike team.
       (4) Coordination.--Each Regional Office strike team shall 
     coordinate the training and exercises of that strike team 
     with the State, local, and tribal governments and private 
     sector and nongovernmental entities which the strike team 
     shall support when a natural disaster, act of terrorism, or 
     other man-made disaster occurs.
       (5) Preparedness.--Each Regional Office strike team shall 
     be trained as a unit on a regular basis and equipped and 
     staffed to be well prepared to respond to natural disasters, 
     acts of terrorism, and other man-made disasters, including 
     catastrophic incidents.
       (6) Authorities.--If the Director determines that statutory 
     authority is inadequate for the preparedness and deployment 
     of individuals in strike teams under this subsection, the 
     Director shall report to Congress regarding the additional 
     statutory authorities that the Director determines are 
     necessary.

     SEC. 106. NATIONAL RESPONSE PLAN.

       (a) In General.--The Director shall--
       (1) in consultation with other Federal departments and 
     agencies and the National Advisory Council, ensure ongoing 
     management and maintenance of the National Incident 
     Management System, the National Response Plan, and any 
     successor to such system or plan; and
       (2) periodically review and report to Congress on the 
     integration of Federal authorities to ensure effective 
     response to address response responsibilities and 
     capabilities in the event of a catastrophic incident.
       (b) Chain of Command.--
       (1) In general.--The Director, in consultation with the 
     Secretary of Homeland Security, shall ensure that the 
     National Response Plan provides for a clear chain of command 
     to lead and coordinate the Federal response to any natural 
     disaster, act of terrorism, or other man-made disaster.
       (2) Director of the federal emergency management agency.--
     The chain of the command specified in the National Response 
     Plan shall--
       (A) provide for a role for the Director consistent with the 
     role of the Director under this Act and the amendments made 
     by this Act; and

[[Page 27800]]

       (B) provide for a role for the Federal Coordinating Officer 
     consistent with the responsibilities under section 302(b) of 
     the Robert T. Stafford Disaster Relief and Emergency 
     Assistance Act (42 U.S.C. 5143(b)).
       (3) Principal federal official.--The Principal Federal 
     Official (or the successor thereto) shall not--
       (A) direct or replace the incident command structure 
     established at the incident; or
       (B) have directive authority over the Senior Federal Law 
     Enforcement Official, Federal Coordinating Officer, or other 
     Federal and State officials.

     SEC. 107. CREDENTIALING AND TYPING.

       The Director shall enter into a memorandum of understanding 
     with the administrators of the Emergency Management 
     Assistance Compact, State, local, and tribal governments, and 
     organizations that represent emergency response providers, to 
     collaborate on developing standards for deployment 
     capabilities, including credentialing of personnel and typing 
     of resources likely needed to respond to natural disasters, 
     acts of terrorism, and other man-made disasters.

     SEC. 108. FEDERAL AND STATE COOPERATION FOR DISASTER INCIDENT 
                   PERIODS.

       In determining the duration of a major disaster or 
     emergency (as those terms are defined in section 102 of the 
     Robert T. Stafford Disaster Relief and Emergency Assistance 
     Act (42 U.S.C. 5122)) or other incident, and in establishing 
     the period for public or individual assistance or other 
     disaster relief assistance for which a State or local 
     government or individual may be eligible, the Director shall 
     defer to weather reports and other substantiating 
     documentation submitted by a State.

     SEC. 109. NATIONAL OPERATIONS CENTER.

       (a) Definition.--In this section, the term ``situational 
     awareness'' means information gathered from a variety of 
     sources that, when communicated to emergency managers and 
     decision makers, can form the basis for incident management 
     decisionmaking.
       (b) Establishment.--The National Operations Center is the 
     principal operations center for the Federal Emergency 
     Management Agency and shall--
       (1) provide situational awareness and a common operating 
     picture for the entire Federal Government, and for State, 
     local, and tribal governments as appropriate, in the event of 
     a natural disaster, act of terrorism, or other man-made 
     disaster; and
       (2) ensure that critical terrorism and disaster-related 
     information reaches government decision-makers.

     SEC. 110. GRANT PROGRAMS.

       (a) In General.--Title XX of the Homeland Security Act of 
     2002 (6 U.S.C. 601 et seq.) is amended--
       (1) in section 2001--
       (A) in paragraph (1)--
       (i) in the paragraph heading, by striking ``Administrator'' 
     and inserting ``Director''; and
       (ii) by striking ``Administrator'' each place that term 
     appears and inserting ``Director'';
       (B) in paragraph (4)(A)(iv), by striking ``Secretary'' and 
     inserting ``Director''; and
       (C) in paragraph (12), by striking ``Secretary'' each place 
     that term appears and inserting ``Director'';
       (2) in section 2002(a), by striking ``The Secretary, 
     through the Administrator,'' and inserting ``The Director'';
       (3) in section 2003--
       (A) by striking ``Administrator'' each place that term 
     appears and inserting ``Director''; and
       (B) by striking ``Department'' each place that term appears 
     and inserting ``Federal Emergency Management Agency'';
       (4) in section 2004, by striking ``Administrator'' each 
     place that term appears and inserting ``Director'';
       (5) in section 2005--
       (A) by striking ``Administrator'' each place that term 
     appears and inserting ``Director''; and
       (B) by striking ``Department'' each place that term appears 
     and inserting ``Federal Emergency Management Agency'';
       (6) in section 2006, by striking ``Administrator'' each 
     place that term appears and inserting ``Director'';
       (7) in section 2007--
       (A) by striking ``Administrator'' each place that term 
     appears and inserting ``Director''; and
       (B) in subsection (a)(1)(E), by striking ``Department'' and 
     inserting ``Federal Emergency Management Agency'';
       (8) in 2008, by striking ``Administrator'' each place that 
     term appears and inserting ``Director'';
       (9) in section 2021--
       (A) in subsection (a), by striking ``Administrator'' and 
     inserting ``Director'';
       (B) in subsection (c)(1), by striking ``(acting through the 
     Administrator)'' and inserting ``, the Director''; and
       (C) by striking ``Department'' each place that term appears 
     and inserting ``Federal Emergency Management Agency''; and
       (10) in section 2022--
       (A) by striking ``Administrator'' each place that term 
     appears and inserting ``Director'';
       (B) by striking ``Department'' each place that term appears 
     and inserting ``Federal Emergency Management Agency'';
       (C) in subsection (a)(3)(F), in the subparagraph heading, 
     by striking ``Administrator'' and inserting ``Director''; and
       (D) in subsection (c), in the subsection heading, by 
     striking ``Administrator'' and inserting ``Director''.
       (b) Other Grant Programs.--
       (1) Emergency management performance grant program.--
     Section 662 of the Post-Katrina Emergency Management Reform 
     Act of 2006 (6 U.S.C. 762) is amended by striking 
     ``Administrator'' each place that term appears and inserting 
     ``Director''.
       (2) Interoperable emergency communications grant program.--
     Section 1809 of the Homeland Security Act of 2002 (6 U.S.C. 
     579) is amended--
       (A) in subsection (a), by striking ``Secretary'' and 
     inserting ``Director of the Federal Emergency Management 
     Agency'';
       (B) in subsection (b), by striking ``Director for Emergency 
     Communications'' and inserting ``Director of the Federal 
     Emergency Management Agency'';
       (C) by amending paragraph (1) of subsection (c) to read as 
     follows:
       ``(1) In general.--The Director of the Federal Emergency 
     Management Agency shall administer the Interoperable 
     Emergency Communications Grant Program.''; and
       (D) by striking ``Administrator'' each place that term 
     appears and inserting ``Director of the Federal Emergency 
     Management Agency''.

     SEC. 111. MODEL STANDARDS AND GUIDELINES; GUIDANCE AND 
                   RECOMMENDATIONS; VOLUNTARY PRIVATE SECTOR 
                   PREPAREDNESS.

       Title V of the Homeland Security Act of 2002 (6 U.S.C. 311 
     et seq.) is amended--
       (1) in section 522, by striking ``Administrator'' each 
     place that term appears and inserting ``Director of the 
     Federal Emergency Management Agency'';
       (2) in section 523--
       (A) by striking ``Administrator'' each place that term 
     appears and inserting ``Director of the Federal Emergency 
     Management Agency''; and
       (B) in subsection (b)(2), by striking ``Secretary'' and 
     inserting ``Director of the Federal Emergency Management 
     Agency''; and
       (3) in section 524--
       (A) by amending subsection (a) to read as follows:
       ``(a) Establishment.--The Administrator (hereinafter 
     referred to in this section as the `designated officer') 
     shall establish and implement the voluntary private sector 
     preparedness accreditation and certification program in 
     accordance with this section.''; and
       (B) by amending subsection (b)(2)(E)(ii)(I) to read as 
     follows:

       ``(I) private sector related programs of the Department; 
     and''.

     SEC. 112. TECHNICAL AND CONFORMING AMENDMENTS.

       (a) In General.--Title V of the Homeland Security Act of 
     2002 (6 U.S.C. 311 et seq.) is amended--
       (1) in section 501, by striking all after ``In this title'' 
     and inserting ``the term `tribal government' means the 
     government of any entity described under section 2(10)(B).'';
       (2) by striking sections 503 through 507, 510, and 515;
       (3) in section 508--
       (A) by striking ``Administrator'' each place that term 
     appears and inserting ``Director of Federal Emergency 
     Management Agency'';
       (B) in subsection (b)(2), by striking ``Department'' and 
     inserting ``Federal Emergency Management Agency''; and
       (C) in subsection (c)--
       (i) in paragraph (1), by inserting ``in consultation with 
     the Secretary,'' before ``and shall, to the extent 
     practicable''; and
       (ii) in paragraph (3), by inserting ``, in consultation 
     with the Secretary,'' before ``shall designate'';
       (4) in section 509--
       (A) in subsection (a), by striking ``Agency'' and inserting 
     ``Department''; and
       (B) by striking subsection (c);
       (5) in section 512(c), by striking ``Administrator'' each 
     place that term appears and inserting ``Secretary'';
       (6) in section 513--
       (A) by striking ``Administrator'' each place that term 
     appears and inserting ``Secretary''; and
       (B) in subsection (b)(2), by striking ``Agency'' and 
     inserting ``Department''; and
       (7) in section 514--
       (A) by striking subsection (a); and
       (B) redesignating subsections (b) and (c) as subsections 
     (a) and (b), respectively.
       (b) Table of Contents.--The table of contents for the 
     Homeland Security Act of 2002 (6 U.S.C. 101) is amended by 
     striking the items relating to sections 503 through 507, 510, 
     and 515.

     SEC. 113. RULE OF CONSTRUCTION.

       Nothing in this Act shall be construed to detract from the 
     Department of Homeland Security's primary mission to secure 
     the homeland from terrorist attacks.

               TITLE II--TRANSFER AND SAVINGS PROVISIONS

     SEC. 201. DEFINITIONS.

       In this title, unless otherwise provided or indicated by 
     the context--
       (1) the term ``Federal agency'' has the meaning given to 
     the term ``agency'' by section 551(1) of title 5, United 
     States Code;
       (2) the term ``function'' means any duty, obligation, 
     power, authority, responsibility, right, privilege, activity, 
     or program; and

[[Page 27801]]

       (3) the term ``office'' includes any office, 
     administration, agency, institute, unit, organizational 
     entity, or component thereof.

     SEC. 202. TRANSFER OF FUNCTIONS.

       There are transferred to the Federal Emergency Management 
     Agency established under section 101 of this Act all 
     functions which the Director of the Federal Emergency 
     Management Agency of the Department of Homeland Security 
     exercised before the date of the enactment of this title, 
     including all the functions described under section 505 of 
     the Homeland Security Act of 2002 (before the repeal of that 
     section under section 104 of this Act).

     SEC. 203. PERSONNEL PROVISIONS.

       (a) Appointments.--The Director of the Federal Emergency 
     Management Agency may appoint and fix the compensation of 
     such officers and employees, including investigators, 
     attorneys, and administrative law judges, as may be necessary 
     to carry out the respective functions transferred under this 
     title. Except as otherwise provided by law, such officers and 
     employees shall be appointed in accordance with the civil 
     service laws and their compensation fixed in accordance with 
     title 5, United States Code.
       (b) Experts and Consultants.--The Director of the Federal 
     Emergency Management Agency may obtain the services of 
     experts and consultants in accordance with section 3109 of 
     title 5, United States Code, and compensate such experts and 
     consultants for each day (including traveltime) at rates not 
     in excess of the rate of pay for level IV of the Executive 
     Schedule under section 5315 of such title. The Director of 
     the Federal Emergency Management Agency may pay experts and 
     consultants who are serving away from their homes or regular 
     place of business, travel expenses and per diem in lieu of 
     subsistence at rates authorized by sections 5702 and 5703 of 
     such title for persons in Government service employed 
     intermittently.

     SEC. 204. DELEGATION AND ASSIGNMENT.

       Except where otherwise expressly prohibited by law or 
     otherwise provided by this title, the Director of the Federal 
     Emergency Management Agency may delegate any of the functions 
     transferred to the Director of the Federal Emergency 
     Management Agency by this title and any function transferred 
     or granted to such Director after the effective date of this 
     title to such officers and employees of the Federal Emergency 
     Management Agency as the Director may designate, and may 
     authorize successive redelegations of such functions as may 
     be necessary or appropriate. No delegation of functions by 
     the Director of the Federal Emergency Management Agency under 
     this section or under any other provision of this title shall 
     relieve such Director of responsibility for the 
     administration of such functions.

     SEC. 205. REORGANIZATION.

       The Director of the Federal Emergency Management Agency is 
     authorized to allocate or reallocate any function transferred 
     under section 202 among the officers of the Federal Emergency 
     Management Agency, and to establish, consolidate, alter, or 
     discontinue such organizational entities in the Federal 
     Emergency Management Agency as may be necessary or 
     appropriate.

     SEC. 206. RULES.

       The Director of the Federal Emergency Management Agency is 
     authorized to prescribe, in accordance with the provisions of 
     chapters 5 and 6 of title 5, United States Code, such rules 
     and regulations as the Director determines necessary or 
     appropriate to administer and manage the functions of the 
     Federal Emergency Management Agency.

     SEC. 207. TRANSFER AND ALLOCATIONS OF APPROPRIATIONS AND 
                   PERSONNEL.

       Except as otherwise provided in this title, the personnel 
     employed in connection with, and the assets, liabilities, 
     contracts, property, records, and unexpended balances of 
     appropriations, authorizations, allocations, and other funds 
     employed, used, held, arising from, available to, or to be 
     made available in connection with the functions transferred 
     by this title, subject to section 1531 of title 31, United 
     States Code, shall be transferred to the Federal Emergency 
     Management Agency. Unexpended funds transferred pursuant to 
     this section shall be used only for the purposes for which 
     the funds were originally authorized and appropriated.

     SEC. 208. INCIDENTAL TRANSFERS.

       The Director of the Office of Management and Budget, at 
     such time or times as the Director shall provide, is 
     authorized to make such determinations as may be necessary 
     with regard to the functions transferred by this title, and 
     to make such additional incidental dispositions of personnel, 
     assets, liabilities, grants, contracts, property, records, 
     and unexpended balances of appropriations, authorizations, 
     allocations, and other funds held, used, arising from, 
     available to, or to be made available in connection with such 
     functions, as may be necessary to carry out the provisions of 
     this title. The Director of the Office of Management and 
     Budget shall provide for the termination of the affairs of 
     all entities terminated by this title and for such further 
     measures and dispositions as may be necessary to effectuate 
     the purposes of this title.

     SEC. 209. EFFECT ON PERSONNEL.

       (a) In General.--Except as otherwise provided by this 
     title, the transfer pursuant to this title of full-time 
     personnel (except special Government employees) and part-time 
     personnel holding permanent positions shall not cause any 
     such employee to be separated or reduced in grade or 
     compensation for one year after the date of transfer of such 
     employee under this title.
       (b) Executive Schedule Positions.--Except as otherwise 
     provided in this title, any person who, on the day preceding 
     the effective date of this title, held a position compensated 
     in accordance with the Executive Schedule prescribed in 
     chapter 53 of title 5, United States Code, and who, without a 
     break in service, is appointed in the Federal Emergency 
     Management Agency to a position having duties comparable to 
     the duties performed immediately preceding such appointment 
     shall continue to be compensated in such new position at not 
     less than the rate provided for such previous position, for 
     the duration of the service of such person in such new 
     position.

     SEC. 210. SAVINGS PROVISIONS.

       (a) Continuing Effect of Legal Documents.--All orders, 
     determinations, rules, regulations, permits, agreements, 
     grants, contracts, certificates, licenses, registrations, 
     privileges, and other administrative actions--
       (1) which have been issued, made, granted, or allowed to 
     become effective by the President, any Federal agency or 
     official thereof, or by a court of competent jurisdiction, in 
     the performance of functions which are transferred under this 
     title, and
       (2) which are in effect at the time this title takes 
     effect, or were final before the effective date of this title 
     and are to become effective on or after the effective date of 
     this title,

     shall continue in effect according to their terms until 
     modified, terminated, superseded, set aside, or revoked in 
     accordance with law by the President, the Director of the 
     Federal Emergency Management Agency or other authorized 
     official, a court of competent jurisdiction, or by operation 
     of law.
       (b) Proceedings Not Affected.--The provisions of this title 
     shall not affect any proceedings, including notices of 
     proposed rulemaking, or any application for any license, 
     permit, certificate, or financial assistance pending before 
     the Federal Emergency Management Agency at the time this 
     title takes effect, with respect to functions transferred by 
     this title but such proceedings and applications shall 
     continue. Orders shall be issued in such proceedings, appeals 
     shall be taken therefrom, and payments shall be made pursuant 
     to such orders, as if this title had not been enacted, and 
     orders issued in any such proceedings shall continue in 
     effect until modified, terminated, superseded, or revoked by 
     a duly authorized official, by a court of competent 
     jurisdiction, or by operation of law. Nothing in this 
     subsection shall be deemed to prohibit the discontinuance or 
     modification of any such proceeding under the same terms and 
     conditions and to the same extent that such proceeding could 
     have been discontinued or modified if this title had not been 
     enacted.
       (c) Suits Not Affected.--The provisions of this title shall 
     not affect suits commenced before the effective date of this 
     title, and in all such suits, proceedings shall be had, 
     appeals taken, and judgments rendered in the same manner and 
     with the same effect as if this title had not been enacted.
       (d) Nonabatement of Actions.--No suit, action, or other 
     proceeding commenced by or against the Federal Emergency 
     Management Agency, or by or against any individual in the 
     official capacity of such individual as an officer of the 
     Federal Emergency Management Agency, shall abate by reason of 
     the enactment of this title.
       (e) Administrative Actions Relating to Promulgation of 
     Regulations.--Any administrative action relating to the 
     preparation or promulgation of a regulation by the Federal 
     Emergency Management Agency relating to a function 
     transferred under this title may be continued by the Federal 
     Emergency Management Agency with the same effect as if this 
     title had not been enacted.

     SEC. 211. SEPARABILITY.

       If a provision of this title or its application to any 
     person or circumstance is held invalid, neither the remainder 
     of this title nor the application of the provision to other 
     persons or circumstances shall be affected.

     SEC. 212. TRANSITION.

       The Director of the Federal Emergency Management Agency is 
     authorized to utilize--
       (1) the services of such officers, employees, and other 
     personnel of the Federal Emergency Management Agency with 
     respect to functions transferred by this title; and
       (2) funds appropriated to such functions for such period of 
     time as may reasonably be needed to facilitate the orderly 
     implementation of this title.

     SEC. 213. REFERENCES.

       Any reference in any other Federal law, Executive order, 
     rule, regulation, or delegation of authority, or any document 
     of or pertaining to a department, agency, or office from 
     which a function is transferred by this title--
       (1) to the head of such department, agency, or office is 
     deemed to refer to the head of the department, agency, or 
     office to which such function is transferred; or

[[Page 27802]]

       (2) to such department, agency, or office is deemed to 
     refer to the department, agency, or office to which such 
     function is transferred.

     SEC. 214. ADDITIONAL CONFORMING AMENDMENTS.

       (a) Recommended Legislation.--After consultation with the 
     appropriate committees of the Congress and the Director of 
     the Office of Management and Budget, the Director of the 
     Federal Emergency Management Agency shall prepare and submit 
     to Congress recommended legislation containing technical and 
     conforming amendments to reflect the changes made by this 
     Act.
       (b) Submission to Congress.--Not later than 6 months after 
     the effective date of this title, the Director of the Federal 
     Emergency Management Agency shall submit the recommended 
     legislation referred to under subsection (a).
                                 ______
                                 
      By Ms. COLLINS (for herself, Mr. Pryor, Mr. Sununu, Mr. Johnson, 
        Mr. Coleman, Mr. Biden, Mr. Thune, Mr. Enzi, and Mr. Carper):
  S. 2215. A bill to amend the Homeland Security Act of 2002 to 
establish the Protective Security Advisor Program Office; to the 
Committee on Homeland Security and Governmental Affairs.
  Ms. COLLINS. Mr. President. I rise to introduce a bill that would 
formally establish and enhance the Protective Security Advisor Program 
Office within the Department of Homeland Security.
  The PSA program, which operates under the DHS Office of 
Infrastructure Protection, has proven its worth on many occasions. For 
example, when the Interstate 35-W bridge in Minneapolis collapsed in 
August of this year, PSAs provided valuable support to the Minnesota 
Department of Public Safety, providing assessments of infrastructure 
impacts relating to emergency services, postal and shipping operations, 
public transit, fuel deliveries, public utilities, and rail operations.
  DHS has deployed more than 70 PSAs in major metropolitan areas around 
the country. These are skilled and savvy people, averaging more than 20 
years of law-enforcement, military, or counter-terror experience. They 
regularly interact and develop working relationships with Government 
agencies at all levels and with private-sector entities, and they can 
be among the first on the scene when disaster strikes.
  Critical infrastructure is not, however, confined to large urban 
areas. Yet, 10 States--Delaware, Idaho, Maine, Montana, New Hampshire, 
North Dakota, Rhode Island, South Dakota, Vermont, and Wyoming--do not 
have a resident PSA dedicated to serving the interests and protecting 
the citizens of those States.
  The bill I introduce today will enhance our national preparedness, 
response capability, and security by providing a minimum Protective 
Security Advisor presence in every State, while preserving the risk-
based principle that provides extra coverage in areas of dense 
population or concentrated critical infrastructure.
  The bill will also enhance the PSA program by providing for 10 
supervisory PSAs for regional coordination and management, and by 
authorizing additional PSAs at DHS headquarters. These headquarters 
PSAs will help manage participation in training and exercises, PSA 
training and certification programs, and day-to-day operations that 
help our Nation prevent, respond to, and limit the consequences of 
terrorist attacks and natural disasters.
  This bill also will advance the goals of the National Infrastructure 
Protection Plan. It will promote governmental and private-sector 
efforts to assess risks to and vulnerabilities of critical 
infrastructure, help stakeholders share information and coordinate 
activities, assist with multi-jurisdictional planning, and provide 
counsel to any designated Principal Federal Official when a joint field 
office must be established.
  State emergency managers recognize the importance of this 
legislation. The Maine Emergency Management Agency has already provided 
a letter of support. Its bipartisan list of cosponsors--Senators Pryor, 
Sununu, Johnson, Coleman, Biden, Thune, Enzi, and Carper--includes 
three other members of the Senate Homeland Security Committee. These 
facts attest to the bill's merit.
  Mr. President, 300 million Americans live in a society that depends 
on a complex and tightly interrelated network of critical 
infrastructure and services including food supply, finance, energy, 
sanitation, transport, and communications.
  The DHS Protective Security Advisors have demonstrated that they are 
a critical element of our homeland-security defenses. This bill will 
expand their numbers, extend their coverage, strengthen their 
organization, and make all of us safer.
  I urge my colleagues to support this measure.
                                 ______
                                 
      By Mr. BAUCUS (for himself, Mr. Crapo, Mr. Wyden, Mr. Salazar, 
        Ms. Cantwell, Mr. Inhofe, Mrs. Dole, Mr. Burr, Mr. Coburn, and 
        Mrs. Hutchison):
  S.J. Res. 22. A joint resolution providing for congressional 
disapproval under chapter 8 of title 5, United States Code, of the rule 
submitted by the Centers for Medicare & Medicaid Services within the 
Department of Health and Human Services relating to Medicare coverage 
for the use of erythropoiesis stimulating agents in cancer and related 
neoplastic conditions; to the Committee on Finance.
  Mr. BAUCUS. Mr. President, today I am introducing a joint resolution 
to disapprove of the Medicare National Coverage Decision on cancer care 
announced by the Centers for Medicare & Medicaid Services on July 30, 
2007. I am taking this action out of concern for America's seniors who 
are afflicted with cancer, a terrible disease that affects thousands of 
Medicare beneficiaries each year.
  At the outset, I want to make very clear that Congress should not 
wantonly second-guess the scientific processes at CMS. The National 
Coverage Decision process is a very important component of the agency's 
governance of the Medicare program and its mission to protect the 
safety of beneficiaries. The agency makes several National Coverage 
Decisions each year that are implemented without any congressional 
involvement. Several more coverage determinations are made by regional 
Medicare carriers at the local level. When scientific evidence supports 
doing so, CMS clearly has authority to limit Medicare coverage for 
drugs and other medical products and services to an extent less than 
the Food and Drug Administration label would otherwise allow. In fact, 
I am working on a proposal that may provide more clinical evidence to 
guide CMS in making these decisions.
  There are some rare occasions, however, when CMS makes a decision 
that intrudes on the clinical judgment of doctors without the support 
of scientific evidence, prompting virtually unanimous opposition from 
the clinicians who treat the patients whose care is at stake. In these 
cases, I believe that Congress not only may but must intervene. This 
National Coverage Decision regarding the use of erythropoiesis-
stimulating agents, or ESAs, for Medicare beneficiaries with cancer and 
cancer-related conditions is precisely such an instance.
  Mr. President, when a cancer patient receives an ESA, the goal is not 
to manage a person's hemoglobin back to the level of a healthy, non-
anemic person. That is because there can be health risks associated 
with raising the hemoglobin to such a level through ESA use. The FDA 
label makes it clear that patients may only be administered enough of 
an ESA to avoid a transfusion, and that ESAs should never be used to 
bring a patient's hemoglobin level above 12 grams per deciliter. So 
there can be risks when a patient does not get enough of an ESA, 
including severe anemia and the need for blood transfusions. And there 
are risks when a patient gets too much of an ESA. The FDA label 
establishes parameters to guard against under-utilization and over-
utilization of these products.
  Now let us compare the FDA label with the National Coverage Decision 
announced by CMS. The National Coverage Decision limits ESA treatment 
to hemoglobin levels less than 10 grams

[[Page 27803]]

per deciliter. This cap fails to recognize the natural fluctuations in 
a patient's hemoglobin. This cap is simply incongruous with the FDA 
label, which recommends that patients should not be treated over 12. I 
should note that the FDA label was recently changed, with the addition 
of new ``black box'' warnings and recent safety information. If the FDA 
believes that scientific evidence warrants changing the label yet 
again, then clearly Medicare should not cover treatments that are not 
consistent with that new label.
  Furthermore, there are other aspects of the CMS National Coverage 
Decision that are contrary to accepted standards of care and scientific 
evidence. CMS imposed 4-week dose limitations that are not based on the 
clinical needs of patients. The FDA labels allow ESAs to be 
administered three times a week, every week, every 2 weeks, or every 3 
weeks. Also, for patients who are slow to respond to ESAs or do not 
respond, CMS has created a one-time dose escalation rule of 25 percent 
of the initial ESA dose. This limitation is contrary to FDA-approved 
dosing instructions. For instance, the FDA approved labeling allows 
doubling the dose for some regimens.
  Mr. President, over the past months, I have seen an outpouring of 
concern with this National Coverage Decision by patients, providers, 
and the professional scientific community for many reasons. The 
American Society of Clinical Oncology, the world's leading professional 
organization representing physicians of all oncology subspecialties who 
care for cancer patients, wrote this to CMS:

       Under the new CMS policy, a patient's hemoglobin could 
     repeatedly fall below 10 following termination of coverage at 
     the end of 4-week periods. This consequence would be 
     inconsistent with the FDA-approved labeling, which, as noted 
     above, states that ESA dosing should be titrated to the 
     individual patient to maintain the hemoglobin level. . . . We 
     strongly urge CMS to reconsider these restrictions in light 
     of the concerns detailed above.
       The current NCD does not allow for interpretation 
     consistent with clinical practice, national guidelines, or 
     the FDA-approved labels in this area. This reopening [of the 
     National Coverage Decision] should occur as soon as possible 
     to avoid continued confusion and uncertainty [for] both 
     physicians and patients. Until these issues are clarified, we 
     also strongly recommend that CMS delay the effective date for 
     the entire NCD.

  The American Society of Hematology, the leading clinical authority on 
disorders affecting the blood, bone marrow, and the immunologic, 
hemostatic, and vascular systems, has stated:

       Consequently, the clinical scenario that is problematic is 
     when a patient's hemoglobin goes above 10 g/dL after 4 weeks 
     of treatment because the physician would then need to 
     discontinue the ESA treatment entirely. This is of concern 
     because some patients might then drop below 10 g/dL 
     justifying a renewal of the ESA treatment and leading to a 
     `roller coaster' of treatment potentially involving stopping 
     and starting ESA treatment several times. This is extremely 
     difficult for both the patient and the physician.

  The Leukemia and Lymphoma Society wrote this in a recent letter to 
CMS:

       As a reimbursement authority, CMS and the Medicare program 
     it administers should be guided by science and data in order 
     to achieve the best result for cancer patients. Accordingly, 
     CMS should defer to the expertise of FDA and of the academic 
     scientists who contribute to the ASCO/ASH guidelines.

  Additionally, I share the concerns of many in the oncology community 
who worry about exposing seniors to the avoidable safety risks of blood 
transfusions, as well as the effect of this policy on our nation's 
blood supply. It has been clearly documented that certain areas of the 
country are already at risk of running out of their blood supply or 
have ongoing shortages. Some areas have 24 hours worth of blood left 
before they completely run out. According to the 2006 Nationwide Blood 
Collection and Utilization Survey, the number of transfusions of red 
blood cells in 2004 was nearly equivalent to the number of units 
collected. This policy, which patients are already telling us are 
forcing them into transfusion units, could put in jeopardy a U.S. blood 
supply that is already fragile and stretched thin.
  The American Red Cross has indicated in their guidelines that 
transfusions are not appropriate for chemotherapy patients when 
alternative treatments are available:

       Red blood cells should not be used to treat anemia that can 
     be corrected with a non-transfusion therapy such as iron or 
     recombinant erythropoietin.

  To my great concern, the CMS National Coverage Decision responds to 
this vital issue with the following:

       The concern about the adequacy of the nation's blood supply 
     is not a relevant factor for consideration in this national 
     coverage determination. Our focus is whether the use of ESA 
     is reasonable and necessary to treat a particular illness.

  The sole purpose for using ESAs, as stated on the FDA label, is to 
avoid a blood transfusion. But CMS has decided that this issue is not 
relevant to a decision regarding the coverage of ESAs. Well, I can 
guarantee you that it is important to the patients who will now be 
forced to seek transfusions as a result of CMS' shortsighted decision.
  Congress continues to demonstrate that it shares the concerns of 
patients and the clinical community about the new CMS policy and the 
detrimental effect that it could have on patient care. Earlier this 
summer, prior to the CMS issuance of the final National Coverage 
Decision, 52 Senators and 235 Members of the House of Representatives 
wrote to CMS expressing an overwhelmingly bipartisan, bicameral concern 
with the CMS policy. CMS, however, ignored these concerns and issued a 
final National Coverage Decision on July 30 that was even more onerous 
than the one proposed.
  On September 4, the Senate sent a strong message of dissatisfaction 
when we passed S. Res. 305, without one Senator objecting. S. Res. 305 
called on CMS to immediately reconsider the National Coverage Decision. 
But CMS has refused to reopen the National Coverage Decision and work 
with the clinical community to develop an appropriate patient-centered 
policy that is consistent with scientific evidence.
  Because CMS has repeatedly ignored our concerns, we now are forced to 
take legislative action that compels CMS to change this flawed policy. 
That is why today I am asking my Colleagues to support this resolution 
of disapproval.
  Let me tell you what this resolution does not do. This resolution 
does not replace the medical judgment of CMS or the FDA with that of 
Congress. This resolution does not ignore the safety concerns of ESAs 
used when a patient's hemoglobins are above the FDA label. Finally, 
this resolution does not reject the notion of any National Coverage 
Decision related to ESAs. This resolution simply asks CMS to go back to 
the drawing board. It compels CMS to work with the oncology community--
the experts and clinicians and patients--to come up with a policy that 
is based on scientific evidence and that the community can support, or 
at least understand. That is why I ask my Colleagues to join me in 
supporting this important legislation.
  Mr. President, I ask unanimous consent that the text of the joint 
resolution be printed in the Record.
  There being no objection, the text of the joint resolution was 
ordered to be printed in the Record, as follows:

                              S.J. Res. 22

       Whereas the Centers for Medicare & Medicaid Services issued 
     a final Medicare national coverage determination on the use 
     of erythropoiesis stimulating agents in cancer and related 
     neoplastic conditions (CAG-000383N) on July 30, 2007;
       Whereas the Centers for Medicare & Medicaid Services 
     submitted to the Congress a copy of the national coverage 
     determination rule, a detailed description of the rule, and 
     the proposed effective date of the rule;
       Whereas 52 Senators and 235 Members of the House of 
     Representatives, representing bipartisan majorities in both 
     chambers, have written to the Centers for Medicare & Medicaid 
     Services expressing significant concerns with the proposed 
     national coverage determination on the use of erythropoiesis 
     stimulating agents in cancer and related neoplastic 
     conditions, issued on May 14, 2007;
       Whereas the leading national medical organization 
     representing physicians who treat patients with cancer has 
     noted that the national coverage determination's hemoglobin 
     level restriction is inconsistent with both the FDA-approved 
     labeling and national guidelines and that its dosing and 
     titration regimen restrictions are inconsistent with 
     established studies, the FDA label, and clinical guidelines 
     and, therefore, has formally requested that the Centers for 
     Medicare &

[[Page 27804]]

     Medicaid Services reconsider these restrictions;
       Whereas the leading national medical organization 
     representing physicians who treat patients with disorders 
     affecting the blood and bone marrow, the Nation's leading 
     health care services network dedicated exclusively to cancer 
     treatment and research, and other national, nonprofit 
     organizations dedicated to improving patient access to care 
     have expressed similar concerns regarding the national 
     coverage determination and have called for its 
     reconsideration; and
       Whereas despite the strong concerns of the oncology and 
     hematology community, the Centers for Medicare & Medicaid 
     Services has failed to take any action: Now, therefore, be it
       Resolved by the Senate and House of Representatives of the 
     United States of America in Congress assembled, That Congress 
     disapproves the rule (CAG-000383N) submitted by the Centers 
     for Medicare & Medicaid Services within the Department of 
     Health and Human Services relating to Medicare coverage for 
     the use of erythropoiesis stimulating agents in cancer and 
     related neoplastic conditions, and such rule shall have no 
     force or effect.

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