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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1399 NEW YORK AVENUE NW |
Address2 | SUITE 300 |
City | WASHINGTON |
State | DC |
Zip Code | 20005 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 15920-12
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6. House ID# 314640000
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TYPE OF REPORT | 8. Year | 2013 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
10. Check if this is a Termination Report | Termination Date |
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11. No Lobbying Issue Activity |
INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
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12. Lobbying | 13. Organizations | ||||||||
INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
Signature | Digitally Signed By: Shannon Steward |
Date | 10/11/2013 10:02:45 PM |
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code HCR
16. Specific lobbying issues
Issues relating to the treatment of biologics in international health programs; proposed cuts to Part B reimbursement. 340b reimbursement policy; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.; Issues concerning trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; S.959, Pharmaceutical Compounding Quality and Accountability Act; H.R. 1416, Cancer Patient Protection Act of 2013; S. 957, Drug Supply Chain Security Act; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; Pandemic preparedness, Tamiflu, Medicare coverage of Cancer Drugs, Appropriations; implementation of section 340B of the Public Health Service Act (42 U.S.C. 256b); Issues relating to the treatment of biologics in international health programs
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Darin |
Gardner |
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Sr. Director Government Affairs |
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Evan |
Morris |
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Vice President of Government Affairs - Roche Diagnostics |
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Katherine |
Martin-Raab |
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Director of Government Affairs |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code TAX
16. Specific lobbying issues
Monitoring of the FY 14 appropriations bills and issues related to comprehensive tax reform.; Research and Development Tax credit,; general tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned US corporations
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
David |
Burt |
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Asst. Director |
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Eli |
Kogan |
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Asst. Director |
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Darin |
Gardner |
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Sr. Director Government Affairs |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code MMM
16. Specific lobbying issues
Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare payment issues.; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to FDA approval of follow-on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicare prescription drug benefit. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010- Implementation issues related to Medicare and Medicaid reimbursement, fees assessed on the pharmaceutical industry, design and structure of the Medicare prescription drug benefit. Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - legislation related to reauthorization of user fees for prescription drug, medical device, and biologics approval. All aspects. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis; Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; Medicare coverage and payment of Part B drugs and biologicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act;
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Evan |
Morris |
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Vice President of Government Affairs |
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Katherine |
Martin-Raab |
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Director |
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David |
Burt |
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Asst. Director |
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Darin |
Gardner |
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Sr. Director Government Affairs |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code BUD
16. Specific lobbying issues
FY13 Labor, HHS and Education Appropriation related to preparedness for pandemic influenza, HIV/AIDS programs, hepatitis screening, care and treatment, and access t breast cancer treatment; Following issues related to the budget and appropriations process FY 13 appropriations for FDA as well as the potential outcomes for negotiations on altering sequestration targets via legislation
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Eli |
Kogan |
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Asst. Director |
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David |
Burt |
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Asst. Director |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code CPT
16. Specific lobbying issues
Cyber security, Transpacific Partnership
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Evan |
Morris |
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vice President of Government Affairs |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code TRD
16. Specific lobbying issues
Trade with India.; Proposed changes in global patent protections. Compulsory License Issues in India
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Eli |
Kogan |
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Asst. Director |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code PHA
16. Specific lobbying issues
Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Darin |
Gardner |
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Sr. Director Government Affairs |
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Evan |
Morris |
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Vice President of Government Affairs |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Information Update Page - Complete ONLY where registration information has changed.
20. Client new address
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21. Client new principal place of business (if different than line 20)
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22. New General description of client’s business or activities
LOBBYIST UPDATE
23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client
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ISSUE UPDATE
24. General lobbying issue that no longer pertains
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AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
Name | Address |
Principal Place of Business (city and state or country) |
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
1 | 2 | 3 |
FOREIGN ENTITIES
27. Add the following foreign entities:
Name | Address |
Principal place of business (city and state or country) |
Amount of contribution for lobbying activities | Ownership percentage in client | ||||||||||
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% |
28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization
1 | 3 | 5 |
2 | 4 | 6 |