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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 701 PENNSYLVANIA AVENUE, N.W., SUITE 800 |
Address2 | |
| City | WASHINGTON |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 17831-12
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6. House ID# 310010000
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| TYPE OF REPORT | 8. Year | 2012 |
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 | |
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. | ||||||||
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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 |
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| Signature | Digitally Signed By: Juan Scott, Senior Executive Vice President and Director, Government Affairs |
Date | 11/20/2012 |
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
Issues related to oversight of implantable devices and price transparency. [Elizabeth Kegler, JC Scott]
Issues related to gainsharing. [Elizabeth Kegler, Duane Wright, JC Scott]
Issues related to the implementation of Section 6002 (Transparency Reports and Reporting of Physician Ownership or Investment Interests) of the Patient Protection and Affordable Care Act (PL 111-148). [Elizabeth Kegler,]
Issues related to physician owned distributors of devices [Elizabeth Kegler]
H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 (Payment Reform) [Duane Wright, Elizabeth Sharp, Leah Kegler, JC Scott]
Issues related to deficit reduction and Medicare [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright]
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Juan |
Scott |
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Elizabeth |
Kegler |
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Elizabeth |
Sharp |
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Duane |
Wright |
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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 HCR
16. Specific lobbying issues
Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
Issues related to diagnostics in the critical care setting. [Leah Kegler, Duane Wright]
Issues related to the medical device user fee program [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
S. 3187 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright]
S. 2516 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright]
H.R. 5651 Food and Drug Administration Reform Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright]
Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
Issues related to diagnostics regulation [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright]
Issues related to the definition of durable for durable medical equipment [Duane Wright]
HR 3209 Premarket Predictability Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3203 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3230 Keeping America Competitive Through Harmonization Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3205 FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3211 Humanitarian Device Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3208 Patients Come First Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3206 Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3214 Food and Drug Administration Mission Reform Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3207 Modernizing Laboratory Test Standards for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright]
HR 3204 Guidance Accountability and Transparency Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3847 Safety of Untested and New Devices Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
HR 3975 a bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 [Elizabeth Sharp, Elizabeth Kegler]
HR 4056 Science and Technology Regulatory Relief Act [Elizabeth Sharp, Elizabeth Kegler]
S 1700 Medical Device Regulatory Improvement Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott]
S 1865 Patient Access to Medical Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
S 1943 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
S 1972 Food and Drug Administration Mission Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
S 1995 Medical Device Patient Safety Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott]
S 2067 Safe, Transparent, and Efficient Medical Device Act [Elizabeth Sharp, Elizabeth Kegler]
S 2113 A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that encourage innovative products to benefit patients and improve public health [Elizabeth Sharp]
S 2193 Ensuring Safe Medical Devices for Patients [Elizabeth Sharp, Elizabeth Kegler]
S 2292 PATIENTS' FDA Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott]
S. 2289 Better Pharmaceuticals and Devices for Children Act of 2012 [Elizabeth Sharp]
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Juan |
Scott |
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Elizabeth |
Kegler |
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Elizabeth |
Sharp |
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Duane |
Wright |
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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
Issues relating to FY13 funding for the Food and Drug Administration [Elizabeth Sharp, JC Scott]
HR 5973 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013 [Elizabeth Sharp, JC Scott]
S 2375 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013 [Elizabeth Sharp, JC Scott]
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Elizabeth |
Sharp |
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Juan |
Scott |
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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
S. 17, S. 262, HR 436, HR 488, HR 734 bills related to the Medical Device Excise Tax [Elizabeth Kegler, Elizabeth Sharp, JC Scott, Duane Wright]
Issues related to tax reform [JC Scott]
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Juan |
Scott |
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Elizabeth |
Sharp |
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Elizabeth |
Kegler |
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Duane |
Wright |
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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 |