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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 12601 Twinbrook Parkway |
Address2 | |
| City | Rockville |
State | MD |
Zip Code | 20852 |
Country | USA |
3. Principal place of business (if different than line 2)
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State | |
Zip Code | |
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5. Senate ID# 400358632-12
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6. House ID# 403600000
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| TYPE OF REPORT | 8. Year | 2009 |
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: Matthew Heyman, Vice President, External Affairs and Strategic Integration |
Date | 04/17/2009 |
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 CSP
16. Specific lobbying issues
-GAO Study on Dietary Supplement Regulation, provided comments for.
-HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization.
-Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics.
-Letter to Acting Commissioner of the FDA regarding FDA budget and standards.
-Communication with Congress on standards of use for heparin and glycerin.
-Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources.
-Letter to President Obama regarding food safety.
-Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources.
-Provided information to Congress for a hearing on drug issues with respect to intellectual property issues for drugs.
-Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, Government Accountability Office (GAO), Health & Human Services - Dept of (HHS), U.S. SENATE, President of the U.S., Food & Drug Administration (FDA)
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 |
Ben |
Firschein |
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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 FOO
16. Specific lobbying issues
-GAO Study on Dietary Supplement Regulation, provided comments for.
-HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization.
-Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics.
-Letter to Acting Commissioner of the FDA regarding FDA budget and standards.
-Communication with Congress on standards of use for heparin and glycerin.
-Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources.
-Letter to President Obama regarding food safety.
-Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources.
-Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality.
-S 510 "FDA Food Safety Modernization Act", regarding all provisions with respect to food ingredient quality.
17. House(s) of Congress and Federal agencies Check if None
Government Accountability Office (GAO), U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), U.S. SENATE, President of the U.S.
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 |
Ben |
Firschein |
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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
-HR 1 "The American Recovery and Reinvestment Act of 2009", regarding provisions related to healthcare research and quality and to NIST Appropriations.
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 |
Ben |
Firschein |
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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 MMM
16. Specific lobbying issues
Response to the Congressional Budget Office on Medicare model guidelines in response to technical inquiry on formulation of guidelines.
17. House(s) of Congress and Federal agencies Check if None
Congressional Budget Office (CBO)
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 |
Ben |
Firschein |
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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 PHA
16. Specific lobbying issues
-GAO Study on Dietary Supplement Regulation, provided comments for.
-HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization.
-Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics.
-Letter to Acting Commissioner of FDA regarding FDA budget and standards.
-Communication with Congress on standards of use for heparin and glycerin.
-Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources.
-Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources.
-Provided information to Congress for a hearing on drug issues regarding intellectual property issues for drugs.
-HR 1298 "Pharmaceutical Market Access & Drug Safety Act of 2009", regarding all provisions on the effect of re-importation provisions on FDA requirements and USP Compendial Standards for Drugs.
-Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality.
-HR 1427 / S 726 "Promoting Innovation and Access to Lifesaving Medicine Act", regarding all provisions on biologics; role and importance of standards, follow-on biologics.
-HR 1548 "Pathway for Biosimilars Act", regarding all provisions on biologics; role of importance of standards, follow-on biologics.
-HR 1105 "FY 2009 Omnibus Appropriations Act", regarding provisions on verification programs, standards and resources for FDA.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Government Accountability Office (GAO), Health & Human Services - Dept of (HHS)
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 |
Ben |
Firschein |
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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 |