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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1779 Massachusetts Avenue, NW |
Address2 | Suite 500 |
City | Washington |
State | DC |
Zip Code | 20036 |
Country | USA |
3. Principal place of business (if different than line 2)
City | Danbury |
State | CT |
Zip Code | 06810 |
Country | USA |
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5. Senate ID# 28264-12
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6. House ID# 306890000
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TYPE OF REPORT | 8. Year | 2019 |
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: Beth Anne Cole |
Date | 10/21/2019 5:48:01 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
Health issues impacting patients with rare diseases.
H.R.2279/S.2546: Safe Step Act.
H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019.
H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases.
Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability.
Newborn Screening.
H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019.
H.R.1379/S.560: Ensuring Lasting Smiles Act.
H.R.4439: Creating Hope Reauthorization Act.
Biosimilars.
Genetic Testing.
FDA User Fee Reauthorization (Legislation Not Yet Introduced).
Medical Foods.
H.R.2501: Medical Nutrition Equity Act of 2019.
Section 1557 of the Patient Protection and Affordable Care Act.
RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance.
Enrollment Practices.
Copay Accumulator Adjustment Programs (CAAPs).
CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold.
Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities.
Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Homeland Security - Dept of (DHS), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)
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 |
Michelle |
Adams |
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Sr. Legislative Asst., Senator Kay Hagan; Senior Legislative Asst./Legislative Director, Rep. Louise Slaughter; Legislative Asst., Rep. Michael Capuano; Staff Asst./Legislative Correspondent, Rep. Cynthia McKinney; Staff Asst., Rep. Bob Ethridge |
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Rose |
Avellino |
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Melanie |
Buzzelli |
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Rachel |
Sher |
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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
Medicare issues impacting patients with rare diseases.
Medicare Part D Program.
Section 1115 Waivers.
Section 1332: State Innovation Waivers.
CMS-2406-P2/RIN: 0938-AT41: Methods for Assuring Access to Covered Medicaid Services - Rescission.
CMS-9936-NC2: Request for Information Regarding State Relief and Empowerment Waivers.
S.J.Res.52: A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers".
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)
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 |
Michelle |
Adams |
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Melanie |
Buzzelli |
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Rachel |
Sher |
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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
Pharmaceutical issues impacting patients with rare diseases.
Orphan Drug Act.
Orphan Drug Tax Credit.
H.R.1332: Fair Care Act of 2019.
Drug Pricing.
S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019.
H.R.3: Lower Drug Costs Now Act of 2019.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)
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 |
Michelle |
Adams |
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Rose |
Avellino |
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Melanie |
Buzzelli |
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Peter |
Saltonstall |
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Rachel |
Sher |
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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
Appropriations for patients with rare diseases.
Food and Drug Administration Appropriations.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Office of Management & Budget (OMB)
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 |
Michelle |
Adams |
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Melanie |
Buzzelli |
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Rachel |
Sher |
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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 CPT
16. Specific lobbying issues
Patent issues impacting patients with rare diseases.
Section 101 of the Patent Act.
H.R.3666: STRONGER Patents Act of 2019.
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 |
Michelle |
Adams |
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Melanie |
Buzzelli |
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Rachel |
Sher |
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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 IMM
16. Specific lobbying issues
Deferred Action.
17. House(s) of Congress and Federal agencies Check if None
U.S. Citizenship & Immigration Services (USCIS)
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 |
Michelle |
Adams |
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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 |
CONVICTIONS DISCLOSURE
29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery,
extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
Lobbyist Name | Description of Offense(s) |