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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1300 Wilson Boulevard |
Address2 | Suite 600 |
| City | Arlington |
State | VA |
Zip Code | 22209 |
Country | USA |
3. Principal place of business (if different than line 2)
| City | Arlington |
State | VA |
Zip Code | 22209 |
Country | USA |
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5. Senate ID# 401104947-12
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6. House ID# 441480001
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| TYPE OF REPORT | 8. Year | 2022 |
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. | ||||||||
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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: Kathleen Sheehan |
Date | 4/20/2022 1:42:42 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 BUD
16. Specific lobbying issues
-Requested that the House and Senate Appropriations LHHS Subcommittee provide at least $135 million for ALS research at NIH in fiscal year 2023 to attract the next generation of scientists, accelerate the discovery and development of new treatments and increase the number of ALS clinical trials.
-Requested the House and Senate Appropriations LHHS Subcommittee provide at least $75 000,000 to implement the expanded access program established by the ACT for ALS Act (P.L. 117-79).
-Requested the House and Senate Appropriations Defense Subcommittee provide at least $60 million for the ALS Research Program in fiscal year 2023 to allow the program to build on a solid foundation of promising preclinical research to increase the number of ALS clinical trials by funding its own early phase trials.
-Requested the House and Senate Appropriations Agriculture Subcommittee provide at least $25 million specifically for ALS research to the FDA Orphan Products Grants Program in fiscal year 2023 to to implement P.L. 117-79 to establish the FDA Rare Neurodegenerative Disease Grant Program which is authorized to provide grants for clinical trials for ALS and other neurodegenerative diseases.
-Requested House and Senate Appropriations LHHS Subcommittee provide at least $10 million to continue the National ALS Registry and Biorepository in fiscal year 2023 to help identify risk factors for ALS to reduce the number of new cases, connect patients with clinical trials, conduct surveillance of incidence and prevalence and collect biospecimens that will lead to a better understanding of who may develop ALS.
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 |
Kathleen |
Sheehan |
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Daniel |
Cramer |
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Denise |
DeMichele-Bailin |
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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
-The Telehealth Modernization Act (H.R. 1332/ S. 368) extends certain COVID telehealth flexibilities. Among other things, the bill allows (1) rural health clinics and federally qualified health centers to serve as the distant site (i.e., the location of the health care practitioner); (2) the home of a beneficiary to serve as the originating site (i.e., the location of the beneficiary) for all services (rather than for only certain services); and (3) all types of practitioners to furnish telehealth services, as determined by the Centers for Medicare & Medicaid Services.
-The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (H.R. 2903/ S. 1512) expands coverage of telehealth services under Medicare. Among other things, the bill allows the Centers for Medicare & Medicaid Services (CMS) to waive certain restrictions, such as geographic restrictions, for services provided in high-need health professional shortage areas; excludes mental health and emergency medical services, as well as services provided at rural health clinics, federally qualified health centers, and Indian Health Service facilities, from such geographic restrictions; and allows the CMS to generally waive coverage restrictions during national emergencies. Additionally, the Medicare Payment Advisory Commission must report on information relating to the access of Medicare beneficiaries to telehealth services at home. The Center for Medicare and Medicaid Innovation may also test alternative payment models relating to expanded telehealth services.
CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms.
Build Back Better Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; and the establishment Advanced Research Projects Agency for Health (ARPA-H).
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 |
Denise |
DeMichele-Bailin |
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Kathleen |
Sheehan |
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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
-Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (H.R. 708/ S. 168) temporarily authorizes the interstate provision of in-person and telehealth services. This authorization applies during, and for at least 180 days after, the COVID-19 (i.e., coronavirus disease 2019) emergency. Specifically, subject to scope of practice and other requirements, a health care professional may provide health services in any U.S. jurisdiction based on that individual's authorization to practice in any one state or territory. The bill also provides certain related powers to health care professional regulatory bodies, such as medical boards. Specifically, a regulatory body may investigate and take disciplinary actions against a professional who provides services pursuant to this bill to a patient in that body's jurisdiction.
-The Promising Pathway Act (S. 1644) would establish a new time-limited "provisional approval" path at the FDA for drug sponsors to market drugs that show promise while additional testing takes place and before full FDA approval is achieved.
-Accelerating Access to Critical Therapies (ACT) for ALS Act (H.R. 3537/ S. 1813) would create 1) a new framework for delivering experimental therapies to people with rare neurodegenerative diseases such as ALS; 2) create a new research grant program at the FDA to such diseases, and; 3) create a new Public-Private Partnership at the Department of Health and Human Services to coordinate federal efforts on developing and approving treatments for such diseases.
-Promising Pathway Act (H.R. 3761/S. 1644) would create a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS.
CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms.
- Build Back Better Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; and the establishment Advanced Research Projects Agency for Health (ARPA-H).
- Telehealth Modernization Act (H.R. 1332/S. 368) -- Provisions related to the modification of requirements relating to coverage of telehealth services under Medicare bill, including certain flexibilities that were initially authorized during the public health emergency relating to COVID-19.
- ACT for ALS (P.L. 117-70) - Conversations surrounding implementation of PL 117-79, the Accessing Critical Therapies for ALS 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 |
Kathleen |
Sheehan |
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Denise |
DeMichele-Bailin |
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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
- CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms.
- Conversations surrounding Prescription Drug User Fee Act VII (PDUFA VII) -- provisions related to modernization of regulatory evidence generation and drug development tools through novel clinical trial design and modeling, improving accountability and transparency of the FDA, enhancing staff retention and resource management.
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 |
Kathleen |
Sheehan |
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Denise |
DeMichele-Bailin |
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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 VET
16. Specific lobbying issues
Justice for ALS Veterans Act (H.R. 5607 / S.3483) -- All Provisions, including those extending Dependency and Indemnity Compensation payments to surviving spouses of veterans who die from ALS, regardless of how long a veteran had ALS prior to death.
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 |
Daniel |
Cramer |
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Denise |
DeMichele-Bailin |
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Kathleen |
Sheehan |
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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 FAM
16. Specific lobbying issues
Build Back Better Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave.
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 |
Denise |
DeMichele-Bailin |
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Kathleen |
Sheehan |
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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 AVI
16. Specific lobbying issues
Air Carrier Amendments Act HR1619/S642 -- provisions related to prohibiting discrimination against disabled individuals by an air carrier.
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 |
Daniel |
Cramer |
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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 CIV
16. Specific lobbying issues
- Air Carrier Amendments Act HR1619/S642 -- provisions related to prohibiting discrimination against disabled individuals by an air carrier.
- Disability Employment Incentive Act HR 3765/S630 - Provisions related to adding SSDI recipients to qualified Work Opportunity Tax Credits, doubling and extending the Work Opportunity Tax Credit, doubling the Disability Access Expenditures Tax Credit, and increasing the Architectural and Transportation Barrier Tax Credit.
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 |
Daniel |
Cramer |
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Denise |
DeMichele-Bailin |
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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) |