Safe RESEARCH Act

S 318, HR 531 Accelerating Biomedical Research Act HR 744, S 320 Medical Innovation Act (Swear Jar bill) HR 777 Permanent Investment in Health Research Act HR 6 21st Century Cures S 289, HR 2104 American Cures Act HR 2101 Research for All Act S 1077 Advancing Breakthrough Devices for Patients HR 2337 To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices HR 160 Protect Medical Innovation Act of 2015 (to repeal the ACA medical device tax) S2014 HR3466 Next Generation Researchers Act HR 3171 HR 3215 HR 3429 S 1917 legislation relating to the regulation of fetal tissue research HR639 Improving Regulatory Transparency for New Medical Therapies Act (signed into law) HR 2820 Stem Cell Therapeutic and Research Reauthorization Act of 2015 (signed into law) HR 2646 S1945 Helping Families in Mental Health Crisis Act of 2015 HR 3731, S 2030 Rare Disease Fund Act of 2015 HR 3729 Limit Fetal Tissue Research S 2141 Transparent Ratings on Usability and Security to Transform Information Technology Act of 2015 or TRUST It Act (with respect to health information technology) S 2624 National Biomedical Research Act S 1878 Advancing Hope Act of 2015 S 2512 Adding Zika Virus to the FDA Priority Review Voucher Program Act S 1101 Medical Electronic Data Technology Enhancement for Consumers' Health Act S 1767 Combination Product Regulatory Fairness Act of 2015 S 1597 Patient-Focused Impact Assessment Act of 2015 S 2055 Medical Countermeasure Innovation Act of 2016 S 1945 Mental Health Reform Act of 2015 S 1622 FDA Device Accountability Act S 849 Advancing Research for Neurological Diseases Act of 2015 S 800 Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S 2700 FDA and NIH Workforce Authorities Modernization Act S 2713 Advancing Precision Medicine Act of 2016 S 2745 NIH Strategic Plan and Inclusion in Clinical Research S 2472 Promoting Biomedical Research and Public Health for Patients Act (to reduce regulatory burden on NIH-funded researchers)

Client expense: $36,139 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

America Competes Reauthorization (HR 1806), Impact of regulatory burden on research, Exascale Computing Leadership Act (S. 454), Legislation to prohibit fetal tissue research (HR 3729, HR 3171), Increased federal funding for Research and Development, Nuclear Energy Innovation Capabilities Act (HR 4084), Support for Fusion Energy Research, Energy Policy Modernization Act (S. 2012), Scientific Research in the National Interest Act (HR 3293), FLIGHT R&D Act (HR 4489), Department of Energys Mission Innovation, The Commercializing on Small Business Innovation Act of 2016 (HR 4783), and the Reauthorization of the SBIR and STTR programs.

Client expense: $110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Contacts in support of the Pain-Capable Unborn Child Protection Act (H.R. 36), to protect pain-capable unborn children beginning at 20 weeks fetal age, as approved by the House of Representatives May 13, 2015, and the Senate companion bill, S. 1553, introduced by Senator Graham (R-SC) on June 11, 2015. Senate motion to proceed to H.R. 36 (cloture failed, September 22, 2015. Contacts in support of No Taxpayer Funding for Abortion Act (H.R. 7, S. 582), to codify government-wide policy against funding abortion (passed House January 22, 2015, 242-179). Contacts in support of Child Interstate Abortion Notification Act (CIANA)(H.R. 803, S. 404) to require an abortionist to notify a parent before performing an abortion on a minor from a different state, with certain exceptions. Contacts in support of the Health Care Conscience Rights Act (H.R. 940, Black, S. 1919, Lankford), to prevent the imposition of regulatory mandates that violate the religious or moral convictions of those who purchase or provide health insurance, and to prevent any level of government from discriminating against health care providers who decline to participate in abortions, and to empower victims to seek relief in court for violations of the federal conscience laws. Contacts in support of inclusion of parallel language in FY 2016 Labor-HHS appropriations bill (H.R. 3020). Amendment to strike those provisions was rejected by the House Appropriations Committee on June 24, 2015, and the bill reported out. Components of the conscience-protection legislation were introduced in the Senate as the Abortion Nondiscrimination Act (ANDA, S. 50), also supported. Contacts in support of retention of pro-life limitations in Senate version of HHS appropriations bill, S. 1695. Contacts in support of inclusion of Abortion Non-Discrimination Act (ANDA) provisions in H.R. 2029, Consolidated Appropriations Act, 2016 (not included). Contacts in support of Dismemberment Abortion Ban Act (H.R. 3515, Smith) and possible Senate companion bill (not introduced during Fourth Quarter). On FY 2016 Financial Services appropriations bill (H.R. 2995, S. 1910). Contacts in support of Harris Amendment, to prohibit coverage of abortion, with certain exceptions, in "multi-state" (national) health plans created by PL 111-148, to be administered by the Office of Personnel Management; amendment adopted by House Appropriations Committee on June 17, 2015. Contacts in support of retention of the "Smith Amendment" (Sections 613-614) to prohibit OPM from paying administrative expenses connected with any FEHB health plan that covers elective abortion. Contacts in support of retention of "D.C. Hyde Amendment" (Section 810), to prohibit use of appropriated funds for abortion by the local government of the District of Columbia, with certain exceptions. The FY 2016 Financial Services appropriations bill (H.R. 2995) approved by the House Appropriations Committee June 17, 2015, contained these three provisions; the second and third were carried over into H.R. 2029, the Consolidated Appropriations Act, 2016. H.R. 2995 also contained the Palazzo Amendment, supported, to prevent use of appropriated funds by the local government of the District of Columbia to enforce the "Reproductive Health Non-Discrimination Act," as reported under DOC; this provision was not carried over into H.R. 2029. Contacts explaining nonsupport for H.R. 426 and H.R. 816, based on lack of clarity and erroneous legal premises, and nonsupport for possible draft Senate companion bill. Contacts in opposition to "Women's Health Protection Act" (H.R. 448, S. 217), a proposed federal statute to invalidate virtually all state and federal regulations pertaining to abortion. Contacts in opposition to "EACH Woman Act" (H.R. 2972), a bill to mandate coverage of abortion without limitation in Medicaid, Medicare, CHIP, and other federally funded health insurance program, to nullify the laws in effect in about half of the states that restrict coverage of abortion in health plans sold on the Obamacare exchanges, and to nullify all other state laws or policies that "inhibit insurance coverage of abortion by private health plans." Contacts in opposition to H.R. 2257 (Rep. Jeff Miller) and S. 469 (Murray), in the forms introduced; these bills would require the Veterans Administration to provide certain services involving the creation, manipulation, and freezing of human embryos; contacts regarding possible revisions to the legislation. Contacts regarding clarifying revisions recommend to H.R. 1356 (gender-specific services by VA). Contacts in support of H.R. 3495 (Duffy), to increase state flexibility to exclude certain abortion providers from Medicaid (passed by the House on Sept. 29. 2015), and Senate companion bill S. 2159 (Vitter). Contacts in support of inclusion of this provision in H.R. 2029, Consolidated Appropriations Act, 2016 (not included). Contacts pertaining to H.R. 3171 (Sensenbrenner), to make certain amendments to current law governing certain federally funded research involving fetal tissue (non-support), and H.R. 3729 (Sensenbrenner) to limit permissible sources of fetal tissue for federally funded research (under review). Responses to inquiries regarding possible revisions to 42 USC Sec. 289g-1 and 289g-2, including H.R. 3429 (Yoder)(legislation to tighten definition of "valuable consideration" in 289g-2, qualified support). Contacts regarding possible legislation to tighten requirements regarding altering method of abortion and consent pertaining to harvesting of baby body parts (qualified support). Contacts regarding nomination of Karen DeSalvo as DHHS Assistant Secretary for Health; opposed to confirmation at this time. Contacts in support of Born-Alive Abortion Survivors Protection Act (H.R. 3504, Franks), passed by the House Sept. 18, 2015, and in support of Senate companion bill, S. 2066 (Sasse). Contacts received regarding provisions of H.R. 2029, and freestanding bill HR 3920, pertaining to drug ESSURE (no position). Contacts regarding H. Res. 461 (Foxx), to establish a Select Panel attached to House Energy and Commerce Committee to investigate certain aspects of abortion industry practice, including body-parts harvesting, live-born infants, and related issues (support), and potential appointments to that panel. H.Res. 461 approved by House October 7, 2015. Contacts in support of "Defund Planned Parenthood Act of 2015," H.R. 3134 and S. 1836. Contacts in support of H.R. 3762, Restoring Americans' Healthcare Freedom Act (budget reconciliation bill), including provision to block most federal funding to Planned Parenthood for one year, including contacts in support of Rule providing for consideration of the bill in the House and House passage on October 23, 2015. Contacts in support of inclusion of similar language in the Senate substitute amendment, and addition of provisions to repeal certain provisions of the Affordable Care Act, including the tax credit program that subsidizes about 1,000 health plans that cover elective abortion. Contacts in opposition to the Collins Amendment to remove the defund-Planned Parenthood provision, and in opposition to the Murray Amendment to replace that provision with a new $1 billion authorization for a fund for which only elective-abortion providers would be eligible (both amendments were rejected). Contacts regarding amendments filed pertaining to Freedom of Access to Clinic Entrances statute; no position (amendments did not come to vote). Contacts in support of passage of the bill in the Senate (bill passed Dec. 3, 2015).

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE