MEDICAL DEVICES

Amendments

Dept. of HHS: establish Advanced Research Projects Agency-Health (H.R. 5585), H5802 [22JN]

——— establish Advanced Research Projects Agency-Health (H.R. 5585), consideration (H. Res. 1191), H5750 [22JN]

Bills and resolutions

Assistive Technology Act: reauthorize (see H.R. 9028), H8313 [29SE]

Business and industry: strengthen medical device supply chains (see S. 3834), S1153 [14MR]

Commission on the COVID–19 Pandemic: establish (see H.R. 7069), H3712 [11MR]

Contraceptives: preempt State bans on prescription, provision, or use of drug, biological product, or device for contraception if approved, licensed, cleared, or otherwise authorized for human use by FDA for contraception (see H.R. 8421), H6882 [19JY]

Crime: prohibit discrimination by abortion against unborn child on basis of results of laboratory developed test (see H.R. 7719), H4860 [11MY]

Defense Production Act: ensure supply of certain medical articles essential to national defense (see S. 3837), S1177 [15MR]

Dept. of Education: prohibit Federal funding to local educational agency requiring any student at schools served by agency to wear face covering or be vaccinated against coronavirus (see H.R. 6456), H288 [20JA]

Dept. of HHS: disapprove rule entitled ‘‘Vaccine and Mask Requirements To Mitigate the Spread of COVID–19 in Head Start Programs’’ (see S.J. Res. 39), S674 [14FE] (see H.J. Res. 81), H4453 [21AP]

——— ensure certain Native American facilities receive items from strategic national stockpile and qualified pandemic or epidemic products (see S. 3444), S49 [5JA] (see H.R. 6372), H43 [11JA]

——— enter partnerships with eligible domestic manufacturers to ensure availability of qualified personal protective equipment to prepare for and respond to national health or other emergencies (see H.R. 6468), H294 [21JA]

——— establish Advanced Research Projects Agency-Health (H.R. 5585), consideration (see H. Res. 1191), H5733 [21JN]

——— establish automated supply-chain tracking application that provides near real-time insight into amount of critical medical and health supplies available in strategic national stockpile (see H.R. 6520), H307 [28JA]

——— establish panel on real world impact of diagnostic medical devices (see H.R. 7192), H3858 [21MR]

——— identify and address barriers to coverage of remote physiologic devices under State Medicaid programs to improve maternal and child health outcomes for pregnant and postpartum women (see H.R. 9546), H9852 [14DE]

——— improve domestic manufacturing surge capacity and capabilities for biodefense and pandemic preparedness (see S. 3588), S546 [7FE]

——— issue regulations on over-the-counter hearing aids (see S. 4043), S2091 [7AP]

——— prohibit discrimination and preferential treatment on basis of race, color, or national origin in administration of health programs (see H.R. 6463), H288 [20JA]

——— prohibit use of Federal funds to purchase sterile needles or syringes for injection of illegal drugs, or for pipes, or other paraphernalia that can be used to smoke, inhale, or ingest narcotics (see S. 3645), S674 [14FE] (see H.R. 6744), H1123 [15FE]

——— provide certain adjustments to Medicare payment for durable medical equipment included in DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supplies) Competitive Bidding Program (see H.R. 6641), H1073 [8FE]

——— purchase rapid tests for coronavirus and make available for free (see H.R. 6377), H77 [12JA]

——— report on interoperability of medical devices (see H.R. 9067), H8315 [29SE]

——— review and update guidance annually on medical device cybersecurity in consultation with Cybersecurity and Infrastructure Security Agency for industry and FDA staff (see S. 4336), S2752 [26MY]

Disasters: streamline sharing of information among Federal disaster assistance agencies, expedite delivery of life-saving assistance to survivors, speed recovery of communities, and protect privacy of survivors (see S. 4599), S3612 [21JY]

Diseases and disorders: improve research and development of medical countermeasures for novel pathogens (see S. 3496), S220 [13JA]

——— prepare for, and respond to, existing viruses, emerging new threats, and pandemics (see S. 3799), S1118 [10MR]

——— prohibit Federal Government from limiting State access to key therapies and from prioritizing Federal contracts over State contracts relative to purchasing supplies to combat coronavirus pandemic (see S. 3440), S23 [4JA] (see H.R. 6832), H1145 [25FE]

——— prohibit use of Federal funds to purchase at-home tests for coronavirus imported from, or manufactured in, China (see S. 3565), S497 [2FE] (see H.R. 6926), H1302 [3MR]

Drugs: improve patient access to emerging medication therapies by clarifying scope of permitted communications between biopharmaceutical manufacturers and population health decision makers (see H.R. 7008), H1421 [9MR] (see H.R. 9297), H8507 [15NO]

FDA: accelerate approval of products for serious or life-threatening diseases or conditions (see H.R. 6996), H1373 [8MR]

——— allow for devices with predetermined change control plan to be marketed without submitting supplemental application or premarket notification if changes are consistent with such plans (see S. 4386), S2910 [13JN] (see H.R. 8299), H5939 [7JY]

——— allow waivers of annual medical device establishment registration fees for small businesses (see S. 4385), S2910 [13JN] (see H.R. 9329), H8587 [17NO]

——— clarify requirements for remanufacturing of medical devices (see H.R. 7253), H3895 [28MR]

——— enhance data reporting on clinical trial demographics and provide resources to improve access to clinical trials in underrepresented communities (see H.R. 6584), H946 [3FE]

——— exempt non-invasive diagnostic devices from regulation as devices (see H.R. 6513), H307 [28JA]

——— notify public about new information relative to medical device in order to reduce or limit number of patients exposed to potential risk identified based on such emerging signal (see S. 4349), S2785 [6JN] (see H.R. 7646), H4713 [3MY]

——— reauthorize Pediatric Device Consortia (PDC) grant program and allow profits for certain Humanitarian Device Exemption (HDE) devices (see H.R. 7679), H4721 [6MY]

——— report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices (see H.R. 6710), H1119 [11FE]

——— require foreign establishments engaged in production of drug or device to register whether or not drug or device undergoes further processing at separate location outside U.S. prior to being imported (see S. 3449), S117 [10JA]

——— require premarket submission of cyber devices to include information demonstrating reasonable assurance of safety and effectiveness throughout life cycle of cyber device (see S. 3983), S1910 [31MR] (see H.R. 7084), H3742 [15MR]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (see S. 4348), S2752 [26MY] (see S. 4535), S3308 [14JY] (see H.R. 7667), H4721 [6MY]

Federal agencies and departments: require time limitation on covered agency mask mandate requirements (see H.R. 8408), H6706 [18JY]

FEMA: designate breast pumps and certain lactation supplies as eligible for certain financial assistance (see H.R. 6555), H330 [1FE]

——— include breast pumps and other lactation supplies and equipment in disaster relief and emergency response (see S. 3601), S575 [8FE]

——— provide, manufacture, and distribute high quality face masks for every individual in U.S. during coronavirus emergency using Defense Production Act and other means (see S. 3486), S189 [12JA] (see H.R. 6385), H78 [12JA]

GAO: conduct study on funding to entities utilizing such funding for human genomic sequencing or genetic services (see H.R. 6363), H8 [10JA]

Health: provide for designation of biological products as qualified infectious disease products (see S. 3478), S159 [11JA]

Insurance: provide coverage for scalp cooling items under group and individual health plans, Federal health care programs and Federal Health Employee Benefits Program (see H.R. 7322), H4071 [31MR]

——— require out-of-network coverage for qualified individuals participating in approved clinical trials (see H.R. 8546), H7255 [27JY]

Medicare: permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to coronavirus (see H.R. 9427), H8757 [5DE]

——— provide coverage for wigs as durable medical equipment (see S. 4708), S3860 [2AU]

——— provide for demonstration project to evaluate fiscal impact of covering low vision devices as durable medical equipment (see H.R. 6848), H1146 [25FE]

——— provide pharmacy reimbursement for coronavirus-related and future emergency services (see H.R. 7213), H3863 [24MR]

NIH: establish Advanced Research Projects Authority for Health (see S. 3819), S1119 [10MR]

——— establish or continue research program to advance discovery and preclinical development of medical products for priority virus families and other viral pathogens with significant pandemic potential (see S. 3489), S189 [12JA]

——— take certain steps to increase clinical trial diversity (see S. 5268), S7252 [15DE] (see H.R. 7845), H5207 [19MY]

Senate: prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages (see S. Res. 631), S2493 [12MY]

Social Security: clarify manufacturer transparency reporting requirements for certain transfers used for educational purposes (see H.R. 9378), H8707 [1DE]

Taxation: provide tax credit for domestic medical and drug manufacturing and advanced medical manufacturing equipment (see H.R. 7410), H4191 [5AP]

Transportation Security Administration: revoke directives to implement Federal mask mandate in public transportation systems (see H.R. 7057), H3712 [11MR]

Letters

Revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products: Xavier Becerra, Sec. of HHS, S5171, S5172, S5173, S5174, S5175, S5176, S5177 [28SE]

Lists

Votes recorded by proxy on Eshoo amendment to H.R. 5585, Advanced Research Project Agency-Health (ARPA-H) Act, H5808 [22JN]

Votes recorded by proxy on H. Res. 1191, consideration of H.R. 5585, Advanced Research Project Agency-Health (ARPA-H) Act, H5752 [22JN]

Votes recorded by proxy on H.R. 3630, Lymphedema Treatment Act, H8577 [17NO]

Votes recorded by proxy on H.R. 5585, Advanced Research Project Agency-Health (ARPA-H) Act, H5809 [22JN]

Votes recorded by proxy on H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5403 [8JN]

Votes recorded by proxy on previous question to H. Res. 1191, consideration of H.R. 5585, Advanced Research Project Agency-Health (ARPA-H) Act, H5751 [22JN]

Notices

Estimated budget effects of H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5330 [7JN]

Remarks in House

Armed Forces: allow reimbursement of beneficiaries through TRICARE for purchase of coronavirus tests, E819 [2AU]

Benevolent Healthcare Foundation: tribute to Project C.U.R.E., E999 [29SE]

Contraceptives: preempt State bans on prescription, provision, or use of drug, biological product, or device for contraception if approved, licensed, cleared, or otherwise authorized for human use by FDA for contraception (H.R. 8421), H6937 [21JY]

Daytona Beach, FL: opening of B. Braun Medical, Inc., pharmaceutical manufacturing plant, E942 [15SE]

Dept. of HHS: establish Advanced Research Projects Agency-Health, H1413 [9MR]

——— establish Advanced Research Projects Agency-Health (H.R. 5585), H5633 [16JN], H5795–H5803 [22JN], H5834 [23JN]

——— establish Advanced Research Projects Agency-Health (H.R. 5585), consideration (H. Res. 1191), H5745–H5752 [22JN], E659 [23JN]

Diseases and disorders: use of budget reconciliation to provide emergency assistance and health care response for individuals, families, and businesses affected by coronavirus pandemic (H.R. 1319), E1302 [15DE]

FDA: enhance data reporting on clinical trial demographics and provide resources to improve access to clinical trials in underrepresented communities, E594 [8JN]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (H.R. 7667), H5298–H5321 [7JN], E594, E599 [8JN], E629 [15JN]

Foundation for the National Institutes of Health: increase funding (S. 1662), H1159 [28FE]

Medicare: provide coverage of certain lymphedema compression treatment items as items of durable medical equipment (H.R. 3630), H8469–H8471 [14NO], E1215 [5DE]

Reagan-Udall Foundation for the Food and Drug Administration: increase funding (S. 1662), H1159 [28FE]

Transportation Security Administration: revoke directives to implement Federal mask mandate in public transportation systems, H4462 [26AP]

Utah: tribute to companies for innovation in health care industry, H8128 [28SE], E961 [21SE]

Remarks in Senate

Biden, President: evaluation of administration relative to coronavirus pandemic, S33 [5JA], S482 [2FE]

Committee on Health, Education, Labor, and Pensions (Senate): accomplishments, S9716–S9718 [21DE]

Coronavirus Aid, Relief, and Economic Security (CARES) Act: anniversary, S1284–S1286 [22MR]

Dept. of HHS: disapprove rule entitled ‘‘Vaccine and Mask Requirements To Mitigate the Spread of COVID–19 in Head Start Programs’’ (S.J. Res. 39), S2265 [3MY], S2294 [4MY]

——— disapprove rule entitled ‘‘Vaccine and Mask Requirements To Mitigate the Spread of COVID–19 in Head Start Programs’’ (S.J. Res. 39), unanimous-consent agreement, S2259 [3MY]

Diseases and disorders: prepare for, and respond to, existing viruses, emerging new threats, and pandemics (S. 3799), S7060 [8DE]

——— prohibit use of Federal funds to purchase at-home tests for coronavirus imported from, or manufactured in, China (S. 3565), S482 [2FE]

——— prohibit use of Federal funds to purchase at-home tests for coronavirus imported from, or manufactured in, China (S. 3565), unanimous-consent request, S482, S483 [2FE]

FDA: revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, S5171 [28SE]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (H.R. 7667), S4630 [15SE]

Mining and mineral resources: urge development of domestic supply chains for rare earth elements and other critical materials, S1014 [7MR]

NIST: establish National Manufacturing Extension Partnership Supply Chain Database (S. 3290), S7280 [19DE]

Senate: prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages (S. Res. 631), S2473–S2476 [12MY]

——— prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages (S. Res. 631), unanimous-consent request, S2475 [12MY]

Reports filed

Advanced Research Project Agency-Health (ARPA-H) Act: Committee on Energy and Commerce (House) (H.R. 5585) (H. Rept. 117–365), H5485 [13JN]

Consideration of H.R. 5585, Advanced Research Project Agency-Health (ARPA-H) Act: Committee on Rules (House) (H. Res. 1191) (H. Rept. 117–381), H5733 [21JN]

Disaster Assistance Simplification Act: Committee on Homeland Security and Governmental Affairs (Senate) (S. 4599) (S. Rept. 117–163), S5051 [27SE]

FDA Safety and Landmark Advancements (FDASLA) Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 4348), S3269 [13JY]

Lymphedema Treatment Act: Committee on Energy and Commerce (House) (H.R. 3630) (H. Rept. 117–430), H7072 [22JY]

Make PPE in America Act: Committee on Homeland Security and Governmental Affairs (Senate) (S. 1306) (S. Rept. 117–269), S7310 [19DE]

National MEP Supply Chain Database Act: Committee on Commerce, Science, and Transportation (Senate) (S. 3290), S7030 [7DE]

Revise and Extend FDA User-Fee Programs for Prescription Drugs, Medical Devices, Generic Drugs, and Biosimilar Biological Products: Committee on Energy and Commerce (House) (H.R. 7667) (H. Rept. 117–348), H5331 [7JN]

Statements

FDA User-Fee Programs for Prescription Drugs, Medical Devices, Generic Drugs, and Biosimilar Biological Products Goals and Procedures: Xavier Becerra, Sec. of HHS, S5177–S5220 [28SE]

Tables

Estimated pay-as-you-go effects of H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5330 [7JN]

Texts of

H. Res. 1191, consideration of H.R. 5585, Advanced Research Project Agency-Health (ARPA-H) Act, H5745 [22JN]

H.R. 3630, Lymphedema Treatment Act, H8469 [14NO]

H.R. 5585, Advanced Research Project Agency-Health (ARPA-H) Act, H5795–H5798 [22JN]

H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5298–H5319 [7JN]

S. 1662, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act, H1159 [28FE]

S. Res. 631, prohibit imposition of vaccination, testing, and masking requirements relative to coronavirus for Senate Pages, S2495 [12MY]

S.J. Res. 39, disapprove Dept. of HHS rule entitled ‘‘Vaccine and Mask Requirements To Mitigate the Spread of COVID–19 in Head Start Programs’’, S675 [14FE], S2265 [3MY]