3.0.0 1597 2023-01-11T13:30:41Z 2023-01-11T13:30:41Z Senate S 2015-06-17 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2016-04-05T20:26:18Z Markup by 2016-03-09T15:00:00Z Referred to 2015-06-17T19:44:31Z 2016-04-05 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 413. Calendars 2016-04-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2016-04-05 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2016-03-09 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2015-06-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-06-17 Introduced in Senate IntroReferral 10000 9 Library of Congress W000437 Sen. Wicker, Roger F. [R-MS] Roger Wicker R MS F. N K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2015-06-17 True C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2015-06-17 True F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2015-06-17 True I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA 2015-06-17 True B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2015-06-17 True D000607 Sen. Donnelly, Joe [D-IN] Joe Donnelly D IN 2015-10-26 False C001095 Sen. Cotton, Tom [R-AR] Tom Cotton R AR 2016-02-29 False M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2016-03-09 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Prescription drugs Health 00 2015-06-17 Introduced in Senate 2016-01-07T19:36:16Z Patient-Focused Impact Assessment Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the package of information published by the Food and Drug Administration (FDA) upon approval of a new drug to include documentation of efforts to assess patient engagement. This documentation must include identification of patient-focused drug development tools and an explanation of whether certain information was reviewed or examined, including patient preferences and patient-reported or caregiver-reported outcomes. The FDA must annually summarize the data collected in this documentation.

The FDA must publish guidance on collaboration between patients, advocacy organizations, and industry for the purposes of developing patient-focused drug development tools and obtaining patient perspectives on medical products under development.]]> 01 2016-04-05 Reported to Senate with amendment(s) 2016-12-13T21:48:13Z Patient-Focused Impact Assessment Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), after approving an application for a new medication, to publish a brief statement on any patient experience data or related information that was part of the application. Patient experience data is information about the impact of a medical condition or a related therapy on a patient's life and the patient's preferences for treatment.

(Sec. 3) The FDA must issue guidance on the collection of patient experience data and the use of that data in drug development.

(Sec. 4) The Paperwork Reduction Act does not apply to voluntary collection of patient experience data.

(Sec. 5) The FDA must report on its review of patient experience data as part of approving applications for new medications.]]> Patient-Focused Impact Assessment Act of 2016 Display Title Patient-Focused Impact Assessment Act of 2016 Official Title as Introduced A bill to enhance patient engagement in the medical product development process, and for other purposes. Introduced in Senate IS Short Titles as Introduced Patient-Focused Impact Assessment Act of 2015 Short Titles as Reported to Senate Patient-Focused Impact Assessment Act of 2016 S Senate Reported to Senate 2016-04-05T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1597rs/xml/BILLS-114s1597rs.xml Introduced in Senate 2015-06-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1597is/xml/BILLS-114s1597is.xml 2016-04-05 Placed on Senate Legislative Calendar under General Orders. Calendar No. 413. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.