3.0.0 1767 2023-01-11T13:30:07Z 2023-01-11T13:30:07Z Senate S 2015-07-15 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2016-04-05T20:27:51Z Markup by 2016-03-09T15:00:00Z Referred to 2015-07-15T14:41:00Z 21st Century Cures Act 114 34 HR 2016-12-13 Became Public Law No: 114-255. Related bill CRS 2016-04-05 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 414. 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 2015-07-15 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-07-15 Introduced in Senate IntroReferral 10000 9 Library of Congress I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA N C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2015-07-15 True R000307 Sen. Roberts, Pat [R-KS] PAT ROBERTS R KS 2015-07-15 True T000461 Sen. Toomey, Patrick [R-PA] Patrick Toomey R PA J. 2015-08-03 False K000360 Sen. Kirk, Mark Steven [R-IL] MARK KIRK R IL STEVEN 2015-09-25 False D000607 Sen. Donnelly, Joe [D-IN] Joe Donnelly D IN 2015-10-20 False C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA 2015-12-14 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) Health technology, devices, supplies Health 00 2015-07-15 Introduced in Senate 2016-03-22T11:19:15Z Combination Product Regulatory Fairness Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide the sponsor of a product the scientific rationale supporting a determination that the product is not a medical device before making that determination. If the FDA preliminarily determines that a product is not a medical device, the sponsor may propose a study to inform the product's classification.

The FDA is prohibited from determining that a combination product (a product that is a combination of drug, device, or biological product) is a drug solely because the product has a chemical action.

The FDA must provide the scientific rationale for deciding the primary mode of action (the most important therapeutic action) of a combination product if the FDA's decision disagrees with the conclusions of the product sponsor. (Combination products are regulated based on their primary mode of action.)

The sponsor of a combination product and the FDA may agree to a combination product review plan regarding the standards and requirements applicable to the product's premarket review, postmarket modification, or manufacturing.

The FDA may allow the sponsor of a combination product that contains an approved constituent product to omit information from the combination product application that is duplicative of information submitted regarding the approved constituent part.

The FDA must describe the responsibilities of each agency center regarding review of combination products.

The FDA's Office of Combination Products must resolve disputes regarding the premarket review of combination products within 90 days and annually report on disputes and meetings.]]> 01 2016-04-05 Reported to Senate with amendment(s) 2017-01-04T16:49:41Z Combination Product Regulatory Fairness Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding products that are a combination of a drug, medical device, or biological product.

The primary mode of action of a combination product must be the mode of action that makes the greatest contribution to the product's therapeutic effect. (Combination products are regulated based on their primary mode of action.) The FDA is prohibited from determining that a combination product is a drug or biological product solely because the product has a chemical action. If the sponsor of a combination product disagrees with the FDA's determination of the primary mode of action of the product, the FDA must provide the rationale for its determination and the sponsor and the FDA may agree to studies to inform a reevaluation of the product.

After the primary mode of action of a product is determined, the sponsor and the FDA may agree to a combination product review plan that may address the standards and requirements applicable to the product's review, postmarket modification, or manufacturing. The plan must remain in effect unless the sponsor and the FDA agree otherwise or an issue essential to determining the safety or effectiveness of the product is identified.

The FDA may require the sponsor of a combination product that contains an approved constituent part to submit to the FDA only information that is necessary to assess the safety and effectiveness of the combination product, taking into account prior findings regarding the approved constituent part. If the approved constituent part is a drug, the application for the combination product must comply with specified requirements for drug applications.

The FDA Office of Combination Products must coordinate reviews of combination products and oversee feedback regarding such reviews. The office must review FDA agreements, guidance, and practices regarding combination products.

The FDA must: (1) issue guidance that describes the process and best practices for review of combination products, and (2) propose that certain types of combination products may adopt good manufacturing practices that vary from requirements in regulations.]]> Combination Product Regulatory Fairness Act of 2016 Display Title Combination Product Regulatory Fairness Act of 2016 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to combination products, and for other purposes. Introduced in Senate IS Short Titles as Introduced Combination Product Regulatory Fairness Act of 2015 Short Titles as Reported to Senate Combination Product Regulatory Fairness Act of 2016 S Senate Reported to Senate 2016-04-05T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1767rs/xml/BILLS-114s1767rs.xml Introduced in Senate 2015-07-15T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1767is/xml/BILLS-114s1767is.xml 2016-04-05 Placed on Senate Legislative Calendar under General Orders. Calendar No. 414. 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.