3.0.0 3631 2023-01-11T13:23:39Z 2023-01-11T13:23:39Z House H HR 2013-12-02 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. HURT:H.R. 3631.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the U.S. Constitution[Page H7394]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-12-06T16:39:18Z Referred to 2013-12-02T19:00:54Z 2013-12-06 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-12-02 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-12-02 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-12-02 Introduced in House IntroReferral 1000 9 Library of Congress H001060 Rep. Hurt, Robert [R-VA-5] Robert Hurt R VA 5 N R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 2013-12-02 True Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Manufacturing Prescription drugs Small business User charges and fees Health 00 2013-12-02 Introduced in House 2014-04-02T20:40:57Z Small Manufacturer Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to grant the owner of a human generic drug facility a waiver from, or reduction of, one or more human generic drug fees if the Secretary finds that the assessment of the fee would present a significant barrier to market entry because of the owner's limited resources or other circumstances.

Requires an owner seeking such fee waiver or reduction to submit a written request no later than 180 days after the fee is due.

Prohibits the Secretary, in determining whether to grant such waiver or reduction, from considering anything other than the circumstances and assets of the owner and any affiliate of the owner.

Makes these provisions applicable to fees authorized to be assessed and collected for FY2014-FY2017.

]]> Small Manufacturer Protection Act of 2013 Display Title Small Manufacturer Protection Act of 2013 Official Title as Introduced To authorize the Commissioner of Food and Drugs to waive or reduce certain fees applicable to generic drug facilities where the fees would present a significant barrier to market entry because of limited resources available to such facilities or other circumstances. Introduced in House IH Short Titles as Introduced Small Manufacturer Protection Act of 2013 Introduced in House 2013-12-02T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr3631ih/xml/BILLS-113hr3631ih.xml 2013-12-06 Referred to the Subcommittee on Health. 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.