3.0.0 3546 2023-03-24T16:27:31Z 2023-03-24T16:27:31Z Senate S S 2006-06-21 109 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2006-09-05T16:24:08Z Markup by 2006-06-28T19:47:33Z Referred to 2006-06-21T19:50:25Z S. Rept. 109-324 Dietary Supplement and Nonprescription Drug Consumer Protection Act 109 6168 HR 2006-10-02 Referred to the Subcommittee on Health. Related bill CRS 2006-12-22 Became Public Law No: 109-462. President E40000 2 House floor actions 2006-12-22 Became Public Law No: 109-462. BecameLaw 36000 9 Library of Congress 2006-12-22 Signed by President. President E30000 2 House floor actions 2006-12-22 Signed by President. BecameLaw 36000 9 Library of Congress 2006-12-20 Presented to President. Floor E20000 2 House floor actions 2006-12-20 Presented to President. President 28000 9 Library of Congress 2006-12-09 03:06:26 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2006-12-09 03:06:25 On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 203 - 98 (Roll no. 543). (text: CR 12/8/2006 H9243-9245) Floor H37300 2 House floor actions 543 https://clerk.house.gov/evs/2006/roll543.xml House 109 2006-12-09T08:06:25Z 2 2006-12-09 03:06:25 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 203 - 98 (Roll no. 543).(text: CR 12/8/2006 H9243-9245) Floor 8000 9 Library of Congress 543 https://clerk.house.gov/evs/2006/roll543.xml House 109 2006-12-09T08:06:25Z 2 2006-12-09 02:53:00 Considered as unfinished business. (consideration: CR 12/8/2006 H9303-9304) Floor H30000 2 House floor actions 2006-12-09 01:42:30 At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed. Floor H37220 2 House floor actions 2006-12-09 01:33:05 DEBATE - The House proceeded with forty minutes of debate on S. 3546. Floor H8D000 2 House floor actions 2006-12-09 01:33:02 Considered under suspension of the rules. (consideration: CR 12/8/2006 H9243-9246) Floor H30000 2 House floor actions 2006-12-09 01:32:44 Mr. Barton (TX) moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2006-12-07 22:52:17 Held at the desk. Floor H15000 2 House floor actions 2006-12-07 10:19:40 Received in the House. Floor H14000 2 House floor actions 2006-12-07 Senate Message on Senate action sent to the House. Floor 2006-12-06 Senate Passed Senate with an amendment by Unanimous Consent. (consideration: CR S11376-11381; text as passed Senate: CR S11377-11378) Floor 2006-12-06 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S11376-11381; text as passed Senate: CR S11377-11378) Floor 17000 9 Library of Congress 2006-09-05 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 586. Calendars 2006-09-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-324. Committee 2006-09-05 Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-324. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2006-06-28 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 2006-06-21 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2006-06-21 Sponsor introductory remarks on measure. (CR S6285-6287) IntroReferral B00100 9 Library of Congress 2006-06-21 Introduced in Senate IntroReferral 10000 9 Library of Congress H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT N D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2006-06-21 True H000206 Sen. Harkin, Tom [D-IA] THOMAS HARKIN D IA RICHARD 2006-06-21 True E000285 Sen. Enzi, Michael B. [R-WY] MICHAEL ENZI R WY B. 2006-06-21 True K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2006-06-21 True C001056 Sen. Cornyn, John [R-TX] John Cornyn R TX 2006-07-10 False 2006-09-12T04:00:00Z S. 3546, Dietary Supplement and Nonprescription Drug and Consumer Protection Act http://www.cbo.gov/publication/18117 <p>Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on September 5, 2006</p> 2006-09-12T04:00:00Z S. 3546, Dietary Supplement and Nonprescription Drug and Consumer Protection Act https://www.cbo.gov/publication/18117 Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on September 5, 2006 2006-12-27T06:00:00Z S. 3546, Dietary Supplement and Nonprescription Drug Consumer Protection Act http://www.cbo.gov/publication/18271 <p>Estimate of direct spending and revenues effects for the bill as cleared by the Congress on December 9, 2006, and signed by the President on December 22, 2006</p> 2006-12-27T06:00:00Z S. 3546, Dietary Supplement and Nonprescription Drug Consumer Protection Act https://www.cbo.gov/publication/18271 Estimate of direct spending and revenues effects for the bill as cleared by the Congress on December 9, 2006, and signed by the President on December 22, 2006 Public Law 109-462 Health Agriculture and Food Birth defects Business records Civil Rights and Liberties, Minority Issues Commerce Crime and Law Enforcement Death Dietary supplements Drug abuse Drug adulteration Drug industry Federal preemption Food safety Foreign Trade and International Finance Fraud Freedom of information Government Operations and Politics Government paperwork Import restrictions Labeling Local laws Nonprescription drugs Right of privacy State laws Health 00 2006-06-21 Introduced in Senate 2006-08-10T14:45:43Z Dietary Supplement and Nonprescription Drug Consumer Protection Act - Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business days any report received of a serious adverse event associated with such drug or supplement when used in the United States; (2) submit within 15 business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records.

Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated into a single report.

Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.

Prohibits any state or local government from establishing or continuing any requirement related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that is not identical to this Act.

Prohibits the responsible person from: (1) refusing to permit access to any required record; or (2) failing to establish or maintain any record, or make any report, required under this Act.

Deems a nonprescription drug or dietary supplement that is marketed in the United States to be misbranded, unless its label includes an address or phone number for the reporting of a serious adverse event.

]]> 01 2006-09-05 Reported to Senate with amendment(s) 2006-10-31T18:27:31Z Dietary Supplement and Nonprescription Drug Consumer Protection Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business days any report of a serious adverse event associated with use of such drug or supplement in the United States; (2) submit within 15 business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records. Allows a retailer whose name appears on the label as a distributor to authorize the manufacturer or packer to submit the required reports so long as the retailer directs all reported adverse events to such manufacturer or packer.

Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated.

Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.

Considers a serious adverse event report to be: (1) a safety report that may be accompanied by a statement, which shall be included in any public disclosure of the report, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and (2) a record about an individual and a medical or similar file the disclosure of which violates the Freedom of Information Act unless all personally identifiable information is redacted.

Provides that the submission of any adverse event report shall not be construed as an admission that the drug or supplement involved caused or contributed to the adverse event.

Prohibits any state or local government from establishing or continuing any requirements related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that are not identical to the requirements of this Act.

Prohibits the responsible person from: (1) refusing to permit access to any required record; or (2) failing to establish or maintain any record, or make any report, required under this Act.

Deems a nonprescription drug or dietary supplement that is marketed in the United States to be misbranded unless its label includes a domestic address or phone number for the reporting of a serious adverse event.

(Sec. 4) Prohibits the falsification of a serious adverse event report.

(Sec. 5) Prohibits the importation of a drug or supplement subject to this Act if the Secretary has credible information indicating that the responsible person has not complied with the requirements of this Act or has not allowed access to its records.

]]> 49 2006-12-22 Public Law 2007-01-22T20:28:54Z (This measure has not been amended since it was reported to the Senate on September 5, 2006. The summary of that version is repeated here.)

Dietary Supplement and Nonprescription Drug Consumer Protection Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to require a manufacturer, packer, or distributor whose name appears on the label of a nonprescription drug or dietary supplement marketed in the United States to: (1) submit to the Secretary of Health and Human Services within 15 business days any report of a serious adverse event associated with use of such drug or supplement in the United States; (2) submit within 15 business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records. Allows a retailer whose name appears on the label as a distributor to authorize the manufacturer or packer to submit the required reports so long as the retailer directs all reported adverse events to such manufacturer or packer.

Requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated.

Allows the Secretary to establish an exemption from such reporting that would have no adverse effect on public health.

Considers a serious adverse event report to be: (1) a safety report that may be accompanied by a statement, which shall be included in any public disclosure of the report, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and (2) a record about an individual and a medical or similar file the disclosure of which violates the Freedom of Information Act unless all personally identifiable information is redacted.

Provides that the submission of any adverse event report shall not be construed as an admission that the drug or supplement involved caused or contributed to the adverse event.

Prohibits any state or local government from establishing or continuing any requirements related to a mandatory system for adverse event reports for nonprescription drugs or dietary supplements that are not identical to the requirements of this Act.

Prohibits the responsible person from: (1) refusing to permit access to any required record; or (2) failing to establish or maintain any record, or make any report, required under this Act.

Deems a nonprescription drug or dietary supplement that is marketed in the United States to be misbranded unless its label includes a domestic address or phone number for the reporting of a serious adverse event.

(Sec. 4) Prohibits the falsification of a serious adverse event report.

(Sec. 5) Prohibits the importation of a drug or supplement subject to this Act if the Secretary has credible information indicating that the responsible person has not complied with the requirements of this Act or has not allowed access to its records.

]]> Dietary Supplement and Nonprescription Drug Consumer Protection Act Display Title Dietary Supplement and Nonprescription Drug Consumer Protection Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, and for other purposes. Introduced in Senate IS Short Titles as Passed House Dietary Supplement and Nonprescription Drug Consumer Protection Act H House Short Titles as Introduced Dietary Supplement and Nonprescription Drug Consumer Protection Act Short Titles as Enacted Dietary Supplement and Nonprescription Drug Consumer Protection Act Short Titles as Passed Senate Dietary Supplement and Nonprescription Drug Consumer Protection Act S Senate Short Titles as Reported to Senate Dietary Supplement and Nonprescription Drug Consumer Protection Act S Senate Enrolled Bill 2006-12-14T05:00:00Z Engrossed in Senate 2006-12-06T05:00:00Z Reported to Senate 2006-09-05T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109s3546rs/xml/BILLS-109s3546rs.xml Introduced in Senate 2006-06-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109s3546is/xml/BILLS-109s3546is.xml 2006-12-23T04:59:59Z Public Law 2006-12-22 Became Public Law No: 109-462. 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.