S. Amdt. 1011 - To Insert Provisions Related to Citizens Petitions.

Prescription Drug User Fee Amendments of 2007

S. 1082 — 110^th Congress (2007–2008)

Summary

An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. (by CRS)

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Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes.

Other Titles

• Prescription Drug User Fee Amendments of 2007
• Food and Drug Administration Revitalization Act
• Best Pharmaceuticals for Children Amendments of 2007
• Enhancing Drug Safety and Innovation Act of 2007
• Medical Device User Fee Amendments of 2007
• Pediatric Medical Device Safety and Improvement Act of 2007
• Pediatric Research Improvement Act
• Food and Drug Administration Revitalization Act
• Best Pharmaceuticals for Children Amendments of 2007
• Domestic Pet Turtle Market Access Act of 2007
• Enhancing Drug Safety and Innovation Act of 2007
• Medical Device User Fee Amendments of 2007
• Pediatric Medical Device Safety and Improvement Act of 2007
• Pediatric Research Improvement Act
• Pharmaceutical Market Access and Drug Safety Act of 2007
• An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.

Sponsor

Edward Kennedy

Co-Sponsors

Subjects

• Medicine
• Abortion
• Actions and defenses
• Administrative fees
• Administrative procedure
• Agriculture
• Agriculture in foreign trade
• Animals
• Antibiotics
• Biomedical engineering
• Budgets
• Business
• Canada
• Cancer
• Chemotherapy
• Child health
• Children
• Clinical trials
• Communicable diseases
• Communication in medicine
• Communications
• Conflict of interests
• Congress
• Congressional investigations
• Congressional oversight
• Congressional reporting requirements
• Consumer education
• Consumers
• Cosmetics
• Counterfeiting
• Criminal justice
• Data banks
• Defective products
• Department of Health and Human Services
• Drug abuse
• Drug adulteration
• Drug approvals
• Drug industry
• Drug interactions
• Drug law enforcement
• Drug therapy
• Drug utilization
• Drugs
• Education
• Electronic data interchange
• Elementary and secondary education
• Environmental protection
• Executive departments
• Eye diseases
• Families
• Federal advisory bodies
• Federal aid to education
• Federal aid to research
• Federal reserve system
• Fines (Penalties)
• Food
• Food additives
• Food and Drug Administration (FDA)
• Food industry
• Food preservation
• Food safety
• Food supply
• Foodborne diseases
• Foundations
• Fraud
• Generic drugs
• Genetic counseling
• Genetic engineering
• Genetics
• Government information
• Government paperwork
• Government publicity
• Hazardous substances
• Health information systems
• Health surveys
• Health warnings
• Higher education
• Imaging systems in medicine
• Import restrictions
• Intellectual property
• Internet
• Labeling
• Law
• Marijuana
• Meat
• Medical care
• Medical education
• Medical laboratories
• Medical records
• Medical statistics
• Medical supplies
• Medicinal plants
• Orphan drugs
• Packaging
• Parent and child
• Patent infringement
• Pesticides
• Pets
• Pharmaceutical research
• Pharmacists
• Physical examinations
• Politics and government
• Preschool education
• Prescription pricing
• Prices
• Produce trade
• Product development
• Product safety
• Protection of animals
• Public meetings
• Research and development
• Research grants
• Restrictive trade practices
• Risk
• Salmonella
• Scholarships
• Science policy
• Seafood
• Shellfish
• Skin cancer
• Skin diseases
• Small business
• Social services
• Strategic planning
• Student loan funds
• Technology
• Telecommunication
• Trade
• Turtles
• User charges
• Web sites

Related Bills

• H.R. 2900 (110^th) : Food and Drug Administration Amendments Act of 2007

Major Actions

Introduced	4/10/2007
Referred to Committee
Amendments (82 proposed)
Passed Senate	5/09/2007

Bill History

• All Votes
• All Actions
• Amendments

	Chamber/Committee	Motion	Date	Result
select this vote	Senate	Amendment SA 1018 agreed to in Senate by Unanimous Consent.	5/02/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1025 agreed to in Senate by Voice Vote.	5/02/2007	PASSED by voice vote
select this vote	Senate	Allard Amdt. No. 982	5/02/2007	This amendment DID NOT PASS the Senate 41 voted YES 53 voted NO 6 voted present/not voting
select this vote	Senate	Durbin Amdt. No. 1022, as Modified	5/02/2007	This amendment PASSED the Senate 94 voted YES 0 voted NO 6 voted present/not voting
select this vote	Senate	Motion to Invoke Cloture on the Dorgan Amdt. No. 990	5/03/2007	This amendment PASSED the Senate 63 voted YES 28 voted NO 9 voted present/not voting
select this vote	Senate	Amendment SA 990 agreed to in Senate by Voice Vote.	5/07/2007	PASSED by voice vote
select this vote	Senate	Cochran Amdt. No. 1010	5/07/2007	This amendment PASSED the Senate 49 voted YES 40 voted NO 11 voted present/not voting
select this vote	Senate	Motion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.1082	5/07/2007	This motion PASSED the Senate 82 voted YES 8 voted NO 10 voted present/not voting
select this vote	Senate	Amendment SA 985 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 987 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1004 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1005 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1006 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1009 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
currently selected	Senate	Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1019 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1026 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1041 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1047 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1049 as modified agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1050 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1053 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Amendment SA 1056 agreed to in Senate by Unanimous Consent.	5/08/2007	PASSED by voice vote
select this vote	Senate	Grassley Amdt. No. 1039	5/09/2007	This amendment DID NOT PASS the Senate 46 voted YES 47 voted NO 7 voted present/not voting
select this vote	Senate	Grassley Amdt. No. 998	5/09/2007	This amendment PASSED the Senate 64 voted YES 30 voted NO 6 voted present/not voting
select this vote	Senate	Durbin Amdt. No. 1034	5/09/2007	This amendment DID NOT PASS the Senate 47 voted YES 47 voted NO 6 voted present/not voting
select this vote	Senate	On Passage - Senate - S.1082 as Amended	5/09/2007	This bill PASSED the Senate 93 voted YES 1 voted NO 6 voted present/not voting

	Action	Date	Description
	Introduced	4/10/2007
		4/10/2007	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
	Put on a legislative calendar	4/18/2007	Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
		4/24/2007	Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
	Put on a legislative calendar	4/24/2007	Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.
		4/30/2007	Measure laid before Senate by unanimous consent.
		5/01/2007	Considered by Senate.
		5/01/2007	The committee reported substitute amendment was modified by Unanimous Consent.
		5/01/2007	Cloture motion on amendment SA 990 presented in Senate.
		5/01/2007	Amendment SA 1004 proposed by Senator Landrieu.
		5/01/2007	Amendment SA 990 proposed by Senator Dorgan.
		5/02/2007	Considered by Senate.
		5/02/2007	Amendment SA 982 proposed by Senator Allard.
		5/02/2007	Amendment SA 983 proposed by Senator Vitter.
		5/02/2007	Amendment SA 985 proposed by Senator Brown for Senator Brownback.
		5/02/2007	Amendment SA 988 proposed by Senator Inhofe.
		5/02/2007	Considered by Senate.
		5/02/2007	Amendment SA 993 proposed by Senator Gregg.
		5/02/2007	Considered by Senate.
		5/02/2007	Amendment SA 1010 proposed by Senator Cochran to Amendment SA 990.
		5/02/2007	Amendment SA 1011 proposed by Senator Stabenow.
		5/02/2007	Amendment SA 1018 proposed by Senator DeMint.
select this vote	Vote	5/02/2007	Amendment SA 1018 agreed to in Senate by Unanimous Consent.
		5/02/2007	Amendment SA 1022 proposed by Senator Durbin.
		5/02/2007	Amendment SA 1025 proposed by Senator Schumer.
select this vote	Vote	5/02/2007	Amendment SA 1025 agreed to in Senate by Voice Vote.
select this vote	Vote	5/02/2007	Allard Amdt. No. 982
select this vote	Vote	5/02/2007	Durbin Amdt. No. 1022, as Modified
		5/03/2007	Considered by Senate.
		5/03/2007	Cloture motion on the committee substitute amendment as modified presented in Senate.
		5/03/2007	Cloture motion on the measure presented in Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
		5/03/2007	Considered by Senate.
select this vote	Vote	5/03/2007	Motion to Invoke Cloture on the Dorgan Amdt. No. 990
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
select this vote	Vote	5/07/2007	Amendment SA 990 agreed to in Senate by Voice Vote.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
		5/07/2007	Considered by Senate.
select this vote	Vote	5/07/2007	Cochran Amdt. No. 1010
select this vote	Vote	5/07/2007	Motion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.1082
		5/08/2007	Considered by Senate.
		5/08/2007	Considered by Senate.
		5/08/2007	Proposed amendment SA 983 withdrawn in Senate.
		5/08/2007	Considered by Senate.
select this vote	Vote	5/08/2007	Amendment SA 985 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 987 proposed by Senator Brown for Senator Inhofe.
select this vote	Vote	5/08/2007	Amendment SA 987 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Considered by Senate.
		5/08/2007	Proposed amendment SA 988 withdrawn in Senate.
		5/08/2007	Considered by Senate.
		5/08/2007	Proposed amendment SA 993 withdrawn in Senate.
		5/08/2007	Amendment SA 998 proposed by Senator Brown for Senator Grassley.
		5/08/2007	Considered by Senate.
select this vote	Vote	5/08/2007	Amendment SA 1004 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1005 proposed by Senator Brown for Senator Levin.
select this vote	Vote	5/08/2007	Amendment SA 1005 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1006 proposed by Senator Brown for Senator Murkowski.
select this vote	Vote	5/08/2007	Amendment SA 1006 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1009 proposed by Senator Brown for Senator Hatch.
select this vote	Vote	5/08/2007	Amendment SA 1009 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Considered by Senate.
currently selected	Vote	5/08/2007	Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1019 proposed by Senator Brown for Senator Casey.
select this vote	Vote	5/08/2007	Amendment SA 1019 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1026 proposed by Senator Brown for Senator Feingold.
select this vote	Vote	5/08/2007	Amendment SA 1026 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1034 proposed by Senator Brown for Senator Durbin.
		5/08/2007	Amendment SA 1039 proposed by Senator Brown for Senator Grassley.
		5/08/2007	Amendment SA 1041 proposed by Senator Brown for Senator Obama.
select this vote	Vote	5/08/2007	Amendment SA 1041 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1047 proposed by Senator Brown for Senator Roberts.
select this vote	Vote	5/08/2007	Amendment SA 1047 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1049 proposed by Senator Brown for Senator Enzi.
select this vote	Vote	5/08/2007	Amendment SA 1049 as modified agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1050 proposed by Senator Brown for Senator Enzi.
select this vote	Vote	5/08/2007	Amendment SA 1050 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1053 proposed by Senator Brown for Senator Enzi.
select this vote	Vote	5/08/2007	Amendment SA 1053 agreed to in Senate by Unanimous Consent.
		5/08/2007	Amendment SA 1056 proposed by Senator Brown for Senator Reed.
select this vote	Vote	5/08/2007	Amendment SA 1056 agreed to in Senate by Unanimous Consent.
		5/09/2007	Considered by Senate.
		5/09/2007	The committee substitute as amended agreed to by Unanimous Consent.
		5/09/2007	Cloture motion on the bill withdrawn by unanimous consent in Senate.
		5/09/2007	Considered by Senate.
		5/09/2007	Considered by Senate.
		5/09/2007	Considered by Senate.
select this vote	Vote	5/09/2007	Grassley Amdt. No. 1039
select this vote	Vote	5/09/2007	Grassley Amdt. No. 998
select this vote	Vote	5/09/2007	Durbin Amdt. No. 1034
select this vote	Senate Vote on Passage	5/09/2007	On Passage - Senate - S.1082 as Amended
		5/10/2007	Message on Senate action sent to the House.
		5/10/2007	Received in the House.
		5/11/2007	Held at the desk.

	Number	Sponsor	Date Offered	Status
select this vote	S. Amdt. 982	Allard, Wayne [R-CO]	April 30, 2007	Failed by roll call vote on May 1, 2007.
	To strike provisions related to market exclusivity. Show amendment details
	S. Amdt. 983	Vitter, David [R-LA]	May 1, 2007	Withdrawn on May 7, 2007.
	To require counterfeit-resistant technologies for prescription drugs. Show amendment details
	S. Amdt. 984	Vitter, David [R-LA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 985	Brownback, Samuel [R-KS]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To establish a priority drug review process to encourage treatments of tropical diseases. Show amendment details
	S. Amdt. 986	Landrieu, Mary [D-LA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 987	Inhofe, James [R-OK]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To amend the Head Start Act to require parental consent for nonemergency intrusive physical examinations. Show amendment details
	S. Amdt. 988	Inhofe, James [R-OK]	May 1, 2007	Withdrawn on May 7, 2007.
	To protect children and their parents from being coerced into administering a controlled substance in order to attend school, and for other purposes. Show amendment details
	S. Amdt. 989	Harkin, Thomas [D-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 990	Dorgan, Byron [D-ND]	May 1, 2007	Passed by voice vote on May 6, 2007.
	To provide for the importation of prescription drugs. Show amendment details
	S. Amdt. 991	Kohl, Herbert [D-WI]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 992	Kohl, Herbert [D-WI]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 993	Gregg, Judd [R-NH]	May 1, 2007	Withdrawn on May 7, 2007.
	To provide for the regulation of Internet pharmacies. Show amendment details
	S. Amdt. 994	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 995	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 996	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 997	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 998	Grassley, Charles [R-IA]	May 1, 2007	Passed by roll call vote on May 8, 2007.
	To provide for the application of stronger civil penalties for violations of approved risk evaluation and mitigation strategies. Show amendment details
	S. Amdt. 999	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1000	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1001	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1002	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1003	Grassley, Charles [R-IA]	May 1, 2007	Offered on April 30, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1004	Landrieu, Mary [D-LA]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To require the Food and Drug Administration to permit the sale of baby turtles as pets so long as the seller uses proven methods to effectively treat salmonella. Show amendment details
select this vote	S. Amdt. 1005	Levin, Carl [D-MI]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To require the Food and Drug Administration to determine whether certain substances create any health risks and mislead consumers. Show amendment details
select this vote	S. Amdt. 1006	Murkowski, Lisa [R-AK]	May 1, 2007	Passed by voice vote on May 7, 2007.
	To modify provisions relating to required experience or certification for prescribing or dispensing certain drugs, and for other purposes. Show amendment details
	S. Amdt. 1008	Grassley, Charles [R-IA]	May 2, 2007	Offered on May 1, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1009	Hatch, Orrin [R-UT]	May 2, 2007	Passed by voice vote on May 7, 2007.
	To insert provisions relating to antibiotic access and innovation and certain enantiomer drugs. Show amendment details
select this vote	S. Amdt. 1010	Cochran, Thad [R-MS]	May 2, 2007	Passed by roll call vote on May 6, 2007.
	To protect the health and safety of the public. Show amendment details
currently selected	S. Amdt. 1011	Stabenow, Debbie Ann [D-MI]	May 2, 2007	Passed by voice vote on May 8, 2007.
	To insert provisions related to citizens petitions. Actions May 2, 2007, 12:00 am ET - Amendment SA 1011 proposed by Senator Stabenow. May 3, 2007, 12:00 am ET - Considered by Senate. May 7, 2007, 12:00 am ET - Considered by Senate. May 8, 2007, 12:00 am ET - Considered by Senate. May 8, 2007, 12:00 am ET - Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent. Full Text of this Amendment SA 1011. Ms. STABENOW (for herself, Mr. Thune, Mr. Lott, Mr. Brown, and Mr. Kohl) submitted an amendment intended to be proposed by her to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; as follows: At the appropriate place, insert the following: SEC. __. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION. Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is amended by adding at the end the following: ``(r) Citizen Petitions and Petitions for Stay of Agency Action.-- ``(1) IN GENERAL.-- ``(A) NO DELAY OF CONSIDERATION OR APPROVAL.-- ``(i) IN GENERAL.--With respect to a pending application submitted under subsection (b)(2) or (j), if a petition is submitted to the Secretary that seeks to have the Secretary take, or refrain from taking, any form of action relating to the approval of the application, including a delay in the effective date of the application, clauses (ii) and (iii) shall apply. ``(ii) NO DELAY OF CONSIDERATION.--The receipt of a petition is not just cause to delay consideration of an application submitted under subsection (b)(2) or (j) and consideration of a petition described in clause (i) shall be separate and apart from the review of an application submitted under either such subsection. ``(iii) NO DELAY OF APPROVAL WITHOUT DETERMINATION.--The Secretary shall not delay approval of an application submitted under subsection (b)(2) or (j) while a petition described in clause (i) is reviewed and considered unless the Secretary determines, not later than 30 days after the submission of the petition, that a delay is necessary to protect the public health. ``(B) DETERMINATION OF DELAY.--With respect to a determination by the Secretary under subparagraph (A)(iii) that a delay is necessary to protect the public health the following shall apply: ``(i) Not later than 5 days after making such determination, the Secretary shall publish on the Internet website of the Food and Drug Administration a detailed statement providing the reasons underlying the determination. The detailed statement shall include a summary of the petition and comments and supplements, the specific substantive issues that the petition raises which need to be considered prior to approving a pending application submitted under subsection (b)(2) or (j), and any clarifications and additional data that is needed by the Secretary to promptly review the petition. ``(ii) Not later than 10 days after making such determination, the Secretary shall provide notice to the sponsor of the pending application submitted under subsection (b)(2) or (j) and provide an opportunity for a meeting with appropriate staff as determined by the Commissioner to discuss the determination. ``(2) TIMING OF FINAL AGENCY ACTION ON PETITIONS.-- ``(A) IN GENERAL.--Notwithstanding a determination made by the Secretary under paragraph (1)(A)(iii), the Secretary shall take final agency action with respect to a petition not later than 180 days of submission of that petition unless the Secretary determines, prior to the date that is 180 days after the date of submission of the petition, that a delay is necessary to protect the public health. ``(B) DETERMINATION OF DELAY.--With respect to a determination by the Secretary under subparagraph (A) that a delay is necessary to protect the public health the following shall apply: ``(i) Not later than 5 days after making the determination under subparagraph (A), the Secretary shall publish on the Internet website of the Food and Drug Administration a detailed statement providing the reasons underlying the determination. The detailed statement should include the state of the review of the petition, the specific outstanding issues that still need to be resolved, a proposed timeframe to resolve the issues, and any additional information that has been requested by the Secretary of the petitioner or needed by the Secretary in order to resolve the petition and not further delay an application filed under subsection (b)(2) or (j). ``(ii) Not later than 10 days after making the determination under subparagraph (A), the Secretary shall provide notice to the sponsor of the pending application submitted under subsection (b)(2) or (j) and provide an opportunity for a meeting with appropriate staff as determined by the Commissioner to discuss the determination. ``(3) VERIFICATIONS.-- ``(A) PETITIONS FOR REVIEW.--The Secretary shall not accept a petition for review unless it is signed and contains the following verification: `I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; and (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition. I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is filed on or about __XXXXXXXX. I received or expect to receive payments, including cash and other forms of consideration, from the following persons or organizations to file this petition: __XXXXXX. I verify under penalty of perjury that the foregoing is true and correct.', with the date of the filing of such petition and the signature of the petitioner inserted in the first and second blank space, respectively. ``(B) SUPPLEMENTAL INFORMATION.--The Secretary shall not accept for review any supplemental information or comments on a petition unless the party submitting such information or comments does so in written form and that the subject document is signed and contains the following verification: `I certify that, to my best knowledge and belief: (a) I have not intentionally delayed submission of this document or its contents. I further certify that the information upon which I have based the action requested herein first became known to me on or about __XXXXXXXX. I received or expect to receive payments, including cash and other forms of consideration, from the following persons or organizations to submit this information or its contents: __XXX. I verify under penalty of perjury that the foregoing is true and correct.', with the date of the submission of such document and the signature of the petitioner inserted in the first and second blank space, respectively. ``(4) ANNUAL REPORT ON DELAYS IN APPROVALS PER PETITION.--The Secretary shall annually submit to the Congress a report that specifies-- ``(A) the number of applications under subsection (b)(2) and (j) that were approved during the preceding 1-year period; ``(B) the number of petitions that were submitted during such period; ``(C) the number of applications whose effective dates were delayed by petitions during such period and the number of days by which the applications were so delayed; and ``(D) the number of petitions that were filed under this subsection that were deemed by the Secretary under paragraph (1)(A)(iii) to require delaying an application under subsection (b)(2) or (j) and the number of days by which the applications were so delayed. ``(5) EXCEPTION.--This subsection does not apply to a petition that is made by the sponsor of the application under subsection (b)(2) or (j) and that seeks only to have the Secretary take or refrain from taking any form of action with respect to that application. ``(6) REPORT BY INSPECTOR GENERAL.--The Office of Inspector General of the Department of Health and Human Services shall issue a report not later than 2 years after the date of enactment of this subsection evaluating evidence of the compliance of the Food and Drug Administration with the requirement that the consideration by the Secretary of petitions that do not raise public health concerns remain separate and apart from the review and approval of an application submitted under subsection (b)(2) or (j). ``(7) DEFINITION.--For purposes of this subsection, the term `petition' includes any request to the Secretary, without regard to whether the request is characterized as a petition.''. (As printed in the Congressional Record for the Senate on May 2, 2007.)
	S. Amdt. 1012	Vitter, David [R-LA]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1013	Vitter, David [R-LA]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1014	Vitter, David [R-LA]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1015	Hagel, Charles [R-NE]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1016	Specter, Arlen [D-PA]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1017	Gregg, Judd [R-NH]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1018	DeMint, Jim [R-SC]	May 2, 2007	Passed by voice vote on May 2, 2007.
	To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies. Show amendment details
select this vote	S. Amdt. 1019	Casey, Robert [D-PA]	May 2, 2007	Passed by voice vote on May 8, 2007.
	To express the sense of the Senate concerning orphan disease treatment in children. Show amendment details
	S. Amdt. 1020	Grassley, Charles [R-IA]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1021	Clinton, Hillary [D-NY]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1022	Durbin, Richard [D-IL]	May 2, 2007	Passed by roll call vote on May 2, 2007.
	To ensure the safety of human and pet food. Show amendment details
	S. Amdt. 1023	Durbin, Richard [D-IL]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1024	Salazar, Ken [D-CO]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1025	Schumer, Charles [D-NY]	May 2, 2007	Passed by voice vote on May 2, 2007.
	To express the sense of the Senate with respect to follow-on biologics. Show amendment details
select this vote	S. Amdt. 1026	Feingold, Russell [D-WI]	May 2, 2007	Passed by voice vote on May 8, 2007.
	To require the Food and Drug Administration to publish certain annual reports. Show amendment details
	S. Amdt. 1027	Durbin, Richard [D-IL]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1028	Rockefeller, John [D-WV]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1029	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1030	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1031	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1032	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1033	Sanders, Bernard [I-VT]	May 2, 2007	Offered on May 2, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1034	Durbin, Richard [D-IL]	May 3, 2007	Failed by roll call vote on May 9, 2007.
	To reduce financial conflict of interest in FDA Advisory Panels. Show amendment details
	S. Amdt. 1035	Burr, Richard [R-NC]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1036	Corker, Bob [R-TN]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1037	Vitter, David [R-LA]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1038	Vitter, David [R-LA]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1039	Grassley, Charles [R-IA]	May 3, 2007	Failed by roll call vote on May 9, 2007.
	To clarify the authority of the Office of Surveillance and Epidemiology with respect to postmarket drug safety pursuant to recommendations by the Institute of Medicine. Show amendment details
	S. Amdt. 1040	Clinton, Hillary [D-NY]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1041	Obama, Barack [D-IL]	May 3, 2007	Passed by voice vote on May 8, 2007.
	To improve the safety and efficacy of genetic tests. Show amendment details
	S. Amdt. 1042	Ensign, John [R-NV]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1043	Reed, John [D-RI]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1044	Kohl, Herbert [D-WI]	May 3, 2007	Offered on May 3, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1045	Obama, Barack [D-IL]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1046	Stabenow, Debbie Ann [D-MI]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1047	Roberts, Pat [R-KS]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To modify provisions relating to direct-to-consumer advertisements. Show amendment details
	S. Amdt. 1048	Snowe, Olympia [R-ME]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1049	Enzi, Michael [R-WY]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To modify provisions relating to user fees, and for other purposes. Show amendment details
select this vote	S. Amdt. 1050	Enzi, Michael [R-WY]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To provide for color certification reports. Show amendment details
	S. Amdt. 1051	Stevens, Ted [R-AK]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1052	Corker, Bob [R-TN]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1053	Enzi, Michael [R-WY]	May 7, 2007	Passed by voice vote on May 8, 2007.
	to modify provisions related to pediatric testing and medical products. Show amendment details
	S. Amdt. 1054	Feingold, Russell [D-WI]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1055	Levin, Carl [D-MI]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
select this vote	S. Amdt. 1056	Reed, John [D-RI]	May 7, 2007	Passed by voice vote on May 8, 2007.
	To require the FDA to conduct consumer testing to determine the appropriateness of the labeling requirements for indoor tanning devices. Show amendment details
	S. Amdt. 1057	Gregg, Judd [R-NH]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1058	DeMint, Jim [R-SC]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1059	Sessions, Jefferson [R-AL]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1060	Hatch, Orrin [R-UT]	May 7, 2007	Offered on May 7, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1061	Dorgan, Byron [D-ND]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1062	Dorgan, Byron [D-ND]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1063	Dorgan, Byron [D-ND]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details
	S. Amdt. 1064	Sessions, Jefferson [R-AL]	May 8, 2007	Offered on May 8, 2007.
	Amendment information not available. Show amendment details