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Bill113th CongressFiled Mar 13, 2014Health
H.R. 4250

Sunscreen Innovation Act

Bill journey · stage 2 of 5

Under committee review

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What it doesSummary passed house amended (Jul 28, 2014)

(This measure has not been amended since it was reported to the House on July 24, 2014. The summary of that version is repeated here.)

Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.

Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.

Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).

Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.

Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.

Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.

Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.

What just happenedJul 29, 2014

Received in the Senate.

Who’s behind it

Rep. Whitfield, Ed [R-KY-1](R-KY)Sponsor
34 cosponsors8 D26 R
Read on Congress.gov
34cosponsors1committees19actions1related bills5subjects
  1. Jul 29, 2014IntroReferral

    Received in the Senate.

  2. Jul 28, 2014FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  3. Jul 28, 2014FloorH37300

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6928-6930)

  4. Jul 28, 2014Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6928-6930)

  5. Jul 28, 2014FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 4250.

  6. Jul 28, 2014FloorH30000

    Considered under suspension of the rules. (consideration: CR H6928-6933)

  7. Jul 28, 2014FloorH30300

    Mr. Whitfield moved to suspend the rules and pass the bill, as amended.

  8. Jul 24, 2014CalendarsH12410

    Placed on the Union Calendar, Calendar No. 418.

  9. Jul 24, 2014CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558.

    Energy and Commerce Committee
  10. Jul 24, 2014Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558.

    Energy and Commerce Committee
  11. Jul 15, 2014Committee

    Ordered to be Reported (Amended) by Voice Vote.

    Energy and Commerce Committee
  12. Jul 15, 2014Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  13. Jul 14, 2014Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  14. Jun 19, 2014Committee

    Forwarded by Subcommittee to Full Committee (Amended) by Unanimous Consent .

    Health Subcommittee
  15. Jun 19, 2014Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  16. Mar 14, 2014Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  17. Mar 13, 2014IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  18. Mar 13, 2014IntroReferralIntro-H

    Introduced in House

  19. Mar 13, 2014IntroReferral1000

    Introduced in House

Passed House amendedJul 28, 201436

(This measure has not been amended since it was reported to the House on July 24, 2014. The summary of that version is repeated here.)

Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.

Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.

Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).

Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.

Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.

Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.

Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.
Reported to House with amendment(s)Jul 24, 201417

Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.

Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.

Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).

Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.

Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.

Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.

Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.
Introduced in HouseMar 13, 2014

Sunscreen Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreens.

Requires the Secretary of Health and Human Services (HHS) to review and determine whether OTC sunscreens are generally recognized as safe and effective and ensure that any sunscreens marketed in the United States are appropriately labeled.

Makes sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act.

Establishes a framework for the review and approval by the Food and Drug Administration (FDA) of OTC sunscreens with new active ingredients. Sets forth time frame requirements for review. Requires applications for review to include safety and efficacy data as well as adverse drug experience information.

Directs the Secretary to report on the progress made in issuing timely decisions on the safety and effectiveness of OTC sunscreens.

Requires the Secretary to make determinations on the testing and labeling of aerosol sunscreens and on whether a sunscreen may contain a label indicating a sun protection factor (SPF) greater than 50.

Sunscreen Innovation Act — Informed