To make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products.
What it does: Adds SEC. 11__. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE at the end of title XI
Sen. Jack Reed (D-RI)What it changes
1 change to S. 3187 · shown in the bill's text
Adds SEC. 11__. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE at the end of title XI
Adds a sectionIn S. 3187 · Placed on Calendar Senate
"(b) Financial Interest.--In this section, the term 'financial interest' means a financial interest under section 208(a) of title 18, United States Code.".
Inserted: SEC. 11__. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.
Inserted: In accordance with the final rule issued by the Commissioner of Food and Drug entitled "Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates" (77 Fed. Reg. 27591 (May 11, 2012)), a product subject to the final rule issued by the Commissioner entitled "Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use" (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with such rule not later than--
Inserted: (1) December 17, 2013, for products subject to such rule with annual sales of less than $25,000 and
Inserted: (2) December 17, 2012, for all other products subject to such rule.
Original wording
At the end of title XI, add the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 2126. Mr. REED submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:
At the end of title XI, add the following:
SEC. 11__. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.
In accordance with the final rule issued by the Commissioner of Food and Drug entitled “Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates” (77 Fed. Reg. 27591 (May 11, 2012)), a product subject to the final rule issued by the Commissioner entitled “Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use” (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with such rule not later than--
(1) December 17, 2013, for products subject to such rule with annual sales of less than $25,000 and
(2) December 17, 2012, for all other products subject to such rule.
Legislative Activity
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Senate amendment agreed to: Amendment SA 2126 agreed to in Senate by Unanimous Consent.
May 23, 2012
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Senate amendment agreed to: Amendment SA 2126 agreed to in Senate by Unanimous Consent.
May 23, 2012
Senate amendment proposed (on the floor): Amendment SA 2126 proposed by Senator Harkin for Senator Reed.(consideration: CR S3506-3507; text: CR S3506-3507)
May 23, 2012
Amendment SA 2126 proposed by Senator Harkin for Senator Reed. (consideration: CR S3506-3507; text: CR S3506-3507) To make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products.
May 23, 2012
Amendment SA 2126 agreed to in Senate by Unanimous Consent.
May 23, 2012
Senate amendment submitted
May 21, 2012