2019-07712. Sunscreen Drug Products for Over-the-Counter Human Use; Correction  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule; correction.

    SUMMARY:

    The Food and Drug Administration (FDA) is correcting a proposed rule relating to the regulation of over-the-counter (OTC) sunscreen monograph products that appeared in the Federal Register of February 26, 2019. The document was published with formulas that were illegible. These corrections are being made to improve the accuracy of the proposed rule.

    DATES:

    Submit either electronic or written comments on the proposed rule by June 27, 2019.

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    FOR FURTHER INFORMATION CONTACT:

    Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993, 240-402-4246.

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    SUPPLEMENTARY INFORMATION:

    In the Federal Register of February 26, 2019 (84 FR 6204), in FR Doc. 2019-03019, on pages 6267 through 6270, the following corrections are made:

    1. On page 6267, in the first column, the formula under § 201.327(i)(2)(ii)(B) is corrected to read:

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    2. On page 6268, in the second column, the formula under § 201.327(i)(3)(ii)(C)(2) is corrected to read:

    3. On page 6268, in the second column, the formulas under § 201.327(i)(3)(ii)(D)(2)(i) are corrected to read:

    4. On page 6269, in the third column, the formula under § 201.327(i)(7)(i) is corrected to read:

    5. On page 6269, in the third column, the formulas under § 201.327(i)(7)(ii) are corrected to read:

    6. On page 6270, in the second column, the formula under § 201.327(j)(4)(ii) is corrected to read:

    7. On page 6270, in the third column, the formulas under § 201.327(j)(5)(i) are corrected to read:

    Start Printed Page 16222

    8. On page 6270, in the third column, the formula under § 201.327(j)(7) is corrected to read:

    9. On page 6270, in the third column, the formula under § 201.327(j)(8) is corrected to read:

    Elsewhere in this issue of the Federal Register, FDA is extending the comment period on the proposed rule.

    Start Signature

    Dated: April 12, 2019.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

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    BILLING CODE 4164-01-P

    [FR Doc. 2019-07712 Filed 4-17-19; 8:45 am]

    BILLING CODE 4164-01-C

Document Information

Published:
04/18/2019
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Proposed Rule
Action:
Proposed rule; correction.
Document Number:
2019-07712
Dates:
Submit either electronic or written comments on the proposed rule by June 27, 2019.
Pages:
16220-16222 (3 pages)
Docket Numbers:
Docket No. FDA-1978-N-0018 (formerly Docket No. FDA-1978-N-0038)
RIN:
0910-AF43: Over-the-Counter (OTC) Drug Review--Sunscreen Products
RINLinks:
https://www.federalregister.gov/regulations/0910-AF43/over-the-counter-otc-drug-review-sunscreen-products
SectionNoes:
PDF File:
2019-07712.pdf
Supporting Documents:
» Reference 63 - FDA Preliminary Regulatory Impact Analysis
» Reference 44 - Hong_2014_Effect of zinc oxide nanoparticles on dams and embryo–fetal development in rats
» Letter from FDA CDER to Bare Escentuals Beauty, Inc.
» Letter from FDA CDER to L'Oreal USA Product
» Reference 211 - Montemarano_1997_Insect repellents and the efficacy of sunscreens
» Reference 210 - Yiin_2015_Assessment of Dermal Absorption of DEET-Containing Insect Repellent and Oxybenzone-Containing Sunscreen
» Reference 209 - Kasichayanula_2007_Percutaneous Characterization of the Insect Repellent DEET and the Sunscreen Oxybenzone
» Reference 208 - Kasichayanula_2005_Simultaneous Analysis of Insect Repellent DEET, Sunscreen Oxybenzone and Five Relevant Metabolites
» Reference 207 - Wang_2007_In vitro percutaneous permeation of the repellant DEET and the sunscreen oxybenzone across human skin
» Reference 206 - Gu_2005_In Vitro Evaluation of Concurrent Use of Commercially Available Insect Repellent and Sunscreen Preparations
CFR: (1)
21 CFR 201