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

  • Start Preamble

    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.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    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:

    Start Printed Page 16221

    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.

    End Signature End Supplemental Information

    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:
Food and Drug Administration
Entry Type:
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)
RINs:
0910-AF43: Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph
RIN Links:
https://www.federalregister.gov/regulations/0910-AF43/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph-
PDF File:
2019-07712.Pdf
Supporting Documents:
» Request for Extension from Personal Care Products Council and Consumer Healthcare Products Association
» Reference 210 - Yiin_2015_Assessment of Dermal Absorption of DEET-Containing Insect Repellent and Oxybenzone-Containing Sunscreen
» Reference 190 - EPA_Using Insect Repellents Safely and Effectively
» Reference 185 - Kong_2015_Assessment of Consumer Knowledge of New Sunscreen Labels
» Reference 180 - TGA_2016_Australian regulatory guidelines for sunscreens
» Reference 179 - Fourtanier_2008_Sunscreens containing the BS UVA absorber prevent cutaneous detrimental effects of UV exposure
» Reference 169 - Damian_2011_An action spectrum for UV radiation-induced immunosuppression in humans
» Reference 154 - Liu_2018_Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inhalation Exposure
» Reference 153 - Liu_2017_Particle Size Distribution Analysis of OTC Drug Products with Unintended Inhalation Exposure to Consumers
» Reference 152 - Brown_2013_Thoracic and Respirable Particle Definitions for Human Health Risk Assessment
CFR: (1)
21 CFR 201