Document ID: FDA-1978-N-0018-1649
Agency: fda
Document Type: Proposed Rule
Title: Sunscreen Drug Products for Over-the-Counter Human Use; Correction
Posted Date: 2019-04-18T04:00Z

[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Proposed Rules]
[Pages 16220-16222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. FDA-1978-N-0018 (formerly Docket No. FDA-1978-N-0038)]
RIN 0910-AF43

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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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.

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.

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 Sec.  
201.327(i)(2)(ii)(B) is corrected to read:
 BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TP18AP19.004

[[Page 16221]]

    2. On page 6268, in the second column, the formula under Sec.  
201.327(i)(3)(ii)(C)(2) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.005

    3. On page 6268, in the second column, the formulas under Sec.  
201.327(i)(3)(ii)(D)(2)(i) are corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.006

    4. On page 6269, in the third column, the formula under Sec.  
201.327(i)(7)(i) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.007

    5. On page 6269, in the third column, the formulas under Sec.  
201.327(i)(7)(ii) are corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.008

    6. On page 6270, in the second column, the formula under Sec.  
201.327(j)(4)(ii) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.009

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

[[Page 16222]]

[GRAPHIC] [TIFF OMITTED] TP18AP19.010

    8. On page 6270, in the third column, the formula under Sec.  
201.327(j)(7) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.011

    9. On page 6270, in the third column, the formula under Sec.  
201.327(j)(8) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.012

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

    Dated: April 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07712 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-C