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

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 Feder...

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Department of Health and Human Services
Food and Drug Administration
  1. 21 CFR Part 201
  2. [Docket No. FDA-1978-N-0018 (formerly Docket No. FDA-1978-N-0038)]
  3. RIN 0910-AF43

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.

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 § 201.327(i)(2)(ii)(B) is corrected to read:

( 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:

( 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.

Dated: April 12, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

BILLING CODE 4164-01-P

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

BILLING CODE 4164-01-C

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

84 FR 16220

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Sunscreen Drug Products for Over-the-Counter Human Use; Correction,” thefederalregister.org (April 18, 2019), https://thefederalregister.org/documents/2019-07712/sunscreen-drug-products-for-over-the-counter-human-use-correction.