[Federal Register Volume 61, Number 199 (Friday, October 11, 1996)]
[Proposed Rules]
[Pages 53340-53341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. 78N-0038]
RIN 0910-AA01


Sunscreen Drug Products for Over-the-Counter Human Use; Amendment 
to the Tentative Final Monograph; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice of 
proposed rulemaking that published in the Federal Register of September 
16, 1996 (61 FR 48645). The document proposed to amend the tentative 
final monograph (proposed rule) for over-the-counter (OTC) sunscreen 
drug products.

[[Page 53341]]

The document was published with several errors. This document corrects 
those errors.

DATES: Written comments by October 16, 1996; written comments on the 
agency's economic impact determination by October 16, 1996. The agency 
is requesting comments within a 30-day period, instead of the normal 90 
days, so that the marketing status of OTC avobenzone-containing 
sunscreen drug products can be determined in an expeditious manner. FDA 
is proposing that any final rule based on this proposal become 
effective 12 months after its date of publication in the Federal 
Register.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Desk copies of these written comments to Debra L. 
Bowen, Center for Drug Evaluation and Research (HFD-560), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:  William E. Gilbertson, Center for 
Drug Evaluation and Research (HFD-105), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-2304.
    In FR Doc. 96-23547, appearing on page 48645 in the Federal 
Register of Monday, September 16, 1996, the following corrections are 
made:
    1. On page 48646, in the third column, lines 3 through 7 are 
removed.
    2. On page 48651, in Table 2, the ingredient ``Octylsalicyulate'' 
is corrected to read ``Octyl salicylate''.

PART 352--SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

    3. The authority citation for 21 CFR part 352 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371).

Sec. 352.20  [Corrected]

    4. On page 48654, in the third column, in Sec. 352.20, paragraph 
(a)(3)(i) is revised; paragraphs (a)(3)(iii) through (a)(3)(xx) are 
redesignated as (a)(3)(iv) through (a)(3)(xxi), respectively; new 
paragraph (a)(3)(iii) is added; in newly redesignated paragraph 
(a)(3)(vii), ``Ethyl .4-[bis(hydroxypropyl]'' is corrected to read 
``Ethyl 4-[bis(hydroxypropyl]''; in newly redesignated paragraph 
(a)(3)(x), the word ``Lawsons'' is corrected to read ``Lawsone''. The 
revision and addition reads as follows:


Sec. 352.20  Permitted combinations of active ingredients.

    (a) * * *
    (3) * * *
    (i) Aminobenzoic acid 5 to 15 percent.
* * * * *
    (iii) Cinoxate 1 to 3 percent.
* * * * *

    Dated: October 8, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-26211 Filed 10-10-96; 8:45 am]
BILLING CODE 4160-01-F