[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
