[Federal Register: August 19, 2004 (Volume 69, Number 160)]
[Rules and Regulations]
[Page 51362]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au04-3]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 310
[Docket Nos. 1978N-0021 and 1978N-021P]
RIN 0910-AF42
Skin Protectant Drug Products for Over-the-Counter Human Use;
Final Monograph; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) published a document in
the Federal Register of June 4, 2003 (68 FR 33362), that established a
final monograph with conditions under which over-the-counter (OTC) skin
protectant drug products are generally recognized as safe and effective
and not misbranded as part of FDA's ongoing review of OTC drug
products. That final monograph included OTC skin protectant drug
products for minor cuts, scrapes, burns, chapped skin and lips, poison
ivy, poison oak, poison sumac, and insect bites. That document also
amended the regulation that lists nonmonograph active ingredients by
adding those OTC skin protectant ingredients that were found to be not
generally recognized as safe and effective. However, that document had
an incorrect ``approved as of'' date (May 7, 1991, instead of November
10, 1993) in Sec. 310.545(a)(18)(v)(A) and (a)(18)(vi)(A) in part 310
(21 CFR part 310) and incorrectly added paragraphs (a)(18)(ii) through
(a)(18)(vi)(A) to Sec. 310.545(d)(1) when those paragraphs should have
been included in Sec. 310.545(d)(11). This document corrects those
errors.
DATES: This rule is effective August 19, 2004.
FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2222.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 310
Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
310 is amended as follows:
PART 310--NEW DRUGS
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1. The authority citation for 21 CFR part 310 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b-263n.
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2. Section 310.545 is amended by revising paragraphs (a)(18)(v)(A) and
(a)(18)(vi)(A) headings and paragraphs (d)(1) and (d)(11) to read as
follows:
Sec. 310.545 Drug products containing certain active ingredients
offered over-the-counter (OTC) for certain uses.
(a) * * *
(18) * * *
(v) * * *
(A) Ingredients--Approved as of November 10, 1993.
* * * * *
(vi) * * *
(A) Ingredients--Approved as of November 10, 1993.
* * * * *
(d) * * *
(1) May 7, 1991, for products subject to paragraphs (a)(1) through
(a)(2)(i), (a)(3)(i), (a)(4)(i), (a)(6)(i)(A), (a)(6)(ii)(A), (a)(7)
(except as covered by paragraph (d)(3) of this section), (a)(8)(i),
(a)(10)(i) through (a)(10)(iii), (a)(12)(i) through (a)(12)(iv)(A),
(a)(14) through (a)(15)(i), and (a)(16) through (a)(18)(i)(A).
* * * * *
(11) November 10, 1993, for products subject to paragraphs
(a)(8)(ii), (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except
products that contain ferric subsulfate as covered by paragraph (d)(22)
of this section) through (a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii),
(a)(23)(i), (a)(24)(i), and (a)(25) of this section.
* * * * *
Dated: August 11, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18975 Filed 8-18-04; 8:45 am]
BILLING CODE 4160-01-S