[Federal Register Volume 59, Number 19 (Friday, January 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1789]


[Federal Register: January 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 358

[Docket No. 82N-0214]
RIN 0905-AA06


Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products for 
Over-the-Counter Human Use; Amendment to the Monograph

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
amending the final monograph for over-the-counter (OTC) dandruff, 
seborrheic dermatitis, and psoriasis drug products to include 0.6 
percent micronized selenium sulfide for the control of dandruff. This 
final rule is part of the ongoing review of OTC drug products conducted 
by FDA.

EFFECTIVE DATE: January 30, 1995.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 4, 1991 
(56 FR 63554), FDA issued a final monograph for OTC dandruff, 
seborrheic dermatitis, and psoriasis drug products in subpart H of part 
358 (21 CFR part 358, subpart H). The monograph lists selenium sulfide 
1 percent in Sec. 358.710(a)(5) as an active ingredient that is used 
for the control of dandruff. The selenium sulfide included in the 
monograph is not micronized (reduced to a fine particle size).
     In the Federal Register of April 5, 1993 (58 FR 17554), the agency 
published a notice of proposed rulemaking to amend the final monograph 
for OTC dandruff, seborrheic dermatitis, and psoriasis drug products to 
include 0.6 percent micronized selenium sulfide in Sec. 358.710(a) as 
an active ingredient for the control of dandruff. The agency also 
proposed to add the following definition for micronized selenium 
sulfide in Sec. 358.703(e): ``Selenium sulfide that has been finely 
ground and that has a median particle size of approximately 5 
micrometers (m), with not more than 0.1 percent of the 
particles greater than 15 m and not more than 0.1 percent of 
the particles less than 0.5 m.'' Interested persons were 
invited to submit written comments and comments on the agency's 
economic impact determination by June 4, 1993.
     No comments were received in response to the proposed amendment. 
As discussed in the proposal (58 FR 17554 at 17556), the agency advised 
that any final rule resulting from this proposed rule would be 
effective 12 months after its date of publication in the Federal 
Register. Therefore, on or after January 30, 1995, any OTC drug product 
that is not in compliance with this amendment to the final rule may not 
be initially introduced or initially delivered for introduction into 
interstate commerce unless it is the subject of an approved application 
or abbreviated application. Further, any OTC drug product subject to 
the rule that is repackaged or relabeled after the effective date of 
the rule must be in compliance with the rule regardless of the date 
that the product was initially introduced or initially delivered for 
introduction into interstate commerce. Manufacturers are encouraged to 
comply voluntarily with the rule at the earliest possible date.
     No comments were received in response to the agency's request for 
specific comment on the economic impact of this rulemaking (58 FR 17554 
at 17557). The agency has examined the economic consequences of this 
final rule in conjunction with other rules resulting from the OTC drug 
review. In a notice published in the Federal Register of February 8, 
1983 (48 FR 5806), the agency announced the availability of an 
assessment of these economic impacts. The assessment determined that 
the combined impacts of all the rules resulting from the OTC drug 
review do not constitute a major rule according to the criteria 
established by Executive Order 12866. The agency therefore concludes 
that no one of these rules, including this amendment of the final 
monograph for OTC dandruff, seborrheic dermatitis, and psoriasis drug 
products, is a major rule.
     The economic assessment also concluded that the overall OTC drug 
review was not likely to have a significant economic impact on a 
substantial number of small entities as defined in the Regulatory 
Flexibility Act (Pub. L. 96-354). That assessment included a 
discretionary regulatory flexibility analysis in the event that an 
individual rule might impose an unusual or disproportionate impact on 
small entities. However, this particular rulemaking for OTC dandruff, 
seborrheic dermatitis, and psoriasis drug products is not expected to 
pose such an impact on small businesses. This final rule will not 
remove any existing products from the market or require any 
reformulation or relabeling of existing products. The final rule will 
increase the scope of active ingredients available to industry for this 
class of OTC drug products. This final rule would allow OTC drug 
products containing 0.6 percent micronized selenium sulfide and labeled 
for the control of dandruff to be marketed without having to obtain an 
approved application, as is currently required. This will be beneficial 
to small manufacturers. Therefore, the agency certifies that this final 
rule will not have a significant economic impact on a substantial 
number of small entities.
     The agency has determined under 21 CFR 25.24(c)(6) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects in 21 CFR Part 358

     Labeling, Over-the-counter drugs.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 358 is amended as follows:

 PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-
COUNTER HUMAN USE

     1. The authority citation for 21 CFR part 358 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).

     2. Section 358.703 is amended by adding paragraph (e) to read as 
follows:


Sec. 358.703  Definitions.

 * * * * *
     (e) Selenium sulfide, micronized. Selenium sulfide that has been 
finely ground and that has a median particle size of approximately 5 
micrometers (m), with not more than 0.1 percent of the 
particles greater than 15 m and not more than 0.1 percent of 
the particles less than 0.5 m.
     3. Section 358.710 is amended by redesignating paragraph (a)(6) as 
paragraph (a)(7) and by adding new paragraph (a)(6) to read as follows:


Sec. 358.710  Active ingredients for the control of dandruff, 
seborrheic dermatitis, or psoriasis.

 * * * * *
     (a) *   *   *
     (6) Selenium sulfide, micronized, 0.6 percent.
 * * * * *

    Dated: August 26, 1993.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-1789 Filed 1-27-94; 8:45 am]
BILLING CODE 4160-01-F