[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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