[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13592]
[[Page Unknown]]
[Federal Register: June 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 346
[Docket No. 80N-0050]
RIN 0905-AA06
Anorectal Drug Products for Over-the-Counter Human Use; Final
Monograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule with opportunity for comments.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
amending the monograph for over-the-counter (OTC) anorectal drug
products. This amendment updates the monograph to incorporate a United
States Pharmacopeia (U.S.P.) name change for an active ingredient
included in the monograph. This final rule is part of the ongoing
review of OTC drug products conducted by FDA.
DATES: This final rule is effective January 1, 1995; written comments
by August 17, 1994.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
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 August 3, 1990
(55 FR 31776), FDA issued a final monograph for OTC anorectal drug
products (21 CFR part 346). That monograph included ``Hamamelis water,
`The National Formulary XI''' as an active ingredient in
Sec. 346.18(b). ``Hamamelis water'' was also cited in Secs. 346.50
(b)(2)(vi) and (d)(8). Because Hamamelis water had last been included
in an official compendium in The National Formulary XI (Ref. 1), it was
named in this manner in Sec. 346.18(b).
In 1993 (Refs. 2 and 3), Hamamelis water was proposed for inclusion
in U.S.P. XXIII, which becomes official on January 1, 1995. The
proposed official name was subsequently changed from ``Hamamelis
water'' to ``Witch Hazel'' (Ref. 3). To be consistent with the change
in compendial status and to give manufacturers advance notice of the
need for revised labeling, the agency is changing the name of the
ingredient ``Hamamelis water'' to ``witch hazel'' in the final
monograph for OTC anorectal drug products. These changes will occur in
Sec. 346.18(b) in the ingredient listing and in Sec. 346.50 in the
introductory text of paragraphs (b)(2)(vi) and (d)(8). These changes
will become effective on January 1, 1995.
The amendment will require revised product labeling to substitute
witch hazel for hamamelis water. This labeling revision represents a
minor clarifying change that does not change the substance of the
labeling requirements contained in the final regulations. Because
sections 502 (e)(1) and (e)(3) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 352 (e)(1) and (e)(3)) require the established name of a
drug to be used, any ``witch hazel'' drug product initially introduced
or initially delivered for introduction into interstate commerce after
January 1, 1995, will need to bear the new established name ``witch
hazel.''
As noted previously, these changes make the final monograph for OTC
anorectal drug products consistent with a change being implemented in
the official compendium (U.S.P.). Because the name change follows from
a U.S.P. change, the Commissioner has determined that notice and
comment are unnecessary (5 U.S.C. 553(b); 21 CFR 10.40(e)(1)).
Therefore, publication of this document constitutes final action on
these changes under the Administrative Procedure Act (5 U.S.C. 553).
This final rule shall become effective on January 1, 1995.
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and, thus, is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. In this final rule, the labeling change could be
implemented by manufacturers at very little cost at the next printing
of labels. There are only a few manufacturers of products containing
this ingredient. Accordingly, the agency certifies that the final rule
will not have a significant economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
The agency invites public comment regarding any economic impact
that this rulemaking would have on the labeling of OTC drug products.
Types of impact may include, but are not limited to, costs associated
with relabeling. Comments regarding the impact of this final rule on
OTC drug products should be accompanied by appropriate documentation.
The agency will consider any comments to determine whether the
regulation should subsequently be modified.
Interested persons may, on or before August 17, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Written comments on the agency's economic impact
determination may be submitted on or before August 17, 1994. Three
copies of all comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document and may be
accompanied by a supporting memorandum or brief. Received comments may
be seen in the office above between 9 a.m. and 4 p.m., Monday through
Friday.
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.
References
(1) ``The National Formulary,'' 11th ed., Mack Publishing Co.,
Easton, PA, p. 158, 1960.
(2) ``Pharmacopeial Forum,'' The United States Pharmacopeial
Convention, Inc., Rockville, MD, pp. 5266-5268, May and June 1993.
(3) ``Pharmacopeial Forum,'' The United States Pharmacopeial
Convention, Inc., Rockville, MD, pp. 6399-6401, November and
December 1993.
List of Subjects in 21 CFR Part 346
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
346 is amended as follows:
PART 346--ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
1. The authority citation for 21 CFR part 346 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 346.18 Astringent active ingredients is amended by
revising paragraph (b) to read as follows:
Sec. 346.18 Astringent active ingredients.
* * * * *
(b) Witch hazel, 10 to 50 percent.
* * * * *
Sec. 346.50 [Amended]
3. Section 346.50 Labeling of anorectal drug products is amended in
the heading of paragraph (b)(2)(vi) by removing the words ``hamamelis
water'' and adding in their place the words ``witch hazel''; and in the
heading of paragraph (d)(8) by removing the words ``hamamelis water''
and adding in their place the words ``witch hazel''.
Dated: May 16, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-13592 Filed 6-2-94; 8:45 am]
BILLING CODE 4160-01-F-M
