[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