[Federal Register Volume 59, Number 69 (Monday, April 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8533]


[[Page Unknown]]

[Federal Register: April 11, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 338

[Docket No. 92N-0349]
RIN 0905-AA06

 

Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use; 
Amendment of Final 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 
to amend the final monograph for over-the-counter (OTC) nighttime 
sleep-aid drug products to revise a warning required for products that 
contain diphenhydramine citrate or diphenhydramine hydrochloride. This 
final rule will ensure that warnings are the same for diphenhydramine 
salts whether the ingredient is used in OTC nighttime sleep-aid, 
antihistamine, or antitussive drug products. This final rule is part of 
the ongoing review of OTC drug products conducted by FDA.

EFFECTIVE DATE: April 11, 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 February 14, 1989 
(54 FR 6814), FDA issued a final monograph for OTC nighttime sleep-aid 
drug products (21 CFR part 338) that included the following warning 
statement in Sec. 338.50(c)(3) (21 CFR 338.50(c)(3)) for products 
containing diphenhydramine salts: ``Do not take this product if you 
have asthma, glaucoma, emphysema, chronic pulmonary disease, shortness 
of breath, difficulty in breathing, or difficulty in urination due to 
enlargement of the prostate gland unless directed by a doctor.''
    In Sec. 341.72 of the tentative final monograph for OTC 
antihistamine drug products, published in the Federal Register of 
January 15, 1985 (50 FR 2200 at 2215), the agency proposed this same 
warning for all OTC antihistamines. Antihistamines should not be used 
by people who have any obstructive pulmonary disease in which clearance 
of secretions is a problem. The agency stated that respiratory distress 
symptoms, such as difficulty in breathing and shortness of breath, are 
characteristic of chronic obstructive pulmonary disease. The agency 
concluded that such descriptive terms should be included in the warning 
in addition to the names of the diseases, in order to provide more 
information to the consumer.
    In the final monograph for OTC antihistamine drug products, 
published in the Federal Register of December 9, 1992 (57 FR 58356 at 
58374), the agency revised this warning to include the broader phrase 
``breathing problem'' to describe symptoms such as shortness of breath 
and difficulty in breathing related to obstructive pulmonary disease. 
The change in wording will allow consumers to recognize respiratory 
distress symptoms more readily. The agency also removed the descriptive 
term ``asthma'' from the warning and replaced the term ``chronic 
pulmonary disease'' with the term ``chronic bronchitis.'' The revised 
warning, which appears in Sec. 341.72(c)(2) of the final monograph (21 
CFR 341.72(c)(2)), reads as follows: ``Do not take this product, unless 
directed by a doctor, if you have a breathing problem such as emphysema 
or chronic bronchitis, or if you have glaucoma or difficulty in 
urination due to enlargement of the prostate gland.''
    In the Federal Register of August 26, 1993 (58 FR 45216 and 45217), 
the agency proposed to revise the same warning in Sec. 336.50(c)(1) (21 
CFR 336.50(c)(1)) for diphenhydramine and the other antiemetic 
ingredients listed in Sec. 336.10 (21 CFR 336.10) (58 FR 45216 at 
45217) and the same warning in Sec. 38.50(c)(3) for diphenhydramine 
used as an OTC nighttime sleep-aid (58 FR 45217 at 45218) to be 
consistent with the warning in Sec. 341.72(c)(2) for OTC antihistamine 
drug products.
    No comments were received in response to the proposed monograph 
amendment. Therefore, the agency is finalizing the amendment as 
proposed. Elsewhere in this issue of the Federal Register, the agency 
is also finalizing the amendment to the final monograph for OTC 
antiemetic drug products mentioned above.
    In the proposal (58 FR 45217 at 45218), the agency advised that any 
final rule resulting from the proposal would be effective 12 months 
after its date of publication in the Federal Register. Therefore, on or 
after April 11, 1995, any OTC drug product that is not in compliance 
with 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. 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 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 45217 
at 45218). The agency has examined the economic consequences of this 
final rule and has determined that it does not require either a 
regulatory impact analysis, as specified in Executive Order 12866, or a 
regulatory flexibility analysis, as defined in the Regulatory 
Flexibility Act (Pub. L. 96-354). This rulemaking for OTC nighttime 
sleep-aid drug products is not expected to have an impact on small 
businesses. This final rule will require a minor, one-time labeling 
revision, which manufacturers will have 1 year to implement. The impact 
of this final rule appears to be minimal. Therefore, the agency 
concludes that this final rule is not a major rule as defined in 
Executive Order 12866. Further, the agency certifies that this final 
rule will not have a significant economic impact on a substantial 
number of small entities as defined in the Regulatory Flexibility Act.
    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 338

    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 
338 is amended as follows:

Part 338--NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER 
HUMAN USE

    1. The authority citation for 21 CFR part 338 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 338.50 is amended by revising paragraph (c)(3) to read 
as follows:


Sec. 338.50  Labeling of nighttime sleep-aid products.

* * * * *
    (c) * * *
    (3) ``Do not take this product, unless directed by a doctor, if you 
have a breathing problem such as emphysema or chronic bronchitis, or if 
you have glaucoma or difficulty in urination due to enlargement of the 
prostate gland.''
* * * * *

    Dated: March 4, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-8533 Filed 4-8-94; 8:45 am]
BILLING CODE 4160-01-F