[Federal Register Volume 63, Number 234 (Monday, December 7, 1998)]
[Rules and Regulations]
[Pages 67399-67400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32391]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
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Federal Register / Vol. 63, No. 234 / Monday, December 7, 1998 /
Rules and Regulations
[[Page 67399]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 201
[Docket No. 78N-036L]
RIN 0910-AA01
Drug Labeling; Warning and Direction Statements for Rectal Sodium
Phosphates for Over-the-Counter Laxative Use; Final Rule; Stay of
Compliance
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; stay of compliance.
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SUMMARY: The Food and Drug Administration (FDA) is staying compliance
for the regulation for warning and direction statements for over-the-
counter (OTC) dibasic sodium phosphate/monobasic sodium phosphate
(sodium phosphates) drug products intended for rectal (enema) use until
December 7, 1998. The regulation established conditions under which the
labeling must include warning and direction statements for oral and
rectal sodium phosphates products. This stay of compliance applies only
to rectal sodium phosphates products and is in response to requests and
a citizen petition that the final rule did not allow sufficient time
for relabeling of these products. This final rule is part of the
ongoing review of OTC drug products conducted by FDA.
DATES: Section 201.307(b)(2)(ii) and (b)(3)(i) published on May 21,
1998 (63 FR 27836), are effective September 18, 1998, however,
compliance with Sec. 201.307(b)(2)(ii) and (b)(3)(i) as they relate to
rectal sodium phosphates products is not mandatory until December 7,
1998.
FOR FURTHER INFORMATION CONTACT: Cheryl A. Turner, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2291.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 31, 1994 (59 FR 15139), the
agency proposed to amend the tentative final monograph for over-the-
counter (OTC) laxative drug products to limit the OTC container size
for sodium phosphates oral solution to not greater than 90 milliliters
(mL). The agency also proposed a warning for all sodium phosphates
products not to exceed the recommended dosage unless directed by a
doctor.
In the Federal Register of May 21, 1998 (63 FR 27836), FDA issued
a final rule for OTC laxative drug products containing sodium
phosphates Sec. 201.307(b)(1), (b)(2), and (b)(3) (21 CFR
201.307(b)(1), (b)(2), and (b)(3)) establishing a container size
limitation of 90 mL for oral sodium phosphates (sodium phosphates oral
solution), and new warning and direction statements for OTC oral and
rectal sodium phosphates for relief of occasional constipation, or for
preparing the colon for x-ray or endoscopic examination. On May 21,
1998 (63 FR 27886), FDA also issued a proposed rule to amend the
tentative final monograph for OTC laxative drug products (21 CFR 334.16
and 334.58) to include additional general labeling and professional
labeling for oral and rectal sodium phosphates and a new time-to-effect
statement for rectal products.
The final rule requires manufacturers to add certain new labeling
for rectal sodium phosphates drug products. The new warning in
Sec. 201.307(b)(2)(ii) states: ``Using more than one enema in 24 hours
can be harmful.'' The new directions in Sec. 201.307(b)(3)(i) state:
``Do not'' (``take'' or ``use'') ``more unless directed by a doctor.
See Warnings.'' The final rule specified an effective date of September
18, 1998, for these warning and direction statements for rectal sodium
phosphates products.
In the final rule (63 FR 27836 at 27842), the agency stated that
relabeling costs of the type required by this final rule generally
average about $2,000 to $3,000 per stock keeping unit (SKU) (individual
products, packages, and sizes). At that time, the agency was aware of
three manufacturers that together produce approximately 125 SKU's of
rectal sodium phosphates drug products. The agency mentioned that there
may be a few additional small manufacturers or a few additional
products in the marketplace that are not identified in the sources FDA
reviewed. The agency stated that some entities, especially those
private label manufacturers that provide labeling for a number of the
affected products, may incur significant impacts (63 FR 27836 at
27843).
In response to the final rule, the agency received two comments
(Refs. 1 and 2) and two citizen petitions (Ref. 3). One private label
manufacturer (Ref. 1) stated that the economic impact of the final rule
was severe because it currently had 126 SKU's of rectal sodium
phosphates products. The manufacturer stated that its relabeling cost
was approximately $3,500 per SKU or $441,000. In addition, the cost of
stickering the current inventory of 2 million printed folding cartons
is $160,000 with a capital expenditure of $25,000. The cost of
obsolescence for unused printed folding cartons during the transition
period was estimated to be $100,000, making total costs approximately
$776,000. The manufacturer requested that the implementation date of
the final rule for enema products be 1 year after its effective date. A
major manufacturer of oral and rectal sodium phosphates products (Ref.
2) objected to the content of the final rule and argued that the new
warning and direction statements were not justified for rectal sodium
phosphates products.
On July 15, 1998, at a public meeting between representatives of
FDA and industry (Ref. 4), industry representatives stated the
following concerns: (1) The warning in Sec. 201.307(b)(2)(ii) would be
confusing for consumers because it may conflict with how some
physicians prescribe rectal sodium phosphates for cleansing the bowel
in preparation for a medical procedure, and (2) 120 days is not enough
time for manufacturers to relabel their rectal sodium phosphates
products. Industry representatives suggested that the agency revise the
warning to read: ``Use only one enema in 24 hours unless recommended by
a doctor. Serious side effects may occur from excess dosage.'' No
revisions were
[[Page 67400]]
suggested for the direction statement in Sec. 201.307(b)(3)(i).
Petitions (Ref. 3) for a ``stay of action and reconsideration'' for
OTC enemas containing sodium phosphates, submitted in response to this
meeting, requested: (1) An indefinite stay of the warning and
directions required by Sec. 201.307(b)(2)(ii) and (b)(3)(i), (2)
revision of the warning in Sec. 201.307(b)(2)(ii) to read: ``Do not use
more than one enema in a 24-hour period unless directed by a doctor,''
and (3) revision of the directions in Sec. 201.307(b)(3)(i) to read:
``Use only single daily dose unless directed by a doctor. See
Warnings.''
II. The Agency's Response
The agency acknowledged in its analysis of impacts in the final
rule (63 FR 27836 at 27842) that private label manufacturers that
provide labeling for a number of the affected products may incur
significant impacts. Based on the comment's information (Ref. 1), the
agency agrees that the economic impact for this specific manufacturer
is high. In addition, other industry representatives concurred that 120
days was insufficient time for manufacturers to relabel their rectal
sodium phosphates products. Therefore, the agency is staying compliance
with the regulation for relabeling of rectal sodium phosphates products
until December 7, 1998, to provide manufacturers additional time to
comply with the labeling requirements of the final rule. Industry was
previously informed of this stay of compliance with the regulation
(Ref. 5). The agency is not granting a longer stay of compliance or an
indefinite stay of compliance of this portion of the final rule because
of the safety concerns discussed in the final rule (63 FR 27836 at
27840 to 27841).
The petitioner's request for reconsideration and revision of the
warning and direction statements based on professional uses of these
products is denied (Ref. 5). The warning in the March 31, 1994,
proposed rule (59 FR 15139 at 15142) was intended to promote the safe,
direct consumer use of these products. The agency considers the warning
in Sec. 201.307(b)(2)(ii) and the directions in Sec. 201.307(b)(3)(i)
in the May 21, 1998, final rule consistent with the safe, direct
consumer use of rectal sodium phosphates products as intended in the
proposed rule. The agency may reconsider the wording in this labeling
if convincing data are submitted that demonstrate consumer confusion.
The agency believes that professional labeling for these products,
which will be reproposed in a future issue of the Federal Register,
will address any remaining labeling concerns.
Publication of this document constitutes final action on the
warning and labeling directions for rectal sodium phosphates products
in Sec. 201.307(b)(2)(ii) and (b)(3)(i) under the Administrative
Procedure Act (5 U.S.C. 553). Because this final rule is a stay of
compliance of the regulation, FDA finds that the notice and comment
procedures are unnecessary and not in the public interest (5 U.S.C.
553(b) and (d)). The agency believes that staying compliance with the
regulation, as it relates to rectal sodium phosphates products, until
December 7, 1998, will provide sufficient time for industry to
implement the labeling revisions required for rectal sodium phosphates
products.
III. References
The following references are on display in the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, and may be seen by interested parties
between 9 a.m. and 4 p.m., Monday through Friday.
1. Comment No. C190, Docket No. 78N-036L, Dockets Management
Branch.
2. Comment No. LET176, Docket No. 78N-036L, Dockets Management
Branch.
3. Comment No. PRC1, Docket No. 78N-036L, Dockets Management
Branch.
4. Comment No. MM16, Docket No. 78N-036L, Dockets Management
Branch.
5. Letter from D. Bowen, FDA, to P. Reichertz, Arent Fox
Kintner Plotkin & Kahn, coded LET178, Docket No. 78N-036L, Dockets
Management Branch.
IV. Analysis of Impacts
The economic impact of the final regulation was discussed in the
final rule (63 FR 27836 at 27842 and 27843). A stay of compliance for
the warning and direction statements for rectal sodium phosphates
products will provide additional time for companies to relabel these
products and will reduce label obsolescence, as there will be
additional time to use up more existing labeling. Thus, this final rule
granting a stay of compliance should reduce the economic impact on
industry.
FDA has examined the impacts of the final rule (stay of compliance)
under Executive Order 12866 and the Regulatory Flexibility Act (5
U.S.C. 601-612). 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 so 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. This final rule provides a stay of compliance, which
will provide manufacturers additional time to use up existing product
labeling. 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.
V. Paperwork Reduction Act of 1995
FDA concludes that the labeling requirements in this document are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the
labeling is a ``public disclosure of information originally supplied by
the Federal Government to the recipient for the purpose of disclosure
to the public'' (5 CFR 1320.3(c)(2)).
VI. Environmental Impact
The agency has determined under 21 CFR 25.31(c) 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.
Dated: December 1, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-32391 Filed 12-4-98; 8:45 am]
BILLING CODE 4160-01-F
