[Federal Register: August 1, 2000 (Volume 65, Number 148)]
[Rules and Regulations]
[Page 46864-46868]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au00-4]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 341

[Docket No. 76N-052T]
RIN 0910-AA01

Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug
Products for Over-the-Counter Human Use; Amendment of Final Monograph
for OTC Antitussive Drug Products

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
amending the final monograph for over-the-counter (OTC) antitussive
drug products (products that relieve cough). Use of topical/inhalant
products containing camphor or menthol near a flame, in hot water, or
in a microwave oven may cause the products to splatter and cause
serious burns to the user. As part of its ongoing review of OTC drug
products, FDA is adding warnings and directions to inform consumers
about these improper uses and is amending its final regulations for OTC
drug labeling requirements to add this new flammability warning for
antitussive drug products containing camphor or menthol.

DATES: This rule is effective May 16, 2002. The compliance date for
products with annual sales less than $25,000 is May 16, 2003. The
compliance date for all other OTC drug products is May 16, 2002.

FOR FURTHER INFORMATION CONTACT: Elizabeth A. Ryland or Gerald M.
Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 12, 1987 (52 FR 30042), the
agency published the final monograph for OTC antitussive drug products.
The monograph included the ingredients camphor and menthol as single
topical antitussives in an ointment vehicle or for steam inhalation
use. Products containing camphor and menthol in combination are being
considered as part of the ongoing rulemaking for OTC cough-cold
combination drug products.
    When the final monograph was published in 1987, the agency was not
aware of safety problems occurring when products that contain camphor
or menthol are added to hot water or used in a microwave oven. In the
Federal Register of July 20, 1998 (63 FR 38762), the agency discussed
new information concerning 34 fire-related events (flashing occurred)
resulting from antitussive drug products containing camphor and menthol
(in an ointment vehicle or an alcohol-based solution) that were placed
in hot water or heated in a microwave oven. As a result, the agency
proposed a flammability signal word and new warning and direction
statements for these products (63 FR 38762 at 38765).
    The agency proposed a flammability signal word and a warning
(``Keep away

[[Page 46865]]

from fire or flame'') for any product containing camphor or menthol in
an ointment vehicle or for steam inhalation use. The agency also
proposed a number of ``do not use'' warnings (e.g., near an open flame
and in a microwave oven) and the following statements in the
directions: ``See important warnings about not using near a flame, in
hot water, or in a microwave oven. Improper use may cause the mixture
to splatter and cause burns.''
    In response to the proposal, the agency received two comments,
copies of which are on public display in the Dockets Management Branch
(HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The
agency's responses to the comments follow.

II. The Agency's Conclusions on the Comments

    (Comment 1) One comment agreed with the proposal to require
additional information to help increase appropriate use of the topical/
inhalant drug products containing camphor and menthol.
    (Comment 2) Two comments requested that the regulation clarify that
a flammability signal word is not required on all products. The
comments pointed out that the flammability signal words in 16 CFR
1500.3(b)(10) and (c)(6) state that ``flammable'' is any substance
having a flashpoint above 20  deg.F and below 100  deg.F and that no
flammability signal word is required if the flashpoint of the substance
is above 150  deg.F. The comments added that camphor and menthol in
ointment/cream products have flashpoints over 150  deg.F and would not
need the flammability signal word or warnings, while steam inhalation
products in an alcohol vehicle have a flashpoint between 20  deg.F and
below 100  deg.F and would be labeled as flammable and contain the two
proposed flammability warnings. One comment provided the results of
flashpoint testing for its ointment, cream, and steam inhalation
products (Ref. 1).
    The agency has reviewed the testing results and concurs that
products with a flashpoint above 150  deg.F would not need the
flammability signal word or warnings. The agency only intended that
those products that meet the criteria in 16 CFR 1500.3(b)(10)
(flashpoint of 150  deg.F or below) be labeled with the flammability
signal word and warnings. Accordingly, the agency is revising
Sec. 341.74(c)(5)(iii) (21 CFR 341.74(c)(5)(iii)) to require that the
labeling contains the appropriate flammability signal word and the
statement ``Keep away from fire or flame'' if the product meets the
definition of one of the signal words (``extremely flammable,''
``flammable,'' ``combustible'') as described in 16 CFR 1500.3(b)(10).
The agency is also amending Sec. 201.66(c)(5)(ii)(C) (21 CFR
201.66(c)(5)(ii)(C)) to include Sec. 341.74(c)(5)(iii) as an example
where a flammability warning is found in an OTC drug monograph.
    (Comment 3) Two comments requested that the warnings about not
using these products in certain ways be included in the ``Directions,''
and not the ``Warnings,'' section. The comments contended that the
warnings relate to appropriate use of the product and belong in the
directions so consumers know how to use the product correctly. The
comments argued that because space limitations on small package sizes
make it very difficult to fit similar information in two places
(warnings and directions), the information should be consolidated in
the ``Directions'' section.
    The agency has determined that this information is more appropriate
in the ``Warnings'' section of the labeling. Under the new OTC drug
product labeling format in Sec. 201.66(c)(5)(vi), which was issued
after the proposal in the current rulemaking, the subheading ``When
using this product'' is used to describe activities consumers should
avoid while using the product. Information about not using the product
near a flame or in a microwave oven belongs under this subheading.
However, because of the importance of the warning information, the
agency is including a short cross-reference in the ``Directions''
section to the location of the information in the ``Warnings'' section.
This approach is consistent with the ``choking'' warning for water-
soluble gums in 21 CFR 201.319 where the information about choking
appears in the ``Warnings'' section and a cross-reference to the
warning appears in the ``Directions'' section.
    The agency proposed a two-sentence cross-reference in the
``Directions'' section that was repetitive of some of the information
in the ``Warnings'' section. The agency is removing the repetitive
information in the first proposed sentence (i.e., about not using near
a flame, in hot water, or in a microwave oven) and shortening the
sentence to refer users to the same information in the ``Warnings''
section. The revised directions statement now reads: ``[bullet] see
important warnings under `When using this product' '' [appears as the
first statement under the heading ``Directions'' and is highlighted in
bold type]. The agency is moving the second proposed statement about
the mixture splattering and causing burns to the ``Warnings'' section
to follow the information about not using near a flame or in a
microwave oven, because the second sentence should immediately follow
that information.
    (Comment 4) Two comments requested that the directions provide
different instructions for ointment and steam inhalation products. One
comment suggested the following wording for ointment products: ``Do not
expose to any heat source (including stove or microwave) or place in
any container in which you are heating water. Improper use may cause
the mixture to splatter and cause burns.'' The comment added that steam
inhalation products would also include the word ``flame'' after
``stove'' and the words ``except when adding to cold water in a hot
steam vaporizer'' after the words ``heating water.''
    The second comment proposed similar but revised wording for
ointment products: ``Do not heat. Never expose to flame, microwave, or
place in any container in which you are heating water. Improper use may
cause the mixture to splatter and cause burns.'' The comment added that
steam inhalation products should also include the words ``except when
adding to cold water in a hot steam vaporizer'' after the words
``heating water.''
    As discussed in part II, comment 3 of this document, this
information about not using the products in certain ways will appear in
the ``Warnings'' section. The agency agrees that ointment, cream, and
steam inhalation products could have slightly different warnings
depending on the flashpoint of the products. The data provided by one
comment (Ref. 1) showed that the flashpoints of an ointment product
were 158 and 165  deg.F, while the flashpoint of a cream product was
152  deg.F. As discussed in part II, comment 2 of this document, other
manufacturers' products might have a flashpoint of 150  deg.F or below
and thus be required to have a flammability signal word and warnings.
The agency agrees with deletion of the word ``flame'' from the warnings
for ointment/cream products if they are not flammable or combustible.
The agency also agrees with inclusion of the words ``except when adding
to cold water only in a hot steam vaporizer'' for steam inhalation
products. To increase the amount of information provided to consumers
and to state the information in a clear and concise way, the agency is
revising the warnings as follows:
    <bullet> For any product containing camphor or menthol in a
suitable ointment vehicle and that does not contain a flammability
signal word as described in 16 CFR 1500.3(b)(10). ``When using this
product, do not <bullet> heat

[[Page 46866]]

<bullet> microwave <bullet> add to hot water or any container where
heating water. May cause splattering and result in burns.''
[Information highlighted in bold type.]
    <bullet> For any product containing camphor or menthol in a
suitable ointment vehicle and that contains a flammability signal word
as described in 16 CFR 1500.3(b)(10). ``When using this product, do not
<bullet> heat <bullet> microwave <bullet> use near an open flame
<bullet> add to hot water or any container where heating water. May
cause splattering and result in burns.'' [Information highlighted in
bold type.]
    <bullet> For any product containing camphor or menthol for steam
inhalation use. ``When using this product, do not <bullet> heat
<bullet> microwave <bullet> use near an open flame <bullet> add to hot
water or any container where heating water except when adding to cold
water only in a hot steam vaporizer. May cause splattering and result
in burns.'' [Information highlighted in bold type.]
    There are two types of products containing camphor or menthol for
steam inhalation use on the market. One is formulated to be added
directly to cold water inside a hot steam vaporizer before the water is
heated, and the other is formulated to be placed into the medication
chamber of the vaporizer. The agency is modifying the directions in
Sec. 341.74(d)(2)(iv) and (d)(2)(v) for products containing camphor or
menthol for steam inhalation use to include appropriate directions for
both types of these products, as follows:
    <bullet> For products formulated to be added directly to cold water
inside a hot steam vaporizer. <bullet> use 1 tablespoonful of solution
for each quart of water or 1\1/2\ teaspoonsful of solution for each
pint of water <bullet> add solution directly to cold water only in a
hot steam vaporizer <bullet> follow manufacturer's directions for using
vaporizer.
    <bullet> For products formulated to be placed in the medication
chamber of a hot steam vaporizer. <bullet> place water in the vaporizer
and follow manufacturer's directions for using vaporizer <bullet> place
solution in the medication chamber only.
    (Comment 5) One comment stated that the proposed warning about not
using an ointment product in a hot steam vaporizer is inappropriate
(because these products are not used in that manner) and will lead to
consumer confusion.
    The agency notes that 1 of the 21 fire-related events discussed in
the proposal (63 FR 38762) involved an ointment product that was added
to hot water in a vaporizer. The agency believes that it is important
to inform consumers about this potential problem. The portion of the
warning about not adding the product to ``hot water'' covers both hot
water in a container on the stove and hot water in a vaporizer; thus,
this information should adequately inform consumers and should not
cause confusion.

III. Reference

    The following reference is on display in the Dockets Management
Branch (address above) and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday.
    1. Comment No. C200, Docket No. 76N-052T, Dockets Management
Branch.

IV. The Agency's Final Conclusions

    The agency concludes that the case reports raise safety concerns
that could be alleviated by providing consumers with additional
warnings and directions for topical/inhalant OTC antitussive drug
products that contain camphor or menthol. Products that meet the
definition of one of the signal words (``extremely flammable,''
``flammable,'' ``combustible'') in 16 CFR 1500.3(b)(10) must state the
signal word and ``Keep away from fire or flame'' in their labeling.
Consumers need to be informed via warnings not to heat or microwave
these products, not to add them to hot water, not to put them in any
container where water is being heated (except for adding a steam
inhalation product to cold water only in a hot steam vaporizer), and
not to use near an open flame (if the product bears a flammability
signal word). The agency has included warnings and directions with
minor differences to fit the variety of products that might exist and a
short cross-reference to the warnings information in the directions
section. The agency has revised proposed warnings and directions in
this final rule to state them in the new OTC drug labeling format
required by Sec. 201.66.

V. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). 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). Under the Regulatory
Flexibility Act, if a rule has a significant economic impact on a
substantial number of small entities, an agency must analyze regulatory
options that would minimize any significant impact of the rule on small
entities. Section 202(a) of the Unfunded Mandates Reform Act requires
that agencies prepare a written statement and economic analysis before
proposing any rule that may result in an expenditure in any one year by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million (adjusted annually for inflation).
    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 purpose of this final rule is to revise and improve the
labeling (add additional warning and direction statements) for safer
use of topical/inhalant products that contain camphor, menthol, or both
ingredients. This revised labeling addresses the flammability of these
products and alerts consumers not to heat or microwave the products,
nor to use near an open flame, add to hot water, or put in any
container in which water is being heated (with an exception for adding
a steam inhalation product to cold water only in a hot steam
vaporizer). Potential benefits include a reduction in the number of
flash fires and serious burns that may occur if consumers should misuse
these products.
    This final rule will require relabeling of topical/inhalant
products that contain camphor, menthol, or both ingredients. The
agency's Drug Listing System identifies about 30 manufacturers and 80
marketers of over 100 stockkeeping units (SKU's) (individual products,
packages, and sizes) of topical/inhalant antitussive drug products
containing camphor, menthol, or both ingredients. There may be a few
additional marketers and products that are not identified in the
sources FDA reviewed.
    The agency indicated in the proposal that relabeling costs of the
type required by this final rule generally average about $2,000 to
$3,000 per SKU. In determining this cost, the agency did not believe
that manufacturers would need to increase the package size to add the
additional labeling information. Almost all of these products are
marketed in an outer carton, which should have adequate space for the
additional information. Assuming that there are about 110 affected OTC
SKU's in the marketplace, FDA estimated that the rule would impose
total one-time compliance costs on industry for

[[Page 46867]]

relabeling of about $220,000 to $330,000. The agency did not receive
any comments on these estimates.
    The agency believes the actual cost could be lower for several
reasons. First, most of the label changes will be made by private label
small manufacturers that tend to use simpler and less expensive
labeling. However, the final rule will not require any new reporting
and recordkeeping activities. Therefore, no additional professional
skills are needed. Second, the agency has made the compliance dates for
this final rule the same as the dates for these monographed products to
be in compliance with the new standardized format and standardized
content requirements for the labeling of OTC drug products
(Sec. 201.66), which are now May 16, 2002 (and May 16, 2003, for
products with annual sales less than $25,000). Manufacturers will not
incur any expenses determining how to state the product's labeling. All
manufacturers should have ample time to use up existing labeling stocks
and the relabeling costs would be mitigated. Thus, all required
labeling changes can be made at the same time, thereby reducing the
labeling cost of this final rule.
    The agency considered but rejected several labeling alternatives:
(1) A shorter or longer implementation period, and (2) an exemption
from coverage for small entities. While the agency believes that
consumers would benefit from having this new labeling in place as soon
as possible, the agency also acknowledges that coordination of this
labeling change with implementation of the new OTC ``Drug Facts''
labeling may significantly reduce the costs of this final rule. Both a
shorter and a longer time period for this rule may cost more if firms
would have to undertake two successive labeling revisions. In addition,
a longer time period would unnecessarily delay the benefit of the new
labeling to consumers who self-medicate with these products. The agency
rejected an exemption for small entities because the new labeling
information is also needed by consumers who purchase products marketed
by those entities.
    The agency does not believe that this final rule will have a
significant economic impact on small entities, using the U.S. Small
Business Administration designations for this industry (750 employees).
The agency believes that any other unidentified manufacturer of these
products is also a small entity. From information available to the
agency, it appears that only one small entity manufactures more than
three SKU's of these products. Based on the limited number of SKU's
each manufacturer has to relabel, the cost for each manufacturer except
one should be minimal.
    Under the Unfunded Mandates Reform Act, FDA is not required to
prepare a statement of costs and benefits for this final rule because
this rule is not expected to result in any 1-year expenditure that
would exceed $100 million adjusted for inflation.
    This analysis shows that the agency has considered the burden to
small entities. Thus, this economic analysis, together with other
relevant sections of this document, serves as the agency's final
regulatory flexibility analysis, as required under the Regulatory
Flexibility Act.

VI. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this final rule 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 requirements are 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)).

VII. Environmental Impact

    The agency has determined under 21 CFR 25.31(a) 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

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 341

    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 parts
201 and 341 are amended as follows:

PART 201--LABELING

    1. The authority citation for 21 CFR part 201 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

    2. Section 201.66 is amended by revising paragraph (c)(5)(ii)(C) to
read as follows:

Sec. 201.66  Format and content requirements for over-the-counter (OTC)
drug product labeling.

* * * * *
    (c) * * *
    (5) * * *
    (ii) * * *
    (C) Flammability warning, with appropriate flammability signal
word(s) (e.g., Secs. 341.74(c)(5)(iii), 358.150(c), and 358.550(c) of
this chapter). This warning shall follow a subheading containing the
appropriate flammability signal word(s) described in an applicable OTC
drug monograph or approved drug application.
* * * * *

PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

    3. The authority citation for 21 CFR part 341 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

    4. Section 341.74 is amended by adding new paragraphs (c)(5)(iii)
through (c)(5)(vii), and by revising paragraphs (d)(2)(i), (d)(2)(ii),
(d)(2)(iv), and (d)(2)(v) to read as follows:

Sec. 341.74  Labeling of antitussive drug products.

* * * * *
    (c) * * *
    (5) * * *
    (iii) For any product containing camphor or menthol in a suitable
ointment vehicle or for steam inhalation use and meets the definition
of one of the signal words (``extremely flammable,'' ``flammable,''
``combustible'') as described in 16 CFR 1500.3(b)(10). The labeling
contains the appropriate flammability signal word(s) followed by a
colon and the statement ``Keep away from fire or flame.''
    (iv) For any product containing camphor or menthol in a suitable
ointment vehicle and that does not contain a flammability signal word
as described in 16 CFR 1500.3(b)(10). ``When using this product, do not
[bullet] \1\ heat [bullet] microwave [bullet] add to hot water or any
container where heating water. May cause splattering and result in
burns.'' [Information highlighted in bold type.]
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    \1\ For a definition of the term ``bullet,'' see
Sec. 201.66(b)(4) of this chapter.
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    (v) For any product containing camphor or menthol in a suitable
ointment vehicle and that contains a flammability signal word as
described in 16 CFR 1500.3(b)(10). ``When using this

[[Page 46868]]

product, do not [bullet] heat [bullet] microwave [bullet] use near an
open flame [bullet] add to hot water or any container where heating
water. May cause splattering and result in burns.'' [Information
highlighted in bold type.]
    (vi) For any product containing camphor or menthol for steam
inhalation use. ``When using this product, do not [bullet] heat
[bullet] microwave [bullet] use near an open flame [bullet] add to hot
water or any container where heating water except when adding to cold
water only in a hot steam vaporizer. May cause splattering and result
in burns.'' [Information highlighted in bold type.]
    (vii) For any product formulated in a volatile vehicle. The
labeling contains the following statement under the heading ``Other
information'': ``Close container tightly and store at room temperature
away from heat.''
    (d) * * *
    (2) * * *
    (i) For products containing camphor identified in Sec. 341.14(b)(1)
in a suitable ointment vehicle. The product contains 4.7 to 5.3 percent
camphor. ``[bullet] see important warnings under `When using this
product' '' [appears as the first statement under the heading
``Directions'' and is highlighted in bold type] [bullet] adults and
children 2 years and older: [bullet] rub on the throat and chest in a
thick layer [bullet] cover with a warm, dry cloth if desired [bullet]
clothing should be loose about throat and chest to help vapors reach
the nose and mouth [bullet] use up to three times daily or as directed
by a doctor [bullet] children under 2 years of age: Ask a doctor.
    (ii) For products containing menthol identified in
Sec. 341.14(b)(2) in a suitable ointment vehicle. The product contains
2.6 to 2.8 percent menthol. ``[bullet] see important warnings under
`When using this product' '' [appears as the first statement under the
heading ``Directions'' and is highlighted in bold type] [bullet] adults
and children 2 years and older: [bullet] rub on the throat and chest in
a thick layer [bullet] cover with a warm, dry cloth if desired [bullet]
clothing should be loose about throat and chest to help vapors reach
the nose and mouth [bullet] use up to three times daily or as directed
by a doctor [bullet] children under 2 years of age: Ask a doctor.
* * * * *
    (iv) For products containing camphor identified in
Sec. 341.14(b)(1) for steam inhalation use. The product contains 6.2
percent camphor. ``[bullet] see important warnings under `When using
this product' '' [appears as the first statement under the heading
``Directions'' and is highlighted in bold type] [bullet] adults and
children 2 years and older: (select one of the following, as
appropriate: For products formulated to be added directly to cold water
inside a hot steam vaporizer. [bullet] use 1 tablespoonful of solution
for each quart of water or 1\1/2\ teaspoonsful of solution for each
pint of water [bullet] add solution directly to cold water only in a
hot steam vaporizer [bullet] follow manufacturer's directions for using
vaporizer or For products formulated to be placed in the medication
chamber of a hot steam vaporizer. [bullet] place water in the vaporizer
and follow manufacturer's directions for using vaporizer [bullet] place
solution in the medication chamber only) [bullet] breathe in the
medicated vapors [bullet] use up to three times daily or as directed by
a doctor [bullet] children under 2 years of age: Ask a doctor.
    (v) For products containing menthol identified in Sec. 341.14(b)(2)
for steam inhalation use. The product contains 3.2 percent menthol.
``[bullet] see important warnings under `When using this product'
''[appears as the first statement under the heading ``Directions'' and
is highlighted in bold type] [bullet] adults and children 2 years and
older: (select one of the following, as appropriate: For products
formulated to be added directly to cold water inside a hot steam
vaporizer. [bullet] use 1 tablespoonful of solution for each quart of
water or 1\1/2\ teaspoonsful of solution for each pint of water
[bullet] add solution directly to cold water only in a hot steam
vaporizer [bullet] follow manufacturer's directions for using vaporizer
or For products formulated to be placed in the medication chamber of a
hot steam vaporizer. [bullet] place water in the vaporizer and follow
manufacturer's directions for using vaporizer [bullet] place solution
in the medication chamber only) [bullet] breathe in the medicated
vapors [bullet] use up to three times daily or as directed by a doctor
[bullet] children under 2 years of age: Ask a doctor.
* * * * *

    Dated: July 21, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19302 Filed 7-31-00; 8:45 am]
BILLING CODE 4160-01-F