[Federal Register: May 10, 2002 (Volume 67, Number 91)]
[Proposed Rules]
[Page 31739-31745]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my02-11]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 358
[Docket No. 02N-0058]
RIN 0910-AA01
Pediculicide Drug Products for Over-the-Counter Human Use;
Proposed Amendment of Final Monograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the final monograph for over-the-counter (OTC) pediculicide drug
products to revise labeling for the statement of identity, warnings,
directions, and other required statements. Pediculicide drug products
are used for the treatment of head, pubic (crab), and body lice. This
proposal is part of FDA's ongoing review of OTC drug products.
DATES: Submit written or electronic comments by August 8, 2002; written
comments on the agency's economic impact determination by August 8,
2002. See section VIII for the effective and compliance dates of any
final rule that may publish based on this proposal.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/
dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Michael T. Benson, 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 December 14, 1993 (58 FR 65452), the
agency published a final rule in the form of a final monograph in part
358 (21 CFR part 358, subpart G) establishing conditions under which
OTC pediculicide drug products are generally recognized as safe and
effective. The effective date of the final rule was December 14, 1994.
Since that time, the agency has determined that labeling in the
statement of identity, warnings, directions, and certain other required
statements in the pediculicide monograph should be amended to
[[Page 31740]]
increase the probability of treatment success with these products.
In the Federal Register of March 17, 1999 (64 FR 13254), the agency
published a final rule for standardized format and content requirements
for OTC drug product labeling in Sec. 201.66 (21 CFR 201.66). In that
same final rule (64 FR 13254 at 13296), the agency amended the final
monograph for OTC pediculicide drug products and removed the
requirement in Sec. 358.650(d)(1) that the direction ``Important: Read
warnings before using'' be printed in all capital letters. The sentence
now needs only to appear in boldface type with only the first letter in
the word ``Important'' and the word ``Read'' capitalized.
II. The Agency's Proposal
A. Introduction
The agency is proposing to revise the statement of identity,
warnings, directions, and certain other required statements in the
monograph for OTC pediculicide drug products for two reasons: (1) To be
in conformance with the new labeling format in Sec. 201.66, and (2) to
increase the probability of treatment success based on some of the new
information being added to the monograph. The agency is also revising
the indications section to the new labeling format in Sec. 201.66.
Several reports have emphasized the importance of combing and
environmental control for treatment success and for prevention of
reinfestation (Refs. 1 through 5). In 1998, Bainbridge et al. (Ref. 6)
reported high clinical efficacy (79/79 treatment successes, defined as
no live lice and no nits within 0.25 inches of the scalp, after a
second treatment using pyrethrum extract with piperonyl butoxide on day
14 of pediculicide treatment). In the study, the hair was saturated
with the pediculicide according to label directions and was thoroughly
combed to remove lice and nits. Parents and guardians were provided
with instructions regarding treatment of personal contacts and family
members of cases, as well as instructed on proper cleaning of the home.
Family members were provided with a marketed pediculicide shampoo to
use at home to prevent reinfestation of the affected patients if they
declined to participate in the study.
Other authors state that thorough combing is necessary to remove
lice and eggs that the pediculicide does not kill (Refs. 1, 2, and 5).
Because lice removed from the human host can survive up to 2 days and
nits can survive away from the host for up to 10 days (Ref. 3), the
agency believes that additional information about careful disposal of
lice and nits combed out of the hair is very important and useful to
consumers.
Other information can also enhance the effectiveness of combing.
Lice and nits are small and hard to see; thus, good lighting is
essential and magnification is recommended (Refs. 4 and 5). Before
hatching, nits are small, whitish-yellow ovals that are found close to
the scalp, cemented firmly to the hair shaft (Ref. 4). Nits hatch
within 7 to 10 days. Once hatched, the empty, white nit case remains
glued to the hair. When searching the hair, other small white objects
may be easily seen. If these objects are displaced easily from the
hair, they are not nits and are most likely dandruff (Refs. 1, 3, and
4).
Lice are transmitted by actual contact with infested persons,
bedding materials, or articles of clothing (Refs. 2 through 5). To
prevent reinfestation, environmental measures need to be taken as
indicated in Sec. 358.650(c) of the monograph. Clothing, linens, and
towels need to be washed in hot water and dried in a hot dryer for at
least 20 minutes. Vacuuming of rugs, carpets, upholstered furniture,
and car seats is also recommended. Anything that cannot be laundered or
vacuumed should be sealed in a plastic bag for 4 weeks. Personal combs
and brushes may be disinfected by soaking in hot water (above 54 deg.C
(130 deg.F)) for 5 to 10 minutes. As discussed above, the agency
believes that it is necessary to inspect and treat family members and
personal contacts and to clean or dispose of fomites\1\ properly (Refs.
3, 4, and 5). These ancillary measures contributed to the high
treatment success rate in the Bainbridge study (Ref. 6). The agency
believes that using plain language in informing consumers about the
reasons for label recommendations would improve compliance.
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\1\ Items such as a book, wooden object, or clothing that is not
in itself harmful, but is able to harbor lice or nits and thus may
serve as an agent of transmission of an infestation.
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A second treatment after 7 to 10 days is essential because the
first treatment: (1) May not kill all of the lice, (2) does not have
any effect on nits within the first 4 days after the eggs have been
laid because the nervous system has not yet developed in the louse
embryo (Refs. 1, 4, and 5), and (3) has no residual lice-killing effect
after the product is washed out of hair.
B. The Agency's Specific Recommendations
The current monograph statement of identity in Sec. 358.650(a)
provides for ``pediculicide (lice treatment)'' or ``lice treatment.''
Because the term ``pediculicide'' is extra wording that is not needed,
the agency is proposing to remove it and to limit the statement of
identity to ``lice treatment.''
The agency is proposing to convert the labeling in
Sec. 358.650(c)(1), (c)(2), and (c)(3) to the format required in
Sec. 201.66(c), using the subheadings ``Do not use,'' ``Ask a doctor
before use if you have,'' ``When using this product,'' and ``Stop use
and ask a doctor if.'' The proposed labeling includes bullets in accord
with Sec. 201.66(d)(4). The agency is deleting Sec. 358.650(c)(4)
because that section is currently addressed by Sec. 330.1(i)(23) (21
CFR 330.1(i)(23)).
The agency is revising the warning statement ``Use with caution on
persons allergic to ragweed'' in Sec. 358.650(c)(1) to read: ``Ask a
doctor before use if you are [bullet] allergic to ragweed. May cause
breathing difficulty or an asthmatic attack.'' This warning would
appear in new Sec. 358.650(c)(3).
The current warnings in Sec. 358.650(c)(2) state in part:
* * * Do not use near the eyes or permit contact with mucous
membranes, such as inside the nose, mouth, or vagina, as irritation
may occur. Keep out of eyes when rinsing hair. Adults and children:
Close eyes tightly and do not open eyes until product is rinsed out.
Also, protect children's eyes with washcloth, towel or other
suitable material, or by a similar method. * * *
The agency is shortening these warning statements by deleting: (1)
``* * * or permit contact with mucous membranes, such as * * *'' and
``* * * as irritation may occur'' from the first sentence, (2) ``Adults
and children:'' from the third sentence, and (3) ``Also,''
``children's'' and ``or other suitable material, or by a similar
method'' from the fourth sentence. The revised warnings appear under
the subheadings ``Do not use'' (new Sec. 358.650(c)(2)) or ``When using
this product'' (new Sec. 358.650(c)(4)), as follows: ``Do not use
[bullet] near eyes [bullet] inside nose, mouth, or vagina'' and ``When
using this product [bullet] keep eyes tightly closed and protect eyes
with a washcloth or towel [bullet] if product gets in eyes, flush with
water right away [bullet] scalp itching or redness may occur.''
The agency is making two minor changes in the last warning
statement in current Sec. 358.650(c)(2) that states ``If product gets
into the eyes, immediately flush with water.'' The agency is
substituting ``in'' for ``into'' and ``right away'' for
``immediately,'' and moving ``right away'' to the end of the warning.
The current warnings in Sec. 358.650(c)(3) state ``If skin
irritation or infection is present or develops, discontinue use and
consult a doctor.
[[Page 31741]]
Consult a doctor if infestation of eyebrows or eyelashes occurs.'' The
agency is revising the first sentence and placing it in new
Sec. 358.650(c)(5) to read: ``Stop use and ask a doctor if [bullet]
skin or scalp irritation continues or infection occurs.'' The agency is
moving the second sentence to under the ``Do not use'' subheading in
new Sec. 358.650(c)(2) to read ``[bullet] on lice in eyebrows or
eyelashes. See a doctor.''
Table 1 shows how, using the format in Sec. 201.66(c)(5), the
agency is revising the warnings in Sec. 358.650(c) of the final
monograph in this proposed amendment.
Table 1.--Revision of Final Monograph Warnings to New Format
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Pediculicide Final Monograph Proposed Amendment to Monograph
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For external use only. For external use only.\2\
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Do not use
Do not use near the eyes near eyes
or permit contact with mucous inside nose, mouth, or
membranes, such as inside the vagina
nose, mouth, or vagina, as
irritation may occur.
Consult a doctor if infestation of on lice in eyebrows or
eyebrows or eyelashes occurs. eyelashes. See a doctor.
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Ask a doctor before use if you are
Use with caution on persons allergic to ragweed. May
allergic to ragweed. cause breathing difficulty or an
asthmatic attack.
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When using this product
Keep out of eyes when rinsing hair. keep eyes tightly closed
Adults and children: Close eyes and protect eyes with a washcloth
tightly and do not open eyes until or towel
product is rinsed out. Also,
protect children's eyes with
washcloth, towel or other suitable
material, or by a similar method.
If product gets into the eyes, if product gets in eyes,
immediately flush with water. flush with water right away
scalp itching or redness
may occur
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Stop use and ask a doctor if
breathing difficulty
occurs
eye irritation occurs
If skin irritation or infection is skin or scalp irritation
present or develops, discontinue continues or infection occurs
use and consult a doctor.
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\2\ In bold type on the line immediately following the line for the
Warnings heading. See Sec. 201.66(c)(5)(i) and (d)(6) of this
chapter.
The agency is amending the ``Directions'' in Sec. 358.650(d) to
provide greater detail. The directions for all products would include
directions for adults and children 2 years and over and direct
consumers to ask a doctor for children under 2 years. The directions
would include new captions entitled ``Treat'' and ``Remove lice and
their eggs (nits)'' and information to see a doctor for other
treatments if infestation continues. The directions for head lice
treatment products would also include a new caption entitled
``Inspect.'' The proposed labeling includes bullets in accord with
Sec. 201.66(d)(4).
The current direction in Sec. 358.650(d)(1) reads: ``For all
products. `Important: Read warnings before using.' [statement in
boldface type].'' The agency is revising this direction by changing
``using'' to ``use,'' and requiring this statement to appear first.
This statement appears in new Sec. 358.650(d)(1).
The agency is adding a heading in new Sec. 358.650(d)(2) that
states: ``adults and children 2 years and over:'' [in bold type]. The
agency has a safety concern that there may be a greater likelihood of
percutaneous absorption of topically applied pediculicide drug products
by children under 2 years of age.
The agency is adding new Sec. 358.650(d)(3) for head lice treatment
products. This new section adds the following statements: ``Inspect
[bullet] check each household member with a magnifying glass in bright
light for lice/nits (eggs) [bullet] look for tiny nits near scalp,
beginning at back of neck and behind ears [bullet] examine small
sections of hair at a time [bullet] unlike dandruff which moves when
touched, nits stick to the hair [bullet] if either lice or nits are
found, treat with this product''.
The agency is moving the information currently in
Sec. 358.650(d)(2) and (d)(3) to new Sec. 358.650(d)(4) for
manufacturers to select the directions for either shampoo or nonshampoo
products. The agency is revising some of the text in the new paragraph
and adding the phrases ``for head lice, first apply behind ears and to
back of neck,'' ``use warm water to form a lather, shampoo, then
thoroughly rinse'' for shampoo products; ``wash area thoroughly with
warm water and soap or shampoo'' for nonshampoo products; and ``for
head lice, towel dry hair and comb out tangles'' for both types of
products.
The agency is adding new ``Remove lice and their eggs (nits)''
information for all products in Sec. 358.650(d)(5). This new
information adds the following statements:
[bullet] use a fine-tooth or special lice/nit comb. Remove any
remaining nits by hand (using a throw-away glove). [bullet] hair
should remain slightly damp while removing nits [bullet] if hair
dries during combing, dampen slightly with water [bullet] for head
lice, part hair into sections. Do one section at a time starting on
top of head. Longer hair may take 1 to 2 hours. [bullet] lift a 1 to
2 inch wide strand of hair. Place comb as close to scalp as possible
and comb with a firm, even motion away from scalp. [bullet] pin back
each strand of hair after combing [bullet] clean comb often. Wipe
nits away with tissue and discard in a plastic bag. Seal bag and
discard to prevent lice from coming back. [bullet] after combing,
thoroughly recheck for lice/nits. Repeat combing if necessary.
[bullet] check daily for any lice/nits that you missed.
The agency is proposing new Sec. 358.650(d)(6) and (d)(7) as
follows: ``[bullet] a second treatment must be done in 7 to 10 days to
kill any newly hatched lice [bullet] if infestation continues, see a
doctor for other treatments''. Paragraph (d)(6) incorporates
information in existing Sec. 358.650(d)(2) and (d)(3).
[[Page 31742]]
Table 2 shows how the agency is revising the directions in
Sec. 358.650(d) of the final monograph in this proposed amendment.
Table 2.--Revision of Final Monograph Directions to New Format
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Pediculicide Final Monograph Proposed Amendment to Monograph
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Important: Read warnings before Important: Read warnings
using. before use.
adults and children 2
years and over:
Inspect
check each household
member with a magnifying glass in
bright light for lice/nits
look for tiny nits near
scalp, beginning at back of neck
behind ears
examine small sections of
hair at a time
unlike dandruff which
moves when touched, nits stick to
the hair
if either lice or nits
(eggs) are found, treat with this
product
Treat
Apply to affected area until all apply thoroughly to hair
the hair is thoroughly wet with or other affected area. For head
product. lice, first apply behind ears and
to back of neck.
Allow product to remain on area for allow product to remain
10 minutes but no longer. for 10 minutes, but no longer
Add sufficient warm water to form a use warm water to form a
lather and shampoo as usual. Rinse lather, shampoo, then thoroughly
thoroughly. rinse\3\
Wash area thoroughly with warm
water and soap or shampoo. wash area thoroughly with
warm water and soap or shampoo\4\
for head lice, towel dry
hair and comb out tangles\5\
Remove lice and their eggs (nits)
A fine-toothed comb or a special use a fine-tooth or
lice/nit removing comb may be used special lice/nit comb. Remove any
to help remove dead lice or their remaining nits by hand (using a
eggs (nits) from hair. throw-away glove).
hair should remain
slightly damp while removing nits
if hair dries during
combing, dampen slightly with
water
for head lice, part hair
into sections. Do one section at a
time starting on top of head.
Longer hair may take 1 to 2 hours.
lift a 1 to 2 inch wide
strand of hair. Place comb as
close to scalp as possible and
comb with a firm, even motion away
from scalp.
pin back each strand of
hair after combing
clean comb often. Wipe
nits away with tissue and discard
in a plastic bag. Seal bag and
discard to prevent lice from
coming back.
after combing, thoroughly
recheck for lice/nits. Repeat
combing if necessary.
check daily for any lice/
nits that you missed
A second treatment must be done in a second treatment must be
7 to 10 days to kill any newly done in 7 to 10 days to kill any
hatched lice. newly hatched lice
if infestation continues,
see a doctor for other treatments
children under 2 years:
ask a doctor.
------------------------------------------------------------------------
\3\ For shampoo products only.
\4\ For nonshampoo products only.
\5\ For shampoo and nonshampoo products.
Current Sec. 358.650(e) describes ``other required statements'' for
these products. The agency is proposing that those statements now
appear under the heading ``Other information,'' in accord with
Sec. 201.66(c)(7), and that this information may appear in a package
insert. If a package insert is used, the ``Other information'' section
shall include a statement referring to the package insert for
additional information. The agency is retaining the current section
titles ``Head lice,'' ``Pubic (crab) lice,'' and ``Body lice'' but
requiring that they appear in bold type. The agency is restating the
text using the bullet format. In the ``Head lice'' section, the agency
is changing from 2 to 4 weeks the time for dry-cleaning or sealing in a
plastic bag items that cannot be washed. The expanded time is being
proposed for greater assurance of preventing reinfestation of the same
items. In the same section, the agency is adding the statement
``[bullet] vacuum all carpets, mattresses, upholstered furniture, and
car seats that may have been used by affected people''.
III. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of
1995 (Public Law 104-4). 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 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 of 1995 requires that agencies prepare a written
statement of anticipated costs and benefits 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).
[[Page 31743]]
The agency believes that this proposed rule is consistent with the
principles set out in Executive Order 12866 and in these two statutes.
In accordance with the Executive order, FDA has analyzed the potential
economic effects of this proposed rule. FDA has determined, as
discussed below, that the proposed 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 Unfunded Mandates Reform Act does not require FDA to prepare a
statement of costs and benefits for this proposed rule, because the
proposed rule is not expected to result in any 1-year expenditure that
would exceed $100 million adjusted for inflation. The current inflation
adjusted statutory threshold is about $110 million.
The purpose of this proposed rule is to revise and improve the
statement of identity, warnings, directions, and other required
labeling statements for OTC pediculicide drug products. The revised
labeling provides more detailed information on the proper use of the
product and should improve consumers' self-use.
The proposed rule would require relabeling of OTC pediculicide drug
products containing pyrethrum extract with piperonyl butoxide. The
agency's drug listing system identifies about 23 manufacturers and 36
marketers of approximately 75 stockkeeping units (SKU) (individual
products, packages, and sizes) of OTC pediculicide drug products. There
may be a few additional marketers and products that are not identified
in the sources FDA reviewed.
The agency does 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 and should
have adequate space for the additional information. Assuming that there
are about 75 affected OTC SKUs in the marketplace, FDA estimates (based
on information provided by OTC drug manufacturers) that the rule would
impose total one-time compliance costs on industry for relabeling of
about $3,000 to $4,000 per SKU, for a total cost of $225,000 to
$300,000.
The agency believes the actual cost could be lower for several
reasons. First, most of the labeling changes will be made by private
label small manufacturers that tend to use simpler and less expensive
labeling.
Second, the compliance dates for labeling OTC pediculicide drug
products in the new standardized format required by Sec. 201.66 are May
16, 2002, and May 16, 2003 (if annual sales of the product are less
than $25,000). (See the Federal Register of June 20, 2000 (65 FR 38191
at 38193).) This proposal alerts manufacturers of these products that
additional labeling revisions will be required in the future. Thus,
manufacturers should be able to control the amount of labeling in
inventory. In addition, the agency is proposing that any final rule
that may issue based on this proposal become effective 18 months after
its publication (with a compliance date of 24 months after publication
for products with annual sales less than $25,000). Thus, manufacturers
should have ample time to use up the first batch of new labeling that
complies with Sec. 201.66, and the labeling changes that result from
this proposed rule may be done in the normal course of business.
The final rule will not require any new reporting and recordkeeping
activities. Therefore, no additional professional skills are needed.
Further, manufacturers will not incur any expenses determining how to
state the product's labeling because the proposed amendment (and
eventual final rule) provide that information.
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 labeling, as proposed, in
place as soon as possible, the agency also acknowledges that labeling
for these products needs to be converted to the new OTC ``Drug Facts''
format by May 16, 2002 (May 16, 2003, for products with annual sales
less than $25,000). A final rule based on this proposal will not issue
before May 16, 2002, and the agency cannot currently predict exactly
when a final rule would issue. The agency believes that 18 months is a
reasonable period of time for manufacturers to use up new labeling that
is printed to comply with the May 16, 2002, date. The agency rejects an
exemption for small entities because the new labeling information is
also needed by consumers who purchase products marketed by those
entities. However, a longer compliance date (24 months) is being
provided for products with annual sales less than $25,000.
OTC pediculicide drug products are not the sole products produced
by manufacturers affected by this rule. The agency believes the
incremental costs of this proposed rule will be less than 1 percent of
any of the manufacturer's total sales. Therefore, the agency certifies
that this proposed rule will not have a significant economic impact on
a substantial number of small entities. No further analysis is required
under the Regulatory Flexibility Act (5 U.S.C. 605(b)).
IV. Paperwork Reduction Act of 1995
FDA tentatively concludes that the labeling requirements proposed
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 proposed statement of identity, warnings,
directions, and other information 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)).
V. 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.
VI. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency tentatively concludes that the proposed rule does not
contain policies that have federalism implications as defined in the
Executive order and, consequently, a federalism summary impact
statement has not been prepared.
VII. Request for Comments
Interested persons may submit written or electronic comments
regarding this proposal to the Dockets Management Branch (address
above) by August 8, 2002. Written comments on the agency's economic
impact determination may be submitted on or before August 8, 2002.
Three copies of all written comments are to be submitted. Individuals
submitting written comments or anyone submitting electronic comments
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.
[[Page 31744]]
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
VIII. Proposed Effective Date
The agency is proposing that any final rule that may issue based on
this proposal become effective 18 months after its date of publication
in the Federal Register. The agency is proposing that the compliance
date for products with annual sales less than $25,000 would be 24
months after the date of publication in the Federal Register. The
compliance date for all other OTC drug products would be 18 months
after the date of publication in the Federal Register.
IX. References
The following references are 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. Elston, D. M., ``What's Eating You? Pediculus Humanus (Head
Louse and Body Louse),'' Cutis, 63:259-264, 1999.
2. Burkhart, C. G. et al., ``An Assessment of Topical and Oral
Prescription and Over-The-Counter Treatments for Head Lice,''
Journal of the American Academy of Dermatology, 38:979-982, 1998.
3. Sokoloff, F., ``Identification and Management of
Pediculosis,'' Nurse Practitioner, 19:62-64, 1994.
4. Clore, E. R., ``Pediculosis Screening and Treatment,'' School
Nurse, 6:14-23, 1990.
5. Shaw, K., ``Eradicating Head Lice: A Review for
Pharmacists,'' Pharmacy Times, 64:48-50, 1998.
6. Bainbridge, C. V. et al., ``Comparative Study of the Clinical
Effectiveness of a Pyrethrin-Based Pediculicide with Combing Versus
a Permethrin-Based Pediculicide with Combing,'' Clinical Pediatrics,
37:17-22, 1998.
List of Subjects in 21 CFR Part 358
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, it is
proposed that 21 CFR part 358 be amended as follows:
PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
1. The authority citation for 21 CFR part 358 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
2. Section 358.650 is revised to read as follows:
Sec. 358.650 Labeling of pediculicide drug products.
(a) Statement of identity. The labeling of the product contains the
established name of the drug, if any, and identifies the product as a
``lice treatment.''
(b) Indications. The labeling of the product states, under the
heading ``Uses,'' the following: ``treats head, pubic (crab), and body
lice.'' Other truthful and nonmisleading statements, describing only
the uses that have been established and listed in this paragraph (b),
may also be used, as provided in Sec. 330.1(c)(2) of this chapter,
subject to the provisions of section 502 of the Federal Food, Drug, and
Cosmetic Act (the act) relating to misbranding and the prohibition in
section 301(d) of the act against the introduction or delivery for
introduction into interstate commerce of unapproved new drugs in
violation of section 505(a) of the act.
(c) Warnings. The labeling of the product contains the following
warnings under the heading ``Warnings'':
(1) ``For external use only'' in accord with Sec. 201.66 (c)(5)(i)
of this chapter.
(2) ``Do not use [bullet]\1\ near eyes [bullet] inside nose, mouth,
or vagina [bullet] on lice in eyebrows or eyelashes. See a doctor.''
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\1\See Sec. 201.66(b)(4) of this chapter for definition of
bullet symbol.
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(3) ``Ask a doctor before use if you are [bullet] allergic to
ragweed. May cause breathing difficulty or an asthmatic attack.''
(4) ``When using this product [bullet] keep eyes tightlyclosed and
protect eyes with a washcloth or towel [bullet] if product gets in
eyes, flush with water right away [bullet] scalp itching or redness may
occur''.
(5) ``Stop use and ask a doctor if [bullet] breathing difficulty
occurs [bullet] eye irritation occurs [bullet] skin or scalp irritation
continues or infection occurs''.
(d) Directions. The labeling of the product contains the following
information under the heading ``Directions'':
(1) The labeling states ``[bullet] Important: Read warnings before
use'' [statement shall appear first and in bold type].
(2) The labeling states ``adults and children 2 years and over:''
[in bold type].
(3) For head lice treatment products ``Inspect [in bold type]
[bullet] check each household member with a magnifying glass in bright
light for lice/nits (eggs) [bullet] look for tiny nits near scalp,
beginning at back of neck and behind ears [bullet] examine small
sections of hair at a time [bullet] unlike dandruff which moves when
touched, nits stick to the hair [bullet] if either lice or nits are
found, treat with this product''.
(4) Select one of the following:
(i) For shampoo products ``Treat [in bold type] [bullet] apply
thoroughly to hair or other affected area. For head lice, first apply
behind ears and to back of neck. [bullet] allow product to remain for
10 minutes, but no longer [bullet] use warm water to form a lather,
shampoo, then thoroughly rinse [bullet] for head lice, towel dry hair
and comb out tangles''.
(ii) For nonshampoo products ``Treat [in bold type] [bullet] apply
thoroughly to hair or other affected area. For head lice, first apply
behind ears and to back of neck. [bullet] allow product to remain for
10 minutes, but no longer [bullet] wash area thoroughly with warm water
and soap or shampoo [bullet] for head lice, towel dry hair and comb out
tangles''.
(5) ``Remove lice and their eggs (nits) [in bold type] [bullet] use
a fine-tooth or special lice/nit comb. Remove any remaining nits by
hand (using a throw-away glove). [bullet] hair should remain slightly
damp while removing nits [bullet] if hair dries during combing, dampen
slightly with water [bullet] for head lice, part hair into sections. Do
one section at a time starting on top of head. Longer hair may take 1
to 2 hours. [bullet] lift a 1 to 2 inch wide strand of hair. Place comb
as close to scalp as possible and comb with a firm, even motion away
from scalp. [bullet] pin back each strand of hair after combing
[bullet] clean comb often. Wipe nits away with tissue and discard in a
plastic bag. Seal bag and discard to prevent lice from coming back.
[bullet] after combing, thoroughly recheck for lice/nits. Repeat
combing if necessary. [bullet] check daily for any lice/nits that you
missed''.
(6) The labeling states ``[bullet] a second treatment must be done
in 7 to 10 days to kill any newly hatched lice''.
(7) The labeling states ``[bullet] if infestation continues, see a
doctor for other treatments''.
(8) The labeling states ``children under 2 years:'' [in bold type]
``ask a doctor''.
(e) The labeling of the product contains the following statements,
as appropriate, under the heading ``Other information.'' This
information may appear in a package insert. If a package insert is
used, the ``Other information'' section shall include a statement
referring to the package insert for additional information.
(1) ``Head lice [highlighted in bold type] [bullet] lay small white
eggs (nits) on hair shaft close to scalp [bullet] nits are most easily
found on back of neck or behind ears [bullet] disinfect hats, hair
ribbons, scarves, coats, towels, and
[[Page 31745]]
bed linens by machine washing in hot water (above 54 deg.C (130
deg.F)), then using hottest dryer cycle for at least 20 minutes
[bullet] items that cannot be washed (bedspreads, blankets, pillows,
stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag
for 4 weeks, then removed outdoors and shaken out very hard before
using again [bullet] items that cannot be washed, dry-cleaned, or
stored may be sprayed with a product designed for this purpose [bullet]
soak all combs and brushes in hot water (above 54 deg.C (130 deg.F))
for at least 10 minutes [bullet] vacuum all carpets, mattresses,
upholstered furniture, and car seats that may have been used by
affected people''.
(2) ``Pubic (crab) lice [highlighted in bold type] [bullet] may be
transmitted by sexual contact. Sexual partners should be treated
simultaneously to avoid reinfestation [bullet] lice are very small and
look like brown or grey dots on skin [bullet] usually cause intense
itching and lay small white eggs (nits) on the hair shaft generally
close to the skin surface [bullet] may be present on the short hairs of
groin, thighs, trunk, and underarms, and occasionally on the beard and
mustache [bullet] disinfect underwear by machine washing in hot water
(above 54 deg.C (130 deg.F)), then using hottest dryer cycle for at
least 20 minutes''.
(3) ``Body lice [highlighted in bold type] [bullet] body lice and
their eggs (nits) are generally found in the seams of clothing
particularly in waistline and armpit area [bullet] body lice feed on
skin then return to clothing to lay their eggs [bullet] disinfect
clothing by machine washing in hot water (above 54 deg.C (130
deg.F)), then using hottest dryer cycle for at least 20 minutes
[bullet] do not seal clothing in a plastic bag because nits can remain
dormant for up to 30 days''.
Dated: April 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-11656 Filed 5-9-02; 8:45 am]
BILLING CODE 4160-01-S