[Federal Register Volume 67, Number 91 (Friday, May 10, 2002)]
[Proposed Rules]
[Pages 31739-31745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11656]


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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.
---------------------------------------------------------------------------

    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
------------------------------------------------------------------------
    Pediculicide Final Monograph       Proposed Amendment to Monograph
------------------------------------------------------------------------
For external use only.               For external use only.\2\
------------------------------------------------------------------------
                                     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.
------------------------------------------------------------------------
                                     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.
------------------------------------------------------------------------
                                     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
------------------------------------------------------------------------
    Pediculicide Final Monograph       Proposed Amendment to Monograph
------------------------------------------------------------------------
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.''
---------------------------------------------------------------------------

    \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