[Federal Register: December 31, 2003 (Volume 68, Number 250)]
[Rules and Regulations]               
[Page 75414-75418]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31de03-16]                         


[[Page 75414]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 358

[Docket No. 2002N-0058]
RIN 0910-AA01

 
Pediculicide Drug Products for Over-the-Counter Human Use; 
Amendment of Final Monograph

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is issuing a final 
rule amending the final monograph (FM) 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. FDA is issuing this final rule as part of its 
ongoing review of OTC drug products after considering public comment on 
its proposed regulation and all relevant data and information that have 
come to the agency's attention.

DATES: Effective Date: This final rule is effective June 30, 2005.
    Compliance Dates: The compliance date for OTC pediculicide drug 
products with annual sales less than $25,000 is January 3, 2006. The 
compliance date for all other OTC pediculicide drug products is June 
30, 2005.

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), FDA 
published a final rule in the form of a FM 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, FDA has determined that labeling in the statement of identity, 
warnings, directions, and certain other required statements in the 
pediculicide monograph should be amended.
    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final rule that established a standardized format and 
standardized 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), FDA amended the FM 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 to appear in boldface type with only 
the word ``Important'' and the first letter in the word ``Read'' 
capitalized.
    In the Federal Register of May 10, 2002 (67 FR 31739), FDA 
published a proposed rule to amend the FM for OTC pediculicide drug 
products to revise labeling for the statement of identity, warnings, 
directions, and other required statements to increase the probability 
of treatment success with these products. In response to that proposal, 
one OTC trade association and a professor of clinical toxicology 
submitted comments, which FDA is responding to in this document.

II. The Agency's Conclusion on the Comments

A. Comments in Agreement with the Proposed Rule

    (Comment 1) One comment agreed completely with the proposed 
recommended label changes. Another comment agreed with the following 
proposed changes:
    [sbull] New statement of identity (i.e., remove ``pediculicide'' 
and just state ``Lice treatment'' by itself);
    [sbull] Simplified indications under the heading ``Uses'';
    [sbull] Formatting changes using subheadings (i.e., ``Do not use,'' 
``Ask a doctor before use,'' ``When using this product,'' and ``Stop 
use and ask adoctor if'');
    [sbull] Bulleted statements under each subheading.

B. Comments with Labeling Recommendations

    (Comment 2) One comment contended that the proposed additional 
directions are too extensive to fit on pediculicide product carton 
labels. The comment stated that lengthy, detailed directions for 
environmental control of lice and combing the hair and ``other 
information'' would be more appropriately provided in a package insert 
than on a carton label. The comment agreed that essential treatment 
directions should be on the outer label, but that consumers do not need 
to be able to read the entire detailed instructions at the point of 
purchase. The comment recommended that the outer package have a 
statement directing consumers to an insert for more complete 
directions. The comment suggested ``See brochure inside for other 
important information to help get rid of lice.'' The comment also added 
that a statement about use of a comb should be optional on the outer 
label and should instruct consumers to see the package insert for 
complete directions and could incorporate a reference to a comb 
provided in the package.
    FDA considered the length of the additional directions and provided 
in the May 10, 2002 proposal (Sec.  358.650(e)) that the detailed 
information required under the heading ``Other information'' may appear 
in a package insert. If that occurs, the ``Other information'' section 
on the outer label only needs to include a statement that refers to the 
package insert for additional information. The information about use of 
a comb is part of the essential treatment directions (Sec.  
358.650(d)(5)) and, thus, needs to appear on the outer label. If the 
product does not have a comb with it, consumers would need to know at 
the point of purchase that they may also need to purchase a special 
comb to use with the product. FDA is clarifying the introductory 
paragraph in Sec.  358.650(e) to read that if a package insert is used, 
the ``Other information'' section on the outer label shall include a 
statement referring to the package insert for additional information.
    (Comment 3) One comment recommended that the directions proposed in 
Sec.  358.650(d)(4)(i) or (d)(4)(ii), (d)(6), (d)(7), and (d)(8) appear 
both on the outer package label and in the package insert. The 
information includes the following provisions:
    [sbull] Application directions for shampoo or nonshampoo products,
    [sbull] Directions for a followup treatment,
    [sbull] Instructions to see doctor if the infestation continues,
    [sbull] Instruction to consult a doctor for children under 2 years 
of age.
    FDA agrees with the comment. Directions that appear on the outer 
package label in accordance with Sec.  201.66(c) may be restated in a 
package insert.
    (Comment 4) One comment disagreed with the agency's change from 2 
weeks to 4 weeks for the time items that cannot be washed should be 
sealed in a plastic bag(Sec.  358.650(e)(1)). The comment stated that 
FDA gave no rationale for doubling the time and pediculicide 
manufacturers know of no evidence showing more than 2 weeks is needed 
to prevent reinfestation.
    FDA initiated the change for sealing items that cannot be washed in 
a plastic bag from 2 to 4 weeks for greater assurance of preventing 
head lice

[[Page 75415]]

reinfestation. In the last few years, pediculosis fact sheets have 
recommended longer sealing times. One sheet (Ref. 1) instructs to 
``pack the items in a sealed plastic bag for a minimum of two weeks.'' 
Another sheet (Ref. 2) instructs to ``pack non-washable items in a 
sealed plastic bag for 21 days to eliminate the risk from dormant 
nits.'' Based on these recent recommendations, the agency has 
determined that a 4-week time period will give greater assurance of 
preventing head lice reinfestation.
    (Comment 5) One comment stated that the amended final monograph 
should allow for special instructions specific to particular products 
to enhance product-specific directions. The comment gave examples of 
``shake the product well before use,'' ``apply to dry hair,'' or 
conditions for storage. The comment requested that the monograph state 
that ``a reasonable degree of flexibility will be given to companies 
choosing to amplify the directions appropriately.''
    The agency disagrees with the need to include the comment's 
suggested statements in the FM for OTC pediculicide drug products. That 
monograph does not prohibit manufacturers from including statements 
such as ``shake well before using'' or information about conditions for 
storage in the product's labeling. The direction under the heading 
``Treat'' for shampoo and nonshampoo products in Sec.  358.650(d)(4)(i) 
and (d)(4)(ii) imply that the hair is dry before the product is first 
applied. FDA is amending these sections to give the option of adding 
the word ``dry'' before ``hair''.

C. Will Labeling for New Drug Application (NDA) Products be Revised at 
the Same Time as the Monograph Products?

    (Comment 6) One comment asked FDA to coordinate the revised NDA 
labeling for OTC pediculicide drug products marketed under NDAs and 
under the OTC drug monograph. The comment stated that the 
implementation for all products should occur at the same time.
    FDA strives for consistency in labeling of similar products that 
are marketed OTC under an OTC drug monograph or an NDA. The effective 
date for the amended labeling in this final rule is 18 months after the 
date of publication in the Federal Register. The agency intends to 
notify NDA holders to make changes in labeling consistent with this 
final rule and believes these changes can be completed by the effective 
date.

III. The Agency's Final Conclusions

A. Summary of Major Labeling Changes

    Based on the available evidence, FDA is issuing a final rule 
amending the FM for OTC pediculicide drug products to make the 
following changes:
    [sbull] Statement of Identity. We revised the ``Statement of 
identity'' to read ``lice treatment'' and eliminated the term 
``pediculicide.''
    [sbull] Warnings.
    (1) We shortened some warnings and stated all warnings in the new 
format in Sec.  201.66 using the subheadings ``Do not use'', ``Ask a 
doctor before use if you are'', ``When using this product'', and ``Stop 
use and ask a doctor if''.
    (2) We revised one warning for greater clarity by adding a few 
words after the statement ``See a doctor'' to read ``Do not use [sbull] 
near eyes [sbull] inside nose, mouth, or vagina [sbull] on lice in 
eyebrows or eyelashes. See a doctor if lice are present in these 
areas.''
    [sbull] Directions. We added the following:
    (1) Two introductory statements entitled ``Important: Read warnings 
before use''[statement shall appear first and in bold type] and 
``adults and children 2 years and over'' [in bold type];
    (2) Headings entitled ``Inspect'', ``Treat'', and ``Remove lice and 
their eggs (nits)'';
    (3) ``Dry'' as an optional word before ``hair'' in the first 
sentence in the heading for ``Treat'' for shampoo and nonshampoo 
products.
    [sbull] Other information.
    (1) We allow information to appear in a package insert.
    (2) We expanded the time for sealing items in a plastic bag from 2 
to 4 weeks.
    (3) We added the statement `` [sbull] vacuum all carpets, 
mattresses, upholstered furniture, and car seats that may have been 
used by affected people''.

B. Statement About Warnings

    Mandating warnings in an OTC drug monograph does not require a 
finding that any or all of the OTC drug products covered by the 
monograph actually caused an adverse event, and FDA does not so find. 
Nor does FDA's requirement of warnings repudiate the prior OTC drug 
monographs and monograph rulemakings under which the affected drug 
products have been lawfully marketed. Rather, as a consumer protection 
agency, FDA has determined that warnings are necessary to ensure that 
these OTC drug products continue to be safe and effective for their 
labeled indications under ordinary conditions of use as those terms are 
defined in the Federal Food, Drug, and Cosmetic Act. This judgment 
balances the benefits of these drug products against their potential 
risks (see 21 CFR 330.10(a)).
    FDA's decision to act in this instance need not meet the standard 
of proof required to prevail in a private tort action (Glastetter v. 
Novartis Pharmaceuticals Corp., 252 F.3d 986, 991 (8th Cir. 2001)). To 
mandate warnings, or take similar regulatory action, FDA need not show, 
nor do we allege, actual causation. For an expanded discussion of case 
law supporting FDA's authority to require such warnings, see Labeling 
of Diphenhydramine-Containing Drug Products for Over-the-Counter Human 
Use final rule (67 FR 72555, December 6, 2002).

C. Marketing Conditions

    No OTC pediculicide drug product that is marketed under part 358, 
subpart G, and that contains a nonmonograph condition may be initially 
introduced or initially delivered for introduction into interstate 
commerce unless it is the subject of an approved NDA:
    [sbull] 24 months after the date of publication of this final rule 
in the Federal Register for products with sales less than $25,000;
    [sbull] 18 months after the date of publication in the Federal 
Register for all other such drug products.
    Further, any OTC drug product subject to this final rule that is 
repackaged or relabeled after the compliance dates in the final rule 
must be in compliance with part 358, subpart G regardless of the date 
the product was initially introduced or initially delivered for 
introduction into interstate commerce. Manufacturers are encouraged to 
comply voluntarily as soon as possible.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and 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 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

[[Page 75416]]

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 1 
year by State, local, and tribal governments, in the aggregate, or by 
the private sector, of $100 million (adjusted annually for inflation).
    FDA concludes that this final rule is consistent with the 
principles set out in Executive Order 12866 and in these two statutes. 
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. As discussed in this section, FDA has determined that this final 
rule will not have a significant economic impact on a substantial 
number of small entities. The Unfunded Mandates Reform Act of 1995 does 
not require FDA to prepare a statement of costs and benefits for this 
final rule, because the final 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 final 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 final rule requires relabeling of OTC pediculicide drug 
products containing pyrethrum extract with piperonyl butoxide. FDA'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.
    FDA 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 which should have 
adequate space for the additional information. In addition, 
manufacturers may include the ``Other information'' section of the 
labeling in a package insert, which generally has a nominal cost. 
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.
    FDA 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, FDA is providing a period of 18 months (24 months for 
products with annual sales less than $25,000) for manufacturers to 
implement the new labeling. Thus, manufacturers should be able to use 
up existing labeling stocks and to make the labeling changes in the 
normal course of business. Further, manufacturers will not incur any 
expenses determining how to state the product's labeling because the 
final rule provides that information. The final rule does not require 
any new reporting and recordkeeping activities. Therefore, no 
additional professional skills are needed.
    FDA 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 a shorter implementation 
period could significantly increase the compliance costs and these 
costs could be passed through to consumers. A longer time period would 
unnecessarily delay the benefit of new labeling to consumers who self-
medicate with these drug products. 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 final rule. FDA believes that the 
incremental costs of this final rule will be less than 1 percent of any 
of the manufacturer's total sales. Therefore, FDA certifies that this 
final 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)).

V. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this document are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the 
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)).

VI. Environmental Impact

    FDA 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.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the 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 concludes that 
the rule does not contain policies that have federalism implications as 
defined in the Executive order and, consequently, a federalism summary 
impact statement is not required.

VIII. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the 
Web site addresses, but FDA is not responsible for any subsequent 
changes to the Web site after this document publishes in the Federal 
Register.)
    1. Fact sheet from Mason County, Washington State Government 
Services, ``Head Lice (Pediculosis),'' http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.co.mason.wa.us/health/Headlice.shtml
.

    2. Fact sheet from King County, Washington State Government 
Services, ``Communicable Disease Fact Sheet Head Lice (Pediculosis),'' 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.metrokc.gov/health/prevcont/headlice.htm.


List of Subjects in 21 CFR Part 358

    Labeling, Over-the-counter drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
358 is amended as follows:

[[Page 75417]]

PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER 
HUMAN USE

0
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.

0
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 if 
lice are present in these areas.''
---------------------------------------------------------------------------

    \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 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''.
    (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 eachhousehold 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] examinesmall 
sections of hair at a time [bullet] unlike dandruff which moves when 
touched, nitsstick 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 (optional, may add ``dry'') 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 (optional, may add ``dry'') 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 othertreatments''.
    (8) The labeling states ``children under 2 years:'' [in bold type] 
``ask a doctor''.
    (e) Other information. 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 on the outer 
carton or container label 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 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''.


[[Page 75418]]


    Dated: December 18, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-32100 Filed 12-30-03; 8:45 am]

BILLING CODE 4160-01-S