Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Amendment to the Monograph, 9849-9852 [E7-3808]
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Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations
term is defined in Executive Order
13132.
4. The provisions of the
Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed
rulemaking, the opportunity for public
participation, and a delay in effective
date, are inapplicable because this
regulation involves a military or foreign
affairs function of the United States (see
5 U.S.C. 553(a)(1)). Further, no other
law requires that a notice of proposed
rulemaking and an opportunity for
public comment be given for this rule.
Because a notice of proposed
rulemaking and an opportunity for
public comment are not required to be
given for this rule by 5 U.S.C. 553, or
by any other law, the analytical
requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601 et. seq., are
not applicable.
List of Subjects
15 CFR Part 740
Administrative practice and
procedure, Exports, Reporting and
recordkeeping requirements.
PART 740—[AMENDED]
1. The authority citation for part 740
continues to read as follows:
I
PART 742—[AMENDED]
Supplement No. 1 to Part 774—
[Amended]
3. The authority citation for part 742
is revised to read as follows:
I
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;
42 U.S.C. 2139a; Sec. 901–911, Pub. L. 106–
387; Sec. 221, Pub. L. 107–56; Sec. 1503, Pub.
L. 108–11,117 Stat. 559; E.O. 12058, 43 FR
20947, 3 CFR, 1978 Comp., p. 179; E.O.
12851, 58 FR 33181, 3 CFR, 1993 Comp., p.
608; E.O. 12938, 59 FR 59099, 3 CFR, 1994
Comp., p. 950; E.O. 13026, 61 FR 58767, 3
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783;
Presidential Determination 2003–23 of May
7, 2003, 68 FR 26459, May 16, 2003; Notice
of August 3, 2006, 71 FR 44551 (August 7,
2006); Notice of October 27, 2006, 71 FR
64109 (October 31, 2006).
2. In § 740.2, revise paragraph (a)(4)
and add paragraph (a)(10) to read as
follows:
I
§ 740.2 Restrictions on all License
exceptions.
(a) * * *
(4) The item being exported or
reexported is subject to the license
requirements described in § 742.7 of the
EAR and the export or reexport is not:
(i) Being made to Australia, Japan,
New Zealand, or a NATO (North
Atlantic Treaty Organization) member
state (see NATO membership listing in
§ 772.1 of the EAR);
(ii) Authorized by § 740.11(b)(2)(ii)
(official use by personnel and agencies
of the U.S. government); or
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§ 742.11 Specially designed implements of
torture, thumbscrews, and thumbcuffs; and
parts and accessories, n.e.s.
(a) License Requirements. In support
of U.S. foreign policy to promote the
observance of human rights throughout
the world, a license is required to export
any commodity controlled by ECCN
0A983 to all destinations including
Canada.
*
*
*
*
*
PART 774—[AMENDED]
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; Sec. 901–911, Pub. L.
106–387; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025,
3 CFR, 2001 Comp., p. 783; Notice of August
3, 2006, 71 FR 44551 (August 7, 2006).
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jackets, plastic handcuffs; and parts
and accessories, n.e.s.
*
*
*
*
*
4. In § 742.11, revise the heading and
paragraph (a) to read as follows:
15 CFR Part 774
Exports, Reporting and recordkeeping
requirements.
I For the reasons set forth in the
preamble, parts 740, 742 and 774 of the
Export Administration Regulations (15
CFR 730–799) are amended as follows:
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(iii) Authorized by § 740.14(e) of the
EAR (certain shotguns and shotgun
shells for personal use).
*
*
*
*
*
(10) The commodity being exported or
reexported is subject to the license
requirements of § 742.11 of the EAR.
*
*
*
*
*
List of Items Controlled
Unit * * *
Related Controls: Thumbcuffs are
controlled under ECCN 0A983.
*
*
*
*
*
7. In Supplement No. 1 to Part 774,
Category 0, Export Control Classification
Number 0A983, revise the heading to
read as follows:
0A983 Specially designed implements
of torture, thumbscrews, and
thumbcuffs; and parts and accessories,
n.e.s.
*
*
*
*
*
I
Dated: February 26, 2007.
Christopher A. Padilla,
Assistant Secretary for Export
Administration.
[FR Doc. E7–3895 Filed 3–5–07; 8:45 am]
BILLING CODE 3510–33–P
I
15 CFR Part 742
Exports, Terrorism.
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9849
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 310 and 358
[Docket No. 2005N–0448]
RIN 0910–AF49
Dandruff, Seborrheic Dermatitis, and
Psoriasis Drug Products Containing
Coal Tar and Menthol for Over-theCounter Human Use; Amendment to
the Monograph
5. The authority citation for part 774
is revised to read as follows:
AGENCY:
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u);
42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C.
1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5;
Sec. 901–911, Pub. L. 106–387; Sec. 221, Pub.
L. 107–56; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025,
3 CFR, 2001 Comp., p. 783; Notice of August
3, 2006, 71 FR 44551 (August 7, 2006).
ACTION:
I
Supplement No. 1 to Part 774—
[Amended]
6. In Supplement No. 1 to Part 774,
Category 0, Export Control Classification
Number 0A982, revise the heading and
the ‘‘Related Controls’’ paragraph in the
‘‘List of Items Controlled’’ section to
read as follows:
0A982 Restraint devices, including leg
irons, shackles, and handcuffs; straight
I
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Food and Drug Administration,
HHS.
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is issuing a final
rule amending the final monograph
(FM) for over-the-counter (OTC)
dandruff, seborrheic dermatitis, and
psoriasis drug products to include the
combination of 1.8 percent coal tar
solution and 1.5 percent menthol in a
shampoo drug product to control
dandruff. FDA did not receive any
comments or data in response to its
previously proposed rule to include this
combination. This final rule is part of
FDA’s ongoing review of OTC drug
products.
DATES: Effective Date: This regulation is
effective April 5, 2007.
FOR FURTHER INFORMATION CONTACT:
Michael L. Chasey, Center for Drug
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MS 5411,
Silver Spring, MD 20993, 301–796–
2090.
SUPPLEMENTARY INFORMATION:
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I. Background
In the Federal Register of December 4,
1979 (44 FR 69768), FDA published an
advance notice of proposed rulemaking
(ANPR) to establish a monograph for
OTC external analgesic drug products.
The ANPR includes the
recommendations of the Advisory
Review Panel on OTC Topical
Analgesic, Antirheumatic, Otic, Burn,
and Sunburn Prevention and Treatment
Drug Products (the Topical Analgesic
Panel). The Topical Analgesic Panel
concluded that menthol is safe and
effective for use as an OTC external
antipruritic (anti-itch) ingredient in
concentrations of 1.0 percent or less and
as an external counterirritant in
concentrations exceeding 1.25 percent
up to 16 percent. In the Federal Register
of February 8, 1983 (48 FR 5852), FDA’s
proposed monograph, or tentative final
monograph (TFM), for OTC external
analgesic drug products included
menthol as an antipruritic ingredient at
concentrations from 0.1 percent to 1.0
percent.
In the Federal Register of December 3,
1982 (47 FR 54646), FDA published an
ANPR to establish a monograph for OTC
dandruff, seborrheic dermatitis, and
psoriasis drug products. The ANPR
includes the recommendations of the
Advisory Review Panel on OTC
Miscellaneous External Drug Products
(the Miscellaneous External Panel)
concerning OTC drug products for the
control of dandruff, seborrheic
dermatitis, and psoriasis. The
Miscellaneous External Panel
recommended coal tar preparations as
safe and effective for use as shampoos
for controlling dandruff. The
Miscellaneous External Panel also
concluded that menthol is safe at
concentrations of 0.04 to 1.5 percent,
but that there were insufficient
effectiveness data to include menthol in
the monograph for controlling dandruff.
The Miscellaneous External Panel
further noted that menthol’s activity to
temporarily relieve itching should not
be considered the same as control of
dandruff.
In the Federal Register of July 30,
1986 (51 FR 27346), FDA published its
TFM for OTC dandruff, seborrheic
dermatitis, and psoriasis drug products.
No new information was submitted for
menthol. Therefore, menthol was not
included in the TFM.
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In the Federal Register of December 4,
1991 (56 FR 63554), FDA issued a FM
for OTC dandruff, seborrheic dermatitis,
and psoriasis drug products (21 CFR
part 358, subpart H). The FM includes
a discussion of a study comparing two
shampoo formulations for relief of scalp
itching associated with dandruff. One
formulation contained the combination
of 9 percent coal tar solution and 1.5
percent menthol and the other
contained coal tar as a single ingredient.
FDA determined that the study had a
number of major design flaws. For
example, the study did not include a
group of subjects who only used
menthol. Thus, the individual
contributions of coal tar and menthol to
the effectiveness of the combination
product could not be determined from
the study. In addition, the statistical
analysis of the study results was not
valid. FDA concluded that the study did
not demonstrate that the combination
product offers any advantage over the
product containing only coal tar. Thus,
FDA concluded that the coal tarmenthol combination is not generally
recognized as safe and effective
(GRASE) for the control of dandruff
based on the study. This combination
was placed in a list of active ingredients
found not to be GRASE (21 CFR
310.545(d)(3)).
II. Amendment of the Dandruff,
Seborrheic Dermatitis, and Psoriasis
FM
In 1993, FDA received a petition
containing new data in support of the
combination of coal tar and menthol for
the relief of scalp itching associated
with dandruff. This new study
addressed the concerns raised by FDA
with the original study in the FM. The
new study was a three-arm study, so the
effectiveness of the individual
ingredients could be properly compared
to the combination product. In addition,
the appropriate statistics were used to
analyze the data. The study shows that
both menthol alone as well as the
combination of menthol and coal tar
provide greater itch relief than coal tar
alone at 5, 15, and 30 minutes after
shampooing and that the differences at
each timepoint were statistically
significant. Although menthol alone
provides itch relief, FDA has no data to
support menthol as a single active
ingredient for general relief and control
of the non-pruritic symptoms of
dandruff (e.g., scaling). Thus, in the
Federal Register of December 9, 2005
(70 FR 73178), FDA published a
proposed rule (PR) to amend the FM for
OTC dandruff, seborrheic dermatitis,
and psoriasis drug products to include
the combination of 1.8 percent coal tar
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solution and 1.5 percent menthol as
GRASE in a shampoo drug product to
control dandruff and relieve scalp
itching associated with dandruff.
FDA did not receive any comments or
data in response to the proposed
amendment to the final rule. Therefore,
in this final rule, FDA is adding the
combination of 1.8 percent coal tar and
1.5 percent menthol to § 358.720 (21
CFR 358.720) and removing the
combination from § 310.545(d)(3) (21
CFR 310.545(d)(3)). As proposed, FDA
is also adding new § 358.760 (21 CFR
358.760) to describe the labeling for this
combination. It reads as follows:
• Statement of identity
(§ 358.760(a)(1)): ‘‘dandruff/anti-itch
shampoo’’ or ‘‘antidandruff/anti-itch
shampoo’’
• Indication (§ 358.760(b)(1) and
(b)(2)): ‘‘[bullet] [select one of the
following: ‘for relief of’ or ‘controls’] the
symptoms of dandruff [bullet] [select
one of the following: ‘additional’ or
‘extra’] relief of itching due to dandruff’’
• Warnings (§ 358.760(c)(1) and
(c)(2)): those listed in § 358.750(c)(1)
and (c)(2)
• Directions (§ 358.760(d)(1)):
‘‘[bullet] wet hair [bullet] apply
shampoo and work into a lather [bullet]
rinse thoroughly [bullet] for best results,
use at least twice a week or as directed
by a doctor’’
Any OTC dandruff, seborrheic
dermatitis, or psoriasis drug product
containing this combination of
ingredients that is initially introduced
or initially delivered for introduction
into interstate commerce after the
effective date of this final rule and is not
in compliance with the regulations is
subject to regulatory action.
FDA is adding the combination of 1.8
percent coal tar and 1.5 percent menthol
and corresponding labeling and is also
revising § 358.720(a) to correct an error.
Section 358.720(a) references ‘‘sulfur
identified in § 358.710(a)(6),’’ but the
paragraph should reference ‘‘sulfur
identified in § 358.710(a)(7).’’ This error
was introduced when micronized
selenium sulfide was added to the
monograph and § 358.710(a) was
renumbered (58 FR 17554 and 59 FR
4000).
III. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866,
the Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (2 U.S.C. 1501 et
seq.). Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
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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
may have a significant economic impact
on a substantial number of small
entities, an agency must analyze
regulatory options that would minimize
any significant impact of the rule on
small entities. Section 202(a) of the
Unfunded Mandates Reform Act of 1995
requires that agencies prepare a written
statement, which includes an
assessment of costs and benefits, before
proposing ‘‘any rule that includes any
Federal mandate that may result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
(adjusted annually for inflation) in any
one year.’’
FDA concludes that this final rule is
consistent with the principles set out in
Executive Order 12866 and in these two
statutes. This 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 significant economic impact on
a substantial number of small entities
under the Regulatory Flexibility Act.
The Unfunded Mandates Reform Act
does not require FDA to prepare a
statement of costs and benefits for this
final rule because the rule is not
expected to result in any 1-year
expenditure that would meet or exceed
$100 million adjusted for inflation. The
current threshold after adjustment for
inflation is about $118 million, using
the most current (2004) Implicit Price
Deflator for the Gross Domestic Product.
The purpose of this final rule is to
allow an additional combination of
active ingredients for OTC antidandruff
drug products. Manufacturers can
reformulate their OTC antidandruff drug
products that contain coal tar to include
the combination or can manufacture a
new combination product containing
coal tar and menthol. Reformulating or
manufacturing a new combination
product might result in additional
product sales but, in either case, is
optional. Thus, this final rule will not
impose a significant economic burden
on affected entities. 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)).
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IV. Paperwork Reduction Act of 1995
FDA 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 labeling
statements 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
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.
VI. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule will have a
preemptive effect on State law. Section
4(a) of the Executive order requires
agencies to ‘‘construe * * * a Federal
statute to preempt State law only where
the statute contains an express
preemption provision or there is some
other clear evidence that the Congress
intended preemption of State law, or
where the exercise of State authority
conflicts with the exercise of Federal
authority under the Federal statute.’’
Section 751 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
379r) is an express preemption
provision. Section 751(a) of the act (21
U.S.C. 379r(a)) provides that:
* * * no State or political subdivision of
a State may establish or continue in effect
any requirement—* * * (1) that relates to
the regulation of a drug that is not subject to
the requirements of section 503(b)(1) or
503(f)(1)(A); and (2) that is different from or
in addition to, or that is otherwise not
identical with, a requirement under this Act,
the Poison Prevention Packaging Act of 1970
(15 U.S.C. 1471 et seq.), or the Fair Packaging
and Labeling Act (15 U.S.C. 1451 et seq.).
Currently, this provision operates to
preempt States from imposing
requirements related to the regulation of
nonprescription drug products. (See
Section 751(b) through (e) of the act for
the scope of the express preemption
provision, the exemption procedures,
and the exceptions to the provision.)
This final rule amends the FM for
OTC dandruff, seborrheic dermatitis,
and psoriasis drug products to include
the combination of 1.8 percent coal tar
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solution and 1.5 percent menthol in a
shampoo drug product to control
dandruff. Although this final rule has a
preemptive effect, in that it precludes
States from promulgating requirements
related to labeling for OTC dandruff,
seborrheic dermatitis, and psoriasis
drug products that are different from or
in addition to, or not otherwise identical
with a requirement in the final rule, this
preemptive effect is consistent with
what Congress set forth in section 751
of the act. Section 751(a) of the act
displaces both State legislative
requirements and State common law
duties. We also note that even where the
express preemption provision is not
applicable, implied pre-emption may
arise (see Geier v. American Honda Co.,
529 US 861 (2000)).
FDA believes that the preemptive
effect of the final rule is consistent with
Executive Order 13132. Section 4(e) of
the Executive order provides that ‘‘when
an agency proposes to act through
adjudication or rulemaking to preempt
State law, the agency shall provide all
affected State and local officials notice
and an opportunity for appropriate
participation in the proceedings.’’
On January 18, 2007, FDA’s Division
of Federal and State Relations provided
notice via fax and email transmission to
elected officials of State governments
and their representatives of national
organizations. The notice provided the
States with further opportunity for input
on the rule. It advised the States of the
publication of the December 9, 2005,
proposed rule and encouraged State and
local governments to review the notice
and to provide any comments to the
docket (2005N–0448) by a date 30 days
from the date of the letter (i.e., by
February 20, 2007), or to contact certain
named individuals. FDA received no
comments in response to this notice.
The notice has been filed in the above
numbered docket.
List of Subjects
21 CFR Part 310
Administrative practice and
procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping
requirements.
21 CFR Part 358
Labeling, Over-the-counter drugs.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 310
and 358 are amended as follows:
PART 310—NEW DRUGS
1. The authority citation for 21 CFR
part 310 continues to read as follows:
I
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Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360b–360f, 360j, 361(a), 371, 374,
375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b–263n.
2. Section 310.545 is amended by
revising paragraph (d)(3) to read as
follows:
I
§ 310.545 Drug products containing
certain active ingredients offered over-thecounter (OTC) for certain uses.
*
*
*
*
*
(d) * * *
(3) December 4, 1992, for products
subject to paragraph (a)(7) of this section
that contain menthol as an antipruritic
in combination with the antidandruff
ingredient coal tar identified in
§ 358.710(a)(1) of this chapter. This
section does not apply to products
allowed by § 358.720(b) of this chapter
after April 5, 2007.
PART 358—MISCELLANEOUS
EXTERNAL DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE
3. The authority citation for 21 CFR
part 358 continues to read as follows:
I
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371.
4. Section 358.720 is revised to read
as follows:
I
§ 358.720 Permitted combinations of
active ingredients.
(a) Combination of active ingredients
for the control of dandruff. Salicylic
acid identified in § 358.710(a)(4) may be
combined with sulfur identified in
§ 358.710(a)(7) provided each ingredient
is present within the established
concentration and the product is labeled
according to § 358.750.
(b) Combination of control of dandruff
and external analgesic active
ingredients. Coal tar identified in
§ 358.710(a)(1) may be used at a
concentration of 1.8 percent coal tar
solution, on a weight to volume basis,
in combination with menthol, 1.5
percent, in a shampoo formulation
provided the product is labeled
according to § 358.760.
I 5. New § 358.760 is added to read as
follows:
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§ 358.760 Labeling of permitted
combinations of active ingredients for the
control of dandruff.
The statement of identity, indications,
warnings, and directions for use,
respectively, applicable to each
ingredient in the product may be
combined to eliminate duplicative
words or phrases so that the resulting
information is clear and understandable.
(a) Statement of identity. For a
combination drug product that has an
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established name, the labeling of the
product states the established name of
the combination drug product, followed
by the statement of identity for each
ingredient in the combination, as
established in the statement of identity
sections of the applicable OTC drug
monographs.
(1) Combinations of control of
dandruff and external analgesic active
ingredients in § 358.720(b). The label
states ‘‘dandruff/anti-itch shampoo’’ or
‘‘antidandruff/anti-itch shampoo’’.
(2) [Reserved]
(b) Indications. The labeling of the
product states, under the heading
‘‘Uses,’’ one or more of the phrases
listed in this paragraph (b), as
appropriate. 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 § 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.
(1) Combinations of control of
dandruff and external analgesic active
ingredients in § 358.720(b). The labeling
states ‘‘[bullet] [select one of the
following: ‘for relief of’ or ‘controls’] the
symptoms of dandruff [bullet] [select
one of the following: ‘additional’ or
‘extra’] relief of itching due to
dandruff’’.
(2) The following terms or phrases
may be used in place of or in addition
to the words ‘‘for the relief of’’ or
‘‘controls’’ in the indications in
paragraph (b)(1) of this section: ‘‘fights,’’
‘‘reduces,’’ ‘‘helps eliminate,’’ ‘‘helps
stop,’’ ‘‘controls recurrence of,’’ ‘‘fights
recurrence of,’’ ‘‘helps prevent
recurrence of,’’ ‘‘reduces recurrence of,’’
‘‘helps eliminate recurrence of,’’ ‘‘helps
stop recurrence of.’’
(3) The following terms may be used
in place of the words ‘‘the symptoms of’’
in the indication in paragraph (b)(1) of
this section: ‘‘scalp’’ (select one or more
of the following: ‘‘itching,’’ ‘‘irritation,’’
‘‘redness,’’ ‘‘flaking,’’ ‘‘scaling’’)
‘‘associated with’’.
(c) Warnings. The labeling of the
product states, under the heading
‘‘Warnings,’’ the warning(s) listed in
§ 358.750(c)(1) and (c)(2).
(d) Directions. The labeling of the
product states, under the heading
‘‘Directions,’’ directions that conform to
the directions established for each
ingredient in the directions sections of
the applicable OTC drug monographs,
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
unless otherwise stated in this
paragraph (d). When the time intervals
or age limitations for administration of
the individual ingredients differ, the
directions for the combination product
may not contain any dosage that
exceeds those established for any
individual ingredient in the applicable
OTC drug monograph(s), and may not
provide for use by any age group lower
than the highest minimum age limit
established for any individual
ingredient.
(1) Combinations of control of
dandruff and external analgesic active
ingredients in § 358.720(b). The labeling
states ‘‘[bullet] wet hair [bullet] apply
shampoo and work into a lather [bullet]
rinse thoroughly [bullet] for best results,
use at least twice a week or as directed
by a doctor’’.
(2) [Reserved]
Dated: February 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–3808 Filed 3–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Part 99
[Public Notice 5705]
RIN 1400–AC–20
Intercountry Adoption—Reporting on
Non-Convention and Convention
Adoptions of Emigrating Children
Department of State.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department of State (the
Department), with the joint review and
approval of the Department of
Homeland Security (DHS), is issuing a
new rule to implement the requirement
in the Intercountry Adoption Act of
2000 (the IAA) to establish a Case
Registry for, inter alia, emigrating
children. This final rule imposes
reporting requirements on adoption
service providers, including
governmental authorities who provide
adoption services, in cases involving
adoptions of children who will emigrate
from the United States. These reporting
obligations apply to all intercountry
adoptions, regardless of whether they
are covered under the 1993 Hague
Convention on Protection of Children
and Co-operation in Respect of
Intercountry Adoption (the Convention).
This final rule, although issued with the
joint review and approval of DHS
pursuant to section 303(d) of the IAA,
only adds a new section to the
E:\FR\FM\06MRR1.SGM
06MRR1
Agencies
[Federal Register Volume 72, Number 43 (Tuesday, March 6, 2007)]
[Rules and Regulations]
[Pages 9849-9852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3808]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 310 and 358
[Docket No. 2005N-0448]
RIN 0910-AF49
Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products
Containing Coal Tar and Menthol for Over-the-Counter Human Use;
Amendment to the Monograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final
rule amending the final monograph (FM) for over-the-counter (OTC)
dandruff, seborrheic dermatitis, and psoriasis drug products to include
the combination of 1.8 percent coal tar solution and 1.5 percent
menthol in a shampoo drug product to control dandruff. FDA did not
receive any comments or data in response to its previously proposed
rule to include this combination. This final rule is part of FDA's
ongoing review of OTC drug products.
DATES: Effective Date: This regulation is effective April 5, 2007.
FOR FURTHER INFORMATION CONTACT: Michael L. Chasey, Center for Drug
[[Page 9850]]
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301-796-
2090.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 4, 1979 (44 FR 69768), FDA
published an advance notice of proposed rulemaking (ANPR) to establish
a monograph for OTC external analgesic drug products. The ANPR includes
the recommendations of the Advisory Review Panel on OTC Topical
Analgesic, Antirheumatic, Otic, Burn, and Sunburn Prevention and
Treatment Drug Products (the Topical Analgesic Panel). The Topical
Analgesic Panel concluded that menthol is safe and effective for use as
an OTC external antipruritic (anti-itch) ingredient in concentrations
of 1.0 percent or less and as an external counterirritant in
concentrations exceeding 1.25 percent up to 16 percent. In the Federal
Register of February 8, 1983 (48 FR 5852), FDA's proposed monograph, or
tentative final monograph (TFM), for OTC external analgesic drug
products included menthol as an antipruritic ingredient at
concentrations from 0.1 percent to 1.0 percent.
In the Federal Register of December 3, 1982 (47 FR 54646), FDA
published an ANPR to establish a monograph for OTC dandruff, seborrheic
dermatitis, and psoriasis drug products. The ANPR includes the
recommendations of the Advisory Review Panel on OTC Miscellaneous
External Drug Products (the Miscellaneous External Panel) concerning
OTC drug products for the control of dandruff, seborrheic dermatitis,
and psoriasis. The Miscellaneous External Panel recommended coal tar
preparations as safe and effective for use as shampoos for controlling
dandruff. The Miscellaneous External Panel also concluded that menthol
is safe at concentrations of 0.04 to 1.5 percent, but that there were
insufficient effectiveness data to include menthol in the monograph for
controlling dandruff. The Miscellaneous External Panel further noted
that menthol's activity to temporarily relieve itching should not be
considered the same as control of dandruff.
In the Federal Register of July 30, 1986 (51 FR 27346), FDA
published its TFM for OTC dandruff, seborrheic dermatitis, and
psoriasis drug products. No new information was submitted for menthol.
Therefore, menthol was not included in the TFM.
In the Federal Register of December 4, 1991 (56 FR 63554), FDA
issued a FM for OTC dandruff, seborrheic dermatitis, and psoriasis drug
products (21 CFR part 358, subpart H). The FM includes a discussion of
a study comparing two shampoo formulations for relief of scalp itching
associated with dandruff. One formulation contained the combination of
9 percent coal tar solution and 1.5 percent menthol and the other
contained coal tar as a single ingredient. FDA determined that the
study had a number of major design flaws. For example, the study did
not include a group of subjects who only used menthol. Thus, the
individual contributions of coal tar and menthol to the effectiveness
of the combination product could not be determined from the study. In
addition, the statistical analysis of the study results was not valid.
FDA concluded that the study did not demonstrate that the combination
product offers any advantage over the product containing only coal tar.
Thus, FDA concluded that the coal tar-menthol combination is not
generally recognized as safe and effective (GRASE) for the control of
dandruff based on the study. This combination was placed in a list of
active ingredients found not to be GRASE (21 CFR 310.545(d)(3)).
II. Amendment of the Dandruff, Seborrheic Dermatitis, and Psoriasis FM
In 1993, FDA received a petition containing new data in support of
the combination of coal tar and menthol for the relief of scalp itching
associated with dandruff. This new study addressed the concerns raised
by FDA with the original study in the FM. The new study was a three-arm
study, so the effectiveness of the individual ingredients could be
properly compared to the combination product. In addition, the
appropriate statistics were used to analyze the data. The study shows
that both menthol alone as well as the combination of menthol and coal
tar provide greater itch relief than coal tar alone at 5, 15, and 30
minutes after shampooing and that the differences at each timepoint
were statistically significant. Although menthol alone provides itch
relief, FDA has no data to support menthol as a single active
ingredient for general relief and control of the non-pruritic symptoms
of dandruff (e.g., scaling). Thus, in the Federal Register of December
9, 2005 (70 FR 73178), FDA published a proposed rule (PR) to amend the
FM for OTC dandruff, seborrheic dermatitis, and psoriasis drug products
to include the combination of 1.8 percent coal tar solution and 1.5
percent menthol as GRASE in a shampoo drug product to control dandruff
and relieve scalp itching associated with dandruff.
FDA did not receive any comments or data in response to the
proposed amendment to the final rule. Therefore, in this final rule,
FDA is adding the combination of 1.8 percent coal tar and 1.5 percent
menthol to Sec. 358.720 (21 CFR 358.720) and removing the combination
from Sec. 310.545(d)(3) (21 CFR 310.545(d)(3)). As proposed, FDA is
also adding new Sec. 358.760 (21 CFR 358.760) to describe the labeling
for this combination. It reads as follows:
Statement of identity (Sec. 358.760(a)(1)): ``dandruff/
anti-itch shampoo'' or ``antidandruff/anti-itch shampoo''
Indication (Sec. 358.760(b)(1) and (b)(2)): ``[bullet]
[select one of the following: `for relief of' or `controls'] the
symptoms of dandruff [bullet] [select one of the following:
`additional' or `extra'] relief of itching due to dandruff''
Warnings (Sec. 358.760(c)(1) and (c)(2)): those listed in
Sec. 358.750(c)(1) and (c)(2)
Directions (Sec. 358.760(d)(1)): ``[bullet] wet hair
[bullet] apply shampoo and work into a lather [bullet] rinse thoroughly
[bullet] for best results, use at least twice a week or as directed by
a doctor''
Any OTC dandruff, seborrheic dermatitis, or psoriasis drug product
containing this combination of ingredients that is initially introduced
or initially delivered for introduction into interstate commerce after
the effective date of this final rule and is not in compliance with the
regulations is subject to regulatory action.
FDA is adding the combination of 1.8 percent coal tar and 1.5
percent menthol and corresponding labeling and is also revising Sec.
358.720(a) to correct an error. Section 358.720(a) references ``sulfur
identified in Sec. 358.710(a)(6),'' but the paragraph should reference
``sulfur identified in Sec. 358.710(a)(7).'' This error was introduced
when micronized selenium sulfide was added to the monograph and Sec.
358.710(a) was renumbered (58 FR 17554 and 59 FR 4000).
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize
[[Page 9851]]
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 may have a
significant economic impact on a substantial number of small entities,
an agency must analyze regulatory options that would minimize any
significant impact of the rule on small entities. Section 202(a) of the
Unfunded Mandates Reform Act of 1995 requires that agencies prepare a
written statement, which includes an assessment of costs and benefits,
before proposing ``any rule that includes any Federal mandate that may
result in the expenditure by state, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million or more
(adjusted annually for inflation) in any one year.''
FDA concludes that this final rule is consistent with the
principles set out in Executive Order 12866 and in these two statutes.
This 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 significant economic impact on a substantial number
of small entities under the Regulatory Flexibility Act. The Unfunded
Mandates Reform Act does not require FDA to prepare a statement of
costs and benefits for this final rule because the rule is not expected
to result in any 1-year expenditure that would meet or exceed $100
million adjusted for inflation. The current threshold after adjustment
for inflation is about $118 million, using the most current (2004)
Implicit Price Deflator for the Gross Domestic Product.
The purpose of this final rule is to allow an additional
combination of active ingredients for OTC antidandruff drug products.
Manufacturers can reformulate their OTC antidandruff drug products that
contain coal tar to include the combination or can manufacture a new
combination product containing coal tar and menthol. Reformulating or
manufacturing a new combination product might result in additional
product sales but, in either case, is optional. Thus, this final rule
will not impose a significant economic burden on affected entities.
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)).
IV. Paperwork Reduction Act of 1995
FDA 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 labeling statements 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
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.
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
will have a preemptive effect on State law. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 751 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 379r) is an express preemption
provision. Section 751(a) of the act (21 U.S.C. 379r(a)) provides that:
* * * no State or political subdivision of a State may establish
or continue in effect any requirement--* * * (1) that relates to the
regulation of a drug that is not subject to the requirements of
section 503(b)(1) or 503(f)(1)(A); and (2) that is different from or
in addition to, or that is otherwise not identical with, a
requirement under this Act, the Poison Prevention Packaging Act of
1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling
Act (15 U.S.C. 1451 et seq.).
Currently, this provision operates to preempt States from imposing
requirements related to the regulation of nonprescription drug
products. (See Section 751(b) through (e) of the act for the scope of
the express preemption provision, the exemption procedures, and the
exceptions to the provision.)
This final rule amends the FM for OTC dandruff, seborrheic
dermatitis, and psoriasis drug products to include the combination of
1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug
product to control dandruff. Although this final rule has a preemptive
effect, in that it precludes States from promulgating requirements
related to labeling for OTC dandruff, seborrheic dermatitis, and
psoriasis drug products that are different from or in addition to, or
not otherwise identical with a requirement in the final rule, this
preemptive effect is consistent with what Congress set forth in section
751 of the act. Section 751(a) of the act displaces both State
legislative requirements and State common law duties. We also note that
even where the express preemption provision is not applicable, implied
pre-emption may arise (see Geier v. American Honda Co., 529 US 861
(2000)).
FDA believes that the preemptive effect of the final rule is
consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.''
On January 18, 2007, FDA's Division of Federal and State Relations
provided notice via fax and email transmission to elected officials of
State governments and their representatives of national organizations.
The notice provided the States with further opportunity for input on
the rule. It advised the States of the publication of the December 9,
2005, proposed rule and encouraged State and local governments to
review the notice and to provide any comments to the docket (2005N-
0448) by a date 30 days from the date of the letter (i.e., by February
20, 2007), or to contact certain named individuals. FDA received no
comments in response to this notice. The notice has been filed in the
above numbered docket.
List of Subjects
21 CFR Part 310
Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
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 parts
310 and 358 are amended as follows:
PART 310--NEW DRUGS
0
1. The authority citation for 21 CFR part 310 continues to read as
follows:
[[Page 9852]]
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b-263n.
0
2. Section 310.545 is amended by revising paragraph (d)(3) to read as
follows:
Sec. 310.545 Drug products containing certain active ingredients
offered over-the-counter (OTC) for certain uses.
* * * * *
(d) * * *
(3) December 4, 1992, for products subject to paragraph (a)(7) of
this section that contain menthol as an antipruritic in combination
with the antidandruff ingredient coal tar identified in Sec.
358.710(a)(1) of this chapter. This section does not apply to products
allowed by Sec. 358.720(b) of this chapter after April 5, 2007.
PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
0
3. 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
4. Section 358.720 is revised to read as follows:
Sec. 358.720 Permitted combinations of active ingredients.
(a) Combination of active ingredients for the control of dandruff.
Salicylic acid identified in Sec. 358.710(a)(4) may be combined with
sulfur identified in Sec. 358.710(a)(7) provided each ingredient is
present within the established concentration and the product is labeled
according to Sec. 358.750.
(b) Combination of control of dandruff and external analgesic
active ingredients. Coal tar identified in Sec. 358.710(a)(1) may be
used at a concentration of 1.8 percent coal tar solution, on a weight
to volume basis, in combination with menthol, 1.5 percent, in a shampoo
formulation provided the product is labeled according to Sec. 358.760.
0
5. New Sec. 358.760 is added to read as follows:
Sec. 358.760 Labeling of permitted combinations of active
ingredients for the control of dandruff.
The statement of identity, indications, warnings, and directions
for use, respectively, applicable to each ingredient in the product may
be combined to eliminate duplicative words or phrases so that the
resulting information is clear and understandable.
(a) Statement of identity. For a combination drug product that has
an established name, the labeling of the product states the established
name of the combination drug product, followed by the statement of
identity for each ingredient in the combination, as established in the
statement of identity sections of the applicable OTC drug monographs.
(1) Combinations of control of dandruff and external analgesic
active ingredients in Sec. 358.720(b). The label states ``dandruff/
anti-itch shampoo'' or ``antidandruff/anti-itch shampoo''.
(2) [Reserved]
(b) Indications. The labeling of the product states, under the
heading ``Uses,'' one or more of the phrases listed in this paragraph
(b), as appropriate. 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.
(1) Combinations of control of dandruff and external analgesic
active ingredients in Sec. 358.720(b). The labeling states ``[bullet]
[select one of the following: `for relief of' or `controls'] the
symptoms of dandruff [bullet] [select one of the following:
`additional' or `extra'] relief of itching due to dandruff''.
(2) The following terms or phrases may be used in place of or in
addition to the words ``for the relief of'' or ``controls'' in the
indications in paragraph (b)(1) of this section: ``fights,''
``reduces,'' ``helps eliminate,'' ``helps stop,'' ``controls recurrence
of,'' ``fights recurrence of,'' ``helps prevent recurrence of,''
``reduces recurrence of,'' ``helps eliminate recurrence of,'' ``helps
stop recurrence of.''
(3) The following terms may be used in place of the words ``the
symptoms of'' in the indication in paragraph (b)(1) of this section:
``scalp'' (select one or more of the following: ``itching,''
``irritation,'' ``redness,'' ``flaking,'' ``scaling'') ``associated
with''.
(c) Warnings. The labeling of the product states, under the heading
``Warnings,'' the warning(s) listed in Sec. 358.750(c)(1) and (c)(2).
(d) Directions. The labeling of the product states, under the
heading ``Directions,'' directions that conform to the directions
established for each ingredient in the directions sections of the
applicable OTC drug monographs, unless otherwise stated in this
paragraph (d). When the time intervals or age limitations for
administration of the individual ingredients differ, the directions for
the combination product may not contain any dosage that exceeds those
established for any individual ingredient in the applicable OTC drug
monograph(s), and may not provide for use by any age group lower than
the highest minimum age limit established for any individual
ingredient.
(1) Combinations of control of dandruff and external analgesic
active ingredients in Sec. 358.720(b). The labeling states ``[bullet]
wet hair [bullet] apply shampoo and work into a lather [bullet] rinse
thoroughly [bullet] for best results, use at least twice a week or as
directed by a doctor''.
(2) [Reserved]
Dated: February 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3808 Filed 3-5-07; 8:45 am]
BILLING CODE 4160-01-S