Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations 9849 

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. 

15 CFR Part 742 

Exports, Terrorism. 

15 CFR Part 774 

Exports, Reporting and recordkeeping 

requirements. 

■ 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: 

PART 740—[AMENDED] 

■ 1. The authority citation for part 740 

continues to read as follows: 

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). 

■ 2. In § 740.2, revise paragraph (a)(4) 

and add paragraph (a)(10) to read as 

follows: 

§ 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 

(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. 

* * * * * 

PART 742—[AMENDED] 

■ 3. The authority citation for part 742 

is revised to read as follows: 

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). 

■ 4. In § 742.11, revise the heading and 

paragraph (a) to read as follows: 

§ 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] 

■ 5. The authority citation for part 774 

is revised to read as follows: 

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). 

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 

jackets, plastic handcuffs; and parts 

and accessories, n.e.s. 

* * * * * 

List of Items Controlled 

Unit * * * 

Related Controls: Thumbcuffs are 

controlled under ECCN 0A983. 

* * * * * 

Supplement No. 1 to Part 774—

[Amended] 

■ 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. 

* * * * * 

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 

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 

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 


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9850 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations 

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 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 

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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Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations 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. 

■ 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: 


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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: 

§ 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: 

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

355, 360, 371. 

■ 4. Section 358.720 is revised to read 

as follows: 

§ 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. 

■ 5. New § 358.760 is added to read as 

follows: 

§ 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 § 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, 

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 

AGENCY: Department of State. 

ACTION: Final rule. 

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 


rwilkins on PROD1PC63 with RULES