Source: https://www.scribd.com/document/2784248/Rule-Human-drugs-Dandruff-seborrheic-dermatitis-and-psoriasis-drug-products-OTC-final-monograph-amendment
Timestamp: 2019-09-22 12:55:09
Document Index: 155616

Matched Legal Cases: ['§ 740', 'arts\n13132', '§ 742', 'ART 742', 'art 774', 'art 742', 'art 774', 'art 740', 'art 742', '§ 742', '§ 742', 'art 774', 'arts 310', 'arts 740', 'art 740', 'ART 774', 'art 774', '§ 740', '§ 740', 'art 774', '§ 742', 'art 774', '§ 772', '§ 740', 'art 358', '§ 358', '§ 310', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', 'art 310', 'art 358', 'arts 310', 'ART 310', 'art 310', '§ 310', '§ 358', '§ 358', '§ 358', '§ 358', '§ 330', 'ART 358', 'art 358', 'art 99', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358']

Rule: Human drugs: Dandruff, seborrheic dermatitis, and psoriasis drug products (OTC); final monograph amendment | Federal Preemption | Over The Counter Drug
Rule: Human drugs: Dandruff, seborrheic dermatitis, and psoriasis drug products (OTC); final monograph amendment, 9849-9852 [E7-3808] Food and Drug Administration
saveSave Rule: Human drugs: Dandruff, seborrheic dermatitis... For Later
74 Fair empl.prac.cas. (Bna) 1849, 73 Empl. Prac. Dec. P 45,289 Mark Abdu-Brisson Ronald H. Buchner Gordon Burgess Robert Burke Thomas D. Callahan Thomas F. Carey Dale E. Carman Louis Carrara T. Barry Casey Lamar Cason Robert T. Cassidy Robert Changery Larry E. Chappel Richard Charbonneau Stanley Checkoway Douglas S. Christensen Lee J. Church James Cirilli Robert Clack Walter M. Clark Philip Claudy Harold T. Cleaver Charles Clements Richard T. Clough Lawrence D. Cobb Wesley Collins Ronald E. Combee Eugene M. Comfort Harry G. Compton John C. Cook Clifford Cool David L. Cooper Donald C. Cory Marcus Covington Eugene Cox Lynn Cox Lynn O. Cox Howard Crowell J.N. Crump Charles Crumpton Joseph C. Cushing Edward Cywinski Thomas G. Dahoney Joseph Dalton Charles R. Davis Gerald E. Davis Wade L. Davis Thomas A. Dean Ernest E. Dell, Jr. Thomas J. Delnickas Henry P. Denoncour Robert Devries Clarence J. Dieter Charles Dike, Jr. Gerald Dion Jack Ditzel Stephen A. Dodge William W. Donnelly Wilfredo H.
Derek J. Smith v. Dunham-Bush, Inc., and the Robins Group, Inc., 959 F.2d 6, 2d Cir. (1992)
FDA Medical Record
Notice: Meetings: Adolescent over-the-counter drug products; public workshop
Reseach and development in pharma
43 / Tuesday, March 6, 2007 / Rules and Regulations 9849
term is defined in Executive Order (iii) Authorized by § 740.14(e) of the jackets, plastic handcuffs; and parts
13132. EAR (certain shotguns and shotgun and accessories, n.e.s.
4. The provisions of the shells for personal use). * * * * *
Administrative Procedure Act (5 U.S.C. * * * * *
553) requiring notice of proposed List of Items Controlled
(10) The commodity being exported or
rulemaking, the opportunity for public reexported is subject to the license Unit * * *
participation, and a delay in effective requirements of § 742.11 of the EAR. Related Controls: Thumbcuffs are
date, are inapplicable because this controlled under ECCN 0A983.
regulation involves a military or foreign * * * * *
affairs function of the United States (see PART 742—[AMENDED]
5 U.S.C. 553(a)(1)). Further, no other Supplement No. 1 to Part 774—
law requires that a notice of proposed ■ 3. The authority citation for part 742 [Amended]
rulemaking and an opportunity for is revised to read as follows: ■ 7. In Supplement No. 1 to Part 774,
public comment be given for this rule. Authority: 50 U.S.C. app. 2401 et seq.; 50 Category 0, Export Control Classification
Because a notice of proposed U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; Number 0A983, revise the heading to
rulemaking and an opportunity for 42 U.S.C. 2139a; Sec. 901–911, Pub. L. 106– read as follows:
public comment are not required to be 387; Sec. 221, Pub. L. 107–56; Sec. 1503, Pub. 0A983 Specially designed implements
given for this rule by 5 U.S.C. 553, or L. 108–11,117 Stat. 559; E.O. 12058, 43 FR of torture, thumbscrews, and
by any other law, the analytical 20947, 3 CFR, 1978 Comp., p. 179; E.O.
12851, 58 FR 33181, 3 CFR, 1993 Comp., p.
thumbcuffs; and parts and accessories,
requirements of the Regulatory n.e.s.
Flexibility Act, 5 U.S.C. 601 et. seq., are 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994
Comp., p. 950; E.O. 13026, 61 FR 58767, 3 * * * * *
not applicable. CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR Dated: February 26, 2007.
List of Subjects 44025, 3 CFR, 2001 Comp., p. 783;
Presidential Determination 2003–23 of May Christopher A. Padilla,
15 CFR Part 740 7, 2003, 68 FR 26459, May 16, 2003; Notice Assistant Secretary for Export
of August 3, 2006, 71 FR 44551 (August 7, Administration.
procedure, Exports, Reporting and 2006); Notice of October 27, 2006, 71 FR [FR Doc. E7–3895 Filed 3–5–07; 8:45 am]
64109 (October 31, 2006). BILLING CODE 3510–33–P
15 CFR Part 742 ■ 4. In § 742.11, revise the heading and
Exports, Terrorism. DEPARTMENT OF HEALTH AND
§ 742.11 Specially designed implements of HUMAN SERVICES
15 CFR Part 774 torture, thumbscrews, and thumbcuffs; and
Exports, Reporting and recordkeeping parts and accessories, n.e.s. Food and Drug Administration
requirements. (a) License Requirements. In support
■ For the reasons set forth in the of U.S. foreign policy to promote the 21 CFR Parts 310 and 358
preamble, parts 740, 742 and 774 of the observance of human rights throughout [Docket No. 2005N–0448]
Export Administration Regulations (15 the world, a license is required to export
any commodity controlled by ECCN RIN 0910–AF49
CFR 730–799) are amended as follows:
0A983 to all destinations including
Canada. Dandruff, Seborrheic Dermatitis, and
Psoriasis Drug Products Containing
■ 1. The authority citation for part 740 * * * * * Coal Tar and Menthol for Over-the-
continues to read as follows: PART 774—[AMENDED] Counter Human Use; Amendment to
Authority: 50 U.S.C. app. 2401 et seq.; 50 the Monograph
U.S.C. 1701 et seq.; Sec. 901–911, Pub. L. ■ 5. The authority citation for part 774 AGENCY: Food and Drug Administration,
106–387; E.O. 13026, 61 FR 58767, 3 CFR, is revised to read as follows: HHS.
1996 Comp., p. 228; E.O. 13222, 66 FR 44025,
Authority: 50 U.S.C. app. 2401 et seq.; 50 ACTION: Final rule.
3 CFR, 2001 Comp., p. 783; Notice of August
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
3, 2006, 71 FR 44551 (August 7, 2006).
7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et SUMMARY: The Food and Drug
■ 2. In § 740.2, revise paragraph (a)(4) seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); Administration (FDA) is issuing a final
and add paragraph (a)(10) to read as 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. rule amending the final monograph
follows: 1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5; (FM) for over-the-counter (OTC)
Sec. 901–911, Pub. L. 106–387; Sec. 221, Pub.
dandruff, seborrheic dermatitis, and
§ 740.2 Restrictions on all License L. 107–56; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, psoriasis drug products to include the
3 CFR, 2001 Comp., p. 783; Notice of August combination of 1.8 percent coal tar
(a) * * * solution and 1.5 percent menthol in a
(4) The item being exported or shampoo drug product to control
reexported is subject to the license Supplement No. 1 to Part 774— dandruff. FDA did not receive any
requirements described in § 742.7 of the [Amended] comments or data in response to its
EAR and the export or reexport is not: previously proposed rule to include this
(i) Being made to Australia, Japan, ■ 6. In Supplement No. 1 to Part 774,
Category 0, Export Control Classification combination. This final rule is part of
New Zealand, or a NATO (North
Number 0A982, revise the heading and FDA’s ongoing review of OTC drug
Atlantic Treaty Organization) member
the ‘‘Related Controls’’ paragraph in the products.
rwilkins on PROD1PC63 with RULES
state (see NATO membership listing in
§ 772.1 of the EAR); ‘‘List of Items Controlled’’ section to DATES: Effective Date: This regulation is
(ii) Authorized by § 740.11(b)(2)(ii) read as follows: effective April 5, 2007.
(official use by personnel and agencies 0A982 Restraint devices, including leg FOR FURTHER INFORMATION CONTACT:
of the U.S. government); or irons, shackles, and handcuffs; straight 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 In the Federal Register of December 4, solution and 1.5 percent menthol as
Drug Administration, 10903 New 1991 (56 FR 63554), FDA issued a FM GRASE in a shampoo drug product to
Hampshire Ave., Bldg. 22, MS 5411, for OTC dandruff, seborrheic dermatitis, control dandruff and relieve scalp
Silver Spring, MD 20993, 301–796– and psoriasis drug products (21 CFR itching associated with dandruff.
2090. part 358, subpart H). The FM includes FDA did not receive any comments or
a discussion of a study comparing two data in response to the proposed
shampoo formulations for relief of scalp amendment to the final rule. Therefore,
I. Background itching associated with dandruff. One in this final rule, FDA is adding the
In the Federal Register of December 4, formulation contained the combination combination of 1.8 percent coal tar and
1979 (44 FR 69768), FDA published an of 9 percent coal tar solution and 1.5 1.5 percent menthol to § 358.720 (21
advance notice of proposed rulemaking percent menthol and the other CFR 358.720) and removing the
(ANPR) to establish a monograph for contained coal tar as a single ingredient. combination from § 310.545(d)(3) (21
OTC external analgesic drug products. FDA determined that the study had a CFR 310.545(d)(3)). As proposed, FDA
The ANPR includes the number of major design flaws. For is also adding new § 358.760 (21 CFR
recommendations of the Advisory example, the study did not include a 358.760) to describe the labeling for this
Review Panel on OTC Topical group of subjects who only used combination. It reads as follows:
Analgesic, Antirheumatic, Otic, Burn, menthol. Thus, the individual • Statement of identity
and Sunburn Prevention and Treatment contributions of coal tar and menthol to (§ 358.760(a)(1)): ‘‘dandruff/anti-itch
Drug Products (the Topical Analgesic the effectiveness of the combination shampoo’’ or ‘‘antidandruff/anti-itch
Panel). The Topical Analgesic Panel product could not be determined from shampoo’’
the study. In addition, the statistical • Indication (§ 358.760(b)(1) and
concluded that menthol is safe and
analysis of the study results was not (b)(2)): ‘‘[bullet] [select one of the
effective for use as an OTC external
valid. FDA concluded that the study did following: ‘for relief of’ or ‘controls’] the
antipruritic (anti-itch) ingredient in
not demonstrate that the combination symptoms of dandruff [bullet] [select
concentrations of 1.0 percent or less and
product offers any advantage over the one of the following: ‘additional’ or
as an external counterirritant in
product containing only coal tar. Thus, ‘extra’] relief of itching due to dandruff’’
concentrations exceeding 1.25 percent • Warnings (§ 358.760(c)(1) and
FDA concluded that the coal tar-
up to 16 percent. In the Federal Register (c)(2)): those listed in § 358.750(c)(1)
menthol combination is not generally
of February 8, 1983 (48 FR 5852), FDA’s and (c)(2)
recognized as safe and effective
proposed monograph, or tentative final • Directions (§ 358.760(d)(1)):
(GRASE) for the control of dandruff
monograph (TFM), for OTC external ‘‘[bullet] wet hair [bullet] apply
based on the study. This combination
analgesic drug products included was placed in a list of active ingredients shampoo and work into a lather [bullet]
menthol as an antipruritic ingredient at found not to be GRASE (21 CFR rinse thoroughly [bullet] for best results,
concentrations from 0.1 percent to 1.0 310.545(d)(3)). use at least twice a week or as directed
percent. by a doctor’’
In the Federal Register of December 3, II. Amendment of the Dandruff, Any OTC dandruff, seborrheic
1982 (47 FR 54646), FDA published an Seborrheic Dermatitis, and Psoriasis dermatitis, or psoriasis drug product
ANPR to establish a monograph for OTC FM containing this combination of
dandruff, seborrheic dermatitis, and In 1993, FDA received a petition ingredients that is initially introduced
psoriasis drug products. The ANPR containing new data in support of the or initially delivered for introduction
includes the recommendations of the combination of coal tar and menthol for into interstate commerce after the
Advisory Review Panel on OTC the relief of scalp itching associated effective date of this final rule and is not
Miscellaneous External Drug Products with dandruff. This new study in compliance with the regulations is
(the Miscellaneous External Panel) addressed the concerns raised by FDA subject to regulatory action.
concerning OTC drug products for the with the original study in the FM. The FDA is adding the combination of 1.8
control of dandruff, seborrheic new study was a three-arm study, so the percent coal tar and 1.5 percent menthol
dermatitis, and psoriasis. The effectiveness of the individual and corresponding labeling and is also
Miscellaneous External Panel ingredients could be properly compared revising § 358.720(a) to correct an error.
recommended coal tar preparations as to the combination product. In addition, Section 358.720(a) references ‘‘sulfur
safe and effective for use as shampoos the appropriate statistics were used to identified in § 358.710(a)(6),’’ but the
for controlling dandruff. The analyze the data. The study shows that paragraph should reference ‘‘sulfur
Miscellaneous External Panel also both menthol alone as well as the identified in § 358.710(a)(7).’’ This error
concluded that menthol is safe at combination of menthol and coal tar was introduced when micronized
concentrations of 0.04 to 1.5 percent, provide greater itch relief than coal tar selenium sulfide was added to the
but that there were insufficient alone at 5, 15, and 30 minutes after monograph and § 358.710(a) was
effectiveness data to include menthol in shampooing and that the differences at renumbered (58 FR 17554 and 59 FR
the monograph for controlling dandruff. each timepoint were statistically 4000).
The Miscellaneous External Panel significant. Although menthol alone
further noted that menthol’s activity to provides itch relief, FDA has no data to III. Analysis of Impacts
temporarily relieve itching should not support menthol as a single active FDA has examined the impacts of the
be considered the same as control of ingredient for general relief and control final rule under Executive Order 12866,
dandruff. of the non-pruritic symptoms of the Regulatory Flexibility Act (5 U.S.C.
In the Federal Register of July 30, dandruff (e.g., scaling). Thus, in the 601–612), and the Unfunded Mandates
1986 (51 FR 27346), FDA published its Federal Register of December 9, 2005 Reform Act of 1995 (2 U.S.C. 1501 et
TFM for OTC dandruff, seborrheic (70 FR 73178), FDA published a seq.). Executive Order 12866 directs
dermatitis, and psoriasis drug products. proposed rule (PR) to amend the FM for agencies to assess all costs and benefits
No new information was submitted for OTC dandruff, seborrheic dermatitis, of available regulatory alternatives and,
menthol. Therefore, menthol was not and psoriasis drug products to include when regulation is necessary, to select
included in the TFM. the combination of 1.8 percent coal tar 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 IV. Paperwork Reduction Act of 1995 solution and 1.5 percent menthol in a
economic, environmental, public health FDA concludes that the labeling shampoo drug product to control
and safety, and other advantages; requirements proposed in this dandruff. Although this final rule has a
distributive impacts; and equity). Under document are not subject to review by preemptive effect, in that it precludes
the Regulatory Flexibility Act, if a rule the Office of Management and Budget States from promulgating requirements
may have a significant economic impact because they do not constitute a related to labeling for OTC dandruff,
on a substantial number of small ‘‘collection of information’’ under the seborrheic dermatitis, and psoriasis
entities, an agency must analyze Paperwork Reduction Act of 1995 (44 drug products that are different from or
regulatory options that would minimize U.S.C. 3501 et seq.). Rather, the labeling in addition to, or not otherwise identical
any significant impact of the rule on statements are a ‘‘public disclosure of with a requirement in the final rule, this
small entities. Section 202(a) of the information originally supplied by the preemptive effect is consistent with
Unfunded Mandates Reform Act of 1995 Federal government to the recipient for what Congress set forth in section 751
the purpose of disclosure to the public’’ of the act. Section 751(a) of the act
requires that agencies prepare a written
(5 CFR 1320.3(c)(2)). displaces both State legislative
statement, which includes an
requirements and State common law
assessment of costs and benefits, before V. Environmental Impact duties. We also note that even where the
proposing ‘‘any rule that includes any express preemption provision is not
Federal mandate that may result in the FDA has determined under 21 CFR
25.31(a) that this action is of a type that applicable, implied pre-emption may
expenditure by state, local, and tribal arise (see Geier v. American Honda Co.,
does not individually or cumulatively
governments, in the aggregate, or by the 529 US 861 (2000)).
have a significant effect on the human
private sector, of $100 million or more FDA believes that the preemptive
environment. Therefore, neither an
(adjusted annually for inflation) in any effect of the final rule is consistent with
environmental assessment nor an
one year.’’ environmental impact statement is Executive Order 13132. Section 4(e) of
FDA concludes that this final rule is required. the Executive order provides that ‘‘when
consistent with the principles set out in an agency proposes to act through
VI. Federalism adjudication or rulemaking to preempt
Executive Order 12866 and in these two
statutes. This final rule is not a FDA has analyzed this final rule in State law, the agency shall provide all
significant regulatory action as defined accordance with the principles set forth affected State and local officials notice
by the Executive order and so is not in Executive Order 13132. FDA has and an opportunity for appropriate
determined that the rule will have a participation in the proceedings.’’
subject to review under the Executive On January 18, 2007, FDA’s Division
order. As discussed in this section, FDA preemptive effect on State law. Section
4(a) of the Executive order requires of Federal and State Relations provided
has determined that this final rule will notice via fax and email transmission to
not have significant economic impact on agencies to ‘‘construe * * * a Federal
statute to preempt State law only where elected officials of State governments
a substantial number of small entities and their representatives of national
under the Regulatory Flexibility Act. the statute contains an express
preemption provision or there is some organizations. The notice provided the
The Unfunded Mandates Reform Act States with further opportunity for input
does not require FDA to prepare a other clear evidence that the Congress
intended preemption of State law, or on the rule. It advised the States of the
statement of costs and benefits for this publication of the December 9, 2005,
where the exercise of State authority
final rule because the rule is not proposed rule and encouraged State and
conflicts with the exercise of Federal
expected to result in any 1-year local governments to review the notice
authority under the Federal statute.’’
expenditure that would meet or exceed and to provide any comments to the
Section 751 of the Federal Food, Drug,
$100 million adjusted for inflation. The docket (2005N–0448) by a date 30 days
and Cosmetic Act (the act) (21 U.S.C.
current threshold after adjustment for from the date of the letter (i.e., by
379r) is an express preemption
inflation is about $118 million, using February 20, 2007), or to contact certain
provision. Section 751(a) of the act (21
the most current (2004) Implicit Price named individuals. FDA received no
U.S.C. 379r(a)) provides that:
Deflator for the Gross Domestic Product. comments in response to this notice.
* * * no State or political subdivision of The notice has been filed in the above
The purpose of this final rule is to a State may establish or continue in effect
allow an additional combination of numbered docket.
any requirement—* * * (1) that relates to
active ingredients for OTC antidandruff the regulation of a drug that is not subject to List of Subjects
drug products. Manufacturers can the requirements of section 503(b)(1) or
503(f)(1)(A); and (2) that is different from or 21 CFR Part 310
reformulate their OTC antidandruff drug
in addition to, or that is otherwise not Administrative practice and
products that contain coal tar to include identical with, a requirement under this Act,
the combination or can manufacture a procedure, Drugs, Labeling, Medical
new combination product containing (15 U.S.C. 1471 et seq.), or the Fair Packaging
devices, Reporting and recordkeeping
coal tar and menthol. Reformulating or and Labeling Act (15 U.S.C. 1451 et seq.). requirements.
manufacturing a new combination Currently, this provision operates to 21 CFR Part 358
product might result in additional preempt States from imposing Labeling, Over-the-counter drugs.
product sales but, in either case, is requirements related to the regulation of
optional. Thus, this final rule will not ■ Therefore, under the Federal Food,
nonprescription drug products. (See
impose a significant economic burden Drug, and Cosmetic Act and under
Section 751(b) through (e) of the act for
on affected entities. Therefore, FDA authority delegated to the Commissioner
the scope of the express preemption of Food and Drugs, 21 CFR parts 310
certifies that this final rule will not have provision, the exemption procedures, and 358 are amended as follows:
a significant economic impact on a and the exceptions to the provision.)
substantial number of small entities. No This final rule amends the FM for PART 310—NEW DRUGS
further analysis is required under the OTC dandruff, seborrheic dermatitis,
Regulatory Flexibility Act (5 U.S.C. and psoriasis drug products to include ■ 1. The authority citation for 21 CFR
605(b)). the combination of 1.8 percent coal tar part 310 continues to read as follows:
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9852 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations
Authority: 21 U.S.C. 321, 331, 351, 352, established name, the labeling of the unless otherwise stated in this
353, 355, 360b–360f, 360j, 361(a), 371, 374, product states the established name of paragraph (d). When the time intervals
375, 379e; 42 U.S.C. 216, 241, 242(a), 262, the combination drug product, followed or age limitations for administration of
263b–263n. by the statement of identity for each the individual ingredients differ, the
■ 2. Section 310.545 is amended by ingredient in the combination, as directions for the combination product
revising paragraph (d)(3) to read as established in the statement of identity may not contain any dosage that
follows: sections of the applicable OTC drug exceeds those established for any
monographs. individual ingredient in the applicable
§ 310.545 Drug products containing (1) Combinations of control of OTC drug monograph(s), and may not
certain active ingredients offered over-the- dandruff and external analgesic active provide for use by any age group lower
counter (OTC) for certain uses. ingredients in § 358.720(b). The label than the highest minimum age limit
* * * * * states ‘‘dandruff/anti-itch shampoo’’ or established for any individual
(d) * * * ‘‘antidandruff/anti-itch shampoo’’. ingredient.
(3) December 4, 1992, for products (2) [Reserved] (1) Combinations of control of
subject to paragraph (a)(7) of this section (b) Indications. The labeling of the dandruff and external analgesic active
that contain menthol as an antipruritic product states, under the heading ingredients in § 358.720(b). The labeling
in combination with the antidandruff ‘‘Uses,’’ one or more of the phrases states ‘‘[bullet] wet hair [bullet] apply
ingredient coal tar identified in listed in this paragraph (b), as shampoo and work into a lather [bullet]
§ 358.710(a)(1) of this chapter. This appropriate. Other truthful and rinse thoroughly [bullet] for best results,
section does not apply to products nonmisleading statements, describing use at least twice a week or as directed
allowed by § 358.720(b) of this chapter only the uses that have been established by a doctor’’.
after April 5, 2007. and listed in this paragraph (b), may (2) [Reserved]
also be used, as provided in § 330.1(c)(2)
PART 358—MISCELLANEOUS of this chapter, subject to the provisions Dated: February 26, 2007.
EXTERNAL DRUG PRODUCTS FOR of section 502 of the Federal Food, Drug, Jeffrey Shuren,
OVER-THE-COUNTER HUMAN USE and Cosmetic Act (the act) relating to Assistant Commissioner for Policy.
misbranding and the prohibition in [FR Doc. E7–3808 Filed 3–5–07; 8:45 am]
■ 3. The authority citation for 21 CFR section 301(d) of the act against the BILLING CODE 4160–01–S
part 358 continues to read as follows: introduction or delivery for introduction
Authority: 21 U.S.C. 321, 351, 352, 353, into interstate commerce of unapproved
355, 360, 371. new drugs in violation of section 505(a) DEPARTMENT OF STATE
■ 4. Section 358.720 is revised to read of the act.
as follows: (1) Combinations of control of 22 CFR Part 99
dandruff and external analgesic active
§ 358.720 Permitted combinations of ingredients in § 358.720(b). The labeling [Public Notice 5705]
active ingredients. states ‘‘[bullet] [select one of the RIN 1400–AC–20
(a) Combination of active ingredients following: ‘for relief of’ or ‘controls’] the
for the control of dandruff. Salicylic symptoms of dandruff [bullet] [select Intercountry Adoption—Reporting on
acid identified in § 358.710(a)(4) may be one of the following: ‘additional’ or Non-Convention and Convention
combined with sulfur identified in ‘extra’] relief of itching due to Adoptions of Emigrating Children
§ 358.710(a)(7) provided each ingredient dandruff’’.
is present within the established (2) The following terms or phrases AGENCY: Department of State.
concentration and the product is labeled may be used in place of or in addition ACTION: Final rule.
according to § 358.750. to the words ‘‘for the relief of’’ or
(b) Combination of control of dandruff ‘‘controls’’ in the indications in SUMMARY: The Department of State (the
and external analgesic active paragraph (b)(1) of this section: ‘‘fights,’’ Department), with the joint review and
ingredients. Coal tar identified in ‘‘reduces,’’ ‘‘helps eliminate,’’ ‘‘helps approval of the Department of
§ 358.710(a)(1) may be used at a stop,’’ ‘‘controls recurrence of,’’ ‘‘fights Homeland Security (DHS), is issuing a
concentration of 1.8 percent coal tar recurrence of,’’ ‘‘helps prevent new rule to implement the requirement
solution, on a weight to volume basis, recurrence of,’’ ‘‘reduces recurrence of,’’ in the Intercountry Adoption Act of
in combination with menthol, 1.5 ‘‘helps eliminate recurrence of,’’ ‘‘helps 2000 (the IAA) to establish a Case
percent, in a shampoo formulation stop recurrence of.’’ Registry for, inter alia, emigrating
provided the product is labeled (3) The following terms may be used children. This final rule imposes
according to § 358.760. in place of the words ‘‘the symptoms of’’ reporting requirements on adoption
in the indication in paragraph (b)(1) of service providers, including
■ 5. New § 358.760 is added to read as
this section: ‘‘scalp’’ (select one or more governmental authorities who provide
of the following: ‘‘itching,’’ ‘‘irritation,’’ adoption services, in cases involving
§ 358.760 Labeling of permitted ‘‘redness,’’ ‘‘flaking,’’ ‘‘scaling’’) adoptions of children who will emigrate
combinations of active ingredients for the ‘‘associated with’’. from the United States. These reporting
control of dandruff. (c) Warnings. The labeling of the obligations apply to all intercountry
The statement of identity, indications, product states, under the heading adoptions, regardless of whether they
warnings, and directions for use, ‘‘Warnings,’’ the warning(s) listed in are covered under the 1993 Hague
respectively, applicable to each § 358.750(c)(1) and (c)(2). Convention on Protection of Children
ingredient in the product may be (d) Directions. The labeling of the and Co-operation in Respect of
combined to eliminate duplicative product states, under the heading Intercountry Adoption (the Convention).
words or phrases so that the resulting ‘‘Directions,’’ directions that conform to This final rule, although issued with the
information is clear and understandable. the directions established for each joint review and approval of DHS
(a) Statement of identity. For a ingredient in the directions sections of pursuant to section 303(d) of the IAA,
combination drug product that has an the applicable OTC drug monographs, only adds a new section to the
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