9852 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations 

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 


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Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations 9853 

Department’s Convention regulations; 

no amendments or additions are made 

to DHS regulations. 

DATES: This rule is effective April 5, 

2007. Information about the date the 

Convention will enter into force with 

respect to the United States is provided 

in 22 CFR 96.17. 

FOR FURTHER INFORMATION CONTACT: 

Anna Mary Coburn at 202–736–9081. 

Hearing-or speech-impaired persons 

may use the Telecommunications 

Devices for the Deaf (TDD) by contacting 

the Federal Information Relay Service at 

1–800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The Convention is a multilateral 

treaty that provides a framework for the 

adoption of children habitually resident 

in one country that is a party to the 

Convention by persons habitually 

resident in another country that is also 

a party to the Convention. The 

Convention establishes procedures to be 

followed in these intercountry adoption 

cases and imposes safeguards to protect 

the best interests of children. When the 

Convention enters into force with 

respect to the United States, it will 

apply to the United States as both a 

country of origin (outgoing cases, i.e., 

where children are emigrating from the 

United States to a foreign country) and 

a receiving country (incoming cases, i.e., 

where children are immigrating to the 

United States from a foreign country). 

The implementing legislation for the 

Convention is the IAA. The IAA 

requires the Department and DHS to 

establish a Case Registry to track all 

intercountry adoption cases: Convention 

and non-Convention; emigrating and 

immigrating cases. The Department is, 

with the joint review and approval of 

DHS, promulgating this final rule to 

require adoption service providers that 

provide adoption services in 

intercountry adoption cases involving a 

child emigrating from the United States 

(including governmental authorities 

who provide such adoption services) to 

report certain information to the 

Department for incorporation into the 

Case Registry. 

II. The Final Rule 

The Department issued a proposed 

rule for public comment (See Proposed 

Rule on Intercountry Adoption—

Reporting on Non-Convention and 

Convention Adoptions of Emigrating 

Children, 71 FR 54001–54005, 

September 13, 2006). No public 

comments were received. The 

Department is now issuing the final rule 

as it was proposed. No changes have 

been made to the text of the rule, except 

that the Department has made certain 

technical clarifications, including 

changing the § 99.2 heading and 

§ 99.2(d)(1) to correct any 

misimpression that the rule applies only 

to U.S. national children and changing 

§ 99.2(a) to clarify that the reporting 

requirements do not take effect until the 

Convention has entered into force for 

the United States. 

III. Regulatory Review 

A. Administrative Procedure Act 

In accordance with provisions of the 

Administrative Procedure Act governing 

rules promulgated by Federal agencies 

that affect the public (5 U.S.C. 533), the 

Department published this rule for 

public comment. 

B. Regulatory Flexibility Act/Executive 

Order 13272: Small Business 

In accordance with the Regulatory 

Flexibility Act, 5 U.S.C. 601–612 and 

Executive Order 13272, section 3(b), the 

Department of State has evaluated the 

effects of this action on small entities, 

and has determined, and hereby 

certifies, pursuant to 5 U.S.C. 605(b), 

that it would not have a significant 

economic impact on a substantial 

number of small entities. Overall, the 

number of outgoing intercountry 

adoption cases is expected to be very 

small in comparison with the number of 

incoming cases. Consequently, very few 

ASPs that are small entities will also be 

involved in outgoing cases. Moreover, 

the rule requires only extremely limited 

reporting requirements for outgoing 

cases. Thus, the Department does not 

believe the economic impact on small 

entities will be significant. The 

Department received no public 

comments on the rule’s impact on small 

entities. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

This rule is not a major rule as 

defined by 5 U.S.C. 804 for purposes of 

congressional review of agency 

rulemaking under the Small Business 

Regulatory Enforcement Fairness Act of 

1996, Pub. L. 104–121. The rule would 

not result in an annual effect on the 

economy of $100 million or more, a 

major increase in costs or prices, or 

significant adverse effects on 

competition, employment, investment, 

productivity, or innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

D. The Unfunded Mandates Reform Act 

of 1995 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UFMA), 

Pub. L. 104–4; 109 Stat. 48; 2 U.S.C. 

1532, generally requires agencies to 

prepare a statement, including costbenefit and other analyses, before 

proposing any rule that may result in an 

annual expenditure of $100 million or 

more by State, local, or tribal 

governments, or by the private sector. 

This rule will not result in the 

expenditure by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

in any year. Moreover, because this rule 

will not significantly or uniquely affect 

small governments, section 203 of the 

UFMA, 2 U.S.C. 1533, does not require 

preparation of a small government 

agency plan in connection with it. 

E. Executive Order 13132: Federalism 

A rule has federalism implications 

under Executive Order 13132 if it has 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. This regulation 

will not have such effects, and therefore 

does not have sufficient federalism 

implications to require consultations or 

to warrant the preparation of a 

federalism summary impact statement 

under section 6 of Executive Order 

13132. 

F. Executive Order 12866: Regulatory 

Review 

The Department of State does not 

consider this rule to be a ‘‘significant 

regulatory action’’ within the scope of 

section 3(f)(1) of Executive Order 12866. 

Nonetheless, the Department has 

reviewed the rule to ensure its 

consistency with the regulatory 

philosophy and principles set forth in 

the Executive Order. 

G. Executive Order 12988: Civil Justice 

Reform 

The Department has reviewed this 

rule in light of sections 3(a) and 3(b)(2) 

of Executive Order 12988 to eliminate 

ambiguity, minimize litigation, establish 

clear legal standards, and reduce 

burden. The Department has made every 

reasonable effort to ensure compliance 

with the requirements in Executive 

Order 12988. 

H. The Paperwork Reduction Act (PRA) 

of 1995 

Under the PRA, 42 U.S.C. 3501 et 

seq., agencies are generally required to 

submit to the Office of Management and 


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9854 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Rules and Regulations 

Budget (OMB) for review and approval 

information collection requirements 

imposed on ‘‘persons’’ as defined in the 

PRA. Section 503(c) of the IAA exempts 

from the PRA information collection 

‘‘for purposes of sections 104, 202(b)(4), 

and 303(d)’’ of the IAA ‘‘or for use as a 

Convention record as defined’’ in the 

IAA. All information collections that 

relate to outgoing non-Convention cases 

will be collections made for the 

purposes of section 303(d) of the IAA, 

and thereby are exempt. All information 

collections that relate to outgoing 

Convention cases will be Convention 

records as defined in and subject to the 

preservation requirements of 22 CFR 

part 98, which implements section 

401(a) of the IAA. Additionally, the 

majority of information collection 

imposed on persons pursuant to this 

rule, with respect to both Convention 

and non-Convention cases, will be for 

the purposes of obtaining information 

for congressional reports required under 

section 104 of the IAA. Accordingly, the 

Department has concluded that the PRA 

does not apply to information collected 

from the public under this rule. 

List of Subjects in 22 CFR Part 99 

Adoption and foster care; 

International agreements; Reporting and 

recordkeeping requirements. 

■ Accordingly, the Department adds 

new part 99 to title 22 of the CFR, 

chapter I, subchapter J, to read as 

follows: 

PART 99—REPORTING ON 

CONVENTION AND NON-CONVENTION 

ADOPTIONS OF EMIGRATING 

CHILDREN 

Sec. 

99.1 Definitions. 

99.2 Reporting requirements for adoption 

cases involving children emigrating from 

the United States. 

99.3 [Reserved]. 

Authority: The Convention on Protection 

of Children and Co-operation in Respect of 

Intercountry Adoption (done at The Hague, 

May 29, 1993), S. Treaty Doc. 105–51 (1998); 

1870 U.N.T.S. 167 (Reg. No. 31922 (1993)); 

The Intercountry Adoption Act of 2000, 42 

U.S.C. 14901–14954. 

§ 99.1 Definitions. 

As used in this part, the term: 

(a) Convention means the Convention 

on Protection of Children and Cooperation in Respect of Intercountry 

Adoption done at The Hague on May 29, 

1993. 

(b) Such other terms as are defined in 

22 CFR 96.2 shall have the meaning 

given to them therein. 

§ 99.2 Reporting requirements for 

adoption cases involving children 

emigrating from the United States. 

(a) Once the Convention has entered 

into force for the United States, an 

agency (including an accredited agency 

and temporarily accredited agency), 

person (including an approved person), 

public domestic authority, or other 

adoption service provider providing 

adoption services in a case involving the 

emigration of a child from the United 

States must report information to the 

Secretary in accordance with this 

section if it is identified as the reporting 

provider in accordance with paragraph 

(b) of this section. 

(b) In a Convention case in which an 

accredited agency, temporarily 

accredited agency, or approved person 

is providing adoption services, the 

primary provider is the reporting 

provider. In any other Convention case, 

or in a non-Convention case, the 

reporting provider is the agency, person, 

public domestic authority, or other 

adoption service provider that is 

providing adoption services in the case, 

if it is the only provider of adoption 

services. If there is more than one 

provider of adoption services in a nonConvention case, the reporting provider 

is the one that has child placement 

responsibility, as evidenced by the 

following factors: 

(1) Entering into placement contracts 

with prospective adoptive parent(s) to 

provide child referral and placement; 

(2) Accepting custody from a 

birthparent or other legal guardian for 

the purpose of placement for adoption; 

(3) Assuming responsibility for liaison 

with a foreign government or its 

designees with regard to arranging an 

adoption; or 

(4) Receiving information from, or 

sending information to a foreign country 

about a child that is under consideration 

for adoption. 

(c) A reporting provider, as identified 

in paragraph (b) of this section, must 

report the following identifying 

information to the Secretary for each 

outgoing case within 30 days of learning 

that the case involves emigration of a 

child from the United States to a foreign 

country: 

(1) Name, date of birth of child, and 

place of birth of child; 

(2) The U.S. State from which the 

child is emigrating; 

(3) The country to which the child is 

immigrating; 

(4) The U.S. State where the final 

adoption is taking place, or the U.S. 

State where legal custody for the 

purpose of adoption is being granted 

and the country where the final 

adoption is taking place; and 

(5) Its name, address, phone number, 

and other contact information. 

(d) A reporting provider, as identified 

in paragraph (b) of this section, must 

report any changes to information 

previously provided as well as the 

following milestone information to the 

Secretary for each outgoing case within 

30 days of occurrence: 

(1) Date case determined to involve 

emigration from the United States 

(generally the time the child is matched 

with adoptive parents); 

(2) Date of U.S. final adoption or date 

on which custody for the purpose of 

adoption was granted in United States; 

(3) Date of foreign final adoption if 

custody for purpose of adoption was 

granted in the United States, to the 

extent practicable; and 

(4) Any additional information when 

requested by the Secretary in a 

particular case. 

§ 99.3 [Reserved]. 

Dated: December 18, 2006. 

Maura Harty, 

Assistant Secretary, Bureau of Consular 

Affairs, Department of State. 

Dated: February 2, 2007. 

Michael Chertoff, 

Secretary of Homeland Security, Department 

of Homeland Security. 

[FR Doc. E7–3684 Filed 3–5–07; 8:45 am] 

BILLING CODE 4710–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD11–07–005] 

RIN 1625–AA09 

Drawbridge Operation Regulations; 

Sacramento River, at Isleton, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Eleventh 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the Isleton 

Drawbridge across the Sacramento 

River, mile 18.7, at Isleton, CA. This 

deviation allows for a 12-hour notice for 

openings. The deviation is necessary for 

the bridge owner, the California 

Department of Transportation (Caltrans), 

to coordinate vessel traffic with their 

scheduled critical maintenance and 

operating upgrades. 


rwilkins on PROD1PC63 with RULES