10168 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 34. The authority citation for 21 CFR 

part 524 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 524.2481 [Redesignated as § 524.2483] 

■ 35. Redesignate § 524.2481 as 

§ 524.2483. 

§ 524.2483 [Amended] 

■ 36. In paragraph (b) of newly 

redesignated § 524.2483, remove 

‘‘015914, 053501, and 054925’’ and in its 

place add ‘‘000010, 015914, and 

054925’’. 

PART 526—INTRAMAMMARY DOSAGE 

FORMS 

■ 37. The authority citation for 21 CFR 

part 526 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 526.363 [Amended] 

■ 38. In paragraph (b) of § 526.363, 

remove ‘‘000856’’ and in its place add 

‘‘000010’’. 

§ 526.365 [Amended] 

■ 39. In paragraph (b) of § 526.365, 

remove ‘‘000856’’ and in its place add 

‘‘000010’’. 

■ 40. In § 526.464a, revise the section 

heading and paragraph (c) to read as 

follows: 

§ 526.464a Cloxacillin benzathine. 

* * * * * 

(c) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter for use in 

dairy cows. 

* * * * * 

§ 526.1130 [Amended] 

■ 41. In § 526.1130, in paragraph (b), 

remove ‘‘000856’’ and in its place add 

‘‘000010’’; and in paragraph (c)(3), 

remove the first sentence. 

Dated: February 26, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–4560 Filed 3–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1313 

[Docket No. DEA–295F] 

RIN 1117–AB07 

Information on Foreign Chain of 

Distribution for Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is finalizing, 

without change, the Notice of Proposed 

Rulemaking published in the Federal 

Register on March 31, 2008 (73 FR 

16793). The Combat Methamphetamine 

Epidemic Act of 2005 (CMEA) requires 

DEA to collect from importers of 

ephedrine, pseudoephedrine, and 

phenylpropanolamine all information 

known to the importer on the foreign 

chain of distribution of the chemical 

from the manufacturer to the importer. 

This rule amends DEA regulations to 

incorporate the requirement for this 

information. 

DATES: Effective Dates: This Final Rule 

is effective May 4, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Mark W. Caverly, Chief, Liaison and 

Policy Section, Office of Diversion 

Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152, Telephone (202) 

307–7297. 

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority 

DEA implements the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, often referred to as the 

Controlled Substances Act (CSA) and 

the Controlled Substances Import and 

Export Act (CSIEA) (21 U.S.C. 801–971), 

as amended. DEA publishes the 

implementing regulations for these 

statutes in Title 21 of the Code of 

Federal Regulations (CFR), parts 1300 to 

1399. These regulations are designed to 

ensure that there is a sufficient supply 

of controlled substances for legitimate 

medical, scientific, research, and 

industrial purposes and to deter the 

diversion of controlled substances to 

illegal purposes. The CSA mandates that 

DEA establish a closed system of control 

for manufacturing, distributing, and 

dispensing controlled substances. Any 

person who manufactures, distributes, 

dispenses, imports, exports, or conducts 

research or chemical analysis with 

controlled substances must register with 

DEA (unless exempt) and comply with 

the applicable requirements for the 

activity. The CSA as amended also 

requires DEA to regulate the 

manufacture, distribution, import, and 

export of chemicals that may be used to 

manufacture controlled substances 

illegally. Listed chemicals that are 

classified as List I chemicals are 

important to the manufacture of 

controlled substances. Those classified 

as List II chemicals may be used to 

manufacture controlled substances. 

On March 9, 2006, the President 

signed the Combat Methamphetamine 

Epidemic Act of 2005 (CMEA), which is 

Title VII of the USA PATRIOT 

Improvement and Reauthorization Act 

of 2005 (Pub. L. 109–177). The changes 

made by this rule are needed to 

implement the statutory provisions. 

This Final Rule amends the language of 

the regulations to be consistent with 

that of the statute. 

Import/Export Declaration 

Requirements 

Under existing DEA regulations (21 

CFR part 1313), importers of listed 

chemicals are required to provide DEA 

with advance notification of imports 

unless the importer has met the 

requirements as a regular importer of 

the listed chemical; for regular 

importers, the notification must be filed 

by the date of importation. In the 

importation declaration (DEA Form 

486), the importer must provide 

information on the chemical (name, size 

and weight of the container, number of 

containers, total weight of chemical), 

importation (date, foreign port of 

shipment, United States port of entry) 

and the foreign supplier (name, address, 

contact information). 

CMEA imposes several new 

requirements on imports of listed 

chemicals. CMEA amended 21 U.S.C. 

971, ‘‘Notification, suspension of 

shipment, and penalties with respect to 

importation and exportation of listed 

chemicals,’’ to require DEA to collect 

information regarding persons to whom 

the U.S. importer, exporter, broker, or 

trader transfers the listed chemical, 

actual quantities shipped, and the date 

the shipment occurred. If the person to 

whom the listed chemical is to be 

transferred is not a regular customer of 

the U.S. importer or exporter, then the 

importer or exporter must notify DEA 

no later than 15 days before the 

transaction is to take place. Further, if 

the person to whom the chemical is to 

be transferred changes subsequent to 

initial notification of DEA, or if the 

amount of the chemical to be transferred 

increases, the importer or exporter shall 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 10169 

update the notice to DEA to identify the 

most recent prospective transferee or the 

most recent quantity or both (as the case 

may be) and may not transfer the listed 

chemical until after the expiration of the 

15-day period beginning on the date on 

which the update is submitted to DEA, 

except that such 15-day restriction does 

not apply if the prospective transferee 

identified in the update is a regular 

customer. These changes apply to all 

listed chemicals. On April 9, 2007, DEA 

published an Interim Final Rule with 

Request for Comment codifying these 

provisions (72 FR 17401). Subsequently, 

due to requests from the regulated 

industry, DEA temporarily stayed 

certain provisions of that rule (72 FR 

28601, May 22, 2007). That Interim 

Final Rule became effective June 8, 

2007. 

Imports of Ephedrine, 

Pseudoephedrine, and 

Phenylpropanolamine 

CMEA added a new paragraph (h) to 

21 U.S.C. 971 that applies specifically to 

the importation of ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. In paragraph 

(h)(1), the Act states that the import 

declaration ‘‘shall include all 

information known to the importer on 

the chain of distribution of such 

chemical from the manufacturer to the 

importer.’’ Paragraphs 971(h)(2) and 

(h)(3) state that the Attorney General 

may ask foreign manufacturers and 

distributors to provide information 

known to them on distribution of the 

chemical, including sales. If the foreign 

manufacturer or distributor refuses to 

cooperate, the Attorney General may 

issue an order prohibiting the 

importation of the three chemicals if the 

foreign manufacturer or distributor is 

part of the chain of distribution. Not 

later than 60 days prior to issuing the 

order, the Attorney General must 

publish in the Federal Register a notice 

of intent to issue the order. Imports 

handled by the foreign distributor may 

not be restricted during the 60-day 

period. In the Conference Report (H.R. 

109–333), Congress stated that the 

‘‘provision will assist U.S. law 

enforcement agencies to better track 

where meth precursors come from, and 

how they get to the U.S. At present, very 

little information exists about the 

international ‘chain of distribution’ for 

these chemicals, hindering effective 

controls.’’ 

In its Notice of Proposed Rulemaking 

proposing implementation of the 

provisions of 21 U.S.C. 971(h) (73 FR 

16793, March 31, 2008), DEA proposed 

to add a new paragraph (d) to 21 CFR 

1313.13, Contents of import declaration, 

to state that importers of ephedrine, 

pseudoephedrine, and 

phenylpropanolamine must provide 

information known to them on the chain 

of distribution from the manufacturer to 

the importer. DEA also proposed to add 

a new 21 CFR 1313.42 to cover the 

provisions of paragraphs (h)(2) and 

(h)(3) on orders to prohibit imports from 

foreign manufacturers and distributors 

who refuse to cooperate with requests 

for information. 

Revision of DEA Form 486: Import/ 

Export Declaration for List I and List II 

Chemicals 

To comply with the changes made to 

the CSA by CMEA, DEA proposed to 

establish a new DEA Form 486A to be 

used by persons importing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine, or drug products 

containing ephedrine, pseudoephedrine, 

or phenylpropanolamine. This new 

form responds to the requirement 

regarding the foreign chain of 

distribution discussed above, as well as 

to requirements implemented regarding 

import quotas for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. In a separate 

rulemaking, ‘‘Import and Production 

Quotas for Certain List I Chemicals’’ 

[Docket No. DEA–293, RIN 1117–AB08] 

(72 FR 37439, July 10, 2007; 73 FR 

73549, December 3, 2008), DEA 

implemented the import quota 

provisions of CMEA. Importers of 

ephedrine, pseudoephedrine, and 

phenylpropanolamine will be required 

to provide information about their 

individual import quota on the DEA 

Form 486A so that DEA may determine 

whether the importer has enough quota 

remaining to import the quantity 

requested. 

Thus, in addition to the fields 

currently present on the DEA Form 486, 

the DEA Form 486A was proposed to 

contain the following fields: 

• Name and address of foreign 

distributor (if applicable). 

• Import quota, including: quota for 

current year; quota used to date for 

current year; and, amount of quota 

remaining. 

Comments Received 

DEA received two comments in 

response to the Notice of Proposed 

Rulemaking. Commenters included one 

member of the public who indicated he 

was a health care provider and one 

chemical manufacturer. The 

commenters generally supported the 

rulemaking, but had a variety of 

comments regarding certain aspects of 

the proposed rule. The comments, and 

DEA’s responses, are discussed below. 

Safety of medication manufactured 

overseas: One commenter stated that he 

supported the rule because he believed 

that improving drug safety can save 

lives. The commenter also asserted that 

‘‘this rule has the potential to improve 

safety of the industry even further by 

putting the burden of finding the foreign 

chain of distribution on the importer.’’ 

The commenter emphasized his concern 

with the safety of medications 

manufactured in foreign countries and 

asserted that the Food and Drug 

Administration (FDA) does not have 

adequate resources to regulate overseas 

manufacturing facilities, and believed 

this rule could be beneficial in that 

regard. The commenter believed that the 

reporting of information about where a 

drug comes from is of interest not only 

to the importer, but to all parties 

concerned, including practitioners who 

prescribe those medications to their 

patients. The commenter believed that it 

is useful to know that medications came 

from ‘‘trustworthy’’ facilities, and that 

such a requirement would be a ‘‘small 

price to pay’’ for protecting lives. 

DEA Response: DEA appreciates the 

commenter’s support. Regarding the 

safety of medications manufactured in 

foreign countries, DEA does not have 

jurisdiction regarding foreign 

manufacture of ephedrine, 

pseudoephedrine, 

phenylpropanolamine, or drug products 

containing those three List I chemicals. 

DEA also emphasizes that information 

regarding the foreign chain of 

distribution will be made known by the 

importer to DEA, but that information 

will not be made known to the general 

public. 

Distributions to countries other than 

the United States: The second 

commenter, a chemical manufacturer, 

asked whether it was DEA’s intent to 

collect information about the foreign 

manufacturer’s use of distribution 

centers for shipments to any destination 

in the world, or only collect information 

on the use of distributors for shipment 

to the United States. 

DEA Response: DEA is only requiring 

collection of the information on the use 

of distributors for shipment to the U.S. 

The CSA and its implementing 

regulations address importation of listed 

chemicals only in regard to the United 

States, not in regard to foreign countries 

(21 U.S.C. 951(a)(1)). Thus, any 

requirements DEA imposes regarding 

importation of listed chemicals relate to 

the U.S. 

Source of distribution data: The 

second commenter also asked DEA to 

clarify in the Final Rule the information 

required to be included on the DEA 

Form 486, stating: ‘‘* * * if distribution 


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10170 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 

data is obtained from a central location 

should the importer include that 

information in the existing foreign 

consignor field (field 2b), or does the 

manufacturing site information from 

which the direct export occurs suffice if 

DEA could obtain distribution data from 

the contact information being provided 

in a timely manner?’’ 

DEA Response: If a foreign exporter 

exports a listed chemical from a 

particular location to the U.S., but the 

information regarding all exports from 

the foreign country to the U.S. is 

aggregated at a central location, the U.S. 

importer should provide information on 

the DEA Form 486 regarding the actual 

export location, not the location at 

which the information is aggregated. 

DEA emphasizes that this requirement 

is not a change from existing 

requirements or policies. 

Quota information on Import 

Declarations: The commenter also 

requested that DEA delay 

implementation of the requirements 

regarding foreign chain of distribution 

until calendar year 2009. The 

commenter believed this would be 

beneficial to the regulated industry as 

that industry had already made 

significant changes to its processes to 

comply with other requirements of 

CMEA. The commenter believed that 

delaying the effective date of the rule 

until calendar year 2009 would ensure 

that both importers and DEA have 

established timely quota processes that 

will not interfere with compliance to the 

proposed rule. 

DEA Response: DEA acknowledges 

that the regulated industry has worked 

to adapt its business process to the 

statutory requirements imposed by 

CMEA. The information sought by the 

new DEA Form 486A regarding foreign 

chain of distribution should not pose a 

significant additional burden to 

importer registrants. Further, the 

information required pertaining to 

import quotas is necessary to fully 

implement the quota provisions of 

CMEA and should already be 

maintained by importers. However, to 

ensure that industry has adequate time 

in which to begin to use the new form, 

DEA is making this rule effective May 

4, 2010. DEA believes industry will 

have adequate time to begin to submit 

the DEA Form 486A based on this 

effective date. 

Implementation of This Rule 

Thus, to comply with the provisions 

of CMEA codified at 21 U.S.C. 971(h), 

this Final Rule adds a new paragraph (d) 

to 21 CFR 1313.13, Contents of import 

declaration, and states that importers of 

ephedrine, pseudoephedrine, and 

phenylpropanolamine must provide 

information known to them on the chain 

of distribution from the manufacturer to 

the importer. This rule adds a new 21 

CFR 1313.42 to cover the provisions of 

paragraphs (h)(2) and (h)(3) on orders to 

prohibit imports from foreign 

manufacturers and distributors who 

refuse to cooperate with requests for 

information. 

Effective May 4, 2010, all U.S. 

importers of the List I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine will be required 

to use the new DEA Form 486A 

‘‘Importation of the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine’’ to notify DEA of 

their imports of those three List I 

chemicals. 

Regulatory Certifications 

Regulatory Flexibility Act 

The Deputy Administrator hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

provisions of the Regulatory Flexibility 

Act (5 U.S.C. 601–612). This rule is 

necessary to comply with statutory 

mandates which require that notices of 

importation for imports of the List I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine provide to 

DEA all information known to the 

importer on the foreign chain of 

distribution of the chemical. As noted 

above, changes to the forms also 

respond to provisions regarding import 

quotas, requiring that importers note on 

the form the amount of quota issued and 

available for each chemical. Without 

these changes, DEA will be unable to 

comply with statutory mandates and 

will not be able to fully administer the 

system of import and production quotas 

mandated for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 

DEA notes that the statute requires 

importers to provide only information 

that is known to them; the burden 

associated with providing names on the 

foreign chain of distribution will be 

minimal. This rule does not impose any 

new costs. DEA notes that, prior to this 

rule, importers of ephedrine, 

pseudoephedrine, and 

phenylpropanolamine were required to 

complete a DEA Form 486 to import 

these List I chemicals. Only the 

information on the form has changed. 

Therefore, this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Executive Order 12866 

The Deputy Administrator further 

certifies that this rulemaking has been 

drafted in accordance with the 

principles in Executive Order 12866 

1(b). It has been determined that this is 

‘‘a significant regulatory action.’’ 

Therefore, this action has been reviewed 

by the Office of Management and 

Budget. As discussed above, this action 

is codifying statutory provisions and 

involves no agency discretion. This 

statutory change imposes minimal costs 

on importers; they simply have to file a 

form with DEA in advance of 

transactions that includes information 

that is known to them. They are not 

required to conduct research to obtain 

information. DEA notes that the 

requirement to complete the form is 

already present in DEA regulations. This 

rule merely requires that importers of 

these three List I chemicals provide 

information known to them regarding 

the foreign chain of distribution of the 

chemicals. 

Paperwork Reduction Act 

This Final Rule revises an existing 

information collection by establishing a 

new form for the reporting of imports of 

the List I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. Specifically, 

DEA is establishing a new DEA Form 

486A, ‘‘Import Declaration for 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine’’. This form 

permits the reporting of any information 

known to the U.S. importer regarding 

the foreign chain of distribution of the 

List I chemical(s). 

Specifically, DEA estimates that 30 

respondents will import ephedrine, 

pseudoephedrine, and 

phenylpropanolamine annually. These 

persons will conduct 350 individual 

importations, necessitating the 

submission of 350 forms and 385 import 

return declarations. Because of the 

additional information required on the 

DEA Form 486A, DEA estimates that 

this form will take 24 minutes to 

complete, as opposed to the DEA Form 

486, which DEA estimates takes 20 

minutes to complete. DEA notes here 

that the completion of the DEA Form 

486A will be in lieu of the currentlyrequired completion of the DEA Form 

486. Therefore, while the number of 

responses remains constant, the hour 

burden increases due to the greater time 

associated with the DEA Form 486A. 

The net increase for this collection is 24 

hours annually. 

DEA solicited comments regarding the 

Paperwork Reduction Act aspects of the 

Notice of Proposed Rulemaking and 

received no comments. Therefore, DEA 

is finalizing the Paperwork Reduction 

Act aspects of this rule without change. 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 10171 

The Department of Justice, Drug 

Enforcement Administration, has 

submitted the following information 

collection request to the Office of 

Management and Budget for review and 

clearance in accordance with review 

procedures of the Paperwork Reduction 

Act of 1995. 

Overview of information collection 

1117–0023: 

(1) Type of Information Collection: 

Revision of an existing collection. 

(2) Title of the Form/Collection: 

Import/Export Declaration for List I and 

List II Chemicals. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: 

Form Number: DEA Form 486 and 

DEA Form 486A. Office of Diversion 

Control, Drug Enforcement 

Administration, Department of Justice. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: 

Primary: Business or other for-profit. 

Other: None. 

Abstract: Persons importing, 

exporting, and conducting international 

transactions with List I and List II 

chemicals must notify DEA of those 

transactions in advance of their 

occurrence, including information 

regarding the person(s) to whom the 

chemical will be transferred and the 

quantity to be transferred. Persons must 

also provide return declarations, 

confirming the date of the importation 

and transfer, and the amounts of the 

chemical transferred. For the List I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine, importers 

must report all information known to 

them on the chain of distribution of the 

chemical from the manufacturer to the 

importer. This information is used to 

prevent shipments not intended for 

legitimate purposes. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 

Number of 

respondents 

Number of 

responses Average time per response Total (hours) 

Form 486 (export) .......................................................................... 193 10,327 0.283 hour (17 minutes) ............ 2,926 

Form 486 (Export Return Declaration) .......................................... 193 10,327 0.166 hour (10 minutes) ............ 1721 .2 

Form 486 (import) .......................................................................... 120 1,268 0.333 hour (20 minutes) ............ 422 .6 

Form 486 (import return declaration) * .......................................... 120 1,395 0.2 hour (12 minutes) ................ 279 

Form 486A (import) ....................................................................... 30 350 0.4 hour (24 minutes) ................ 140 

Form 486A (import return declaration) * ........................................ 30 385 0.2 hour (12 minutes) ................ 77 

Form 486 (international transaction) ............................................. 14 14 0.2 hour (12 minutes) ................ 2 .8 

Form 486 (international transaction return declaration) ................ 14 14 0.08 hour (5 minutes) ................ 1 .2 

Quarterly reports for imports of acetone, 2-butanone, and toluene.110 440 0.5 hour (30 minutes) ................ 220 

Total ............................................................................................... 193 .................... .................................................... 5,789 .8 

* DEA assumes 10% of all imports will not be transferred in the first 30 days and will necessitate submission of a subsequent return 

declaration. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: DEA estimates that this 

collection will take 5,790 hours 

annually. 

If additional information is required, 

contact Lynn Bryant, Department 

Clearance Officer, Information 

Management and Security Staff, Justice 

Management Division, Department of 

Justice, Patrick Henry Building, Suite 

1600, 601 D Street, NW., Washington, 

DC 20530. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988, Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of state law; nor 

does it impose enforcement 

responsibilities on any state; nor does it 

diminish the power of any state to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1313 

Administrative practice and 

procedure, Drug traffic control, Exports, 

Imports, Reporting and recordkeeping 

requirements. 

Dated: February 25, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

■ For the reasons set out above, 21 CFR 

part 1313 is amended as follows: 

PART 1313—IMPORTATION AND 

EXPORTATION OF LIST I AND LIST II 

CHEMICALS 

■ 1. The authority citation for part 1313 

continues to read as follows: 

Authority: 21 U.S.C. 802, 830, 871(b), 971. 

■ 2. Section 1313.13 is amended by 

adding paragraph (d) to read as follows: 

§ 1313.13 Contents of import declaration. 

* * * * * 

(d) Any regulated person importing 

ephedrine, pseudoephedrine, or 

phenylpropanolamine must submit, on 

the import declaration, all information 

known to the importer on the chain of 

distribution of the chemical from the 

manufacturer to the importer. 

Ephedrine, pseudoephedrine, or 

phenylpropanolamine include each of 

the salts, optical isomers, and salts of 

optical isomers of the chemical. 


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10172 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 

■ 3. Section 1313.42 is added to read as 

follows: 

§ 1313.42 Prohibition of shipments from 

certain foreign sources. 

(a) If the Administrator determines 

that a foreign manufacturer or 

distributor of ephedrine, 

pseudoephedrine, or 

phenylpropanolamine has refused to 

cooperate with a request by the 

Administrator for information known to 

the manufacturer or distributor on the 

distribution of the chemical, including 

sales, the Administrator may issue an 

order prohibiting the importation of the 

chemical in any case where the 

manufacturer or distributor is part of the 

chain of distribution. 

(b) Not later than 60 days prior to 

issuing the order to prohibit 

importation, the Administrator shall 

publish in the Federal Register a notice 

of intent to issue the order. During the 

60-day period, imports from the foreign 

manufacturer or distributor may not be 

restricted under this section. 

[FR Doc. 2010–4716 Filed 3–4–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9424] 

RIN 1545–BB61 

Unified Rule for Loss on Subsidiary 

Stock; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains a 

correction to final regulations (TD 9424) 

that were published in the Federal 

Register on Wednesday, September 17, 

2008 (73 FR 53934). 

The regulations apply to corporations 

filing consolidated returns, and 

corporations that enter into certain taxfree reorganizations. The regulations 

provide rules for determining the tax 

consequences of a member’s transfer 

(including by deconsolidation and 

worthlessness) of loss shares of 

subsidiary stock. 

DATES: Effective Date: This correction is 

effective on March 5, 2010, and is 

applicable on September 17, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Maury Passman, (202) 622–7550 or 

Theresa Abell, (202) 622–7700 (not tollfree numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations (TD 9424) that 

are the subject of this document are 

under sections 337, 358, 362 and 1502 

of the Internal Revenue Code. 

Need for Correction 

As published, the final regulations 

(TD 9424) contain an error that may 

prove to be misleading and is in need 

of clarification. The final regulations 

revised § 1.1502–35(a) to provide that, 

in general, § 1.1502–35 would only 

apply to transactions completed prior to 

September 17, 2008. The final 

regulations also revised the operative 

rules in § 1.1502–35. However, the 

effective date prescribed in § 1.1502– 

35(j) appeared to preclude the 

application of the revised § 1.1502–35 to 

transactions completed prior to 

September 17, 2008. The final 

regulations are clarified to provide that 

the revised rules in § 1.1502–35 

(including the ten-year termination of 

application of § 1.1502–35 described in 

Background section 2.A. of the 

preamble) apply after September 16, 

2008, to all transactions subject to that 

section. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Correction of Publication 

■ Accordingly, 26 CFR part 1 is 

corrected by making the following 

correcting amendment: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

■ Par. 2. Section 1.1502–35 is amended 

by revising the first sentence of 

paragraph (j) to read as follows: 

§ 1.1502–35 Transfers of subsidiary stock 

and deconsolidations of subsidiaries. 

* * * * * 

(j) Effective/applicability dates. This 

section applies after September 16, 

2008. * * * 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel, (Procedure and Administration). 

[FR Doc. 2010–4756 Filed 3–4–10; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2009–0796] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Chester River, Chestertown, MD 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is changing 

the drawbridge operation regulations of 

the S213 Bridge, at mile 26.8, across 

Chester River at Chestertown, MD. This 

final rule allows the bridge to open on 

signal if at least six hours notice is given 

and will provide for the reasonable 

needs of navigation, due to the 

anticipated infrequency of requests for 

vessel openings of the drawbridge. 

DATES: This rule is effective April 5, 

2010. 

ADDRESSES: Comments and related 

materials received from the public, as 

well as documents mentioned in this 

preamble as being available in the 

docket, are part of docket USCG–2009– 

0796 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2009–0796 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ This 

material is also available for inspection 

or copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

Regulatory Information 

On September 25, 2009, we published 

a notice of proposed rulemaking 

(NPRM) entitled ‘‘Drawbridge Operation 

Regulations; Chester River, 

Chestertown, MD’’ in the Federal 

Register (74 FR 48889). We received no 

comments on the proposed rule. No 

public meeting was requested, and none 

was held. 

Background and Purpose 

Maryland Department of 

Transportation-State Highway 

Administration (MDOT) is responsible 

for the operation of the S213 Bridge, at 

mile 26.8, across Chester River at 

Chestertown, MD. MDOT requested 

advance notification for vessel openings 

year-round due to the anticipated 

infrequency of requests for vessel 

openings of the drawbridge. 


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