20518 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

options that would minimize any 

significant impact of a rule on small 

entities. Because the final rule allows 

the Director of CBER or the Director of 

CDER, as appropriate, to approve 

exceptions or alternatives to the 

regulations for constituent materials, 

this action increases the flexibility and 

reduces the regulatory burden for 

affected entities. Therefore, FDA 

certifies that the final rule will not have 

a significant economic impact on a 

substantial number of 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 anticipated 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 $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

The benefit of this regulatory action is 

its reduction, through greater flexibility 

in the regulatory requirements, of 

burdens on the biological products 

industry. These issues are discussed in 

greater detail in section I of this 

document. Industry cost reductions may 

result in consumers being offered lower 

prices or wider availability of existing 

and new biological products; this would 

have a positive effect on patients’ 

welfare. 

Any administrative and paperwork 

costs associated with this regulatory 

action are expected to be minimal and 

widely dispersed among affected 

entities. Based on FDA experience, we 

estimate that we would receive a total 

of approximately three requests 

annually for an exception or alternative 

under § 610.15. FDA experience with 

similar information collection 

requirements suggests that 

approximately 1 hour would be required 

to prepare and submit each such 

request. 

We received comments expressing 

concern that this rule would generate 

additional costs in the form of negative 

public health effects. FDA has 

considered the potential for adverse 

consequences, including increased 

morbidity and mortality, associated 

with allowing deviations from the 

constituent materials regulations set 

forth in § 610.15(a) through (c), and will 

grant exemptions only in cases where 

data indicate that biological products in 

their exempted forms will be safe, pure, 

and potent for the conditions for which 

the applicant is seeking approval. As 

experience with the October 1981 rule 

has shown, FDA is able to conduct a 

constituent materials exemption process 

in a manner that is consistent with its 

public health mandate. For all these 

reasons, we believe the final rule will 

impose no overall public health cost. 

B. Environmental Impact 

The Agency has determined under 21 

CFR 25.31(h) that this action is of a type 

that does not individually or 

cumulatively have a significant adverse 

effect on the human environment. 

Therefore, neither an environmental 

assessment nor an environmental 

impact statement is required. 

C. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the final rule does not 

contain policies that have 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. Accordingly, the 

Agency has concluded that the final rule 

does not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VI. Paperwork Reduction Act of 1995 

Section 610.15(d) of this final rule 

contains reporting requirements that 

were submitted for review and approval 

to the Director of the Office of 

Management and Budget (OMB), as 

required by section 3507(d) of the 

Paperwork Reduction Act of 1995. The 

requirements were approved and 

assigned OMB control number 0910– 

0666. 

List of Subjects in 21 CFR Part 610 

Biologics, Labeling, Reporting and 

recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, 21 CFR part 610 is amended 

as follows: 

PART 610—GENERAL BIOLOGICAL 

PRODUCTS STANDARDS 

■ 1. The authority citation for 21 CFR 

part 610 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 360c, 360d, 360h, 360i, 371, 

372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 

264. 

■ 2. Amend § 610.15 by adding 

paragraph (d) to read as follows: 

§ 610.15 Constituent materials. 

* * * * * 

(d) The Director of the Center for 

Biologics Evaluation and Research or 

the Director of the Center for Drug 

Evaluation and Research may approve 

an exception or alternative to any 

requirement in this section. Requests for 

such exceptions or alternatives must be 

in writing. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8885 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1314 

[Docket No. DEA–347I] 

RIN 1117–AB30 

Self-Certification and Employee 

Training of Mail-Order Distributors of 

Scheduled Listed Chemical Products 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Interim final rule with request 

for comment. 

SUMMARY: On October 12, 2010, the 

President signed the Combat 

Methamphetamine Enhancement Act of 

2010 (MEA). It establishes new 

requirements for mail-order distributors 

of scheduled listed chemical products. 

Mail-order distributors must now selfcertify to DEA in order to sell scheduled 

listed chemical products at retail. Sales 

at retail are those sales intended for 

personal use; mail-order distributors 

that sell scheduled listed chemical 

products not intended for personal use, 

e.g., sale to a university, are not affected 

by the new law. This self-certification 

must include a statement that the mailorder distributor understands each of 

the requirements that apply under part 

1314 and agrees to comply with these 

requirements. Additionally, mail-order 

distributors are now required to train 

their employees prior to self 

certification. DEA is promulgating this 

rule to incorporate the statutory 

provisions and make its regulations 

consistent with the new requirements 


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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20519 

and other existing regulations related to 

self-certification. 

DATES: Effective Date: This rule is 

effective April 13, 2011. 

Comment Date: Written comments 

must be postmarked and electronic 

comments must be submitted on or 

before June 13, 2011. Commenters 

should be aware that the electronic 

Federal Docket Management System 

will not accept comments after midnight 

Eastern Time on the last day of the 

comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–347’’ on all written and 

electronic correspondence. Comments 

may be sent electronically through 

http://www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the http:// 

www.regulations.gov Web site. 

Comments may be sent to DEA by 

sending an electronic message to 

dea.diversion.policy@usdoj.gov. DEA 

will accept attachments to electronic 

comments in Microsoft Word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file formats other than those specifically 

listed here. 

Please note that DEA is requesting 

that electronic comments be submitted 

before midnight Eastern Time on the 

day the comment period closes because 

http://www.regulations.gov terminates 

the public’s ability to submit comments 

at midnight Eastern Time on the day the 

comment period closes. Commenters in 

time zones other than Eastern Time may 

want to consider this so that their 

electronic comments are received. 

Written comments sent via regular or 

express mail should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODL, 8701 Morrissette Drive, 

Springfield, VA 22152. 

All comments sent via regular or 

express mail will be considered timely 

if postmarked on the day the comment 

period closes. 

FOR FURTHER INFORMATION CONTACT: 

Cathy A. Gallagher, Acting Chief, 

Liaison and Policy Section, Office of 

Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152; telephone: (202) 

307–7297. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record and made available for 

public inspection online at http:// 

www.regulations.gov and in the Drug 

Enforcement Administration’s public 

docket. Such information includes 

personal identifying information (such 

as your name, address, etc.) voluntarily 

submitted by the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted and the comment, in 

redacted form, will be posted online and 

placed in the Drug Enforcement 

Administration’s public docket file. 

Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION CONTACT

paragraph. 

DEA’s Legal Authority 

DEA implements and enforces 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 (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 

1321. 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, importation, and 

exportation 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 October 12, 2010, the President 

signed the Combat Methamphetamine 

Enhancement Act of 2010 (MEA) (Pub. 

L. 111–268). Generally, the 

Administrative Procedure Act (APA) (5 

U.S.C. 553) requires agencies to provide 

notice of proposed rulemaking and the 

opportunity for public comment in its 

regulations implementing an Act of 

Congress. However, an agency may find 

good cause to exempt a rule from certain 

provisions of the APA, including notice 

of proposed rulemaking and the 

opportunity for public comment, if it is 

determined to be unnecessary, 

impracticable, or contrary to the public 

interest. DEA is invoking the APA good 

cause exception and promulgating this 

rule as an interim final rule rather than 

a proposed rule because the 

requirements of the MEA addressed by 

this rulemaking are self-implementing 

and changes in this rulemaking provide 

conforming amendments to make the 

language of the regulations consistent 

with that of the law. The MEA also 

specifically states that ‘‘[t]he Attorney 

General may issue regulations on an 

interim basis as necessary to ensure the 

implementation of this Act by the 

effective date.’’ Public Law 111–268, 

Sec. 6(b). DEA is accepting comments 

on this rulemaking. 

Mail-Order Distributor 

DEA regulations do not specifically 

define ‘‘mail-order distributor.’’ 

However, part 1314 of the regulations 

defines ‘‘mail-order sale’’ as ‘‘a retail sale 

of scheduled listed chemical products 

for personal use where a regulated 

person uses or attempts to use the U.S. 

Postal Service or any private or 

commercial carrier to deliver the 

product to the customer.’’ 21 CFR 

1314.03. Also, mail-order sale ‘‘includes 

purchase orders submitted by phone, 


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20520 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

mail, fax, Internet, or any method other 

than face-to-face transaction.’’ 21 CFR 

1314.03. 

The idea of mail-order distributor is 

further developed later in part 1314, 

which discusses a ‘‘regulated person 

who makes a sale at retail of a 

scheduled listed chemical product and 

is required under § 1310.03(c) of this 

chapter to submit a report of the sales 

transaction to the Administration 

***’’ 21 CFR 1314.100(a). The CSA 

(21 U.S.C. 830(b)(3)) and its 

implementing regulations impose 

recordkeeping and reporting 

requirements on ‘‘[e]ach regulated 

person who engages in a transaction 

with a nonregulated person or who 

engages in an export transaction that 

involves ephedrine, pseudoephedrine, 

phenylpropanolamine, or gammahydroxybutyric acid, including drug 

products containing these chemicals, 

and uses or attempts to use the Postal 

Service or any private or commercial 

carrier * * *’’ 21 CFR 1310.03(c). Such 

persons are obligated to file monthly 

reports with DEA. 21 CFR 1310.03(c). 

Combat Methamphetamine 

Enhancement Act of 2010 

The MEA amends the CSA to change 

the regulations for selling scheduled 

listed chemical products— 

nonprescription products that contain 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, their salts, 

optical isomers, and salts of optical 

isomers. The law requires that each 

regulated person making sales at retail 

of a scheduled listed chemical product 

who is required under Title 21 of the 

United States Code ((21 U.S.C. 

830(b)(3)) to submit monthly reports of 

sales transactions to the Attorney 

General (referred to as mail-order 

distributors) may not sell any scheduled 

listed chemical product at retail unless 

such regulated person has submitted to 

the Attorney General a self-certification. 

Sales at retail are those sales intended 

for personal use; mail-order distributors 

that sell scheduled listed chemical 

products not intended for personal use, 

e.g., sale to a university, are not affected 

by the new law. The requirement of selfcertification becomes effective April 10, 

2011 (180 days after enactment on 

October 10, 2010). Mail-order 

distributors must be self-certified before 

they can sell scheduled listed chemical 

products. Such self-certification must be 

consistent with the criteria established 

for certifications of regulated sellers— 

i.e., retail stores and mobile retail 

vendors—of scheduled listed chemical 

products. 

To that end, and pursuant to the 

requirements of 21 U.S.C. 

830(e)(1)(B)(ii)(II), DEA is requiring that 

each mail-order distributor must be selfcertified at each place of business at 

which they sell these products at retail. 

For a mail-order distributor, this would 

mean that each location that prepares or 

packages product for distribution to 

customers, and each location where 

employees accept payment for such 

sales, must be self-certified. 

Pursuant to the requirements of 21 

U.S.C. 830(e)(1)(B)(iii)(I) pertaining to 

regulated sellers, the self-certification 

for mail-order distributors is required to 

take place via the Internet on DEA’s 

Web site. Self-certification includes a 

statement that the mail-order 

distributors understand the 

requirements and agree to comply with 

them. MEA also makes it unlawful to 

negligently fail to self-certify as required 

under 21 U.S.C. 830, by an amendment 

to 21 U.S.C. 842(a)(10). Public Law 111– 

268, Sec. 5. This applies to regulated 

sellers and mail-order distributors. 

The MEA also includes a provision 

which states that ‘‘[t]he Attorney 

General shall by regulation establish 

criteria for certifications of mail-order 

distributors that are consistent with the 

criteria established for the certifications 

of regulated sellers under paragraph 

(1)(B).’’ 21 U.S.C. 830(e)(2)(C), as 

amended by Public Law 111–268, Sec. 

2. This means that mail-order 

distributors are now required to train 

their employees prior to self 

certification. 

Provisions of the Combat 

Methamphetamine Enhancement Act of 

2010 

Prior to MEA, mail-order distributors 

of scheduled listed chemical products, 

which covered any sale where the 

product is shipped using the Postal 

Service or any private or commercial 

carrier, did not have to self-certify. They 

did have to file monthly reports of all 

sales of scheduled listed chemical 

products with DEA, and they were 

required to verify the identity of their 

customer before shipping scheduled 

listed chemical products. 21 U.S.C. 

830(b)(3) and 830(e)(2)(A). 

Sales of scheduled listed chemical 

products by mail-order distributors. 

MEA requires that on and after April 10, 

2011, a mail-order distributor must not 

sell scheduled listed chemical products 

at retail unless it has self-certified to 

DEA, through DEA’s Web site. The selfcertification requires the mail-order 

distributor to confirm the following: 

• Its employees who will be engaged 

in the sale of scheduled listed chemical 

products have undergone training 

regarding provisions of the Combat 

Methamphetamine Epidemic Act of 

2005 (CMEA). 

• Records of the training are 

maintained. 

• Sales to individuals do not exceed 

3.6 grams of ephedrine, 

pseudoephedrine, or 

phenylpropanolamine per day. For 

mail-order distributors, sales to 

individuals do not exceed 7.5 grams of 

ephedrine, pseudoephedrine, or 

phenylpropanolamine per 30-day 

period. 

• Nonliquid forms are packaged as 

required. The mail-order distributor 

must train its employees and self-certify 

before either the mail-order distributor 

or individual employees may sell 

scheduled listed chemical products. The 

law governing self-certification of mailorder distributors does not explicitly 

make such certifications subject to 18 

U.S.C. 1001, as is the case for regulated 

sellers whose sales are limited almost 

exclusively to face-to-face retail 

transactions. Compare 21 U.S.C. 

830(e)(1)(B) to 830(e)(2)(C). However, a 

mail-order distributor who knowingly or 

willfully self-certifies to facts that are 

not true is subject to fines and 

imprisonment by virtue of general 

applicability of 18 U.S.C. 1001. Also, 

when Congress directed that regulations 

of the Attorney General establish criteria 

for the certification of mail-order 

distributors ‘‘that are consistent with the 

criteria established for the certification 

of regulated sellers under paragraph 

(1)(B),’’ it must have intended that this 

Federal false statements statute apply. 

Training. DEA has developed training 

that it has made available on its Web 

site (http:// 

www.deadiversion.usdoj.gov). 

Employers must use the content of this 

training in the training of their 

employees who sell scheduled listed 

chemical products. An employer may 

include content in addition to DEA’s 

content, but DEA’s content must be 

included in the training. For example, a 

mail-order distributor may elect to 

incorporate DEA’s content into initial 

training for new employees. 

Training records. On and after April 

10, 2011, each employee of a mail-order 

distributor who is responsible for 

delivering scheduled listed chemical 

products to purchasers or who deals 

directly with purchasers by obtaining 

payment for the scheduled listed 

chemical products must undergo 

training and must sign an 

acknowledgement of training received 

prior to selling scheduled listed 

chemical products. This record must be 

kept in the employee’s personnel file. 

Self-certification. MEA adds the 

requirement that mail-order distributors 


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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20521 

self-certify with DEA. As noted 

previously, MEA also makes it unlawful 

for mail-order distributors to negligently 

fail to self-certify as required under 21 

U.S.C. 830. 

On and after April 10, 2011, under the 

requirements of MEA, mail-order 

distributors who sell at retail must selfcertify to DEA as described above. DEA 

has established a Web page that will 

allow mail-order distributors of 

scheduled listed chemical products to 

complete the self-certification online 

and submit it to DEA electronically. A 

self-certification certificate will 

immediately be generated by DEA upon 

receipt of the application. The mailorder distributors will print this selfcertification certificate, or if they are 

unable to print it, DEA will print and 

mail the certificate to the self-certifier. 

Time for self-certification. MEA 

requires that mail-order distributors 

self-certify by April 10, 2011. When a 

regulated person files the initial selfcertification, the Administration will 

assign the regulated person to one of 

twelve groups. The expiration date of 

the self-certification for all regulated 

persons in any group will be the last day 

of the month designated for that group. 

In assigning a regulated person to a 

group, the Administration may select a 

group with an expiration date that is not 

less than 12 months or more than 23 

months from the date of selfcertification. After the initial 

certification period, the regulated 

person must update the self-certification 

annually. It is the responsibility of the 

mail-order distributor to ensure that 

they renew the self-certification before it 

lapses. 

Fee for self-certification. To comply 

with the requirement of the CSA that 

fees be set at a level to ensure the 

recovery of the full costs of operating 

the various aspects of the Diversion 

Control Program, DEA established an 

annual self-certification fee for certain 

regulated sellers selling scheduled listed 

chemical products at retail. The annual 

self-certification fee for regulated sellers 

who are not DEA pharmacy registrants 

is $21. To make regulations regarding 

mail-order distributors consistent with 

those for regulated sellers, the same selfcertification fee will apply to any mailorder distributor that is not a DEAregistered pharmacy. 

Table 1 summarizes the requirements 

for mail-order distributors of scheduled 

listed chemical products that are now in 

place since the passage of the MEA. 

TABLE 1—SUMMARY OF

REQUIREMENTS BY TYPE OF SELLER

Mail-order sellers 

Daily sales limit ............... 3.6 gm/chemical. 

30-day sales limit ............ 7.5 gm. 

Blister packs .................... Yes. 

Storage ............................ NA. 

Logbook ........................... NA. 

Customer ID .................... Verify ID. 

Train employees .............. Yes. 

Self-Certify ....................... Yes. 

Monthly reports ................ Yes. 

Theft and loss reports ..... Yes. 

Discussion of the Rule 

To make the rule easier to follow for 

regulated sellers and mail-order 

distributors, DEA previously created 

part 1314 that includes all requirements 

related to the sale of scheduled listed 

chemical products to end users. Subpart 

A contains requirements that apply to 

any retail sale. Subpart B applies to 

regulated sellers (retail distributors and 

mobile retail vendors). Subpart C 

applies to retail sales that are shipped 

by mail or private or commercial 

carriers, regardless of how those sales 

are ordered. 

In Subpart C, Section 1314.101 is 

being added to address employee 

training for mail-order distributors. 

Section 1314.102 is added to address 

self-certification for mail-order 

distributors. Section 1314.103 covers 

the self-certification fee and the time of 

payment for this fee. As discussed 

above, DEA is setting an annual period 

for renewal of the certification. DEA has 

developed a page on its Web site that 

will allow mail-order distributors to 

complete and submit the selfcertification form online and print out a 

self-certification certificate for their 

records. The information required will 

include the name and address of the 

location, a point of contact, and tax 

identification number. 

Regulatory Certifications 

Administrative Procedure Act (5 U.S.C. 

553) 

The Administrative Procedure Act 

(APA) generally requires that agencies, 

prior to issuing a new rule, publish a 

Notice of Proposed Rulemaking in the 

Federal Register. However, the Combat 

Methamphetamine Enhancement Act 

specifically states, ‘‘[t]he Attorney 

General may issue regulations on an 

interim basis as necessary to ensure the 

implementation of this Act by the 

effective date.’’ Public Law 111–268, 

Sec. 6(b). Additionally, the APA 

provides that agencies may be excepted 

from this requirement when ‘‘the agency 

for good cause finds (and incorporates 

the finding and a brief statement of 

reasons therefor in the rules issued) that 

notice and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest.’’ 5 U.S.C. 

553(b)(B). 

With publication of this interim final 

rule, DEA is invoking this ‘‘good cause’’ 

exception to the APA’s notice 

requirement based on the combination 

of several factors. The MEA is effective 

180 days after its passage. Mail-order 

distributors selling scheduled listed 

chemical products at retail must selfcertify with DEA in order to continue to 

sell these products. Based on the 

effective date and the requirements of 

the MEA, it is impracticable for DEA to 

comply with the APA’s notice and 

comment requirements due to the 

limited time involved. Were DEA not to 

publish this interim final rule with 

Request for Comment, mail-order 

distributors selling scheduled listed 

chemical products at retail would not be 

able to self-certify by the date specified 

in the law. As a result, these mail-order 

distributors would be forced to stop 

selling scheduled listed chemical 

products, or violate the law by doing so. 

Thus, DEA also finds it is contrary to 

the public interest to DEA to comply 

with the APA’s notice and comment 

requirements due to the potential 

disruption of sales of scheduled listed 

chemical products by mail-order 

distributors. 

In light of these factors, DEA finds 

that ‘‘good cause’’ exists to issue this 

interim rule without engaging in 

traditional notice and comment 

rulemaking. 

Regulatory Flexibility Act 

The Deputy Assistant Administrator, 

Office of Diversion Control, hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

601–612). The Regulatory Flexibility 

Act (RFA) applies to rules that are 

subject to notice and comment. DEA has 

determined, as explained above, that 

public notice and comment are 

impracticable and contrary to the public 

interest. Consequently, the RFA does 

not apply. 

Although the RFA does not apply to 

this interim final rule, DEA has 

reviewed the potential impacts. DEA 

does not believe that it will have a 

significant economic impact on small 

entities. Based on reports filed, DEA 

expects that the rule will affect only 9 

firms, two of which are not small based 

on the Small Business Administration’s 

size standards. For the seven small 

firms, the only costs are the $21 annual 

fee, the time required to complete the 


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20522 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

certification (0.5 hours or about $20 for 

a new self-certification application), and 

cost of training (0.5 hours or about $10). 

The cost of compliance for these firms, 

which appear to have between 5 and 25 

employees, not all of whom would need 

to be trained, is less than $200 and in 

most cases, less than $100. The smallest 

mail order pharmacies (those with fewer 

than five employees) have average 

annual sales of $1 million. The cost of 

compliance is, therefore, less than 0.1 

percent of sales and would not impose 

a significant economic burden on any 

small entity. 

Executive Order 12866 

The Deputy Assistant Administrator, 

Office of Diversion Control, 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. However, 

DEA has reviewed the potential benefits 

and costs following OMB Circular A–4. 

The time for a mail-order distributor 

to self-certify is estimated at 0.5 hours. 

Additionally, the time for a mail-order 

distributor to train employees is 

estimated at 0.5 hours. The nine affected 

firms range in size from 5 employees to 

more than 800. DEA assumes that the 

smallest firms will train half their 

employees and the two large firms will 

train 20 percent, based on the 

percentage of retail sales persons, order 

clerks, and order fillers to total 

employment in the retail mail order 

sector. The total cost of the rule is 

estimated to be less than $2,600. DEA 

does not expect that the rule will lead 

any of the firms to discontinue sales of 

the products because they are already 

reporting to DEA on these sales. The 

low cost of compliance is unlikely to 

discourage firms from selling the 

products. 

Benefits. Congress passed the MEA to 

better track retail sales of scheduled 

listed chemical products by requiring 

self-certification of mail-order 

distributors in addition to regulated 

sellers (retailers). The MEA also makes 

it more difficult for regulated sellers and 

mail-order distributors to obtain 

scheduled listed chemical products 

from distributors by prohibiting 

distributors from selling to them if they 

have not self-certified. This leaves less 

opportunity for diversion at the retail 

level. 

Methamphetamine remains the 

primary drug produced in illicit 

laboratories within the United States. 

The vast majority of these laboratories 

used pharmaceutical products 

containing pseudoephedrine, ephedrine, 

and phenylpropanolamine as the source 

of precursor material. 

Conclusion. MEA’s requirements will 

not impose an annual cost on the 

economy of $100 million or more, the 

standard for an economically significant 

rule under Executive Order 12866. 

Executive Order 13563 

Published on January 18, 2011, 

Executive Order 13563 supplements and 

reaffirms the principles established in 

Executive Order 12866. 76 FR 3821. The 

new Executive Order emphasizes the 

importance of public participation and 

cost-effectiveness within the context of 

the regulatory process. DEA has 

carefully considered the requirements of 

the Executive Order and has concluded 

that this rule satisfies the applicable 

requirements. Although the MEA 

provides authorization to issue rules on 

an interim basis in order to implement 

the self-certification requirements of 

Section 2 of the Act, DEA has requested 

public comment in order to ensure that 

its regulatory process maintains a 

flexible approach and seeks the view of 

all persons potentially affected by the 

MEA’s requirements. Further, because 

this rule contains a 60-day comment 

period and utilizes regulations.gov 

regarding its rulemaking docket, it 

complies with the specific requirements 

of Section 2(b) of the Executive Order. 

76 FR 3821, 3822. Finally, DEA believes 

its rule to be cost-effective and tailored 

to impose the least possible burden. 

There are only 9 mail-order distributors 

that would be affected by this rule and 

the cost of implementation is low. 

Paperwork Reduction Act of 1995 

To address the new mandates of MEA, 

DEA is revising an existing information 

collection ‘‘Self-Certification, Training, 

and Logbooks for Regulated Sellers and 

Mail-Order Distributors of Scheduled 

Listed Chemical Products,’’ Information 

Collection 1117–0046. MEA requires 

mail-order distributors to train any 

employee who will be involved in 

selling scheduled listed chemical 

products and to document the training. 

Mail-order distributors must also selfcertify to DEA that all affected 

employees have been trained and that 

the mail-order distributor is in 

compliance with all provisions of the 

CMEA. 

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. The information collection 

is published to obtain comments from 

the public and affected agencies. 

All comments and suggestions, or 

questions regarding additional 

information, to include obtaining a copy 

of the information collection instrument 

with instructions, should be directed to 

Cathy A. Gallagher, Acting Chief, 

Liaison and Policy Section, Office of 

Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152. Written 

comments and suggestions from the 

public and affected agencies concerning 

the collection of information are 

encouraged. Your comments on the 

information collection-related aspects of 

this rule should address one or more of 

the following four points: 

• Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

• Evaluate the accuracy of the 

agency’s estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; 

• Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

• Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of Information Collection 

1117–0046 

(1) Type of Information Collection: 

Revision of an existing collection. 

(2) Title of the Form/Collection: Selfcertification, Training and Logbooks for 

Regulated Sellers and Mail-Order 

Distributors of Scheduled Listed 

Chemical Products. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: 

Form Number: DEA Form 597. 

Office of Diversion Control, Drug 

Enforcement Administration, U.S. 

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: The Controlled Substances 

Act mandates that regulated sellers of 


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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20523 

scheduled listed chemical products 

maintain a written or electronic logbook 

of sales. The CSA also requires that 

regulated sellers and mail-order 

distributors retain a record of employee 

training, and complete a selfcertification form verifying the training 

and compliance with CMEA provisions 

regarding retail sales of scheduled listed 

chemical products. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond. 

As discussed in the previous section, 

DEA estimates the number of mail-order 

distributors to be around 9. The average 

annual burden hour per respondent is 

1.8 hours. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 16 hours. 

The following table presents the 

burden hour calculations. 

TABLE 2—ESTIMATE OF TOTAL BURDEN HOURS

Activity Unit burden hour Number of 

activities 

Total burden 

hours 

Training record ............................................................. 0.05 hour (3 minutes) .................................................. 410,228 20,511 .4 

Self-certification (regulated sellers) ............................. 0.25 hour (15 minutes) ................................................ 64,000 16,000 

Self-certification (mail-order distributors) ..................... 0.5 hours (30 minutes) ................................................ 9 4 .5 

Transaction record ....................................................... 0.033 hour (2 minutes) ................................................ 25,500,000 850,000 

Customer time .............................................................. 0.033 hour (2 minutes) ................................................ 25,500,000 850,000 

Total ...................................................................... ...................................................................................... ........................ 1,736,515 .9 

If additional information is required 

contact: Lynn Murray, Department 

Clearance Officer, Information 

Management and Security Staff, Justice 

Management Division, Department of 

Justice, Two Constitution Square, 145 N 

Street, NE., Suite 2E–502, 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 impose 

enforcement responsibilities on any 

State; nor does it diminish the power of 

any State to enforce its own laws. These 

requirements, however, are mandated 

under MEA, and DEA has no authority 

to alter them or change the preemption. 

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 $126,400,000 or more 

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. It will not cause 

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 1314 

Drug traffic control, Reporting and 

recordkeeping requirements. 

For the reasons set out above, 21 CFR 

part 1314 is amended as follows: 

PART 1314—RETAIL SALE OF 

SCHEDULED LISTED CHEMICAL 

PRODUCTS 

■ 1. The authority citation for part 1314 

continues to read as follows: 

Authority: 21 U.S.C. 802, 830, 842, 871(b), 

875, 877, 886a. 

■ 2. Section 1314.101 is added to read 

as follows: 

§ 1314.101 Training of sales personnel. 

Each regulated person who makes a 

sale at retail of a scheduled listed 

chemical product and is required under 

§ 1310.03(c) of this chapter to submit a 

report of the sales transaction to the 

Administration must ensure that its 

sales of a scheduled listed chemical 

product at retail are made in accordance 

with the following: 

(a) In the case of individuals who are 

responsible for preparing and packaging 

scheduled listed chemical products for 

delivery to purchasers through the 

Postal Service or any private or 

commercial carrier or who deal either 

directly or indirectly with purchasers by 

obtaining payments for the products, the 

regulated person has submitted to the 

Administration a self-certification that 

all such individuals have, in accordance 

with criteria issued by the 

Administration, undergone training 

provided by the regulated person to 

ensure that the individuals understand 

the requirements that apply under this 

part. 

(b) The regulated person maintains a 

copy of each self-certification and all 

records demonstrating that individuals 

referred to in paragraph (a) of this 

section have undergone the training. 

■ 3. Section 1314.102 is added to read 

as follows: 

§ 1314.102 Self-certification. 

(a) A regulated person who makes a 

sale at retail of a scheduled listed 

chemical product and is required under 

§ 1310.03 of this chapter to submit a 

report of the sales transaction to the 

Attorney General must submit to the 

Administration the self-certification 

referred to in § 1314.101(a) in order to 

sell any scheduled listed chemical 

product. The certification is not 

effective for purposes of this section 

unless, in addition to provisions 

regarding the training of individuals 

referred to in § 1314.101(a), the 

certification includes a statement that 

the regulated person understands each 

of the requirements that apply in this 

part and agrees to comply with the 

requirements. 

(b) When a regulated person files the 

initial self-certification, the 

Administration will assign the regulated 

person to one of twelve groups. The 

expiration date of the self-certification 

for all regulated persons in any group 

will be the last day of the month 

designated for that group. In assigning a 

regulated person to a group, the 

Administration may select a group with 

an expiration date that is not less than 

12 months or more than 23 months from 


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20524 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

the date of self-certification. After the 

initial certification period, the regulated 

person must update the self-certification 

annually. 

(c) The regulated person who makes 

a sale at retail of a scheduled listed 

chemical product and is required under 

§ 1310.03 of this chapter to submit a 

report of the sales transaction to the 

Attorney General must provide a 

separate certification for each place of 

business at which the regulated person 

sells scheduled listed chemical products 

at retail. 

■ 4. Section 1314.103 is added to read 

as follows: 

§ 1314.103 Self-certification fee; time and 

method of fee payment. 

(a) Each regulated person who makes 

a sale at retail of a scheduled listed 

chemical product and is required under 

§ 1310.03 of this chapter to submit a 

report of the sales transaction to the 

Administration must pay a fee for each 

self-certification. For each initial 

application to self-certify, and for the 

renewal of each existing selfcertification, a regulated seller shall pay 

a fee of $21. 

(b) The fee for self-certification shall 

be waived for any person holding a 

current, DEA registration in good 

standing as a pharmacy to dispense 

controlled substances. 

(c) A regulated person shall pay the 

fee at the time of self-certification. 

(d) Payment shall be made by credit 

card. 

(e) The self-certification fee is not 

refundable. 

Dated: April 8, 2011. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2011–9016 Filed 4–12–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9515] 

RIN 1545–BH20 

Guidance Under Section 1502; 

Amendment of Matching Rule for 

Certain Gains on Member Stock 

Correction 

In rule document 2011–4846 

appearing on pages 11956–11959 in the 

issue of Friday, March 4, 2011, make the 

following corrections: 

1. On page 11956, in the third 

column, under the Background heading, 

in the third line, ‘‘See’’ should read 

‘‘See’’. 

2. On page 11957, in the first column, 

in the sixth line from the top, ‘‘See’’ 

should read ‘‘See’’. 

PART 1—[CORRECTED] 

3. On page 11958, in the first column, 

in the fourth line, in amendatory 

instruction 3., ‘‘Paragraph (c)(7(iii)’’ 

should read ‘‘Paragraph (c)(7)(iii)’’. 

§ 1.1502–13 [Corrected] 

4. On the same page, in § 1.502– 

13(c)(7)(ii), in Example 16(b), in the 

third column, in the 36th line, ‘‘See’’ 

should read ‘‘See’’. 

5. On the same page, in § 1.502– 

13(c)(7)(ii), in Example 17(b), in the 

third column, in the fourth line from the 

bottom, ‘‘See’’ should read ‘‘See’’. 

6. On page 11959, in § 1.502– 

13(c)(7)(ii), in Example 17(b), in the first 

column, in the 16th line from the top, 

‘‘See’’ should read ‘‘See’’. 

7. On the same page, in § 1.502– 

13(c)(7)(iii)(B), in the first column, in 

the third line, ‘‘see’’ should read ‘‘see’’. 

8. On the same page, in § 1.502– 

13(c)(7)(iii)(B), in the first column, in 

the seventh line, ‘‘see’’ should read ‘‘see’’. 

§ 1.502–13T [Corrected] 

9. On the same page, in § 1.502– 

13T(a), in the first column, in the 

second line, ‘‘see’’ should read ‘‘see’’. 

10. On the same page, in § 1.502– 

13T(a)(B)(2), in the second column, in 

the 14th line, ‘‘see’’ should read ‘‘see’’. 

11. On the same page, in § 1.502–13T, 

in the second column, in paragraph 

(f)(5)(ii)(B)(3) through (f)(5)(ii)(E), in the 

second line, ‘‘see’’ should read ‘‘see’’. 

12. On the same page, in § 1.502– 

13T(a)(F)(2), in the second column, in 

the third line, ‘‘see’’ should read ‘‘see’’. 

[FR Doc. C1–2011–4846 Filed 4–12–11; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 110 

[Docket No. USCG–2008–1082] 

RIN 1625–AA01 

Anchorage Regulations; Port of New 

York 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is revising 

Anchorage Ground No. 19 located east 

of the Weehawken-Edgewater Federal 

Channel on the Hudson River. The 

revision is necessary to facilitate safe 

navigation and provide safe and secure 

anchorages for vessels operating in the 

area. This action is intended to increase 

the safety of life and property of both 

the anchored vessels and those 

operating in the area as well as to 

provide for the overall safe and efficient 

flow of commerce. 

DATES: This rule is effective May 13, 

2011. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2008–1082 and are 

available online by going to http:// 

www.regulations.gov, inserting USCG– 

2008–1082 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. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Jeff Yunker, Coast Guard 

Sector New York, Waterways 

Management Division; telephone 

718–354–4195, e-mail 

Jeff.M.Yunker@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

On September 18, 2009, we published 

a notice of proposed rulemaking 

(NPRM) entitled Anchorage Regulations; 

Port of New York in the Federal 

Register (74 FR 47906). We received one 

comment on the NPRM. No public 

meeting was requested and none was 

held. On April 28, 2010, we published 

a supplemental notice of proposed 

rulemaking (SNPRM) entitled 

Anchorage Regulations; Port of New 

York in the Federal Register (75 FR 

22323). We received one comment on 

the SNPRM. A public meeting was 

requested by the New York City 

Department of Parks and Recreation 

(NYC Parks) but the Coast Guard 

determined a public meeting was not 

necessary in this case. Instead, a 

meeting with representatives from the 

NYC Parks, Sandy Hook Pilots 

Association, and U.S. Army Corps of 

Engineers New York District was held 

on August 31, 2010, to discuss their 

comment in relation to commercial 


emcdonald on DSK2BSOYB1PROD with RULES