53958 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations

Substances Limitations

* * * * * * *

Nylon 6/66 resins complying with § 177.1500(b), item 4.2 of this chapter

(CAS Reg. 24993–04–2).

For use only with:

1. Nonalcoholic foods at temperatures not to exceed 82.2 °C (180 °F).

Laminate structures with authorized food-contact materials yield no

more than 0.15 milligram of epsilon-caprolactam per square inch

when extracted with water at 82.2 °C (180 °F) for 5 hours.

2. Nonalcoholic foods at temperatures not to exceed 100 °C (212 °F).

Laminate films with authorized food-contact materials yield no more

than 0.15 milligram of epsilon-caprolactam per square inch when extracted with water at 100 °C (212 °F) for 5 hours.

* * * * * * *

Dated: September 30, 1997.

Janice F. Oliver,

Deputy Director for Systems and Support,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–27527 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1309

[DEA Number—169N]

Comprehensive Methamphetamine

Control Act of 1996; Registration Fees

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Notice of fee wavier.

SUMMARY: DEA is waiving a portion of

the registration fee for non-retail

distributors of pseudoephedrine,

phenylpropanolamine, and combination

ephedrine drug products. Under the

Comprehensive Methamphetamine

Control Act of 1996 (MCA), wholesale

distributors of these drug products are

subject to the existing List I chemical

registration and fee requirements.

However, because the drug products are

distributed in substantially different

channels than other List I chemicals, the

existing pre-registration investigation

procedures, which were established

primarily with respect to the handlers of

chemicals, as opposed to drug products,

are not necessarily applicable to the

new type of applicant. DEA will be

reviewing the pre-registration

investigation procedures to determine

what changes will be necessary to

account for the different manner of

distribution of the drug products.

Recognizing that changes are likely to be

made in the pre-registration process,

thus causing changes to the fees

assessed, DEA is waiving a portion of

the fee at this time, rather than requiring

that new applicants pay a fee that would

not be consistent with the resources

actually expended in the issuance of the

registration.

EFFECTIVE DATE: October 17, 1997.

FOR FURTHER INFORMATION CONTACT:

G. Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, D.C.

20537, Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: The

MCA’s removal of the exemption for

pseudoephedrine,

phenylpropanolamine, and combination

ephedrine drug products (regulated drug

products) opens up to chemical

registration and regulation a new and

different segment of industry from that

previously subject to the chemical

controls. Prior to the MCA the group

subject to chemical registration

consisted primarily of specialty

chemical handlers distributing products

of limited consumer end-use to a largely

industrial customer base. By contrast,

the principal group subject to

registration under the MCA consists of

general merchandisers distributing a

wide variety of consumer products to

retail outlets for sale to the public.

Often, one company will operate several

distribution centers to serve wholly

owned or independent retail outlets. In

response to applications submitted by

this new group, DEA is re-examining the

pre-registration investigation process for

issuing registrations. This process will

affect the registration application fees.

The procedures for issuing a chemical

registration and the associated

application fee were developed in 1994

as part of the implementation of the

Domestic Chemical Diversion Control

Act of 1993 (DCDCA). (For specific

details regarding the procedures and

fees, see DEA’s notice of proposed

rulemaking (NPRM) regarding

Implementation of the Domestic

Chemical Diversion Control Act of 1993

(Pub. L. 103–200) which was published

in the Federal Register on October 13,

1994 (59 FR 51887)). The procedures

were developed based on the type of

applicants expected under the DCDCA,

e.g., specialty chemical handlers dealing

with products of limited consumer enduse. These applicants dealt almost

exclusively in chemicals and often

distributed from contract operated

warehouses/storage depots. Pursuant to

the requirements of the Office of

Management and Budget (OMB)

Circular A–25, the costs and resources

required to conduct the pre-registration

investigation and issue the registration

were assessed to the applicants as the

application fee.

The group subject to registration

under the MCA is significantly different,

consisting principally of general

merchandisers distributing hundreds or

thousands of different consumer

products, often from a large number of

applicant-owned warehouse/

distribution centers, to retail outlets for

sale to the public. The volume of

regulated drug products handled is

often only a very small portion of the

total volume of products distributed by

the location. For these applicants,the

pre-registration procedures developed

for chemical handlers are not entirely

suitable. DEA has, therefore, initiated a

review of the pre-registration

procedures to determine what changes

will be necessary to make the process

consistent with the different activities of

this group of applicants. This review

will affect the costs and resources

associated with the issuance of

registrations to these applicants and,

thus, the fee to be charged. DEA will

publish notice, with opportunity for

comment, in the Federal Register

regarding any proposed change to the

procedures and consequent changes to

the fees.

The MCA removed the exemption

from regulation for combination

ephedrine drug products effective
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations 53959

October 3, 1996, and will remove the

exemption from regulation for

pseudoephedrine and

phenylpropanolamine drug products

effective October 3, 1997, making

persons who distribute the respective

products subject to the registration

requirement on those dates.

Determination of the appropriate

procedures and amendment of the

regulations to set the new fees will

extend well beyond those deadlines for

registration. Therefore, DEA is waiving

a portion of the application fee for new

registration. It would be inconsistent

with the principles of OMB Circular A–

25 to charge a fee for a specific service,

e.g., completing the processing of the

application and the pre-registration

investigation, knowing that the costs

and resources to be expended in

providing that service will change.

Persons who have already applied for

registration to distribute regulated drug

products and paid the existing fee will

be refunded the amount of fee that is

being waived.

The Acting Deputy Administrator of

DEA is, therefore, waiving that portion

of the fee for registration as a non-retail

distributor of regulated drug products

associated with the 12 hours of

investigator time allocated for the onsite visit and travel time, which, at

$39.92 per hour, amounts to $479.00

(See 59 FR 51892). The remaining

administrative costs and time allotted

for background checks and reports will

continue. Thus the fee for an initial

application for registration as a nonretail distributor of regulated drug

products is $116.00. That fee will

remain in effect until the review of the

registration procedures has been

completed and a determination has been

made regarding how the processing of

such applications and the preregistration investigation will be carried

out. At that time, a notice will be

published in the Federal Register

regarding the procedures to be followed

and fee that will be required for future

applications.

This waiver applies only to applicants

for registration as non-retail distributors

of regulated drug products. All other

applicants remain subject to the full

fees, as set forth in Title 21, Code of

Federal Regulations, Section 1309.11.

As noted earlier, persons who have

already submitted an application for

registration as a non-retail distributor of

regulated drug products and paid the

full fee will be provided with a $479.00

refund.

Dated: October 8, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–27452 Filed 10–16–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309 and 1310

[DEA Number 168I]

RIN 1117–AA46

Temporary Exemption From Chemical

Registration for Distributors of

Pseudoephedrine and

Phenylpropanolamine Products

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Interim Rule with request for

comments.

SUMMARY: DEA is amending its

regulations to provide a temporary

exemption from registration for persons

who distribute pseudoephedrine and

phenylpropanolamine drug products.

The Comprehensive Methamphetamine

Control Act of 1996 (MCA) amends the

Controlled Substances Act of 1970

(CSA) to require that, effective October

3, 1997, persons who distribute these

drug products shall be subject to the

chemical registration requirement. To

avoid interruption in the legitimate

distribution of the drug products

pending promulgation of final

regulations and issuance of

registrations, DEA is amending its

regulations to provide certain temporary

exemptions from the registration

requirement.

DATES: October 17, 1997. Persons

required to register to handle

pseudoephedrine or

phenylpropanolamine must submit an

application on or before December 3,

1997, in order to continue their

activities pending final action by DEA

on their application. Written comments

or objections must be submitted on or

before December 16, 1997.

ADDRESSES: Comments and objections

should be submitted in quintuplicate to

the Deputy Administrator, Drug

Enforcement Administration,

Washington, DC 20537, Attention: DEA

Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: G.

Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, DC 20537,

Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: The

Comprehensive Methamphetamine

Control Act of 1996 (MCA) requires that,

effective October 3, 1997,

pseudoephedrine and

phenylpropanolamine drug products

(regulated drug products) will become

subject to regulation as List I chemicals.

Under this new requirement, any person

who wishes to distribute, import, or

export these products must first obtain

a DEA chemical registration. Because

full implementation of this provision

and issuance of the registrations will not

be possible prior to the October 3, 1997

deadline, DEA is establishing temporary

exemptions from the registration

requirement for persons handling

regulated drug products to allow for

continuation of legitimate commerce in

the products. In addition, the existing

exemptions from chemical registration

for persons registered with DEA to

handle controlled substances, which is

contained in 21 CFR 1309.25, and for

distributors of prescription drug

products, which is contained in 21 CFR

1309.28, will also apply to the regulated

drug products.

The first exemption applies to retail

distributors of regulated drug products.

A single transaction limit of 24 grams

has been established by the MCA for

retail distributions of regulated drug

products. Consistent with previous

proposals regarding the regulation of

retail distributions of drug products that

contain List I chemicals, DEA is

temporarily exempting retail

distributors from the registration

requirement. Under this exemption,

retail distributors will not be required to

obtain a registration if they engage

exclusively in distributions of regulated

drug products below the 24-gram limit

in a single transaction for legitimate

medical use, either directly to walk-in

customers or in face-to-face transactions

by direct sales. This exemption is set

out in 21 CFR 1309.29(b).

The second exemption applies to

those persons who are required to

obtain a registration. Any such person

who submits an application for

registration for activities involving

regulated drug products on or before

December 3, 1997 will be exempt from

the registration requirement for their

lawful activities with regulated drug

products until the Administration has

taken final action with respect to that

application. This exemption is set out in

21 CFR 1310.09.

DEA recognizes that, unlike the

second exemption, which provides a

general benefit to all affected persons,

the first exemption is limited in its

application. Therefore, while the

regulatory changes in this notice take