Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Rules and Regulations 53957

Signed at Washington, D.C., this 14th day

of October 1997.

Bernard E. Anderson,

Assistant Secretary for Employment

Standards.

Shelby Hallmark,

Acting Director, Office of Workers’

Compensation Programs.

[FR Doc. 97–27593 Filed 10–16–97; 8:45 am]

BILLING CODE 4510–27–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 93F–0111]

Indirect Food Additives: Polymers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of Nylon 6/66 copolymers

as components of nonfood-contact

layers of multilayer food packaging used

at temperatures that do not exceed 212

°F. This action is in response to a

petition filed by Allied-Signal, Inc.

DATES: The regulation is effective

October 17, 1997; written objections and

requests for a hearing by November 17,

1997.

ADDRESS: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

May 3, 1993 (58 FR 26325), FDA

announced that a food additive petition

(FAP 3B4369) had been filed by AlliedSignal, Inc., c/o 1100 G St. NW.,

Washington, DC 20001 (presently c/o

Keller and Heckman, 1001 G St. NW.,

suite 500 West, Washington, DC 20001).

The petition proposed to amend the

food additive regulations in § 177.1395

Laminate structures for use at

temperatures between 120 °F and 250 °F

(21 CFR 177.1395) to provide for the

safe use of Nylon 6/66 copolymers

complying with 21 CFR 177.1500(b),

item 4.2, as components of nonfoodcontact layers of multilayer food

packaging used at temperatures that do

not exceed 100 °C (212 °F).

In reviewing the environmental

assessment (EA), the agency found that

the petitioner’s proposed regulation was

much broader than the proposed use

covered in the EA. Whereas the analysis

in the EA considered only the use of

Nylon 6/66 copolymers in laminate

films, the petitioner proposed the use of

these copolymers in laminate structures,

which includes the use in laminate

films. In a subsequent communication

with the agency, the petitioner agreed

that the proposed regulation should be

narrowed to state specifically that the

intended use of Nylon 6/66 copolymers

is in laminate films. Therefore, this

regulation limits the use of these

copolymers to laminate films, which is

consistent with the proposed use

covered in the EA.

FDA has evaluated data in the

petition and other relevant material. The

agency concludes that the proposed use

of the additive is safe, that the additive

will have the intended technical effect,

and therefore, that the regulations in

§ 177.1395 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before November 17, 1997,

file with the Dockets Management

Branch (address above) written

objections thereto. Each objection shall

be separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 177

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 177 is

amended as follows:

PART 177—INDIRECT FOOD

ADDITIVES: POLYMERS

1. The authority citation for 21 CFR

part 177 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 177.1395 is amended in the

table in paragraph (b)(4) by revising the

entry for ‘‘Nylon 6/66 resins complying

with § 177.1500(b), item 4.2 * * *’’ to

read as follows:

§ 177.1395 Laminate structures for use at

temperatures between 120 °F and 250 °F.

* * * * *

(b) * * *

(4) * * *
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