66522 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Rules and Regulations

Amendment to the Regulations

Part 4, Customs Regulations (19 CFR

part 4), is amended as set forth below.

PART 4—VESSELS IN FOREIGN AND

DOMESTIC TRADES

1. The general authority for Part 4 and

relevant specific authority continue to

read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66,

1431, 1433, 1434, 1624; 46 U.S.C. App. 3, 91.

* * * * *

Section 4.22 also issued under 46

U.S.C. App. 121, 128, 141;

* * * * *

§ 4.22 [Amended]

2. Section 4.22 is amended by adding

‘‘Hong Kong’’ in appropriate

alphabetical order.

Dated: December 15, 1997

Harold M. Singer,

Chief, Regulations Branch.

[FR Doc. 97–33169 Filed 12–18–97; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 94N–0421]

Revocation of Regulation on Positron

Emission Tomography Drug Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; revocation.

SUMMARY: The Food and Drug

Administration (FDA) is revoking a

regulation on positron emission

tomography (PET) radiopharmaceutical

drug products. The regulation permits

FDA to approve requests from

manufacturers of PET drugs for

exceptions or alternatives to provisions

of the current good manufacturing

practice (CGMP) regulations. FDA is

taking this action in accordance with

provisions of the Food and Drug

Administration Modernization Act of

1997 (Modernization Act). Elsewhere in

this issue of the Federal Register, FDA

is publishing a notice revoking two

notices concerning certain guidance

documents on PET drugs and the

guidance documents to which the

notices relate.

EFFECTIVE DATE: December 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Brian L. Pendleton, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5649.

SUPPLEMENTARY INFORMATION: On

November 21, 1997, President Clinton

signed into law the Food and Drug

Administration Modernization Act of

1997 (Pub. L. 105–115). Section

121(c)(1)(A) of the Modernization Act

directs FDA to develop appropriate

procedures for the approval of PET

drugs as well as CGMP requirements for

such drugs, taking into account any

relevant differences between not-forprofit institutions that compound PET

drugs and commercial manufacturers.

FDA is to establish these procedures

and requirements not later than 2 years

after the date of enactment. In doing so,

the agency must consult with patient

advocacy groups, professional

associations, manufacturers, and

persons licensed to make or use PET

drugs.

Under section 121(c)(2) of the

Modernization Act, FDA cannot require

the submission of new drug applications

or abbreviated new drug applications for

compounded PET drugs that are not

adulterated under section 501(a)(2)(C) of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 351(a)(2)(C)) for a period

of 4 years after the date of enactment,

or 2 years after the date that the agency

adopts special approval procedures and

CGMP requirements for PET drugs,

whichever is longer.

Section 121(d) of the Modernization

Act requires FDA, within 30 days of

enactment, to publish in the Federal

Register a notice terminating the

application of FDA’s final rule,

published in the Federal Register of

April 22, 1997 (62 FR 19493), permitting

the agency to approve requests from

manufacturers of PET drug products for

exceptions or alternatives to provisions

of FDA’s CGMP regulations (21 CFR

211.1(d)). FDA already has received one

such request for an exception or

alternative to the CGMP requirements

for PET drugs in the form of a citizen

petition submitted by Case Western

Reserve University (CWRU) (Docket No.

97P–0198/CP1). As required by the

Modernization Act, the final rule on

exceptions and alternatives is hereby

revoked, which also renders the CWRU

citizen petition moot. The information

and views presented in the CWRU

citizen petition will be considered as a

part of the rulemaking proceeding to

establish appropriate CGMP

requirements for PET drugs under

section 121(c)(1)(A)(ii) of the

Modernization Act.

Section 121(d) of the Modernization

Act also directs FDA to terminate the

application of two notices concerning

certain guidance documents on PET

drugs. Elsewhere in this issue of the

Federal Register, FDA is publishing a

notice revoking these two notices and

the guidance documents to which the

notices relate.

The revocation of the final rule on

CGMP exceptions or alternatives for

PET drugs is effective December 21,

1997.

In accordance with section

121(c)(1)(A) of the Modernization Act,

FDA intends to begin the development

of new PET drug approval procedures

and CGMP requirements immediately

and will obtain appropriate public input

during this process.

List of Subjects in 21 CFR Part 211

Drugs, Labeling, Laboratories,

Packaging and containers.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 211 is

amended as follows:

PART 211—CURRENT GOOD

MANUFACTURING PRACTICE FOR

FINISHED PHARMACEUTICALS

1. The authority citation for 21 CFR

part 211 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 355,

356, 357, 360b, 371, 374.

§ 211.1 [Amended]

2. Section 211.1 Scope is amended by

removing paragraph (d).

Dated: December 16, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–33187 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Decoquinate and Bacitracin

Zinc

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of an abbreviated new animal

drug application (ANADA) filed by

Alpharma Inc. The ANADA provides for

using approved decoquinate and

bacitracin zinc Type A medicated
Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Rules and Regulations 66523

articles to make Type C medicated

broiler chicken feeds used for

prevention of coccidiosis, increased rate

of weight gain, and improved feed

efficiency.

EFFECTIVE DATE: December 19, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of

ANADA 200–213 that provides for

combining approved decoquinate and

bacitracin zinc Type A medicated

articles to make Type C medicated feeds

for broilers containing decoquinate 27.2

grams per ton (g/t) and bacitracin zinc

10 to 50 g/t. The Type C medicated feed

is used as an aid in the prevention of

coccidiosis caused by Eimeria tenella, E.

necatrix, E. acervulina, E. brunetti, E.

mivati, and E. maxima; and for

increased rate of weight gain; and

improved feed efficiency.

ANADA 200–213, filed by Alpharma

Inc., is approved as a generic copy of

Rhone Poulenc’s NADA 45–348. The

ANADA is approved as of September

19, 1997, and the regulations are

amended in the table in 21 CFR

558.195(d) to reflect the approval. The

basis for approval is discussed in the

freedom of information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33(a)(1) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.195 [Amended]

2. Section 558.195 Decoquinate is

amended in the table in paragraph (d),

in the entry for ‘‘27.2 (0.003 pct)’’, in the

second column, in the entry for

‘‘Bacitracin 10 to 50’’, under the column

‘‘Limitations’’ by removing ‘‘No.

000061’’ and adding in its place ‘‘Nos.

046573 and 011716’’.

Dated: December 8, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33095 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 175

[DoD Instruction 4165.67]

RIN 0790–AF62

Revitalizing Base Closure

Communities and Community

Assistance

AGENCY: Department of Defense, Office

of the Deputy Under Secretary of

Defense (Industrial Affairs and

Installations).

ACTION: Final rule.

SUMMARY: This rule establishes

procedures for implementing section

2837 of the National Defense

Authorization Act for FY96 concerning

the Federal Agency leaseback of

property transferred to Local

Redevelopment Authorities (LRAs) at

installations approved for closure or

realignment, and informs communities

affected by base closure of these

procedures.

EFFECTIVE DATE: December 19, 1997.

FOR FURTHER INFORMATION CONTACT:

Jennifer Atkin, Base Closure and

Community Reinvestment Office, 400

Army-Navy Drive, Suite 200, Arlington,

VA 22202, telephone (703) 604–2400.

SUPPLEMENTARY INFORMATION:

Regulatory History and Background

Information

DoD published a proposed rule on

February 21, 1997 (62 FR 7966)

implementing section 2837 of the

National Defense Authorization Act for

FY96 (Pub. L. 104–106). Public

comments were accepted until April 22,

1997. This final rule addresses the

comments received on the proposed

rule.

Discussion of Public Comments

During the public comment period,

the Department received over 40 public

comments from 14 sources, including

numerous LRAs. The comments are

summarized generically below. Changes

that have been made to the rule in

response to public comments are noted.

The comments fall into eight broad

categories including:

Federal Tenant Procurement Authority

Many comments requested that the

rule revise the provisions regarding

what services a Federal tenant may pay

for and how the services can be

obtained. Examples include: (1) The

rule should authorize LRAs to charge

Federal leaseback tenants a Common

Area Maintenance Fee; (2) the rule

should authorize Federal tenants to sole

source for ‘‘landlord’’ services; and, (3)

the rule should require Federal tenants

to pay for services if the Agency paid for

the services when it owned the property

(note: this would only apply to existing

Federal tenants rather than agencies

relocating to the site).

Response: The Federal Government

cannot pay for municipal services that

are provided by a locality to its

population using tax revenues. Doing so

would, in effect, result in a taxing of the

Federal Government. But, as evidenced

by numerous Supreme Court Cases

interpreting the Supremacy Clause of

Article VI of the United States

Constitution, States cannot tax the

Federal Government. With respect to

other services, Federal tenants can only

pay for those services that are a

requirement of the Federal Government.

Paying a Common Area Maintenance

Fee could result in the Federal tenant

paying for services that are above and

beyond what is needed to use the

property being leased. For those services

that are necessary, the leaseback

authority does not remove the Federal

Government’s responsibility to abide by

existing procurement laws. As a result,

such services must be acquired using

existing procurement laws and

regulations. In some circumstances, a

sole source contract may be allowable.

Leaseback Transfer Approval/Rejection

Authority

Out of concern that prospective

Federal tenants will reject an LRA’s

request for a leaseback transfer with

virtually no justification, some

comments requested that the rule

establish criteria that would have to be