63268 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations

discrepancies, and corrective action, if

necessary.

Comments

Interested persons have been afforded

an opportunity to participate in the

making of this amendment. No

comments were submitted in response

to the proposal or the FAA’s

determination of the cost to the public.

Conclusion

The FAA has determined that air

safety and the public interest require the

adoption of the rule as proposed.

Cost Impact

The FAA estimates that 3 Model

SAAB 2000 series airplanes of U.S.

registry will be affected by this AD, that

it will take approximately 4 work hours

per airplane to accomplish the required

actions, and that the average labor rate

is $60 per work hour. Based on these

figures, the cost impact of the AD on

U.S. operators is estimated to be $720,

or $240 per airplane. The cost impact figure discussed

above is based on assumptions that no

operator has yet accomplished any of

the requirements of this AD action, and

that no operator would accomplish

those actions in the future if this AD

were not adopted.

Regulatory Impact

The regulations adopted herein will

not 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. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (1) is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3)

will not have a significant economic

impact, positive or negative, on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A final evaluation has

been prepared for this action and it is

contained in the Rules Docket. A copy

of it may be obtained from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

97–24–14 Saab Aircraft AB: Amendment

39–10221. Docket 97–NM–126–AD.

Applicability: Model SAAB 2000 airplanes,

having serial numbers –002 through –043

inclusive, certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent discrepancies of the check

valve, which could result in improper

functioning of the engine fire extinguishing

system, accomplish the following:

(a) Within 2 months after the effective date

of this AD, perform an inspection of the twoway check valve on the engine fire

extinguishing system for discrepancies, in

accordance with Saab Service Bulletin 2000–

26–010, dated July 5, 1996. If any

discrepancy is found, prior to further flight,

install a new two-way check valve in

accordance with the service bulletin.

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

International Branch, ANM–116, FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, International Branch,

ANM–116.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(d) The actions shall be done in accordance

with Saab Service Bulletin 2000–26–010,

dated July 5, 1996. This incorporation by

reference was approved by the Director of the

Federal Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may be

obtained from Saab Aircraft AB, SAAB

Aircraft Product Support, S–581.88,

Linko ̈ping, Sweden. Copies may be inspected

at the FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Note 3: The subject of this AD is addressed

in Swedish airworthiness directive SAD No.

1–099, dated July 8, 1996.

(e) This amendment becomes effective on

January 2, 1998.

Issued in Renton, Washington, on

November 19, 1997.

Stewart R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–31030 Filed 11–26–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 85N–0214]

Policy on 180-Day Marketing

Exclusivity for Drugs Marketed Under

Abbreviated New Drug Applications;

Clarification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Clarification.

SUMMARY: The Center for Drug

Evaluation and Research (CDER) of the

Food and Drug Administration (FDA) is

publishing this document to clarify the

status of its practices governing 180

days of marketing exclusivity for generic

drugs and the approval of abbreviated

new drug applications (ANDA’s) subject

to patent litigation. This document is

being published due to recent court

decisions interpreting provisions of the

Drug Price Competition and Patent

Term Restoration Act of 1984 (Pub. L.

98–417) (the 1984 amendments).

FOR FURTHER INFORMATION CONTACT: Jerry

Phillips, Center for Drug Evaluation and
Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations 63269

Research (HFD–605), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–5846.

SUPPLEMENTARY INFORMATION:

I. Background

The 1984 amendments included a

provision, codified under section

505(j)(4)(B)(iv) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 355(j)(4)(B)(iv)), granting 180

days of marketing exclusivity to the first

applicant to submit an ANDA

containing a challenge to a listed patent.

Regulations interpreting this provision

were proposed in 1989 (54 FR 28872,

July 10, 1989), and made final in 1994

(59 FR 50338, October 3, 1994). These

regulations are codified under

§ 314.107(c) (21 CFR 314.107(c)).

The regulations state that for a generic

drug to qualify for 180 days of

marketing exclusivity, the first ANDA

applicant submitting a certification

under section 505(j)(2)(A)(vii)(IV) of the

act (paragraph IV certification) to the

listed patent must, in addition to

submitting the certification, be sued for

patent infringement and successfully

defend that suit (§ 314.107(c)). This

interpretation has been the subject of

legal action in Inwood Laboratories, Inc.

v. Young, 723 F. Supp. 1523 (D.D.C.

1989), vacated as moot, 43 Fed.3d 712

(D.C.Cir. 1989); Mova Pharmaceutical

Corp. v. Shalala, 955 F. Supp. 128

(D.D.C. 1997), and Granutec, Inc. et al.

v. Shalala et al., No. 5:97–CV–485–

BO(1)(E.D.N.C. July 3, 1997). Both the

Inwood and Mova courts held that 180

days of marketing exclusivity should be

granted to the first ANDA applicant who

files a paragraph IV certification,

regardless of whether the applicant is

subsequently sued for patent

infringement. The Mova decision has

been appealed to the U.S. Court of

Appeals for the District of Columbia

Circuit.

Following the Mova decision, in June

1997, the Office of Generic Drugs

notified applicants with ANDA’s for

ranitidine hydrochloride (HCl) that the

agency would acquiesce to the court’s

holding in Mova, pending an appellate

decision. The agency determined that

temporarily acquiescing to the court’s

holding in Mova would promote

administrative uniformity in the

application of section 505(j)(4)(B)(iv) of

the act and would prevent forum

shopping among disappointed ANDA

applicants. Subsequently, the U.S.

District Court for the Eastern District of

North Carolina addressed the validity of

§ 314.107(c) in Granutec v. Shalala, and,

in a holding contrary to the earlier Mova

decision, ordered FDA to follow its

regulations in approving ANDA’s for

ranitidine HCl. The Granutec decision

was stayed and is on expedited appeal

to the U.S. Court of Appeals for the 4th

Circuit.

Because the uncertain state of the law

makes it difficult for the industry to

make business plans and other

arrangements, CDER wishes to clarify its

policy with respect to these exclusivity

issues, pending their final resolution by

the courts.

II. 180-Day Marketing Exclusivity

It is the agency’s position that, given

the uncertainty created by the conflict

among the courts, the most reasonable

policy is to apply the 180-day

exclusivity provisions of the statute as

set forth in § 314.107(c) to all ANDA’s

to which the regulation would, on its

face, apply, whether they were

submitted before or after the Mova

decision. The only ANDA’s to which the

agency applied the Mova analysis, other

than those ANDA’s directly involved in

the Mova litigation, were those for

ranitidine HCl.

The regulations in § 314.107(c) were

issued through notice and comment

rulemaking with the active participation

of the pharmaceutical industry and

consumer groups. They are the product

of careful consideration by the agency of

the complex factors at issue in granting

a period of exclusivity to generic drug

applicants and in ensuring that the

statute is implemented in a manner

most consistent with its original

purpose. These regulations will be

applied until such time as the appellate

courts complete their analyses of the

agency’s interpretation.

III. Approval of ANDA’s After

Judgment in the District Courts

The agency does not intend to

acquiesce to the court’s decision in

Torpharm v. Shalala, Civil Action No.

97–1925 (JR) (D.D.C. Sept. 15, 1997), in

which the court, finding that the term

‘‘the court’’ in section 505(j)(4)(B)(iii) of

the act means district court, ordered

FDA to approve an ANDA after the

applicant had prevailed in patent

infringement litigation in the district

court, but before either the appeal was

resolved or the 30-month stay had

lapsed. The U.S. Court of Appeals for

the District of Columbia has granted the

appeal of Torpharm an expedited

review. While Torpharm is pending on

appeal, FDA will continue to interpret

the statute as described in § 314.107(e),

which defines ‘‘the court’’ as ‘‘the court

that enters final judgment from which

no appeal can be or has been taken.’’

Dated: November 7, 1997.

Roger Williams,

Deputy Center Director for Pharmaceutical

Science.

[FR Doc. 97–31150 Filed 11–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and

558

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for 47 new animal

drug applications (NADA’s) from Rhone

Merieux, Inc., and 54 NADA’s from

Merck Research Laboratories, Division

of Merck & Co., Inc., to Merial Ltd.

EFFECTIVE DATE: November 28, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Rhone

Merieux, Inc., 7101 College Blvd.,

Overland Park, KS 66210, and Merck

Research Laboratories, Division of

Merck & Co., Inc., Rahway, NJ 07065 has

informed FDA that it has transferred

ownership of, and all rights and

interests in, the approved NADA’s to

Merial Ltd., 2100 Ronson Rd., Iselin, NJ

08830–3077.

Accordingly, the agency is amending

the regulations in 21 CFR parts 510, 520,

522, 524, and 558 to reflect the change

of sponsor. The agency is also amending

§ 510.600(c)(1) and (c)(2) to remove the

sponsor name for Rhone Merieux, Inc.,

and Merck Research Laboratories,

Division of Merck & Co., Inc., because

the firm no longer is the holder of any

approved NADA’s. The drug labeler

code assigned to Rhone Merieux, Inc., is

being retained as the drug labeler code

for Merial Ltd.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 520, 522, 524, and 558

Animal drugs.