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.
63270 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations

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 parts 510, 520, 522, 524, and 558

are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

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

353, 360b, 371, 379e.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by removing

the entries for ‘‘Rhone Merieux, Inc.’’

and ‘‘Merck Research Laboratories,

Division of Merck & Co., Inc.’’ and by

alphabetically adding a new entry for

‘‘Merial Ltd.,’’ and in the table in

paragraph (c)(2) by removing the entry

for ‘‘000006’’ and by revising the entry

for ‘‘050604’’ to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Merial Ltd., 2100 Ronson Rd., Iselin, NJ 08830–3077 ............................ 050604

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

050604 ...................................................................................................... Merial Ltd., 2100 Ronson Rd., Iselin, NJ 08830–3077

* * * * * * *

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

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

§ 520.100a [Amended]

4. Section 520.100a Amprolium

drinking water is amended in paragraph

(b) by removing ‘‘000006’’ and adding in

its place ‘‘050604’’.

§ 520.100b [Amended]

5. Section 520.100b Amprolium

drench is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.100c [Amended]

6. Section 520.100c Amprolium

crumbles is amended in paragraph (b)

by removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.300a [Amended]

7. Section 520.300a Cambendazole

suspension is amended in paragraph (b)

by removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.300b [Amended]

8. Section 520.300b Cambendazole

pellets is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.300c [Amended]

9. Section 520.300c Cambendazole

paste is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.420 [Amended]

10. Section 520.420 Chlorothiazide

tablets and boluses is amended in

paragraph (a)(2) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 520.462 [Amended]

11. Section 520.462 Clorsulon drench

is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.804 [Amended]

12. Section 520.804 Enalapril tablets

is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.1192 [Amended]

13. Section 520.1192 Ivermectin paste

is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.1193 [Amended]

14. Section 520.1193 Ivermectin

tablets and chewables is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 520.1194 [Amended]

15. Section 520.1194 Ivermectin

drench is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.1195 [Amended]

16. Section 520.1195 Ivermectin

liquid is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.1196 [Amended]

17. Section 520.1196 Ivermectin and

pyrantel pamoate chewable tablet is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 520.1197 [Amended]

18. Section 520.1197 Ivermectin

sustained-release bolus is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 520.2170 [Amended]

19. Section 520.2170

Sulfabromomethazine sodium boluses is
Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations 63271

amended in paragraph (c) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 520.2380a [Amended]

20. Section 520.2380a Thiabendazole

top dressing and mineral protein feed

block is amended in paragraph (c)(2) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.2380b [Amended]

21. Section 520.2380b Thiabendazole

drench or oral paste is amended in

paragraph (c) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 520.2380c [Amended]

22. Section 520.2380c Thiabendazole

bolus is amended in paragraph (c) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.2380d [Amended]

23. Section 520.2380d Thiabendazole,

piperazine citrate suspension is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 520.2380f [Amended]

24. Section 520.2380f Thiabendazole,

piperazine phosphate powder is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

25. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.1150 [Amended]

26. Section 522.1150

Hydrochlorothiazide injection is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 522.1192 [Amended]

27. Section 522.1192 Ivermectin

injection is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 522.1193 [Amended]

28. Section 522.1193 Ivermectin and

clorsulon injection is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 522.1452 [Amended]

29. Section 522.1452 Nalorphine

hydrochloride injection is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 522.1885 [Amended]

30. Section 522.1885 Prednisolone

tertiary butylacetate suspension is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

31. The authority citation for 21 CFR

part 524 continues to read as follows:

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

§ 524.1193 [Amended]

32. Section 524.1193 Ivermectin pouron is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 524.1484g [Amended]

33. Section 524.1484g Neomycin

sulfate-thiabendazole-dexamethasone

solution is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 524.1883 [Amended]

34. Section 524.1883 Prednisolone

sodium phosphate-neomycin sulfate

ophthalmic ointment is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

35. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.55 [Amended]

36. Section 558.55 Amprolium is

amended in paragraph (a) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 558.58 [Amended]

37. Section 558.58 Amprolium and

ethopabate is amended in the table in

paragraph (d)(1), in the ‘‘Limitations’’

column by removing ‘‘000006’’ each

time it appears and adding in its place

‘‘050604’’.

§ 558.95 [Amended]

38. Section 558.95 Bambermycins is

amended in paragraphs (d)(1)(ii)(b),

(d)(1)(iii)(b), (d)(1)(iv)(b), (d)(1)(v)(b),

and (d)(1)(xiii)(b)(2)(iii)(b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 558.235 [Amended]

39. Section 558.235 Efrotomycin is

amended in paragraph (a) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 558.300 [Amended]

40. Section 558.300 Ivermectin is

amended in paragraphs (a)(1) and (a)(2)

by removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 558.615 [Amended]

41. Section 558.615 Thiabendazole is

amended in paragraph (a) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

Dated: November 10, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–31148 Filed 11–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 96N–0249]

RIN 0910–AB19

Exemption From Preemption of State

and Local Cigarette and Smokeless

Tobacco Requirements; Applications

for Exemption Submitted by Various

State Governments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is granting

exemptions from Federal preemption for

certain cigarette and smokeless tobacco

requirements in Alabama, Alaska, and

Utah. These exemptions will permit

those States to continue to enforce

certain restrictions on the sale and

distribution of cigarettes and smokeless

tobacco that are more stringent than

FDA counterpart restrictions under its

regulations.

EFFECTIVE DATE: December 29, 1997.

FOR FURTHER INFORMATION CONTACT:

Anne M. Kirchner, Office of Policy (HF–

11), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–5321.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 521(a) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360k(a)), any State or local

requirement applicable to a device is

preempted if such requirement: (1) Is

different from, or in addition to, any

requirement applicable under the act to

the device; and (2) relates to the safety

or effectiveness of the device or any