29476 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations

List of substances Limitations

Monochlorobenzene

Monochlorobenzene.

Not to exceed 500 parts

per million as residual

solvent in finished

basic resin in paragraph (a)(1) of this

section.

N-methyl-2-

pyrrolidone.

Not to exceed 0.01 percent (100 parts per

million) as residual

solvent in finished

basic resin in paragraph (a)(2) of this

section.

* * * * *

Dated: May 17, 1996.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–14697 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

21 CFR Parts 200, 250, and 310

[Docket No. 95N–0310]

Revocation of Obsolete Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking

certain regulations that are obsolete or

are no longer necessary to achieve

public health goals. These regulations

were among those identified for

revocation in a page-by-page review

conducted in response to the

Administration’s ‘‘Reinventing

Government’’ initiative, which seeks to

streamline government to ease the

burden on regulated industry and

consumers.

EFFECTIVE DATE: July 11, 1996.

FOR FURTHER INFORMATION CONTACT:

Christine F. Rogers, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 13,

1995 (60 FR 53480), FDA published a

proposed rule to revoke certain

regulations. This was done in response

to the President’s order to all Federal

agencies to conduct a page-by-page

review of all their regulations and to

‘‘eliminate or revise those that are

outdated or otherwise in need of

reform.’’ The proposed rule contained a

section-by-section analysis of all the

regulations (21 CFR parts 100, 101, et

al.) that FDA intended to revoke. This

final rule pertains only to those

regulations (21 CFR parts 200, 250, and

310) pertaining exclusively to the Center

for Drug Evaluation and Research. No

comments were received in response to

the proposal to revoke these regulations.

II. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule, which is the

revocation of certain regulations that are

obsolete or are no longer necessary, is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

final rule is not a significant regulatory

action as defined by the Executive Order

and so is not subject to review under the

Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this final rule is the

revocation of certain regulations that are

obsolete or are no longer necessary, the

agency is not aware of any adverse

impact this final rule will have on any

small entities, and the agency certifies

that the final rule will not have a

significant economic impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(9) 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

21 CFR Part 200

Drugs, Prescription drugs.

21 CFR Part 250

Drugs.

21 CFR Part 310

Administrative practice and

procedure, Drugs, Labeling, Medical

devices, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301

et seq.) and under authority delegated to

the Commissioner of Food and Drugs,

21 CFR parts 200, 250, and 310 are

amended as follows:

PART 200—GENERAL

1. The authority citation for 21 CFR

part 200 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 508, 515, 701, 704, 705 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,

358, 360e, 371, 374, 375).

2. Sections 200.100 and 200.101 are

removed and the heading for subpart D

is reserved.

PART 250—SPECIAL REQUIREMENTS

FOR SPECIFIC HUMAN DRUGS

3. The authority citation for 21 CFR

part 250 continues to read as follows:

Authority: Secs. 201, 306, 402, 502, 503,

505, 601(a), 602(a) and (c), 701, 705(b) of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 336, 342, 352, 353, 355, 361(a),

362(a) and (c), 371, 375(b)).

§ 250.104 [Removed]

4. Section 250.104 Status of salt

substitutes under the Federal Food,

Drug, and Cosmetic Act is removed.

§ 250.203 [Removed]

5. Section 250.203 Status of

fluoridated water and foods prepared

with fluoridated water is removed.

PART 310—NEW DRUGS

6. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 512–516, 520, 601(a), 701, 704,

705, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 355, 356, 357, 360b–360f, 360j, 361(a),

371, 374, 375, 379e); secs. 215, 301, 302(a),

351, 354–360F of the Public Health Service

Act (42 U.S.C. 216, 241, 242(a), 262, 263b–

263n).

§ 310.101 [Removed]

7. Section 310.101 FD&C Red No. 4;

procedure for discontinuing use in new

drugs for ingestion; statement of policy

is removed.
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29477

§ 310.304 [Removed]

8. Section 310.304 Drugs that are

subjects of approved new drug

applications and that require special

studies, records, and reports is removed.

Dated: June 3, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–14587 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Pyrantel Pamoate Suspension

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

Lambert-Kay, Div. of Carter-Wallace,

Inc. The ANADA provides for oral use

of pyrantel pamoate suspension for

removal of large roundworms and

hookworms in puppies and dogs and to

prevent reinfections of Toxocara canis

in puppies and adult dogs and in

lactating bitches after whelping.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

Sandra K. Woods, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1616.

SUPPLEMENTARY INFORMATION: LambertKay, Div. of Carter-Wallace, Inc., P.O.

Box 1001, Half Acre Rd., Cranbury, NJ

08512–0181, filed ANADA 200–028,

which provides for oral use of Evict,

Lassie, and Vet’s OwnTM (pyrantel

pamoate) liquid wormer for removal of

large roundworms (T. canis and

Toxascaris leonina) and hookworms

(Ancylostoma caninum and Uncinaria

stenocephala) in puppies and dogs and

to prevent reinfections of T. canis in

puppies and adult dogs and in lactating

bitches after whelping. The product

contains pyrantel pamoate equivalent to

2.27 milligrams of pyrantel base.

Approval of ANADA 200–028 for

Lambert-Kay’s pyrantel pamoate

suspension is as a generic copy of

Pfizer’s NADA 100–237 NemexTM

(pyrantel pamoate). The ANADA is

approved as of March 28, 1996, and the

regulations in 21 CFR 520.2043(b)(2) are

amended to reflect the approval. The

basis of approval is discussed in the

freedom of information summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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 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.

List of Subjects in 21 CFR Part 520

Animal drugs.

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.2043 is amended by

revising paragraph (b)(2) to read as

follows:

§ 520.2043 Pyrantel pamoate suspension.

* * * * *

(b) * * *

(2) Sponsors. See No. 000069 for use

of 2.27 and 4.54 milligrams per

milliliter product. See No. 011615 for

use of 2.27 milligrams per milliliter

product.

* * * * *

Dated: May 15, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14647 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 520, 556, and 558

Animal Drugs, Feeds, and Related

Products; Fenbendazole-Containing

Animal Drug and Feed Products

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 three supplemental new

animal drug applications (NADA’s) filed

by Hoechst-Roussel Agri-Vet Co. The

supplemental NADA’s expand use of

fenbendazole-containing suspension,

paste, and medicated animal feed

products to include use in dairy cattle

of breeding age for the removal and

control of gastrointestinal parasites and

lungworm. They also provide for the

establishment of a safe concentration

and tolerance for fenbendazole residues

in milk of treated dairy cattle and no

requirement for discard of milk from the

animals.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: HoechstRoussel Agri-Vet Co., Rt. 202–206

North, P.O. Box 2500, Somerville, NJ

08876–1258, is the sponsor of NADA’s

which cover the following

fenbendazole-containing animal drug

and medicated feed products: 128–620

for 10 percent suspension, 132–872 for

10 percent paste, and 137–600 for 20

percent Type A medicated article, 0.5

percent pelleted top dressing, and 35

percent free-choice mineral feed. The

firm holds approvals for use of the

products in beef and dairy cattle not of

breeding age for the removal and control

of gastrointestinal parasites and

lungworm (as provided for in

§§ 520.905a, 520.905c, and 558.258 (21

CFR 520.905a, 520.905c, and 558.258)).

The firm has submitted supplements to

the NADA’s providing for expanding

use of the drug products to include use

in dairy cattle of breeding age for the

same uses currently approved for the

above-mentioned production classes.

Safe concentrations for total

fenbendazole residues in edible cattle

tissues, a tolerance for parent

fenbendazole in cattle liver (21 CFR

556.275), and a safe withdrawal time for

treated beef cattle were established

based on data and information

submitted with the original NADA 128–

620. Based on the evaluation of data

generated by additional studies

submitted with these supplements, the

agency is establishing a safe

concentration and tolerance for

fenbendazole residues in milk of treated

dairy cattle. Also, based on the data, no

discard of milk (zero milk withdrawal)

is required and the slaughter