29502 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules

operator of the affected airplane has not

performed the inspection or

modification.

The regulations proposed herein

would 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

proposal would 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) if

promulgated, 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 copy of the draft

regulatory evaluation prepared for this

action has been placed in the Rules

Docket. A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend 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 a new airworthiness directive

(AD) to read as follows:

Pilatus Aircraft Ltd.: Docket No. 95–CE–85–

AD.

Applicability: Model PC–6 Airplanes

(serial numbers 825 through 892).

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 (e) 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 within the next 75

hours time-in-service (TIS), after the effective

date of this AD, unless already accomplished.

Note 2: The compliance time required in

this AD takes precedence over the

compliance time in Pilatus Service Bulletin

PC–6 165, dated February 7, 1994.

To prevent structural failure of the hinge

bracket on the horizontal stabilizer, which

could result in partial or complete loss of

control of the horizontal stabilizer and loss

of control of the airplane, accomplish the

following:

(a) Inspect the hinge brackets on the

horizontal stabilizer for sheared or loose

rivets in accordance with paragraph 2.A. in

the ACCOMPLISHMENT INSTRUCTIONS

section of Pilatus Service Bulletin (SB) PC–

6 165, dated February 7, 1994.

(b) Inspect the spacing tolerance of the

hinge bracket in accordance with paragraph

2.C. in the ACCOMPLISHMENT

INSTRUCTIONS section of Pilatus SB PC–6

165, dated February 7, 1994.

(c) If there are loose or sheared rivets or if

the bracket spacing is out of the spacing

tolerance, prior to further flight, modify the

position and space tolerance of the hinge

brackets and replace any loose or sheared

rivets in accordance with paragraph 2.D. in

the ACCOMPLISHMENT INSTRUCTIONS

section of Pilatus SB PC–6 165, dated

February 7, 1994.

(d) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviations Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(e) An alternative method of compliance or

adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Small Airplane

Directorate. The request shall be forwarded

through an appropriate FAA Maintenance

Inspector, who may add comments and then

send it to the Manager, Small Airplane

Directorate.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Small Airplane

Directorate.

(f) All persons affected by this directive

may obtain copies of the document referred

to herein upon request to Pilatus Aircraft

Ltd., CH–6370 Stans, Switzerland; or may

examine this document at the FAA, Central

Region, Office of the Assistant Chief Counsel,

Room 1558, 601 E. 12th Street, Kansas City,

Missouri.

Issued in Kansas City, Missouri on June 4,

1996.

Henry A. Armstrong,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 96–14694 Filed 6–10–96; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 200, 250, and 310

[Docket No. 96N–0183]

RIN 0910–AA53

Consolidation of Drug Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

consolidate a list of drugs, previously

determined by rulemaking to be new

drugs, into one section. This document

would also remove the sections now

providing for these drugs, except for

certain information in the regulations

that FDA considers to be necessary. This

action, which will make the regulations

more concise and efficient, is being

taken in response to the President’s

regulatory reinvention initiative

(REGO).

DATES: Written comments by August 26,

1996. FDA proposes that any final rule

based on this proposal become effective

2 weeks after its date of publication in

the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–7), 7500

Standish Pl., Rockville, MD 20855, 301–

594–2041.

SUPPLEMENTARY INFORMATION:

I. Introduction

On March 4, 1995, President Clinton

issued a memorandum titled

‘‘Regulatory Reinvention Initiative.’’

This memorandum, part of the reform of

the Federal regulatory system, directed

heads of departments and agencies to

undertake a page-by-page review of their

existing regulations and to eliminate or

modify those that are outdated or

otherwise in need of reform. FDA has

conducted a comprehensive review of
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules 29503

its existing regulations and has

identified regulations to eliminate or

modify. As a result of that review and

as part of its response to the President’s

directive, FDA is proposing to amend or

remove those parts of its drug

regulations codified in Parts 200, 250,

and 310 (21 CFR parts 200, 250, and

310) regarding certain drugs determined

by rulemaking to be new drugs. FDA is

preparing other revisions resulting from

the page-by-page review for future

publication.

FDA is proposing to revise § 310.502

to consolidate into one section a list of

drugs that have been determined by

previous rulemaking procedures to be

new drugs within the meaning of

section 201(p) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 321(p)) for which approved new

drug applications under section 505 of

the act (21 U.S.C. 355) and 21 CFR part

314 are required for marketing. The list

would include those new drugs now

codified in parts 200, 250, and 310. As

the agency identifies other new drugs as

being new drugs through its rulemaking

procedures, FDA would add such other

new drugs to the list.

Revised § 310.502 would list the

names of the drugs and would not

include the existing background

information describing the agency’s

basis for determination of new drug

status and, for some drugs, requirements

for marketing. FDA has determined that

with the exception of certain

information in § 310.509 that FDA

considers to be necessary, the

background information no longer needs

to be set out in the regulations. For some

drugs, the information is outdated. For

other drugs, removal of the existing

explanatory text should not present a

hardship or burden because the

information is available from other

sources. This proposal would make the

regulations more concise and efficient.

II. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) 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.

III. Analysis of Impacts

FDA has examined the impacts of the

proposed 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 proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed 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 document merely

proposes to consolidate existing

regulations, the agency certifies that the

proposed rule will not have a significant

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act no further analysis is

required.

IV. Request for Comments

Interested persons may, on or before

August 26, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

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

Monday through Friday.

V. Effective Date

FDA proposes that any final rule

based on this proposal be effective 2

weeks after its date of publication in the

Federal Register.

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, the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, it is proposed that 21 CFR

parts 200, 250, and 310 be 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).

Subpart B [Removed]

2. Subpart B, consisting of §§ 200.30

and 200.31 is removed and 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)).

§ 250.10 [Removed]

4. Section 250.10 Oral prenatal drugs

containing fluorides intended for

human use is removed.

§ 250.103 [Removed]

5. Section 250.103 Thorium dioxide

for drug use is removed.

§ 250.106 [Removed]

6. Section 250.106 Cobalt

preparations intended for use by man is

removed.

PART 310—NEW DRUGS

7. 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).

8. Section 310.502 is revised to read

as follows:

§ 310.502 Certain drugs accorded new

drug status through rulemaking

procedures.

(a) The drugs listed in this paragraph

(a) have been determined by rulemaking

procedures to be new drugs within the

meaning of section 201(p) of the act.

Except as provided in paragraph (b) of

this section, an approved new drug

application under section 505 of the act

and part 314 of this chapter is required

for marketing the following drugs:

(1) Aerosol drug products for human

use containing 1,1,1-trichloroethane.

(2) Aerosol drug products containing

zirconium.
29504 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules

(3) Amphetamines (amphetamine,

dextroamphetamine, and their salts, and

levamfetamine and its salts) for human

use.

(4) Camphorated oil drug products.

(5) Certain halogenated salicylanilides

(tribromsalan (TBS, 3,4’,5-

tribromosalicylanilide), dibromsalan

(DBS, 4’, 5-dibromosalicylanilide),

metabromsalan (MBS, 3, 5-

dibromosalicylanilide), and 3,3’, 4,5’-

tetrachlorosalicylanilide (TC-SA)) as an

ingredient in drug products.

(6) Chloroform used as an ingredient

(active or inactive) in drug products.

(7) Cobalt preparations intended for

use by man.

(8) Intrauterine devices for human use

for the purpose of contraception that

incorporate heavy metals, drugs, or

other active substances.

(9) Oral prenatal drugs containing

fluorides intended for human use.

(10) Parenteral drug products in

plastic containers.

(11) Sterilization of drugs by

irradiation.

(12) Sweet spirits of nitre drug

products.

(13) Thorium dioxide for drug use.

(14) Timed release dosage forms.

(15) Vinyl chloride as an ingredient,

including propellant, in aerosol drug

products.

(b) Any drug listed in paragraph (a) of

this section, when composed wholly or

partly of any antibiotic drug, must be

certified under section 507 of the act or

exempted from certification under

section 507 of the act for marketing.

§ 310.504 [Removed]

9. Section 310.504 Amphetamines

(amphetamine, dextroamphetamine,

and their salts and levamfetamine and

its salts) for human use is removed.

§ 310.506 [Removed]

10. Section 310.506 Use of vinyl

chloride as an ingredient, including

propellant, of aerosol drug products is

removed.

§ 310.507 [Removed]

11. Section 310.507 Aerosol drug

products for human use containing

1,1,1-trichloroethane is removed.

§ 310.508 [Removed]

12. Section 310.508 Use of certain

halogenated salicylanilides as an

inactive ingredient in drug products is

removed.

13. Section 310.509 is revised to read

as follows:

§ 310.509 Parenteral drug products in

plastic containers.

(a) Any parenteral drug product

packaged in a plastic immediate

container is not generally recognized as

safe and effective, is a new drug within

the meaning of section 201(p) of the act,

and requires an approved new drug

application as a condition for marketing.

An ‘‘Investigational New Drug

Application’’ set forth in part 312 of this

chapter is required for clinical

investigations designed to obtain

evidence of safety and effectiveness.

(b) As used in this section, the term

‘‘large volume parenteral drug product’’

means a terminally sterilized aqueous

drug product packaged in a single-dose

container with a capacity of 100

milliliters or more and intended to be

administered or used intravenously in a

human.

(c) Until the results of compatibility

studies are evaluated, a large volume

parenteral drug product for intravenous

use in humans that is packaged in a

plastic immediate container on or after

April 16, 1979, is misbranded unless its

labeling contains a warning that

includes the following information:

(1) A statement that additives may be

incompatible.

(2) A statement that, if additive drugs

are introduced into the parenteral

system, aseptic techniques should be

used and the solution should be

thoroughly mixed.

(3) A statement that a solution

containing an additive drug should not

be stored.

(d) This section does not apply to a

biological product licensed under the

Public Health Service Act of July 1,

1944 (42 U.S.C. 201).

§ 310.510 [Removed]

14. Section 310.510 Use of aerosol

drug products containing zirconium is

removed.

§ 310.513 [Removed]

15. Section 310.513 Chloroform, use

as an ingredient (active or inactive) in

drug products is removed.

§ 310.525 [Removed]

16. Section 310.525 Sweet spirits of

nitre drug products is removed.

§ 310.526 [Removed]

17. Section 310.526 Camphorated oil

drug products is removed.

Dated: June 5, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–14706 Filed 6–6–96; 11:50 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 935

[OH–237–FOR, #71]

Ohio Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the Ohio

regulatory program (hereinafter the

‘‘Ohio program’’) under the surface

Mining Control and Reclamation Act of

1977 (SMCRA). The proposed

amendment consists of changes to

provisions of the Ohio rules pertaining

to inspections. The amendment is

intended to revise the Ohio program to

be consistent with the corresponding

Federal regulations.

DATES: Written comments must be

received by 4:00 p.m., [E.D.T.] July 11,

1996. If requested, a public hearing on

the proposed amendment will be held

on July 8, 1996. Requests to speak at the

hearing must be received by 4:00 p.m.,

[E.D.T.], on June 26, 1996.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to George

Rieger, Field Branch chief, at the

address listed below.

Copies of the Ohio program, the

proposed amendment, a listing of any

scheduled public hearings, and all

written comments received in response

to this document will be available for

public review at the addresses listed

below during normal business hours,

Monday through Friday, excluding

holidays. Each requester may receive

one free copy of the proposed

amendment by contacting OSM’s

Appalachian Regional Coordinating

Center.

George Rieger, Field Branch Chief,

Appalachian Regional Coordinating

Center, Office of Surface Mining

Reclamation and Enforcement, 3

Parkway Center, Pittsburgh, PA

15220, Telephone: (412) 937–2153

Ohio Division of Mines and

Reclamation, 1855 Fountain Square

Court, Columbus, Ohio 43224,

Telephone: (614) 265–1076.

FOR FURTHER INFORMATION CONTACT:

George Rieger, Field Branch Chief,

Appalachian Regional Coordinating

Center, Telephone: (412) 937–2153.