2732 Federal Register / Vol. 61, No. 19 / Monday, January 29, 1996 / Proposed Rules

Aviation Administration, Docket No.

95–ANM–29, Lind Avenue SW., Renton,

Washington 98055–4056; telephone

number: (206) 227–2535.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested parties are invited to

participate in this proposed rulemaking

by submitting such written data, views,

or arguments as they may desire.

Comments that provide the factual basis

supporting the views and suggestions

presented are particularly helpful in

developing reasoned regulatory

decisions on the proposal. Comments

are specifically invited on the overall

regulatory, aeronautical, economic,

environmental, and energy-related

aspects of the proposal.

Communications should identify the

airspace docket number and be

submitted in triplicate to the address

listed above. Commenters wishing the

FAA to acknowledge receipt of their

comments on this notice must submit

with those comments a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Airspace Docket No. 95–

ANM–29.’’ The postcard will be date/

time stamped and returned to the

commenter. All communications

received on or before the specified

closing date for comments will be

considered before taking action on the

proposed rule. The proposal contained

in this notice may be changed in the

light of comments received. All

comments submitted will be available

for examination at the address listed

above both before and after the closing

date for comments. A report

summarizing each substantive public

contact with FAA personnel concerned

with this rulemaking will be filed in the

docket.

Availability of NPRM’s

Any person may obtain a copy of this

NPRM by submitting a request to the

Federal Aviation Administration,

System Management Branch, ANM–530,

1601 Lind Avenue SW., Renton,

Washington 98055–4056.

Communications must identify the

notice number of this NPRM. Persons

interested in being placed on a mailing

list for future NPRM’s should also

request a copy of Advisory Circular No.

11–2A, which describes the application

procedure.

The Proposal

The FAA is considering an

amendment to part 71 of the Federal

Aviation Regulations (14 CFR part 71) to

amend Class D and Class E airspace at

Hailey, Idaho, to accommodate a new

GPS SIAP at Friedman Memorial

Airport. The area would be depicted on

aeronautical charts for pilot reference.

The coordinates for this airspace docket

are based on North American Datum 83.

Class D airspace areas extending

upward from the surface of the earth,

and Class E airspace areas extending

upward from 700 feet or more above the

surface of the earth are published in

paragraph 5000 and paragraph 6005,

respectively, of FAA Order 7400.9C

dated August 17, 1995, and effective

September 16, 1995, which is

incorporated by reference in 14 CFR

71.1. The Class D and Class E airspace

designations listed in this document

would be published subsequently in the

Order.

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current. It,

therefore, (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) does not warrant

preparation of a regulatory evaluation as

the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this rule,

when promulgated, will not have a

significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFR

part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9C, Airspace

Designations and Reporting Points,

dated August 17, 1995, and effective

September 15, 1995, is amended as

follows:

Paragraph 5000 Class D airspace

* * * * *

ANM ID D Hailey, ID [Revised]

Friedman Memorial Airport, Hailey, ID

(lat. 43°30′17′′ N, long. 114°17′48′′ W)

That airspace extending upward from the

surface to, and including 7,800 feet MSL

within a 4.1-mile radius of the Friedman

Memorial Airport, and that airspace within

1.8 miles each side of the 159° bearing from

the airport, extending from the 4.1-mile

radius to 6 miles southeast of the airport.

This Class D airspace area is effective during

the specified dates and times established in

advance by a Notice to Airmen. The effective

date and time will thereafter be continuously

published in the Airport/Facility Directory.

* * * * *

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ANM ID E5 Hailey, ID [Revised]

Friedman Memorial Airport, Hailey, ID

(lat. 43°30′17′′ N, long. 114°17′48′′ W)

M–SUN MLS

(lat. 43°30′02′′ N, long. 114°17′37′′ W)

That airspace extending upward from 700

feet above the surface within 1.8 miles each

side of the M–SUN MLS 328° azimuth, from

7.4 miles northwest to 4.3 miles southeast of

the M–SUN MLS, and 1.8 miles each side of

the 159° bearing from the airport, extending

from the airport to 7.6 miles southeast of the

airport; that airspace extending upward from

1,200 feet above the surface, within 3.5 miles

each side of the M–SUN MLS 328° azimuth,

from 15.7 miles northwest to the M–SUN

MLS, and that airspace from lat. 43°36′00′′ N,

long. 114°27′03′′ W, thence eastbound to lat.

43°36′00′′ N, long. 114°00′03′′ W, thence

southbound to lat. 43°17′30′′ N, long.

114°03′03′′ W, thence westbound to lat.

43°17′30′′ N, long. 114°27′03′′ W, thence

northbound to the point of beginning;

excluding that airspace overlying V–231 on

the east side and V–500 on the south side.

* * * * *

Issued in Seattle, Washington, on January

5, 1996.

Richard E. Prang,

Acting Assistant Management, Air Traffic

Division, Northwest Mountain Region.

[FR Doc. 96–1435 Filed 1–26–96; 8:45 am]

BILLING CODE 4910–13–M
Federal Register / Vol. 61, No. 19 / Monday, January 29, 1996 / Proposed Rules 2733

DEPARTMENT OF ENERGY

Federal Energy Regulatory

Commission

18 CFR Part 35

[Docket Nos. RM95–8–000 and RM94–7–

001]

Promoting Wholesale Competition

Through Open Access NonDiscriminatory Transmission Services

by Public Utilities; Recovery of

Stranded Costs by Public Utilities and

Transmitting Utilities

January 19, 1996.

AGENCY: Federal Energy Regulatory

Commission.

ACTION: Proposed rule; extension of time

for comments on Draft Environmental

Impact Statement (DEIS).

SUMMARY: On November 17, 1995, the

staff of the Federal Energy Regulatory

Commission issued a draft

environmental impact statement for the

proposed rule in this proceeding (60 FR

58304, November 27, 1995). On January

3, 1996, an extension of time for the

filing of comments on the DEIS was

granted because certain departments

and agencies of the Federal government

were closed for all but emergency

matters due to a lack of appropriated

funds.

DATES: Comments by all parties shall be

filed on or before February 2, 1996.

ADDRESSES: Federal Energy Regulatory

Commission, 888 First Street, N.E.,

Washington, D.C. 20426.

FOR FURTHER INFORMATION CONTACT:

Bill Meroney, Office of Economic

Policy, (202) 208–1069.

Lois D. Cashell,

Secretary.

[FR Doc. 96–1530 Filed 1–26–96; 8:45 am]

BILLING CODE 6717–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600 and 601

[Docket No. 95N–0411]

RIN 0910–AA68

Well-Characterized Biotechnology

Products; Elimination of Establishment

License Application

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the biologics regulations to

eliminate the establishment license

application (ELA) requirement for wellcharacterized biotechnology products

licensed under the Public Health

Service Act (PHS Act). The proposed

rule would also exempt wellcharacterized biotechnology products

licensed under the PHS Act from certain

biologics regulations and harmonize the

requirements applicable to these

products with those applicable to

similar drug products which are

approved under the Federal Food, Drug,

and Cosmetic Act (the act).

This action is part of FDA’s

continuing effort to achieve the

objectives of the President’s

‘‘Reinventing Government’’ initiatives,

and it is intended to reduce unnecessary

burdens for industry without

diminishing public health protection.

DATES: Written comments on this

proposed rule by February 28, 1996.

Submit written comments on the

information collection requirements by

February 28, 1996, but not later than

March 29, 1996. The agency proposes

that any final rule that may issue based

on this proposal become effective upon

its date of publication in the Federal

Register.

ADDRESSES: Submit written comments

on this proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Submit written comments on the

information collection requirements to

the Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Tracey H. Forfa, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–594–3074.

SUPPLEMENTARY INFORMATION

I. Background

In the Federal Register of December 8,

1995 (60 FR 63048), the agency

announced its interim definition of a

well-characterized therapeutic

recombinant DNA-derived and

monoclonal antibody biotechnology

product, as follows:

A chemical entity(ies) whose identity,

purity, impurities, potency, and quantity can

be determined and controlled.

Identity:

a. Recombinant DNA Biotechnology

Products

The primary structure is known (i.e.,

amino acid sequence), and

The secondary structure is known (e.g.

disulfide linkage), and

Post-translational modifications are known

(e.g., glycosylation), or

b. Monoclonal Antibodies

The identity can be determined by rigorous

physicochemical and immunochemical

characterization without fully knowing its

chemical structure.

Purity and impurities:

The purity is quantifiable.

The impurities are quantifiable, and

identified if feasible.

Potency and quantity:

The biological activity is measurable.

The quantity is measurable.

A well-characterized therapeutic

recombinant DNA-derived and monoclonal

antibody product requires proper raw

material controls, process validation and

controls, and sensitive and validated test

methods and specifications.

As announced in the Federal Register

of October 25, 1995 (60 FR 54695), FDA

held a scientific workshop on December

11, 12, and 13, 1995, to discuss the

definition of a well-characterized

therapeutic recombinant DNA-derived

and monoclonal antibody product and

to identify the information necessary to

characterize such products. FDA

intends to consider information

received at the workshop, as well as

comments received in response to this

proposed rule, to determine whether the

definition previously given in this

document should be expanded to

include other categories of products that

would be considered to be wellcharacterized, such as certain vaccines

and biologic devices, e.g., test kits for

screening blood.

FDA is proposing to use the phrase

‘‘well-characterized biotechnology

product,’’ to describe the products that

would be eligible for a single license

application so that the regulatory

language would accommodate such

additional categories of products. FDA

has not included a definition of a wellcharacterized biotechnology product in

the proposed regulations because the

agency intends to clarify the definition

in a guidance document that can be

more readily modified to reflect changes

that may be warranted as scientific

knowledge progresses. FDA specifically

invites public comment on whether a

definition of a well-characterized

biotechnology product should be

included in the regulations and, if so,

what the scope of such a definition

should be.

Well-characterized therapeutic

recombinant DNA-derived and

monoclonal antibody products that are

viruses, therapeutic sera, toxins,

antitoxins, vaccines, blood, blood

components or derivatives, allergenic

products, or analogous products

applicable to the prevention, treatment,

or cure of human diseases or injuries are

‘‘biologics’’ within the meaning of