4220 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Proposed Rules

(Lat. 44°15′10′′ N, long. 121°18′13′′ W)

Within a 5.1-mile radius of Roberts Field,

and within 1.4 miles each side of the

Deschutes VORTAC 269° and 089° radials

extending from the 5.1-mile radius of the

airport to .9 mile west of the VORTAC. This

Class E airspace area is effective during the

specific 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.

* * * * *

Issued in Seattle, Washington, on January

13, 1997.

Glenn A. Adams III,

Assistant Manager, Air Traffic Division,

Northwest Mountain Region.

[FR Doc. 97–2092 Filed 1–28–97; 8:45 am]

BILLING CODE 4910–13–M

14 CFR Part 71

[Airspace Docket No. 96–ANM–027]

Proposed Amendment of Class E

Airspace; Montrose, Colorado

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This proposed rule would

amend the Montrose, Colorado, Class E

airspace to accommodate a new Global

Positioning System (GPS) Standard

Instrument Approach Procedure (SIAP)

to the Montrose Regional Airport. The

area would be depicted on aeronautical

charts for pilot reference.

DATES: Comments must be received on

or before March 15, 1997.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager,

Operations Branch, ANM–530, Federal

Aviation Administration, Docket No.

96–ANM–027, 1601 Lind Avenue SW,

Renton, Washington 98055–4056.

The official docket may be examined

at the same address.

An informal docket may also be

examined during normal business hours

at the address listed above.

FOR FURTHER INFORMATION CONTACT:

James C. Frala, ANM–532.4, Federal

Aviation Administration, Docket No.

96–ANM–027, 1601 Lind Avenue SW,

Renton, Washington 98055–4056;

telephone number: (206) 277–2535.

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. 96–

ANM–027.’’ 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,

Operations 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 E airspace at Montrose,

Colorado, to accommodate a new GPS

SIAP to the Montrose Regional 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 E airspace areas extending upward

from the surface of the earth, and from

700 feet or more above the surface of the

earth, are published in Paragraph 6002

and Paragraphs 6005, respectively, of

FAA Order 7400.9D dated September 4,

1996, and effective September 16, 1996,

which is incorporated by reference in 14

CFR 71.1. The Class E airspace

designations listed on 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 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6002 Class E airspace areas

designated as a surface area for an airport.

* * * * *

ANM CO E2 Montrose, CO [Revised]

Montrose Regional Airport, CO

(Lat. 38°30′32′′ N, long. 107°53′38′′ W)

Montrose VOR/DME

(Lat. 38°30′23′′ N, long. 107°53′58′′ W)

That airspace extending upward from the

surface within a 4.8-mile radius of the

Montrose Regional Airport, and within 3.5

miles each side of the Montrose VOR/DME

313° radial extending from the 4.8-mile

radius to 12.2 miles northwest of the VOR/

DME, and within 2.5 miles each side of the

Montrose VOR/DME 360° radial extending

from the 4.8-mile radius to 8.5 miles north

of the VOR/DME. This Class E airspace area

is effective during the specific dates and
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Proposed Rules 4221

times established 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 CO E5 Montrose, CO [Revised]

Montrose Regional Airport, CO

(Lat. 38°30′32′′ N, long. 107°53′38′′ W)

Montrose VOR/DME

(Lat. 38°30′23′′ N, long 107°53′58′′ W)

That airspace extending upward from 700

feet above the surface within 4.3 miles

northeast and 8.3 miles southwest of the

Montrose VOR/DME 313° and 133° radials

extending from 6.1 miles southeast to 21.4

miles northwest of the VOR/DME, and within

4 miles each side of the Montrose VOR/DME

360° radial extending to 9.5 miles north of

the VOR/DME; and that airspace extending

upward from 1,200 feet above the surface

within an area bounded by a point beginning

at lat. 38°40′00′′ N, long. 108°46′00′′ W; to lat.

38°25′00′′ N, long. 108°42′30′′ W; to lat.

37°58′00′′ N, long. 108°10′00′′ W; to lat.

38°09′00′′ N, long. 107°35′00′′ W; to lat.

38°43′00′′ N, long. 107°39′30′′ W; to lat.

38°51′30′′ N, long. 107°41′00′′ W; to lat.

38°50′00′′ N, long. 107°53′00′′ W; to lat.

38°53′00′′ N, long. 108°03′30′′ W; thence to

the point of beginning.

* * * * *

Issued in Seattle, Washington, on January

13, 1997.

Glenn A. Adams III,

Assistant Manager, Air Traffic Division,

Northwest Mountain Region.

[FR Doc. 97–2093 Filed 1–28–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600, 601, and 606

[Docket No. 96N–0395]

Revision of the Requirements for a

Responsible Head for Biological

Establishments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the biologics regulations by

deleting the requirements for a biologics

establishment to name a ‘‘responsible

head’’ or ‘‘designated qualified person’’

to represent the establishment in its

dealings with FDA. Because many

manufacturers of biological products are

firms that have more than one

manufacturing location and complex

corporate structures, it may no longer be

practical for one individual to represent

a manufacturer in all matters. The

proposed rule would provide

manufacturers with more flexibility in

assigning control and oversight

responsibility within a company. This

proposed rule is part of FDA’s

continuing effort to achieve the

objectives of the President’s

‘‘Reinventing Government’’ initiative,

and it is intended to reduce the burden

of unnecessary regulations on industry

without diminishing public health

protection.

DATES: Comments must be submitted on

or before April 29, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Corporations should submit two copies

of any comments and individuals may

submit one copy. Comments should be

identified with the docket number

found in brackets in the heading of this

document. Received comments are

available for public examination in the

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

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Carayiannis, 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

Under § 600.10(a) (21 CFR 600.10(a)),

a manufacturer of biological products is

required to name a ‘‘responsible head’’

who is to exercise control of the

manufacturing establishment in all

matters relating to compliance with

regulations in parts 600 through 680 (21

CFR parts 600 through 680) and who is

to represent the manufacturer in all

pertinent matters with the Center for

Biologics Evaluation and Research

(CBER). This individual must also have

an understanding of the scientific

principles and techniques related to the

manufacture of biological products.

When FDA announced in the Federal

Register of June 3, 1994 (59 FR 28821

and 28822), the review by CBER of

certain biologics regulations to identify

those regulations that are outdated,

burdensome, inefficient, duplicative, or

otherwise unsuitable or unnecessary,

§ 600.10(a) was included. FDA also held

a public meeting on January 26, 1995, to

discuss the retrospective review effort

and to provide a forum for the public to

voice its comments on the retrospective

review.

Many of the comments submitted

requested revision or elimination of the

requirements for a ‘‘responsible head’’

in § 600.10(a). The majority of the

comments supported deletion of the

regulation. The comments stated that

the requirement for a responsible head

to be an expert in multiple functions

and to be responsible for a number of

facility locations is incompatible with

current industry practice. The

comments added that the list of

activities in § 600.10(a) is extremely

broad and this regulation could be

interpreted to require the responsible

head to have an intimate understanding

of a wide variety of extremely complex

activities. All of these activities require

specific expertise, and it may not be

practical to expect one person to be an

expert in all of those areas. Some

comments addressed the requirement

that the responsible head be responsible

for training and have the authority to

enforce discipline, stating that direct

line supervision and management

personnel are much better qualified and

in a better position to ‘‘enforce or direct

the enforcement of discipline and

performance of assigned functions by

employees engaged in the manufacture

of products.’’ Many comments requested

the designation of an alternate

responsible head, especially in the

situation of multiple locations.

As part of the President’s

‘‘Reinventing Government’’ initiative, a

report entitled ‘‘Reinventing the

Regulation of Drugs Made From

Biotechnology’’ was issued in November

1995. The report announced several

initiatives to reduce the burden of FDA

regulations on the biologics industry

without reducing public health

protection, including a proposal to

remove the requirements in § 600.10(a)

for a ‘‘responsible head.’’ The proposed

revision, reflecting comments submitted

in response to the January 26, 1995,

public meeting, would enable firms to

designate more than one person to

communicate directly with FDA on

official matters related to the biological

products they manufacture. The

commitment to remove requirements for

a ‘‘responsible head’’ was based on

FDA’s determination that, with the

many changes that have occurred in

science, technology, and corporate

structure, it no longer may be practical

for most biologics manufacturers to rely

on one individual to meet the

requirements included in § 600.10(a). In

addition, the responsible corporate

officer doctrine, e.g., United States v.

Park, 421 U.S. 658 (1975); United States

v. Dotterweich, 320 U.S. 277 (1943),