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),
4222 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Proposed Rules

places the burden of ensuring

compliance with the statutes and

regulations applicable to biological

products on corporate officials

‘‘standing in responsible relation to a

public danger.’’ (Dotterweich, 320 U.S.

at 281.) Thus, it is not necessary to

require manufacturers to designate a

‘‘responsible head’’ in order to enforce

the duty responsible corporate officials

have to implement measures to ensure

that violations do not occur. (Park, 421

U.S. at 672.)

In accordance with a recent revision

to the definition of ‘‘manufacturer’’ in

§ 600.3 (see 61 FR 24227, May 14, 1996),

a biologics applicant may apply for and

obtain a license for a product to be

manufactured at more than one

manufacturing site that may or may not

be owned by the applicant. Therefore,

firms may want to designate more than

one person with primary responsibility

to maintain adequate oversight of

multiple manufacturing sites and ensure

that each is conforming to FDA’s

requirements for current good

manufacturing practices and the

applicable biologics standards. Many

biologics manufacturers also

manufacture drugs that are regulated by

the Center for Drug Evaluation and

Research (CDER) under the Federal

Food, Drug, and Cosmetic Act whose

regulations do not contain an analogous

requirement for the responsible head.

FDA’s proposal to revise the

requirements with respect to a

responsible head is an effort to

harmonize CBER’s and CDER’s policies

and requirements and to keep pace with

changes in science, technology, and

corporate structure.

II. Proposed Rule

Under the proposed revision, an

authorized official would be chosen by

the applicant to receive and send

correspondence to CBER. The applicant

could choose to have more than one

authorized official. Accordingly, the

agency proposes to amend § 600.10 by

removing and reserving paragraph (a)

and revising the heading of paragraph

(b) to read ‘‘Personnel’’. The agency also

proposes to amend § 601.2 Applications

for establishment and product licenses;

procedures for filing by adding the

statement ‘‘The applicant, or the

applicant’s attorney, agent, or other

authorized official shall sign the

application’’ in paragraph (a) and new

paragraph (c)(6). Finally, the agency

proposes to amend § 601.25(b)(3)(VIII)

by replacing ‘‘signed by the responsible

head (as defined in § 600.10 of this

chapter of the licensee)’’ with ‘‘signed

by an authorized official of the

licensee’’.

FDA is also proposing to remove

§ 606.20(a), which contains language

similar to that in § 600.10(a) and applies

to all blood establishments, including

registered, unlicensed blood

establishments. Like other components

of the biologics industry, the blood

industry has experienced changes in

science, technology, and corporate

structure. Complex donor and

transfusion recipient issues, the

evolution of sophisticated computerized

laboratory and donor equipment,

complicated serology problems, and

state-of-the-art laboratory techniques

have all contributed to changes within

the structure of blood establishments,

regardless of size. To ensure the quality

and safety of the blood supply, many

blood establishments employ personnel

who are experts in donor issues,

infectious disease, computers,

molecular biology, serology, transfusion

issues, quality control, administration,

and management. It is no longer

practical to expect one individual to

have expertise in all the subspecialties

of transfusion medicine. Accordingly, to

provide sufficient flexibility for a blood

establishment to select a person with

appropriate training and experience to

be responsible for each facet of its

operation, the agency proposes to

remove and reserve § 606.20(a).

FDA intends that a final rule would

become effective as soon as possible

after publication in the Federal

Register.

III. Economic Impact

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612). 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.

Under the Regulatory Flexibility Act,

if a rule has a significant impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

impact of a rule on small entities. The

proposed rule would have no

compliance costs and would not result

in any new requirements. Therefore,

under the Regulatory Flexibility Act (5

U.S.C. 605(b)), the Commissioner of

Food and Drugs certifies that the

proposed rule will not have a significant

economic impact on a substantial

number of small entities. No further

analysis is required.

IV. 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.

Interested persons may, on or before

April 29, 1997, 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.

List of Subjects

21 CFR Part 600

Biologics, Reporting and

recordkeeping requirements.

21 CFR Part 601

Administrative practice and

procedure, Biologics, Confidential

business information.

21 CFR Part 606

Blood, Labeling, Laboratories,

Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, it is proposed that 21 CFR

parts 600, 601, and 606 be amended as

follows:

PART 600—BIOLOGICAL PRODUCTS:

GENERAL

1. The authority citation for 21 CFR

part 600 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 519, 701, 704 of the Federal Food, Drug,

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

353, 355, 360, 360i, 371, 374); secs. 215, 351,

352, 353, 361, 2125 of the Public Health

Service Act (42 U.S.C. 216, 262, 263, 263a,

264, 300aa–25).

§ 600.10 [Amended]

2. Section 600.10 Personnel is

amended by removing and reserving
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Proposed Rules 4223

paragraph (a) and by revising the

heading of paragraph (b) to read

‘‘Personnel.’’

PART 601—LICENSING

3. The authority citation for 21 CFR

part 601 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 513–516, 518–520, 701, 704, 721, 801 of

the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 351, 352, 353, 355, 360, 360c–

360f, 360h–360j, 371, 374, 379e, 381); secs.

215, 301, 351, 352 of the Public Health

Service Act (42 U.S.C. 216, 241, 262, 263);

secs. 2–12 of the Fair Packaging and Labeling

Act (15 U.S.C. 1451–1461).

4. Section 601.2 is amended by

adding a sentence before the last

sentence in paragraph (a), and by adding

new paragraph (c)(6) to read as follows:

§ 601.2 Applications for establishment and

product licenses; procedures for filing.

(a) * * * The applicant, or the

applicant’s attorney, agent, or other

authorized official shall sign the

application. * * *

* * * * *

(c) * * *

(6) The applicant, or the applicant’s

attorney, agent, or other authorized

official shall sign the application.

5. Section 601.25 is amended by

revising the first sentence of paragraph

(b)(3)(VIII) to read as follows:

§ 601.25 Review procedures to determine

that licensed biological products are safe,

effective, and not misbranded under

prescribed, recommended, or suggested

conditions of use.

* * * * *

(b) * * *

(3) * * *

(VIII) If the submission is by a licensee, a

statement signed by an authorized official of

the licensee shall be included, stating that to

the best of his or her knowledge and belief,

it includes all information, favorable and

unfavorable, pertinent to an evaluation of the

safety, effectiveness, and labeling of the

product, including information derived from

investigation, commercial marketing, or

published literature. * * *

* * * * *

PART 606—CURRENT GOOD

MANUFACTURING PRACTICE FOR

BLOOD AND BLOOD COMPONENTS

6. The authority citation for 21 CFR

part 606 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 505,

510, 520, 701, 704 of the Federal Food, Drug,

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

352, 355, 360, 360j, 371, 374); secs. 215, 351,

353, 361 of the Public Health Service Act (42

U.S.C. 216, 262, 263a, 264).

§ 606.20 [Amended]

7. Section 606.20 Personnel is

amended by removing and reserving

paragraph (a).

Dated: January 10, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–2238 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Saint Lawrence Seaway Development

Corporation

33 CFR Parts 404 Through 407

Seaway Regulations and Rules: Great

Lakes Pilotage Regulations; Public

Meeting

AGENCY: Saint Lawrence Seaway

Development Corporation, DOT.

ACTION: Public meeting.

SUMMARY: This document announces a

public meeting that will be held from 10

a.m. until 3 p.m., on March 11, 1997, in

the Lambert Room at the Sheraton

Airport Hotel at Cleveland Hopkins

Airport in Cleveland, Ohio. The purpose

of the meeting is to gather information

and to provide a forum for members of

the public to discuss their ideas for

improving the safety, reliability and

efficiency of the Great Lakes Pilotage

System.

DATES: The public meeting will be held

from 10 a.m. until 3 p.m., on March 11,

1997.

ADDRESSES: The public meeting will be

held in the Lambert Room at the

Sheraton Airport Hotel at Cleveland

Hopkins Airport, 5300 Riverside Dr.,

Cleveland, OH 44135, phone (216) 267–

1500.

FOR FURTHER INFORMATION CONTACT:

Scott A. Poyer, Chief Economist, Saint

Lawrence Seaway Development

Corporation, Office of Great Lakes

Pilotage, United States Department of

Transportation, 400 7th Street SW.,

Suite 5424, Washington, DC 20590,

phone 1–800–785–2779.

SUPPLEMENTARY INFORMATION: On

September 25, 1996, the Saint Lawrence

Seaway Development Corporation

(SLSDC) published a notice of proposed

rulemaking and hearing in the Federal

Register (61 FR 50258) (the NPRM),

which proposed to increase Great Lakes

pilotage rates. In response to the NPRM

and public hearing, the SLSDC received

many comments which were beyond the

scope of the NPRM. Many commenters

recommended changes to the entire

system of pilotage on the Great Lakes.

The current system of pilotage on the

Great Lakes was established by the Great

Lakes Pilotage Act of 1960 (46 U.S.C.

Chapter 93), and its attendant Great

Lakes Pilotage Regulations (33 CFR

Parts 404–407). In the 36 years since the

Great Lakes pilotage system was

established the pilotage system has

remained virtually unchanged, even

though the maritime industry on the

Great Lakes has changed substantially.

Many commenters on the NPRM raised

questions concerning the current

pilotage system’s safety, reliability and

efficiency. These commenters,

representing all facets of the maritime

industry on the Great Lakes, requested

a comprehensive review of this issue.

The purpose of the public meeting

announced in this notice is to provide

a forum for the public to discuss with

the SLSDC, and with each other, ideas

for improving the safety, reliability, and

efficiency of the Great Lakes Pilotage

System.

Issued at Washington, D.C. on January 23,

1997.

Saint Lawrence Seaway Development

Corporation.

Gail C. McDonald,

Administrator.

[FR Doc. 97–1993 Filed 1–28–97; 8:45 am]

BILLING CODE 4910–61–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 97–26, RM–8968]

Radio Broadcasting Services; Detroit,

TX

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: The Commission requests

comments on a petition by Great Plains

Radiocasting requesting the allotment of

Channel 294C2 at Detroit, Texas, as the

community’s first local FM service.

Channel 294C2 can be allotted to Detroit

in compliance with the Commission’s

minimum distance separation

requirements with a site restriction of

22.0 kilometers (13.7 miles) northwest

in order to avoid a short-spacing conflict

with the licensed operation of Station

KWSK(FM), Channel 295A,

Daingerfield, Texas, at coordinates 33–

49–16 NL; 95–24–16 WL.

DATES: Comments must be filed on or

before March 17, 1997, and reply

comments on or before April 1, 1997.

ADDRESSES: Federal Communications

Commission, Washington, DC. 20554. In