53534 Federal Register / Vol. 62, No. 199 / Wednesday, October 15, 1997 / Rules and Regulations

Note 3: The subject of this AD is addressed

in British airworthiness directive 005–05–95.

(g) This amendment becomes effective on

November 19, 1997.

Issued in Renton, Washington, on October

7, 1997.

James V. Devany,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–27089 Filed 10–14–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF COMMERCE

Foreign-Trade Zones Board

15 CFR Part 400

[Docket No. 97092934–7234–01]; Order No.

929

RIN 0625–AA49

Technical Amendments to Regulations

of the Foreign-Trade Zones Board

AGENCY: Foreign-Trade Zones Board,

International Trade Administration,

Commerce.

ACTION: Final rule.

SUMMARY: The Foreign-Trade Zones

(FTZ) Board adopts the following

technical amendments to its regulations

to reflect recent changes both to the

Foreign-Trade Zones Act of 1934 (‘‘FTZ

Act’’) and in the organizational structure

of the United States Customs Service.

EFFECTIVE DATE: October 15, 1997.

FOR FURTHER INFORMATION CONTACT: John

J. Da Ponte, Jr., Executive Secretary,

Foreign-Trade Zones Board, room 3716,

U.S. Department of Commerce,

Pennsylvania Avenue and 14th Street

NW, Washington, DC 20230 (202/482–

2862).

SUPPLEMENTARY INFORMATION:

Background

The regulations of the Foreign-Trade

Zones Board are amended to conform

with the following changes: (1) An

amendment to the FTZ Act, pursuant to

section 910 of the National Defense

Authorization Act of 1996, Pub. L. 104–

201, 110 Stat. 2422, 2620 (1996), which

removed the Secretary of the Army from

membership on the Foreign-Trade

Zones Board; and 2) recent revisions by

the U.S. Customs Service to its

organizational structure, which

eliminated Regional Commissioner and

District Director positions, broadening

the role of Port Directors.

Classification

This rulemaking action was

determined to be not significant for

purposes of Executive Order 12866. The

Administrative Procedure Act

requirements of notice and comment

and delayed effective date are

unnecessary for these technical

amendments because the FTZ Board has

no discretion in making these

amendments which are required by Pub.

L. 104–201 and reorganization within

the U.S. Customs Service. Because

notice and comment are not required by

5 U.S.C. 553(b)(B) or any other statute

for these technical amendments and

procedures, a regulatory flexibility

analysis is not required and was not

prepared for purposes of the Regulatory

Flexibility Act. This rulemaking

involves information collection

requirements which are cleared under

OMB Control No. 0625–0139 for

purposes of the Paperwork Reduction

Act. Notwithstanding any other

provision of law, no person is required

to respond to nor shall a person be

subject to a penalty for failure to comply

with a collection of information subject

to the requirements of the Paperwork

Reduction Act unless that collection of

information displays a currently valid

OMB Control Number

List of Subjects in 15 CFR Part 400

Administrative practice and

procedure, Confidential business

information, Customs duties and

inspection, Foreign-trade zones,

Harbors, Imports, Reporting and

recordkeeping requirements.

For the reasons set forth in the

preamble, 15 CFR part 400 is amended

as set forth below:

PART 400—REGULATIONS OF THE

FOREIGN–TRADE ZONES BOARD

1. The authority for 15 CFR part 400

continues to read as follows:

Authority: Foreign-Trade Zones Act of

June 18, 1934, as amended (Pub. L. 397, 73rd

Congress, 48 Stat. 998–1003 (19 U.S.C. 81a–

81u)).

2. Section 400.2 is revised to read as

follows:

§ 400.2 Definitions.

(a) Act means the Foreign-Trade

Zones Act of 1934, as amended.

(b) Board means the Foreign-Trade

Zones Board, which consists of the

Secretary of the Department of

Commerce (chairman) and the Secretary

of the Treasury, or their designated

alternates.

(c) Customs Service means the United

States Customs Service of the

Department of the Treasury.

(d) Executive Secretary is the

Executive Secretary of the ForeignTrade Zones Board.

(e) Foreign-trade zone is a restrictedaccess site, in or adjacent to a Customs

port of entry, operated pursuant to

public utility principles under the

sponsorship of a corporation granted

authority by the Board and under

supervision of the Customs Service.

(f) Grant of authority is a document

issued by the Board which authorizes a

zone grantee to establish, operate and

maintain a zone project or a subzone,

subject to limitations and conditions

specified in this part and in 19 CFR part

146. The authority to establish a zone

includes the authority to operate and

the responsibility to maintain it.

(g) Manufacturing, as used in this

part, means activity involving the

substantial transformation of a foreign

article resulting in a new and different

article having a different name,

character, and use.

(h) Port Director is normally the

director of Customs for the Customs

jurisdictional area in which the zone is

located.

(i) Port of entry means a port of entry

in the United States, as defined by part

101 of the regulations of the Customs

Service (19 CFR part 101), or a user fee

airport authorized under 19 U.S.C. 58b

and listed in part 122 of the regulations

of the Customs Service (19 CFR part

122).

(j) Private corporation means any

corporation, other than a public

corporation, which is organized for the

purpose of establishing a zone project

and which is chartered for this purpose

under a law of the state in which the

zone is located.

(k) Processing, when referring to zone

activity, means any activity involving a

change in condition of merchandise,

other than manufacturing, which results

in a change in the Customs

classification of an article or in its

eligibility for entry for consumption.

(l) Public corporation means a state, a

political subdivision (including a

municipality) or public agency thereof,

or a corporate municipal

instrumentality of one or more states.

(m) State includes any state of the

United States, the District of Columbia,

and Puerto Rico.

(n) Subzone means a special-purpose

zone established as an adjunct to a zone

project for a limited purpose.

(o) Zone means a foreign-trade zone

established under the provisions of the

Act and these regulations. Where used

in this part, the term also includes

subzones, unless the context indicates

otherwise.

(p) Zone grantee is the corporate

recipient of a grant of authority for a

zone project. Where used in this part,
Federal Register / Vol. 62, No. 199 / Wednesday, October 15, 1997 / Rules and Regulations 53535

the term ‘‘grantee’’ means ‘‘zone

grantee’’ unless otherwise indicated.

(q) Zone operator is a corporation,

partnership, or person that operates a

zone or subzone under the terms of an

agreement with the zone grantee or an

intermediary entity, with the

concurrence of the Port Director.

(r) Zone project means the zone plan,

including all of the zone and subzone

sites that the Board authorizes a single

grantee to establish.

(s) Zone site means the physical

location of a zone or subzone.

(t) Zone user is a party using a zone

under agreement with the zone grantee

or operator.

3. Section 400.11 is amended by

revising paragraph (d)(1) to read as

follows.

§ 400.11 Authority of the Board.

* * * * *

(d) Determinations of the Board. (1)

The determination of the Board will be

based on the unanimous vote of the

members (or alternate members) of the

Board.

* * * * *

4. Section 400.24 is amended by

revising paragraph (d)(5)(i)(B) to read as

follows:

§ 400.24 Application for zone.

* * * * *

(d) Exhibits. * * *

(5) Exhibit Five (Maps) shall consist

of:

(i) The following maps and drawings:

* * * * *

(B) A local community map showing

in red the location of the proposed zone;

and

* * * * *

5. Section 400.24 is further amended

by revising paragraph (h) to read as

follows:

§ 400.24 Application for zone.

* * * * *

(h) Format and number of copies.

Unless the Executive Secretary alters the

requirements of this paragraph, submit

an original and 8 copies of the

application on 81⁄2′′ × 11′′ (216 × 279

mm) paper. Exhibit Five of the original

application shall contain full-sized

maps, and copies shall contain lettersized reductions.

* * * * *

6. Section 400.26 is amended by

revising paragraph (a)(2) to read as

follows:

§ 400.26 Application for expansion or

other modification to zone project.

(a) In general. * * *

(2) The Executive Secretary, in

consultation with the Port Director, will

determine whether the proposed

modification involves a major change in

the zone plan and is thus subject to

paragraph (b) of this section, or is minor

and subject to paragraph (c) of this

section. In making this determination

the Executive Secretary will consider

the extent to which the proposed

modification would:

(i) Substantially modify the plan

originally approved by the Board; or

(ii) Expand the physical dimensions

of the approved zone area as related to

the scope of operations envisioned in

the original plan.

* * * * *

7. Section 400.27 is amended by

revising paragraph (c)(3) to read as

follows:

§ 400.27 Procedure for processing

application.

* * * * *

(c) Procedure—Executive Secretary

responsibilities. * * *

(3) Send copies of the filing and

initiation notice and the application to

the Commissioner of Customs and the

Port Director, or a designee.

* * * * *

8. Section 400.27 is further amended

by revising paragraph (d)(1) to read as

follows:

§ 400.27 Procedure for processing

application.

* * * * *

(d) Case reviews—procedure and time

schedule—(1) Customs review. The Port

Director, or a designee, in accordance

with agency regulations and directives,

will submit a technical report to the

Executive Secretary within 45 days of

the conclusion of the public comment

period described in paragraph (c)(2) of

this section.

* * * * *

9. Section 400.27 is further amended

by revising paragraph (d)(2)(v)(C) to

read as follows:

§ 400.27 Procedure for processing

application.

* * * * *

(d) Case reviews—procedure and time

schedule—* * *

(2) Examiners reviews—nonmanufacturing/processing. * * *

(v) * * *

(C) The Customs adviser shall be

notified when necessary for further

comments, which shall be submitted

within 45 days after notification.

* * * * *

§ 400.27 [Amended]

10. In § 400.27, paragraph (f)(1) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

11. In § 400.27, paragraph (f)(2) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

§ 400.28 [Amended]

12. In § 400.28, paragraph (a)(1) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

13. In § 400.28, paragraph (a)(6) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

§ 400.32 [Amended]

14. In § 400.32, paragraph (b)(1)(iv) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

§ 400.41 [Amended]

15. In § 400.41, the third sentence is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

§ 400.42 [Amended]

16. In § 400.42, paragraph (a)(1) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

17. In § 400.42, paragraph (b)(1) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

18. In § 400.42, paragraph (b)(3) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

§ 400.44 [Amended]

19. In § 400.44, paragraph (b)(4) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

20. In § 400.44, paragraph (c)(3) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

§ 400.45 [Amended]

21. In § 400.45, paragraph (a) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

22. In § 400.45, paragraph (b) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

23. In § 400.45, paragraph (c) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.

§ 400.46 [Amended]

24. In § 400.46, paragraph (c) is

amended by removing ‘‘District

Director’’ where appearing therein, and

adding in its place, ‘‘Port Director’’.
53536 Federal Register / Vol. 62, No. 199 / Wednesday, October 15, 1997 / Rules and Regulations

By order of the Foreign-Trade Zones Board,

Washington, DC, this 6th day of October

1997.

Robert S. LaRussa,

Assistant Secretary of Commerce for Import

Administration Alternate Chairman, ForeignTrade Zones Board.

[FR Doc. 97–27145 Filed 10–14–97; 8:45 am]

BILLING CODE 3510–DS–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600, 601, and 606

[Docket No. 96N–0395]

RIN 0910–AA93

Revision of the Requirements for a

Responsible Head for Biological

Establishments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

biologics regulations by deleting the

requirements for a biologics

establishment to name a ‘‘responsible

head’’ or ‘‘designated qualified person’’

to exercise control of the establishment

in all matters relating to compliance

with regulatory requirements and 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 or possess expertise in

all matters. This change will provide

manufacturers with more flexibility in

assigning control and oversight

responsibility within a company. This

final 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.

EFFECTIVE DATE: October 15, 1997.

FOR FURTHER INFORMATION CONTACT:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of January 29,

1997 (62 FR 4221), FDA published a

proposed rule 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.

Under § 600.10(a) (21 CFR 600.10(a)),

a manufacturer of biological products

currently is required to name a

responsible head who is to exercise

control of the 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 involved in

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 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 better qualified and in a

better position to enforce or direct the

enforcement of discipline and the

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 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 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), 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 revision to the

definition of ‘‘manufacturer’’ in § 600.3

(see 61 FR 24227, May 14, 1996), an

applicant may apply for and obtain a

license for a biological product to be

manufactured at more than one

manufacturing site that may or may not

be owned by the applicant. Therefore,

applicants 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. CDER’s

regulations do not contain an analogous

requirement for a 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. Highlights of the Final Rule

Under the final rule, an authorized

official may be chosen by the applicant