Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Rules and Regulations 24233

categories of products shall be handled

as set forth in paragraph (c) of this

section:

(1) Therapeutic DNA plasmid

products;

(2) Therapeutic synthetic peptide

products of 40 or fewer amino acids;

(3) Monoclonal antibody products for

in vivo use; and

(4) Therapeutic recombinant DNAderived products.

* * * * *

(c)(1) To obtain marketing approval

for a therapeutic DNA plasmid product,

therapeutic synthetic peptide product of

40 or fewer amino acids, monoclonal

antibody product for in vivo use, or

therapeutic recombinant DNA-derived

product, an applicant shall submit to

the Director, Center for Biologics

Evaluation and Research, a biologics

license application on a form prescribed

by the Director, Center for Biologics

Evaluation and Research. For such

products, a separate establishment

license application shall not be

required. An application for a license

for such a product shall include:

(i) Data derived from nonclinical

laboratory and clinical studies that

demonstrate that the manufactured

product meets prescribed standards of

safety, purity, and potency; with respect

to each nonclinical laboratory study,

either a statement that the study was

conducted in compliance with the

requirements set forth in part 58 of this

chapter, or,

(ii) If the study was not conducted in

compliance with such regulations, a

brief statement of the reason for the

noncompliance;

(iii) Statements regarding each

clinical investigation involving human

subjects contained in the application,

that it either was conducted in

compliance with the requirements for

institutional review set forth in part 56

of this chapter or was not subject to

such requirements in accordance with

§§ 56.104 or 56.105 of this chapter, and

was conducted in compliance with

requirements for informed consent set

forth in part 50 of this chapter;

(iv) A full description of

manufacturing methods;

(v) Data establishing stability of the

product through the dating period;

(vi) Sample(s) representative of the

product to be sold, bartered, or

exchanged or offered, sent, carried or

brought for sale, barter, or exchange;

(vii) Summaries of results of tests

performed on the lot(s) represented by

the submitted samples; and

(viii) Specimens of the labels,

enclosures, and containers proposed to

be used for the product.

(2) An application for license shall

not be considered as filed until all

pertinent information and data have

been received from the applicant by the

Center for Biologics Evaluation and

Research. The applicant shall also

include either a claim for categorical

exclusion under § 25.24 of this chapter

or an environmental assessment under

§ 25.31 of this chapter.

(3) Approval of the biologics license

application and issuance of the

biologics license shall constitute a

determination that the establishment

and the product meet applicable

standards established in this chapter to

ensure the continued safety, purity, and

potency of such products. Applicable

standards for the maintenance of

establishments for the manufacture of a

product subject to this paragraph (c)

shall include the good manufacturing

practice requirements set forth in parts

210 and 211 of this chapter. The

following sections in parts 600 through

680 of this chapter shall not be

applicable to such products:

§§ 600.10(b) and (c), 600.11, 600.12,

600.13, 601.1, 601.30, 601.31, 601.32,

610.11, 610.53, and 610.62 of this

chapter.

(4) The term ‘‘product license

application,’’ as it is used in those

sections of parts 600 through 680 of this

chapter that are applicable to products

subject to this paragraph (c) shall

include a biologics license application

for a therapeutic DNA plasmid product,

therapeutic synthetic peptide product of

40 or fewer amino acids, monoclonal

antibody product for in vivo use, or

therapeutic recombinant DNA-derived

product.

(5) To the extent that the requirements

in this paragraph (c) conflict with other

requirements in this subchapter, this

paragraph (c) shall supersede such other

requirements.

5. Section 601.22 is amended by

adding a sentence after the second

sentence to read as follows:

§ 601.22 Products in short supply; initial

manufacturing at other than licensed

establishment.

* * *For persons and places authorized

under this section to conduct the initial

and partial manufacturing of a product

for shipment solely to a manufacturer of

a product subject to licensure under

§ 601.2(c), the following additional

regulations shall not be applicable:

§§ 600.10(b) and (c), 600.11, 600.12,

600.13, 610.11, and 610.53 of this

chapter * * *.

Dated: May 6, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–12144 Filed 5–10–96; 10:13 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Coast Guard

33 CFR Part 52

[OST Docket No. OST–95–878]

RIN 2105–AC31

Coast Guard Board for Correction of

Military Records; Procedural

Regulation

AGENCY: Office of the Secretary, Coast

Guard, DOT.

ACTION: Final Rule.

SUMMARY: The Department is amending

its regulation with respect to

reconsideration of final decisions of the

Board for Correction of Military Records

of the Coast Guard (BCMR). This action

is taken on the Department’s initiative

in order to streamline processing of

these cases and to clarify the

circumstances under which final

decisions can be reconsidered. The

amendment will make it possible for the

BCMR to expedite the processing of

reconsideration requests and it will

increase the resources available to meet

the requirement that all cases be

decided within 10 months of the receipt

of a completed application.

EFFECTIVE DATE: June 13, 1996.

FOR FURTHER INFORMATION CONTACT:

Robert H. Joost, Chairman, Board for

Correction of Military Records of the

Coast Guard, C–60, Office of the General

Counsel, U.S. Department of

Transportation, 400 Seventh Street, SW,

Washington, D.C. 20590–0001.

Telephone: (202) 366–9335.

SUPPLEMENTARY INFORMATION:

Comments on Proposed Rulemaking

Proposed rulemaking was published

on pages 63489–63491 of the Federal

Register of December 11, 1995 [60 FR

63489], and invited comments for 60

days ending February 9, 1996.

Comments were received from the

following sources: (1) Eugene R. Fidell,

Esq., an attorney in private practice; and

(2) Michael J. Calabro, Esq., an attorney

in private practice. The comments and

the actions taken in response to the

comments are summarized below.

Both attorneys expressed concern

with respect to the amount of time that
24234 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Rules and Regulations

may be consumed in processing a

reconsideration request. The BCMR

appreciates this concern, but believes

that delay, which is a problem in the

current reconsideration process, would

be significantly reduced under the

proposed rule. The proposed rule, by

eliminating duplicative review of a

reconsideration application, as required

by the current § 52.67(c), and by

providing for an expedited process in

handling facially defective

reconsideration requests, will require

less time per reconsideration request

than the current rule.

One of the commenting attorneys

questioned the authority given to the

Chairman in proposed § 52.67(b) on the

ground that the enabling statute (10

U.S.C. § 1552) requires BCMR decisions

to be made by the Secretary acting

through a board. That is true, but it is

only true with respect to an original

decision. Section 1552 of title 10 does

not provide for, nor does it prohibit, the

reconsideration of original decisions.

Reconsideration authority has been

added by the BCMR’s regulations and its

parameters can therefore be determined

by those regulations.

Comments were also offered on other

aspects of the correction board process

for the Coast Guard. One attorney asked

that the BCMR’s basic time limit

regulation be updated, even though that

was not a subject addressed in the

proposed rule. Both attorneys made

suggestions with regard to

administrative matters that do not bear

on the proposed rule and do not require

a rules change to implement:

appropriate designations and numbering

for docketed reconsideration requests;

the formalization and publication of the

Secretary’s delegate’s authority;

improvement of the system for indexing

and retrieval of redacted Coast Guard

BCMR decisions; availability of redacted

decisions to all who are interested by

bulletin board, CD–ROM, or mailed to

subscribers on a mailing list, in return

for a reasonable fee. None of these

comments bear on the reconsideration

regulation that is being considered in

this rulemaking process. Therefore,

while these matters remain under

consideration, they are not addressed at

this time.

Final Rule

This final rule explicitly authorizes

the Board to consider applications for

reconsideration upon a showing that the

Board committed legal or factual error

in the original determination that could

have resulted in a determination other

than that made.

This final rule also authorizes the

Chairman not to docket applications for

reconsideration that do not meet the

threshold requirements for

reconsideration, i.e., applications that

only (1) present evidence or information

previously considered by the Board, (2)

present new evidence or information

that is clearly not material to the result

in the case, (3) present new evidence or

information that could have been

submitted earlier with the exercise of

reasonable diligence, or (4) make

arguments as to legal or factual error

that are clearly not material to the

result. The phrase ‘‘otherwise comes to

the attention of the Board’’ has been

deleted, however, as unnecessary.

This final rule also provides that no

Board member who considered an

applicant’s original application for

correction would participate in the

consideration of that person’s

application for reconsideration. There

will, to the extent practicable, be a

related prohibition on the staff member;

the person who drafted the original

decision would not draft the

reconsideration decision. In light of

these safeguards, it would not be

necessary for the Secretary’s designate

to approve each denial of a

reconsideration request, thus expediting

the review process.

Section-by-Section Analysis

Section 52.67, Reconsideration, is

rewritten to add the new requirements

outlined above, and to simplify the

procedure on reconsideration.

Paragraph (a) provides that

reconsideration of an application may

occur if the applicant meets at least one

of two sets of criteria. The first of these,

paragraph (a)(1), directs reconsideration

if an applicant presents evidence or

information that was not previously

considered by the Board if that evidence

or information could result in a different

determination and if it ‘‘could not have

been presented to the Board prior to its

original determination if the applicant

had exercised reasonable diligence.’’

The second of these, paragraph (a)(2),

directs reconsideration if an applicant

presents evidence or information that

the Board committed legal or factual

error in the original determination that

could have resulted in a different result.

Paragraph (b) directs the Chairman to

docket a reconsideration request if it

meets the requirements of paragraph

(a)(1) or (a)(2). If neither of these

requirements is met, the Chairman shall

not docket the request, and shall return

the application to the applicant with a

statement that no action is being taken

due to a failure to meet the threshold

requirements for docketing.

Paragraph (c) provides that the Board

shall consider each application for

reconsideration that has been docketed

under paragraph (b). This paragraph

also provides that the final decision on

reconsideration shall involve a different

Board than the one that initially

considered the application.

Paragraph (d) provides that the

Board’s final action on docketed

application for reconsideration shall be

the same as if they were original

applications for correction.

Paragraph (e) provides that an

applicant’s request for reconsideration

must be filed within two years after the

issuance of a final decision, subject to

other legal rules such as the Soldier’s

and Sailor’s Civil Relief Act. The twoyear statute of limitations parallels the

time period allowed by Article 73 of the

Uniform Code of Military Justice for

petitioning for a new trial after the

approval of a court-martial sentence on

the grounds of newly discovered

evidence or fraud on the court. If the

Chairman dockets an applicant’s request

for reconsideration under paragraph (b),

the two-year requirement may be

waived if the Board finds that it would

be in the interest of justice to consider

the request despite its untimeliness.

Regulatory Process Matters

This is not a significant rule under

Executive Order 12681 or the

Department’s Regulatory Policies and

Procedures. The costs of a purely

procedural change in the Board’s rule

would be negligible. The rule will not

have a significant economic effect on a

substantial number of small entities, as

defined in the Regulatory Flexibility

Act. There are no Federalism factors to

warrant the preparation of a Federalism

assessment.

List of Subjects in 33 CFR Part 52

Administrative practice and

procedure, Archives and records,

Military personnel, Military records.

Issued this 8th day of May 1996, at

Washington, D.C.

Federico Pen ̃ a,

Secretary of Transportation.

For the reasons set forth in the

preamble, the Office of the Secretary of

the U.S. Department of Transportation

amends 33 CFR Part 52 as follows:

PART 52—[AMENDED]

1. The authority citation for Part 52 is

revised to read as follows:

Authority: 10 U.S.C. 1552; 49 U.S.C. 108;

Pub. L. 101–225, 103 Stat. 1908, 1914.

2. Section 52.67 is revised to read as

follows:
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Rules and Regulations 24235

§ 52.67 Reconsideration.

(a) Reconsideration of an application

for correction of a military record shall

occur if an applicant requests it and the

request meets the requirements set forth

in paragraph (a)(1) or (a)(2) of this

section.

(1) An applicant presents evidence or

information that was not previously

considered by the Board that could

result in a determination other than that

originally made. Evidence or

information may only be considered if

it could not have been presented to the

Board prior to its original determination

if the applicant had exercised

reasonable diligence; or

(2) An applicant presents evidence or

information that the Board, or the

Secretary as the case may be, committed

legal or factual error in the original

determination that could have resulted

in a determination other than that

originally made.

(b) The Chairman shall docket a

request for reconsideration of a final

decision if it meets the requirements of

paragraph (a)(1) or (a)(2) of this section.

If neither of these requirements is met,

the Chairman shall not docket such

request.

(c) The Board shall consider each

application for reconsideration that has

been docketed. None of the Board

members who considered an applicant’s

original application for correction shall

participate in the consideration of that

applicant’s application for

reconsideration.

(d) Action by the Board on a docketed

application for reconsideration is

subject to § 52.64(b).

(e) An applicant’s request for

reconsideration must be filed within

two years after the issuance of a final

decision, except as otherwise required

by law. If the Chairman dockets an

applicant’s request for reconsideration,

the two-year requirement may be

waived if the Board finds that it would

be in the interest of justice to consider

the request despite its untimeliness.

[FR Doc. 96–12030 Filed 5–13–96; 8:45 am]

BILLING CODE 4910–62–P

Coast Guard

33 CFR Part 117

[CGD09–96–003]

RIN 2115–AE47

Drawbridge Operation Regulations;

Saginaw River, MI

AGENCY: Coast Guard, DOT.

ACTION: Direct final rule.

SUMMARY: By this direct final rule, the

Coast Guard is revising the regulations

governing the operations of the CSX

(formerly the Chessie System) railroad

bridge at mile 18.0 over the Saginaw

River in Saginaw, Michigan. The owners

have made a request to the Coast Guard

to maintain the bridge as a fixed

structure with the stipulation and

understanding that the bridge may be

placed back into operation within six

months upon notification of the Coast

Guard.

DATES: This rule is effective on August

12, 1996, unless the Coast Guard

receives written adverse comments or

written notice of intent to submit

adverse comments on or before July 15,

1996. If such comments or notice are

received, the Coast Guard will withdraw

this direct final rule, and a timely notice

of withdrawal will be published in the

Federal Register.

ADDRESSES: Comments may be mailed to

Commander (obr), Ninth Coast Guard

District, 1240 E. Ninth St., Cleveland,

OH 44199–2060, or may be delivered to

room 2083 at the same address between

7 a.m. and 3 p.m., Monday through

Friday, except Federal holidays. The

telephone number is (216) 522–3993.

The District Commander maintains

the public docket for this rulemaking.

Comments will become part of this

docket and will be available for

inspection or copying at the above

address during the same time.

FOR FURTHER INFORMATION CONTACT:

Mr. Scott M. Striffler, Project Manager,

at (216) 522–3993.

SUPPLEMENTARY INFORMATION:

Request for Comments

Any comments must identify the

name and address of the person

submitting the comment, specify the

rulemaking docket (CGD09–96–003) and

the specific section of this rule to which

each comment applies, and give the

reason for each specific comment.

Please submit two copies of all

comments and attachments in an

unbound format, no larger than 81⁄2 by

11 inches, suitable for copying and

electronic filing. Persons wanting

acknowledgment of receipt of comments

should enclose stamped, self-addressed

postcards or envelopes.

Regulatory Information

The Coast Guard is publishing a direct

final rule, the procedures of which are

outlined in 33 CFR 1.05–55, because no

adverse comments are anticipated. If no

adverse comments or any written

notices of intent to submit adverse

comment are received within the

specified comment period, this rule will

become effective as stated in the DATES

section. In that case, approximately 30

days prior to the effective date, the

Coast Guard will publish a notice in the

Federal Register stating that no adverse

comment was received and confirming

that this rule will become effective as

scheduled. However, if the Coast Guard

receives written adverse comment or

written notice of intent to submit

adverse comment, the Coast Guard will

publish a notice in the final rule section

of the Federal Register to announce

withdrawal of all or part of this direct

final rule. If adverse comments apply to

only part of this rule, and it is possible

to remove that part without defeating

the purpose of this rule, the Coast Guard

may adopt as final those parts of this

rule on which no adverse comments

were received. The part of this rule that

was the subject of adverse comment will

be withdrawn. If the Coast Guard

decides to proceed with a rulemaking

following receipt of adverse comments,

a separate Notice of Proposed

Rulemaking (NPRM) will be published

and a new opportunity for comment

provided.

A comment is considered ‘‘adverse’’ if

the comment explains why this rule

would be inappropriate, including a

challenge to the rule’s underlying

premise or approach, or would be

ineffective or unacceptable without a

change.

Background and Purpose

The placement of a movable bridge in

a ‘‘fixed status’’ means that the bridge is

essentially locked in the closed position

and all the operating gear removed. This

rule will allow the owners (CSX

Railroad Corp.) of the CSX (formerly the

Chessie System) railroad bridge, at mile

18.0 over the Saginaw River in Saginaw,

Michigan, to maintain the bascule

bridge in a ‘‘fixed status’’. The owners

initiated this action due to the absence

of any requests to open the bridge for

commercial traffic since 1988.

Furthermore, the bridge is unattended

and subject to high maintenance costs

from recurring vandalism. As part of the

background for this rulemaking, the

Coast Guard requested bridgetender logs

for the previous five years, but CSX

stated that it did not maintain records

for this bridge during the period because

no requests for openings were made.

The Coast Guard asked for confirmation

of the owner’s claims from the local

Coast Guard Station in Saginaw,

Michigan. The Station verified that the

bridge had not opened within the

experience of the personnel assigned

there. The Station also noted that they

are not aware of any commercial traffic

that has, or will have, a need to pass