48174 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

part 229 of this chapter (Regulation CC),

the Uniform Commercial Code, and the

Reserve Banks’ operating circulars. A

paying bank that receives a cash item

from a Reserve Bank also may return the

item prior to settlement, in accordance

with § 210.9(b) of this subpart and the

Reserve Banks’ operating circulars. The

rules or practices of a clearinghouse

through which the item was presented,

or a special collection agreement under

which the item was presented, may not

extend these return times, but may

provide for a shorter return time.

(2) Return of checks not handled by

Reserve Banks. A paying bank that

receives a check as defined in § 229.2(k)

of this chapter (Regulation CC), other

than from a Reserve Bank, and that

determines not to pay the check, may

send the returned check to any Reserve

Bank (unless its Administrative Reserve

Bank directs it to send the returned

check to a specific Reserve Bank) in

accordance with subpart C of part 229

of this chapter (Regulation CC), the

Uniform Commercial Code, and the

Reserve Banks’ operating circulars. A

returning bank may send a returned

check to any Reserve Bank (unless its

Administrative Reserve Bank directs it

to send the returned check to a specific

Reserve Bank) in accordance with

subpart C of part 229 of this chapter

(Regulation CC), the Uniform

Commercial Code, and the Reserve

Banks’ operating circulars.

(b) Handling of returned checks. (1)

The following parties, in the following

order, are deemed to have handled a

returned check sent to a Reserve Bank

under paragraph (a) of this section——

(i) The paying or returning bank;

(ii) The paying bank’s or returning

bank’s Administrative Reserve Bank;

(iii) The Reserve Bank that receives

the returned check from the paying or

returning bank (if different from the

paying bank’s or returning bank’s

Administrative Reserve Bank); and

(iv) Another Reserve Bank, if any, that

receives the returned check from a

Reserve Bank.

(2) A Reserve Bank that is not

described in paragraph (b)(1) of this

section is not a party that handles a

returned check and is not a returning

bank with respect to a returned check.

(3) The identity and order of the

parties under paragraph (b)(1) of this

section determine the relationships and

the rights and liabilities of the parties

under this subpart, part 229 of this

chapter (Regulation CC), and the

Uniform Commercial Code.

(c) Paying bank’s and returning

bank’s agreement. * * *

(1) Authorizes the paying or returning

bank’s Administrative Reserve Bank,

and any other Reserve Bank or returning

bank to which the returned check is

sent, to handle the returned check (and

authorizes any Reserve Bank that

handles settlement for the returned

check to make accounting entries)

subject to this subpart and to the

Reserve Banks’ operating circulars;

* * * * *

(d) Warranties by Reserve Bank. By

handling a returned check under this

subpart, a Reserve Bank makes the

returning bank warranties as set forth in

§ 229.34 of this chapter, subject to the

terms of part 229 of this chapter

(Regulation CC). * * *

* * * * *

(f) Methods of recovery. (1) The

Reserve Bank may recover the amount

stated in paragraph (d) of this section by

charging any account on its books that

is maintained or used by the paying or

returning bank (or by charging another

returning Reserve Bank), if——

(i) The Reserve Bank made seasonable

written demand on the paying or

returning bank to assume defense of the

action or proceeding; and

(ii) The paying or returning bank has

not made any other arrangement for

payment that is acceptable to the

Reserve Bank.

(2) The Reserve Bank is not

responsible for defending the action or

proceeding before using this method of

recovery. A Reserve Bank that has been

charged under this paragraph (f) may

recover from the paying or returning

bank in the manner and under the

circumstances set forth in this

paragraph (f). A Reserve Bank’s failure

to avail itself of the remedy provided in

this paragraph (f) does not prejudice its

enforcement in any other manner of the

indemnity agreement referred to in

paragraph (c)(3) of this section.

* * * * *

(h) Settlement. A subsequent

returning bank or depositary bank shall

settle with its Administrative Reserve

Bank for returned checks in the same

manner and by the same time as for cash

items presented for payment under this

subpart. Settlement with its

Administrative Reserve Bank is deemed

to be settlement with the Reserve Bank

from which the returning bank or

depositary bank received the item.

(i) Security interest. When a paying or

returning bank sends a returned check

to a Reserve Bank, the paying bank,

returning bank, and any prior returning

bank grant to the paying bank’s or

returning bank’s Administrative Reserve

Bank a security interest in all of their

respective assets in the possession of, or

held for the account of, any Reserve

Bank, to secure their respective

obligations due or to become due to the

Administrative Reserve Bank under this

subpart or subpart C of part 229 of this

chapter (Regulation CC). * * *

By order of the Board of Governors of the

Federal Reserve System, September 10, 1997.

William W. Wiles,

Secretary of the Board.

[FR Doc. 97–24405 Filed 9–12–97; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

Biological Product Standards;

Technical Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for biological products

standards to update a reference to the

United States Pharmacopeia (USP). The

agency has determined that the 1995

edition of the USP should be referenced

rather than previous editions. This

action is necessary to ensure the

consistency and accuracy of the

regulations.

DATES: The regulation is effective

September 15, 1997. The Director of the

Office of the Federal Register approves

the incorporation by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51 of a certain publication in

21 CFR 610.12(f), effective September

15, 1997.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852, 301–594–3074.

SUPPLEMENTARY INFORMATION: Section

610.12(f) (21 CFR 610.12(f)) incorporates

by reference the 1985 edition of the USP

concerning test procedures for

membrane filtration. Since the USP has

been revised and the 1995 edition of the

USP (23d Revision, 1995) is more

readily available to the public, FDA has

determined that § 610.12(f) should

reference the test standards for the ‘‘Test

Procedures Using Membrane Filtration’’

in the 1995 edition, in lieu of the test

standards in the 1985 edition. The test

standards for membrane filtration in the

1995 edition of the USP are identical to
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48175

those in the 1985 edition with the

following exceptions:

(1) In the second paragraph under

‘‘Apparatus,’’ the 1985 edition states ‘‘A

membrane generally suitable for sterility

testing has a normal porosity of .45 +/

-0.02um, * * *,’’ while the 1995 edition

does not include the ‘‘+/-0.02um’’; and

(2) the 1985 edition did not have a

section on ‘‘Filterable Solids,’’ because

information of filterable solids was not

available in 1985. The 1995 edition now

has this information.

Because these differences in the two

editions of the USP are insignificant,

and the 1995 edition is more readily

available to the public, the agency

believes that the regulation should be

amended, as indicated herein, to reflect

the more recent version of the test

standards. Accordingly § 610.12(f) is

being amended to reflect the 1995

edition of the USP (23d Revision, 1995).

Publication of this document

constitutes final action on this change

under the Administrative Procedure Act

(5 U.S.C. 553(b)(3)(B)). Notice and

public procedure are unnecessary

because FDA is merely updating a

reference in its regulations.

List of Subjects in 21 CFR Part 610

Biologics, Incorporation by reference,

Labeling, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 610 is

amended as follows:

PART 610—GENERAL BIOLOGICAL

PRODUCTS STANDARDS

1. The authority citation for 21 CFR

part 610 continues to read as follows:

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

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371); secs. 215, 351, 352, 353, 361

of the Public Health Service Act (42 U.S.C.

216, 262, 263, 263a, 264).

2. Section 610.12 is amended by

revising paragraph (f) to read as follows:

§ 610.12 Sterility.

* * * * *

(f) Membrane filtration. Bulk and final

container material or products

containing oil products in waterinsoluble ointments may be tested for

sterility using the membrane filtration

procedure set forth in the United States

Pharmacopeia (23d Revision, 1995),

section entitled ‘‘Test Procedures Using

Membrane Filtration,’’ pp. 1689 to 1690,

which is incorporated by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies are available from

the United States Pharmacopeial

Convention, Inc., 12601 Twinbrook

Pkwy., Rockville, MD 20852, or

available for inspection at the Center for

Drug Evaluation and Research’s

Division of Medical Library, 5600

Fishers Lane, rm. 11B–40, Rockville,

MD, or at the Office of the Federal

Register, 800 North Capitol St. NW.,

suite 700, Washington, DC, except that:

(1) The test samples shall conform

with paragraph (d) of this section; and

(2) In addition, for products

containing a mercurial preservative, the

product shall be tested in a second test

using Fluid Thioglycollate Medium

incubated at 20 to 25 °C in lieu of the

test in Soybean-Casein Digest Medium.

* * * * *

Dated: September 2, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24349 Filed 9-12-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1910

RIN 1218–AA95

Methylene Chloride; Amendment;

Extension of Start-Up Date

AGENCY: Occupational Safety and Health

Administration (OSHA), Department of

Labor.

ACTION: Final Rule; amendment;

extension of start-up date for

compliance.

SUMMARY: The Occupational Safety and

Health Administration (OSHA) is

extending the start-up date for most

provisions of the methylene chloride by

30 days to November 6, 1997 for larger

employers. Employers with fewer than

20 employees and foam manufacturers

with 20 to 99 employees have

substantially later start-up dates which

are not changed.

DATES: The effective date of this

amendment is September 15, 1997.

Compliance: The start-up date for all

provisions of the methylene chloride

standard except initial monitoring and

engineering controls for employers

specified in § 1910.1052(n)(2)(iii)(c) is

extended to November 6, 1997 (210 days

after the effective date of the standard).

FOR FURTHER INFORMATION CONTACT:

Bonnie Freeman, Director, OSHA Office

of Public Affairs, U.S. Department of

Labor, Room N3647, 200 Constitution

Avenue, NW., Washington, DC 20210,

telephone (202) 219–8151.

SUPPLEMENTARY INFORMATION: OSHA

published a new methylene chloride

standard January 10, 1997 (62 FR 1494).

That standard included extended startup dates for its various provisions

depending on the size of the employer.

The three categories of employers were

employers with fewer than 20

employees, foam manufacturers with

20–99 employees and ‘‘all other

employers.’’

OSHA published notification of OMB

approval of information collection

requirements on August 8, 1997 (62 FR

42666). As the start-up date for initial

monitoring for ‘‘all other employers’’

was August 8, 1997, OSHA extended

that date to September 7, 1997 to

provide added notice to implement

compliance.

The next start-up date specified for

‘‘all other employers’’ is October 7, 1997

for all provisions except engineering

controls and initial monitoring. That is

only 30 days after the extended date for

completion of initial monitoring.

OSHA has concluded that more time

is needed between completion of initial

monitoring and implementation of the

other provisions except engineering

controls. This allows for a more efficient

and effective implementation of those

provisions such as for training, medical

surveillance and other specified

provisions. This is also consistent with

OSHA’s initial determination that 60

days is needed between completion of

initial monitoring and implementation

of the other provisions. OSHA is

amending § 1910.1052(n)(2)(iii)(c) to

implement this decision.

The date for completion of initial

monitoring for employers with fewer

than 20 employees is February 4, 1998

and for foam manufacturers with 20–99

employees is November 6, 1997. The

date for all other provisions except

engineering controls is 60 days later for

each group. See 62 FR 1606 (January 10,

1997) for a listing of effective and startup dates.

OSHA finds that there is good cause

to issue this extension without notice

and public comment because following

such procedures would be impractical,

unnecessary or contrary to the public

interest in this case. OSHA believes that

it is in the public interest to give certain

employers additional time between

completion of initial monitoring and

implementation of other provisions.

Authority And Signature

This document was prepared under

the direction of Gregory R. Watchman,

Acting Assistant Secretary of Labor for

Occupational Safety and Health, U.S.