Federal Register / Vol. 60, No. 90 / Wednesday, May 10, 1995 / Proposed Rules 24805

1See Credit Practices Rule: Statement of Basis

and Purpose and Regulatory Analysis (SBP), 49 FR

7740, 7743–7745 (1984).

2Comments were received from the Credit Union

National Association (‘‘CUNA’’), which represents

5,000 state and 7,000 federal credit unions in the

United States; the CUNA Mutual Insurance Group

(‘‘CMIG’’), which provides form contracts and

compliance support, as well as insurance coverage,

to CUNA members; the Illinois Credit Union

System, which represents 645 state and federal

credit unions in Illinois; and the Missouri Bankers

Association, a trade association representing 500

commercial banks in Missouri.

3Comments were received from the National

Consumer Law Center, Inc. (‘‘NCLC’’); the UAW–

GM Legal Service Plan (‘‘UAW–GM’’), which

provides legal services to auto workers and retirees;

and the law firm of Williams & Eoannou, which

represents consumer debtors in bankruptcy

proceedings and in cases involving possible

violations of federal and state credit laws.

Authority: Secs. 53, 161, 68 Stat. 930, 948,

as amended, sec. 147, 94 Stat. 780 (42 U.S.C.

2073, 2167, 2201); sec. 201, as amended, 204,

88 Stat. 1242, as amended, 1245 (42 U.S.C.

5841, 5844).

Section 73.1 also issued under secs. 135,

141, Pub. L. 97–425, 96 Stat. 2232, 2241 (42

U.S.C. 10155, 10161). Section 73.37(f) also

issued under sec. 301, Pub. L. 96–295, 94

Stat. 789 (42 U.S.C. 5841 note). Section 73.57

is issued under sec. 606, Pub. L. 99–399, 100

Stat. 876 (42 U.S.C. 2169).

§ 73.55 [Amended]

2. In § 73.55, paragraph (d)(8) is

removed and paragraph (d)(9) is

redesignated as (d)(8).

Dated at Rockville, Maryland, this 2nd day

of May, 1995.

For the Nuclear Regulatory Commission.

James M. Taylor,

Executive Director for Operations.

[FR Doc. 95–11482 Filed 5–9–95; 8:45 am]

BILLING CODE 7590–01–P

FEDERAL TRADE COMMISSION

16 CFR Part 444

Regulatory Flexibility Act Review of

Trade Regulation Rule Concerning

Credit Practices

AGENCY: Federal Trade Commission.

ACTION: Termination of review.

SUMMARY: In accordance with the

Regulatory Flexibility Act (5 U.S.C. 601)

(‘‘the RFA’’) and a published plan for

Periodic Review of Commission Rules

(46 FR 35118 (July 7, 1981)), the Federal

Trade Commission solicited comments

and data on whether the Trade

Regulation Rule Concerning Credit

Practices (16 CFR part 444) (the ‘‘Rule’’)

has had a significant impact on a

substantial number of small entities,

and if it has, whether the Rule should

be amended to minimize any significant

impact on small entities (59 FR 18009

(April 15, 1994)). The Commission also

requested comments about the overall

costs and benefits of the Rule and its

overall regulatory and economic impact

as a part of it systematic review of all

current Commission regulations and

guides. The notice required comments

to be submitted to the Commission no

later than June 14, 1994. Based on the

comments received, which are

summarized in this notice, the

Commission finds that there is an

insufficient basis to conclude that the

Rule has had a significant economic

impact upon a substantial number of

number entities of otherwise merits

revision. The Commission is therefore

terminating this review.

DATES: This action is effective as of May

10, 1995.

FOR FURTHER INFORMATION CONTACT:

Sandra M. Wilmore, Attorney, Division

of Credit Practices, Bureau of Consumer

Protection, Room S4429, Federal Trade

Commission, 6th and Pennsylvania

Avenue NW., Washington, D.C. 20580.

Tel: (202) 326–3224.

SUPPLEMENTARY INFORMATION: The RFA

requires the Federal Trade Commission

to conduct a periodic review of rules

issued by the Commission that have or

will have a significant economic impact

on a substantial number of small

entities. For the purpose of the RFA

review, the term ‘‘small entity’’ is

defined under the Small Business Size

Standards, codified at 13 CFR part 121

and revised by the Small Business

Administration (49 FR 5024–5048 (Feb.

9, 1984)). In addition, the Commission

has determined, as a part of its oversight

responsibilities, to review rules and

guides periodically. These reviews will

seek information about the costs and

benefits of the Commission’s rules and

guides and their regulatory and

economic impact. The information

obtained will assist the Commission in

identifying rules and guides that

warrant modification or rescission. This

periodic review is conducted in

accordance with the Commission’s plan

for periodic review of rules (46 FR

35118 (July 7, 1981)).

I. Background and Summary

The Commission promulgated the

Rule on March 1, 1984, (49 FR 7740),

and it became effective on March 1,

1985. The Rule applies to lenders and

retail installment sellers (creditors) and

prohibits them from directly or

indirectly taking or receiving from a

consumer an obligation that includes

certain contract provisions determined

to be unfair, failing to provide a notice

to potential cosigners, or using an unfair

method of calculating late fees.

In promulgating the Rule, the

Commission found that: (1) consumers

suffers substantial economic and noneconomic injury from creditors’ use of

the remedies that the Rule restricts; (2)

consumers themselves cannot

reasonable avoid these remedies or

avoid the harsh consequences of the

remedies by avoiding default; and (3)

the overall costs to consumers are

greater than the countervailing benefits

that the use of these remedies provide

to consumers or creditors.1

The notice that initiated this review

requested comments on whether any

part of the Rule has had a significant

impact on a substantial number of small

entities and, if so, whether any such

impact can be reduced consistent with

the operation of the Rule.

In addition, the Commission

requested comments on a number of

other issues relating to the operation of

the Rule.

II. Public Comments

In response to the Federal Register

notice, the Commission received a total

of seven comments, four from creditor

trade associations 2 and three from legal

organizations representing consumers.3

The commenters’ responses to the

questions posed in the notice are

summarized and analyzed below.

Unless otherwise noted, the

Commission is not aware of other

information bearing on the issues

discussed.

1. Continuing Need for the Rule

Two commenters directly addressed

the question of the continuing need for

the Rule. The UAW–GM and NCLC

stated that consumers continue to need

the protection of the Rule. According to

Williams & Eoannou, consumers have

benefited from the Rule because it

‘‘eliminated the use of a limited number

of onerous and overreaching boilerplate

contract provisions * * * the limited

utility of which in collecting debts was

more than offset by their brutally

invasive and disruptive impact on

consumers and their families.’’ No

commenter discussed any costs imposed

on consumers by the Rule.

2. Proposed Changes to the Rule to

Benefit Consumers

All of the commenters made some

recommendation regarding changes to

the Rule. Except as noted, the

commenters who proposed changes to

benefit consumers did not discuss the

cost to creditors of those changes.
24806 Federal Register / Vol. 60, No. 90 / Wednesday, May 10, 1995 / Proposed Rules

4Those provisions of the Bankruptcy Act provide

an exemption for:

The debtor’s interest, not to exceed $200 in value

in any particular item or $4,000 in aggregate value,

in household furnishing, household goods, wearing

apparel, appliances, books, animals, crops, or

musical instruments, that are held primarily for

* * * personal, family, or household use. * * *

5See SBP at page 7767.

6 In contrast, the Missouri Bankers Association

stated that there should be no expansion of the

definition of household goods and that any

expansion would restrict the collateral that could be

provided by consumers who are not homeowners.

7See SBP at pages 7767 and 7768.

8Section 5(m)(1)(A) of the FTC Act states that:

The Commission may commence a civil action to

recover a civil penalty * * * against any person

* * * which violates any rule under this Act

respecting unfair or deceptive acts or practices

* * * with actual knowledge or knowledge fairly

implied on the basis of objective circumstances that

such act is unfair or deceptive and is prohibited by

such rule. (Emphasis added.)

9Section 226.4 of Regulation Z, which

implements the Truth in Lending Act, allows

creditors to exclude such insurance premiums from

the finance charge if the insurance coverage may be

obtained from a person of the consumer’s choice,

if that fact is disclosed to the consumer, and if the

coverage is obtained through the creditor, the

insurance premium and the term of the insurance

are disclosed.

10See McCarran-Ferguson Act, 15 U.S.C. 1012.

11According to the SBP:

Cross-collateralization occurs when goods

purchased from a retailer on credit are used to

secure credit extended for subsequent purchases

until the account is cleared. A provision of the

proposed rule that we have decided not to

promulgate would have restricted cross-collateral

clauses in installment sales contracts. Essentially,

the provision would have required first-in, first-out

accounting for credit contracts covering multiple

purchases.

SBP, 49 FR 7740, 7786 (March 1, 1984).

12See SBP at page 7786.

a. Security Interests in Household

Goods

i. Definition of Household Goods

One commenter, UAW–GM, stated

that the Rule’s definition of household

goods is too limited. According to

UAW–GM, consumers would be better

protected and the law would be more

consistent with other federal

formulations if the definition of

household goods under the Rule were

changed to parallel the household goods

exemption and lien-avoidance

provisions of the Bankruptcy Code, 11

U.S.C. 552 (d)(3) and (f)(2).4 The

exemptions provided under the

Bankruptcy Act include items not

covered by the Rule, notably books,

animals, crops, and musical

instruments, but do not include the

Rule’s coverage of wedding rings and

personal effects.

The Commission did not address this

question directly at the time that it

promulgated the Rule, but did indicate

that it was aware of the lien-avoidance

provision of the Bankruptcy Act. The

SBP refers to the fact that 1978

amendments to the Bankruptcy Act

created an exception to the old rule that

secured loans survived bankruptcy for

those loans secured by blanket security

interests in household goods, 11 U.S.C.

552(f)(2), discussed above. The

reference occurs in a discussion of the

treatment of the refinancing of purchase

money security interests and does not

indicate that the Commission ever

considered conforming the definition of

household goods in the Rule to the

definition contained in the Bankruptcy

Act provision discussed.5

Since bankruptcy is one of the

situations in which a creditor’s security

interest in the personal possessions of

the debtor is most likely to be at issue,

a consistent federal standard as to

which items are protected is sensible.

However, we have no evidence that the

lack of such a parallel standard is

sufficiently problematic to warrant

amending the rule.

Alternatively, UAW–GM proposed

that the list of specific items included

in the definition be described as

illustrative and not exclusive.6 In the

SBP, the Commission stated its

intention to limit coverage to necessities

and to the class of goods for which the

injury to consumers from a security

interest exceeds offsetting benefits.7

Conceivably, the Rule could be

expanded to apply to any other items

meeting that test. However, this could

raise certain enforcement difficulties. It

is not clear that, if a creditor took a

security interest in items not

enumerated as household goods, the

Commission could establish the

requisite knowledge on the part of the

creditor to bring a civil penalty action

for a rule violation.8 Again, we have no

evidence of problems with the Rule’s

current definition of household goods

sufficient to justify an amendment to the

Rule.

ii. Property Insurance

The NCLC presumes that creditors

take security interests in the consumer’s

personal property in order to sell

excessively priced property insurance to

the consumer and that the Rule should

be amended to address this problem.

The Truth in Lending Act and

Regulation Z impose disclosure

requirements relating to the sale of

property insurance by creditors.9 Given

the legal restrictions on the

Commission’s ability to regulate the

business of insurance, this agency may

not have the authority to address the

pricing of insurance directly or the

expertise to determine what constitutes

fair pricing.10 We found no evidence to

justify attempting to do so as an

amendment to the Rule.

iii. Cross-Collateralization

Williams & Eoannou observed that the

use of cross-collateral security clauses

in revolving charge agreements is

increasing. The commenter notes that

the Rule as initially proposed would

have prohibited such clauses, and that

that provision was deleted from the

final rule.11 The Commission is urged

by the commenter to amend the Rule to

prohibit the use of cross-collateral.

The Commission did not adopt the

provision initially because it found

insufficient evidence in the record that

the use of cross-collateral clauses was

prevalent or that cross-collateral, when

used, caused any notable degree of

consumer injury. It, therefore,

concluded that the benefits of the

provision would not outweigh its

costs.12 As the comment did not provide

specific information about the

prevalence of cross-collateralization or

the degree of injury resulting from its

use, we find no basis for revising that

conclusion.

b. Notice to Cosigners

Commenters addressed various

aspects of the Rule’s cosigner provision,

which will be discussed in turn below.

i. Definition of Cosigner

UAW-GM stated that the cosigner

definition should be clarified. The Rule

defines a cosigner as a person who is

‘‘liable for the obligation of another

person without compensation.’’ A

person is considered not to have

received compensation if that person

does not receive goods, services, or

money in return. According to the

commenter, in connection with the

financing of automobiles, the cosigner’s

name is sometimes placed on the title to

the vehicle with the name of the

purchaser in order to avoid the Rule’s

protections for cosigners.

The commenter states that this is

done without the cosigner’s knowledge

in situations where the cosigner has no

actual access to the vehicle securing the

loan. The cosigner’s name on the title

suggests that he has received an

ownership interest in the car in

exchange for his commitment to pay

and is, therefore, not a cosigner within

the meaning of the Rule. According to

UAW–GM, the Commission should

amend the Rule to make clear that, in

the absence of an actual possessory

interest in the security, the Rule should

apply.

At the time the Rule was

promulgated, the Commission
Federal Register / Vol. 60, No. 90 / Wednesday, May 10, 1995 / Proposed Rules 24807

13 Id. at page 7778.

14 16 CFR 444.1(k).

15 16 CFR 444.3(a)(1).

16 50 FR 47,036 (1985) and 51 FR 39,646 (1986),

Q14(a)-2.

17Section 18(f) of the Federal Trade Commission

Act requires, within 60 days after the Commission

issues a trade regulation rule declaring certain acts

or practices to be unfair or deceptive, that the bank

regulatory agencies issue a substantially similar rule

for creditors subject to their jurisdiction unless the

agencies find that the practices of their creditors are

not unfair or deceptive or that to promulgate such

a rule would ‘‘seriously conflict with essential

monetary and payment systems policies. . . .’’

Accordingly, the FRB and other agencies issued

their own versions of the Rule.

18The FHLBB is now the Office of Thrift

Supervision (‘‘OTS’’), Department of the Treasury.

19SBP at page 7778.

20 Id. at pages 7785–7786.

21 Id.

22Since the Rule was enacted, the Commission

has brought one case against a creditor for abusive

third party contacts and other unfair or deceptive

debt collection practices. See Avco Fin. Serv., 104

F.T.C. 485 (1984) (Consent Agreement).

23See SBP at pages 7784–7785.

24 Id.

considered comments stating that the

cosigner provisions of the Rule could be

avoided by requiring potential cosigners

to become co-applicants for credit. In

response, the Commission revised the

final Rule to define as a cosigner ‘‘any

person whose signature is obtained after

the initial applicant is told that the

signature of another person is

necessary.’’ 13 The cosigner definition

also states that:

A person is a consigner within the meaning

of this definition whether or not he or she is

designated as such on a credit obligation.14

Thus, the Commission clearly

intended that the definition of cosigner

turn on the circumstances under which

the person became obligated to pay

rather than how the person is

characterized by the creditor on the

documents evidencing the transaction.

Accordingly, the current Rule would

apply to the situation described by the

commenter.

In addition, the Rule currently states

that it is a deceptive act or practice for

a creditor, ‘‘directly or indirectly, to

misrepresent the nature of extent of

cosigner liability to any person.’’15

Therefore, it should be possible to

challenge creditor practices that seek to

avoid the effect of the rule by concealing

the cosigner’s status. Such a challenge

may be made using the existing

provision without the necessity of

amending the Rule.

ii. Cosigner Liability

UAW–GM also stated that the Rule

should provide that a creditor cannot

collect from a cosigner who was not

given the required Notice. The

commenter observed that the Federal

Reserve Board (‘‘FRB’’) Staff Guidelines

on that agency’s version of the Rule 16

say that an attempt to collect from a

cosigner who did not receive the Notice

is a violation of the Rule.17

The SBP does not indicate that the

Commission considered the question of

the private enforceability of consumer

credit contracts entered into in violation

of the Rule. The FRB, which followed

the Commission’s lead, did consider

this question, as did the Federal Home

Loan Bank Board (‘‘FHLBB’’) 18. Making

a contract entered into in violation of

the Rule unenforceable against the

cosigner could potentially provide a

private enforcement mechanism for

consumers and give creditors an

additional incentive to comply.

However, the commenter provided no

information about the actual experience

of cosigners with creditors subject to the

other regulatory agencies’ versions of

the Rule, including whether their

versions effectively prevented violations

or provided relief to consumers.

Consequently, the Commission lacks

sufficient information to decide that a

proceeding to amend the Rule in such

a manner is justified.

iii. The Notice as a Separate Document

The three credit union-related

associations asked that the Rule be

amended to permit creditors to include

the Notice in the documents evidencing

the consumer credit obligation rather

than requiring that it be a separate

document. The commenters noted that

the versions of the Rule promulgated by

the National Credit Union

Administration (‘‘NCUA’’), the FRB, and

the OTS do not require the notice to be

on a separate document. While the

commenters requested this change

primarily for the benefit of creditors, the

Illinois Credit Union System also

expressed the view that consumers

would be better served if they received

a document that included both the

Notice and the terms of the credit

obligation.

In the SBP, the Commission explained

its reason for requiring that the Notice

be a separate document:

The purpose of this requirement is to

assure that the cosigner will actually become

aware of the notice before becoming

obligated. Thus, the notice document cannot

be affixed to other documents unless the

notice document appears before any other

document in a package, and it may not

include any other statement * * *.19

Thus, if the result of combining the

Notice with the contract were to make

the Notice’s message less meaningful to

the consumer, as the Commission

believed, this benefit would come with

a substantial cost to the consumer. On

balance, and in the absence of

information about the experience of

cosigners with creditors subject to the

other regulatory agencies’ versions of

the Rule, we have determined to retain

the existing cosigner notice provision.

c. Other Rule Provisions

i. Third Party Contacts

The NCLC stated that many creditors

continue to contact third parties in

order to coerce consumers into paying

debts. When the Rule was enacted, the

Commission considered, but rejected, a

provision to prohibit most creditor

contacts with third parties.20 The

Commission stated that the record in the

rulemaking proceeding did not contain

evidence of widespread abusive third

party contacts, that the cost of the

provision would outweigh its benefits,

and that the Commission considered a

case-by-case approach more appropriate

‘‘to stem abusive third party contacts

without restricting legitimate

contacts.’’21 We feel that this approach

has been adequate to deter abusive third

party contacts.22

ii. Attorney’s Fees

The NCLC also stated that consumers

who pay creditors’ attorney’s fees are

routinely overcharged to subsidize the

attorney’s unsuccessful collection

efforts against other consumers. The

Commission considered, but rejected, a

Rule provision prohibiting credit

contract clauses requiring that debtors

pay attorney’s fees incurred by creditors

in debt collection.23

The Commission expressed the view

that, because the proposed Rule

provision would not have restricted the

power of courts to impose attorney’s

fees on defaulting consumers under

state law, the provision might have had

little effect. While the Commission

found that most creditors included

attorney’s fee provisions in contracts

when permitted to do so by state law,

it found that the cost of restricting this

practice outweighed the benefits of

doing so. Although the Commission

found that attorney’s fees tend to be

based on a percentage of the amount of

the outstanding obligation, and

sometimes bear little relation to the

amount of work performed by the

attorney, it stated specifically that this

does not imply that debtors

overcompensate creditors for their

attorney’s fees.24 Thus the Commission

previously rejected the premise of the

NCLC comment. We have received no

information in connection with this
24808 Federal Register / Vol. 60, No. 90 / Wednesday, May 10, 1995 / Proposed Rules

25The three credit union-related associations

asked that the Rule be amended to permit creditors

to include the Notice in the documents evidencing

the consumer credit obligation rather than requiring

that it be a separate document, as discussed above.

26The Commission has handled inquiries of this

nature through staff interpretation letters, which are

placed on the public record. To date, more than 70

such letters interpreting the Rule have been issued.

27Federally-chartered credit unions are subject to

the NCUA’s version of the Rule.

28See Small Business Size Regulations, 13 CFR

Part 121.601.

review that would lead us to revise that

position.

3. Impact of the Rule on Creditors

CUNA, the only creditor

representative to discuss the subject,

stated that ‘‘Generally, credit unions

have not reported any significant

economic or regulatory impact on their

operations due to this rule.’’

4. Proposed Changes to the Rule to

Benefit Creditors

The Missouri Bankers Association

posited that the Rule provision

prohibiting the pyramiding of late fees

is not sufficiently clear as to what

constitutes a late fee.25 The Association

questioned whether a returned check

fee, for example, would be a late fee

under the Rule, and, if so, whether the

creditor would be permitted under the

Rule to collect it.

This comment calls for an explanation

of the Rule, rather than a modification

to it.26 The Rule does not prohibit a

creditor from collecting a late fee, nor

would it prohibit a creditor from

collecting a returned check fee. The

Rule states that, where a charge is

assessed with respect to only one late

payment and that charge remains

unpaid, the creditor may not for that

reason deem all subsequent payments to

be late or incomplete and assess late

charges with respect to those payments

as well.

In the example provided by the

commenter, if one check was returned

for insufficient funds, the creditor could

assess a returned check fee if permitted

by state law and the terms of the

contract to do so. What the creditor

could not do, assuming the consumer

did not promptly pay the returned

check fee, is to declare all subsequent

payments to be late or incomplete solely

for that reason and assess fees on those

payments.

5. Effect on Other Regulations

Except for the comparisons to the

Federal Reserve Board and other

agencies’ versions of the Rule discussed

above, no commenter discussed the

Rule’s effect on other federal, state or

local laws or regulations.

6. Effect of Technology or Economic

Conditions

No commenter discussed the effects,

if any, of changes in relevant technology

or economic conditions on the Rule.

7., 8., and 9. Effect on Small Businesses

According to CUNA, the Rule applies

to 5,000 state-chartered credit unions.27

CMIG states that the majority of those

credit unions have assets of $100

million or less. Thus, they are

considered to be small entities for the

purposes of the RFA.28 The only burden

that the commenters who claim to

represent such entities identified as

having been imposed by the Rule on

small entities was the requirement

discussed above of providing the

cosigner notice as a separate document.

10. The Notice to Cosigner

No commenter discussed the wording

of the notice.

11. Effect on the Cost and Availability

of Credit

As mentioned above, CUNA stated

that its members generally reported no

significant economic impact on their

operations due to the Rule. Williams &

Eoannou stated that the Rule has had no

negative impact on the cost or

availability of credit and that the use of

credit by consumers has increased since

the Rule became effective. NCLC

provided statistics purporting to show

the increase in consumer debt in the

years following the Rule’s

implementation. In its view, this

increase can be explained in part by

increased consumer demand for what

became, as a result of the Rule, a more

attractive type of credit. No commenter

suggested any adverse economic impact

from the Rule.

12. Disclosure Alternative to the Rule

No commenter addressed the question

of an alternative Rule that would require

disclosure of the existence of contract

provisions that might cause injury to

consumers, as opposed to restricting the

use of such provisions.

III. Conclusion

The Notice attracted limited public

interest. The discussion of issues

relating to small entities, the parties

protected by the RFA, was minimal. A

number of varying suggestions were

made to expand the Rule, but none of

these had extensive support.

After carefully considering the

comments, the Commission believes

that they do not present a sufficient

basis to conclude that the Rule has had

a significant impact on a substantial

number of small entities. Similarly,

none of the other issues raised in the

comments merits revision of the Rule at

this time. The Commission is therefore

terminating this review.

List of Subjects in 16 CFR Part 444

Federal Trade Commission, Consumer

credit contracts, Consigner disclosures,

Trade practices, Truth in Lending.

Authority: The Regulatory Flexibility Act,

5 U.S.C. Section 601 (1980).

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 95–11360 Filed 5–9–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 582, and 589

[Docket No. 94G–0239]

GRAS Status of Propylene Glycol;

Exclusion of Use in Cat Food

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations to exclude from

generally recognized as safe (GRAS)

status the use of propylene glycol (PG)

in or on cat food. This proposed action

is based on FDA’s review of currently

available information which has raised

significant questions about the safety of

this use. Semimoist pet foods containing

PG were not in existence when the

GRAS status for use in animal feeds was

established, thus this GRAS

determination does not apply to the

newly intended uses of PG. FDA is

proposing that PG in or on cat food is

a food additive and is not prior

sanctioned for this use, and subject to

certain provisions of the Federal Food,

Drug, and Cosmetic Act (the act).

DATES: Written comments by July 24,

1995.

ADDRESSES: Written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

David A. Dzanis, Center for Veterinary

Medicine (HFV–222), Food and Drug