36324 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

devices, 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 310 is

amended as follows:

PART 310—NEW DRUGS

1. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 360b-360f, 360j, 361(a), 371, 374,

375, 379e; 42 U.S.C. 216, 241, 242(a), 262,

263b-263n.

2. Section 310.545 is amended by

revising paragraph (d)(31) to read as

follows:

§ 310.545 Drug products containing

certain active ingredients offered over-thecounter (OTC) for certain uses.

* * * * *

(d) * * *

(31) December 31, 2002, for products

subject to paragraph (a)(29) of this

section.

Dated: May 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–14212 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 98N–0786]

General Hospital and Personal Use

Devices; Classification of Liquid

Chemical Sterilants/High Level

Disinfectants and General Purpose

Disinfectants

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying

liquid chemical sterilants/high level

disinfectants intended for use as the

terminal step in processing critical and

semicritical medical devices prior to

patient use into class II (special

controls), and general purpose

disinfectants intended to process

noncritical medical devices and

equipment surfaces into class I (general

controls). FDA is also exempting the

general purpose disinfectants from the

premarket notification requirements.

This action is being taken under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (the SMDA), and the Food

and Drug Administration Modernization

Act of 1997 (the FDAMA).

DATES: This rule is effective July 10,

2000.

FOR FURTHER INFORMATION CONTACT:

Chiu S. Lin, Center for Devices and

Radiological Health (CDRH) (HFZ–480),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8913.

SUPPLEMENTARY INFORMATION:

I. Background

The act (21 U.S.C. 301 et seq.), as

amended by the 1976 amendments

(Public Law 94–295), the SMDA (Public

Law 101–629), and the FDAMA (Public

Law 105–115), established a

comprehensive system for the regulation

of medical devices intended for human

use. Section 513 of the act (21 U.S.C.

360c) established three categories

(classes) of devices, depending on the

regulatory controls needed to provide

reasonable assurance of their safety and

effectiveness. The three categories of

devices are class I (general controls),

class II (special controls), and class III

(premarket approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act (21

U.S.C. 360c(f))) into class III without

any FDA rulemaking process. Those

devices remain in class III and require

premarket approval, unless and until:

(1) The device is reclassified into class

I or II; (2) FDA issues an order

classifying the device into class I or II

in accordance with new section

513(f)(2) of the act, as amended by the

FDAMA; or (3) FDA issues an order

finding the device to be substantially

equivalent, in accordance with section

513(i) of the act, to a predicate device

that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and 21 CFR part 807

of the regulations.

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA issues a

final regulation under section 515(b) of

the act (21 U.S.C. 360e(b)) requiring

premarket approval.

Consistent with the act and the

regulations, FDA consulted with the

General Hospital and Personal Use

Devices Panel (the Panel), an FDA

advisory committee, regarding the

classification of these devices.

The FDAMA added a new section

510(l) to the act. New section 510(l) of

the act provides that a class I device is

exempt from the premarket notification

requirements under section 510(k) of the

act, unless the device is intended for a

use which is of substantial importance

in preventing impairment of human

health or it presents a potential

unreasonable risk of illness or injury.

Hereafter, these are referred to as

‘‘reserved criteria.’’ FDA has considered

the general purpose disinfectants in

accordance with the reserved criteria

and determined that these devices do

not require premarket notification. Such

an exemption permits manufacturers to

introduce into commercial distribution

generic types of devices without first

submitting a premarket notification to

FDA.

II. Regulatory History of the Device

In the Federal Register of November

6, 1998 (63 FR 59917), FDA proposed to

classify both liquid chemical sterilants

intended for use as the terminal step in

processing critical and semicritical

medical devices prior to patient use into

class II and general purpose

disinfectants intended to process

noncritical medical devices and

equipment surfaces into class I. In the

same issue of the Federal Register, FDA

proposed to exempt the general purpose

disinfectants from the premarket

notification requirements. FDA

recognizes a ‘‘high level disinfectant’’ as

a potential separate or subordinate

condition of use of a sterilant and has

included it in the final rule to clarify its

classification status. Initially, interested

persons were given until February 4,

1999, to comment on the proposed

regulation. Subsequently, FDA extended

the comment period to March 8, 1999,

in response to an extension request.

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36325

FDA received one comment on the

proposed rule from a non-profit trade

association.

III. Summary of Final Rule

As required by 21 CFR 860.84(g)(1) of

the regulations, FDA is classifying

liquid chemical sterilants/high level

disinfectants into class II with the

following special controls: The 510(k)

guidance document (Ref. 1) and user

information and training. FDA is also

classifying general purpose disinfectants

into class I and exempting these devices

from premarket notification.

Persons interested in obtaining a copy

of the guidance (Ref. 1) may do so using

the Internet. CDRH maintains an entry

on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. The CDRH home page may be

accessed at http://www.fda.gov/cdrh.

‘‘Guidance on the Content and Format

of Premarket Notification (510(k))

Submissions for Liquid Chemical

Sterilants/High Level Disinfectants’’

available at http://www.fda.gov/cdrh/

ode/397.pdf.

IV. Analysis of Comment and FDA’s

Response

The one comment FDA received

requested that general purpose

disinfectants, in addition to being

exempt from the premarket notification

procedures, also be exempt from the

good manufacturing practice (GMP)

requirements set forth in the Quality

System Regulation (21 CFR part 820).

The comment stated that general

purpose disinfectants should be exempt

from the GMP requirements because the

Environmental Protection Agency (EPA)

and state controls on them are sufficient

to assure their quality for commercial

distribution.

FDA disagrees with the comment. The

agency recognizes the dual regulatory

functions and responsibilities of the

FDA and EPA, but the functions and

responsibilities of these agencies

address different aspects of the product.

Because of the continued classification

of the general purpose disinfectants as

a medical device, they remain subject to

the GMP requirements of the act.

General purpose disinfectants are also

regulated by EPA as environmental

pesticides under the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA). The EPA controls (EPA

product registration, Good Laboratory

Practices, State registration and testing,

maintenance of records, and EPA

establishment registration) focus on the

quality and integrity of pesticide data.

Although some States have programs

regulating the sale and use of general

purpose disinfectants as pesticides, not

all States have adopted the same

enforcement programs. This lack of

uniformity does not provide the

additional safeguard needed for the

national use of these products for

disinfection of medical devices.

Therefore, under section 513 of the

act, FDA is adopting the summary of

reasons for the Panel’s recommendation

and the summary of data upon which

the Panel’s recommendation is based, in

their entirety. FDA also agrees with the

assessment of the risks to public health

stated in the proposed rule published on

November 6, 1998. FDA is issuing this

final rule, which classifies these generic

types of devices as follows: Liquid

chemical sterilants/high level

disinfectants into class II and general

purpose disinfectants into class I.

V. Reference

The following reference has been

placed on display in the Dockets

Management Branch (HFA–305), 5630

Fishers Lane, rm. 1061, Rockville, MD

20852, and may be seen by interested

persons between 9 a.m. and 4 p.m.,

Monday through Friday.

1. FDA, Center for Devices and

Radiological Health, Office of Device

Evaluation, ‘‘Guidance on the Content

and Format of Premarket Notification

(510(k)) Submissions for Liquid

Chemical Sterilants/High Level

Disinfectants,’’ January 3, 2000.

VI. Environmental Impact

The agency has determined under 21

CFR 25.34(b) 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.

VII. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Enforcement Fairness Act of 1996

(Public Law 104–121), and the

Unfunded Mandates Reform Act of 1995

(Public Law 104–4)). 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 final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The classification of these

devices formalizes the current process

for the class I and II devices. For the

class I devices, FDA is not adding any

additional burden, because they are

effectively regulated as class I devices

now. For the class II devices, they are

in compliance with the guidance. The

agency therefore certifies that this final

rule will not have a significant

economic impact on a substantial

number of small entities. In addition,

this final rule will not impose costs of

$100 million or more on either the

private sector or State, local, and tribal

governments in the aggregate and,

therefore a summary statement or

analysis under section 202(a) of the

Unfunded Mandates Reform Act of 1995

is not required.

VIII. Paperwork Reduction Act of 1995

FDA concludes that this final rule

contains no information that is subject

to review by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995. The special

controls do not require the respondent

to submit additional information to the

public.

List of Subjects in 21 CFR Part 880

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 880 is

amended as follows:

PART 880—GENERAL HOSPITAL AND

PERSONAL USE DEVICES

1. The authority citation for 21 CFR

part 880 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 880.6885 is added to

subpart G to read as follows:

§ 880.6885 Liquid chemical sterilants/high

level disinfectants.

(a) Identification. A liquid chemical

sterilant/high level disinfectant is a

germicide that is intended for use as the

terminal step in processing critical and

semicritical medical devices prior to

patient use. Critical devices make

contact with normally sterile tissue or

36326 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

body spaces during use. Semicritical

devices make contact during use with

mucous membranes or nonintact skin.

(b) Classification. Class II (special

controls). Guidance on the Content and

Format of Premarket Notification

(510(k)) Submissions for Liquid

Chemical Sterilants/High Level

Disinfectants, and user information and

training.

3. Section 880.6890 is added to

subpart G to read as follows:

§ 880.6890 General purpose disinfectants.

(a) Identification. A general purpose

disinfectant is a germicide intended to

process noncritical medical devices and

equipment surfaces. A general purpose

disinfectant can be used to preclean or

decontaminate critical or semicritical

medical devices prior to terminal

sterilization or high level disinfection.

Noncritical medical devices make only

topical contact with intact skin.

(b) Classification. Class I (general

controls). The device is exempt from the

premarket notification procedures in

subpart E of part 807 of this chapter

subject to the limitations in § 880.9.

Dated: May 23, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–14462 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–1–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 40

[TD 8887]

RIN 1545–AV02

Deposits of Excise Taxes

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations; and removal

of temporary regulations.

SUMMARY: This document contains final

regulations relating to the availability of

the safe harbor deposit rule based on

look-back quarter liability and affects

persons required to make deposits of

excise taxes. This document also

contains final regulations related to

floor stocks taxes and affects persons

liable for those taxes. The regulations

implement changes made by the Small

Business Job Protection Act of 1996 and

the Airport and Airway Trust Fund Tax

Reinstatement Act of 1997.

DATES: Effective Date: These regulations

are effective June 8, 2000.

Applicability Dates: For dates of

applicability of these regulations, see

§§ 40.6302(c)–1(c)(2)(iv)(C) and

40.6302(c)–2(b)(2)(iii)(C).

FOR FURTHER INFORMATION CONTACT:

Susan Athy, (202) 622–3130 (not a tollfree number).

SUPPLEMENTARY INFORMATION:

Background

Temporary regulations (TD 8740)

relating to the safe harbor deposit rule

based on look-back quarter liability and

to floor stock taxes were published in

the Federal Register on December 29,

1997 (62 FR 67568) along with a notice

of proposed rulemaking (REG–102894–

97) cross-referencing the temporary

regulations (62 FR 67589). Written

comments and requests for a public

hearing were solicited. However, no

comments or requests were received and

no public hearing was held.

The proposed regulations are adopted

without revision by this Treasury

decision.

Effect on Other Documents

The following publication is obsolete

as of June 8, 2000:

Notice 97–15, 1997–1 C.B. 387.

Special Analyses

It has been determined that this

Treasury decision is not a significant

regulatory action as defined in

Executive Order 12866. Therefore, a

regulatory assessment is not required. It

also has been determined that section

553(b) of the Administrative Procedure

Act (5 U.S.C. chapter 5) does not apply

to these regulations and, because these

regulations do not impose on small

entities a collection of information

requirement, the Regulatory Flexibility

Act (5 U.S.C. chapter 6) does not apply.

Therefore, a Regulatory Flexibility

Analysis is not required. Pursuant to

section 7805(f) of the Internal Revenue

Code, the notice of proposed rulemaking

was submitted to the Chief Counsel for

Advocacy of the Small Business

Administration for comment on its

impact on small business.

Drafting Information

The principal author of these

regulations is Susan Athy, Office of

Assistant Chief Counsel (Passthroughs

and Special Industries). However, other

personnel from the IRS and Treasury

Department participated in their

development.

List of Subjects in 26 CFR Part 40

Excise taxes, Reporting and

recordkeeping requirements.

Adoption of Amendments to the

Regulations

Accordingly, 26 CFR part 40 is

amended as follows:

PART 40—EXCISE TAX PROCEDURAL

REGULATIONS

Paragraph 1. The authority citation

for part 40 continues to read in part as

follows:

Authority: 26 U.S.C. 7805 * * *

Par. 2. In § 40.0–1, paragraph (a) is

amended by revising the second

sentence to read as follows:

§ 40.0–1 Introduction.

(a) * * * The regulations set forth

administrative provisions relating to the

excise taxes imposed by chapters 31, 32,

33, 34, 36, 38, and 39 (except for the

chapter 32 tax imposed by section 4181

(firearms tax) and the chapter 36 taxes

imposed by sections 4461 (harbor

maintenance tax) and 4481 (heavy

vehicle use tax)), and to floor stocks

taxes imposed on articles subject to any

of these taxes. * * *

* * * * *

§ 40.0–1T [Removed]

Par. 3. Section 40.0–1T is removed.

Par. 4. In § 40.6011(a)–1, paragraph

(a)(2)(iii) is added to read as follows:

§ 40.6011(a)–1 Returns.

(a) * * *

(2) * * *

(iii) Floor stocks tax return. A return

reporting liability for a floor stocks tax

described in § 40.0–1(a) is a return for

the calendar quarter in which the tax

payment is due and not the calendar

quarter in which the liability for tax is

incurred.

* * * * *

§ 40.6011(a)–1T [Removed]

Par. 5. Section 40.6011(a)–1T is

removed.

Par. 6. Section 40.6302(c)–1 is

amended as follows:

1. Paragraph (c)(2)(iv) is added.

2. Paragraph (f)(1) is amended by

adding a sentence to the end of the

paragraph.

The additions read as follows:

§ 40.6302(c)–1 Use of Government

depositaries.

* * * * *

(c) * * *

(2) * * *

(iv) Modification for new or reinstated

taxes—(A) Applicability. The safe

harbor rule of paragraph (c)(2)(i) of this

section is modified for any calendar

quarter in which a person’s liability for