26854 Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Proposed Rules

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 17, 1995

(60 FR 9554), FDA issued a proposed

rule to include additional labeling

(warning and directions) for all

topically-applied acne treatment drug

products containing benzoyl peroxide.

Interested persons were given until May

18, 1995, to submit written comments

on the proposal.

In response to the proposal, the

Nonprescription Drug Manufacturers

Association (NDMA) requested a 2-

month extension of the comment

period. NDMA states that the request

was on behalf of member companies

who manufacture and distribute overthe-counter (OTC) acne drug products

containing benzoyl peroxide. NDMA

indicated that it intended to comment

on FDA’s proposal to require additional

labeling on acne drug products at the

request of its Benzoyl Peroxide Study

Group. NDMA stated that it needed

more time to document fully questions

about certain facts included in the

proposal. NDMA added that the

precedent-breaking nature of the

agency’s proposal demanded careful

scrutiny and thoughtful consideration

and that coordination of the Benzoyl

Peroxide Study Group’s efforts in these

regards was time-consuming.

FDA has carefully considered the

request and acknowledges the

uniqueness of the proposal. The agency

believes that additional time for

comment is in the public interest and

will be of assistance in establishing

labeling that will help consumers safely

use drug products containing benzoyl

peroxide for the treatment of acne.

Accordingly, the comment period is

extended to July 17, 1995.

Interested persons may, on or before

July 17, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding the

proposal. Three copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

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

Monday through Friday.

Dated: May 16, 1995.

William K. Hubbard,

Acting Deputy Commissioner for Policy.

[FR Doc. 95–12399 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 896

[Docket No. 83N–0193]

RIN 0905–AD83

Performance Standard for the Infant

Apnea Monitor; Extension of Comment

Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; extension of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

August 21, 1995, the comment period

on the proposed rule that published in

the Federal Register of February 21,

1995 (60 FR 9762). The document

proposed to establish a mandatory

performance standard for infant apnea

monitors, which are a subset of

breathing frequency monitors, also

called neonatal apnea monitors. The

infant apnea monitor is a system

intended for use on infants to detect

cessation of breathing. This action is

based on a request from industry.

DATES: Written comments by August 21,

1995.

ADDRESSES: Submit 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:

James J. McCue, Center for Devices and

Radiological Health (HFZ–84), Food and

Drug Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–4765.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 21, 1995

(60 FR 9762), FDA published a

proposed rule to establish a mandatory

performance standard for infant apnea

monitors, which are a subset of

breathing frequency monitors, also

called neonatal apnea monitors. The

infant apnea monitor is a system

intended for use on infants to detect

cessation of breathing. FDA believes

that a performance standard is necessary

to ensure that infant apnea monitors

accurately and reliably detect the

absence of effective respiration and

provide an alarm in such cases.

Interested persons were invited to

comment by May 22, 1995. FDA

received one request from industry to

extend the comment period for 90 days.

The request stated that this timeframe

would allow sufficient time to gather

the necessary data to develop effective

comments.

FDA is extending the comment period

for 90 days to ensure adequate time for

preparation of comments. Accordingly,

FDA finds under section 520(d) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360j(d)) that there is good

cause for such an extension.

Interested persons may, on or before

August 21, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding this notice.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: May 10, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–12293 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[PS–013–88]

RIN 1545–AL57

Certain Publicly Traded Partnerships

Treated as Corporations; Correction

AGENCY: Internal Revenue Service,

Treasury.

ACTION: Correction to notice of proposed

rulemaking and notice of public

hearing.

SUMMARY: This document contains

corrections to the notice of proposed

rulemaking and notice of public hearing

(PS–013–88) which was published in

the Federal Register on Tuesday, May 2,

1995 (60 FR 21475), relating to the

classification of certain publicly traded

partnerships as corporations.

FOR FURTHER INFORMATION CONTACT:

Christopher T. Kelley, (202) 622–3080,

(not a toll-free call).

SUPPLEMENTARY INFORMATION:

Background

The notice of proposed rulemaking

and notice of public hearing that is the

subject of these corrections proposes to

add § 1.7704–1 to the Income Tax

Regulations relating to the definition of

a publicly traded partnership under

section 7704(b) of the Internal Revenue

Code.

Need for Correction

As published, the notice of proposed

rulemaking and notice of public hearing