Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32673

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 91F–0392]

Phoenix Medical Technology, Inc.;

Withdrawal of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal of a food additive petition

(FAP 1B4273) proposing that the food

additive regulations be amended to

provide for the safe use of 2,4,4’-

trichloro-2-hydroxydiphenyl ether as an

antimicrobial agent in the manufacture

of polyvinyl chloride gloves for foodcontact use.

FOR FURTHER INFORMATION

CONTACT:Julius Smith, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St., SW., Washington, DC 20204,

202–418–3091.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 6, 1991 (56 FR 56656), FDA

announced that a food additive petition

(FAP 1B4273) had been filed by Phoenix

Medical Technology, Inc., P.O. Box 346,

Andrews, SC 29510. The petition

proposed to amend the food additive

regulations to provide for the safe use of

2,4,4’-trichloro-2-hydroxydiphenyl ether

as an antimicrobial agent in the

manufacture of polyvinyl chloride

gloves for food-contact use.

On August 3, 1996, the Food Quality

Protection Act (Pub. L. No. 104–170),

which amended the Federal Food, Drug,

and Cosmetic Act (the act), transferred

from FDA the regulatory authority over

the petitioned use of this substance as

a food additive under section 409 (21

U.S.C. 348) of the act to the

Environmental Protection Agency (EPA)

as a pesticide chemical under section

408 (21 U.S.C. 346a) of the act, as

amended.

In response to a request by the

petitioner, which was prompted by the

change in regulatory authority over the

antimicrobial substance that is the

subject of this petition, FDA transferred

the records for Food Additive Petition

1B4273, including all of FDA’s reviews

of information in the petition, to EPA.

Phoenix Medical Technology, Inc.,

has now withdrawn the petition.

Dated: May 21, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–15766 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0487]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Abbreviated New Drug Application

Regulations, Patent and Exclusivity

Provision’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 12, 1997

(62 FR 65431), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0305. The

approval expires on May 31, 2001.

Dated: June 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15768 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 89N–0474]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Specific Requirements on Content and

Format of Labeling for Human

Prescription Drugs, Addition of

‘Geriatric Use’ Subsection in the

Labeling’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of Wednesday, August

27, 1997 (62 FR 45313), the agency

announced that the proposed

information collection had been

submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0370. The

approval expires on May 31, 2001.

Dated: June 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15813 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0365]

Revised Guidance for Industry and

Reviewers on Repeal of Section 507 of

the Federal Food, Drug, and Cosmetic

Act

AGENCY: Food and Drug Administration,

HHS.