69606 Federal Register / Vol. 69, No. 229 / Tuesday, November 30, 2004 / Notices 

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26331 Filed 11–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0063]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Voluntary Registration of Cosmetic 

Product Establishments

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Voluntary Registration of Cosmetic 

Product Establishments’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 19, 2004 (69 FR 

43001), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 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 0910–0027. The 

approval expires on November 30, 2007. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26332 Filed 11–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004F–0455]

Sterigenics International, Inc.; Filing of 

Food Additive Petition

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Sterigenics International, Inc., has 

filed a petition proposing that the food 

additive regulations be amended to 

provide for the safe use of ionizing 

radiation in the production of shelf 

stable foods, including multiple 

ingredient shelf stable foods.

FOR FURTHER INFORMATION CONTACT:

Lane A. Highbarger, Center for Food 

Safety and Applied Nutrition (HFS–

255), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1204.

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))), 

notice is given that a food additive 

petition (FAP 3M4744) has been filed by 

Sterigenics International, Inc., P.O. Box 

17349, Memphis, TN 31817–0349. The 

petition proposes that the food additive 

regulations in part 179 Irradiation in the 

Production, Processing and Handling of 

Food (21 CFR 179) be amended to 

provide for the safe use of ionizing 

radiation in the production of fully 

cooked shelf stable foods, including 

fully cooked multiple ingredient shelf 

stable foods, where the absorbed dose 

required to cause a 12-log reduction in 

Clostridium botulinum has been 

established.

The agency has determined under 21 

CFR 25.32(j) 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.

Dated: October 28, 2004.

Laura M. Tarantino,

Deputy Director, Office of Food Additive 

Safety, Center for Food Safety and Applied 

Nutrition.

[FR Doc. 04–26334 Filed 11–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0383]

Guidance for Industry and Food and 

Drug Administration Staff; Use of 

Symbols on Labels and in Labeling of 

In Vitro Diagnostic Devices Intended 

for Professional Use; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Use of Symbols on Labels and in 

Labeling of In Vitro Diagnostic Devices 

Intended for Professional Use.’’ This 

document provides guidance on the use 

of selected symbols from international 

standards already recognized by FDA in 

place of text to convey some of the 

information required for in vitro 

diagnostic devices (IVDs) intended for 

professional use by FDA’s labeling 

requirements for IVDs.

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Use of 

Symbols on Labels and in Labeling of In 

Vitro Diagnostic Devices Intended for 

Professional Use’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance.

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Paula G. Silberberg, Center for Devices 

and Radiological Health (HFZ–230), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, 301–

594–1217; or Sheryl A. Kochman, 

Center for Biologics Evaluation and