58448 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 

II. Electronic Access

Persons with access to the Internet 

may obtain the documents at http://

www.fda.gov/cdrh/pmapage.html.

Dated: September 23, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–21873 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0438]

Guidance for Industry: Use of Material 

from Bovine Spongiform 

Encephalopathy-Positive Cattle in 

Animal Feed; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

(#174) entitled ‘‘Use of Material from 

BSE-Positive Cattle in Animal Feed.’’

This guidance document describes 

FDA’s current thinking regarding the 

use in all animal feed of all material 

from cattle that test positive for BSE 

(bovine spongiform encephalopathy).

DATES: Submit written or electronic 

comments on agency guidances at any 

time.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the guidance 

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

dockets/ecomments. Comments should 

be identified with the full title of the 

guidance and the docket number found 

in brackets in the heading of this 

document. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the document.

Submit written requests for single 

copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests.

FOR FURTHER INFORMATION CONTACT: Burt 

Pritchett, Center for Veterinary 

Medicine (HFV–222), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6860, email: burt.pritchett@fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

BSE belongs to a family of animal and 

human diseases called transmissible 

spongiform encephalopathies (TSEs). 

These include BSE or ‘‘mad cow’’

disease in cattle; scrapie in sheep and 

goats; and classical and variant 

Creutzfeldt-Jakob diseases (CJD and 

vCJD) in humans. There is no known 

treatment for these diseases, and there is 

no vaccine to prevent them. In addition, 

although validated postmortem 

diagnostic tests are available, there are 

no validated diagnostic tests for BSE or 

other TSEs that can be used to test for 

the disease in live animals or humans.

Under FDA’s BSE feed regulation (21 

CFR 589.2000) any protein-containing 

portion of mammalian animals is 

prohibited for use in feed for ruminant 

animals with the exception of certain 

products. FDA took this action to 

minimize the potential for any 

undetected BSE infectivity in animal 

feed to spread to ruminants via their 

feed. This guidance document describes 

FDA’s recommendations regarding the 

use in all animal feed of all material 

from cattle that test positive for BSE.

II. Paperwork Reduction Act of 1995

FDA concludes that this guidance 

contains no collections of information. 

Therefore, clearance by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 is not 

required.

III. Significance of Guidance

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices (GGPs) regulation in 

§ 10.115(21 CFR 10.115). It is being 

implemented immediately without prior 

public comment, under § 10.115(g)(2), 

because FDA believes that, in light of 

the increased BSE testing activities by 

the U.S. Department of Agriculture, it is 

of public health importance to clarify 

that cattle that test positive for BSE are 

adulterated and are not to be used in 

any animal feed.

This guidance represents the agency’s 

current thinking on the topic. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternate method 

may be used as long as it satisfies the 

requirements of applicable statutes and 

regulations.

IV. Comments

As with all of FDA’s guidance, the 

public is encouraged to submit written 

or electronic comments with new data 

or other new information pertinent to 

this guidance. FDA periodically will 

review the comments in the docket and, 

where appropriate, will amend the 

guidance. The public will be notified of 

any such amendments through a 

document in the Federal Register.

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper 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 Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

V. Electronic Access

Copies of this guidance document 

may be obtained from the Center for 

Veterinary Medicine home page (http:/

/www.fda.gov/cvm) and from the 

Division of Dockets Management Web 

site (http://www.fda.gov/ohrms/dockets/

default.htm).

Dated: September 24, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22014 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0385]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Hepatitis A Serological Assays for the 

Clinical Laboratory Diagnosis of 

Hepatitis A Virus; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Class II Special Controls 

Guidance Document: Hepatitis A 

Serological Assays for the Clinical 

Laboratory Diagnosis of Hepatitis A 

Virus.’’ This draft guidance document 

describes a means by which in vitro 

diagnostic devices for the laboratory 

diagnosis of Hepatitis A Virus may 

comply with the requirement of special 

controls for class II devices. Elsewhere 

in this issue of the Federal Register, 

FDA is publishing a proposed rule to 

reclassify these device types from class 

III into class II (special controls).

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 58449

DATES: Submit written or electronic 

comments on this draft guidance by 

December 29, 2004.

ADDRESSES: Submit written requests for 

single copies on a 3.5’’ diskette of the 

draft guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Hepatitis A Serological Assays for the 

Clinical Laboratory Diagnosis of 

Hepatitis A Virus’’ 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 draft 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:

Sally Hojvat, Center for Devices and 

Radiological Health (HFZ- 440), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2096.

SUPPLEMENTARY INFORMATION:

I. Background

This draft document was developed 

as a special control to support the 

classification of in vitro diagnostic 

devices for the laboratory diagnosis of 

Hepatitis A Virus (HAV) into class II 

(special controls). Hepatitis A Virus 

Tests, Product Code LOL, are devices 

that detect immunoglobulins M, (IgM), 

immunoglobulin G (IgG), and total 

antibodies (IgM and IgG) reactive to 

HAV. The detection of HAV-specific 

antibodies in human serum or plasma is 

laboratory evidence of HAV infection, 

with the presence of IgM type 

antibodies differentiating an acute 

infection from past infection.

This draft guidance document 

identifies the classification regulation 

and product code for HAV-specific IgM, 

IgG, and total antibody assays. In 

addition, other sections of this guidance 

document list the risks to health 

identified by FDA and describe 

measures that, if followed by 

manufacturers and combined with the 

general controls, will generally address 

the risks associated with these assays 

and lead to a timely premarket 

notification (510(k)) review and 

clearance. This document supplements 

other FDA documents regarding the 

specific content of a premarket 

notification submission.

II. Significance of Guidance

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on Class II special controls for in vitro 

diagnostic devices for the laboratory 

diagnosis of Hepatitis A Virus. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations.

III. Electronic Access

To receive ‘‘Class II Special Controls 

Guidance Document: Hepatitis A 

Serological Assays for the Clinical 

Laboratory Diagnosis of Hepatitis A 

Virus’’ by fax machine, call the CDRH 

Facts-On-Demand system at 800–899–

0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the 

system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number 1536 followed by the 

pound sign (#). Follow the remaining 

voice prompts to complete your request.

IV. Paperwork Reduction Act of 1995

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 USC 3501–3520) (the PRA). The 

collections of information addressed in 

the guidance document have been 

approved by OMB in accordance with 

the PRA under the regulations 

governing premarket notification 

submissions (21 CFR part 807, subpart 

E, OMB No. 0910–0120). The labeling 

provisions addressed in the guidance 

have been approved by OMB under 

OMB No. 0910–0485.

V. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, 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. Comments 

received may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: September 21, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–22010 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0412]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Sirolimus Test Systems; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Sirolimus Test 

Systems.’’ This guidance document 

describes a means by which sirolimus 

test systems may comply with the 

requirement of special controls for class 

II devices. Elsewhere in this issue of the 

Federal Register, FDA is publishing a 

final rule to classify sirolimus test 

systems into class II (special controls). 

This guidance document is immediately 

in effect as the special control for 

sirolimus test systems but it remains 

subject to comment in accordance with 

the agency’s good guidance practices 

(GGPs).

DATES: Submit written or electronic 

comments on this guidance at any time.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Sirolimus Test Systems’’ 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://