Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Notices 16425 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0091] 

Draft Guidance for Industry: Testing 

for Salmonella Species in Human 

Foods and Direct-Human-Contact 

Animal Foods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Testing for 

Salmonella Species in Human Foods 

and Direct-Human-Contact Animal 

Foods.’’ The draft guidance, when 

finalized, is intended for firms that 

manufacture, process, pack, or hold 

human foods or direct-human-contact 

animal foods intended for distribution 

to consumers, institutions, or food 

processors. The draft guidance does not 

apply to egg producers and other 

persons who are covered by FDA’s final 

rule ‘‘Prevention of Salmonella 

Enteritidis in Shell Eggs During 

Production, Storage, and 

Transportation.’’ The draft guidance 

addresses testing procedures for 

Salmonella species (spp.) in human 

foods (except shell eggs) and directhuman-contact animal foods, and the 

interpretation of test results, when the 

presence of Salmonella spp. in the food 

may render the food injurious to human 

health. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115 (g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

concerning the draft guidance by June 

21, 2011. 

ADDRESSES: Submit electronic 

comments on the draft guidance to 

http://www.regulations.gov. Submit 

written comments on the draft guidance 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

written requests for single copies of the 

draft guidance to the Office of Food 

Safety, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

Michael E. Kashtock, Center for Food 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740,301–436–2022. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Testing for Salmonella Species in 

Human Foods and Direct-HumanContact Animal Foods.’’ The draft 

guidance, when finalized, is intended 

for firms that manufacture, process, 

pack, or hold human foods or directhuman-contact animal foods intended 

for distribution to consumers, 

institutions, or food processors. The 

draft guidance does not apply to egg 

producers and other persons who are 

covered by FDA’s final rule ‘‘Prevention 

of Salmonella Enteritidis in Shell Eggs 

During Production, Storage, and 

Transportation’’ (21 CFR part 118; the 

shell egg final rule). The draft guidance 

addresses testing procedures for 

Salmonella spp. in human foods (except 

shell eggs) and direct-human-contact 

animal foods, and the interpretation of 

test results, when the presence of 

Salmonella spp. in the food may render 

the food injurious to human health. 

FDA intends to issue a separate 

guidance document responding to 

questions FDA has received on the shell 

egg final rule since its publication and 

include in that document guidance on 

environmental and egg testing for 

Salmonella Enteritidis. 

Salmonella spp. can cause serious 

and sometimes fatal infections in young 

children, frail or elderly people, and 

others with weakened immune systems. 

Healthy persons infected with 

Salmonella spp. often experience fever, 

diarrhea (which may be bloody), nausea, 

vomiting, and abdominal pain. In rare 

circumstances, infection with 

Salmonella spp. can result in the 

organism getting into the blood stream 

and producing more severe illnesses 

such as arterial infections (i.e., infected 

aneurysms), endocarditis, and arthritis. 

In addition, direct-human-contact 

animal foods contaminated with 

Salmonella spp. pose a significant 

health risk to humans who have direct 

contact with the foods at homes, petting 

zoos, agricultural fairs, or similar 

venues. 

The draft guidance represents the 

Agency’s current thinking on testing for 

Salmonella spp. in human foods and 

direct-human-contact animal foods. 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 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/FoodGuidances or 

http://www.regulations.gov. Always 

access an FDA guidance document by 

using the Web sites listed previously to 

find the most current version of the 

guidance. 

Dated: March 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6793 Filed 3–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0028] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Ovarian Adnexal Mass Assessment 

Score Test System; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the special controls 

guidance entitled ‘‘Class II Special 

Controls Guidance Document: Ovarian 

Adnexal Mass Assessment Score Test 

System.’’ This guidance document 

describes a means by which the ovarian 

adnexal mass assessment score test 

system 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 these device types 

into class II (special controls). This 


jlentini on DSKJ8SOYB1PROD with NOTICES
16426 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Notices 

guidance document is immediately in 

effect as the special control for the 

ovarian adnexal mass assessment score 

test system, 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. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Ovarian Adnexal 

Mass Assessment Score Test System’’ to 

the Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Donna Roscoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, Bldg., 66, rm. 5540, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, 301–796–6183; or 

Marina Kondratovich, Center for 

Devices and Radiological Health, 

Food and Drug Administration, 

Bldg.66, rm. 5666, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–6036. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

codifying the classification of the 

ovarian adnexal mass assessment score 

test system into class II (special 

controls) under section 513(f)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360c(f)(2)). 

This guidance document will serve as 

the special control for the ovarian 

adnexal mass assessment score test 

system. Section 513(f)(2) of the FD&C 

Act provides that any person who 

submits a premarket notification under 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1). 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Under 

this authority, on September 11, 2009, 

FDA by order classified into class II, 

subject to this special control guidance 

document, the ovarian adnexal mass 

assessment score test system. Because of 

the timeframes established by section 

513(f)(2) of the FD&C Act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the ovarian adnexal 

mass assessment score test system. 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 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Class II Special Controls 

Guidance Document: Ovarian Adnexal 

Mass Assessment Score Test System,’’ 

you may either send an e-mail request 

to dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1707 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807 subpart E have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 801 and 21 

CFR 809.10 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078. 

FDA concludes that labeling 

provisions for the Black Box 

Restrictions of this guidance are not 

subject to review by the Office of 

Management and Budget because they 

do not constitute a ‘‘collection of 

information’’ under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). Rather, the black box warning on 

all labeling, advertising, and 

promotional materials for ovarian 

adnexal mass assessment score test 

system devices is a ‘‘public disclosure of 

information originally supplied by the 

Federal Government to the recipient for 

the purpose of disclosure to the public.’’ 

(see 5 CFR 1320.3(c)(2)). 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

Dated: March 16, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6622 Filed 3–22–11; 8:45 am] 

BILLING CODE 4160–01–P 


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