Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38439 

harvesting, packing, processing, and 

distribution of tomatoes, along with 

retail and food service preparation. 

Such tomatoes may be grown and 

harvested either from an open field or 

a greenhouse; they may be packed or 

repacked either for the fresh market or 

for ‘‘fresh-cut/value-added processing’’ 

(i.e., minimally processed, such as by 

slicing or dicing, and then bagged or 

prepackaged); and then shipped either 

to food service operations or retail 

establishments where they are offered 

for sale to the consumer. The use of the 

term ‘‘tomatoes’’ in this document 

includes raw agricultural commodities 

and fresh-cut/value-added products. 

This draft guidance is based primarily 

on tomato industry guidelines issued in 

July 2008 (Ref. 1), along with agency 

experience and information from other 

recent public and private programs. 

FDA is issuing this draft guidance as 

Level 1 draft guidance consistent with 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 the 

microbiological hazards that may result 

in contamination of fresh and fresh-cut 

tomatoes and the recommended control 

measures for such hazards in the 

growing, harvesting, packing, 

processing, and distribution of 

tomatoes, along with retail and food 

service preparation. 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 statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to publish notice in the 

Federal Register soliciting public 

comment on each proposed collection of 

information before submitting the 

collection to OMB for approval. To 

comply with this requirement, FDA will 

publish a 60-day notice on the proposed 

collection of information in a future 

issue of the Federal Register. 

III. 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 paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The draft 

guidance and received comments may 

be seen in the Division of Dockets 

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

Monday through Friday. 

IV. 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. 

V. References 

The following reference has been 

placed on display in the Division of 

Dockets Management, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852 

and may be seen by interested persons 

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

through Friday. 

1. North American Tomato Trade 

Workgroup and United Fresh Produce 

Association. ‘‘Commodity Specific Food 

Safety Guidelines for the Fresh Tomato 

Supply Chain.’’ 2d ed., July 2008. Accessed 

online at http://www.fda.gov/Food/ 

FoodSafety/Product-SpecificInformation/ 

FruitsVegetablesJuices/GuidanceCompliance

RegulatoryInformation/ucm171695.htm. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18453 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0348] 

Draft Guidance for Industry: Guide to 

Minimize Microbial Food Safety 

Hazards of Leafy Greens; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Guidance for Industry: Guide to 

Minimize Microbial Food Safety 

Hazards of Leafy Greens.’’ This draft 

guidance is intended to cover the entire 

leafy greens supply chain, both 

domestic firms and foreign firms 

exporting leafy greens products into the 

United States, to enhance the safety of 

leafy greens by recommending practices 

to minimize microbial food safety 

hazards and to prevent microbial 

contamination. This draft guidance, 

when finalized, will supplement 

existing FDA guidances, including the 

1998 ‘‘Guidance to Industry: Guide to 

Minimize Microbial Food Safety 

Hazards for Fresh Fruits and 

Vegetables,’’ which applies to fresh 

produce commodities, and the 2008 

‘‘Guidance to Industry: Guide to 

Minimize Microbial Food Safety 

Hazards of Fresh-cut Fruits and 

Vegetables,’’ which applies to fresh-cut 

produce. 

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 

written or electronic comments on the 

draft guidance by October 2, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Food Safety (HFS–317), Center 

for Food Safety and Applied Nutrition, 

5100 Paint Branch Pkwy., College Park, 

MD 20740. Send one self-addressed 

adhesive label to assist that office in 

processing your request, or fax your 

request to 301–436–2651. 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 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

Amy Green, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–2025. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Guidance for 

Industry: Guide to Minimize Microbial 

Food Safety Hazards of Leafy Greens.’’ 

This draft guidance covers leafy greens 

that are grown and harvested then 

packed or cooled for fresh market or for 

‘‘fresh-cut/value-added processing’’ (i.e., 

minimally processed, such as chopped 

or shredded, moved through a series of 

washes, and then bagged or 

prepackaged), shipped to food service or 

retail establishments, and offered for 


sroberts on DSKD5P82C1PROD with NOTICES
38440 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

sale to the consumer. The term ‘‘leafy 

greens’’ as used in this draft guidance 

includes raw agricultural commodities 

and fresh-cut/value-added products. 

Examples of leafy greens include iceberg 

lettuce, romaine lettuce, leaf lettuce, 

butter lettuce, baby leaf lettuce 

(immature lettuce or leafy greens), 

escarole, endive, spring mix, spinach, 

cabbage, kale, arugula, and chard. Leafy 

greens do not include herbs such as 

cilantro and parsley. 

This draft guidance is based primarily 

on leafy greens industry guidelines 

issued in 2006 (Ref. 1), along with 

agency experience and information from 

other recent public and private 

programs. The leafy greens industry has 

since updated and supplemented its 

2006 guidelines with additional 

recommendations on the production 

and harvest of leafy greens that include 

quantitative metrics and measures to 

assist industry in implementing the 

guidelines (Ref. 2). This draft guidance 

does not include these more specific 

and quantitative metrics and measures. 

We are considering the extent to which 

more specific measures, including 

metrics, should be utilized to help 

verify the implementation and efficacy 

of the Federal recommendations and 

industry practices. We are also 

evaluating the extent to which metrics 

can be applied to diverse geographic 

areas within the United States and 

internationally. FDA invites comment 

on whether such information should be 

incorporated into the guidance, when 

finalized. 

FDA is issuing this draft guidance as 

Level 1 draft guidance 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 the 

microbiological hazards presented by 

fresh and fresh-cut leafy greens products 

and the recommended control measures 

for such hazards in production and 

harvesting, postharvest operations, 

processing, distribution, and retail and 

food service handling of such produce. 

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 statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to publish notice in the 

Federal Register soliciting public 

comment on each proposed collection of 

information before submitting the 

collection to OMB for approval. To 

comply with this requirement, FDA will 

publish a 60-day notice on the proposed 

collection of information in a future 

issue of the Federal Register. 

III. 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 paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The draft 

guidance and received comments may 

be seen in the Division of Dockets 

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

Monday through Friday. 

IV. 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. 

V. References 

The following references have been 

placed on display in the Division of 

Dockets Management, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852 

and may be seen by interested persons 

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

through Friday. 

1. Gorny, J., et al., editors, ‘‘Commodity 

Specific Food Safety Guidelines for the 

Lettuce and Leafy Greens Supply Chain’’ (1st 

ed.); International Fresh-cut Produce 

Association, Produce Marketing Association, 

United Fresh Fruit and Vegetable 

Association, Western Growers Association; 

April 25, 2006. Accessed online at http:// 

www.fda.gov/Food/FoodSafety/ProductSpecificInformation/FruitsVegetablesJuices/ 

GuidanceComplianceRegulatoryInformation/ 

ucm168630.htm. 

2. See ‘‘Commodity Specific Food Safety 

Guidelines for the Production and Harvest of 

Lettuce and Leafy Greens’’; Produce 

Marketing Association, United Fresh Fruit 

and Vegetable Association, and Western 

Growers Association; last revised June 13, 

2008. Accessed online at http:// 

www.caleafygreens.ca.gov/trade/documents/ 

LGMAAcceptedGAPs06.13.08.pdf. (FDA has 

verified the Web site address, but FDA is not 

responsible for any subsequent changes to 

the Web site after this document publishes in 

the Federal Register.) 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18451 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

Federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Treatment of Cancer Using Metal 

Coordinating Compounds That Kill 

Multi-Drug Resistant Cancer Cells 

Description of Invention: One of the 

major hindrances to successful cancer 

chemotherapy is the development of 

multi-drug resistance (MDR) in cancer 

cells. MDR is frequently caused by the 

increased expression or activity of ABC 

transporter proteins in response to the 

toxic agents used in chemotherapy. 

Research has generally been directed to 

overcoming MDR by inhibiting the 

activity of ABC transporters. However, 

compounds that inhibit ABC transporter 

activity often elicit strong and 

undesirable side-effects, restricting their 

usefulness as therapeutics. 

In an alternative approach to reducing 

the debilitating effects of MDR during 

cancer therapy, scientists at the NIH 

have identified a family of compounds 


sroberts on DSKD5P82C1PROD with NOTICES