Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38437 

in U.S. currency by check, bank draft, or 

U.S. postal money order payable to the 

order of the Food and Drug 

Administration, by wire transfer, or by 

automatic clearing house (ACH) using 

Pay.gov. (The Pay.gov payment option is 

available to you after you submit a cover 

sheet. Click the ‘‘Pay Now’’ button). On 

your check, bank draft, U.S. or postal 

money order, please write your 

application’s unique Payment 

Identification Number, beginning with 

the letters ‘‘AG’’, from the upper righthand corner of your completed Animal 

Generic Drug User Fee Cover Sheet. 

Also write the FDA post office box 

number (PO Box 953877) on the 

enclosed check, bank draft, or money 

order. Your payment and a copy of the 

completed Animal Generic Drug User 

Fee Cover Sheet can be mailed to: Food 

and Drug Administration, P.O. Box 

953877, St. Louis, MO, 63195–3877. 

If payment is made via wire transfer, 

send payment to U. S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Account Name: 

Food and Drug Administration, Account 

Number: 75060099, Routing Number: 

021030004, Swift Number: FRNYUS33. 

You are responsible for any 

administrative costs associated with the 

processing of a wire transfer. Contact 

your bank or financial institution 

regarding the amount of the fees that 

need to be paid in addition to the wire 

transfer amount. 

If you prefer to send a check by a 

courier such as FEDEX or UPS, the 

courier may deliver the check and 

printed copy of the cover sheet to: US 

Bank, Attn: Government Lockbox 

953877, 1005 Convention Plaza, St. 

Louis, Missouri 63101. (Note: This 

address is for courier delivery only. If 

you have any questions concerning 

courier delivery contact the US Bank at 

314–418–4821. This phone number is 

only for questions about courier 

delivery.) 

The tax identification number of the 

Food and Drug Administration is 

530196965. (Note: In no case should the 

payment for the fee be submitted to FDA 

with the application.) 

It is helpful if the fee arrives at the 

bank at least a day or two before the 

abbreviated application arrives at FDA’s 

Center for Veterinary Medicine. FDA 

records the official abbreviated 

application receipt date as the later of 

the following: The date the application 

was received by FDA’s Center for 

Veterinary Medicine, or the date US 

Bank notifies FDA that your payment in 

the full amount has been received, or 

when the U. S. Department of the 

Treasury notifies FDA of payment. US 

Bank and the United States Treasury are 

required to notify FDA within one 

working day, using the Payment 

Identification Number described 

previously. 

B. Application Cover Sheet Procedures 

Step One—Create a user account and 

password. Log onto the AGDUFA 

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

ForIndustry/UserFees/Animal

GenericDrugUserFeeActAGDUFA/ 

ucm137049.htm and scroll down the 

page until you find the link ‘‘Create 

AGDUFA User Fee Cover Sheet.’’ Click 

on that link and follow the directions. 

For security reasons, each firm 

submitting an application will be 

assigned an organization identification 

number, and each user will also be 

required to set up a user account and 

password the first time you use this site. 

Online instructions will walk you 

through this process. 

Step Two—Create an Animal Generic 

Drug User Fee Cover Sheet, transmit it 

to FDA, and print a copy. After logging 

into your account with your user name 

and password, complete the steps 

required to create an Animal Generic 

Drug User Fee Cover Sheet. One cover 

sheet is needed for each abbreviated 

animal drug application. Once you are 

satisfied that the data on the cover sheet 

is accurate and you have finalized the 

Cover Sheet, you will be able to transmit 

it electronically to FDA and you will be 

able to print a copy of your cover sheet 

showing your unique Payment 

Identification Number. 

Step Three—Send the Payment for 

your application as described in Section 

VII.A of this document. 

Step Four—Please submit your 

application and a copy of the completed 

Animal Generic Drug User Fee Cover 

Sheet to the following address: Food 

and Drug Administration, Center for 

Veterinary Medicine, Document Control 

Unit (HFV–199), 7500 Standish Pl., 

Rockville, MD 20855. 

C. Product and Sponsor Fees 

By December 31, 2009, FDA will issue 

invoices and payment instructions for 

product and sponsor fees for FY 2010 

using this fee schedule. Fees will be due 

and payable 30 days after the issuance 

of the invoices. FDA will issue invoices 

in November 2010 for any products and 

sponsors subject to fees for FY 2010 that 

qualify for fees after the December 2009 

billing. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18458 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–0347] 

Draft Guidance for Industry: Guide to 

Minimize Microbial Food Safety 

Hazards of Melons; 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 Melons.’’ This draft guidance 

is intended to cover the entire melon 

supply chain, both domestic firms and 

foreign firms exporting melons into the 

United States, to enhance the safety of 

melons 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: 

Willette Crawford, Center for Food 


sroberts on DSKD5P82C1PROD with NOTICES
38438 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1111. 

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 Melons.’’ This 

draft guidance covers melons that are 

grown and harvested for fresh market 

(i.e., fresh, unprocessed form) or for 

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

minimally processed, such as trimmed, 

peeled, sliced or diced, and then bagged 

or prepackaged), cooled, shipped to 

retail, wholesale or for processing, and 

offered for sale to the consumer. The 

term ‘‘melons’’ as used in this draft 

guidance includes raw agricultural 

commodities and fresh-cut/value-added 

products derived from cantaloupe (also 

known as muskmelons), honeydew, 

watermelon, and variety melons (e.g., 

‘‘Canary,’’ ‘‘Crenshaw,’’ and ‘‘Galia’’). 

This draft guidance is based primarily 

on melon industry guidelines issued in 

2005 (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 presented by 

fresh and fresh-cut melons 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 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. Fleming, P., Pool, W., and Gorny, J., 

editors; ‘‘Commodity Specific Food Safety 

Guidelines for the Melon Supply Chain’’ (1st 

ed.); Produce Marketing Association and 

United Fresh Produce Association; November 

7, 2005. Accessed online at http:// 

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

GuidanceComplianceRegulatoryInformation/ 

ucm168609.htm. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18452 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–0346] 

Draft Guidance for Industry: Guide to 

Minimize Microbial Food Safety 

Hazards of Tomatoes; 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 Tomatoes.’’ This guidance is 

intended to cover the entire tomato 

supply chain, both domestic firms and 

foreign firms exporting tomatoes into 

the United States, to enhance the safety 

of tomatoes 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 for Industry: Guide to 

Minimize Microbial Food Safety 

Hazards for Fresh Fruits and 

Vegetables,’’ which applies to fresh 

produce commodities, and the 2008 

‘‘Guidance for 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: 

Michelle A. Smith, Center for Food 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2024. 

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 Tomatoes.’’ This 

draft guidance covers the growing, 


sroberts on DSKD5P82C1PROD with NOTICES