38434 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18459 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–N–0340] 

Animal Generic Drug User Fee Rates 

and Payment Procedures for Fiscal 

Year 2010 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates and payment procedures for fiscal 

year (FY) 2010 generic new animal drug 

user fees. The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Animal Generic Drug User Fee Act 

of 2008 (AGDUFA), authorizes FDA to 

collect user fees for certain abbreviated 

applications for generic new animal 

drugs, on certain generic new animal 

drug products, and on certain sponsors 

of such abbreviated applications for 

generic new animal drugs and/or 

investigational submissions for generic 

new animal drugs. This notice 

establishes the fee rates for FY 2010. 

For FY 2010, the generic animal drug 

user fee rates are: $75,000 for each 

abbreviated application for a generic 

new animal drug; $3,255 for each 

generic new animal drug product; 

$54,050 for each generic new animal 

drug sponsor paying 100 percent of the 

sponsor fee; $40,537 for each generic 

new animal drug sponsor paying 75 

percent of the sponsor fee; and $27,025 

for a generic new animal drug sponsor 

paying 50 percent of the sponsor fee. 

FDA will issue invoices for FY 2010 

product and sponsor fees by December 

31, 2009. These fees will be due and 

payable within 30 days of the issuance 

of the invoices. 

The application fee rates are effective 

for all abbreviated applications for a 

generic new animal drug submitted on 

or after October 1, 2009, and will remain 

in effect through September 30, 2010. 

Applications will not be accepted for 

review until the FDA has received full 

payment of related application fees and 

any other fees owed under the Animal 

Generic Drug User Fee program. 

FOR FURTHER INFORMATION CONTACT: Visit 

the FDA Web site at http://www.fda.gov/ 

ForIndustry/UserFees/Animal

GenericDrugUserFeeActAGDUFA/ 

default.htm or contact Bryan Walsh, 

Center for Veterinary Medicine (HFV– 

10), Food and Drug Administration, 

7529 Standish Pl., Rockville, MD 20855, 

240–276–9730. For general questions, 

you may also e-mail the Center for 

Veterinary Medicine (CVM) at: 

cvmagdufa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 741 of the act (21 U.S.C. 379j– 

21) establishes three different kinds of 

user fees: (1) Fees for certain types of 

abbreviated applications for generic new 

animal drugs, (2) annual fees for certain 

generic new animal drug products, and 

(3) annual fees for certain sponsors of 

abbreviated applications for generic new 

animal drugs and/or investigational 

submissions for generic new animal 

drugs (21 U.S.C. 379j–21(a)). When 

certain conditions are met, FDA will 

waive or reduce fees for generic new 

animal drugs intended solely to provide 

for a minor use or minor species 

indication (21 U.S.C. 379j–21(d)). 

For FY 2009 through FY 2013, the act 

establishes aggregate yearly base 

revenue amounts for each of these fee 

categories. Base revenue amounts 

established for years after FY 2009 may 

be adjusted for workload. Fees for 

applications, products, and sponsors are 

to be established each year by FDA so 

that the revenue for each fee category 

will approximate the level established 

in the statute, after the level has been 

adjusted for workload. 

II. Revenue Amount for FY 2010 

A. Statutory Fee Revenue Amounts 

AGDUFA (Title II of Public Law 110– 

316 signed by the President on August 

14, 2008) specifies that the aggregate 

revenue amount for FY 2010 for 

abbreviated application fees is 

$1,532,000 and each of the other two 

generic new animal drug user fee 

categories, annual product fees and 

annual sponsor fees, is $1,787,000 each, 

before any adjustment for workload is 

made (see 21 U.S.C. 379j–21(b)). 

B. Inflation Adjustment to Fee Revenue 

Amount 

The amounts established in AGDUFA 

for each year for FY 2009 through FY 

2013 include an inflation adjustment, so 

no inflation adjustment is required. 

C. Workload Adjustment to Inflation 

Adjusted Fee Revenue Amount 

For each FY beginning after FY 2009, 

AGDUFA provides that statutory fee 

revenue amounts shall be further 

adjusted to reflect changes in review 

workload (21 U.S.C. 379j–21(c)(1)). 

FDA calculated the average number of 

each of the four types of applications 

and submissions specified in the 

workload adjustment provision 

(abbreviated applications for generic 

new animal drugs, manufacturing 

supplemental abbreviated applications 

for generic new animal drugs, 

investigational generic new animal drug 

study submissions, and investigational 

generic new animal drug protocol 

submissions) received over the 5-year 

period ended on September 30, 2008 

(the base years), and the average number 

of each of these types of applications 

and submissions over the most recent 5- 

year period that ended on June 30, 2009. 

The results of these calculations are 

presented in the first two columns of 

table 1 of this document. Column 3 

reflects the percent change in workload 

over the two 5-year periods. Column 4 

shows the weighting factor for each type 

of application, reflecting how much of 

the total FDA generic new animal drug 

review workload was accounted for by 

each type of application or submission 

in the table during the most recent 5 

years. Column 5 of table 1 is the 

weighted percent change in each 

category of workload, and was derived 

by multiplying the weighting factor in 

each line in column 4 by the percent 

change from the base years in column 3. 

At the bottom right of table 1, the sum 

of the values in column 5 is calculated, 

reflecting a total change in workload of 

negative 11.2 percent for FY 2010. This 

is the workload adjuster for FY2010. 

TABLE 1.—WORKLOAD ADJUSTER CALCULATION

Application type 

Column 1 

5-Year Avg. (Base 

Years) 

Column 2 

Latest 5-Year Avg. 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Colum 5 

Weighted Percent 

Change 

Abbreviated New Animal Drug Applications (ANADAs) 44 .20 38 .00 -14% 59% -8 .3% 


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TABLE 1.—WORKLOAD ADJUSTER CALCULATION—Continued 

Application type 

Column 1 

5-Year Avg. (Base 

Years) 

Column 2 

Latest 5-Year Avg. 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Colum 5 

Weighted Percent 

Change 

Manufacturing Supplements ANADAs 114 .80 101 .20 -12% 15% -1 .8% 

Generic Investigational Study Submissions 18 .00 19 .60 9% 10% .9% 

Generic Investigational Protocol Submissions 21 .60 18 .80 -13% 16% -2 .1% 

FY 2010 AGDUFA Workload Adjuster -11 .2% 

AGDUFA specifies that the workload 

adjuster may not result in fees for a 

fiscal year that are less than the 

statutory revenue amount (21 U.S.C. 

379j–21(c)(1)(B)) for that fiscal year. 

Because applying the workload adjuster 

for FY 2010 would result in fees less 

than the statutory amount, the workload 

adjustment will not be applied in FY 

2010. As a result, the statutory revenue 

amount for each category of fees for FY 

2010 ($1,532,000 for application fees 

and $1,787,000 for both product and 

sponsor fees) becomes the revenue 

target for the fees in FY 2010, for a total 

inflation-adjusted fee revenue target in 

FY 2010 of $5,106,000 for fees from all 

three categories. 

III. Abbreviated Application Fee 

Calculations for FY 2010 

The term ‘‘abbreviated application for 

a generic new animal drug’’ is defined 

in 21 U.S.C. 379j–21(k)(1). 

A. Application Fee Revenues and 

Numbers of Fee-Paying Applications 

The application fee must be paid for 

abbreviated applications for a generic 

new animal drug that is subject to fees 

under AGDUFA and that is submitted 

on or after July 1, 2008. The application 

fees are to be set so that they will 

generate $1,532,000 in fee revenue for 

FY 2010. This is the amount set out in 

the statute. 

To set fees for abbreviated 

applications for generic new animal 

drugs to realize $1,532,000, FDA must 

first make some assumptions about the 

number of fee-paying abbreviated 

applications it will receive during FY 

2010. 

The agency knows the number of 

applications that have been submitted 

in previous years. That number 

fluctuates significantly from year to 

year. FDA is making estimates and 

applying different assumptions for two 

types of submissions: Original 

submissions of abbreviated applications 

for generic new animal drugs and 

‘‘reactivated’’ submissions of 

abbreviated applications for generic new 

animal drugs. Any original submissions 

of abbreviated applications for generic 

new animal drugs that were received by 

the FDA before July 1, 2008, were not 

assessed fees (21 U.S.C. 379j– 

21(a)(1)(A)). Some of these nonfee 

paying submissions were later 

resubmitted after July 1 because the 

initial submission was not approved by 

the FDA (i.e. the FDA marked the 

submission as incomplete and requested 

additional nonadministrative 

information) or because the original 

submission was withdrawn by the 

sponsor. Because these abbreviated 

applications for generic new animal 

drugs are resubmitted after July 1, 2008, 

they are assessed fees. In this notice, 

FDA refers to these resubmitted 

applications as ‘‘reactivated’’ 

applications. 

Regarding original submissions of 

abbreviated applications for generic new 

animal drugs, FDA is assuming that the 

number of applications that will pay 

fees in FY 2010 will equal 30-percent 

less than the average number of 

submissions over the 5 most recent 

years. This 30-percent reduction is 

made because of the anticipated impact 

of fees on the number on submissions. 

During FY 2010, FDA estimates it will 

receive only 5 original submissions of 

abbreviated applications for generic new 

animal drugs, compared to average 

receipts of 16.2 per year over the latest 

5 years, including our FY 2009 estimate. 

Applying a 30-percent reduction to the 

16.2 average, the estimate for original 

submissions of abbreviated applications 

for generic new animal drugs for FY 

2010 is 11.3. (If the number of original 

submissions of abbreviated applications 

for generic new animal drugs does not 

increase over the next year, a higher 

percent reduction will have to be 

applied a year from now when fees are 

set for FY 2011.) 

Regarding reactivated submissions of 

abbreviated applications for generic new 

animal drugs, FDA is applying a 50- 

percent reduction based on the FDA’s 

experience with these types of 

submissions during the second year of 

other user fee programs. This 

assumption is based on the fact that 

there were a limited number of original 

submissions of abbreviated applications 

for generic new animal drugs received 

by FDA before July 1, 2008, and which 

were not assessed fees. For these 

original submissions that were not 

approved before July 1, 2008, 

resubmission to the FDA would trigger 

an application fee (21 U.S.C. 379j– 

21(a)(1)(A)). Once these initial original 

submissions of abbreviated applications 

for generic new animal drugs received 

by the FDA before July 1, 2008, have 

either been withdrawn or resubmitted, 

‘‘reactivation submissions’’ will cease 

completely. This reduction is consistent 

with estimates made when this user fee 

program was in the development 

process. During FY 2009, FDA estimates 

it will receive only 3 reactivated 

submissions of abbreviated applications 

for generic new animal drugs, compared 

to average receipts of 18.2 per year over 

the most recent 5 years, including our 

estimate for FY 2009. Applying a 50- 

percent reduction to the 18.2 average, 

the estimate for reactivated submissions 

of abbreviated applications for generic 

new animal drugs for FY 2010 is 9.1. 

These reductions may not fully account 

for possible year to year fluctuations in 

numbers of fee-paying applications, but 

FDA believes that this is a reasonable 

approach after about 6 years of 

experience with a similar user fee 

program. 

Based on the previous assumptions, 

FDA is estimating that it will receive a 

total of 20.4 fee paying generic new 

animal drug applications in FY 2010 

(11.3 original applications and 9.1 

reactivations). 

B. Fee Rates for FY 2010 

FDA must set the fee rates for FY 2010 

so that the estimated 20.4 abbreviated 

applications that pay the fee will 

generate a total of $1,532,000. To 

generate this amount, the fee for a 


sroberts on DSKD5P82C1PROD with NOTICES
38436 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

generic new animal drug application, 

rounded to the nearest hundred dollars, 

will have to be $75,000. 

IV. Generic New Animal Drug Product 

Fee Calculations for FY 2010 

A. Product Fee Revenues and Numbers 

of Fee-Paying Products 

The generic new animal drug product 

fee (also referred to as the product fee) 

must be paid annually by the person 

named as the applicant in an 

abbreviated new animal drug 

application or supplemental abbreviated 

application for generic new animal 

drugs for an animal drug product 

submitted for listing under section 510 

of the act (21 U.S.C. 360), and who had 

an abbreviated application for a generic 

new animal drug or supplemental 

abbreviated application for a generic 

new animal drug pending at FDA after 

September 1, 2008 (see 21 U.S.C. 379j– 

21(a)(2)). The term ‘‘generic new animal 

drug product’’ means each specific 

strength or potency of a particular active 

ingredient or ingredients in final dosage 

form marketed by a particular 

manufacturer or distributor, which is 

uniquely identified by the labeler code 

and product code portions of the 

national drug code, and for which an 

abbreviated application for a generic 

new animal drug or supplemental 

abbreviated application for a generic 

new animal drug has been approved (21 

U.S.C. 379j–21(k)(6)). The product fees 

are to be set so that they will generate 

$1,787,000 in fee revenue for FY 2010. 

This is the amount set out in the statute 

and no further adjustments are required 

for FY 2010. 

To set generic new animal drug 

product fees to realize $1,787,000, FDA 

must make some assumptions about the 

number of products for which these fees 

will be paid in FY 2010. FDA gathered 

data on all generic new animal drug 

products that have been submitted for 

listing under section 510 of the act, and 

matched this to the list of all persons 

who FDA estimated would have an 

abbreviated new animal drug 

application or supplemental abbreviated 

application pending after September 1, 

2008. FDA estimates a total of 610 

products submitted for listing by 

persons who had an abbreviated 

application for a generic new animal 

drug or supplemental abbreviated 

application for a generic new animal 

drug pending after September 1, 2008. 

Based on this, FDA believes that a total 

of 610 products will be subject to this 

fee in FY 2010. 

In estimating the fee revenue to be 

generated by generic new animal drug 

product fees in FY 2010, FDA is 

assuming that 10 percent of the 

products invoiced, or 61, will not pay 

fees in FY 2010 due to fee waivers and 

reductions. Based on experience with 

other user fee programs and the first 6 

years of ADUFA, FDA believes that this 

is a reasonable basis for estimating the 

number of fee-paying products in FY 

2010. 

Accordingly, the agency estimates 

that a total of 549 (610 minus 61) 

products will be subject to product fees 

in FY 2010. 

B. Product Fee Rates for FY 2010 

FDA must set the fee rates for FY 2010 

so that the estimated 549 products that 

pay fees will generate a total of 

$1,787,000. To generate this amount 

will require the fee for a generic new 

animal drug product, rounded to the 

nearest five dollars, to be $3,255. 

V. Generic New Animal Drug Sponsor 

Fee Calculations for FY 2010 

A. Sponsor Fee Revenues and Numbers 

of Fee-Paying Sponsors 

The generic new animal drug sponsor 

fee (also referred to as the sponsor fee) 

must be paid annually by each person 

who: (1) is named as the applicant in an 

abbreviated application for a new 

generic animal drug, except for an 

approved application for which all 

subject products have been removed 

from listing under section 510 of the act, 

or has submitted an investigational 

submission for a generic new animal 

drug that has not been terminated or 

otherwise rendered inactive; and (2) had 

an abbreviated application for a generic 

new animal drug, supplemental 

abbreviated application for a generic 

new animal drug, or investigational 

submission for a generic new animal 

drug pending at FDA after September 1, 

2008 (see 21 U.S.C. 379j–21(k)(7) and 

379j–21(a)(3)). A generic new animal 

drug sponsor is subject to only one such 

fee each fiscal year (see 21 U.S.C. 379j– 

21(a)(3)(B)). Applicants with more than 

6 approved abbreviated applications 

will pay 100 percent of the sponsor fee, 

applicants with 2 to 6 approved 

abbreviated applications will pay 75 

percent of the sponsor fee, and 

applicants with 1 or fewer approved 

abbreviated applications will pay 50 

percent of the sponsor fee (see 21 U.S.C. 

379j–21(a)(3)(B)). The sponsor fees are 

to be set so that they will generate 

$1,787,000 in fee revenue for FY 2010. 

This is the amount set out in the statute 

and no adjustments are required for FY 

2010. 

To set generic new animal drug 

sponsor fees to realize $1,787,000, FDA 

must make some assumptions about the 

number of sponsors who will pay these 

fees in FY 2010. Based on the number 

of firms that meet this definition, FDA 

estimates that in FY 2010, 11 sponsors 

will pay 100 percent fees, 11 sponsors 

will pay 75 percent fees, and 35 

sponsors will pay 50 percent fees. That 

totals the equivalent of 36.75 full 

sponsor fees (11 times 100 percent or 

11, plus 11 times 75 percent or 8.25, 

plus 35 times 50 percent or 17.5). 

FDA estimates that about 10 percent 

of all of these sponsors, or 3.675, may 

qualify for a minor use/minor species 

waiver. 

Accordingly, the agency estimates 

that the equivalent of 33.075 full 

sponsor fees (36.75 minus 3.675) are 

likely to be paid in FY 2010. 

B. Sponsor Fee Rates for FY 2010 

FDA must set the fee rates for FY 2010 

so that the estimated equivalent of 

33.075 full sponsor fees will generate a 

total of $1,787,000. To generate this 

amount will require the 100-percent fee 

for a generic new animal drug sponsor, 

rounded to the nearest $50, to be 

$54,050. Accordingly, the fee for those 

paying 75 percent of the full sponsor 

fee, rounded to the nearest $5, will be 

$40,537, and the fee for those paying 50 

percent of the full sponsor fee will be 

$27,025. 

VI. Fee Schedule for FY 2010 

The fee rates for FY 2010 are 

summarized in table 2 of this document. 

TABLE 2.—FY 2010 FEE RATES

Generic New Animal Drug User 

Fee Category 

Fee Rate 

for FY 2010 

Abbreviated Application Fee for 

Generic New Animal Drug 

Application $75,000 

Generic New Animal Drug 

Product Fee $3,255 

100 Percent Generic New Animal Drug Sponsor Fee(1) $54,050 

75 Percent Generic New Animal Drug Sponsor Fee(1) $40,537 

50 Percent Generic New Animal Drug Sponsor Fee(1) $27,025 

(1)An animal drug sponsor is subject to only 

one fee each fiscal year 

VII. Procedures for Paying FY 2010 

Generic New Animal Drug User Fees 

A. Abbreviated Application Fees and 

Payment Instructions 

The FY 2010 fee established in the 

new fee schedule must be paid for an 

abbreviated new animal drug 

application subject to fees under 

AGDUFA that is submitted on or after 

October 1, 2009. Payment must be made 


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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 


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