Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Availability, 38437-38438 [E9-18452]

Download as PDF sroberts on DSKD5P82C1PROD with NOTICES Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 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 VerDate Nov<24>2008 16:05 Jul 31, 2009 Jkt 217001 38437 required to notify FDA within one working day, using the Payment Identification Number described previously. DEPARTMENT OF HEALTH AND HUMAN SERVICES B. Application Cover Sheet Procedures [Docket No. FDA–2009–D–0347] Step One—Create a user account and password. Log onto the AGDUFA website at https://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. Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Availability 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Food and Drug Administration 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 https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Willette Crawford, Center for Food E:\FR\FM\03AUN1.SGM 03AUN1 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: sroberts on DSKD5P82C1PROD with NOTICES 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 VerDate Nov<24>2008 16:05 Jul 31, 2009 Jkt 217001 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 https://www.fda.gov/FoodGuidances or https://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 https:// 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. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 https:// 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, E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38437-38438]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18452]


-----------------------------------------------------------------------

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 https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:  Willette Crawford, Center for Food

[[Page 38438]]

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 https://www.fda.gov/FoodGuidances or https://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 https://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/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
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