Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Availability, 38437-38438 [E9-18452]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