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Federal Register / Vol. 73, No.

37 / Monday, February 25, 2008 / Notices 10037

DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: provisions in the draft guidance. After
HUMAN SERVICES Rhoma Johnson, Center for Food Safety providing the 60-day notice requesting
and Applied Nutrition (HFS–317), Food public comment, section 3507 of the
Food and Drug Administration and Drug Administration, 5100 Paint PRA (44 U.S.C. 3507) requires Federal
Branch Pkwy., College Park, MD 20740, agencies to submit the proposed
[FDA–2008–D–0108 (formerly Docket No. collection to OMB for review and
301–436–2066 or FAX: 301–436–2651.
2006D–0079)]
SUPPLEMENTARY INFORMATION: clearance. In compliance with 44 U.S.C.
Guidance for Industry: Guide to 3507, FDA submitted the proposed
I. Background collection of information to OMB for
Minimize Food Safety Hazards for
Fresh-cut Fruits and Vegetables; Fresh-cut fruits and vegetables are review and clearance.
Availability minimally processed fruits and On March 13, 2007, FDA published in
vegetables that have been altered in the Federal Register a notice
AGENCY: Food and Drug Administration, form by peeling, slicing, chopping, announcing the availability of a ‘‘Draft
HHS. shredding, coring, or trimming, with or Final Guidance for Industry: Guide to
ACTION: Notice. without washing or other treatment, Minimize Food Safety Hazards for
prior to being packaged for use by the Fresh-Cut Fruits and Vegetables’’ (72 FR
SUMMARY: The Food and Drug consumer or a retail establishment. The 11364). This document was issued as a
Administration (FDA) is announcing the methods by which produce is grown, ‘‘draft final’’ guidance pending OMB
availability of a final guidance harvested, and processed may approval of the collection of
document entitled ‘‘Guidance for contribute to its contamination with information. FDA announced OMB’s
Industry: Guide to Minimize Microbial pathogens and, consequently, the role of approval of the collection of information
Food Safety Hazards of Fresh-cut Fruits in a notice published on October 19,
the produce in transmitting foodborne
and Vegetables’’ (the fresh-cut guidance 2007 (72 FR 59295). With OMB
illness. Factors such as the high degree
or guidance). Previously, FDA approval, FDA is publishing this notice
of handling and mixing of the product,
announced the availability of the fresh- announcing that the fresh-cut guidance
the release of cellular fluids during
cut guidance as a ‘‘draft final’’ is final and providing an OMB control
cutting or chopping, the high moisture
document, pending approval by the number (See section II of this
content of the product, the absence of a
Office of Management and Budget document).
step lethal to pathogens, and the The fresh-cut guidance is being issued
(OMB) of the information collection potential for temperature abuse in the
provisions in the guidance. FDA is consistent with FDA’s good guidance
processing, storage, transport, and retail practices regulation (21 CFR 10.115).
publishing this notice to announce that display all enhance the potential for
the fresh-cut guidance is now final. The The fresh-cut guidance is intended to
pathogens to survive and grow in fresh- assist processors in minimizing
text of the guidance has not changed cut produce.
from the previously published draft microbial food safety hazards common
On March 6, 2006, FDA published in to the processing of most fresh-cut fruits
final version. The fresh-cut guidance the Federal Register a notice entitled
complements FDA’s current good and vegetables sold to consumers and
‘‘Draft Guidance for Industry: Guide to retail establishments in a ready-to-eat
manufacturing practice (CGMP) Minimize Food Safety Hazards of Fresh-
requirements for foods by providing form. This guidance represents FDA’s
Cut Fruits and Vegetables’’ (71 FR current thinking on the microbiological
specific guidance on the processing of 11209) (the March 2006 notice). FDA
fresh-cut produce. The fresh-cut hazards presented by most fresh-cut
gave interested persons 60 days to fruits and vegetables and the
guidance and the CGMP regulations are comment on the draft guidance. The
intended to assist processors in recommended control measures for such
comment period closed on May 5, 2006. hazards in the processing of such
minimizing microbial food safety The draft guidance was revised based on
hazards common to the processing of produce. It does not create or confer any
public comments. The draft guidance rights for or on any person and does not
most fresh-cut fruits and vegetables sold contained information collection
to consumers and retail establishments operate to bind FDA or the public. You
provisions subject to review by OMB may use an alternative approach if such
in a ready-to-eat form. under the Paperwork Reduction Act of
DATES: Submit written or electronic
approach satisfies the requirements of
1995 (PRA) (44 U.S.C. 3501–3520). the applicable statutes and regulations.
comments on the guidance at any time. Under the PRA, Federal agencies must
ADDRESSES: Submit written comments obtain approval from OMB for each II. Paperwork Reduction Act of 1995
on the guidance to the Division of collection of information they conduct This guidance contains information
Dockets Management (HFA–305), Food or sponsor. ‘‘Collection of information’’ collection provisions that are subject to
and Drug Administration, 5630 Fishers is defined in 44 U.S.C. 3502(3) and 5 review by the Office of Management and
Lane, rm. 1061, Rockville, MD 20852. CFR 1320.3 and includes agency Budget (OMB) under the Paperwork
Submit electronic comments to http:// requests or requirements that members Reduction Act of 1995 (44 U.S.C. 3501–
www.regulations.gov. See the of the public submit reports, keep 3520). The collection of information in
SUPPLEMENTARY INFORMATION section for records, or provide information to a this guidance was approved under OMB
electronic access to the guidance third party. Section 3506(c)(2)(A) of the control number 0910–0609.
document. Submit written requests for PRA (44 U.S.C. 3506(c)(2)(A)) requires
single copies of the guidance to the Federal agencies to provide a 60-day III. Comments
Office of Food Safety (HFS–317), Center notice in the Federal Register Interested persons may submit to the
for Food Safety and Applied Nutrition, concerning each proposed collection of Division of Dockets Management (see
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Food and Drug Administration, 5100 information before submitting the ADDRESSES) written or electronic
Paint Branch Pkwy., College Park, MD collection to OMB for approval. To comments regarding this guidance
20740, 301–436–1700 or FAX: 301–436– comply with this requirement, in the document at any time. Submit a single
2651. Send one self-addressed adhesive March 2006 notice (71 FR 11209), FDA copy of electronic comments or two
label to assist the Center in processing gave interested persons 60 days to paper copies of any mailed comments,
your request. comment on the information collection except that individuals may submit one

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10038 Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Notices

paper copy. Comments are to be NIH, Bethesda, MD 20892, 301–496–6844, Office, National Institute on Aging, Gateway
identified with the docket number iwl@helix.nih.gov. Building, 7201 Wisconsin Avenue/Suite
found in brackets in the heading of this Any interested person may file written 2C212, Bethesda, MD 20892, (301) 496–7705,
comments with the committee by forwarding hsul@exmur.nia.nih.gov.
document. The guidance and received
the statement to the Contact Person listed on Name of Committee: National Institute on
comments may be seen in the Division this notice. The statement should include the Aging Special Emphasis Panel, Menopause
of Dockets Management between 9 a.m. name, address, telephone number and when Symptoms and Interventions.
and 4 p.m., Monday through Friday. applicable, the business or professional Date: March 18, 2008.
Please note that on January 15, 2008, affiliation of the interested person. Time: 8 a.m. to 4 p.m.
the FDA Web site transitioned to the In the interest of security, NIH has Agenda: To review and evaluate grant
Federal Dockets Management System instituted stringent procedures for entrance applications.
(FDMS). FDMS is a Government-wide, onto the NIH campus. All visitor vehicles, Place: Crowne Plaza Hotel, 8777 Georgia
electronic docket management system. including taxicabs, hotel, and airport shuttles Avenue, Silver Spring, MD 20910.
Electronic submissions will be accepted will be inspected before being allowed on Contact Person: Elaine Lewis, PhD,
campus. visitors will be asked to show one Scientific Review Administrator, Scientific
by FDA through FDMS only. form of identification (for example, a Review Office, National Institute on Aging,
IV. Electronic Access government-issued photo ID, driver’s license, Gateway Building, Suite 2C212, MSC–9205,
or passport) and to state the purpose of their 7201 Wisconsin Avenue, Bethesda, MD
Persons with access to the Internet visit. 20892, (301) 402–7707,
may obtain the guidance document at (Catalogue of Federal Domestic Assistance elainelewis@.nia.nih.gov.
the following Web site: http:// Program Nos. 93.847, Diabetes, Name of Committee: National Institute on
www.cfsan.fda.gov/guidance.html. Endocrinology and Metabolic Research; Aging Special Emphasis Panel, Health Care
Dated: February 15, 2008. 93.848, Digestive Diseases and Nutrition Productivity.
Jeffrey Shuren, Research; 93.849, Kidney Diseases, Urology Date: April 4, 2008.
and Hematology Research, National Institutes Time: 1:30 p.m. to 5:30 p.m.
Assistant Commissioner for Policy. of Health, HHS) Agenda: To review and evaluate grant
[FR Doc. E8–3417 Filed 2–22–08; 8:45 am] applications.
Dated: February 15, 2008.
BILLING CODE 4160–01–S
Jennifer Spaeth, Place: National Institute on Aging,
Bethesda, MD 20770 (Telephone Conference
Director, Office of Federal Advisory Call).
DEPARTMENT OF HEALTH AND Committee Policy. Contact Person: Wilbur C. Hadden, PhD,
HUMAN SERVICES [FR Doc. 08–815 Filed 2–22–08; 8:45 am] Health Scientist Administrator, National
BILLING CODE 4140–01–M Institute on Aging, Gateway Building, Room
National Institutes of Health 2C212, 7201 Wisconsin Avenue, Bethesda,
MD 20892, haddenw@mail.nih.gov.
National Institute of Diabetes and DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance
Digestive and Kidney Diseases; Notice HUMAN SERVICES Program Nos. 93.866, Aging Research,
of Closed Meeting National Institutes of Health, HHS)
National Institutes of Health Dated: February 15, 2008.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as Jennifer Spaeth,
National Institute on Aging; Notice of
amended (5 U.S.C. Appendix 2), notice Closed Meetings Director, Office of Federal Advisory
is hereby given of a meeting of the Committee Policy.
Board of Scientific Counselors, NIDDK. Pursuant to section 10(d) of the [FR Doc. 08–816 Filed 2–22–08; 8:45 am]
The meeting will be closed to the Federal Advisory Committee Act, as BILLING CODE 4140–01–M
public as indicated below in accordance amended (5 U.S.C. Appendix 2), notice
with the provisions set forth in section is hereby given of the following
552b(c)(6), Title 5 U.S.C., as amended meetings. DEPARTMENT OF HEALTH AND
for the review, discussion, and The meetings will be closed to the HUMAN SERVICES
evaluation of individual intramural public in accordance with the
programs and projects conducted by the provisions set forth in sections National Institutes of Health
National Institute of Diabetes and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and National Institute on Drug Abuse;
Digestive and Kidney Diseases,
the discussions could disclose Notice of Closed Meetings
including consideration of personnel
qualifications and performance, and the confidential trade secrets or commercial Pursuant to section 10(d) of the
competence of individual investigators, property such as patentable material, Federal Advisory Committee Act, as
the disclosure of which would and personal information concerning amended (5 U.S.C. Appendix 2), notice
constitute a clearly unwarranted individuals associated with the grant is hereby given of the following
invasion of personal privacy. applications, the disclosure of which meetings.
would constitute a clearly unwarranted The meetings will be closed to the
Name of Committee: Board of Scientific
Counselors, NIDDK.
invasion of personal privacy. public in accordance with the
Date: April 3, 2008. Name of Committee: National Institute on provisions set forth in sections
Time: 8 a.m. to 6:45 p.m. Aging Special Emphasis Panel, Non Nsaid 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Agenda: To review and evaluate personal Action in AD. as amended. The grant applications and
qualifications and performance, and Date: March 17, 2008. the discussions could disclose
competence of individual investigators. Time: 1 p.m. to 4:30 p.m. confidential trade secrets or commercial
Place: National Institutes of Health, Agenda: To review and evaluate grant
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property such as patentable material,


Building 10, 10 Center Drive, 9S235, applications.
Bethesda, MD 20892. Place: National Institute on Aging,
and personal information concerning
Contact Person: Ira W. Levin, PhD, Chief, Bethesda, MD 20770 (Telephone Conference individuals associated with the grant
Section on Molecular Biophysics, Division of Call). applications, the disclosure of which
Intramural Research, National Institute of Contact Person: Louise L. Hsu, PhD, Health would constitute a clearly unwarranted
Diabetes and Digestive, and Kidney Diseases, Scientist Administrator, Scientific Review invasion of personal privacy.

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