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Federal Register / Vol. 71, No.

33 / Friday, February 17, 2006 / Notices 8597

DEPARTMENT OF HEALTH AND recommendations to consumers about II. Comments

HUMAN SERVICES healthy eating patterns and wise food
choices. Such advice originated with the Interested persons may submit to the
Food and Drug Administration ‘‘Basic Four’’ and has progressed Division of Dockets Management (see
ADDRESSES) written or electronic
[Docket No. 2006D–0066] through today’s ‘‘Dietary Guidelines for
Americans’’ (developed jointly by the comments regarding this document.
U.S. Department of Health and Human Submit a single copy of electronic
Draft Guidance for Industry and FDA comments or two paper copies of any
Staff: Whole Grains Label Statements; Services and the U.S. Department of
Agriculture). ‘‘Dietary Guidelines for mailed comments, except that
Availability individuals may submit one paper copy.
Americans, 2005’’ (2005 DG)
AGENCY: Food and Drug Administration, recommends that Americans, among Comments are to be identified with the
HHS. other things, ‘‘consume 3 or more docket number found in brackets in the
ACTION: Notice. ounce-equivalents of whole grain heading of this document. If you base
products per day, with the rest of the your comments on scientific evidence or
SUMMARY: The Food and Drug data, please submit copies of the
recommended grains coming from
Administration (FDA) is announcing the enriched or whole-grain products’’ and specific information along with your
availability of a document entitled that ‘‘in general at least half the grains comments. Received comments may be
‘‘Guidance for Industry and FDA Staff: should come from whole grains’’ (Ref. seen in the Division of Dockets
Whole Grain Label Statements.’’ The 1). Management between 9 a.m. and 4 p.m.,
draft guidance is intended to provide Manufacturers may make factual Monday through Friday.
guidance to industry about what the statements about whole grains on the
agency considers to be ‘‘whole grain’’ III. Electronic Access
label of their products, such as ‘‘100%
and to assist manufacturers in labeling whole grain’’ (as percentage labeling Persons with access to the Internet
their products. under 21 CFR 102.5(b)) or ‘‘10 grams of may obtain the draft guidance at: http://
DATES: Submit written or electronic whole grains’’ (21 CFR 101.13(i) (3))
comments concerning the draft provided that the statements are not IV. References
guidance by April 18, 2006, to ensure false or misleading under section 403(a)
their adequate consideration in of the Federal Food, Drug, and Cosmetic The following reference has been
preparation of the final guidance. Act (the act) (21 U.S.C. 343(a)) and do placed on display in the Division of
General comments on agency guidance not imply a particular level of the Dockets Management (see ADDRESSES)
documents are welcome at any time. ingredient, i.e., ‘‘high’’ or ‘‘excellent and may be seen by interested persons
ADDRESSES: Submit written requests for source.’’ In addition, manufacturers may between 9 a.m. and 4 p.m., Monday
single copies of the draft guidance use health claims relating whole grains through Friday.
document to the Office of Nutritional to a reduced risk of coronary heart 1. U.S. Department of Health and Human
Products, Labeling, and Dietary disease and certain cancers on their Services and U.S. Department of Agriculture,
Supplements (HFS–800), Center for product labels for qualifying foods ‘‘Dietary Guidelines for Americans, 2005,’’
based on notifications FDA received
Food Safety and Applied Nutrition, dietaryguidelines, 2005.
Food and Drug Administration, 5100 under section 403(r) (3) (C) of the act (21
Paint Branch Pkwy., College Park, MD U.S.C. 343(r)(3)(C)) (health claims based Dated: February 14, 2006.
20740. Include a self-addressed on an authoritative statement of a Jeffrey Shuren,
adhesive label to assist that office in scientific body) (see http:// Assistant Commissioner for Policy.
processing your request. Submit written [FR Doc. 06–1509 Filed 2–15–06; 8:45 am]
comments on the draft guidance, to the labfdama.html). To assist manufacturers BILLING CODE 4160–01–S
Division of Dockets Management (HFA– in labeling their products, the agency
305), Food and Drug Administration, has reviewed various industry and
5630 Fishers Lane, rm. 1061, Rockville, scientific definitions of ‘‘whole grains’’ DEPARTMENT OF HEALTH AND
MD 20852. Submit electronic comments and developed guidance to industry HUMAN SERVICES
to about what the agency considers to be
ecomments. To ensure more timely ‘‘whole grain.’’ National Institutes of Health
processing of comments, FDA is no The agency has adopted good
guidance practices (GGPs) that set forth Government-Owned Inventions;
longer accepting comments submitted to
the agency’s policies and procedures for Availability for Licensing
the agency by e-mail. See the
SUPPLEMENTARY INFORMATION section for the development, issuance, and use of
guidance documents (21 CFR 10.115). AGENCY: National Institutes of Health,
electronic access to the draft guidance Public Health Service, HHS.
document. This draft guidance is being issued as a
Level 1 guidance document consistent ACTION: Notice.
FOR FURTHER INFORMATION CONTACT: with the GGPs. The draft guidance
Shellee Anderson, Center for Food represents the agency’s current thinking SUMMARY: The inventions listed below
Safety and Applied Nutrition (HFS– on the topic. It does not create or confer are owned by an agency of the U.S.
830), Food and Drug Administration, any rights for or on any person and does Government and are available for
5100 Paint Branch Pkwy., College Park, not operate to bind FDA or the public. licensing in the U.S. in accordance with
MD 20740, 301–436–1491, e-mail: You may use an alternative approach if 35 U.S.C. 207 to achieve expeditious such approach satisfies the commercialization of results of
requirements of applicable statutes and federally-funded research and
sroberts on PROD1PC70 with NOTICES

regulations. If you want to discuss an development. Foreign patent
I. Background alternative approach, contact the FDA applications are filed on selected
Through the years, the Federal staff responsible for implementing this inventions to extend market coverage
Government has worked to provide guidance (see FOR FURTHER INFORMATION for companies and may also be available
consistent and scientifically sound CONTACT). for licensing.

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8598 Federal Register / Vol. 71, No. 33 / Friday, February 17, 2006 / Notices

ADDRESSES: Licensing information and comprising one or more HIV–1 integrase Contact Person: Timothy C. Meeker, MD,
copies of the U.S. patent applications inhibitor compounds, as well as Ph.D., Scientific Review Administrator,
listed below may be obtained by writing methods for treatment or prevention of Resources and Training Review Branch,
Division of Extramural Activities, National
to the indicated licensing contact at the HIV infection. These compounds are
Cancer Institute, 6116 Executive Boulevard,
Office of Technology Transfer, National alpha-hydroxytropolone or its salt, Room 8088, Bethesda, MD 20892. (301) 594–
Institutes of Health, 6011 Executive solvate or hydrate, and they have been 1279,
Boulevard, Suite 325, Rockville, shown to inhibit the integrase by This notice is being published less than 15
Maryland 20852–3804; telephone: 301/ interfering with the enzyme catalytic days prior to the meeting due to the timing
496–7057; fax: 301/402–0220. A signed site by chelating magnesium ions, and limitations imposed by the review and
Confidential Disclosure Agreement will have been shown to inhibit the strand funding cycle.
be required to receive copies of the transfer reaction. Integrase is an (Catalogue of Federal Domestic Assistance
patent applications. important target for AIDS therapy since Program Nos. 93.392, Cancer Construction;
it is critical for viral replication, and 93.393, Cancer Cause and Prevention
Anti-Viral Griffithsin Compounds, Research; 93.394, Cancer Detection and
does not have cellular counterparts,
Compositions, and Methods of Use Diagnosis Research; 93.395, Cancer
which can potentially reduce toxic side
Barry R. O’Keefe et al. (NCI) Treatment Research; 93.396, Cancer Biology
effects. Thus, the compounds of this
U.S. Provisional Application No. 60/ Research; 93.397, Cancer Centers Support;
invention can be developed as novel 93.398, Cancer Research Manpower; 93.399,
741,403 filed 01 Dec 2005 (HHS anti-viral agents that can be used in Cancer Control, National Institutes of Health,
Reference No. E–025–2006/0–US–01). combinational therapy, especially since HHS)
Licensing Contact: Sally H. Hu, Ph.D., they might be less toxic than other anti-
M.B.A.; 301/435–5606; Dated: February 10, 2006.
viral agents. In addition to licensing, the Anna Snouffer,
The invention provides for a technology is available for further Acting Director, Office of Federal Advisory
composition of an anti-viral development through collaborative Committee Policy.
polypeptide, Griffithsin, glycosylation- research opportunities with the [FR Doc. 06–1467 Filed 2–16–06; 8:45 am]
resistant Griffithsin, and related inventors. BILLING CODE 4140–01–M
conjugates, compositions, nucleic acids, Dated: February 10, 2006.
vectors, host cells, antibodies and
Steven M. Ferguson,
methods of production and use. More DEPARTMENT OF HEALTH AND
Director, Division of Technology Development HUMAN SERVICES
specifically, Griffithsin inhibits viral
and Transfer, Office of Technology Transfer,
binding, fusion and entry into the host National Institutes of Health.
cells by binding to viral envelope gp120. National Institutes of Health
[FR Doc. E6–2357 Filed 2–16–06; 8:45 am]
Thus, subject invention can be
BILLING CODE 4140–01–P National Cancer Institute; Notice of
developed as an inhibitor
Closed Meeting
therapeutically or prophylactically
against retroviral infections including DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the
HIV–1 and HIV–2 as well as FIV, SIV, HUMAN SERVICES Federal Advisory Committee Act, as
MLV, BLV, equine infectious virus, amended (5 U.S.C. Appendix 2), notice
avian sarcoma viruses, and HTLV. National Institutes of Health is hereby given of the following
Subject invention also can be developed meetings.
as an inhibitor against non-retroviruses National Cancer Institute; Notice of The meetings will be closed to the
infectious such as influenza virus, Closed Meeting public in accordance with the
including H5N1, SARS, Hepatitis C, and provisions set forth in sections
Pursuant to section 10(d) of the
Ebola, measles, varicella, human herpes 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Federal Advisory Committee Act, as
viruses and others. In addition, as amended. The contract proposals and
amended (5 U.S.C. Appendix 2), notice
Griffithsin can be used in combination the discussions could disclose
is hereby given of the following
with other anti-viral agents to treat confidential trade secrets or commercial
patients who have drug-resistant virus. The meeting will be closed to the property such as patentable material,
In addition to licensing, the public in accordance with the and personal information concerning
technology is available for further provisions set forth in sections individuals associated with the contract
development through collaborative 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., proposals, the disclosure of which
research opportunities with the as amended. The grant applications and would constitute a clearly unwarranted
inventors. the discussions could disclose invasion of personal privacy.
Discovery of Tropolone Inhibitors of confidential trade secrets or commercial Name of Committee: National Cancer
HIV–1 Integrase That Can Be Used for property such as patentable material, Institute Special Emphasis Panel; SBIR Topic
the Treatment of Retroviral Infection, and personal information concerning 217, ‘‘Nanoparticle Biosensors for
individuals associated with the grant Recognition of Exposure and Risk Analysis in
Including AIDS
Yves Pommier, Christophe Marchand, applications, the disclosure of which Date: March 16, 2006.
Elena Semenova, Allison Johnson would constitute a clearly unwarranted Time: 12 p.m. to 4 p.m.
(NCI). invasion of personal privacy. Agenda: To review and evaluate contract
U.S. Provisional Application No. 60/ Name of Committee: National Cancer applications.
741,769 filed 01 Dec 2005 (HHS Institute Initial Review Group, Subcommittee Place: National Institutes of Health, 6116
Reference No. E–308–2005/0–US–01). H—Clinical Groups. Executive Boulevard, Rockville, MD 20852.
sroberts on PROD1PC70 with NOTICES

Licensing Contact: Sally H. Hu, Ph.D., Date: March 6–8, 2006. (Telephone Conference Call).
Time: 6 p.m. to 9:30 a.m. Contact Person: C. Michael Kerwin PhD,
M.B.A.; 301/435–5606; MPH, Scientific Review Administrator,
Agenda: To review and evaluate grant applications. Special Review and Logistics Branch,
This invention provides Place: Providence Biltmore, 11 Dorrance Division of Extramural Activities, National
pharmaceutical compositions Street, Providence, RI 02903. Cancer Institute, National Institutes of

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