Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements; Withdrawal of Guidance, 3060 [E9-964]
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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices
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III. Comments
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Submit a single copy of electronic
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IV. Electronic Access
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V. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site address, but FDA is not
responsible for any subsequent changes
to this Web site after this document
publishes in the Federal Register.)
1. American Cancer Society, Cancer Facts
and Figures, 2004.
2. The Alpha-Tocopherol, Beta Carotene
Cancer Prevention Study Group, ‘‘The Effect
of Vitamin E and Beta Carotene on the
Incidence of Lung Cancer and Other Cancers
in Male Smokers, New England Journal of
Medicine, 330:1029–1035, 1994.
3. Barton S., ‘‘Which Clinical Studies
Provide the Best Evidence? The Best RCT
Still Trumps the Best Observational Study,’’
British Medical Journal, 321:255–256, 2000.
4. Cade, J., R. Thompson, V. Burley, et al.,
‘‘Development, Validation and Utilization of
Food-Frequency Questionnaires—A Review,
Public Health Nutrition, 5:567–587, 2002.
5. Federal Judicial Center, Reference
Manual on Scientific Evidence, 2d ed., 2000.
6. Flegal K.M., ‘‘Evaluating
Epidemiological Evidence of the Effects of
Food and Nutrient Exposures,’’ American
Journal of Clinical Nutrition, 69:1339S–
1344S, 1999.
7. Greer N., G. Mosser, G. Logan, et al., ‘‘A
Practical Approach to Evidence Grading,’’
Joint Commission Journal on Quality
Improvements, 26:700–712, 2000.
8. Hill A.B., ‘‘The Environment and
Disease: Association or Causation?,’’
Proceedings of the Royal Society of Medicine,
58:295–300, 1965.
9. Hord N.G. and J.I. Fenton, ‘‘Context is
Everything: Mining the Normal and
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10. IOM, Institute of Medicine, ‘‘Dietary
Supplements: A Framework for Evaluating
Safety,’’ National Academies Press,
Washington, DC, 2005.
11. Kraemer H.C., K.K. Lowe, D.J. Kupfer,
To Your Health: How to Understand What
Research Tell Us About Risk, Oxford
University Press, 2005.
12. Kris-Etherton, P.M. and J. Dietschy,
‘‘Design Criteria for Studies Examining
Individual Fatty Acid Effects on
Cardiovascular Disease Risk Factors: Human
and Animal Studies,’’ American Journal of
Clinical Nutrition, 1590S–1596S, 1997.
13. Lichtenstein, A.H. and R.M. Russell,
‘‘Essential Nutrients: Food or Supplements?’’
Journal of American Medical Association,
294:351–358, 2005.
14. Milner J.A., ‘‘Diet and Cancer: Facts
and Controversies,’’ Nutrition and Cancer,
56: 216–224, 2006.
15. National Cancer Institute, Dictionary of
Cancer Terms, https://www.cancer.gov/
dictionary.
16. National Research Council, ‘‘Diet and
Health: Implications for Reducing Chronic
Disease Risk,’’ National Academy Press,
Washington, DC, 1989.
17. Omenn, G.S., G.E. Goodman, M.D.
Thornquist, et al., ‘‘Effects of a Combination
of Beta Carotene and Vitamin A on Lung
Cancer and Cardiovascular Disease,’’ New
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18. Peto, R., R. Doll, J.D. Buckley, et al.,
‘‘Can Dietary Beta-Carotene Materially
Reduce Human Cancer Rates?,’’ Nature,
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19. Sempos C.T., K. Liu, N.D. Earnst,
‘‘Food and Nutrient Exposures: What to
Consider When Evaluating Epidemiologic
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20. Torun B., ‘‘Protein-Energy
Malnutrition,’’ In: Modern Nutrition in
Health and Disease, Williams and Williams,
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21. Spilker, B., Guide to Clinical Studies,
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22. Subar, A., et al., ‘‘Comparative
Validation of the Block, Willett, and National
Cancer Institute Food Frequency
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23. Szklo M. and F.J. Nieto, Epidemiology
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24. Willett, W.C., ‘‘Overview of Nutritional
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Dated: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–957 Filed 1–15–09; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–0170] (formerly
Docket No. 1999D–5424)
Guidance for Industry: Significant
Scientific Agreement in the Review of
Health Claims for Conventional Foods
and Dietary Supplements; Withdrawal
of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of a guidance entitled
‘‘Guidance for Industry: Significant
Scientific Agreement in the Review of
Health Claims for Conventional Foods
and Dietary Supplements,’’ that was
issued December 1999.
DATES: The withdrawal is effective
January 16, 2009.
FOR FURTHER INFORMATION CONTACT:
Paula R. Trumbo, Center for Food Safety
and Applied Nutrition (HFS–830), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD, 20740,
301–436–2579.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
December 22, 1999 (64 FR 71794), FDA
announced the availability of a guidance
entitled ‘‘Guidance for Industry:
Significant Scientific Agreement in the
Review of Health Claims for
Conventional Foods and Dietary
Supplements.’’ This guidance is being
withdrawn because it is obsolete.
Dated: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–964 Filed 1–15–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2003–N–0103] (formerly
Docket No. 2003N–0069)
Release of Task Force Report;
Guidance for Industry and FDA:
Interim Evidence-Based Ranking
System for Scientific Data; Withdrawal
of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\16JAN1.SGM
Notice; withdrawal.
16JAN1
]]>Agencies
[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Notices]
[Page 3060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-964]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-0170] (formerly Docket No. 1999D-5424)
Guidance for Industry: Significant Scientific Agreement in the
Review of Health Claims for Conventional Foods and Dietary Supplements;
Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a guidance entitled ``Guidance for Industry: Significant
Scientific Agreement in the Review of Health Claims for Conventional
Foods and Dietary Supplements,'' that was issued December 1999.
DATES: The withdrawal is effective January 16, 2009.
FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD, 20740, 301-436-2579.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of December 22, 1999 (64 FR 71794), FDA announced the
availability of a guidance entitled ``Guidance for Industry:
Significant Scientific Agreement in the Review of Health Claims for
Conventional Foods and Dietary Supplements.'' This guidance is being
withdrawn because it is obsolete.
Dated: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-964 Filed 1-15-09; 8:45 am]
BILLING CODE 4160-01-S
