Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 3059 

would not make sense in a particular 

context. 

The guidance states that a 

certification body should immediately 

notify FDA and the establishment it is 

certifying if an auditor finds or 

discovers a situation in which there is 

a reasonable probability that the food or 

feed from the audited establishment will 

cause serious adverse health 

consequences or death to humans or 

animals. We believe that such reporting 

is appropriate. Although the 

certification body is not a regulatory 

entity, we believe it would help protect 

public health for such circumstances to 

be reported to FDA so that we can 

investigate the situation. The guidance 

also notes that an establishment that 

receives this information may be subject 

to the requirement imposed by section 

1005 of the Food and Drug 

Administration Amendments Act of 

2007 to report certain information to 

FDA via an electronic portal. 

The guidance states that while FDA 

may provide incentives for 

participation, neither establishments 

nor certifying bodies are under an 

obligation to participate. FDA does not 

intend to target uncertified 

establishments or products for 

inspection or sampling, for example, 

based solely on their lack of 

certification. 

One comment raised a concern 

regarding the ability of a foreign 

Government to serve as a certification 

body. As in the draft guidance, the 

guidance states that foreign 

Governments may be certification 

bodies. More specifically, the definition 

of certification body states that it could 

be a Federal, State, local, or foreign 

Government agency, as well as a nonGovernment entity that is independent 

of the businesses it certifies and free 

from conflicts of interest. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on voluntary thirdparty certification programs for foods 

and feeds. 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. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the guidance. 

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 the brackets in 

the heading of this document. A copy of 

the guidance and received comments 

are available for public examination in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS 

athttp://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/oc/guidance/ 

thirdpartycert.html or http:// 

www.regulations.gov. 

Dated: January 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–861 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–2007–D–0371 (formerly 

Docket No. 2007D–0125)] 

Guidance for Industry: EvidenceBased Review System for the Scientific 

Evaluation of Health Claims 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Guidance for Industry: 

Evidence-Based Review System for the 

Scientific Evaluation of Health Claims.’’ 

This guidance outlines the agency’s 

approach to the review of the scientific 

evidence for health claims that meet the 

significant scientific agreement standard 

(SSA) and qualified health claims. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

withdrawal of the guidance documents 

entitled ‘‘Guidance for Industry and 

FDA: Interim Evidence-Based Ranking 

System for Scientific Data’’ and 

‘‘Guidance for Industry: Significant 

Scientific Agreement in the Review of 

Health Claims for Conventional Foods 

and Dietary Supplements.’’ 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Nutrition, Labeling, and 

Dietary Supplements, Center for Food 

Safety and Applied Nutrition, (HFS– 

830), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740. Send two self-addressed 

adhesive labels to assist that office in 

processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the guidance to 

http://www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

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, 

301–436–1191. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 9, 2007 

(72 FR 37246), FDA announced the 

availability of a draft guidance entitled 

‘‘Guidance for Industry: Evidence-Based 

Review System for the Scientific 

Evaluation of Health Claims.’’ The 

agency considered received comments 

as it finalized this guidance. The 

primary purpose of this guidance is to 

provide a description of the scientific 

evaluation process that FDA uses in 

determining the strength of the 

relationship of a substance to decreasing 

the risk of a disease or health-related 

condition. 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the agency’s 

current thinking on the evaluation of 

scientific evidence for health claims. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

mstockstill on PROD1PC66 with NOTICES

3060 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR 101.14 and 101.70 have been 

approved under OMB control no. 0910– 

0381. 

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. 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 guidance at http:// 

www.cfsan.fda.gov/guidance.html. 

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 

Preneoplastic Microenvironment for Insights 

Into the Diet and Cancer Risk Conundrum,’’ 

Molecular Nutrition and Food Research, 

51:100–106, 2007. 

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, http://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 

England Journal of Medicine, 334:1150–1155, 

1996. 

18. Peto, R., R. Doll, J.D. Buckley, et al., 

‘‘Can Dietary Beta-Carotene Materially 

Reduce Human Cancer Rates?,’’ Nature, 

290:201–208, 1981. 

19. Sempos C.T., K. Liu, N.D. Earnst, 

‘‘Food and Nutrient Exposures: What to 

Consider When Evaluating Epidemiologic 

Data,’’ American Journal of Clinical 

Nutrition, 69:1330S–1338S, 1999. 

20. Torun B., ‘‘Protein-Energy 

Malnutrition,’’ In: Modern Nutrition in 

Health and Disease, Williams and Williams, 

New York, 2006. 

21. Spilker, B., Guide to Clinical Studies, 

Raven Press, New York, 1991. 

22. Subar, A., et al., ‘‘Comparative 

Validation of the Block, Willett, and National 

Cancer Institute Food Frequency 

Questionnaires,’’ American Journal of 

Epidemiology, 154:1089–1099, 2001. 

23. Szklo M. and F.J. Nieto, Epidemiology 

Beyond the Basics, Aspen Publishing, 2000. 

24. Willett, W.C., ‘‘Overview of Nutritional 

Epidemiology,’’ Nutritional Epidemiology, 

Oxford University Press, Oxford, 1990. 

25. Willett, W.C., ‘‘Issues in Analysis and 

Presentation of Dietary Data,’’ In Nutritional 

Epidemiology, 2d ed., Oxford University 

Press, Oxford, 1998. 

26. Wilson, E.B., ‘‘An Introduction to 

Scientific Research,’’ General Publishing Co., 

Toronto, 1990. 

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 

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: Notice; withdrawal. 

mstockstill on PROD1PC66 with NOTICES