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

Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 3061 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of the guidance entitled 

‘‘Guidance for Industry and FDA: 

Interim Evidence-Based Ranking System 

for Scientific Data’’ that was issued on 

July 10, 2003. 

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 

July 11, 2003 (68 FR 41387), FDA 

announced the availability of a guidance 

entitled ‘‘Guidance for Industry and 

FDA: Interim Evidence-Based Ranking 

System for Scientific Data.’’ This 

guidance is being withdrawn because it 

is obsolete. 

Dated: January 13, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–959 Filed 1–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to OMB under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer on (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Uncompensated 

Services Assurance Report (OMB No. 

0915–0077)—Extension 

Under the Hill-Burton Act, the 

Government provides grants and loans 

for construction or renovation of health 

care facilities. As a condition of 

receiving this construction assistance, 

facilities are required to provide 

services to persons unable to pay. A 

condition of receiving this assistance 

requires facilities to provide assurances 

periodically that the required level of 

uncompensated care is being provided, 

and that certain notification and 

recordkeeping procedures are being 

followed. These requirements are 

referred to as the uncompensated 

services assurance. 

ESTIMATE OF INFORMATION COLLECTION BURDEN

Type of requirement and regulatory citation No. of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total 

hour burden 

Disclosure burden (42 CFR) 

Published Notices (124.504(c)) ........................................... 86 1 86 0.75 65 

Individual Notices (124.504(c)) ............................................ 86 1 86 43.6 3,750 

Determinations of Eligibility (124.507) ................................. 86 86 7,396 0.75 5,547 

Subtotal Disclosure Burden .......................................... ........................ ........................ ........................ ........................ 9,362 

Reporting 

Uncompensated Services Report—HRSA–710 Form 

(124.509(a)) ...................................................................... 10 1 10 11.0 110 

Application for Compliance Alternatives: 

Public Facilities (124.513) ............................................ 4 1 4 6.0 24 

Small Obligation Facilities (124.514(c)) ........................ 0 ........................ ........................ ........................ ........................

Charitable Facilities (124.516(c)) .................................. 2 1 2 6.0 12 

Annual Certification for Compliance Alternatives: 

Public Facilities (124.509(b)) ........................................ 37 1 37 0.5 18.5 

Charitable Facilities (124.509(b)) ................................. 4 1 14 0.5 7 

Small Obligation Facilities (124.509(c)) ........................ 0 1 0 0.5 0 

Complaint Information (124.511(a)): 

Individuals ..................................................................... 10 1 10 0.25 3 

Facilities ........................................................................ 10 1 10 0.5 5 

Subtotal Reporting Burden .................................... ........................ ........................ ........................ ........................ 179.5 

Recordkeeping Number of 

recordkeepers Hours per year Total hour burden 

Non-alternative Facilities (124.510(a)) .................................................................................. 86 50 4,300 

Subtotal Recordkeeping Burden ............................................................................. .......................... .......................... 4,300 

mstockstill on PROD1PC66 with NOTICES