Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 52667 

II. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

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

through Friday. (FDA has verified the 

Web site addresses but is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. Passel, J.S. and C. D’Vera, ‘‘U.S. 

Population Projections: 2005–2050,’’ Pew 

Research Center, Washington, DC, February 

11, 2008, (http://pewhispanic.org/files/

reports/85.pdf). 

2. CDC, ‘‘Prevalence of Overweight, 

Obesity, and Extreme Obesity Among Adults: 

United States, Trends 1976–80 Through 

2005–2006,’’ December 2008, (http://

www.cdc.gov/nchs/data/hestat/overweight/

overweight_adult.pdf). 

3. CDC, ‘‘Differences in Prevalence of 

Obesity Among Black, White, and Hispanic 

Adults—United States, 2006–2008,’’ 

Morbidity and Mortality Weekly Report, 

58(27):740–744, July 17, 2009, (http://

www.cdc.gov/mmwr/preview/mmwrhtml/

mm5827a2.htm). 

4. CDC, ‘‘Health Disparities Experienced by 

Hispanics—United States,’’ Morbidity and 

Mortality Weekly Report, 53(40):935–937, 

October 15, 2004, (http://www.cdc.gov/

mmwr/preview/mmwrhtml/mm5340a1.htm). 

5. National Heart, Lung and Blood 

Institute, ‘‘Epidemiologic Research in 

Hispanic Populations: Opportunities, 

Barriers and Solutions,’’ December 3, 2003, 

(http://www.nhlbi.nih.gov/meetings/

workshops/hispanic.htm). 

6. Information Resources, Inc., ‘‘Times & 

Trends: Hispanic Consumers—Capturing 

CPG Market Potential,’’ April 2008, (http://

www.symphonyiri.com/portals/0/articlePdfs/

TT_April_2008_Hispanic_Consumers.pdf). 

7. Yang, S., M.G. Leff, D. McTague, et al., 

‘‘Multistate Surveillance for Food-Handling, 

Preparation, and Consumption Behaviors 

Associated With Foodborne Diseases: 1995 

and 1996 Behavioral Risk Factor Surveillance 

Systems Food-Safety Questions,’’ Morbidity 

and Mortality Weekly Report, 47(SS–4):33– 

54, September 11, 1998, (http://www.cdc.gov/ 

mmwr/preview/mmwrhtml/00054714.htm). 

8. Lin, C.-T.J. and S.T. Yen, ‘‘Knowledge of 

Dietary Fats Among U.S. Consumers,’’ 

Journal of the American Dietetic Association, 

110(4):613–618, April 2010. 

9. Marin, G., F. Sabogal, B.V. Marin, et al., 

‘‘Development of a Short Acculturation Scale 

for Hispanics,’’ Hispanic Journal of 

Behavioral Sciences, 9(2):183–205, 1987. 

10. Satia-About, J., R.E. Patterson, M.L. 

Neuhouser, et al., ‘‘Dietary Acculturation: 

Applications to Nutrition Research and 

Dietetics,’’ Journal of the American Dietetic 

Association, 102(8):1105–1118, August 2002. 

11. Lin, H., O.I. Bermudez, and K.L. 

Tucker, ‘‘Dietary Patterns of Hispanic Elders 

Are Associated With Acculturation and 

Obesity,’’ Journal of Nutrition, 133:3651– 

3657, 2003. 

12. Otero-Sabogal, R., F. Sabogal, E.J. 

Pe ́rez-Stable, et al., ‘‘Dietary Practices, 

Alcohol Consumption, and Smoking 

Behavior: Ethnic, Sex, and Acculturation 

Differences,’’ Journal of National Cancer 

Institute Monograph, 18:73–82, 1995. 

13. Lara, M., C. Gamboa, M.I. 

Kahramanian, et al., ‘‘Acculturation and 

Latino Health in the United States: A Review 

of the Literature and its Sociopolitical 

Context,’’ Annual Review of Public Health, 

26:367–397, 2005. 

14. Winkleby, M.A., S.P. Fortmann, and B. 

Rockhill, ‘‘Health-Related Risk Factors in a 

Sample of Hispanics and Whites Matched on 

Sociodemographic Characteristics: The 

Stanford Five-City Project,’’ American 

Journal of Epidemiology 137(12):1365–1375, 

1993. 

15. Byrd, T.L., H. Balcazar, and R.A. 

Hummer, ‘‘Acculturation and Breast-Feeding 

Intention and Practice in Hispanic Women 

on the U.S.-Mexico Border,’’ Ethnicity & 

Disease, 11(1):72–79, 2001. 

16. Cobas, J.A., H. Balcazar, M.B. Benin, et 

al., ‘‘Acculturation and Low-Birthweight 

Infants Among Latino Women: A Reanalysis 

of Hispanic Health and Nutrition 

Examination Survey Data With Structural 

Equation Models,’’ American Journal of 

Public Health, 86(3):394–396, 1996. 

17. Dixon, L.B., J. Sundquist, and M. 

Winkleby, ‘‘Differences in Energy, Nutrient, 

and Food Intakes in a U.S. Sample of 

Mexican-American Women and Men: 

Findings From the Third National Health and 

Nutrition Examination Survey, 1988–1994,’’ 

American Journal of Epidemiology, 

152(6):548–557, 2000. 

18. Khan, L.K., J. Sobal, and R. Martorell, 

‘‘Acculturation, Socioeconomic Status, and 

Obesity in Mexican Americans, Cuban 

Americans, and Puerto Ricans,’’ International 

Journal of Obesity, 21(2):91–96, 1997. 

19. Markides, K.S., D.J. Lee, and L.A. Ray, 

‘‘Acculturation and Hypertension in Mexican 

Americans,’’ Ethnicity & Disease, 3:70–74, 

1993. 

20. Stern, M.P., C. Gonzalez, B.D. Mitchell, 

et al., ‘‘Genetic and Environmental 

Determinants of Type II Diabetes in Mexico 

City and San Antonio,’’ Diabetes, 41(4):484– 

492, 1992. 

21. Sundquist, J., and M.A. Winkleby, 

‘‘Cardiovascular Risk Factors in Mexican 

American Adults: A Transcultural Analysis 

of National Health and Nutrition 

Examination Survey III, 1988–1994,’’ 

American Journal of Public Health, 

89(5):723–730, 1999. 

22. Thomson, M.D., and L. Hoffman-Goetz, 

‘‘Defining and Measuring Acculturation: A 

Systematic Review of Public Health Studies 

With Hispanic Population in the United 

States,’’ Social Science & Medicine, 69:983– 

991, 2009. 

Dated: August 18, 2011. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2011–21485 Filed 8–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0386] 

International Conference on 

Harmonisation; Guidance on E2F 

Development Safety Update Report; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘E2F 

Development Safety Update Report.’’ 

The guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance describes the format, 

content, and timing of a development 

safety update report (DSUR) for an 

investigational drug. The DSUR will 

serve as a common standard for periodic 

reporting on drugs under development 

(including marketed drugs that are 

under further study) among the ICH 

regions. The DSUR can be submitted in 

the United States in place of an annual 

report for an investigational new drug 

application (IND). The harmonized 

DSUR is intended to promote a 

consistent approach to annual clinical 

safety reporting among the ICH regions 

and enhance efficiency by reducing the 

number of reports generated for 

submission to the regulatory authorities. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448. Send one self-addressed adhesive 

label to assist the office in processing 

your requests. The guidance may also be 

obtained by mail by calling the Center 

for Biologics Evaluation and Research at 

1–800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES

52668 Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Ellis F. Unger, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 4208, Silver Spring, 

MD 20993–0002, 301–796–2270; or 

Peter F. Bross, Center for Biologics 

Evaluation and Research (HFM–755), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–5102. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 3506, 

Silver Spring, MD 20993, 301–796– 

8377. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of August 5, 

2008 (73 FR 45462), FDA published a 

notice announcing the availability of a 

draft guidance entitled ‘‘E2F 

Development Safety Update Report.’’ 

The notice gave interested persons an 

opportunity to submit comments by 

November 3, 2008. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the guidance was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in 

August 2010. 

The guidance describes the format, 

content, and timing of a DSUR for an 

investigational drug. The DSUR will 

serve as a common standard for periodic 

reporting on drugs under development 

(including marketed drugs that are 

under further study) among the ICH 

regions. The DSUR is patterned after the 

periodic safety update report (used for 

safety reporting in the postmarketing 

environment) and can be submitted in 

the United States in place of an annual 

report for an IND. The harmonized 

DSUR is intended to promote a 

consistent approach to annual clinical 

safety reporting among the ICH regions 

and enhance efficiency by reducing the 

number of reports generated for 

submission to the regulatory authorities. 

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 this topic. 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) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://www.

regulations.gov, http://www.fda.gov/

Drugs/GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm. 

Dated: August 16, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21447 Filed 8–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Vaccines and Related Biological 

Products Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the Vaccines 

and Related Biological Products 

Advisory Committee. This meeting was 

announced in the Federal Register of 

July 22, 2011 (76 FR 44016). The 

amendment is being made to reflect a 

change in the Date and Time, Location, 

Agenda, Procedure, and Closed 

Committee Deliberations portions of the 

document. There are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Donald W. Jehn or Denise Royster, 

Center for Biologics Evaluation and 

Research (HFM–71), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852, 301–827–0314, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington DC area), and follow 

the prompts to the desired center or 

product area. Please call the Information 

Line for up-to-date information on this 

meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 22, 2011, FDA 

announced that a meeting of the 

Vaccines and Related Biological 

Products Advisory Committee would be 

held on September 20, 2011. On page 

44016, in the 2nd and 3rd column and 

on page 44017, in the 1st column, the 

Date and Time, Location, Agenda, 

Procedure, and Closed Committee 

Deliberations portions of the document 

are changed to read as follows: 

mstockstill on DSK4VPTVN1PROD with NOTICES