International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; Availability, 52667-52668 [2011-21447]

Download as PDF Federal Register / Vol. 76, No. 163 / Tuesday, August 23, 2011 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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, (https://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, (https:// 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, (https:// 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, (https://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, (https://www.nhlbi.nih.gov/meetings/ workshops/hispanic.htm). 6. Information Resources, Inc., ‘‘Times & Trends: Hispanic Consumers—Capturing CPG Market Potential,’’ April 2008, (https:// 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, (https://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. VerDate Mar<15>2010 16:33 Aug 22, 2011 Jkt 223001 12. Otero-Sabogal, R., F. Sabogal, E.J. ´ Perez-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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 52667 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. 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 https://www.regulations.gov. SUMMARY: E:\FR\FM\23AUN1.SGM 23AUN1 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: mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 16:33 Aug 22, 2011 Jkt 223001 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. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the Internet may obtain the document at https://www. regulations.gov, https://www.fda.gov/ Drugs/GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://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: E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52667-52668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21447]


-----------------------------------------------------------------------

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 https://www.regulations.gov.

[[Page 52668]]

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 
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.