Statement of Cooperation Between the Food and Drug Administration and the Secretaria of Health of the United Mexican States: Safety and Sanitary Quality of Fresh and Frozen Molluscan Shellfish Exported From Mexico to the United States, 41418-41428 [2012-17081]

Download as PDF 41418 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public meeting topics. The deadline for submitting comments related to this public meeting is October 12, 2012 (2 weeks after the public meeting). Regardless of attendance at the public meeting, interested persons may submit either electronic or written comments. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in section III of this document, please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted at https://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcript will also be available approximately 45 days after the public meeting on the Internet at https:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this meeting from the posted events list.) SUPPLEMENTARY INFORMATION: I. Background In the event of an accident or terrorist attack that exposes a large population to radiation, an accurate assessment of the absorbed ionizing radiation dose received by victims will be essential for triage and medical management. Because there is currently no cleared or approved radiation biodosimeter for use in a mass exposure scenario, the development of proper radiation biodosimetry tools is a critical unmet public health need. However, because it is impossible to obtain samples that accurately reflect the intended use population of the device, validating the performance of radiation biodosimeters VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 poses significant scientific and regulatory challenges. As such, FDA is holding this public meeting to obtain input from academia, Government, industry, and other stakeholders on the clinical application and scientific and technological challenges for performance validation of radiation biodosimetry devices. Individual perspectives from meeting participants may help to identify solutions for the scientific challenges associated with radiation biodosimetry development, and may clarify the regulatory path forward to ensure device safety and effectiveness and thereby provide significant clinical and public health benefits. II. Meeting Overview The public meeting will consist of the following: (1) Presentations providing background on anticipated uses of radiation biodosimetry medical countermeasure devices, (2) the device design and performance evaluation challenges identified by FDA, (3) specific technology considerations in radiation biodosimetry, (4) an open public comment session, and (5) an open discussion on topics identified by FDA and those raised by the presentations (see section III of this document). The purpose of this meeting is for participants to share individual perspectives during the discussions. FDA is not seeking group opinions, recommendations, or advice on any matter. Additional information, including a meeting agenda, will be available on the Internet immediately after publication of this document in the Federal Register. This information will be placed on file in the public docket (docket number found in brackets in the heading of this document), which is available at https://www.regulations.gov. This information will also be available at https://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select the appropriate meeting from the list.) III. Topics for Discussion at the Public Meeting The following questions represent the kinds of topics that will be discussed at the meeting. 1. Performance Evaluation for Radiation Biodosimetry: A. What data would support the use of ex vivo radiation human samples in device performance validation? B. What types of in vivo radiation human samples may be available to validate the performance of radiation biodosimeters? C. What pre-clinical or clinical animal model testing might be necessary to PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 demonstrate radiation biodosimeter performance? D. Would a non-human primate pivotal clinical study be appropriate to support clearance/approval of biodosimetry MCM devices? E. What data would support device applicability to both partial body and total body irradiation scenarios? F. How should the impact of delays in sampling, delays in testing, combined injury, and other potential confounders on the performance of a radiation biodosimeter be assessed? G. What challenges does the use of novel technologies bring to radiation biodosimetry development and performance validation? 2. Public Health Considerations for Radiation Biodosimetry: A. What device design elements would address the need for rapid patient triage in a crisis scenario? B. What device design elements should be included to account for the potential for high demand, device use by untrained medical personnel, and therapeutic decisionmaking based on limited resources? C. What information should the Agency clarify in regards to the regulatory path forward for radiation biodosimetry MCM devices? Dated: July 5, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–17082 Filed 7–12–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0004] Statement of Cooperation Between the Food and Drug Administration and the Secretaria of Health of the United Mexican States: Safety and Sanitary Quality of Fresh and Frozen Molluscan Shellfish Exported From Mexico to the United States AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is providing notice of a Statement of Cooperation (SOC) between FDA and Secretariat of Health (SS) of the United Mexican States, through the Federal Commission for Protection from Sanitary Risks (COFEPRIS). The purpose of the SOC is to safeguard public health and to ensure the safety and sanitary quality of fresh SUMMARY: E:\FR\FM\13JYN1.SGM 13JYN1 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 Office, Office of International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 3550, Silver Spring, MD 20993–0002, 301–796–8400, Fax: 301–595–7941. In accordance with 21 CFR 20.108(c), which states that all written agreements SUPPLEMENTARY INFORMATION: PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 and MOUs between FDA and others shall be published in the Federal Register, the Agency is publishing notice of this MOU. Dated: July 5, 2012. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160–01–P E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY12.005</GPH> srobinson on DSK4SPTVN1PROD with NOTICES and frozen molluscan shellfish harvested from aquacultured and wild populations that are now or may be exported into the United States. DATES: The arrangement came into effect on June 28, 2012 for 5 years. FOR FURTHER INFORMATION CONTACT: Phyllis Marquitz, Latin American 41419 VerDate Mar<15>2010 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY12.006</GPH> srobinson on DSK4SPTVN1PROD with NOTICES 41420 VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 41421 EN13JY12.007</GPH> srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices VerDate Mar<15>2010 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY12.008</GPH> srobinson on DSK4SPTVN1PROD with NOTICES 41422 VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 41423 EN13JY12.009</GPH> srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices VerDate Mar<15>2010 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY12.010</GPH> srobinson on DSK4SPTVN1PROD with NOTICES 41424 VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 41425 EN13JY12.011</GPH> srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices VerDate Mar<15>2010 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY12.012</GPH> srobinson on DSK4SPTVN1PROD with NOTICES 41426 VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4725 E:\FR\FM\13JYN1.SGM 13JYN1 41427 EN13JY12.013</GPH> srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 41428 [FR Doc. 2012–17081 Filed 7–12–12; 8:45 am] BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICE Indian Health Services [HHS–2012–IHS–HLY–0001] Healthy Lifestyles in Youth Project; Proposed Single Source Cooperative Agreement With National Congress of American Indians srobinson on DSK4SPTVN1PROD with NOTICES Application Due Date: August 16, 2012. Review Date: August 21, 2012. Earliest Start Date: September 1, 2012. I. Funding Opportunity Description The Indian Health Service (IHS) proposes a single source competing continuation cooperative agreement with the National Congress of American Indians (NCAI) for the purpose of continued implementation of the Healthy Lifestyles in Youth Project in selected Native American Boys and Girls Clubs of America. This program promotes healthy lifestyles among American Indian and Alaska Native (AI/ VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 AN) youth using the curriculum ‘‘Together Raising Awareness for Indian Life’’ (TRAIL) among selected Boys and Girls Club sites. This program is authorized under the authority of the Snyder Act, 25 U.S.C. 13; the Transfer Act, 42 U.S.C. 2001; and the Public Health Service Act, as amended, 42 U.S.C. 241(a). Under this cooperative agreement, IHS proposes to enter into a collaborative effort/ initiative with NCAI, because of their unique experience partnering with the IHS and Boys and Girls Clubs of America in successfully establishing this program, as well as, their overall expertise and experience in addressing and evaluating healthy lifestyle techniques in AI/AN youth. This program is described in the Catalog of Federal Domestic Assistance (CFDA) under 93.933. The focus of the project continues to be on addressing healthy lifestyle development, emphasizing nutrition and physical activity for AI/AN children and youth 6 through 17 years of age. The long term goal is to prevent or delay the onset of obesity and related diseases such as type 2 diabetes. NCAI will continue partnering work with selected PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Tribal Boys and Girls Club sites to: (a) Provide health and physical education programs; (b) help youth achieve and maintain healthy lifestyles through participation in fitness programs; (c) help youth to acquire a range of physical skills; and (d) help youth develop a sense of teamwork and cooperation. These early intervention strategies provide evidence based opportunities to reduce and/or halt the increasing trend of obesity and diabetes among youth and young adults. Clubs that develop a health promotion program that includes the TRAIL curriculum may help curtail the effects of unhealthy eating behaviors and lack of physical activity that can lead to obesity, diabetes, and other chronic diseases later in life. The T.R.A.I.L. curriculum was developed to provide information on good nutrition and to promote physical activity among youth participating in Tribal Boys and Girls Clubs. T.R.A.I.L. is a three-month (12 lessons) program that provides youth with a comprehensive understanding of healthy lifestyles in order to prevent diabetes. Woven throughout the program are self-esteem and prevention activities. Participants E:\FR\FM\13JYN1.SGM 13JYN1 EN13JY12.014</GPH> Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices

Agencies

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41418-41428]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0004]


Statement of Cooperation Between the Food and Drug Administration 
and the Secretaria of Health of the United Mexican States: Safety and 
Sanitary Quality of Fresh and Frozen Molluscan Shellfish Exported From 
Mexico to the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a Statement of Cooperation (SOC) between FDA and Secretariat of Health 
(SS) of the United Mexican States, through the Federal Commission for 
Protection from Sanitary Risks (COFEPRIS). The purpose of the SOC is to 
safeguard public health and to ensure the safety and sanitary quality 
of fresh

[[Page 41419]]

and frozen molluscan shellfish harvested from aquacultured and wild 
populations that are now or may be exported into the United States.

DATES: The arrangement came into effect on June 28, 2012 for 5 years.

FOR FURTHER INFORMATION CONTACT: Phyllis Marquitz, Latin American 
Office, Office of International Programs, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 31, Rm. 3550, Silver Spring, MD 20993-
0002, 301-796-8400, Fax: 301-595-7941.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the Agency is publishing 
notice of this MOU.

    Dated: July 5, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
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[FR Doc. 2012-17081 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-C
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