Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH), 733-734 [2012-31694]

Download as PDF mstockstill on DSK4VPTVN1PROD with Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Notices conference call dial the following information: (866) 659–0537, Participant Pass Code 9933701. Background: The ABRWH was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the compensation program. Key functions of the ABRWH include providing advice on the development of probability of causation guidelines that have been promulgated by the Department of Health and Human Services (HHS) as a final rule; advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule; advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program; and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the ABRWH to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2013. Purpose: The ABRWH is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is a reasonable likelihood that such radiation doses may have endangered the health of members of this class. The Subcommittee on Procedures Review was established to aid the ABRWH in carrying out its duty to advise the Secretary, HHS, on dose reconstructions. The Subcommittee on Procedures Review is responsible for overseeing, tracking, and participating in the reviews of all procedures used in the dose reconstruction process by the NIOSH Division of Compensation Analysis and Support (DCAS) and its dose reconstruction contractor. Matters to be Discussed: The agenda for the Subcommittee meeting includes discussion of the following ORAU and DCAS procedures: OCAS TIB–0009 (‘‘Estimation of Ingestion Intakes’’), DCAS TIB–0013 (‘‘Selected Geometric Exposure Scenario Considerations for External Dose Reconstruction at Uranium Facilities’’), DCAS OTIB–0010 (‘‘Best Estimate External Dose Reconstruction for Glovebox Workers’’), DCAS IG–001 (‘‘External Dose Reconstruction Implementation Guidelines’’), DCAS IG–003 (‘‘Radiation Exposures Covered for Dose Reconstructions under Part B of the Energy Employees Occupational Illness Compensation Program Act’’), DCAS IG–005 (‘‘Use of Classified Information’’), Program Evaluation Report 014 (‘‘Construction Trades Workers’’), Program Evaluation Report 017 VerDate Mar<15>2010 16:34 Jan 03, 2013 Jkt 229001 (‘‘Evaluation of Incomplete Internal Dose Records from Idaho, Argonne-East and Argonne-West National Laboratories’’), Program Evaluation Report 029 (‘‘Hanford’’), ORAUT–PROC–0044 (‘‘Special Exposure Cohort’’); Discussion of New Summaries of Completed Reviews; and a continuation of the comment-resolution process for other dose reconstruction procedures under review by the Subcommittee. The agenda is subject to change as priorities dictate. This meeting is open to the public, but without an oral public comment period. In the event an individual wishes to provide comments, written comments may be submitted. Any written comments received will be provided at the meeting and should be submitted to the contact person below in advance of the meeting. Contact Person for More Information: Theodore Katz, Executive Secretary, NIOSH, CDC, 1600 Clifton Road NE., Mailstop E–20, Atlanta Georgia 30333, Telephone: (513) 533–6800, Toll Free 1(800)CDC–INFO, Email dcas@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dana Redford, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–31685 Filed 1–3–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned subcommittee: Time and Date: 8:30 a.m.–5:00 p.m., February 4, 2013. Place: Cincinnati Airport Marriott, 2395 Progress Drive, Hebron, Kentucky 41018, Telephone: (859)334–4611, Fax: (859)334– 4619. Status: Open to the public, but without an oral public comment period. To access by conference call dial the following information 1(866)659–0537, Participant Pass Code 9933701. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 733 Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines that have been promulgated by the Department of Health and Human Services (HHS) as a final rule; advice on methods of dose reconstruction, which have also been promulgated by HHS as a final rule; advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program; and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2013. Purpose: The Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advise the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. The Subcommittee for Dose Reconstruction Reviews was established to aid the Advisory Board in carrying out its duty to advise the Secretary, HHS, on dose reconstruction. Matters to be Discussed: The agenda for the Subcommittee meeting includes: reconsidering the Board’s dose reconstruction case review process; dose reconstruction program quality management and assurance activities, including: current findings from NIOSH internal dose reconstruction blind reviews; and discussion of dose reconstruction cases under review (sets 8–9, Savannah River Site, Rocky Flats Plant, and Los Alamos National Laboratory cases from sets 10–13). The agenda is subject to change as priorities dictate. In the event an individual cannot attend, written comments may be submitted. Any written comments received will be provided at the meeting and should be submitted to the contact person below well in advance of the meeting. Contact person for More Information: Theodore Katz, Executive Secretary, NIOSH, CDC, 1600 Clifton Road NE., Mailstop E–20, Atlanta Georgia 30333, Telephone: (513)533– 6800, Toll Free 1(800)CDC–INFO, Email ocas@cdc.gov. E:\FR\FM\04JAN1.SGM 04JAN1 734 Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Notices The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dana Redford, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–31694 Filed 1–3–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSK4VPTVN1PROD with ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 14, 2013, from 8 a.m. to 3 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at http://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Diane Goyette, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, email: MIDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously VerDate Mar<15>2010 16:34 Jan 03, 2013 Jkt 229001 announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http://www.fda. gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On February 14, 2013, the committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. The proposed indication (use) for this product is for magnetic resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues that help protect the brain) and/or abnormal vascularity (abnormal blood circulation). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 31, 2013. Oral presentations from the public will be scheduled between approximately 12:30 p.m. and 1:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 23, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 24, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Diane Goyette at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 28, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–31676 Filed 1–3–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 4, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– E:\FR\FM\04JAN1.SGM 04JAN1

Agencies

[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Pages 733-734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31694]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory 
Board on Radiation and Worker Health (ABRWH or the Advisory Board), 
National Institute for Occupational Safety and Health (NIOSH)

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC), announces the following meeting for the 
aforementioned subcommittee:

    Time and Date: 8:30 a.m.-5:00 p.m., February 4, 2013.
    Place: Cincinnati Airport Marriott, 2395 Progress Drive, Hebron, 
Kentucky 41018, Telephone: (859)334-4611, Fax: (859)334-4619.
    Status: Open to the public, but without an oral public comment 
period. To access by conference call dial the following information 
1(866)659-0537, Participant Pass Code 9933701.
    Background: The Advisory Board was established under the Energy 
Employees Occupational Illness Compensation Program Act of 2000 to 
advise the President on a variety of policy and technical functions 
required to implement and effectively manage the new compensation 
program. Key functions of the Advisory Board include providing 
advice on the development of probability of causation guidelines 
that have been promulgated by the Department of Health and Human 
Services (HHS) as a final rule; advice on methods of dose 
reconstruction, which have also been promulgated by HHS as a final 
rule; advice on the scientific validity and quality of dose 
estimation and reconstruction efforts being performed for purposes 
of the compensation program; and advice on petitions to add classes 
of workers to the Special Exposure Cohort (SEC).
    In December 2000, the President delegated responsibility for 
funding, staffing, and operating the Advisory Board to HHS, which 
subsequently delegated this authority to CDC. NIOSH implements this 
responsibility for CDC. The charter was issued on August 3, 2001, 
renewed at appropriate intervals, and will expire on August 3, 2013.
    Purpose: The Advisory Board is charged with (a) providing advice 
to the Secretary, HHS, on the development of guidelines under 
Executive Order 13179; (b) providing advice to the Secretary, HHS, 
on the scientific validity and quality of dose reconstruction 
efforts performed for this program; and (c) upon request by the 
Secretary, HHS, advise the Secretary on whether there is a class of 
employees at any Department of Energy facility who were exposed to 
radiation but for whom it is not feasible to estimate their 
radiation dose, and on whether there is reasonable likelihood that 
such radiation doses may have endangered the health of members of 
this class. The Subcommittee for Dose Reconstruction Reviews was 
established to aid the Advisory Board in carrying out its duty to 
advise the Secretary, HHS, on dose reconstruction.
    Matters to be Discussed: The agenda for the Subcommittee meeting 
includes: reconsidering the Board's dose reconstruction case review 
process; dose reconstruction program quality management and 
assurance activities, including: current findings from NIOSH 
internal dose reconstruction blind reviews; and discussion of dose 
reconstruction cases under review (sets 8-9, Savannah River Site, 
Rocky Flats Plant, and Los Alamos National Laboratory cases from 
sets 10-13).
    The agenda is subject to change as priorities dictate.
    In the event an individual cannot attend, written comments may 
be submitted. Any written comments received will be provided at the 
meeting and should be submitted to the contact person below well in 
advance of the meeting.
    Contact person for More Information: Theodore Katz, Executive 
Secretary, NIOSH, CDC, 1600 Clifton Road NE., Mailstop E-20, Atlanta 
Georgia 30333, Telephone: (513)533-6800, Toll Free 1(800)CDC-INFO, 
Email ocas@cdc.gov.

[[Page 734]]

    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining 
to announcements of meetings and other committee management 
activities, for both the Centers for Disease Control and Prevention 
and the Agency for Toxic Substances and Disease Registry.

Dana Redford,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-31694 Filed 1-3-13; 8:45 am]
BILLING CODE 4163-18-P