Meeting of the Advisory Committee on Blood Safety and Availability, 61143-61144 [2010-24735]

Download as PDF Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices Participation Agreement at approximately $115 million. jlentini on DSKJ8SOYB1PROD with NOTICES VI. The Proposed Complaint The Commission’s Complaint alleges that TCCC and DPSG are direct competitors in the highly concentrated and difficult to enter (a) branded concentrate and (b) branded directstore-delivered carbonated soft drink markets. The concentrate market is national, and the branded soft drink markets are local. Total United States sales of concentrate is about $9 billion, and total United States sales of carbonated soft drinks, measured at retail, is about $70 billion. To carry out the distribution activities currently undertaken by the bottler and contemplated under the license agreement, DPSG will need to provide commercially sensitive confidential information about its marketing plans to CCR, the newly created TCCC bottler subsidiary. DPSG currently provides this sort of information to CCE in order for it to perform its bottler or distribution functions. The Commission is concerned that TCCC’s access to this information could enable it to use the information in ways that could impair DPSG’s ability to compete and ultimately injure competition by weakening a competitor or facilitating coordination in the industry. The Complaint alleges that TCCC’s access to DPSG’s confidential information could eliminate competition between TCCC and DPSG, increase the likelihood that TCCC may unilaterally exercise market power, and facilitate coordinated interaction in the industry. VII. The Proposed Consent Order Under the proposed Consent Order, to remedy the alleged competitive concern associated with access to the DPSG commercially sensitive confidential information, TCCC will be required to set up a ‘‘firewall’’ to ensure that persons at TCCC who may be in a position to use the DPSG commercially sensitive information in ways that may injure DPSG and/or facilitate coordination will not be allowed access to such information. Persons at TCCC who are assigned to perform traditional ‘‘bottler functions’’– the kinds of functions that CCE have historically performed for DPSG – will be permitted access to the DPSG information. Persons responsible for ‘‘concentrate-related functions’’– the kinds of functions that TCCC engaged in as a competitor of DPSG when both had their brands distributed by CCE – will not be permitted access to the DPSG information. The proposed Consent Agreement provides for the appointment of a VerDate Mar<15>2010 18:22 Oct 01, 2010 Jkt 223001 61143 monitor to assure TCCC’s compliance with the Consent Order. The monitor will have a fiduciary responsibility to the Commission. The monitor will be appointed for a five (5) year term, but the Commission may extend or modify the term as appropriate. The proposed Consent Agreement contains a prior notice provision for subsequent acquisitions by TCCC of its franchised bottlers that also are licensed to distribute DPSG products. Under the order, TCCC will be required to give the Commission forty-five (45) advance notice of a proposed acquisition that is not subject to the Hart-Scott-Rodino Act and provide the Commission with all management documents relating to the proposed acquisition. If the 45-day period expires without Commission action, TCCC will be permitted to consummate the proposed acquisition and use DPSG confidential information in the territories of the newly acquired bottler as specified in this order. The standard Hart-Scott-Rodino procedures and time periods would continue to apply for Hart-Scott-Rodino reportable transactions. The order, like the DPSG-TCCC license agreement, will have a term of twenty (20) years. In notice document 2010–23374 beginning on page 57274 in the issue of Monday, September 20, 2010 make the following corrections: 1. On page 57275, in the first column, under the ADDRESSES section, in the second line, ‘‘(GAO–1O–853G)’’ should read ‘‘(GAO–10–853G)’’. 2. On the same page, in the same column, under the ADDRESSES section, in the third and fourth lines, ‘‘https:// www.gao.gov/govaud/vbkO1.htm.’’ should read ‘‘https://www.gao.gov/ govaud/ybk01.htm.’’. 3. On the same page, in the same column, under the SUPPLEMENTARY INFORMATION section, in the seventh line, ‘‘yeJlowbookgao.gov’’ should read ‘‘yellowbook@gao.gov.’’ VIII. Opportunity for Public Comment Meeting of the Advisory Committee on Blood Safety and Availability The Consent Agreement has been placed on the public record for thirty (30) days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will again review the proposed Consent Agreement, as well as the comments received, and will decide whether it should withdraw from the Consent Agreement or make final the Decision and Order. By accepting the Consent Agreement subject to final approval, the Commission anticipates that the competitive problem alleged in the Complaint will be resolved. The purpose of this analysis is to invite and facilitate public comment concerning the Consent Agreement. It is not intended to constitute an official interpretation of the proposed Consent Agreement, nor is it intended to modify the terms of the Decision and Order in any way. By direction of the Commission, Commissioner Ramirez recused. Donald S. Clark, Secretary. [FR Doc. 2010–24838 Filed 10–1–10; 12:10 pm] BILLING CODE 6750–01–S PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 GOVERNMENT ACCOUNTABILITY OFFICE Financial Management and Assurance; Government Auditing Standards Correction [FR Doc. C1–2010–23374 Filed 10–1–10; 8:45 am] BILLING CODE 1505–01–D DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public. DATES: The meeting will take place Thursday, November 4, and Friday, November 5, 2010, from 8:30 a.m. to 5 p.m. ADDRESSES: The Universities at Shady Grove, 9630 Gudelsky Drive, Rockville, Maryland 20850, Phone: 301–738–6000. FOR FURTHER INFORMATION CONTACT: Jerry A. Holmberg, PhD, Executive Secretary, Advisory Committee on Blood Safety and Availability, Office of the Assistant Secretary for Health, Department of Health and Human Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852, (240) 453–8803, FAX (240) 453–8456, e-mail ACBSA@hhs.gov. SUPPLEMENTARY INFORMATION: The Advisory Committee on Blood Safety SUMMARY: E:\FR\FM\04OCN1.SGM 04OCN1 jlentini on DSKJ8SOYB1PROD with NOTICES 61144 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices and Availability provides advice to the Secretary and the Assistant Secretary for Health on a range of policy issues that includes (1) definition of public health parameters around safety and availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related to transfusion and transplantation safety, and (3) the implications for safety and the availability of various economic factors affecting product cost and supply. In keeping with its established mission, the ACBSA will be asked to review and comment on previous ACBSA recommendations including elements of a strategic plan for transfusion and transplantation safety. The review is intended to align the transfusion and transplantation safety initiatives to the Secretary’s Strategic Initiatives and Key Inter-Agency Collaborations: (https://www.hhs.gov/ secretary/about/secretarialstrategic initiatives2010.pdf). The Committee will also be asked to comment and make recommendations on prioritizing previous and outstanding recommendations in light of the Assistant Secretary for Health’s mission statement: ‘‘Mobilizing Leadership in Science and Prevention for a Healthier Nation’’ and strategic priorities: Creating Better Systems of Prevention; Eliminating Health Disparities and Achieving Health Equity; and Making Healthy People Come Alive for all Americans. The public will have opportunity to present their views to the Committee on both meeting days. A public comment session has been scheduled for November 5, 2010. Comments will be limited to five minutes per speaker and must be pertinent to the discussion. Preregistration is required for participation in the public comment session. Any member of the public who would like to participate in this session is encouraged to contact the Executive Secretary at his/her earliest convenience to register for time (limited to 5 minutes) and registration must be prior to close of business on November 3, 2010. It is requested that those who wish to have printed material distributed to the Committee provide thirty (30) copies of the document to the Executive Secretary, ACBSA, prior to close of business on November 3, 2010. If it is not possible to provide 30 copies of the material to be distributed, then individuals are requested to provide at a minimum one (1) copy of the document(s) to be distributed prior to the close of business on November 3, 2010. It also is requested that any member of the public who wishes to VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 provide comments to the Committee utilizing electronic data projection submit the necessary material to the Executive Secretary prior to close of business on November 3, 2010. Electronic comments must adhere to disability accessibility guidelines (Section 508 compliance). Dated: September 28, 2010. Richard A. Henry, Deputy Executive Secretary, Advisory Committee on Blood Safety and Availability. [FR Doc. 2010–24735 Filed 10–1–10; 8:45 am] BILLING CODE 4150–41–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Proposed Project: Evaluation of Pregnant and Postpartum Women (PPW) Program The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT), is funding 11 fiscal year (FY) 2009 Services Grants for the Residential Treatment for Pregnant and Postpartum Women (PPW) Program. The purpose of the PPW Program is to provide cost-effective, comprehensive, residential treatment services for pregnant and postpartum women who suffer from alcohol and other drug use problems, and for their infants and children impacted by the perinatal and environmental effects of maternal substance use and abuse. Section 508 [290bb–1] of the Public Health Service Act mandates the evaluation and dissemination of findings of residential treatment programs for pregnant and postpartum women. This cross-site accountability assessment will assess project activities implemented for these services. CSAT is requesting approval for a total of 8,404 burden hours for this new data collection. CSAT is requesting approval for a total of 23 instruments. Of these 23 instruments, 18 instruments are client-level tools and 5 instruments PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 are process-level tools. To examine the effectiveness and impact of the PPW program, the current design includes both client-level outcomes and process evaluation components. The purpose of the outcome evaluation component is to examine the extent to which grantees accomplish the five core goals specified by the PPW program request for applications (RFA). These goals include: • Decrease the use and/or abuse of prescription drugs, alcohol, tobacco, illicit and other harmful drugs (e.g., inhalants) among pregnant and postpartum women; • Increase safe and healthy pregnancies; improve birth outcomes; and reduce related effects of maternal drug abuse on infants and children; • Improve the mental and physical health of the women and children; • Improve family functioning, economic stability, and quality of life; and • Decrease involvement in and exposure to crime, violence, sexual and physical abuse, and child abuse and neglect. In order to help interpret client-level outcomes, the process evaluation will explore what grantees are actually doing, how well they are doing it, any challenges encountered, and strategies grantees used to address them. Data collection instruments will be used to collect outcome and process data for this cross-site accountability evaluation, program and treatment planning, and local evaluations. For clients, data will be collected from women at four time points (intake, 6months post-intake, discharge, and 6months post-discharge), consistent with the GPRA data collection schedule. The schedule for collecting child data is similar to the mothers, with the addition of a 3-month post-intake time point. The following interview instruments will be used for women, fathers/mother’s partner, and children: Women Focused Tools • BASIS–24® (psychological symptomology). • Child Abuse Potential Inventory (overall risk for child physical abuse). • Ferrans and Powers Quality of Life Index (quality of life measure). • Family Support Scale (helpfulness of sources of support to parents raising a young child). • Women’s Discharge Tool (services received, length of stay, treatment goals achieved). • Staff Completed Women’s Items (pregnancy status, problems and outcomes). • Items Administered to Women (children residing with mother in E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 75, Number 191 (Monday, October 4, 2010)]
[Notices]
[Pages 61143-61144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24735]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Advisory Committee on Blood Safety and 
Availability

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services is hereby giving notice that 
the Advisory Committee on Blood Safety and Availability (ACBSA) will 
hold a meeting. The meeting will be open to the public.

DATES: The meeting will take place Thursday, November 4, and Friday, 
November 5, 2010, from 8:30 a.m. to 5 p.m.

ADDRESSES: The Universities at Shady Grove, 9630 Gudelsky Drive, 
Rockville, Maryland 20850, Phone: 301-738-6000.

FOR FURTHER INFORMATION CONTACT: Jerry A. Holmberg, PhD, Executive 
Secretary, Advisory Committee on Blood Safety and Availability, Office 
of the Assistant Secretary for Health, Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852, (240) 
453-8803, FAX (240) 453-8456, e-mail ACBSA@hhs.gov.

SUPPLEMENTARY INFORMATION: The Advisory Committee on Blood Safety

[[Page 61144]]

and Availability provides advice to the Secretary and the Assistant 
Secretary for Health on a range of policy issues that includes (1) 
definition of public health parameters around safety and availability 
of the blood supply and blood products, (2) broad public health, 
ethical and legal issues related to transfusion and transplantation 
safety, and (3) the implications for safety and the availability of 
various economic factors affecting product cost and supply.
    In keeping with its established mission, the ACBSA will be asked to 
review and comment on previous ACBSA recommendations including elements 
of a strategic plan for transfusion and transplantation safety. The 
review is intended to align the transfusion and transplantation safety 
initiatives to the Secretary's Strategic Initiatives and Key Inter-
Agency Collaborations: (https://www.hhs.gov/secretary/about/secretarialstrategicinitiatives2010.pdf).
    The Committee will also be asked to comment and make 
recommendations on prioritizing previous and outstanding 
recommendations in light of the Assistant Secretary for Health's 
mission statement: ``Mobilizing Leadership in Science and Prevention 
for a Healthier Nation'' and strategic priorities: Creating Better 
Systems of Prevention; Eliminating Health Disparities and Achieving 
Health Equity; and Making Healthy People Come Alive for all Americans.
    The public will have opportunity to present their views to the 
Committee on both meeting days. A public comment session has been 
scheduled for November 5, 2010. Comments will be limited to five 
minutes per speaker and must be pertinent to the discussion. Pre-
registration is required for participation in the public comment 
session. Any member of the public who would like to participate in this 
session is encouraged to contact the Executive Secretary at his/her 
earliest convenience to register for time (limited to 5 minutes) and 
registration must be prior to close of business on November 3, 2010. It 
is requested that those who wish to have printed material distributed 
to the Committee provide thirty (30) copies of the document to the 
Executive Secretary, ACBSA, prior to close of business on November 3, 
2010. If it is not possible to provide 30 copies of the material to be 
distributed, then individuals are requested to provide at a minimum one 
(1) copy of the document(s) to be distributed prior to the close of 
business on November 3, 2010. It also is requested that any member of 
the public who wishes to provide comments to the Committee utilizing 
electronic data projection submit the necessary material to the 
Executive Secretary prior to close of business on November 3, 2010. 
Electronic comments must adhere to disability accessibility guidelines 
(Section 508 compliance).

    Dated: September 28, 2010.
Richard A. Henry,
Deputy Executive Secretary, Advisory Committee on Blood Safety and 
Availability.
[FR Doc. 2010-24735 Filed 10-1-10; 8:45 am]
BILLING CODE 4150-41-P
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