This PDF is the current document as it appeared on Public Inspection on 10/22/2014 at 08:45 am.
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services (HHS) is hereby announcing that the charters have been renewed for the following federal advisory committees for which the Office of the Assistant Secretary for Health provides management support: Chronic Fatigue Syndrome Advisory Committee (CFSAC); President's Council on Fitness, Sports, and Nutrition (PCFSN); Secretary's Advisory Committee on Human Research Protections (SACHRP); and Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). Functioning as federal advisory committees, these committees are governed by the provisions of the Federal Advisory Committee Act (FACA). Under FACA, it is stipulated that the charter for a federal advisory committee must be renewed every two years in order for the committee to continue to operate.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Olga B. Nelson, Committee Management Officer, Office of the Assistant Secretary for Health; U.S. Department of Health and Human Services; 200 Independence Avenue SW., Room 714B; Washington, DC 20201; (202) 690-5205.End Further Info End Preamble Start Supplemental Information
CFSAC was established on September 5, 2002 as a discretionary federal advisory committee. The Committee provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on abroad range of issues and topics pertaining to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), including (1) the current state of knowledge and research and the relevant gaps in knowledge and research about the epidemiology, etiologies, biomarkers, and risk factors relating to ME/CFS, and identifying potential opportunities in these areas; (2) impact and implications of current and proposed diagnosis and treatment methods for ME/CFS; (3) development and implementation of programs to inform the public, health care professionals, and the biomedical, academic, and research communities about ME/CFS advances; and (4) partnering to improve the quality of life of ME/CFS patients.
There was one amendment proposed and approved for the new charter. The charter has been amended to change all references to chronic fatigue syndrome (CFS) to include the myalgic encephalomyelitis (ME). This amendment to the charter was proposed to satisfy a recommendation previously made by CFSAC. During the October 2010 meeting, the Committee had recommended that the Department should “adopt [use of] the term ME/CFS across all HHS programs. After the recommendation was made, the Committee elected to use ME/CFS when discussing this health condition. Amending the charter to reflect the use of ME/CFS demonstrates that the Department supports the Committee's recommendation.
On September 5, 2014, the Secretary of Health and Human Services approved for the CFSAC charter with the proposed amendment to be renewed. The new charter has been made effective; the charter was filed with the appropriate Congressional committees and the Library of Congress on September 5, 2014. Renewal of the CFSAC charter provides authorization for the Committee to continue to operate until September 5, 2016. A copy of the Committee charter is available on the CFSAC Web site at http://www.hhs.gov/advcomcfs.
The PCFSN is a non-discretionary federal advisory committee. The PCFSN was established under Executive Order 13545, dated June 22, 2010. This authorizing directive was issued to amend the purpose, function, and name of the Council, which formerly operated as the President's Council on Physical Fitness and Sports (PCPFS). The scope Start Printed Page 63402of the Council was changed to include nutrition to bring attention to the importance of good nutritional habits with regular physical activity for maintaining a healthy lifestyle. The PCFSN is the only federal advisory committee that is focused solely on the promotion of physical activity, fitness, sports, and nutrition. Since the PCFSN was established by Presidential directive, appropriate action had to be taken by the President or agency head to authorize continuation of the PCFSN. The President issued Executive Order 13652, dated September 30, 2013, to give authorization for the PCFSN to continue to operate until September 30, 2015.
No amendments were recommended for the PCFSN charter. The charter was approved by the Secretary of Health and Human Services and filed with the appropriate Congressional committees and the Library of Congress on September 10, 2014. A copy of the Council charter is available on the PCFSN Web site at http://fitness.gov.
SACHRP is a discretionary federal advisory committee. SACHRP provides advice to the Secretary, through the Assistant Secretary for Health, on matters pertaining to the continuance and improvement of functions within the authority of the Department of Health and Human Services concerning protections for human subjects in research.
No amendments were recommended for the SACHRP charter. On October 1, 2014, the Secretary of Health and Human Services approved for the SACHRP charter to be renewed. The new charter also was filed with the appropriate Congressional committees and the Library of Congress on October 1, 2014. SACHRP is authorized to continue to operate until October 1, 2016. A copy of the charter is available on the Committee Web site at http://www.hhs.gov/ohrp/sachrp/.
The ACBTSA is a discretionary federal advisory committee. The Committee provides advice to the Secretary, through the Assistant Secretary for Health, on a range of policy issues related to the safety of blood, blood products, organs, and tissues. For organs and blood stem cells, the Committee's work is limited to policy issues related to donor derived infectious disease complications of transplantation.
The following amendments were proposed and approved for the ACBTSA charter: (1) Under Objectives and Scope of Activities, the term “human” has been removed. Xenotransplantation is the transplantation of living cells, tissues, and organs from one species to another. Such cells, tissues or organs are called xenografts. Due to the unavailability of certain human organs, animal (pig) tissues are used in transplantation. All aspects of transplantation need to be covered as the shorter life span and diseases of animals are different from that of humans; (2) Under Designated Federal Officer (DFO), the text has been amended to include information about the Alternate DFO assuming the responsibilities associated with the position in the absence of the DFO; (3) Under Membership and Designation, the reference to an organ procurement organization as one of the official industry representatives was changed to reflect the Association of Organ Procurement Organizations (AOPO) because this is the only organ procurement organization from which a qualified representative can be selected. Also under this section, the information about the number of non-voting ex-officio members was changed from nine to eight. As the charter was previously worded, it appeared that the National Institutes of Health (NIH) was authorized to have two representative positions—one each for intra- and extramural research. Authorization had been given for NIH to have only one representative member on the ACBTSA. The charter has been changed to reflect that there are eight non-voting ex-officio members, and the description of the representation to be provided for the NIH has been removed.
On October 8, 2014, the new charter was approved by the Secretary of Health and Human Services and filed with the appropriate Congressional committees and the Library of Congress. ACBTSA is authorized to operate until October 9, 2016. A copy of the charter can be obtained on the ACBTSA Web site at http://www.hhs.gov/ash/bloodsafety.
Copies of the charters for the designated committees also can be obtained by accessing the FACA database that is maintained by the Committee Management Secretariat under the General Services Administration. The Web site address for the FACA database is http://facadatabase.gov/.Start Signature
Dated: October 15, 2014.
Wanda K. Jones,
Acting Assistant Secretary for Health.
[FR Doc. 2014-25155 Filed 10-22-14; 8:45 am]
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