Blood Banking and Regulation Procedures, Problems, and Alternatives (1996) / Chapter Skim
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Appendixes
Appendixes
Pages 107-125
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Appendixes
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(6) Agencies have the authority to establish negotiated rulemaking committees under the laws establishing such agencies and their activities and under the Federal Advisory Committee Act (5 U.S.C.
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"facilitator" means a person who impartially aids in the discussions and negotiations among the members of a negotiated rulemaking committee to develop a proposed rule; (5) "interest" means, with respect to an issue or matter, multiple parties which have a similar point of view or which are likely to be affected in .
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Determination of need by the agency. An agency may establish a negotiated rulemaking committee to negotiate and develop a proposed rule, if the head of the agency determines that the use of the negotiated rulemaking procedure is in the public interest.
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an announcement that the agency intends to establish a negotiated rulemaking committee to negotiate and develop a proposed rule; (2) a description of the subject and scope of the rule to be developed, and the issues to be considered;
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a description of administrative support for the committee to be provided by the agency, including technical assistance; (7) a solicitation for comments on the proposal to establish the committee, and the proposed membership of the negotiated rulemaking committee; and (8)
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If after considering comments and applications submitted under section 564, the agency determines that a negotiated rulemaking committee can adequately represent the interests that will be significantly affected by a proposed rule and that it is feasible and appropriate in the particular rulemaking, the agency may establish a negotiated rulemaking committee. In establishing and administering such a committee, the agency shall comply with the Federal Advisory Committee Act with respect to such committee, except as otherwise provided in this subchapter.
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Notwithstanding section lO(e) of the Federal Advisory Committee Act an agency may nominate either a person from the Federal Government or a person from outside the Federal Government to serve as a facilitator for the negotiations of the committee, subject to the approval of the committee by consensus.
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and (c) of the Federal Advisory Committee Act.
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Members of a negotiated rulemaking committee shall be responsible for their own expenses of participation in such committee, except that an agency may, in accordance with section 7(d) of the Federal Advisory Committee Act pay for a member's reasonable travel and per diem expenses, expenses to obtain technical assistance, and a reasonable rate of compensation, if (1)
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Each agency engaged in negotiated rulemaking shall provide to the Administrative Conference of the United States a copy of any reports submitted to the agency by negotiated rulemaking committees under section 566 and such additional information as necessary to enable the Administrative Conference of the United States to comply with this subsection.
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The Administrative Conference of the United States is authorized to provide training in negotiated rulemaking techniques and procedures for personnel of the Federal Government either on a reimbursable or nonreimbursable basis. Such training may be extended to private individuals on a reimbursable basis.
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Kroemer U.S. General Accounting Office Jan Lane American Red Cross Karen Shoos Lipton CEO American Association of Blood Banks Jane Mackey, MBA Topeka Blood Bank, Inc.
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McLean, VA Lee Ann Weitekamp The Blood Center of Southeastern Wisconsin Milwaukee, WI WORKSHOP ON MANAGING THREATS TO THE BLOOD SUPPLY September 21-22, 1995 Lew Barker Efficacy Trials Branch Vaccine and Prevention Research Program Division of AIDS NIAID/NIH Patricia Bezjak Chief Operating Officer Metropolitan Washington Blood Banks Celso Bianco, M.D. Vice President/Medical Affairs New York Blood Center
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Hammes Associate Counsel Bayer Corporation Harriet Newman (MT) ASCP Donor Advocate Virginia Blood Services Nancy Newman Knapp, Petersen & Clark 123 Jean Otter American Association of Blood Banks Stephen Redhead Analyst Congressional Research Service Library of Congress James Reilly Executive Director American Blood resources Association Paul Schmidt, M.D.
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c Acronyms ACUS Administrative Conference of the United States AIDS Acquired Immune Deficiency Syndrome ARC American Red Cross AABB American Association of Blood Banks ABRA American Blood Resources Association CAP College of American Pathologists CBER Center for Biologics Evaluation and Research, Food and Drug Administration CCBC Council of Community Blood Centers CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations CLIA Clinical Laboratories Improvement Act CJD Creutzfeldt-Jakob Disease EPA Environmental Protection Agency FAA Federal Aviation Administration FACA Federal Advisory Committee Act FDA Food and Drug Administration FD&C Food, Drug, and Cosmetic Act GMP good manufacturing practices HIV human immunodeficiency virus NIH National Institutes of Health OSHA Occupational Safety and Health Administration PDUFA Pharmaceutical Drug Users Fee Act PLA Product Licensing Application 125
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