Appendixes



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Blood Banking and Regulation: Procedures, Problems, and Alternatives Appendixes

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Blood Banking and Regulation: Procedures, Problems, and Alternatives This page in the original is blank.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives A Negotiated Rule-Making Procedure [Added November 29, 1990] 5 U.S. Code §§ 561 et seq. Preamble The Congress makes the following findings: Government regulation has increased substantially since the enactment of the Administrative Procedure Act. Agencies currently use rulemaking procedures that may discourage the affected parties from meeting and communicating with each other, and may cause parties with different interests to assume conflicting and antagonistic positions and to engage in expensive and time-consuming litigation over agency rules. Adversarial rulemaking deprives the affected parties and the public of the benefits of face-to-face negotiations and cooperation in developing and reaching agreement on a rule. It also deprives them of the benefits of shared information, knowledge, expertise, and technical abilities possessed by the affected parties. Negotiated rulemaking, in which the parties who will be significantly affected by a rule participate in the development of the rule, can provide significant advantages over adversarial rulemaking. Negotiated rulemaking can increase the acceptability and improve the substance of rules, making it less likely that the affected parties will resist enforcement or challenge such rules in court. It may also shorten the amount of time needed to issue final rules. 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. App.). Several agencies have successfully used negotiated rulemaking. The process has not been widely used by other agencies, however, in part because such

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Blood Banking and Regulation: Procedures, Problems, and Alternatives agencies are unfamiliar with the process or uncertain as to the authority for such rulemaking. § 561. Purpose The purpose of this subchapter is to establish a framework for the conduct of negotiated rulemaking, consistent with section 553 of this title, to encourage agencies to use the process when it enhances the informal rulemaking process. Nothing in this subchapter should be construed as an attempt to limit innovation and experimentation with the negotiated rulemaking process or with other innovative rulemaking procedures otherwise authorized by law. § 562. Definitions For the purposes of this subchapter the term— "agency" has the same meaning as in section 551(1) of this title; "consensus" means unanimous concurrence among the interests represented on a negotiated rulemaking committee established under this subchapter unless such committee— agrees to define such term to mean a general but not unanimous concurrence; or agrees upon another specified definition; "convener" means a person who impartially assists an agency in determining whether establishment of a negotiated rulemaking committee is feasible and appropriate in a particular rulemaking; "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; "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 a similar manner; "negotiated rulemaking" means rulemaking through the use of a negotiated rulemaking committee;

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Blood Banking and Regulation: Procedures, Problems, and Alternatives "negotiated rulemaking committee" or "committee" means an advisory committee established by an agency in accordance with this Subchapter and the Federal Advisory Committee Act to consider and discuss issues for the purpose of reaching a consensus in the development of a proposed rule; "party" has the same meaning as in section 551(3) of this title; "person" has the same meaning as in section 551(2) of this title; "rule" has the same meaning as in section 551(4) of this title; and "rulemaking" means "rule making" as that term is defined in section 551(5) of this title. § 563. Determination of need for negotiated rulemaking committee 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. In making such a determination, the head of the agency shall consider whether— there is a need for a rule; there are a limited number of identifiable interests that will be significantly affected by the rule; there is a reasonable likelihood that a committee can be convened with a balanced representation of persons who— can adequately represent the interests identified under paragraph (2); and are willing to negotiate in good faith to reach a consensus on the proposed rule; there is a reasonable likelihood that a committee will reach a consensus on the proposed rule within a fixed period of time; the negotiated rulemaking procedure will not unreasonably delay the notice of proposed rulemaking and the issuance of the final rule;

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Blood Banking and Regulation: Procedures, Problems, and Alternatives the agency has adequate resources and is willing to commit such resources, including technical assistance, to the committee; and the agency, to the maximum extent possible consistent with the legal obligations of the agency, will use the consensus of the committee with respect to the proposed rule as the basis for the rule proposed by the agency for notice and comment. Use of conveners. Purposes of conveners. An agency may use the services of a convener to assist the agency in— identifying persons who will be significantly affected by a proposed rule, including residents of rural areas; and conducting discussions with such persons to identify the issues of concern to such persons, and to ascertain whether the establishment of a negotiated rulemaking committee is feasible and appropriate in the particular rulemaking. Duties of conveners. The convener shall report findings and may make recommendations to the agency. Upon request of the agency, the convener shall ascertain the names of persons who are willing and qualified to represent interests that will be significantly affected by the proposed rule, including residents of rural areas. The report and any recommendations of the convener shall be made available to the public upon request § 564. Publication of notice; applications for membership on committees Publication of notice. If, after considering the report of a convener or conducting its own assessment, an agency decides to establish a negotiated rulemaking committee, the agency shall publish in the Federal Register and, as appropriate, in trade or other specialized publications, a notice which shall include— an announcement that the agency intends to establish a negotiated rulemaking committee to negotiate and develop a proposed rule; a description of the subject and scope of the rule to be developed, and the issues to be considered;

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Blood Banking and Regulation: Procedures, Problems, and Alternatives a list of the interests which are likely to be significantly affected by the rule; a list of the persons proposed to represent such interests and the person or persons proposed to represent the agency; a proposed agenda and schedule for completing the work of the committee, including a target date for publication by the agency of a proposed rule for notice and comment; a description of administrative support for the committee to be provided by the agency, including technical assistance; a solicitation for comments on the proposal to establish the committee, and the proposed membership of the negotiated rulemaking committee; and an explanation of how a person may apply or nominate another person for membership on the committee, as provided under subsection (b). Applications for membership or committee. Persons who will be significantly affected by a proposed rule and who believe that their interests will not be adequately represented by any person specified in a notice under subsection (a)(4) may apply for, or nominate another person for, membership on the negotiated rulemaking committee to represent such interests with respect to the proposed rule. Each application or nomination shall include— the name of the applicant or nominee and a description of the interests such person shall represent; evidence that the applicant or nominee is authorized to represent parties related to the interests the person proposes to represent; a written commitment that the applicant or nominee shall actively participate in good faith in the development of the rule under consideration; and the reasons that the persons specified in the notice under subsection (a)(4) do not adequately represent the interests of the person submitting the application or nomination.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Period for submission of comments and applications. The agency shall provide for a period of at least 30 calendar days for the submission of comments and applications under this section. § 565. Establishment of committee Establishment. Determination to establish committee. 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. Determination not to establish committee. If after considering such comments and applications, the agency decides not to establish a negotiated rulemaking committee, the agency shall promptly publish notice of such decision and the reasons therefor in the Federal Register and, as appropriate, in trade or other specialized publications, a copy of which shall be sent to any person who applied for, or nominated another person for membership on the negotiating rulemaking committee to represent such interests with respect to the proposed rule. Membership. The agency shall limit membership on a negotiated rulemaking committee to 25 members, unless the agency head determines that a greater number of members is necessary for the functioning of the committee or to achieve balanced membership. Each committee shall include at least one person representing the agency. Administrative support. The agency shall provide appropriate administrative support to the negotiated rulemaking committee, including technical assistance.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives § 566. Conduct of committee activity Duties of committee. Each negotiated rulemaking committee established under this subchapter shall consider the matter proposed by the agency for consideration and shall attempt to reach a consensus concerning a proposed rule with respect to such matter and any other matter the committee determines is relevant to the proposed rule. Representatives of agency on committee. The person or persons representing the agency on a negotiated rulemaking committee shall participate in the deliberations and activities of the committee with the same rights and responsibilities as other members of the committee, and shall be authorized to fully represent the agency in the discussions and negotiations of the committee. Selecting facilitator. Notwithstanding section 10(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. If the committee does not approve the nominee of the agency for facilitator, the agency shall submit a substitute nomination. If a committee does not approve any nominee of the agency for facilitator, the committee shall select by consensus a person to serve as facilitator. A person designated to represent the agency in substantive issues may not serve as facilitator or otherwise chair the committee. Duties of facilitator. A facilitator approved or selected by a negotiated rulemaking committee shall— chair the meetings of the committee in an impartial manner; impartially assist the members of the committee in conducting discussions and negotiations; and manage the keeping of minutes and records as required under section 10(b) and (c) of the Federal Advisory Committee Act, except that any personal notes and materials of the facilitator or of the members of a committee shall not be subject to section 552 of this title. Committee procedures. A negotiated rulemaking committee established under this subchapter may adopt procedures for the operation of

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Blood Banking and Regulation: Procedures, Problems, and Alternatives the committee. No provision of section 553 of this title shall apply to the procedures of a negotiated rulemaking committee. Report of committee. If a committee reaches a consensus on a proposed rule, at the conclusion of negotiations the committee shall transmit to the agency that established the committee a report containing the proposed rule. If the committee does not reach a consensus on a proposed rule, the committee may transmit to the agency a report specifying any areas in which the committee reached a consensus. The committee may include in a report any other information, recommendations, or materials that the committee considers appropriate. Any committee member may include as an addendum to the report additional information, recommendations, or materials. Records of committee. In addition to the report required by subsection (f), a committee shall submit to the agency the records required under section 10(b) and (c) of the Federal Advisory Committee Act. § 567. Termination of committee A negotiated rulemaking committee shall terminate upon promulgation of the final rule under consideration, unless the committee's charter contains an earlier termination date or the agency, after consulting the committee, or the committee itself specifies an earlier termination date. § 568. Services, facilities, and payment of committee member expenses Services of conveners and facilitators. In general. An agency may employ or enter into contracts for the services of an individual or organization to serve as a convener or facilitator for a negotiated rulemaking committee under this subchapter, or may use the services of a Government employee to act as a convener or a facilitator for such a committee. Determination of conflicting interests. An agency shall determine whether a person under consideration to serve as convener or facilitator of a committee under paragraph (1) has any financial or other interest that would preclude such person from serving in an impartial and independent manner.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Services and facilities of other entities. For purposes of this subchapter, an agency may use the services and facilities of other Federal agencies and public and private agencies and instrumentalities with the consent of such agencies and instrumentalities, and with or without reimbursement to such agencies and instrumentalities, and may accept voluntary and uncompensated services without regard to the provisions of section 1342 of title 31. The Federal Mediation and Conciliation Service may provide services and facilities, with or without reimbursement, to assist agencies under this subchapter, including furnishing conveners, facilitators, and training in negotiated rulemaking. Expenses of committee members. 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— such member certifies a lack of adequate financial resources to participate in the committee; and the agency determines that such member's participation in the committee is necessary to assure an adequate representation of the member's interest. Status of member as Federal employee. A member's receipt of funds under this section or section 569 shall not conclusively determine for purposes of sections 202 through 209 of title 18 whether that member is an employee of the United States Government. § 569. Role of the Administrative Conference of the United States and other entities Consultation by agencies. An agency may consult with the Administrative Conference of the United States or other public or private individuals or organizations for information and assistance in forming a negotiated rulemaking committee and conducting negotiations on a proposed rule. Roster of potential conveners and facilitators. The Administrative Conference of the United States, in consultation with the Federal Mediation and Conciliation Service, shall maintain a roster of individuals

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Blood Banking and Regulation: Procedures, Problems, and Alternatives who have acted as or are interested in serving as conveners or facilitators in negotiated rulemaking proceedings. The roster shall include individuals from government agencies and private groups, and shall be made available upon request. Agencies may also use rosters maintained by other public or private individuals or organizations. Procedures to obtain conveners and facilitators. Procedures. The Administrative Conference of the United States shall develop procedures which permit agencies to obtain the services of conveners and facilitators on an expedited basis. Payment for services. Payment for the services of conveners or facilitators shall be made by the agency using the services, unless the Chairman of the Administrative Conference agrees to pay for such services under subsection (f). Compilation of data on negotiated rulemaking; report to Congress. Compilation of data. The Administrative Conference of the United States shall compile and maintain data related to negotiated rulemaking and shall act as a clearinghouse to assist agencies and parties participating in negotiated rulemaking proceedings. Submission of information by agencies. 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. Reports to Congress. The Administrative Conference of the United States shall review and analyze the reports and information received under this subsection and shall transmit a biennial report to the Committee on Governmental Affairs of the Senate and the appropriate committees of the House of Representatives that— provides recommendations for effective use by agencies of negotiated rulemaking; and describes the nature and amounts of expenditures made by the Administrative Conference of the United States to accomplish the purposes of this subchapter.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Training in negotiated rulemaking. 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. Payment of expenses of agencies. The Chairman of the Administrative Conference of the United States is authorized to pay, upon request of an agency, all or part of the expenses of establishing a negotiated rulemaking committee and conducting a negotiated rulemaking. Such expenses may include, but are not limited to— the costs of conveners and facilitators; the expenses of committee members determined by the agency to be eligible for assistance under section 568(c); and training costs. Determinations with respect to payments under this section shall be at the discretion of such Chairman in furthering the use by Federal agencies of negotiated rulemaking. Use of funds of the Conference. The Administrative Conference of the United States may apply funds received under section 595(c)(12) of this title to carry out the purposes of this subchapter. § 570. Judicial review Any agency action relating to establishing, assisting, or terminating a negotiated rulemaking committee under this subchapter shall not be subject to judicial review. Nothing in this section shall bar judicial review of a rule if such judicial review is otherwise provided by law. A rule which is the product of negotiated rulemaking and is subject to judicial review shall not be accorded any greater deference by a court than a rule which is the product of other rulemaking procedures.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives B Workshop Participants WORKSHOP ON RISK AND REGULATION January 23–24, 1995 Lew Barker Efficacy Trials Branch Vaccine and Prevention Research Program Division of AIDS NIAID, NIH Celso Bianco Vice President Medical Affairs New York Blood Center Penny Chan, Ph.D. Commission of Inquiry Blood Systems in Canada Toronto, Ontario Harry W. Chen HemaSure Corporation Marlborough, MA Eileen Church Communications Manager American Association of Blood Banks Marcia Crosse Program Evaluation and Methodology Division U.S. General Accounting Office Jacqueline D'Alessio, Ph.D. U.S. General Accounting Office Leonard I. Friedman American Red Cross Holland Lab Elizabeth Goss Fox, Bennett & Turner Washington, DC Harold Kaplan, M.D. University of Texas Southwestern Medical Center Kurt R. 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. James MacPherson Executive Director Council of Community Blood Centers

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Blood Banking and Regulation: Procedures, Problems, and Alternatives John McCray HemaSure Inc. Marlborough, MA Brian McDonough American Red Cross Arlington, VA Charles Mosher Blood Centers of America, Inc. E. Greenwich, RI Jean Otter Director of Regulatory Affairs American Association of Blood Banks Mary K. Pendergast Deputy Commissioner and Senior Advisor to the Commissioner Food and Drug Administration Barbara Peoples American Red Cross Holland Lab Mark Philip IMMUNO US, INC. Rochester, MI Beatrice Pierce National Hemophilia Foundation Rancho Santa Fe, CA William H. Portman The Institute for Transfusion Medicine Pittsburgh, PA James Reilly Executive Director Director American Blood Resources Association Miriam Sparrow, Esq. New York Blood Center, Inc. Edwin Steane, Ph.D. ICCBBA Eugene Timm IMMUNO US, INC. Rochester, MI Peter Tomasulo, M.D. TM Consulting, Inc. 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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Blood Banking and Regulation: Procedures, Problems, and Alternatives Irene Church American Association of Blood Banks Brian P. Conway, Esq. Bayer Corporation Richard J. Davey, M.D. Chief Medical Officer American Red Cross Rob Dickstein Director, Regulatory Affairs Pall Corporation Sandra Ellisor Ortho Diagnostic Systems, Inc. Susan Frantz-Bohn FDA/CBER Division of Congressional and Pub Affairs Steve Friedman Dechert, Price, & Rhoads Eric Goosby Office of HIV/AIDS Policy Elizabeth Goss Attorney Fox, Bennett & Turner William J. Hammes Associate Counsel Bayer Corporation Harriet Newman (MT) ASCP Donor Advocate Virginia Blood Services Nancy Newman Knapp, Petersen & Clark 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. Head, Transfusion Medicine Transfusion Medicine Academic Center Florida Blood Services Toby Simon, M.D. President and CEO Blood Systems, Inc. Harold C. Sox, Jr., M.D. Chairman, Dept. of Medicine Dartmouth-Hitchcock Medical Center Miriam Sparrow, Esq. New York Blood Center, Inc. Jane Starkey Deputy Director Council of Community Blood Centers Ron Welborn Community Bioresources, Inc. Edward Wolf Sr. Associate General Council American Red Cross Sam Wortham Group Vice President Pall Corporation

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Blood Banking and Regulation: Procedures, Problems, and Alternatives 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