THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) POLICIES AND PROCEDURES FOR DEVELOPMENT OF RECOMMENDATIONS FOR VACCINE USE AND FOR THE VACCINES FOR CHILDREN JULY, 1998 TABLE OF CONTENTS I. Development of ACIP Recommendations for Use of Vaccine and related Biological Products A. Purpose.................................................................................................................. 3 B. Membership........................................................................................................... 3 C. Member Responsibilities 1. Attendance at Meetings........................................................................ 5 2. ACIP Related Contacts......................................................................... 5 3. Media Interaction.................................................................................. 5 D. Electronc Recording by Public Media............................................................. 6 E. Financial Interests 1. Prohibition............................................................................................ 6 2. Inherent Potential.................................................................................. 7 3. Waivers................................................................................................. 7 4. Integrity of Committee.......................................................................... 7 a. Scope of Waivers............................................................................. 7 b. Current Financial Interest................................................................. 7 c. Direct Financial Interest.................................................................. 7 5. Financial Disclosures by Members........................................................ 7 6. Disclosure Not Required - Uncontrolled interests..................................................................... 8 7. De Minimus Financial Interest - Honoraria and Travel Support for Scientific Interchange....................................... 8 8. Voting Restrictions............................................................................... 8 F. Selection of Topics.......................................................................................... 8 G. Process for Developing Recommendations...................................................... 9 1. Techncal Aspects.................................................................................. 9 2. Policy Analysis...................................................................................... 11 a. Verify, define, and detail the problem....................................... 11 b. Establish evaluation criteria....................................................... 11 c. Identify alternative policies........................................................ 11 d. Evaluate alternative policies...................................................... 11 e. Display and distinguish among alternative policies................... 11 3. Resources............................................................................................. 12 4. Developing the Recommendations........................................................ 12 H. Publication of Recommendations.................................................................... 12 I. Implementation and Evaluation of the Recommendations................................. 13 J. Other issues..................................................................................................... 13 II. ACIP Recommendations for the Vaccines for Children (VFC) Program..................... 13 THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) POLICIES AND PROCEDURES FOR DEVELOPMENT OF RECOMMENDATIONS FOR VACCINE USE AND FOR VACCINES FOR CHILDREN I. Development of ACIP Recommendations for Use of Vaccine and Related Biological Products A. Purpose The ACIP provides advice and guidance to the Secretary, the Assistant Secretary for Health, and the Director, Centers for Disease Control and Prevention (CDC) on the most effective means to prevent vaccine-preventable diseases. According to its current charter, the ACIP provides advice and guidance regarding the most appropriate application of antigens and related agents (e.g., vaccines, antisera, immune globulins) for effective disease control in the civilian population. We are proposing that the ACIP charter be modified to acknowledge the broader scope of ACIP recommendations (e.g., use of antivirals, chemotherapy or prophylaxis). The ACIP develops written recommendations, subject to the approval of the Director, CDC, for the routine administration of vaccines to the pediatric and adult populations, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines. The ACIP is the only entity in the federal government which makes such recommendations taking into account all available information (published or unpublished, submitted under an IND or not) about a vaccine and placing that information in the larger context of the various health care delivery systems in the U.S., the current epidemiology of the disease, implementation issues, ethical and legal constraints, and other factors. The overall goals of the ACIP are to provide advice which will assist the Department and the Nation in reducing the incidence of vaccine preventable diseases and to increase the safe usage of vaccines and related biological products, including active and passive immunoprophylaxis. The target populations for ACIP recommendations are public and private health care providers who administer vaccines, public and private officials who make vaccine policy, and the general public. B. Membership The Committee charter was amended on May 8, 1997 to authorize twelve regular voting members, selected by the Secretary, Department of Health and Human Services, from authorities who are knowledgeable in the field of immunization practices, have multi disciplinary expertise in public health, and have expertise in the use of vaccines and immunologic agents in both clinical and preventive medicine. ACIP members are selected based on their expertise to contribute to the Committee's responsibilities. Departmental policy provides that committee membership be fairly balanced in terms of points of view represented and the committee's function. Consideration is given to representation from diverse geographic areas, both genders, ethnic and minority groups, and the disabled. Nominees must be U.S. citizens. Each year, suggestions for regular voting members to serve a 4-year term are sought from a variety of sources including current and former ACIP members, professional societies, vaccine manufacturers, and the general public. These individuals are encouraged to contact members of their institutions, professional organizations, and peers to develop a broad slate of candidates. In addition, suggestions for membership to the Committee are received from various sources during the year, and compiled for consideration at the appropriate time. Once an individual is submitted for possible nomination to the Committee, the name and information received on the candidate is held and reconsidered each time a member needs to be replaced. The candidate remains on the list until withdrawn or nominated to the Committee. A listing of possible nominees to the Committee is updated and submitted to the Chair, ACIP; Executive Secretary, ACIP; Director, National Immunization Program (NIP); Director, Epidemiology and Surveillance Division, NIP; and representatives from the National Center for Infectious Diseases and the National Center for HIV, STD and TB Prevention. These individuals then discuss the candidates for nomination to the Committee, and develop a slate of possible nominees. These candidates are then contacted to determine their willingness to serve on the Committee. With concurrence of the candidate, the slate of nominees is submitted to the Director, CDC for permission to prepare the nomination package. Upon endorsement of the Director, CDC, the nomination package is prepared for the Secretary, HHS. If approved, the new members are appointed to a term of four years. A member who is unable to fill the full four year appointment to the Committee may resign by submitting a letter of resignation. When this occurs, a new candidate is nominated to fill the remainder of the unexpired term of the member who has resigned. In addition to the regular voting members, the Committee has ex-officio members from other Federal agencies (who may be designated to vote in specific circumstances by the Executive Secretary) and non-voting liaison representatives from professional societies and organizations responsible for the development and execution of immunization programs for children and adults. The function of ex-officio members and non-voting liaison representatives is not clearly delineated in federal regulations or in the Committee charter. However, in contrast to regular voting members who are expected to express their personal opinions on all substantive issues before the committee, ex officio and liaison members comments are expected, to the extent possible, to represent the position and views of their sponsoring organizations. Ex officio and liaison members are expected to contribute to committee discussions when issues of importance to their organizations are being discussed and when they possess information important to the discussion which has not been contributed by another member. These members and others can serve as appointed consultants to working groups and subcommittees to provide expert advice and apprise the working group of the position their organization endorses. The Committee shall not take a vote unless at least seven members qualified to vote are present. Whenever six or more members are not eligible to vote by reason of financial conflict of interest, the Executive Secretary, or designee, shall have the authority to temporarily designate the ex officio members as voting members. C. Member Responsibilities 1. Attendance at Meetings The ACIP meeting dates are published a year in advance. Except in the event of an emergency, regular voting members of the ACIP assume the responsibility of attending all meetings. When a member does not attend a meeting or attends a portion of a meeting, the member is provided background material on the issues discussed, and is expected to be prepared for the next meeting. If a regular voting member finds it difficult to attend meetings, he/she has the responsibility to resign from the Committee. This will allow for a new member to be appointed to carry out the term. 2. ACIP Related Contacts ACIP members may be solicited to participate in interviews or surveys on vaccine issues that are addressed by ACIP. ACIP members should not participate in such surveys if they must reveal their personal identity or if their ACIP membership status is known or revealed. The Department's Standards of conduct prohibit "speaking" on matters related to an ACIP member's official duties outside committee or working group meetings. ACIP members are prohibited from receiving compensation for any speech or publication in which the purpose is to report on the member's work on the ACIP. Also, the regular voting member should be concerned with, and report to the Executive Secretary, any solicitation of information about the committee's activities by persons not officially affiliated with the committee. 3. Media Interaction As a public agency, CDC's meetings are open to the public and the media. Therefore, committee members may be approached by the press for an unscheduled interview. While members are certainly free to give interviews and express their opinions, they are not obligated to give an interview to the press either at the time they are approached or at a later time. If they choose to be interviewed, CDC offers the following guidance:  ACIP members may choose to do interviews with other ACIP members or CDC staff.  Or they may feel more comfortable referring the interviewer to the CDC Office of Health Communications representative.  CDC discourages members from speaking with the press about the likely outcome of an ACIP vote in a manner that would indicate they have already decided the issue prior to presentation of the issue and relevant data at the meeting. Views of a member may change during the course of a meeting, and it could be premature and misleading to make public statements prior to the end of the meeting.  Members may discuss the public meeting and their views, but should be careful not to disclose any proprietary information.  Consider whether an issue could come before the advisory committee in the future. Members should be aware that any strong public statements following one meeting could affect their future participation in related meetings because of the need to avoid the appearance of bias.  Members speaking to the press must remember not to speak as representatives of either the committee or the CDC, unless the agency designates a member to speak for the committee (e.g., the Chair).  Regarding closed portions of committee meetings, only the topic of discussion may be made public. Prior to discussing any matter, the member should consult with the Executive Secretary or a knowledgeable CDC staff member. D. Electronic Recording by Public Media It is CDC policy that advisory committee meetings are open to the public to the extent allowed by law and physical environment. The Chair and the Executive Secretary have the authority to regulate all aspects of the meetings, including electronic coverage. In order to ensure that a meeting is conducted in a fair and expeditious manner, the Chair may restrict or deny use of electronic recording equipment. Any member finding lights or recording equipment disruptive to the conduct of business at the meeting should inform the Chair or Executive Secretary. Factors to guide the Chair in this determination include the potential for significant disruption, prejudicial impact on the meeting, fairness, and impairment of a participant's ability to make a presentation. E. Financial Interests Financial Conflicts of Interest and 208 (b)(3) Waivers 1. Prohibition. Federal law (18 U.S.C.  208) prohibits Federal executive branch employees, including special government employees (i.e. members of Federal advisory committees such as ACIP), from participating in matters in which, to his/her knowledge, he/she, his/her spouse, minor child, or organization has a financial interest. 2. Inherent Potential. Federal advisory committees usually have members who may have potential financial conflicts of interest because members are chosen for service based on their expertise in the areas in which advice is sought by the government. 3. Waivers. Congress has recognized the need for service by these experts on Federal advisory committees, despite the potential for conflicts of interest, by providing for waivers of the conflict of interest prohibitions under 18 U.S.C.  208 (b)(3) when "the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved." 4. Integrity of Committee. Nevertheless, CDC is sensitive to concerns about potential conflicts of interest by members serving on the ACIP, particularly given the ACIP's role under OBRA '93, which involves decision making with substantial financial implications (i.e. VFC resolutions). The agency, therefore, has taken steps to assure that there is not only technical compliance with the provisions of 18 U.S.C.  208, but that the spirit of those provisions is also fulfilled as follows - a. Scope of Waivers. 208 (b)(3) limited waivers are being issued to ACIP members who have potential conflicts of interest so that the Department may benefit from the scientific and public health expertise of each member. Under these waivers: Each member with a potential or actual financial conflict of interest is granted a waiver to participate in all committee discussions, but only if (a) the member publicly discloses all relevant interests at the beginning of each ACIP meeting and (b) abstains on votes involving entities with which the member has a current direct financial interest (except as noted below under "De Minimus Interest"). b. Current Financial Interest. Financial relationships within the past 12 months c. Direct Financial Interest (applicable to member, spouse & minor children) - examples (1) stock-ownership (2) employment (3) contract (4) receipt of grant funds, directly or as part of salary, when the member also works on the grant from which the funds come. (The member does not have to be the principal investigator on the grant for this to apply.) 5. Financial Disclosures by Members. Members will be requested to disclose relevant financial interests at the beginning of each meeting. 6. Disclosure Not Required - Uncontrolled Interests. The member's institution may have financial interests which provide income to the member (e.g. grant funds deposited into a common account), but which interests are outside the member's area of work. Such interests are considered outside the member's control, as are the university's financial interests which do not provide income to the member. Given the lack of control, those interests are not required to be disclosed and there are no restrictions on committee activities based on such interests. 7. De Minimus Financial Interests - Honoraria and Travel Support for Scientific Interchange. Support for expenses associated with attendance at scientific meetings is considered a de minimus financial interest. Honoraria received for presentations at scientific meetings is also considered de minimus to the extent that the total honoraria received in each calendar year does not exceed $1,000 per manufacturer or other entity. (Travel expenses included in honoraria payments are excluded from the cap, to the extent that the travel expenses can be segregated from the honoraria.) The restriction on voting does not apply regarding these de minimus interests if all relevant reimbursing entities within the past 12 months are disclosed at each ACIP meeting. 8. Voting Restrictions Where a direct financial interest exists with a particular manufacturer, the member should recuse himself or herself from voting (i.e. abstain) on matters affecting any vaccine of that manufacturer. (It is the relationship with the manufacturer that creates the financial conflict, not just work on a particular vaccine; thus, the prohibition is on votes affecting any vaccine that is a product of the manufacturer.) However, the scope of the voting restriction is limited to issues that could potentially result in a significant financial impact on the affected manufacturer. For example, votes to recommend additional doses of a vaccine or to recommend administration of a vaccine to additional (or fewer) birth cohorts would be subject to the recusal restriction. On the other hand, no restriction would exist on votes pertaining to the list of contraindications to administration of a vaccine. F. Selection of topics Potential topics for ACIP consideration can be suggested by anyone, but are most often proposed by CDC program staff, ACIP members, and vaccine manufacturers. Approximately ten weeks prior to an upcoming meeting, a memorandum requesting potential agenda items is sent to ACIP members, CDC staff, and vaccine manufacturers. A list of topics based on action or follow-up items from the last meeting or previously suggested is included in the memorandum. Also attached is an information sheet to be completed by the person suggesting the topic (See attachment A). The person suggesting an agenda item is asked to specify the topic to be on the agenda, issues of concern, and specific questions to be addressed by ACIP. Those proposing topics from outside CDC should identify one or more possible CDC staff members to coordinate the presentation; however, the final selection of the appropriate CDC staff member will be done by the program director. Agenda items are accepted for presentation by the Executive Secretary in consultation with the Chair, and representatives from the National Immunization Program, the National Center for Infectious Diseases, and the National Center for HIV, STD, and TB Prevention. The Executive Secretary has the authority to approve, disapprove, or hold over to another meeting any agenda item submitted for the agenda. The priority of a topic for ACIP consideration will be based on a variety of factors including the burden of illness (mortality, morbidity, disability); cost of the illness; cost of the intervention; availability of data on the efficacy, safety, cost effectiveness or economic impact, of the intervention; acceptability of a vaccine in the target populations and the quality of these data; availability of vaccine supplies; current utilization patterns of the vaccine and variations in practice; the feasibility of implementing effective vaccination programs; and the perceived potential of a change in the recommendations to improve health outcomes or improve safe usage of vaccines and biologicals. The ACIP will review every major vaccine preventable disease at least once every five years to consider whether a revised recommendation is needed. The committee management specialist will maintain a tickler system to facilitate this process. A file containing ACIP recommendations including title and date of publication is maintained on the Internet. For minor revisions, ACIP may choose not to revise the entire statement but instead issue a short update in the MMWR and on the Internet. G. Process for Developing Recommendations All recommendations are subject to extensive review by staff of the CDC, ACIP members, and outside expert consultants. 1. Technical Aspects Working groups are formed to develop recommendations and extensively analyze the research data for presentation to the formal Committee. These working groups 1) must include one or more regular voting members, 2) must include CDC staff members and 3) may include ex-officio and liaison representatives and other consultants. Either CDC staff from the relevant programs or ACIP members may take the lead for drafting recommendations for the working group, but the decision about who has lead responsibility for drafting must be made early and reported to the Committee Management Specialist. The process of developing ACIP recommendations includes (1) a review of the labeling/package inserts for each vaccine; (2) a thorough review of the scientific literature (both published and unpublished, when available) on the safety, efficacy, acceptability, and effectiveness of the immunizing agent, with consideration of the relevance, quality, and quantity of published and unpublished data; (3) an assessment of cost effectiveness; (4) a review of the morbidity and mortality associated with the disease in the population in general and in specific risk groups; (5) a review of the recommendations of other groups; and (6) a consideration of the feasibility of vaccine use in existing child and adult immunization programs. Feasibility issues include (but are not limited to) acceptability to the community, parents, and patients; vaccine distribution and storage; access to vaccine and vaccine administration; impact on the various health care delivery systems; population distribution effects; and social, legal and ethical concerns. ACIP recommendations may be developed and issued jointly with nongovernmental professional organizations or other PHS advisory committees. When this is done, the composition of the working group is modified to include members of the other organization(s). Whenever the data permit, specific rules of evidence, such as those followed by the U.S. Preventive Services Task Force1, will be used by the ACIP to judge the quality of data and make decisions regarding the nature and strength of the recommendations. When requested by the ACIP members, evidence tables will be developed for the vaccine or other prophylactic agent. In the absence of data or when data are inadequate, the expert opinions of voting members and other experts will be used to make recommendations. Depending upon the relative importance of the issue, either formal (e.g., Delphi, nominal group techniques) or informal methods for soliciting expert opinions will be used. The methods used for developing recommendations will be made explicit in the published recommendations. When necessary for adequate decision making and when requested by the ACIP, a systematic review (meta-analysis) of the literature will be done. Such analyses should adhere to CDC recommendations2 and those on Cost Effectiveness in Health and Medicine.3 Published and unpublished economic analyses (e.g., cost-effectiveness) relevant to vaccine issues will be routinely reviewed. If no such studies have been done, the ACIP may request that they be done, either prior to or subsequent to issuing a recommendation. Issues of both general cost, effectiveness, and the cost effectiveness of specific components of the recommendations will be considered. Published recommendations will explicitly state the basis upon which the recommendations were made, i.e., what inputs there were such as controlled trials, case- control studies, case series, expert opinion, meta-analysis, Delphi surveys, focus groups, cost effectiveness analysis, and other inputs. 2. Policy Analysis Many of the issues addressed by the Committee are not technical but policy issues. In such cases, a simple but formal policy analysis should be considered and may be requested and/or performed by the ACIP. Although other methods of analysis may be proposed and accepted, the usual (default) approach that should be used by the Committee is the process outlined by Carl Patton and David Sawicki in Basic Methods of Policy Analysis and Planning.4 This process is: a. Verify, define, and detail the problem Do not accept the initial statement of the problem without questioning whether it is framed correctly. Verify that the problem actually exists and is an important problem. Be sure the problem is relevant to the objectives of the ACIP and CDC. Determine the magnitude, nature, and extent of the problem. Determine who is concerned about the problem and why. b. Establish evaluation criteria Determine which criteria will be used to evaluate proposed solutions. Some common measures include cost, benefits, cost-benefit ratios, relative or marginal cost-effectiveness, effectiveness, efficiency, equity, administrative ease, legality, and distributive effects. Those criteria central to the problem must be selected and the relative importance of each measure must be determined. c. Identify alternative policies Alternatives can be identified through a variety of means such as literature searches, brainstorming, public comment, and others. The no-action or no change option should always be considered. d. Evaluate alternative policies The expected impact of each alternative policy should be projected and the extent to which it satisfies the evaluation criteria should be determined. A variety of techniques can be used such as risk-benefit or cost-benefit analysis, cost-effectiveness analysis, and linear programming. The method(s) chosen should be appropriate for the problem and the proposed alternative policy; no one method is appropriate for every problem or every alternative. e. Display and distinguish among alternative policies This can be done in a number of ways, e.g., through matrices, pros and cons, value-comparisons, scenarios, and others. Ranking or weighting schemes can be used. As the Committee assesses the policy options, input should be sought from a wide variety of stakeholders. 3. Resources Adequate resources must be available to carry out the analyses outlined above. CDC should place a high priority on identifying these resources so that the high quality of ACIP recommendations can be maintained and enhanced. 4. Developing the Recommendations Recommendations are subject to extensive review by staff of the Centers for Disease Control and Prevention (CDC), ACIP members, outside expert consultants and vaccine manufacturers. Working groups are often formed to extensively analyze the research data for presentation to the full Committee. They should first seek additional data which have been overlooked, corrections in data content, appropriateness of the interpretation of data, and critique and challenge expert opinions. Public comments are solicited during the Committee meetings, and are also considered during the decision making process. Program staff compile and organize comments received and discuss them with the appropriate working group while redrafting recommendations. The chair of the working group is responsible for the final review of the draft recommendations submitted for deliberation and approval by the full voting Committee. Controversial issues will always be brought to the attention of the full Committee during an open Committee meeting. Areas in need of additional research or data should be clearly identified and each statement should include a specific delineation of data gaps. Documents and data which will be discussed at the meeting must be disseminated to the Committee in a timely manner for the members to have the time to analyse the information and prepare for productive discussions. It is the responsibility of the presenters/authors to meet the timelines set by the committee management specialist. These timelines are set ten weeks in advance of the meeting. Materials are routinely scheduled to be express mailed to the Committee members fourteen days prior to the meeting dates. H. Publication of Recommendations ACIP recommendations are one of the most valuable products of CDC. Although the recommendations are those of the Committee, they may or may not be accepted by the agency. After agency acceptance, ACIP recommendations are published in the Morbidity and Mortality Weekly Report Recommendations and Reports series, and occasionally reprinted in other publications. CDC must ensure that a high priority is placed on providing adequate resources to prepare ACIP recommendations for publication in a timely manner. The format of the recommendations for specific vaccines will generally follow that shown in attachment B. The final document will indicate the strength and quality of the evidence supporting each of the major recommendations. I. Implementation and Evaluation of the Recommendations Implementation and evaluation of the impact of the recommendations is the responsibility of the relevant CDC program, and not the ACIP. However, CDC programs will develop an implementation and evaluation plan for each set of recommendations and periodically report information relevant to these activities to the ACIP, and others who may be involved in implementing the recommendation (e.g., managed care, private practitioners). J. Other issues For other issues relevant to guideline development which are not mentioned in this document, the ACIP will consult CDC Guidelines: Improving the Quality.5 II. ACIP Recommendations for the Vaccines for Children (VFC) Program ACIP recommendations for the VFC Program are developed and voted upon as a distinct process, separate from other ACIP functions. This process is based upon the unique statutory authority for the VFC program established by the Omnibus Budget Reconciliation Act of 1993 (42 U.S.C. 1396s) [see attachment C]. This legislation gave the ACIP the responsibility and authority to determine the vaccines, number of doses, schedule and contraindications for the VFC Program. The ACIP applies a systematic and rational approach to developing VFC recommendations. The process for selection of vaccines, schedules, doses, and contraindications for VFC begins with a review of ACIP recommendations for use of each vaccine currently recommended for all or some groups of children or of other available information, and of recommendations by other groups such as the American Academy of Pediatrics. In addition to the considerations which go into the process of issuing general ACIP recommendations, this process also includes a more intensive consideration of (1) the programmatic feasibility of implementing the recommendation in the public and private sectors, (2) implementation strategies which are most likely to be successful, (3) the speed with which implementation can be achieved, (4) the availability of adequate quantities of vaccine, and (5) the cost-effectiveness of using the vaccine in various relevant groups. For each of these issues, background information is discussed, sometimes initially by a working group of ACIP members, and subsequently by the full Committee. Draft VFC resolutions are discussed at full Committee meetings, which are open to the public, before a formal ACIP vote is held. For each vaccine considered for inclusion in the VFC program, written resolutions on the vaccine, schedule, dose, contraindications, and other issues relevant to appropriate uses of vaccines are reviewed by the Committee and are adopted or rejected through votes by voting ACIP members only. A record of issues voted on is maintained at CDC by the Executive Secretary, ACIP. ACIP15.REC REFERENCES 1. U.S. Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. Baltimore: Williams & Wilkins, 1996. 2. Haddix AC, Teutsch S, Shafer PA, et al. Prevention Effectiveness: A Guide to Decision Analysis an Economic Evaluation. New York: Oxford University Press, 1996. 3. Gold M, Siegal J. Cost-Effectiveness Analysis in Health and Medicine. New York: Oxford Univeristy Press, 1996. 4. Carl Patton and David Sawicki. Basic Methods of Policy Analysis and Planning. 2nd ed. Englewood Cliffs, NJ:Prentice Hall, 1993. 5. Centers for Disease Control and Prevention. CDC GUIDELINES: Improving the Quality. Atlanta: Centers for Disease Control and Prevention, 1996.Attachment A THIS FORM MUST BE FILLED OUT FOR YOUR ITEM TO BE CONSIDERED FOR THE FEBRUARY ACIP MEETING ACIP AGENDA PROPOSAL Meeting Date: Month 00, 1997 Due: 00/00/00 to Gloria Kovach, MS D50 404-639-7250(FAX:404-639-7342) Topic:______________________________________________________ Presenter(s) and Address PHONE # MS __________________________________________ ____ ____ __________________________________________ ____ ____ __________________________________________ ____ ____ Time Required: Presentation _____________ min. Discussion _____________ min. Total _____________ min. Questions to be Addressed by ACIP 1. ________________________________________________________ 2. ________________________________________________________ 3. ________________________________________________________ 4. ________________________________________________________ Please circle all that apply: Discussion Information Decision VFC Vote *Background Materials to be Provided Yes No *Draft Statement to be Distributed Yes No Visual Aids Required Yes No If yes, circle all applicable Slides Overheads Handouts * Due to Gloria Kovach, D50 no later than 14 working days before the meeting. Otherwise, BRING 100 COPIES to the meeting and give directly to Gloria. We appreciate your input in planning an interesting and productive meeting, and we appreciate you providing background materials and draft statements well in advance so the Committee has time to review them before the discussion. Attachment B FORMAT FOR RECOMMENDATION(S) Summary Purpose of Recommendation(s) Clinical Description of Disease Diagnosis and Treatment Epidemiology of Disease 1.) Route(s) of transmission 2.) Morbidity, Mortality, Disability 3.) Cost Association with Illness 4.) Risk Groups Efficacy, Effectiveness, and Cost Effectiveness of Intervention(s) Precautions and Contraindications Adverse Events Recommendation(s) of ACIP with summary score for evidence and strength of recommendation Recommendation(s) of Other Groups Discussion of Rationale for ACIP Recommendation(s) Recommended Surveillance, Research, Education, and Program Evaluation Activities Attachment C To be inserted.