,,ii #aaith ,,congress #ast ,session ,s4 #ccbc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #c1 #bjbe,mr4 ,hickenlooper 7for himself1 ,mr4 ,markey1 ,ms4 ,blunt ,rochester1 ,mr4 ,blumenthal1 ,ms4 ,alsobrooks1 ,mr4 ,kim1 ,mr4 ,schiff1 ,mr4 ,heinrich1 and ,mr4 ,van ,hollen7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act to codify the ,advisory ,committee on ,immunization ,practices1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,family ,vaccine ,protection ,act4 #b4 ,codification of ,advisory ,committee on ,immunization ,practices 7a7 ,in general ,title ,,ii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bjb et seq47 is amended by inserting after section #bbb 7#db ,u4,s4,c4 #bag;a7 the following3 #bbb;,a4 ,advisory ,committee on ,immunization ,practices 7a7 ,in general ,the ,advisory ,committee on ,immunization ,practices established pursuant to section #bbb 7referred to in this section as the ,advisory ,committee7 shall carry out the duties specified in this section4 7b7 ,application of chapter #aj of title #e1 ,united ,states ,code ,the provisions of chapter #aj of title #e1 ,united ,states ,code 7other than section #ajac71 shall apply with respect to the ,advisory ,committee4 7c7 ,advice1 guidance1 and recommendations from ,advisory ,committee 7#a7 ,in general ,the ,advisory ,committee shall1 based on a preponderance of the best available1 peer-reviewed scientific evidence1 provide advice and guidance1 and make recommendations1 to the ,director of the ,centers for ,disease ,control and ,prevention 7referred to in this section as the ,director7 regarding the use of vaccines and related agents licensed under section #cea for effective control of vaccine-preventable diseases in the civilian population of the ,united ,states4 7#b7 ,procedure for publication 7,a7 ,in general ,the ,director shall review any recommendations received under paragraph 7#a74 ,the ,director shall adopt any such recommendation unless the ,director determines such recommendation is not supported by a preponderance of the best available1 peer-reviewed scientific evidence and publishes the results of that review4 7,b7 ,adopted ,if the ,director adopts such a recommendation-- 7i7 such recommendation shall be considered as an official recommendation of the ,secretary1 acting through the ,director1 upon such adoption2 and 7ii7 the ,director shall-- 7,i7 publish such recommendation on the public website of the ,department of ,health and ,human ,services2 and 7,,ii7 inform the ,secretary and the ,assistant ,secretary for ,health1 in writing1 of such recommendation4 7,c7 ,not adopted ,if the ,director does not adopt such a recommendation1 the ,director shall-- 7i7 publish the basis for not adopting such recommendation1 including an explanation on why the ,director found that the recommendation does not support the findings of a preponderance of the best available1 peer-reviewed scientific evidence2 and 7ii7 not later than #dh hours after such determination1 submit a notification to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate containing the information described in clause 7i74 7#c7 ,consideration of new vaccines ,upon the licensure of any vaccine or any new indication for a vaccine under section #cea1 the ,advisory ,committee shall-- 7,a7 consider the use of the vaccine not later than its next regularly scheduled meeting2 7,b7 not later than #ij days after receiving a notification in writing from the holder of the license of the vaccine or new indication for a vaccine under section #cea1 make a recommendation with respect to the use of such vaccine under paragraph 7#a72 and 7,c7 submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate an update on the status of the ,advisory ,committee's consideration of the use of the vaccine4 7#d7 ,consideration for breakthrough therapies and for potential use during public health emergency ,the ,advisory ,committee shall make recommendations under paragraph 7#a7 with respect to the use of vaccines that-- 7,a7 are designated as a breakthrough therapy under section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act and licensed under section #cea of this ,act2 or 7,b7 are intended to address a public health emergency as determined by the ,secretary under section #cai4 7#e7 ,limitation ,if the ,secretary or the ,director takes an action regarding the use of vaccines and related agents licensed under section #cea for effective control of vaccine-preventable diseases in the civilian population of the ,united ,states 7including an action with respect to coverage under section #bgac or the listing of vaccines for purposes of the program under section #aibh of the ,social ,security ,act7 that is contrary to a recommendation of the ,advisory ,committee1 the ,secretary or the ,director 7as applicable7 shall-- 7,a7 publish the basis for the action1 including an explanation on why the ,secretary or the ,director 7as applicable7 found that the action supports the findings of a preponderance of the best available1 peer-reviewed scientific evidence2 and 7,b7 not later than #dh hours after taking such action1 the ,secretary or the ,director 7as applicable7 shall submit a notification to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate containing the information described in subparagraph 7,a74 7d7 ,duties 7#a7 ,in general 7,a7 ,in general ,the ,advisory ,committee shall do the following3 7i7 ,provide advice and guidance1 and make recommendations1 to the ,director as specified in subsection 7c77#a74 7ii7 ,make immunization recommendations for purposes of the requirement under section #bgac for group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for immunizations that have in effect a recommendation from the ,advisory ,committee4 7iii7 ,in accordance with section #aibh of the ,social ,security ,act and this section1 establish and periodically review and1 as appropriate1 revise the list of vaccines for administration to children and adolescents eligible to receive vaccines through the ,vaccines for ,children ,program1 along with schedules regarding the appropriate dose and dosing interval1 and contraindications to administration of the pediatric vaccines4 7,b7 ,use of list ,the ,secretary1 and as delegated1 the ,director1 shall use the list established by the ,advisory ,committee for the purpose of the purchase1 delivery1 and administration of pediatric vaccines in the ,vaccines for ,children ,program under section #aibh of the ,social ,security ,act4 7#b7 ,advice and guidance content ,advice and guidance provided under paragraph 7#a7-- 7,a7 shall address-- 7i7 the general use of vaccines and immune globulin preparations as a class of biologic agents2 7ii7 the use of specific antibody products for prevention of infectious diseases2 and 7iii7 special situations or populations that may warrant modification of the routine recommendations for vaccine use2 7,b7 may include recommendations for the administration of immune globulin preparations or antimicrobial therapy shown to be effective in controlling a vaccine-preventable disease for which a vaccine is available2 and 7,c7 with respect to each vaccine described in such paragraph1 shall include-- 7i7 population groups or circumstances in which a vaccine or related agent is recommended2 7ii7 contraindications and precautions for use of the vaccine and related agents2 and 7iii7 information on recognized adverse events associated with the use of such vaccine4 7#c7 ,emergency use authorization ,guidance for use of vaccines and related agents authorized for emergency use under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act may be developed by the ,advisory ,committee if circumstances warrant1 including in the case of a public health emergency1 as determined by the ,secretary under section #cai4 7#d7 ,considerations for recommendation development or withdrawal of recommendation ,the ,advisory ,committee1 when making new recommendations under subsection 7c77#a71 or revisions or withdrawals of such recommendations under paragraph 7#e71 shall review evidence in the following categories3 7,a7 ,identification of the specific intervention1 including dosage and schedule4 7,b7 ,the strength of the design of the study used to provide the evidence considered4 7,c7 ,randomized controlled trials or overwhelming evidence from observational studies4 7,d7 ,comparison and outcome of the target population for the vaccine1 including standard of care1 existing vaccines1 and other prevention options4 7,e7 ,prevention outcome or scientifically verified adverse effects associated with vaccination4 7#e7 ,revision or withdrawal of recommendation ,the ,advisory ,committee may revise or withdraw any recommendation regarding a particular vaccine under this subsection if and when new information on disease epidemiology1 vaccine effectiveness or safety1 or other data become available1 and as supported by a preponderance of the best available1 peer-reviewed scientific evidence4 7e7 ,administration 7#a7 ,reporting structure ,the ,advisory ,committee shall report to the ,director4 ,the ,director shall inform the ,secretary1 the ,assistant ,secretary for ,health1 and the ,administrator of the ,centers for ,medicare ,medicaid ,services of immunization recommendations made by the ,advisory ,committee4 7#b7 ,agency support ,for purposes of supporting the ,advisory ,committee in carrying out this section-- 7,a7 the ,office of the ,director of the ,national ,center for ,immunization and ,respiratory ,diseases of the ,centers for ,disease ,control and ,prevention shall provide management and support services2 and 7,b7 the ,advisory ,committee may enter into an agreement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine to provide external support4 7#c7 ,designated ,federal ,officer 7,a7 ,selection ,the ,director shall select a full-time or permanent part-time ,federal employee to serve as the ,designated ,federal ,officer4 7,b7 ,duties ,the ,designated ,federal ,officer selected under subparagraph 7,a7 shall-- 7i7 attend each meeting of the ,advisory ,committee 7and any subcommittee thereof7 or select a designee to attend such a meeting2 7ii7 ensure that all procedures of the ,advisory ,committee for such a meeting are within applicable statutory1 regulatory1 and ,,hhs ,general ,administration ,manual directives2 and 7iii7 approve and prepare all policies and agendas for each such meeting1 call any such meeting1 adjourn any meeting when the ,designated ,federal ,officer deems adjournment to be in the public interest1 and chair meetings when directed to do so by the official to whom the ,advisory ,committee reports4 7,c7 ,assignment ,in the event that the ,designated ,federal ,officer cannot fulfill the assigned duties of the ,advisory ,committee1 one or more full-time or permanent part-time ,federal employees shall be assigned as the ,designated ,federal ,officer and carry out such duties on a temporary basis4 7f7 ,meetings 7#a7 ,frequency ,pursuant to the call of the ,designated ,federal ,officer1 in consultation with the ,chair of the ,advisory ,committee1 meetings shall be held-- 7,a7 not less frequently than #c times per calendar year2 and 7,b7 upon the licensure of any vaccine1 or any new indication for a vaccine1 under section #cea7;a71 not later than #ij days after the date of the first marketing of such vaccine4 7#b7 ,open to the public ,meetings of the ,advisory ,committee shall be open to the public except as determined otherwise by the ,director1 or other official1 to whom the authority has been delegated1 in accordance with sections #eeb;b7c7 and #ajji of title #e1 ,united ,states ,code4 ,notice of all such meetings shall be given to the public4 7g7 ,membership 7#a7 ,in general ,the ,secretary shall appoint at least #ae and not more than #ai individuals to serve as members 7including the chairperson7 of the ,advisory ,committee4 ,such individuals shall be appointed from among individuals recommended by the ,comptroller ,general of the ,united ,states4 ,such members shall serve as ,special ,government ,employees4 7#b7 ,required expertise ,the ,comptroller ,general of the ,united ,states may recommend as a member of the ,advisory ,committee only an individual who has expertise or experience with respect to one or more of the following3 7,a7 ,a prevalence of peer-reviewed and best available scientific research4 7,b7 ,expertise relating to epidemiology and vaccine-preventable disease burden4 7,c7 ,expert experience to rigorously evaluate the best available scientific evidence with immunization recommendations and public health4 7,d7 ,expertise in immunology as evidenced by publications on the topic of immunology in peer-reviewed journals4 7,e7 ,expertise in the use of vaccines and other immunobiologic agents in clinical practice or preventive medicine4 7,f7 ,expertise in infectious diseases1 particularly human immune responses to vaccines1 assessment of vaccine efficacy or effectiveness1 or vaccine safety1 as evidenced by publications on the topic in peer-reviewed journals4 7,g7 ,expertise with clinical or laboratory vaccine research4 7,h7 ,expertise in assessment of vaccine efficacy and safety4 7,i7 ,knowledge about consumer perspectives or the social and community aspects of immunization programs1 or both4 7#c7 ,ex-officio members ,in addition to the individuals appointed under paragraph 7#a71 the membership of the ,advisory ,committee shall include the following #f non-voting ex-officio members 7or their designees73 7,a7 ,the ,administrator of the ,health ,resources and ,services ,administration4 7,b7 ,the ,commissioner of ,food and ,drugs4 7,c7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7,d7 ,the ,director of the ,national ,institutes of ,health4 7,e7 ,the ,director of the ,indian ,health ,service4 7,f7 ,the ,director of the ,national ,vaccine ,program ,office4 7#d7 ,quorum ,two-thirds of the voting members of the ,advisory ,committee shall constitute a quorum for purposes of meetings of the ,advisory ,committee4 7#e7 ,voting if less than quorum present ,if fewer than a quorum of members of the ,advisory ,committee are eligible to vote due to absence or a financial or other conflict of interest at any meeting of the ,advisory ,committee1 the ,designated ,federal ,officer1 or their designee1 shall have the authority to temporarily designate the ex-officio members under paragraph 7#c7 as voting members4 7#f7 ,non-voting liaison representatives ,meetings of the ,advisory ,committee may be attended by non-voting liaison representatives who shall be deemed representatives from a stakeholder organization4 7#g7 ,terms 7,a7 ,in general ,except as specified in subparagraph 7,b71 individuals appointed under paragraph 7#a7 shall be invited to serve as members of the ,advisory ,committee for overlapping terms of #d years1 except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of that term4 ,a member of the ,advisory ,committee may continue to serve on the ,advisory ,committee for a period not to exceed #ahj days after the expiration of that member's term if a successor has not taken office4 7,b7 ,chairperson ,the term of the ,chairperson of the ,advisory ,committee shall be #g years4 7h7 ,subcommittees 7#a7 ,in general ,the ,advisory ,committee may1 subject to approval by the ,secretary 7or the ,secretary's designee71 establish subcommittees composed1 in part1 of members of the ,advisory ,committee and other subject matter experts4 7#b7 ,reporting ,the subcommittees shall report back to the parent committee and may not provide advice or work products directly to the ,department of ,health and ,human ,services4 7#c7 ,department ,committee ,management ,officer ,the ,secretary shall-- 7,a7 notify the ,committee ,management ,officer of the ,department of ,health and ,human ,services upon establishment of each subcommittee2 and 7,b7 provide to such ,officer information on the name1 membership1 function1 and estimated frequency of meetings of such subcommittee4 7i7 ,recordkeeping ,the records of the ,advisory ,committee1 established subcommittees1 or other subgroups of the committee1 shall be managed in accordance with ,general ,records ,schedule #f4b1 ,federal ,advisory ,committee ,records1 or other approved agency records disposition schedule4 ,such records shall be available for public inspection and copying1 subject to section #eeb of title #e1 ,united ,states ,code4 7j7 ,definitions ,in this section3 7#a7 ,stakeholder organization ,the term stakeholder organization means-- 7,a7 the ,american ,academy of ,family ,physicians2 7,b7 the ,american ,academy of ,pediatrics2 7,c7 the ,american ,academy of ,physician ,associates2 7,d7 the ,american ,college ,health ,association2 7,e7 the ,american ,college of ,nurse ,midwives2 7,f7 the ,american ,college of ,obstetricians and ,gynecologists2 7,g7 the ,american ,college of ,physicians2 7,h7 the ,american ,geriatrics ,society2 7,i7 the ,america's ,health ,insurance ,plans2 7,j7 the ,american ,immunization ,registry ,association2 7,k7 the ,american ,medical ,association2 7,l7 the ,american ,nurses ,association2 7,m7 the ,american ,osteopathic ,association2 7,n7 the ,american ,pharmacists ,association2 7,o7 the ,association of ,immunization ,managers2 7,p7 the ,association for ,prevention ,teaching and ,research2 7,q7 the ,association of ,state and ,territorial ,health ,officials2 7,r7 the ,biotechnology ,innovation ,organization2 7,s7 the ,council of ,state and ,territorial ,epidemiologists2 7,t7 the ,canadian ,national ,advisory ,committee on ,immunization2 7,u7 the ,infectious ,diseases ,society of ,america2 7,v7 the ,international ,society of ,travel ,medicine2 7,w7 the ,national ,association of ,county and ,city ,health ,officials2 7,x7 the ,national ,association of ,pediatric ,nurse ,practitioners2 7,y7 the ,national ,foundation for ,infectious ,diseases2 7,z7 the ,national ,medical ,association2 7,,aa7 the ,pediatric ,infectious ,diseases ,society2 7,,bb7 the ,pharmaceutical ,research and ,manufacturers of ,america2 7,,cc7 the ,society for ,adolescent ,health and ,medicine2 7,,dd7 the ,american ,public ,health ,association2 7,,ee7 the ,society for ,healthcare ,epidemiology of ,america2 and 7,,ff7 such other non-voting liaison as the ,secretary determines necessary to effectively carry out the functions of the ,advisory ,committee4 7#b7 ,vaccine ,the term vaccine means any substance 7and any related agent7 that is licensed under section #cea for the prevention of #a or more diseases4 ,such term includes related agents that are administered prophylactically for active or passive antigen-specific immunity4 7k7 ,funding ,there are authorized to be appropriated to carry out this section1 including operating costs1 compensation and travel expenses for members1 and staff support of the ,advisory ,committee1 #b1hjj1jjj for each of fiscal years #bjbf through #bjbi4 4 7b7 ,rule of construction ,except as expressly provided in the amendment made by subsection 7a71 nothing in such amendment shall be construed as limiting the authority of the ,advisory ,committee on ,immunization ,practices1 or the duties of such ,advisory ,committee1 that were in effect as of the day before the date of the enactment of this ,act1 including with respect to subsections 7c77#b77;,b77i7 and 7e7 of section #aibh of the ,social ,security ,act 7#db ,u4,s4,c4 #acifs7 and section #bgac7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ac7;a77#b77 7as such sections were in effect on the day before the date of the enactment of this ,act74 #c4 ,national ,vaccine ,injury ,compensation ,program ,subsection 7c7 of section #baad of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#ad7 is amended by adding at the end the following3 7#e7 ,any removal of a vaccine from the ,vaccine ,injury ,table1 or any other modification under paragraph 7#a71 including any additions to the list of injuries1 disabilities1 illnesses1 conditions1 and deaths for which compensation may be provided1 shall be supported by the preponderance of the best available scientific evidence regarding the safety or efficacy of the vaccine4 ,nothing in the preceding sentence shall be construed to limit the authority of the ,secretary to amend the ,vaccine ,injury ,table to include new vaccines pursuant to subsection 7e74 4