,i #aaith ,,congress #b;d ,session ,h4 ,r4 #hddg ,,in ,,the ,,house ,,of ,,representatives ,april #bb1 #bjbf,mr4 ,larsen of ,washington 7for himself1 ,ms4 ,ross1 ,ms4 ,stansbury1 ,ms4 ,norton1 ,ms4 ,barragn1 and ,mr4 ,thanedar7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on the ,budget1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to protect against seasonal and pandemic influenza1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,protecting ,america from ,seasonal and ,pandemic ,influenza ,act of #bjbf4 #b4 ,findings ,the ,congress finds the following3 7#a7 ,influenza occurs seasonally each year1 and throughout history1 has caused devastating pandemics4 ,the #aiah influenza pandemic killed an estimated #fge1jjj ,americans4 7#b7 ,in an average season1 influenza results in #f1cjj to #eb1jjj deaths in the ,united ,states1 including over #ajj pediatric deaths4 ,additionally1 influenza causes hundreds of thousands of hospitalizations and millions of illnesses4 7#c7 ,the ,council of ,economic ,advisors issued a report in #bjai estimating that seasonal influenza costs the ,united ,states approximately #cfa1jjj1jjj1jjj per year1 and that an influenza pandemic has the potential to cause up to #c1gij1jjj1jjj1jjj in losses4 ,this report was issued prior to the ,,covid-#ai pandemic1 which will cost the ,united ,states an estimated #af1jjj1jjj1jjj1jjj4 7#d7 ,strategies that increase seasonal influenza vaccination rates will also improve pandemic readiness4 7#e7 ,the ,national ,influenza ,vaccine ,modernization ,strategy of #bjbj-bjcj1 established pursuant to ,executive ,order #achhg1 titled ,modernizing ,influenza ,vaccines in the ,united ,states to ,promote ,national ,security and ,public ,health1 should be fully implemented to ensure the ,nation's vaccine enterprise is highly responsive1 flexible1 scalable1 and effective at reducing the impact of seasonal and pandemic influenza viruses4 7#f7 ,critical ,united ,states pharmaceutical supply chains are dangerously reliant on ,china1 and the ,united ,states must take actions to strengthen its position as the global leader in biotechnology research and development4 7#g7 ,vaccine hesitancy in the ,united ,states represents a threat to the ,nation's national security and public health4 ,efforts must be taken to restore trust and confidence in scientific data and public health messaging4 7#h7 ,support for communication1 outreach1 and administration across public health and health care settings is critical to ensure awareness of and access to influenza vaccines1 treatments1 and medical countermeasures4 #c4 ,strengthening and diversifying influenza vaccine1 therapeutics1 and diagnostics development1 manufacturing1 and supply chain 7a7 ,timely delivery of first doses of finished influenza vaccine 7#a7 ,national goal ,it is a national goal for the ,united ,states1 not later than #c years after the date of enactment of this ,act1 to have the capacity to deliver first doses of finished influenza vaccine within #ab weeks of emergence of an influenza strain with pandemic potential4 7#b7 ,plan ,not later than #f months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 the ,assistant ,secretary for ,preparedness and ,response1 and the ,director of the ,biomedical ,advanced ,research and ,development ,authority shall publish a plan to achieve the goal specified in paragraph 7#a74 7b7 ,universal influenza vaccine 7#a7 ,national goal ,it is a national goal for the ,united ,states1 not later than #aj years after the date of enactment of this ,act1 to have developed a universal influenza vaccine4 7#b7 ,plan 7,a7 ,publication ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 the ,director of the ,national ,institutes of ,health1 and the ,director of the ,biomedical ,advanced ,research and ,development ,authority shall publish a plan to achieve the goal specified in paragraph 7#a7 in partnership with vaccine manufacturers4 7,b7 ,interim support ,the plan under subparagraph 7,a7 shall include provisions1 as necessary to achieve such goal1 for support over the period of #e years following the publication of such plan of the following3 7i7 ,incremental vaccine efficacy improvements4 7ii7 ,the research workforce4 7c7 ,strengthening the vaccine supply chain 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall-- 7,a7 establish public-private partnerships to strengthen the domestic vaccine supply chain2 and 7,b7 evaluate the capabilities1 capacity1 and utilization of such partnerships1 including by assessing and testing relevant logistical and interoperable technology with stakeholders in the supply chain4 7#b7 ,domestic vaccine supply chain ,for purposes of this subsection1 the term domestic vaccine supply chain includes the full domestic supply chain1 including-- 7,a7 production of ingredients and manufacturing and distribution of finished vaccines2 7,b7 fill-finish capacity2 and 7,c7 the supply chain of ancillary supplies such as needles and syringes4 7d7 ,national ,influenza ,vaccine ,modernization ,strategy ,the ,secretary of ,health and ,human ,services shall-- 7#a7 fully implement the portions of the ,national ,influenza ,vaccine ,modernization ,strategy #bjbj-bjcj that are within the authority of the ,department of ,health and ,human ,services to carry out 7under other applicable provisions of law72 and 7#b7 by ,june #ae each calendar year through #bjcj1 submit to the ,congress a report on such implementation4 7e7 ,assistant ,secretary for ,preparedness and ,response ,section #bhaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#c71 by inserting 1 including the pandemic influenza medical countermeasures program under paragraphs 7#b77;,e7 and 7#d77;,h7 of section #cai,l7c7 after qualified pandemic or epidemic products 7as defined in section #cai;,f-#c72 and 7,b7 in paragraph 7#g71 by inserting 1 including through the pandemic influenza medical countermeasures program under paragraphs 7#b77;,e7 and 7#d77;,h7 of section #cai,l7c7 after for each such threat2 and 7#b7 in subsection 7d77#b7-- 7,a7 in subparagraph 7,j71 by striking and at the end2 7,b7 by redesignating subparagraph 7,k7 as subparagraph 7,l72 and 7,c7 by inserting after subparagraph 7,j7 the following3 7,k7 evaluate progress with respect to implementing the ,national ,influenza ,vaccine ,modernization ,strategy1 issued in ,june #bjbj1 or any successor strategy2 and 4 7f7 ,biomedical advanced research and development authority 7#a7 ,preparedness activities ,section #cai,l7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77 is amended-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,c71 by striking and at the end2 7ii7 in subparagraph 7,d71 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end of the following3 7,e7 supporting pandemic influenza countermeasure preparedness4 2 and 7,b7 in paragraph 7#d71 by adding at the end of the following3 7,h7 ,pandemic influenza medical countermeasures program ,in carrying out paragraph 7#b77;,e71 the ,secretary shall establish and implement a program that-- 7i7 supports research and development activities for qualified pandemic or epidemic products 7as defined in section #cai;,f-#c71 including by-- 7,i7 developing innovative technologies to enhance rapid response to pandemic influenza threats2 7,,ii7 developing influenza vaccines with potential universal vaccination capability2 7,,iii7 developing influenza vaccines with longer lasting broad spectrum protective immunity against a wider range of antigenically divergent influenza strains2 7,,iv7 developing alternative vaccine delivery approaches2 7,v7 developing novel small- and large-molecule novel influenza antivirals1 monoclonal antibodies1 and other products that provide better influenza treatment and prevention2 7,,vi7 developing innovative technologies to enhance rapid diagnosis of influenza2 and 7,,vii7 implementing the ,national ,influenza ,vaccine ,modernization ,strategy1 issued in ,june #bjbj1 or any successor strategy2 7ii7 ensures readiness to respond to qualified pandemic and epidemic threats1 including by-- 7,i7 supporting development and manufacturing of influenza virus seeds1 clinical trial lots1 and stockpiles of novel influenza strains2 7,,ii7 supporting the stockpile of influenza antivirals through diversifying and replenishing the existing stockpile of influenza antivirals2 7,,iii7 supporting manufacturing and fill-finish rapid response infrastructure2 7,,iv7 supporting the stockpile of influenza testing equipment and supplies2 and 7,v7 testing and evaluating pandemic threat rapid response capabilities through regular preparedness drills with key public and private sector partners that examine the range of activities 7including production and clinical testing of influenza diagnostics1 vaccines1 and therapeutics7 required to effectively respond to novel threats2 and 7iii7 builds1 sustains1 and replenishes qualified pandemic and epidemic stockpiles of bulk antigen and adjuvant material1 including by-- 7,i7 annually testing the potency and shelflife potential of all existing pandemic and epidemic stockpiles held by the ,department of ,health and ,human ,services2 and 7,,ii7 developing1 and disseminating to key public and private sector partners1 a life cycle management plan4 4 7g7 ,authorization of appropriations ,section #cai,l7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7d77 is amended by adding at the end the following3 7#c7 ,pandemic influenza ,to carry out this section and section #bhaa with respect to pandemic influenza1 in addition to amounts authorized to be appropriated by paragraph 7#b7 and any amounts authorized to be appropriated by section #bhaa1 there is authorized to be appropriated #cce1jjj1jjj for each of the fiscal years #bjbg through #bjca1 to remain available until expended4 4 #d4 ,promoting innovative approaches and use of new technologies to detect1 prevent1 and respond to influenza 7a7 ,prioritizing influenza1 influenza combination1 and pathogen agnostic tools 7#a7 ,,nih ,the ,director of the ,national ,institutes of ,health may conduct or support basic research prioritizing the development of-- 7,a7 agnostic tools to detect influenza and other pathogens2 and 7,b7 technologies that automate sample preparation for such tools4 7#b7 ,,barda ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority may conduct or support advanced development of novel sequencing modalities prioritizing tools described in paragraph 7#a77;,a7 and technologies described in paragraph 7#a77;,b74 7b7 ,development of point-of-,care and self-,testing diagnostics ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 in collaboration with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,director of the ,national ,institutes of ,health1 and the ,commissioner of ,food and ,drugs1 may conduct or support development of rapid1 accurate1 easily accessible1 self-administrable diagnostic tests that are readable at the point of care or at home4 7c7 ,incorporating diagnostics supply chain resiliency into influenza pandemic planning ,the ,assistant ,secretary for ,preparedness and ,response1 in collaboration with the ,commissioner of ,food and ,drugs1 the ,director of the ,centers for ,disease ,control and ,prevention1 the ,secretary of ,commerce1 and the ,secretary of ,transportation1 shall-- 7#a7 incorporate diagnostics supply chain resiliency into influenza pandemic planning that supports a health care system that tests to treat and bolsters testing and vaccine delivery supply chains2 and 7#b7 not later than #a year after the date of enactment of this ,act1 publish a plan for rapidly expanding public and private diagnostic testing capacity 7including at clinical laboratories1 at public health department laboratories1 and by means of self-testing7 in an influenza pandemic1 including addressing transportation infrastructure1 the need for sterilization1 and sourcing critical raw materials1 components1 and parts4 7d7 ,scaling ,up prophylactic influenza antibody products that address gaps in coverage ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority may conduct or support preventive approaches1 including those still in preclinical and clinical stages1 to rapidly scale up preexposure prophylactic influenza antibody products that address influenza infection4 7e7 ,modernizing potency assays ,the ,commissioner of ,food and ,drugs shall work with vaccine manufacturers to modernize potency assays across a variety of manufacturing technologies so as to reduce by #f weeks the period required to first evaluate new vaccine candidates during a pandemic4 7f7 ,improved influenza therapeutics ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority may conduct or support improved influenza therapeutics that-- 7#a7 are more broadly protective2 and 7#b7 meet the needs of high-risk and high-exposure patients4 #e4 ,increasing influenza vaccine1 therapeutics1 and testing access and coverage across all populations 7a7 ,annual report on public communication strategy ,the ,director of the ,centers for ,disease ,control and ,prevention shall submit an annual report to the ,congress on the public communication strategy of the ,centers to increase public confidence in the safety and effectiveness of vaccines4 7b7 ,sense of ,congress ,it is the sense of ,congress that the ,national ,institutes of ,health1 the ,director of the ,centers for ,disease ,control and ,prevention1 the ,secretary of ,defense1 the ,secretary of ,veterans ,affairs1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 and the ,commissioner of ,food and ,drugs should support research using large data sets from multiple sources of health data to further support and evaluate vaccine safety and effectiveness over multiple influenza seasons4 7c7 ,addressing misinformation and disinformation 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall create partnerships to educate individuals about the safety and efficacy of influenza vaccines and the potential harms of influenza1 particularly for unvaccinated individuals4 7#b7 ,requirement ,the partnerships under paragraph 7#a7 shall allow for dissemination of best practices and lessons learned between partnering organizations4 7#c7 ,members ,the members of the partnerships under paragraph 7#a7 shall include representatives of organizations with experience working with vulnerable populations1 including-- 7,a7 individuals with chronic health conditions2 7,b7 older ,americans2 7,c7 parents of young children2 7,d7 pregnant women2 7,e7 ,tribal communities2 7,f7 racial and ethnic minorities2 and 7,g7 rural communities4 7#d7 ,conferring with partnering organizations ,the ,secretary of ,health and ,human ,services shall confer with organizations represented in partnerships under paragraph 7#a7-- 7,a7 in advance of each seasonal influenza season1 on messaging and communications2 and 7,b7 at the end of each seasonal influenza season1 on best practices and lessons learned4 7#e7 ,report to ,congress ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall report to the ,congress on the partnerships created1 and activities conducted1 under this section4 7d7 ,communications public-,private partnership 7#a7 ,in general ,not later than six months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall implement a targeted demonstration project that provides for the establishment of a communications public-private partnership initiative for increasing vaccine confidence4 7#b7 ,requirements ,the demonstration project under paragraph 7#a7 shall-- 7,a7 be implemented through an independent1 nongovernmental1 nonprofit entity2 7,b7 focus on individuals with chronic illness or other comorbidities who tend to have worse clinical outcomes from influenza 7such as individuals with heart disease or diabetes1 and racial and ethnic minorities72 7,c7 support behavioral research around sources of vaccine hesitancy2 and 7,d7 develop and implement a targeted1 multimodal communications campaign1 using internet platforms1 television1 and nontraditional targeted social media and community outreach in an effort to reach individuals who may be especially vaccine hesitant4 7#c7 ,report ,not later than six months after completion of the demonstration project under paragraph 7#a71 the ,secretary of ,health and ,human ,services shall-- 7,a7 prepare a report on the demonstration project1 including an evaluation of the project's methods1 findings1 and results2 and 7,b7 make such report publicly available on the website of the ,department of ,health and ,human ,services4 7e7 ,incorporating health outreach into seasonal and pandemic influenza planning and response ,the ,director of the ,centers for ,disease ,control and ,prevention and the ,assistant ,secretary for ,preparedness and ,response shall-- 7#a7 incorporate health outreach into the seasonal and pandemic influenza planning and response programs overseen by such officials2 and 7#b7 include in such programs strategies to reach rural communities1 communities with lower socioeconomic status1 racial and ethnic minorities1 seniors1 and individuals with disabilities1 including addressing barriers to vaccinations1 therapeutics1 and diagnostics in the point-of-care and at-home1 self-testing settings4 7f7 ,expanding access to influenza treatment through a test-,to-,treat demonstration program 7#a7 ,demonstration project 7,a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall initiate an influenza test-to-treat demonstration project4 7,b7 ,length2 locations ,this demonstration project under subparagraph 7,a7 shall run for the length of one seasonal influenza season and be based in one or more of the following locations3 7i7 ,facilities that serve vulnerable populations1 such as populations who are in long-term care facilities1 are #fe years of age or older1 may have other medical conditions1 and will be in unavoidable close contact with others4 7ii7 ,federal health care facilities that serve at-risk and vulnerable communities1 such as ,indian ,health ,service clinics1 federally qualified health centers 7as defined in section #ahfa7;aa7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7aa7771 and facilities of the ,department of ,veterans ,affairs4 7iii7 ,other appropriate locations identified by the ,secretary of ,health and ,human ,services1 in consultation with external stakeholder organizations1 to test the operational feasibility and impact of influenza test-to-treat programs4 7#b7 ,report ,not later than #f months after completion of the demonstration project1 the ,secretary of ,health and ,human ,services shall-- 7,a7 prepare a report on the demonstration project under paragraph 7#a71 including an evaluation of the project's methods1 findings1 and results2 and 7,b7 make such report publicly available on the website of the ,department of ,health and ,human ,services4 7g7 ,creating administration pathways ,the ,secretary of ,health and ,human ,services may award grants to ,states to create administration pathways for pharmacy personnel to administer influenza vaccines1 tests1 and therapeutics1 in order to increase vaccination1 testing1 and relevant treatment as needed for adults and children4 7h7 ,strategic ,national ,stockpile and security countermeasure procurements 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall incorporate into the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 products needed to respond to pandemic influenza1 including through-- 7,a7 dynamic management of antivirals2 7,b7 vendor-managed inventory of testing equipment and supplies2 7,c7 replenishment of aging antivirals1 testing equipment1 supplies1 and other products2 and 7,d7 diversification of stockpiled products4 7#b7 ,medical countermeasures preparedness review ,the ,assistant ,secretary for ,preparedness and ,response shall incorporate into the annual ,medical ,countermeasures ,preparedness ,review under section #cai;,f-#b of the ,public ,health ,service 7#db ,u4,s4,c4 #bdg;d-#f;b7 an assessment of the supplies available for an influenza pandemic1 including replenishment of used and expired medical countermeasures and an assessment of existing ,state-level stockpiles4 7#c7 ,,gao study ,the ,comptroller ,general of the ,united ,states shall conduct a study of existing ,state-level pandemic stockpiles1 guidance provided by ,strategic ,national ,stockpile to ,state stockpiles1 and the sufficiency of such guidance4 7i7 ,monitoring and distributing influenza antiviral supplies ,the ,secretary of ,health and ,human ,services shall-- 7#a7 monitor influenza antiviral supplies throughout the country and publicly report challenges in availability in any region1 ,state1 county1 or metropolitan area2 and 7#b7 establish a process1 to be used in the case of a pandemic or during times when influenza antiviral supply availability is challenged1 to ensure rapid and effective distribution of products to areas of urgent need in close coordination with manufacturers1 distributors1 and ,state and local health officials4 7j7 ,plan for ensuring access to appropriate influenza therapeutics1 preexposure prophylaxis1 and diagnostics 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall publish a plan for ensuring access to appropriate influenza therapeutics1 preexposure prophylaxis influenza antibody products1 and influenza diagnostics1 including during times when availability is challenged in certain regions or localities1 for-- 7,a7 high-risk patients1 such as nursing home and pediatric patients2 7,b7 high-exposure patients1 such as first responders and health care workers2 and 7,c7 low-income individuals1 individuals covered by ,medicaid1 uninsured individuals1 ,tribal communities1 and other underserved populations4 7#b7 ,communications efforts ,the plan required by paragraph 7#a7 shall include communications efforts to educate the public about the benefits of early use of influenza diagnostics1 therapeutics1 and preexposure prophylaxis products4 #f4 ,authorizing sustainable funding for the influenza ecosystem 7a7 ,influenza ,planning and ,response ,program ,there is authorized to be appropriated #bca1ceh1jjj for fiscal year #bjbg and each subsequent fiscal year for programs and activities of the ,centers for ,disease ,control and ,prevention relating to influenza planning and response4 7b7 ,strategic ,national ,stockpile ,there is authorized to be appropriated #a1jjj1jjj1jjj for fiscal year #bjbg and each subsequent fiscal year for the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74 7c7 ,industrial base management and supply chain ,there is authorized #aj1jj1jjjj for fiscal year #bjbg and each subsequent fiscal year for the ,center for ,industrial ,base ,management and ,supply ,chain of the ,administration for ,strategic ,preparedness and ,response4 7d7 ,hospital ,preparedness ,program ,there is authorized to be appropriated #cjg1jjj1jjj for fiscal year #bjbg and each subsequent fiscal year for the ,hospital ,preparedness ,program of the ,administration for ,strategic ,preparedness and ,response4 7e7 ,universal ,flu ,vaccine ,research ,there is authorized to be appropriated #bgj1jjj1jjj for fiscal year #bjbg and each subsequent fiscal year for research of the ,national ,institutes of ,health to develop a universal flu vaccine4 7f7 ,immunization ,program ,there is authorized to be appropriated #fha1icc1jjj for fiscal year #bjbg and each subsequent fiscal year for the immunization program of the ,centers for ,disease ,control and ,prevention under section #cag of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b74 7g7 ,public ,health ,emergency ,preparedness ,program ,there is authorized to be appropriated #gce1jjj1jjj for fiscal year #bjbg and each subsequent fiscal year for the ,public ,health ,emergency ,preparedness ,program of the ,centers for ,disease ,control and ,prevention4 7h7 ,data ,modernization ,initiative ,there is authorized to be appropriated #ahe1jjj1jjj for fiscal year #bjbg and each subsequent fiscal year for the ,public ,health ,data ,modernization ,initiative of the ,centers for ,disease ,control and ,prevention4 7i7 ,advanced ,molecular ,detection ,program ,there is authorized to be appropriated #dc1jjj1jjj for fiscal year #bjbg and each subsequent fiscal year for the ,advanced ,molecular ,detection ,program at the ,centers for ,disease ,control and ,prevention4 7j7 ,health defense operations budget matters 7#a7 ,designation ,section #bea7;b77#b7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe 7#b ,u4,s4,c4 #ija7;b77#b77 is amended by adding at the end the following3 7,h7 ,health defense operations 7i7 ,if1 for any fiscal year1 appropriations for discretionary accounts are enacted that the ,congress designates in statute on an account-by-account basis as being for health defense operations1 then the adjustment for that fiscal year shall be the total of such appropriations for that fiscal year4 7ii7 ,any report or explanatory statement accompanying an appropriations ,act that contains an account with amounts that are designated as being for health defense operations pursuant to clause 7i7 shall specify each program1 project1 or activity that will be funded by such amounts1 and a specific dollar amount provided for each such program1 project1 or activity4 4 7#b7 ,professional bypass budget ,title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by inserting after section #djb;,b the following3 #djb;,c4 ,health defense operations professional bypass budget 7a7 ,in general ,for fiscal year #bjbh and each fiscal year thereafter1 the ,director of the ,centers for ,disease ,control and ,prevention1 the ,director of the ,national ,institutes of ,health1 and the ,assistant ,secretary for ,preparedness and ,response shall prepare and submit directly to the ,president for review and transmittal to ,congress1 after reasonable opportunity for comment1 but without change1 by the ,secretary of ,health and ,human ,services1 an annual budget estimate 7including an estimate of the number and type of personnel needs for the ,institutes7 for amounts to be designated as being for health defense operations pursuant to subparagraph 7,h7 of section #bea7;b77#b7 of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe4 7b7 ,programs1 projects1 and activities ,any budget estimate submitted pursuant to subsection 7a7 by the ,director shall include any program1 project1 or activity that received funds designated under such subparagraph 7,h7 for the fiscal year during which such budget is submitted1 except that the ,director may modify the programs1 projects1 or activities contained in such budget estimate as circumstances warrant4 4