Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments.
Identifieur interne : 000500 ( Main/Exploration ); précédent : 000499; suivant : 000501Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments.
Auteurs :Source :
- Federal register [ 0097-6326 ] ; 2005.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Allemagne, Contrôle des maladies contagieuses (économie), Couverture d'assurance, Coûts des médicaments, Department of Health and Human Services (USA), Enfant, Enfant d'âge préscolaire, Frais et honoraires, Grippe humaine (), Grippe humaine (traitement médicamenteux), Grippe humaine (économie), Grippe humaine (épidémiologie), Humains, Medicare part B (USA), Médicaments en essais cliniques (ressources et distribution), Médicaments en essais cliniques (usage thérapeutique), Médicaments en essais cliniques (économie), Nourrisson, Sujet âgé, Vaccins antigrippaux (ressources et distribution), Vaccins antigrippaux (usage thérapeutique), Vaccins antigrippaux (économie), Établissements de soins ambulatoires (ressources et distribution), Établissements de soins ambulatoires (économie), États-Unis d'Amérique (épidémiologie).
- MESH :
- ressources et distribution : Médicaments en essais cliniques, Vaccins antigrippaux, Établissements de soins ambulatoires.
- traitement médicamenteux : Grippe humaine.
- usage thérapeutique : Médicaments en essais cliniques, Vaccins antigrippaux.
- économie : Contrôle des maladies contagieuses, Grippe humaine, Médicaments en essais cliniques, Vaccins antigrippaux, Établissements de soins ambulatoires.
- épidémiologie : Grippe humaine, États-Unis d'Amérique.
- Adolescent, Adulte, Adulte d'âge moyen, Allemagne, Couverture d'assurance, Coûts des médicaments, Department of Health and Human Services (USA), Enfant, Enfant d'âge préscolaire, Frais et honoraires, Grippe humaine, Humains, Medicare part B (USA), Nourrisson, Sujet âgé.
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Ambulatory Care Facilities (economics), Ambulatory Care Facilities (supply & distribution), Centers for Disease Control and Prevention, U.S., Child, Child, Preschool, Communicable Disease Control (economics), Drug Costs, Drugs, Investigational (economics), Drugs, Investigational (supply & distribution), Drugs, Investigational (therapeutic use), Fees and Charges, Germany, Humans, Infant, Influenza Vaccines (economics), Influenza Vaccines (supply & distribution), Influenza Vaccines (therapeutic use), Influenza, Human (drug therapy), Influenza, Human (economics), Influenza, Human (epidemiology), Influenza, Human (prevention & control), Insurance Coverage, Medicare Part B, Middle Aged, United States (epidemiology), United States Dept. of Health and Human Services.
- MESH :
- chemical , economics : Drugs, Investigational, Influenza Vaccines.
- chemical , supply & distribution : Influenza Vaccines.
- chemical , therapeutic use : Influenza Vaccines.
- geographic , epidemiology : United States.
- geographic : Germany.
- drug therapy : Influenza, Human.
- economics : Ambulatory Care Facilities, Communicable Disease Control, Influenza, Human.
- epidemiology : Influenza, Human.
- prevention & control : Influenza, Human.
- supply & distribution : Ambulatory Care Facilities, Drugs, Investigational.
- chemical , therapeutic use : Drugs, Investigational.
- Adolescent, Adult, Aged, Centers for Disease Control and Prevention, U.S., Child, Child, Preschool, Drug Costs, Fees and Charges, Humans, Infant, Insurance Coverage, Medicare Part B, Middle Aged, United States Dept. of Health and Human Services.
Abstract
We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.
PubMed: 15669145
Affiliations:
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type="geographic" xml:lang="fr"><term>États-Unis</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="HSR"><PMID Version="1">15669145</PMID><DateCompleted><Year>2005</Year><Month>01</Month><Day>28</Day></DateCompleted><DateRevised><Year>2019</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0097-6326</ISSN><JournalIssue CitedMedium="Print"><Volume>70</Volume><Issue>15</Issue><PubDate><Year>2005</Year><Month>Jan</Month><Day>25</Day></PubDate></JournalIssue><Title>Federal register</Title><ISOAbbreviation>Fed Regist</ISOAbbreviation></Journal><ArticleTitle>Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments.</ArticleTitle><Pagination><MedlinePgn>3490-3</MedlinePgn></Pagination><Abstract><AbstractText>We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><CollectiveName>Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS)</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Fed Regist</MedlineTA><NlmUniqueID>7808722</NlmUniqueID><ISSNLinking>0097-6326</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015507">Drugs, Investigational</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>T</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000554" MajorTopicYN="Y">Ambulatory Care Facilities</DescriptorName><QualifierName UI="Q000191" MajorTopicYN="N">economics</QualifierName><QualifierName UI="Q000600" MajorTopicYN="N">supply & distribution</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002487" MajorTopicYN="N">Centers for Disease Control and Prevention, U.S.</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, 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MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="Y">Influenza Vaccines</DescriptorName><QualifierName UI="Q000191" MajorTopicYN="N">economics</QualifierName><QualifierName UI="Q000600" MajorTopicYN="N">supply & distribution</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="Y">Influenza, Human</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName><QualifierName UI="Q000191" MajorTopicYN="N">economics</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019458" MajorTopicYN="N">Insurance Coverage</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016345" MajorTopicYN="N">Medicare Part B</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014483" MajorTopicYN="N">United States Dept. of Health and Human Services</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2005</Year><Month>1</Month><Day>27</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2005</Year><Month>1</Month><Day>29</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2005</Year><Month>1</Month><Day>27</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">15669145</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list></list><tree></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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