,,ib ,union ,calendar ,no4 #fbg #aahth ,,congress #b;d ,session ,h4 ,r4 #debi ,report ,no4 #aah-gef ,,in ,,the ,,house ,,of ,,representatives ,july #aa1 #bjbc,mrs4 ,rodgers of ,washington introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,november #ai1 #bjbd;,additional sponsor3 ,mr4 ,crenshaw ,november #ai1 #bjbd,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed,strike out all after the enacting clause and insert the part printed in italic,for text of introduced bill1 see copy of bill as introduced on ,july #aa1 #bjbc ,a ,,bill ,to amend the ,public ,health ,service ,act regarding guidance documents of the ,centers for ,disease ,control and ,prevention1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,public ,health ,guidance ,transparency and ,accountability ,act of #bjbc4 #b4 ,,cdc guidance documents ,the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 is amended by inserting after section #cag,v of such ,act 7#db ,u4,s4,c4 #bdg;b-#bd7 the following3 #cag,w4 ,,cdc guidance documents 7a7 ,good guidance practices 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention 7in this section referred to as the ,secretary71 shall1 by regulation1 develop1 establish1 and maintain good guidance practices setting forth the policies and procedures of the ,centers for the development1 issuance1 dissemination1 and use of guidance documents of the ,centers for ,disease ,control and ,prevention4 7#b7 ,contents ,the regulation required by paragraph 7#a7 shall-- 7,a7 incorporate each requirement of subsections 7b7 through 7j72 and 7,b7 require guidance documents of the ,centers for ,disease ,control and ,prevention to be developed with public participation4 7#c7 ,initial regulation ,the ,secretary shall-- 7,a7 not later than #cj days after the date of enactment of the ,public ,health ,guidance ,transparency and ,accountability ,act of #bjbc1 initiate the rulemaking process for the initial regulation under paragraph 7#a72 and 7,b7 not later than #b years after the date of enactment of the ,public ,health ,guidance ,transparency and ,accountability ,act of #bjbc1 finalize such regulation4 7b7 ,no creation1 conferring1 restricting1 or revoking of rights1 responsibilities1 or liabilities ,guidance documents of the ,centers for ,disease ,control and ,prevention may present views on matters under the jurisdiction of the ,centers1 but shall not-- 7#a7 create1 confer1 restrict1 or revoke any rights1 responsibilities1 or liabilities for or on any person2 7#b7 be treated 7including in any civil or criminal proceeding7 as having the force and effect of law2 or 7#c7 include any provision that-- 7,a7 is binding on the public or a ,state1 local1 ,tribal1 or ,territorial government2 or 7,b7 requires an individual to take or refrain from an action4 7c7 ,training ,the ,secretary shall-- 7#a7 provide training to employees of the ,centers for ,disease ,control and ,prevention in how to develop1 issue1 disseminate1 and use guidance documents of the ,centers in accordance with the regulation under subsection 7a77#a72 and 7#b7 monitor the development1 issuance1 dissemination1 and use of such documents to ensure compliance with the regulation under subsection 7a77#a74 7d7 ,public participation in process 7#a7 ,in general ,subject to paragraph 7#b71 the ,secretary shall ensure that public participation required by subsection 7a77#b77;,b7 occurs prior to finalization and implementation of any guidance document of the ,centers for ,disease ,control and ,prevention1 including any guidance document that sets forth-- 7,a7 initial interpretations of a statute1 a regulation1 or an emerging public health situation2 7,b7 changes or updates in interpretation or policy that are of more than a minor nature2 7,c7 complex scientific issues2 or 7,d7 highly controversial issues4 7#b7 ,exceptions ,the ,secretary may provide for public participation required by subsection 7a77#b77;,b7 with respect to a guidance document of the ,centers for ,disease ,control and ,prevention to occur after the guidance document has been finalized and after implementation of the guidance document has begun if-- 7,a7 the ,secretary determines that commencing public participation sooner is not feasible or appropriate2 or 7,b7 the guidance document sets forth only existing practices or minor changes in policy4 7#c7 ,consideration ,in finalizing1 implementing1 and revising a guidance document of the ,centers for ,disease ,control and ,prevention1 the ,secretary shall take into account public comments received during public participation on the guidance document4 7e7 ,uniform nomenclature ,in developing guidance documents of the ,centers for ,disease ,control and ,prevention1 the ,secretary shall ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents4 7f7 ,indication of nonbinding nature ,the ,secretary shall ensure that guidance documents of the ,centers for ,disease ,control and ,prevention and revisions of such documents are properly dated and indicate the nonbinding nature of the documents4 7g7 ,periodic review ,the ,secretary shall periodically review all guidance documents of the ,centers for ,disease ,control and ,prevention and1 where appropriate1 revise such documents4 7h7 ,list of documents ,the ,secretary shall maintain electronically1 and update and publish periodically in the ,federal ,register1 a list of all guidance documents of the ,centers for ,disease ,control and ,prevention4 7i7 ,public availability ,the ,secretary shall make available to the public the list under subsection 7h7 and all guidance documents of the ,centers for ,disease ,control and ,prevention1 including by posting on the public website of the ,centers4 7j7 ,appeals mechanism ,the ,secretary shall ensure that an effective appeals mechanism is in place to address complaints that guidance documents of the ,centers for ,disease ,control and ,prevention are not being developed1 issued1 disseminated1 or used in accordance with this section4 4 ,november #ai1 #bjbd,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed