| public reporting burden "... os custos de geração de informação para o público estão estimados em 100 horas por ...".
Explanation:
Agora sim, acho que está correto (um amigo de outra lista ajudou!)
Hope it helps!
--------------------------------------------------
Note added at 11 hrs 1 min (2004-02-10 02:13:08 GMT)
--------------------------------------------------
FDA again invited comments on the collection of information, specifically: (1) whether the proposed collection of information is necessary for the proper performance of FDA\'s functions, including whether the information will have practical utility; (2) the accuracy of FDA\'s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Comments were made about the estimate of the \"hours per response\". One comment correctly stated that the \"estimate may be about right for the physical act of filling out the form itself\". Because the 3500A is used for mandatory reporting subject to different regulations (i.e., 21 CFR 310.305, 314.80, 600.80 and 803), this estimate for reporting burden is limited to completing the form. Estimates of the burden placed on user facilities, importers and manufacturers to investigate a report and compile the necessary information would be addressed in the final rules for those regulations.
http://www.fda.gov/OHRMS/DOCKETS/98fr/960393ss.doc
--------------------------------------------------
Note added at 11 hrs 7 mins (2004-02-10 02:19:03 GMT)
--------------------------------------------------
Based on a total information collection burden of 322,414 hours for mandatory form 3500A the annual labor cost to the industry would be $7,415,522.
Approximately 273,109 reports from pharmaceutical manufacturers, and 49,305 device reports from user-facilities, importers or manufacturers, including follow-up reports, can be expected to be submitted to FDA annually using the mandatory 3500A form. Each report requires about one hour for data entry and review. This includes 30 minutes for a data entry technician at a pay rate of $17.00 per hour and 30 minutes for a health professional at a pay rate of $29.00 per hour for review.
--------------------------------------------------
Note added at 11 hrs 9 mins (2004-02-10 02:20:36 GMT)
--------------------------------------------------
The increase in reporting burden reflects a natural increase in the number of reports coming into the Agency. As more medical products are approved by the FDA and marketed, and as knowledge increases of the importance of notifying FDA when adverse events and product problems are observed, it can be expected that more reports will be submitted to the Agency directly (voluntary form 3500). The number of reports submitted via the manufacturer/user?-are fully implemented. The following is based on actual experience in CY1999
--------------------------------------------------
Note added at 1 day 56 mins (2004-02-10 16:07:54 GMT) Post-grading
--------------------------------------------------
Oi Kathleen!
Sabe que o termo do Leiria, que à primeira vista me pareceu totalmente fora de propósito, afinal de contas é mesmo adequado? (trata-se, na verdade, de uma \"carga documental\" de referências públicas, ou seja, são os tais formulários de usuários de produtos, em lançamento ou recém-lançados - alguns obrigatórios - que o pessoal do FDA tem que processar (grande parte gerado por lei, ou seja, muitos deles são compulsórios!) E esse processamento custa uma nota PRETA ao governo...
De toda forma, da próxima vez, esse termo não vai ser novidade nenhuma pra gente, né? ;-)
Valeu, um abraço!
Maria
-------Mensagem original-------
De: [email protected]
Data: 02/10/04 07:26:01
Para: [email protected]
Assunto: [ProZ.com Mail] public reporting burden
-----------
You have been sent a message via your ProZ.com page.
Author: Kathleen Goldsmith
Author\'s Profile: http://www.proz.com/pro/21568
Author\'s IP address: 200.185.145.75
Message type: KudoZ-related
-----------
Nossa, Maria, que pesquisa completa! Muito obrigada!
Concordo com você quanto ao significado, mas eu estava
procurando um termo correspondente e parece que o que foi
indicado por MLeiria é correto.
De qualquer forma, \"valeu\"!
Um abraço,
Kathleen
| Lúcia Lopes
Brazil
Local time: 10:28
Native speaker of:  Portuguese
PRO pts in category: 12
|
|
peer agreement (net): +2