| 通報號: G/TBT/N/USA/986 |
ICS號: 11.040
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發(fā)布日期: 2015-04-22
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截至日期: 2015-06-29
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通報成員: 美國
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目標(biāo)和理由: 保護(hù)人類安全和健康
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內(nèi)容概述: 食品藥品管理局(FDA)擬修訂聯(lián)邦電離輻射性能標(biāo)準(zhǔn)，修改草案中關(guān)于熒光設(shè)備測量的錯誤。我們采取本措施以澄清和改進(jìn)法規(guī)準(zhǔn)確性。
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正文:
| 世界貿(mào)易組織 |
G/TBT/N/USA/986
2015-04-22
15-2111
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| 技術(shù)性貿(mào)易壁壘 |
原文：英語
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通 報
以下通報根據(jù)TBT協(xié)定第10.6條分發(fā)
| 1. |
通報成員: 美國
如可能，列出涉及的地方政府名稱 ( 3.2條和7.2 條)：
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| 2. |
負(fù)責(zé)機(jī)構(gòu):衛(wèi)生及公共服務(wù)部(HHS)食品藥品管理局(FDA)[1004]
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| 3. |
通報依據(jù)條款:2.9.2
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| 4. |
覆蓋的產(chǎn)品： 熒光設(shè)備；醫(yī)療設(shè)備（ICS: 11.040）
HS編碼:90 ICS編碼:11.040
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| 5. |
通報標(biāo)題： 電離輻射放射產(chǎn)品性能標(biāo)準(zhǔn)；熒光設(shè)備
語言：英語 頁數(shù)：3 鏈接網(wǎng)址：
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| 6. |
內(nèi)容簡述： 食品藥品管理局(FDA)擬修訂聯(lián)邦電離輻射性能標(biāo)準(zhǔn)，修改草案中關(guān)于熒光設(shè)備測量的錯誤。我們采取本措施以澄清和改進(jìn)法規(guī)準(zhǔn)確性。
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| 7. |
目標(biāo)與理由:保護(hù)人類健康安全
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| 8. |
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| 9. |
擬批準(zhǔn)日期:待定
擬生效日期:待定
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| 10. |
意見反饋截止日期： 2015/06/29
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| 11. |
文本可從以下機(jī)構(gòu)得到:
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正文(英):
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6
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1.
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Notifying Member: United States of America
If applicable, name of local government involved (Article 3.2 and 7.2):
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2.
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Agency responsible: Food and Drug Administration (FDA), Health and Human Services (HHS) [1004]
Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above: Please submit comments to: USA WTO TBT Enquiry Point, Email: ncsci@nist.gov
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3.
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Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:
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4.
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Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Fluoroscopic equipment; Medical equipment (ICS: 11.040)
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5.
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Title, number of pages and language(s) of the notified document: Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment (3 pages, in English).
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6.
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Description of content: The Food and Drug Administration (FDA) is proposing to amend a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations.
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7.
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Objective and rationale, including the nature of urgent problems where applicable: Protection of Human health or Safety
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8.
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Relevant documents: 80 Federal Register (FR) 19589, 13 April 2015; Title 21 Code of Federal Regulations (CFR) Part 1020. Will appear in the Federal Register when adopted. A direct final rule was issued 13 April 2015 and will be issued as Add.1:
http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/html/2015-08360.htm
http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/pdf/2015-08360.pdf
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9.
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Proposed date of adoption: To be determined
Proposed date of entry into force: To be determined
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10.
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Final date for comments: 29 June 2015
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11.
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Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:
http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/html/2015-08361.htm
http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/pdf/2015-08361.pdf
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