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美國關(guān)于標(biāo)準(zhǔn)準(zhǔn)備、效力限制和生物產(chǎn)品標(biāo)注日期限制的直接最終法規(guī)手冊

嘉峪檢測網(wǎng)        2017-04-22 19:44

通報(bào)號: G/TBT/N/USA/1121
ICS號: 11.020
發(fā)布日期: 2016-05-09
截至日期: 2016-07-18
通報(bào)成員: 美國
目標(biāo)和理由: 保護(hù)消費(fèi)者;防止欺詐行為
內(nèi)容概述: 食品藥品管理局(FDA或我們)現(xiàn)提出修訂涉及標(biāo)注日期的生物產(chǎn)品通用標(biāo)準(zhǔn),撤銷涉及標(biāo)準(zhǔn)準(zhǔn)備和效力限制的某些標(biāo)準(zhǔn)。FDA提出本措施以便更新過時(shí)的要求,適應(yīng)新的發(fā)展中的技術(shù)和測試能力,同時(shí)不降低公眾健康保護(hù)。本措施提案是FDA為回應(yīng)行政法令而回顧檢查法規(guī)的一部分。
正文: 
世界貿(mào)易組織
G/TBT/N/USA/1121
2016-05-09
16-2554
 
技術(shù)性貿(mào)易壁壘
原文:英語
 
通 報(bào)


                   以下通報(bào)根據(jù)TBT協(xié)定第10.6條分發(fā)

1.
通報(bào)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):
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)[1139]
3.
通報(bào)依據(jù)條款:
[X] 2.9.2
[ ] 2.10.1
[ ] 5.6.2
[ ] 5.7.1
通報(bào)依據(jù)的條款其他:
4.
覆蓋的產(chǎn)品: 生物產(chǎn)品。數(shù)學(xué)。自然科學(xué) (詞匯),醫(yī)學(xué)科學(xué)和衛(wèi)生保健設(shè)施綜合。 ICS: 01.040.07、11.020 HS:
HS編碼:   ICS編碼:11.020
5.
通報(bào)標(biāo)題: 標(biāo)準(zhǔn)準(zhǔn)備、效力限制和生物產(chǎn)品標(biāo)注日期限制;直接最終法規(guī)手冊。

語言:英語 頁數(shù):7 鏈接網(wǎng)址:
 
6.
內(nèi)容簡述: 食品藥品管理局(FDA或我們)現(xiàn)提出修訂涉及標(biāo)注日期的生物產(chǎn)品通用標(biāo)準(zhǔn),撤銷涉及標(biāo)準(zhǔn)準(zhǔn)備和效力限制的某些標(biāo)準(zhǔn)。FDA提出本措施以便更新過時(shí)的要求,適應(yīng)新的發(fā)展中的技術(shù)和測試能力,同時(shí)不降低公眾健康保護(hù)。本措施提案是FDA為回應(yīng)行政法令而回顧檢查法規(guī)的一部分。
7.
目標(biāo)與理由:防止欺詐行為和消費(fèi)者保護(hù)。
8.
相關(guān)文件: 2016年5月4日聯(lián)邦紀(jì)事(FR)第81卷第26753頁;聯(lián)邦法規(guī)法典(CFR)第21編第610部分。批準(zhǔn)時(shí)公布在聯(lián)邦紀(jì)事。 2016年5月4日公布的直接最終法規(guī)將作為Add.1頒布: https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/html/2016-10385.htm  https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10385.pdf  
9.
擬批準(zhǔn)日期:待定
擬生效日期:待定
10.
意見反饋截止日期: 2016/07/18
11.
文本可從以下機(jī)構(gòu)得到:
[ ] 國家通報(bào)機(jī)構(gòu)
[ ] 國家咨詢點(diǎn),或其他機(jī)構(gòu)的聯(lián)系地址、傳真及電子郵件地址(如能提供):

正文(英): 

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: United States of America

If applicable, name of local government involved (Article 3.2 and 7.2):  

2.

Agency responsible: Food and Drug Administration (FDA), Health and Human Services (HHS) [1139]

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: usatbtep@nist.gov

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Biological products. Mathematics. Natural sciences (Vocabularies) (ICS 01.040.07), Medical sciences and health care facilities in general (ICS 11.020)

5.

Title, number of pages and language(s) of the notified document: Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule (7 pages, in English).

6.

Description of content: The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.

7.

Objective and rationale, including the nature of urgent problems where applicable: Prevention of deceptive practices and consumer protection

8.

Relevant documents: 81 Federal Register (FR) 26753, 4 May 2016; Title 21 Code of Federal Regulations (CFR) Part 610.  Will appear in the Federal Register when adopted.

Direct Final Rule published 4 May 2016 will be issued as Add.1:
https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/html/2016-10385.htm
https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10385.pdf  

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 18 July 2016

11.

Texts available from: National enquiry point [  ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

https://members.wto.org/crnattachments/2016/TBT/USA/16_1849_00_e.pdf

 

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