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全部话题 - 话题: cfr
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u****n
发帖数: 7521
1
印度为什么经常都放在中国的前面呢?老美很给印度面子啊!
http://www.cfr.org/publication/23776/new_cfr_book.html?cid=rss-
---------
New CFR Book: How American Innovation Can Overcome the Asian Challenge
January 11, 2011
As the United States struggles to emerge from recession, India and China's
continued robust growth is the subject of much interest and concern. In his
new book, Advantage: How American Innovation Can Overcome the Asian
Challenge, Council on Foreign Relations (CFR) Senior Fellow Adam Segal
analyzes Asia's tech... 阅读全帖
l****f
发帖数: 168
2
拟修改法案原文
§ 204.5 Petitions for employment-based immigrants.
(n)
(3) Validity of approved petitions. Unless approval is revoked under section
203(g) or 205 of the Act, an employment-based petition is valid
indefinitely.
§ 205.1 Automatic revocation.
(a) * * *
(3) * * *
(iii) * * *
(C) In employment-based preference cases, upon written notice of withdrawal
filed
by the petitioner to any officer of USCIS who is authorized to grant or deny
petitions,
where the withdrawal is filed less than 180 days a... 阅读全帖
c*****a
发帖数: 1238
3
来自主题: Military版 - LI Lu - member of CFR
CFR: council of foreign relations
The CFR is the promotional arm of illuminati (free masonery)
d****g
发帖数: 1099
4
大家在写eb1(a)或(b)的petition letter中,不用eb1a或eb1b,而用203(b)(1)(A), 8
CFR 204.5(h)(2)这样的数字,这样的字眼显得非常专业,不知在移民局网站什么地方
找到?
谢谢。
c***1
发帖数: 652
5
赞研究精神,根据这段话来看,PERM是必须重新做的了。
,If an employment-based petition on behalf of an alien is withdrawn, the
job offer of the petitioning employer is rescinded and the alien must obtain
a new employment-based preference petition on his or her behalf in order to
seek adjustment of status or issuance of an immigrant visa as an employment
-based immigrant, unless eligible for adjustment of status under section 204
(j) of the Act and in accordance with 8 CFR 245.25.
automatic revocation是老的内容,就是说如果雇主申请withdr... 阅读全帖
k****t
发帖数: 2288
6
来自主题: SanFrancisco版 - 房奴,CFR是什么意思?
收到一封mail,是CFR(Claim for Refund),是退钱吗?看后面是说deposit the ref
und check and write one check for the entire payment due.又有点不明白了。
m****e
发帖数: 87
7
【 以下文字转载自 Accounting 讨论区 】
发信人: mytree (Nothing), 信区: Accounting
标 题: Anyone knows where I can download a free CFR?
发信站: BBS 未名空间站 (Fri Dec 19 20:46:09 2008)
Code of Federal Regulations, title 19.
Thanks~ : )
m****e
发帖数: 87
8
【 以下文字转载自 Accounting 讨论区 】
发信人: mytree (Nothing), 信区: Accounting
标 题: Anyone knows where I can download a free CFR?
发信站: BBS 未名空间站 (Fri Dec 19 20:46:09 2008)
Code of Federal Regulations, title 19.
Thanks~ : )
m****e
发帖数: 87
9
来自主题: PoliticalScience版 - Anyone knows where I can download a free CFR? (转载)
【 以下文字转载自 Accounting 讨论区 】
发信人: mytree (Nothing), 信区: Accounting
标 题: Anyone knows where I can download a free CFR?
发信站: BBS 未名空间站 (Fri Dec 19 20:46:09 2008)
Code of Federal Regulations, title 19.
Thanks~ : )
i****w
发帖数: 329
10
I found the informaiton is very uselful, while preparing for my RFE response
to Eb1a petition.
The original document link is as follows:
http://imminfo.com/Library/green_cards/EB/extraordinary_ability
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
The USCIS Adjudicator's Field Manual provides the following guidance to
center adjudicators:
(i) Special Considerations Relating to EB-1 Cases.
Certain alien beneficiaries are exempted from the labor certification
application process by virtue of their e... 阅读全帖
q***l
发帖数: 177
11
Health One Pharmaceuticals, Inc. of El Monte, CA was warned by the FDA that
a September/October inspection of the company's dietary supplement
manufacturing facility revealed serious violations of FDA's Current Good
Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements regulation, including failure to
conduct at least one appropriate test or examination to verify the identity
of a component that is a dietary ingredient
WARNING LETTER
V... 阅读全帖
q***l
发帖数: 177
12
【 以下文字转载自 LosAngeles 讨论区 】
发信人: qdssl (honeydot), 信区: LosAngeles
标 题: FDA查处美国海尔斯制药有限公司在中国热卖的一氧化氮等保健产品
发信站: BBS 未名空间站 (Sat May 5 13:27:59 2012, 美东)
Health One Pharmaceuticals, Inc. of El Monte, CA was warned by the FDA that
a September/October inspection of the company's dietary supplement
manufacturing facility revealed serious violations of FDA's Current Good
Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements regulation, includin... 阅读全帖
n**b
发帖数: 13203
13
【 以下文字转载自 SanFrancisco 讨论区 】
发信人: qdssl (honeydot), 信区: SanFrancisco
标 题: FDA查处美国海尔斯制药有限公司在中国热卖的一氧化氮等保健产品 (转载)
发信站: BBS 未名空间站 (Sat May 5 13:29:53 2012, 美东)
发信人: qdssl (honeydot), 信区: LosAngeles
标 题: FDA查处美国海尔斯制药有限公司在中国热卖的一氧化氮等保健产品
发信站: BBS 未名空间站 (Sat May 5 13:27:59 2012, 美东)
Health One Pharmaceuticals, Inc. of El Monte, CA was warned by the FDA that
a September/October inspection of the company's dietary supplement
manufacturing facility revealed serious violations of FDA's Current Good
Manu... 阅读全帖
s********n
发帖数: 26222
14
流传很久的是, 米犹有建立world government的计划, 毁灭单个的国家政府, 而把
全世界置于米犹的控制之下。
这和正在发生的事情非常相似。
GEORGE SOROS AND THE ROTHSCHILD CONNECTION
Who was George Soros?
[H: Better yet: Who IS this man? Meet one of the most prominent of the
players in your downfall. He very much ‘was’ but he also IS and did, in
fact wreck the economy of Southeast Asia in very short order. He is a top
player in such as Bilderbergers and all the other controlling groups while
doing nothing “illegal”. But then no one can do anything illegal i... 阅读全帖
s**********8
发帖数: 25265
15
来自主题: MedicalDevice版 - 学术第一贴 - 美国器械分类.
510K
Premarket Notification (510k)
Introduction
What is Substantial Equivalence
Who is Required to Submit a 510(k)
When a 510(k) is Required
When a 510(k) is not Required
Third Party Review Program
Introduction
Each person who wants to market in the U.S., a Class I, II, and III device
intended for human use, for which a Premarket Approval (PMA) is not required
, must submit a 510(k) to FDA unless the device is exempt from 510(k)
requirements of the Federal Food, Drug, and Cosmetic Act (the Act) ... 阅读全帖
s**********8
发帖数: 25265
16
来自主题: MedicalDevice版 - Institutional review board
Frequently Asked Questions About the IRB:
The following is a compilation of questions frequently asked regarding
Institutional Review Boards, human subject protection and compliance with
federal regulations. These questions are organized according to whether they
pertain to:
I. Institutional Review Board regulations;
II. Informed Consent regulations;
III. Clinical investigations involving drugs;
IV. Clinical investigations involving medical devices; and
V. Other
I. INSTITUTIONAL REV... 阅读全帖
q****e
发帖数: 410
17
2018年初,在网上和微信有一篇“北大飞”同学写的文章流传,题目是《川普政府反移
民再出狠招,大刀向H-1B们的头上砍去》。我作为北大校友,目前在美国做移民律师,
读了“北大飞”的文章以后,发现里面有若干错误。几天后,又看到“北大飞”同学自
己在后续文章中提到,他的这篇文章“引起了广泛重视,其阅读量超过10万”。更严重
的是,他在题为《对川普政府取消H-1B签证延期的深度解读,前景不容乐观》的后续文
章里面对于当前生效的美国法律(具体来说是关于H-1B延期的条款)做出了错误解读,
可能会误导很多人。因此,我认为有必要澄清“北大飞”这两篇文章中的错误,包括似
是而非和不完整不明确的地方。
先说最重要的,也是大家关心的,对于AC21法律里面的Section 106(a),(b)的解读。
“AC21”,即“American Competitiveness in the Twenty-first Century Act of
2000”,是美国第106届国会在2000年10月17日通过的法律,对美国移民法(Immigration
and Nationality Act)的一些条款做出了修改。具... 阅读全帖
s**********8
发帖数: 25265
18
来自主题: MedicalDevice版 - FDA Regulation of Medical Devices
http://www.qrasupport.com/FDA_MED_DEVICE.html
Overview: FDA Regulation of Medical Devices
The following information is provided as general guidance to the Food and
Drug Administration (FDA) regulation of medical devices. The Center for
Devices and Radiological Health (CDRH) is the division of FDA responsible
for medical device regulation. CDRH maintains a very informative web site.
The CDRH web site is located at: http://www.fda.gov/cdrh/devadvice/default.htm.
For support in working with the FDA... 阅读全帖
s**********8
发帖数: 25265
19
In fiscal year 2013, FDA’s Center for Devices and Radiological Health (CDRH
) issued 217 Warning Letters, seven more than the center issued in FY12. EAS
reviewed a total of 105 of the warning letters issued to manufacturers or
other establishments that market medical devices in the U.S. The following
were the Top 10 observations noted in those letters:
1. 21 CFR 803.17 - Failure to develop, maintain, and implement written
Medical Device Reporting procedures.
2.21 CFR 820.22 - Failure to establis... 阅读全帖
l*********d
发帖数: 315
20
Department of Homeland Security ( DHS ) RIN: 1615-AB97
U.S. Citizenship and Immigration Services ( USCIS ) Publication: 201410
View Related Documents
Title: Implementation of AC21, the VWPPA, and the ACWIA
Abstract: The American Competitiveness in the 21st Century Act (AC21),
Public Law 106-313, was enacted in October 2000, along with two other laws,
the Visa Waiver Permanent Program Act (VWPPA), Public Law 106-396, and a law
to increase the fee for certain H-1B petitions, Public L... 阅读全帖
l*********d
发帖数: 315
21
Department of Homeland Security ( DHS ) RIN: 1615-AB97
U.S. Citizenship and Immigration Services ( USCIS ) Publication: 201410
View Related Documents
Title: Implementation of AC21, the VWPPA, and the ACWIA
Abstract: The American Competitiveness in the 21st Century Act (AC21),
Public Law 106-313, was enacted in October 2000, along with two other laws,
the Visa Waiver Permanent Program Act (VWPPA), Public Law 106-396, and a law
to increase the fee for certain H-1B petitions, Public L... 阅读全帖
k****i
发帖数: 1126
22
Investigations covered under the IDE regulation are subject to differing
levels of regulatory control depending on the level of risk. The IDE
regulation distinguishes between significant and nonsignificant risk device
studies and the procedures for obtaining approval to begin the study differ
accordingly. Also, some types of studies are exempt from the IDE regulations.
Significant Risk Device
A significant risk device presents a potential for serious risk to the
health, safety, or welfare of a s... 阅读全帖
i*****9
发帖数: 3157
23
【 以下文字转载自 EB23 讨论区 】
发信人: purewhite (iLoveJenny), 信区: EB23
标 题: 不说不舒服: 在美国不要做法盲,要学法,才能保护自己
发信站: BBS 未名空间站 (Tue Nov 22 17:20:46 2016, 美东)
最基本的是要明白3权分立。不要只知道名字,不明其意。我不是学法律的,但是觉得
在美国就得懂法。
总统DJT有多大能耐?他不是习总,说改法就改法,说花钱就花钱。他是总统,是国家
的行政首脑。对了,什么叫行政?普通说就是执法,按照法律办事。法律哪来的?是总
统订的?百度告诉你,在美国,行政权指政府,立法权指国会的参众议院制度,司法权
指法院。
那么,现在的移民法又是什么?是uscis网站上告诉你的怎么办绿卡的流程?或者是某
律师告诉你的怎么申请h1-b,怎么申请旅游观光签证?都不是,是Immigration Act of
1990。如果你没去读过,看过原文,那至少应该去看看wikipedia的介绍。 改这个法
需要重新立法,比如来个immigration act of 2018.需要国会参众院通过,然后总统签
字,才能... 阅读全帖
c*********n
发帖数: 60
24
CFR 其實與法律是差不多的東西. 有空可以翻翻移民法的書, 引例解釋都是 quote CFR
的多. 不能說CFR說的就沒有效
力. 你要否定CFR的說法, 有兩種可能,
第一是, 你找到CFR與INA有明顯conflict的地方. 顯然, CFR只是深入定義什麼是
professional, 明確什麼條件可以
porting, 並沒有與INA有conflict.
第二是, 你認為CFR的對INA的解釋是錯誤的, 這是更加復雜的問題. 你很難去證明 BS
+5 Yrs 不應該是 equivalent.
實際上你還需要一個案件, 以此作為提出訴訟的基礎, 而且這個案要把CFR對Porting的
要求的不合理之處帶出來. 使到法
官有機會去重新解釋法律.
難度很大的.

了。
p*******e
发帖数: 2310
25
最基本的是要明白3权分立。不要只知道名字,不明其意。我不是学法律的,但是觉得
在美国就得懂法。
总统DJT有多大能耐?他不是习总,说改法就改法,说花钱就花钱。他是总统,是国家
的行政首脑。对了,什么叫行政?普通说就是执法,按照法律办事。法律哪来的?是总
统订的?百度告诉你,在美国,行政权指政府,立法权指国会的参众议院制度,司法权
指法院。
那么,现在的移民法又是什么?是uscis网站上告诉你的怎么办绿卡的流程?或者是某
律师告诉你的怎么申请h1-b,怎么申请旅游观光签证?都不是,是Immigration Act of
1990。如果你没去读过,看过原文,那至少应该去看看wikipedia的介绍。 改这个法
需要重新立法,比如来个immigration act of 2018.需要国会参众院通过,然后总统签
字,才能生效。
被国会通过的法律,都很难读,也很难索引。于是,为了方便,国会的法律会被编写进
united states code,简称usc. 一共52卷,分门别类,方便引用。USC上写的,就是法
律,叫做statute.
那法律怎么执行?联邦政府根据法律,写成各种条条框框的“准则... 阅读全帖
s**********8
发帖数: 25265
26
来自主题: MedicalDevice版 - 什么样的医疗器械是国内没得的
Here is a discussion:
INVESTIGATIONAL DEVICES GUIDANCE AND PROCEDURES
Research that involves the use of investigational devices must conform to
FDA and DHHS regulations. FDA regulations for investigational devices are
listed in 21 CFR 812; FDA informed consent and IRB (IRB) regulations are
listed in 21 CFR 50 and 56, respectively. The IRB documents in its minutes
if a device is a significant-risk or non-significant risk device.
Definitions
Medical device: Any health care product that does not ac... 阅读全帖
s**********8
发帖数: 25265
27
来自主题: MedicalDevice版 - 什么样的医疗器械是国内没得的
Here is a discussion:
INVESTIGATIONAL DEVICES GUIDANCE AND PROCEDURES
Research that involves the use of investigational devices must conform to
FDA and DHHS regulations. FDA regulations for investigational devices are
listed in 21 CFR 812; FDA informed consent and IRB (IRB) regulations are
listed in 21 CFR 50 and 56, respectively. The IRB documents in its minutes
if a device is a significant-risk or non-significant risk device.
Definitions
Medical device: Any health care product that does not ac... 阅读全帖
s**********8
发帖数: 25265
28
来自主题: MedicalDevice版 - 学术第一贴 - 美国器械分类.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
Device Classification
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s1 and Premarket Approvals2
Classify Your Medical Device
Introduction
How To Determine Classification
Introduction
The Food and Drug Administration (FDA) has established classifications for
approximately 1,700 different generic types of devices and grouped them into
16 medical specialties referred to as panels. Each ... 阅读全帖
b*******s
发帖数: 5216
29
☆─────────────────────────────────────☆
xiaoputi (小葡萄) 于 (Mon Jun 20 23:08:12 2011, 美东) 提到:
国内应该什么都有,但偶想总有些是美国的比较好,所以,问问,什么样的医疗器械是
国内缺少的。
恭喜开版~~
☆─────────────────────────────────────☆
skycaptain08 (太尉) 于 (Tue Jun 21 03:04:20 2011, 美东) 提到:
现在美国有的成熟器械, 大部分国内都有。 美国公司研发器械, 第一步是通过欧盟
认证 (CE mark). 对大公司来说, CE mark 很容易, 因为欧盟对器械管理主要看
safety, 对efficacy要求不高。 CE mark好比探路,公司一般用CE mark 的package来
申请美国的IDE (investiagtional device exemption), FDA 批准IDE后, 就可以在美
国进行clinical trial. clinical trial 完了以后申请P... 阅读全帖
b*******s
发帖数: 5216
30
☆─────────────────────────────────────☆
xiaoputi (小葡萄) 于 (Mon Jun 20 23:08:12 2011, 美东) 提到:
国内应该什么都有,但偶想总有些是美国的比较好,所以,问问,什么样的医疗器械是
国内缺少的。
恭喜开版~~
☆─────────────────────────────────────☆
skycaptain08 (太尉) 于 (Tue Jun 21 03:04:20 2011, 美东) 提到:
现在美国有的成熟器械, 大部分国内都有。 美国公司研发器械, 第一步是通过欧盟
认证 (CE mark). 对大公司来说, CE mark 很容易, 因为欧盟对器械管理主要看
safety, 对efficacy要求不高。 CE mark好比探路,公司一般用CE mark 的package来
申请美国的IDE (investiagtional device exemption), FDA 批准IDE后, 就可以在美
国进行clinical trial. clinical trial 完了以后申请P... 阅读全帖
t*******r
发帖数: 22634
31
另外我记得你前面提到睡觉时 stand-by on-call 的时间都算是
工作时间。但是从 CFR 来看,这个对 live-in domestic worker
似乎不成立。似乎应该是睡觉段 respond on-call 的那段时间
算工作时间,睡觉时 stand-by 的那段时间不算。
具体在 29 CFR 552.102(a) 和 29 CFR 785.23
http://www.law.cornell.edu/cfr/text/29/552.102
29 CFR 552.102 Live-in domestic service employees.
(a) ... ... If the sleeping time, meal periods or other
periods of free time are interrupted by a call to duty,
the interruption must be counted as hours worked. See
regulations part 785, § 785.23.
http://www.law.corn... 阅读全帖
s**********8
发帖数: 25265
32
来自主题: MedicalDevice版 - 学术第一贴 - 美国器械分类.
PMA
Premarket Approval (PMA)

Please note: As of October 1, 2002, FDA charges a fee for review of
Premarket Approvals1
Overview
When a PMA is Required
Devices Used in Blood Establishments
Data Requirements
References
Overview
Premarket approval (PMA) is the FDA process of scientific and regulatory
review to evaluate the safety and effectiveness of Class III medical devices
. Class III devices are those that support or sustain human life, are of
substantial importance in preventing impairment of... 阅读全帖
s**********8
发帖数: 25265
33
来自主题: MedicalDevice版 - quality system regulations (GMP for device)
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
Introduction
Flexibility of the QS Regulation
Applicability of the QS Regulation
GMP Exemptions
Additional Quality System Information
Quality System Regulation and Preamble1
Introduction
Manufacturers must establish and follow quality systems to help ensure that
their products consistently meet applicable requirements and specifications.
The quality systems for FDA-regulated products (food, drugs, biologics, and
devices) ... 阅读全帖
t**********8
发帖数: 1683
34
中国PX遇阻重演铁矿石丧失定价权悲剧 日韩扩产涨价 中方扩产屡遭阻挠
字号:小中大 2013-06-15 20:03:39
更多 110关键字 >> PX中国PX项目定价权日韩PX扩产昆明PX大连PX厦门PXPX之争
“每次知道中国的PX项目遇阻,国际价格就会短期波动。现在大家都知道,中国的PX扩
产是扩不起的”
坐拥几乎是全世界最大的需求,却在定价问题上逐渐失去发言权——曾经出现在铁矿石
领域的一幕似乎又将在石化工业领域再次上演。只不过这次的主角是在中国境内频繁引
发群体性事件的PX。
在中国PX项目由于频繁的群体性事件而停滞或下马的同时,包括韩国现代Oilbank、SK
,日本科斯莫石油公司、太阳石油公司等在内的亚洲PX主要生产商,已经开始实施规模
超过500万吨的PX产能扩产计划,而其产成品的主要销路,便是出口中国。
PX的标准中文名称是“对二甲苯”,在其基础上产出的PTA(精对苯二甲酸)是下游化纤
、纺织工业的重要原材料。然而,我国在PX上的对外依存度从2010 年的37.33%上升至
2012 年45.57%。在国内产能仅能满足约55%需求,而部分项目又因群体性事件迟迟不能
... 阅读全帖

发帖数: 1
35
来自主题: Military版 - 好消息! Trump连任有戏誒!
【美國】從Trump的支持率談起
2019/09/18 12:27:30
上個月,《CNBC》刊出了一篇政治類文章《Trump is ruining our markets》(參見
http://www.cnbc.com/2019/08/10/trump-is-ruining-our-markets-farmers-lose-a-huge-customer-to-trade-war----china.html
),討論美國農民在過去這一年,承受了各種天災人禍,在貿易戰導致大豆無法出口,
被大批堆存之後,偏偏又遭遇歷史性的水災,以致美國的農場主們面臨了1980年代以來
最大的破產潮。
我以前曾經指出,美國主流媒體的專業性比台港要高很多,除了政黨鬥爭、財團利益和
政治正確這三類偏見有優先權之外,一般的報導多半還算詳實,常有可參考的細節;這
篇文章也不例外:雖然《CNBC》是《NBC》的金融新聞部門,而《NBC》是美國幾大電視
網中最偏民主黨的一個,所以他們的記者會去寫這個題材,當然有唱衰Trump的用意,
但是文章的内容仍然算是準確持平,到了最後一節,還抱怨了美國農民在被Trump落井
下... 阅读全帖
f*******n
发帖数: 12623
36
obamacare里面说的lawfully present肯定包括B2和其他合法非移民身份。纠结的不是
这部分。
通过exchange申请保险的资格在45 CFR 155.305
http://www.law.cornell.edu/cfr/text/45/155.305
(a) Eligibility for enrollment in a QHP through the Exchange. The Exchange
must determine an applicant eligible for enrollment in a QHP through the
Exchange if he or she meets the following requirements:
(1) Citizenship, status as a national, or lawful presence. Is a citizen or
national of the United States, or is a non-citizen who is lawfully present
in the Un... 阅读全帖
f*******n
发帖数: 12623
37
obamacare里面说的lawfully present肯定包括B2和其他合法非移民身份。纠结的不是
这部分。
通过exchange申请保险的资格在45 CFR 155.305
http://www.law.cornell.edu/cfr/text/45/155.305
(a) Eligibility for enrollment in a QHP through the Exchange. The Exchange
must determine an applicant eligible for enrollment in a QHP through the
Exchange if he or she meets the following requirements:
(1) Citizenship, status as a national, or lawful presence. Is a citizen or
national of the United States, or is a non-citizen who is lawfully present
in the Un... 阅读全帖
j*e
发帖数: 1987
38
因为他们设计这套行政方法的时候,简单的认为485递上去不久就能批准,所以简单的
把递485和批485的排期合二为一。他们当时可能没想到排期会一下子前进3-5年,又一
下子倒退3-5年这样的抽风式情况出现。
递交485和批准485排期二合一规定的出处原文:见
8 CFR 245.1 (g) (1) http://edocket.access.gpo.gov/cfr_2010/janqtr/8cfr245.1.htm,该页倒数第7段,我copy在下面。
这个Code of Federal Regulations简称CFR,是美国政府的行政法规,就是说正式移民
法写的比较粗,实施细则就看这个行政法规。CFR的基本知识见http://en.wikipedia.org/wiki/Code_of_Federal_Regulations
哪位感兴趣,想要浏览整部CFR Title 8--Aliens and Nationality,可以从这里http://www.access.gpo.gov/nara/cfr/waisidx_10/8cfrv1_10.html点进去,然后点Part 245 ADJU... 阅读全帖
r****t
发帖数: 212
39
来自主题: Military版 - 死亡率的定义
Case fatality rate (CFR) – or case fatality risk, case fatality ratio or
just fatality rate – is the proportion of deaths within a designated
population of "cases" (people with a medical condition) over the course of
the disease. A CFR is conventionally expressed as a percentage and
represents a measure of risk. CFRs are most often used for diseases with
discrete, limited time courses, such as outbreaks of acute infections.
For example: Assume 9 deaths among 100 people in a community all diagnos... 阅读全帖
S*A
发帖数: 7142
40
来自主题: Food版 - 不锈钢锅有剧毒,小心
查了, FDA 没有规定什么样的不锈钢可以用于食物处理。
有人专门去问了,这个回信是最接近回答这个问题的:
They just send me a general e-mail ....
Thank you for writing the Division of Drug Information, in the FDA's Center
for Drug Evaluation and Research (CDER).
FDA does not approve or prohibit specific materials used in contact with
pharmaceutical products or maintain a schedule or list of approved materials
. 21 CFR 211.65 requires equipment (surfaces that contact) components, in-
process materials, or drug products shall not be reactive, addit... 阅读全帖
J**********D
发帖数: 160
41
来自主题: JobHunting版 - Job - pharmaceutical validation
From a recruiter, please contact him directly if interested.
Hello Professionals,
This is Krishna from KRG TECHNOLOGIES; We are looking for Product Software
Validation Engineer in Ann Arbor, MI
I also kindly request you to forward this opportunity to your friends or
colleagues; so that we can help someone who may be in search of a job or
looking for a change.
Title : Product Software Validation Engineer
Location : Ann Arbor, MI
Duration : 6+ Months Contract
Job description:
Respon... 阅读全帖

发帖数: 1
42
来自主题: JobHunting版 - 被laid off后办过H1b transfer的来说说
我在六楼贴的这段话一共才二句,算不上长篇,是DHS制定规则期间对网上相关comment
的回答。
请你仔细读读,DHS明明白白写了最后结论:
“the final rule does not allow eligible nonimmigrants to be employed during
either the 10- or 60-day grace periods unless otherwise authorized under 8
CFR 274a.12. ”
请看:“UNLESS OTHERWISE authorized under 8 CFR 274a.12.” 这句话就等同于说
持H1B申请的receipt不能被雇佣。
除非你满足 8 CFR 274a.12列出的条件之外,不允许在grace period工作。去找找 8
CFR 274a.12 耐心读读吧,里面并没有包含H1B申请的 “receipt”。
我“断章取义”?
你读了全篇,那么请给大家贴出支持在grave period时持新雇主H1B transfer receipt
可以合法工作的、被我“断”掉的那些章节。... 阅读全帖
C********e
发帖数: 492
43
来自主题: Immigration版 - 关于485PD180天换工作的问题
你的485收据上是一个统一的说明,不是针对eb1a,所以用的是"may"。
这里贴几个关于180天以及换工作的原文(https://www.federalregister.gov/
documents/2016/11/18/2016-27540/retention-of-eb-1-eb-2-and-eb-3-immigrant-
workers-and-program-improvements-affecting-high-skilled)
---- Retention of employment-based immigrant visa petitions. To enhance job
portability for certain workers with approved Form I-140 petitions in the EB
-1, second preference (EB-2), and third preference (EB-3) categories, but
who are unable to obtain LPR status due to immigra... 阅读全帖
w********i
发帖数: 1721
44
View Rule
View EO 12866 Meetings Printer-Friendly Version Download RIN Data in
XML
DHS/USCIS RIN: 1615-AC05 Publication ID: Fall 2015
Title: Retention of EB-1, EB-2, and EB-3 Immigrant Workers and Program
Improvements Affecting Highly-Skilled H-1B Alien Workers
Abstract:
The Department of Homeland Security (DHS) is proposing to amend its
regulations affecting certain employment-based immigrant and nonimmigrant
classifications. This rule proposes to amend current regulations to provi... 阅读全帖
k*********r
发帖数: 362
45
来自主题: Law版 - Patent bar 真题请教,谢谢
Registered practitioner Roni files a utility patent application under 37 CFR
1.53(b) in the USPTO having one claim on May 6, 1998. A proper final
rejection of claim 1 was mailed on June 28, 2000. Roni files a request for
continued examination with the appropriate fee on September 12, 2000, and
submits an amendment to claim 1 with the request. On October 7, 2000, Roni
learns about a publication (the “Columbus reference”) which she knows to
be material to patentability of claim 1, but which was no... 阅读全帖
s*********e
发帖数: 884
46
来自主题: MedicalDevice版 - 美国进口医疗器械程序: basics
Source:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/I
Importing into the U.S.
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s and Premarket Approvals
Overview
Foreign firms that manufacture medical devices and/or products that emit
radiation that are imported into the United States must comply with
applicable U.S. regulations before, during, and after importing into the U.S
. or its territories. In order to import medical device... 阅读全帖
s**********8
发帖数: 25265
47
来自主题: MedicalDevice版 - Humanitarian Use Devices (HUD)
DEFINITIONS:
I. HUMANITARIAN USE DEVICE (HUD): A device that is intended to benefit
patients
by treating or diagnosing a disease or condition that affects fewer than 4,
000
individuals in the United States per year.
II. HUMANITARIAN USE DEVICE EXEMPTION (HDE): Food and Drug Administration
(FDA) approval of an HDE permits the marketing of an HUD, subject to
restrictions
on charges and use. Specifically, HUDs cannot be sold for profit, except in
the
limited circumstance when indicated for use in c... 阅读全帖
h********e
发帖数: 2823
48
来自主题: MedicalDevice版 - How to market a medical device, by FDA
Source:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H
How to Market Your Device
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s and Premarket Approvals
Introduction
Three Steps to Obtaining Marketing Clearance from CDRH
Classify Your Device
Selecting the Appropriate Marketing Application
Other Requirements Besides Marketing Clearance
In Vitro Diagnostic Devices
Introduction
One of the most difficult aspects of getting a medical... 阅读全帖
I********l
发帖数: 8702
49
估计这个是重大发现。
搜到郑必坚是这个外国情报机构Nicolas Berggruen Institute的成员。每两年开一次
会。
http://berggruen.org
该机构自我介绍为:The Nicolas Berggruen Institute is dedicated to exploring
new ideas of good governance. The NBI is an independent, non-partisan think
tank which – with the commitment and dedication of elder statesmen and
women, global thinkers, leading entrepreneurs who volunteer their time and
advice - engages in the design and implementation of systems of governance
suited to the new and complex challenges of the 2... 阅读全帖
I********l
发帖数: 8702
50
刚才搜到郑必坚是Nicolas Berggruen Institute的成员。该组织每两年开一次会。
http://berggruen.org
该机构自我介绍为:The Nicolas Berggruen Institute is dedicated to exploring
new ideas of good governance. The NBI is an independent, non-partisan think
tank which – with the commitment and dedication of elder statesmen and
women, global thinkers, leading entrepreneurs who volunteer their time and
advice - engages in the design and implementation of systems of governance
suited to the new and complex challenges of the 21st century。
查了... 阅读全帖
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