Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004




НазваниеTechnology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004
страница6/7
Дата конвертации03.02.2013
Размер0.57 Mb.
ТипДокументы
1   2   3   4   5   6   7


Standard Ref premarket approval application (PMA) or a

Discussion The Food and Drug Administration (FDA) is proposing to

require the filing of a premarket approval application (PMA) or a

notice of completion of a product development protocol (PDP) for the

Note Section 513 of the act (21 U.S.C. 360(c)) requires FDA to classify

medical devices into one of three regulatory categories (classes):

Class I (general controls), class II (special controls), and class III

Topic Motor carrier safety standards:

Date-Document-Source 3/5/2004 04–4783 DOT TEXT PDF

Standard Ref regulations inform motor carriers engaged in the interstate

Discussion The Federal Motor Carrier Safety Administration (FMCSA) amends

its interim final rule governing the interstate transportation of

household goods (68 FR 35064, Jun. 11, 2003). On August 25, 2003, the

Note In order to publish the rule text in the October 1, 2003, edition

of the Code of Federal Regulations (CFR), we established the interim

final rule's effective date as September 9, 2003. However, compliance

Topic Air pollutants, hazardous; national emission standards:

Date-Document-Source 3/5/2004 04–4530 EPA TEXT PDF

Standard Ref ASTM D6348-03, ``Standard Test

Discussion This action promulgates national emission standards for

hazardous air pollutants (NESHAP) for stationary combustion turbines.

We have identified stationary combustion turbines as major sources of

Note following standards in the final rule: EPA Methods 1, 1A, 3A, 3B, 4,

and 320. Consistent with the NTTAA, EPA conducted searches to identify

voluntary consensus standards in addition to these EPA methods. No

Topic E-Government Act (2002) implementation; Electronic Records Policy Working Group; meeting and

Date-Document-Source 3/8/2004 04–5091 NARA TEXT PDF

Standard Ref Perceived barriers to effective management of ``Government

Discussion The Electronic Records Policy Working Group is inviting

interested persons to provide their written views on issues relating to

implementing section 207(e)(1)(A) of the E-Government Act of 2002. That

Note The Working Group is seeking feedback on the following topics in

their meetings and this notice.

1. The definition of ``Government information on the Internet and

Topic Information Security and Privacy Advisory Board,

Date-Document-Source 3/8/2004 04–5165 NIST TEXT PDF

Standard Ref Discussion of Federal IT security professional

Discussion Welcome and overview;

Customer Service Management (CRM) activities

session;

Note Discussion of Federal IT security professional

credentials;

Topic Report of Inspections Required

Date-Document-Source 3/8/2004 04–5151 FAA TEXT PDF

Standard Ref , Certification Procedures

Discussion 2120-0018, Certification Procedures for Products and Parts FAR

21. 14 CFR part 21 prescribes certification procedures for aircraft,

aircraft engines, propellers, products and parts. The information

Note 2. 2120-0022, Certificate: Mechanics, Repairmen, Parachute Riggers,

and Inspection Authorizations--FAR Part 65. Title 49 U.S.C. sections

44702 and 44703 authorize the issuance of airman certificates. FAR part

Topic Title: Requirements for Cargo Tanks.

Date-Document-Source 3/8/2004 04–5100 DOT TEXT PDF

Standard Ref Manufacturers' data reports, certificates and related papers:

Discussion information collection provisions in parts 178 and 180 of the HMR

involving the manufacture, qualification, maintenance and use of all

specification cargo tank motor vehicles. It also includes the

Note (2) Requalification and maintenance reports: These reports are

prepared by persons who requalify or maintain cargo tanks. This

information is used by cargo tank owners, operators and users, and DOT

Topic FDA Modernization Act of 1997—

Date-Document-Source 3/8/2004 E4–479 FDA TEXT PDF

Standard Ref ISO; ASTM :NEMA; ISO; IEC; USP;NCCLS; ANSI; ADA; AAMI

Discussion The Food and Drug Administration (FDA) is announcing a

publication containing modifications the agency is making to the list

of standards FDA recognizes for use in premarket reviews (FDA

Note A. Biocompatibility

Topic Guidance for Federal Agencies and State and Local Governments;

Date-Document-Source 3/8/2004 04–5107 FDA TEXT PDF

Standard Ref Potassium Iodide

Discussion The Food and Drug Administration (FDA) is announcing the

availability of a guidance for Federal agencies and State and local

governments entitled ``Potassium Iodide Tablets Shelf Life Extension.''

Note entitled ``Potassium Iodide Tablets Shelf Life Extension.'' This

guidance discussed FDA recommendations on the testing for shelf life

extensions, the qualifications of laboratories suitable to conduct the

Topic Premarket Notification 510(k) Submissions--21 CFR Part 807 (OMB Control

Date-Document-Source 3/9/2004 04–5196 FDA TEXT PDF

Standard Ref Premarket

Discussion Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the

act) (21 U.S.C. 360(k)) requires a person who intends to market a

medical device to submit a 510(k) submission to FDA at least 90 days

Note Section 510(k) of the act allows for exemptions to the 510(k)

submissions, i.e., a 510(k) submission would not be required if FDA

determines that premarket notification is not necessary for the

Topic Radiation detection instrument evaluations,

Date-Document-Source 3/9/2004 04–5289 NIST TEXT PDF

Standard Ref ANSI N42.32, N42.33, N42.34 and

Discussion On behalf of the Department of Homeland Security (DHS), the

National Institute of Standards and Technology (NIST) is coordinating

performance tests, supporting the ANSI N42.32, N42.33, N42.34 and

Note On behalf of the Department of Homeland

Security, the National Institute of Standards and Technology (NIST) is

coordinating performance tests of commercially available equipment

Topic Antimicrobial Drug Development; Public Workshop

Date-Document-Source 3/9/2004 04–5191 FDA TEXT PDF

Standard Ref public workshop,

Discussion The Food and Drug Administration (FDA) is announcing a public

workshop, cosponsored with the Infectious Diseases Society of America

(IDSA) and the International Society of Anti-Infective Pharmacology

Note FDA is announcing a public workshop,

cosponsored with IDSA and ISAP, regarding antimicrobial drug

development. This public workshop will focus on general considerations

Topic Title: Commercial Availability of Navigation Devices and

Date-Document-Source 3/9/2004 04–5270 FCC TEXT PDF

Standard Ref unidirectional digital cable televisions and other unidirectional

Discussion Needs and Uses: On October 9, 2003, the FCC released the Second

Report and Order and Second Further Notice of Proposed Rulemaking (2nd

R&O), In the Matter of Implementation of Section 304 of the

Note

Topic Nonregulated Status for Cotton

Date-Document-Source 3/9/2004 04–5252 USDA TEXT PDF

Standard Ref whether these cotton

Discussion SUMMARY: We are advising the public that the Animal and Plant Health

Inspection Service has received two petitions from Mycogen Seeds c/o

Dow AgroSciences LLC seeking determinations of nonregulated status for

Note The regulations in 7 CFR part 340,

``Introduction of Organisms and Products Altered or Produced Through

Genetic Engineering Which Are Plant Pests or Which There Is Reason To

Topic Requirements on Content and Format of

Date-Document-Source 3/9/2004 04–5195 FDA TEXT PDF

Standard Ref Labeling for Human

Discussion Specific Requirements on Content and Format of Labeling for Human

Prescription Drugs; Addition of ``Geriatric Use'' Subsection in the

Labeling (OMB Control Number 0910-0370)--Extension Section 201.57(f)(10) (21 CFR

Note

Section 201.57(f)(10) requires that a specific geriatric

indication, if any, that is supported by adequate and well-controlled

Topic Preparing a Claim of Categorical Exclusion or an Environmental

Date-Document-Source 3/9/2004 04–5193 FDA TEXT PDF

Standard Ref Claim of Categorical Exclusion or an Environmental

Discussion FDA's regulation in 21 CFR 25.20 specifies the types of actions

related to food additive petitions, color additive petitions, requests

for exemption from regulation as a food additive under Sec. 170.39 (21

Note Thus, FDA collects information on the potential for environmental

impacts of its actions in the form of environmental assessments and

claims for categorical exclusions from interested parties who request

Topic Child restraint systems—

Date-Document-Source 3/9/2004 04–5168 NHTSA TEXT PDF

Standard Ref The agency searched for, but did not find any voluntary consensus

Discussion In response to a petition from a child restraint manufacturer,

the agency issued an interim final rule published on October 22, 2002,

and amended on November 28, 2003, adopting a temporary provision

Note This document permanently adopts the interim amendments to Federal

Motor Vehicle Safety Standard (FMVSS) No. 213, Child restraint systems

(49 CFR 571.213), which excluded properly labeled harnesses

Topic U.S.-Australia Free Trade Agreements; potential economywide and selected sectoral effects,

Date-Document-Source 3/9/2004 04–5159 ITC TEXT PDF

Standard Ref U.S.-Australia Free Trade Agreement

Discussion Following receipt on February 17, 2004 of a request from the

United States Trade Representative (USTR), the Commission instituted

investigation No. TA-2104-11, U.S.-Australia Free Trade Agreement:

Note Public Hearing: A public hearing in connection with this

investigation is scheduled to begin at 9:30 a.m. on March 30, 2004, at

the U.S. International Trade Commission Building, 500 E Street SW.,

Topic Focus Groups as Used by the Food and Drug Administration--(OMB Control Number

Date-Document-Source 3/9/2004 04–5194 FDA TEXT
1   2   3   4   5   6   7

Похожие:

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconTechnology, Trade, Legal, Regulatory Policy and Standards Related Notices April 11 April 25, 2005

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconThe National Institute of Standards and Technology (nist) is a non-regulatory federal agency within the Commerce Department’s Technology Administration. Nist’s

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconAssociate Professor, August 2004 – March 2009 School of Electrical and Computer Engineering Georgia Institute of Technology, Atlanta, ga senior Advisor, March 2005 March 2008

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconPakistan trade policy project (dfid and aasr) study on trade in services (Volume I)

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconAnd Other Legal Notices

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconJan 2, us secretary of State John Hay announced the Open Door Policy to prompt trade with China. This policy rejected efforts to carve up China or restrict its

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconRelated to the activities of the Action (February 2006)

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconPaper prepared for the nsw coastal Volunteers Forum, Wollongong February 27-March 2011

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 icon31 March 1596 11 February 1650 was a French philosopher and writer who spent most of his adult life in the

Technology, Trade, Legal, Regulatory Policy and Standards Related Notices February 26 March 10, 2004 iconDictionary of trade policy terms / Walter Goode


Разместите кнопку на своём сайте:
lib.convdocs.org


База данных защищена авторским правом ©lib.convdocs.org 2012
обратиться к администрации
lib.convdocs.org
Главная страница