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
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FederalRegister

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

Topic Animal Drug User Fee Cover Sheet

Date-Document-Source 2/26/2004 04–4309 FDA TEXT PDF

Standard Ref assure that each animal drug user fee payment and each animal

Discussion The proposed collection of

information, Animal Drug User Fee Cover Sheet (cover sheet), will be

used to assure that each animal drug user fee payment and each animal

Note Under section 740 of the act, as amended by ADUFA (21 U.S.C. 379j-

12), FDA has the authority to assess and collect for certain animal

drug user fees. Because the submission of user fees concurrently with

Topic 2007 World Radiocommunication Conference Advisory Committee,

Date-Document-Source 2/26/2004 04–4264 FCC TEXT PDF

Standard Ref 2007 World Radiocommunication

Discussion In accordance with the Federal Advisory Committee Act, this

notice advises interested persons that the second meeting of the WRC-07

Advisory Committee will be held on June 8, 2004, at the Federal

Note he Federal Communications Commission (FCC)

established the WRC-07 Advisory Committee to provide advice, technical

support and recommendations relating to the preparation of United

Topic Network Reliability and Interoperability Council

Date-Document-Source 2/26/2004 04–4263 FCC TEXT PDF

Standard Ref assure optimal reliability and interoperability of wireless, wireline,

Discussion In accordance with the Federal Advisory Committee Act (FACA),

this notice advises interested persons of the first meeting the Network

Reliability and Interoperability Council (Council) under its charter

Note The purpose of the Council is to provide

recommendations to the FCC and to the communications industry that, if

implemented, shall under all reasonably foreseeable circumstances

Topic Roadway maintenance machine safety,

Date-Document-Source 2/26/2004 04–4251 FRA TEXT PDF

Standard Ref safety standards for railroad on-track roadway maintenance machines and hi-rail vehicles

Discussion This document responds to petitions for reconsideration of

FRA's July 28, 2003 final rule which prescribed safety standards for

railroad on-track roadway maintenance machines and hi-rail vehicles.

Note As background, RSAC provides a forum for developing consensus

recommendations on rulemaking and other safety program issues, and

includes representatives from all of FRA's major customer groups,

Topic Human drugs and biological products:

Date-Document-Source 2/26/2004 04–4249 FDA TEXT PDF

Standard Ref accredited by ANSI EAN.UCC or HIBCC format ANSI; JCAHO; IEC; AAMI

Discussion The Food and Drug Administration (FDA) is issuing a new rule

to require certain human drug and biological product labels to have bar

codes. The bar code for human drug products and biological products

Note In the Federal Register of March 14, 2003 (68 FR 12500), FDA (we)

published a proposed rule that would require certain human drug and

biological product labels to have a linear bar code (the March 2003

Topic Guidance for Industry on Continuous Marketing Applications: Pilot 2-Scientific Feedback and

Date-Document-Source 2/26/2004 04–4248 FDA TEXT PDF

Standard Ref Development of Fast Track

Discussion FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for

the reporting and recordkeeping requirements contained in the guidance

for industry entitled ``Continuous Marketing Applications: Pilot 2-

Note FDA's regulation at Sec. 312.23 (21 CFR 312.23) states that

information provided to the agency as part of an IND must be submitted

in triplicate and with an appropriate cover form. Form FDA 1571 must

Topic Color Additive Certification Requests and Recordkeeping--21 CFR Part 80

Date-Document-Source 2/26/2004 04–4247 FDA TEXT PDF

Standard Ref requirements for color additive certification

Discussion FDA has regulatory oversight for color additives used in foods,

drugs, cosmetics, and medical devices. Section 721(a) of the Federal

Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a)) provides

Note The requirements for color additive certification are described in

part 80 (21 CFR part 80). In the certification procedure, a

representative sample of a new batch of color additive, accompanied by

Topic Dairy products; grading and inspection:

Date-Document-Source 2/26/2004 04–4222 USDA TEXT PDF

Standard Ref Federal dairy grading and inspection services

Discussion The Agricultural Marketing Service (AMS) is revising the

hourly fees charged for Federal dairy grading and inspection services

performed by the Dairy Grading Branch. Dairy grading and inspection

Note The Secretary of Agriculture is authorized by the Agricultural

Marketing Act of 1946 (AMA), as amended (7 U.S.C. 1621, et seq.), to

provide voluntary Federal dairy grading and inspection services to

Topic Copyright claims registration; “Best Edition” of published motion pictures for Library of Congress

Date-Document-Source 2/26/2004 04–3958 LOC TEXT PDF

Standard Ref amend the best edition requirements for

Discussion Owners of motion pictures that have been published must submit

copies of their movies to the Copyright Office for the Library of

Congress to use and include in its collections. This mandatory deposit

Note Sections 407 and 408 of title 17, United States Code, require that

owners of any motion picture that has been published must deposit a

copy of the work with the Copyright Office for the use of the Library

Topic Criminal Penalty Safe Harbor Provision

Date-Document-Source 2/26/2004 04–4278 NHTSA TEXT PDF

Standard Ref very few criminal prosecutions under

Discussion Summary of the Collection of Information--Each person seeking safe

harbor protection from criminal penalties under 49 U.S.C. 30170 related

to an improper report or failure to report is required to submit the

Note Description of the Likely Respondents, Including Estimated Number

and Proposed Frequency of Response to the Collection of Information--

This collection of information applies to any person who seeks a ``safe

Topic Manufacturing; Federal Government policy to encourage innovation (EO 13329),

Date-Document-Source 2/26/2004 04–4436 President TEXT PDF

Standard Ref Continued technological innovation is critical to a strong manufacturing sector in the

Discussion Encouraging Innovation in Manufacturing

By the authority vested in me as President by the

Note Sec. 2. Duties of Department and Agency Heads. The head

of each executive branch department or agency with one

or more SBIR programs or one or more STTR programs

Topic Independent Diagnostic Testing Facility and Supporting Regulations contained in 42

Date-Document-Source 2/26/2004 04–4215 HHS TEXT PDF

Standard Ref Independent Diagnostic Testing

Discussion Use: The

information collection requirements associated with an Independent

Diagnostic Testing Facilities involve documentation of proficiency of

Note

Topic Executive Order 13330--Human Service Transportation Coordination

Date-Document-Source 2/26/2004 04–4451 President TEXT PDF

Standard Ref access to community services for persons who are transportation-disadvantaged, I

Discussion Executive Order 13330 of February 24, 2004

Note Sec. 2. Definitions. (a) As used in this order, the

term ``agency'' means an executive department or agency

of the Federal Government.

Topic Packaging and closure requirements, mailing containers, and parcel sorting equipment; changes,

Date-Document-Source 2/26/2004 04–4212 Postal Service TEXT PDF

Standard Ref packaging and closure

Discussion This proposed rule contains minor changes to the Domestic Mail

Manual (DMMTM) that would clarify packaging and closure

requirements, types of acceptable mailing containers, and standards for

Note Throughout this document and the relevant DMM sections, the term

``package'' is used to mean a parcel, and is not to be confused with

the same term used in conjunction with mail preparation and presort

Topic Draft Guidance on Marketed Unapproved Drugs; Compliance Policy Guide

Date-Document-Source 2/27/2004 04–4310 FDA TEXT PDF

Standard Ref Marketing

Discussion The Food and Drug Administration (FDA) is reopening until

April 27, 2004, the comment period on the draft guidance for industry

entitled ``Marketing Unapproved Drugs; Compliance Policy Guide.'' The

Note In the Federal Register of October 23, 2003 (68 FR 60702), FDA

published the draft guidance for industry entitled ``Marketing

Unapproved Drugs; Compliance Policy Guide.'' This draft guidance

Topic National Animal Agriculture Conservation Framework,

Date-Document-Source 2/27/2004 04–4323 USDA TEXT PDF

Standard Ref voluntary, proactive efforts to foster

Discussion The Natural Resources Conservation Service is announcing the

publication of the National Animal Agriculture Conservation Framework

(NAACF). The NAACF presents a blueprint for assisting livestock and

Note Addressing the conservation needs of

America's livestock and poultry producers is a public policy priority.

The 2002 Farm Bill made clear that producers should receive assistance

Topic Occupant protection in interior impact; head impact protection,

Date-Document-Source 2/27/2004 04–4277 NHTSA TEXT PDF

Standard Ref Standard No. 201, ``Occupant

Discussion This document amends the upper interior impact requirements of

the Federal motor vehicle safety standard on occupant protection in

interior impact to increase the minimum separation distance between

Note In an August 18, 1995 final rule (60 FR 43031) adding requirements

for upper interior impact protection to Standard No. 201, ``Occupant

Protection in Interior Impact,'' NHTSA estimated that even with air

Topic nonconforming 2000 Land Rover Discovery multipurpose passenger vehicles (MPVs) are eligible

Date-Document-Source 2/27/2004 04–4398 NHTSA TEXT
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