Unknown. Notice of availability of guidance
2,505 words·~11 min read·
/register/2004/02/17/04-3421·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2004-02-17.xml --- 69 31 Tuesday, February 17, 2004 Contents Agency Agency for Healthcare Research and Quality NOTICES Medicare and Medicaid: Hospital CAHPS (HCAHPS) instrument; request for volunteer testing prior to national implementation, 7489-7490 04-3332 Agricultural Agricultural Research Service NOTICES Meetings: Biotechnology and 21st Century Agriculture Advisory Committee, 7413 04-3299 Agriculture Agriculture Department See Agricultural Research Service See Forest Service Antitrust Antitrust Division NOTICES Competitive impact statements and proposed consent judgments:
DNH International Sarl et al., 7497-7506 04-3384 Arctic Arctic Research Commission NOTICES Meetings, 7417 04-3297 Civil Civil Rights Commission NOTICES Meetings; State advisory committees: Massachusetts, 7417 04-3285 Coast Guard Coast Guard RULES Ports and waterways safety: Lower Mississippi River, Above Head of Passes, New Orleans, LA; safety zone, 7367-7369 04-3397 Commerce Commerce Department See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration See Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 7417 04-3294 Defense Defense Department See Navy Department RULES Privacy Act; implementation, 7366-7367 04-3356 NOTICES Agency information collection activities; proposals, submissions, and approvals, 7456 04-3290 Meetings:
Defense Intelligence Agency Advisory Board, 7456 04-3292 Science Board task forces, 7456 04-3291 Drug Drug Enforcement Administration RULES Precursors and essential chemicals; importation and exportation: International sales of listed chemicals; use of Internet to arrange, 7348-7349 04-3355 Employee Employee Benefits Security Administration NOTICES Employee benefit plans; individual exemptions: Bank of America, N.A., 7506-7510 04-3415 Blue Cross and Blue Shield of Kansas et al.; withdrawn, 7506 04-3416 Employment Employment and Training Administration NOTICES Adjustment assistance:
American Fast Print LTD, 7510 04-3316 Arkansas Catfish Growers, 7510 04-3321 Chicago Rawhide, 7510 04-3327 Eastman Machine Co., 7510-7511 04-3310 Eljer Plumbingware, 7511 04-3322 EMF Corp., 7511 04-3312 Encee, Inc., 7511-7512 04-3318 International Mill Service, 7512 04-3325 Kokusai Semiconductor Equipment Corp., 7512 04-3324 Manpower Inc., 7512 04-3313 Metso Minerals Industries, Inc., 7512-7513 04-3317 Millennium A.R. Haire, 7513 04-3315 Paradise Fisheries, 7513 04-3328 PolyOne Corp., 7513-7514 04-3309 Quest Star Medical, Inc., 7514 04-3326 Rogers Corp., 7514 04-3311 Symtech, Inc., 7514-7515 04-3320 Thermotech Co., 7515 04-3319 Tri Star Precision, Inc., 7515 04-3314 Tyson Foods, Inc., 7515 04-3323 Energy Energy Department See Energy Information Administration See Federal Energy Regulatory Commission Energy Energy Information Administration NOTICES Reports and guidance documents; availability, etc.:
Confidential Information Protection and Statistical Efficiency Act of 2002 surveys; energy information collections; comment request, 7457-7458 04-3342 Statistical information based on alternative fueled vehicles and alternative transportation fuels survey data; disclosure limitation policy; comment request, 7459-7460 04-3341 Statistical information based on renewable fuels survey data; disclosure limitation policy; comment request, 7458-7459 04-3340 EPA Environmental Protection Agency RULES Air pollutants, hazardous; national emission standards:
Pulp and paper industry, 7372-7375 04-3370 Air quality implementation plans; approval and promulgation; various States: California, 04-3076 7370-7372 04-3220 PROPOSED RULES Air pollutants, hazardous; national emission standards: Pulp and paper industry, 7397 04-3369 Air pollution; standards of performance for new stationary sources: Commercial or industrial solid waste incineration units, 7390-7397 04-3366 Air quality implementation plans; approval and promulgation; various States:
California, 7389-7390 04-3221 NOTICES Meetings: Clean Air Act Advisory Committee, 7478 04-3365 Reports and guidance documents; availability, etc.: Pesticides— Washington Toxics Coalition v. EPA litigation; court orders regarding sale, distribution and use of certain pesticides, 7478-7480 04-3364 Superfund program: Prospective purchaser agreements— Broderick Wood Products Site et al., CO, 7480 04-3367 Executive Executive Office of the President See Trade Representative, Office of United States FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives:
Burkhart Grob Luft-Und Raumfahrt GmbH & Co., 7378-7380 04-3354 Glasflugel, 7382-7384 04-3352 Schempp-Hirth Flugzeugbau GmbH, 7380-7382 04-3353 NOTICES Passenger facility charges; applications, etc.: Little Rock National Airport, AR, 7534 04-3398 FCC Federal Communications Commission RULES Organization, functions, and authority delegations: Communications Business Opportunities Office, 7376-7377 04-3361 PROPOSED RULES Radio frequency devices: Cognitive radio technologies and software defined radios, 7397-7411 04-3240 NOTICES Agency information collection activities; proposals, submissions, and approvals, 04-3358 04-3359 04-3360 7480-7483 04-3362 Meetings;
Sunshine Act, 7483-7484 04-3458 Rulemaking proceedings; petitions filed, granted, denied, etc., 7484-7485 04-3363 Federal Emergency Federal Emergency Management Agency NOTICES Agency information collection activities; proposals, submissions, and approvals, 7494-7495 04-3337 04-3338 04-3339 Federal Energy Federal Energy Regulatory Commission NOTICES Agency information collection activities; proposals, submissions, approvals, E4-291 7460-7462 E4-292 Electric rate and corporate regulation filings, 7470 E4-302 Hydroelectric applications, 7470-7477 E4-273 E4-274 E4-275 E4-276 E4-277 E4-278 E4-279 E4-293 Meetings:
Dominion Transmission, Inc.; Fink Capacity Maintenance Project, site visit, 7477 E4-290 Off-the-record communications, 7477-7478 E4-280 *Applications, hearings, determinations, etc.:* Algonquin Gas Transmission Co., 7462-7463 E4-284 E4-297 Cheniere Sabine Pass Pipeline Co., 7463-7464 E4-301 DC Energy, LLC, 7464 E4-272 Dominion Cove Point LNG, LP, 7464 E4-294 East Tennessee Natural Gas Co., E4-281 7465 E4-299 Egan Hub Storage, LLC, 7465-7466 E4-283 Gas Transmission Northwest Corp., 7466 E4-296 Iroquois Gas Transmission System, L.P., E4-271 7466-7467 E4-286 Maritimes & Northeast Pipeline, L.L.C., 7467 E4-282 Northern Natural Gas Co., 7467 E4-287 Northwest Pipeline Corp., 7467-7468 E4-295 Tennessee Gas Pipeline Co., 7468 E4-288 Texas Eastern Transmission, LP, 7468-7469 E4-285 E4-289 E4-298 Texas Gas Transmission, LLC, 7469-7470 E4-300 Federal Housing Federal Housing Finance Board NOTICES Meetings;
Sunshine Act, 7485 04-3439 Federal Railroad Federal Railroad Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 7534-7537 04-3399 04-3400 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Change in bank control, 7485 04-3308 Formations, acquisitions, and mergers, 7485 04-3307 FTC Federal Trade Commission NOTICES Prohibited trade practices: California Pacific Medical Group, Inc., 7485-7488 04-3375 Food Food and Drug Administration RULES Reports and guidance documents; availability, etc.:
Registration of food facilities; questions and answers regarding interim final rule, 7347 04-3421 NOTICES Meetings: Medical Devices Advisory Committee, 7490 04-3334 Reports and guidance documents; availability, etc.: MedWatch voluntary and mandatory reporting forms; availability, 7490-7492 04-3333 Noncontraceptive estrogen class labeling; industry guidance, 7492-7493 04-3330 Forest Forest Service NOTICES Environmental statements; notice of intent: San Juan National Forest, CO, 7413-7415 04-3343 Umatilla National Forest, OR, 7415-7416 04-3047 Meetings:
Resource Advisory Committees— Alpine County, 7416 04-3345 Lincoln County, 7416 04-3344 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health NOTICES Scientific misconduct findings; administrative actions: Palmer, Pat J., 7488-7489 04-3336 Health Health Resources and Services Administration RULES Smallpox Vaccine Injury Compensation Program:
Administrative implementation; correction, 7376 04-3331 NOTICES Meetings: Childhood Vaccines Advisory Commission, 7493 04-3335 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Industry Industry and Security Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 7417-7418 04-3293 04-3295 Information Information Security Oversight Office NOTICES Meetings: National Industrial Security Program Policy Advisory Committee, 7516 04-3385 Interior Interior Department See Reclamation Bureau See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service RULES Income taxes:
Taxable stock transactions; information reporting requirements; correction, 7350-7351 04-3262 PROPOSED RULES Income taxes: Life insurance contracts value when distributed from qualified retirement plan, 7384-7389 04-3402 Variable annuity, endowment, and life insurance contracts; diversification requirements; hearing, 7389 04-3401 NOTICES Agency information collection activities; proposals, submissions, and approvals, 04-3403 7537-7538 04-3404 04-3405 Meetings: Taxpayer Advocacy Panels, 7538-7540 04-3406 04-3407 04-3408 04-3409 International International Trade Administration NOTICES Antidumping:
Tapered roller bearings and parts, finished and unfinished, from— Japan, 7418-7419 04-3388 Countervailing duties: Stainless steel sheet and strip in coils from— Korea, 7419-7421 04-3389 International International Trade Commission NOTICES Import investigations: Sildenafil or any pharmaceutically acceptable salt, such as sildenafil citrate, and products containing same, 7497 04-3306 Justice Justice Department See Antitrust Division See Drug Enforcement Administration Labor Labor Department See Employee Benefits Security Administration See Employment and Training Administration See Occupational Safety and Health Administration National Archives National Archives and Records Administration See Information Security Oversight Office National Credit National Credit Union Administration NOTICES Meetings;
Sunshine Act, 7516-7517 04-3483 NIH National Institutes of Health NOTICES Meetings: National Cancer Institute, 7493 04-3303 National Institute on Aging, 7493-7494 04-3301 04-3302 NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management: Magnuson-Stevens Act provisions— Domestic fisheries; exempted fishing permit applications, 7411-7412 04-3391 04-3392 NOTICES Fishery conservation and management: Magnuson-Stevens Act provisions— Bering Sea/Aleutian Islands king and tanner crabs; fishing capacity reduction program, 7421-7450 04-3393 Meetings:
South Atlantic Fishery Management Council, 7451-7452 04-3394 Permits: Endangered and threatened species; correction, 7452 04-3395 National Telecommunications National Telecommunications and Information Administration NOTICES Grants and cooperative agreements; availability, etc.: Technology Opportunities Program, 7452-7454 04-3296 Navy Navy Department NOTICES Patent licenses; non-exclusive, exclusive, or partially exclusive: DynCorp Technical Services, LLC, 7456-7457 04-3373 Nuclear Nuclear Regulatory Commission NOTICES Operating licenses, amendments; no significant hazards considerations; biweekly notices, 7517-7529 04-3180 Nuclear Nuclear Waste Technical Review Board NOTICES Meetings:
Nuclear Waste Technical Board, 7529-7530 04-3298 Occupational Occupational Safety and Health Administration RULES Safety and health standards, etc.: Commercial driving operations, 7351-7366 04-3289 NOTICES Agency information collection activities; proposals, submissions, and approvals, 7515-7516 04-3372 Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Patent Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 7454-7455 04-3346 Postal Postal Rate Commission NOTICES Meetings:
Windows-based CRA/Cost Rollforward model; development and components, 7530-7531 04-3305 Reclamation Reclamation Bureau NOTICES Meetings: Glen Canyon Dam Adaptive Management Work Group, 7496 04-3347 SBA Small Business Administration NOTICES Disaster loan areas: Maine, 7531 04-3374 State State Department RULES International Traffic in Arms regulations: Congo; denial policy modification, 7349-7350 04-3383 NOTICES Committees; establishment, renewal, termination, etc.: Leadership and Management Advisory Committee, 7531 04-3381 Meetings:
International Economic Policy Advisory Committee, 7531 04-3382 Shipping Coordinating Committee, 7531-7532 04-3379 04-3380 Surface Surface Mining Reclamation and Enforcement Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 7496-7497 04-3286 Trade Trade Representative, Office of United States NOTICES Trade Policy Staff Committee: U.S.-Andean Free Trade Agreement; intent to initiate negotiations; hearing and comment request, 7532-7534 04-3390 Transportation Transportation Department See Federal Aviation Administration See Federal Railroad Administration Treasury Treasury Department See Internal Revenue Service Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 69 31 Tuesday, February 17, 2004 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. 2003D-0545] Guidance for Industry: Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 3);
Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability of guidance. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a revised guidance entitled “Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 3).” The guidance responds to various questions raised about section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which require facilities that manufacture/process, pack, or hold food for consumption in the United States to register with FDA by December 12, 2003. DATES: Submit written or electronic comments on the agency guidance at any time. ADDRESSES: Submit written requests for single copies of the guidance to the registration help desk, 1-800-216-7331 or 301-575-0156, or FAX: 301-210-0247. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Melissa S. Scales, Office of Regulations and Policy (HFS-24), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1720. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of October 10, 2003 (68 FR 58894), FDA issued an interim final rule to implement section 305 of the Bioterrorism Act. The registration regulation requires facilities that manufacture/process, pack, or hold food (including animal feed) for consumption in the United States to register with FDA by December 12, 2003. On December 4, 2003, FDA issued the first edition of a guidance entitled “Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities.” Subsequently, in the **Federal Register** of January 12, 2004 (69 FR 1675), FDA announced the availability of a revision of that guidance entitled “Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 2)”. This guidance entitled “Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 3)” is a revision of the guidance announced on January 9, 2004, and responds to additional questions about the interim final rule on registration. It is intended to help the industry better understand and comply with the regulation in 21 CFR part 1, subpart H. FDA is issuing this guidance entitled “Questions and Answers Regarding the Interim Final Rule on Registration of Food Facilities (Edition 3)” as a level 1 guidance. Consistent with FDA's good guidance practices regulation § 10.115(g)(2) (21 CFR 10.115), the agency will accept comments, but it is implementing the guidance document immediately, in accordance with § 10.115(g)(2), because the agency has determined that prior public participation is not feasible or appropriate. As noted, the Bioterrorism Act requires that covered facilities be registered with FDA by December 12, 2003. Clarifying the provisions of the interim final rule will facilitate prompt registration by covered facilities and thus, complete implementation of the interim final rule. FDA continues to receive a large number of questions regarding the registration interim final rule, and is responding to these inquires under § 10.115 as promptly as possible, using a question-and-answer format. The agency believes that it is reasonable to maintain all responses to questions concerning food facilities registration in a single document that is periodically updated as the agency receives and responds to additional questions. The following four indicators will be employed to help users of the guidance identify revisions:
(1)The guidance will be identified as a revision of a previously issued document,
(2)the revision date of the guidance will appear on its cover,
(3)the edition number of the guidance will be included in its title, and
(4)questions and answers that have been added to the original guidance will be identified as such in the body of the guidance. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the guidance at any time. Two copies of any mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.cfsan.fda.gov/guidance.html* . Dated: February 11, 2004. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 04-3421 Filed 2-12-04; 11:07 am]
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