COURTHOUSE NEWS SERVICE
Federal Regulation Brief
Nov. 25, 2008
Today’s Brief Includes:
AGRICULTURE, HEALTH, EDUCATION, LAW, SOCIAL SERVICES
(Nov. 10-14)
Agriculture (USDA) – Includes proposed regulations
Education (USDE) – No newly published regulations this time
Health (HHS)– Includes proposed regulations
Housing (HUD)– Includes selected notices
Justice (DOJ)- Proposed regulations only
Legal Services Corporation (LSC)– No newly published regulations this time
Sentencing Commission (USSC)– No newly published regulations this time
Social Security (SSA)– Includes proposed regulations
Veterans Affairs (VA)
NATIONAL SECURITY, COMMUNICATION
(Nov. 11 - 17)
Communication (FCC) – Includes proposed regulations
Defense (DOD)
Homeland Security (DHS) – Includes proposed regulations
Selective Service System (SSS) – No newly published regulations this time
State (DOS)– No newly published regulations this week
Presidential Documents – Iran, Weapons of Mass Destruction
MONEY, TRANSPORTATION
(Nov. 12-18)
Federal Deposit Insurance (FDIC) – Proposed regulations only
Federal Reserve (FRS)
National Transportation Safety Board (NTSB)– No newly published regulations this time
Transportation (DOT) – Includes proposed regulations
Treasury (USDT) – Includes proposed regulations
AGRICULTURE (USDA)
NEWLY PUBLISHED REGULATIONS
AGRICULTURAL MARKETING SERVICE(AMS)
Almonds grown in California, relaxation of incoming quality control requirements:Almonds Grown in California; Relaxation of Incoming Quality Control Requirements, Federal Register,November 12, 2008, Volume 73, Number 219, Rules and Regulations, Page 66719, 7 CFR Part 981, Docket No. AMS-FV-08-0044, FV08-981-1 FIR, Final rule.
[TEXT][PDF]
(This final rule is effective December 12, 2008.)
SUMMARY: The Department of Agriculture (USDA) adopts as a final rule, without change, an interim final rule relaxing the incoming quality control requirements prescribed under the California almond marketing order (order). The order regulates the handling of almonds grown in California and is administered locally by the Almond Board of California (Board). This rule continues in effect the action that changed the date by which almond handlers must satisfy their inedible disposition obligation from August 31 to September 30 of each year. This change provides handlers more flexibility in their operations in light of larger almond crops.
THIS REGULATION IS NOT FURTHER ANALYZED HERE. IF YOU NEED MORE INFORMATION, PLEASE SEE THE FULL TEXT OF THE REGULATION IN THE LINKED DOCUMENT.
Avocados grown in South Florida, revisions to grade and container requirements: Avocados Grown in South Florida; Revisions to Grade and Container Requirements, Federal Register,November 12, 2008, Volume 73, Number 219, Rules and Regulations, Page 66715, 7 CFR Part 915, Docket No. AMS-FV-08-0022, FV08-915-1 FR, Final rule.
[TEXT][PDF]
(This final rule is effective November 13, 2008.)
SUMMARY: The Agricultural Marketing Service (AMS) changes the grade and container requirements currently prescribed under the marketing order for avocados grown in South Florida (order). The order regulates the handling of avocados grown in South Florida and is administered locally by the Avocado Administrative Committee (Committee). This change establishes a minimum grade of a U.S. No. 2 for shipments within the production area, requiring these shipments to meet the same grade as currently prescribed for shipments leaving the production area. This rule also makes changes to the container and container marking requirements under the order. These changes provide a grade and a pack to meet consumer demand and improve the identification and traceability of avocado shipments.
THIS REGULATION IS NOT FURTHER ANALYZED HERE. IF YOU NEED MORE INFORMATION, PLEASE SEE THE FULL TEXT OF THE REGULATION IN THE LINKED DOCUMENT.
PROPOSED REGULATIONS
ANIMAL AND PLANT HEALTH INSPECTION SERVICE(APHIS)
Certain genetically engineered organisms, importation, interstate movement, and release into the environment, correction: Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms; Correction, Federal Register, November 10, 2008, Volume 73, Number 218, Proposed Rules, Page 66563, 7 CFR Part 340, Docket No. APHIS-2008-0023, RIN 0579-AC31, Proposed rule, correction.
[TEXT][PDF]
SUMMARY: The Animal and Plant Health Inspection Service (APHIS) corrects an error in its proposed rule to revise the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. The proposed rule was published in the Federal Register October 9, 2008 (73 FR 60008-60048, Docket No. APHIS 2008-0023).
CORRECTION: In FR Doc. E8-23584, published October 9, 2008 (73 FR 60008-
60048), the following correction is made:
On page 60037, first column, under the heading “D. Executive Order 12988,”“No State or local laws or regulations would be preempted by this rule” is corrected to read “AllState and local laws or regulations that are inconsistent with this rule will be preempted”.
Importation of eggplant From Israel:Importation of Eggplant From Israel, Federal Register,November 12, 2008, Volume 73, Number 219, Proposed Rules, Page 66807, 7 CFR Part 319, Docket No. APHIS-2007-0153, RIN 0579-AC88, Proposed rule.
[TEXT][PDF]
(All comments received on or before January 12, 2009 will be considered.)
SUMMARY: The Animal and Plant Health Inspection Service (APHIS) proposes to allow the importation of commercial shipments of fresh eggplant from Israel. As a condition of entry, the eggplant would be grown under a systems approach that would include requirements for pest exclusion at the production site, fruit fly trapping inside and outside the production site, and pest-excluding packinghouse procedures. The eggplant would also be required to be accompanied by a phytosanitary certificate issued by the Israeli national plant protection organization with an additional declaration confirming that the eggplant had been produced in accordance with the proposed requirements. This action would allow for the importation of commercial consignments of fresh eggplant from Israel into the United States while continuing to provide protection against the introduction of quarantine pests.
THIS PROPOSED REGULATION IS NOT FURTHER ANALYZED HERE. IF YOU NEED MORE INFORMATION, PLEASE SEE THE FULL TEXT IN THE LINKED DOCUMENT.
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HEALTH (HHS)
NEWLY PUBLISHED REGULATIONS
CENTERS FOR MEDICARE & MEDICAID SERVICES(CMS)
Medicare program, revisions to the Medicare Advantage and prescription drug benefit programs, clarification of compensation plans: Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs: Clarification of Compensation Plans, Federal Register, November 14, 2008, Volume 73, Number 221, Rules and Regulations, Page 67406, 42 CFR Parts 422 and 423, CMS-4138-IFC2, RIN 0938-AP52, Interim final rule with comment period.
[TEXT][PDF]
(This interim final rule is effective n November 10, 2008.To be assured consideration, any comments must be received at one of the addresses provided in the linked document, no later than 5 p.m.December 15, 2008.)
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) revises the regulations for the Medicare Advantage (MA) program (Part C), and prescription drug benefit program (Part D). This interim final rule with comment period (IFC) sets forth new requirements for the marketing of Part C and Part D plans which by statute must be in place at a date specified by the Secretary, but no later than November 15, 2008. The new marketing requirements, which set forth new limits on the compensation that can be paid to agents or brokers with respect to Part C and Part D plans, are based on authority under provisions in the Medicare Improvements for Patients and Providers Act (MIPPA) that became law July 15, 2008.
THIS REGULATION IS NOT FURTHER ANALYZED HERE. IF YOU NEED MORE INFORMATION, PLEASE SEE THE FULL TEXT OF THE REGULATION IN THE LINKED DOCUMENT.
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FOOD AND DRUG ADMINISTRATION(FDA)
Food labeling, health claims, calcium and osteoporosis, and calcium, vitamin D, and osteoporosis: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis, Federal Register,November 12, 2008, Volume 73, Number 219, Rules and Regulations, Page 66754, 21 CFR Part 101, Docket No. FDA-2004-P-0205, formerly Docket No. 2004P-0464, Final rule, correction.
[TEXT][PDF]
(This final rule, correction, is effective November 12, 2008.)
SUMMARY: The Food and Drug Administration (FDA) corrects a final rule that appeared in the Federal Register of September 29, 2008 (73 FR 56477). The final rule was published with an inadvertent error in the “Analysis of Economic Impacts” section. This action corrects that error.
CORRECTION: In FR Doc. E8-22730, appearing on page 56477 in the Federal Register of September 29, 2008, the following correction is made:
On page 56481, in the second column, starting in the forth line, the sentence “Therefore, because of the limited use of the current calcium and osteoporosis health claim, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.” is corrected to read “Therefore, because of the limited use of the current calcium and osteoporosis health claim, the agency believes that the final rule will not have a significant economic impact on a substantial number of small entities.”
Maximum civil money penalty amounts and compliance with the Federal Civil Penalties Inflation Adjustment Act: Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act, Federal Register,November 12, 2008, Volume 73, Number 219, Rules and Regulations, Page 66750, 21 CFR Part 17, Docket No. FDA-2008-N-0561, Direct final rule.
[TEXT][PDF]
(This direct final rule is effective March 27, 2009, without further notice, unless the Food and Drug Administration (FDA) receives significant adverse comment by January 26, 2009. If the FDA receives no timely significant adverse comments, it will publish a document in the Federal Register before February 25, 2009, confirming the effective date of this direct final rule. If the FDA receives any timely significant adverse comments, it will publish a document in the Federal Register withdrawing this direct final rule before March 27, 2009.)
SUMMARY: The Food and Drug Administration (FDA) issues a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within its jurisdiction. The FDA takes this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20,
2004 (69 FR 43299), and the FCPIAA requires federal agencies to adjust their civil money penalties at least once every 4 years. This rule does not adjust the civil money provisions enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA). The FDA uses direct final rulemaking for this action because it expects there will be no significant adverse comment on this rule. In the proposed rule section of this issue of the Federal Register, the FDA concurrently proposes and solicits comments on this rule. If significant adverse comments are received, the FDA will withdraw this final rule and address the comments in a subsequent final rule. There will not be a second comment period.
THIS REGULATION IS NOT FURTHER ANALYZED HERE. IF YOU NEED MORE INFORMATION, PLEASE SEE THE FULL TEXT OF THE REGULATION IN THE LINKED DOCUMENT.
Obstetrical and gynecological devices, designation of special controls for male condoms made of natural rubber latex: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex, Federal Register,November 10, 2008, Volume 73, Number 218, Rules and Regulations, Page 66522, 21 CFR Part 884, Docket No. FDA-2004-N-0511, formerly Docket No. 2004N-0556, RIN 0910-AF21, Final rule.
[TEXT][PDF] Final rule.
[TEXT][PDF] Draft guidance document.
(This final rule is effective January 9, 2009.Premarket notification submissions (510(k)s) for latex condoms filed on or after the effective date of this rule are expected to comply with the requirement of special controls at the time that the 510(k) is submitted. Latex condoms cleared for marketing on or after the effective date of the rule but submitted in 510(k)s filed before the effective date of the rule are expected to comply with the requirement of special controls on or before March 10, 2009. Latex condoms legally marketed before the effective date of this rule are expected to comply with the requirement of special controls December 10, 2009. Specific information on how the rule is implemented can be found in Section II.B in the linked final rule document.)
SUMMARY: The Food and Drug Administration (FDA) amends the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.” The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document by January 9. A draft is linked, above.
HIGHLIGHTS OF CHANGES: The FDA concludes that scientific evidence today continues to fully support the overall effectiveness of latex condoms in reducing the risk of transmission of common sexually transmitted infections (STIs). That evidence supports the conclusions that correct and consistent use of latex condoms reduces the risk of transmission of HIV/AIDS and other STIs such as gonorrhea that are sexually transmitted solely by contact with the head of the penis (via genital fluids). Also, the evidence available today provides even more support than what was available at the time of publication of the proposed rule for the conclusion that latex condoms are effective in reducing the risk of transmission of other STIs, such as genital herpes and HPV, that can be transmitted not only by contact with the head of the penis, the area covered by a latex condom, but also by contact with infected skin,outside the area covered by the latex condom.
AMENDMENT: 21 CFR Part 884--OBSTETRICAL AND GYNECOLOGICAL DEVICESSection 884.5300 is amended as follows:
Section 884.5300 Condom.
(a) Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
(b) Classification.
(1) Class II (special controls) for condoms made of materialsother than natural rubber latex, including natural membrane (skin) or synthetic.
(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See Section 884.1(e) for the availability of this guidance document.
THIS REGULATION IS NOT FURTHER ANALYZED HERE. IF YOU NEED MORE INFORMATION, PLEASE SEE THE FULL TEXT OF THE REGULATION IN THE LINKED DOCUMENT.
PROPOSED REGULATIONS
FOOD AND DRUG ADMINISTRATION (FDA)
Maximum civil money penalty amounts and compliance with the Federal Civil Penalties Inflation Adjustment Act: Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act, Federal Register,November 12, 2008, Volume 73, Number 219, Proposed Rules, Page 66811, 21 CFR Part 17, Docket No. FDA-2008-N-0561, Proposed rule.
[TEXT][PDF]
(Any written or electronic comments on the proposed rule must be submitted by
December 26, 2008. If the Food and Drug Administration (FDA) receives any timely significant adverse comments, it will publish a document withdrawing the direct final rule within 30 days after the comment period ends. The FDA will then proceed to respond to comments under this proposed rule using the usual notice-and-comment procedures.)
SUMMARY: The Food and Drug Administration (FDA) publishes this companion proposed rule to the direct final rule, published elsewhere in the November 12, 2008 issue of the Federal Register, which is intended to amend its regulations to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within its jurisdiction. The FDA takes this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended.
The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires federal agencies to adjust their civil money penalties at least once every 4 years. This proposed rule does not adjust the civil money provisionsenacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
THIS PROPOSED REGULATION IS NOT FURTHER ANALYZED HERE. IF YOU NEED MORE INFORMATION, PLEASE SEE THE FULL TEXT IN THE LINKED DOCUMENT.
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JUSTICE (DOJ)
PROPOSED REGULATIONS
JUSTICE DEPARTMENT(DOJ)
Application procedures and criteria for approval of providers of a personal financial management instructional course by United States Trustees:Application Procedures and Criteria for Approval of Providers of a Personal Financial Management Instructional Course by United States Trustees, Federal Register, November 14, 2008, Volume 73, Number 221, Proposed Rules, Page 67435, 28 CFR Part 58, Docket No: EOUST 104, RIN 1105-AB31, Notice of proposed rulemaking.
[TEXT][PDF]
(Any comments must be submitted on or before January 13, 2009.)
SUMMARY: The Executive Office for United States Trustees (EOUST), Department of Justice (DOJ) sets forth proposed procedures and criteria United States Trustees must use when determining whether applicants seeking to become and remain an approved provider of a personal financial management instructional course satisfy all prerequisites of the United States Code, as implemented under this rule. Under the current law, individual debtors must participate in an instructional course for personal financial management before receiving a discharge of debts. The current law enumerates mandatory prerequisites and minimum standards applicants seeking to become approved providers of a personal financial management instructional course must meet. Under this rule, United States Trustees approve applicants for inclusion on publicly available provider lists in one or more federal judicial districts if an applicant establishes it meets all the requirements of the United States Code, as implemented under this rule. After obtaining such an approval, a provider will be authorized to provide an instructional course in a federal judicial district during the time the provider remains approved.