Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays; Correction, 12653-12654 [E6-3522]

Download as PDF Federal Register / Vol. 71, No. 48 / Monday, March 13, 2006 / Proposed Rules (e) Refunds. We will promptly refund to the debtor any amounts collected that the debtor does not owe. Refunds do not bear interest unless required or permitted by law or contract. 5. Section 422.317 is revised to read as follows: wwhite on PROD1PC61 with PROPOSALS § 422.317 Review of the debt. (a) Notification and presentation of evidence by the debtor. A debtor who receives a notice described in § 422.305(b), § 422.306(b), or § 422.310(c) has a right to have a review of the debt and the payment schedule for Federal salary offset stated in the notice. To exercise this right, the debtor must notify us and give us evidence that he or she does not owe all or part of the debt, or that we do not have the right to collect it, or that the payment schedule for Federal salary offset stated in the notice would cause financial hardship. (1) If the debtor notifies us and presents evidence within 60 calendar days from the date of our notice (except as provided for Federal salary offset in paragraph (a)(3) of this section), we will not take the action described in our notice unless and until review of all of the evidence is complete and we send the debtor the findings that all or part of the debt is overdue and legally enforceable. (2) If the debtor notifies us and presents evidence after that 60 calendarday period expires (except as provided for Federal salary offset in paragraph (a)(4) of this section) and paragraph (b) of this section does not apply, the review will occur, but we may take the actions described in our notice without further delay. (3) If the debtor notifies us and presents evidence within 30 calendar days from the date of our notice, we will not refer the debt for Federal salary offset unless and until review of all of the evidence is complete and we send the debtor the findings that all or part of the debt is overdue and legally enforceable and (if appropriate) the findings on the payment schedule for Federal salary offset. (4) If the debtor notifies us and presents evidence after that 30 calendarday period expires and paragraph (b) of this section does not apply, the review will occur, but we may refer the debt for Federal salary offset without further delay. (b) Good cause for failure to timely request review. (1) If we decide that the debtor has good cause for failing to request review within the applicable period mentioned in paragraphs (a)(1) and (a)(3) of this section, we will treat VerDate Aug<31>2005 16:18 Mar 10, 2006 Jkt 208001 the request for review as if we received it within the applicable period. (2) We will determine good cause under the rules in § 422.410(b)(1) and (2) of this chapter. (c) Review of the evidence. The review will cover our records and any evidence and statements presented by the debtor. (d) Special rules regarding Federal salary offset. (1) When we use Federal salary offset to collect a debt owed by an employee of the Federal Government, an official designated in accordance with 5 U.S.C. 5514(a)(2) will conduct the review described in this section and will issue the findings. (2) In addition to the requirements in paragraphs (a) and (b) of this section, the Federal employee must submit the request for review in writing. The request must: (i) Be signed by the employee, (ii) Explain with reasonable specificity the facts and evidence that support the employee’s position, and (iii) Include the names of any witnesses. (3) In reviewing the payment schedule described in the notice to the Federal employee, the reviewing official must apply the rules in § 422.415(b), (c), and (d) of this chapter regarding financial hardship. (4) The reviewing official will review our records and any documents, written statements, or other evidence submitted by the debtor and issue written findings. (5) The reviewing official will complete the review within 60 calendar days from the date on which the request for review and the debtor’s evidence are received. If the reviewing official does not complete the review within that 60day period and the debt was referred to the Department of the Treasury for Federal salary offset, we will notify the Department of the Treasury to suspend Federal salary offset. Offset will not begin or resume before we send the debtor findings that all or part of the debt is overdue and legally enforceable or (if appropriate) findings on the payment schedule. (e) The findings. (1) Following the review described in paragraphs (c) or (d) of this section, we will send the written findings to the debtor. The findings will state the nature and origin of the debt, the analysis, findings and conclusions regarding the amount and validity of the debt, and, when appropriate, the repayment schedule for Federal salary offset. Issuance of these findings will be the final action on the debtor’s request for review. (2) If the findings state that an individual does not owe the debt, or the debt is not overdue, or we do not have the right to collect it, we will not send PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 12653 information about the debt to consumer or other credit reporting agencies or refer the debt to the Department of the Treasury for administrative offset. If we had referred the debt to the Department of the Treasury for administrative offset, we will cancel that action. If we had informed consumer or credit reporting agencies about the debt, we will inform them of the findings. (3) If the findings state that the payment schedule for Federal salary offset would cause financial hardship, we will notify the debtor and the Department of the Treasury of the new payment schedule. [FR Doc. E6–3509 Filed 3–10–06; 8:45 am] BILLING CODE 4191–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. 2005N–0471] Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. SUMMARY: The Food and Drug Administration is correcting a proposed rule that appeared in the Federal Register of January 9, 2006 (71 FR 1399). That document proposed the reclassification of herpes simplex virus (types 1 and/or 2) serological assays from class III (premarket approval) to class II (special controls). That document inadvertently included a list of references related to a draft guidance that also was announced in the Federal Register of January 9, 2006 (71 FR 1432). The draft guidance contains the correct list of references. This document corrects the error. FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0496, ext. 114. In FR Doc. 06–173, appearing on page 1399, in the Federal Register of Monday, January 9, 2006, the following correction is made: 1. On pages 1402–1403, section XII. References is removed. SUPPLEMENTARY INFORMATION: E:\FR\FM\13MRP1.SGM 13MRP1 12654 Federal Register / Vol. 71, No. 48 / Monday, March 13, 2006 / Proposed Rules Dated: March 3, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–3522 Filed 3–10–06; 8:45 am] Request for Comments We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (CGD13–06–001), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them. BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD13–06–001] RIN 1625–AA11 Regulated Navigation Area; Middle Waterway EPA Superfund Cleanup Site, Commencement Bay, Tacoma, WA Coast Guard, DHS. Notice of proposed rulemaking. AGENCY: wwhite on PROD1PC61 with PROPOSALS ACTION: SUMMARY: The Coast Guard proposes to create a permanent regulated navigation area on a portion of Commencement Bay, Tacoma, Washington. This regulated navigation area would be used to preserve the integrity of a clean sediment cap placed over certain areas of the Middle Waterway as part of the remediation process at the Commencement Bay, Nearshore/ Tideflats Environmental Protection Agency (EPA) superfund cleanup site. This regulated navigation area would prohibit activities that would disturb the seabed, such as anchoring, dragging, trawling, or other activities that involve disrupting the integrity of the cap. It would not affect transit or navigation of the area. DATES: Comments and related material must reach the Coast Guard on or before April 12, 2006. ADDRESSES: You may mail comments and related material to Sector Commander, Sector Seattle, 1519 Alaskan Way South, Seattle, Washington 98134. Sector Seattle maintains the public docket [CGD13– 06–001] for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket and will be available for inspection or copying at Sector Seattle between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: LTJG Jes Hagen, c/o Captain of the Port Puget Sound, 1519 Alaskan Way South, Seattle, WA 98134, (206) 217–6232. SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 16:18 Mar 10, 2006 Jkt 208001 Public Meeting We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to Sector Seattle at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register. Background and Purpose The Middle Waterway is part of the Commencement Bay Nearshore/ Tideflats Superfund Cleanup Site and is located between the Thea Foss Waterway and the St. Paul Waterway in Commencement Bay, Washington. The site includes property owned by Foss Maritime Company, Simpson Timber Company, and the Washington State Department of Natural Resources (DNR), as well as property leased by Marine Industries Northwest, Inc. (MINI). Part of the remediation process for the site consists of covering the contaminated sediments with a thicklayer cap. The thick-layer caps consist of approximately three feet of sand, gravel, and light-loose riprap and were placed in various locations within the waterway to contain contaminated sediments. The thick-layer cap areas cover approximately two acres of sediment in the waterway. Discussion of Proposed Rule This is to be a permanent regulation restricting activities such as anchoring, dragging, trawling, or other activities that involve disrupting the integrity of the cap. Activities common in the proposed regulated areas include tugboat and log-rafting activities, tugboat moorage, removal and launching of boats for repair and other boat repair and maintenance activities. The thick-layer cap areas were designed PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 to be compatible with the activities described above that are associated with a working waterfront. The material used for the cap was chosen to be able to contain underlying sediments without altering the main activities of the working waterway. Regulatory Evaluation This proposed rule is not a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not ‘‘significant’’ under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the fact that the regulated areas established by the rule would encompass a small area that should not impact commercial or recreational traffic. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term ‘‘small entities’’ comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which may be small entities: The owners or operators of vessels intending to anchor, dredge, spud, lay cable or disturb the seabed in any fashion when this rule is in effect. The zone would not have a significant economic impact due to its small area. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small E:\FR\FM\13MRP1.SGM 13MRP1

Agencies

[Federal Register Volume 71, Number 48 (Monday, March 13, 2006)]
[Proposed Rules]
[Pages 12653-12654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2005N-0471]


Immunology and Microbiology Devices; Reclassification of Herpes 
Simplex Virus (Types 1 and/or 2) Serological Assays; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration is correcting a proposed rule 
that appeared in the Federal Register of January 9, 2006 (71 FR 1399). 
That document proposed the reclassification of herpes simplex virus 
(types 1 and/or 2) serological assays from class III (premarket 
approval) to class II (special controls). That document inadvertently 
included a list of references related to a draft guidance that also was 
announced in the Federal Register of January 9, 2006 (71 FR 1432). The 
draft guidance contains the correct list of references. This document 
corrects the error.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496, ext. 114.

SUPPLEMENTARY INFORMATION: In FR Doc. 06-173, appearing on page 1399, 
in the Federal Register of Monday, January 9, 2006, the following 
correction is made:
    1. On pages 1402-1403, section XII. References is removed.


[[Page 12654]]


    Dated: March 3, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-3522 Filed 3-10-06; 8:45 am]
BILLING CODE 4160-01-S

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