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

---
identifier: "/us/fr/E6-3522"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "E6-3522"
section_name: "Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays; Correction"
positive_law: false
currency: "2006-03-13"
last_updated: "2006-03-13"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "E6-3522"
document_type: "proposed_rule"
publication_date: "2006-03-13"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 866"
fr_citation: "71 FR 12653"
fr_volume: 71
docket_ids:
  - "Docket No. 2005N-0471"
fr_action: "Proposed rule; correction."
---


#  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 That document inadvertently included a list of references related to a draft guidance that also was announced in the *Federal Register* of January 9, 2006 (71 FR 1432). The draft guidance contains the correct list of references.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.

**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.

Dated: March 3, 2006.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.