Product Jurisdiction; Correction

---
identifier: "/us/fr/2018-12201"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Product Jurisdiction; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2018-12201"
section_name: "Product Jurisdiction; Correction"
positive_law: false
currency: "2018-06-07"
last_updated: "2018-06-07"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2018-12201"
document_type: "proposed_rule"
publication_date: "2018-06-07"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 3"
fr_citation: "83 FR 26392"
fr_volume: 83
docket_ids:
  - "Docket No. FDA-2004-N-0191"
comments_close_date: "2018-07-16"
fr_action: "Proposed rule; correction."
---


#  Product Jurisdiction; Correction

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Proposed rule; correction.

**SUMMARY:**

The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the *Federal Register* of May 15, 2018. The document was published with an error in the discussion of the preliminary economic analysis impact. This document corrects that error.

**DATES:**

Submit either electronic or written comments on the proposed rule by July 16, 2018.

**FOR FURTHER INFORMATION CONTACT:**

Melissa Burns, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of Tuesday, May 15, 2018, beginning on page 22428 for FR Doc. 2018-10321, table 1 on page 22433 is corrected to read:

| Category | Primary | Low | High | Units | Year | Discount rate | Period | Notes |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Costs: |  |  |  |  |  |  |  |  |
| Annualized | $17,000 | $12,000 | $27,000 | 2016 | 7 | 10 |  |  |
| Monetized $/year | 15,000 | 10,000 | 23,000 | 2016 | 3 | 10 |  |  |
| Annualized |  |  |  |  | 7 |  |  |  |
| Quantified |  |  |  |  | 3 |  |  |  |
| Qualitative |  |  |  |  |  |  |  |  |
| Benefits: |  |  |  |  |  |  |  |  |
| Annualized | 28,000 | 25,000 | 89,000 | 2016 | 7 | 10 |  |  |
| Monetized $/year | 28,000 | 25,000 | 89,000 | 2016 | 3 | 10 |  |  |
| Annualized |  |  |  |  | 7 |  |  |  |
| Quantified |  |  |  |  | 3 |  |  |  |
| Qualitative | Firms and FDA may realize savings from sponsors choosing to submit electronic RFDs |  |  |  |  |  |  |  |
| Transfers: |  |  |  |  |  |  |  |  |
| Federal |  |  |  |  | 7 |  |  |  |
| Annualized |  |  |  |  |  |  |  |  |
| Monetized $millions/year |  |  |  |  | 3 |  |  |  |
| From/To | From: | To: |  |  |  |  |  |  |
| Other |  |  |  |  | 7 |  |  |  |
| Annualized |  |  |  |  |  |  |  |  |
| Monetized $millions/year |  |  |  |  | 3 |  |  |  |
| From/To | From: | To: |  |  |  |  |  |  |
| Effects: |  |  |  |  |  |  |  |  |
| State, Local or Tribal Government: |  |  |  |  |  |  |  |  |
| Small Business: Will not have a significant impact on a substantial number of small entities. |  |  |  |  |  |  |  |  |
| Wages: |  |  |  |  |  |  |  |  |
| Growth: |  |  |  |  |  |  |  |  |

Dated: June 1, 2018.

Leslie Kux,

Associate Commissioner for Policy.