2016-19874. Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development; Correction

AGENCY:

Food and Drug Administration, HHS

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration is correcting a notice entitled “Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development” that appeared in the Federal Register of December 29, 2016 (80 FR 81335). The document announced the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 2016. The document was published with the incorrect number of years in which CDRH committed to finalize, withdraw, re-open the comment period, or issue another draft guidance on the topic for 80 percent of the documents. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Lisa Granger, Office of Policy, Planning, Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION:

In the Federal Register of Tuesday, December 29, 2015, in FR Doc. 2015-32726, the following correction is made:

1. On page 81336, in the third column, in the 13th sentence of the second paragraph under section II. CDRH Guidance Development Initiative, “2 years” is corrected to read “3 years”.

Dated: August 16, 2016.

Peter Lurie,

Associate Commissioner for Public Health Strategy and Analysis.