[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Pages 51822-51823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2537]


Request for Quality Metrics; Notice of Draft Guidance 
Availability and Public Meeting; Request for Comments; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of draft guidance availability and public meeting; 
request for comments; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of draft guidance availability and public 
meeting that appeared in the Federal Register of July 28, 2015, and 
August 7, 2015. In the notice of draft guidance availability and public 
meeting, FDA requested comments on a number of specific questions 
identified in the document. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the notice of draft 
guidance availability and public meeting published July 28, 2015 (80 FR 
44973) and August 7, 2015 (80 FR 47493). Submit either electronic or 
written comments by November 27, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug

[[Page 51823]]

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2015-D-2537) for this notice of draft guidance availability and 
public meeting. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lesley DeRenzo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5161, Silver Spring, MD 20993-0002, 240-
402-4612.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 28, 2015, and August 7, 2015, FDA 
published a notice of draft guidance availability and public meeting 
with a 60-day comment period and requested comments on a number of 
specific questions identified throughout the document. Comments on the 
notice of draft guidance availability and public meeting will inform 
FDA's development and planned implementation of a quality metrics 
program launched under the authority of the Federal Food, Drug, and 
Cosmetic Act.
    FDA is extending the comment period for an additional 60 days, 
until November 27, 2015. The Agency believes that an additional 60-day 
extension of the comment period for the notice of draft guidance 
availability and public meeting will allow adequate time for interested 
persons to submit comments without significantly delaying Agency 
decisionmaking on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). You should annotate and 
organize your comments to identify the specific questions or topic to 
which they refer. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

    Dated: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21149 Filed 8-25-15; 8:45 am]
 BILLING CODE 4164-01-P