Document ID: FDA-2013-N-0757-0001
Agency: fda
Document Type: Notice
Title: Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138
Posted Date: 2013-07-11T04:00Z

[Federal Register Volume 78, Number 133 (Thursday, July 11, 2013)]
[Notices]
[Page 41803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16617]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0757]

Establishment of a Public Docket for Comment on the Report 
Prepared Under the Food and Drug Administration Safety and Innovation 
Act Section 1138

AGENCY: Food and Drug Administration, HHS.

ACTION: Establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket for comments pertaining to the report 
mandated under the Food and Drug Administration Safety and Innovation 
Act (FDASIA) Section 1138, enacted July 9, 2012, and posted on the FDA 
Web site on July 9, 2013. This docket is intended to solicit input on 
this report from all relevant stakeholders.

DATES: Submit electronic or written comments by September 9, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonca Bull, Office of Minority Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 
4274, Silver Spring, MD 20993-0002, 301-796-8000, email: 
jonca.bull@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) 
into law. Section 1138 of FDASIA requires that FDA review and modify, 
as necessary, the FDA communication plan to inform and educate health 
care providers and patients on the benefits and risks of medical 
products, with particular focus on underrepresented subpopulations, 
including racial subgroups.
    Section 1138 of FDASIA requires that FDA shall publicly post the 
communication plan on the Internet Web site of the Office of Minority 
Health of FDA, and provide links to any other appropriate Internet Web 
site, and seek public comment on the communication plan.
    FDA is opening a docket for 60 days to solicit input from all 
relevant stakeholders regarding the communication plan and Internet 
links. This docket is intended to ensure that stakeholders have an 
opportunity to provide comments for further improvements to the plan.

II. 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). 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 
will be posted to the docket at http://www.regulations.gov and may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: July 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16617 Filed 7-10-13; 8:45 am]
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