
[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19100-19101]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07658]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0339]


Proposed Risk-Based Regulatory Framework and Strategy for Health 
Information Technology Report; Notice to Public of Availability of the 
Report and Web Site Location; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of the report and Web site location where 
the Agency has posted the report entitled ``Food and Drug 
Administration Safety and Innovation Act (FDASIA) Health IT Report: 
Proposed Risk Based Regulatory Framework.'' In addition, FDA has 
established a docket where stakeholders may provide comments.

DATES: Submit either electronic or written comments by July 7, 2014.

ADDRESSES: Submit electronic comments on this document 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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD, 301-796-5528, 
Bakul.patel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Safety and Innovation Act (FDASIA) 
(Pub. L. 112-144) became law on July 9, 2012. Section 618 of FDASIA 
requires that FDA, in consultation with the Office of the National 
Coordinator for Health Information Technology (ONC) and the Federal 
Communication Commission (FCC), develop and post on their respective 
Web sites ``a report that contains a proposed strategy and 
recommendations on an appropriate, risk-based regulatory framework 
pertaining to health information technology (IT), including mobile 
medical applications, that promotes innovation, protects patient 
safety, and avoids regulatory duplication.'' This ``FDASIA Health IT 
Report: Proposed Risk Based Regulatory Framework'' report fulfills that 
requirement.
    This notice announces the availability and Web site location of 
``FDASIA Health IT Report: Proposed Risk Based Regulatory Framework.'' 
FDA, ONC, and FCC invite interested persons to submit comments on this 
report. We have established a docket where comments may be submitted 
(see ADDRESSES). We believe this docket is an important tool for 
receiving feedback on this report from interested parties and for 
sharing this information with the public. To access ``FDASIA Health IT 
Report: Proposed Risk Based Regulatory Framework,'' visit FDA's Web 
site http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm390588.htm or

[[Page 19101]]

ONC's Web site, www.healthit.gov/FDASIA.

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). 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: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07658 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P


