Document ID: FDA-2013-N-0271-0033
Agency: fda
Document Type: Notice
Title: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of Comment Period
Posted Date: 2013-10-01T04:00Z

[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60290-60291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23794]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0271]

Availability of Masked and De-identified Non-Summary Safety and 
Efficacy Data; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice entitled ``Availability of Masked and De-
identified Non-Summary Safety and Efficacy Data; Request for 
Comments,'' which appeared in the Federal Register of June 4, 2013 (78 
FR 33421). The Agency is reopening the comment period in response to 
requests for additional time and to allow interested persons more time 
to submit comments.

DATES: Submit either electronic or written comments by October 31, 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 at the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., HILL-3110, Silver Spring, MD 20993, 301-796-3603, FAX: 
301-431-6351, Nancy.sager@fda.hhs.gov; Stephen Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210; or Aaliyah Eaves-Leanos, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5435, 301-796-2948, FAX: 301-847-8510, 
Aaliyah.Eaves-Leanos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 4, 2013 (78 FR 33421), FDA 
published a request for public comments from interested persons on the 
proposed availability of de-identified and masked data derived from 
medical product applications. In that notice, FDA requested comments by 
August 5, 2013, on the following topics: (1) What factors should be 
considered in masking study data (e.g., data fields from regulatory 
submissions to remove or modify, number of different products to pool 
within a product class); (2) what limitations, if any, should there be 
on the Agency's ability to make available the masked data as described 
previously; (3) are there any additional factors FDA should consider in 
de-identifying data in addition to FDA's requirement to remove any 
names and other information (e.g., birth date, death date, local 
geographic information, contact information) that would identify 
patients or research subjects before disclosing information; (4) would 
regulatory changes facilitate implementation of such a proposal, and if 
so, what changes would be most useful; and (5) which situations do you 
believe disclosing masked data would be most useful to advance public 
health?
    The comment period was 60 days, but the Agency has received 
requests for an additional 30 days for submitting comments. Each 
request conveyed concern that the 60-day comment period did not allow 
sufficient time to develop a meaningful or thoughtful response.
    FDA has considered the requests and will reopen the comment period 
for an additional 30 days, thus extending the comment period to October 
31, 2013. The Agency believes that an additional 30 days allows 
adequate time for interested persons to submit comments without 
significantly delaying the Agency's consideration of these important 
issues.

II. How To Submit 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.

[[Page 60291]]

    Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23794 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P