
[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Proposed Rules]
[Pages 21085-21086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08120]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-0365]


Establishment of a Public Docket for Administrative Detention 
Under the Food and Drug Administration Safety and Innovation Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Establishment of docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket for comments pertaining to the 
implementation of its administrative detention authority with respect 
to drugs under the Food and Drug Administration Safety and Innovation 
Act (FDASIA). This document is intended to solicit input from all 
relevant stakeholders before FDA issues regulations to implement its 
administrative detention authority with respect to drugs and to 
announce that such information submitted to FDA is available to all 
interested persons in a timely fashion.

DATES: Submit electronic or written comments by May 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: Charlotte Hinkle, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 4345, Silver Spring, MD 20993-0002, 301-796-5300, 
FDASIAImplementationORA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) 
into law. Section 709 of FDASIA amends section 304(g) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to 
provide FDA administrative detention authority with respect to drugs. 
Section 304(g) of the FD&C Act, as amended by FDASIA, provides FDA the 
same authority to detain drugs that section 304(g) had already provided 
FDA with respect to devices and tobacco products.
    Section 709 of FDASIA requires the Secretary to ``consult with 
stakeholders, including manufacturers of drugs'' before issuing 
implementing regulations. Section 709 also provides that FDA must issue 
a final rule to implement its administrative detention authority with 
respect to drugs before the amendments to section 304(g) of the FD&C 
Act take effect.
    FDA is opening a docket for 30 days to solicit input from all 
relevant stakeholders regarding FDA's issuance of a regulation for the 
administrative detention of drugs. This docket is intended to ensure 
that stakeholders have an opportunity to provide comments before FDA 
issues regulations on administrative detention with

[[Page 21086]]

respect to drugs and that such information submitted to FDA is 
available to all interested persons in a timely fashion.

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: April 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08120 Filed 4-8-13; 8:45 am]
BILLING CODE 4160-01-P


