[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Proposed Rules]
[Pages 21085-21086]
[FR Doc No: 2013-08120]

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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.

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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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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

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]
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