[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Page 42387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16841]



  Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / 
Notices  

[[Page 42387]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0710]


Draft Guidance for Industry on Circumstances That Constitute 
Delaying, Denying, Limiting, or Refusing a Drug Inspection; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Circumstances 
that Constitute Delaying, Denying, Limiting, or Refusing a Drug 
Inspection.'' The Food and Drug Administration Safety and Innovation 
Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act 
(FD&C Act) concerning inspections that would make a drug adulterated. 
This guidance defines, by way of example, the circumstances that FDA 
would consider to constitute delaying, denying, or limiting inspection, 
or refusing to permit entry or inspection for the purposes of making a 
drug adulterated.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 13, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Policy and Risk Management, Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., 
Rm. 4138, Rockville, MD 20857. Send one self-addressed adhesive label 
to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT: Emily M. Leongini, Office of Policy 
and Risk Management, Office of Regulatory Affairs, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4339, Silver 
Spring, MD 20903, 301-796-5300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Circumstances That Constitute Delaying, Denying, Limiting, 
or Refusing a Drug Inspection.'' On July 9, 2012, FDASIA (Pub. L. 112-
144) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C 
Act (21 U.S.C. 351(j) to make a drug adulterated that ``has been 
manufactured, processed, packed, or held in any factory, warehouse, or 
establishment and the owner, operator, or agent of such factory, 
warehouse, or establishment delays, denies, or limits an inspection, or 
refuses to permit entry or inspection.'' As required by section 707, 
FDA is issuing this guidance to define the types of action, inaction, 
and circumstances that FDA considers to constitute delaying, denying, 
or limiting inspection, or refusing to permit entry or inspection for 
the purposes of section 501(j) of the FD&C Act.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on 
``Circumstances That Constitute Delaying, Denying, Limiting, or 
Refusing a Drug Inspection.'' It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

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 
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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122044.htm 
or http://www.regulations.gov.

    Dated: July 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16841 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P