[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Page 63130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 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 provision to the Food, Drug, and Cosmetic Act (the 
FD&C Act) concerning inspections that makes a drug adulterated. This 
guidance defines the types of actions, inaction, and circumstances that 
FDA considers to constitute delaying, denying, or limiting inspection, 
or refusing to permit entry or inspection for the purposes of making a 
drug adulterated.

DATES: Submit either electronic or written comments on Agency guidance 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 guidance document.
    Submit electronic comments on the 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, 10902 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 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 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.
    In July 2013, FDA issued a draft guidance for industry of the same 
title (78 FR 42387, July 15, 2013). In response to docket comments, we 
revised the guidance to clarify FDA's expectations regarding the types 
of action, inaction, and circumstances that make a drug adulterated 
under 501(j) of the FD&C Act. Among other things, we added examples 
that may constitute reasonable explanations for actions, inactions, or 
circumstances that could otherwise be considered delaying, denying, or 
limiting inspection, or refusing to permit entry or inspection.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25033 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P