[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Draft Guidance for Industry on Circumstances That Constitute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availability of a draft guidance for industry entitled ``Circumstances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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 13, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy and Risk Management, Office of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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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