Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability, 63130 [2014-25033]

Download as PDF 63130 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices 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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: October 15, 2014. Leslie Kux, Assistant Commissioner for Policy. I. Background [FR Doc. 2014–25048 Filed 10–21–14; 8:45 am] BILLING CODE 4164–01–P 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. 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:22 Oct 21, 2014 Jkt 235001 INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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: 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Regulatory Information/Guidances/ucm122044.htm or https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Seventh Annual Sentinel Initiative; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Seventh Annual Sentinel Initiative Public Workshop.’’ Convened by the Engelberg Center for Health Care Reform at the Brookings Institution and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an overview of the transition from the Mini-Sentinel pilot program to the full Sentinel System and what that means for patients and other critical stakeholders. Additionally, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel projects. E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Page 63130]
From the Federal Register Online via the Government Printing 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.

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

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 https://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 https://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 https://www.regulations.gov.

III. Electronic Access

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

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