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 http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: October 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[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. 

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/Regulatory

Information/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 

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. 

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