Federal Register / Vol. 79, No. 231 / Tuesday, December 2, 2014 / Notices 71435 

VI. Reference 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and is available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site address in this reference 

section, but we are not responsible for 

any subsequent changes to the Web site 

after this document publishes in the 

Federal Register.) 

1. The FDA guidance entitled ‘‘Draft 

Guidance for Industry and FDA 

Staff: Total Product Life Cycle: 

Infusion Pump—Premarket 

Notification [510(k)] Submissions,’’ 

available at http://www.fda.gov/

medicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/

ucm206153.htm. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28267 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0295] 

Guidance for Industry on Scale-Up 

Post-Approval Changes: 

Manufacturing Equipment Addendum; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a scale-up and postapproval changes (SUPAC) guidance for 

industry entitled ‘‘SUPAC: 

Manufacturing Equipment Addendum.’’ 

This replaces the draft guidance of the 

same name that combined and 

superseded ‘‘SUPAC IR/MR: Immediate 

Release and Modified Release Solid Oral 

Dosage Forms: Manufacturing 

Equipment Addendum,’’ published on 

January 1, 1999; and ‘‘SUPAC–SS: 

Nonsterile Semisolid Dosage Forms; 

Manufacturing Equipment Addendum,’’ 

published as a draft on December 1, 

1998. FDA revised the draft 

manufacturing equipment addenda to 

remove the equipment examples and to 

clarify the types of processes being 

referenced. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Food and Drug Administration, 10001 

New Hampshire Ave., Hillandale 

Building, 4th Floor, Silver Spring, MD 

20993. 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: 

Akm Khairuzzaman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3886. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a SUPAC guidance for industry entitled 

‘‘SUPAC: Manufacturing Equipment 

Addendum.’’ This guidance replaces the 

draft guidance of the same name that 

superseded the following guidances for 

industry: (1) ‘‘SUPAC IR/MR: Immediate 

Release and Modified Release Solid Oral 

Dosage Forms: Manufacturing 

Equipment Addendum,’’ published on 

January 1, 1999, and (2) ‘‘SUPAC–SS: 

Nonsterile Semisolid Dosage Forms; 

Manufacturing Equipment Addendum, 

‘‘published as draft on December 1, 

1998. When published, these guidances 

included tables that listed specific 

equipment that were misinterpreted as a 

list of FDA required equipment. In 

addition, FDA is concerned that the 

equipment addenda may no longer 

reflect current practices and may be 

limiting, instead of encouraging, 

manufacturers to continually evaluate 

and update practices. FDA has removed 

the tables listing specific manufacturing 

equipment from these guidances and 

combined them into a single addendum. 

FDA has also made some changes to 

clarify the types of processes being 

referenced. 

This guidance should be used with 

the following guidances for industry to 

determine what documentation should 

be submitted to FDA regarding 

equipment changes: (1) ‘‘SUPAC–IR: 

Immediate Release Solid Oral Dosage 

Forms—Scale-Up and Post-Approval 

Changes: Chemistry, Manufacturing and 

Controls, In Vitro Dissolution Testing, 

and In Vivo Bioequivalence 

Documentation,’’ (2) ‘‘SUPAC–MR: 

Modified Release Solid Oral Dosage 

Forms Scale-Up and Post-Approval 

Changes: Chemistry, Manufacturing and 

Controls; In Vitro Dissolution Testing 

and In Vivo Bioequivalence 

Documentation,’’ and (3) ‘‘SUPAC–SS: 

Nonsterile Semisolid Dosage Forms, 

Scale-Up and Post Approval Changes: 

Chemistry Manufacturing and Controls; 

In Vitro Release Testing and In Vivo 

Bioequivalence Documentation.’’ 

As part of a greater effort, FDA is 

thoroughly reviewing the SUPAC 

guidance series to determine how these 

guidances fit with current 

manufacturing practices, including, but 

not limited to, risk-based assessment 

approaches and quality by design 

principles. This guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). This guidance represents the 

Agency’s current thinking on 

manufacturing equipment. 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/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28256 Filed 12–1–14; 8:45 am] 

BILLING CODE 4164–01–P 


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