
[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Page 50636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2986]


Technical Document for Using the Inactive Ingredient Database; 
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, or the Agency) is 
announcing the establishment of a public docket to receive comments 
from interested parties on enhancing the utility and usability of the 
Inactive Ingredient Database (IID) (also known as the Inactive 
Ingredient Guide). These comments will help FDA identify best practices 
to assist Agency staff in designing the IID and maintaining the 
information contained therein. We intend to identify and further 
develop these best practices in a technical guide or draft guidance to 
be issued at a later date.

DATES: Submit either electronic or written comments by October 19, 
2015.

ADDRESSES: Submit electronic comments 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. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-
402-7930.

SUPPLEMENTARY INFORMATION: 

I. Background

    The IID provides information on inactive ingredients in FDA-
approved drug products. An inactive ingredient, or excipient, is any 
component of a drug product other than an active ingredient (21 CFR 
210.3(b)(8)). Generally, the IID identifies excipients that appear in 
approved drug products for a particular dosage form and route of 
administration.
    In September 2011, FDA created the IID Working Group to develop a 
set of questions and answers to facilitate use of the IID. During the 
development of questions and answers, FDA has worked with the 
International Pharmaceutical Excipients Council (IPEC Americas).\1\ FDA 
is opening a public docket to solicit comments from additional 
stakeholders on enhancing the utility and usability of the IID. FDA 
will then develop a comprehensive technical guide or draft guidance for 
industry and reviewers.
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    \1\ See Meetings between FDA and the International 
Pharmaceutical Excipients Council (IPEC), available at http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm380688.htm.
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II. Establishment of a Public Docket and Request for Comments

    To help FDA identify and ultimately establish best practices and 
issue a technical guide or draft guidance, FDA is requesting public 
comments regarding the enhancement of the IID.
    FDA is requesting comments and supporting information, including 
proposed questions and proposed answers, on the following topics 
related to the IID:
    1. How can we improve nomenclature in the IID (e.g., use of 
preferred ingredient names and synonyms in the database)?
    2. How should we identify excipient amounts listed in the IID?
    3. How should we reflect updates to the current IID to ensure 
completeness and accuracy?
    4. Should we restructure the IID, and if so, how?
    5. Are there additional suggestions or comments for IID 
improvement?
    FDA will consider all comments submitted. FDA generally will not 
respond directly to the person or organization submitting the comment.

III. 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.

    Dated: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20556 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P


