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Using the Inactive Ingredient Database; Draft Guidance for Industry; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Using the Inactive Ingredient Database.” This draft guidance describes FDA's Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products. It is intended to give applicants a clearer understanding of the information provided in the IID and its terminology.

DATES:

Submit either electronic or written comments on the draft guidance by October 9, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

ADDRESSES:

You may submit comments on any guidance at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-D-2397 for “Using the Inactive Ingredient Database.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. 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.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Susan Zuk, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6162, Silver Spring, MD 20993-0002, 240-402-9133, Susan.Zuk@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Using the Inactive Ingredient Database.” Industry may use the information in FDA's IID to support the safety of an excipient, which can affect application filing and scientific review. Inclusion in the IID is evidence that the excipient has previously been used in FDA-approved drug products. If an excipient has been used in approved drug products for a particular route of administration, the excipient generally is not considered new and may warrant less extensive assessment the next time it is included in a new drug product for the same route of administration. This information is useful to industry when developing new drug products. The draft guidance explains how to use the IID in the development of drug products.

The draft guidance explains the meaning of terms used in the IID. It describes the information users will find in the IID for each excipient. It explains the link between FDA's Global Substance Registration System and nomenclature in the IID to facilitate ingredient searches. The draft guidance also clarifies terminology used in the IID, such as “maximum potency,” how that information is described for certain dosage forms, and when potency information is not provided.Start Printed Page 33078

The draft guidance provides advice on how applicants may use the IID to support the safety of excipients to facilitate application assessment. Topics such as referencing the IID for various excipient grades and ingredients in colors and flavors are addressed. Since the IID is referenced in many types of applications, topics of general concern to all application types and those specific to investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs) are described.

Finally, the draft guidance provides information about where and how to contact FDA with questions about excipients and information related to specific IID listings.

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 current thinking of FDA on “Using the Inactive Ingredient Database.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 314, including the submission of NDAs and ANDAs, has been approved under OMB control number 0910-0001. The collection of information in 21 CFR part 312, including the submission of INDs, has been approved under OMB control number 0910-0014. The collection of information entitled “Guidance for Industry on Formal Meetings between FDA and Sponsors and Applicants for PDUFA Products” has been approved under OMB control number 0910-0429. The collection of information entitled “Controlled Correspondence Related to Generic Drug Development” has been approved under OMB control number 0910-0797.

In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidances.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov.

Start Signature

Dated: July 8, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-14780 Filed 7-10-19; 8:45 am]

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