[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Notices]
[Pages 33077-33078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14780]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2397]
Using the Inactive Ingredient Database; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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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the availability of a draft guidance for industry entitled ``Using the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 This draft guidance describes FDA's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DATES: Submit either electronic or written comments on the draft
guidance by October 9, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.
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,
[email protected].
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.
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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.
Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14780 Filed 7-10-19; 8:45 am]
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