[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43211-43212]
[FR Doc No: 2016-15704]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1692]

Elemental Impurities in Drug Products; Draft Guidance for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the availability of a draft guidance for industry entitled ``Elemental
Impurities in Drug Products.'' This draft guidance provides
recommendations regarding the control of elemental impurities of human
drug products marketed in the United States consistent with
implementation of International Council for Harmonisation (ICH)
guidance for industry ``Q3D Elemental Impurities.'' This draft guidance
will also assist manufacturers of compendial drug products in
responding to the issuance of the United States Pharmacopeia (USP)
requirement for the control of elemental impurities.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 30, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-1692 for Elemental Impurities in Drug Products. Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    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; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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: John Kauffman, Center for Drug
Evaluation and Research (HFD-920), Food and Drug Administration, 645 S.
Newstead Ave., St. Louis, MO 63110,<PHONE_NUMBER>; or Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Elemental Impurities in Drug Products.'' This draft guidance
provides recommendations regarding the control of elemental impurities
of human drug products marketed in the United States consistent with
implementation of ICH Q3D. The draft guidance will also assist
manufacturers of compendial drug products in responding to the issuance
of the USP requirement for the control of elemental impurities.
    USP introduced new limits and analytical procedures for elemental
impurities in General Chapters Elemental Impurities--Limits and
Elemental Impurities--Procedures. Their primary goals are to (1) set
limits for acceptable levels of elemental impurities in finished drug
products, and (2) update the methodology used to test for elemental
impurities in drug products to include modern analytical procedures.
ICH Q3D contains recommendations for manufacturers of human drugs and
biologics on applying a risk-based approach to control elemental
impurities and permitted daily exposure. USP worked closely with ICH to
align its new General Chapters with ICH Q3D.
    Because elemental impurities pose toxicological concerns and do not
provide any therapeutic benefit to the patient, their levels in drug
products should be controlled within acceptable limits. In general, FDA
recommends that the manufacturer of any U.S. marketed drug product
follow ICH Q3D recommendations to establish appropriate procedures for
identifying and controlling elemental impurities in the drug product
based on risk assessment and product-specific considerations, unless
the drug product must comply with USP-NF requirements. This draft
guidance outlines approaches for implementation of USP, and ICH Q3D in
new and existing products.
    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 elemental
impurities in drug products. 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.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314 for submitting
NDAs and ANDAs, including supplemental applications and annual reports,
have been approved under OMB control number 0910-0001. The collections
of information in 21 CFR part 211 and part 212 (CGMPs) have been
approved under OMB control numbers 0910-0139 and 0910-0667.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: June 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15704 Filed 6-30-16; 8:45 am]
 BILLING CODE 4164-01-P