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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2018-D-0943]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability; reopening of the comment period.

# SUMMARY:

                        The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice of availability that published in the                         **Federal Register**                         on March 27, 2018. In that document, FDA requested comments on the draft guidance for industry (GFI) #255 entitled “Elemental Impurities in Animal Drug Products—Questions and Answers.” The Agency is taking this action in response to requests for an extension to allow interested parties additional time to develop and submit comments.                    

# DATES:

FDA is reopening the comment period on the notice of availability published March 27, 2018 (83 FR 13134). Submit either electronic or written comments on the draft guidance by October 15, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2018-D-0943 for “Elemental Impurities in Animal Drug Products—Questions and Answers.” 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       ( print page 40525)                          “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 Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 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:

                        Michael Brent, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0647,                         *michael.brent@fda.hhs.gov.*

# SUPPLEMENTARY INFORMATION:

## I. Background

                    In the                     **Federal Register**                     of March 27, 2018, FDA published a notice of availability with a 60-day comment period to request comments on draft GFI #255 entitled “Elemental Impurities in Animal Drug Products—Questions and Answers.”                

This level 1 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 Animal Drug Products—Questions and Answers”, providing recommendations to sponsors regarding the control of elemental impurities in animal drug products, including all dosage forms and routes of administration. 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 guidance is not subject to Executive Order 12866.

The Agency received two requests for an extension of the comment period for the draft guidance. The requestors indicated they needed more time to complete development of comments to submit in response to the draft guidance.

FDA has considered the requests and is reopening the comment period for the draft guidance for 60 days, until October 15, 2018. The Agency believes that a 60-day reopening of the comment period allows adequate time for interested persons to submit comments to ensure that the Agency can consider the comments on this draft guidance before it begins work on the final version of the guidance.

## II. Electronic Access

                    Persons with access to the internet may obtain the draft guidance at either                     *https://www.fda.gov/​AnimalVeterinary/​GuidanceComplianceEnforcement/​GuidanceforIndustry/​default.htm*                     or                     *https://www.regulations.gov.*

Dated: August 9, 2018.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2018-17525 Filed 8-14-18; 8:45 am]

 BILLING CODE 4164-01-P