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Notice

Acceptability of Draft Labeling To Support Abbreviated New Drug Application Approval; Guidance for Industry; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Acceptability of Draft Labeling to Support ANDA Approval.”Start Printed Page 60388

This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs). It explains FDA's interpretation of the regulatory provision related to submission of copies of applicants' proposed labeling and clarifies that FDA's Office of Generic Drugs (OGD) will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

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-2015-D-3378 for “Acceptability of Draft Labeling to Support ANDA Approval, Guidance for Industry.” 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 this 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 guidance document.

Submit electronic comments on the guidance 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.

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FOR FURTHER INFORMATION CONTACT:

Tamara Coley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6903.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Acceptability of Draft Labeling to Support ANDA Approval.” This guidance is being issued consistent with FDA's Good Guidance Practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). The Agency made this determination because the guidance presents a less burdensome policy consistent with the public health. Although this guidance document is immediately in effect, it remains subject to comment in accordance with the Agency's GGP regulation.

This guidance provides recommendations and information related to the submission of copies of proposed labeling with ANDAs under section 505(j)(2)(A)(v) (21 U.S.C. 355(j)(2)(A)(v)) of the Federal Food, Drug, and Cosmetic Act and FDA's implementing regulations (21 CFR 314.94(a)(8)). This guidance clarifies that OGD will accept and approve ANDAs based on draft labeling.

In the past, OGD generally asked applicants to submit copies of FPL as opposed to draft labeling before receiving ANDA approval. OGD generally requested FPL before approving ANDAs because this version of the labeling reflected an accurate presentation of both the content and the formatting of the labeling.

As ANDA labeling submissions have evolved over time, particularly with respect to the submission of electronic versions of labeling, OGD has found that draft versions of labeling can enable an appropriate labeling review before FPL is produced.

Given changes in submission practices and the applicable regulations over time, OGD is clarifying that it will approve ANDAs on the basis of draft Start Printed Page 60389labeling, provided that OGD is able to make a determination that the draft labeling complies with applicable requirements (other than editorial or similar minor deficiencies).

The guidance represents the Agency's current thinking on the acceptability of draft labeling to support ANDA approval. 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. Electronic Access

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

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Dated: September 30, 2015.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2015-25351 Filed 10-5-15; 8:45 am]

BILLING CODE 4164-01-P