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Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications

A Notice by the Food and Drug Administration on 05/11/2016

Published Document: 2016-11114 (81 FR 29273)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2013-N-0450]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of abbreviated new animal drug applications.

DATES:

Submit either electronic or written comments on the collection of information by July 11, 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 ( printed page 29274) 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-2013-N-0450] for “Abbreviated New Animal Drug Applications.” 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.

FOR FURTHER INFORMATION CONTACT:

FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, .

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Abbreviated New Animal Drug Applications—Sections 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1)) (OMB Control Number 0910-0669))—Extension

Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), any person may file an abbreviated new animal drug application (ANADA) seeking approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an ANADA is described in section 512(n)(1) of the FD&C Act. Among other things, an ANADA is required to contain information to show that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved new animal drug. We use the information submitted, among other things, to assess bioequivalence to the originally approved drug and thus, the safety and effectiveness of the generic new animal drug. We allow applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review. Applicants may submit Form FDA 356v with a complete ANADA or a phased review submission to ensure efficient and accurate processing of information.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden 1
FD&C Act sections 512 (b)(2) and (n)(1) FDA Form Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours
ANADA 356v 18 1 18 159 2,862
( printed page 29275)
Phased Review with Administrative ANADA 356v 3 5 15 31.8 477
Total 3,339
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimates on our experience with ANADA submissions and requests for phased review. We estimate that we will receive 21 ANADA submissions per year over the next three years and that three of those submissions will request phased review. We estimate that each applicant that uses the phased review process will have approximately five phased reviews per application. We estimate that an applicant will take approximately 159 hours to prepare either an ANADA or the estimated 5 ANADA phased review submissions and the administrative ANADA.

Dated: May 5, 2016.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2016-11114 Filed 5-10-16; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2016-11114 (81 FR 29273)