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Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions; Draft Guidance for Industry; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” The Pre-Submission Facility Correspondence (PFC) process was identified as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018-2022 (GDUFA II). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned abbreviated new drug application (ANDA) submission. This draft guidance describes PFC content and format, as well as the Agency's approach to assessing this information.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 18, 2017. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by September 18, 2017.

ADDRESSES:

You may submit comments 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-2017-D-3101 for “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” 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.

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 Start Printed Page 28073INFORMATION section for electronic access to the draft guidance document.

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FOR FURTHER INFORMATION CONTACT:

Nikhil Thakur, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4164, Silver Spring, MD 20993, 301-796-5536.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” As one of the enhancements specified in the GDUFA II commitment letter, the PFC is a mechanism to achieve expedited review of priority ANDAs, prior approval supplements (PASs), and their amendments (collectively ANDAs). Under the performance goals and program enhancements for GDUFA II, FDA agreed to a shorter goal date for action on a priority generic drug submission if:

  • A complete and accurate PFC is submitted to FDA 2 months ahead of the planned ANDA submission, and
  • facility information remains unchanged in the ANDA.

A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission. This critical 2-month lead time provides the Agency the opportunity to determine whether facility inspections will be needed, and, when they are, to initiate inspection planning earlier in the review of the ANDA, enabling FDA to meet the shorter review timeframe.

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 “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” 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. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), 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 before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing the proposed collection of information set forth in this notice of availability that would result from the submission of PFCs.

With respect to the following collection of information, FDA invites comment 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 on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Draft Guidance for Industry on ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.

Description: As described in the draft guidance, the GDUFA II commitments included an agreement to establish a mechanism to facilitate a shortened GDUFA goal date for ANDAs, PASs, and their amendments that have been designated as a “Priority” by FDA. For planned ANDAs that successfully meet FDA's priority review criteria, applicants may submit a PFC as a mechanism to facilitate evaluation of facilities associated with a planned ANDA.

Section IV of the draft guidance describes the information that should be submitted in the PFC to enable FDA's facility assessment:

A. General information, including the planned ANDA pre-assigned number (which the applicant must request from FDA before submitting the PFC), PFC submission date, and the applicant's identifying information;

B. statement of ANDA eligibility for priority review;

C. manufacturing process and testing facility information; and

D. bioequivalence summary and site/organization information.

The Appendix of the draft guidance describes the format that should be used to submit the PFC, including a standardized format for administrative information related to manufacturing process and testing sites, and summary tables for bioequivalence sites and organizations and for bioavailability studies.

The PFC should be submitted in the PDF file format through the FDA electronic submissions gateway, and, as explained in the draft guidance, should be submitted 2 or 3 months ahead of the planned ANDA submission.

We estimate that a total of approximately 125 applicants “number of respondents” in table 1) will submit annually approximately 275 PFCs as described in the draft guidance (“total annual responses” in table 1). We estimate that preparing and submitting each PFC as described in the draft guidance will take approximately 32 hours “hours per response” in table 1). We base our estimates for the number of applicants and the number of PFCs on information from our database of annual ANDA submissions, and on the criteria set forth in the FDA Center for Drug Evaluation's Manual of Policies and Procedures 5240.3 and the number of “priority” submissions. Our estimate of the time applicants would need to prepare and submit each PFC takes into consideration that much of the PFC includes information already gathered for the ANDA submission. Thus, the burden estimate for the submission of the PFC does not double-count the burden of gathering information that is accounted for under OMB control number 0910-0001, under which OMB has approved the submission of ANDAs and related amendments, supplements, and other information required under Subpart C of Part 314 in Title 21 of the CFR.

We invite comments on these estimates.Start Printed Page 28074

Table 1—Estimated Annual Reporting Burden 1

No. of respondentsNo. of responses per respondentTotal annual responsesHours per responseTotal hours
PFC1252.20275328,800
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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.

Start Signature

Dated: June 15, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

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[FR Doc. 2017-12836 Filed 6-19-17; 8:45 am]

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