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

###### Food and Drug Administration

          - [Docket No. FDA-2017-D-5928]

# 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).

# DATES:

Submit either electronic or written comments on the draft guidance by December 15, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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                            ( print page 48094)                          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-5928 for “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA; Draft Guidance for Industry; Availability.” 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.                

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 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 draft guidance document.                

# FOR FURTHER INFORMATION CONTACT:

Tamara R. Coley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 75, Rm. 1668, Silver Spring, MD 20903, 240-402-6903.

**SUPPLEMENTARY INFORMATION:**

## I. Background

                        FDA is announcing the availability of a draft guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The Generic Drug User Fee Amendments of 2017 (GDUFA II), reauthorizing generic drug user fees for Fiscal Years 2018-2022, was signed into law on August 18, 2017, to facilitate timely access to quality, affordable generic medicines. In accordance with the GDUFA II Commitment Letter [1]                                                  that accompanied the legislation, FDA agreed to certain review goals and procedures for the review of post-CRL meetings received on or after October 1, 2017.                    

The GDUFA II Commitment Letter adds time frames within which FDA will provide a scheduled date for, and will conduct, post-CRL meetings. Under GDUFA I, FDA committed to close out a certain number of teleconference requests in fiscal year (FY) 2015 through FY 2017. In accordance with the GDUFA II Commitment Letter, FDA committed to schedule and conduct 90 percent of post-CRL meetings within prescribed time frames.

As described in the GDUFA II Commitment Letter, post-CRL meetings will be used by applicants “to seek clarification concerning deficiencies identified in a CRL.” Under GDUFA II, post-CRL meetings are available for both major and minor CRLs and for first and subsequent review cycles. FDA will grant any complete post-CRL meeting request that satisfies the criteria outlined in section IV. FDA will only grant post-CRL meeting requests that pose questions to clarify identified deficiencies. Other issues, including questions requiring further Agency review, disputes about classification of complete response amendments, or new information submitted by the applicant, will not be addressed in a post-CRL meeting.

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 “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” 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.

## II. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 have been approved under OMB control number 0910-0001.

## 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.*

      ( print page 48095)    
Dated: October 3, 2017.

Anna K. Abram,

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

# Footnotes

1.                                 Available at                             *http://www.fda.gov/​downloads/​ForIndustry/​UserFees/​GenericDrugUserFees/​UCM525234.pdf.*
        Back to Citation      

[FR Doc. 2017-22288 Filed 10-13-17; 8:45 am]

 BILLING CODE 4164-01-P