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

###### Food and Drug Administration

          - [Docket No. FDA-2017-N-3615]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public meeting; request for comments; extension of comment period.

# SUMMARY:

                        The Food and Drug Administration (FDA or the Agency) is extending the comment period for the public meeting on “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access” for which the notice of public meeting appeared in the                         **Federal Register**                         of June 22, 2017. In the notice of public meeting, FDA requested comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to help ensure that the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.                    

# DATES:

FDA is extending the comment period on the notice of public meeting published June 22, 2017 (82 FR 28493). Submit either electronic or written comments by November 17, 2017.

# ADDRESSES:

                        You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 17, 2017. The                         *https://www.regulations.gov*                         electronic filing system will accept comments until midnight Eastern Time at the end of November 17, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.                    

### 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       ( print page 43768)                          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-N-3615 for “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting; Request for Comments.” Received comments, those filed in a timely manner (see                     **ADDRESSES**                    ), 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.                

# FOR FURTHER INFORMATION CONTACT:

                        Philip Bonforte, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993, 240-402-6980, email:                         *GenericDrugPolicy@fda.hhs.gov.*

# SUPPLEMENTARY INFORMATION:

                    In the                     **Federal Register**                     of June 22, 2017, FDA published a notice of public meeting with a 60-day comment period to request comments on the appropriate balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs. Interested persons were originally given until September 18, 2017, to comment.                

Following publication of the June 22, 2017, notice of public meeting with request for comments, FDA received requests to allow interested persons additional time to comment. The requesters asserted that the time period of 60 days was insufficient to respond fully to FDA's specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues.

FDA has considered the requests and is extending the comment period for the notice of public meeting until November 17, 2017.

Dated: September 14, 2017.

Anna K. Abram,

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

[FR Doc. 2017-19904 Filed 9-18-17; 8:45 am]

 BILLING CODE 4164-01-P