Document ID: FDA-2017-N-3615-0053
Agency: fda
Document Type: Notice
Title: Administering the Hatch-Waxman Amendments: Ensuring a Balance
Between Innovation and Access; Public Meeting; Request for Comments; Extension of Comment Period
Posted Date: 2017-09-19T04:00Z

[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43767-43768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19904]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Administering the Hatch-Waxman Amendments: Ensuring a Balance 
Between Innovation and Access; Public Meeting; Request for Comments; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

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

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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

[[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