Document ID: FDA-2015-N-1260-0008
Agency: fda
Document Type: Proposed Rule
Title: Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period
Posted Date: 2016-04-18T04:00Z

[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Proposed Rules]
[Page 22549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08888]

[[Page 22549]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 300, 330, and 610

[Docket No. FDA-2015-N-1260]
RIN 0910-AF89

Fixed-Combination and Co-Packaged Drugs: Applications for 
Approval and Combinations of Active Ingredients Under Consideration for 
Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of 
the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the proposed rule, published in the Federal Register 
of December 23, 2015 (80 FR 79776), revising its regulations on 
prescription and nonprescription fixed-combination and co-packaged 
drugs and on combinations of active ingredients under consideration for 
inclusion in an over-the-counter monograph. FDA is reopening the 
comment period to permit time for additional comments.

DATES: Submit either electronic or written comments by May 18, 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 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-2015-N-1260 for ``Fixed-Combination and Co-Packaged Drugs: 
Applications for Approval and Combinations of Active Ingredients Under 
Consideration for Inclusion in an Over-the-Counter Monograph Proposed 
Rule; Reopening of the Comment Period.'' 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: Diana J. Pomeranz, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-
402-4654.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 23, 2015 
(80 FR 79776), FDA published a proposed rule to revise its regulations 
on prescription and nonprescription fixed-combination and co-packaged 
drugs and on combinations of active ingredients under consideration for 
inclusion in an over-the-counter monograph. Interested persons were 
originally given until March 22, 2016, to comment on the proposed rule.
    On March 21, 2016, FDA received a request to allow interested 
persons additional time to comment. The requester asserted that the 
time period of 90 days was insufficient to respond fully to FDA's 
specific requests for comments and to thoroughly evaluate and address 
pertinent issues. Accordingly, we are reopening the comment period.

    Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08888 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P