22549 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Proposed Rules 
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. 
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 
DEPARTMENT OF THE TREASURY 
Internal Revenue Service 
26 CFR Part 1 
[REG–109822–15] 
RIN 1545–BM70 
Country-by-Country Reporting; 
Hearing 
AGENCY : Internal Revenue Service (IRS), 
Treasury. 
ACTION : Notice of a public hearing on 
notice of proposed rulemaking. 
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