Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period, 78796-78797 [2013-30881]

Download as PDF 78796 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules 110°18′52″ W.; to lat. 34°30′00″ N., long. 109°35′00″ W.; to lat. 34°00′00″ N., long. 108°53′00″ W.; to lat. 33°52′30″ N., long. 108°45′00″ W.; to lat. 32°29′30″ N., long. 110°45′45″ W.; to lat. 33°33′12″ N., long. 111°51′21″ W.; to lat. 34°01′00″ N., long. 114°00′00″ W.; to lat. 34°40′00″ N., long. 114°00′00″ W.; to lat. 34°52′00″ N., long. 113°42′00″ W.; to lat. 34°55′00″ N., long. 113°37′00″ W.; to lat. 35°15′20″ N., long. 112°55′40″ W.; to lat. 35°23′00″ N., long. 112°40′00″ W.; to lat. 35°23′48″ N., long. 112°09′11″ W.; to lat. 35°24′00″ N., long. 112°00′00″ W.; to lat. 35°46′00″ N., long. 111°50′30″ W.; to lat. 35°42′00″ N., long. 110°14′00″ W., thence to the point of beginning. Issued in Seattle, Washington, on December 11, 2013. Christopher Ramirez, Acting Manager, Operations Support Group, Western Service Center. [FR Doc. 2013–31093 Filed 12–26–13; 8:45 am] BILLING CODE 4910–13–P November 13, 2013, at 78 FR 67985, and on information collection issues under the Paperwork Reduction Act of 1995. Submit either electronic or written comments on the proposed rule by March 13, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 11, 2014 (see the ‘‘Paperwork Reduction Act of 1995’’ section of the proposed rule). ADDRESSES: You may submit comments, identified by Docket No. FDA–2013–N– 0500 and/or Regulatory Information Number (RIN) 0910–AG94, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the ‘‘Paperwork Reduction Act of 1995’’ section of the proposed rule. Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Parts 314 and 601 Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. [Docket No. FDA–2013–N–0500] Written Submissions RIN 0910–AG94 Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2013–N–0500 and RIN 0910–AG94 for this rulemaking. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Request for Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http:// www.regulations.gov and insert the docket number(s), 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: Janice L. Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6304, Food and Drug Administration Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; correction and extension of comment period. ACTION: The Food and Drug Administration (FDA) is correcting, and extending the comment period for, the proposed rule that appeared in the Federal Register of November 13, 2013. In the proposed rule, FDA requested comments on the proposal to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA’s review of the change. The proposed rule published without a reference or a link to the accompanying Regulatory Impact Analysis. The Agency is taking this action to correct this omission and to extend the comment period in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. DATES: FDA is extending the comment period on the proposed rule published tkelley on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 19:07 Dec 26, 2013 Jkt 232001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 13, 2013 (78 FR 67985), FDA published a proposed rule with a 60-day comment period to request comments on the proposal to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA’s review of the change. Comments on the proposal to permit holders of abbreviated new drug applications to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug upon submission of a ‘‘changes being effected’’ supplement will inform FDA’s rulemaking. The proposed rule published without reference or a link to the accompanying Regulatory Impact Analysis. Accordingly, the following corrections are made to FR Doc. 2013–26799, appearing on page 67985, in the Federal Register of November 13, 2013: 1. On page 67996, in the first column, at the end of section IV. Analysis of Impacts, the following is added as a third full paragraph: ‘‘The full discussion of economic impacts is available in docket FDA–2013–N–0500 and at http://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ EconomicAnalyses/default.htm (Ref. 3).’’ 2. On page 67997, in the third column, the following is added as a third reference: ‘‘3. Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, available at http:// www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ EconomicAnalyses/default.htm.’’ The Agency has received requests for a 60-day extension of the comment period for the proposed rule. These requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the requests and is extending the comment period for the proposed rule for 60 days, until March 13, 2014. FDA also is extending the comment period for information collection issues under the Paperwork E:\FR\FM\27DEP1.SGM 27DEP1 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules Reduction Act of 1995 for 60 days, until February 11, 2014. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. II. Request for Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: December 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–30881 Filed 12–26–13; 8:45 am] BILLING CODE 4160–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R08–OAR–2011–0834; FRL–9904–90– Region 8] Approval and Promulgation of Air Quality Implementation Plans; State of Colorado; Second Ten-Year PM10 Maintenance Plan for Pagosa Springs Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to partially approve and partially disapprove State Implementation Plan (SIP) revisions submitted by the State of Colorado. On March 31, 2010, the Governor of Colorado’s designee submitted to EPA a revised maintenance plan for the Pagosa Springs area for the National Ambient Air Quality Standards (NAAQS) for particulate matter with an aerodynamic diameter less than or equal to 10 microns (PM10). The State adopted the revised maintenance plan on November 19, 2009. As required by Clean Air Act (CAA) section 175A(b), this revised maintenance plan addresses maintenance of the PM10 standard for a second 10-year period beyond the area’s original redesignation to attainment for the PM10 NAAQS. EPA is proposing to approve the revised maintenance plan tkelley on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 19:07 Dec 26, 2013 Jkt 232001 with the exception of one aspect of the plan’s contingency measures. EPA’s proposed approval includes the revised maintenance plan’s 2021 transportation conformity motor vehicle emissions budget for PM10. In proposing to approve the revised maintenance plan, we are proposing to exclude from use in determining that Pagosa Springs continues to attain the PM10 NAAQS, exceedances of the PM10 NAAQS that were recorded at the Pagosa Springs PM10 monitor on March 22, 2009, April 3, 2009, April 5, 2010, April 28, 2010, April 29, 2010, May 11, 2010, and May 22, 2010 because the exceedances meet the criteria for exceptional events caused by high wind natural events. This action is being taken under sections 110 and 175A of the CAA. DATES: Written comments must be received on or before January 27, 2014. ADDRESSES: Submit your comments, identified by Docket number EPA–R08– OAR–2011–0834, by one of the following methods: • http://www.regulations.gov. Follow the on-line instructions for submitting comments. • Email: olson.kyle@epa.gov. • Fax: (303) 312–6064 (please alert the individual listed in the FOR FURTHER INFORMATION CONTACT section if you are faxing comments). • Mail: Carl Daly, Director, Air Program, Environmental Protection Agency (EPA), Region 8, Mailcode 8P–AR, 1595 Wynkoop Street, Denver, Colorado 80202–1129. • Hand Delivery: Carl Daly, Director, Air Program, Environmental Protection Agency (EPA), Region 8, Mailcode 8P–AR, 1595 Wynkoop Street, Denver, Colorado 80202–1129. Such deliveries are only accepted Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding Federal holidays. Special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–R08–OAR–2011– 0834. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at http:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http:// www.regulations.gov or email. The http://www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 78797 or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA, without going through http:// www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional instructions on submitting comments, go to Section I. General Information of the SUPPLEMENTARY INFORMATION section of this document. Docket: All documents in the docket are listed in the http:// www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http:// www.regulations.gov or in hard copy at the Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mailcode 8P–AR, 1595 Wynkoop Street, Denver, Colorado 80202–1129. EPA requests that if at all possible, you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding Federal holidays. FOR FURTHER INFORMATION CONTACT: Kyle Olson, Air Program, U.S. Environmental Protection Agency, Region 8, Mailcode 8P–AR, 1595 Wynkoop Street, Denver, Colorado 80202–1129, (303) 312–6002, olson.kyle@epa.gov. SUPPLEMENTARY INFORMATION: Definitions For the purpose of this document, we are giving meaning to certain words or initials as follows: i. The words or initials Act or CAA mean or refer to the Clean Air Act, unless the context indicates otherwise. ii. The initials APCD mean or refer to the Colorado Air Pollution Control Division. iii. The initials AQCC mean or refer to the Colorado Air Quality Control Commission. E:\FR\FM\27DEP1.SGM 27DEP1

Agencies

[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Proposed Rules]
[Pages 78796-78797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. FDA-2013-N-0500]
RIN 0910-AG94


Supplemental Applications Proposing Labeling Changes for Approved 
Drugs and Biological Products; Correction and Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction and extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting, and 
extending the comment period for, the proposed rule that appeared in 
the Federal Register of November 13, 2013. In the proposed rule, FDA 
requested comments on the proposal to revise and clarify procedures for 
application holders of an approved drug or biological product to change 
the product labeling to reflect certain types of newly acquired 
information in advance of FDA's review of the change. The proposed rule 
published without a reference or a link to the accompanying Regulatory 
Impact Analysis. The Agency is taking this action to correct this 
omission and to extend the comment period in response to requests for 
an extension to allow interested persons additional time to submit 
comments on the proposed rule.

DATES: FDA is extending the comment period on the proposed rule 
published November 13, 2013, at 78 FR 67985, and on information 
collection issues under the Paperwork Reduction Act of 1995. Submit 
either electronic or written comments on the proposed rule by March 13, 
2014. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by February 11, 2014 (see the 
``Paperwork Reduction Act of 1995'' section of the proposed rule).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0500 and/or Regulatory Information Number (RIN) 0910-AG94, by any of 
the following methods, except that comments on information collection 
issues under the Paperwork Reduction Act of 1995 must be submitted to 
the Office of Information and Regulatory Affairs, Office of Management 
and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section 
of the proposed rule.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-0500 and RIN 0910-AG94 for this rulemaking. 
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For 
additional information on submitting comments, see the ``Request for 
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), 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: Janice L. Weiner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 13, 2013 (78 FR 67985), FDA 
published a proposed rule with a 60-day comment period to request 
comments on the proposal to revise and clarify procedures for 
application holders of an approved drug or biological product to change 
the product labeling to reflect certain types of newly acquired 
information in advance of FDA's review of the change. Comments on the 
proposal to permit holders of abbreviated new drug applications to 
distribute revised product labeling that differs in certain respects, 
on a temporary basis, from the labeling of its reference listed drug 
upon submission of a ``changes being effected'' supplement will inform 
FDA's rulemaking.
    The proposed rule published without reference or a link to the 
accompanying Regulatory Impact Analysis. Accordingly, the following 
corrections are made to FR Doc. 2013-26799, appearing on page 67985, in 
the Federal Register of November 13, 2013:
    1. On page 67996, in the first column, at the end of section IV. 
Analysis of Impacts, the following is added as a third full paragraph: 
``The full discussion of economic impacts is available in docket FDA-
2013-N-0500 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 3).''
    2. On page 67997, in the third column, the following is added as a 
third reference: ``3. Preliminary Regulatory Impact Analysis, Initial 
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act 
Analysis for Supplemental Applications Proposing Labeling Changes for 
Approved Drugs and Biological Products, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.''
    The Agency has received requests for a 60-day extension of the 
comment period for the proposed rule. These requests conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 60 days, until March 13, 2014. FDA also is 
extending the comment period for information collection issues under 
the Paperwork

[[Page 78797]]

Reduction Act of 1995 for 60 days, until February 11, 2014. The Agency 
believes that a 60-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30881 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P