Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products; Extension of Comment Period, 12364-12365 [2015-05336]

Download as PDF 12364 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Proposed Rules by the Manager, International Branch, ANM– 116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus’s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature. (i) No Alternative Actions or Intervals After accomplishing the revision required by paragraph (g) of this AD, no alternative actions (e.g., inspections) or intervals may be used unless the actions or intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (j)(1) of this AD. tkelley on DSK3SPTVN1PROD with PROPOSALS MZ4339390–02X, MZ4306000–02X, MZ4339390–10X, or MZ4306000–10X as ‘‘March 5, 2010,’’ the calendar compliance time is April 14, 2011 (18 months after October 14, 2009 (the effective date of AD 2009–18–20, Amendment 39–16017 (74 FR 46313, September 9, 2009))). (6) Where Note (6) of ‘‘ATA 27–64– 00 Flight Control—Spoiler Hydraulic Actuation,’’ of Sub-part 4–2–1, ‘‘Life Limits,’’ of Sub-part 4–2, ‘‘Systems Life Limited Components,’’ of Airbus A330 ALS Part 4— Aging Systems Maintenance, Revision 04, dated August 27, 2013, defines a calendar date of ‘‘September 5, 2008,’’ as a date for the determination of accumulated flight cycles since the aircraft initial entry into service, the date is October 14, 2009 (the effective date of AD 2009–18–20, Amendment 39–16017 (74 FR 46313, September 9, 2009)). (7) Where Note (6) of ‘‘ATA 27–64–00 Flight Control—Spoiler Hydraulic Actuation,’’ of Sub-part 4–2–1, ‘‘Life Limits,’’ of Sub-part 4–2, ‘‘Systems Life Limited Components,’’ of Airbus A330 ALS Part 4— Aging Systems Maintenance, Revision 04, dated August 27, 2013, defines a calendar compliance time as ‘‘March 5, 2010,’’ for the modification of affected servo controls, the calendar compliance time is April 14, 2011 (18 months after October 14, 2009 (the effective date of AD 2009–18–20, Amendment 39–16017 (74 FR 46313, September 9, 2009))). [FR Doc. 2015–05031 Filed 3–6–15; 8:45 am] 15 CFR Part 702 AGENCY: (j) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1138; fax 425–227–1149. Information may be emailed to: 9-ANM-116ACO-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved [RIN 0694–AG17] HHS. VerDate Sep<11>2014 17:26 Mar 06, 2015 Jkt 235001 (k) Related Information (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency (EASA) AD 2013– 0268, dated November 7, 2013, for related information. You may examine the MCAI in the AD docket on the Internet at https:// www.regulations.gov/ #!documentDetail;D=FAA-2013-0834-0003. (2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email airworthiness.A330–A340@airbus.com; Internet https://www.airbus.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. Issued in Renton, Washington, on February 20, 2015. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. Comments may be submitted: • Via the Federal eRulemaking Portal: https://www.regulations.gov. Search for this rule using its regulations.gov docket number: BIS–2015–0010. • By email directly to publiccomments@bis.doc.gov. Include ‘‘RIN 0694–AG17’’ in the subject line. • By mail or delivery to Regulatory Policy Division, Bureau of Industry and Security, U.S. Department of Commerce, Room 2099B, 14th Street and Pennsylvania Avenue NW., Washington, DC 20230. Refer to ‘‘RIN 0694–AG17.’’ ADDRESSES: Dated: March 3, 2015. Matthew S. Borman, Deputy Assistant Secretary for Export Administration. [FR Doc. 2015–05324 Filed 3–6–15; 8:45 am] BILLING CODE 3510–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 606, and 610 [Docket No. FDA–2007–N–0363] BILLING CODE 4910–13–P RIN 0910–AG18 DEPARTMENT OF COMMERCE Bureau of Industry and Security U.S. Industrial Base Surveys Pursuant to the Defense Production Act of 1950; Correction Bureau of Industry and Security, Commerce. ACTION: Proposed rule; correction. AGENCY: This rule corrects the preamble to a proposed rule published in the Federal Register of March 3, 2015, regarding U.S. Industrial Base Surveys by adding the inadvertently omitted ADDRESSES Caption. DATES: March 9, 2015. FOR FURTHER INFORMATION CONTACT: William Arvin, Bureau of Industry and Security Regulatory Policy Division, 202–482–2440 or william.arvin@ bis.doc.gov. SUMMARY: Correction In proposed rule FR Doc. 2015–04299, on page 11350 in the issue of March 3, 2015, in the first column, immediately following the DATES section, add the following: PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products; Extension of Comment Period Food and Drug Administration, Proposed rule; extension of comment period. ACTION: The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of December 18, 2014. In the proposed rule, FDA requested comments on its proposal to amend its labeling regulations for human prescription drugs and biological products to require that the prescribing information intended for health care professionals that is on or within the package from which the product is dispensed be distributed electronically and not in paper form, except as provided by the proposed rule. 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 proposed rule published on December 18, 2014 (79 FR 75506). Submit either electronic or written comments by May 18, 2015. SUMMARY: E:\FR\FM\09MRP1.SGM 09MRP1 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Proposed Rules You may submit comments to the proposed rule by any of the following methods: ADDRESSES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// 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 Docket No. FDA– 2007–N–0363 for this rulemaking. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Emily Gebbia, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993, 240–402– 0980. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with PROPOSALS I. Background In the Federal Register of December 18, 2014, FDA published a proposed rule to amend its labeling regulations for human prescription drugs and biological products to require that the prescribing information intended for health care professionals that is on or within the package from which the product is dispensed be distributed electronically and not in paper form, except as provided by the proposed rule. The proposed rule is intended to facilitate the distribution of updated prescribing information as new information becomes available and as changes in prescribing information are made. FDA is proposing the change to help ensure that the most current VerDate Sep<11>2014 17:26 Mar 06, 2015 Jkt 235001 prescribing information will be available and readily accessible to health care professionals at the time of clinical decision making and dispensing. FDA provided a 90-day comment period (i.e., until March 18, 2015) for the proposed rule. The Agency has received a request for a 60-day extension of the comment period for the proposed rule. The request conveyed concern that the current 90-day comment period does not allow sufficient time for entities and individuals who will be most affected by a final rule to examine and to comment upon the proposed rule. The request suggested that FDA would benefit by granting stakeholders sufficient time to develop their comments and to address as many relevant issues as possible. FDA has considered the request and is extending the comment period for the proposed rule for 60 days, until May 18, 2015. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on this important issue. II. Request for Comments Interested persons may submit either electronic comments regarding the proposed rule to https:// 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 https:// www.regulations.gov. Dated: March 3, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–05336 Filed 3–6–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2015–0071] RIN 1625–AA08 Safety Zone; 24 Mile Tampa Bay Marathon Swim, Tampa Bay, Tampa, FL AGENCY: PO 00000 Coast Guard, DHS. Frm 00014 Fmt 4702 Sfmt 4702 ACTION: 12365 Notice of proposed rulemaking. The Coast Guard is proposing to establish a temporary moving safety zone on the waters of the Tampa Bay in Tampa, Florida during the 24 Mile Tampa Bay Marathon Swim. The swim is scheduled to take place from 4 a.m. to 9 p.m. on April 25, 2015. Approximately 30 swimmers are anticipated to participate in the marathon swim event. No spectators are expected to be present during the event. The safety zone is necessary to provide for the safety of the participants, participant vessels, and the general public on the navigable waters of the United States during the event. The safety zone will establish a moving protective area around all swimmers involved in the race. Persons and vessels, except those participating in the event, will be prohibited from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port St. Petersburg or a designated representative. SUMMARY: Requests for public meetings, comments or related material must be received by the Coast Guard on or before March 16, 2015. ADDRESSES: You may submit comments identified by docket number using any one of the following methods: (1) Federal eRulemaking Portal: https://www.regulations.gov. (2) Fax: (202) 493–2251. (3) Mail or Delivery: Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590–0001. Deliveries accepted between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. The telephone number is (202) 366–9329. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section below for further instructions on submitting comments. To avoid duplication, please use only one of these three methods. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Tyrone J. Stafford, Sector St. Petersburg Prevention Department, Coast Guard; telephone (813) 228–2191, email D07-SMB-TampaWWM@uscg.mil. If you have questions on viewing or submitting material to the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: DATES: E:\FR\FM\09MRP1.SGM 09MRP1

Agencies

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Proposed Rules]
[Pages 12364-12365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 606, and 610

[Docket No. FDA-2007-N-0363]
RIN 0910-AG18


Electronic Distribution of Prescribing Information for Human 
Prescription Drugs, Including Biological Products; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the proposed rule that appeared in the Federal 
Register of December 18, 2014. In the proposed rule, FDA requested 
comments on its proposal to amend its labeling regulations for human 
prescription drugs and biological products to require that the 
prescribing information intended for health care professionals that is 
on or within the package from which the product is dispensed be 
distributed electronically and not in paper form, except as provided by 
the proposed rule. 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 proposed rule 
published on December 18, 2014 (79 FR 75506). Submit either electronic 
or written comments by May 18, 2015.

[[Page 12365]]


ADDRESSES: You may submit comments to the proposed rule by any of the 
following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://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 Docket No. 
FDA-2007-N-0363 for this rulemaking. All comments received may be 
posted without change to https://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``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 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 Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Emily Gebbia, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993, 240-402-
0980.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 18, 2014, FDA published a 
proposed rule to amend its labeling regulations for human prescription 
drugs and biological products to require that the prescribing 
information intended for health care professionals that is on or within 
the package from which the product is dispensed be distributed 
electronically and not in paper form, except as provided by the 
proposed rule. The proposed rule is intended to facilitate the 
distribution of updated prescribing information as new information 
becomes available and as changes in prescribing information are made. 
FDA is proposing the change to help ensure that the most current 
prescribing information will be available and readily accessible to 
health care professionals at the time of clinical decision making and 
dispensing. FDA provided a 90-day comment period (i.e., until March 18, 
2015) for the proposed rule.
    The Agency has received a request for a 60-day extension of the 
comment period for the proposed rule. The request conveyed concern that 
the current 90-day comment period does not allow sufficient time for 
entities and individuals who will be most affected by a final rule to 
examine and to comment upon the proposed rule. The request suggested 
that FDA would benefit by granting stakeholders sufficient time to 
develop their comments and to address as many relevant issues as 
possible.
    FDA has considered the request and is extending the comment period 
for the proposed rule for 60 days, until May 18, 2015. The Agency 
believes that a 60-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
this important issue.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
the proposed rule to https://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 https://www.regulations.gov.

    Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05336 Filed 3-6-15; 8:45 am]
BILLING CODE 4164-01-P
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