80 FR 12364 - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 45 (March 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 45 (March 9, 2015)
| Page Range | 12364-12365 | |
| FR Document | 2015-05336 |
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)] [Proposed Rules] [Pages 12364-12365] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05336] ======================================================================= ----------------------------------------------------------------------- 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: 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 Docket No. FDA-2007-N-0363 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 ``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, 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 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: 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
![12364 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Proposed Rules
MZ4339390–02X, MZ4306000–02X, by the Manager, International Branch, ANM– ADDRESSES: Comments may be
MZ4339390–10X, or MZ4306000–10X as 116, Transport Airplane Directorate, FAA; or submitted:
‘‘March 5, 2010,’’ the calendar compliance the European Aviation Safety Agency • Via the Federal eRulemaking Portal:
time is April 14, 2011 (18 months after (EASA); or Airbus’s EASA Design
Organization Approval (DOA). If approved by
http://www.regulations.gov. Search for
October 14, 2009 (the effective date of AD
2009–18–20, Amendment 39–16017 (74 FR the DOA, the approval must include the this rule using its regulations.gov docket
46313, September 9, 2009))). DOA-authorized signature. number: BIS–2015–0010.
(6) Where Note (6) of ‘‘ATA 27–64– • By email directly to
(k) Related Information
00 Flight Control—Spoiler Hydraulic publiccomments@bis.doc.gov. Include
Actuation,’’ of Sub-part 4–2–1, ‘‘Life Limits,’’ (1) Refer to Mandatory Continuing ‘‘RIN 0694–AG17’’ in the subject line.
of Sub-part 4–2, ‘‘Systems Life Limited Airworthiness Information (MCAI) European • By mail or delivery to Regulatory
Components,’’ of Airbus A330 ALS Part 4— Aviation Safety Agency (EASA) AD 2013–
0268, dated November 7, 2013, for related Policy Division, Bureau of Industry and
Aging Systems Maintenance, Revision 04, Security, U.S. Department of Commerce,
dated August 27, 2013, defines a calendar information. You may examine the MCAI in
the AD docket on the Internet at http:// Room 2099B, 14th Street and
date of ‘‘September 5, 2008,’’ as a date for the
determination of accumulated flight cycles www.regulations.gov/ Pennsylvania Avenue NW., Washington,
since the aircraft initial entry into service, the #!documentDetail;D=FAA-2013-0834-0003. DC 20230. Refer to ‘‘RIN 0694–AG17.’’
(2) For service information identified in
date is October 14, 2009 (the effective date Dated: March 3, 2015.
this AD, contact Airbus SAS, Airworthiness
of AD 2009–18–20, Amendment 39–16017 Matthew S. Borman,
Office—EAL, 1 Rond Point Maurice Bellonte,
(74 FR 46313, September 9, 2009)).
31707 Blagnac Cedex, France; telephone +33 Deputy Assistant Secretary for Export
(7) Where Note (6) of ‘‘ATA 27–64–00
5 61 93 36 96; fax +33 5 61 93 45 80; email Administration.
Flight Control—Spoiler Hydraulic airworthiness.A330–A340@airbus.com;
Actuation,’’ of Sub-part 4–2–1, ‘‘Life Limits,’’ [FR Doc. 2015–05324 Filed 3–6–15; 8:45 am]
Internet http://www.airbus.com. You may
of Sub-part 4–2, ‘‘Systems Life Limited view this service information at the FAA, BILLING CODE 3510–33–P
Components,’’ of Airbus A330 ALS Part 4— Transport Airplane Directorate, 1601 Lind
Aging Systems Maintenance, Revision 04, Avenue SW., Renton, WA. For information
dated August 27, 2013, defines a calendar on the availability of this material at the
compliance time as ‘‘March 5, 2010,’’ for the FAA, call 425–227–1221. DEPARTMENT OF HEALTH AND
modification of affected servo controls, the HUMAN SERVICES
calendar compliance time is April 14, 2011 Issued in Renton, Washington, on February
(18 months after October 14, 2009 (the 20, 2015. Food and Drug Administration
effective date of AD 2009–18–20, Victor Wicklund,
Amendment 39–16017 (74 FR 46313, Acting Manager, Transport Airplane 21 CFR Parts 201, 606, and 610
September 9, 2009))). Directorate, Aircraft Certification Service.
(i) No Alternative Actions or Intervals [FR Doc. 2015–05031 Filed 3–6–15; 8:45 am] [Docket No. FDA–2007–N–0363]
BILLING CODE 4910–13–P
After accomplishing the revision required
RIN 0910–AG18
by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be
Electronic Distribution of Prescribing
used unless the actions or intervals are DEPARTMENT OF COMMERCE
approved as an alternative method of Information for Human Prescription
compliance (AMOC) in accordance with the Bureau of Industry and Security Drugs, Including Biological Products;
procedures specified in paragraph (j)(1) of Extension of Comment Period
this AD. 15 CFR Part 702 AGENCY: Food and Drug Administration,
(j) Other FAA AD Provisions [RIN 0694–AG17] HHS.
The following provisions also apply to this Proposed rule; extension of
ACTION:
AD: U.S. Industrial Base Surveys Pursuant comment period.
(1) Alternative Methods of Compliance to the Defense Production Act of 1950;
(AMOCs): The Manager, International Correction SUMMARY: The Food and Drug
Branch, ANM–116, Transport Airplane Administration (FDA) is extending the
Directorate, FAA, has the authority to AGENCY: Bureau of Industry and
Security, Commerce. comment period for the proposed rule
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
that appeared in the Federal Register of
ACTION: Proposed rule; correction.
In accordance with 14 CFR 39.19, send your December 18, 2014. In the proposed
request to your principal inspector or local SUMMARY: This rule corrects the rule, FDA requested comments on its
Flight Standards District Office, as preamble to a proposed rule published proposal to amend its labeling
appropriate. If sending information directly in the Federal Register of March 3, regulations for human prescription
to the International Branch, send it to ATTN: 2015, regarding U.S. Industrial Base drugs and biological products to require
Vladimir Ulyanov, Aerospace Engineer, Surveys by adding the inadvertently that the prescribing information
International Branch, ANM–116, Transport intended for health care professionals
Airplane Directorate, FAA, 1601 Lind
omitted ADDRESSES Caption.
DATES: March 9, 2015. that is on or within the package from
Avenue SW., Renton, WA 98057–3356;
telephone 425–227–1138; fax 425–227–1149. FOR FURTHER INFORMATION CONTACT:
which the product is dispensed be
Information may be emailed to: 9-ANM-116- William Arvin, Bureau of Industry and distributed electronically and not in
ACO-AMOC-REQUESTS@faa.gov. Before Security Regulatory Policy Division, paper form, except as provided by the
using any approved AMOC, notify your 202–482–2440 or william.arvin@ proposed rule. The Agency is taking this
appropriate principal inspector, or lacking a action in response to a request for an
tkelley on DSK3SPTVN1PROD with PROPOSALS
bis.doc.gov.
principal inspector, the manager of the local extension to allow interested persons
flight standards district office/certificate Correction additional time to submit comments.
holding district office. The AMOC approval
letter must specifically reference this AD.
In proposed rule FR Doc. 2015–04299, DATES: FDA is extending the comment
(2) Contacting the Manufacturer: For any on page 11350 in the issue of March 3, period on the proposed rule published
requirement in this AD to obtain corrective 2015, in the first column, immediately on December 18, 2014 (79 FR 75506).
actions from a manufacturer, the action must following the DATES section, add the Submit either electronic or written
be accomplished using a method approved following: comments by May 18, 2015.
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![Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Proposed Rules 12365
ADDRESSES: You may submit comments prescribing information will be ACTION: Notice of proposed rulemaking.
to the proposed rule by any of the available and readily accessible to
following methods: health care professionals at the time of SUMMARY: The Coast Guard is proposing
clinical decision making and to establish a temporary moving safety
Electronic Submissions zone on the waters of the Tampa Bay in
dispensing. FDA provided a 90-day
Submit electronic comments in the comment period (i.e., until March 18, Tampa, Florida during the 24 Mile
following way: 2015) for the proposed rule. Tampa Bay Marathon Swim. The swim
• Federal eRulemaking Portal: http:// The Agency has received a request for is scheduled to take place from 4 a.m.
www.regulations.gov. Follow the a 60-day extension of the comment to 9 p.m. on April 25, 2015.
instructions for submitting comments. period for the proposed rule. The Approximately 30 swimmers are
request conveyed concern that the anticipated to participate in the
Written Submissions marathon swim event. No spectators are
current 90-day comment period does
Submit written submissions in the not allow sufficient time for entities and expected to be present during the event.
following ways: individuals who will be most affected The safety zone is necessary to provide
• Mail/Hand delivery/Courier (for by a final rule to examine and to for the safety of the participants,
paper submissions): Division of Dockets comment upon the proposed rule. The participant vessels, and the general
Management (HFA–305), Food and Drug request suggested that FDA would public on the navigable waters of the
Administration, 5630 Fishers Lane, Rm. benefit by granting stakeholders United States during the event. The
1061, Rockville, MD 20852. sufficient time to develop their safety zone will establish a moving
Instructions: All submissions received comments and to address as many protective area around all swimmers
must include the Docket No. FDA– relevant issues as possible. involved in the race. Persons and
2007–N–0363 for this rulemaking. All FDA has considered the request and vessels, except those participating in the
comments received may be posted is extending the comment period for the event, will be prohibited from entering,
without change to http:// proposed rule for 60 days, until May 18, transiting through, anchoring in, or
www.regulations.gov, including any 2015. The Agency believes that a 60-day remaining within the regulated area
personal information provided. For extension allows adequate time for unless authorized by the Captain of the
additional information on submitting interested persons to submit comments Port St. Petersburg or a designated
comments, see the ‘‘Comments’’ heading without significantly delaying representative.
of the SUPPLEMENTARY INFORMATION rulemaking on this important issue. DATES: Requests for public meetings,
section of this document.
II. Request for Comments comments or related material must be
Docket: For access to the docket to
received by the Coast Guard on or before
read background documents or Interested persons may submit either March 16, 2015.
comments received, go to http:// electronic comments regarding the
www.regulations.gov and insert the ADDRESSES: You may submit comments
proposed rule to http://
docket number, found in brackets in the www.regulations.gov or written identified by docket number using any
heading of this document, into the comments to the Division of Dockets one of the following methods:
‘‘Search’’ box and follow the prompts Management (see ADDRESSES). It is only (1) Federal eRulemaking Portal:
and/or go to the Division of Dockets necessary to send one set of comments. http://www.regulations.gov.
Management, 5630 Fishers Lane, Rm. Identify comments with the docket (2) Fax: (202) 493–2251.
1061, Rockville, MD 20852. number found in brackets in the (3) Mail or Delivery: Docket
FOR FURTHER INFORMATION CONTACT: heading of this document. Received Management Facility (M–30), U.S.
Emily Gebbia, Center for Drug comments may be seen in the Division Department of Transportation, West
Evaluation and Research, Food and of Dockets Management between 9 a.m. Building Ground Floor, Room W12–140,
Drug Administration, 10903 New and 4 p.m., Monday through Friday, and 1200 New Jersey Avenue SE.,
Hampshire Ave., Bldg. 51, Rm. 6226, will be posted to the docket at http:// Washington, DC 20590–0001. Deliveries
Silver Spring, MD 20993, 240–402– www.regulations.gov. accepted between 9 a.m. and 5 p.m.,
0980. Monday through Friday, except federal
Dated: March 3, 2015.
holidays. The telephone number is (202)
SUPPLEMENTARY INFORMATION: Leslie Kux, 366–9329.
Associate Commissioner for Policy. See the ‘‘Public Participation and
I. Background
[FR Doc. 2015–05336 Filed 3–6–15; 8:45 am] Request for Comments’’ portion of the
In the Federal Register of December BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION section
18, 2014, FDA published a proposed
below for further instructions on
rule to amend its labeling regulations for
submitting comments. To avoid
human prescription drugs and
DEPARTMENT OF HOMELAND duplication, please use only one of
biological products to require that the
SECURITY these three methods.
prescribing information intended for
health care professionals that is on or FOR FURTHER INFORMATION CONTACT: If
Coast Guard you have questions on this rule, call or
within the package from which the
product is dispensed be distributed email Tyrone J. Stafford, Sector St.
33 CFR Part 165 Petersburg Prevention Department,
electronically and not in paper form,
Coast Guard; telephone (813) 228–2191,
tkelley on DSK3SPTVN1PROD with PROPOSALS
except as provided by the proposed [Docket Number USCG–2015–0071]
rule. The proposed rule is intended to email D07-SMB-Tampa-
facilitate the distribution of updated RIN 1625–AA08 WWM@uscg.mil. If you have questions
prescribing information as new on viewing or submitting material to the
Safety Zone; 24 Mile Tampa Bay docket, call Cheryl Collins, Program
information becomes available and as Marathon Swim, Tampa Bay, Tampa,
changes in prescribing information are Manager, Docket Operations, telephone
FL (202) 366–9826.
made. FDA is proposing the change to
help ensure that the most current AGENCY: Coast Guard, DHS. SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 17:26 Mar 06, 2015 Jkt 235001 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\09MRP1.SGM 09MRP1](https://thefederalregister.org/doc/80_FR_12409/page/2.svg)
Document Created: 2015-12-18 12:06:15
Document Modified: 2015-12-18 12:06:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule; extension of comment period. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 12364 | |
| RIN Number | 0910-AG18 | |
| CFR Citation | 21
CFR
201 21 CFR 606 21 CFR 610 |
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