[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52931-52932]
[FR Doc No: 2013-20893]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0938]

Draft Guidance for Industry on Abbreviated New Drug Applications:
Stability Testing of Drug Substances and Products, Questions and
Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``ANDAs:
Stability Testing of Drug Substances and Products, Questions and
Answers.'' This draft guidance clarifies stability testing
recommendations for abbreviated new drug applications (ANDAs) by
providing responses to public comments in a questions-and-answers
format. This draft guidance addresses public comments regarding FDA's
recommendation to generic drug manufacturers to follow International
Conference on Hamonisation (ICH) stability guidances Q1A (R2) through
Q1E.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 28, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Radhika Rajagopalan, Center for Drug
Evaluation and Research (HFD-640), Food and Drug Administration, 7500
Standish Pl., MPN2, Rm. 243, Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``ANDAs: Stability Testing of Drug Substances and Products,
Questions and Answers.'' Because of increases in the number and
complexity of ANDAs and FDA's desire to standardize generic drug
review, on September 25, 2012 (77 FR 58999), FDA published a draft and
on June 20, 2013 (78 FR 37231), published a final guidance recommending
the generic industry follow the approach in the ICH stability-related
guidances: (1) ``Q1A(R2) Stability Testing of New Drug Substances and
Products,'' November 2003; (2) ``Q1B Photostability Testing of New Drug
Substances and Products,'' November 1996; (3) ``Q1C Stability Testing
for New Dosage Forms,'' November 1996; (4) ``Q1D Bracketing and
Matrixing Designs for Stability Testing of New Drug Substances and
Products,'' January 2003; and (5) ``Q1E Evaluation of Stability Data,''
June 2004. These guidances can be found on the FDA Guidances (Drugs)
Web site under International Conference on Harmonisation--Quality at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm. FDA also recommended that industry follow the
ICH outlined definitions, glossaries, references, and attachments.
    While carefully considering the public comments on the September
2012 draft guidance, we decided to publish a draft guidance in a
questions-and-answers format. This draft guidance discusses stability
testing relating to general questions, drug master files, drug product
manufacturing and packaging, amendments to pending ANDA applications,
and stability studies.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on ANDAs:
Stability Testing of Drug Substances and Products, Questions and
Answers. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. 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.

III. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20893 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Rules and Regulations]
[Pages 14444-14446]
[FR Doc No: 2013-05132]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0918]
RIN 1625-AA09

Drawbridge Operation Regulation; Lake Champlain, Swanton, VT

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is changing the drawbridge operation
regulation that governs the operation of the New England Central
Railroad Bridge across Missisquoi Bay, mile 105.6, at Swanton, Vermont,
and removing the regulation for the SR78 highway bridge at mile 105.9.
The owner of the New England Central Railroad Bridge has requested to
operate the bridge from a remote location, at St. Albans, Vermont. It
is expected that this change to the regulations will provide relief to
the bridge owner from crewing the bridge while continuing to meet the
reasonable needs of navigation.

DATES: This rule is effective April 5, 2013.

ADDRESSES: Comments and related materials received from the public, as
well as documents mentioned in this preamble as being available in the
docket, are part of docket USCG-2012-0918 and are available online by
going to http://www.regulations.gov, inserting USCG-2012-0918 in the
``Keyword'' box, and then clicking ``Search.'' This material is also
available for inspection or copying at the 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, between
9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. John W. McDonald, Project Officer, First Coast Guard
District Bridge Branch,<PHONE_NUMBER><EMAIL_ADDRESS>If you
have questions on viewing the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. Regulatory History and Information

    On November 9, 2012, we published a notice of proposed rulemaking
(NPRM) entitled ``Drawbridge Operation Regulation; Lake Champlain,
Swanton, VT'' in the Federal Register (77 FR 67319). We received no
comments on the proposed rule. No public meeting was requested, and
none was held.

B. Basis and Purpose

    The New England Central Railroad Bridge, formerly the Central
Vermont Railway Bridge, at mile 105.6, across Missisquoi Bay, at
Swanton, Vermont, has a vertical clearance in the closed position that
ranges between 9.5 feet and zero feet depending on the time of year and
other conditions. The waterway users are predominantly seasonal
recreational vessels.
    The existing drawbridge operation regulations are listed at 33 CFR
117.993(c), which require the draw to operate as follows: From June 15
through September 15, the draw shall open on signal, Monday through
Friday between 9 a.m. and 5 p.m. and on Saturday, Sunday, Independence
Day, and Labor Day, between 7 a.m. and 11 p.m. At all other times,
after at least a two hour notice is given. From September 16 through
June 14, on signal after at least a twenty four hour notice is given.
    The Coast Guard received a request from the owner of the bridge,
New England Central Railroad Inc., to change the drawbridge operation
regulations to allow the bridge to be operated remotely from the New
England Central Railroad Dispatcher's Office located at St. Albans,
Vermont.
    The bridge had been operated manually by hand crank since it was
constructed in 1912. An operator would be dispatched to the bridge to
manually close the draw to facilitate the passage of a train and then
crank the draw back into the open position.
    The Federal Railroad Administration funded the motorization of the
bridge to allow remote operation of the bridge by New England Central
Railroad. As a result, in 2012, the operating system was modified by
adding electric bridge opening motors to swing the draw open and
closed, a standby electric generator to be used in the event of a power
outage, local bridge operation controls installed at the tenders
building on the bridge to be used to locally operate the draw, LED
navigation lights, and

electric illuminated signs both up and down stream to warn mariners
that the bridge will be closing for the passage of an approaching
train.
    Presently, rail traffic crosses the bridge seven days a week. There
are normally two train passages daily crossing the bridge in the
morning and returning later in the same day.
    Under this final rule the bridge will be opened and closed
remotely, from the New England Central Railroad Dispatchers Office at
St. Albans, Vermont.
    During the boating season, June 15 through September 15, the bridge
will remain in the open position at all times, except for the passage
of rail traffic. Once rail traffic crosses the bridge the bridge will
be returned to the full open position.
    In the off season, September 16 through June 14, the bridge may
remain in the closed position at all times.
    The bridge will be opened for the passage of vessel traffic
September 16 through June 14, upon receipt of a twenty four hour
advance notice to open the bridge.
    The bridge opens on average two to three times a week during the
period 16 September through 14 June when the bridge will open after a
twenty four hour advance notice is given.
    The waterway is normally frozen December through April each winter
when the recreational vessels that normally transit this bridge are in
winter storage.
    As a result of the above information the Coast Guard believes it is
reasonable for the bridge owner to operate the bridge from a remote
location and that the reasonable needs of navigation will continue to
be addressed.
    The SR78 highway bridge has been replaced with a new fixed span
highway bridge; therefore, the drawbridge operations for that bridge
will be deleted because they are now obsolete and unnecessary.
    The New England Central Railroad Bridge is listed in the existing
regulations as the Central Vermont Railway Bridge. We are changing the
name of the bridge under this rule to update the present name and
ownership of the bridge.

C. Discussion of Comments and Changes

    The Coast Guard received no comments in response to the notice of
proposed rulemaking. As a result, no changes have been made to this
final rule.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. This conclusion is based on the fact that
the bridge will continue to operate the same, except that, it will be
opened and closed from a remote location in St. Albans, Vermont.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
received no comments from the Small Business Administration on this
rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule will have no effect on small entities since this
drawbridge will continue to operate the same except that it will be
operated from a remote location.
    There is no new restriction or regulation being imposed by this
rule; therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that
this final rule will not have a significant economic impact on a
substantial number of small entities

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule, if the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

6. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

7. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

8. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

9. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

10. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

11. Energy Effects

    This action is not a ``significant energy action'' under Executive
order 13211, Actions Concerns Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

12. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

13. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule involves operating the bridge from a remote
location. This rule is categorically excluded, under figure 2-1,
paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.   117.993, revise paragraph (c) and remove paragraph (d).
    The revision reads as follows:

Sec.  117.993  Lake Champlain.

* * * * *
    (c) The draw of the New England Central Railroad Bridge across
Missiquoi Bay, mile 105.6, at Swanton, Vermont, shall operate as
follows:
    (1) From June 15 through September 15, the draw shall remain in the
full open position at all times and shall only be closed for the
passage of rail traffic or the performance of maintenance authorized in
accordance with subpart A of this part.
    (2) From September 16 through June 14, the draw may remain in the
closed position and shall be opened on signal for the passage of vessel
traffic after at least a twenty four hour notice is given by calling
the number posted at the bridge.
    (3) The draw may be operated either remotely by the New England
Central Railroad train dispatcher located at St. Albans, Vermont or
manually by a draw tender located at the bridge.
    (4) A sufficient number of infrared cameras shall be maintained in
good working order at all times with a clear unobstructed view of the
channel under the bridge, and the up and down stream approaches to the
bridge. A signal horn and message boards located both up and down
stream, necessary to warn marine traffic that the bridge will be
closing, shall also be maintained in good working order at all times.
In the event that any of the cameras, navigation lights, horn, or
message board become disabled, personnel shall be deployed to the
bridge to be on scene within two hours from the known time of the
equipment failure.
    (5) The draw may operate remotely as follows: Once it is determined
that the draw must be opened or closed, the train dispatcher shall
observe the waterway both up and down stream via the infrared cameras
to verify that the channel is clear of all approaching vessel traffic.
All approaching vessel traffic shall be allowed to pass before the
bridge may be closed. Once it is determined that no vessel traffic is
approaching the dispatcher shall sound the warning horn and activate
the up and down stream message boards indicating that the bridge will
be closing. After at least a one minute delay the draw may then be
closed and the swing span navigation lights shall display as red to
indicate the bridge is in the closed position. Once the train clears
the bridge the draw shall be returned to the full open position and the
swing span lights shall display as green to indicate the draw is in the
full open position.
    (6) In the event that the dispatcher cannot verify that the channel
is clear of all vessel traffic and the bridge cannot be safely closed,
an on-scene train crewmember shall observe the waterway for any vessel
traffic and then communicate with the train dispatch office either by
radio or telephone to request the bridge be safely closed. Personnel
shall then be deployed to the bridge to arrive within two hours to
inspect and repair the bridge remote operation equipment.
    (7) The bridge shall be operated manually from the tender's house
located at the bridge until all necessary repairs are completed to the
remote operation equipment.

    Dated: February 20, 2013.
Daniel B. Abel,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2013-05132 Filed 3-1-13; 4:15 pm]
BILLING CODE 9110-04-P