[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59756-59757]
[FR Doc No: 2011-24723]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65368; File No. SR-NYSE-2011-38]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Designation of a Longer Period for Commission Action on
Proposed Rule Change Amending Sections 102.01 and 103.01 of the
Exchange's Listed Company Manual To Adopt Additional Listing
Requirements for Companies Applying To List After Consummation of a
``Reverse Merger'' With a Shell Company

September 21, 2011.
    On July 22, 2011, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt additional listing requirements for
companies applying to list after consummation of a ``reverse merger''
with a shell company. The proposed rule change was published for
comment in the Federal Register on August 10, 2011.\3\ The Commission
received one comment letter on the proposal.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 65034 (August 4,
2011), 76 FR 49513.
    \4\ See Letter from James Davidson, Hermes Equity Ownership
Services Limited to Elizabeth Murphy, Secretary, Commission dated
August 31, 2011.
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    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is September 24, 2011.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period to take action on the proposed
rule change so that it has sufficient time to consider the Exchange's
proposal, which would establish additional listing requirements for
companies applying to list after consummation of a ``reverse merger''

with a shell company, and to consider the comment letter that has been
submitted in connection with the proposed rule change.
    Accordingly, pursuant to Section 19(b)(2) of the Act,\6\ the
Commission designates November 8, 2011 as the date by which the
Commission should either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File Number SR-NYSE-2011-38).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-24723 Filed 9-26-11; 8:45 am]
BILLING CODE 8011-01-P


February 7, 2008

COMPUTATIONAL TOXICOLOGY SUBCOMMITTEE

DRAFT AGENDA

Wednesday, February 20, 2008

10:00 a.m. – 12:00 noon eastern time

CONFERENCE CALL

Participation by Teleconference Only

10:00-10:05 a.m.	Welcome and Overview	Dr. George Daston, Chair

	- Purpose of Teleconference Call	Computational Toxicology

		Subcommittee

10:05–10:10 a.m.	DFO Remarks	Lori Kowalski, Office of

		Research and Development

10:10–10:45 a.m.	Subcommittee Draft Letter Report	Dr. George Daston, Chair,

	-  Overview	Computational Toxicology

	-  Draft responses to charge questions

-  Discussion	Computational Toxicology

		Subcommittee

10:45–11:00 a.m.	Public Comment

11:00–11:45 a.m.	Subcommittee Draft Letter Report (Cont.)	Dr. George Daston, Chair,

	-  Discussion	Computational Toxicology

		Subcommittee

11:45-12:00 noon	Final Draft Letter Report	Dr. George Daston, Chair,

Next steps 	Computational Toxicology

		Subcommittee

12:00 noon	Adjourn

bosc computational toxicology Subcommittee June 2006 draft meeting agenda

  PAGE  3

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development


[Federal Register Volume 81, Number 230 (Wednesday, November 30, 2016)]
[Rules and Regulations]
[Pages 86268-86270]
[FR Doc No: 2016-28754]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-2337]

Food Additives Permitted in Feed and Drinking Water of Animals;
Guanidinoacetic Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of
guanidinoacetic acid as a substance that spares arginine and serves as
a precursor of creatine in broiler chicken and turkey feeds. This
action is in response to a food additive petition filed by Alzchem AG.

DATES: This rule is effective November 30, 2016. Submit either written
or electronic objections and requests for a hearing by December 30,
2016. See section V of this document for information on the filing of
objections.

ADDRESSES: You may submit objections and requests for a hearing as
follows:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection 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 objection, that information will be
posted on http://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection 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 objections submitted to the Division of
Dockets Management, FDA will post your objection, 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-F-2337 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Guanidinoacetic Acid.'' Received objections 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 an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies in 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 objections. 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 objections 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 objections 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: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of July 16, 2015
(80 FR 42069), FDA announced that we had filed a food additive petition
(animal use) (FAP 2292) submitted by Alzchem AG, Chemiepark Trostberg,
Dr.-Albert-Frank-Str. 32, 83308, Trostberg, Germany. The petition
proposed that the regulations for food additives permitted in feed and
drinking water of animals be amended to provide for the safe use of
guanidinoacetic acid as a substance that spares arginine and serves as
a precursor of creatine in broiler chicken and turkey feeds. The notice
of petition provided for a 30-day comment period on the petitioner's
request for categorical exclusion from preparing an environmental
assessment or environmental impact statement.

II. Conclusion

    FDA concludes that the data establish the safety and utility of
guanidinoacetic acid for use as a substance that spares arginine and
serves as a precursor of creatine in broiler chicken and turkey feeds
and that the food additive regulations should be amended as set forth
in this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h) (21 CFR 571.1(h)), the petition
and documents we considered and relied upon in reaching our decision to
approve the petition will be made available for public disclosure (see
FOR FURTHER INFORMATION CONTACT). As provided in Sec.  571.1(h), we
will delete from the documents any materials that are not available for
public disclosure before making the documents available for inspection.

IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.32(r) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
shall constitute a waiver of the right to a hearing on the objection.
    Any objections received in response to the regulation 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.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is
amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS

0
1. The authority citation for part 573 continues to read as follows:

    Authority:  21 U.S.C. 321, 342, 348.

0
2. Add Sec.  573.496 to read as follows:

Sec.  573.496   Guanidinoacetic acid.

    The food additive, guanidinoacetic acid, may be safely used in
broiler chicken and turkey feeds in accordance with the following
prescribed conditions:
    (a) The additive is manufactured by reacting glycine with cyanamide
in an aqueous solution.

    (b) The additive is used or intended for use to spare arginine and
as a precursor of creatine in broiler chicken and turkey feeds at
levels not to exceed 0.12 percent of the complete feed.
    (c) The additive consists of not less than 97 percent
guanidinoacetic acid [N-(aminoiminomethyl)-glycine] (CAS 352-97-6) by
weight.
    (d) The additive meets the following specifications:
    (1) Dicyandiamide not to exceed 0.5 percent;
    (2) Cyanamide not to exceed 0.01 percent;
    (3) Melamine not to exceed 15 parts per million (ppm);
    (4) Sum of ammeline, ammelide, and cyanuric acid not to exceed 35
ppm; and
    (5) Water not to exceed 1 percent.
    (e) To assure safe use of the additive in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and
complete feed shall contain the name of the additive.
    (2) The label and labeling of the additive and any feed premix
shall also contain:
    (i) A statement to indicate that the maximum use level of
guanidinoacetic acid must not exceed 0.12 percent of the complete feed
for broiler chickens and turkeys; and
    (ii) Adequate directions for use.

    Dated: November 22, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-28754 Filed 11-29-16; 8:45 am]
BILLING CODE 4164-01-P


Straightforward Complex Department of Defense Respondents* 162.0 Department of Defense Respondents 4.5 Management Technical Clerical Management Technical Clerical 1) Become familiar with the conformity processes 2.4 6.6 1) Become familiar with the conformity processes 16 40 2) Determine applicability 4.0 5.1 2) Determine applicability 60 200 3) Consult with EPA, State and local air agencies, and MPO 2.0 5.2 3) Consult with EPA, State and local air agencies, and MPO 20 40 4) Collect data from MPO and from State or local air agency 6.1 4) Collect data from MPO and from State or local air agency 8 20 5) Perfrom air quality analysis 11.6 52.9 10.7 5) Perfrom air quality analysis 100 500 20 6) Perform mitigation analysis 40 100 7) Negotiate mitigation analysis 100 100 6) Prepare draft determination 8) Prepare draft determination 60 400 40 7) Prepare notice of draft determination 9) Prepare notice of draft determination 16 40 20 8) Receive and consider comments 10) Receive and consider comments 20 60 20 9) Prepare final determination 11) Prepare final determination 60 100 20 Subtotal  hours per respondent 20.0 75.9 10.7 Subtotal  hours per respondent 500 1600 120 Total Hours  DOD 3,240 12,294 1,728 Total Hours  DOD 2,250 7,200 540 Straightforward Complex Minerals Management Service Respondents 1.0 Minerals Management Service Respondents 1.0 Management Technical Clerical Management Technical Clerical 1) Become familiar with the conformity processes 8 1) Become familiar with the conformity processes 8 2) Determine applicability 24 2) Determine applicability 24 3) Consult with EPA, State and local air agencies, and MPO 8 4 3) Consult with EPA, State and local air agencies, and MPO 16 8 4) Collect data from MPO and from State or local air agency 8 4) Collect data from MPO and from State or local air agency 16 5) Perfrom air quality analysis 12 5) Perfrom air quality analysis 24 6) Perform mitigation analysis 16 7) Negotiate mitigation analysis 8 6) Prepare draft determination 24 8) Prepare draft determination 32 7) Prepare notice of draft determination 4 4 9) Prepare notice of draft determination 4 4 8) Receive and consider comments 8 2 10) Receive and consider comments 16 6 9) Prepare final determination 8 11) Prepare final determination 16 Subtotal  hours per respondent 0 104 10 Subtotal  hours per respondent 0 180 18 Total Hours  MMS 0 104 10 Total Hours  MMS 0 180 18 Straightforward Complex Bureau of Land Management Respondents 400.0 Bureau of Land Management Respondents 1.0 Management Technical Clerical Management Technical Clerical 1) Become familiar with the conformity processes 1) Become familiar with the conformity processes 2) Determine applicability 0.25 2) Determine applicability 2.00 3) Consult with EPA, State and local air agencies, and MPO 0.25 3) Consult with EPA, State and local air agencies, and MPO 4.00 4) Collect data from MPO and from State or local air agency < 0.25 4) Collect data from MPO and from State or local air agency 4.00 5) Perfrom air quality analysis 0.25 5) Perfrom air quality analysis 10.00 6) Perform mitigation analysis 5.00 7) Negotiate mitigation analysis 1.00 6) Prepare draft determination 0.25 0.25 < 0.25 8) Prepare draft determination 0.25 3.00 0.25 7) Prepare notice of draft determination 0.25 < 0.25 9) Prepare notice of draft determination 2.00 < 0.25 8) Receive and consider comments 0.25 0.50 10) Receive and consider comments 1.00 5.00 9) Prepare final determination 0.25 0.25 0.25 11) Prepare final determination 0.25 1.75 0.50 Subtotal  hours per respondent 0.75 2.00 0.25 Subtotal  hours per respondent 1.50 37.75 0.75 Total Hours  BLM 300.00 800.00 100.00 Total Hours  BLM 1.50 37.75 0.75 Exhibit 1. Straightforward Conformity Determination Exhibit 2. Complex Conformity Determination Total Annual Respondent Burdens Total Annual Respondent Burdens * The 162 DOD respondents includes the 36 preliminary ( complex) assessments and the 126 straightforward assessments. Values are a weighted average.

1 of 3 Total Hours Federal Agency Respondents 3540 13198 1838 Total Hours Federal Agency Respondents 2252 7418 559 Weighted Avg. Hrs/ Respondent * 6.3 23.4 3.3 Weighted Avg. Hrs/ Respondent * 346 1141 86 Labor Cost $ 55.41 $ 29.95 $ 17.95 Labor Cost $ 55.41 $ 29.95 $ 17.95 Number of Determinations ** 1,325 1,325 1,325 Number of Determinations ** 13 13 13 Total Hours 8,331 31,061 4,326 Total Hours 4,503 14,836 1,118 Total Federal Agency Hours for All Labor Types 43,718 Total Federal Agency Hours for All Labor Types 20,456 Total Cost per Labor Type $ 461,635 $ 930,277 $ 77,646 Total Cost per Labor Type $ 249,511 $ 444,323 $ 20,059 Total Federal Agency Cost for All Labor Types $ 1,469,558 Total Federal Agency Cost for All Labor Types $ 713,894 Total Hours for both Straightforward and Complex Determinations 64,174 Total Cost for both Straightforward and Complex determinations $ 2,183,452 * Weighted Average is based on burden estimates provided by DOD, BLM and MMS. The FAA only provided number of determinations without a burden estimate ** The annual number of determinations ( and the estimated burden) is based on data provided by the DOD, BLM, MMS, and FAA.

2 of 3 Exhibit 3. Basis for Estimating Non Federal Respondent Burden Labor Rate $ 56.16 Fraction of Burden Complex 0.33 Fraction of Burden Straightforward 0.67 Total Hours 9,000 Total Cost $ 505,440.00 Exhibit 4. Summary of Respondent Burden Straightforward Complex Total Federal Agency Hours 43,718 20,456 64,174 Non Federal Agency Hours 6,057 2,943 9,000 Total Respondent Hours 49,775 23,399 73,174 Federal Agency Cost $ 1,469,558 $ 713,894 $ 2,183,452 Non Federal Agency Cost $ 340,183 $ 165,257 $ 505,440 Total Respondent Cost $ 1,809,741 $ 879,150 $ 2,688,892 3 of 3 Straightforward Complex EPA Region 10 Respondents 1.7 EPA Region 10 Respondents 0.7 Management Technical Clerical Management Technical Clerical 1) Become familiar with the conformity processes 1) Become familiar with the conformity processes 4 2) Determine applicability 4 2) Determine applicability 8 3) Consult with EPA, State and local air agencies, and MPO 2 3) Consult with EPA, State and local air agencies, and MPO 1 6 State or local air agency 4 State or local air agency 5) Perfrom air quality analysis 5) Perfrom air quality analysis 24 6) Perform mitigation analysis 4 7) Negotiate mitigation analysis 6) Prepare draft determination 8) Prepare draft determination 4 7) Prepare notice of draft determination 9) Prepare notice of draft determination 10) Receive and consider comments 4 10) Receive and consider comments 1 6 8) Prepare final determination 2 11) Prepare final determination 2 Subtotal  hours per respondent 16 Subtotal  hours per respondent 2 58 Total Hours Region 10 0 27 0 Total Hours Region 10 1 39 0 Straightforward Complex EPA Region 9 Respondents 8.0 EPA Region 9 Respondents 6.0 Management Technical Clerical Management Technical Clerical 1) Become familiar with the conformity processes 1) Become familiar with the conformity processes 2) Determine applicability 2) Determine applicability 3) Consult with EPA, State and local air agencies, and MPO 3) Consult with EPA, State and local air agencies, and MPO State or local air agency State or local air agency 5) Perfrom air quality analysis 5) Perfrom air quality analysis 6) Perform mitigation analysis 7) Negotiate mitigation analysis 6) Prepare draft determination 8) Prepare draft determination 7) Prepare notice of draft determination 9) Prepare notice of draft determination 10) Receive and consider comments 10) Receive and consider comments 8) Prepare final determination 11) Prepare final determination Subtotal  hours per respondent 6 0 Subtotal  hours per respondent 12 0 Total Hours Region 9 48 0 0 Total Hours Region 9 72 0 0 Total Hours Region 9 and 10 48 27 0 Total Hours Region 9 and 10 73 39 0 Weighted Avg. Hr/ Respondent 5.0 2.8 0.0 Weighted Avg. Hr/ Respondent 11.0 5.8 0.0 EPA Regional Agency Burden Summary Labor Cost $ 55.41 $ 29.95 $ 17.95 Labor Cost $ 55.41 $ 29.95 $ 17.95 Number of Determinations 665 665 665 Number of Determinations 13 13 13 Total Hours 3,302 1,834 0 Total Hours 143 75 0 Total Hours for All Labor Types 5,137 Total Hours for All Labor Types 218 Total Cost per Labor Type $ 182,968 $ 54,943 $ 0 Total Cost per Labor Type $ 7,924 $ 2,258 $ 0 Total Cost for All Labor Types $ 237,910 Total Cost for All Labor Types $ 10,182 Total Hours for both Straightforward and Complex Determinations 5,355 Total Cost for both Straightforward and Complex determinations $ 248,092 Exhibit 5. Straightforward Conformity Determination Exhibit 6. Complex Conformity Determination Total Annual Agency Burdens Total Annual Agency Burdens 1 of 2 Exhibit 7. State and Local Agency Burden Summary Labor Cost $ 55.41 $ 29.95 $ 17.95 Labor Cost $ 55.41 $ 29.95 $ 17.95 Number of Determinations 133 133 133 Number of Determinations 13 13 13 Total Hours 660 367 0 Total Hours 143 75 0 Total Hours for All Labor Types 1,027 Total Hours for All Labor Types 218 Total Cost per Labor Type $ 36,594 $ 10,989 $ 0 Total Cost per Labor Type $ 7,924 $ 2,258 $ 0 Total Cost for All Labor Types $ 47,582 Total Cost for All Labor Types $ 10,182 Total Hours for both Straightforward and Complex Determinations 1,246 Total Cost for both Straightforward and Complex determinations $ 57,764 2 of 2 Exhibit 8a Summary of Total Annual Respondent + Burdens and Costs for 2001 Hours Cost Federal Agencies 64,174 $ 2,183,452 Non Federal Agencies 9,000 $ 505,440 EPA Region Agencies 5,355 $ 248,092 State and Local Agencies 1,246 $ 57,764 Grand Total 79,775 $ 2,994,748 Exhibit 8b Summary of Total Annual Burdens and Costs for 3 year period Hours Cost Federal Agencies 192,522 $ 6,550,355 Non Federal Agencies 27,000 $ 1,516,320 EPA Region Agencies 16,065 $ 744,277 State and Local Agencies 3,737 $ 173,292 Grand Total 239,324 $ 8,984,244 1 of 1


[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Proposed Rules]
[Pages 72868-72869]
[FR Doc No: 2011-30572]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0828; Airspace Docket No. 11-AGL-16]

Proposed Establishment of Class E Airspace; Boyne City, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at Boyne
City, MI. Controlled airspace is necessary to accommodate new Standard
Instrument Approach Procedures (SIAP) at Boyne City Municipal Airport.
The FAA is taking this action to enhance the safety and management of
Instrument Flight Rules (IFR) operations for SIAPs at the airport.

DATES: Comments must be received on or before January 12, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2011-0828/Airspace Docket No. 11-
AGL-16, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-(800) 647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2011-0828/
Airspace Docket No. 11-AGL-16.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Central Service Center, 2601 Meacham Blvd., Fort
Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), part 71 by establishing Class E airspace extending upward
from 700 feet above the surface for new standard instrument approach
procedures at Boyne City Municipal Airport, Boyne City, MI. Controlled
airspace is needed for the safety and management of IFR operations at
the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9V, dated August 9, 2011 and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish controlled airspace at Boyne City Municipal
Airport, Boyne City, MI.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration

proposes to amend 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9V, Airspace Designations and Reporting Points, dated August 9,
2011, and effective September 15, 2011, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AGL MI E5 Boyne City, MI [New]

Boyne City Municipal Airport, MI
    (Lat. 45[deg]12'32'' N., long. 84[deg]59'24'' W.)

    That airspace extending upward from 700 feet above the surface
within a 9.9-mile radius of Boyne City Municipal Airport, and within
2 miles each side of the 080 degree bearing from the airport
extending from the 9.9-mile radius to 11.9 miles east of the
airport.

    Issued in Fort Worth, TX, on November 9, 2011.
Gail L. Kasson,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2011-30572 Filed 11-25-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 30, 2009 (Volume 74, Number 228)]
[Rules and Regulations]
[Page 62490-62491]
[DOCID:fr30no09-8]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2009-N-0665]

Oral Dosage Form New Animal Drugs; Chlortetracycline Powder

AGENCY: Food and Drug Administration, HHS.

ACTION:  Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Alpharma Inc. The ANADA provides for use
of generic chlortetracycline soluble powder to make medicated drinking
water for cattle, swine, chickens, and turkeys for the treatment of
several bacterial diseases.

DATES: This rule is effective November 30, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Alpharma Inc., 440 Route 22, Bridgewater, NJ
08807, filed ANADA 200-441 that provides for the use of A-MYCIN
(chlortetracycline) Soluble Powder to make medicated drinking water for
cattle, swine, chickens, and turkeys for the treatment of several
bacterial diseases. Alpharma Inc.'s A-MYCIN Soluble Powder is approved
as a generic copy of Fort Dodge Animal Health, A Division of Wyeth
Holdings Corp.'s AUREOMYCIN (chlortetracycline) Soluble Powder,
approved under NADA 65-440. The ANADA is approved as of October 9,
2009, and the regulations are amended in 21 CFR 520.445b to reflect the
approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.445b, revise paragraph (b)(2) to read as follows:

Sec.  520.445b  Chlortetracycline powder.

* * * * *
    (b) * * *
    (2) Nos. 046573 and 053501 for use as in paragraph (d) of this
section.
* * * * *

    Dated: November 23, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-28468 Filed 11-27-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36588-36589]
[FR Doc No: 2023-11900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1480]

Drug-Drug Interaction Assessment for Therapeutic Proteins;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Drug-Drug
Interaction Assessment for Therapeutic Proteins.'' With the continued
market growth and increased clinical use of therapeutic proteins, it is
important to understand the nature of and the potential for drug-drug
interactions (DDIs) with these products. The purpose of this guidance
is to help sponsors of investigational new drug applications (INDs) and
applicants of biologics license applications (BLAs) determine the need
for DDI studies for a therapeutic protein by providing a systematic,
risk-based approach. This guidance finalizes the draft guidance of the
same title issued on August 10, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on June 5, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2020-D-1480 for ``Drug-Drug Interaction Assessment for Therapeutic
Proteins.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Elimika Pfuma Fletcher, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2162, Silver Spring, MD 20993, 301-796-
3473; or Diane Maloney, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Drug-Drug Interaction Assessment for Therapeutic Proteins.''
With the continued market growth and increased clinical use of
therapeutic proteins, it is important to understand the nature of and
the potential for DDIs with these products. This guidance supplements
the final FDA guidances for industry entitled ``In Vitro Drug
Interaction Studies--Cytochrome P450 Enzyme- and Transporter-Mediated
Drug Interactions'' and ``Clinical Drug Interaction Studies--Cytochrome
P450 Enzyme- and Transporter-Mediated Drug Interactions'' (January
2020) by providing recommendations for a systematic, risk-based
approach to determining the need for DDI studies for therapeutic
proteins. This guidance discusses considerations for assessing DDIs for
therapeutic proteins, including situations where determining the DDI
potential of a therapeutic protein is warranted. The guidance also
discusses various types of DDI assessments,

considerations for study design, and recommendations for labeling.
    This guidance finalizes the draft guidance entitled ``Drug-Drug
Interaction Assessment for Therapeutic Proteins'' issued on August 10,
2020 (85 FR 48259). FDA considered comments received on the draft
guidance as the guidance was finalized. Changes from the draft to the
final guidance include: (1) clarifying that FDA review divisions should
be consulted related to novel modalities, and that limitations exist in
knowledge related to effect of therapeutic proteins on transporters;
(2) including more literature references; (3) limiting the text related
to antibody-drug conjugates (ADCs) because a draft guidance on clinical
pharmacology considerations for ADCs has been published; and (4)
including language about potential use of various modeling approaches
on a case by case basis. In addition, editorial changes were made to
improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Drug-Drug Interaction Assessment for
Therapeutic Proteins.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for the submission of investigational new drug
applications in 21 CFR part 312 have been approved under OMB control
number 0910-0014. The collections of information for the submission of
new drug applications in 21 CFR part 314 have been approved under OMB
control number 0910-0001. The collections of information for the
submission of biologics license applications in 21 CFR part 601 have
been approved under OMB control 0910-0338. The collections of
information pertaining to the submission of prescription drug labeling
under 21 CFR 201.56 and 201.57 have been approved under OMB control
number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11900 Filed 6-2-23; 8:45 am]
BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

On behalf of myself, I am requesting that the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491, be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer. The Proposed Rule asks many different questions I want to respond to. I want to provide my thoughts and comments on many of these issues, but the 75 day limit is too short.

I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comments into account.

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further. If you wish to discuss this with me, please feel free to contact me at<EMAIL_ADDRESS> You have my permission to use my comment in any of your reports or documentation.


[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Page 34091]
[FR Doc No: 2013-13396]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP13-73-000; CP13-74-000]

Sierrita Gas Pipeline LLC; Notice of Public Meeting for the
Proposed Sierrita Pipeline Project

    On June 18, 2013, the Federal Energy Regulatory Commission (FERC or
Commission) Office of Energy Projects staff will hold a meeting to
discuss Sierrita Gas Pipeline LLC's (Sierrita) plans for restoring the
proposed Sierrita Pipeline Project right-of-way. The meeting is open to
the public; however, the intent of the meeting is to provide the Altar
Valley Conservation Alliance members and the landowners directly
affected by the Sierrita Pipeline Project the opportunity to provide
input on the design of Sierrita's restoration measures. The FERC staff
will conduct this public meeting as part of its preparation of an
environmental impact statement for the project. The meeting is
scheduled as follows:

------------------------------------------------------------------------
             Date and time                           Location
------------------------------------------------------------------------
Tuesday, June 18, 2013, 9:00 a.m. local  Casino Del Sol Conference Room,
 time.                                    5655 W Valencia Road, Tucson,
                                          AZ 85757.
------------------------------------------------------------------------

    All public meetings will be posted on the Commission's calendar
located at www.ferc.gov/EventCalendar/EventsList.aspx along with other
related information.
    Additional information about the Sierrita Pipeline Project is
available from the Commission's Office of External Affairs, at (866)
208-FERC, or on the FERC Web site at www.ferc.gov using the
``eLibrary'' link. Click on the eLibrary link, click on ``General
Search'' and enter the docket number, excluding the last three digits,
in the Docket Number field (i.e., CP13-73). Be sure you have selected
an appropriate date range. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>,
or for TTY, contact<PHONE_NUMBER>.

    Dated: May 30, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-13396 Filed 6-5-13; 8:45 am]
BILLING CODE 6717-01-P