[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31041-31042]
[FR Doc No: 2015-13105]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1804]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Studies
To Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
General Approach To Establish an Acute Reference Dose; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #232 entitled
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in
Human Food: General Approach to Establish an Acute Reference Dose
(ARfD)'' (VICH GL54). This draft guidance has been developed for
veterinary use by the International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). This draft VICH guidance document is intended to
address the nature and types of data that can be useful in determining
an ARfD for residues of veterinary drugs, the studies that may generate
such data, and how the ARfD may be calculated based on these data.

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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 31, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Policy and Regulations Staff (HFV-6), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your request. 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INFORMATION section for electronic access to the draft guidance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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tong Zhou, Center for Veterinary
Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
#232 entitled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: General Approach to Establish an Acute
Reference Dose (ARfD)'' (VICH GL54). In recent years, many important
initiatives have been undertaken by regulatory authorities and industry
associations to promote the international harmonization of regulatory
requirements. FDA has participated in efforts to enhance harmonization
and has expressed its commitment to seek scientifically based
harmonized technical procedures for the development of pharmaceutical
products. One of the goals of harmonization is to identify, and then
reduce, differences in technical requirements for drug development
among regulatory agencies in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) for several years to develop
harmonized technical requirements for the approval of human
pharmaceutical and biological products among the European Union, Japan,
and the United States. The VICH is a parallel initiative for veterinary
medicinal products. The VICH is concerned with developing harmonized
technical requirements for the approval of veterinary medicinal
products in the European Union, Japan, and the United States, and
includes input from both regulatory and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission; European Medicines Evaluation Agency;
European Federation of Animal Health; Committee on Veterinary Medicinal
Products; FDA; the U.S. Department of Agriculture; the Animal Health
Institute; the Japanese Veterinary Pharmaceutical Association; the
Japanese Association of Veterinary Biologics; and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
    Six observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one

representative from the government of Canada, one representative from
the industry of Canada, one representative from the government of South
Africa, and one representative from the industry of South Africa. The
VICH Secretariat, which coordinates the preparation of documentation,
is provided by the International Federation for Animal Health (IFAH).
An IFAH representative also participates in the VICH Steering Committee
meetings.

II. Draft Guidance on Studies To Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: General Approach To Establish an Acute
Reference Dose (ARfD)

    The VICH Steering Committee held a meeting in February 2015 and
agreed that the draft guidance document entitled ``Studies to Evaluate
the Safety of Residues of Veterinary Drugs in Human Food: General
Approach to Establish an Acute Reference Dose (ARfD)'' (VICH GL54)
should be made available for public comment. This draft VICH guidance
document is intended to address the nature and types of data that can
be useful in determining an ARfD for residues of veterinary drugs, the
studies that may generate such data, and how the ARfD may be calculated
based on these data.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This draft guidance, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the current
thinking of FDA on Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: General Approach to Establish an Acute
Reference Dose (ARfD). 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.

IV. 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 Action of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control number 0910-0032.

V. 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.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13105 Filed 5-29-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Notices]
[Page 53131]
[FR Doc No: 2016-19067]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-485-000]

Notice of Request Under Blanket Authorization: Natural Gas
Pipeline Company of America, LLC

    Take notice that on July 29, 2016, Natural Gas Pipeline Company of
America, LLC (Natural), 3250 Lacey Road, Suite 700, Downers Grove,
Illinois 60515, filed in Docket No. CP16-485-000 a prior notice request
pursuant to sections 157.205 and 157.216 of the Commission's
regulations under the Natural Gas Act (NGA), requesting authorization
to plug and abandon the Karcher 9 injection/withdrawal well and abandon
and remove related meter and surface facilities as well as a related
lateral and tap at Natural's Herscher Galesville Storage Field located
in Kankakee County, Illinois. Natural states that, as a result of the
proposed abandonment project, there will be no impact on the Herscher
Galesville Storage Field's certificate parameters and that there will
be no decrease in service to customers. Natural estimates the cost of
the project to be $268,000, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Bruce
H. Newsome, Vice President, Regulatory Products and Services, Natural
Gas Pipeline Company of America, LLC, 3250 Lacey Road, Suite 700,
Downers Drove, Illinois 60515-7918, by telephone at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and seven copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426.

    Dated: August 4, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-19067 Filed 8-10-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Notices]
[Pages 43063-43064]
[FR Doc No: 2017-19446]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 38a-1, OMB Control No. 3235-0586, SEC File No. 270-522.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget a request for extension of the previously
approved collection of information discussed below.
    Rule (17 CFR 270.38a-1) under the Investment Company Act of 1940
(15 U.S.C. 80a) (``Investment Company Act'') is intended to protect
investors by fostering better fund compliance with securities laws. The
rule requires every registered investment company and business
development company (``fund'') to: (i) Adopt and implement written
policies and procedures reasonably designed to prevent violations of
the federal securities laws by the fund, including procedures for
oversight of compliance by each investment adviser, principal
underwriter, administrator, and transfer agent of the fund; (ii) obtain
the fund board of directors' approval of those policies and procedures;
(iii) annually review the adequacy of those policies and procedures and
the policies and procedures of each investment adviser, principal
underwriter, administrator, and transfer agent of the fund, and the
effectiveness of their implementation; (iv) designate a chief
compliance officer to administer the fund's policies and procedures and
prepare an annual report to the board that addresses certain specified
items relating to the policies and procedures; and (v) maintain for
five years the compliance policies and procedures and the chief
compliance officer's annual report to the board.
    The rule contains certain information collection requirements that
are designed to ensure that funds establish and maintain comprehensive,
written internal compliance programs. The information collections also
assist the Commission's examination staff in assessing the adequacy of
funds' compliance programs.
    While Rule 38a-1 requires each fund to maintain written policies
and procedures, most funds are located within a fund complex. The
experience of the Commission's examination and oversight staff suggests
that each fund in a complex is able to draw extensively from the fund
complex's ``master'' compliance program to assemble appropriate
compliance policies and procedures. Many fund complexes already have
written policies and procedures documenting their compliance programs.
Further, a fund needing to develop or revise policies and procedures on
one or more topics in order to achieve a comprehensive compliance
program can draw on a number of outlines and model programs available
from a variety of industry representatives, commentators, and
organizations.
    There are approximately 4,133 funds subject to Rule 38a-1. Among
these funds, 97 were newly registered in the past year. These 97 funds,
therefore, were required to adopt and document the policies and
procedures that make up their compliance programs. Commission staff
estimates that the average annual hour burden for a fund to adopt and
document these policies and procedures is 105 hours. Thus, we estimate
that the aggregate annual

burden hours associated with the adoption and documentation requirement
is 10,185 hours.
    All funds are required to conduct an annual review of the adequacy
of their existing policies and procedures and the policies and
procedures of each investment adviser, principal underwriter,
administrator, and transfer agent of the fund, and the effectiveness of
their implementation. In addition, each fund chief compliance officer
is required to prepare an annual report that addresses the operation of
the policies and procedures of the fund and the policies and procedures
of each investment adviser, principal underwriter, administrator, and
transfer agent of the fund, any material changes made to those policies
and procedures since the date of the last report, any material changes
to the policies and procedures recommended as a result of the annual
review, and certain compliance matters that occurred since the date of
the last report. The staff estimates that each fund spends 49 hours per
year, on average, conducting the annual review and preparing the annual
report to the board of directors. Thus, we estimate that the annual
aggregate burden hours associated with the annual review and annual
report requirement is 202,517 hours.
    Finally, the staff estimates that each fund spends 6 hours
annually, on average, maintaining the records required by proposed Rule
38a-1. Thus, the annual aggregate burden hours associated with the
recordkeeping requirement is 24,798 hours.
    In total, the staff estimates that the aggregate annual information
collection burden of Rule 38a-1 is 237,500 hours. The estimate of
burden hours is made solely for the purposes of the Paperwork Reduction
Act. The estimate is not derived from a comprehensive or even a
representative survey or study of the costs of Commission rules.
Complying with this collection of information requirement is mandatory.
Responses will not be kept confidential. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: September 8, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-19446 Filed 9-12-17; 8:45 am]
 BILLING CODE 8011-01-P