[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Page 8710]
[FR Doc No: 2019-04329]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-64-000.
    Applicants: Canal 3 Generating LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Canal 3 Generating LLC.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5197.
    Comments Due: 5 p.m. ET 3/26/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-2030-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Request for Deferral of Effective
Date--Revisions to RNU Rounding Process to be effective N/A.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5198.
    Comments Due: 5 p.m. ET 3/26/19.

    Docket Numbers: ER19-836-001.
    Applicants: El Paso Electric Company.
    Description: Tariff Amendment: Service Agreement No. 315, EDF PTP
to be effective 5/18/2019.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5133.
    Comments Due: 5 p.m. ET 3/26/19.

    Docket Numbers: ER19-1188-000.
    Applicants: RC Cape May Holdings, LLC.
    Description: Tariff Cancellation: Notice of Cancellation of
Reliability Must-Run Agreement to be effective 5/1/2019.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5129.
    Comments Due: 5 p.m. ET 3/26/19.

    Docket Numbers: ER19-1189-000.
    Applicants: RC Cape May Holdings, LLC.
    Description: Tariff Cancellation: RC Cape May Notice of
Cancellation MBR Tariff to be effective 5/1/2019.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5132.
    Comments Due: 5 p.m. ET 3/26/19.

    Docket Numbers: ER19-1190-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to 5 WMPAs; SA No.
3147, 3318, 3524, 4083, 3094 re: Marina to GRSP to be effective 10/11/
2011.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5153.
    Comments Due: 5 p.m. ET 3/26/19.

    Docket Numbers: ER19-1191-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: Brother Solar LGIA Filing to
be effective 2/21/2019.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5155.
    Comments Due: 5 p.m. ET 3/26/19.

    Docket Numbers: ER19-1193-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: Kruger Energy North Sumter
Solar LGIA Filing to be effective 2/25/2019.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5157.
    Comments Due: 5 p.m. ET 3/26/19.

    Docket Numbers: ER19-1194-000.
    Applicants: Canal 3 Generating LLC.
    Description: Baseline eTariff Filing: Baseline New to be effective
3/6/2019.
    Filed Date: 3/5/19.
    Accession Number: 20190305-5191.
    Comments Due: 5 p.m. ET 3/26/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 5, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-04329 Filed 3-8-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10857-10858]
[FR Doc No: 2016-04597]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0099; FRL-9942-65]

Premanufacture Notice for a Certain New Chemical; Extension of
Review Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's extension of the review period for
a premanufacture notice (PMN) P-14-0627 under the Toxic Substances
Control Act (TSCA). Based on analysis, the Agency requires an extension
of the review period to investigate further potential risk, examine
regulatory options, and prepare the necessary documents, should
regulatory action be required.

DATES: The review period is extended to May 25, 2016.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Jeff Bauer, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the chemical manufacturing company that
submitted the PMN. This action may also be of interest to persons
concerned about health, environmental, and/or economic aspects of this
new chemical substance. Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0099, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What chemical is subject to this notice?

    On June 19, 2014, EPA received PMN number P-14-0627 for a new
chemical substance, identified as Cyclic amide. The submitter claimed
the company name, specific chemical identity, production volume, use
information, process information, and other information to be CBI.

III. What action is the Agency taking?

    The notice of receipt for this PMN was published in the Federal
Register of September 16, 2014 (79 FR 55460) (FRL-9915-80). The running
of the PMN review period was voluntarily suspended by the PMN submitter
with EPA's agreement. The PMN review period has been resumed. As
extended,

the review period for this PMN expires May 25, 2016.

IV. What is EPA's authority for taking this action?

    Section 5(c) of TSCA and 40 CFR 720.75(c) authorizes EPA to extend,
for good cause, the 90-day PMN review period for additional periods not
to exceed in the aggregate 90 days. For this PMN, EPA finds that there
is good cause to extend the review period. Based on analysis, EPA may
need to regulate this new chemical substance and the Agency needs an
extension of the review period to further investigate potential risk,
examine regulatory options, and prepare the necessary documents, should
regulatory action be required.

    Authority:  15 U.S.C. 2601 et seq.

    Dated: February 25, 2016.
Greg Schweer,
Chief, New Chemicals Notice Management Branch, Office of Pollution
Prevention and Toxics.
[FR Doc. 2016-04597 Filed 3-1-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Proposed Rules]
[Page 11049-11050]
[DOCID:fr16mr09-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0884 FRL-8771-2]

 Approval and Promulgation of Implementation Plans; Hawaii;
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Clean Air Act, EPA is proposing to correct errors in
certain final rules approving or compiling the Hawaii state
implementation plan. These errors relate to the title of the plan,
removal of variance provisions, and compilations of federally
enforceable regulations. The intended effect is to ensure that the
Hawaii state implementation plan is correctly identified in the
applicable part of the Code of Federal Regulations.

DATES: Any comments on this proposal must arrive by April 15, 2009.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2008-0884, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the
online instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Ginger Vagenas (AIR-2), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or e-mail.
The www.regulations.gov portal is an ``anonymous access'' system, and
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send e-mail directly to
EPA, your e-mail address will be automatically captured and included as
part of the public comment. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Ginger Vagenas, Plannning Office (AIR-
2), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses corrections to
errors made by EPA in a 1997 final rule removing variance-related
provisions from the Hawaii SIP and in a 2005 final rule compiling the
Hawaii SIP. In the Rules and Regulations section of this Federal
Register, we are correcting these errors in a direct final action
without prior proposal because we believe these actions are not
controversial.
    If we receive adverse comments, however, we will publish a timely
withdrawal of the direct final rule and address the comments in
subsequent action based on this proposed rule. Please note that if we
receive adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, we may adopt as

final those provisions of the rule that are not the subject of an
adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: February 25, 2009.
Jane Diamond,
Acting Regional Administrator, Region IX.
[FR Doc. E9-4800 Filed 3-13-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34566-34568]
[FR Doc No: 2017-15569]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2017-0032]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 43 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on May 13, 2017. The exemptions
expire on May 13, 2019.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On April 12, 2017, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 43 individuals and requested
comments from the public (82 FR 17728). The public comment period
closed on May 12, 2017 and one comment was received.
    FMCSA has evaluated the eligibility of the 43 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 43 applicants have had ITDM over a range of 1 to 30 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and the medical condition of each applicant were
stated and discussed in detail in the April 12, 2017, Federal Register
notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received one comment in this proceeding. Mark Skubik stated
that he believes ``FMCSA should err on the side of safety'' when making
an exemption determination. He also stated that he believes drivers
should be required to carry ``at least $2,000,000 in liability
insurance beyond the minimal insurance requirements for commercial
drivers,'' citing safety concerns. FMCSA sets minimum financial
responsibility levels for carriers, based on their operations (general
freight, passenger, hazmat, etc.). If a carrier obtains additional
insurance, above and beyond the minimum requirements, that is decided
by the carrier. FMCSA does not regulate insurance levels of drivers,
just the companies and their operations, based on their granted
authority. The Agency doesn't feel that drivers should carry additional
insurance. FMCSA has reviewed the medical records for each driver in
this document and has determined that granting the exemptions will
likely achieve a level of safety equal to or greater than that existing
without the exemption.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's

or optometrist's report to the medical examiner at the time of the
annual medical examination; and (4) that each individual provide a copy
of the annual medical certification to the employer for retention in
the driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must also
have a copy of the certification when driving, for presentation to a
duly authorized Federal, State, or local enforcement official.

VI. Conclusion

    Based upon its evaluation of the 43 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(3):

Lucas L.R. Adams (NE)
Ronald E. Allen, Jr. (CA)
Kevin N. Blair (KS)
Justin D. Bodily (ID)
George C. Burbach (CA)
Paul T. Caputo (IN)
Frederic J. Conti (PA)
Joshua L. Crider (MN)
Culley R. Despain (MO)
Mitchell F. Durkan (CO)
Ray A. Espinoza (CA)
Christopher J. Fisher (OR)
Jacob L. Flatt (OK)
Terry Fleharty (NM)
Kevin P. Fulcher (MA)
Michael F. Fulton (AZ)
Ivan R. Grove (PA)
Nathaniel M.I. Hicks (OR)
Daniel J. Lacroix (MA)
Kenneth S. LeColst (MA)
John G. Liebl (MN)
William E. McClain (IL)
Kevon T. McCray (NC)
Rodney G. Moore (WA)
Brian M. Morel (NJ)
Keith E. Newbauer (IN)
Herbert L. Redd (IN)
Quentin M. Rembert (WI)
Philip J. Richard (PA)
Lars A. Sandaker (MN)
John E. Sargent, Jr. (MA)
Kevin R. Sewell (NC)
Donald J. Smith (VT)
Larry D. Smith (TN)
Warren A. Smith (NJ)
Daniel J. Spauling (ID)
Russell D. Swanson (SD)
Scot D. Thompson (NY)
Wayne F. Todd (NE)
Harold W. Trombly, III (MA)
Steven L. Welker (IA)
Christopher U. Williams (LA)
Craig L. Woodard (OH)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: July 18, 2017.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2017-15569 Filed 7-24-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: October 25, 2010 (Volume 75, Number 205)]
[Notices]
[Page 65495-65496]
[DOCID:fr25oc10-69]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]

Draft Guidance for Industry on Qualification Process for Drug
Development Tools; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Qualification
Process for Drug Development Tools.'' This draft guidance describes the
qualification process for drug development tools (DDTs) intended for
potential use, over time, in multiple drug development programs. The
draft guidance provides a framework for interactions between the Center
for Drug Evaluation and Research (CDER) and DDT sponsors to support
work towards qualification of an identified DDT and creates a mechanism
for formal review of data by CDER to qualify the DDT and ensure that
the evaluation is comprehensive and reliable.

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 January 24, 2011.

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 that 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,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shaniece Gathers, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 4555, Silver Spring, MD 20993-0002, 301-
796-2600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Qualification Process for Drug Development Tools.'' In March
2006, FDA issued the ``Critical Path Opportunities Report'' and the
``Critical Path Opportunities List.'' In these reports, FDA described
six key areas along the critical path to improved therapies, and a list
of specific opportunities for advancement within these topic areas. The
opportunities report noted that a new product

development toolkit containing new scientific and technical methods was
needed to improve the efficiency of drug development. Too often,
attention to a needed DDT is delayed until the time when the
registration study protocols are under development and the available
DDTs are inadequate. Innovative and improved DDTs are among the methods
that can help streamline the drug development process, improve the
chances for clinical trial success, and yield more information about
the treatment and/or disease. DDTs include, but are not limited to
biomarkers and patient reported outcome instruments. This draft
guidance describes a formal process that CDER will use in working with
sponsors of these tools to guide them as they refine the tools and
rigorously evaluate them for use in the regulatory process.
    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 the
qualification process for DDTs . 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. 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 312.30, 21 CFR 314.50(d)(5), and
21 CFR 314.126(b)(6) have been approved under OMB control numbers 0910-
0001 and 0910-0014.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

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: October 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26927 Filed 10-22-10; 8:45 am]
BILLING CODE 4160-01-P