[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]
[Page 25823-25825]
[DOCID:fr07my08-151]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice and Request For Comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Requirements (ICRs) abstracted below have been forwarded to
the Office of Management and Budget (OMB) for review and comment. Each
ICR describes the nature of the information collection and its expected
burden. The Federal Register notice with a 60-day comment period
soliciting comments on the collections of information listed below was
published on February 26, 2008 (See 73 FR 10322).

DATES: Comments must be submitted on or before June 6, 2008.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 25, Washington, DC 20590 (telephone:
(202) 493-6292), or Ms. Nakia Poston, Office of Information Technology,
RAD-20, Federal Railroad Administration, 1200 New Jersey Ave., SE.,
Mail Stop 35, Washington, DC 20590 (telephone:<PHONE_NUMBER>). (These
telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Pub. L. 104-13, section 2, 109 Stat. 163 (1995) (codified as revised at
44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR Part
1320, require Federal agencies to issue two notices seeking public
comment on information collection activities before OMB may approve
paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1),
1320.12. On February 26, 2008, FRA published a 60-day notice in the
Federal Register soliciting comment on ICRs that the agency was seeking
OMB approval. 73 FR 10322. FRA received no comments in response to this
notice.
    Before OMB decides whether to approve this proposed collection of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30 day
notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30 day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure having their full effect. 5

CFR 1320.12(c); see also 60 FR 44983, Aug. 29, 1995.
    The summaries below describe the nature of the information
collection requirements (ICRs) and the expected burden. The revised
requirements are being submitted for clearance by OMB as required by
the PRA.
    Title: Railroad Locomotive Safety Standards and Event Recorders.
    OMB Control Number: 2130-0004.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Form(s): FRA F 6180.49A.
    Abstract: The Locomotive Inspection requires railroads to inspect,
repair, and maintain locomotives and event recorders so that they are
safe, free of defects, and can be placed in service without peril to
life. Crashworthy locomotive event recorders provide FRA with
verifiable factual information about how trains are maintained and
operated, and are used by FRA and State inspectors for Part 229 rule
enforcement. The information garnered from crashworthy event recorders
is also used by railroads to monitor railroad operations and by
railroad employees (locomotive engineers, train crews, dispatchers) to
improve train handling, and promote the safe and efficient operation of
trains throughout the country, based on a surer knowledge of different
control inputs.
    Annual Estimated Burden: 863,951 hours.
    Title: Qualifications for Locomotive Engineers.
    OMB Control Number: 2130-0533.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Form(s): N/A.
    Abstract: Section 4 of the Rail Safety Improvement Act of 1988
(RSIA), Public Law 100-342, 102 Stat. 624 (June 22, 1988), later
amended and re-codified by Public Law 103-272, 108 Stat. 874 (July 5,
1994), required that FRA issue regulations to establish any necessary
program for certifying or licensing locomotive engineers. The
collection of information is used by FRA to ensure that railroads
employ and properly train qualified individuals as locomotive engineers
and designated supervisors of locomotive engineers. The collection of
information is also used by FRA to verify that railroads have
established required certification programs for locomotive engineers
and that these programs fully conform to the standards specified in the
regulation.
    Annual Estimated Burden: 271,000 hours.
    Title: Roadway Worker Protection (Roadway Maintenance Machines).
    OMB Control Number: 2130-0539.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Form(s): FRA F 6180.119.
    Abstract: This rule establishes regulations governing the
protection of railroad employees working on or near railroad tracks.
The regulation requires that each railroad devise and adopt a program
of on-track safety to provide employees working along the railroad with
protection from the hazards of being struck by a train or other on-
track equipment. Elements of this on-track safety program include an
on-track safety manual; a clear delineation of employers'
responsibilities, as well as employees' rights and responsibilities
thereto; well-defined procedures for communication and protection; and
annual on-track safety training. The program adopted by each railroad
is subject to review and approval by FRA.
    Annual Estimated Burden: 817,358 hours.
    Title: Locomotive Cab Sanitation Standards.
    OMB Control Number: 2130-0552.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Form(s): N/A.
    Abstract: The collection of information is used by FRA to promote
rail safety and the health of railroad workers by ensuring that all
locomotive crew members have access to toilet/sanitary facilities--on
as needed basis--which are functioning and hygienic. Also, the
collection of information is used by FRA to ensure that railroads
repair defective locomotive toilet/sanitary facilities within 10
calendar days of the date on which these units becomes defective.
    Annual Estimated Burden: 1,272 hours.
    Title: Positive Train Control.
    OMB Control Number: 2130-0553.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Railroads.
    Form(s): N/A.
    Abstract: The collection of information is used by FRA to ensure
that new or novel signal and train control technologies, essentially
electronic or processor-based systems, meet the ``performance
standard'' stipulated in FRA's rule and work as intended in the U.S.
rail environment. These new signal and train control technologies are
known as ``Positive Train Control'' (PTC).
    Annual Estimated Burden: 250,966 hours.
    Title: Post-Traumatic Stress in Train Crew Members After a Critical
Incident.
    OMB Control Number: 2130-0567.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Train Crew Members.
    Form(s): FRA-F-186, FRA-F-187, FRA-F-188.
    Abstract: Nearly 1,000 fatalities occur every year in this country
from trains striking motor vehicles at grade crossings and individual
trespassers along the track. These events can be very traumatic to
train crew members, who invariably are powerless to prevent such
collisions. Exposure of train crews to such work-related traumas can
cause extreme stress and result in safety-impairing behaviors, such as
are seen in Post-Traumatic Stress Disorder or Acute Stress Disorder.
Most railroads have Critical Incident Stress Debriefing (CISD)
intervention programs designed to mitigate problems caused by exposure
to these traumas. However, they are quite varied in their approach, and
it is not certain which components of these programs are most
effective. The purpose of this collection of information is to identify
``best practices'' for CISD programs in the railroad industry. By means
of written and subsequent oral interviews with train crew members that
will each take approximately 45 minutes, the approved study aims to
accomplish the following: (1) Benchmark rail industry best practices of
CISD programs; (2) Establish the extent of traumatic stress disorders
due to grade crossing and trespasser incidents in the rail industry
(not by region or railroad) and identify at-risk populations; and (3)
Evaluate the effectiveness of individual components of CISD programs.
It should be noted that only the components of CISD programs will be
evaluated, not an individual railroad's overall intervention program.
    Annual Estimated Burden: 2,043 hours.

ADDRESSES: Send comments regarding these information collections to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 Seventeenth Street, NW., Washington, DC, 20503; Attention:
FRA Desk Officer. Comments may also be sent via e-mail to the Office of
Information and Regulatory Affairs (OIRA) of the Office of Management
and Budget at the following address<EMAIL_ADDRESS>    Comments are invited on the following: Whether the proposed
collections of information are necessary for the proper performance of
the functions of FRA, including whether the information will have
practical utility; the accuracy of FRA's estimates of the

burden of the proposed information collections; ways to enhance the
quality, utility, and clarity of the information to be collected; and
ways to minimize the burden of the collections of information on
respondents, including the use of automated collection techniques or
other forms of information technology.
    A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on May 1, 2008 .
Kimberly Orben,
Acting Director, Office of Financial Management, Federal Railroad
Administration.
 [FR Doc. E8-10091 Filed 5-6-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register: August 11, 2010 (Volume 75, Number 154)]
[Notices]
[Page 48667-48669]
[DOCID:fr11au10-54]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0012; FRL-8840-6]

Notice of Receipt of Several Pesticide Petitions Filed for
Residues of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the Agency's receipt of several initial
filings of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before September 10, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse

human health impacts or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.

II. What Action is the Agency Taking?

     EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. EPA has determined that
the pesticide petitions described in this notice contain the data or
information prescribed in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petitions.
Additional data may be needed before EPA can make a final determination
on these pesticide petitions.
     Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this notice, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://
www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerance

    1. PP 0E7738. (EPA-HQ-OPP-2010-0619). IR-4, 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to establish tolerances in
40 CFR part 180 for the combined residues of the insecticide avermectin
B1 (a mixture of avermectins containing greater than or
equal to 80% avermectinB1a (5-O- demethyl avermectin
A1) and less than or equal to 20% avermectin B1b
(5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin
A1)) and its delta-8,9-isomer, in or on bean, dry, seed at
0.01 parts per million (ppm); chive, dried leaves at 0.07 ppm; chive,
fresh leaves at 0.01 ppm; and onion, bulb, subgroup 3-07A at 0.01 ppm.
The analytical methods involve homogenization, filtration, partition,
and cleanup with analysis by high performance liquid chromatography
(HPLC)-fluorescence detection. The methods are sufficiently sensitive
to detect residues at or above the tolerances proposed. All methods
have undergone independent laboratory validation as required by PR
Notice 96-1. Contact: Laura E. Nollen,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    2. PP 0F7721. (EPA-HQ-OPP-2010-0615). Syngenta Crop Protection,
Inc., Regulatory Affairs, P.O. Box 18300, Greensboro, NC 27419-8300,
proposes to establish tolerances in 40 CFR part 180 for residues of the
fungicide sedaxane as a seed treatment, in or on barley, grain, seed at
0.01 ppm; barley, hay, seed at 0.05 ppm; barley, straw, seed at 0.01
ppm; canola, seed at 0.01 ppm; oat, grain, seed at 0.01 ppm; rye, seed
at 0.01 ppm; soybean, forage, seed at 0.06 ppm; soybean, hay, seed at
0.4 ppm; soybean, seed at 0.01 ppm; triticale, seed at 0.01 ppm; wheat,
forage, seed at 0.02 ppm; wheat, grain, seed at 0.01 ppm; wheat, hay,
seed at 0.07 ppm; and wheat, straw, seed at 0.01 ppm. Various crops
were analyzed for sedaxane (parent only) using a procedure for analysis
of sedaxane (SYN524464) that can distinguish between its trans
(SYN508210) and cis (SYN508211) isomers. Plant matrices using method
GRM023.01A or modified method GRM023.01B are taken through an
extraction procedure with final determination by high performance
liquid chromatography with triple quadrupole mass spectrometric
detection (LC-MS/MS). Contact: Heather Garvie,<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>    3. PP 0F7734. (EPA-HQ-OPP-2010-0602). Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27410, proposes to establish a
tolerance in 40 CFR part 180 for residues of the insecticide
thiamethoxam, (3-[(2-chloro-5-thiazolyl) methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine) and its metabolite [N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine], in or on food
commodities/feed commodities (other than those covered by a higher
tolerance as a result of use on growing crops) in food/feed handling
establishments at 0.01 ppm. Syngenta Crop Protection has submitted
practical analytical methodology for detecting and measuring levels of
thiamethoxam in or on raw agricultural commodities. This method is
based on crop specific cleanup procedures and determination by liquid
chromatography with either ultraviolet (UV) or mass spectrometry (MS)
detections. The limit of detection (LOD) for each analyte of this
method is 1.25 ng injected for samples analyzed by UV and 0.25 ng
injected for samples analyzed by MS, and the limit of quantification
(LOQ) is 0.005 ppm for milk and juices, and 0.01 ppm for all other
substrates. Contact: Kable Bo Davis,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    4. PP 0F7739. (EPA-HQ-OPP-2010-0603). Chemtura Corporation, 199
Benson Road (2-5), Middlebury, CT 06749, proposes to establish
tolerances in 40 CFR part 180 for residues of the insecticide
diflubenzuron, N-[[(4-chlorophenyl) amino]carbonyl]-2,6-
difluorobenzamide (DFB) and its metabolites 4-chlorophenylurea (CPU)
and 4-chloroaniline (PCA), in or on citrus fruit, crop group 10 at 1.3
ppm, and citrus, oil processed commodity at 39 ppm. A practical
analytical method for detecting and quantifying levels of diflubenzuron
in or on food with a LOD that allows monitoring of the residue at or
above the level set in the tolerance was used to determine residues in
citrus raw agricultural commodities (RAC) and processed commodities.
Contact: Kable Bo Davis,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: August 3, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 2010-19831 Filed 8-10-10; 8:45 am]
BILLING CODE 6560-50-S


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: April 6, 2006 SUBJECT: Fenarimol: Re evaluation of the FQPA Safety Factor FROM: Vicki Dellarco, PhD, Senior Science Advisor William Burnam, Senior Scientist Health Effects Division ( 7509C), Office of Pesticide Programs TO: Christina Swartz, Branch Chief, Registration Action Branch 2 Health Effects Division ( 7509C), Office of Pesticide Programs In a July 29, 2002 HIARC report on fenarimol, it was concluded that a 3X FQPA Safety Factor be retained because of the potential of fenarimol to affect the hormone system during reproductive development and the need to better characterize its endocrine effects. This concern was based on the observation from an in vitro study that fenarimol inhibited aromatase ( an enzyme complex responsible for estrogen biosynthesis that converts androgens into estrogens, and thus aromatase inhibition would result in attenuate estradiol levels) and its affect on fertility in males ( which occurred at the mid and high treatment doses, 8 and 20 mg/ kg per day, respectively) and dystocia in females ( which occurred at 35 mg/ kg per day, the only dose tested).

Since this HIARC memorandum, fenarimol has been evaluated in studies considered in EPA's Endocrine Disruptor Screening Program including the Pubertal Female and Uterotrophic Assays. The Pubertal Female Assay involves the use of rats to screen for estrogenic and thyroid activity in females during sexual maturation, and examines abnormalities associated with sex organs and puberty markers, as well as thyroid tissue. This assay examines abnormalities associated with sex organs and puberty markers, as well as thyroid tissue. The Uterotrophic assay involves the use of female rats to screen for estrogenic effects. In this in vivo assay, uterine weight changes are measured in ovariectomised or immature female rats.

No adverse effects were found in the female pubertal assay when SD rats were treated at 50 and 250 mg/ kg day for 21 days, except for a decrease in T4 and an increase in circulating TSH levels ( George et al., 2002). In the Uterotrophic assay, a dose of 200 mg/ kg day results in a significant increase of uterine 2 weights which were accompanied by an increase in serum FSH levels and a decrease in serum T3 levels ( Anderson et al, 2006). The uterotrophic response and the effects found on thyroid hormone levels are found at much higher doses than the regulatory endpoints based on the rat multi generation study where fenarimol reduced fertility of males at 1.2 mg/ kg per day with a NOAEL of 0.6 mg/ kg per day. The 0.6 mg/ kg NOAEL is over 300 fold lower than the uterotrophic response found in rats at 200 mg/ kg.

In conclusion, no additional studies are needed on fenarimol. This is because of the new special studies ( the pubertal and uterotrophic assays) along with the existing standard 2 generation rat reproductive study provides an adequate characterization of the reproductive, developmental and endocrine effects of fenarimol,. In particular, the new rat pubertal study by George et al., provides a sensitive indicator ( i. e., delay in vaginal opening) of potential adverse effects on the young that may arise because of aromatase inhibition. With these new data, there is greater confidence in the current NOAEL of 0.6 mg/ kg per day, and thus the 3X FQPA safety factor be reduced to 1X because there are adequate data evaluating the potential endocrine effects of fenarimol during reproduction and development in the young animal.

References:

George JD, Tyl R, Hamby BT, Myers C, and MC Marr ( May 20, 2002). Assessment of Pubertal Developmental and Thyroid Function in Juvenile Female CD ( Sprague Dawley) Rats after exposure to Selected Chemicals administered by Gavage on Postantal days 22 to 42/ 43. Final Report Date August 22, 2002. PDF FILE ATTACHED Anderson et. al., ( 2006) Estrogenic effects in vitro and in vivo of the fungicide fenarimol. Tox Lettters 163: 142 152. PDF FILE ATTACHED CC: TINA LEVINE


[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3403-3404]
[FR Doc No: 2023-00953]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER15-1434-006.
    Applicants: ISO New England Inc., Emera Maine.
    Description: Compliance filing: ISO New England Inc. submits tariff
filing per 35: Versant Power; Docket No. ER15-1434 Revised Joint offer
of Settlement to be effective N/A.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5000.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER20-2119-002.
    Applicants: ISO New England Inc., Versant Power.
    Description: Compliance filing: ISO New England Inc. submits tariff
filing per 35: Versant Power; Docket No. ER20-2119 Revised Joint Offer
of Settlement to be effective N/A.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5001.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER23-226-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: Deficiency Response--Fourth Amended
and Restated WDJAs to be effective 12/28/2022.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5072.
    Comment Date: 5 p.m. ET 1/25/23.

    Docket Numbers: ER23-446-001.
    Applicants: Duke Energy Indiana, LLC.
    Description: Tariff Amendment: DEI- Request to Defer Action on
Construction Agreement to be effective 12/31/9998.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5071.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER23-817-000.
    Applicants: WPL Bear Creek Solar, LLC.
    Description: Tariff Amendment: WPL Bear Creek Solar Cancellation of
MBR Tariff to be effective 1/11/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5126.

    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-818-000.
    Applicants: WPL Crawfish River Solar, LLC.
    Description: Tariff Amendment: WPL Crawfish River Solar Notice of
Cancel MBR Tariff to be effective 1/11/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5128.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-819-000.
    Applicants: WPL North Rock Solar, LLC.
    Description: Tariff Amendment: WPL North Rock Solar Notice of
Cancel MBR Tariff to be effective 1/11/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5129.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-820-000.
    Applicants: WPL Wood County Solar, LLC.
    Description: Tariff Amendment: WPL Wood County Solar, LLC Notice of
Cancel MBR Tariff to be effective 1/11/2023.
    Filed Date: 1/11/23.
    Accession Number: 20230111-5131.
    Comment Date: 5 p.m. ET 2/1/23.

    Docket Numbers: ER23-821-000.
    Applicants: New York State Reliability Council, L.L.C.
    Description: Informational Filing of the Revised Installed Capacity
Requirement of the New York Control Area by the New York State
Reliability Council, L.L.C.
    Filed Date: 12/22/22.
    Accession Number: 20221222-5340.
    Comment Date: 5 p.m. ET 1/18/23.

    Docket Numbers: ER23-822-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2023-01-12_SA 3339
Termination of MidAmerican-Contrail Wind Project E&P (J611) to be
effective 1/13/2023.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5017.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER23-823-000.
    Applicants: EnerSmart Chula Vista BESS LLC.
    Description: Sec.  205(d) Rate Filing: Request to Make Capacity
Sales at Market-Based Rates to be effective 3/14/2023.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5022.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER23-824-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, Service
Agreement No. 5999; Queue No. AC2-012 to be effective 3/10/2021.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5087.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER23-825-000.
    Applicants: Appalachian Power Company.
    Description: Sec.  205(d) Rate Filing: OATT--Revise Attachment K,
AEP Texas Inc. Compliance with PUCT Project 53169 to be effective 12/
31/9998.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5088.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER23-826-000.
    Applicants: Northern States Power Company, a Minnesota corporation.
    Description: Sec.  205(d) Rate Filing: 2023-1-12 ERPC Nighthawk
CIAC 716-NSP to be effective 3/13/2023.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5114.
    Comment Date: 5 p.m. ET 2/2/23.

    Docket Numbers: ER23-827-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Sec.  205(d) Rate Filing: Filing of Certificate of
Concurrence to be effective 3/13/2023.
    Filed Date: 1/12/23.
    Accession Number: 20230112-5115.
    Comment Date: 5 p.m. ET 2/2/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: January 12, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-00953 Filed 1-18-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Pages 40748-40749]
[FR Doc No: 2014-16347]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14338-001]

Commission of Public Works of the City of Spartanburg, South
Carolina; Notice of Intent To File License Application, Filing of Pre-
Application Document, and Approving Use of the Traditional Licensing
Process

    a. Type of Filing: Notice of Intent To File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14338-001.
    c. Date Filed: May 27, 2014.
    d. Submitted By: Commission of Public Works of the City of
Spartanburg, South Carolina (Spartanburg Water System).
    e. Name of Project: Blalock Hydroelectric Project.
    f. Location: At the existing Lake Blalock Dam on the Pacolet River,
in Spartanburg County, South Carolina. No federal lands are occupied by
the project works or located within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Ken Tuck, Spartanburg Water System,
200 Commerce Street, P.O. Box 251, Spartanburg, South Carolina 29304;
(864) 580-5642<EMAIL_ADDRESS>    i. FERC Contact: Rachel McNamara at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Spartanburg Water System filed its request to use the
Traditional Licensing Process on May 27, 2013. Spartanburg Water System
provided public notice of its request on May 25, 2013. In a letter
dated July 7, 2014, the Director of the Division of Hydropower
Licensing approved Spartanburg Water System's request to use the
Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the South Carolina State Historic Preservation
Officer, as required by section 106, National Historical Preservation
Act, and the implementing regulations of the Advisory Council on
Historic Preservation at 36 CFR 800.2.

    l. With this notice, we are designating Spartanburg Water System as
the Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act; and consultation pursuant to section 106 of the
National Historic Preservation Act.
    m. Spartanburg Water System filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

     Dated: July 7, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-16347 Filed 7-11-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 15, 2010 (Volume 75, Number 199)]
[Notices]
[Page 63528-63530]
[DOCID:fr15oc10-150]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63068; File No. SR-BYX-2010-001]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing of a Proposed Rule Change To Amend BYX Rule 11.8, Entitled
``Obligations of Market Makers''

October 8, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\

notice is hereby given that on September 27, 2010, BATS Y-Exchange,
Inc. (``BYX'' or the ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to amend BYX Rule 11.8, which relates to
the obligations of market makers registered with BYX (``Market
Makers'').
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to adopt rules to enhance minimum quotation
requirements for market makers. Under the proposal, the Exchange will
require market makers for each stock in which they are registered to
continuously maintain a two-sided quotation within a designated
percentage of the National Best Bid (``NBB'') and National Best Offer
(``NBO'') (or, if there is no NBB or NBO, the last reported sale).
These enhanced market maker quotation requirements are intended to
eliminate trade executions against market maker placeholder quotations
traditionally priced far away from the inside market, commonly known as
``stub quotes.'' They are also intended to augment and work in relation
to the single stock pause standards already in place on a pilot basis
for stocks in the S&P 500[supreg] Index,\3\ the Russell 1000[supreg]
Index, as well as a pilot list of Exchange Traded Products.\4\
---------------------------------------------------------------------------

    \3\ See, e.g., Securities Exchange Act Release No. 62340 (June
21, 2010), 75 FR 36768 (June 28, 2010) (SR-BATS-2010-014). The
Exchange is separately working to amend its rules prior to
commencement of operations to make clear that it will pause trading
in Circuit Breaker Securities when an individual stock trading pause
is issued by a primary listing market.
    \4\ See, e.g., Securities Exchange Act Release No. 62884
(September 10, 2010), 75 FR 56618 (September 16, 2010) (SR-BATS-
2010-018); see id.
---------------------------------------------------------------------------

    Under the proposal, the Exchange will require registered market
makers to enter and maintain quotes priced at no more than a certain
percentage away from the national inside bid and offer. Permissible
quotes are determined by the individual character of the security, the
time of day in which the quote is entered, and other factors which are
summarized below.
    For issues subject to an individual stock trading pause, a
permissible quote is determined by first looking at the applicable
individual stock pause trigger percentage of the security and then
reducing that number by 2%. Since currently the individual stock pause
trigger percentage utilized by the primary listing markets is 10%, a
market maker's quote in a [sic] such a security may not be more than 8%
away from the NBBO as appropriate. Once a compliant quote is entered,
it may rest without adjustment until such time as it moves to within
\1/2\ of 1% of the applicable stock pause trigger percentage (i.e.,
currently 9.5%) whereupon the market maker must immediately move its
quote back to at least the permissible default level of 8% away from
the NBBO. During times in which a stock pause trigger percentage is not
applicable (e.g., before 9:45 a.m. and after 3:35 p.m.), a market maker
must maintain a quote no further than 20% away from the inside (i.e.,
it may rest without adjustment until it reaches 21.5%). In the absence
of a NBB or NBO, the above calculations will remain the same, but will
use the national last sale instead of the absent bid or offer.
    For securities not subject to any individual stock trading pause,
the proposal will a [sic] assume a hypothetical 32% stock pause trigger
percentage, apply a 2% reduction, and require market makers in those
issues to maintain quotes no more than 30% away from the NBBO. Like
securities subject to stock trading pauses, once a compliant quote is
entered, it may rest without adjustment until such time as it moves to
within \1/2\ of 1% of its applicable pause trigger percentage (31.5%)
whereupon the market maker must immediately move its quote back to at
least the permissible default level of 30%. These requirements shall
apply to Regulation NMS securities during normal market hours.
    Nothing in the above precludes a market maker from voluntarily
quoting at price levels that are closer to the NBBO than required under
the proposal.
    The Exchange proposes to offer optional functionality to Exchange
Market Makers to assist such Market Makers with the quotation
obligations proposed by this filing. Specifically, at 9 a.m. Eastern
Time, the Exchange will extract information submitted by the Market
Maker that provides specific quote instructions for the Exchange to
enter a quote on the Market Maker's behalf consistent with proposed
paragraph (d). The Exchange proposes to enter the initial bid and offer
at the Designated Percentage and to cancel and replace the bid or offer
if it drifts away from the NBBO to the Defined Limit or away from the
Designated Percentage towards the NBBO by a number of percentage points
determined by the Exchange. The Exchange will determine and publish
this percentage in a circular distributed to Members from time to time;
the Exchange wishes to retain this flexibility in the event it wishes
to modify the number periodically in the future, for instance, to
mitigate the amount of quotation information resulting from Exchange
generated Market Maker quotes. If a bid or offer entered pursuant to
proposed paragraph (e) is executed, the Exchange will re-enter a new
bid or offer on behalf of a Market Maker. Bids and offers entered by
the Exchange consistent with proposed paragraph (e) to replace a
cancelled or executed quotation will be entered at the Designated
Percentage away from the NBBO. Such orders will be posted by the
Exchange as BATS Only Orders,\5\ and will be maintained on the Exchange
during Regular Trading Hours \6\ unless cancelled by the Market Maker
pursuant to the Exchange's Rules. In the event a Market Maker cancels
the quotations entered by the Exchange in accordance with proposed
paragraph (e), such Market Maker remains responsible for compliance
with the requirements of paragraph (d).
---------------------------------------------------------------------------

    \5\ As defined in Rule 11.9(c)(4).
    \6\ Defined in Rule 1.5(w) as 9:30 a.m. to 4:00 p.m. Eastern
Time.
---------------------------------------------------------------------------

    In order to adopt the above-described market maker quotation
obligations, the Exchange proposes to modify Rule 11.18(a)(1), which
currently contains a two-sided quotation obligation, to cross-reference
the above-described market maker quotation obligations in new

paragraph (d). In addition, because proposed paragraph (d) makes clear
that the obligations of that paragraph apply during Regular Trading
Hours, the Exchange proposes to delete paragraph (b) of current Rule
11.8 related to the [sic] when the current quoting obligations apply.
Finally, the Exchange proposes deletion of current Rule 11.8(e),
related to temporary withdrawal, because Exchange Rule 11.5(d) already
provides a Market Maker with the ability to withdraw his or her status
as a Market Maker and Rule 11.7(b) already provides a Market Maker with
the ability to terminate his or her registration in a security. The
Exchange believes that these mechanisms are sufficient for a Market
Maker to withdraw or terminate its registration in a security or as a
Market Maker without the need for an additional provision related to
withdrawal.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\7\ In particular, the
proposed change is consistent with Section 6(b)(5) of the Act,\8\
because it would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system, and, in general, protect investors and
the public interest. The proposed rule change is also designed to
support the principles of Section 11A(a)(1) \9\ of the Act in that it
seeks to assure fair competition among brokers and dealers and among
exchange markets. The Exchange believes that the proposed rule meets
these requirements in that it promotes uniformity across markets
concerning minimum market maker quotation requirements. The Exchange
believes that the proposed optional functionality to assist Exchange
Market Makers in maintaining continuous, two-sided limit orders in the
securities in which they are registered will encourage Market Makers to
remain registered with and trade on the Exchange, thus providing
valuable liquidity to the Exchange; at the same time, the Exchange
believes that the proposed functionality will keep Exchange generated
quotations within reasonable reach of the NBBO and that the elimination
of ``stub quotes'' is important for the protection of investors and the
public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BYX-2010-001 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

    All submissions should refer to File Number SR-BYX-2010-001. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for website
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
publicly available. All submissions should refer to File Number SR-BYX-
2010-001 and should be submitted on or before November 5, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-25952 Filed 10-14-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 26, 2007 (Volume 72, Number 80)]
[Rules and Regulations]
[Page 20728-20730]
[DOCID:fr26ap07-10]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2006-0568; FRL-8305-1]

Approval and Promulgation of Air Quality Implementation Plans;
New Mexico; Albuquerque/Bernalillo County; Prevention of Significant
Deterioration (PSD) and New Source Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is approving revisions to the State Implementation
Plan (SIP) for the Albuquerque/Bernalillo County, New Mexico, area that
were adopted on December 14, 2005, and submitted to EPA by the Governor
of New Mexico on May 24, 2006. The SIP revisions modify the PSD and
Nonattainment New Source Review (NNSR) regulations in the SIP. They
were submitted to make the area's PSD and NNSR rules consistent with
the Federal PSD and NNSR revised regulations, which were promulgated by
EPA on December 31, 2002, (67 FR 80186), and reconsidered with minor
changes on November 7, 2003, (68 FR 63021), (collectively, the ``2002
New Source Review (NSR) Reform rules''). The revisions include
provisions for baseline emissions calculations, an actual-to-projected-
actual methodology for calculating emissions changes, options for
plantwide applicability limits, and recordkeeping and reporting
requirements. The EPA is approving these revisions pursuant to section
110, part C, and part D of the Federal Clean Air Act.

DATES: This final rule is effective on May 29, 2007.

ADDRESSES: The EPA has established a docket for this action under
Docket ID Number EPA-R06-OAR-2006-0568. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in the

index, some information is not publicly available, e.g., Confidential
Business information or other information the disclosure of which is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or in hard

copy at the Air Permits Section (6PD-R), Environmental Protection
Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. The file
will be made available by appointment for public inspection in the
Region 6 Freedom of Information Act Review Room between the hours of
8:30 a.m. and 4:30 p.m. weekdays except for legal holidays. Contact the
person listed in the FOR FURTHER INFORMATION CONTACT paragraph below to
make an appointment. If possible, please make the appointment at least
two working days in advance of your visit. There will be a 15 cent per
page fee for making photocopies of documents. On the day of the visit,
please check in at the EPA Region 6 reception area at 1445 Ross Avenue,
Suite 700, Dallas, Texas.
    The State submittal is also available for public inspection at the
State Air Agency listed below during official business hours by
appointment:
    Albuquerque Environmental Health Department, Air Pollution Control
Division, One Civic Plaza, Albuquerque, New Mexico 87103.

FOR FURTHER INFORMATION CONTACT: Mr. Stanley M. Spruiell, Air Permits
Section (6PD-R), Environmental Protection Agency, Region 6, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>;
fax number<PHONE_NUMBER>; or e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, any reference to
``we,'' ``us,'' or ``our'' means EPA.

Outline

I. What Action Is EPA Taking?
II. Statutory and Executive Order Reviews

I. What Action Is EPA Taking?

    The EPA is taking final action to approve the SIP revisions that
the Governor of New Mexico submitted May 24, 2006. This submittal
consists of revisions to two regulations that are already part of the
Albuquerque/Bernalillo County SIP. The affected regulations are:
20.22.60 New Mexico Administrative Code (NMAC) (Permitting in
Nonattainment Areas) and 20.22.61 NMAC (Prevention of Significant
Deterioration). These revisions update the Albuquerque/Bernalillo
County Air Quality Control Board (AQCB) NNSR and PSD regulations to
ensure that the regulations are consistent with the 2002 New Source
Review Reform Rules.
    The SIP revision also includes other non-substantive changes to
AQCB's PSD and NNSR rules needed to update the regulatory citations,
make clarifying revisions to the regulatory text, correct typographical
errors, and ensure that the regulations are consistent with all

current Federal requirements for PSD and NNSR. These non-substantive
changes do not change the regulatory requirements.
    On February 15, 2007 (72 FR 7361), we published our proposed
approval of this SIP revision. The February 15, 2007, proposal provided
detailed information about the Albuquerque/Bernalillo County SIP
revisions that are being approved today. The proposal also provided a
detailed analysis of EPA's rationale for approving the Albuquerque/
Bernalillo County SIP revisions. In the proposal, we provided
opportunity for public comment on the proposed action. The public
comment period for this proposed rulemaking ended March 19, 2007. We
received no comments, adverse or otherwise, on the proposed rulemaking.
We are therefore finalizing our proposed approval without changes. For
more details on this submittal, please refer to the proposed rulemaking
and to the Technical Support Document, which is in the docket for this
action.
    The EPA is also making a non-substantive administrative change to
the title of the second table under 40 CFR 52.1620(c), which
incorporates the SIP-approved Albuquerque/Bernalillo County
regulations. The title of this table currently is ``EPA Approved
Albuquerque/Bernalillo County, NN Regulations.'' The EPA is changing
this title to ``EPA Approved Albuquerque/Bernalillo County, NM
Regulations.''

II. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves State law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by State law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under State law and does
not impose any additional enforceable duty beyond that required by
State law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on: One or more Indian tribes, the
relationship between the Federal Government and Indian tribes, or the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, the relationship between the national government and the
States, or the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a State rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. The EPA interprets Executive Order 13045, ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), as applying only to those regulatory actions
that concern health or safety risks such that the analysis required
under section 5-501 of the Executive Order has the potential to
influence the regulation. This rule is not subject to Executive Order
13045 because it approves a State program. Executive Order 12898 (59 FR
7629, February 16, 1994) establishes Federal executive policy on
environmental justice. Because this rule merely approves a State rule
implementing a Federal standard, EPA lacks the discretionary authority
to modify today's regulatory decision on the basis of environmental
justice considerations.
    In reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 25, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: April 17, 2007.
 Richard E. Greene,
Regional Administrator, Region 6.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart GG--New Mexico

0
2. Section 52.1620 is amended as follows:
0
a. The title of the second table in paragraph (c) is revised to read:
``EPA Approved Albuquerque/Bernalillo County, NM Regulations''
0
b. The second table in Sec.  52.1620(c) entitled ``EPA Approved
Albuquerque/Bernalillo County, NM Regulations'' is amended as follows:

0
i. By revising the entry for Part 60 (20.11.60).
0
ii. By revising the entry for Part 61 (20.11.61).
    The amendments read as follows:

Sec.  52.1620  Identification of plan.

* * * * *
    (c) * * *

                       EPA-Approved Albuquerque/Bernalillo County, New Mexico Regulations

----------------------------------------------------------------------------------------------------------------
                                                             State
          State citation              Title/subject       submittal/     EPA approval date       Explanation
                                                        effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
New Mexico Administrative Code Title 20--Environmental Protection, Chapter 11--Albuquerque/Bernalillo County Air
 Quality Control Board
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Part 60 (20.11.60)...............  Permitting in              12/14/05  4/26/07 [Insert FR
                                    Nonattainment                        page number where
                                    Areas.                               document begins].
Part 61 (20.11.61)...............  Prevention of              12/14/05  4/26/07 [Insert FR
                                    Significant                          page number where
                                    Deterioration.                       document begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
 [FR Doc. E7-7896 Filed 4-25-07; 8:45 am]

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[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3425-3426]
[FR Doc No: 2014-00992]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213

Extension:
    Form 6-K; OMB Control No. 3235-0116, SEC File No. 270-107.

    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 (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Form 6-K (17 CFR 249.306) is a disclosure document under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) that must be
filed by a foreign private issuer to report material information
promptly after the occurrence of specified or other important corporate
events that are disclosed in the foreign private issuer's home country.
The purpose of Form 6-K is to ensure that U.S. investors have access to
the same information that foreign investors do when making investment
decisions. Form 6-K takes approximately 8.7 hours per response and is
filed by approximately 20,812 issuers annually. We estimate that 75% of
the 8.7 hours per response (6.525 hours) is prepared by the issuer for
a total annual reporting burden of 135,798 hours (6.525 hours per
response x 20,812 responses).
    Written comments are invited on: (a) Whether this collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden
imposed

by the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    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 OMB control number.
    Please direct your written comment to Thomas Bayer, 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>
    Dated: January 14, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-00992 Filed 1-17-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Page 23491]
[FR Doc No: 2023-08042]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2023-0975]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Experimental
Permits for Reusable Suborbital Rockets

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The FAA collects information from applicants for
experimental permits in order to determine whether they satisfy the
requirements for obtaining an experimental permit.

DATES: Written comments should be submitted by June 16, 2023.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By Mail: Charles Huet, 800 Independence Avenue SW, Room 331,
Washington, DC 20591.

FOR FURTHER INFORMATION CONTACT: Charles Huet by email at:
[email protected] or; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0722.
    Title: Experimental Permits for Reusable Suborbital Rockets.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on June 19, 2017 (82 FR 27949). There were no comments.
14 CFR part 437 established requirements for the FAA's authority to
issue experimental permits for reusable suborbital rockets to authorize
launches for the purpose of research and development, crew training and
showing compliance with the regulations. The information collected
includes data required for performing a safety review, which includes a
technical assessment to determine if the applicant can launch a
reusable suborbital rocket without jeopardizing public health and
safety and the safety of property. This information collection
requirement is intended for incorporating acquired data into the
experimental permit, which then becomes binding on the launch or
reentry operator. The applicant is required to submit information that
enables FAA to determine, before issuing a permit, if issuance of the
experimental permit would jeopardize the foreign policy or national
security interests of the U.S.
    Respondents: Approximately 10 applicants for experimental permits.
    Frequency: On occasion.
    Estimated Average Burden per Response: 18.6 Hours.
    Estimated Total Annual Burden: 2,567 Hours.

James A. Hatt,
Space Policy Division Manager, Office of Commercial Space
Transportation.
[FR Doc. 2023-08042 Filed 4-14-23; 8:45 am]
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[Federal Register Volume 84, Number 74 (Wednesday, April 17, 2019)]
[Notices]
[Pages 16022-16023]
[FR Doc No: 2019-07711]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3758]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Individual Patient
Expanded Access Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 17,
2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0814.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Individual Patient Expanded Access
Applications: Form FDA 3926

OMB Control Number 0910-0814--Extension

    This information collection supports Agency regulations, associated
guidance, and Form FDA 3926 concerning individual patient expanded
access. Individual patient expanded access allows an individual patient
who has a serious or immediately life-threatening disease or condition
and there is no comparable or satisfactory alternative therapy to
diagnose, monitor, or treat the disease or condition, the use of an
investigational new drug (IND) outside of a clinical investigation, or
the use of an approved drug where availability is limited by a risk
evaluation and mitigation strategy. When applicable criteria in Sec.
312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded
access) and the criteria in Sec.  312.310(a) (21 CFR 312.310(a)) (which
apply specifically to individual patient expanded access, including for
emergency use) are met, FDA may permit expanded access.
    Section 312.305(b) sets forth the submission requirements for all
types of expanded access requests. To assist respondents with
requirements in Sec.  312.305, we developed Form FDA 3926 (Individual
Patient Expanded Access Investigational New Drug Application) and the
guidance document entitled, ``Individual Patient Expanded Access
Applications: Form FDA 3926,'' which are available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm and https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm432717.pdf, respectively.
    The physician may satisfy some of the submission requirements by
referring to information in an existing IND, ordinarily the one held by
the investigational drug's manufacturer, if the physician obtains
permission from that IND holder. If permission is obtained, the
physician should then provide to FDA a letter of authorization (LOA)
from the existing IND holder that permits FDA to reference that IND.
    One of the requirements under Sec.  312.305(b)(2) is that a ``cover
sheet'' must be included ``meeting the requirements of Sec.
312.23(a).'' This provision applies to several types of submissions
under part 312 (21 CFR part 312), ranging from commercial INDs under
Sec.  312.23 that involve large groups of patients enrolled in clinical
trials to requests from physicians to use an investigational drug for
an individual patient. Sponsors currently use Form FDA 1571 for all
types of IND submissions to meet the requirements in Sec.  312.23(a).
    Concerned that physicians requesting expanded access for an
individual patient may encounter difficulty in completing Form FDA 1571
and the associated documents because the form is not tailored to
requests for individual patient expanded access, we developed Form FDA
3926 to comply with the IND submission requirements in Sec. Sec.
312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a
streamlined means to request expanded access and is available for
licensed physicians. FDA considers a completed Form FDA 3926 with the
box in Field 10 checked and the form signed by the physician to be a
request in accordance with Sec.  312.10 for a waiver of any additional
requirements in part 312 for an IND submission, including additional
information currently provided in Form FDA 1571 and Form FDA 1572
(Statement of Investigator, which provides the identity and
qualifications of the investigator conducting the clinical
investigation).
    Under Sec.  312.310(d), in an emergency situation that requires the
patient to be treated before a written submission can be made, the
request to use the investigational drug for individual patient expanded
access may be made by telephone (or other rapid means of communication)
to the appropriate FDA review division. Authorization of the emergency
use may be given by an FDA official over the telephone, provided the
physician explains how the expanded access use will meet the
requirements of Sec. Sec.  312.305 and 312.310 and agrees to submit an
expanded access application within 15 working days of FDA's initial
authorization of the expanded access use (Sec.  312.310(d)). The
physician may choose to use Form FDA 3926 for the expanded access
application.
    As explained in the instructions for Form FDA 3926 and discussed in
the guidance document, the following information is submitted to FDA:
     Initials for the patient and date of submission.
     Type of submission (initial or followup submission).
     Clinical information, including indication, brief clinical
history of the patient (age, gender, weight, allergies, diagnosis,
prior therapy, response to prior therapy), and the reason for

requesting the proposed treatment, including an explanation of why the
patient lacks other therapeutic options.
     Treatment information, including the investigational
drug's name and the name of the entity supplying the drug (generally
the manufacturer), the applicable FDA review division (if known), and
the treatment plan. This should include the planned dose, route and
schedule of administration, planned duration of treatment, monitoring
procedures, and planned modifications to the treatment plan in the
event of toxicity.
     LOA, generally obtained from the entity that is the
sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being
referenced, if applicable.
     Physician's qualification statement. An appropriate
statement includes medical school attended, year of graduation, medical
specialty, State medical license number, current employment, and job
title. Alternatively, the relevant portion of the physician's
curriculum vitae may be attached.
     Physician's contact information, including name, physical
address, email address, telephone number, facsimile number, and
physician's IND number, if previously issued by FDA.
     Contents of submission (for followup/additional
submissions), including the type of submission being made. FDA accepts
Form FDA 3926 for certain followup/additional submissions, which
include the following: Initial written IND safety report (Sec.
312.32(c)); followup to a written IND safety report (Sec.  312.32(d));
annual report (Sec.  312.33); summary of expanded access use (treatment
completed) (Sec.  312.310(c)(2)); change in treatment plan (Sec.
312.30); general correspondence or response to FDA request for
information (Sec.  312.41); and response to clinical hold (Sec.
312.42(e)).
     Request for authorization to use Form FDA 3926 for
individual patient expanded access application.
     Signature of the physician certifying that treatment will
not begin until 30 days after FDA receives the completed application
and all required material unless the submitting physician receives
earlier notification from FDA that the treatment may proceed. The
physician agrees not to begin or continue clinical investigations
covered by the IND if those studies are placed on clinical hold. The
physician also certifies that informed consent will be obtained in
compliance with Federal requirements (including FDA's regulations in 21
CFR part 50) and that an institutional review board (IRB) that complies
with all Federal requirements (including FDA's regulations in 21 CFR
part 56) will be responsible for initial and continuing review and
approval of the expanded access use. The physician also acknowledges
that in the case of an emergency request, treatment may begin without
prior IRB approval, provided the IRB is notified of the emergency
treatment within 5 working days of treatment. The physician agrees to
conduct the investigation in accordance with all other applicable
regulatory requirements.
    In the Federal Register of November 7, 2018 (83 FR 55723), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
 Guidance on individual patient expanded access  applications: Form     Number of      responses per     Total annual    Average burden    Total hours
                              FDA 3926                                 respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expanded access submission elements included in Form FDA 3926......             790             3.03            2,394   0.75 (45 mins.)           1,795
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection, we are retaining
the currently approved burden estimate. The estimates for ``number of
respondents,'' ``number of responses per respondent,'' and ``total
annual responses'' were obtained from reports and data management
systems from the Center for Drug Evaluation and Research (CDER) and
from other sources familiar with the number of submissions received for
individual patient expanded access use under part 312. The estimates
for ``average burden per response'' were based on information CDER
provided and personnel of the U.S. Department of Health and Human
Services familiar with preparing and reviewing expanded access
submissions by practicing physicians.
    Based on data from the Document Archiving, Reporting, and
Regulatory Tracking System for the number of submissions to FDA using
FDA Form 3926 during fiscal years 2015, 2016, and 2017, we estimate
that approximately 790 licensed physicians would use FDA Form 3926 to
submit 1.46 requests per physician (respondent) for individual patient
expanded access, for a total of 1,153 responses annually. Based on
these estimates, FDA calculates the total annual responses to be 2,394
(1,153 requests for individual patient expanded access and 1,241
followup submissions) by 790 physicians for an average of 3.03
responses per respondent. FDA estimates the average burden per response
to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates
the total burden to be 1,795 hours.

    Dated: April 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07711 Filed 4-16-19; 8:45 am]
 BILLING CODE 4164-01-P