[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42509-42510]
[FR Doc No: 2015-17619]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2015-0378; OMB Control Number 1625-0010]

Information Collection Request to Office of Management and Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of an
extension of a currently approved collection: 1625-0010, Defect/
Noncompliance Report and Campaign Update Report. Our ICR describes the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before September 15,
2015.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2015-0378] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICR(s) are available through the docket on the
Internet at http://www.regulations.gov. Additionally, copies are
available from: COMMANDANT (CG-612), ATTN PAPERWORK REDUCTION ACT
MANAGER, US COAST GUARD, 2703 MARTIN LUTHER KING JR AVE. SE., STOP
7710, WASHINGTON, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Cheryl Collins, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and

other important information describing the Collection. There is one ICR
for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise these ICRs or decide not to seek approval
of revisions of the Collection. We will consider all comments and
material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2015-0378], and
must be received by September 15, 2015. We will post all comments
received, without change, to http://www.regulations.gov. They will
include any personal information you provide. We have an agreement with
DOT to use their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2015-0378], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit your comments and material by electronic means,
mail, fax, or delivery to the DMF at the address under ADDRESSES; but
please submit them by only one means. To submit your comment online, go
to http://www.regulations.gov, and type ``USCG-2015-0378'' in the
``Search'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing comments and documents: To view comments, as well as
documents mentioned in this Notice as being available in the docket, go
to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Search'' box
insert ``USCG-2015-0378'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. You may also visit the DMF in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Request

    1. Title: Defect/Noncompliance Report and Campaign Update Report.
    OMB Control Number: 1625-0010.
    Summary: Manufacturers whose products contain defects that create a
substantial risk of personal injury to the public or fail to comply
with an applicable Coast Guard safety standard are required to conduct
defect notification and recall campaigns in accordance with 46 U.S.C.
4310. Regulations in 33 CFR 179 require manufacturers to submit certain
reports to the Coast Guard concerning progress made in notifying owners
and making repairs.
    Need: Under 46 U.S.C. 4310(d) and (e); 33 CFR 179.13 and 179.15,
the manufacturer shall provide the Commandant of the Coast Guard with
an initial report consisting of certain information about the defect
notification and recall campaign being conducted and follow up reports
describing progress. Upon receipt of information from a manufacturer
indicating the initiation of a recall, the Recreational Boating Product
Assurance Branch assigns a recall campaign number, and sends the
manufacturer CG forms CG-4917 and CG-4918 for supplying the
information.
    Forms: CG-4917; Defect/Noncompliance Report and CG-4918; Campaign
Update Report.
    Respondents: Manufacturers of boats and certain items of
``designated'' associated equipment (inboard engines, outboard motors,
sterndrive engines or an inflatable personal flotation device approved
under 46 CFR 160.076.
    Frequency: Quarterly.
    Burden Estimate: The estimated burden has decreased from 252 to 207
hours annually. The number of campaigns has decreased due to the pro-
active nature of the Coast Guard factory inspectors who detect and
correct recreational boat deficiencies before a watercraft is placed in
the market for sale.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: July 8, 2015.

    Sincerely,
Thomas P. Michelli,
U. S. Coast Guard, Deputy Chief Information Officer.
[FR Doc. 2015-17619 Filed 7-16-15; 8:45 am]
BILLING CODE 9110-04-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OSWER/ OEPPR/ Oil Program 2. OMB control number b. G None a. 2050 0135 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c.   Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a.   Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes   No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a.   Three years from approval date b. G Other Specify: / /___

7. Title Oil Pollution Act Facility Response Plan Requirements ( 40 CFR part 112) ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR # 1630.08 9. Keywords Facility Response Plan, Product Schedule, Oil Spill Mitigation Agents 10. Abstract This information collection request ( ICR) renewal pertains to EPA's Facility Response Plan ( FRP) requirements as codified in 40 CFR 112.20 and 112.21. This regulation implements requirements mandated by the Oil Pollution Act ( OPA) of 1990. Facilities subject to the FRP rule are a subset of the facilities regulated by the EPA's Spill Prevention, Control and Countermeasure ( SPCC) rule. The SPCC regulation ( 40 CFR 112) requires all non transportation related facilities with an aboveground oil storage capacity of 1,320 gallons or more, located where there is a possibility of a discharge into navigable water, to prepare site specific plans to prevent oil discharges. The FRP rule adds additional requirements for those owners and operators of facilities that could cause " substantial harm" to the environment by discharging oil into navigable water bodies or adjoining shorelines prepare plans for responding, to the maximum extent practicable, to a worst case discharge of oil, and to a substantial threat of such a discharge. The total burden on the entire FRP regulated community over a three year period is estimated to be 1,904,980 hours ( adjusted for burden attributable to compliance with State and other Federal regulations). The estimated costs include approximately $ 62,100 in capital costs over the three year period and $ 54,000,000 in total costs ( including labor costs associated with facility and contractor personnel). EPA does not anticipate that FRP facilities will incur operating and maintenance ( O& M) costs since there are no anticipated costs associated with hard copy or electronic document storage.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. X Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. X Voluntary b. X Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 10,644 b. Total annual responses 10,644 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 634,994 d. Current OMB inventory 583,130 e. Difference 51,864 f. Explanation of difference 1. Program Change 0 2. Adjustment 51,864 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 21 b. Total annual costs ( O& M) $ 0 c. Total annualized cost requested $ 21 d. Current OMB inventory $ 22 e. Difference $ 1 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 1 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a.   Recordkeeping b. Q Third party disclosure c.   Reporting 1.   On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennually 8.   Other ( describe) As needed 17. Statistical methods Does this information collection employ statistical methods?   Yes Q No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Leigh DeHaven Phone: ( 703) 603 9065 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5820-5821]
[FR Doc No: 2013-01629]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final Notice.

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SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The effective date of April 16, 2013 which has been established
for the FIRM and, where applicable, the supporting FIS report showing
the new or modified flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at www.msc.fema.gov by the effective date indicated
above.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and ninety (90) days have elapsed since that publication.
The Deputy Associate Adminstrator for Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

------------------------------------------------------------------------
              Community                 Community map repository address
------------------------------------------------------------------------
            Suwannee County, Florida, and Incorporated Areas
                         Docket No.: FEMA-B-1239
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City of Live Oak.....................  City Hall, 101 White Oak Avenue
                                        Southeast, Live Oak, FL 32064.
Unincorporated Areas of Suwannee       Suwannee County Courthouse,
 County.                                County Coordinator's Office, 200
                                        Ohio Avenue South, Live Oak, FL
                                        32064.
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           Pottawattamie County, Iowa, and Incorporated Areas
                         Docket No.: FEMA-B-1242
------------------------------------------------------------------------
City of Avoca........................  City Hall, 201 North Elm Street,
                                        Avoca, IA 51521.
City of Carson.......................  City Hall, 316 South Commercial
                                        Street, Carson, IA 51525.
City of Council Bluffs...............  City Hall, 209 Pearl Street, Room
                                        207, Council Bluffs, IA 51503.
City of Hancock......................  City Hall, 202 North Main Street,
                                        Hancock, IA 51536.
City of Macedonia....................  City Hall, 322 Main Street,
                                        Macedonia, IA 51549.
City of Minden.......................  City Hall, 207 Main Street,
                                        Minden, IA 51553.
City of Neola........................  City Hall, 105 3rd Street, Neola,
                                        IA 51559.
City of Oakland......................  City Hall, 101 North Main Street,
                                        Oakland, IA 51560.
City of Treynor......................  City Hall, 7 South Eyeberg
                                        Avenue, Treynor, IA 51575.
City of Underwood....................  City Hall, 218 2nd Street,
                                        Underwood, IA 51576.
City of Walnut.......................  City Hall, 229 Antique City
                                        Drive, Walnut, IA 51557.
Unincorporated Areas of Pottawattamie  Pottawattamie County Courthouse,
 County.                                227 South 6th Street, Council
                                        Bluffs, IA 51501.
------------------------------------------------------------------------
             Lewis County, Kentucky, and Incorporated Areas
                         Docket No.: FEMA-B-1238
------------------------------------------------------------------------
City of Concord......................  City Hall, 12913 West KY-8,
                                        Vanceburg, KY 41179.
City of Vanceburg....................  Visitors Center, 151 3rd Street,
                                        Vanceburg, KY 41179.
Unincorporated Areas of Lewis County.  Lewis County Emergency Management
                                        Annex, 36 Court Street,
                                        Vanceburg, KY 41179.
------------------------------------------------------------------------
             Mason County, Kentucky, and Incorporated Areas
                         Docket No.: FEMA-B-1239
------------------------------------------------------------------------
City of Dover........................  City Hall, 2060 Lucretia Street,
                                        Dover, KY 41034.
City of Maysville....................  City Hall, 216 Bridge Street,
                                        Maysville, KY 41056.

Unincorporated Areas of Mason County.  Maysville City Hall, 216 Bridge
                                        Street, Maysville, KY 41056.
------------------------------------------------------------------------
              Pike County, Kentucky, and Incorporated Areas
                         Docket No.: FEMA-B-1246
------------------------------------------------------------------------
City of Coal Run Village.............  Coal Run Village City Hall, 81
                                        Church Street, Pikeville, KY
                                        41501.
City of Pikeville....................  City Hall, 118 College Street,
                                        Pikeville, KY 41501.
Unincorporated Areas of Pike County..  Pike County Courthouse, 146 Main
                                        Street, Pikeville, KY 41501.
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

James A. Walke,
Acting Deputy Associate Administrator for Mitigation, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2013-01629 Filed 1-25-13; 8:45 am]
BILLING CODE 9110-12-P


 EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING FOR PESTICIDE PETITION

  Docket ID Number: EPA-HQ-OPP-2012-0586

 EPA Registration Division contact: Sidney Jackson<PHONE_NUMBER>

 Interregional Research Project Number 4
 Pesticide Petition Number (PP #): 2E8050
 EPA has received a pesticide petition (PP#: 2E8050) from Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters,  Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08450 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of halosulfuron-methyl, methyl 3-chloro-5- [[[[(4,6-dimethoxy-2  pyrimidinyl)amino] carbonyl]amino]sulfonyl]-1-methyl-1 H- pyrazole-4-carboxylate, and its metabolites and degradates  in or on the raw agricultural commodities can berry and artichokes. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

 A. Residue Chemistry

      1. Plant metabolism. The metabolism of halosulfuron-methyl as well as the nature of
the residues in plants is adequately understood for the purposes of these tolerances. Metabolism studies were conducted with three crops, vis.; field com, sugarcane and soybeans.  Metabolism depends on the mode of application.   Pre-emergent applications result in rapid soil degradation of halosulfuron-methyl followed by crop uptake of the resulting pyrazole moiety.  The pyrimidine ring binds tightly to soil and is eventually converted to carbon dioxide by microbial degradation.  In post-emergent applications, little metabolism and translocation take place, resulting in unmetabolized parent compound as the major residue on the directly treated foliar surfaces.
      2. Analytical method. A practical analytical method, gas chromatography with a
nitrogen-specific detector, is available for enforcement purposes. The analytical method
accounts for parent halosulfuron-methyl and for the halosulfuron-methyl  rearrangement ester, sometimes referred to as "RRE" and "MON 5781." This product results from the abstraction for the S02NHCO moiety between the rings, such that the two rings are then joined together only by an NH group. In caneberries, the limit of detection and limit of quantification was 0.016 ppm and 0.047 ppm, respectively. The limit of detection in artichokes was 0.0126 ppm and the limit of quantification was 0.0387 ppm.

 3. Magnitude of residues. Studies were conducted to determine the residues of halosulfuron in caneberry in EPA Regions 1, 2,5,10, and 12 as well as PMRA region SA. Caneberry rows were treated with 0.094 lbs halosulfuron-methyl a.i./A and berries were collected 13-15 days after application. The maximum residue of halosulfuron-methyl was below the limit of detection (LOD) of 0.016 ppm.

 Artichokes studies were conducted in Region 10. Treated plots received one halosulfuron-methyl  application directed onto ditches and bed shoulder 5 days prior to harvest at the rate of .094 lb halosulfuron-methyl  a.i./A.  The maximum residue of halosulfuron-methyl in artichokes buds was below the limit of quantification (LOQ) of 0.0378 ppm.

 B. Toxicological Profile

 1.  Acute toxicity.  Halosulfuron-methyl has low acute toxicity via the oral, dermal, and inhalation routes.  It is a non-irritant for skin and eyes and is not a dermal sensitizer.

 2.	Genotoxicty. Carcinogenicity studies in rats and mice show no increase in treatment-related tumor incidence, and halosulfuron-methyl was classified as "not likely to be carcinogenic to humans." Halosulfuron-methyl is negative for mutagenicity in a battery of genotoxicity studies.  Bacterial and mammalian microsomal mutagenicity assays showed halosulfuron-methyl not to be mutagenic.  Gene mutation and chromosomal aberration studies were negative.  An unscheduled DNA test in primary rat hepatocytes was negative.  An in vivo mouse micronucleus assay did not cause a significant increase in the frequency of micronucleated polychromaticerythrocytes in bone marrow cells.

 3.	Reproductive and developmental toxicity. Although the halosulfuron methyl data indicated an increase in qualitative susceptibility in fetuses following
 prenatal exposure in rats and rabbits, the developmental effects were seen in the presence
 mg/kg/day in males and 147 mg/kg/day in females.  The LOAEL was 497 mg/kg/day for males and 640 mg/kg/day in females. Decreased body weight gain was observed in females in the subchronic oral toxicity study. In the rat and mouse, there was a decrease in body weight gains at high dose levels in short- and long-term oral and dermal studies. The results of both acute and subchronic neurotoxicity studies showed no neurotoxic effects. There was no quantitative evidence for increased susceptibility following pre- and/or post-natal developmental effects.

      4. Subchronic toxicity. A 90-day feeding study in rats resulted in a NOAEL of 116
 mg/kg/day in males and 147 mg/kg/day in females.  The LOAEL was 497 mg/kg/day for
 males and 640 mg/kg/day in females. Decreased body weight gain was observed in females in the subchronic oral toxicity study. In the rat and mouse, there was a decrease in body weight gains at high dose levels in short- and long-term oral and dermal studies. The results of both acute and subchronic neurotoxicity studies showed no neurotoxic effects. There was no quantitative evidence for increased susceptibility following pre- and/or post-natal developmental effects.	·

 5. Chronic toxicity. With repeated dosing, available data show that the dog is the most sensitive mammalian species.  In the dog, decreased body weight was seen in the chronic oral toxicity study.  Carcinogenicity studies in rats and mice show no increase in treatment-related tumor incidence, and halosulfuron-methyl was classified as "not likely to be carcinogenic to humans."

 6. Animal metabolism. The Agency has determined that the nature of the residue in ruminants is adequately understood.  In the tissues and milk of goats, the major extractable residue was the unmetabolized parent compound.  The Agency has not required tolerances for residues in poultry.  In the rat metabolism study, parent compound was absorbed rapidly but incompletely.  Excretion was relatively rapid at all doses tested, and the majority of the radioactivity was eliminated in the urine and feces within 72 hours.  Fecal elimination was the result of unabsorbed parent compound.

       7. Metabolite toxicology. Various toxicity studies have shown that the metabolite
 3-CSA is of lower toxicity than the parent compound, and the Agency has concluded that it should not be included in the tolerance expression.  However, in the residue analytical method for animal products, halosulfuron-methyl and all of its metabolites are
 hydrolyzed to 3-CSA, which is analyzed and the results expressed as parent equivalents. The tolerance expression for plant commodities consists of only parent compound.

 8. Endocrine disruption. No specific tests have been conducted with halosulfuron methyl to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other endocrine effects.
 However, there were no significant findings in relevant toxicology studies;  e.g., teratology and reproduction studies, which suggest that halosulfuron-methyl produces effects characteristic of the estrogen disruption. Halosulfuron is not on the initial EPA screening list and a test order has not been issued.

 C. Aggregate Exposure

 I. Dietary exposure. Tolerances have previously been established for residues in a variety of raw agricultural commodities (40 CFR 180.479).  Additionally, tolerances have been established for halosulfuron-methyl and its metabolites in the meat byproducts of cattle, goats, hogs, horses and sheep.

 i. Food. Chronic Dietary Exposure. A chronic dietary analysis for halosulfuron methyl was conducted by the Agency using tolerance levels and 100% CT for all existing uses on April 5, 2010.  The EDWC for surface water from EFED (59.2 ppb based on
 modeled use on rice) was incorporated directly into the exposure analysis.  The drinking
 water estimate should be considered highly conservative.   The results of the analysis indicate that chronic risk from the dietary exposure to halosulfuron-methyl does not exceed HED's LOC for the general U.S. population or any population subgroup.  The estimated risk for the general U.S. population is 2% of the chronic PAD (cPAD), and the highest exposure is to all infants (<1 year old) at 5% ofthe cPAD. The addition of residues in caneberries and artichokes were at the LOD or LOQ and, therefore would not be expected to contribute significantly to chronic dietary exposure.

 Acute Dietary Exposure. An acute dietary exposure analysis for halosulfuron-methyl was conducted using tolerance-level residues and 100 %crop treated (CT) for all existing on April 5, 2010.  Estimated drinking surface water concentrations (EDWCs) from EFED (59.2 ppb based on modeled use on rice) were incorporated directly into the exposure analysis.  The only population with a toxicological endpoint attributable to a single dose of halosulfuron-methyl was females 13-49 years old.  The results of the analysis indicate that acute risk from the dietary exposure to halosulfuron-methyl is less than 1% of the acute population adjusted dose (aPAD) for females 13-49 years old, and therefore did not exceed HED's LOC.

 ii. Drinking water. Based on the First Index Reservoir Screening Tool (FIRST), Pesticide Root Zone Model I Exposure Analysis Modeling System (PRZM/ EXAMS)and Screening Concentration  in Ground Water (SCI -GROW) models, the estimated drinking water concentrations (EDWCs) of  halosulfuron methyl are Tier I  EDWCs based on a maximum annual application rate of  0.125 lb active ingredient ai/A. The seasonal use proposed on caneberries and artichokes is 0.094 lb halosulfuron ai/A, well below the maximum annual rate used in the models derived for estimating drinking water concentrations.  For acute and chronic dietary risk assessment, the water concentration value of 59.2 ppb was used to assess the contribution to drinking water.

 2. Non-dietary exposure. Halosulfuron-methyl is registered for use on residential turfgrass and landscaped areas.  The short-term aggregate risk assessment estimates risks that are likely to result from exposures up to 30 days.  The same toxicological effect upon which endpoints were defined (decreased bodyweight gain) was observed across all
 routes of exposure.  The Agency's level of concern is a short-term aggregate (food, water and residential) MOE of less than 300.  However, the Agency has previously calculated aggregate MOEs of 3,100 or greater.  The proposed uses of halosulfuron methyl on caneberries and artichokes should have negligible effect on the Agency's previous calculations.

 D. Cumulative Effects

 EPA has not made a common mechanism of toxicity finding regarding halosulfuron-methyl and any other substance.  Halosulfuron-methyl does not appear to produce a toxic metabolite that is produced by any other substance.  Therefore, for the purposes of this tolerance action, EPA has not assumed that halosulfuron-methyl has a common mechanism of toxicity with other substances.

 E. Safety Determination
 1. U.S. population. Chronic dietary (food and drinking water) exposure to halosulfuron methyl is below EPA's level of concern for the general U.S. population and all population subgroups.   The Agency determined the chronic RID for halosulfuron methyl at 0.1 mg/kg/day for all populations based on the chronic dog study NOAEL at
 1 0 mg/kg/day and I OOx uncertainty factor.  The chronic dietary exposure estimates are
 2% of the cPAD for the general U.S. population and 5% of the cPAD for all infants (<1 year old), the most highly exposed population subgroup, much lower than the LOC at 100% of the cRtD.

 2. Infants and children. In rat and rabbit developmental toxicity studies and a 2- generation reproduction toxicity study in rats there was no quantitative evidence for increased susceptibility following pre-natal and/or post natal exposure. In those studies, NOAELs/ LOAELs for halosulfuron developmental and maternal toxicities, and developmental effects were seen in the presence of maternal toxicity, and the effects were only seen at the high dose. Additionally, in rats, developmental effects were seen at a
 dose which is approaching the limit-dose. The degree of concern is low and there is no residual uncertainty for prenatal toxicity in both rats and rabbits.

 F. International Tolerances

 FFDCA §408(b)(4)  requires the Agency to consider international standards in establishing a tolerance.  There is no established Codex MRL specifically for artichokes however, a tolerance of 0.0 I ppm has been maintained for vegetable fresh or frozen. There is no Codex MRL for raspberries or blackberries http://www.mrldatabase.com/results.cfm - retrieved 2/7/20 I2).


[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Notices]
[Pages 19819-19821]
[FR Doc No: 2011-8374]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64174; File No. SR-NASDAQ-2011-042]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend the Pilot Period of the Trading Pause for Individual Stocks
Contained in the Standard & Poor's 500 Index, Russell 1000 Index, and
Specified Exchange Traded Products That Experience a Price Change of
10% or More During a Five-Minute Period

April 4, 2011.
    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 March 31, 2011, The NASDAQ Stock Market LLC (``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.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to extend the pilot period of the trading
pause for individual stocks contained in the Standard & Poor's 500
Index, Russell 1000 Index, and specified Exchange Traded Products that
experience a price change of 10% or more during a five-minute period,
so that the pilot will now expire the earlier of August 11, 2011 or the
date on which a limit up/limit down mechanism to address extraordinary
market volatility, if adopted, applies.
    The text of the proposed rule change is below. Proposed new
language is italicized; proposed deletions are in brackets.
* * * * *

4120. Trading Halts

(a) Authority To Initiate Trading Halts or Pauses

    In circumstances in which Nasdaq deems it necessary to protect
investors and the public interest, Nasdaq, pursuant to the
procedures set forth in paragraph (c):
    (1)-(10) No change.
    (11) shall, between 9:45 a.m. and 3:35 p.m., or in the case of
an early scheduled close, 25 minutes before the close of trading,
immediately pause trading for 5 minutes in any Nasdaq-listed
security when the price of such security moves 10 percent or more
within a 5-minute period. At the end of the trading pause, Nasdaq
will re-open the security using the Halt Cross process set forth in
Nasdaq Rule 4753. In the event of a significant imbalance at the end
of a trading pause, Nasdaq may delay the re-opening of a security.
    Nasdaq will issue a notification if it cannot resume trading for
a reason other than a significant imbalance.
    Price moves under this paragraph will be calculated by changes
in each consolidated last-sale price disseminated by a network
processor over a five minute rolling period measured continuously.
Only regular way in-sequence transactions qualify for use in
calculations of price moves. Nasdaq can exclude a transaction price
from use if it concludes that the transaction price resulted from an
erroneous trade.
    If a trading pause is triggered under this paragraph, Nasdaq
shall immediately notify the single plan processor responsible for
consolidation of information for the security pursuant to Rule 603
of Regulation NMS under the Securities Exchange Act of 1934. If a
primary listing market issues an individual stock trading pause,
Nasdaq will pause trading in that security until trading has resumed
on the primary listing market or notice has been received from the
primary listing market that trading may resume. If the primary
listing market does not reopen within 10 minutes of notification of
a trading pause, Nasdaq may resume trading the security.
    The provisions of this paragraph shall only apply to securities
in the Standard & Poor's 500 Index, the Russell 1000 Index, as well
as a pilot list of Exchange Traded Products.
    The provisions of this paragraph shall be in effect during a
pilot set to end on the earlier of August 11, 2011 or the date on
which a limit up/limit down mechanism to address extraordinary
market volatility, if adopted, applies[April 11, 2011].
* * * * *

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 aspects of such
statements.
1. Purpose
    On June 10, 2010, the Commission granted accelerated approval, for
a pilot period to end December 10, 2010, for a proposed rule change
submitted by the Exchange, together with related rule changes of the
BATS Exchange, Inc., NASDAQ OMX BX, Inc., Chicago Board Options
Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange,
Inc., EDGX Exchange, Inc., International Securities Exchange LLC, New
York Stock Exchange LLC (``NYSE''), NYSE Amex LLC (``NYSE Amex''), NYSE
Arca, Inc. (``NYSE Arca''), and National Stock Exchange, Inc.
(collectively, the ``Exchanges''), to pause trading during periods of
extraordinary market volatility in S&P 500 stocks.\3\ The rules require
the Listing Markets \4\ to issue five-minute trading pauses for
individual securities for which they are the primary Listing Market if
the transaction price of the security moves ten percent or more from a
price in the preceding five-minute period. The Listing Markets are
required to notify the other Exchanges and market participants of the
imposition of a trading pause by immediately disseminating a special
indicator over the consolidated tape. Under the rules, once the Listing
Market issues a trading pause, the other Exchanges are required to
pause trading in the security on their markets. On September 10, 2010,
the Commission approved the respective rule filings of the Exchanges to
expand application of the pilot to the Russell 1000[supreg] Index and
specified Exchange Traded Products.\5\ On December 7, 2010, the
Exchange filed an immediately effective filing to extend the existing
pilot program for four months, so that the pilot would expire on April
11, 2011.\6\
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 62252 (June 10, 2010),
75 FR 34186 (June 16, 2010) (SR-NASDAQ-2010-061).
    \4\ The term ``Listing Markets'' refers collectively to NYSE,
NYSE Amex, NYSE Arca, and the Exchange.
    \5\ Securities Exchange Act Release No. 62884 (September 10,
2010), 75 FR 56618 (September 16, 2010) (SR-NASDAQ-2010-079).
    \6\ Securities Exchange Act Release No. 63505 (December 9,
2010), 75 FR 78302 (December 15, 2010) (SR-NASDAQ-2010-162).
---------------------------------------------------------------------------

    The Exchange believes that the pilot program has been successful in
reducing the negative impacts of sudden, unanticipated price movements
in the securities covered by the pilot. The Exchange also believes that
an additional four month extension of the pilot is warranted so that it
may continue to assess whether circuit breakers are the best means to
reduce the negative impacts of sudden, unanticipated price movements or
whether alternative mechanisms would be more effective in achieving
this goal. In this regard, the Exchange notes that the Exchanges are
developing a ``limit up/limit down'' mechanism to reduce the negative
impacts of sudden, unanticipated price movements in securities traded
on the Exchanges. As such, the proposed extension may be shorter in
duration should the Exchange adopt a limit up/limit down mechanism to
address extraordinary market volatility. Accordingly, the Exchange is
filing to further extend the pilot program until the earlier of August
11, 2011 or the date on which a limit up/limit down mechanism to
address extraordinary market volatility, if adopted, applies.
2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Securities Exchange Act of 1934 (the ``Act''),\7\ which requires
the rules of an

exchange to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. The proposed rule change also is designed to support
the principles of Section 11A(a)(1) \8\ 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 transparency and uniformity across
markets concerning decisions to pause trading in a security when there
are significant price movements.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(5).
    \8\ 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 will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). When filing a proposed rule change
pursuant to Rule 19b-4(f)(6) under the Act, an exchange is required
to give the Commission written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date
of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Commission notes that the Exchange
has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\11\
However, Rule 19b-4(f)(6) \12\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ Id.
---------------------------------------------------------------------------

    The Commission has considered the Exchange's request to waive the
30-day operative delay. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest, as it will allow the pilot program to continue
uninterrupted, thereby avoiding the investor confusion that could
result from a temporary interruption in the pilot program.\13\ For this
reason, the Commission designates the proposed rule change to be
operative upon filing.
---------------------------------------------------------------------------

    \13\ For the purposes only of waiving the operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
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, as amended, 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-NASDAQ-2011-042 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2011-042. 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 Web site
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 offices 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
available publicly.
    All submissions should refer to File Number SR-NASDAQ-2011-042, and
should be submitted on or before April 29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-8374 Filed 4-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Page 33585]
[FR Doc No: 2014-13616]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4176-DR; Docket ID FEMA-2014-0003]

Alabama; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alabama (FEMA-4176-DR), dated May 2, 2014, and related
determinations.

DATES: Effective Date: May 8, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Alabama is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of May 2, 2014.

Blount, DeKalb, Etowah, Mobile, and Tuscaloosa Counties for
Individual Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-13616 Filed 6-10-14; 8:45 am]
BILLING CODE 9111-23-P


Site Visit

Safety Kleen – Chicago Recycle Center

5/17/2006

On May 17, 2006, representatives of EPA’s Hazardous Waste
Identification Division visited Safety Kleen’s Chicago Recycle Center
to discuss the operations of their recycling facility and service. In
attendance:

Kathy Blanton		EPA

Amy Lile		EPA

Alfred Aghapour	Safety Kleen	Chicago	Facility Manager

Gary Malinowski	Safety Kleen	Chicago	EH&S Manager

Mike Fusco	Safety Kleen 	Director of Legislative Affairs, NE Region EH&S
Manager

Dave Sprinkle	Safety Kleen 	Executive Vice President of Operations

Lin Longshore	Safety Kleen	Senior Vice President of Engineering and EH&S

The Chicago Recycle Center is Safety Kleen’s main facility for tolling
services. EPA and Safety Kleen representatives discussed the
capabilities of this facility, its operating capacity, and its operating
procedures as well as how this facility fits into Safety Kleen’s
national operations. EPA participated in a site tour to see materials
arrival areas, waste and product storage areas, and distillation
equipment. Discussions topics included the nature of the relationship
between Safety Kleen and their customers, and the nature of tolling
contracts and how they are different from Safety Kleen’s other
recycling operations.


[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74196-74197]
[FR Doc No: 2012-30034]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1005]

Draft Guidance for Industry on Safety Considerations for Product
Design To Minimize Medication Errors; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Safety
Considerations for Product Design to Minimize Medication Errors.'' The
draft guidance provides sponsors of investigational new drug
applications, new drug applications, biologics licensing applications,
abbreviated new drug applications, and nonprescription drugs marketed
without an approved application (e.g., monograph) with a set of
principles for developing drug products using a systems approach to
minimize medication errors relating to product design. The draft
guidance includes recommendations intended to improve the drug product
and container closure design at the earliest stages of product
development for all prescription and nonprescription drug products.

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 comments 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 February 11, 2013.

ADDRESSES: Submit written requests for single copies of this 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: Carol Holquist, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4416, Silver Spring, MD 20993-0002, 301-
796-0171.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Safety Considerations for Product Design to Minimize
Medication Errors.'' In Title I of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), Congress reauthorized
and expanded the Prescription Drug User Fee Act program for fiscal
years (FYs) 2008 through 2012 (PDUFA IV). As part of the performance
goals and procedures set forth in an enclosure to the letter from the
Secretary of Health and Human Services referred to in section 101(c) of
FDAAA, FDA committed to certain performance goals and procedures. (See
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm). In that letter, FDA stated that it would use fees
collected under PDUFA to implement various measures to reduce
medication errors related to look-alike and sound-alike proprietary
names, unclear label abbreviations, acronyms, dose designations, and
error-prone label and packaging designs. Among these measures, FDA
agreed that by the end of FY 2010, after public consultation with
academia, industry, other stakeholders, and the general public, the
Agency would publish draft guidance describing practices for naming,
labeling, and packaging drugs and biologics to reduce medication
errors. On June 24 and 25, 2010, FDA held a public workshop and opened
a public docket (Docket No. FDA-2010-N-0168) to receive comments on
these measures.
    This draft guidance document, which addresses safety achieved
through drug product design, is the first in a series of planned
guidance documents to minimize risks contributing to medication errors.
The second guidance will focus on minimizing risks with the design of
drug product container labels, carton labeling, and packaging
configurations, and the third guidance will focus on minimizing risks
with drug product nomenclature.
    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 addressing
safety achieved through drug product design to minimize medication
errors. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. 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 part 312 have been approved under
OMB control number 0910-0014. The collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

IV. Electronic Access

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

    Dated: December 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30034 Filed 12-12-12; 8:45 am]
BILLING CODE 4160-01-P