[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51374-51375]
[FR Doc No: 2011-21043]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0012]

Direct Discovery of HLA Associated Influenza Epitopes Isolated
From Human Cells for Vaccine and Therapeutic Evaluation and Development
(U01)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of a sole source
cooperative agreement with the University of Oklahoma Health Sciences
Center. The goal of the FDA, Center for Drug Evaluation and Research,
Office of Chief Scientist, is to develop technology to molecularly
characterize peptide epitopes that are processed and presented on
soluble HLA (human leucocyte antigen) expressed by human cells. Initial
studies will examine and characterize influenza peptides isolated from
several different soluble Class I HLAs produced from influenza infected
human lung cell lines. There is a growing interest in developing
universal vaccines for influenza by targeting conserved internal
proteins to stimulate cross-protective CTLs (cytolytic T lymphocyte) to
provide long-lasting immunity. It is therefore critically important to
identify which viral epitopes are generated by antigen processing in
influenza infected lung cells, the target cells of cell mediated immune
response to respiratory viruses. FDA seeks a collaboration to develop
this technology for this purpose which can then be applied to
identifying and characterizing other HLA-presented epitopes in viral
infections, cancer, and immune toxicities.

DATES: Important dates are as follows:
    1. The application due date is September 1, 2011.
    2. The anticipated start date is November 1, 2011.
    3. The opening date is August 18, 2011.
    4. The expiration date is November 2, 2011.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
    For Programmatic questions and concerns contact: Michael Norcross,
Center for Drug Evaluation and Research, Food and Drug Administration,
9000 Rockville Pike, N29B, Rm. 4NN (HFD 122), Bethesda, MD 20892,
Telephone:<PHONE_NUMBER>; E-mail<EMAIL_ADDRESS>    For Financial and Administrative questions and concerns contact:
Gladys M. Bohler, Food and Drug Administration, Office of Acquisitions
and Grant Services, 5630 Fisher's Lane, Rm. 1078 (HFA 500), Rockville,
MD 20857, Telephone:<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088761.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Funding Opportunity Number: RFA-FD-12-001.
Catalog of Federal Domestic Assistance Number: 93.103.

A. Background

    Knowledge on how viral and self proteins are processed and
presented in HLA molecules is important to understand how the body
defends itself from infection and how immune responses can lead to
tissue toxicities. Developing technology to allow direct identification
of epitopes bound by HLA molecules is critical to vaccine and
therapeutic immune strategies. FDA is interested in collaborative
research to develop and implement this technology which will be
valuable in evaluation and review of vaccines and therapeutics. Initial
studies will address identifying epitopes from influenza that are
presented by different HLA alleles in infected lung cells.
    Influenza virus infection affects a significant proportion of the
population and is associated with serious morbidity and mortality.
Although many epitopes can be predicted by computer programs and by
screening peripheral blood cells with panels of viral peptides from
influenza, the peptides that are presented on the infected target cells
in the tissues and the infiltrating T cells that recognize the HLA-
peptide complexes are the critical elements to control and recover from
infection. The technology of directly identifying viral epitopes in HLA
can elucidate viral targets for T cells and provide the foundation for
new approaches for rapid development of effective vaccines. More
effective vaccines to prevent and control influenza infections will
have broad public health benefits by reducing morbidity and mortality
of this infectious disease.

B. Research Objectives

    For this purpose, a direct epitope elution approach is needed to
allow milligram quantities of HLA-peptide complexes to be purified from
influenza infected lung cells lines that express soluble HLA. Human
lung cell lines engineered to secrete soluble HLA from three supertypes
(A*01, A*03, and B*27) should be infected with at least two current
influenza strains and HLA collected during infection. HLA will be
purified and bound peptides eluted. Influenza peptides should be
systematically identified by mass spectrometry analysis and sequencing.
Synthetic viral peptides can then be tested for binding to recombinant
HLA to verify binding specificity and affinity. Influenza epitopes
identified in this initial phase of the project can be evaluated for
immunogenicity and antigenicity in follow up studies.
    This project will provide the regulatory science to facilitate
development and evaluation of direct discovery of HLA presented
epitopes. The direct epitope methodology will be applied to current
influenza strains initially, but has the flexibility to address novel
pandemic strains and other pathological agents.
    Goal 1: Identify virus-encoded class I HLA peptides presented
during influenza infection of human lung cells.
    Goal 2: In vitro validation of class I HLA-presented influenza
peptides.
    Goal 3: Develop HLA-epitope direct-discovery technology for use in
FDA laboratories.

C. Eligibility Information

    The technology requires extensive infrastructure for growing cells,
purifying HLA from culture supernatants, and for mass spectrometry
analysis. Staff at the University of Oklahoma Health Sciences Center
are leaders in this technology and have published the first reports on
applying this method to influenza. Support of this project will allow
the extension of the methodology to examine other HLA types. FDA
believes this is a novel and valuable methodology that should be
implemented at FDA. Funding this collaborative initiative will allow
FDA to acquire the proteomic expertise, training, and tissue culture
support to establish a laboratory in the field of immunoproteomics. The
direct

identification of viral epitopes is critically important to
understanding immune responses to infection and vaccination, and there
are currently no comparable methods besides the classic screening of
vast arrays of overlapping viral peptides on blood lymphocytes. Peptide
screening methods only identify possible target epitopes, but do not
define which epitopes are expressed in lung tissue. The technology will
be valuable for vaccine development and evaluation, and has the
flexibility to allow rapid analysis of novel pandemic strains for
immunogenic epitopes. The technology can be applied to other infectious
diseases, cancer, and immunotoxicities.

II. Award Information/Funds Available

A. Award Amount

    Only one grant award will be made in fiscal year (FY) 2012. The
application budget is not limited, but it needs to reflect the actual
needs of the proposed project. However, presently for FY 2012, the
funds are available in the amount of $400,000 (total cost), and are
subject to change based on the availability of funds.

B. Length of Support

    The maximum period is 1 year with the option of 4 more years of
budget support depending on the availability of funds.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants
should first review the full announcement located at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088761.htm. Persons
interested in applying for a grant may obtain an application at http://grants2.nih.gov/grants/funding/phs398/phs398.html. For all paper
application submissions, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With Central Contractor Registration.
     Step 3: Register With Electronic Research Administration
(eRA) Commons.
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to: Gladys Bohler, Grants Management
Specialist (see FOR FURTHER INFORMATION CONTACT section of this
document).

    Dated: August 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21043 Filed 8-17-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69690-69691]
[FR Doc No: 2013-27769]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0576]

Draft Guidance for Industry: Considerations for the Design of
Early-Phase Clinical Trials of Cellular and Gene Therapy Products;
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the draft guidance for industry entitled ``Guidance
for Industry: Considerations for the Design of Early-Phase Clinical
Trials of Cellular and Gene Therapy Products'' that appeared in the
Federal Register of July 2, 2013 (78 FR 39736). The draft guidance
document provides sponsors of Investigational New Drug Applications for
cellular therapy (CT) and gene therapy (GT) products (referred to
collectively as CGT products) with recommendations to assist in
designing early-phase clinical trials of CGT products. In the notice,
we requested comments on the draft guidance. We are taking this action
to allow interested persons additional time to submit comments and to
allow for public discussion at the February 25-26, 2014, Cellular,
Tissue, and Gene Therapies Advisory Committee meeting, where FDA will
present the draft guidance document for review.

DATES: FDA is extending the comment period on the draft guidance.
Submit either electronic or written comments by May 9, 2014.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
request. The draft guidance may also be obtained by mail by calling
CBER at 1-800-835-

4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document

FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 2, 2013 (78 FR 39736), FDA
published a notice announcing the availability of a draft guidance
document entitled ``Guidance for Industry: Considerations for the
Design of Early-Phase Clinical Trials of Cellular and Gene Therapy
Products.'' The notice invited comments on the draft guidance by
November 22, 2013.
    We are extending the comment period for the draft guidance to May
9, 2014. We are taking this action to allow interested persons
additional time to submit comments and to allow for public discussion
at the April 10-11, 2014, Cellular, Tissue, and Gene Therapies Advisory
Committee meeting, where FDA will present the draft guidance document
for review.
    The Agency believes that this extension will not significantly
delay further FDA action on this guidance.

II. Request for Comments

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

    Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27769 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P


IMPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font (Times New Roman 8pt).

 Do not change table lines (although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5. 1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706. 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: United States Environmental Protection Agency/ Office of Solid Waste 2. OMB control number b. G None a 2050 0145 3. Type of information collection (check one) a. X New collection b. G Revision of a currently approved collection c. G 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. X 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 X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: Mercury Containing Equipment Reuse and Recycling 8. Agency form number( s) (If applicable) EPA ICR# 1597.05 9. Keywords Hazardous waste mercury containing equipment, universal waste rule 10. Abstract The Agency has decided to add mercury containing equipment (MCEs) to the existing universal waste regulations at 40 CFR Part 273. The hazardous waste MCE rule requires universal waste entities involved with the management of MCEs to follow procedures for maintaining the condition of MCEs (e. g., proper packaging), storing (e. g., accumulation time limits, labeling), notifying EPA as specified, and responding to releases.

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. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 2, 495 b. Total annual responses 2,495 1. Percentage of these responses collected electronically 0 % c. Total hours requested 15,630 d. Current OMB inventory 0 e. Difference 15,630 f. Explanation of difference 1. Program Change Newly proposed requirements 2. Adjustment 14. Annual reporting and recordkeeping cost burden (in thousands of dollars)

a. Total annualized capital/ startup costs 1. 4 b. Total annual costs (O& M) 113 c. Total annualized cost requested 825.5 d. Current OMB inventory 0 e. Difference 825.5 f. Explanation of difference 1. Program change Newly proposed requirements 2. Adjustment 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. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other (describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact (person who can best answer questions regarding the content of this submission) Name: Teena Wooten Phone: 703 308 8751 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 Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads "As part of the agency submission to OMB of a proposed collection of information, the agency (through the head of the agency, the Senior Official or their designee) shall certify (and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection (together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit (citing authority), or mandatory (citing authority); "( v) the nature and extent of confidentiality to be provided, if any (citing authority); and "( vi) the fact that any 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."

OMB 83 I (Instructions) 10/ 95


[Federal Register Volume 79, Number 5 (Wednesday, January 8, 2014)]
[Notices]
[Pages 1381-1382]
[FR Doc No: 2014-00090]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Nonprescription Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Nonprescription Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 26, 2014, from
8 a.m. to 12:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Glendolynn S. Johnson, Center for Drug Evaluation
and

Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On February 26, 2014, the committee will meet to discuss
whether over-the-counter (OTC) bronchodilators administered by hand-
held rubber bulb nebulizers for the temporary relief of mild symptoms
of intermittent asthma (shortness of breath, tightness of chest, and
wheezing) should be removed from the monograph. Specific drugs to be
discussed include epinephrine, epinephrine bitartrate, and
racepinephrine hydrochloride (21 CFR 341.16).
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 10, 2014. Oral presentations from the public will be scheduled
between approximately 10:15 a.m. and 11:15 a.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before January 31, 2014.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by February 3, 2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Glendolynn S.
Johnson at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 3, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00090 Filed 1-7-14; 8:45 am]
BILLING CODE 4160-01-P


                  Use of AgDRIFT and AGDISP in OPP Risk Assessments

      Scientific Basis for the Models
      EPA uses two peer-reviewed spray drift models (AgDRIFT and AGDISP) to estimate the contribution of spray drift to ecological and human health risk assessments. Both models estimate drift fractions, as applicable to spray of liquid materials. In addition, AGDISP has limited capability to estimate drift fractions from dry materials application.
      The Spray Drift Task Force (SDTF), a coalition of pesticide registrants, was formed in 1990, with the goal of developing a generic database of off-target drift information in support of spray drift data requirements for the registration of pesticides. In developing test protocols for laboratory and field studies, the SDTF consulted with technical experts from research institutions around the world and compiled a list of over 2,000 drift-related studies from the scientific literature. Between 1992 and 1995, the SDTF conducted a series of field and laboratory studies that provided the scientific basis for spray deposition and downwind drift predictions. These SDTF studies were designed and conducted in consultation with scientists at universities and research institutions, and were intended to provide a quantitative measure of the potential environmental exposure of non-target organisms to a chemical of concern as well as for use in predicting human exposure from spray drift.  More than 300 applications were made in 10 field studies to quantify spray drift from aerial, ground, and orchard airblast applications. After the field studies were completed, the results were peer reviewed at two public meetings of the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP).  The report from the December 1997 meeting is available at http://www.epa.gov/scipoly/sap/meetings/1997/121097_mtg.htm  and the report from the July 1999 meeting is available at http://www.epa.gov/scipoly/sap/meetings/1999/072099_mtg.htm.
      Using the data from the SDTF field trials, the AgDRIFT model was developed to assess a variety of spray drift conditions.  AgDRIFT, a modified version of the AGricultural DISPersal (AGDISP) model developed by the US Forest Service, was created under a Cooperative Research and Development Agreement between the EPA, the US Department of Agriculture's Forest Service, and the SDTF for estimating spray drift from aerial, ground, and orchard airblast applications.  AGDISP is a "first-principles," science-based aerial model which has been well established and can be used beyond the STDF test conditions. AGDISP/AgDRIFT algorithms have been formally validated using 161 SDTF field trial data for a wide range of aerial application and meteorological conditions  .
      Based on the SDTF data, AgDRIFT can predict Tier 1 (screening-level) drift fractions for aerial, ground, and orchard air blast applications.  AgDRIFT can also predict drift fractions for higher-tiered modeling for aerial applications.   Input features of the AGDISP and AgDRIFT models provide the capability to alter over 30 parameters related to the aerial application method including application technique, meteorology, spray material and atmospheric stability.  AgDRIFT can also provide alternate, empirically based, predictions for ground and airblast sprayers which represent applications under different conditions. The AGDISP model also has application modules for ground spray and limited capability to model the spray of dry materials.
      In general, OPP uses the AgDRIFT model to assess spray drift from agricultural applications, whereas AGDISP is used for other types of pesticide applications, such as aerial application of mosquito adulticides. Both of these spray drift models are widely accepted in the scientific community for determining off-site spray drift and have been used by many US federal agencies and by pesticide regulatory authorities worldwide.
      Several updates have occurred in recent years to improve the performance and reliability of AgDRIFT and AGDISP.  When updates occur, OPP evaluates the latest versions of these models, and determines if changes are needed to OPP's methodologies for estimating exposure and risk.  For more information regarding these models, refer to:  http://www.epa.gov/pesticides/science/models_db.htm.

      Harmonized Model-Generated Spray Drift Fractions Usage in OPP Risk Assessments
      The Agency has determined to use the AgDRIFT model generated spray drift fractions to assess spray drift exposure for pesticide applications. A harmonized understanding of the process for estimating spray drift fractions by both ecological and human health risk assessors will ensure consistency and provide more realistic risk estimates. Both of the draft guidances use harmonized AgDRIFT model scenarios for risk assessment purposes.  In the absence of application parameters such as droplet size spectrum, release height, wind speed, and percent of swath displacement, as well as relevant meteorological conditions, on the product label, the following model input parameters for various application scenarios will be used to estimate spray drift fractions:
          *              Ground Applications: high boom height, ASAE very fine to fine Drop Size Distribution (DSD), and a 90[th] percentile data without extended settings
          * Orchard/Airblast:  Sparse (Young/Dormant) AgDRIFT
          # Aerial Application: Tier I module. Additional parameters for aerial application include the following:
                o ASAE Fine to Medium DSD,
                o a wind speed of 10 mph
                o 60 foot swath width,
                o release height of 10 feet,
                o Boom Length of 76.3%, and
                o Swath Displacement of 37%.

      Most of these parameters are recommended in the AgDRIFT model by the SDTF.  The recommended droplet size spectra were also suggested in university extension material for various pesticide types or uses and were consistent with SDTF recommendations.
      Currently, this harmonized approach is being implemented for both ecological and human health risk assessments.


[Federal Register Volume 75, Number 241 (Thursday, December 16, 2010)]
[Notices]
[Page 78798]
[FR Doc No: 2010-31698]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Alternate Energy Holdings, Inc.; Order of
Suspension of Trading

December 14, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Alternate Energy Holdings, Inc. (``AEHI'') because of questions
regarding the accuracy and adequacy of disclosures by AEHI concerning,
among other things: (1) The stock sales of certain AEHI officers, (2)
the status and viability of funding to build a nuclear reactor, and (3)
executive compensation. AEHI is quoted on the OTC Bulletin Board and on
the Pink Sheets operated by Pink OTC Markets, Inc. under the ticker
symbol ``AEHI.''
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EST, on
December 14, 2010 through 11:59 p.m. EST, on December 28, 2010.

By the Commission.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-31698 Filed 12-14-10; 4:15 pm]
BILLING CODE 8011-01-P