Section 1: Program History
      The President's Environmental Youth Awards (PEYA) recognizes outstanding environmental projects by K-12 youth. PEYA promotes awareness of our nation's natural resources and encourage positive community involvement. Each year the PEYA program honors a wide variety of projects developed by young individuals, school classes (kindergarten through high school), summer camps, public interest groups, and youth organizations to promote environmental awareness.

      Past projects have included building nature trails, recycling programs, restoring native habitats, installing renewable energy projects, and participating in many other creative, sustainable efforts. To read about past award-winning projects, visit: https://www.epa.gov/education/presidents-environmental-youth-award-peya-winners.

Section 2: How the Program Works
      The U.S. Environmental Protection Agency (EPA) has ten regional offices across the country. Each regional office will be responsible for selecting up to two winners per region, based on the evaluation criteria in Section 6. Applicants are welcome to include youth across multiple grade levels; however, the application will be categorized based on the applicant with the highest-grade level. For example, if one applicant group consists of two 4th graders, one 3rd grader and one 6th grader, the application will be evaluated in the Grade 6-12 category.

      Each award-winning project will receive a Presidential plaque. All qualified applicants will receive recognition from EPA leadership honoring them for their efforts to protect human health and the environment.

Section 3: Eligibility

 Project is completed while the applicant(s) is in kindergarten through 12th grade.
 Applicant(s) is a citizen of the United States or its territories or has been lawfully admitted for permanent residency.
 Each applicant or group of applicants applying for PEYA must be represented preferably by a teacher sponsor. Sponsors/co-sponsor must sign and date page A-2 of the application.
 Projects started on or after January 1, 2019 are eligible for consideration. As long as there was activity on the project after January 1, 2019, a project initiated prior to that date is eligible for consideration.
 Consent forms must be signed for each applicant; and attached to application as a requirement for eligibility and participation in the awards ceremony in the event the application wins the PEYA award.
 Projects must include an environmental stewardship component.
 Completed video license agreement form for all video and photos submitted with application.

Section 4: Sponsors
      Each applicant or group of applicants applying for PEYA must be represented preferably by a teacher sponsor. If the sponsor is not a teacher, the sponsor must seek a co-sponsor that is a teacher. The sponsor/co-sponsor must be an adult at least 21 years of age and may be a parent, teacher, youth group adviser, summer camp counselor or community leader. The adult sponsor plays an important role in helping a young person or group of young people carry out a project and apply for PEYA.  The teacher must certify that the project was been completed by all applicants.

      Typically, a sponsor/co-sponsor offers suggestions and advice throughout the project to: develop a well-thought-out project; implement the project; work with other groups and individuals in the community; complete the application form (for K-5 applicants); and assist in preparing accompanying materials. The sponsor/co-sponsor must also sign and date the application.

Application Validation
 By signing, both the teacher and sponsor/co-sponsor(s) certifies that the applicant(s) has performed this project.
 The teacher is responsible for receiving PEYA awards for non-attending winners at school location.
 The teacher is responsible for coordinating with the sponsor and co-sponsor to distribute the awards and certificates.
 By receiving a signed EPA multi-media consent form for each applicant (s) guardian.

         *Questions about the role of the teacher or sponsor/co-sponsor should be directed to<EMAIL_ADDRESS>
Section 5: How to Apply
      A blank application is provided on page A-1. A PDF version of this document can be viewed or downloaded at: https://www.epa.gov/education/presidents-environmental-youth-award-peya- application.
Requirements
 A project summary of up to 300 words must be provided on the application form. Please note that applicants that are applying in the 6-12 grade level category must complete the project summary section themselves. Applicants in the K-5 grade level may be advised by the sponsor /co-sponsors and may assist in the writing of the project summary.
 A more detailed description of the project, no more than five pages, and addressing each of the evaluation criterion should be attached to the application.
 Applicants may submit up to five additional pages of photographs, newspaper articles, and other supporting materials to provide a more comprehensive view of the project. Accompanying videos must be web-based with functioning links (e.g., no CDs).
 Each applicant or group of applicants applying for PEYA must be represented preferably by a teacher sponsor. Sponsors/co-sponsor must sign and date page A-2 of the application.
  All application materials must be and received by December 13, 2019. See instructions below for submitting an application.
Multimedia Consent Forms
 Consent forms must be signed for each applicant; and attached to application as a requirement for eligibility and participation in the awards ceremony in the event the application wins the PEYA award.
 "Video and photos may be taken at all events and will be shared on social media and on the website. By attending, you are consenting to having your photo taken. Multimedia Consent Forms to be signed by parents/guardians are being collected for all minors attending the events. We will not use the last names of children in the ceremony speeches or on the website, for privacy purposes. We will share the video and photographs with you after the event, along with any press releases, so you can share with family and friends."

Submissions Instructions
 Applications can be submitted electronically (email) or by hard copy (U.S. mail or commercial delivery service).
 All sponsors/co-sponsor will receive a confirmation email upon receipt of the application package.
 Email completed application materials to<EMAIL_ADDRESS>by 11:59 p.m. ET on December 13, 2019. Applicants are encouraged to combine application materials into as few attachments as possible.
 Hard copies must be delivered by 5:00 p.m. ET on December 13, 2019, to be eligible for consideration.
               o Mail completed application materials to:
                  U.S. Environmental Protection Agency Office of Environmental Education
                  Attn: President's Environmental Youth Award Program William Jefferson Clinton North, Room 1426
                  1200 Pennsylvania Ave, NW, MC 1704-A Washington, DC 20460

Section 6: How Applications Are Judged
      Each application is evaluated by a regional awards panel. The panel members review and evaluate each application based on the criteria. There are separate evaluation criteria for K-5 and 6-12 applications. A maximum of 100 points can be awarded to a given application.

Evaluation Criteria K-5 (100 points)

Youth Initiative (15 points)
            How did the applicant(s) come up with the idea for the project? To what extent does the applicant(s) take charge of the project?

      Environmental Stewardship* and Impact (30 points)
            Was there an environmental stewardship component to the project? How did the applicant(s) identify the environmental need for this project? How did the project positively affect the environment?

      Competition and project goals (15 points)
            Winning projects may highlight environmental stewardship in a variety of areas, including the following: environmental sustainability; a healthy school environment, including projects that reduce food waste in school cafeterias; environmentally friendly agriculture practices; reducing and preventing human contributions to ocean litter; school gardens; recycling; or using STEM to teach environmental education.

            Did the project address one of the focus areas of the competition including: projects that reduce food waste in school cafeterias; environmentally friendly agriculture practices; reducing and preventing human contributions to ocean litter; school gardens; recycling; or using STEM to teach environmental education?

      Did students complete the project?

      Community Involvement (15 points)
            To what extent did the project involve others in the school or community? Please describe the community.

      Project Creativity and/or Innovation (15 points)
            What creative and/or innovative approach(es) did the applicant(s) use for the project?

      Project Approach (10 points)
            To what extent does the application tell a complete story about the project? Did the applicant(s) have a thought-out approach to solving the problem?
      *Definition: "Environmental or Conservation Stewardship" is voluntary commitment, behavior, and action that results in environmental protection or improvement, or conservation of our natural resources. Stewardship refers to an acceptance of personal responsibility for actions to improve environmental quality and to achieve conservation outcomes. Stewardship involves lifestyles and business practices, initiatives and actions that enhance the state of the environment and natural resources. Some examples are: living or conducting business in such a way as to minimize or eliminate pollution at its source; using natural resources efficiently; decreasing the use of hazardous chemicals; recycling wastes effectively; and conserving or restoring soil, forests, prairies, wetlands, rivers, and parks. Stewardship can be practiced by individuals, groups, schools, organizations, companies, communities, and state and local governments.

Evaluation Criteria 6-12 (100 points)
      Youth Initiative (15 points)
            To what extent was the project designed, coordinated and implemented due to applicant
            (s) initiative? How was the project created and completed by the applicant(s)? The driving force for the project must be the applicant(s), not the sponsor/co-sponsor.

      Environmental Need and Appropriateness (20 points)
            To what extent was there a clear environmental need for the project? How appropriate was the project for the community in which it was performed?

      Environmental Stewardship* and Impact (15 points)
            Was there an environmental stewardship component to the project? How did the project positively affect the community? Were there any long-term environmental benefits or outcomes of the project?

      Competition and project goals (15 points)
            Winning projects may highlight environmental stewardship in a variety of areas, including the following: environmental sustainability; a healthy school environment, including projects that reduce food waste in school cafeterias; environmentally friendly agriculture practices; reducing and preventing human contributions to ocean litter; school gardens; recycling; or using STEM to teach environmental education.

            Did the project address one of the focus areas of the competition including: projects that reduce food waste in school cafeterias; environmentally friendly agriculture practices; reducing and preventing human contributions to ocean litter; school gardens; recycling; or using STEM to teach environmental education?

      Did students complete the project?

      Community Involvement (15 points)
            To what extent did the project positively involve others in the community? Please describe the community. What community resources, expertise, leadership, or publicity did the applicant(s) use?

      Project Creativity and Innovation (10 points)
            How did the applicant(s) use innovative approaches to achieve positive results?

      Soundness of Approach, Rationale, and Scientific Design (10 points)
            Was the approach to the problem clear? Did the applicant(s) have a sound justification for choosing that approach? If so, what is that justification?

            *Definition: "Environmental or Conservation Stewardship" is voluntary commitment, behavior, and action that results in environmental protection or improvement, or conservation of our natural resources. Stewardship refers to an acceptance of personal responsibility for actions to improve environmental quality and to achieve conservation outcomes. Stewardship involves lifestyles and business practices, initiatives and actions that enhance the state of the environment and natural resources. Some examples are: living or conducting business in such a way as to minimize or eliminate pollution at its source; using natural resources efficiently; decreasing the use of hazardous chemicals; recycling wastes effectively; and conserving or restoring soil, forests, prairies, wetlands, rivers, and parks. Stewardship can be practiced by individuals, groups, schools, organizations, companies, communities, and state and local governments.

Individual Application
 Name:

 Title of Project:

 Project Location:
 (include city, state, zip code and the name of the school)

 Date Project Began:

 Date Project Ended:

                                        OR
   Team Application
 Individual/Group Name:

 Title of Project:

 Project Location:
 (include city, state, zip code and the name of the school)

 Total Number of Applicants:

 Date Project Began:

 Date Project Ended:

   Please check the box for the grade level you are applying for below.
         ☐	K-5	☐	6-12
   Did the project receive press coverage? If yes, please attach press clippings.
 Yes	☐	No

Applicants:
   Fill in the table below with information for each of the youth applicants. If necessary, continue a separate sheet.  Each applicant must have a completed and signed multi-media consent form (see below). Please also complete the attached media consent form for all applicants.  Additional sheets may be necessary.
   Name
 Grade

 I__________________________SAMPLE (see attached)_______________________________ (Print First and Last Name) hereby agree to waive compensation and authorize video, photo(s) and or voice recording(s) to be made of me (or the above-named individual acting as legal guardian or custodian) by the Environmental Protection Agency.

 To be used for informational, educational, and or public relations purposes both within the EPA and by the general public, since all EPA prepared video, photo(s) and or voice recording(s) remain in the public domain.
       The end product will be shown on various EPA social media pages such as Facebook (www.facebook.com/EPA),YouTube (www.youtube.com/user/USEPAgov), and Twitter (www.twitter.com/epagov)
        I understand the video, photo(s) and/or voice may appear online as soon as 30 minutes after the taping, and will remain online indefinitely and may subsequently appear in EPA paper publications or other non-EPA publications that EPA deems appropriate that help promote or publicize the event or purpose that the video, photo(s) and/or voice recording was prepared.

 I authorize disclosure and release of the video, photo(s) and/or voice recording to U.S. Environmental Protection Agency.

 I have read and understand the foregoing and I consent to the use of my video, photo(s) and/or voice recording as specified for the above-described purpose(s) or that of my custodian. I further understand that no royalty, fee or other compensation of any character shall become payable to me or my custodian by the U.S. Environmental Protection Agency for such use. I understand that consent to use mine or that of my custodian's video, photo(s) and/or voice recording is voluntary.

 In addition, I waive the right to inspector approve the finished product, including written or electronic copy, wherein mine or that of my custodian's video likeness appears.

 I hereby hold harmless and release and forever discharge the United States and U.S. Environmental Protection Agency from all claims, demands, and causes of action which I, my heirs, representatives, executors, administrators, or any other persons acting on my behalf or on behalf of my estate or that of my custodian have or may have by reason of this authorization.

 I am at least 18 years of age, and or the legal guardian/custodian, and I am competent to contract in my own name or in the name of my child and I have read this release before signing below and I fully understand the contents, meaning, and impact of this release.

 nature of Individual or other legally authorized person
                                                             Date

 Print Name

 Title

Project Name:

Production Notes:

Teacher (*Teachers provide ONLY work associated information)
   List the name and contact information for the adult sponsor/co-sponsor. The sponsor or co-sponsor must sign and date page A-2 of the application.
 Name:

 School Name/ Address/City/State: (*Teacher Only)

 Relationship to Applicant(s):
      Sponsor          Co-sponsor
 Work Phone Number:

 Work Email:

   Sponsor/Co-sponsor
 Name:

 Relationship to Applicant(s):
      Sponsor          Co-sponsor
 Phone Number:

 Email:

Description of the Project
   Please provide a project summary (of up to 300 words in Times Roman 12pt font) of the project in the space provided below and identify the results achieved. The purpose and goals of the project should be included in the summary. A more detailed description of the project, addressing the evaluation criteria, should be included separately in 3-5 pages, double-spaced, Times New Roman, font size 12.  Please provide project description in typed format as described above.  No hand -written project descriptions. You may also include up to 5 additional pages of photographs, press clippings, and other supporting materials.   Please complete the EPA photo license agreement for all photos and videos submitted with this application.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                         WASHINGTON, D.C. 20460

                  VIDEO/AUDIO/PHOTO LICENSE AGREEMENT

 This license agreement dated	       , is between U.S. Environmental Protection Agency,
                                                 {Date)
 referred to as the "Licensee" and, ____________________________________________
                                                 (Name of Company/Organization)
 referred to as the "Licensor." This will confirm that the Licensor has granted Licensee the right to use
  ___________ (the "Material") solely in connection with Licensee's
            (Photos, Videos, Audio Clips, Etc.)
  	  Entitled __________
       (Project Types: Video. Podcast, Photo, Slideshow)	{Name of Project}
 and the production, distribution, promotion, broadcast at public meetings/conferences and online posting thereof. EPA will not offer, distribute or make available any of the Material provided by the Licensor or portions of the completed EPA public service announcement containing the Material in any form, except through the EPA website and social media channels.

 Licensor agrees to license the Material for use in all media now known or hereafter devised in perpetuity throughout the universe. Licensee shall not provide Licensor with an on-screen courtesy/credit for the Material used in the public service announcement; the courtesy/credit will be listed in the description field of the EPA social media channel entry.

 Licensor warrants and represents that it is the sole owner of the Material and that it has the legal right to enter into and fully perform this agreement and grant the rights contained herein. Licensor shall indemnify, defend and hold Licensee harmless from and against any and all suits, claims, liabilities, demands, costs, expenses, or damages arising out of Licensee's Use of the Material as provided herein or arising out of the breach of warranty or agreement made by Licensor herein.

 This License contains the full understanding and agreement of the parties with respect to the subject matter hereof.

                                                          AGREED AND ACCEPTED BY:

 U.S. Environmental Protection Agency
 Office of 	_
 _______________________________________

 Licensor

By signing below, the teacher and sponsor/co-sponsor(s) certifies that the applicant(s) has performed this project. The sponsor also certifies that parent or guardian permission has been obtained for each applicant to participate in the PEYA program.

   X		Date:
   Teacher Signature

   X		Date:
   Sponsor/Co-sponsor Signature

    President's Environmental Youth Award Application	Revised September 2019	A-2

Additional photo release and media consent forms. Remember you must have an photo license agreement form complete for each picture submitted with the application and a media consent form for each applicant as an requirement for application.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                         WASHINGTON, D.C. 20460

                  VIDEO/AUDIO/PHOTO LICENSE AGREEMENT

 This license agreement dated	       , is between U.S. Environmental Protection Agency,
                                                 {Date)
 referred to as the "Licensee" and, ____________________________________________
                                                 (Name of Company/Organization)
 referred to as the "Licensor." This will confirm that the Licensor has granted Licensee the right to use
  ___________ (the "Material") solely in connection with Licensee's
            (Photos, Videos, Audio Clips, Etc.)
  	  Entitled __________
       (Project Types: Video. Podcast, Photo, Slideshow)	{Name of Project}
 and the production, distribution, promotion, broadcast at public meetings/conferences and online posting thereof. EPA will not offer, distribute or make available any of the Material provided by the Licensor or portions of the completed EPA public service announcement containing the Material in any form, except through the EPA website and social media channels.

 Licensor agrees to license the Material for use in all media now known or hereafter devised in perpetuity throughout the universe. Licensee shall not provide Licensor with an on-screen courtesy/credit for the Material used in the public service announcement; the courtesy/credit will be listed in the description field of the EPA social media channel entry.

 Licensor warrants and represents that it is the sole owner of the Material and that it has the legal right to enter into and fully perform this agreement and grant the rights contained herein. Licensor shall indemnify, defend and hold Licensee harmless from and against any and all suits, claims, liabilities, demands, costs, expenses, or damages arising out of Licensee's Use of the Material as provided herein or arising out of the breach of warranty or agreement made by Licensor herein.

 This License contains the full understanding and agreement of the parties with respect to the subject matter hereof.

                                                          AGREED AND ACCEPTED BY:

 U.S. Environmental Protection Agency
 Office of 	_
 _______________________________________

 Licensor

 Please make sure that each applicant to the PEYA program completes the below media consent form.  This form is a requirement
 for application eligibility.

 I_________________________________________________________ (Print First and Last Name) hereby agree to waive compensation and authorize video, photo(s) and or voice recording(s) to be made of me (or the above-named individual acting as legal guardian or custodian) by the Environmental Protection Agency.

 To be used for informational, educational, and or public relations purposes both within the EPA and by the general public, since all EPA prepared video, photo(s) and or voice recording(s) remain in the public domain.
       The end product will be shown on various EPA social media pages such as Facebook (www.facebook.com/EPA),YouTube (www.youtube.com/user/USEPAgov), and Twitter (www.twitter.com/epagov)
        I understand the video, photo(s) and/or voice may appear online as soon as 30 minutes after the taping, and will remain online indefinitely and may subsequently appear in EPA paper publications or other non-EPA publications that EPA deems appropriate that help promote or publicize the event or purpose that the video, photo(s) and/or voice recording was prepared.

 I authorize disclosure and release of the video, photo(s) and/or voice recording to U.S. Environmental Protection Agency.

 I have read and understand the foregoing and I consent to the use of my video, photo(s) and/or voice recording as specified for the above-described purpose(s) or that of my custodian. I further understand that no royalty, fee or other compensation of any character shall become payable to me or my custodian by the U.S. Environmental Protection Agency for such use. I understand that consent to use mine or that of my custodian's video, photo(s) and/or voice recording is voluntary.

 In addition, I waive the right to inspector approve the finished product, including written or electronic copy, wherein mine or that of my custodian's video likeness appears.

 I hereby hold harmless and release and forever discharge the United States and U.S. Environmental Protection Agency from all claims, demands, and causes of action which I, my heirs, representatives, executors, administrators, or any other persons acting on my behalf or on behalf of my estate or that of my custodian have or may have by reason of this authorization.

 I am at least 18 years of age, and or the legal guardian/custodian, and I am competent to contract in my own name or in the name of my child and I have read this release before signing below and I fully understand the contents, meaning, and impact of this release.

 nature of Individual or other legally authorized person
                                                             Date

 Print Name

 Title

Project Name:

Production Notes:


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 Vol. 108 No. 1 (2017)
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 Original articles
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Quality check of safety data sheets for plant protection product co-formulants: hazard classification and coherence of the information
Main Article Content
Valerio Di Mare
International Centre for Pesticides and Health Risk Prevention ICPS ASST Fatebenefratelli Sacco - Polo Universitario Via G.B. Grassi, 74 Pad. 17 20157 Milano - Italy web www.icps.it phone + 39 02 35686654 fax + 39 02 38203163

Gaetano Garramone
International Centre for Pesticides and Health Risk Prevention ICPS ASST Fatebenefratelli Sacco - Polo Universitario Via G.B. Grassi, 74 Pad. 17 20157 Milano - Italy web www.icps.it phone + 39 02 35686654 fax + 39 02 38203163

Maristella Rubbiani
Reparto di Valutazione del pericolo di preparati e miscele, Centro Nazionale Sostanze Chimiche (CSC) - Istituto Superiore di Sanità - Viale Regina Elena 299, 00161 Roma (Italia)

Angelo Moretto
Dipartimento di Scienze Biomediche e Cliniche, Università degli Studi di Milano, Via G.B. Grassi 74, 20157 Milano (Italia) - International Centre for Pesticides and Health Risk Prevention ICPS ASST Fatebenefratelli Sacco - Polo Universitario Via G.B. Grassi, 74 Pad. 17 20157 Milano - Italy web www.icps.it phone + 39 02 35686654 fax + 39 02 38203163

Keywords
Safety data sheets, hazard classification, plant protection product co-formulants
Abstract
Background: Hazard classification of chemicals can be defined as a logic-mathematical operation aimed at identifying the type and severity of the inherent hazards of a substance or a mixture. Objectives: The purpose of this study was to evaluate, in 134 safety data sheets (SDSs): i) the hazard classification and ii) its coherence with sections 9 (physical-chemical properties), 11 (toxicological properties) and 12 (ecological properties) of the SDSs. Methods: Hazard classification and the information provided in sections 9, 11 and 12 of the SDSs have been evaluated against the criteria provided in annexes VI of the Dangerous Substance Directive, II and III of the Dangerous Preparations Directive, I and VI of the Regulation (EC) n. 1272/2008. Results: Most of the analyzed SDSs of substances (62%) was associated to non-classified chemicals (61.4%), although 19.6% of them should have been classified. By contrast, 59.4% of classified substances (representing 38.6% of analyzed ones) were wrongly classified. Fifty-four %, 54% and 67% of suggested substances hazard classification were in line with sections 9 (physical-chemical properties), 11 (toxicological properties) and 12 (ecological properties). Conclusions: The proportion of hazard classification mistakes in SDS was significant, suggesting the need of more qualified experts to derive classification. The introduction of an ad hoc evaluation team, managed by a single, qualified specialist, could represent a solution to ensure the needed improvement of SDSs quality.


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45259-45261]
[FR Doc No: 2011-19139]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0510]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances Prohibited From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the recordkeeping requirements
for substances prohibited for use in animal food or feed.

DATES: Submit electronic or written comments on the collection of
information by September 26, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of

Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Substances Prohibited From Use in Animal Food or Feed--21 CFR Part 589
(OMB Control Number 0910-0627)--(Extension)

    The final rule on bovine spongiform encephalopathy (BSE) (73 FR
22720, April 25, 2008) prohibits the use of certain cattle origin
materials in the food or feed of all animals to help prevent the spread
of BSE in U.S. cattle. BSE is a progressive and fatal neurological
disorder of cattle that results from an unconventional transmissible
agent. BSE belongs to the family of diseases known as transmissible
spongiform encephalopathies (TSEs). All TSEs affect the central nervous
system of infected animals. These measures will further strengthen
existing safeguards against BSE.
    Description of Recordkeeping for Respondents: Rendering facilities,
medicated feed manufacturers, livestock feeders.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                     21 CFR Section                        recordkeepers    records per       records           per         Total hours     maintenance
                                                                           recordkeeper                    recordkeeper                        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
589.2001 (c)(2)(vi) and (c)(3)(i).......................             175               1             175              20           3,500         $59,500
589.2001 (c)(2)(ii).....................................              50               1              50              20           1,000          17,000
589.2001 (c)(3)(i)(A)...................................             175               1             175              26           4,550          80,580
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............           9,050         157,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    The number of recordkeepers times the number of records per
recordkeeper equals total annual records. Total annual records times
average burden per recordkeeper equals total hours.
    Description of Respondents for Reporting; The final rule on BSE (73
FR 22720) included a provision that exempts cattle materials prohibited
in animal feed (CMPAF) from designated countries from the prohibition
on its use in animal feed (21 CFR 589.2001(b)(1)(vi)). A foreign
country seeking this designation will submit a written request to FDA
that includes a variety of information about the countries' BSE status
(21 CFR 589.2001(f)). FDA estimates that 10 countries could submit a
request to FDA to be exempted from CMPAF restrictions.
    FDA estimates the reporting burden for this information collection
as follows:

                         Table 2--Estimated One-Time and Recurring Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
589.2001(b)(1) \2\..............              10               1              10              80             800
589.2001(f).....................              10               1              10              26             260
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with the collection of information.
\2\ One-time burden.

    Dated: July 20, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19139 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P