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 USEPA Office of Water, Office of Wastewater Management 2. OMB control number b. G None a 2 0 4 0  0 1 0 1 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X 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: Questionnaire for Nominees for the Annual National Clean Water Act Recognition Awards Program 8. Agency form number( s) ( If applicable) ICR No. 1287.07 9. Keywords: Clean Water Act Awards; O& M Awards; Wastewater Awards: EPA Awards Program.

10. Abstract: This is a revision of a currently approved ICR to collect data from EPA's Clean Water Act ( CWA) Recognition Awards nominees. Awards are for the Operations and Maintenance ( O& M), Biosolids Management, Storm Water Management ( SW), and Combined Sewer Overflow Controls ( CSO) program categories. Information collection approval for the Pretreatment awards category is included in the National Pretreatment Program ICR ( OMB Control No. 2040 0009. EPA, ICR No. 0002.09), approved through November 30, 2003. The Awards Program is managed in EPA's Office of Wastewater Management ( OWM). By authority of Section 501( e) of the CWA, as amended, the Awards Program recognizes wastewater treatment industries and municipalities which have demonstrated outstanding technological achievements, or innovative processes, methods or devices in their waste treatment and pollution abatement programs. Over 40 first and second place awards are presented at an annual EPA Ceremony for management excellence in the above categories. Occasionally, nominated activities may receive an honorable mention or special award. The wastewater management achievements are summarized in reports, news articles and national publications. The completed questionnaire is returned to the applicant at the end of the year. The collection of information is estimated to include 195 respondents and 2030 burden hours ( 1160/ 8 hour responses and 870/ 6 hour responses for States), and $ 94,975 ($ 55,245 for respondents and $ 39,730 for States). The cost to the Federal government is $ 128,080 per year. Participation by respondents is voluntary. No confidential information is requested.

11. Affected public ( Mark primary with " P" and all others that apply with" X")

a. Individuals or households d. Farms b._ Business or other for profit e. X Federal Government c. X Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. P Voluntary b. X Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 195 b. Total annual responses 290 1. Percentage of these responses collected electronically 20 % c. Total hours requested 2030 d. Current OMB inventory 2800 e. Difference  770 f. Explanation of difference 1. Program Change 0 2. Adjustment  770 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. P Application for benefits e. __ Program planning or management b. X Program evaluation f. ___ Research c. __ General purpose statistics g. __ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. X 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: Maria E. Campbell Phone: 202 564 0628 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 James A. Hanlon Director Office of Wastewater Management Date Signature of Senior Official or designee Doreen Sterling, Acting 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 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Page 4227]
[FR Doc No: 2012-1754]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2011-N-0003]

Implantation or Injectable Dosage Form New Animal Drugs;
Gonadotropin Releasing Factor Analog-Diphtheria Toxoid Conjugate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pfizer, Inc. The supplemental NADA extends
the slaughter interval for intact male swine injected with gonadotropin
releasing factor analog-diphtheria toxoid conjugate injectable
solution.

DATES: This rule is effective January 27, 2012.

FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed a supplement to NADA 141-322 for IMPROVEST (gonadotropin
releasing factor analog-diphtheria toxoid conjugate) Sterile Solution
for Injection, administered as two doses 4 weeks apart to intact male
pigs for the reduction of boar taint. The supplement extends the
slaughter interval from 4 to 8 weeks after the second dose to 3 to 10
weeks. The supplemental NADA is approved as of November 30, 2011, and
the regulations in 21 CFR 522.1083 are amended to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
    The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  522.1083, revise paragraphs (c)(1) and (c)(3) to read as
follows:

Sec.  522.1083  Gonadotropin releasing factor analog-diphtheria toxoid
conjugate.

* * * * *
    (c) * * *
    (1) Amount. Administer 0.4 mg (2 milliliter (mL)) by subcutaneous
injection no earlier than 9 weeks of age. A second subcutaneous
injection of 0.4 mg (2 mL) should be administered at least 4 weeks
after the first dose.
* * * * *
    (3) Limitations. Not approved for use in female pigs and barrows.
Do not use in intact male pigs intended for breeding because of the
disruption of reproductive function. Federal law restricts this drug to
use by or on the order of a licensed veterinarian. Pigs should be
slaughtered no earlier than 3 weeks and no later than 10 weeks after
the second dose.

    Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1754 Filed 1-26-12; 8:45 am]
BILLING CODE 4160-01-P


	Redline of Coal Prep changes since 09-18-09 ROCIS submittal

	Mary Johnson

	to:

	Higgins, Cortney

	09/23/2009 05:22 PM

	Cc:

	RobertJ Wayland, Sonja Rodman, Thomas Gillis, Teresa Clemons

	Show Details

Cortney,

Attached is a redline version of the Coal Preparation and Processing FR

notice that reflects changes made since formal submittal through ROCIS.

Please let us know if you have additional comments or concerns.

Thanks.

Mary Johnson

Environmental Engineer

U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Mail Code D 243-01

Research Triangle Park, NC  27711

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>