Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``FDA Oversight of PET Drug ProductsQuestions and Answers.'' This guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.

The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on October 5, 2012 (77 FR 61084). The document updated the list of HHS and overlap biological agents and toxins and designated certain select agents and toxins as Tier 1 agents.

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

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.

This notice announces a $532.00 calendar year (CY) 2013 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2013 and on or before December 31, 2013.

The Food and Drug Administration (FDA) is amending the food additive regulations to increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen. This action is in response to a petition filed by the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS).

A notice was published in the Federal Register of Friday, October 26, 2012, Vol. 77, No. 208, to announce the intent to establish the 2015 Dietary Guidelines Advisory Committee and solicit nominations of individuals who are interested in being appointed to the Committee membership. This notice is being amended to extend the solicitation period to allow additional time for nominations to be received. The new due date for all nominations to be received is no later than close of business on December 11, 2012.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,'' dated November 2012. The draft guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products regulated by the Center for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current expectations regarding the preclinical information that supports an investigational new drug application (IND) and a biologics license application (BLA) for these product areas.

The Food and Drug Administration (FDA or we) is establishing January 1, 2016, as the uniform compliance date for food labeling regulations that are issued between January 1, 2013, and December 31, 2014. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 15, 2010, we established January 1, 2014, as the uniform compliance date for food labeling regulations issued between January 1, 2011, and December 31, 2012.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting (Webinar format only). The meeting will be open to the public. Registration is required.

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved injectable drug products containing sodium nitrite labeled for the treatment of cyanide poisoning and unapproved injectable drug products containing sodium thiosulfate labeled for the treatment of cyanide poisoning, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Cyanide antidotes carry serious risks and some unapproved drug products may lack Boxed Warnings and other warnings required in the labeling of approved cyanide antidotes. These unapproved drug products compete with approved products, and thus pose a direct challenge to the drug approval system. Injectable drug products containing sodium nitrite or sodium thiosulfate that are labeled for the treatment of cyanide poisoning are new drugs that require approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in order to be legally marketed.

This notice is a request for information to seek public comments regarding health plan quality management in Affordable Insurance Exchanges.

This notice announces the first semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel), (the Ambulatory Payment Classification (APC) Panel) for 2013. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the APC groups and their associated weights, and hospital outpatient therapeutic supervision issues.

This notice announces the HIT Policy Committee's request for comments on its draft recommendations for meaningful use Stage 3.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary, Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0302, scheduled to expire on November 31, 2012. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

This proposed rule details standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this proposed rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This proposed rule also proposes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and an amendment which provides an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.

This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2014 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2014 new medical services and technologies applications meet the substantial clinical improvement criterion.

The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's implementation of the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) related to medical gases. This action is intended to ensure that information submitted to FDA on the implementation of the medical gas provisions of FDASIA is available to all interested persons in a timely fashion.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' FDA is issuing this guidance to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems.

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products. Currently, patient preoperative skin preparations are not required to be sterile. Bacteria can contaminate these products at the time of manufacture or during product use. Contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes. At this public hearing, FDA is interested in obtaining public comment about certain scientific and product use issues related to patient preoperative skin preparations. Date and Time:The public hearing will be held on December 12 and 13, 2012, from 9 a.m. to 4 p.m. The meeting may be extended or may end early, depending on the level of public participation. Location: The public hearing will be held at the DoubleTree by Hilton Hotel Washington, DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD 20910. Contact Person: Lee Lemley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-3441, FAX: 301- 847-8753, email: AntisepticPreOpPublicMeeting@fda.hhs.gov. Registration: The public hearing is free, and seating will be on a first-come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register. If you need special accommodations due to disability, please contact Lee Lemley (see Contact Person) at least 7 days in advance. Requests for Oral Presentations: If you wish to make an oral presentation during the hearing, you must register by submitting a written or electronic request by close of business on November 27, 2012, to Lee Lemley (see Contact Person). Provide your name, title, business affiliation (if applicable), address, telephone and fax numbers, email address, and type of organization you represent (e.g., pharmaceutical company or consumer organization). You also should submit a brief summary of the presentation, including the discussion topic(s) that will be addressed and the approximate time requested for your presentation. We encourage individuals and organizations with common interests to consolidate or coordinate their presentations to allow adequate time for each request for presentation. Persons registered to make an oral presentation should check in before the hearing. Participants should submit a copy of each presentation to Lee Lemley (see Contact Person) no later than December 7, 2012. We will file the hearing schedule, indicating the order of presentation and the time allotted to each person, with the Division of Dockets Management (see Comments). We will mail, email, or telephone the schedule to each participant before the hearing. In anticipation of the hearing presentations moving ahead of schedule, participants are encouraged to arrive early to ensure their designated order of presentation. Participants who are not present when called risk forfeiting their scheduled time. Comments: Interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic comments to https:// www.regulations.gov. Comments will be accepted after the hearing until February 12, 2013. Persons who wish to provide additional materials for consideration should file these materials with the Division of Dockets Management. You should annotate and organize your comments to identify the specific questions identified by the topic to which they refer. 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 https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Ventron Corporation facility, in Beverly, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 12, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2013. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2013 are $209.80 for aged enrollees and $235.50 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2013 is $104.90, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2012 standard premium rate was $99.90.) The Part B deductible for 2013 is $147.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage.

This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2013 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2013, the inpatient hospital deductible will be $1,184. The daily coinsurance amounts for CY 2013 will be: $296 for the 61st through 90th day of hospitalization in a benefit period; $592 for lifetime reserve days; and $148 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Eric J. Smart, Ph.D., University of Kentucky: Based on the report of an investigation conducted by the University of Kentucky (UK) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Eric J. Smart, former Professor of Pediatrics and Physiology, Department of Pediatrics and Physiology, UK, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants R01 HL062844, R01 HL058475, R01 HL064056, R01 HL068059, and R01 HL073693, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R56 DK063025, and National Center for Research Resources (NCRR), NIH, grant P20 RR105592. ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in ten (10) published papers, one (1) submitted manuscript, seven (7) grant applications, and three (3) progress reports over a period of ten (10) years. Respondent reported experimental data for knockout mice that did not exist in five (5) grant applications and three (3) progress reports and also falsified and/or fabricated images in 45 figures included in the following:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document revises and updates the draft guidance entitled ``Electronic Source Documentation in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA- regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is announcing the availability of guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for designing and conducting clinical effectiveness studies and describes criteria that the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of anticoccidial drugs intended for use in poultry and other food-producing animals. The guidance suggests times during the evaluation of effectiveness when sponsors may wish to consult with CVM.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

As required by section 423(c) of the Social Security Act (42 U.S.C. 623(c)), the Department is publishing the allotment percentage for each State under the Title IV-B Subpart 1, Child Welfare Services State Grants Program. Under section 423(a), the allotment percentages are one of the factors used in the computation of the Federal grants awarded under the Program.

The Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug Administration (FDA) is in the process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption.

The Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining.

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking of giving a co-exclusive license in Africa, and an exclusive license in all territories other than Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Merial Limited, having a place of business in Duluth, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application(s) to be licensed are:

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a worldwide, exclusive license to practice the inventions listed in the patent referred to below to Flow Applications, Inc., having a place of business in Okawville, Illinois. The patent rights in these inventions have been assigned to the government of the United States of America. The patent to be licensed is:

This major final rule with comment period addresses changes to the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also implements provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it implements statutory changes regarding the termination of non-random prepayment review. This final rule with comment period also includes a discussion in the Supplementary Information regarding various programs . (See the Table of Contents for a listing of the specific issues addressed in this final rule with comment period.)

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

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 information collection provisions of the guidance document entitled ``Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.''

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 information collection associated with FDA's technical assistance reference manuals provided to State, local, territorial, and tribal jurisdictions, and other Federal Agencies to interpret and promote the application of Hazard Analysis and Critical Control Point (HACCP) principles to reduce the risk of foodborne illness in the operation of retail and food service establishments.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This information collection was previously published in the Federal Register on June 29, 2012, page 38840 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_ submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Amanda Greene, Office of Science Policy and Public Liaison, NINR, NIH, Democracy One, 6701 Democracy Blvd., Suite 700, Bethesda, MD 20892 or call non-toll-free number (301) 496-9601 or Email your request, including your address to: amanda.greene@nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2013 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program. We are continuing the electronic reporting pilot for the Electronic Health Record (EHR) Incentive Program, and revising the various regulations governing Quality Improvement Organizations (QIOs), including the secure transmittal of electronic medical information, beneficiary complaint resolution and notification processes, and technical changes. The technical changes to the QIO regulations reflect CMS' commitment to the general principles of the President's Executive Order on Regulatory Reform, Executive Order 13563 (January 18, 2011).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 23, 2012 (Volume 77, Number 36) and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment, to correct the omission of the peers survey in the previous notice, and to correct the errant data that appeared in Table 1 and Table 2 of the notice. The data in Table 1 and Table 2 of this notice are correct. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. This proposed information collection project was previously published in the Federal Register (77 FR 52748) on August 30, 2012, and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917- 0034, ``Indian Health Service (IHS) Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form.'' Type of Information Collection Request: Extension without revision of the currently approved information collection, 0917-0034, ``IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form,'' which was previously approved under the title ``Director's 3 Initiative Best Practice, Promising Practice, and Local Efforts Form.'' Although the name of the form has changed, the contents of the form remain the same. Forms: 0917-0034, ``IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form.'' Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/ AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and to provide the product/service to IHS, Tribal, and Urban (I/T/U) programs, the Office of Preventive and Clinical Services' program divisions (i.e., Behavioral Health, Health Promotion/Disease Prevention, Nursing, and Dental) have developed a centralized program database of best practices, promising Practices and local efforts and resources. This database was previously referred as OSCAR, but the name will be changed to BPPPLE to reflect the revised name of the form. The purpose of this collection is to develop a database of BPPPLE and resources to be published on the IHS.gov Web site which will be a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities. All information submitted is on a voluntary basis; no legal requirement exists for collection of this information. The information collected will enable the Indian Health systems to: (a) Identify evidence based approaches to prevention programs among the I/T/Us when no system is currently in place, and (b) Allow the program managers to review BPPPLE occurring among the I/T/Us when considering program planning for their communities. Affected Public: Individuals. Type of Respondents: I/T/U programs' staff. The table below provides: Types of data collection instruments, Number of respondents, Responses per respondent, Average burden hour per response, and Total annual burden hour(s).