Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health associated with electrocardiograph electrodes: Adverse tissue reaction to the skin- contacting electrode materials and misdiagnosis. The guidance document provides information on how to mitigate these risks and recommends testing and labeling for these devices. This guidance document describes a means by which electrocardiograph electrodes may comply with the requirement of special controls for class II devices.

The Administration for Children and Families (ACF), Administration for Native Americans (ANA), announces the award of ten expansion supplement awards to Native American Tribes that are currently combating the epidemic of health issues in Native America. Expansion supplement funds will support activities associated with the First Lady's initiative, Let's Move! in Indian Country. Under the program, grantee Tribes have set forth goals and milestones that will benefit Native youth, children, and families. The following projects will be supported by the expansion supplement awards: Native Village of Afognak, Kodiak, AK ($20,000). The project will include Let's Move! activities as part of their summer youth camps. Pueblo of Tesuque, Santa Fe, NM ($20,025). The project will include Let's Move! activities in its existing project of building a comprehensive prevention and early intervention program that is focused on building community member awareness of, and ability to, confront challenges. Riverside-San Bernardino County Indian Health, Inc., Banning, CA ($20,000). The project will include healthy living and healthy lifestyles of the Let's Move! initiative in its already existing project that focuses on providing pre-marital, dating violence and communication education. The project also provides pre-marital education to pregnant and parenting adolescents. Yerington Paiute Tribe, Yerington, NV ($19,034). This project will include Let's Move! activities that support the development of a family/community wellness support system. The system provides prevention, intervention, referral and follow-up services to community members. Cornerstone Ministries, Inc., Crownpoint, NM ($20,001). This project will implement Let's Move! activities in its project to increase the awareness and value of healthy families and will include activities in its training of youth workers to conduct relationship education. Eastern Shawnee Tribe of Oklahoma, Wyandotte, OK ($17,490). This project will include Let's Move! activities in its project to encourage healthy eating and exercise to reduce the rate of diabetes among elderly tribal members. Leech Lake, Cass Lake, MN ($19,999). This project will include Let's Move! activities in its project to increase relevant academic and cultural content for an intensive in-service for teachers. Chickaloon Native Village, Chickaloon, AK ($16,948). This project will include Let's Move! activities in its project that encourages tribal governance and land stewardship of Chickaloon traditional lands by designing and implementing a trails and recreation planning, management, and ecotourism plan. White Earth Band of Chippewa, White Earth, MN ($19,940). This project will include Let's Move! activities in its project to improve child well-being and social stability by providing family support services to disadvantaged parents and their children. The American Indian Child Resource Center, Oakland, CA ($20,000). This project will include Let's Move! activities in its project to providing life skills training that fosters and promotes decision making, critical thinking, and independent living skills among young Native Americans living in urban environments.

The Food and Drug Administration (FDA) is announcing a public workshop on the adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems. The purpose of this workshop is to engage multiple stakeholders to obtain information and comments on issues confronting the effective and efficient incorporation of UDIs into appropriate data sets, to identify barriers and incentives to their adoption and use, and to understand the best solutions and practices to resolve open issues. Dates and Times: The public workshop will be held on September 12, 2011, from 1 to 5 p.m. and on September 13, 2011, from 9 a.m. to 5 p.m. Submit electronic and written comments by October 13, 2011. Location: The public workshop will be held at the Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD 20852; 301-822-9200. Contact Person: Jay Crowley, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-980-1936, e-mail: jay.crowley@fda.hhs.gov Registration: Registration is free and will be on a first-come, first-served basis. To register for the public workshopwhether attending in person or for the Web castplease visit https:// www.fda.gov/UDI (or go the FDA Medical Devices News & EventsWorkshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, and telephone number. For those without Internet access, please contact Jay Crowley (see Contact Person) to register. Registration requests should be received by 5 p.m. on September 5, 2011. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 11 a.m. Hotel reservations can be made by calling the hotel and requesting the group rate for the ``FDA UDI Public Workshop'' room block. If you need special accommodations due to a disability, please contact Jay Crowley (jay.crowley@fda.hhs.gov) at least 7 days in advance. The meeting will also be Web cast. Persons interested in participating by Web cast must register online by 5 p.m. on September 5, 2011. Web cast participants will be sent connection requirements. More information on the Web cast can be found on our Web site at http:/ /www.fda.gov/UDI. By August 12, 2011, and then as available, FDA will post the workshop agenda and discussion topics, registration information, information about lodging, and other relevant information on the Internet at https://www.fda.gov/UDI. Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments by October 13, 2011. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled, ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document describes a means by which focused ultrasound stimulator systems for aesthetic use may comply with the requirement of special controls for class II devices. This guidance document is being immediately implemented as the special control for focused ultrasound stimulator systems for aesthetic use, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, July 8, 2011 (76 FR 40374). The document announced that a proposed collection information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The document was published with an incorrect docket number. This document corrects that error.

The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Community Demonstration Programs announces the award of an Assets for Independence (AFI) demonstration grant to the United Way of Abilene, Inc. of Abilene, TX in the amount of $126,974. The purpose of this award is to enable the United Way of Abilene, Inc. to implement an Assets for Independence (AFI) project helping program participants save earned income in special-purpose, matched savings accounts called Individual Development Accounts (IDAs). Every dollar in savings deposited into an IDA by participants is matched, from $1 to $8 combined Federal and non-Federal funds, promoting savings and enabling participants to acquire a lasting economic asset. AFI project families use their IDA savings, including the matching funds, to achieve any of three objectives: Acquiring a first home; capitalizing a small business; or enrolling in postsecondary education or training. Additionally, the United Way of Abilene, Inc. provides basic financial management training and supportive services, such as financial education on owning and managing a bank account; credit counseling and repair; guidance in accessing refundable tax credits, including the Earned Income Tax Credit and the Child Tax Credit; and specialized training in owning particular economic assets for the long term.

This notice announces a forthcoming meeting of a public advisory committee of ACF. The meeting will be open to the public. Name of Committee: Advisory Committee for Head Start Research and Evaluation. General Function of Committee: The Advisory Committee for Head Start Research and Evaluation will provide feedback on the published final report for the Head Start Impact Study, offering interpretations of the findings, discussing implications for practice and policy, and providing recommendations on follow-up research, including additional analysis of the Head Start Impact Study data. The Committee will also be asked to provide recommendations to the Secretary regarding how to improve Head Start and other early childhood programs by enhancing the use of research-informed practices in early childhood. Finally, the Committee will be asked to provide recommendations on the overall Head Start research agenda, includingbut not limited tohow the Head Start Impact Study fits within this agenda. The Committee will provide advice regarding future research efforts to inform HHS about how to guide the development and implementation of best practices in Head Start and other early childhood programs around the country.

The Office of the Assistant Secretary for Health, Office on Women's Health, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics related to chronic fatigue syndrome (CFS). The appointments of three Committee members are scheduled to end during the 2012 calendar year. Nominations of qualified candidates are being sought to fill these future vacancies.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the OPPS. These proposed changes would be applicable to services furnished on or after January 1, 2012. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we set forth the proposed relative payment weights and payment amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other proposed ratesetting information for the CY 2012 ASC payment system. These proposed changes would be applicable to services furnished on or after January 1, 2012. We are proposing to revise the requirements for the Hospital Outpatient Quality Reporting (IQR) Program, add new requirements for ASC Quality Reporting System, and make additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program. We also are proposing to allow eligible hospitals and CAHs participating in the Medicare Electronic Health Record (EHR) Incentive Program to meet the clinical quality measure reporting requirement of the EHR Incentive Program for payment year 2012 by participating in the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot. In addition, we are proposing to make changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses.'' 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 in vitro diagnostic devices intended for the detection or detection and differentiation of influenza viruses.

This proposed rule would implement the new Affordable Insurance Exchanges (``Exchanges''), consistent with title I of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. A detailed Preliminary Regulatory Impact Analysis associated with this proposed rule is available at https://cciio.cms.gov under ``Regulations and Guidance.'' A summary of the aforementioned analysis is included as part of this proposed rule.

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.

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.

This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the following 7 grantees: Colorado, Iowa, Kansas, Louisiana, Minnesota, South Carolina, and Vermont to develop and implement their Tracking Networks. These activities are proposed by the above-mentioned grantees in their FY 2011 applications submitted under funding opportunity EH09-907, ``National Environmental Public Health Tracking ProgramNetwork Implementation (EPHT),'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $4,920,000 in ACA funding will be awarded to the grantees for network expansion and enhancement. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 [42 U.S.C. 300u-11]; (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH09-907:

This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the following 17 grantees: California, Connecticut, Florida, Maine, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, New Mexico, New York City, New York State, Oregon, Pennsylvania, Utah, Washington, and Wisconsin to develop and implement their Tracking Networks. These activities are proposed by the above-mentioned grantees in their FY 2011 applications submitted under funding opportunity EH11-1103, ``National Environmental Public Health Tracking Program-Network Implementation (EPHT),'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $16,500,000 in ACA funding will be awarded to the grantees for network expansion and enhancement. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 [42 U.S.C. 300u-11]; (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH11-1103:

This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the following grantee: National Association for Public Health Statistics and Information Systems (NAPHSIS) to collaborate with CDC to identify and overcome barriers that limit access to work with CDC, states and local grantees to develop electronic vital records reporting systems to ensure Public Health Information Network-(PHIN) compatibility that would promote data interoperability across public health systems. These activities are proposed by the above mentioned grantee in their FY 2011 application submitted under funding opportunity EH10-1004, ``National Environmental Public Health Tracking Program (EPHT),'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $125,000.00 in ACA funding will be awarded to the grantee for network expansion and enhancement. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 [42 U.S.C. 300u-11]; (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH10-1004:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Restaurant Menu and Vending Machine Labeling: Recordkeeping and Mandatory Third Party Disclosure Under Section 4205 of the Patient Protection and Affordable Care Act of 2010'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and MEDSCAPE, LLC AND WEBMD LLC. The purpose of the MOU is to complement FDA's capacity to educate and communicate with health care professionals. It will also promote the timely dissemination to health care professionals of accurate information on public health and emerging safety issues and products safety recalls.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement with the National Institute for Pharmaceutical Technology and Education Initiative (NIPTE). Development of the Critical Path Manufacturing Sector Initiative has focused attention on the continuing need for this kind of research in a way that can improve reliability of pharmaceutical product manufacturing and quality across the entire industry. This shared knowledge will increase the likelihood of successfully manufacturing products that have been identified in the clinical development community. The goal of this agreement is to improve the overall manufacturing and quality and the knowledge base.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The original ANADA provides for the use of amprolium soluble powder for the treatment of coccidiosis in chickens and turkeys.

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.

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.

This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including: The national standardized 60- day episode rates, the national per-visit rates, the low utilization payment amount (LUPA), and outlier payments under the Medicare prospective payment system for home health agencies effective January 1, 2012.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Alpharma, LLC, to Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc. The sponsor's mailing address will also be changed.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Cosmetic Registration Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NIHCD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23605-23606, 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.

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.

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 (the PRA).

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.

This proposed rule would update and make certain revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2012. This proposed rule would also set forth proposed requirements for the ESRD quality incentive program (QIP) for payment years (PYs) 2013 and 2014. In addition, this proposed rule would revise the ambulance fee schedule regulations to conform with statutory changes. Finally, this proposed rule would revise the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime criterion that must be met by an item or device in order to be considered durable for the purpose of classifying the item under the Medicare benefit category for DME. (See the Table of Contents for a listing of the specific issues addressed in this proposed rule.)

The Food and Drug Administration (FDA) is announcing that a

The Food and Drug Administration (FDA) is announcing a public

This notice announces the intention of the Agency for

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of address for Huvepharma AD, a sponsor of approved new animal drug applications.

The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.

This notice informs interested parties of an opportunity to participate in the Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration. The Demonstration is mandated by section 3113 of the Affordable Care Act. This notice also serves to notify interested parties that they must obtain a temporary code from CMS for tests currently billed using a ``not otherwise classified (NOC)'' code but that would otherwise meet the criteria set forth in section 3113 for being a complex diagnostic laboratory test under the Demonstration. The statute requires a Report to Congress that includes an assessment of the impact of the Demonstration on access to care, quality of care, health outcomes, and expenditures.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as ``NDI notifications'').

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement between the Center for Food Safety and Applied Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy, and educating the general public.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 15, 2011 (76 FR 21383). One public comment was received on April 15 requesting a copy of the data collection package. The submission was sent to the requestor on April 21. 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. Proposed Collection: Title: Food Reporting Comparison Study (FORCS) and Food and Eating Assessment Study (FEAST) (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The title of this collection was previously, ``24-Hour Dietary Recall Method Comparison and the National Cancer Institute (NCI) Observational Feeding Studies.'' The objective of the two studies is to compare the performance of the newly developed computerized Automated Self- Administered 24-Hour Recall (ASA24) approach to collecting 24-hour recall (24HR) data with the current standard, the interviewer- administered Automated Multiple Pass Method (AMPM). The ultimate goal is to determine to what extent the new automated instrument can be used instead of the more expensive interviewer-administered instrument in the collection of dietary intake data. Frequency of Response: Twice. Affected Public: Individuals. Type of Respondents: For the FORCS study, approximately 1,200 adult members from three health maintenance organization plans (in Minnesota, California, and Michigan) between ages 20 and 70 years. For the FEAST study, approximately 90 adult residents from the Washington, DC metropolitan area between ages 20 and 70 years. The annual reporting burden is estimated at 866 hours (see table below). This amounts to an estimated 2598 burden hours over the 3-year data collection period with a total cost to the respondents $54,293. There are no Capital costs, Operating costs, and/or Maintenance costs to report.

Title I of the James Zadroga Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program, which will be administered in part by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), will provide medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. The proposed rule establishes the processes by which the WTC Program Administrator may add a new condition to the list of WTC-related health conditions through rulemaking, including a process for considering petitions by interested parties to add a new condition.

Title I of the James Zadroga Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) by adding Title XXXIII, which establishes the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program, which will be administered in part by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), will provide medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. This interim final rule establishes the processes by which eligible responders and survivors may apply for enrollment in the WTC Health Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions. This interim final rule also establishes a process for the certification of health conditions, and reimbursement rates for providers who provide initial health evaluations, treatment, and health monitoring.

The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of June 20, 2011 (FR Doc. 2011-15194), on page 35900, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915-0193).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is announcing the opening of a docket to solicit comments, data, and other information helpful to assess the current research, policy, and practice environment in public health genomics. HHS/CDC is currently leading a process to assess the most important steps for public health genomics in the next five years.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component 2012-2013.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23609-23611, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study and federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Collection Request: Generic Clearance. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states: