Department of Health and Human Services 2013 – Federal Register Recent Federal Regulation Documents

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), 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 reinstatement of a previously-approved information collection assigned OMB control number 4040-0004, which expired on March 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. 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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), 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 reinstatement of a previously-approved information collection assigned OMB control number 4040-0010, which expired on August 31, 2011. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. The SF-424 Project Abstract form and the SF-424 Key Contacts form were previously assigned to OMB control number 4040-0003. EGOV seeks to move these two instruments to the OMB control number 4040-0010. 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.

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.

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 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 or we) is requesting comments and scientific data and information that may help us in performing a quantitative assessment of the risk of human salmonellosis (an infection with bacteria called Salmonella) associated with the consumption of tree nuts. The purpose of the risk assessment will be to quantify the public health risk associated with the consumption of potentially Salmonella contaminated tree nuts and to evaluate the impact of risk-based preventive controls on the risk of human salmonellosis arising from consumption of tree nuts.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on Vitamin D and Calcium. Scientific information is being solicited to inform the Vitamin D and Calcium: A Systematic Review of Health Outcomes project, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on vitamin D and calcium will improve the quality of this systematic review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). AHRQ is republishing this document due to errors found on our first publication of July 3, 2013 (https://www.gpo.gov/fdsys/pkg/FR-2013-07- 03/pdf/2013-5730.pdf). Please disregard the July 3 publication.

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 proposed information collection was previously published in the Federal Register on April 2, 2013, page 19723 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 John E. Fogarty International Center (FIC), 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. Direct Comments to OMB: 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: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

HRSA will be transferring a School-Based Health Center Capital (SBHCC) Program grant, as authorized by the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148), Title IV, Section 4101(a)), originally awarded to ICAN/ICAN TOO Organization, Inc., Havana, Florida, in order to ensure that significant and pressing capital needs to improve service delivery and support the expansion of services at school-based health centers will continue.

The U.S. Food and Drug Administration (FDA) is issuing an order, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), withdrawing its January 13, 2012, order debarring Anneri Izurieta from importing food or offering food for importation into the United States. FDA is issuing this order because the U.S. Court of Appeals for the Eleventh Circuit issued an order vacating the conviction and sentence of Anneri Izurieta.

The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to correct the description of ammonium formate used as an acidifying agent in swine feed. This action is being taken to improve the accuracy of the regulations.

The Food and Drug Administration (FDA) is announcing the withdrawal of the compliance policy guide (CPG) entitled ``Sec. 690.700 Salmonella Contamination of Dry Dog Food.'' This CPG is obsolete.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive start-up patent license, to practice the inventions embodied in U.S. Patent 8,132,911 (HHS Ref. No. E-279-2006/0) to OptoBiometrics Designs, Inc., a company incorporated under the laws of the State of California having its headquarters in Pleasant Hill, California. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to ocular fundus examination devices and systems.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive evaluation option license to practice the inventions embodied in U.S. provisional Applications 61/392,096 (E-211-2010/0-US-01) filed October 12, 2010 and 61/411,509 filed November 9, 2010 (E-211-2010/1- US-01); PCT application No. PCT/US2011/055902 filed October 12, 2011 (E-211-2010/2-PCT-01); US patent application No. 13/878,832 filed April 11, 2013 (E-211-2010/2-US-06); European patent application No. 11773158.8 filed May 2, 2013 (E-211-2010/2-EP-04); Canadian application No. 2,814,694 filed April 11, 2013 (E-211-2010/2-CA-03); Australia application No. 2011316657 filed April 12, 2013 (E-211-2010/2-AU-02); and Indian application No. 1137/KOLNP/2013 filed April 22, 2013 (E-211- 2010/2-IN-05); each entitled ``Methods of Treating Giardiasis'' by Wei Zheng et al. to BrioMed, Inc., having a place of business at 1743 S. Westgate Ave, Los Angeles, CA 90025 USA. The patent rights in this invention have been assigned to the United States of America and the University of Maryland.

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 proposed information collection was previously published in the Federal Register on March 24, 2013, page 17935-17936 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director (OD), 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. Direct Comments to OMB: 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: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Substance Abuse and Mental Health Services Administration (SAMHSA), an operating division of the U.S. Department of Health and Human Services, is announcing a new opportunity for individuals and organizations to help solve a critical problem in today's health environment. Specifically, there are high levels of involuntary breaks in health insurance coverage among the non-elderly population in the United States. These breaks are referred to as ``churning''when people transition from one source of insurance coverage to another when eligibility for assistance changes. Churning makes programs more complicated and costly to administer and can interrupt continuity of care, create gaps in coverage, reduce health plans' incentive to invest in their members' long-term wellness, and interfere with the accurate and comprehensive measurement of health care quality. According to a study by the Urban Institute, a total of 29.4 million people will have their eligibility status change each year beginning in 2014 \1\. This challenge aligns with SAMHSA's mission to reduce the impact of mental and substance use disorders on America's communities. SAMHSA recognizes that enrollment in health insurance plays a significant role in fulfilling this mission, from preventive health care to behavioral health treatment and recovery. The National Survey on Drug Use and Health estimates that of the individuals currently uninsured and expected to be covered under the Affordable Care Act, 11 million will have a behavioral health need. The literature on the causes of breaks in coverage (i.e., income, housing volatility), and the high prevalence of behavioral health conditions among the uninsured, points to an interrelationship between behavioral health symptoms and difficulties complying with administrative requirements in applying for and maintaining continuous coverage. Additionally, churning has a significant amount of administrative as well as health costs, and there is a disproportionate impact of this problem among individuals with behavioral health disorders. Therefore, SAMHSA is announcing two challenge projects to help develop innovative solutions to the barriers to developing a communications strategy targeting individuals who experience churn. The statutory authority for this challenge competition is section 105 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Reauthorization Act of 2010 (COMPETES Act).

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing the availability of the CDER Data Standards Strategy (version 1.0) and the CDER Data Standards StrategyAction Plan (version 1.0). This action is being taken to ensure that all interested stakeholders are aware that the data standards program documents are available and is intended to increase awareness of CDER's data standards plans, ongoing projects, and avenues of communication. Comments may be submitted to the email address listed below.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Department of Defense (DoD), Defense Manpower Data Center (DMDC). We have provided background information about the proposed matching program in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed matching program, CMS invites comments on all portions of this notice. See ``Effective Dates'' section below for comment period.

This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act. This final rule finalizes new Medicaid eligibility provisions; finalizes changes related to electronic Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices and delegation of appeals; modernizes and streamlines existing Medicaid eligibility rules; revises CHIP rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; and amends requirements for benchmark and benchmark- equivalent benefit packages consistent with sections 1937 of the Social Security Act (which we refer to as ``alternative benefit plans'') to ensure that these benefit packages include essential health benefits and meet certain other minimum standards. This rule also implements specific provisions including those related to authorized representatives, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also updates and simplifies the complex Medicaid premium and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities. It includes transition policies for 2014 as applicable.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 requirements for FDA regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP).

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 the establishment of a public docket for comments pertaining to the report mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 1138, enacted July 9, 2012, and posted on the FDA Web site on July 9, 2013. This docket is intended to solicit input on this report from all relevant stakeholders.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. 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.

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 requirements relating to FDA regulations for human tissue intended for transplantation.

HRSA is publishing Agency Guidance (``Policy Information Notice'' (PIN) 2013-01) to provide clarification on the budgeting and accounting requirements for federally-funded health centers and Look- Alikes. The PIN, ``Health Center Budgeting and Accounting Requirements'' is available on the Internet at https://bphc.hrsa.gov/ policiesregulations/policies/pin201301.html. Background: HHS' Health Resources and Services Administration (HRSA) provides grants to eligible health centers under section 330 of the Public Health Service Act to support the delivery of preventive and primary care services to medically underserved communities and vulnerable populations. In 2012, grants helped fund more than 1,200 health center grantees that provided services at nearly 9,000 health care delivery sites and served more than 21 million people. There are also over 100 Look-Alikes. Look-Alikes, as described in section 1861(aa)(4) and section 1905(l)(2)(B) of the Social Security Act, do not receive federal funding under section 330 of the PHS Act; however, to receive the Look-Alike designation and benefits, Look-Alikes must meet the statutory, regulatory, and policy requirements for health centers programs under section 330. Under 45 CFR Part 74, a key requirement of the Health Center Program is for a health center to establish a budget that reflects the cost of operations, expenses, and revenues necessary to accomplish the service delivery plan. All section 330-funded health centers and Look- Alikes must prepare a budget that meets these requirements. The purpose of this PIN is to provide clarification regarding budgeting and accounting requirements for health centers to ensure transparency and accountability. In addition to making the final PIN available on HRSA's Web site, HRSA is also making available a section of this PIN for public comment. HRSA will review and analyze all comments on this section and issue final PIN. When finalized, this section of the PIN will supersede all other previous Health Center Program guidance and policy issued on this program requirement.

HRSA will be issuing a grantee transfer without competition for the Detroit Michigan Healthy Start program to the Institute for Population Health (IPH). The IPH will assume responsibility for the Healthy Start program and receive year 5 funding in the amount of $1,575,000, from Grant Number H49MC00147, during the budget period of 6/1/2013-5/31/2014 to support the objectives of the Eliminating Disparities in Perinatal Health Healthy Start Program. The Eliminating Disparities in Perinatal Health Healthy Start Program (H49), CFDA No. 93.926, is authorized by the Public Health Service Act, Title III, Part D, Section 330H (42 USC 254c-8). The purpose of the Eliminating Disparities in Perinatal Health Healthy Start Program is to address significant disparities in perinatal health. Differences in perinatal health indicators may occur by virtue of education, income, disability, or living in rural/isolated areas. To address disparities and the factors contributing to them, project services have been designed to cover the pregnancy and interconceptional phases for women and infants residing in the proposed project area. In order to promote longer interconceptional periods and prevent relapses of risk behaviors, the women and infants are to be followed through the infant's second year of life and/or two years following delivery.

HRSA will be transferring the Michigan Family-to-Family Health Information Center (F2F HIC) grant (H84MC09365) from the Family Center for Children and Youth with Special Health Care Needs (FCCYSHCN) in Detroit, Michigan, to the Michigan Public Health Institute (MPHI) in Okemos, Michigan, to ensure the continued provision of health resources, financing, related services, and parent-to-parent support for families with children and youth with special health care needs (CYSHCN) in the state of Michigan.

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 medical devices third-party review under the Food and Drug Administration Modernization Act of 1997 (FDAMA).

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended to update FDA's policy and to further clarify FDA's interpretations of the regulation requirements and, when final, will supersede the previous manufacturer guidances issued in 1988 and 1997. This draft guidance also provides answers to frequently asked questions and includes a section on common reporting errors. This draft guidance is not final nor is it in effect at this time.

This notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, indicates that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive commercialization license to practice the inventions embodied in: (a) Technology families E-047-1994/0 and E-047-1994/1, including U.S. Patent 5,635,599 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-US-01], PCT Application PCT/ US95/04468 entitled ``Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/0-PCT-02], European Patent 0754192 entitled ``Proteins Comprising Circularly Permuted Ligand'' [HHS Ref. E-047-1994/0-EP-15, validated in Austria, Belgium, France, Italy, Liechtenstein, The Netherlands, Spain, Switzerland and the United Kingdom], Canadian Patent 2187283 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], Australian Patent 694211 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], and U.S. Patent 6,011,002 entitled ``Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/1-US-01]; (b) Technology family E-021-2010/0, including U.S. Patent Application 61/105,408 entitled ``Targeted Cargo Protein Combination Therapy'' [HHS Ref. E-021-2010/0-US-01] and U.S. Patent Application 12/ 579,281 entitled ``Targeted Cargo Protein Combination Therapy'' [HHS Ref. E-021-2010/0-US-02]; and all related continuing and foreign patents/patent applications for these technology families, to Medicenna Therapeutics, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective start-up exclusive commercialization license territory may be worldwide, and the field of use may be limited to:

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: ``Pretest of the Ambulatory Surgery/Procedure Survey on Patient Safety Culture Questionnaire (Ambulatory Surgery SOPS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The Secretary of Homeland Security determined on September 23, 2008, that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracispursuant to section 564(b)(1)(A) of the Federal Food, Drug, and Cosmetic (FD&C) Act.\1\ On the basis of that determination, and pursuant to section 564(b) of the FD&C Act, the Secretary of Health and Human Services (HHS) is declaring that circumstances exist justifying the authorization of emergency use of all oral formulations of doxycycline accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under section 564(a) of the FD&C Act. This notice is being issued in accordance with section 564(b)(4) of the FD&C Act.

The Food and Drug Administration (FDA) is extending the comment period for the public docket on lung cancer patient-focused drug development. In the Federal Register of June 5, 2013 (78 FR 33581), FDA announced an opportunity for public comment on this topic and explained that the comment period would close on July 29, 2013. The Agency is taking this action to allow interested persons additional time to submit comments.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or we) 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 the Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, the low- utilization payment adjustment (LUPA) add-on, the nonroutine medical supplies (NRS) conversion factor, and outlier payments under the Medicare prospective payment system for home health agencies (HHAs), effective January 1, 2014. As required by the Affordable Care Act, this rule also proposes rebasing adjustments, with a 4-year phase-in, to the national, standardized 60-day episode payment rates; the national per- visit rates; and the NRS conversion factor. Finally, the proposed rule would also establish home health quality reporting requirements for CY 2014 payment and subsequent years and would clarify that a state Medicaid program must provide that, in certifying home health agencies, the state's designated survey agency must carry out certain other responsibilities that already apply to surveys of nursing facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF-IID), including sharing in the cost of HHA surveys. For that portion of costs attributable to Medicare and Medicaid, we would assign 50 percent to Medicare and 50 percent to Medicaid, the standard method that CMS and states use in the allocation of expenses related to surveys of SNF/NF nursing homes.

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Pubic Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the Northern Metropolitan Patient Safety Institute of its status as a PSO, and has delisted the PSO accordingly.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on Vitamin D and Calcium. Scientific information is being solicited to inform the Vitamin D and Calcium: A Systematic Review of Health Outcomes project, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on vitamin D and calcium will improve the quality of this systematic review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

This document contains final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. These final regulations simplify and clarify the religious employer exemption. These final regulations also establish accommodations with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), as well as student health insurance coverage arranged by eligible organizations that are institutions of higher education. These regulations also finalize related amendments to regulations concerning Affordable Insurance Exchanges.

On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. The Administrator has determined to publish a proposed rule adding malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile'' 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 announcing that a collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' 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 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 paperwork associated with designation under the Minor Use and Minor Species (MUMS) Act.

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 the availability of a draft guidance for industry entitled ``Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus or species of bacteria).

This document corrects a typographical error that appeared in the notice published in the Federal Register on May 31, 2013 entitled ``Notification of Closure of Teaching Hospitals and Opportunity to Apply for Available Slots.''

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is exempting a system of records from certain requirements of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings.

This final rule implements certain functions of the Affordable Insurance Exchanges (``Exchanges''). These specific statutory functions include determining eligibility for and granting certificates of exemption from the individual shared responsibility payment described in section 5000A of the Internal Revenue Code. Additionally, this final rule implements the responsibilities of the Secretary of Health and Human Services, in coordination with the Secretary of the Treasury, to designate other health benefits coverage as minimum essential coverage by providing that certain coverage be designated as minimum essential coverage. It also outlines substantive and procedural requirements that other types of individual coverage must fulfill in order to be certified as minimum essential coverage.

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 Cancer Institute (NCI), 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency'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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Linda Nebeling, Ph.D., Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Room 3E102, Bethesda, MD 20892-9671 or call non-toll-free number 240-276-6855 or Email your request, including your address to: nebelinl@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Family Life, Activity, Sun, Health, and Eating (FLASHE) Study 0925NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The FLASHE study seeks to examine psychosocial, generational (parent-adolescent), and environmental correlates of cancer preventive behaviors. FLASHE will examine the science of cancer and obesity prevention by examining correlates of cancer preventive behaviors, mainly diet, activity, and sedentary behaviors (but also examining other behaviors such as sleep, sun-safety, and tobacco) in new ways not previously addressed comprehensively on other surveys. The survey's goal is to advance understanding of the dynamic relationship between the environment, psychosocial factors, and behavior from a dyadic perspective. Data collected will ultimately be a public use dataset and resource to the research community. FLASHE will be collecting data from parents and their adolescent children through a web survey with a final sample size of 2,500 dyads with motion sensing data collected in a subsample of 900 adolescents. OMB approval is requested for two years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,931.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). This draft guidance is not final nor is it in effect at this time.