Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents

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Medicaid Program: Initial Core Set of Health Quality Measures for Medicaid-Eligible Adults
Document Number: 2010-32978
Type: Notice
Date: 2010-12-30
Agency: Office of the Secretary, Department of Health and Human Services
This notice identifies an initial core set of health quality measures recommended for Medicaid-eligible adults, as required by section 2701 of the Affordable Care Act, for voluntary use by State programs administered under title XIX of the Social Security Act (the Act), health insurance issuers and managed care entities that enter into contracts with Medicaid, and providers of items and services under these programs. This notice also solicits comments on these initial measures, on facilitating the use of these measures by States and on identifying priority areas for measure enhancement and development.
Proposed Consolidated Vaccine Information Materials for Multiple Infant Vaccines
Document Number: 2010-32965
Type: Notice
Date: 2010-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on a proposed new vaccine information statement that consolidates the six vaccine information statements for the following childhood vaccines: DTaP, Haemophilus influenzae type b, inactivated polio vaccine, pneumococcal conjugate vaccine, hepatitis B, and rotavirus. This consolidated Vaccine Information Statement is available to be used by vaccination providers as an alternative to providing the six individual Vaccine Information Statements for the same vaccines.
Stakeholders Meeting To Provide Updates on NIOSH-Funded Research, Certification and Standards, Educate Participants on Resources To Reinforce the Proper Use of NIOSH-Certified Respirators, and Explore Personal Protective Technology Use in Industry Sectors
Document Number: 2010-32964
Type: Notice
Date: 2010-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), Personal Protective Technology (PPT) Program and National Personal Protective Technology Laboratory (NPPTL) will conduct a stakeholders meeting to provide updates on NIOSH-funded research, certification and standards, educate participants on resources to reinforce the proper use of NIOSH-certified respirators, and explore personal protective technology use in industry sectors. In addition, conformity assessment (certification and standards) needs and gaps relative to the personal protective technology will be discussed at this meeting.
Development of Health Risk Assessment Guidance; Public Forum
Document Number: 2010-32963
Type: Notice
Date: 2010-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On November 16, 2010, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published a notice in the Federal Register (75 FR 70009) requesting public comment to assist development of guidance for Health Risk Assessments (HRAs). Section 4103 of the Affordable Care Act (ACA) (Pub. L. 111-148) requires that a Health Risk Assessment be included in the annual wellness visit benefit authorized for Medicare beneficiaries under the ACA. CDC is collaborating with the Centers for Medicare and Medicaid Services (CMS), also located within HHS, in the development of guidance for this type of assessment. This guidance is also intended to be useful for HRAs conducted in other patient populations, including those persons covered by employer healthcare plans. In the November 16, 2010 notice, CDC also announced that it would hold a public forum in early February 2011 to obtain additional public comment. Today's notice announces the public forum.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2010-32957
Type: Notice
Date: 2010-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Designated New Animal Drugs for Minor Use and Minor Species
Document Number: 2010-32948
Type: Notice
Date: 2010-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Designated New Animal Drugs for Minor Use and Minor Species'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: 2010-32946
Type: Notice
Date: 2010-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
Document Number: 2010-32925
Type: Notice
Date: 2010-12-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request; Testing Successful Health Communications Surrounding Aging-Related Issues From the National Institute on Aging (NIA)
Document Number: 2010-32911
Type: Notice
Date: 2010-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Aging, 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 09-27-2010 at 08:45:00 (http://federalregister.gov/a/2010-24277, Vol. 75, No. 187, Page: 59723-59724 (2 pages); Document Citation: 75 FR 59723; Document Number: 2010-24277) and allowed 60-days for public comment. One comment was received from an organization who requested to be considered as a contractor for NIA's project. No other public comments were received. 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: Testing successful health communications surrounding aging-related issues from the National Institute on Aging (NIA). Type of Information Collection Request: New. Need and Use of Information Collection: This study will support NIA's mission ``to communicate information about aging and advances in research on aging to the scientific community, health care providers, and the public.'' The primary objectives of this study are to: Assess audiences' trusted/preferred sources for information, knowledge, attitudes, behaviors, and other characteristics for the planning/development of health messages and communications strategies; Pre-test health messages and outreach strategies while they are in developmental form to assess audience response, including their likes and dislikes.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2010-32907
Type: Notice
Date: 2010-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2010-32858
Type: Notice
Date: 2010-12-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Corrections to the Medical Loss Ratio Interim Final Rule With Request for Comments
Document Number: 2010-32526
Type: Rule
Date: 2010-12-30
Agency: Department of Health and Human Services
This document corrects technical errors that appeared in the interim final rule with request for comments that appeared in the December 1, 2010 Federal Register (FR Doc 2010-29596 (75 FR 74864)) entitled ``Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act.''
Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Correcting Amendment
Document Number: 2010-32861
Type: Rule
Date: 2010-12-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects typographical and technical errors identified in the final rule entitled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program'' that appeared in the July 28, 2010 Federal Register.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2010-32800
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2010-32797
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2010-32795
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2010-32794
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2010-32752
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2010-32750
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2010-32748
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2010-32747
Type: Notice
Date: 2010-12-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Dental and Craniofacial Research; Notice of Meeting
Document Number: 2010-32746
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-32745
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Data to Support Food and Nutrition Product Communications, as Used by the Food and Drug Administration
Document Number: 2010-32739
Type: Notice
Date: 2010-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance to collect information to support communications about nutrition and food products regulated by FDA. This data collection will gauge, informally, public opinion on a variety of subjects related to consumer, patient, or health care professional perceptions and use of nutrition and food products and related materials, including but not limited to, food advertising, food and nutrition labeling, emerging risk communications, online sales of food products, and consumer and professional education.
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
Document Number: 2010-32735
Type: Notice
Date: 2010-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-32708
Type: Notice
Date: 2010-12-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Safeguarding Child Support Information
Document Number: 2010-32424
Type: Rule
Date: 2010-12-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) created and expanded State and Federal Child Support Enforcement databases under title IV-D of the Social Security Act (the Act) and significantly enhanced access to information for title IV-D child support purposes. States are moving toward a more integrated service delivery to better serve families and further the mission of the Child Support Enforcement program, while protecting confidential data. This final rule specifies requirements for: State Parent Locator Service responses to authorized location requests; and State Child Support Enforcement program safeguards for confidential information and authorized disclosures of this information. This final rule revises certain aspects of the State Parent Locator Service; Safeguarding Child Support Information final rule published on September 26, 2008 with an effective date delayed until December 30, 2010. This final rule will prohibit the disclosure of confidential and personally identifiable information to private collection agencies and expand disclosure to child welfare programs and the Supplemental Nutrition Assistance Program (SNAP).
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2010-32705
Type: Proposed Rule
Date: 2010-12-28
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Government-Owned Inventions; Availability for Licensing
Document Number: 2010-32671
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2010-32669
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
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.
Submission for OMB Review; Comment Request; National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative
Document Number: 2010-32659
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Resources, the National Institutes of Health 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 October 12, 2010, pages 62543-62544, 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 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: The National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative. Type of Information Collection Request: New. Need and Use of Information Collection: The CTSA Initiative is directed at transforming the way biomedical research is conducted nationwide by reducing the time it takes for basic science or laboratory discoveries to become treatments for patients, and for those treatments in turn to be incorporated and disseminated throughout community practice. The primary purpose of this data collection is to provide information about the process and early outcomes associated with 46 awardees participating in the first four cohorts of CTSA awards, in order to fulfill the congressional expectations for external program evaluation. NIH will use the results to understand the extent to which the CTSA Initiative is bringing about transformational changes in clinical and translational science among academic medical centers and their research partners, increasing the efficiency of the research process, and enhancing the capacity of the field to conduct clinical and translational research. All information collected will be used to provide analytical and policy support to NCRR, assisting NIH in making decisions about current CTSA programming, future funding, and other initiatives to improve clinical and translational science. It may also provide information for NIH's Government Performance and Results Act (GPRA) report. Frequency of Response: Biennial. Affected Public: Individuals. Type of Respondents: Scientific researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 3,563; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.13; Estimated Total Annual Burden Hours Requested: 451.5. The annualized cost to respondents is estimated at $14,056. There are no capital or start-up costs, and no maintenance or service cost components to report.
The Consumer Operated and Oriented Plan (CO-OP) Advisory Board; Office of Consumer Information and Insurance Oversight, January 13, 2011
Document Number: 2010-32649
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services
This notice announces a forthcoming meeting of an advisory committee of the Office of Consumer Information and Insurance Oversight (OCIIO) in accordance with the Federal Advisory Committee Act. The meeting is open to the public. The purpose of the meeting is to assist and advise the Secretary and Congress through the Department of Health and Human Services' Office of Consumer Information and Insurance Oversight (OCIIO) on the Department's strategy to foster the creation of qualified nonprofit health insurance issuers. Specifically, the Committee shall advise the Secretary and Congress concerning the award of grants and loans related to Section 1322 of the Affordable Care Act. In these matters, the Committee shall consult with all components of the Department, other federal entities, and non-federal organizations, as appropriate; and examine relevant data sources to assess the grant and loan award strategy to provide recommendations to OCIIO. Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App. 2).
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2010-32645
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-32639
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2010-32638
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2010-32631
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2010-32630
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2010-32629
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, National Institutes of Health
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.
Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels
Document Number: 2010-32624
Type: Notice
Date: 2010-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2011.
Request for Information Regarding Value-Based Insurance Design in Connection With Preventive Care Benefits
Document Number: 2010-32612
Type: Proposed Rule
Date: 2010-12-28
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains a request for information on how group health plans and health insurance issuers can employ value-based insurance design in the coverage of recommended preventive services.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third Party Review Program Under the Food and Drug Administration Modernization Act
Document Number: 2010-32603
Type: Notice
Date: 2010-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
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).
Submission for OMB Review; Comment Request
Document Number: 2010-32592
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting
Document Number: 2010-32591
Type: Notice
Date: 2010-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2010-32588
Type: Notice
Date: 2010-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-32562
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-32561
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting
Document Number: 2010-32560
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, Health Resources and Service Administration, Health Resources and Services Administration
Findings of Misconduct in Science; Correction
Document Number: 2010-32555
Type: Notice
Date: 2010-12-28
Agency: Office of the Secretary, Department of Health and Human Services
This document corrects errors that appeared in the notice published in the November 29, Federal Register entitled ``Findings of Misconduct in Science.''
New Animal Drugs; Deslorelin
Document Number: 2010-32554
Type: Rule
Date: 2010-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Thorn Bioscience LLC. The NADA provides for the use of deslorelin acetate injectable suspension in mares for inducing ovulation.
Privacy Act of 1974; System of Records
Document Number: 2010-32527
Type: Notice
Date: 2010-12-28
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
The Office of Inspector General (OIG) is deleting from its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.