Department of Health and Human Services September 20, 2012 – Federal Register Recent Federal Regulation Documents

Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2012-23276
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from Titanium Alloys Manufacturing in Niagara Falls, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On August 23, 2012, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2012-23272
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from Winchester Engineering and Analytical Center in Winchester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2012-23265
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from Hanford Engineer Works in Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Applications for New Awards; Race to the Top-Early Learning Challenge; Phase 2
Document Number: 2012-23260
Type: Notice
Date: 2012-09-20
Agency: Department of Education, Department of Health and Human Services
Final Requirements-Race to the Top-Early Learning Challenge; Phase 2
Document Number: 2012-23259
Type: Rule
Date: 2012-09-20
Agency: Department of Education, Department of Health and Human Services
The Secretary of Education and the Secretary of Health and Human Services (hereafter ``the Secretaries'') announce requirements for Phase 2 of the Race to the TopEarly Learning Challenge (RTT-ELC) program. In Phase 2, we will make awards to certain States that applied for, but did not receive, funding under the RTT-ELC competition held in fiscal year (FY) 2011 (FY 2011 RTT-ELC competition). Specifically, we will consider eligible the five highest scoring applicants that did not receive funding in the FY 2011 RTT-ELC competition, each of which received approximately 75 percent or more of the available points under the competition. We take this action to fund down the slate of the FY 2011 RTT-ELC competition and to establish the information and assurances that the five eligible applicants will need to provide in order to receive funding under Phase 2 of the RTT-ELC program.
Announcing the Award of Three Single-Source Program Expansion Supplement Grants to Unaccompanied Alien Children's Shelter Care Grantees
Document Number: 2012-23247
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, Office of Refugee Resettlement
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to two current grantees, for a total of $2,659,864. The additional funding provided by the awards will support services to unaccompanied alien children through September 30, 2012. The supplement grant will support the expansion of bed capacity to meet the number of unaccompanied alien children referrals from the Department of Homeland Security (DHS). The funding program is mandated by Section 462 of the Homeland Security Act to ensure appropriate placement of all referrals from the DHS. The program is tied to DHS apprehension strategies and sporadic number of border crossers. One expansion supplement award is made to Florence Crittenton Services of Orange County, Inc., in Fullerton, CA, in the amount of $226,800 to support expansion of bed capacity to meet the needs of the high number of unaccompanied alien children transferred from the DHS. Award funds will support services to unaccompanied alien children through September 30, 2012. Two expansion supplement awards are made to International Education Services, Inc., in Los Fresnos, TX. One award for $1,588,827 will provide unaccompanied alien children with temporary 24-hour licensed shelter care in facilities in South Texas. The other award for $844,237 will support the International Education Services, Inc. Harlingen Foster Care Program that provides unaccompanied children with temporary 24-hour family care in private homes within the Cameron County in South Texas.
Announcing the Award of Two Urgent Single-Source Grants To Support Unaccompanied Alien Children Program Services
Document Number: 2012-23246
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, Office of Refugee Resettlement
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of two urgent single- source grants for a total of $4,767,696. Award funds will support grants to two organizations that are providing services under the Unaccompanied Alien Children's program.
Announcing the Award of 24 Single-Source Program Expansion Supplement Grants Under the Unaccompanied Alien Children's Shelter Care Program
Document Number: 2012-23245
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, Office of Refugee Resettlement
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of 24 single-source program expansion supplement grants for a total of $60,835,955. The additional funding provided to current grantees under ORR's UAC program will support services to unaccompanied alien children through September 30, 2012. The ORR UAC grantees that have received single-source program expansion supplements are:
Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the University of Boston for the Institute for Community Inclusion (ICI) in Boston, MA
Document Number: 2012-23244
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Developmental and Intellectual Disabilities (AIDD) announces the award of a grant in the amount of $300,000 to the University of Massachusetts for the Institute for Community Inclusion, Boston, MA.
Proposed Collection: Comment Request: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI)
Document Number: 2012-23243
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, National Institutes of Health
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), 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. Proposed Collection: Title: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI) (OMB No. 0925-0613). Type of Information Collection Request: Revision. Need and Use of Information Collection: The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI) responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer. Data obtained from the Drug Accountability Record is used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. NCI and/or its auditors use this information for compliance purposes. Frequency of Response: Up to 16 times per year. Affected Public: Private sector including businesses, other for-profit organizations, and non-profit institutions. Type of Respondents: Investigators, pharmacists, nurses, pharmacy technicians, and data managers. The annualized respondents' burden for record keeping is estimated to require 14,223 hours (see Table 1). There are no capital costs, operating costs, or maintenance costs.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2012-23214
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from Medina Modification Center in San Antonio, Texas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2012-23207
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from Clarksville Modification Center, Ft. Campbell, in Clarksville, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-23203
Type: Notice
Date: 2012-09-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-23197
Type: Notice
Date: 2012-09-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-23194
Type: Notice
Date: 2012-09-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2012-23193
Type: Notice
Date: 2012-09-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics Subcommittee (ES)
Document Number: 2012-23192
Type: Notice
Date: 2012-09-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2012-23186
Type: Notice
Date: 2012-09-20
Agency: Food and Drug Administration, Department of Health and Human Services
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: 2012-23185
Type: Notice
Date: 2012-09-20
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium Capsule; Availability
Document Number: 2012-23177
Type: Notice
Date: 2012-09-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for pentosan polysulfate sodium capsule.
Notice of Meeting
Document Number: 2012-23166
Type: Notice
Date: 2012-09-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ Patient Centered Outcomes Research (PCOR) Pathway to Independence Award (K99/ROC)''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-23165
Type: Notice
Date: 2012-09-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 27th, 2012 and allowed 60 days for public comment. Several comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Notice of Meetings
Document Number: 2012-23164
Type: Notice
Date: 2012-09-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d),'5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-23163
Type: Notice
Date: 2012-09-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 13th, 2012 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-23162
Type: Notice
Date: 2012-09-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``CHIPRA Pediatric Quality Measures Program Candidate Measure Submission Form.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 18th, 2012 and allowed 60 days for public comment. Two public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Secretary's Advisory Committee on Human Research Protections
Document Number: 2012-23143
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-ninth meeting. The meeting will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.hhs.gov/ohrp/sachrp/mtgings/ index.html.
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: 2012-23129
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2012-23128
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2012-23127
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2012-23120
Type: Notice
Date: 2012-09-20
Agency: Department of Health and Human Services, Administration for Children and Families
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