Department of Health and Human Services October 19, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Notice of the Award of a Single-Source Grant to The WorkPlace, Inc., in Bridgeport, CT
The Administration for Children and Families (ACF), Office of Family Assistance (OFA), Health Profession Opportunity Grants (HPOG) program announces the award of a single-source grant (cooperative agreement) to The WorkPlace, Inc. a local, non-profit workforce investment board located in Bridgeport, CT. Award funds will support a program to provide education and training to Temporary Assistance to Needy Families (TANF) recipients, and other low-income individuals, for occupations in the health care field that pay well and are expected to either experience labor shortages or be in high demand. The city of Bridgeport, CT, faces high levels of unemployment. The WorkPlace, Inc., proposes working with numerous community partners to coordinate referrals, conduct assessments, and provide remedial and life skills training, supportive services, and occupational skills training. If performance by the grantee is deemed satisfactory and funds are available, the grantee may be awarded future funding in the form of annual noncompetitive continuation grants.
Proposed Collection; Comment Request; Grantee Outcomes and Satisfaction
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 Environmental Health Sciences (NIEHS), 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: DERT Extramural Grantee Data Collection. Type of Information Collection Request: New. Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research. Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research. Frequency of Response: Once per grantee, per NIEHS research portfolio. Affected Public: Current or past NIEHS grantees. Type of Respondents: Principal Investigators with current or past NIEHS research or training grants. The annual reporting burden is as follows: Estimated Number of Respondents: 600 over 3 years; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .5; and Estimated Total Annual Burden Hours Requested: 100. The annualized cost to respondents is estimated at: Approximately $17. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: 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.
Orphan Drug Regulations
The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.
Decision To Evaluate a Petition To Designate a Class of Employees From Oak Ridge National Laboratory (X-10), Oak Ridge, TN, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Oak Ridge National Laboratory (X-10), Oak Ridge, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Oak Ridge National Laboratory (X-10) Location: Oak Ridge, Tennessee. Job Titles and/or Job Duties: All contractor employees, subcontractor employees, and AEC employees who were monitored or should have been monitored for any of the various radionuclides and fission products present at the X-10 plant. Period of Employment: January 1, 1943 through December 31, 1952.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Communications To Educate Consumers on How To Safely Purchase Drugs Online
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.
Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 11, 2009 (74 FR 6896). The document withdrew approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple applicants. The document inadvertently withdrew approval of NDA 50-435 for GEOCILLIN (carbenicillin indanyl sodium) Tablets held by Pfizer, Inc., 235 East 42d St., New York, NY 10017. FDA confirms that approval of NDA 50-435 is still in effect.
Beverages: Bottled Water Quality Standard; Establishing an Allowable Level for di(2-ethylhexyl)phthalate
The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by establishing an allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP). As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for DEHP at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for DEHP as often as necessary, but at least once every year unless they meet the criteria for source water monitoring exemptions under the CGMP regulations. This final rule will ensure that FDA's standards for the minimum quality of bottled water, as affected by DEHP, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.
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