October 30, 2015 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Extension
The EIA invites public comment on the proposed collection of information, EIA-882T, ``Generic Clearance for Questionnaire Testing, Evaluation, and Research'' that EIA is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. Comments are invited on whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; 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; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
National Assessment Governing Board Quarterly Board Meeting
This notice sets forth the agenda for the November 19-21, 2015 Quarterly Meeting of the National Assessment Governing Board (hereafter referred to as Governing Board). This notice provides information to members of the public who may be interested in attending the meeting or providing written comments on the meeting. The notice of this meeting is required under section 10(a)(2) of the Federal Advisory Committee Act (FACA).
Privacy Act of 1974, Altered System of Records
The Department of Commerce publishes this notice to announce the effective date of a Privacy Act System of Records notice entitled Notice of Proposed Amendment to Privacy Act System of Records: COMMERCE/CENSUS-9, Longitudinal Employer-Household Dynamics System.
Proposed Collection; 60-Day Comment Request; A Generic Clearance for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)
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 NICHD, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address 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) the quality, utility, and clarity of the information to be collected; and (4) 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 forms, submit comments in writing, or request more information on the proposed project, contact: Rohan Hazra, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, 6100 Executive Blvd., Room 4B11, Bethesda, MD 20892-7510, or call non-toll- free number 301-435-6868 or Email your request, including your address to: hazrar@mail.nih.gov. Formal requests for additional plans and forms 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: Data and Specimen Hub (DASH), 0925NEW, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: The NICHD Data and Specimen Hub (DASH) is being established by NICHD as a data sharing mechanism for biomedical research investigators. It will serve as a centralized resource for investigators to store and access de-identified data from studies funded by NICHD. The potential for public benefit to be achieved through sharing research study data for secondary analysis is significant. NICHD DASH supports NICHD's mission to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation. Data sharing and reuse will promote testing of new hypotheses from data already collected, facilitate trans-disciplinary collaboration, accelerate scientific findings and enable NICHD to maximize the return on its investments in research. Anyone can access NICHD DASH to browse and view descriptive information about the studies and data archived in NICHD DASH without creating an account. Users who wish to submit or request research study data must register for an account. Information will be collected from those wishing to create an account, sufficient to identify them as unique Users. Those submitting or requesting data will be required to provide additional supporting information to ensure proper use and security of NICHD DASH data. The information collected are limited to the essential data required to ensure that the management of Users in NICHD DASH is efficient and the sharing of data among investigators is effective. The primary uses of the information collected from Users by NICHD will be to:
Notice of Intent To Prepare an Environmental Impact Report/Environmental Impact Statement for the Sacramento Regional County Sanitation District South County Ag Water Recycling Program
The Bureau of Reclamation, the lead Federal agency, and the Sacramento Regional County Sanitation District (Regional San), the lead state agency, will prepare a joint Environmental Impact Report/ Environmental Impact Statement (EIR/EIS) for the South County Ag Water Recycling Program (Project). The Project would deliver approximately 45,000 acre-feet per year of Title 22 disinfected tertiary treated recycled water to about 16,000 acres of irrigated lands in southern Sacramento County for agricultural and urban landscape uses and to the Stone Lakes National Wildlife Refuge. The Project could also provide an additional 5,000 acre-feet per year of recycled water for groundwater recharge, for a total recycled water delivery of 50,000 acre-feet per year.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing a new information collection for Office of Management and Budget (OMB) approval titled, ``Policy on No-Action Letters.''
Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Programmatic Clearance for NPS-Sponsored Public Surveys
We (National Park Service, NPS) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. The National Park Service (NPS) sponsors public surveys to provide park managers with information needed for park planning, management, operations and evaluation of performance related to protecting park resources and meeting the needs of the public. In consultation with the Office of Management and Budget (OMB) and the Department of the Interior (DOI), the NPS has developed a Programmatic Clearance Process for NPS-sponsored public surveys. It significantly streamlines the information collection review process. To comply with the Paperwork Reduction Act of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this ICR.
Privacy Act of 1974; System of Records
The Department of the Navy proposes to add a new system of records, N01000-6, entitled ``Strategic Programs (SP) 205 Training Records'' to provide support and track the training progress of naval personnel (commissioned officers and enlisted) who manage, operate, and maintain Strategic Weapons System (SWS) and Attack Weapon System (AWS). To document and track the completion of and/or validate the training courses. To provide the status of the training to the commands, DoD training managers, and to the Navy personnel.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Defense Security Cooperation Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have a practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
TRICARE; Calendar Year 2016 TRICARE Young Adult Program Premium Update
This notice provides the updated TRICARE Young Adult program premiums for Calendar Year (CY) 2016.
Charter Amendment of Department of Defense Federal Advisory Committees
The Department of Defense is publishing this notice to announce that it is amending the charter for the Threat Reduction Advisory Committee (``the Committee'').
Privacy Act of 1974; System of Records
The Department of the Army (DOA) proposes to reinstate a system of records, A0351 AMC, entitled ``Student/Faculty Records: AMC Schools Systems'' to its inventory of record systems to the Privacy Act of 1974, as amended. After publication of the deletion notice in the Federal Register (October 3, 2012, 77 FR 60412), the DOA discovered that the records had not yet been transferred to the National Personnel Records Center. Therefore, the DOA system of records notice should not have been deleted and is being reinstated in full below.
Submission for OMB Review; Comment Request
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry'' announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' published in the Federal Register of December 24, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff,'' published in the Federal Register of December 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff, with recommendations for applying the criterion of ``homologous use'' as it applies to HCT/Ps. The interpretation and application of the homologous use criterion and related definitions have been of considerable interest to industry stakeholders since they were first proposed during the Agency's rulemaking on HCT/Ps.
Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a 1-day public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). These draft guidances were issued by FDA in response to stakeholders' requests for guidance on FDA's current views about how manufacturers, establishments, and distributors of HCT/Ps and health care professionals can meet the criteria under the Agency's regulations that apply to HCT/Ps. FDA will consider information it obtains from the public hearing in the finalization of these guidances.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Resource Justification Model
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ``Resource Justification Model,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). Public comments on the ICR are invited.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Hooker Electrochemical Corporation in Niagara Falls, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Special Conditions: Honda Aircraft Company (Honda) Model HA-420, HondaJet; Cruise Speed Control System
These special conditions are issued for the Honda Aircraft Company HA-420 airplane. This airplane will have a novel or unusual design feature(s) associated with the use of a cruise speed control system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Announcement of Meetings: North American Wetlands Conservation Council; Neotropical Migratory Bird Conservation Advisory Group
The North American Wetlands Conservation Council (Council) will meet to select North American Wetlands Conservation Act (NAWCA) grant proposals for recommendation to the Migratory Bird Conservation Commission (Commission). This meeting is open to the public. The Advisory Group for the Neotropical Migratory Bird Conservation Act (NMBCA) grants program (Advisory Group) also will meet. This meeting is also open to the public, and interested persons may present oral or written statements.
Estimate of Peanuts and Peanut Products Available for Donation
On behalf of the Commodity Credit Corporation (CCC), the Farm Service Agency estimates that during fiscal year 2016, peanuts and peanut products in CCC inventory may be made available for programming under section 416 of the Agricultural Act of 1949, as amended, in such quantities as may be determined appropriate for direct human feeding in a manner consistent with United States obligations under its international trade agreements.
Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area
NMFS is exchanging unused Community Development Quota (CDQ) for CDQ acceptable biological catch (ABC) reserves. This action is necessary to allow the 2015 total allowable catch of rock sole and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.
Vocational Factors of Age, Education, and Work Experience in the Adult Disability Determination Process; Extending of the Comment Period
On September 14, 2015, we published in the Federal Register an advanced notice of proposed rulemaking (ANPRM) regarding Vocational Factors of Age, Education, and Work Experience in the Adult Disability Determination Process and solicited public comments. We provided a 60- day comment period ending on November 13, 2015. We are extending the comment period to December 14, 2015. Our extension of the comment date accommodates and facilitates public comments we expect in response to the National Disability Forum we are sponsoring on Friday, November 20, 2015. During the forum, we are hosting a moderator-led discussion entitled: The Realities of Work for Individuals with Disabilities: Impact of Age, Education, and Work Experience (for information on the forum see the SUPPLEMENTARY INFORMATION section).
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Diesel Emissions Reduction Act (DERA) Rebate Program (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``Diesel Emissions Reduction Act (DERA) Rebate Program'' (EPA ICR No. 2461.02, OMB Control No. 2060- 0686) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through October 31, 2015. Public comments were previously requested via the Federal Register on August 25, 2015 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Procurement List Additions
This action adds a product and service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Procurement List; Proposed Additions and Deletion
The Committee is proposing to add services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities and, deletes a product previously furnished by an agency. Comments Must be Received on or Before: 11/29/2015.
Notice of Availability of a Draft Environmental Impact Statement (EIS) for the Reconfiguration of VA Black Hills Health Care System (BHHCS)
VA proposes to reconfigure health care services throughout the 100,000-square mile VA BHHCS service area, including the addition of purchased care for Veterans from community providers to improve geographic access to care. In accordance with the National Environmental Policy Act (NEPA), VA has prepared a Draft EIS that analyzes the potential impacts of six alternatives for changes to VA's facilities in Hot Springs and Rapid City, South Dakota, to support the proposed services reconfiguration. The Draft EIS uses the substitution approach for integrating compliance with Section 106 of the National Historic Preservation Act into the EIS process. The Draft EIS is available for review on the agency Web site and at public libraries in the service area.
Delta Research Station, Sacramento, CA; Draft Environmental Impact Report/Environmental Impact Statement, and Announcement of Public Meetings
This notice announces the availability of the Delta Research Station Draft Environmental Impact Report/Environmental Impact Statement (EIR/EIS) for public review and comment. The Draft EIR/EIS evaluates impacts regarding construction and operation of the Delta Research Station (DRS) in the San Francisco Bay/Sacramento-San Joaquin Delta Estuary (Bay-Delta), California. The planned DRS would consist of two facilities, a proposed Estuarine Research Station (ERS) and Fish Technology Center (FTC). The U.S. Fish and Wildlife Service (USFWS) is the lead Federal agency responsible for coordinating the environmental analysis for the proposed action under the National Environmental Policy Act (NEPA). The California Department of Water Resources (DWR) is the lead State agency responsible for coordinating the environmental analysis under the California Environmental Quality Act (CEQA).
Proposed Collection; 60-Day Comment Request Consumer Health Information in Public Libraries User Needs Survey (NLM)
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 Library of Medicine (NLM), 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: David Sharlip, Office of Administrative and Management Analysis Services,, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 402-9680, or Email your request, including your address to: sharlipd@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: Consumer Health Information in Public Libraries User Needs Survey (NLM)), 0925New, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: In 1994, the NLM was designated a ``Federal Reinvention Laboratory'' with a major objective of improving its methods of delivering information to the public. NLM has become an international leader in health informatics research and development, especially in consumer health informatics. As a result, NLM needs to remain contemporary in consumer health informatics research by utilizing research methods that yield a better understanding of the predictors of consumer satisfaction. Without ongoing insights into the predictors of consumer satisfaction, NLM will lack the research findings to make evidence-based changes in the content, design and editorial management of its consumer Web sites and will not optimally serve the public. Public libraries have been identified as a key resource for public information about the Patient Protection and Affordable Care Act (PPACA), which took full effect on October 1, 2013. A national anonymous survey of library staff will help us better understand the challenges and successes of information provision in this critical area of high information need. Research and funding into the challenges of health information in public libraries is, at present, almost nonexistent. In the present environment of health insurance reform and presumption of informed consumer choice, this is a critical knowledge gap. Information collection from library workers will supply much- needed feedback on the specific areas of challenge for information provision by public libraries. The results of this study will be used by the Principal Investigators' home institutionsthe University of Wisconsin-Madison, an institution of higher education preparing future library workers, and the Specialized Information Services division of the National Library of Medicineto inform preparation of outreach and training materials as well as advising other organizations and institutions providing PPACA information provision assistance to public libraries (e.g., American Library Association). To improve our understanding of the challenges and gaps in information provision and awareness around PPACA, the information we get from this survey will be used to inform and improve NLM's services to public libraries, as well as increase our understanding of the resource and education needs of public library workers. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 390.
60-Day Notice of Request for Renewal of a Previously Approved Collection
The Office of the Secretary, Office of Small and Disadvantaged Business Utilization (OSDBU), invites public comments about our intention to request the Office of Management and Budget's (OMB) approval to renew a collection. This collection renewal request includes one Short Term Lending Program (STLP) application used for both new loan guarantee applicants and renewal loan guarantee applicants. The information collected in the STLP application will determine the applicant's eligibility and is necessary to approve or deny a loan. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995, Public Law 104-13.
Agency Information Collection (Supplement to VA Form 21P-4703) Activity Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Certain Radiotherapy Systems and Treatment Planning Software, and Components Thereof; Institution of Investigation
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 25, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Varian Medical Systems, Inc. of Palo Alto, California and Varian Medical Systems International AG of Switzerland. Supplements were filed on October 13, 2015. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain radiotherapy systems and treatment planning software, and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,945,021 (``the '021 patent''); U.S. Patent No. 8,116,430 (``the '430 patent''); U.S. Patent No. 8,867,703 (``the '703 patent''); U.S. Patent No. 7,880,154 (``the '154 patent''); U.S. Patent No. 7,906,770 (``the '770 patent''); and U.S. Patent No. 8,696,538 (``the '538 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 150 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
New Postal Product
The Commission is noticing a recent Postal Service filing concerning a notice of classification change to Country Price Lists for International Mail. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submission for OMB Review; Comment Request
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
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