Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act of 1995, Public Law (Pub. L.) 104-13 [44 United States Code (U.S.C.) Sec. 3507(a)(1)(D)], the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection titled, ``Indian Health Service (IHS) Sharing What Works Best Practice, Promising Practice, and Local Effort (BPPPLE) Form,'' Office of Management and Budget (OMB) Control Number 0917-0034. This previously approved information collection project was last published in the Federal Register (80 FR 61215) on October 9, 2015, and allowed 60 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit this collection, which expires January 31, 2016, to OMB for approval of an extension, and to solicit comments on specific aspects for the proposed information collection. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0008). Proposed Collection: Title: 0917- 0034, Indian Health Service (IHS) Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. Type of Information Collection Request: Extension, without revision, of the currently approved information collection, 0917-0034, IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. There are no program changes or adjustments in burden hours. Form(s): 0917-0034, IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and encourage the creation and utilization of performance driven products/ services by IHS, Tribal, and urban Indian health (I/T/U) programs, the Office of Preventive and Clinical Services' program divisions (i.e., Behavioral Health, Health Promotion/Disease Prevention, Nursing, and Dental) have developed a centralized program database of best practices, promising practices and local efforts (BPPPLE) and resources. The purpose of this collection is to further the development of a database of BPPPLE, resources, and policies which are available to the public on the IHS.gov Web site. This database will be a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities. All information submitted is on a voluntary basis; no legal requirement exists for collection of this information. The information collected will enable the Indian health systems to: (a) Identify evidence based approaches to prevention programs among the I/T/Us when no system is currently in place, and (b) Allow the program managers to review BPPPLEs occurring among the I/T/Us when considering program planning for their communities. Affected Public: Individuals. Type of Respondents: I/T/U health programs' staff. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).

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 Cancer Therapy Evaluation Program (CTEP)/Division of Cancer Therapy and Diagnostics (DCTD), 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 instruments, submit comments in writing, or request more information on the proposed project, contact, Charles Hall, RPh, M.S., Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, RM 5W240, MSC 9725, Bethesda, Maryland 20892. Or call non-toll-free number (240) 276-6575, or email your request, include your address to: hallch@mail.nih.gov. 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: Title: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer, 0925-0613, Expiration Date 03/31/ 2016, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: Revision. 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. The frequency of Response is up to 16 times per year. The affected public is private sector including businesses, other for-profit organizations, and non-profit institutions. The type of respondents are investigators, pharmacists, nurses, pharmacy technicians, and data managers. OMB approval is requested for 3 years. There are no capital costs, operating costs or maintenance costs. The total estimated annualized burden hours are 22,645 hours.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the National Advisory Council on Migrant (NACMH). The NACMH is authorized under 42 U.S.C. 218, section 217 of the Public Health Service (PHS) Act, as amended and governed by provisions of Public Law 92-463, as amended, (5 U.S.C. Appendix 2).

This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2016 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2016, the inpatient hospital deductible will be $1,288. The daily coinsurance amounts for CY 2016 will be: (1) $322 for the 61st through 90th day of hospitalization in a benefit period; (2) $644 for lifetime reserve days; and (3) $161.00 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

This document, originally published on October 29, 2015 (80 FR 66549), has been amended to extend the comment receipt date to December 31, 2015. The Office of Dietary Supplements (ODS) at the National Institutes of Health, in partnership with the National Library of Medicine (NLM), has developed a Dietary Supplement Label Database (DSLD) that is compiling all information from the labels of dietary supplements marketed in the United States. ODS welcomes comments about features to add and functionality improvements to make so the DSLD may become a more useful tool to users. A federal stakeholder panel for the DSLD will consider all comments received. The ODS requests input from academic researchers, government agencies, the dietary supplement industry, and other interested parties, including consumers. The DSLD can be accessed online at http:/ /dsld.nlm.nih.gov.

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 (the 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.

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.

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 a meeting that 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.dhhs.gov/ohrp/sachrp/mtgings/.

This proposed rule would implement the Workforce Innovation and Opportunity Act enacted on July 22, 2014 and reflects the transfer of Independent Living Services and Centers for Independent Living programs from the Department of Education to the Department of Health and Human Services. The previous regulations were issued by the Department of Education. This proposed rule will consolidate the Independent Living (IL) regulations into a single part, align the regulations with the current statute and HHS policies, and will provide guidance to IL grantees.

The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests regarding nitroglycerin drug products in transdermal systems under Docket No. FDA-1977-N-0356 (formerly 77N-0240) (DESI 1786) have been withdrawn. Therefore, shipment in interstate commerce of any nitroglycerin drug product in a transdermal system identified in this docket, or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the effective date of this notice.

The Food and Drug Administration (FDA or we) is correcting the preamble to a final rule that appeared in the Federal Register of September 24, 2015. This final rule provided FDA with categorical exclusions from the requirement to prepare environmental assessments for certain actions regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule also included amendments to certain environmental impact regulations to include tobacco products, where appropriate, in light of its authority under the Tobacco Control Act. The document published with technical errors in reference numbers cited in the document. This document corrects those errors. We are placing a corrected copy of the rule in the docket.

The Food and Drug Administration (FDA) is canceling the November 18, 2015, session and postponing the November 19, 2015, session of the Gastroenterology and Urology Devices Panel meeting. The meeting was announced in the Federal Register of October 7, 2015 (80 FR 60686). The November 19, 2015, session has been postponed due to the cancellation of the November 18, 2015, meeting. Future meeting dates will be announced in the Federal Register.

This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Beacon Biomedical, Inc. (``Beacon'') located in Scottsdale, AZ, USA. A notice was previously published on December 6, 2013 in Volume 78, Number 235 for a period of thirty (30) days. Herein, the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is proposing a modification to the contents of the previous notice regarding the following intellectual property:

NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Battelle King Avenue site in Columbus, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Guidance on Qualification of BiomarkerGalactomannan in Studies of Treatments of Invasive Aspergillosis.'' This guidance provides a qualified context of use (COU) for Galactomannan detection in serum and/or bronchoalveolar lavage (BAL) fluid as the sole microbiological criterion to classify patients as having probable invasive Aspergillosis (IA) for enrollment in clinical trials. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the CDER Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' 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 collection of information associated with the reporting of harmful and potentially harmful constituents in tobacco products and tobacco smoke under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the use of the term ``natural'' in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering. We are taking this action in part because we received three citizen petitions asking that we define the term ``natural'' for use in food labeling and one citizen petition asking that we prohibit the term ``natural'' on food labels. We also note that some Federal courts, as a result of litigation between private parties, have requested administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as ``natural.'' We are working with the United States Department of Agriculture (USDA) Agricultural Marketing Service and Food Safety and Inspection Service to also examine the use of the term ``natural'' in meat, poultry, and egg products, and are considering areas for coordination between FDA and USDA. We invite public comment on the term ``natural'' in the context of food labeling and on specific questions contained in this document.

The Administration for Community Living (ACL) 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 the continuation of an existing collection for Performance Progress Reports previously approved for discretionary grants funded by the U.S. Administration for Community Living (ACL).