Department of Health and Human Services October 2015 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 354
Prescription Drug User Fee Act; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until April 29, 2016, the comment period for the notice of public meeting that appeared in the Federal Register of May 13, 2015 (80 FR 27323). In the notice of public meeting, FDA invited public comment as the Agency begins the process to reauthorize the Prescription Drug User Fee Act (PDUFA) in fiscal years (FYs) 2018 to 2022. The Agency is taking this action to allow interested persons additional time to submit comments.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public except for parts that are closed, as indicated on the agenda. Registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration will be available at https://ntp.niehs.nih.gov/go/165.
Draft Report on Carcinogens Monographs on Five Viruses; Availability of Documents; Request for Comments; Notice of Peer-Review Meeting
The notice announces a meeting to peer review Draft Report on Carcinogens (RoC) Monographs on Five Viruses: Epstein-Barr virus [EBV], human immunodeficiency virus type 1 [HIV-1], human T-cell lymphotropic virus type 1 [HTLV-1], Kaposi sarcoma-associated herpesvirus [KSHV], and Merkel cell polyomavirus [MCV]. The monographs were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/38853.
Family Violence Prevention and Services Programs
The Administration for Children and Families proposes to revise regulations applying to the Family Violence Prevention and Services Programs. These proposed revisions would update existing rules to reflect statutory changes, would update procedures for soliciting and awarding grants, and would make other changes to increase clarity and reduce potential confusion over statutory and regulatory standards. The proposed revisions would codify standards already used by the program in the Funding Opportunity Announcements and awards, in technical assistance, in reporting requirements, and in sub-regulatory guidance.
Proposed Data Collection Submitted for Public Comment and Recommendations
The notice ``Proposed Data Collection Submitted for Public Comment and Recommendations'' on Personal Protective Equipment Information (PPE-Info) Database (80 FR 60906, October 8, 2015) is cancelled. This noticed invited comment on the Personal Protective Equipment Information (PPE-Info) Database which is a compendium of personal protective equipment (PPE) Federal regulations and consensus standards. This proposed data collection will be resubmitted at a later date for public comment once the review to include one additional standard is completed on the data collection instrument.
Issuance of Final Guidance Publications
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following 15 Skin Notation Profiles [DHHS (NIOSH) Publication Nos. 2015-191 to 2015-195 and 2015-226 to 2015-235]:
Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of June 22, 2016, for the final rule that appeared in the Federal Register of June 23, 2015. The final rule amended the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.
Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Information in Direct-to-Consumer Television Advertisements
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 research entitled ``Quantitative Information in Direct-to-Consumer Television Advertisements.'' The objective of this research is to test consumers' understanding of quantitative information about prescription drugs in DTC television advertisements (ads).
Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Cosmetic Good Manufacturing Practices
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including collections of information in current guidance documents, and allow 60 days for public comment. This notice invites comments on the recommended recordkeeping associated with our draft guidance entitled, ``Draft Guidance for Industry: Cosmetic Good Manufacturing Practices.'' Our draft guidance remains unchanged by this notice. We are publishing this notice in compliance with the PRA. This notice does not represent any new regulatory initiative.
Submission for OMB Review; 30-Day Comment Request: National Institute of Mental Health (NIMH) Recruitment Milestone Reporting System
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), 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 June 1, 2015, page 31053, and allowed 60-days for public comment. Four (4) public comments were received. Comments include concerns about the clarity of the announcement, the utility of the information collected, and the frequency of tri-annual and monthly reporting. NIMH carefully considered all comments received and has changed the language in the supporting statement to confirm that reporting of recruitment milestones in the RMR applies to participants in all extramural NIMH- sponsored clinical trials, regardless of size, as well as other clinical research studies that plan to enroll 150 or more human subjects in a single study. Investigators who fail to meet their milestones may be requested to submit interim monthly reports. NIMH has determined tri-annual reporting to be the minimum necessary to provide effective recruitment monitoring. When studies fall significantly behind their recruitment goals, monthly reporting is necessary in order to ensure the study can be completed within the proposed budget and timeframe. Based on current study performance, NIMH expects less than 5% of respondents will require monthly reporting. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health, 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Submission for OMB Review; 30-Day Comment Request: International HIV/AIDS Research Fellowship Award Program (NIDA)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 8, 2014, page 60895, 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 Institute on Drug Abuse (NIDA), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy
The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device ``nonthermal shortwave therapy'' (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices.
Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 67 new drug applications (NDAs) and 128 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application; Penicillin G Procaine
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) providing for the use of penicillin G procaine in medicated feed of poultry and swine. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsor, a change of sponsor's address, a revised food safety warning, the voluntary withdrawal of approval of an NADA, and a technical amendment. This technical amendment is being made to improve the accuracy of the regulations.
Meeting of the National Advisory Committee on Children and Disasters
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.
Request for Information From Non-Federal Stakeholders on Progress and Accomplishments (2010-2015) Towards the Goals of the National Vaccine Plan
The development of a National Vaccine Plan was mandated by Congress as a mechanism for the Director of the National Vaccine Program (the Assistant Secretary for Health) to communicate priorities for achieving the Program's responsibilities of ensuring adequate supply of and access to vaccines and ensuring the effective and optimal use of vaccines. The National Vaccine Plan, released in 2010, provides a comprehensive 10-year national strategy for enhancing all aspects of the National Vaccine Program including: Research and development, supply, financing, distribution, safety, informed decision making by consumers and health care providers, vaccine preventable disease surveillance, vaccine effectiveness and use monitoring, and global cooperation (https://www.hhs.gov/nvpo/vacc_plan/). In accordance with the 2010 National Vaccine Plan (NVP), the National Vaccine Program Office (NVPO) is conducting a mid-course review of the Plan following five years of its implementation. This review is intended to ensure that the priorities and activities outlined in the NVP are appropriately aligned towards the goals described therein given significant changes in the immunization landscape that have occurred since the NVP was released in 2010. The NVP is intended to be a national plan that includes contributions from both federal and non-federal stakeholders. In order to collect information from non-federal stakeholders in a uniform and systematic way, the NVPO is issuing a Request for Information (RFI) through a structured survey accessed on the NVPO Web site at https:// www.hhs.gov/nvpo/vacc_plan/#mid-course-review. The RFI will solicit specific information regarding the priorities, goals, and objectives within the NVP, significant accomplishments since 2010, remaining gaps, and stakeholder perspectives on priorities of the vaccine and immunization community for the remaining years of the NVP (2016-2020). Finally, stakeholders will also be provided the opportunity to briefly inform NVPO of the top contributions from their organization.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a 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.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service (IHS) Sharing What Works-Best Practice, Promising Practice, and Local Effort (BPPPLE) Form (OMB NO. 0917-0034)
In compliance with the Paperwork Reduction Act of 1995, Public Law (Pub. L.) 104-13 [44 United States Code (U.S.C.) Sec. 3506(c)(2)(A)], 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 (77 FR 67657) on November 13, 2012, and allowed 30 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).
National Institute of Biomedical Imaging and Bioengineering (NIBIB) Announcement of Requirements and Registration for the 2015 Design by Biomedical Undergraduate Teams (DEBUT) Challenge
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) Design by Biomedical Undergraduate Teams (DEBUT) Challenge is open to teams of undergraduate students working on projects that develop innovative solutions to unmet health and clinical problems. NIBIB's mission is to improve health by leading the development and accelerating the application of biomedical technologies. The goals of the DEBUT Challenge are to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building and debugging solutions for such open-ended problems; to generate novel, innovative tools to improve healthcare, consistent with NIBIB's purpose to support research, training, the dissemination of health information, and other programs with respect to biomedical imaging and engineering and associated technologies and modalities with biomedical applications; and to highlight and acknowledge the contributions and accomplishments of undergraduate students.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Ambulatory Medical Care Survey (NAMCS). The purpose of NAMCS is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Congenital Heart Surveillance to Recognize Outcomes, Needs and well-being (CHSTRONG). CDC seeks to collect data for the purpose of providing insight into the public health questions that remain for the population and to develop services and allocate resources to improve long-term health and wellbeing.
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