Department of Health and Human Services August 2013 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 283
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications
Document Number: 2013-20712
Type: Notice
Date: 2013-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
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; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2013-20711
Type: Notice
Date: 2013-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
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 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 invites comments on the procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to us upon which it has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Network (Pet Event Tracking Network and LivestockNET)-State, Federal Cooperation To Prevent Spread of Pet Food and Animal Feed Related Diseases
Document Number: 2013-20710
Type: Notice
Date: 2013-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
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 paperwork burden to the public of the Animal Feed Network, which includes the Pet Event Tracking Network (PETNet) and LivestockNET, for reporting of pet food or animal feed related instances, respectively.
Documents to Support Submission of an Electronic Common Technical Document; Availability
Document Number: 2013-20697
Type: Notice
Date: 2013-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability on the Agency Web site of revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1,'' version 2.2 (which includes the U.S. regional document type definition (DTD), version 3.2); ``The Comprehensive Table of Contents Headings and Hierarchy,'' version 2.2; ``Specifications for eCTD Validation Criteria,'' version 3.0; and ``Example Submissions using eCTD Backbone Files Specification for Module 1,'' version 1.2. Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 days' advance notice to industry.
Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability
Document Number: 2013-20696
Type: Notice
Date: 2013-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Draft Guidance on Risperidone.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-20659
Type: Notice
Date: 2013-08-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-20658
Type: Notice
Date: 2013-08-26
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-20645
Type: Notice
Date: 2013-08-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-20644
Type: Notice
Date: 2013-08-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-20643
Type: Notice
Date: 2013-08-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Indirect Food Additives: Adhesives and Components of Coatings
Document Number: 2013-20702
Type: Rule
Date: 2013-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-20642
Type: Notice
Date: 2013-08-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
Document Number: 2013-20616
Type: Rule
Date: 2013-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs), held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.
Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
Document Number: 2013-20615
Type: Notice
Date: 2013-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs) held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-20609
Type: Notice
Date: 2013-08-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-20563
Type: Notice
Date: 2013-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging Notice of Closed Meeting
Document Number: 2013-20562
Type: Notice
Date: 2013-08-23
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-20561
Type: Notice
Date: 2013-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-20560
Type: Notice
Date: 2013-08-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Children's Study, Vanguard (Pilot) Study Proposed Collection; 60-day Comment Request
Document Number: 2013-20549
Type: Notice
Date: 2013-08-23
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (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 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: Ms. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-7898 or Email your request, including your address to glavins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: The National Children's Study, Vanguard (Pilot) Study, 0925-0593, Expiration 8/31/2014Revision, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this request is to continue data collection activities for the NCS Vanguard Study and receive a renewal of the Vanguard Study clearance. The NCS also proposes the initiation of a new enrollment cohort, the addition of new Study visits, revisions to existing Study visits, and the initiation of methodological substudies. The NCS Vanguard Study is a prospective, longitudinal pilot study of child health and development that will inform the design of the Main Study of the National Children's Study. Background: The National Children's Study is a prospective, national longitudinal study of the interaction between environment, genetics on child health, and development. The Study defines ``environment'' broadly, taking a number of natural and man-made environmental, biological, genetic, and psychosocial factors into account. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible. The National Children's Study (NCS) has several components, including a pilot or Vanguard Study, and a Main Study to collect exposure and outcome data. The NCS Vanguard Study continues to follow the children and families enrolled in the Vanguard Study, conducting Study visits in participants' homes and over the telephone. Data Collection visits may include the administration of questionnaires, neurodevelopmental assessments, physical measures, and the collection of biospecimens and environmental measures. The Vanguard Study has yielded valuable data and field experience related to participant recruitment, the conduct of Study assessments, and operational requirements associated with NCS infrastructure and field efforts. The purpose of the proposed data collection is to obtain further operational and performance data on processes and administration Study visit measures. Research Questions: The primary research goal is to systematically pilot additional study visit measures and collections for scientific robustness, burden to participants and study infrastructure, and cost for use in the Vanguard (Pilot) Study and to inform the Main Study. A secondary goal is to increase enrollment in the Vanguard Study through the identification of subsequent pregnancies among enrolled women. Methods: The NCS Vanguard Study data collection schedule includes pre-pregnancy, pregnancy, and birth periods, as well as post-natal collection points at defined intervals between 3 and 60 months. We propose to add or modify the selected measures below to address analytic goals of assessing feasibility, acceptability, and cost of specific study visit measures. Enrollment of Sibling Birth Cohort: We will enroll approximately 1,000 sibling births identified among currently enrolled women. Following new pregnancies will allow us to pilot the collection of biospecimens, environmental samples, and standardized neurodevelopmental assessments on sufficient numbers of participants to understand what activities are feasible in specific settings, participants' willingness to complete requested measures, and whether measures are useful and scalable. Participants will be administered the same protocol as approved for the NCS Vanguard Study by the Office of Information and Regulatory Affairs within the Office of Management and Budget, including the collection of environmental samples, biospecimens and physical measurements during pre-pregnancy and pre- and post-natal visits. Those who report that they are trying to conceive will be initially administered the protocols approved for preconception data collection. Others who self-report a pregnancy at a later time will receive pregnancy visit instrumentation and collections.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-20544
Type: Notice
Date: 2013-08-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Council on Graduate Medical Education; Notice of Meeting
Document Number: 2013-20543
Type: Notice
Date: 2013-08-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone
Document Number: 2013-20541
Type: Notice
Date: 2013-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) at the sponsors' request because the products are no longer manufactured or marketed.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin
Document Number: 2013-20540
Type: Rule
Date: 2013-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request because the products are no longer manufactured or marketed.
Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education Funding Opportunity
Document Number: 2013-20535
Type: Notice
Date: 2013-08-23
Agency: Department of Health and Human Services, Indian Health Service
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-20531
Type: Notice
Date: 2013-08-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of the Assistant Secretary for Financial Resources, Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-20525
Type: Notice
Date: 2013-08-22
Agency: Department of Health and Human Services, Office of the Secretary
Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents; Availability
Document Number: 2013-20506
Type: Notice
Date: 2013-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' This guidance is intended to help small entities and other stakeholders comply with FDA's regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-20477
Type: Notice
Date: 2013-08-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Document Number: 2013-20471
Type: Notice
Date: 2013-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies on Consumer Responses to Nutrient Content Claims on Fortified Foods
Document Number: 2013-20469
Type: Notice
Date: 2013-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Announcement of Requirements and Registration for “Healthy Young America Video Contest”
Document Number: 2013-20468
Type: Notice
Date: 2013-08-22
Agency: Department of Health and Human Services, Office of the Secretary
In an effort to enroll the maximum number of uninsured young Americans into individual health plans in the upcoming open enrollment period, multiple mediums and methods of reaching the uninsured population are necessary. HHS and Young Invincibles are co-sponsoring the ``Healthy Young America'' Video Contest with two primary goals: First, directly reaching the uninsured population through video views and votes; and second, the production of high-quality videos that can be further promoted to the target population.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-20422
Type: Notice
Date: 2013-08-22
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Document Number: 2013-20415
Type: Notice
Date: 2013-08-22
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), 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: CAPT Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program, Operations and Informatics Branch, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number (240) 276-6080 or Email your request, including your address to: mike.montello@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: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 0925-0625, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides a centralized approach to human subject protection and provides a cost efficient approach avoiding duplication of effort at each institution. The CIRB provides the services of a fully constituted IRB and provides a comprehensive and efficient mechanism to meet regulatory requirements pertaining to human subject protections including: Initial reviews, continuing reviews, review of amendments, and adverse events. The Initiative consists of three central IRBs: Adult CIRBlate phase emphasis, Adult CIRBearly phase emphasis, and Pediatric CIRB. CIRB membership includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists, attorneys and other health professionals. The benefits of the CIRB Initiative reaches research participants, investigators and research staff, Institutional Review Boards (IRB), and Institutions. Benefits include: Study participants having dedicated review of NCI-sponsored trials for participant protections, access to more trials more quickly and access to trials for rare diseases, accrual to trials begin more rapidly, ease of opening trials, elimination of need to submit study materials to local IRBs, and elimination of the need for a full board review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials Network include a cost efficient approach that avoids duplication of efforts at each institution. A variety of information collection tools are needed to support NCI's CIRB activities which include: Worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,199.
Request for Comments on the Food and Drug Administration Safety and Innovation Act Section 907 Report
Document Number: 2013-20352
Type: Notice
Date: 2013-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments pertaining to the report issued as required by section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA). This notice is intended to solicit input from all relevant stakeholders before FDA issues an action plan to address issues raised in the report and to announce that such information submitted to FDA is available to all interested persons in a timely fashion.
Announcement of the Second 2015 Dietary Guidelines Advisory Committee Meeting and Invitation for Oral Testimony
Document Number: 2013-20410
Type: Notice
Date: 2013-08-21
Agency: Department of Agriculture, Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S. Department of Agriculture (USDA), are hereby giving notice that a meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held. This meeting will be open to the public.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-20400
Type: Notice
Date: 2013-08-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2013-20396
Type: Notice
Date: 2013-08-21
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services
Notice of FY 2013 Refugee Social Services Formula Awards to States and Wilson/Fish Alternative Project Grantees
Document Number: 2013-20377
Type: Notice
Date: 2013-08-21
Agency: Department of Health and Human Services, Office of Refugee Resettlement
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), announces the allocation of Refugee Social Services formula awards to States and Wilson/Fish Alternative Project grantees. The FY 2013 formula allocations for Social Services are available on ORR's Web site at: http://www.acf.hhs.gov/programs/orr/ spotlight#announcements.
The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop
Document Number: 2013-20371
Type: Notice
Date: 2013-08-21
Agency: Food and Drug Administration, Department of Health and Human Services
Notice of FY 2013 Refugee Targeted Assistance Formula Awards to States and Wilson/Fish Alternative Project Grantees
Document Number: 2013-20370
Type: Notice
Date: 2013-08-21
Agency: Department of Health and Human Services, Office of Refugee Resettlement
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), announces the allocation of Refugee Targeted Assistance formula awards to States and Wilson/Fish Alternative Project grantees.
Fees for Sanitation Inspections of Cruise Ships
Document Number: 2013-20349
Type: Notice
Date: 2013-08-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2014. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly inspections and, when necessary, re-inspection.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2013-20343
Type: Notice
Date: 2013-08-21
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Alternative Medicine Notice of Meeting
Document Number: 2013-20342
Type: Notice
Date: 2013-08-21
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-20341
Type: Notice
Date: 2013-08-21
Agency: Department of Health and Human Services, National Institutes of Health
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2013-20305
Type: Notice
Date: 2013-08-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft Report on Carcinogens Monographs for ortho-Toluidine and Pentachlorophenol and By-Products of Its Synthesis; Availability of Documents; Request for Comments; Notice of Meeting
Document Number: 2013-19928
Type: Notice
Date: 2013-08-21
Agency: Department of Health and Human Services, National Institutes of Health
The notice announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monographs for ortho-Toluidine and Pentachlorophenol and By-products of its Synthesis (hereafter referred to as ``pentachlorophenol''). These documents 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).
Privacy Act of 1974; CMS Computer Match No. 2013-10; HHS Computer Match No. 1310
Document Number: 2013-20173
Type: Notice
Date: 2013-08-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Department of Homeland Security (DHS), United States Citizenship and Immigration Services (USCIS).
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-20111
Type: Notice
Date: 2013-08-19
Agency: Food and Drug Administration, Department of Health and Human Services
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Document Number: 2013-20087
Type: Proposed Rule
Date: 2013-08-19
Agency: Food and Drug Administration, Department of Health and Human Services
Under the National Environmental Policy Act of 1969 (NEPA), as implemented by the Council on Environmental Quality (CEQ) regulations, the Food and Drug Administration (FDA) announces its intent to prepare an Environmental Impact Statement (EIS) to evaluate the potential environmental effects of the proposed rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in an EIS. Information on the proposed rule may be accessed using the docket number found in brackets in the heading of this document.