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

Results 201 - 250 of 391
Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability
Document Number: 2013-25124
Type: Proposed Rule
Date: 2013-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of, and requesting comment on, a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA). The purpose of the draft RA is to provide a science-based risk analysis of those activity/ animal food combinations that would be considered low risk. FDA conducted this draft RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.
Medicare Program: Conditions of Participation (CoPs) for Community Mental Health Centers
Document Number: 2013-24056
Type: Rule
Date: 2013-10-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule establishes, for the first time, conditions of participation (CoPs) that community mental health centers (CMHCs) must meet in order to participate in the Medicare program. These CoPs focus on the care provided to the client, establish requirements for staff and provider operations, and encourage clients to participate in their care plan and treatment. The new CoPs enable CMS to survey CMHCs for compliance with health and safety requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
Document Number: 2013-25300
Type: Notice
Date: 2013-10-28
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 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 provisions of our guidance document entitled, ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification
Document Number: 2013-25298
Type: Notice
Date: 2013-10-28
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 “System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies Ideation Challenge”
Document Number: 2013-25280
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services
The deadline for all submissions to the ``System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies'' Ideation Challenge is extended from October 20 2013, to October 31, 2013 at 11:59 p.m. The ``System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies'' Ideation Challenge seeks ideas to establish a system for monitoring the location and status of life-sustaining durable medical equipment (DME) during a prolonged power outage or disaster situation. This information would be used by a network of family and friends, formal caregivers, emergency responders and others responding to a disaster to better assist individuals who are dependent on DME. The current Challenge focuses on obtaining information about DME; however, this is part of a larger effort to ensure that these people get the necessary help as quickly as possible. Submissions can be existing applications, or applications developed specifically for this challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-25253
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Amended Notice of Meeting
Document Number: 2013-25252
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-25248
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2013-25246
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2013-25245
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Health
Document Number: 2013-25244
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2013-25243
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2013-25242
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-25241
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-25240
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-25239
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-25238
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-25237
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-25236
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-25235
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2013-25234
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2013-25233
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2013-25232
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment; Notice of Meeting
Document Number: 2013-25231
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-25230
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2013-25229
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2013-25228
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2013-25227
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke Amended Notice of Meeting
Document Number: 2013-25226
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-25225
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-25224
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-25223
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-25222
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-25221
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-25220
Type: Notice
Date: 2013-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Turtles Intrastate and Interstate Requirements
Document Number: C1-2013-17751
Type: Rule
Date: 2013-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
Kidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee; Urology Subcommittee Workshop
Document Number: 2013-25278
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
The Urology Subcommittee of the Kidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee (KUHICC) will hold a 1-day workshop on November 4, 2013. The workshop will be open to the public, with attendance limited to space available.
Notice of Vitamin D Standardization Program (VDSP) Symposium: Tools To Improve Laboratory Measurement
Document Number: 2013-25277
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health, Office of Dietary Supplements (ODS), and the National Institute of Standards and Technology (NIST), are sponsoring a one-day symposium on November 14, 2013, to present information about the Vitamin D Standardization Program (VDSP) to those with an interest in the effort to standardize vitamin D measurement. These groups include commercial assay manufacturers; commercial, clinical, and research laboratory personnel; vitamin D researchers; and members of professional societies with clinical and public health interest in vitamin D.
HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver; Application Requirements
Document Number: 2013-25276
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White Program or RWHAP), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the statute. The statute also grants the Secretary authority to waive this requirement if there are no waiting lists for the AIDS Drug Assistance Program (ADAP) and core medical services are available to all individuals identified and eligible under Title XXVI in an applicant's state, jurisdiction, or service area, as applicable. The requirements for submitting an application to waive the statutory requirement that a grantee spend at least 75 percent of its funds on core medical were previously outlined in HIV/AIDS Bureau (HAB) Policy Notice 08-02. On May 24, 2013, the Health Resources and Services Administration (HRSA) published a Final Notice with Opportunity to Comment in the Federal Register, revising HAB Policy Notice 08-02, and requesting public comment on this revised policy. This Federal Register notice seeks to address comments made by the public and to implement this policy as originally written.
``Low-Income Levels'' Used for Various Health Professions and Nursing Programs
Document Number: 2013-25275
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low-income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low- income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Tobacco Products Scientific Advisory Committee
Document Number: 2013-25188
Type: Notice
Date: 2013-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of a nonvoting industry representative to represent the interests of the tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products, notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancy effective with this notice. Elsewhere in this issue of the Federal Register, FDA is publishing a separate document announcing the Request for Notification for Voting Members on the Tobacco Products Scientific Advisory Committee.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-25187
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0162, which expires on January 31, 2014. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-25184
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0025, scheduled to expire on October 31, 2013. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
Document Number: 2013-25172
Type: Rule
Date: 2013-10-25
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 approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2013. 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 sponsorship for an ANADA.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-25171
Type: Notice
Date: 2013-10-25
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Availability of Interaction Profile for Chlorinated Dibenzo-p -Dioxins, Polybrominated Diphenol Ethers, and Phthalates
Document Number: 2013-25145
Type: Notice
Date: 2013-10-25
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services announces the availability of the interaction profile for Chlorinated Dibenzo-p- Dioxins, Polybrominated Diphenol Ethers, and Phthalates. This interaction profile evaluates a mixture of chemicals often found in human blood, adipose tissue, and breast milk. The purpose of this interaction profile is to investigate the possible joint actions of these chemicals on endocrine, developmental, and neurobehavioral endpoints in humans. This interaction profile has undergone external peer-review and review by ATSDR's Interagency Workgroup on Mixtures.
Submission for OMB Review; Comment Request
Document Number: 2013-25128
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Administration for Children and Families
Clinical Investigator Training Course
Document Number: 2013-25127
Type: Notice
Date: 2013-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-25093
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 0937-0191, which expired on May 31, 2011. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2013-25059
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services