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

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Document Number: 2015-18606
Type: Notice
Date: 2015-07-29
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 0990-0331, scheduled to expire on 08/31/2015. 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.
Document Number: 2015-18603
Type: Notice
Date: 2015-07-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Document Number: 2015-18587
Type: Notice
Date: 2015-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18475
Type: Notice
Date: 2015-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18442
Type: Notice
Date: 2015-07-29
Agency: Department of Health and Human Services
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.
Document Number: 2015-17503
Type: Proposed Rule
Date: 2015-07-29
Agency: Department of Health and Human Services
The Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.
Document Number: 2015-18456
Type: Notice
Date: 2015-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 a proposed information collection entitled Monitoring and Reporting System for the Prescription Drug Overdose Prevention for States Cooperative Agreement. CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.
Document Number: 2015-18455
Type: Notice
Date: 2015-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-18448
Type: Notice
Date: 2015-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), is announcing the availability of a draft guidance for industry entitled ``Request for Quality Metrics'' and a public meeting regarding the Agency's plans associated with a quality metrics reporting program. The draft guidance and public meeting are intended to gain stakeholders' perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the authority of the Food, Drug, and Cosmetic Act (the FD&C Act). The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for postapproval manufacturing changes. FDA intends to consider the input from this public meeting as we finalize this guidance and the planned implementation of this program, including FDA's initial set of requests for quality metrics data.
Document Number: 2015-18445
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will be holding a meeting to continue discussions and possibly develop recommendations regarding People Living with HIV/AIDS. PACHA members will hear panels on performance measures, HIV and the youth, the National AIDS Housing Coalition and other issues related to people living with HIV. Additionally, PACHA members will discuss the updated National HIV/AIDS Strategy. The meeting will be open to the public.
Document Number: 2015-18444
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Document Number: 2015-18443
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty second meeting on September 2, 2015. At this meeting, the Commission will continue to discuss the role of deliberation and deliberative methods to engage the public and inform consideration in bioethics, and how to integrate pubic dialogue into the bioethics conversation; bioethics education as a forum for fostering deliberative skills, and preparing students to participate in public dialogue in bioethics; goals and methods of bioethics education; and integrating bioethics education across a range of professional disciplines and educational levels.
Document Number: 2015-18440
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-18430
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF), will host a Tribal Consultation to consult on ACF programs and tribal priorities.
Document Number: 2015-18429
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2015-18428
Type: Notice
Date: 2015-07-28
Agency: Substance Abuse and Mental Health Services Administration, Department of Health and Human Services
Document Number: 2015-18424
Type: Notice
Date: 2015-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-18421
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18420
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18410
Type: Notice
Date: 2015-07-28
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.
Document Number: 2015-18358
Type: Notice
Date: 2015-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18357
Type: Notice
Date: 2015-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 comments on a proposed CDC- funded information collection entitled ``Capacity Building Assistance Assessment for HIV Prevention''. This request is for a one-year Office of Management and Budget approval to assess the capacity of each community-based organizations (CBOs) and their partnership who receive federal funds to implement their Comprehensive High-Impact HIV Prevention activities.
Document Number: 2015-18327
Type: Notice
Date: 2015-07-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of temporary moratoria on the enrollment of new ambulance suppliers and home health agencies, subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse.
Document Number: 2015-18415
Type: Notice
Date: 2015-07-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2015-18301
Type: Notice
Date: 2015-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 an information collection pertaining to the collection of tuberculosis-related information from United States Panel Physicians.
Document Number: 2015-18295
Type: Notice
Date: 2015-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2015-18270
Type: Notice
Date: 2015-07-27
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 ``Analytical Procedures and Methods Validation for Drugs and Biologics.'' This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ``Analytical Procedures and Methods Validation'' and the 1987 FDA guidance for industry on ``Submitting Samples and Analytical Data for Methods Validation.'' This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.
Document Number: 2015-18250
Type: Notice
Date: 2015-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18245
Type: Notice
Date: 2015-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18244
Type: Notice
Date: 2015-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18242
Type: Notice
Date: 2015-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18070
Type: Rule
Date: 2015-07-27
Agency: Department of Health and Human Services
This rule implements the Developmental Disabilities Assistance and Bill of Rights Act of 2000. The previous regulations were completed in 1997 before the current law was passed. The rule will align the regulations and current statute and will provide guidance to AIDD grantees.
Document Number: 2015-17929
Type: Proposed Rule
Date: 2015-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening, as to specific documents, the comment period regarding our proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are reopening the comment period for 60 days for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats.
Document Number: 2015-17928
Type: Proposed Rule
Date: 2015-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is revising certain provisions of the proposed rule, issued in March 2014, that would amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices (``the NFL/SFL proposed rule''). We are proposing text for the footnotes to be used on the Nutrition Facts label. We are taking this action after completing our consumer research in which we tested various footnote text options for the label. We are also proposing to establish a Daily Reference Value (DRV) of 10 percent of total energy intake from added sugars, proposing to require the declaration of the percent Daily Value (DV) for added sugars on the label, and are providing additional rationale for the declaration of added sugars on the label. We are taking these actions based, in part, on the science underlying a new report released by the 2015 Dietary Guidelines Advisory Committee.
Document Number: 2015-18241
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18203
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-18198
Type: Notice
Date: 2015-07-24
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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Document Number: 2015-18191
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18190
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18185
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-18179
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
Health Resources and Services Administration is issuing this notice to change the meeting dates for the Notice is hereby given of a change in the meeting of the Secretary's Advisory Committee on Infant Mortality (SACIM). The meeting was originally scheduled for July 13-14, 2015 and was published in the Federal Register on June 26, 2015, 80 FR 123 (page 36826).
Document Number: 2015-18148
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, Administration for Children and Families
In compliance with the Privacy Act of 1974, as amended by Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, ACF is publishing a notice of a computer matching program. The purpose of this computer match is to identify specific individuals who receive benefits from the Department of Veterans Affairs (VA) and also receive payments pursuant to various benefit programs administered by both the Department of Health and Human Services (HHS) and the Department of Agriculture. ACF will facilitate this program on behalf of SPAAs that participate in PARIS for verification of continued eligibility for public assistance. The match will utilize VA and SPAA records.
Document Number: 2015-18147
Type: Notice
Date: 2015-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 a proposed information collection entitled ``Screening and Counseling of Male EVD Survivors to reduce Risk of Sexually Transmitting Ebola Virus''. This activity will collect information on participants' laboratory results and sexual activity prior to and during participation in the screening program.
Document Number: 2015-18146
Type: Notice
Date: 2015-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-18142
Type: Notice
Date: 2015-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The draft guidance, when finalized, will contain FDA recommendations on third-party auditor/ certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA).
Document Number: 2015-18141
Type: Proposed Rule
Date: 2015-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this proposed rule to amend the proposed rule, ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications'' (Accreditation of Third-Party Auditors proposed rule) and to propose to establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA).
Document Number: 2015-18140
Type: Notice
Date: 2015-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2015-18121
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-18101
Type: Notice
Date: 2015-07-24
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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