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

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Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-29991
Type: Notice
Date: 2013-12-17
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.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-29945
Type: Notice
Date: 2013-12-17
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: 2013-29944
Type: Notice
Date: 2013-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-29933
Type: Notice
Date: 2013-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
Opportunity for Co-Sponsorship of the President's Challenge Physical Activity and Fitness Awards Program
Document Number: 2013-29919
Type: Notice
Date: 2013-12-17
Agency: Department of Health and Human Services
The President's Council on Fitness, Sports, and Nutrition (PCFSN) announces the opportunity for non-federal public and private sector entities to co-sponsor and administer a series of financially self-sustaining activities related to the President's Challenge Physical Activity and Fitness Awards Program (President's Challenge). Potential co-sponsors must have a demonstrated interest in and be capable of managing the day-to-day operations associated with the program and be willing to participate substantively in the co-sponsored activity.
Patient Protection and Affordable Care Act; Maximizing January 1, 2014 Coverage Opportunities
Document Number: 2013-29918
Type: Rule
Date: 2013-12-17
Agency: Department of Health and Human Services
This interim final rule amends the date by which a qualified individual must select a qualified health plan (QHP) through any Exchange for an effective coverage date of January 1, 2014. This rule generally allows consumers to select a QHP until December 23, 2013, which is a change from the previously stated regulatory date of December 15, 2013, but permits State Exchanges to select a different date. It also establishes a related policy regarding the date by which a consumer needs to pay any applicable initial premium to ensure timely effectuation of coverage. This rule pertains to the individual market and Small Business Health Options Program in both the Federally- facilitated Exchanges and State Exchanges. This rule does not change the plan selection or premium payment dates for coverage offered outside of the Exchanges.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-29917
Type: Notice
Date: 2013-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; 30-Day Comment Request: Outcomes Evaluation of the National Cancer Institute (NCI) Cancer Prevention Fellowship Program (CPFP)
Document Number: 2013-29868
Type: Notice
Date: 2013-12-17
Agency: Department of Health and Human Services, National Institutes of Health
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 August 12, 2013, (Vol. 78 FR p. 48879) and allowed 60 days for public comment. One public comment was received on August 18, 2013 which questioned the effectiveness of the program and whether the study was an effective use of taxpayer funds. An email response was sent on September 9, 2013 stating, ``Your response will be reviewed in further consideration of all comments submissions made during the 60-day public notice period for this proposed information collection. Thank you for your inquiry, comments and/or suggestions''. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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. Comments 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.
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record
Document Number: 2013-29814
Type: Proposed Rule
Date: 2013-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being safe for antiseptic handwash use by consumers based on safety data evaluated by FDA as part of our ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic wash active ingredients have data that demonstrate a clinical benefit from the use of these consumer antiseptic wash products compared to nonantibacterial soap and water.
New Animal Drugs for Use in Animal Feeds; Bambermycins
Document Number: 2013-29810
Type: Rule
Date: 2013-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for which free-choice, loose-mineral medicated feeds containing bambermycins are approved. This action is being taken because a level of selenium for inclusion in such feeds has not been established for dairy cattle under the food additive regulation for selenium.
Submission for OMB Review; Comment Request
Document Number: 2013-29798
Type: Notice
Date: 2013-12-16
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act
Document Number: 2013-29796
Type: Notice
Date: 2013-12-16
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.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-29767
Type: Notice
Date: 2013-12-16
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-29759
Type: Notice
Date: 2013-12-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-29750
Type: Notice
Date: 2013-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2013-29749
Type: Notice
Date: 2013-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office for State, Tribal, Local and Territorial Support (OSTLTS)
Document Number: 2013-29746
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute)
Document Number: 2013-29745
Type: Notice
Date: 2013-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-29742
Type: Notice
Date: 2013-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-29726
Type: Notice
Date: 2013-12-13
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-29725
Type: Notice
Date: 2013-12-13
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.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-29723
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-29722
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-29721
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-29720
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2013-29719
Type: Notice
Date: 2013-12-13
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: 2013-29718
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-29717
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-29716
Type: Notice
Date: 2013-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-29715
Type: Notice
Date: 2013-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209; Availability
Document Number: 2013-29697
Type: Notice
Date: 2013-12-12
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 213 entitled ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry 209.'' The purpose of this document is to provide information to sponsors of certain antimicrobial new animal drug products who are interested in revising conditions of use for those products consistent with FDA's Guidance for Industry (GFI) 209, ``The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines for stakeholders wishing to comply voluntarily with this guidance.
Veterinary Feed Directive
Document Number: 2013-29696
Type: Proposed Rule
Date: 2013-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This proposed amendment is intended to improve the efficiency of FDA's VFD program.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-29695
Type: Notice
Date: 2013-12-12
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2013-29668
Type: Notice
Date: 2013-12-12
Agency: Department of Health and Human Services, Administration for Children and Families
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-29613
Type: Notice
Date: 2013-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Independent Assessment of the Process for the Review of Device Submissions; High Priority Recommendations
Document Number: 2013-29612
Type: Notice
Date: 2013-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is presenting Booz Allen Hamilton's high priority recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 to 2017. The assessment is described in section V, ``Independent Assessment of Review Process Management'', of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The high priority recommendations are the first of a series of deliverables, as outlined in the contract statement of work,\2\ to be published as part of Phase 1 of the assessment.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-29515
Type: Notice
Date: 2013-12-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-29511
Type: Notice
Date: 2013-12-11
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-29510
Type: Notice
Date: 2013-12-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-29509
Type: Notice
Date: 2013-12-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-29508
Type: Notice
Date: 2013-12-11
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.
Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties
Document Number: 2013-29473
Type: Proposed Rule
Date: 2013-12-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This advance notice of proposed rulemaking (ANPRM) solicits public comment on specific practices for which civil money penalties (CMPs) may or may not be imposed for failure to comply with Medicare Secondary Payer reporting requirements for certain group health and non-group health plans arrangements.
National Institute of Nursing Research; Notice of Meeting
Document Number: 2013-29469
Type: Notice
Date: 2013-12-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-29468
Type: Notice
Date: 2013-12-11
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: 2013-29467
Type: Notice
Date: 2013-12-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-29466
Type: Notice
Date: 2013-12-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; National Survey of Older Americans Act Participants
Document Number: 2013-29436
Type: Notice
Date: 2013-12-10
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the information collection requirements contained in consumer assessment surveys that are used by ACL to measure program performance for programs funded under Title III of the Older Americans Act.