Department of Health and Human Services December 17, 2013 – Federal Register Recent Federal Regulation Documents

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.