Department of Health and Human Services June 11, 2015 – Federal Register Recent Federal Regulation Documents

Statement of Organization, Functions, and Delegations of Authority
Document Number: 2015-14313
Type: Notice
Date: 2015-06-11
Agency: Department of Health and Human Services, Administration for Children and Families
This notice amends Part K of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (DHHS), Administration for Children and Families (ACF), as follows: Office of the Assistant Secretary for Children and Families, as last amended by77 FR 61002, September 21, 2012, and Office of Refugee Resettlement, as last amended by 80 FR 3614, January 23, 2015. This notice adds a new office, the Office on Trafficking in Persons to the Office of the Assistant Secretary for Children and Families and transfers the functions of the Division of Anti- Trafficking in Persons to this office. The changes are as follows:
Office of Community Services; Notice of Meeting
Document Number: 2015-14312
Type: Notice
Date: 2015-06-11
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services, Administration for Children and Families, Office of Community Services (OCS) will host a virtual Tribal Consultation to consult on the Assets for Independence (AFI) program proposed Performance Progress Report (PPR).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Health Care Practitioners for Device Labeling Format and Content
Document Number: 2015-14290
Type: Notice
Date: 2015-06-11
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 ``Survey of Health Care Practitioners for Device Labeling Format and Content'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms
Document Number: 2015-14285
Type: Notice
Date: 2015-06-11
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 ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry; Availability
Document Number: 2015-14261
Type: Notice
Date: 2015-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry.'' The guidance document is to assist sponsors and investigators in designing early-phase clinical trials for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products). The guidance document provides recommendations regarding clinical trials in which the primary objectives are the initial assessments of safety, tolerability, or feasibility of administration of investigational products. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2013.
Health Center Program
Document Number: 2015-14236
Type: Notice
Date: 2015-06-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Awarding Agency Grants Administration Manual (AAGAM) Chapter 2.04.103, the Bureau of Primary Health Care (BPHC) has been granted a class deviation from the exceptions to maximum competition requirements contained in the AAGAM Chapter 2.04.104A-5 to provide additional funding without competition to the 115 Health Center Program awardees whose budget period ends October 31, 2015, for up to 4 months. The extension allows BPHC to eliminate the November 1 budget period start date by redistributing these grants to established starting dates later in the fiscal year, thereby allowing awardees comparable opportunity to prepare and submit applications while allowing BPHC to remain compliant with internal process timelines.
Health Center Controlled Networks
Document Number: 2015-14235
Type: Notice
Date: 2015-06-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Awarding Agency Grants Administration Manual (AAGAM) Chapter 2.04.103, the Bureau of Primary Health Care (BPHC) has been granted a class deviation from the exceptions to maximum competition requirements contained in the AAGAM Chapter 2.04.104A-5 to provide additional funding without competition to the 37 Health Center Controlled Networks (HCCNs) awarded under announcement HRSA-13-237, extending their December 1, 2014, to November 31, 2015, budget period through July 31, 2016. This action will align the project period end dates of all active HCCN grants and ensure maximum competition for a single HCCN funding opportunity in fiscal year (FY) 2016.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Loan Repayment Program (LRP)
Document Number: 2015-14234
Type: Notice
Date: 2015-06-11
Agency: Department of Health and Human Services, Indian Health Service
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``IHS Loan Repayment Program (LRP)'' (OMB Control Number 0917-0014), which expires July 31, 2015. This proposed information collection project was recently published in the Federal Register (80 FR 23558) on April 28, 2015, and allowed 60 days for public comment, as required by 44 U.S.C. 3506(c)(2)(A). The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0003). Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension of currently approved information collection, 0917-0014, ``Indian Health Service Loan Repayment Program.'' The LRP application is available in an electronically fillable and fileable format. Form(s): The IHS LRP Information Booklet contains the instructions and the application format. Need and Use of Information Collection: The IHS LRP identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract through which the IHS agrees to repay part or all of their indebtedness in exchange for an initial two-year service commitment to practice full- time at an eligible Indian health program. The LRP is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS LRP. A two-year contract obligation is signed by both parties, and the individual agrees to work at an eligible Indian health program location and provide health services to American Indian and Alaska Native individuals. The information collected via the on-line application from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant accepts employment at a location, the applicant in turn ``picks-up'' the score of that location. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Amended Notice of Meeting
Document Number: 2015-14224
Type: Notice
Date: 2015-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-14197
Type: Notice
Date: 2015-06-11
Agency: Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
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