Department of Health and Human Services June 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a Technical Specifications Document entitled ``Quality Metrics Technical Conformance Guide, Version 1.0.'' This Guide provides technical recommendations for the submission of quality metric data. It serves as the technical reference for implementation of the draft FDA guidance for industry, when finalized, on ``Request for Quality Metrics,'' dated July 28, 2015.

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.

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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.

The Food and Drug Administration (FDA or we) is extending the comment period for the final rule, published in the Federal Register of June 3, 2016, amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in broiler chicken feed. This action is in response to a food additive petition filed by Kemin Industries, Inc. We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.

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 a 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.

Pursuant to the Preventing Sex Trafficking and Strengthening Families Act of 2014, Public Law 113-183, notice is hereby given of an opportunity to submit a Statement of Interest for the National Advisory Committee on Trafficking of Children and Youth in the United States (Committee). The purpose of the Committee is to advise the Secretary and the Attorney General on practical and general policies concerning improvements to the Nation's response to the sex trafficking of children and youth in the United States. The Committee will be composed of not more than 21 members whose diverse experience and background enable them to provide balanced points of view with regard to carrying out the duties of the Committee.

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.

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 the proposed generic information collection entitled CDC Fellowship Programs Assessments. CDC is requesting Office of Management and Budget approval for a new generic clearance for data collection associated with quality improvement for the CDC fellowship programs that develop the current, emerging, and future public health workforce.

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.

The Food and Drug Administration (FDA) is announcing that it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) Account Management function. Participation will be needed from a small group of Filers, Importers of Record, and Consignees, who will use the new ITACS Account Management function and provide feedback to FDA. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of June 16, 2016. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.

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 for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 15, 2016, page 22289 and allowed 60 days for public comment. There were no comments received. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), 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. Comment 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.