Department of Health and Human Services June 27, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability, published in the Federal Register of May 4, 2016 (81 FR 26799), announcing the draft guidance for industry entitled ``Special Protocol Assessment.'' We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.

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.