Department of Health and Human Services February 14, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for BELEODAQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

In compliance with the Paperwork Reduction Act (PRA) 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, 2018. This proposed information collection project was recently published in the Federal Register (82 FR 55107) on November 20, 2017, and allowed 60 days for public comment, as required by the PRA. The IHS received 20 anonymous comments regarding this collection but they did not pertain to the LRP notice. 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_FRDOC_0001).

The Food and Drug Administration (FDA) has determined the regulatory review period for JUVEDERM VOLUMA XC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KERYDIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OSURNIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

In compliance with of the Paperwork Reduction Act of 1995, 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.

OHS issues this request for comments to invite public feedback on information we inadvertently omitted from the ``CLASS Condition of the Head Start Designation Renewal System,'' request for comments, published on December 8, 2017. The document withdrawing the ``CLASS Condition of the Head Start Designation Renewal System'' request for comments is published elsewhere in this issue of the Federal Register. This request for comments is similar to the withdrawn publication in that it invites the public to comment on specific changes OHS is considering for the CLASS condition, as well as other Designation Renewal System (DRS) conditions and processes more broadly. Additionally, OHS seeks comments on ways it can: Incentivize robust competition to include new applicants, facilitate smooth transitions when there is a new grantee as a result of competition, and improve the DRS processes. The comment period is 30 days to allow for the public to address the additional issues in this reissued request for comments. We will consider comments submitted under the ``CLASS Condition of the Head Start Designation Renewal System'' request for comments.

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted to FDA in an electronic format that we can process, review, and archive. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.