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

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 This request for comments is similar to the withdrawn publication in that it invites the public to comment on specific changes OHS is considering for the CLASS condition, as well as other Designation Renewal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.

The Food and Drug Administration (FDA) is withdrawing the approval of abbreviated new drug application (ANDA) 075726 for PEMOLINE Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC (Mallinkrodt). Mallinkrodt requested withdrawal of this application and has waived its opportunity for a hearing.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the National Mammography Quality Assurance Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held on March 2, 2018, for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public via teleconference; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting via teleconference and who wish to participate in the public comment session. Individuals who wish to send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website https:// www.hhs.gov/ash/carb/ and must be completed by February 26, 2018. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/ash/carb/ on the Meetings page.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Bacillus Calmette-Gu[eacute]rin (BCG)-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' This guidance was developed to assist in the development of drugs and biologics for patients with a form of bladder cancer that is not amenable to currently available medical therapy and remains an unmet medical need. This guidance finalizes the draft guidance of the same name issued on November 18, 2016.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FARYDAK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications.''

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast health, breast cancer, disease prevention and risk reduction, survivorship (including metastatic breast cancer), hereditary breast and ovarian cancer (HBOC), or in related disciplines with a specific focus on young women. Persons with personal experience with early onset breast cancer are also eligible to apply. This includes, but may not be limited to breast cancer survivors

Pursuant to the Section 2203 of Public Law 114-322 (Water Infrastructure Improvements for the Nation Act)(Registry for Lead Exposure and Advisory Committee), and the Federal Advisory Committee Act of October 6, 1972, the Director, Centers for Disease Control and Prevention (CDC), announces the establishment of the Lead Exposure and Prevention Advisory Committee. The Lead Exposure and Prevention Advisory Committee shall, at a minimum: (1) Review the Federal programs and services available to individuals and communities exposed to lead; (2) review current research on lead exposure to identify additional research needs; (3) review and identify best practices, or the need for best practices regarding lead screening and the prevention of lead poisoning; (4) identify effective services, including services relating to healthcare, education, and nutrition for individuals and communities affected by lead exposure and lead poisoning, including in consultation with, as appropriate, the lead exposure registry as established in Section 2203(b) of Public Law 114-322; and (5) undertake any other review or activities that the Secretary determines to be appropriate. This advisory committee will review research and Federal programs and services related to lead poisoning and to identify effective services and best practices for addressing and preventing lead exposures in communities.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of December 28, 2017. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.