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

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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 the collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LYMPHOSEEK 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 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 Medical Device Labeling Regulations.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OFEV 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 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 administrative practices and procedures; formal evidentiary public hearing.

ACF, ORR, announces the issuance of one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of $15,000,000. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 450 beds in an expedited manner.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) coordinated the development of a strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States. This document, prepared with support from the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is now available.

The National Toxicology Program (NTP) announces a meeting to peer review the Draft NTP Research Report on the CLARITY-BPA Core Study. This report presents the results of the core, guideline- compliant, chronic, extended-dose-range study of bisphenol A (BPA) in rats conducted as part of the CLARITY-BPA Research Program. The U.S. Food and Drug Administration's National Center for Toxicological Research (NCTR) conducted the study under the auspices of the National Toxicology Program and prepared the draft report in collaboration with the National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting will be held at NIEHS in Research Triangle Park, NC and is open to the public. Registration is requested for attendance at the meeting either in-person or by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/rrprp.

The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the LEPAC. The LEPAC consists of 15 Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of the committee's objectives. Nominees will be selected based on expertise in the fields of epidemiology, toxicology, mental health, pediatrics, early childhood education, special education, diet and nutrition, and environmental health. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of LEPAC objectives.

In compliance with the requirement for opportunity for public comment on proposed data collection of the Paperwork Reduction Act of 1995, 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 or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.

The Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), and all ORA Laboratories have modified the structure. This new organizational structure was approved by the Secretary of Health and Human Services and effective on June 6, 2016.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled EEOICPA Dose Reconstruction Interviews and Forms. This data collection permits claimants under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) to provide information potentially useful in reconstructing radiation doses, and to confirm that they have no further information to submit.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PORTRAZZA 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 biological product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DARZALEX 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 biological product.

The Food and Drug Administration (FDA, Agency, or we) 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 the information collection provisions of FDA regulations requiring the declaration of color additives on animal food labels.