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

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 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 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.

The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will develop recommendations regarding: Leading Health Indicators; the setting of targets for a more focused set of measurable, nationally representative objectives; the roles of health and well-being, health equity, and law in Healthy People 2030; and the creation of a logic model for communicating the role of Healthy People 2030, disease prevention, and health promotion. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.

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 (the 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 requirements relating to FDA's regulation of current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donation testing, donor notification, and ``lookback''.

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 collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Draft Guidance for Industry: Modified Risk Tobacco Product Applications'' (MRTPA).

The Food and Drug Administration (FDA or Agency) is announcing the timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36 months for certain INDs after publication of the final guidance ``Providing Regulatory Submissions in Electronic FormatStandardized Study'' in December 2014. When future updates to study data standards listed in the FDA Data Standards Catalog (Catalog) occur, these updated standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice announcing such updates is published. When future new study data standards are listed in the Catalog, these new standards will be required in studies with a start date no earlier than 24 months after a Federal Register notice announcing such new standards is published.

The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the BCCEDCAC. The BCCEDCAC consists of 14 experts in fields associated with breast cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Two members may be representatives of the general public with personal experience in issues related to breast or cervical cancer early detection and control. 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 cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BCCEDCAC objectives.

In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the ``2018 Requirements.'' The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NINLARO 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 the Agency) has determined the regulatory review period for ZURAMPIC 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.

In accordance with the Federal Advisory Committee Act, the CDC National Institute for Occupational Safety and Health (NIOSH), announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). This meeting is open to the public, limited only by the number of telephone lines. The room will accommodate approximately 100 persons. The public is also welcome to listen to the meeting by dial-in number 1 (888) 982- 4611, the passcode 3778171, and will accommodate up to 50 callers. To view the web conference, enter the following web address in your web browser: https://odniosh.adobeconnect.com/wtchpstac18-1/.

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 ``DELTA Impact Recipient Monitoring and Assessment Tools.'' Information collected will be used for implementation and performance monitoring of cooperative agreement CDC-RFA-CE18-1801: Domestic Violence Prevention Enhancement and Leadership through Alliances (DELTA) Impact.