January 23, 2018 – Federal Register Recent Federal Regulation Documents

The FAA is issuing this notice to advise the public of a meeting of Eighty Seventh RTCA SC-147 Plenary Session.

We (the U.S. Fish and Wildlife Service) invite you to provide us with information and recommendations on animal and plant species to be considered as candidates for U.S. proposals to amend Appendices I and II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, or the Convention) at the upcoming eighteenth meeting of the Conference of the Parties (CoP18). Such amendments may concern the addition of species to Appendix I or II, the transfer of species from one Appendix to another, or the removal of species from Appendices. We also describe the U.S. approach to preparations for CoP18. We will publish a second Federal Register notice specifically to solicit information and recommendations on possible resolutions, decisions, and agenda items for discussion at CoP18 and to provide information on how to request approved observer status.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' This draft guidance document, when finalized, will help animal food facilities comply with the requirements for hazard analysis and risk-based preventive controls under our regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.''

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.

The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the reports on Margin Credit (FR G-1, FR G-2, FR G-4; OMB No. 7100- 0011. FR G-3; OMB No. 7100-0018. FR T-4; OMB No. 7100-0019. FR U-1; OMB No. 7100-0115).

The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Reporting, Recordkeeping, and Disclosure Requirements Associated with the Guidance on Response Programs for Unauthorized Access to Customer Information (FR 4100; OMB No. 7100-0309).

In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information collection.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.

The Postal Service is adding language for clarification purposes to ensure that the purpose of a contract or interagency agreement complies with the Postal Reorganization Act and the Privacy Act of 1974.