Department of Health and Human Services October 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register of October 3, 2017, concerning request for comments on Agency Forms Undergoing Paperwork Reduction Act ReviewEvaluation of the National Tobacco Prevention and Control Public Education Campaign. The document provided the incorrect proposed project type (Revision).

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the information collection project entitled National Youth Tobacco Surveys (NYTS) 2018-2020, which aims to collect data on tobacco use among middle- and high school students.

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 entitled Implementing the 6[verbar]18 Initiative: Case Studies. CDC proposes to seek a three-year clearance to conduct semi-structured interviews with state public health department and Medicaid agency officials. CDC designed this information collection project to improve understanding of facilitators and barriers to increased utilization of evidence-based interventions for selected chronic and infectious diseases.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is appropriate for the submission of a marketing application to FDA.

The Food and Drug Administration (FDA, the Agency, or we) is correcting a proposed rule that published in the Federal Register of September 13, 2017. That proposed rule proposes to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' regulation. We are placing a corrected copy of the proposed rule in the docket.

The Food and Drug Administration (FDA or we) is announcing the following public meetings entitled ``Agricultural Biotechnology Education and Outreach Initiative.'' The purpose of the public meetings is to provide the public with an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

The United States has a long history of providing conscience protections in the regulation of health care for entities and individuals with objections based on religious beliefs or moral convictions. These interim final rules expand exemptions to protect moral convictions for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration, a component of the United States Department of Health and Human Services, to maintain the guidelines requiring contraceptive coverage where no regulatorily recognized objection exists. These rules also provide certain morally objecting entities access to the voluntary ``accommodation'' process regarding such coverage. These rules do not alter multiple other Federal programs that provide free or subsidized contraceptives for women at risk of unintended pregnancy.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC). This meeting is open to the public, limited only by room seating (36 seats), audio phone lines (50 audio lines) and net conference access (50 net conference lines) available. The public is welcome to listen to the meeting by accessing the call-in number, 1- 888-596-9856, the passcode, 38181337; 50 audio lines will be available. Online Registration Required: In order to expedite the security clearance process required for entry into a Federal building, all BCCEDCAC Meeting attendees must register for the meeting online at least 8 business days in advance at https://www.cdc.gov/cancer/nbccedp/ advisory-committee/registration.htm . Please complete all the required fields and submit your registration no later than November 20, 2017. Each meeting day, in-person attendees must check-in and present identification (driver's license/state issued ID, or passport) to CDC security.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of antiviral drug development for prophylaxis and treatment of disease caused by respiratory syncytial virus (RSV) infection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Requests for Reconsideration at the Division Level Under GDUFA.'' This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance also provides information for applicants to consider before pursuing a request for reconsideration, procedures for submitting a request for reconsideration, and the Agency's process for responding to those requests.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The topics to be discussed will include the current status of electronic submissions and data standards initiatives to improve the predictability and consistency of the electronic submissions process in support of the human drug review program. FDA is seeking input from a variety of stakeholdersindustry, academia, patient advocates, professional societies and other interested partiesas it fulfills its commitment under the Prescription Drug User Fee Act of 2017 (PDUFA) to hold annual public meetings to seek stakeholder input related to enhancing the transparency and accountability of the electronic submission and data standards activities. FDA will use the information from the public meeting to inform the development of the FDA Information Technology (FDA IT) Strategic Plan and electronic submissions gateway target timeframes.