Department of Health and Human Services July 11, 2018 – Federal Register Recent Federal Regulation Documents

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 information collection provisions of FDA's postmarketing adverse drug experience reporting and recordkeeping requirements.

The Administration for Children and Families (ACF) is proposing an increase in the number of sites for data collection activities to be conducted as part of the Evaluation of Employment Coaching for TANF and Other Low-Income Populations. The Office of Management and Budget (OMB) Office of Information and Regulatory Affairs approved this information collection in March 2018 (0970-0506). As approved, we planned to include three employment programs. We have since identified three additional employment programs to include in the study. This Notice provides the opportunity for public comment on the addition of three sites. This study will provide an opportunity to learn more about the potential of coaching to help clients achieve self-sufficiency and other desired employment-related outcomes. The programs included in the study are Temporary Assistance for Needy Families (TANF) agencies and other public or private employment programs that serve low-income individuals. Selected sites include a robust coaching component and have the capacity to conduct a rigorous impact evaluation, among other criteria. This study will provide information on whether coaching helps people obtain and retain jobs, advance in their careers, move toward self-sufficiency, and improve their overall well-being. To meet these objectives, this study includes an impact and implementation study. The impact study involves participants being randomly assigned to either a ``program group,'' who will be paired with a coach, or to a ``control group,'' who will not be paired with a coach. The effectiveness of the coaching will be determined by differences between members of the program and control groups in outcomes such as obtaining and retaining employment, earnings, measures of self-sufficiency, and measures of self-regulation. The implementation study will document coaching practices, describe lessons learned from implementing coaching, and enhance interpretation of the impact study findings. The proposed information collection activities have not changed since OMB/OIRA approval. The only change to this information collection is to add three additional sites. Respondents: Program staff and individuals enrolled in the Evaluation of Employment Coaching for TANF and Other Low-Income Populations. Program staff may include coaches, case managers, workshop instructors, job developers, supervisors, and managers. All participants will be able to opt out of participating in the data collection activities.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by 60 room seating and 100 ports for audio phone lines. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, August 13, 2018. Persons who desire to make an oral statement, may request it at the time of the public comment period on August 21, 2018 at 3:20 p.m., EDT.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance revises the draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention'' issued on November 23, 2007.