Department of Health and Human Services February 4, 2020 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluating the Dissemination and Implementation of PCOR to Increase Referral, Enrollment, and Retention through Automatic Referral to Cardiac Rehabilitation (CR) with Care Coordination.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar ProductsQuestions and Answers.'' FDA is issuing this guidance to provide manufacturers, packers, distributors, and their representatives (firms) with information to consider when developing FDA-regulated promotional labeling and advertisements (promotional materials) for prescription reference and biosimilar products licensed under the Public Health Service Act (PHS Act). Although the guidance covers promotional issues involving both reference and biosimilar products, some questions and answers are focused on only biosimilar product promotional materials. The guidance does not discuss considerations unique to promotional materials for interchangeable biosimilars.

The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), is proposing to collect data on the child welfare workforce as part of the third cohort of children and families for the National Survey of Child and Adolescent Well-Being (NSCAW III). Previous and current data collections for NSCAW have been approved by OMB under OMB #0970-0202. This request is for additional data collection.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Cervical Ripening in the Outpatient Setting, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Food Labeling: Revision of the Nutrition and Supplement Facts LabelingSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with a final rule we issued in the Federal Register of May 27, 2016, entitled ``Food Labeling: Revision of the Nutrition and Supplement Facts Labeling.''