Department of Health and Human Services August 2019 – 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 requests for feedback submitted under the Q-Submission Program for medical devices.

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 Comprehensive HIV Prevention and Care for Men Who Have Sex with Men of Color. This study is designed to support state and local health departments to develop and implement demonstration projects for provision of comprehensive human immunodeficiency virus (HIV) prevention and care services for men who have sex with men (MSM) of color by creating a collaborative with community based organizations (CBOs), clinics and other health care providers, and behavioral health and social services providers in their jurisdiction.

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 a Generic Information Collection Request for Cognitive Testing and Pilot Testing for the National Center for Chronic Disease Prevention and Health Promotion. A generic clearance is needed to support methodological studies that improve information quality and the efficiency of information collection.

The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 7, 2021.

The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice of public meeting entitled ``Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Request for Comments'' that appeared in the Federal Register of July 9, 2019. In the notice of public meeting, FDA requested comments on the use of complex adaptive and other novel investigation designs, data from foreign countries, real world evidence, and biomarkers and surrogate endpoints in animal drug development and regulatory decision making. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Office of Grants Management (OGM), in the Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-OGM-SF-PPR-B (OMB #0970-0406, expiration 9/30/2019). There are no changes requested to the form.

The Food and Drug Administration (FDA, the Agency, or we) is holding a public meeting on November 7, 2019 entitled ``Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA's Office of New Drugs.'' The purpose of the public meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's (CDER's) Office of New Drugs to promote effective drug development programs without compromising our regulatory standards for the assessment of safety and effectiveness.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the form OCSE- 75Tribal Child Support Enforcement Annual Data Report (OMB # 0970- 0320, expiration 03/31/2020). There are no changes requested to the form.

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 Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 30 days for public comment in response to the notice. This notice solicits comments on the Proposed New Collection and solicits comments on the information collection requirements related to the Application for Older Americans Act, Title VI Parts A/B and C Grants.

The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments on transit times to slaughter, milking frequency, and how end users interpret zero-day withdrawal period or zero-day milk discard time statements found on new animal drug labeling.

The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) at the sponsors' request because these products are no longer manufactured or marketed.

This proposed rule proposes revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2020 based on our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, in this proposed rule, we are proposing to establish requirements for all hospitals in the United States for making hospital standard charges available to the public; establish a process and requirements for prior authorization for certain covered outpatient department services; revise the conditions for coverage of organ procurement organizations; and revise the regulations to allow grandfathered children's hospitals-within- hospitals to increase the number of beds without resulting in the loss of grandfathered status. We also solicit comments on potential revisions to the laboratory date of service policy under the Clinical Laboratory Fee Schedule. Finally, we solicit comments on an appropriate remedy in litigation involving our OPPS payment policy for 340B- acquired drugs, which would inform future rulemaking in the event of an adverse decision on appeal in that litigation.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.''

The Food and Drug Administration (FDA or Agency) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2018.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to attend the meeting should email OMH-ACMH@hhs.gov by August 16, 2019. Information about the meeting is available from the designated contact person and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.