Department of Health and Human Services July 2019 – Federal Register Recent Federal Regulation Documents

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for VLNTM King and VLNTM Menthol King, combusted, filtered cigarettes, submitted by 22nd Century Group, Inc.

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 ``Monitoring and reporting for the Overdose Data to Action Cooperative Agreement.'' This new data collection effort is to collect information from grantees funded under the Overdose Data to Action (CDC-RFA-CE19-1904) funding opportunity. The information collected will be used to monitor the progress on set performance activities, and progress towards stated grant objectives.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2020 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2019, and will remain in effect through September 30, 2020.

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 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 Office of Community Services (OCS), Administration for Children and Families (ACF) is requesting approval of a three-year extension of the Assets for Independence (AFI) Performance Progress Report (PPR) Long Form and AFI PPR Short Form (OMB #0970-0483, expiration 8/31/2019). There are no changes requested to the forms.

The Administration for Children and Families (ACF) is requesting a three-year extension of the Court Improvement Program (CIP) Program Instruction, Strategic Plan Template, and Annual CIP Self-Assessment (OMB #0970-0307, expiration 8/31/2019). There are minimal updates to the form to reflect new legislation. The collections are necessary to continue operating the program in compliance with congressional reauthorization.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by room space, and audio web conference lines (80 audio and web conference lines available). The public is also welcome to listen to the meeting by accessing the call-in number, 1-800-857-4868, passcode, 1218986 (80 lines are available). The web conference access is https://adobeconnect.cdc.gov/radjn2o1shbb/. Online Registration Required: All ACBCYW Meeting participants must register for the meeting online at least 7 business days in advance at https://www.cdc.gov/cancer/breast/what_cdc_is_doing/conferenc e.htm. Please complete all the required fields before submitting your registration and submit no later than August 9, 2019. All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; limited only by available seating. The meeting room accommodates approximately 78 people. Requests to make oral presentations should be submitted in writing to Gwen Mustaf, 301-458- 4500, glm4@cdc.gov, or Sayeedha Uddin, isx9@cdc.gov. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by August 14, 2019.

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 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 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

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.