Department of Health and Human Services March 2018 – Federal Register Recent Federal Regulation Documents

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Office of Head Start invites public comment on several major changes to the Head Start Program Information Report (PIR) to better align with the comprehensive revision of the Head Start Program Performance Standards (HSPPS), reduce reporting burden, and improve the data collection. Major changes include proposals to remove, add, and significantly update PIR questions. To view proposed changes to the PIR to go into effect for the 2019-20 PIR, please visit https:// eclkc.ohs.acf.hhs.gov/sites/default/files/pdf/summary-of-prop osed- changes-to-the-pir-for-public-comment.pdf.

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 record retention requirement of the soy protein/coronary heart disease health claim.

This notice fulfills obligations under section 3002 of the Public Health Service Act (PHSA), as amended by the 21st Century Cures Act. Section 3002(b) (5) of the PHSA, as amended, mandates that the Health Information Technology Advisory Committee shall develop a schedule for the assessment of policy recommendations and the Secretary shall publish such schedule in the Federal Register.

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 we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal shock wave device for treatment of chronic wounds' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number at 1- 866-659-0537; the pass code is 9933701. The conference line has 150 ports for callers. The Web conference by which the public can view presentations as they are presented is https://webconf.cdc.gov/zab6/yzdq02pl?sl=1.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.

The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between October 23, 2017, and March 16, 2018, on FDA's website but not presented at the March 23, 2018, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.

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 ``Minimum Data Elements (MDEs) for the National Breast and Cervical Cancer Early Detection Program (NBCCEDP).''

This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning CMS programs, initiatives, and priorities. This meeting is open to the public.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical AmendmentsSmall 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: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.'' The final rule is designed to ensure that serving sizes are based on more recent consumption data and that consumers have serving size information on the Nutrition Facts label that will assist them in maintaining healthy dietary practices.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Proper Labeling of Honey and Honey Products.'' The guidance advises firms on the proper labeling of honey and honey products to help ensure that honey and honey products are not adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' The guidance describes our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods.