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

This proposed notice acknowledges the receipt of an application from Accreditation Association of Hospitals/Health SystemsHealthcare Facilities Accreditation Program for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.

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 the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2020, which apply from October 1, 2019, through September 30, 2020. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2020, you should not submit a Small Business Certification Request. This document provides information on how the fees for FY 2020 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2020 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2020 rates for the small business establishment fee ($5,599), the non-small business establishment fee ($18,288), and the re-inspection fee ($16,798) for outsourcing facilities; provides information on how the fees for FY 2020 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective 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 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 or Agency) is announcing the availability of a draft guidance for industry entitled ``Rare Pediatric Disease Priority Review Vouchers.'' This draft guidance is a revision of the guidance of the same title that published in 2014. This draft guidance provides information on the rare pediatric disease priority review voucher program under the Federal Food, Drug, and Cosmetic Act (FD&C Act), under which FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the relevant statutory criteria. These priority review vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases.

This Request for Information (RFI) seeks comment on ensuring legitimate access to controlled substances, including opioids, while also preventing diversion and abuse, as well as how federal, state, local, and tribal entities can collaborate to address these issues.

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: ``Embedded Research in Care Delivery Systems.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. This guidance finalizes the draft guidance of the same name issued March 23, 2017.

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 and Implementing the Six Building Blocks Team Approach to Improve Opioid Management in Primary Care.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 12, 2019, and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

This Request for Information (RFI) seeks comment on ensuring legitimate access to controlled substances, including opioids, while also preventing diversion and abuse, as well as how federal, state, local, and tribal entities can collaborate to address these issues.

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 (the Court) is charged by statute with responsibility for considering and acting upon the petitions.

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2020 rates for GDUFA II fees.

This is to notify the public that the previously scheduled September 24, 2019, meeting of the National Advisory Council on Nurse Education and Practice (NACNEP) is cancelled. This meeting was announced in the Federal Register, Vol. 84, No. 45 on Thursday, March 7, 2019 (FR Doc. 2019-04074 Filed 3-6-19). Future meetings will occur in calendar year 2020 and be announced through the Federal Register at a later date.