Department of Health and Human Services September 2018 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 279
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies, Federal facilities, and other entities that hold a radioactive materials (RAM) license for medical use issued by the Nuclear Regulatory Commission (NRC) or by an Agreement State. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it generally does not intend to take action for violations of certain provisions of the FD&C Act when these entities compound or repackage radiopharmaceuticals.
Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' Specifically, this guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA generally intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA generally does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
National Vaccine Injury Compensation Program: List of Petitions Received
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.
Head Start Program
The Office of Head Start will further delay the compliance date for programs to meet background checks requirements and participate in their state or local Quality Rating and Improvement Systems (QRIS). The Department delayed the compliance dates for these standards through a previous document in the Federal Register. Since then, we have learned programs could benefit from more time as they work to align with state systems to meet these federal standards.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Purchased/Referred Care Proof of Residency
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for approval of a new collection of information titled, ``Purchased/Referred Care Proof of Residency'' (OMB Control Number 0917-XXXX). This proposed information collection project was recently published in the Federal Register (83 FR 13764) on March 30, 2018, and allowed 60 days for public comment. The IHS received one comment regarding this collection. The question summary and response is listed in the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Agency Information Collection Request. 30-Day Public Comment Request
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.
Agency Forms Undergoing Paperwork Reduction Act Review; Withdraw
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on September 7, 2018 for public comment.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 ``Maritime Illness Database and Reporting System (MIDRS)''. The purpose of this data collection is to provide U.S.-bound passenger vessel operators an electronic reporting system to assist with their legal requirement to notify CDC of the number of passengers and crew members onboard their ship who have reportable acute gastroenteritis (AGE) as defined by federal quarantine regulations.
Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period
The Food and Drug Administration (FDA or Agency) is reopening the comment period provided in the notice entitled ``Pediatric Medical Device Development; Public Meeting; Request for Comments'' that appeared in the Federal Register on February 16, 2018. That notice announced the public meeting to be held on August 13 and 14, 2018, and requested comments by September 14, 2018. FDA is reopening the public meeting's comment period until November 26, 2018. The Agency is taking this action to allow interested parties additional time to submit comments.
Abbreviated New Drug Application Submissions-Content and Format; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA SubmissionsContent and Format.'' This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug and Cosmetic Act (the FD&C Act).
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ``Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.'' This draft guidance describes the fundamental values and operational principles that serve as the foundation for the review process. It also clarifies the roles and responsibilities of review staff and identifies ways in which applicants may support a robust and efficient review process. This draft guidance revises the guidance for review staff and industry entitled ``Good Review Management Principles and Practices for PDUFA Products'' issued April 2005.
Further Testing of Donations That Are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV). The draft guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. The draft guidance, when finalized, will update the recommendations related to the use of an appropriate multiantigen supplemental test contained in ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' dated December 2010.
Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components with recommendations for a requalification method for deferred donors, based on a determination that their previous reactive test results for anti-HTLV-I/II were falsely positive.
Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2019
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug or biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the applicants of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2019.
Benefit-Risk Factors To Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) With Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics.'' This guidance document describes factors FDA considers when evaluating the benefit-risk profile of a device in comparison to a predicate device in a 510(k) when the device has the same intended use as the predicate device, and different technological characteristics that do not raise different questions of safety and effectiveness. This guidance can be helpful in situations when there is an increase in risk and increase or equivalent benefit, or a decrease in benefit and a decrease or equivalent risk when comparing a new device to a predicate device. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process.
Listing of Color Additives Subject to Certification; D&C Yellow No. 8
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. We are taking this action in response to a color additive petition submitted by Glo Eyes, LLC.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
The Food and Drug Administration (FDA, Agency, or we) 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 collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet
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 collection of information using Form FDA 3794, entitled ``Generic Drug User Fee Cover Sheet.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the ultrasound cyclodestructive device, a postamendments class III device (regulated under product code LZR), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these devices from class III to class II (special controls) and reduce regulatory burdens as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0915-0278-Extension
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.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http:/ /www.dhhs.gov/ohrp/sachrp-committee/meetings/.
Government-Owned Inventions; Availability for Licensing
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.
Patient Engagement Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Modified Risk Tobacco Product Application: Application for Copenhagen® Snuff Fine Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless Tobacco Company LLC
The Food and Drug Administration (FDA) is announcing the availability for public comment of a modified risk tobacco product application (MRTPA) for Copenhagen[supreg] Snuff Fine Cut, a loose moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. LLC.
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.'' The draft guidance provides the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) regarding civil money penalties that may be assessed against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate applicable Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibitions relating to requirements, including implementing regulations, submitting registration and/or results information to the ClinicalTrials.gov data bank, and/or certain certifications to FDA.
Privacy Act of 1974; Matching Program
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new computer matching program between CMS and the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS), ``Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.'' In this matching program, DHS/USCIS provides CMS with immigrant, nonimmigrant, and naturalized or derived citizenship status information needed to make enrollment and exemption eligibility determinations as required by the Patient Protection and Affordable Care Act (ACA).
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019. The calendar year 2019 AIC threshold amounts are $160 for ALJ hearings and $1,630 for judicial review.
Notice of New NIH Policy Manual 1311-Preventing and Addressing Harassment and Inappropriate Conduct and New Policy Statement on Inappropriate Relationships in the Workplace
The National Institutes of Health (NIH) announces Policy Manual Chapter: 1311Preventing and Addressing Harassment and Inappropriate Conduct and a new Policy Statement addressing Personal Relationships in the Workplace. These policies apply to federal employees, contractors, trainees, and fellows who perform work for the NIH. The NIH expects that organizations receiving NIH funds have in place similarly rigorous policies and related procedures for their employees, contractors, trainees, and fellows who engage in agency- funded activities.
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be grandfathered from certain requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance issued on November 27, 2017.
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; Availability
The Food and Drug Administration FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.'' This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products. Sections of the FD&C Act require manufacturers and repackagers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning November 27, 2017, and November 28, 2018, respectively. This draft guidance intends to clarify these requirements.
Government-Owned Inventions; Availability for Licensing
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.
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