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

Results 201 - 250 of 27,499
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21177
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21176
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2018-21175
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2018-21174
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-21173
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21171
Type: Notice
Date: 2018-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2018 Performance Review Board (PRB)
Document Number: 2018-21169
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2018 Performance Review Board.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
Document Number: 2018-21148
Type: Notice
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Document Number: 2018-21147
Type: Rule
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 12 new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
Document Number: 2018-21146
Type: Rule
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name, and to make technical amendments to improve the accuracy of the regulations.
Label Requirement for Food That Has Been Refused Admission Into the United States
Document Number: 2018-21145
Type: Proposed Rule
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the withdrawal of a proposed rule that published in the Federal Register. This proposed rule is not currently considered a viable candidate for final action. FDA is taking this action because this proposed rule does not reflect current technology and industry practice.
The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-21141
Type: Notice
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Special 510(k) Program.'' FDA established the Special 510(k) Program to facilitate the submission, review, and clearance of changes to a manufacturer's own legally marketed predicate device. This draft guidance, when finalized, will provide the framework that FDA will use when considering whether a premarket notification (510(k)) is appropriate for review as a Special 510(k). This draft guidance is not final nor is it in effect at this time.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2018-21137
Type: Notice
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reporting Information Regarding Falsification of Data
Document Number: 2018-21133
Type: Proposed Rule
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, we) is announcing the withdrawal of two proposed rules that published in the Federal Register. These proposed rules are not currently considered viable candidates for final action. FDA is taking this action because the regulatory requirements set forth in the proposed rules are not needed at this time to protect the public health.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
Document Number: 2018-21096
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Tailored Therapeutics, LLC. (``Tailored''), located in Potomac, MD.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-21093
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-21092
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-21090
Type: Notice
Date: 2018-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Laboratory Improvement Advisory Committee (CLIAC); Meeting
Document Number: 2018-21083
Type: Notice
Date: 2018-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. The public is also welcome to view the meeting by webcast. Check the CLIAC website on the day of the meeting for the webcast link http://cdclabtraining.adobeconnect.com/ cliac/.
Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
Document Number: 2018-21044
Type: Rule
Date: 2018-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to ``single-use internal condom,'' a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. FDA is also amending the existing device identification for ``female condom,'' a preamendments class III device (product code OBY), by renaming the device ``multiple-use female condom,'' to distinguish it from the ``single-use internal condom.'' This order reclassifies single-use internal condoms from class III to class II and reduces regulatory burden because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome 510(k) before marketing their device.
Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-21042
Type: Notice
Date: 2018-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.'' The draft guidance, when finalized, establishes guidance for industry and FDA staff on how and when FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods. While FDA intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the draft guidance. FDA's goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies and Companion Guidance Document; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Reopening of the Comment Period
Document Number: 2018-21041
Type: Notice
Date: 2018-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability, published in the Federal Register of March 27, 2008. In that document, FDA requested comments on two draft guidance documents entitled ``Coronary Drug-Eluting StentsNonclinical and Clinical Studies'' and ``Coronary Drug-Eluting StentsNonclinical and Clinical Studies Draft Companion Guidance Document.'' The Agency is reopening the comment period to allow interested persons to provide updated comments and any new information.
Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
Document Number: 2018-21039
Type: Notice
Date: 2018-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collections regarding financial disclosure by clinical investigators.
Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Combination Product Review Practices
Document Number: 2018-21038
Type: Notice
Date: 2018-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews with entities that submit a Request for Designation (RFD) or pre-RFD, an Investigational New Drug (IND) application or pre-IND request, or a New Drug Application (NDA) or Biologics License Application (BLA) for a combination product to FDA.
Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2019
Document Number: 2018-21033
Type: Notice
Date: 2018-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric 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 Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the applicants of rare pediatric disease product applications that meet all of the requirements of this program and that are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA to review of a human drug application designated as priority review in the previous FY and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2019 and outlines the payment procedures for such fees.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-20994
Type: Notice
Date: 2018-09-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Request for Public Comment: 60-Day Proposed Information Collection: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions
Document Number: 2018-20989
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection titled, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions,'' Office of Management and Budget (OMB) Control Number 0917-0028.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-20984
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20983
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20982
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-20981
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20980
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-20979
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20978
Type: Notice
Date: 2018-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Dilip Patel; Denial of Hearing; Final Debarment Order
Document Number: 2018-20977
Type: Notice
Date: 2018-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Dilip Patel and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Patel for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Patel was convicted of a conspiracy to commit a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. Patel failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications
Document Number: 2018-20947
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Cigarette Warnings
Document Number: 2018-20913
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study of cigarette warnings that is being conducted in support of the graphic label statement provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2019
Document Number: 2018-20912
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2019 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2019.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019
Document Number: 2018-20911
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2019 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2019.
Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019
Document Number: 2018-20910
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the applicants of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review of a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2019 and outlines the payment procedures for such fees.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2018-20909
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
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
Document Number: 2018-20908
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
Allergenic Products Advisory Committee; Notice of Meeting
Document Number: 2018-20905
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee (APAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Tobacco Product Application Review; Public Meeting; Request for Comments
Document Number: 2018-20904
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Tobacco Product Application Review.'' This meeting is intended to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Insanitary Conditions at Compounding Facilities; Revised Draft Guidance for Industry; Availability
Document Number: 2018-20903
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled, ``Insanitary Conditions at Compounding Facilities.'' Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. FDA is issuing this revised draft guidance to help compounding facilities identify insanitary conditions so that they can implement appropriate corrective actions. This revised draft guidance is also intended to help state regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health. This guidance revises the draft guidance entitled ``Insanitary Conditions at Compounding Facilities'' that was published on August 4, 2016.
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities; Guidance for Industry; Availability
Document Number: 2018-20902
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2018-20901
Type: Notice
Date: 2018-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
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: Submission for OMB Review; Comment Request
Document Number: 2018-20887
Type: Notice
Date: 2018-09-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-20868
Type: Notice
Date: 2018-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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
Document Number: 2018-20863
Type: Notice
Date: 2018-09-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.