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

Results 301 - 350 of 27,905
Denial of Hearing Request Regarding Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Abuse-Deterrent Formulation, Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Order Refusing Approval
Document Number: 2018-23710
Type: Notice
Date: 2018-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Chief Scientist is denying a request for a hearing regarding the proposal by the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA or Agency) to refuse to approve a new drug application submitted by Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. The Chief Scientist denies approval.
Medicare Program; International Pricing Index Model for Medicare Part B Drugs
Document Number: 2018-23688
Type: Proposed Rule
Date: 2018-10-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comments on potential options we may consider for testing changes to payment for certain separately payable Part B drugs and biologicals (hereafter called ``drugs''). Specifically, CMS intends to test whether phasing down the Medicare payment amount for selected Part B drugs to more closely align with international prices; allowing private-sector vendors to negotiate prices for drugs, take title to drugs, and compete for physician and hospital business; and changing the 4.3 percent (post-sequester) drug add-on payment in the model to reflect 6 percent of historical drug costs translated into a set payment amount, would lead to higher quality of care for beneficiaries and reduced expenditures to the Medicare program.
Meeting of the National Advisory Council on Nurse Education and Practice
Document Number: 2018-23685
Type: Notice
Date: 2018-10-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
The National Advisory Council on Nurse Education and Practice (NACNEP or the Council) has scheduled a public meeting. Information about NACNEP and the agenda for this meeting can be found on the NACNEP website at https://www.hrsa.gov/advisory-committees/nursing/index.html.
Zinpro Corp.; Filing of Food Additive Petition (Animal Use)
Document Number: 2018-23672
Type: Proposed Rule
Date: 2018-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as an anticaking agent for the use with zinc-L-selenomethionine as a feed component.
Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)
Document Number: 2018-23671
Type: Proposed Rule
Date: 2018-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that Adisseo France S.A.S. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as a carrier for selenomethionine hydroxy analogue at a level not to exceed 95 percent of the selenomethionine hydroxy analogue in its packaged form.
21st Century Cures: Announcing the Establishment of a Surrogate Endpoint Table; Establishment of a Public Docket; Request for Comments
Document Number: 2018-23641
Type: Notice
Date: 2018-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to receive suggestions and comments from interested parties (including academic institutions, regulated industry, and patient groups) on the Agency's publication of the surrogate endpoint table (SE table). FDA has developed a web page, available at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/ucm613636.htm that displays the SE table, describes the purpose of the table, and provides additional background information. Comments received on the SE table will help FDA determine its utility and may assist FDA in developing future iterations of the SE table and identifying best methods for conveying information about SEs on the FDA's website.
Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry; Availability
Document Number: 2018-23637
Type: Notice
Date: 2018-10-30
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 draft document entitled ``Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry.'' This guidance is intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States. The draft guidance document provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions.
Sesame as an Allergen in Foods
Document Number: 2018-23635
Type: Notice
Date: 2018-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) invites data and other information on the prevalence and severity of sesame allergies in the United States and the prevalence of sesame-containing foods sold in the United States that are not required to disclose sesame as an ingredient. We are taking this action to inform possible regulatory action on sesame to protect and promote the public health.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-23616
Type: Notice
Date: 2018-10-30
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is jointly owned by an agency of the U.S. Government with Pontificia Universidad Catolica de Chile 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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2018-23615
Type: Notice
Date: 2018-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-23614
Type: Notice
Date: 2018-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2018-23613
Type: Notice
Date: 2018-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued CMS-Approval of Its Outpatient Physical Therapy and Speech Language Pathology Services Accreditation Program
Document Number: 2018-23611
Type: Notice
Date: 2018-10-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for continued recognition as a national accrediting organization (AO) for clinics, rehabilitation agencies, or public health agencies that furnish outpatient physical therapy and speech language pathology services that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-23590
Type: Notice
Date: 2018-10-29
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.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2018-23577
Type: Notice
Date: 2018-10-29
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 Circulatory System Devices Panel of the Medical Devices Advisory Committee. 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-23576
Type: Notice
Date: 2018-10-29
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0906-xxxx-NEW
Document Number: 2018-23547
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-23536
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services, Administration for Children and Families
Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications
Document Number: 2018-23528
Type: Notice
Date: 2018-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 new drug applications (NDAs) 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; RAINDROP NEAR VISION INLAY
Document Number: 2018-23527
Type: Notice
Date: 2018-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RAINDROP NEAR VISION INLAY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Modified Risk Tobacco Product Applications for Snus Products Submitted by Swedish Match North America Inc.; Reopening of the Comment Period
Document Number: 2018-23524
Type: Notice
Date: 2018-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) for specific General Snus products submitted by Swedish Match North America Inc. and announcing the availability for public comment of a recently received amendment to the MRTPAs. The original notice of availability for the applications appeared in the Federal Register of August 27, 2014. In that notice, FDA requested comments on the originally filed MRTPAs that are posted on https://www.regulations.gov and FDA's website. In the Federal Register of July 31, 2015, FDA issued a notice to reopen and extended the comment period for comments on amendments to the MRTPAs. That comment period closed on August 31, 2015. FDA is now reopening the comment period to seek comment specifically on a recent amendment to the MRTPAs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims
Document Number: 2018-23523
Type: Notice
Date: 2018-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, 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.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-23522
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services
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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-23514
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-23513
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-23512
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2018-23511
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-23510
Type: Notice
Date: 2018-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Health Reimbursement Arrangements and Other Account-Based Group Health Plans
Document Number: 2018-23183
Type: Proposed Rule
Date: 2018-10-29
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document sets forth proposed rules to expand opportunities for working men and women and their families to access affordable, quality healthcare through proposed changes to regulations under various provisions of the Public Health Service Act (PHS Act), the Employee Retirement Income Security Act (ERISA), and the Internal Revenue Code (Code) regarding health reimbursement arrangements (HRAs) and other account-based group health plans. (For simplicity, this preamble generally refers only to HRAs, but references to HRAs should also be considered to include other account-based group health plans, unless indicated otherwise.) Specifically, these proposed rules allow integrating HRAs with individual health insurance coverage, if certain conditions are met. The proposed rules also set forth conditions under which certain HRAs would be recognized as limited excepted benefits. Also, the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) propose rules regarding premium tax credit (PTC) eligibility for individuals offered coverage under an HRA integrated with individual health insurance coverage. In addition, the Department of Labor (DOL) proposes a clarification to provide plan sponsors with assurance that the individual health insurance coverage the premiums of which are reimbursed by an HRA or a qualified small employer health reimbursement arrangement (QSEHRA) does not become part of an ERISA plan, provided certain conditions are met. Finally, the Department of Health and Human Services (HHS) proposes rules that would provide a special enrollment period in the individual market for individuals who gain access to an HRA integrated with individual health insurance coverage or who are provided a QSEHRA. The goal of these proposed rules is to expand the flexibility and use of HRAs to provide more Americans with additional options to obtain quality, affordable healthcare. The proposed rules would affect employees and their family members; employers, employee organizations, and other plan sponsors; group health plans; health insurance issuers; and purchasers of individual health insurance coverage.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2018-23484
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; TALTZ
Document Number: 2018-23438
Type: Notice
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TALTZ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; REBINYN
Document Number: 2018-23437
Type: Notice
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REBINYN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
National Institute of Nursing Research; Notice to Close Meeting
Document Number: 2018-23429
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Biopharmaceutics Classification System-Based Biowaivers; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2018-23425
Type: Notice
Date: 2018-10-26
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 draft guidance for industry entitled ``Biopharmaceutics Classification System-Based Biowaivers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance will provide recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of in vivo bioequivalence (BE) studies for drug products. In vivo BE studies are needed to demonstrate lack of impact of significant formulation changes on a drug's bioavailability during its development, for post-approval line extensions, and when developing a generic product. Utilizing the critical properties of the drug substance and the drug product, and applying the BCS framework, assurance of in vivo BE findings can be obtained using extensive in vitro studies. The draft guidance is intended to avoid unnecessary human BE trials based on extensive in vitro characterization of the drug substance and drug product properties.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
Document Number: 2018-23422
Type: Notice
Date: 2018-10-26
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, 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 regulations requiring distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System
Document Number: 2018-23412
Type: Rule
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system 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 active implantable bone conduction hearing system's 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.
Medical Devices; Anesthesiology Devices; Classification of the High Flow Humidified Oxygen Delivery Device
Document Number: 2018-23409
Type: Rule
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the high flow humidified oxygen delivery device 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 high flow humidified oxygen delivery device's 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.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2018-23394
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-23393
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-23392
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-23391
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Product-Specific Guidance; Revised Draft Guidance for Industry on Sucralfate; Reopening of Comment Period
Document Number: 2018-23386
Type: Notice
Date: 2018-10-26
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 a revised draft product-specific guidance on Sucralfate that appeared in a notice of availability, published in the Federal Register of October 20, 2017. In that notice, FDA requested comments on the revised draft guidance for industry on Sucralfate, as well as comments on other product-specific guidances. FDA is reopening the comment period for the Draft Guidance on Sucralfate (revised October 2017) to facilitate submission of comments pertaining to this draft guidance following an FDA response to two citizen petitions. The petition response suggests that the petitioners submit to the docket comments relating to the guidance.
Proposed Collection; 60-Day Comment Request; Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute)
Document Number: 2018-23313
Type: Notice
Date: 2018-10-25
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-23312
Type: Notice
Date: 2018-10-25
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-23311
Type: Notice
Date: 2018-10-25
Agency: Department of Health and Human Services, National Institutes of Health
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.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2018-23308
Type: Notice
Date: 2018-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that REVCOVI (elapegademase-lvlr) Injection, manufactured by Leadiant Bioscience Inc., meets the criteria for a priority review voucher.
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability
Document Number: 2018-23306
Type: Notice
Date: 2018-10-25
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 draft guidance for industry entitled ``Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.'' The draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this draft guidance covers the statutory verification system requirements that include quarantine and investigation of a product determined to be suspect and quarantine and disposition of a product determined to be illegitimate. The draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because it is determined that the product is not an illegitimate product.
Testicular Toxicity: Evaluation During Drug Development; Guidance for Industry; Availability
Document Number: 2018-23304
Type: Notice
Date: 2018-10-25
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 ``Testicular Toxicity: Evaluation During Drug Development.'' The guidance addresses nonclinical findings that may raise concerns of a drug-related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of a safety clinical trial assessing drug-related testicular toxicity. The guidance is intended to assist sponsors developing drugs and therapeutic biologics regulated within the Center for Drug Evaluation and Research to identify nonclinical signals of testicular toxicity and to evaluate the potential for such toxicity in humans. This guidance finalizes the draft guidance of the same name issued on July 17, 2015.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)-RFA-CE19-001; Correction
Document Number: 2018-23297
Type: Notice
Date: 2018-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-23293
Type: Notice
Date: 2018-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services