Department of Health and Human Services August 2, 2021 – Federal Register Recent Federal Regulation Documents

Medical Device User Fee Rates for Fiscal Year 2022
Document Number: 2021-16408
Type: Notice
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2022. 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 2022, which apply from October 1, 2021, through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16407
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-16406
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16405
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16402
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2021-16385
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
Document Number: 2021-16384
Type: Notice
Date: 2021-08-02
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-16377
Type: Notice
Date: 2021-08-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-16376
Type: Notice
Date: 2021-08-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a continued information collection project titled ``Assessments to Inform Program Refinement for HIV, other STD, and Pregnancy Prevention among Middle and High-School Aged Youth.'' This is a generic information collection package that supports qualitative and quantitative data collection from adolescents (ages 11- 19) and their parents/caregivers for the purpose of needs assessment and program refinement for programs and services designed to prevent HIV, other sexually transmitted diseases (STDs), and pregnancy among middle and high school aged adolescents.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-16356
Type: Notice
Date: 2021-08-02
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 Antimicrobial Drugs Advisory Committee. The general function of the committee 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.
Belen G. Ngo; Denial of Hearing; Final Debarment Order
Document Number: 2021-16352
Type: Notice
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying Belen G. Ngo's (Ms. Ngo's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ms. Ngo 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 Ms. Ngo was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Ms. Ngo's debarment, FDA considered the relevant factors listed in the FD&C Act. Ms. Ngo failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Vithal K. Patel; Denial of Hearing; Final Debarment Order
Document Number: 2021-16350
Type: Notice
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Vithal K. Patel (Mr. Patel) and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Mr. Patel for 1 year 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 Mr. Patel was convicted of conspiracy to commit a felony under Federal law for conduct relating to the regulation of drug products under the FD&C Act and that the type of conduct underlying the conviction undermined the process for the regulation of drugs. In determining the appropriateness and period of Mr. Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. Mr. Patel has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Regulations Regarding “Intended Uses”
Document Number: 2021-15980
Type: Rule
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product ``intended use'' regulations. This final rule amends FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective.