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

Privacy Act of 1974; Matching Program
Document Number: 2021-19067
Type: Notice
Date: 2021-09-02
Agency: Department of Health and Human Services, Administration for Children and Families
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services, Administration for Children and Families, Office of Planning, Research, and Evaluation (HHS/ACF/ OPRE), is providing notice of a re-established matching program between the Department of Defense, Defense Manpower Data Center (DoD/DMDC) and State Public Assistance Agencies (SPAAs), ``Verification of Continued Eligibility for Benefits Through the Public Assistance Reporting Information System (PARIS) Program.'' HHS/ACF/OPRE facilitates the matching program.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-19012
Type: Notice
Date: 2021-09-02
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.
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
Document Number: 2021-18995
Type: Rule
Date: 2021-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories at levels consistent with good manufacturing practice. We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of Sensient Colors, LLC (Sensient).
Food and Drug Administration; Delegation of Authority
Document Number: 2021-18985
Type: Notice
Date: 2021-09-02
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18980
Type: Notice
Date: 2021-09-02
Agency: Department of Health and Human Services, National Institutes of Health
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: 2021-18974
Type: Notice
Date: 2021-09-02
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).
Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing
Document Number: 2021-18928
Type: Notice
Date: 2021-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Intarcia Therapeutics, Inc. (Intarcia), for ITCA 650 (exenatide in DUROS device) in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Intarcia an opportunity to request a hearing on the matter.
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