Department of Health and Human Services February 8, 2022 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; System of Records
The Department of Health and Human Services (HHS) is modifying a system of records maintained by the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF), number 09-80-0325, titled ``Internet Refugee Arrivals Data System (iRADS),'' and is renaming it ``Refugee Arrivals Data System (RADS).'' In addition, HHS is rescinding system of records number 09-80-0329, titled ``ORR Unaccompanied Refugee Minors Records,'' as duplicative of modified system of records 09-80-0325. The modifications are explained in the SUPPLEMENTARY INFORMATION section of this notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program
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 Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Program
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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment Registration and Device Listing for Manufacturers and Importers of Devices
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 information collection associated with establishment registration and device listing for manufacturers and importers of devices.
Meeting of the National Advisory Council on the National Health Service Corps
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on the National Health Service Corps (NACNHSC) will hold public meetings for the 2022 calendar year (CY). Information about NACNHSC, agendas, and materials for these meetings can be found on the NACNHSC website at: https:// www.hrsa.gov/advisory-committees/national-health-service-corp s.
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clinical Pharmacology Considerations for Antibody-Drug Conjugates,'' which provides recommendations for the development of antibody-drug conjugates (ADCs). Specifically, this guidance addresses the FDA's current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dose selection and adjustment, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug- drug interactions (DDIs). Currently, there are no FDA guidances outlining the clinical pharmacology considerations for antibody-drug conjugates. This draft guidance is not final nor is it in effect at this time.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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 for OMB Review; Public Comment Request; Process Evaluation of the Aging Network and Its Return on Investment; OMB #0985-New
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the information collection requirements for the Process Evaluation of the Aging Network and its Return on Investment [OMB #0985-New].
Agency Information Collection Activities: Proposed Collection; Public Comment Request; of the One Protection and Advocacy Annual Program Performance Report OMB #0985-0063
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 IC Revision solicits comments on the information collection requirements relating to the One Protection and Advocacy Annual Program Performance Report [OMB #0985-0063].
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