Change Requests

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Previous ICR	202211-0910-003

Federal Register Notices

Authorizing Statutes

Abstract

This information collection is intended to support research conducted by the Food and Drug Administration (FDA or we). Understanding patients, consumers, and health care professionals' perceptions and behaviors plays an important role in improving FDA's regulatory decisionmaking processes and communications impacting various stakeholders. To better understand patients, consumers, and health care professionals' perceptions and behaviors regarding various issues and patient reported outcomes associated with the safety and administration of drug products overseen by the agency, FDA is requesting approval of this generic information collection request for the purpose of conducting studies in these areas.

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Previous ICR	202209-0572-004CF

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Previous ICR	202202-0578-001CF

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Previous ICR	202203-0578-007CF

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Previous ICR	202209-0970-011

Federal Register Notices

Authorizing Statutes

Abstract

The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) intends to collect demographic, programmatic, and outcome data on Services for Survivors of Torture (SOT) grant recipients and the clients they serve. This collection of information is necessary for grant monitoring and is authorized under Section 5(a) of the "Torture Victims Relief Act of 1998," Pub. L. 105-320 (22 U.S.C. § 2152 note) Assistance for Treatment of Torture Victims. ORR will collect these data on the new cohort of Services for SOT grant recipients. Grant recipients submit aggregated data on new and continuing clients annually, including demographic information, characteristics related to experiences of torture, services received, and well-being across six outcome domains. Grant recipients will also provide information about community attendance at trainings and pro-bono services donated to the program. This data collection will allow ORR to learn more about the populations served by SOT grant recipients; the types and effectiveness of services provided; methods, challenges, and facilitators of implementing services; and grant recipients’ progress towards programmatic goals. The data collected will also be used for collaborative research projects to provide technical assistance to grant recipients. A summary of the information collected will be used by ORR in reports to stakeholders, including a required report to Congress, and in responses to funding requests. In January 2025, the current Administration released multiple Executive Orders (EO) and memoranda requiring updates to information collections that request gender and/or gender identity, to only request “Sex” with the options Male/Female. Additionally, presidential actions focused on the removal of diversity, equity, and inclusion (DEI)-specific activities. To be responsive to the new administration, ACF is submitting change requests for a number of implicated information collections. This request is specific to updates related to a recent presidential action, as detailed in the accompanying Justification for a NonSubstantive Change Memo.

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Previous ICR	202001-2132-002CF

Authorizing Statutes

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Previous ICR	202202-1653-003

Federal Register Notices

Authorizing Statutes

Abstract

The data collected on Form I-312 is used by ICE to ensure that an Obligor presents an official request for remittance of collateral security and/or accrued interest to a duly appointed Attorney In Fact for an Obligor when the Obligor chooses to invoke this option. The data collected on Form I-312A is used by ICE to ensure that an Obligor’s intent to expressly revoke a previously valid Attorney In Fact designation is properly documented. ICE is requesting instructional updates to obligors and attorneys-in-fact.

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Previous ICR	202212-1894-001

Federal Register Notices

Authorizing Statutes

Abstract

In accordance with section 70914 of the Build America Buy America Act (Pub. L. No. 117-58 §§ 70901-70953) (BABAA), grantees funded under Department of Education (the Department) programs that allow funds to be used for infrastructure projects (infrastructure programs), i.e., construction and broadband infrastructure, may not use their grant funds for these infrastructure projects or activities unless they comply with the following BABAA sourcing requirements: 1) All iron and steel used in the infrastructure project or activity are produced in the United States, 2) All manufactured products used in the infrastructure project or activity are produced in the United States, and 3) All construction materials are manufactured in the United States. The Department may, in accordance with sections 70914(b) and (d), 70921(b), 70935, and 70937 of BABAA, and the Office of Management and Budget Memorandum M 22-11, Initial Implementation Guidance on Application of Buy America Preference in Federal Financial Assistance Programs for Infrastructure, approve waivers to BABAA sourcing requirements submitted by grantees under programs it has identified as infrastructure programs when it determines that exceptions to these requirements apply. The Department may approve, subject to notice and comment requirements and the Office of Management and Budget Made in America Office (MIAO) review, the types of waivers listed below when one or more of the following conditions are met: 1) Public Interest Waiver - Applying the BABAA sourcing requirement would be inconsistent with the public interest, 2) Non-availability Waiver - The types of iron, steel, manufactured products, or construction materials are not produced in the United States in sufficient and reasonably available quantities or of a satisfactory quality, and 3) Unreasonable Cost Waiver - The inclusion of iron, steel, manufactured products, or construction materials produced in the United States will increase the cost of the overall project by more than 25 percent. This is a new information collection and it includes the following two documents: 1) the Build America, Buy America Act (BABAA) Domestic Sourcing Requirements Waiver - United States Department of Education BABAA Waiver Request Form (BABAA Waiver Request Form); and 2) a document listing the BABAA Waiver Request Form data elements.

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Previous ICR	202001-2132-004CF

Authorizing Statutes

Key Information

Previous ICR	202312-0970-008

Federal Register Notices

Authorizing Statutes

Abstract

The overall purpose of the Building Evidence on Employment Strategies (BEES) study is to conduct rigorous evaluations of innovative interventions aimed at improving employment outcomes, advances in the labor market, and economic security for low-income individuals and families. Populations of particular interest for BEES include individuals facing substance and opioid use disorders, disability or mental health challenges, and their families; criminal justice-involved populations; or others at increased risk of enrolling in TANF or SSI/SSDI. While the target population and domains may vary, all interventions will include an employment services component. BEES includes impact and/or implementation studies of 20 different programs. ACF requests a non-substantive modification of the BEES survey token of appreciation structure as part of our ongoing efforts to address lower-than-expected response rates and observable non-response bias for the follow-up wave of key respondents. As indicated in the table above, response rates are falling short of the targets in many of the studies, and response rates are substantially lower for control group members than for program group members. In addition, refusal rates are higher than in similar studies at 12 percent, and only about 13 percent have been unlocatable. These response rates raise concern about whether BEES will produce unbiased estimates of the programs being studied. The proposed increase in token of appreciation comes after many other efforts to address these concerns. The included nonsubstantive change memo highlights ACF’s efforts to date to secure the planned number of responses and address emerging non-response bias; describes proposed changes for the final phase of survey fielding; and explains the hypothesized benefits of the proposed approach and terms for assessment of the effort.

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Previous ICR	202003-0570-001CF

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Previous ICR	202110-0570-009CF

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Previous ICR	202011-0560-002CF

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Previous ICR	202001-0570-001CF

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Previous ICR	202001-0570-002CF

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Previous ICR	202001-1018-001CF

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Previous ICR	202301-0910-010

Federal Register Notices

Authorizing Statutes

Abstract

This information collection request supports agency rulemaking. FDA is amending its regulations for requirements for certain reporting and records of electronic products by removing specific reporting, as well as repealing outdated recommendations for radiation protection and performance standards, and removing submission requirements for copies of certain applications and forms to alleviate regulatory burden to both FDA and industry.

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Previous ICR	202302-0596-001CF

Key Information

Authorizing Statutes

Abstract

HRSA’s Office of Pharmacy Affairs (OPA) is introducing this 340B Rebate Model Pilot Program to test the rebate model on selected drugs with an agreed-upon Maximum Fair Price (MFP) for price applicability year 2026 starting on January 1, 2026. This approach will test the rebate model in a methodical and thoughtful manner. This information collection request includes the collection of 340B Rebate Model Pilot Program plans, the collection of periodic sales data from drug manufacturers for OPA’s evaluation of the pilot program and for overall 340B Program surveillance, and the collection of data submitted by covered entities to manufacturers to request a rebate.Emergency Justfication:HRSA is seeking emergency clearance because HRSA will need to begin the information collection by October 2025. If HRSA does not receive emergency approval, then manufacturers may argue that they do not have the tools they need to effectuate nonduplication of the MFP and the 340B discount. HRSA has taken all practicable steps to consult with the public to minimize burden (including a 30-day comment period on the “340B Program Notice: Application Process for the 340B Rebate Model Pilot Program” (90 FR 36163). HRSA is submitting this ICR to the Office of Management and Budget for a 5-month emergency approval. Once this clearance is granted, HRSA will create a regular ICR for this collection.

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Previous ICR	202206-2127-006

Federal Register Notices

Authorizing Statutes

Abstract

The FARS is a voluntary information collection of fatal motor vehicle traffic crashes. The FARS is in its forty-sixth year of operation and is a census of all defined crashes involving fatalities in the country. The FARS collects data from all 50 States, the District of Columbia, and Puerto Rico under cooperative agreements. State employees extract and transcribe information from existing State files including police crash reports as well as driver license, vehicle registration, highway department, and vital statistics files. NHTSA aggregates the data for research and analysis in support of motor vehicle regulations and highway safety programs. This supports NHTSA’s mission to save lives, prevent injuries, and reduce economic losses resulting from motor vehicle crashes by providing the agency vital information about fatal crashes. The aggregated data comprises a national database that is NHTSA’s and many States’ principal means of tracking trends in fatalities and quantifying problems or potential problems in highway safety. The FARS data are used extensively by all the NHTSA program and research offices, other DOT modes, States, and local jurisdictions. The highway research community uses the FARS data for trend analysis, problem identification, and program evaluation. Congress uses the FARS data for making decisions concerning safety programs. The FARS data are also available upon request to anyone interested in highway safety. The annual burden has been adjusted from 106,244 to 107,209 hours (an increase of 965 hours) costs have decreased from $100,000 to $0 (a decrease of $100,000). The adjustment in burden hours is due to the increase in the complexity of coding the FARS cases and an increase in the number of fatal crashes across most States. The increase also accounts for the time to process the non-traffic fatalities for NTS. Furthermore, while time for manually inputting data has decreased with States implementing systems to electronically transfer police report data that prepopulate NHTSA’s data systems, including FARS, the overall burden increased because, over the past two years, there has been an increase in staff turnover at the State level, adding an increase in administrative hours, training, and coding assistance to continue operations. The decrease in costs is a result of removing labor costs associated with labor hours that were incorrectly included in our last ICR.

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Previous ICR	202411-0920-004

Federal Register Notices

Authorizing Statutes

Abstract

The intended use of data collected is to inform the planning, implementation, and continuous quality improvement of CDC Fellowship Programs. Data collection methods include focus groups, interviews, and surveys, using both purposive and probabilistic samples. Respondent populations include potential applicants, fellows, alumni, supervisors, mentors, and employers of alumni. Data will be analyzed relative to the data collection methods and purpose. The Change Request contains minor changes and adheres to recent executive orders.

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Previous ICR	202501-1212-001

Federal Register Notices

Authorizing Statutes

Abstract

ERISA section 4010 requires the annual reporting of actuarial and financial information by controlled groups that sponsor pension plans that have significant underfunding. PBGC uses this information to detect and monitor financial problems with the controlled groups and to respond quickly when it learns that a controlled group intends to engage in a transaction that may reduce the assets available to pay plan liabilities.