Change Requests

What is an ICR?

An Information Collection Request (ICR) is a federal agency's request for approval from the Office of Management and Budget (OMB) to collect information from the public. Under the Paperwork Reduction Act (PRA), agencies must justify why the information is needed and how it will be used.

When are they submitted?

Federal agencies are required to submit an ICR whenever they create, renew, modify an information collection. Each ICR includes a description of the collection, supporting materials and documentation (such as forms, surveys, or scripts), and proof that the agency has met the requirements of the PRA.

The ICR is submitted to the The Office of Information and Regulatory Affairs (OIRA) within OMB for review and approval. OIRA grants approval for a maximum of three years, after which the collection must be renewed through a new ICR submission.

Where to find an ICR?

ICRs are publicly available on RegInfo.gov, and additional guidance can be found in the FAQs.

Note: Presidential Action influences are notated for ICRs received between January 20, 2025 and July 19, 2025.

Showing 25 of 15642 results

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Title
Reference Number
OMB Control Number
Agency
Received
Concluded
Action
Status
Request Type
Presidential Action

Title:

County Committee Election

Reference Number:

Omb Control Number:

0560-0229

Agency:

USDA/FSA

Received:

2024-08-14

Concluded:

2024-08-26

Action:

Approved without change

Status:

Active

Request Type:

No material or nonsubstantive change to a currently approved collection
County Committee Election

Key Information

Abstract

FSA collects information to prepare a report of County Committee election results (to Congress and public) that include the types of nominees who voluntarily participate in the election.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

15 USC 590

Presidential Action:

-

Title:

Department of the Interior us of the Build America Buy America Waiver Request Data Collection Common Form

Reference Number:

Omb Control Number:

0505-0028

Agency:

DOI/OS

Received:

2024-08-14

Concluded:

2024-08-23

Action:

Approved without change

Status:

Active

Request Type:

RCF New
Department of the Interior us of the Build America Buy America Waiver Request Data Collection Common Form

Key Information

Presidential Action:

-

Title:

Defined Monetary Assistance Victims Reserve

Reference Number:

Omb Control Number:

1103-0121

Agency:

DOJ/DOJADM

Received:

2024-08-14

Concluded:

2024-12-18

Action:

Approved without change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Defined Monetary Assistance Victims Reserve

Key Information

Abstract

The Amy Vicky Andy Act of 2018 (AVAA), which is codified at 18 U.S.C. §§2259, 2259A, 2259B, and 34 U.S.C. §2010(d), established the Child Pornography Victims Reserve (Reserve), also known as the Defined Monetary Assistance Victims’ Reserve, to provide monetary assistance to eligible individuals who are depicted in child pornography that is the basis of certain convictions under 18 U.S.C. chapter 10. The final rule, “Implementing the Child Pornography Victims Reserve” is found at 28 C.F.R. 81. Any person or their authorized representative may submit a claim to the Reserve for payment through the Department of Justice (Department). The information requested in the claim form is necessary for the determination of eligibility for payment from the Reserve. If a court determines that a claimant is a victim, and thereby eligible for payment from the Reserve, then the Department will use some of the information collected in order to make payment from the Reserve to the victim.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

Pub.L. 115 - 299 4-5

Presidential Action:

-

Title:

MDUFMA Small Business Qualification Certification

Reference Number:

Omb Control Number:

0910-0508

Agency:

HHS/FDA

Received:

2024-08-14

Concluded:

2024-09-16

Action:

Approved without change

Status:

Active

Request Type:

No material or nonsubstantive change to a currently approved collection
MDUFMA Small Business Qualification Certification

Key Information

Abstract

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) requires FDA to collect a user fee from each person who submits certain medical device applications for FDA review. A "small business" is eligible for reduced or waived fees. If an applicant does not provide information to FDA demonstrating to FDA's satisfaction that the applicant is a small business, the applicant must pay the standard (full) fee for any application it submits.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

21 USC 379j

Presidential Action:

-

Title:

Accounting Requirements for RUS Electric and Telecommunications Borrowers

Reference Number:

Omb Control Number:

0572-0003

Agency:

USDA/RUS

Received:

2024-08-14

Concluded:

None

Action:

None

Status:

Received in OIRA

Request Type:

Revision of a currently approved collection
Accounting Requirements for RUS Electric and Telecommunications Borrowers

Key Information

Abstract

The regulations supported by this information collection package set forth basic accounting requirements for maintaining accounting records on an accrual basis.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

7 USC 901

Presidential Action:

-

Title:

Internet Request for Replacement of Form SSA-1099/SSA-1042S

Reference Number:

Omb Control Number:

0960-0583

Agency:

SSA

Received:

2024-08-14

Concluded:

2024-08-19

Action:

Approved without change

Status:

Active

Request Type:

No material or nonsubstantive change to a currently approved collection
Internet Request for Replacement of Form SSA-1099/SSA-1042S

Key Information

Abstract

Title II recipients use Forms SSA-1099 and SSA-1042S, Social Security Benefit Statement, to determine if their Social Security benefits are taxable and the amount they need to report to the Internal Revenue Service. In cases where the original forms are unavailable (e.g., lost, stolen, mutilated), an individual may use SSA's Internet request form or automated telephone application to request a replacement SSA-1099 and SSA-1042S. SSA uses the information from the Internet and automated telephone requests to verify the identity of the requestor and to provide replacement copies of the forms. The Internet and automated telephone options educe requests to the National 800 Number Network (N8NN) and visits to local Social Security field offices. The respondents are applicants for, or claimants of, SSI payments. We are submitted a Non-Substantive Change Request to make changes to the system to allow callers to obtain any or all of the 5-tax year SSA-1099 or SSA-1042s prior to the current closed tax year they can already obtain for themselves or a deceased person.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

42 USC 405
26 USC 6050F

Presidential Action:

-

Title:

Child Nutrition Programs: Community Eligibility Provision – Increasing Options for Schools

Reference Number:

Omb Control Number:

0584-0697

Agency:

USDA/FNS

Received:

2024-08-14

Concluded:

2024-09-16

Action:

Approved with change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Child Nutrition Programs: Community Eligibility Provision – Increasing Options for Schools

Key Information

Abstract

This is a request for a new collection to cover the existing information collection requirements, currently approved under OMB Control Number 0584-0026, which are being impacted by the final rule, Child Nutrition Programs: Community Eligibility Provision – Increasing Options for Schools. The final rule changes requirements related to electing the Community Eligibility Provision and the household income application process. FNS plans to merge this collection into Control Number 0584-0026 at a later date.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

42 USC 1751 et seq
42 USC 1779

Presidential Action:

-

Title:

Reporting Executive Compensation and First-tier Subcontract Awards

Reference Number:

Omb Control Number:

9000-0177

Agency:

FAR

Received:

2024-08-13

Concluded:

2024-09-16

Action:

Approved without change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Reporting Executive Compensation and First-tier Subcontract Awards

Key Information

Abstract

This clearance covers the information that contractors must submit to comply with the requirements of the following sections of FAR clause 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards: a. FAR 52.204-10(d)(2), First-tier subcontract information. Contractors shall report the following information for their first-tier subcontracts at http://www.fsrs.gov by the end of the month following the month of award of a first-tier subcontract valued at or above $30,000: (i) Unique entity identifier for the subcontractor receiving the award and for the subcontractor's parent company, if the subcontractor has a parent company. (ii) Name of the subcontractor. (iii) Amount of the subcontract award. (iv) Date of the subcontract award. (v) A description of the products or services (including construction) being provided under the subcontract, including the overall purpose and expected outcomes or results of the subcontract. (vi) Subcontract number (the subcontract number assigned by the contractor). (vii) Subcontractor's physical address including street address, city, state, and country. Also include the nine-digit zip code and congressional district. (viii) Subcontractor's primary performance location including street address, city, state, and country. Also include the nine-digit zip code and congressional district. (ix) The prime contract number, and order number if applicable. (x) Awarding agency name and code. (xi) Funding agency name and code. (xii) Government contracting office code. (xiii) Treasury account symbol as reported in FPDS. (xiv) The applicable North American Industry Classification System code. Contractors shall follow the instructions at FSRS (FSRS.gov) to report the data. Contractors may access FSRS with their Electronic Subcontract Reporting System (eSRS) user account since access to FSRS and eSRS is accomplished with a single account/ log-in. The burden for the eSRS information collection is covered under OMB Control No. 9000-0007, Subcontracting Plans. b. FAR 52.204-10(d)(3), Executive compensation of the first-tier subcontractor. Contractors shall report the names and total compensation of each of the five most highly compensated executives for their first-tier subcontractors for that first-tier subcontractor's preceding completed fiscal year at http://www.fsrs.gov, if— (i) In the subcontractor's preceding fiscal year, the subcontractor received— (A) 80 percent or more of its annual gross revenues from Federal contracts (and subcontracts), loans, grants (and subgrants), cooperative agreements, and other forms of Federal financial assistance; and (B) $25,000,000 or more in annual gross revenues from Federal contracts (and subcontracts), loans, grants (and subgrants), cooperative agreements, and other forms of Federal financial assistance; and (ii) The public does not have access to information about the compensation of the executives through periodic reports filed under section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986. (To determine if the public has access to the compensation information, see the U.S. Security and Exchange Commission total compensation filings at http://www.sec.gov/answers/execomp.htm.) c. FAR 52.204-10(d)(1) requires contractors to report the names and total compensation of each of the five most highly compensated executives for its preceding completed fiscal year as part of the contractor’s annual registration requirement in the System for Award Management (SAM) (FAR provision 52.204-7). The burden for the SAM information collection is covered under OMB Control No. 9000-0189, Certain Federal Acquisition Regulation Part 4 Requirements.

Federal Register Notices

60-Day FRN
30-Day FRN

Presidential Action:

-

Title:

Federal Home Loan Bank Directors

Reference Number:

Omb Control Number:

2590-0006

Agency:

FHFA

Received:

2024-08-13

Concluded:

2024-09-12

Action:

Approved with change

Status:

Active

Request Type:

Reinstatement with change of a previously approved collection
Federal Home Loan Bank Directors

Key Information

Abstract

The information collection concerns administration of the Federal Home Loan Bank (Bank) director election process. It is necessary to enable the Federal Housing Finance Agency and the Banks to determine whether prospective and incumbent Bank directors satisfy statutory and regulatory eligibility and reporting requirements and to run the director election process.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

12 USC 1427

Presidential Action:

-

Title:

Underground Construction Standard (29 CFR 1926.800)

Reference Number:

Omb Control Number:

1218-0067

Agency:

DOL/OSHA

Received:

2024-08-13

Concluded:

2024-10-02

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Underground Construction Standard (29 CFR 1926.800)

Key Information

Abstract

The information collection requests contained in the Standard requires employers to post warning signs and notices, certify inspection records for hoists, and maintain records of air quality tests.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

29 USC 655
29 USC 657
29 USC 651

Presidential Action:

-

Title:

Consumer Response Government and Congressional Portal Boarding Forms

Reference Number:

Omb Control Number:

3170-0057

Agency:

CFPB

Received:

2024-08-13

Concluded:

2024-12-02

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Consumer Response Government and Congressional Portal Boarding Forms

Key Information

Abstract

Section 1013(b)(3)(A) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act or Act) requires the Bureau of Consumer Financial Protection (“the Bureau”) to facilitate the coordinated collection, monitoring, and response to consumer complaints regarding certain financial products and services. The Consumer Financial Protection Act further provides for consumer complaint information sharing between the Bureau and State and Federal agencies (“agencies”) and for consumer complaint sharing and reporting to Congress. To fulfill these mandates, the Bureau has developed separate portals for Agencies and Congressional users as part of its secure web portal offerings (the “Government Portal” and the “Congressional Portal,” respectively). Via the Government Portal, agencies can view consumer-submitted complaint data in a user-friendly format that allows easy identification of complaints currently active in the Bureau process, complaints referred to a prudential federal regulator, and other closed/archived complaints. This portal includes features for Agencies to export selected complaint data and search by company, consumer name, consumer financial product and more. This portal also allows Agencies to identify whether a named company has responded to a complaint and view the company closure response category. The Congressional Portal has some of the same capabilities as the Government Portal and provides members of Congress and authorized congressional office staff with the ability to view consumer complaints they submit on behalf of their constituents with the consumer’s express written authorization for the release of their personal information. The Congressional Portal only displays information about complaints submitted by the individual congressional office.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

Pub.L. 111 - 203 1013(b)(3)(A)

Presidential Action:

-

Title:

Section 24.103, Construction Requirements

Reference Number:

Omb Control Number:

3060-0625

Agency:

FCC

Received:

2024-08-13

Concluded:

2024-08-13

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Section 24.103, Construction Requirements

Key Information

Abstract

The Commission's narrowband Personal Communications Services rules adopted in this proceeding on May 18, 2000 will improve the efficiency of spectrum use, reduce the regulatory burden on spectrum users, encourage competition, and promote service to the largest feasible number of users. The reporting and recordkeeping requirements will be used to determine whether the proposed partitionee or disaggreatee is qualified to obtain a partioned or disaggregated spectrum license.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

47 USC 303

Presidential Action:

-

Title:

Forging Machines (29 CFR 1910.218)

Reference Number:

Omb Control Number:

1218-0228

Agency:

DOL/OSHA

Received:

2024-08-13

Concluded:

2024-10-02

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Forging Machines (29 CFR 1910.218)

Key Information

Abstract

Employers must establish periodic inspections of forging machines, guards, and point-of-operation protection devices and to mark manually controlled valves and switches. These requirements reduce workers' risks of death or serious injury by ensuring that forging machines used by them are in safe operating condition, and that they are able to identify manually operated valves and switches.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

29 USC 655
29 USC 651
29 USC 657

Presidential Action:

-

Title:

Ionizing Radiation Standard (29 CFR 1910.1096)

Reference Number:

Omb Control Number:

1218-0103

Agency:

DOL/OSHA

Received:

2024-08-13

Concluded:

2024-10-02

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Ionizing Radiation Standard (29 CFR 1910.1096)

Key Information

Abstract

The purpose of the Ionizing Radiation Standard and its information collection requirements are to document that employers are providing their workers with protection from hazardous ionizing radiation exposure.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

29 USC 651
29 USC 655
29 USC 657

Presidential Action:

-

Title:

Entry Evaluation & Exit Evidence Forms

Reference Number:

Omb Control Number:

1894-0024

Agency:

ED/OS

Received:

2024-08-13

Concluded:

2024-10-10

Action:

Approved without change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Entry Evaluation & Exit Evidence Forms

Key Information

Abstract

ED will use the Entry Evidence ICR form and the Evaluation & Exit Evidence ICR form for discretionary grant programs that: (1) Use the standard ED 524-B Grant Performance Report form as approved by OMB. The use of the standard ED 524-B Grant Performance Report promotes the standardization and streamlining of ED discretionary grant performance reporting. These performance reporting components are necessary to standardize information collection about Entry evidence, and Evaluation & Exit evidence use in grant implementation and to ensure a better, more comprehensive understanding of the use of evidence from what is provided in a grant application to the actual implementation of the grant project.

Federal Register Notices

60-Day FRN
30-Day FRN

Presidential Action:

-

Title:

Carbon Dioxide Removal (CDR) Purchase Disclosures

Reference Number:

Omb Control Number:

1910-5209

Agency:

DOE/DOEOA

Received:

2024-08-12

Concluded:

2024-12-09

Action:

Approved with change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Carbon Dioxide Removal (CDR) Purchase Disclosures

Key Information

Abstract

The U.S. Department of Energy (DOE) seeks information about transactions involving carbon dioxide removal (CDR) services from organizations buying or facilitating these services. DOE will use information collected to administer its suite of CDR programs. This information collection request (ICR) will also serve as the application to join a specific program, the Voluntary CDR Purchasing Challenge (hereafter “Challenge”). DOE intends to publish some information collected to recognize participants in the Challenge using specific transactions. Respondents may be U.S. or international private or public sector organizations that purchase CDR services. Responses are voluntary but required to participate in the Challenge and potentially other future programs.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

Pub.L. 117 - 58 41005
42 USC 16298d

Presidential Action:

-

Title:

Quality Payment Program/Merit-Based Incentive Payment System (MIPS) Surveys and Feedback Collections (CMS-10695)

Reference Number:

Omb Control Number:

0938-1399

Agency:

HHS/CMS

Received:

2024-08-12

Concluded:

2024-11-15

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Quality Payment Program/Merit-Based Incentive Payment System (MIPS) Surveys and Feedback Collections (CMS-10695)

Key Information

Abstract

This generic clearance is for a program of survey and feedback collections supporting the Quality Payment Program which includes the Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (AAPMs). This clearance is necessary to enable CMS to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improve quality and reduce complexity and burden. The information collected from MIPS eligible clinicians, third-party intermediaries, Medicare beneficiaries, and any other audiences that would support CMS in improving MIPS or the Quality Payment Program will help ensure that all stakeholders have an effective and efficient experience. This feedback will help improve user experience, assess methods for simplifying participation including data submission, improve and enhance the utility of web-based tools, and increase the effectiveness of communication with stakeholders.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

42 USC 1395w-4(s)
Pub.L. 114 - 10 101
Pub.L. 114 - 255 4002(b)(1)(b)

Presidential Action:

-

Title:

Pre-Employment Medical and Driver Medical Evaluation Forms

Reference Number:

Omb Control Number:

-

Agency:

STATE/AFA

Received:

2024-08-12

Concluded:

None

Action:

None

Status:

Received in OIRA

Request Type:

New collection (Request for a new OMB Control Number)
Pre-Employment Medical and Driver Medical Evaluation Forms

Key Information

Abstract

This collection is necessary for the U.S. Department of State’s (DOS) Bureau of Medical Services (MED) to evaluate medical eligibility for employment and operating a government owned vehicle (GOV) overseas, and for gathering supplemental pertinent medical information regarding identified conditions that could pose a safety risk to employees and others.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

22 USC 4084
5 USC 552a

Presidential Action:

-

Title:

Industrial Capabilities Questionnaire

Reference Number:

Omb Control Number:

0704-0377

Agency:

DOD/DODDEP

Received:

2024-08-12

Concluded:

2024-10-30

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Industrial Capabilities Questionnaire

Key Information

Abstract

This information collection is necessary to provide the Department of Defense (DoD) with a vehicle to assess the current industrial base supporting DoD programs and to ensure that a diverse, healthy, and competitive industrial base exists and is capable of meeting current DoD demands and future mobilization requirements. Additionally, the information is required to perform industrial assessments as mandated by U.S. Code Title 10, Subtitle A, Part IV, Chapter 148, Subchapter II, “Policies and Planning.” The information also supports the development of a defense industrial base information system as required by Section 722 (“Defense Industrial Base System”) of the 1992 Defense Production Act, as amended, and Executive Order 12919, Part VIII, Section 802, “Defense Industrial Base Information System.”

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

Pub.L. 102 - 558 722
10 USC Chapter 148

Presidential Action:

-

Title:

Federal Post Card Application (FPCA)

Reference Number:

Omb Control Number:

0704-0503

Agency:

DOD/DODDEP

Received:

2024-08-12

Concluded:

2024-10-03

Action:

Approved with change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Federal Post Card Application (FPCA)

Key Information

Abstract

The Federal government neither collects nor retains any personal information associated with these forms. The burden for collecting this information resides with the States. The Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA), 52 U.S.C. 203, requires the Presidential designee (Secretary of Defense) to prescribe an official post card form, containing both an absentee voter registration application and an absentee ballot application, for use by the States who have the authority to collect personal information as part of the absentee voting process.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

52 USC 203

Presidential Action:

-

Title:

Federal Write-In Absentee Ballot (FWAB)

Reference Number:

Omb Control Number:

0704-0502

Agency:

DOD/DODDEP

Received:

2024-08-12

Concluded:

2024-10-03

Action:

Approved with change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Federal Write-In Absentee Ballot (FWAB)

Key Information

Abstract

The Uniformed and Overseas Citizens Absentee Voting Act(UOCAVA),42 USC 1973ff, requires the Presidential designee (SECDEF) to prescribe the Federal write-in absentee ballot for absent uniformed service voters and overseas voters in general elections for Federal office. The form serves as a backup ballot for voters who did not receive their State ballot with enough time to vote and return it to their local election official. The authority for the States to collect personal information comes from UOCAVA.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

52 USC 203

Presidential Action:

-

Title:

Federal Bureau of Investigation Hazardous Devices School Course Application (FD-731)

Reference Number:

Omb Control Number:

1110-0074

Agency:

DOJ/FBI

Received:

2024-08-09

Concluded:

2024-11-19

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Federal Bureau of Investigation Hazardous Devices School Course Application (FD-731)

Key Information

Abstract

DOJ's FBI HDS is requesting a PRA approval for a new collection utilized by HDS to collect information needed during a review process of the identification and qualification of prospective students, and to initiate a review of security clearance status prior to being granted access to law enforcement sensitive and classified facilities and information.

Federal Register Notices

60-Day FRN
30-Day FRN

Presidential Action:

-

Title:

Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8

Reference Number:

Omb Control Number:

0930-0206

Agency:

HHS/SAMHSA

Received:

2024-08-09

Concluded:

2024-09-11

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8

Key Information

Abstract

These regulations specify requirements for opioid treatment programs, which must apply for certification and adhere to recordkeeping, disclosure and reporting specifications. In addition, entities that wish to become accreditation bodies under the regulations must apply to and obtain approval from SAMHSA. Such bodies must develop and submit accreditation elements for SAMHSA acceptance. Upon designation as an accreditation body, entities must keep certain records of accreditation surveys and submit them to SAMHSA.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

42 USC 501

Presidential Action:

-

Title:

Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Reference Number:

Omb Control Number:

0910-0594

Agency:

HHS/FDA

Received:

2024-08-09

Concluded:

2025-03-13

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Key Information

Abstract

In the special control guidance document, FDA recommends that manufacturers include in their annual reports a summary of adverse reactions that are maintained by the collecting or transfusing facility or similar reports of adverse events collected in addition to those required under the MDR regulation. The reporting of adverse device events summarized in an annual report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported under the MDR regulation.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

21 USC 360
Pub.L. 101 - 629 104

Presidential Action:

-

Title:

Male Survivors of Sexual Assault – Investigating Challenges around seeking help (MOSAIC)

Reference Number:

Omb Control Number:

0703-0099

Agency:

DOD/NAVY

Received:

2024-08-09

Concluded:

2024-09-18

Action:

Approved with change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Male Survivors of Sexual Assault – Investigating Challenges around seeking help (MOSAIC)

Key Information

Abstract

Given the devastating effects of Military Sexual Trauma (MST) and limited information on male MST specifically, the U.S. Congress specified a requirement to improve the prevention of and response to sexual trauma affecting male service members in Section 538 of the National Defense Authorization Act for Fiscal Year 2016 (Pub. L. 114–92). Furthermore, the Department of Defense (DoD) developed a formalized plan of action to improve prevention and response efforts for male MST. Despite these efforts and consistent with prior research, DoD reports found that active duty men are substantially less likely to report MST relative to active duty women counterparts. As part of the DoD-wide effort to promote help-seeking for sexual assault survivors, the Department of Navy (DoN) Office of Force Resiliency (OFR) developed and recently updated the Prevention Plan of Action (aka Prevention Plan of Action 2.0, 2022-2024; PPoA 2.0). The PPoA 2.0 is a strategy framework leveraging public health science in military environments to prevent sexual assault in the military and improve response efforts. As part of this initiative, OFR commissioned this study (Agreement #NMR-24-11717) to investigate the help-seeking among men who experienced military sexual violence (i.e., sexual assault or sexual harassment). This study will address this requirement by conducting interviews with men who have experienced military sexual violence.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

Pub.L. 114 - 92 538

Presidential Action:

-
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