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 15496 results

CSV Download

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

Title:

Forest Service Law Enforcement and Investigations Ride-Along Program

Reference Number:

Omb Control Number:

0596-0170

Agency:

USDA/FS

Received:

2023-07-17

Concluded:

2023-07-18

Action:

Approved with change

Status:

Active

Request Type:

Revision of a currently approved collection
Forest Service Law Enforcement and Investigations Ride-Along Program

Key Information

Abstract

The information collection is voluntary and submitted by the public as an application to participate as a Ride-along with a USDA-Forest Service law enforcement officer or agent.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

16 USC 551

Presidential Action:

-

Title:

Loans to Plan Participants and Beneficiaries Who Are Parties in Interest with Respect to the Plan Regulation

Reference Number:

Omb Control Number:

1210-0076

Agency:

DOL/EBSA

Received:

2023-07-17

Concluded:

2023-08-23

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Loans to Plan Participants and Beneficiaries Who Are Parties in Interest with Respect to the Plan Regulation

Key Information

Abstract

Section 408(b)(1)(C) of ERISA requires plan loans to be made in accordance with specific provisions set forth in the plan document. The Department's regulation at 29 CFR 2550.408b-1(d) prescribes eight specific provisions that must be included in the plan documents, including: (1) an explicit authorization for the plan fiduciary responsible for investing plan assets to establish such a loan program; (2) the identity of the person or position authorized to administer the program; (3) a procedure for applying for loans; (4) the basis on which loans will be approved or denied; (5) limitations (if any) on the types and amounts of loans offered; (6) the procedure for determining a reasonable rate of interest; (7) types of collateral that may secure a participant loan; and (8) the events constituting default and the steps that will be taken to preserve plan assets in the event of such default. The collected information will be used by plan participants and beneficiaries wishing to obtain plan loans. It also will be used by plan administrators in administering their plans' loan program. The Department also will use the information in any enforcement proceedings regarding plan loans.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

29 USC 1108

Presidential Action:

-

Title:

Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Reference Number:

Omb Control Number:

3084-0159

Agency:

FTC

Received:

2023-07-17

Concluded:

2023-08-29

Action:

Approved with change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Key Information

Abstract

The FTC requests renewed OMB approval for the generic clearance to collect qualitative feedback from the public regarding agency service delivery.

Federal Register Notices

60-Day FRN
30-Day FRN

Presidential Action:

-

Title:

Procedures for Monitoring Bank Secrecy Act Compliance

Reference Number:

Omb Control Number:

3064-0087

Agency:

FDIC

Received:

2023-07-17

Concluded:

2023-10-11

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Procedures for Monitoring Bank Secrecy Act Compliance

Key Information

Abstract

All insured state nonmember banks must establish and maintain procedures designed to assure and monitor their compliance with the requirements of the Bank Secrecy Act (31 USC 5311 et seq.) and the Department of Treasury's implementing regulations at 31 CFR 103.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

12 USC 1818(s)
31 USC 5311
12 USC 5301 et seq.

Presidential Action:

-

Title:

Form N-PX under the Investment Company Act of 1940, Annual Report of Proxy Voting Record

Reference Number:

Omb Control Number:

3235-0582

Agency:

SEC

Received:

2023-07-14

Concluded:

2023-09-25

Action:

Approved with change

Status:

Active

Request Type:

Revision of a currently approved collection
Form N-PX under the Investment Company Act of 1940, Annual Report of Proxy Voting Record

Key Information

Abstract

Registered management investment companies use Form N-PX to file annual reports with the Commission containing their complete proxy voting record for the most recent twelve-month period ended June 30. Institutional investment managers also use Form N-PX to file annual reports with the Commission containing their executive compensation proxy voting record.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

15 USC 78n-1
15 USC 80a-29

Presidential Action:

-

Title:

Voluntary Prelisting Conservation Actions

Reference Number:

Omb Control Number:

1018-0177

Agency:

DOI/FWS

Received:

2023-07-14

Concluded:

2024-05-03

Action:

Approved with change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Voluntary Prelisting Conservation Actions

Key Information

Abstract

The U.S. Fish and Wildlife Service (we, Service) is charged with implementing the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.) (Act). The goal of the Act is to provide a means to conserve the ecosystems upon which listed species depend and a program for listed species conservation. Through our Candidate Conservation Program, we encourage the public to take conservation actions for species prior to them being listed under the Act. Doing so may result in precluding the need to list a species, may result in listing a species as threatened instead of endangered, or, if a species becomes listed, may provide the basis for its recovery and eventual removal from the protections of the Act.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

16 USC 1531 et seq

Presidential Action:

-

Title:

Sections 90.1207(e)–(f), Amendment of Part 90 of the Commission's Rules

Reference Number:

Omb Control Number:

3060-1312

Agency:

FCC

Received:

2023-07-14

Concluded:

2023-09-07

Action:

Approved without change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Sections 90.1207(e)–(f), Amendment of Part 90 of the Commission's Rules

Key Information

Abstract

New Sections 90.1207(e) and (f) of the Commission’s rules require incumbent public safety licensees and public safety applicants in the 4940-4990 MHz (4.9 GHz) band to submit granular technical data into the Commission’s Universal Licensing System (ULS).

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

47 USC 154(i), 161, 303(g), 303(r)
47 USC 332(c)(7), 1401-1473

Presidential Action:

-

Title:

Petitions for Declaratory Order

Reference Number:

Omb Control Number:

2140-0031

Agency:

STB

Received:

2023-07-14

Concluded:

2023-12-06

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Petitions for Declaratory Order

Key Information

Abstract

Congress provided the Board with the ability to terminate controversy and remove uncertainty in matters that arise under the Interstate Commerce Act, 49 U.S.C. §§ 10101-16106 (ICA) or corresponding regulations. Under this authority, the Board allows persons to seek declaratory orders before the Board for a broad range of issues under the ICA.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

5 USC 554(e)
49 USC 1321

Presidential Action:

-

Title:

Form N-CSR under the Securities Exchange Act of 1934 and under the Investment Company Act of 1940, Certified Shareholder Report of Registered Management Investment Companies

Reference Number:

Omb Control Number:

3235-0570

Agency:

SEC

Received:

2023-07-14

Concluded:

2023-09-25

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Form N-CSR under the Securities Exchange Act of 1934 and under the Investment Company Act of 1940, Certified Shareholder Report of Registered Management Investment Companies

Key Information

Abstract

Form N-CSR is a combined reporting form used by management investment companies to file certified shareholder reports under the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.) ("Investment Company Act") and under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (Securities Exchange Act"). Form N-CSR is to be used for reports under section 30(b)(2) of the Investment Company Act and section 13(a) or 15(d) of the Securities Exchange Act, filed pursuant to rule 30b2-1(a) under the Investment Company Act (17 CFR 270.30b2-1(a)).The information provided on Form N-CSR may be used by the Commission in its regulatory disclosure review, inspection, and policymaking roles. The information filed with the Commission also permits the verification of compliance with securities law requirements and assures the public availability and dissemination of the information. On May 3, 2023, the Commission adopted amendments to modernize and improve the disclosure requirements, including those pursuant to Form N-CSR, for repurchases of an issuer’s equity securities that are registered under the Securities Exchange Act.

Federal Register Notices

60-Day FRN

Authorizing Statutes

15 USC 78m
15 USC 78o
15 USC 80a-29

Presidential Action:

-

Title:

Report of Fuel Cost, Consumption, and Surcharge Revenue

Reference Number:

Omb Control Number:

2140-0014

Agency:

STB

Received:

2023-07-14

Concluded:

2023-08-28

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Report of Fuel Cost, Consumption, and Surcharge Revenue

Key Information

Abstract

The Board requires all Class I railroads (defined as carriers having revenues in excess of $250 million in 1991 dollars) to report quarterly the following: (1) total monthly fuel cost; (2) gallons of fuel consumed during the month; (3) increased or decreased cost of fuel over the previous month; (4) total monthly revenue from fuel surcharges; and (5) total monthly revenue from fuel surcharges on regulated traffic only. The Board has authority to collect information about rail costs and revenues under 49 U.S.C. 11144 and 11145.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

49 USC 11144, 11145

Presidential Action:

-

Title:

Dispute Resolution Procedures

Reference Number:

Omb Control Number:

2140-0036

Agency:

STB

Received:

2023-07-14

Concluded:

2023-08-28

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Dispute Resolution Procedures

Key Information

Abstract

Under 49 CFR 1109, parties to a dispute involving the State-Sponsored Route Committee or the Northeast Corridor Committee may request the Board’s informal assistance in securing outside professional mediation services.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

Pub.L. 114 - 94 11204

Presidential Action:

-

Title:

Guidance for the Tribal Temporary Assistance for Needy Families (TANF) Program

Reference Number:

Omb Control Number:

0970-0157

Agency:

HHS/ACF

Received:

2023-07-14

Concluded:

2023-08-23

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Guidance for the Tribal Temporary Assistance for Needy Families (TANF) Program

Key Information

Abstract

42 U.S.C. 612 (section 412 of the Social Security Act) requires each Indian tribe that elects to administer and operate a TANF program to submit a Tribal Family Assistance Plan (TFAP). The TFAP is a mandatory statement submitted to the Secretary by the Indian tribe, which consists of an outline of how the Indian tribe's TANF program will be administered and operated. It is used by the Secretary to determine whether the TFAP is approvable and to determine that the Indian tribe is eligible to receive a TANF assistance grant. It is also made available to the public. Requirements for the content of the TFAP can be found in the Code of Federal Regulations at 45 CFR 286.70.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

42 USC 612

Presidential Action:

-

Title:

FERC-510, Application for Surrender of Hydropower License

Reference Number:

Omb Control Number:

1902-0068

Agency:

FERC

Received:

2023-07-14

Concluded:

2024-03-06

Action:

Approved with change

Status:

Active

Request Type:

Extension without change of a currently approved collection
FERC-510, Application for Surrender of Hydropower License

Key Information

Abstract

The Commission is responsible for licensing non-federal hydropower projects if they are on lands or waters subject to Congressional authority. Part I of the Federal Power Act (FPA) gives the Commission the authority to issue licenses for hydroelectric projects on these waters. The Commission issues licenses for terms of up to 50 years that best adapted to a comprehensive plan for improving or developing a waterway or for the use or benefit of interstate or foreign commerce. Licenses are also issued for the improvement and utilization of waterpower development; for the adequate protection, mitigation, and enhancement of fish and wildlife; and for other beneficial public uses, including irrigation, flood control, water supply, recreation. Licenses may be surrendered, but only after the licensee fulfills all obligations of the license and any conditions imposed by the Commission necessary to protect dam safety, public safety and environmental resources. The Commission often needs certain information from the licensee in order to determine the conditions under which a surrender application can be granted.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

16 USC sections 791 et. seq.

Presidential Action:

-

Title:

Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization Model Process and Requirements (CMS-10708)

Reference Number:

Omb Control Number:

0938-1380

Agency:

HHS/CMS

Received:

2023-07-14

Concluded:

2024-04-02

Action:

Approved with change

Status:

Active

Request Type:

Revision of a currently approved collection
Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization Model Process and Requirements (CMS-10708)

Key Information

Abstract

The Centers for Medicare & Medicaid Services (CMS) is currently testing the Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization Model, in limited states, under the authority of section 1115A of the Social Security Act (the Act). Section 515(b) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) added paragraph (16) to section 1834(l) of the Act, which requires that, beginning January 1, 2017, the Secretary expand the model to all states if the model expansion meets certain statutory requirements for expanding models that are tested by the Center for Medicare and Medicaid Innovation (Innovation Center) under the authority of section 1115A of the Act. The expansion criteria, described in paragraphs (1) through (3) of section 1115A(c) of the Act, require that; (1) the Secretary determines that such expansion is expected to—(A) reduce spending under applicable title without reducing the quality of care; or (B) improve the quality of patient care without increasing spending; and (2) the Chief Actuary of the Centers for Medicare & Medicaid Services certifies that such expansion would reduce (or would not result in any increase in) net program spending under applicable titles; and (3) the Secretary determines that such expansion would not deny or limit the coverage or provision of benefits under the applicable title for applicable individuals. Because section 1834(l)(16) of the Act requires the Secretary to expand the RSNAT Prior Authorization Model to all States if it meets the statutory expansion criterial in 1115A(c)(1 through 3) of the Act, the exemption from Paperwork Reduction Act (PRA) process in 1115A(d)(3) is not applicable for the purposes of the nationwide expansion of this model. Therefore, in order to move forward with potential nationwide expansion, contingent on the Secretary’s determination that the expansion criteria are met, CMS must complete the PRA approval process, as required by chapter 35 of title 44, United States Code. As part of the process for working towards potential expansion of the RSNAT Prior Authorization Model under section 1834(1)(16) of the Act, CMS is seeking approval for the collection of information under PRA.

Federal Register Notices

60-Day FRN
30-Day FRN

Presidential Action:

-

Title:

Application for Federally Supported Health Centers Assistance Act (FSHCAA) / Federal Tort Claims Act (FTCA) Particularized Determination of Coverage

Reference Number:

Omb Control Number:

0906-0077

Agency:

HHS/HRSA

Received:

2023-07-14

Concluded:

2023-11-27

Action:

Approved without change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Application for Federally Supported Health Centers Assistance Act (FSHCAA) / Federal Tort Claims Act (FTCA) Particularized Determination of Coverage

Key Information

Abstract

The FTCA Program uses a web-based application system within HRSA’s Electronic Handbooks (EHBs) system for deeming applications. These electronic application forms decrease the time and effort required to complete the older, paper-based approved deeming application forms. HRSA is proposing a new paper application that will be transitioned into an electronic application within the EHB system for Particularized Determinations (PD). PDs extend liability protections under FSCHAA, including FTCA coverage, for certain medical services provided to individuals who are not patients of a covered entity. This application will help ensure health centers provide all the necessary information required to make determinations appropriately and efficiently in response to their requests. By including the application within the EHBs, health centers will have access to all information from prior applications and have that information readily available if making future requests. The paper form of the application is an interim solution to support health centers until the electronic application becomes available in the FTCA module of the EHBs. After the electronic application is available in the EHBs, all PD requests will be submitted electronically, and the paper application will no longer be used for submissions.

Federal Register Notices

60-Day FRN
30-Day FRN

Presidential Action:

-

Title:

Prohibited Transaction Class Exemption 1985-68 to Permit Employee Benefit Plans to Invest in Customer Notes of Employers

Reference Number:

Omb Control Number:

1210-0094

Agency:

DOL/EBSA

Received:

2023-07-14

Concluded:

2023-08-23

Action:

Approved with change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Prohibited Transaction Class Exemption 1985-68 to Permit Employee Benefit Plans to Invest in Customer Notes of Employers

Key Information

Abstract

This class exemption, which was granted on April 3, 1985, and replaced Prohibited Transaction Exemption 79-9, describes the conditions under which a plan is permitted to acquire customer notes accepted by an employer of employees covered by the plan in the ordinary course of the employer’s business activity and thus be exempt from the prohibited transaction restrictions, provided that the conditions of the exemption are met. The class exemption covers sales as well as contributions of customer notes by an employer to its plan. The customer notes must have been accepted by the employer in its primary business activity as the seller of tangible personal property that is being financed by the notes, so that the exemption does not apply to notes of an employer’s affiliate. In order to ensure that the class exemption is not abused, that the rights of the participants and beneficiaries are protected, and that the exemption’s conditions are being complied with, the Department of Labor often requires minimal information collection pertaining to the affected transactions.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

29 USC 1108

Presidential Action:

-

Title:

Education Award Transfer Forms

Reference Number:

Omb Control Number:

3045-0136

Agency:

CNCS

Received:

2023-07-14

Concluded:

2023-08-30

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Education Award Transfer Forms

Key Information

Abstract

This information collection consists of the questions members answer to request a transfer of their education award or revoke a transfer, and recipients answer to accept or decline the transfer or rescind their acceptance. The information collected identifies those qualified to transfer their award, the transfer award amount, and those qualified to receive the award transfer, as well as establish a trust account for the transfer recipient. The revision is being requested because the regulations are being revised to clarify that an award may be transferred to no more than two individuals, that a transfer may be declined in part of in full or revoked in part or in full, and to allow for re-transfer without obtaining a waiver.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

42 USC 12501 et seq.

Presidential Action:

-

Title:

Catch-all Petitions

Reference Number:

Omb Control Number:

2140-0030

Agency:

STB

Received:

2023-07-14

Concluded:

2023-12-06

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Catch-all Petitions

Key Information

Abstract

Congress provided the Board with the ability to adjudicate matters that arise under the Interstate Commerce Act, 49 U.S.C. §§ 10101-16106 (ICA) or corresponding regulations. Among those matters, the Board's regulations provide for a catch-all petition, 49 C.F.R. § 1117, under which persons may seek to make requests or claims not otherwise specifically provided for under the Board's other regulations but within the Board's jurisdiction under the ICA.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

49 USC 1321

Presidential Action:

-

Title:

Section 90.175(g)(2), Amendment of Part 90 of the Commission's Rules

Reference Number:

Omb Control Number:

3060-1313

Agency:

FCC

Received:

2023-07-14

Concluded:

2023-09-07

Action:

Approved without change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Section 90.175(g)(2), Amendment of Part 90 of the Commission's Rules

Key Information

Abstract

New Section 90.175(g)(2) of the Commission’s rules requires public safety applicants seeking to license new or modify existing facilities in the 4940-4990 MHz (4.9 GHz) band to obtain a frequency recommendation from the newly established nationwide Band Manager before the application is filed with the Commission.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

47 USC 154(i), 161, 303(g), 303(r)
47 USC 332(c)(7), 1401-1473

Presidential Action:

-

Title:

Sections 74.165, 74.432 and 74.832, Filing of Station Licenses

Reference Number:

Omb Control Number:

3060-0633

Agency:

FCC

Received:

2023-07-14

Concluded:

2023-09-07

Action:

Approved without change

Status:

Active

Request Type:

Revision of a currently approved collection
Sections 74.165, 74.432 and 74.832, Filing of Station Licenses

Key Information

Abstract

The Commission released a Report and Order, Amendment of Parts 0, 1, 5, 73, and 74 of the Commission’s Rules Regarding Posting of Station Licenses and Related Information, MB Docket No. 18-121, FCC 18-174, on December 11, 2018. In this Report and Order, the Commission eliminated rule sections 47 CFR Sections 73.1230, 74.564, 74.664, 74.765 and 74.1265 to remove the posting information requirements from the Commission’s rules. This collection is being revised to remove these rule sections from this information collection. Also, the posting information requirements are being removed from Sections 74.432 and 74.832 with this revision to the Office of Management and Budget. The remaining information collection requirements for this collection are as follows: 47 CFR 74.165 requires that the instrument of authorization for an experimental broadcast station be available at the transmitter site. 47 CFR 74.432(j) requires that the license of a remote pickup broadcast/low power auxiliary station shall be retained in the licensee's files and the address shown on the authorization. 47 CFR 74.832(j) (low power auxiliary stations) requires that the license shall be retained in the licensee’s files at the address shown on the authorization.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

47 USC 154

Presidential Action:

-

Title:

Request for Title IV Reimbursement or Heightened Cash Monitoring 2 (HCM2)

Reference Number:

Omb Control Number:

1845-0089

Agency:

ED/FSA

Received:

2023-07-13

Concluded:

2023-09-25

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Request for Title IV Reimbursement or Heightened Cash Monitoring 2 (HCM2)

Key Information

Abstract

34 CFR Part 668—Student Assistance General Provisions, Subpart K—Cash Management (§668.162) establishes the rules and procedures for a participating institution to request, maintain, disburse, and manage the Title IV (TIV) program funds. Institutions must complete and submit a Form 270 to request TIV program funds while participating under the Reimbursement and Heightened Cash Monitoring payment methods as explained in §668.162(c) and (d). We are requesting an extension of the currently approved information collection. There have been no changes to the information requested or the form since its prior approval in September 2020.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

20 USC 1094

Presidential Action:

-

Title:

Administration of U.S. Fish and Wildlife Service Investigational New Animal Drug (INAD) Program

Reference Number:

Omb Control Number:

1018-0201

Agency:

DOI/FWS

Received:

2023-07-13

Concluded:

2024-11-14

Action:

Approved without change

Status:

Active

Request Type:

Existing collection in use without an OMB Control Number
Administration of U.S. Fish and Wildlife Service Investigational New Animal Drug (INAD) Program

Key Information

Abstract

The Aquatic Animal Drug Approval Partnership (AADAP) Program is part of the Fish and Aquatic Conservation fish health network, operating under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA; 21 U.S.C. 360b(j)) which permits the use of an investigational new animal drug to generate data to support a NADA approval, is part of the Fish and Aquatic Conservation fish health network. It is the only program in the United States singularly dedicated to obtaining U. S. Food and Drug Administration (FDA) approval of new medications needed for use in fish culture and fisheries management. Ultimately, the AADAP program allows fisheries professionals to more effectively and efficiently rear and manage a variety of fish species to meet production goals, stock healthy fish, and maintain a healthy environment. In order for participants (U.S. aquaculture facilities or researchers) to be able to use an unapproved drug under AADAP’s National Investigational New Animal Drug (INAD) Program, they need to follow the FDA-approved study protocol(s) and submit the required data forms, including the INAD treatment data, to AADAP’s INAD Program. Data collection is required by the FDA under the following regulations: • 21 CFR part 511 (New Animal Drugs for Investigational Use) and • 21 CFR part 514, Subpart A (514.1 - 514.15, New Animal Drug Applications, General Provisions).

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

21 USC 360b(j)

Presidential Action:

-

Title:

Application for Extension of Time to Furnish Recipient Statements (Form 15397)

Reference Number:

Omb Control Number:

1545-2313

Agency:

TREAS/IRS

Received:

2023-07-13

Concluded:

2023-10-26

Action:

Approved without change

Status:

Active

Request Type:

New collection (Request for a new OMB Control Number)
Application for Extension of Time to Furnish Recipient Statements (Form 15397)

Key Information

Abstract

The Secretary may grant an extension of time in which to furnish to employees/contractors the statements required by law. Currently, regulations allow the taxpayer to request an extension of time via letter, however, no official form exists for taxpayers to submit a request for the extension of time to furnish statements to recipients. This form provides taxpayers with more structure which will result in faster processing.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

26 USC 31.6051-1

Presidential Action:

-

Title:

Suspicious Activity Reporting Using the Protected Web Server

Reference Number:

Omb Control Number:

3150-0219

Agency:

NRC

Received:

2023-07-13

Concluded:

2023-11-20

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Suspicious Activity Reporting Using the Protected Web Server

Key Information

Abstract

The NRC licensees voluntarily report information on suspicious incidents on an ad-hoc basis, as these incidents occur. This information is shared with authorized nuclear industry officials and Federal, State, and local government agencies using PWS. Information provided by licensees is considered OFFICIAL USE ONLY and is not made public.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

Pub.L. 83 - 103 1-311

Presidential Action:

-

Title:

Human Cells, Tissues, and Cellular and Tissue-Based Products

Reference Number:

Omb Control Number:

0910-0543

Agency:

HHS/FDA

Received:

2023-07-13

Concluded:

2023-08-14

Action:

Approved without change

Status:

Active

Request Type:

Extension without change of a currently approved collection
Human Cells, Tissues, and Cellular and Tissue-Based Products

Key Information

Abstract

The information collection supports agency regulations regarding eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Respondents to the collection are manufacturers of these products subject to public health protection provisions under the Federal Food, Drug, and Cosmetic Act.

Federal Register Notices

60-Day FRN
30-Day FRN

Authorizing Statutes

42 USC 264

Presidential Action:

-
Subscribe