Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Institutional Review Board Authorization Agreement for Human Research” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on October 30, 2023, to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Institutional Review Board Authorization Agreement for Human Research—New—Office of Science (OS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The CDC Human Research Protection Office (HRPO) often receives requests from outside institutions seeking to rely on the CDC Institutional Review Board (IRB) for review of a research study. This arrangement also allows multiple institutions to use, or rely on, the CDC IRB for centralized review and approval of research studies instead of review by the site-specific IRBs, which helps reduce duplication of effort, delays, and expenses. To meet regulatory requirements, institutions that elect to rely on the CDC IRB are required to complete a CDC IRB Authorization Agreement for Human Research and a Local Context Survey. The goal is to use the agreement and survey to provide regulatory oversight for human subjects research, to maintain records, and to track those institutions that have elected to rely on the CDC IRB for review.

CDC requests OMB approval for an estimated 450 annual burden hours. There is no cost to respondents other than their time to participate.