2015-03244. Proposed Data Collections Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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 [phone] or send an email to [e-mail]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Assisted Reproductive Technology (ART) Program Reporting System (OMB No. 0920-0556, expires 8/31/2015)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Section 2(a) of Public Law 102-493 (known as the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-1(a)), requires that each assisted reproductive technology (ART) program shall annually report to the Secretary through the Centers for Disease Control and Prevention: (1) pregnancy success rates achieved by such ART program, and (2) the identity of each embryo laboratory used by such ART program and whether the laboratory is certified or has applied for such certification under the Act. Information is transmitted to CDC electronically through the Web-based National ART Surveillance System (NASS) or NASS-compatible files extracted from other record systems. CDC requests OMB approval to continue information collection for three years, with changes that will be phased in during this period.

Information collection will continue under currently approved procedures through December 31, 2015. Revised reporting requirements are planned for ART cycles initiated on or after January 1, 2016. The proposed changes reflect CDC's ongoing dialogue with subject matter experts including partner organizations and the data collection contractor. These consultations identify changes to the NASS data elements that are essential to keep pace with changes in medical practice and other opportunities for improvement. The proposed changes to the NASS data elements will ensure that reported success rates reflect standardized data definitions and provide additional insight into factors that may affect success rates. Concurrent with changes to data elements, the NASS data entry pages will be redesigned for more intuitive grouping of data items and improved skip logic that will route users to the minimum number of applicable questions. Finally, CDC will continue to collect feedback from ART clinics on NASS reporting procedures. Participation in the brief Feedback Survey is voluntary and is not required by the FCSRCA.

During the period of this Revision, estimated annualized burden will increase due to an anticipated increase in the number of responding clinics, an anticipated increase in the average number of ART cycles reported by each clinic, and a modest increase in the estimated burden per response for reporting each ART cycle. The Revision request also includes a one-time allocation of 40 burden hours per clinic. This allocation acknowledges the time needed to deploy the updated NASS platform and train staff on revised reporting requirements.

The collection of ART cycle information allows CDC to publish an annual report to Congress as specified by the FCSRCA and to provide information needed by consumers. Overall, the proposed changes will support CDC's ability to generate timely, accurate, and relevant information about fertility clinic success rates and improve user satisfaction with the NASS interface.

OMB approval is requested for three years. The total estimated annualized burden hours are 116,425. There are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Respondents	Form name	Number of respondents	Average number of responses per respondent	Average burden per response (in hours)
ART Clinics	NASS	447	353	42/60
	Feedback Survey	335	1	2/60
	One-time System Deployment	149	1	40

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.