2014-27351. Agency Forms Undergoing Paperwork Reduction Act Review

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

Clinic Context Matters Study—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The daily use of specific antiretroviral medications by persons without HIV infection, but at high risk of sexual or injection exposure to HIV, has been shown to be a safe and effective HIV prevention method. The Food and Drug Administration approved the use of Truvada® for preexposure prophylaxis PrEP) in July 2012 and CDC has issued Public Health Service clinical practice guidelines for its use.

Because approximately 50,000 new HIV infections continue to occur in the U.S. each year, with rates of HIV infection increasing most rapidly for young MSM and because severe disparities in HIV infection continue among African-American men and women, incorporation of PrEP into HIV prevention is important. However, as a prevention tool in very early stages of introduction and use, there is much we need to learn about how to implement PrEP in real-world settings.

CDC is requesting OMB approval to collect data over a 3-year period that will be used to conduct research among clinicians about their knowledge, attitudes, and practices related to a new intervention (PrEP) over the period of its initial introduction in their clinics. The knowledge gained will be used to refine measurement instruments and methods (for example, identify modifications to questions in the current surveys that are unclear to participants), develop training and educational resources and tools for use by CDC/DHAP (Division of HIV/AIDS Prevention)-funded partners, and other organizations supporting delivery of PrEP in clinical settings. The project will be conducted in clinics in each of four cities (Houston, Newark, Chicago, and Philadelphia) where PrEP has recently become available at local community health centers. Once per year for 3 years, CDC will conduct an online survey of clinicians at participating clinics to collect data on the demographics of the respondents and their knowledge, attitudes, practices, and organizational factors related to PrEP and its delivery in their clinics. Surveys will be administered through an online survey Web site.

There are no costs to respondents other than their time. The total annual burden hours are 88.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average hours per response
Clinician	Clinician Consent and Interview	175	1	30/60

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.