2019-18659. Proposed Update of the CDC's 2006 Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is seeking public comment for updating the following guideline: Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings (2006). The purpose of this notice is to solicit feedback on best approaches on HIV screening in clinical settings and prompt linkage to treatment and care. CDC will update this guideline to ensure that HIV testing providers, public health agencies, and other stakeholders have access to up-to-date and consistent information about new evidence, current approaches, and resources for HIV testing in clinical settings.

DATES:

Written comments must be received on or before October 28, 2019.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2019-0069 by any of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.
• Mail: DHAP Guideline Team, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS D21, Atlanta, Georgia 30329.

Instructions: All submissions must include the agency name and Docket Number. All relevant comments received will be posted without change to https://www.regulations.gov,, including any personal information provided. For access to the docket to read background documents or comments received, go to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Priya Jakhmola, Health Scientist, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D21, Atlanta, Georgia 30329. Telephone: [phone], Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Public Participation

Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. In addition, CDC invites comments specifically on opt-out routine HIV testing, including, but not limited to:

• Suggestions for revisions, edits, and new additions
• Contemporary issues and new evidence
• Implementation barriers, challenges, and lessons learned
• Examples of innovative models, partnerships, and collaborations

Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information, inappropriate language, or examples of a mass-mail campaign. CDC will carefully consider all comments submitted in preparation of the final document and may revise the final document as appropriate.

Background

The CDC guideline “Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings” was published on September 22, 2006 in CDC's Morbidity and Mortality Weekly Report (MMWR). Since then, there have been changes in evidence related to HIV testing technologies and interventions, disease epidemiology, outcomes, implementation resources, and related guidelines. This evidence will be identified, assessed, and analyzed to inform the update.

CDC will update the 2006 Guidelines based on input from subject matter experts, public health agencies, the public, and other stakeholders. The guideline development process will draw on up-to-date nationally and internationally accepted guideline development criteria, tools, and resources, including CDC guideline development standards. The process will include a rigorous systematic review of key questions formulated through the PICO (Patient-Intervention-Comparator-Outcome) method. PICO is the foundation of an evidence-based process and facilitates the search for relevant evidence by identifying key concepts and formulating a search strategy. Graded recommendations will be developed using quality and strength of underlying evidence.

Throughout the process of updating the guideline, there will be multiple opportunities for the public to comment on the drafts. We welcome input from a diverse range of perspectives, which will inform the development of the guideline, improve its credibility, and increase the transparency of the process.

Dated: August 26, 2019.

Sandra Cashman,

Executive Secretary, Centers for Disease Control and Prevention.