Summary of Proposed Changes (25CG)

Summary of Proposed Changes in Data Collection Instruments for the

National HIV Surveillance System (NHSS) OMB # 0920-0573

Summary of Changes

We are requesting a non-substantial change to the information collection request (ICR) for the National HIV Surveillance System (NHSS) OMB #0920-0573. Specifically, we are requesting modifications to the Pediatric Case Report Form (PCRF). In January 2023, the US Department of Health and Human Services updated their guidelines on infant feeding among people with HIV, to include the shared decision making between a provider and the birthing person, regarding feeding of the infant. The new guidelines include supporting birthing persons with HIV who are on ART with a sustained undetectable viral load and choose to breastfeed/chestfeed their infant. Breastfeeding or chestfeeding of an infant, by a birthing person living with HIV, could result in an extended exposure period of HIV to the infant. To capture the extended exposure period, we must collect the start and stop dates of breastfeeding/chestfeeding. The PCRF includes the approved variable “Child breastfed/chestfed by birthing person”. Our request is to add a Start Date and Stop Date following this variable. Specific changes are outlined in Table 1 and a file with PCRF changes tracked is attached. The final version of the PCRF with the added date field change accepted, as well as the proposed updates to form instructions in the technical guidance for the PCRF with changes tracked and accepted are also attached. The proposed addition of the two date variables is within the scope of the already approved data element, “Child breastfed/chestfed by birthing person” and will not result in additional abstraction time from the medical record. These additions will not result in any changes to the burden estimate for the PCRF or the overall burden estimate for this ICR. We plan to begin data collection and implement these changes in the eHARS reporting software in July of 2025.

Table 1. PCRF Changes

Form, Page, Section, Question/Field	Change Proposed	Reason for Change Proposed
PCRF Page 2 of 6	Addition of “Start Date” and “Stop Date” in MM/DD/YYYY format for the previously established question “Child breastfed/chestfed by birthing person”	Start and Stop date of breastfeeding/chestfeeding of an infant will allow for calculation of a prolonged exposure period of the infant to HIV. The stop date will be used to initiate a follow-up time period to capture laboratory tests on the infant to determine final HIV status.

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