Change Request

Summary of Proposed Changes in the ICR for the

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

October 18, 2019

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 a non-substantial change to the Standards Evaluation Report (SER) as provided in Attachment 1 and the specific changes are outlined in Table 1. The changes are related to the transition from cooperative agreement PS13-1302 to cooperative agreement PS18-1802 and automation of processes and outcome measures that were previously captured manually. The proposed form will be provided to jurisdictions in January 2019 to report their 2017 outcomes. These changes will result in fewer overall questions. However, we estimate the burden to complete the new SER remain unchanged and take one work day (approximately 8 hours) to complete. Therefore no changes to the burden table are requested. The current burden table for this ICR (with no changes) is provided in Exhibit 12.A. The revised SER in Attachment 1 replaces Attachment 3e in our current ICR. There are no changes to Supporting Statement A.

Table 1. Summary of Changes to the Standards Evaluation Report (SER)

OMB Form 0920-0573	New Proposed Form	Changed Proposed	Reason for Change Proposed
Page 1. Death Ascertainment	Page 1. Death Ascertainment	Removed “All Results Loaded in eHARS?” and “Results Loaded Manually or Imported” columns. Condensed tables associated with questions 1 and 2 on the old form to a single table on the new form.	Developed automated programs to answer the two questions removed to reduce burden.
Page 2. Routine Interstate Duplicate Review (RIDR)	NA	Removed this entire section.	Developed automated programs to compute these outcome measures to reduce burden. See page 4 of the new proposed form where the jurisdiction just reports the result of the automated program.
Page 3. Laboratory	Page 1. Laboratory	Combined questions 3 and 4 on the old form into a single question 3 on the new form. By combining them we reduced the number of follow-up questions from 9 to 4 (see bullet points under questions). Previously if they answered “Yes” to either question they had to answer up to 8 additional questions and, if “No”, 1 additional question. On the new form if they answer “Yes” there are only 3 additional questions and, if “No”, 1 additional question.	Reduce repetition and reduce burden.
Page 8. Part 4. Perinatal HIV Exposure Surveillance	Page 3. Pediatric/ Perinatal	Changed the 2 questions.	Re-alignment with the requirements of the new cooperative agreement PS18-1802.
Page 9. PART 5. Geocoding and Data Linkage (GDL)	NA	Removed this entire section	Developed automated programs to compute these outcome measures to reduce burden.
NA	Page 3. Cluster Detection and Response	Added 3 checkbox questions about maintaining an outbreak detection and response plan, analyzing molecular data and conducting time-space analyses.	Requirement of the new cooperative agreement PS18-1802
Page 5. Submission of Required SAS Outcome Tables	Page 4. Submission of Required SAS Outcome Tables	Increased the number of automated tables to be submitted from 5 sets to 7 sets (see the beginning of Section E checkboxes that confirm they have attached tables).	Developed automated programs noted on lines 1 and 2 above and automated 7 new outcome measures that are requirements of the new cooperative agreement PS18-1802. These tables run automatically with CDC developed software thus increase jurisdiction burden very little.
Page 5. Population of Outcomes Standard Results Table from SAS Outcome Tables	Page 4. Population of Outcomes Standard Results Table from SAS Outcome Tables	As noted above, the third “Measure” (RIDR) was added because the outcome was automated and they only need to report the result. Five new outcome measures were added at the bottom of the table and are all obtained from automated tables.	Developed automated programs to compute these outcome measures to reduce burden. The last five measures in the tables are requirements of the new cooperative agreement PS18-1802.
Page 5. Data Reporting and Dissemination	Page 5. Data Reporting and Dissemination	Broke this out from Outcome Measures table. There are no changes to the questions.	Improved readability and document flow.
Page 5. Security and Confidentiality	Page 6. Security and Confidentiality	The first four questions remain the same on both documents. Added 5 checkbox questions below them related to guideline for sub-contractors, procedures for secure data sharing with internal and external partners, and data breaches.	Expanded data sharing due to requirements of the new cooperative agreement PS18-1802 necessitate broadening questions to include partners and breaches.
Page 6. Part 2. Process and Outcomes Standards for HIV Incidence Surveillance	NA	Removed this entire section.	No longer a requirement under the new cooperative agreement PS18-1802.
Page 7. Part 3. Molecular HIV Surveillance (MHS)	NA	Removed this entire section.	The two outcome measures associated with this activity now run automatically with CDC developed software and are collected on page 5 of the new proposed form. See Measures titled “Nucleotide Sequence” and “Antiretroviral History”.

Exhibit 12.A Estimates of Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Total No. of Annual Responses	Avg. Burden per Response (in hours)	Total Annual Burden (in hours)
Health Departments	Adult HIV Case Report(att 3a,3c,4a)	59	1,061	62,599	20/60	20,866
Health Departments	Pediatric HIV Case Report (att 3b,3c,4b)	59	5	295	20/60	98
Health Departments	Case Report Evaluations (att 3a,3b,3c)	59	107	6,313	20/60	2,104
Health Departments	Case Report Updates (att 3a,3b,3c,4a,4b)	59	1,576	92,984	2/60	3,099
Health Departments	Laboratory Updates (att 3a,3b,3c,4a,4b)	59	6,303	371,877	1/60	6,198
Health Departments	HIV Incidence Surveillance (HIS) (att 3a,3c,4c)	25	2,288	57,200	10/60	9,533
Health Departments	Molecular HIV Surveillance (MHS) (att 3a,3b,3c, 4a,4d)	53	829	43,937	5/60	3,661
Health Departments	Perinatal HIV Exposure Reporting (PHER) (att 3c,3d,4b)	35	114	3,990	30/60	1,995
Health Departments	Annual Reporting: Standards Evaluation Report (SER)(att 3e)	59	1	59	8	472
Total						48,026

Note: The estimates of total annualized burden hours are based on the estimated total number of case reports (i.e., Total No. Annual Responses) expected to be completed by state and local health departments each year (see narrative for description).

Attachment 1. 2019 Standards Evaluation Report (SER)