View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-1080
ICR Reference No:
202011-0920-013
Status:
Historical Active
Previous ICR Reference No:
201808-0920-004
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1080
Title:
HIV Outpatient Study (HOPS)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/22/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/07/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/29/2024
36 Months From Approved
09/30/2021
Responses
3,150
0
2,950
Time Burden (Hours)
428
0
405
Cost Burden (Dollars)
10,994
0
0
Abstract:
The HIV Outpatient Study (HOPS) combines medical records data abstraction on HIV-infected adults at 8 HIV clinics in the U.S. with a brief behavioral survey for patients who agree to complete the survey annually. The 7-minute survey administered by telephone or through a web interface includes questions on HIV-positive patients' risk behaviors (including sexual, drug use, tobacco use) which can then be linked to diagnoses, treatments and laboratory findings obtained through the abstraction of medical records, in order to inform secondary HIV prevention. The HOPS allows for examining the trends in the epidemiology of chronic HIV disease in this aging U.S. cohort; the identification of interactions between HIV disease, antiretroviral therapy, and other comorbidities; the characterization of the optimal management strategies for HIV-infected patients to reduce morbidity and mortality (e.g., data on drug toxicities, effectiveness of clinical interventions); and monitoring of sexual and drug use behaviors of HIV-infected patients to inform risk-reduction programs.
Authorizing Statute(s):
US Code:
30 USC (241)a
Name of Law: Research and Investigations
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 56616
09/14/2020
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 1112
01/07/2021
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Behavioral Survey
n/a
Behavioral Survey (screenshots)
Informed Consent
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
3,150
2,950
0
200
0
0
Annual Time Burden (Hours)
428
405
0
23
0
0
Annual Cost Burden (Dollars)
10,994
0
0
10,994
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a request for extension of the approved collection. In the previous approval period, the burden for the annual behavioral assessment was based on the estimated participation of 2,500 respondents. This was an empirical estimate of likely participation. In the current request, the burden for the annual behavioral assessment is estimated on the basis of 2,700 respondents (i.e., the total size of the HOPS cohort). CDC revised this estimate to ensure that the HOPS clearance provides capacity for the maximum number of respondents. This change adds 23 burden hours to the previous estimate. There are no changes to information collection content or methods.
Annual Cost to Federal Government:
$2,281,603
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Renita Macaluso 770 488-6458 arp5@cdc.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
01/07/2021
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