Federal Register - July 12, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices characteristics, medical care, HIV
testing, pre-exposure prophylaxis, antiretroviral treatment, sexually transmitted diseases STD history, symptoms of early HIV infection, substance use and sexual behavior.
Data from the surveys will be merged with HIV test results and relevant clinical data using the unique identification ID number. Data will be stored on a secure server managed by the awardees Information Technology IT Services. The participation of respondents is voluntary. There is no cost to the respondents other than their time. The total estimated annual burden hours for the proposed project are 1,594
hours.
become concordant i.e., at the last Phase 2 visit participants will complete the Phase 2 Behavioral Survey to identify any behavioral changes during follow-up. Of the 50 Phase 2
participants; it is estimated that no more than 26, annually, will have early HIV
infection.
All data for the proposed information collection will be collected via an electronic Computer Assisted SelfInterview CASI survey. Participants will complete the surveys on an encrypted computer, with the exception of the Phase 2 Symptom and Care survey, which will be administered by a research assistant and then electronically entered into the CASI
system. Data to be collected via CASI
include questions on sociodemographic
indicating one or more false-positive test results in Phase 1.
The follow-up schedule will consist of up to nine visits scheduled at regular intervals over a 70-day period. At each follow-up visit, participants will be tested with the new HIV tests and additional oral fluid and blood specimens will also be collected for storage and use in future HIV test evaluations at CDC. Participants will be followed only to the point at which all their test results become concordant. At each time point, participants will be asked to complete the Phase 2 HIV
Symptom and Care survey to collect information on symptoms associated with early HIV infection as well as access to HIV care and treatment since the last Phase 2 visit. When all tests
ESTIMATED ANNUALIZED BURDEN HOURS
Average burden per response in hours
Total burden in hours
Form name
Persons eligible for study.
Enrolled participants
Phase 1 Consent
2,334
1
15/60
584
Phase Phase Phase Phase
Enrollment Survey
Consent
HIV Symptom and Care survey
Behavioral Survey
1,867
50
50
50
1
1
9
1
30/60
15/60
5/60
30/60
934
13
38
25
Total
1,594
1
2
2
2
Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
FR Doc. 202114754 Filed 7921; 8:45 am BILLING CODE 416318P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and Prevention 30 Day211242
Agency Forms Undergoing Paperwork Reduction Act Review
khammond on DSKJM1Z7X2PROD with NOTICES
Number of responses per respondent
Number of respondents
Type of respondents
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention CDC
has submitted the information collection request titled Strengthening U.S. Response to Resistant Gonorrhea SURRG to the Office of Management and Budget OMB for review and approval. CDC previously published a Proposed Data Collection Submitted for Public Comment and Recommendations notice on September 30, 2020 to obtain comments from the public and affected agencies.
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CDC received one non-substantive comment related to the previous notice.
This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project.
The Office of Management and Budget is particularly interested in comments that:
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,
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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 404 6397570.
Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular information collection by selecting Currently under 30-day ReviewOpen for Public Comments or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to 202 3955806. Provide written comments within 30 days of notice publication.
Proposed Project Strengthening U.S. Response to Resistant Gonorrhea SURRG OMB
Control No. 09201242, Exp. 9/30/
2021RevisionNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB
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