Federal Register - August 2, 2021
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Fuente: Federal Register
41475
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices and non-biological parents such as adoptive, foster, or stepparents.
The types of information collection activities included in this generic package are:
1 Quantitative data collection through electronic, telephone, or paper questionnaires to gather information about programmatic and service activities related to the prevention of HIV and other STDs among adolescents of middleand high-school age.
2 Qualitative data collection through electronic, telephone, or paper means to gather information about programmatic and service activities related to the prevention of HIV and other STDs among adolescents of middleand highschool age. Qualitative data collection may involve focus groups and in-depth interviewing through group interviews, and cognitive interviewing.
For adolescents, data collection instruments will include questions on demographic characteristics;
experiences with programs and services to reduce the risk of HIV and other STD
transmission; and knowledge, attitudes,
collection instruments will be pilottested, and will be culturally, developmentally, and age appropriate for the adolescent populations included.
Similarly, parent data collection instruments will be pilot-tested, and the data collection instruments will reflect the culture, developmental stage, and age of the parents adolescent children.
All data collection procedures will receive review and approval by an Institutional Review Board for the Protection of Human Subjects and follow appropriate consent and assent procedures as outlined in the IRBapproved protocols. These will be described in the individual information collection requests put forward under this Generic package.
The table below provides the estimated annualized response burden for up to 15 individual data collections per year under this generic clearance at 57,584 hours. Participation of respondents is voluntary. There is no cost to participants other than their time.
behaviors, and skills related to sexual risk and protective factors on the individual, interpersonal, and community levels.
For parents and caregivers, data collection instruments will include questions on demographic characteristics as well as parents/
caregivers 1 perceptions about programs and services provided to adolescents; 2 knowledge, attitudes, and perceptions about their adolescents health risk and protective behaviors;
and 3 parenting knowledge, attitudes, behaviors, and skills.
Any data collection request put forward under this generic clearance will identify the programs and/or services to be informed or refined, and will include a cross-walk of data elements to the aspects of the program the project team seeks to inform or refine. Because this request includes a wide range of possible data collection instruments, specific requests will include items of information to be collected and copies of data collection instruments. It is expected that all data
ESTIMATED ANNUALIZED BURDEN HOURS
Number of responses per respondent
Average burden per response in hours
Total burden in hours
Form name
Middle and High School Age Adolescents.
Middle and High School Age Adolescents.
Middle and High School Age Adolescents.
Parents/caregivers of adolescents
Parents/caregivers of adolescents
Youth Questionnaire
20,000
1
50/60
16,667
Pre/Post youth questionnaire
10,000
2
50/60
16,667
Youth interview/focus group guide
3,000
2
90/60
9,000
Parent/Caregiver questionnaire
Parent/Caregiver interview/focus group guide.
7,500
3,000
2
2
25/60
90/60
6,250
9,000
Total
57,584
Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
FR Doc. 202116376 Filed 73021; 8:45 am BILLING CODE 416318P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration khammond on DSKJM1Z7X2PROD with NOTICES
Number of respondents
Type of respondents
Docket No. FDA2021N0758
Antimicrobial Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
VerDate Sep<11>2014
17:21 Jul 30, 2021
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The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
SUMMARY:
The meeting will be held on October 7, 2021, from 9 a.m. to 5 p.m.
Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID19 pandemic, all meeting participants will be joining this DATES:
Food and Drug Administration, Health and Human Services HHS.
AGENCY:
Notice; establishment of a public docket; request for comments.
ACTION:
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advisory committee meeting via an online teleconferencing platform.
Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for public comment on this meeting. The docket number is FDA2021N0758.
The docket will close on October 6, 2021. Submit either electronic or written comments on this public meeting by October 6, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 6, 2021. The https
www.regulations.gov electronic filing
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02AUN1