Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
08/31/2026 |
Annual Federal Government Cost: |
$3,500,000 |
Annual Response: |
5,400 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
2,700 |
Survey Respondent: |
Private Sector |
Authorizing Statute: |
US Code: 21 USC 360c Name of Law: FFDCA; Medical Devices for Human Use |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202212-0910-005 |
Customer/Partner Satisfaction Service Surveys
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
10/31/2026 |
Annual Federal Government Cost: |
$338,464 |
Annual Response: |
85,000 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
35,700 |
Survey Respondent: |
State Local and Tribal Governments, Private Sector, Individuals or Households |
Authorizing Statute: |
EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202309-0910-007 |
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
02/28/2026 |
Annual Federal Government Cost: |
$2,329,109 |
Annual Response: |
109,470 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
27,368 |
Survey Respondent: |
Private Sector, Individuals or Households |
Authorizing Statute: |
US Code: 21 USC 393 Name of Law: Food and Drug Administration; General Responsibilities |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202311-0910-005 |
Data to Support Drug Product Communications
Agency: |
HHS |
Subject: |
Not Available |
Subagency: |
FDA |
Detailed Subject: |
Not Available |
Expiration Date: |
08/31/2027 |
Annual Federal Government Cost: |
$2,180,000 |
Annual Response: |
45,000 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Not Avaiable |
Annual Time Burden (hrs): |
13,750 |
Survey Respondent: |
Not Available |
Authorizing Statute: |
US Code: 21 USC 301 et seq. Name of Law: Federal Food Drug and Cosmetic Act |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202403-0910-002 |
FDA Focus Groups and Interviews
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
12/31/2026 |
Annual Federal Government Cost: |
$350,000 |
Annual Response: |
12,000 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
21,000 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
US Code: 21 USC 355 Name of Law: FFDCA |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202310-0910-007 |
Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food Dietary Supplements Cosmetics and Animal Food and Feed
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
09/30/2026 |
Annual Federal Government Cost: |
$1,056,031 |
Annual Response: |
20,464 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
7,394 |
Survey Respondent: |
Individuals or Households, Private Sector |
Authorizing Statute: |
None |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202302-0910-006 |
Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN)
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
03/31/2025 |
Annual Federal Government Cost: |
$953,432 |
Annual Response: |
93,744 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
10,498 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
US Code: 21 USC 393(d)(2)(D) Name of Law: FFDCA; Objectives of Agency Plan |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202201-0910-003 |
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Agency: |
HHS |
Subject: |
Not Available |
Subagency: |
FDA |
Detailed Subject: |
Not Available |
Expiration Date: |
03/31/2028 |
Annual Federal Government Cost: |
$1,029,504 |
Annual Response: |
28,174 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Not Avaiable |
Annual Time Burden (hrs): |
14,934 |
Survey Respondent: |
Not Available |
Authorizing Statute: |
US Code: 21 USC 355 Name of Law: Family Smoking Prevention And Tobacco Control Act AND US Code: 21 USC 393 Name of Law: FFDCA |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202406-0910-003 |
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Agency: |
HHS |
Subject: |
Not Available |
Subagency: |
FDA |
Detailed Subject: |
Not Available |
Expiration Date: |
nan |
Annual Federal Government Cost: |
$1,029,503 |
Annual Response: |
1,768,000 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Not Avaiable |
Annual Time Burden (hrs): |
188,534 |
Survey Respondent: |
Not Available |
Authorizing Statute: |
US Code: 21 USC 355 Name of Law: Federal Food Drug and Cosmetic Act AND PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act AND US Code: 21 USC 372 Name of Law: Federal Food Drug and Cosmetic Act AND US Code: 21 USC 393(d)(2)(D) Name of Law: Federal Food Drug and Cosmetic Act AND US Code: 42 USC 241(a) Name of Law: Public Health Service Act |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202412-0910-014 |
National Agriculture and Food Defense Strategy Survey
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Public Health Monitoring |
Expiration Date: |
11/30/2027 |
Annual Federal Government Cost: |
$11,500 |
Annual Response: |
500 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
165 |
Survey Respondent: |
State Local and Tribal Governments |
Authorizing Statute: |
PL: Pub.L. 111 - 353 108 Name of Law: FSMA; National Agricultural and Food Defense Strategy |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202407-0910-002 |
Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Health Care Services |
Qualitative Feedback on Food and Drug Administration Service Delivery
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
01/31/2027 |
Annual Federal Government Cost: |
$338,464 |
Annual Response: |
26,400 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
14,725 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202311-0910-013 |
Quantitative Research on Front of Package Labeling on Packaged Foods
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
08/31/2026 |
Annual Federal Government Cost: |
$350,000 |
Annual Response: |
41,600 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
4,430 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
US Code: 21 USC 393(d)(2)(C) Name of Law: FFDCA |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202306-0910-004 |
Rapid Response Surveys
Agency: |
HHS |
Subject: |
Not Available |
Subagency: |
FDA |
Detailed Subject: |
Not Available |
Expiration Date: |
02/28/2027 |
Annual Federal Government Cost: |
$338,464 |
Annual Response: |
10,000 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Not Avaiable |
Annual Time Burden (hrs): |
5,000 |
Survey Respondent: |
Not Available |
Authorizing Statute: |
US Code: 21 USC 393 Name of Law: FFDCA |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202308-0910-001 |
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Public Health Monitoring, Consumer Health and Safety |
Expiration Date: |
10/31/2027 |
Annual Federal Government Cost: |
$531,776 |
Annual Response: |
824 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
1,602 |
Survey Respondent: |
Private Sector |
Authorizing Statute: |
US Code: 42 USC 243 Name of Law: Public Health Service Act AND US Code: 21 USC 301 Name of Law: Federal Food Drug and Cosmetic Act AND US Code: 31 USC 1535 Name of Law: The Economy Act of 1932 |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202401-0910-002 |
Targeted Mechanism of Action Presentations in Prescription Drug Promotion
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
11/30/2025 |
Annual Federal Government Cost: |
$526,321 |
Annual Response: |
990 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
891 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
US Code: 42 USC 300u(a)(4) Name of Law: PHS Act AND US Code: 21 USC 393(d)(2)(c) Name of Law: FFDCA |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202305-0910-004 |
Testing Communications On Medical Devices and Radiation-Emitting Products
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
05/31/2026 |
Annual Federal Government Cost: |
$1,719,390 |
Annual Response: |
9,124 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
2,391 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
US Code: 21 USC 393 Name of Law: FFDCA |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202303-0910-022 |
Text Analysis of Proprietary Drug Name Interpretations
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
11/30/2025 |
Annual Federal Government Cost: |
$858,663 |
Annual Response: |
1,100 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
374 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
US Code: 21 USC 393(d)(2)(C) Name of Law: FFDCA AND US Code: 42 USC 300u(a)(4) Name of Law: PHS Act |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202306-0910-001 |
The Real Cost Campaign Outcomes Evaluation Study
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |
Expiration Date: |
06/30/2026 |
Annual Federal Government Cost: |
$2,280,544 |
Annual Response: |
856,316 |
Annual Cost Burden: |
$0 |
Respondent Obligation: |
Voluntary |
Annual Time Burden (hrs): |
115,399 |
Survey Respondent: |
Individuals or Households |
Authorizing Statute: |
PL: Pub.L. 111 - 31 1 Name of Law: Family Smoking Prevention and Tobacco Control Act |
Survey Reference Link: |
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202410-0910-004 |
Voluntary Total Product Life Cycle Advisory Program Pilot
Agency: |
HHS |
Subject: |
Health |
Subagency: |
FDA |
Detailed Subject: |
Consumer Health and Safety |