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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:
0910-0435
ICR Reference No:
202105-0910-006
Status:
Active
Previous ICR Reference No:
201804-0910-016
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements
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:
07/28/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/25/2021
Terms of Clearance:
Terms continue: Approved consistent with the understanding that, upon finalization of any agency rulemaking amending 21 CFR Part 203 (see RIN 0910-AH56), FDA will submit a request to revise the information collection accordingly.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2024
36 Months From Approved
07/31/2021
Responses
373,063
0
64,805,294
Time Burden (Hours)
61,544
0
2,629,106
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports implementation of the Prescription Drug Marketing Act and FDA regulations. The regulations are intended to protect the public against the threat of subpotent, adulterated, counterfeit, and misbranded drugs posed by the existence of drug diversion schemes and a drug diversion submarket, and the absence of appropriate controls over and creation and maintenance of appropriate records regarding the distribution of prescription drugs.
Authorizing Statute(s):
None
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:
86 FR 14128
03/03/2021
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 33717
06/25/2021
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
Prescription Drug Marketing: Recordkeeping
Prescription Drug Marketing: Reporting
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
373,063
64,805,294
0
0
-64,432,231
0
Annual Time Burden (Hours)
61,544
2,629,106
0
0
-2,567,562
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The information collection reflects adjustments. Since last renewal we have adjusted our estimate of the overall burden downward to reflect a decrease of 2,567,562 hours and 64,432,231 records annually. This reflects the removal of burden associated with provisions in 21 CFR Part 203 that are no longer in effect following enactment of the Drug Supply Chain Security Act (DSCSA). The agency is currently in the process of making corresponding changes to the regulations (0910-AH56). While we have not received any such reports, the information collection is provided for in the regulations and we retain the 1 hour of annual burden and 1 annual response in the event such submissions are received.
Annual Cost to Federal Government:
$825,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
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.
No
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:
Domini Bean 301 796-5733 domini.bean@fda.hhs.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:
06/25/2021
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