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:
0910-0800
ICR Reference No:
202005-0910-004
Status:
Historical Active
Previous ICR Reference No:
201808-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/21/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/14/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2023
36 Months From Approved
10/31/2021
Responses
9,080
0
110
Time Burden (Hours)
8,730
0
941
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports implementation of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and includes reporting, recordkeeping, and disclosures. Section 503B pertains to outsourcing facilities and sets forth criteria under which sections 502(f)(1), 505, and 582 do not apply for a drug compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility. Section 503A pertains to human drug compounding and sets forth criteria under which sections 501(a)(2)(b), 502(f)(1), and 505 of the FD&C Act do not apply for a drug product compounded for an identified individual patient based on the receipt of a valid prescription order approved by a practitioner. Respondents to the collection are those who compound drugs, outsourcing facilities, and State Boards of Pharmacy or other State Agencies entering into a MOU with FDA to address certain distributions of compounded human drug products.
Authorizing Statute(s):
PL:
Pub.L. 116 - 8 503A; 503B
Name of Law: FD&C Act: Pharmacy Compounding; Outsourcing Facilities
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 45631
09/10/2018
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 28961
05/14/2020
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
503A; Disclosure
503A; Recordkeeping
503A; Reporting
503B Recordkeeping; AERs
503B Reporting: AERs
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
9,080
110
0
0
8,970
0
Annual Time Burden (Hours)
8,730
941
0
0
7,789
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 is being revised to include the collection of related data elements. This results in an additional 8,970 annual responses and 7,789 additional hours of estimated burden to the information collection.
Annual Cost to Federal Government:
$1,180,197
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.
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:
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:
05/14/2020
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