Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0045 SS Revision in support of Aug 2016 Final Rule.pdf	Supporting Statement A	Uploaded 2016-12-13	Available
Reg and Listing FRIA 31 Aug 2016.pdf	Supplementary Document	Uploaded 2016-12-09	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5696	Initial establishment registration	Other-Agency Guidance	Modified
187822	RECORDKEEPING: SOP Maintenance		Modified
187821	RECORDKEEPING: One-Time Preparation of SOP		Modified
187820	Waiver requests		Unchanged
183175	June and December review and updates (or certifications) of listing (including NDC) information	Other-Agency Guidance	Modified
183174	Requests for exemptions from public disclosures under 207.81	Other-Agency Guidance	Modified
183173	Initial listing (including NDC) information	Other-Agency Guidance	Modified
183172	Annual Updates of Registration Information (including expedited updates)	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0045	ICR Reference No: 201612-0910-005
Status: Historical Active	Previous ICR Reference No: 201507-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
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: 12/29/2016
	Date Received in OIRA: 12/16/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2018
Responses	135,826	0	135,534
Time Burden (Hours)	149,561	0	633,868
Cost Burden (Dollars)	0	0	0

---

Abstract: Manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishments. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States. This information collection supports agency regulations regarding these requirements.

---

Authorizing Statute(s): US Code: 21 USC 360 Name of Law: Federal Food, Drug, & Cosmetic Act; Registration of producers of drugs or devices
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 85 224 Name of Law: FDA Amendments Act; Electronic Registration and Listing

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AA49	Final or interim final rulemaking	81 FR 60170	08/31/2016

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 51276	08/29/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 60170	08/31/2016
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 8

table that charts list of burden

IC Title	Form No.	Form Name
Initial establishment registration
Initial listing (including NDC) information
Annual Updates of Registration Information (including expedited updates)
Requests for exemptions from public disclosures under 207.81
June and December review and updates (or certifications) of listing (including NDC) information
Waiver requests
RECORDKEEPING: One-Time Preparation of SOP
RECORDKEEPING: SOP Maintenance

---

ICR Summary of Burden

table that charts list 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	135,826	135,534	292	0	0	0
Annual Time Burden (Hours)	149,561	633,868	-484,307	0	0	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:

---

Annual Cost to Federal Government: $3,250,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

---

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: 12/16/2016

---