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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
5696	Initial establishment registration Other-Agency Guidance	Modified
250057	CARES 3112 reporting and exemptions	New
187821	RECORDKEEPING: One-Time Preparation of SOP	Unchanged
187820	Waiver requests	Unchanged
183175	June and December review and updates (or certifications) of listing (including NDC) information Other-Agency Guidance	Unchanged
183174	Requests for exemptions from public disclosures under 207.81 Other-Agency Guidance	Unchanged
183173	Initial listing (including NDC) information Other-Agency Guidance	Unchanged
183172	Annual Updates of Registration Information (including expedited updates) Other-Agency Guidance	Unchanged

ICR Details

OMB Control No: 0910-0045	ICR Reference No: 202110-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202010-0910-006
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	Date Submitted to OIRA: 11/03/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2021
Responses	380,481	132,531
Time Burden (Hours)	208,254	146,266
Cost Burden (Dollars)	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 301 et seq. 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:
	Not associated with rulemaking
	Other Documents for OIRA Review

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 24871	05/10/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 59402	10/27/2021
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Annual Updates of Registration Information (including expedited updates)
CARES 3112 reporting and exemptions
Initial establishment registration
Initial listing (including NDC) information
June and December review and updates (or certifications) of listing (including NDC) information
RECORDKEEPING: One-Time Preparation of SOP
Requests for exemptions from public disclosures under 207.81
Waiver requests

---

ICR Summary of Burden

	Total Request	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	380,481	132,531	247,950	0	0	0
Annual Time Burden (Hours)	208,254	146,266	61,988	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: The information collection reflects both changes and adjustments. We have revised the scope of the collection to include new reporting elements and exemptions mandated by section 3112 of the CARES Act, which results in an increase of 247,950 responses and 61,988 burden hours annually.

---

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

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

---

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: 11/03/2021

---