Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Inlcuding Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Final Rule

Forms and Documents

Document Name	Status
Reg and Listing Supporting Statement for Final Rule 2016.pdf Supporting Statement A	2016-11-29
Reg and Listing FRIA 31 Aug 2016.pdf Supplementary Document	2016-11-29
praedrlscm.doc Supplementary Document	2006-08-31

IC Document Collections

IC ID	Document Title	Status
45561	Registration and Listing under 21 CFR Part 207	Modified
224639	Registration and Listing under 21 CFR Part 1271	New
224638	Registration and Listing under 21 CFR Part 607	New
224636	Recordkeeping under Part 207	New

ICR Details

OMB Control No: 0910-0829	ICR Reference No: 201611-0910-011
Status: Historical Active	Previous ICR Reference No: 200610-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Inlcuding Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Final Rule
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/23/2017
	Date Received in OIRA: 11/30/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved
Responses	142,599	0	0
Time Burden (Hours)	152,721	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports agency rulemaking that reorganizes, consolidates, clarifies, and modifies current regulations on registering establishments and listing drugs codified in part 207 for human and animal drugs, in part 607 for blood and blood products, and in part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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

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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

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Registration and Listing under 21 CFR Part 207
Recordkeeping under Part 207
Registration and Listing under 21 CFR Part 607
Registration and Listing under 21 CFR Part 1271

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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	142,599	0	0	142,599	0	0
Annual Time Burden (Hours)	152,721	0	0	-28,434	181,155	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: This is a new information collection request in support of agency rulemaking.

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Annual Cost to Federal Government: $0

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

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Common Form ICR:  No

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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: 11/30/2016

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