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; Proposed Rule

Forms and Documents

Document Name	Status
edrlsPROPOSAL.pdf Proposed Rule Document	2006-09-07
praedrlscm.doc Supplementary Document	2006-08-31
praedrls ss (2).doc Supporting Statement A	2006-09-07

IC Document Collections

IC ID	Document Title	Status
45561	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are regulated under a Biologics License Application, and Animal Drugs; Proposed Rule	New

ICR Details

OMB Control No: 0910-0829	ICR Reference No: 200610-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
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; Proposed 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: Comment filed on proposed rule	Conclusion Date: 01/04/2007
	Date Received in OIRA: 10/05/2006
Terms of Clearance: The information collection requirements associated with this proposed rule are not approved at this time. FDA will consider comments received from the public on the proposed information collection requirements contained in the rule and will resubmit at the final rule stage.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 21 CFR part 207 implements section 510 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360), under which FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution.

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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	Proposed rulemaking	71 FR 51276	08/29/2006

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are regulated under a Biologics License Application, and Animal Drugs; Proposed Rule

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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: The proposed rule would reorganize, consolidate, clarify, and modify current regulations on registering establishments and listing human and animal drugs under 21 CFR 207, blood and blood products under part 607, and HCT/Ps under part 1271. The proposal describes when and how to register and list and what information must be submitted for registration and listing. The proposal makes certain changes to the NDC system for drugs and would require the appropriate NDC number to appear on drug labels (for drugs subject to the drug listing requirements). The proposed regulations would require the electronic submission of all registration and most listing information instead of the current use of paper forms.

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Annual Cost to Federal Government: $7,500,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/27/2006

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