Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

Forms and Documents

Document Name	Status
coverOMBmemo (2).doc Supplementary Document	0000-00-00
praBSEpr ss.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
178924	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants	New
178923	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants	New
178922	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants	New

ICR Details

OMB Control No: 0910-0602	ICR Reference No: 200703-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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: 06/06/2007
	Date Received in OIRA: 03/01/2007
Terms of Clearance: The information collection requirements contained in this proposed rule are not approved at this time. FDA will consider comments received on the proposal and will resubmit for OMB review when finalizing the requirements.

	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: Proposal to prohibit the use of certain cattle material in, or in the manufacture(including processing)of,drugs,biologics,and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products, and in drugs intended for use in ruminant animals.

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Authorizing Statute(s): US Code: 21 USC 600.16 Name of Law: FFDCA
   US Code: 21 USC 200(b)(2) Name of Law: FFDCA
   US Code: 21 USC 500.200 Name of Law: FFDCA
   US Code: 21 USC 895.102 Name of Law: FFDCA
   US Code: 21 USC 1271.470(b) Name of Law: FFDCA
   US Code: 21 USC 300.200 Name of Law: FFDCA
   US Code: 21 USC 500.200(c)(5) Name of Law: FFDCA
   US Code: 21 USC 600.16(c)(5) Name of Law: FFDCA
   US Code: 21 USC 895.102(c)(5) Name of Law: FFDCA
   US Code: 21 USC 1271.470(c)(5) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF54	Proposed rulemaking	72 FR 1582	01/12/2007

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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: 3

IC Title	Form No.	Form Name
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

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

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information.

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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]? 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: 03/01/2007

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