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

ICR 200703-0910-001

OMB: 0910-0602

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
0000-00-00
Supporting Statement A
0000-00-00
ICR Details
0910-0602 200703-0910-001
Historical Inactive
HHS/FDA
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 06/06/2007
Retrieve Notice of Action (NOA) 03/01/2007
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
36 Months From Approved
0 0 0
0 0 0
0 0 0

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.

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
  
None

0910-AF54 Proposed rulemaking 72 FR 1582 01/12/2007

No

Yes
Miscellaneous Actions
No
This is a new collection of information.

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/01/2007


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