Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

ICR 201309-0910-001

OMB: 0910-0670

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-08-30
ICR Details
0910-0670 201309-0910-001
Historical Active 201007-0910-004
HHS/FDA 20420
Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Extension without change of a currently approved collection   No
Regular
Approved without change 12/02/2013
Retrieve Notice of Action (NOA) 09/10/2013
  Inventory as of this Action Requested Previously Approved
12/31/2016 36 Months From Approved 11/30/2013
21 0 71
410 0 14
0 0 0

This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. The appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling.

US Code: 21 USC 358,360,360b,360gg-ss,371,374 Name of Law: FD&C Act
   US Code: 42 USC 216,241,262,264 Name of Law: FD&C Act
   US Code: 21 USC 321,331,351-353,355 Name of Law: FD&C Act
   US Code: 21 USC 379e Name of Law: FD&C Act
  
None

Not associated with rulemaking

  78 FR 23271 04/18/2013
78 FR 52199 08/22/2013
No

2
IC Title Form No. Form Name
Cardiovascular Outcome Claim Supplement Submission
Submission to Docket Number FDA-2008-D-0150

  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 21 71 0 0 -50 0
Annual Time Burden (Hours) 410 14 0 0 396 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The requested burden hours for the 2010 ICR was 290 hours. ROCIS erroneously approved the total hours as 14 so the current total burden hours shows as 14 in ICRAS/ROCIS. Therefore, although ICRAS/ROCIS shows an increase in burden (from 14 to 410) the actual increase in burden is 290 to 410 (a difference of 120 hours) which results from an adjustment based on a review of the data we received on this ICR over the past few years.

$3,080
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
09/10/2013


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