GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims

ICR 201911-0910-010

OMB: 0910-0670

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0670 201911-0910-010
Active 201610-0910-011
GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims
Extension without change of a currently approved collection   No
Approved without change 12/31/2019
Retrieve Notice of Action (NOA) 12/05/2019
  Inventory as of this Action Requested Previously Approved
12/31/2022 36 Months From Approved 01/31/2020
5 0 2
90 0 30
7,650 0 0

The information supports Agency guidance 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: 42 USC 216,241,262,264 Name of Law: PHS Act
   US Code: 21 USC 321,331,351-353,355 Name of Law: FD&C Act
   US Code: 21 USC 358,360,360b,360gg-ss,371,374 Name of Law: FD&C Act
   US Code: 21 USC 379e Name of Law: FD&C Act

Not associated with rulemaking

  84 FR 33952 07/16/2019
84 FR 62537 11/15/2019

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 5 2 0 0 3 0
Annual Time Burden (Hours) 90 30 0 0 60 0
Annual Cost Burden (Dollars) 7,650 0 0 0 7,650 0
The information collection reflects an increase of 80 annual hours and 3 annual submissions that corresponds with supplemental labeling claim submissions we have received since last approval of the information collection. We have also uploaded reported costs associated with the information collection so that they appear on to assist readers.

Domini Bean 301 796-5733 [email protected]


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.

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