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

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT 0670 FINAL 8-30-13.doc	Supporting Statement A	Uploaded 2013-08-30	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
193930	Cardiovascular Outcome Claim Supplement Submission	Other-Guidance	Modified
193929	Submission to Docket Number FDA-2008-D-0150	Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0670	ICR Reference No: 201309-0910-001
Status: Historical Active	Previous ICR Reference No: 201007-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 20420
Title: Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/02/2013
	Date Received in OIRA: 09/10/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	36 Months From Approved	11/30/2013
Responses	21	0	71
Time Burden (Hours)	410	0	14
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 23271	04/18/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 52199	08/22/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

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

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ICR Summary of Burden

	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

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $3,080

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 09/10/2013

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