Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims

Forms and Documents

Document Name	Status
hypert guidance.doc Supplementary Document	2010-07-06
HypertensionFGuidance SS 6 2010.doc Supporting Statement A	2010-07-06

IC Document Collections

IC ID	Document Title	Status
193930	Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims	New
193929	Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims	New

ICR Details

OMB Control No: 0910-0670	ICR Reference No: 201007-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims
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: Approved without change	Conclusion Date: 10/18/2010
	Date Received in OIRA: 07/26/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved
Responses	71	0	0
Time Burden (Hours)	14	0	0
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 the intent of the guidance is to provide common labeling for antihypertensive drugs except where differences are clearly supported by clinical data. The guidance encourages applicants to submit labeling supplements containing the new language.rugs that are indicated to treat hypertension.

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Authorizing Statute(s): US Code: 21 USC 355 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 13547	03/22/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 37816	06/30/2010
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
Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims
Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims

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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	71	0	0	71	0	0
Annual Time Burden (Hours)	14	0	0	14	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: The final guidance document contains provisions that are subject to the PRA. The guidance will assist applicants when developing labeling for outcome claims for drugs.

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Annual Cost to Federal Government: $10,720

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: 07/26/2010

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