This information collection supports FDA guidance covering drug and device manufacturer communications with payors, formulary committees, and similar entities (collectively referred to as payors). If a manufacturer communicates health care economic information (HCEI) for approved prescription drugs (including biological products that also meet the definition of “drug” under the Federal Food, Drug, and Cosmetic Act) and approved/cleared medical devices (collectively referred to as medical products) to payors, FDA recommends the inclusion of certain information (e.g., study design and methodology of economic analysis, limitations to an economic analysis, FDA-approved indication).
This is a new information collection in support of agency guidance.
$0
No
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
GFI: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers