Drug and Device Manufacturer
Communications With Payors, Formulary Committees, and Similar
Entities Questions and Answers
Extension without change of a currently approved collection
No
Regular
07/29/2021
Requested
Previously Approved
36 Months From Approved
08/31/2021
9,012
8,912
139,353
137,353
0
0
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).
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