In accordance
with 5 CFR 1320, the information collection is not approved at this
time. Prior to publication of the final rule, the agency should
provide to OMB a summary of all comments received on the proposed
information collection and identify any changes made in response to
these comments.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
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The Food and Drug Administration (FDA)
is proposing to amend the 1992 Orphan Drug Regulations, 21 CFR Part
316 (Attachment A). The 1992 regulations were issued to implement
sections 525 through 528 (Attachment B) of the Orphan Drug Act
Amendments to the Food, Drug, and Cosmetic Act. The 1992
regulations specify the procedures for sponsors of orphan drugs to
use in obtaining the incentives provided for in the Act and set
forth the procedures that FDA will use in administering the
Act.
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.