This information is required in the
implementation and administration of the Orphan Drug Act, 21
U.S.C., Sections 526-528. The information is necessary to show that
applicants qualify and continue to qualify for the incentives and
assistance provided by the statute and regulations.
The total number of requests
for orphan designation have increased as a result of increased
interest by the public and pharmaceutical industry in developing
products for people with rare diseases and conditions. The burden
was adjusted to reflect this increase. Since there is an increase
of applications, sponsors who request a designation from only the
FDA have the option of submitting the FDA Orphan Drug Designation
Request Form (FDA Form 4035). The estimated annual hourly burden,
formerly estimated as 106,407 hours, has increased by 8,250 hours
to a total estimated annual hourly burden of 114,657 hours. We are
consolidating into this request for approval 0910-0787, “Guidance
for Industry, Researchers, Patient Groups, and Food and Drug
Administration Staff on Meetings With the Office of Orphan Products
Development” which represents an additional increase in total
burden hours of 9,016 hours. Therefore, the increase in total
burden hours is 17,266. For the purpose of ease of entry in ROCIS
the previously entered eight ICs was reduced to one IC.
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.