Under section 520(m) (21 U.S.C.
360j(m)) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), the FDA is authorized to exempt a humanitarian use device
(HUD) from the effectiveness requirements in sections 514 and 515
of the FD&C Act. HUDs are subject to the general restriction
that no profit may be made on their use. For HUDs labeled for use
in certain populations, FDA exempts a certain number of these
devices each year from the prohibition on profit. This number is
known as the ADN. The information gathered by this collection
enables FDA to set this number. Failure to collect this information
would prevent FDA from assigning an ADN. Section 520(m)(6)(A)(ii),
as amended by FDASIA, provides that the Secretary of Health and
Human Services (the Secretary) will assign an annual distribution
number (ADN) for devices that meet the eligibility criteria to be
permitted to be sold for profit.. The ADN is defined as the number
of devices "reasonably needed to treat, diagnose, or cure a
population of 4,000 individuals in the United States," and
therefore shall be based on the following information in a
humanitarian device exemption (HDE) application: the number of
devices reasonably necessary to treat such individuals. FDA is
requesting OMB approval for the collection of information required
under the statutory mandate of sections 515A and 520(m) of the
FD&C Act as amended. Reporting Requirements: Pediatric
Subpopulation and Patient Information--Section 515A(a)(2) Requires
that an HDE application include a description of any pediatric
subpopulations that suffer from the disease or condition that the
device is intended to treat, diagnose, or cure and the number of
affected pediatric patients.
FDA revised the title of the
information collection to more accurately reflect its content
subsequent to the FDASIA amendment. FDA has increased the reporting
burden estimate slightly to reflect the expected number of
respondents for pediatric subpopulation and patient information
based on updated data from the last three years and our expectation
of an increase due to the FDASIA legislation. The total burden
hours will, therefore, increase by 120 to 1,370. The annualized
cost burden estimate has increased by $53,640 to $57,540 due to
updated wage rates and to correct a miscalculation in the
previously approved cost burden estimate, which only accounted for
the cost burden for a single response to a 100-hour burden. Under
section 1136 of the Food and Drug Administration Safety and
Innovation Act of 2012 (FDASIA), FDA now requires an eCopy of
submissions. We have added text describing the eCopy requirement in
section 3 of this supporting statement, "Use of Improved
Information Technology and Burden Reduction." As described in
section 3, the new eCopy requirement does not change any cost or
hourly burden. OMB approved this non-material/nonsubstantive change
on December 17, 2012.
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.
0661--Info to Accompany HDEs--supporting statement Final.doc
Request for Determination of Eligibility Criteria--613(b) of FDASIA