The information FDA receives from
establishments complying with registration and listing requirements
is necessary to regulate the industries involved with the recovery,
screening, testing, processing, storage, and distribution of
HCT/Ps. The information allows FDA to efficiently and effectively
handle emerging public health concerns related to HCT/Ps. The
information also aids FDA to monitor the industry, to distribute
educational materials, and to inform the industry about FDA
requirements, guidances, and policies, and to identify entities
that may be subject to FDA regulation. Documentation of donor
eligibility determination provides to the user that all of the
donor's medical history and social behavior were reviewed for high
risk for or clinical evidence of communicable diseases, and that
all of the required testing was completed. Each distributed HCT/P
must have the certain accompanying documentation, e.g., a summary
of the records used to determine eligibility. Other reporting and
recordkeeping requirements in 21 CFR Part 1271 are designed to
fully disclose the screening and testing results to the user when
using products from donors who are determined to be ineligible or
whose eligibility has not yet been determined in an urgent medical
need. HCT/P establishments are required to maintain records for a
minimum of 10 years. Certain HCT/Ps have long storage periods and
advances in medical diagnosis and therapy also have created
opportunities for disease prevention or treatment many years after
a recipient's exposure to a donor later determined to be at risk
for communicable disease agents or diseases. The CGTP information
collection provisions provide, e.g., additional measures for
preventing the introduction, transmission, or spread of
communicable disease.
US Code:
42
USC 264 Name of Law: Public Health Service Act
The previous burden estimate in
2011 was 3,871,713 hours. The slight overall increase in burden to
3,928,592 hours (66,879 hours) is mostly attirubted to an inrease
in the number of establishments and corresponding records under
Sections 1271.47, 1271.50, 1271.55, 1271.270, and 1271.320 in the
recordkeeping burden chart. A third-party disclosure chart was
added for followng regulations previously included under the
reporting burden chart: Sections 1271.55, 1271.60, 1271.290, and
1271.370. Therefore, there was a decrese under the reporting chart
from 1,905,773 hours in 2011 to 4,018 (-1,901,755) hours; and a
correspondeing new increase of 1,903,336 hours under the disclosure
chart.
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.
Form 3356 1271.10(b)(1) and 1271.21(b) - Are my HCT/P's Regulated Solely Under Section 361 of the PHS Act and the regulations in This Part and if so What Must I Do?
SUPPORTING STATEMENT FINAL 11-26-13.doc
1271.10(b)(1) and 1271.21(b) - Are my HCT/P's Regulated Solely Under Section 361 of the PHS Act and the regulations in This Part and if so What Must I Do?