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.
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?