Source: https://www.federalregister.gov/documents/2013/07/12/2013-16692/agency-information-collection-activities-proposed-collection-comment-request-human-cells-tissues-and
Timestamp: 2018-04-22 22:25:00
Document Index: 576644335

Matched Legal Cases: ['art 1271', 'art 1271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', 'art 1271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', 'art 1271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', 'art 1271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', 'art 1271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271', '§\u20091271']

Submit either electronic or written comments on the collection of information by September 10, 2013.
41934-41937 (4 pages)
https://www.federalregister.gov/d/2013-16692 https://www.federalregister.gov/d/2013-16692
Start Preamble Start Printed Page 41934
The regulations in part 1271 (21 CFR part 1271) require domestic and foreign establishments that recover, process, store, label, package, or distribute an HCT/P described in § 1271.10(a), or that perform screening or testing of the cell or tissue donor to register with FDA (§ 1271.10(b)(1)) and submit a list of each HCT/P manufactured (§ 1271.10(b)(2)). Section 1271.21(a) requires an establishment to follow certain procedures for initial registration and listing of HCT/Ps, and § 1271.25(a) and (b) identifies the required initial registration and HCT/P listing information. Section 1271.21(b), in brief, requires an annual update of the establishment registration. Section 1271.21(c)(ii) requires establishments to submit HCT/P listing updates if a change as described in § 1271.25(c) has occurred. Section 1271.25(c) identifies the required HCT/P listing update information. Section 1271.26 requires establishments to submit an amendment if ownership or location of the establishment changes. FDA requires the use of a registration and listing form (Form FDA 3356: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)) to submit the required information (§§ 1271.10, 1271.21, 1271.25, and 1271.26)). To further facilitate the ease and speed of submissions, electronic submission is accepted (http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​EstablishmentRegistration/​TissueEstablishmentRegistration/​default.htm).
In brief, FDA requires certain HCT/P establishments described in § 1271.1(b) to determine donor eligibility based on donor screening and testing for relevant communicable disease agents and diseases except as provided under § 1271.90. The documented determination of a donor's eligibility is made by a responsible person as defined in § 1271.3(t) and is based on the results of required donor screening, which includes a donor medical history interview (defined in § 1271.3(n)), and testing (§ 1271.50(a)). Certain records must accompany an HCT/P once the donor-eligibility determination has been made (§ 1271.55(a)). This requirement applies both to an HCT/P from a donor who is determined to be eligible as well as to an HCT/P from a donor who is determined to be ineligible or where the donor-eligibility determination is not complete if there is a documented Start Printed Page 41935urgent medical need, as defined in § 1271.3(u) (§ 1271.60). Once the donor-eligibility determination has been made, the HCT/P must be accompanied by a summary of records used to make the donor eligibility determination (§ 1271.55(b)), and a statement whether, based on the results of the screening and testing of the donor, the donor is determined to be eligible or ineligible (§ 1271.55(a)(2)). Records used in determining the eligibility of a donor, i.e., results and interpretations of testing for relevant communicable disease agents, the donor eligibility determination, the name and address of the testing laboratory or laboratories, and the name of the responsible person (defined in § 1271.3(t)) who made the donor-eligibility determination and the date of the determination, must be maintained (§ 1271.55(d)(1)). If any information on the donor is not in English, the original record must be maintained and translated to English, and accompanied by a statement of authenticity by the translator (§ 1271.55(d)(2)). HCT/P establishments must retain the records pertaining to a particular HCT/P at least 10 years after the date of its administration, or, if the date of administration is not known, then at least 10 years after the date of the HCT/P's distribution, disposition, or expiration, whichever is latest (§ 1271.55(d)(4)).
FDA requires HCT/P establishments to follow CGTP (§ 1271.1(b)). Section 1271.155(a) permits the submission of a request for FDA approval of an exemption from or an alternative to any requirement in subpart C or D of part 1271. Section 1271.290(c) requires establishments to affix a distinct identification code to each HCT/P that they manufacture that relates the HCT/P to the donor and to all records pertaining to the HCT/P. Whenever an establishment distributes an HCT/P to a consignee, § 1271.290(f) requires the establishment to inform the consignee, in writing, of the product tracking requirements and the methods the establishment uses to fulfill these requirements. Non-reproductive HCT/P establishments described in § 1271.10 are required under § 1271.350(a)(1) and (a)(3) to investigate and report to FDA adverse reactions (defined in § 1271.3(y)) using Form FDA-3500A (§ 1271.350(a)(2)). Form FDA-3500A is approved under OMB Control No. 0910-0291. Section 1271.370(b) and (c) requires establishments to include specific information either on the HCT/P label or with the HCT/P.
The standard operating procedures (SOPs) provisions under part 1271 include the following: (1) Section 1271.160(b)(2) (receiving, investigation, evaluating, and documenting information relating to core CGTP requirements, including complaints, and for sharing information with consignees and other establishments); (2) § 1271.180(a) (to meet core CGTP requirements for all steps performed in the manufacture of HCT/Ps); (3) § 1271.190(d)(1) (facility cleaning and sanitization); (4) § 1271.200(b) (cleaning, sanitizing, and maintenance of equipment); (5) § 1271.200(c) (calibration of equipment); (6) § 1271.230(a) and (c) (validation of a process and review and evaluation of changes to a validated process); (7) § 1271.250(a) (controls for labeling HCT/Ps); (8) § 1271.265(e) (receipt, predistribution shipment, availability for distribution, and packaging and shipping of HCT/Ps); (9) § 1271.265(f) (suitable for return to inventory); (10) § 1271.270(b) (records management system); (11) § 1271.290(b)(1) (system of HCT/P tracking); and (12) § 1271.320(a) (review, evaluation, and documentation of complaints as defined in § 1271.3(aa)).
Section 1271.155(f) requires an establishment operating under the terms of an exemption or alternative to maintain documentation of FDA's grant of the exemption or approval and the date on which it began operating under the terms of the exemption or alternative. Section 1271.160(b)(3) requires the quality program of an establishment that performs any step in the manufacture of HCT/Ps to document corrective actions relating to core CGTP requirements. Section 1271.160(b)(6) requires documentation of HCT/P deviations. Section 1271.160(d) requires, in brief, documentation of validation of computer software if the establishment relies upon it to comply with core CGTP requirements. Section 1271.190(d)(2) requires documentation of all cleaning and sanitation activities performed to prevent contamination of HCT/Ps. Section 1271.195(d) requires documentation of environmental control and monitoring activities. Section 1271.200(e) requires documentation of all equipment maintenance, cleaning, sanitizing, calibration, and other activities. Section 1271.210(d) requires, in brief, documentation of the receipt, verification, and use of each supply or reagent. Section 1271.230(a) requires documentation of validation activities and results when the results of processing described in § 1271.220 cannot be fully verified by subsequent inspection and tests. Section 1271.230(c) requires that when changes to a validated process subject to 1271.230(a) occur, documentation of the review and evaluation of the process and revalidation, if necessary, must occur. Section 1271.260(d) and (e) requires documentation of any corrective action taken when proper storage conditions are not met and documentation of the storage temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation that all release criteria have been met before distribution of an HCT/P. Section 1271.265(c)(3) requires documentation of any departure from a procedure relevant to preventing risks of communicable disease transmission at the time of occurrence. Section 1271.265(e) requires documentation of Start Printed Page 41936the activities in paragraphs (a) through (d) of this section, which must include identification of the HCT/P and the establishment that supplied the HCT/P, activities performed and the results of each activity, date(s) of activity, quantity of HCT/P subject to the activity, and disposition of the HCT/P. Section 1271.270(a) requires documentation of each step in manufacturing required in part 1271, subparts C and D. Section 1271.270(e) requires documentation of the name and address, and a list of responsibilities of any establishment that performs a manufacturing step for the establishment. Section 1271.290(d) and (e) require documentation of a method for recording the distinct identification code and type of each HCT/P distributed to a consignee to enable tracking from the consignee to the donor and to enable tracking from the donor to the consignee or final disposition. Section 1271.320(b) requires an establishment to maintain a record of each complaint that it receives. The complaint file must contain sufficient information about each complaint for proper review and evaluation of the complaint and for determining whether the complaint is an isolated event or represents a trend.
There are an estimated 2,706 HCT/P establishments (conventional tissue, eye tissue, peripheral blood stem cell, stem cell products from cord blood, reproductive tissue, and sperm banks), including 741 manufacturers of HCT/P products regulated under the Federal Food, Drug, and Cosmetic Act and section 351 of the PHS Act (42 U.S.C. 262), that have registered and listed with FDA. In addition, we estimate that 218 new establishments have registered with FDA (§§ 1271.10(b)(1) and (b)(2) and 1271.25(a) and (b)). There are an estimated 3,737 listing updates (§§ 1271.10(b)(2), 1271.21(c)(2)(ii), and 1271.25(c)) and 1,222 location/ownership amendments (§ 1271.26).
Under § 1271.55(a), an estimated total of 2,167,396 HCT/Ps (which include conventional tissues, eye tissues, hematopoetic stem cells/progenitor cells, and reproductive cells and tissues), and an estimated total of 2,026,861 non-reproductive cells and tissues (total HCT/Ps minus reproductive cells and tissues) are distributed per year by an estimated 1,965 establishments (2,706 − 741 = 1,965) establishments with approved applications).
Under § 1271.60(c) and (d)(2), FDA estimates that 1,375 establishments shipped an estimated 286,000 HCT/P under quarantine, and that an estimated 26 establishments requested 40 exemptions from or alternative to any requirement under part 1271, subpart C or D, specifically under § 1271.155(a).
FDA estimates that 1,353 HCT/P establishments (2,706 × 50% = 1,353) and 847 non-reproductive HCT/P establishments (1,694 × 50% = 847) record and justify a departure from the procedures (§§ 1271.47(d) and 1271.265(c)(3)).
FDA estimates that 812 HCT/P establishments (2,706 × 30% = 812) document an urgent medical need of the product to notify the physician using the HCT/P (§§ 1271.60(d)(3) and 1271.65(b)(3)).
FDA also estimates that 2,165 HCT/P establishments (2,706 × 80% = 2,165) have to maintain records for an average of 2 contract establishments to perform their manufacturing process (§ 1271.270(e) and 1,353 HCT/P establishments maintain an average of 5 complaint records annually (§ 1271.320(b)).
1271.10(b)(2), 1271.21(c)(2)(ii) and 1271.25(c) 2 3,737 1 3,737 .5 (30 minutes) 1,869
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1271.60(d)(3) and (d)(4) 1271.65(b)(3)(iii) 812 1 812 2 1,624
[FR Doc. 2013-16692 Filed 7-11-13; 8:45 am]