This PDF is the current document as it appeared on Public Inspection on 12/03/2013 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by January 3, 2014.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to email@example.com. All comments should be identified with the OMB control number 0910-0302. Also include the FDA docket number found in brackets in the heading of this document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
FDA PRA Staff, Office of Operations, Food Start Printed Page 72896and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov.End Further Info End Preamble Start Supplemental Information
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Human Tissue Intended for Transplantation—21 CFR Part 1270 (OMB Control Number 0910-0302)—Extension
Under section 361 of the Public Health Services (PHS) Act (42 U.S.C. 264), FDA issued regulations under part 1270 (21 CFR part 1270) to prevent the transmission of human immunodeficiency virus, hepatitis B, and hepatitis C through the use of human tissue for transplantation. The regulations provide for inspection by FDA of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue. These facilities are required to meet provisions intended to ensure appropriate screening and testing of human tissue donors and to ensure that records are kept documenting that the appropriate screening and testing have been completed.
Section 1270.31(a) through (d) requires written procedures be prepared and followed for the following steps: (1) All significant steps in the infectious disease testing process under § 1270.21; (2) all significant steps for obtaining, reviewing, and assessing the relevant medical records of the donor as prescribed in § 1270.21; (3) designating and identifying quarantined tissue; and (4) prevention of infectious disease contamination or cross-contamination by tissue during processing. Section 1270.31(a) and (b) also requires recording and justification of any deviation from the written procedures. Section 1270.33(a) requires records to be maintained concurrently with the performance of each significant step required in the performance of infectious disease screening and testing of human tissue donors. Section 1270.33(f) requires records to be retained regarding the determination of the suitability of the donors and of the records required under § 1270.21. Section 1270.33(h) requires all records to be retained for at least 10 years beyond the date of transplantation if known, distribution, disposition, or expiration of the tissue, whichever is the latest. Section 1270.35(a) through (d) requires specific records to be maintained to document the following: (1) The results and interpretation of all required infectious disease tests; (2) information on the identity and relevant medical records of the donor; (3) the receipt and/or distribution of human tissue; and (4) the destruction or other disposition of human tissue.
Respondents to this collection of information are manufacturers of human tissue intended for transplantation. Based on information from the Center for Biologics Evaluation and Research's (CBER's) database system, FDA estimates that there are approximately 281 tissue establishments of which 185 are conventional tissue banks and 96 are eye tissue banks. Based on information provided by industry, there are an estimated total of 1,959,270 conventional tissue products and 82,741 eye tissue products distributed per year with an average of 25 percent of the tissue discarded due to unsuitability for transplant. In addition, there are an estimated 30,380 donors of conventional tissue and 49,026 donors of eye tissue each year.
Accredited members of the American Association of Tissue Banks (AATB) and Eye Bank Association of America (EBAA) adhere to standards of those organizations that are comparable to the recordkeeping requirements in part 1270. Based on information provided by CBER's database system, 90 percent of the conventional tissue banks are members of AATB (185 × 90 percent = 166), and 85 percent of eye tissue banks are members of EBAA (96 × 85 percent = 82). Therefore, recordkeeping by these 248 establishments (166 + 82 = 248) is excluded from the burden estimates as usual and customary business activities (5 CFR 1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the remaining 33 establishments, which is 12 percent of all establishments (281−248 = 33, or 33 ÷ 281 = 12 percent).
FDA assumes that all current tissue establishments have developed written procedures in compliance with part 1270. Therefore, their information collection burden is for the general review and update of written procedures estimated to take an annual average of 24 hours, and for the recording and justifying of any deviations from the written procedures under § 1270.31(a) and (b), estimated to take an annual average of 1 hour. The information collection burden for maintaining records concurrently with the performance of each significant screening and testing step and for retaining records for 10 years under § 1270.33(a), (f), and (h) include documenting the results and interpretation of all required infectious disease tests and results, and the identity and relevant medical records of the donor required under § 1270.35(a) and (b). Therefore, the burden under these provisions is calculated together in table 1 of this document. The recordkeeping estimates for the number of total annual records and hours per record are based on information provided by industry and FDA experience.
In the Federal Register of July 10, 2013 (78 FR 41403), FDA published a 60-day notice requesting public comment on the proposed collection of information. One letter of comment was received from a trade organization. The comment requested that the notice be corrected to reflect that an estimated total of 1,959,270 conventional tissue products are distributed (not recovered) per year. The comment also requested a revision in the number of donors of conventional tissues based on the AATB Annual Survey 2007. FDA agrees with these comments and made the recommended changes.
FDA estimates the burden of this information collection as follows:
|21 CFR Part||Number of recordkeepers||Number of records per recordkeeper||Total annual records||Average burden per recordkeeping||Total hours|
|1270.31(a), (b), (c), and (d) 2||33||1||33||24||792|
|1270.31(a) and 1270.31(b) 3||33||2||66||1||66|
|1270.33(a), (f), and (h), and 1270.35(a) and (b)||33||7,714.24||254,570||1||254,570|
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|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
|2 Review and update of standard operating procedures (SOPs).|
|3 Documentation of deviations from SOPs.|
Dated: November 27, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-28989 Filed 12-3-13; 8:45 am]
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