Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice, 61685-61690 [2016-21351]

Download as PDF 61685 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices Elaine L. Baker, MPH, DLP, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). DEPARTMENT OF HEALTH AND HUMAN SERVICES comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0607. Also include the FDA docket number found in brackets in the heading of this document. Food and Drug Administration FOR FURTHER INFORMATION CONTACT: [FR Doc. 2016–21400 Filed 9–6–16; 8:45 am] BILLING CODE 4163–18–P [Docket No. FDA–2013–N–0514] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. DATES: Fax written comments on the collection of information by October 7, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Requests for Clinical Laboratory Improvement Amendments of 1988 Categorization—42 CFR 493.17—OMB Control Number 0910–0607—Extension A guidance document entitled ‘‘Guidance for Administrative Procedures for CLIA Categorization’’ was released on May 7, 2008. The document describes procedures FDA uses to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In this way, no additional burden is incurred by the manufacturer because the labeling (including operating instructions) is included in the premarket notification (510(k)) or premarket approval application (PMA). In some cases, however, a manufacturer may request Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization (e.g. name change, exempt from 510(k) review). The guidance recommends that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available. In the Federal Register of April 27, 2016 (81 FR 24820), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Request for CLIA Categorization ............. mstockstill on DSK3G9T082PROD with NOTICES 1 Number of responses per respondent 60 Total annual responses 15 Average burden per response 900 Total hours 1 Total operating and maintenance costs 900 $46,800 There are no capital costs associated with this collection of information. The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $52 per hour (52 × 900), totaling $46,800. This includes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. The burden hours are based on FDA familiarity with the types of documentation typically included in a sponsor’s categorization requests, and costs for basic office supplies (e.g., paper). VerDate Sep<11>2014 18:44 Sep 06, 2016 Jkt 238001 Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–21352 Filed 9–6–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0731] Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and TissueBased Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice AGENCY: Food and Drug Administration, HHS. ACTION: Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM Notice. 07SEN1 61686 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for FDA regulations related to human cells, tissues, and cellular and tissuebased products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP). DATES: Submit either written or electronic comments on the collection of information by November 7, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions mstockstill on DSK3G9T082PROD with NOTICES Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2013–N–0731 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and TissueBased Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A– 12M, North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice—OMB Control Number 0910–0543—Extension Under section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States or possessions or from foreign E:\FR\FM\07SEN1.SGM 07SEN1 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES countries into the States. As derivatives of the human body, all HCT/Ps pose some risk of carrying pathogens that could potentially infect recipients or handlers. FDA has issued regulations related to HCT/Ps involving establishment registration and listing using Form FDA 3356, eligibility determination for donors, and CGTP. Establishment Registration and Listing; Form FDA 3356 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 TissueBased 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 at http://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/ EstablishmentRegistration/ TissueEstablishmentRegistration/ default.htm. Form FDA 3356 is being revised as follows: (1) Adding import contact information including an email address and phone number; (2) deleting columns related to HCT/Ps subject to registration and listing under 21 CFR part 207 or 807; and (3) revising the instructions accordingly. The estimated burden is not affected by these changes. Eligibility Determination for Donors In brief, FDA requires certain HCT/P establishments described in § 1271.1(b) to determine donor eligibility based on VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 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 urgent medical need, as defined in § 1271.3(u) (§ 1271.60). Once the donoreligibility 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)). When a product is shipped in quarantine, as defined in § 1271.3(q), before completion of screening and testing, the HCT/P must be accompanied by records identifying the donor stating that the donor-eligibility determination has not been completed and stating that the product must not be implanted, transplanted, infused, or transferred until completion of the donor-eligibility determination, except in cases of urgent medical need, as PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 61687 defined in § 1271.3(u) (§ 1271.60(c)). When a HCT/P is used in cases of documented urgent medical need, the results of any completed donor screening and testing, and a list of any required screening and testing that has not yet been completed also must accompany the HCT/P (§ 1271.60(d)(2)). When a HCT/P is used in cases of urgent medical need or from a donor who has been determined to be ineligible (as permitted under § 1271.65), documentation by the HCT/P establishment is required showing that the recipient’s physician received notification that the testing and screening were not complete (in cases of urgent medical need), and upon the completion of the donor-eligibility determination, of the results of the determination (§§ 1271.60(d)(3) and (d)(4), and 1271.65(b)(3)). An HCT/P establishment is also required to establish and maintain procedures for all steps that are performed in determining eligibility (§ 1271.47(a)), including the use of a product from a donor of viable, leukocyte-rich cells or tissue testing reactive for cytomegalovirus (§ 1271.85(b)(2)). The HCT/P establishment must record and justify any departure from a procedure relevant to preventing risks of communicable disease transmission at the time of its occurrence (§ 1271.47(d)). Current Good Tissue Practice (CGTP) 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 number 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. E:\FR\FM\07SEN1.SGM 07SEN1 mstockstill on DSK3G9T082PROD with NOTICES 61688 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices The standard operating procedures (SOP) provisions under part 1271 include the following: (1) § 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 VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 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 the 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. Respondents to this information collection are establishments that recover, process, store, label, package, or distribute any HCT/P, or perform donor screening or testing. The estimates provided below are based on most recent available information from FDA’s database system and trade organizations. The hours per response and hours per record are based on data provided by the Eastern Research Group, or FDA experience with similar recordkeeping or reporting requirements. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 There are an estimated 2,218 HCT/P establishments (conventional tissue, eye tissue, peripheral blood stem cell, stem cell products from cord blood, reproductive tissue, and sperm banks), including 667 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 182 new establishments have registered with FDA (§§ 1271.10(b)(1) and (b)(2) and 1271.25(a) and (b)). There are an estimated 1,221 listing updates (§§ 1271.10(b)(2), 1271.21(c)(ii), and 1271.25(c)) and 588 location/ownership amendments (§ 1271.26). Under § 1271.55(a), an estimated total of 2,206,890 HCT/Ps (which include conventional tissues, eye tissues, hematopoetic stem cells/progenitor cells, and reproductive cells and tissues), and an estimated total of 2,066,890 non-reproductive cells and tissues (total HCT/Ps minus reproductive cells and tissues) are distributed per year by an estimated 1,551 establishments (2,218¥667 = 1,551) with approved applications). Under § 1271.60(c) and (d)(2), FDA estimates that 1,375 establishments shipped an estimated 572,000 HCT/P under quarantine, and that an estimated 25 establishments requested 78 exemptions from or alternative to any requirement under part 1271, subpart C or D, specifically under § 1271.155(a). Under §§ 1271.290(c) and 1271.370(b) and (c), the estimated 1,561 nonreproductive HCT/P establishments label each of their 2,066,890 HCT/Ps with certain information. These establishments are also required to inform their consignees in writing of the requirements for tracking and of their established tracking system under § 1271.290(f). FDA estimates 34 HCT/P establishments submitted 166 adverse reaction reports with 136 involving a communicable disease (§ 1271.350(a)(1)). FDA estimates that 182 new establishments will create SOPs, and that 2,218 establishments will review and revise existing SOPs annually. FDA estimates that 1,109 HCT/P establishments (2,218 × 50 percent = 1,109) and 781 non-reproductive HCT/ P establishments (1,561 × 50 percent = 781) record and justify a departure from the procedures (§§ 1271.47(d) and 1271.265(c)(3)). Under § 1271.50(a), HCT/P establishments are required to have a documented medical history interview about the donor’s medical history and relevant social behavior as part of the E:\FR\FM\07SEN1.SGM 07SEN1 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices donor’s relevant medical records for each of the estimated total of 109,019 donors (which include conventional tissue donors, eye tissue donors, peripheral and cord blood stem cell donors, and reproductive cell and tissue donors), and the estimated total of 103,419 non-reproductive cells and tissue donors (total donors minus reproductive cell and tissue donors). FDA estimates that 665 HCT/P establishments (2,218 × 30 percent = 665) 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 1,774 HCT/P establishments (2,218 × 80 percent = 1,774) have to maintain records for an average of 2 contract establishments to perform their manufacturing process (§ 1271.270(e), and 1,249 HCT/P establishments (1,561 × 80 percent = 1,249) maintain an average of 5 61689 complaint records annually (§ 1271.320(b)). In some cases, the estimated burden may appear to be lower or higher than the burden experienced by individual establishments. The estimated burden in these charts is an estimated average burden, taking into account the range of impact each regulation may have. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section Number of responses per respondent Total annual responses Average burden per response Total hours 3 1271.10(b)(1) and 1271.21(b) 2 ............................... 1271.10(b)(1) and (b)(2), 1271.21(a), and 1271.25(a) and (b) 2 1271.10(b)(2), 1271.21(c)(2)(ii) and 1271.25(c) 2 .... 1271.26 2 .................................................................. 1271.155(a) .............................................................. 1271.350(a)(1) and (a)(3) ........................................ 2,218 182 1 1 2,218 182 .5 (30 minutes) .......... .75 (45 minutes) ........ 1,109 137 1,221 588 25 34 1 1 3.12 4.88 1,221 588 78 166 .5 (30 minutes) .......... .25 (15 minutes) ........ 3 ................................ 1 ................................ 611 147 234 166 Total .................................................................. ........................ ........................ ........................ .................................... 2,404 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Form FDA 3356. 3 Rounded to the nearest whole number. 2 Using TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of record-keepers mstockstill on DSK3G9T082PROD with NOTICES 21 CFR Section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 3 New SOPs 2 ............................................................. SOP Update 2 ........................................................... 1271.47(d) ................................................................ 1271.50(a) ................................................................ 1271.55(d)(1) ........................................................... 1271.55(d)(2) ........................................................... 1271.55(d)(4) ........................................................... 1271.60(d)(3) and (d)(4) 1271.65(b)(3)(iii) .............. 1271.155(f) ............................................................... 1271.160(b)(3) and (b)(6) ........................................ 1271.160(d) .............................................................. 1271.190(d)(2) ......................................................... 1271.195(d) .............................................................. 1271.200(e) .............................................................. 1271.210(d) .............................................................. 1271.230(a) .............................................................. 1271.230(c) .............................................................. 1271.260(d) .............................................................. 1271.260(e) .............................................................. 1271.265(c)(1) .......................................................... 1271.265(c)(3) .......................................................... 1271.265(e) .............................................................. 1271.270(a) .............................................................. 1271.270(e) .............................................................. 1271.290(d) and (e) ................................................. 1271.320(b) .............................................................. 182 2,218 1,109 2,218 2,218 2,218 2,218 665 25 1,561 1,561 1,561 1,561 1,561 1,561 1,561 1,561 1,561 1,561 1,561 781 1,561 1,561 1,774 1,561 1,249 1 1 1 49.15 49.15 1 1 1 3.12 12 12 12 12 12 12 12 1 12 365 1,324.08 1 1,324.08 1,324.08 2 66.25 5 182 2,218 1,109 109,019 109,019 2,218 2,218 665 78 18,732 18,732 18,732 18,732 18,732 18,732 18,732 1,561 18,732 569,765 2,066,890 781 2,066,890 2,066,890 3,548 103,419 6,245 48 .............................. 24 .............................. 1 ................................ 5 ................................ 1 ................................ 1 ................................ 120 ............................ 2 ................................ .25 (15 minutes) ........ 1 ................................ 1 ................................ 1 ................................ 1 ................................ 1 ................................ 1 ................................ 1 ................................ 1 ................................ .25 (15 minutes) ........ .083 (5 minutes) ........ .083 (5 minutes) ........ 1 ................................ .083 (5 minutes) ........ .25 (15 minutes) ........ .5 (30 minutes) .......... .25 (15 minutes) ........ 1 ................................ 8,736 53,232 1,109 545,095 109,019 2,218 266,160 1,330 20 18,732 18,732 18,732 18,732 18,732 18,732 18,732 1,561 4,683 47,291 171,552 781 171,552 516,723 1,774 25,855 6,245 Total .................................................................. ........................ ........................ ........................ .................................... 2,066,060 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 1271.250(a), and 1271.265(e). 3 Rounded to the nearest whole number. 2 Sections VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1 61690 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents 21 CFR Section Total annual disclosures Average burden per disclosure Total hours 1271.55(a) ................................................................ 1271.60(c) and (d)(2) ............................................... 1271.290(c) .............................................................. 1271.290(f) ............................................................... 1271.370(b) and (c) ................................................. 1,551 1,375 1,561 1,561 1,561 1,422.88 416 1,324.08 1 1,324.08 2,206,890 572,000 2,066,890 1,561 2,066,890 .5 (30 minutes) .......... .5 (30 minutes) .......... .083 (5 minutes) ........ 1 ................................ .25 (15 minutes) ........ 1,103,445 286,000 171,552 1,561 516,723 Total .................................................................. ........................ ........................ ........................ .................................... 2,079,281 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 31, 2016. Leslie Kux, Associate Commissioner for Policy. FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. [FR Doc. 2016–21351 Filed 9–6–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1486] Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as requested by Viracor-IBT Laboratories, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:30 Sep 06, 2016 The Authorization is effective as of July 19, 2016. ADDRESSES: Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. DATES: BILLING CODE 4164–01–P Jkt 238001 FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F–2 of the Public Health Service (PHS) Act (42 U.S.C. 247d–6b) sufficient to affect national security or the health and security of U.S. citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61685-61690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21351]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0731]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based 
Products: Establishment Registration and Listing; Eligibility 
Determination for Donors; and Current Good Tissue Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 61686]]

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements for FDA regulations related to human cells, tissues, and 
cellular and tissue-based products (HCT/Ps) involving establishment 
registration and listing using Form FDA 3356; eligibility determination 
for donors; and current good tissue practice (CGTP).

DATES: Submit either written or electronic comments on the collection 
of information by November 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0731 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Human Cells, Tissues, and 
Cellular and Tissue-Based Products: Establishment Registration and 
Listing; Eligibility Determination for Donors; and Current Good Tissue 
Practice.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 11601 Landsdown 
St., 10A-12M, North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Human Cells, Tissues, and Cellular and Tissue-Based Products: 
Establishment Registration and Listing; Eligibility Determination for 
Donors; and Current Good Tissue Practice--OMB Control Number 0910-
0543--Extension

    Under section 361 of the Public Health Service Act (the PHS Act) 
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to 
prevent the introduction, transmission, or spread of communicable 
diseases between the States or possessions or from foreign

[[Page 61687]]

countries into the States. As derivatives of the human body, all HCT/Ps 
pose some risk of carrying pathogens that could potentially infect 
recipients or handlers. FDA has issued regulations related to HCT/Ps 
involving establishment registration and listing using Form FDA 3356, 
eligibility determination for donors, and CGTP.

Establishment Registration and Listing; Form FDA 3356

    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 Sec.  1271.10(a), or that 
perform screening or testing of the cell or tissue donor to register 
with FDA (Sec.  1271.10(b)(1)) and submit a list of each HCT/P 
manufactured (Sec.  1271.10(b)(2)). Section 1271.21(a) requires an 
establishment to follow certain procedures for initial registration and 
listing of HCT/Ps, and Sec.  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 Sec.  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 (Sec. Sec.  1271.10, 1271.21, 1271.25, and 1271.26). To 
further facilitate the ease and speed of submissions, electronic 
submission is accepted at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm.
    Form FDA 3356 is being revised as follows: (1) Adding import 
contact information including an email address and phone number; (2) 
deleting columns related to HCT/Ps subject to registration and listing 
under 21 CFR part 207 or 807; and (3) revising the instructions 
accordingly. The estimated burden is not affected by these changes.

Eligibility Determination for Donors

    In brief, FDA requires certain HCT/P establishments described in 
Sec.  1271.1(b) to determine donor eligibility based on donor screening 
and testing for relevant communicable disease agents and diseases 
except as provided under Sec.  1271.90. The documented determination of 
a donor's eligibility is made by a responsible person as defined in 
Sec.  1271.3(t) and is based on the results of required donor 
screening, which includes a donor medical history interview (defined in 
Sec.  1271.3(n)), and testing (Sec.  1271.50(a)). Certain records must 
accompany an HCT/P once the donor-eligibility determination has been 
made (Sec.  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 urgent medical 
need, as defined in Sec.  1271.3(u) (Sec.  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 (Sec.  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 (Sec.  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 Sec.  1271.3(t)) who made the donor-eligibility 
determination and the date of the determination, must be maintained 
(Sec.  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 (Sec.  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 (Sec.  
1271.55(d)(4)).
    When a product is shipped in quarantine, as defined in Sec.  
1271.3(q), before completion of screening and testing, the HCT/P must 
be accompanied by records identifying the donor stating that the donor-
eligibility determination has not been completed and stating that the 
product must not be implanted, transplanted, infused, or transferred 
until completion of the donor-eligibility determination, except in 
cases of urgent medical need, as defined in Sec.  1271.3(u) (Sec.  
1271.60(c)). When a HCT/P is used in cases of documented urgent medical 
need, the results of any completed donor screening and testing, and a 
list of any required screening and testing that has not yet been 
completed also must accompany the HCT/P (Sec.  1271.60(d)(2)). When a 
HCT/P is used in cases of urgent medical need or from a donor who has 
been determined to be ineligible (as permitted under Sec.  1271.65), 
documentation by the HCT/P establishment is required showing that the 
recipient's physician received notification that the testing and 
screening were not complete (in cases of urgent medical need), and upon 
the completion of the donor-eligibility determination, of the results 
of the determination (Sec. Sec.  1271.60(d)(3) and (d)(4), and 
1271.65(b)(3)).
    An HCT/P establishment is also required to establish and maintain 
procedures for all steps that are performed in determining eligibility 
(Sec.  1271.47(a)), including the use of a product from a donor of 
viable, leukocyte-rich cells or tissue testing reactive for 
cytomegalovirus (Sec.  1271.85(b)(2)). The HCT/P establishment must 
record and justify any departure from a procedure relevant to 
preventing risks of communicable disease transmission at the time of 
its occurrence (Sec.  1271.47(d)).

Current Good Tissue Practice (CGTP)

    FDA requires HCT/P establishments to follow CGTP (Sec.  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, Sec.  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 Sec.  
1271.10 are required under Sec.  1271.350(a)(1) and (a)(3) to 
investigate and report to FDA adverse reactions (defined in Sec.  
1271.3(y)) using Form FDA 3500A (Sec.  1271.350(a)(2)). Form FDA 3500A 
is approved under OMB control number 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.

[[Page 61688]]

    The standard operating procedures (SOP) provisions under part 1271 
include the following: (1) Sec.  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) Sec.  1271.180(a) (to 
meet core CGTP requirements for all steps performed in the manufacture 
of HCT/Ps); (3) Sec.  1271.190(d)(1) (facility cleaning and 
sanitization); (4) Sec.  1271.200(b) (cleaning, sanitizing, and 
maintenance of equipment); (5) Sec.  1271.200(c) (calibration of 
equipment); (6) Sec.  1271.230(a) and (c) (validation of a process and 
review and evaluation of changes to a validated process); (7) Sec.  
1271.250(a) (controls for labeling HCT/Ps); (8) Sec.  1271.265(e) 
(receipt, predistribution shipment, availability for distribution, and 
packaging and shipping of HCT/Ps); (9) Sec.  1271.265(f) (suitable for 
return to inventory); (10) Sec.  1271.270(b) (records management 
system); (11) Sec.  1271.290(b)(1) (system of HCT/P tracking); and (12) 
Sec.  1271.320(a) (review, evaluation, and documentation of complaints 
as defined in Sec.  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 Sec.  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 Sec.  
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 the 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.
    Respondents to this information collection are establishments that 
recover, process, store, label, package, or distribute any HCT/P, or 
perform donor screening or testing. The estimates provided below are 
based on most recent available information from FDA's database system 
and trade organizations. The hours per response and hours per record 
are based on data provided by the Eastern Research Group, or FDA 
experience with similar recordkeeping or reporting requirements.
    There are an estimated 2,218 HCT/P establishments (conventional 
tissue, eye tissue, peripheral blood stem cell, stem cell products from 
cord blood, reproductive tissue, and sperm banks), including 667 
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 182 
new establishments have registered with FDA (Sec. Sec.  1271.10(b)(1) 
and (b)(2) and 1271.25(a) and (b)). There are an estimated 1,221 
listing updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(ii), and 
1271.25(c)) and 588 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.55(a), an estimated total of 2,206,890 HCT/Ps 
(which include conventional tissues, eye tissues, hematopoetic stem 
cells/progenitor cells, and reproductive cells and tissues), and an 
estimated total of 2,066,890 non-reproductive cells and tissues (total 
HCT/Ps minus reproductive cells and tissues) are distributed per year 
by an estimated 1,551 establishments (2,218-667 = 1,551) with approved 
applications).
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,375 
establishments shipped an estimated 572,000 HCT/P under quarantine, and 
that an estimated 25 establishments requested 78 exemptions from or 
alternative to any requirement under part 1271, subpart C or D, 
specifically under Sec.  1271.155(a).
    Under Sec. Sec.  1271.290(c) and 1271.370(b) and (c), the estimated 
1,561 non-reproductive HCT/P establishments label each of their 
2,066,890 HCT/Ps with certain information. These establishments are 
also required to inform their consignees in writing of the requirements 
for tracking and of their established tracking system under Sec.  
1271.290(f).
    FDA estimates 34 HCT/P establishments submitted 166 adverse 
reaction reports with 136 involving a communicable disease (Sec.  
1271.350(a)(1)).
    FDA estimates that 182 new establishments will create SOPs, and 
that 2,218 establishments will review and revise existing SOPs 
annually.
    FDA estimates that 1,109 HCT/P establishments (2,218 x 50 percent = 
1,109) and 781 non-reproductive HCT/P establishments (1,561 x 50 
percent = 781) record and justify a departure from the procedures 
(Sec. Sec.  1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT/P establishments are required to have a 
documented medical history interview about the donor's medical history 
and relevant social behavior as part of the

[[Page 61689]]

donor's relevant medical records for each of the estimated total of 
109,019 donors (which include conventional tissue donors, eye tissue 
donors, peripheral and cord blood stem cell donors, and reproductive 
cell and tissue donors), and the estimated total of 103,419 non-
reproductive cells and tissue donors (total donors minus reproductive 
cell and tissue donors).
    FDA estimates that 665 HCT/P establishments (2,218 x 30 percent = 
665) document an urgent medical need of the product to notify the 
physician using the HCT/P (Sec. Sec.  1271.60(d)(3) and 1271.65(b)(3)).
    FDA also estimates that 1,774 HCT/P establishments (2,218 x 80 
percent = 1,774) have to maintain records for an average of 2 contract 
establishments to perform their manufacturing process (Sec.  
1271.270(e), and 1,249 HCT/P establishments (1,561 x 80 percent = 
1,249) maintain an average of 5 complaint records annually (Sec.  
1271.320(b)).
    In some cases, the estimated burden may appear to be lower or 
higher than the burden experienced by individual establishments. The 
estimated burden in these charts is an estimated average burden, taking 
into account the range of impact each regulation may have.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR Section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses                                                      \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b) \2\............           2,218               1           2,218  .5 (30 minutes)...........................           1,109
1271.10(b)(1) and (b)(2), 1271.21(a), and                182               1             182  .75 (45 minutes)..........................             137
 1271.25(a) and (b) \2\
1271.10(b)(2), 1271.21(c)(2)(ii) and                   1,221               1           1,221  .5 (30 minutes)...........................             611
 1271.25(c) \2\.
1271.26 \2\.................................             588               1             588  .25 (15 minutes)..........................             147
1271.155(a).................................              25            3.12              78  3.........................................             234
1271.350(a)(1) and (a)(3)...................              34            4.88             166  1.........................................             166
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           2,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Using Form FDA 3356.
\3\ Rounded to the nearest whole number.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR Section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                              record-keepers   recordkeeper       records                                                       \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
New SOPs \2\................................             182               1             182  48........................................           8,736
SOP Update \2\..............................           2,218               1           2,218  24........................................          53,232
1271.47(d)..................................           1,109               1           1,109  1.........................................           1,109
1271.50(a)..................................           2,218           49.15         109,019  5.........................................         545,095
1271.55(d)(1)...............................           2,218           49.15         109,019  1.........................................         109,019
1271.55(d)(2)...............................           2,218               1           2,218  1.........................................           2,218
1271.55(d)(4)...............................           2,218               1           2,218  120.......................................         266,160
1271.60(d)(3) and (d)(4) 1271.65(b)(3)(iii).             665               1             665  2.........................................           1,330
1271.155(f).................................              25            3.12              78  .25 (15 minutes)..........................              20
1271.160(b)(3) and (b)(6)...................           1,561              12          18,732  1.........................................          18,732
1271.160(d).................................           1,561              12          18,732  1.........................................          18,732
1271.190(d)(2)..............................           1,561              12          18,732  1.........................................          18,732
1271.195(d).................................           1,561              12          18,732  1.........................................          18,732
1271.200(e).................................           1,561              12          18,732  1.........................................          18,732
1271.210(d).................................           1,561              12          18,732  1.........................................          18,732
1271.230(a).................................           1,561              12          18,732  1.........................................          18,732
1271.230(c).................................           1,561               1           1,561  1.........................................           1,561
1271.260(d).................................           1,561              12          18,732  .25 (15 minutes)..........................           4,683
1271.260(e).................................           1,561             365         569,765  .083 (5 minutes)..........................          47,291
1271.265(c)(1)..............................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.265(c)(3)..............................             781               1             781  1.........................................             781
1271.265(e).................................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.270(a).................................           1,561        1,324.08       2,066,890  .25 (15 minutes)..........................         516,723
1271.270(e).................................           1,774               2           3,548  .5 (30 minutes)...........................           1,774
1271.290(d) and (e).........................           1,561           66.25         103,419  .25 (15 minutes)..........................          25,855
1271.320(b).................................           1,249               5           6,245  1.........................................           6,245
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       2,066,060
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 1271.250(a), and
  1271.265(e).
\3\ Rounded to the nearest whole number.


[[Page 61690]]


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                                                 Number of      disclosures    Total annual
               21 CFR Section                   respondents         per         disclosures          Average burden per disclosure          Total hours
                                                                respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(a)..................................           1,551        1,422.88       2,206,890  .5 (30 minutes)...........................       1,103,445
1271.60(c) and (d)(2).......................           1,375             416         572,000  .5 (30 minutes)...........................         286,000
1271.290(c).................................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.290(f).................................           1,561               1           1,561  1.........................................           1,561
1271.370(b) and (c).........................           1,561        1,324.08       2,066,890  .25 (15 minutes)..........................         516,723
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       2,079,281
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21351 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-P