Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice, 16040-16044 [2017-06398]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES 16040 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices Revocable Trust dated October 7, 2008, James P. Stein Trust Number One, and the Inter Vivos Stock Trust of Simon G. Stein IV FBO James P. Stein, Muscatine, Iowa; James P. Stein as trustee of the James P. Stein Revocable Trust dated December 16, 2005 and the Inter Vivos Stock Trust of Simon G. Stein IV FBO James P. Stein, Muscatine, Iowa; Timothy J. Stein as trustee of the Timothy J. Stein Revocable Trust dated August 10, 2012, James P. Stein Trust Number One, and the Inter Vivos Stock Trust of Simon G. Stein IV FBO James P. Stein, Lakeway, Texas; Carrie A. Zorich as trustee of the Carrie A. Zorich Revocable Trust dated July 23, 2007, James P. Stein Trust Number One, and the Inter Vivos Stock Trust of Simon G. Stein IV FBO James P. Stein, Muscatine, Iowa; Maryann Bramhall-Lambert as trustee of the GST Exempt Trust for benefit of James P. Stein Family, Iowa City, Iowa; GST Exempt Trust for benefit of James P. Stein Family, Muscatine, Iowa; Daniel P. Stein Revocable Trust dated October 7, 2008, Muscatine, Iowa; James P. Stein Revocable Trust dated December 16, 2005, Muscatine, Iowa; Timothy J. Stein Revocable Trust dated August 10, 2012, Lakeway, Texas; Carrie A. Zorich Revocable Trust dated July 23, 2007, Muscatine, Iowa; James P. Stein Trust Number One, Muscatine, Iowa; Inter Vivos Stock Trust of Simon G. Stein IV FBO James P. Stein, Muscatine, Iowa; Thomas L. Lambert, Iowa City, Iowa; Francis L. Lambert, Rock Island, Illinois; and Susan M. Yeast, West Liberty, Iowa; in addition to, James P. Stein; Timothy J. Stein; Carrie A. Zorich; Daniel P. Stein; Benjamin L. Parks, Iowa City, Iowa; William M. Parks; and Ruth M. Parks, Muscatine, Iowa, as members of Sawyer Group Family Council which votes and controls shares owned by the Ann F. Parks Special Trust Number One; GST Exempt Trust for benefit of James P. Stein Family; Daniel P. Stein Revocable Trust dated October 7, 2008; James P. Stein Revocable Trust dated December 16, 2005; Timothy J. Stein Revocable Trust dated August 10, 2012; Carrie A. Zorich Revocable Trust dated July 23, 2007; James P. Stein Trust Number One; and the Inter Vivos Stock Trust of Simon G. Stein IV FBO James P. Stein, as a group acting in concert; to retain voting shares of Central Bancshares, Inc. and thereby indirectly retain shares of CBI Bank & Trust, Muscatine, Iowa, and The Farmers and Mechanics Bank, Galesburg, Illinois. B. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166–2034. Comments can also be sent VerDate Sep<11>2014 16:31 Mar 30, 2017 Jkt 241001 electronically to Comments.applications@stls.frb.org: 1. Craig L. Weiss, Memphis, Tennessee; to acquire shares of Paragon Financial Solutions, Inc., and thereby indirectly acquire shares of Paragon Bank, both of Memphis, Tennessee. C. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. Keitha Ann Nilsson, Daingerfield, Texas, and Mickey Wiley Carter, Jr., Omaha, Texas; to join the Holton Family Group, a group acting in concert; to retain voting shares of WSB Bancshares, Inc., and indirectly retain shares of Wellington State Bank, both of Wellington, Texas. Board of Governors of the Federal Reserve System, March 28, 2017. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2017–06394 Filed 3–30–17; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 27, 2017. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 A. Federal Reserve Bank of Philadelphia (William Spaniel, Senior Vice President) 100 North 6th Street, Philadelphia, Pennsylvania 19105– 1521. Comments can also be sent electronically to Comments.applications@phil.frb.org: 1. Hamilton Bancorp, Inc., Ephrata, Pennsylvania; to become a bank holding company by acquiring Stonebridge Bank, West Chester, Pennsylvania. Board of Governors of the Federal Reserve System, March 28, 2017. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2017–06395 Filed 3–30–17; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0731] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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: Notice. The Food and Drug Administration (FDA or we) 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 May 1, 2017. SUMMARY: 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0543. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: For specific questions for FDA related to this document, contact JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White FOR FURTHER INFORMATION CONTACT: E:\FR\FM\31MRN1.SGM 31MRN1 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–3794. 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. sradovich on DSK3GMQ082PROD with NOTICES 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 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 Current Good Tissue Practice (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 VerDate Sep<11>2014 16:31 Mar 30, 2017 Jkt 241001 further facilitate the ease and speed of submissions, electronic submission is accepted at http://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ EstablishmentRegistration/Tissue EstablishmentRegistration/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 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 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 16041 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 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 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 E:\FR\FM\31MRN1.SGM 31MRN1 sradovich on DSK3GMQ082PROD with NOTICES 16042 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices 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. The standard operating procedures (SOP) 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 VerDate Sep<11>2014 16:31 Mar 30, 2017 Jkt 241001 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 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 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 proper review and evaluation of the complaint and for determining whether the complaint is an isolated event or represents a trend. Section 1271.420(a) requires importers of HCT/Ps to notify FDA District Director having jurisdiction over the port of entry through which the HCT/Ps are offered for import. The HCT/Ps must be held intact or transported under quarantine until they are inspected and released by FDA. 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 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 (§§ 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 E:\FR\FM\31MRN1.SGM 31MRN1 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices 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 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 16043 complaint records annually (§ 1271.320(b)). FDA estimates that under 1271.420(a), 200 establishments will submit 560 reports of HCT/Ps offered for imports. 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 on respondents. In the Federal Register of September 7, 2016 (81 FR 61685), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. One comment was received beyond the scope of the four information collection topics solicited and therefore we have not discussed it in this document. 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) ........................................ 1271.420(a) .............................................................. 2,218 182 1 1 2,218 182 .5 (30 minutes) .......... .75 (45 minutes) ........ 1,109 137 1,221 588 25 34 200 1 1 3.12 4.88 2.8 1,221 588 78 166 560 .5 (30 minutes) .......... .25 (15 minutes) ........ 3 ................................ 1 ................................ .25 (15 minutes) ........ 611 147 234 166 140 Total .................................................................. ........................ ........................ ........................ .................................... 2,544 1 There 2 Using are no capital costs or operating and maintenance costs associated with this collection of information. Form FDA 3356. to the nearest whole number. 3 Rounded TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers sradovich on DSK3GMQ082PROD with NOTICES 21 CFR section 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) .......................................................... VerDate Sep<11>2014 16:31 Mar 30, 2017 Jkt 241001 PO 00000 Number of records per recordkeeper 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 Frm 00025 Fmt 4703 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 Sfmt 4703 Total annual records 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 E:\FR\FM\31MRN1.SGM Average burden per recordkeeping 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 ................................ 31MRN1 Total hours 3 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 16044 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers 21 CFR section 1271.265(e) 1271.270(a) 1271.270(e) 1271.290(d) 1271.320(b) Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 3 .............................................................. .............................................................. .............................................................. and (e) ................................................. .............................................................. 1,561 1,561 1,774 1,561 1,249 1,324.08 1,324.08 2 66.25 5 2,066,890 2,066,890 3,548 103,419 6,245 .083 (5 minutes) ........ .25 (15 minutes) ........ .5 (30 minutes) .......... .25 (15 minutes) ........ 1 ................................ 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), 1271.265(e), 1271.265(f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a). 3 Rounded to the nearest whole number. 2 Sections TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents 21 CFR section Number of disclosures per respondent 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: March 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–06398 Filed 3–30–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Roadmap for Engaging With the Food and Drug Administration’s Center for Drug Evaluation and Research; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), is announcing the following public workshop entitled ‘‘Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research (CDER).’’ The purpose of this workshop is to help the public learn how to successfully engage with CDER. DATES: The public workshop will be held on May 12, 2017, from 9 a.m. to 3 p.m. sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:31 Mar 30, 2017 Jkt 241001 The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20903–0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Chris Melton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–7381, NAVCDER@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public workshop entitled ‘‘Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research (CDER).’’ This workshop is intended to help the public learn the most effective ways to successfully engage with CDER. There will be presentations on learning about the drug approval process, as well as the PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 opportunity for questions and answers following each presentation. II. Participating in the Public Workshop Registration: Persons interested in attending this workshop must register online at https://www.eventbrite.com/e/ fda-public-workshop-roadmap-forengaging-with-fdas-center-for-drugevaluation-and-research-cder-tickets28608664285?utm_source=eb_ email&utm_medium=email&utm_ campaign=new_event_email&utm_ term=viewmyevent_button. Please provide complete contact information for each attendee, including name, title, affiliation, address, email and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by May 5, 2016, 6 p.m. EST. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public workshop. If you need special accommodations due to a disability, please contact Chris Melton no later than May 1, 2017. E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 82, Number 61 (Friday, March 31, 2017)]
[Notices]
[Pages 16040-16044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06398]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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 May 1, 
2017.

ADDRESSES: 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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0543. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: For specific questions for FDA related 
to this document, contact JonnaLynn Capezzuto, Office of Operations, 
Food and Drug Administration, Three White

[[Page 16041]]

Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-
796-3794.

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.

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 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 Current Good Tissue Practice (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

    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

[[Page 16042]]

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.
    The standard operating procedures (SOP) 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) 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 
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.
    Section 1271.420(a) requires importers of HCT/Ps to notify FDA 
District Director having jurisdiction over the port of entry through 
which the HCT/Ps are offered for import. The HCT/Ps must be held intact 
or transported under quarantine until they are inspected and released 
by FDA.
    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 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

[[Page 16043]]

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 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)).
    FDA estimates that under 1271.420(a), 200 establishments will 
submit 560 reports of HCT/Ps offered for imports. 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 on respondents.
    In the Federal Register of September 7, 2016 (81 FR 61685), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. One comment was received 
beyond the scope of the four information collection topics solicited 
and therefore we have not discussed it in this document.
    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
1271.420(a).................................             200             2.8             560  .25 (15 minutes)..........................             140
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...................................  ..............  ..............  ..............  ..........................................           2,544
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
                                               recordkeepers   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

[[Page 16044]]

 
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
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    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),
  1271.265(e), 1271.265(f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
\3\ Rounded to the nearest whole number.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...................................  ..............  ..............  ..............  ..........................................       2,079,281
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06398 Filed 3-30-17; 8:45 am]
 BILLING CODE 4164-01-P