80 FR 11444 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 41 (March 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 41 (March 3, 2015)
| Page Range | 11444-11449 | |
| FR Document | 2015-04381 |
[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)] [Notices] [Pages 11444-11449] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-04381] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-N-0161] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ``Lookback'' AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 April 2, 2015. 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 [email protected]. All comments should be identified with the OMB control number 0910-0116. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ``Lookback''--(OMB Control Number 0910-0116)-- Extension All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). Section 351(a) requires that manufacturers of biological products, which include blood and blood components intended for further [[Page 11445]] manufacture into injectable products, have a license, issued upon a demonstration that the product is safe, pure, and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of the product. In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary of Health and Human Services, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Section 351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic (FD&C) Act also applies to biological products. Blood and blood components for transfusion or for further manufacture into injectable products are drugs, as that term is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and blood components are drugs under the FD&C Act, blood and plasma establishments must comply with the substantive provisions and related regulatory scheme of the FD&C Act. For example, under section 501 of the FD&C Act (21 U.S.C. 351(a)), drugs are deemed ``adulterated'' if the methods used in their manufacturing, processing, packing, or holding do not conform to current good manufacturing practice (CGMP) and related regulations. The CGMP regulations for blood and blood components (21 CFR part 606) and related regulations implement FDA's statutory authority to ensure the safety, purity, and potency of blood and blood components. The public health objective in testing human blood donors for evidence of infection due to communicable disease agents and in notifying donors is to prevent the transmission of communicable disease. For example, the ``lookback'' requirements are intended to help ensure the continued safety of the blood supply by providing necessary information to users of blood and blood components and appropriate notification of recipients of transfusion who are at increased risk for transmitting human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection. The information collection requirements in the CGMP, donor testing, donor notification, and ``lookback'' regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventive and remedial purposes. The third-party disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing of a product back to its original source. The reporting requirements inform FDA of certain information that may require immediate corrective action. Under the reporting requirements, Sec. 606.170(b), in brief, requires that facilities notify FDA's Center for Biologics Evaluation and Research (CBER), as soon as possible after confirming a complication of blood collection or transfusion to be fatal. The collecting facility is to report donor fatalities, and the compatibility testing facility is to report recipient fatalities. The regulation also requires the reporting facility to submit a written report of the investigation within 7 days after the fatality. In fiscal year 2013, FDA received 72 of these reports. Section 610.40(g)(2) (21 CFR 610.40(g)(2)) requires an establishment to obtain written approval from FDA to ship human blood or blood components for further manufacturing use prior to completion of testing for evidence of infection due to certain communicable disease agents. Section 610.40(h)(2)(ii)(A), in brief, requires an establishment to obtain written approval from FDA to use or ship human blood or blood components found to be reactive by a screening test for evidence of certain communicable disease agent(s) or collected from a donor with a record of a reactive screening test. Under the third-party disclosure requirements, Sec. 610.40(c)(1)(ii), in brief, requires that each donation dedicated to a single identified recipient be labeled as required under Sec. 606.121 and with a label containing the name and identifying information of the recipient. The information collection requirements under Sec. 606.121 are part of usual and customary business practice. Sections 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), in brief, require an establishment to label certain reactive human blood and blood components with the appropriate screening test results, and, if they are intended for further manufacturing use into injectable products, to include a statement on the label indicating the exempted use specifically approved by FDA. Also, Sec. 610.40(h)(2)(vi) requires each donation of human blood or blood components, excluding Source Plasma, that tests reactive by a screening test for syphilis and is determined to be a biological false positive to be labeled with both test results. Section 610.42(a) requires a warning statement ``indicating that the product was manufactured from a donation found to be reactive by a screening test for evidence of infection due to the identified communicable disease agent(s)'' in the labeling for medical devices containing human blood or a blood component found to be reactive by a screening test for evidence of infection due to a communicable disease agent(s) or syphilis. In brief, Sec. Sec. 610.46 and 610.47 require blood collecting establishments to establish, maintain, and follow an appropriate system for performing HIV and HCV prospective ``lookback'' when: (1) A donor tests reactive for evidence of HIV or HCV infection or (2) the collecting establishment becomes aware of other reliable test results or information indicating evidence of HIV or HCV infection (prospective ``lookback'') (see Sec. Sec. 610.46(a)(1) and 610.47(a)(1)). The requirement for ``an appropriate system'' requires the collecting establishment to design standard operating procedures (SOPs) to identify and quarantine all blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection. Within 3 calendar days of the donor testing reactive by an HIV or HCV screening test or the collecting establishment becoming aware of other reliable test results or information, the collecting establishment must, among other things, notify consignees to quarantine all identified previously collected in-date blood and blood components (Sec. Sec. 610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B)) and, within 45 days, notify the consignees of supplemental test results, or the results of a reactive screening test if there is no available supplemental test that is approved for such use by FDA (Sec. Sec. 610.46(a)(3) and 610.47(a)(3)). Consignees also must establish, maintain, and follow an appropriate system for performing HIV and HCV ``lookback'' when notified by the collecting establishment that they have received blood and blood components previously collected from donors who later tested reactive for evidence of HIV or HCV infection, or when the collecting [[Page 11446]] establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection in a donor (Sec. Sec. 610.46(b) and 610.47(b)). This provision for a system requires the consignee to establish SOPs for, among other things, notifying transfusion recipients of blood and blood components, or the recipient's physician of record or legal representative, when such action is indicated by the results of the supplemental (additional, more specific) tests or a reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application (IND) or an investigational device exemption (IDE), is exempted for such use by FDA. The consignee must make reasonable attempts to perform the notification within 12 weeks of receipt of the supplemental test result or receipt of a reactive screening test result when there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA (Sec. Sec. 610.46(b)(3) and 610.47(b)(3)). Section 630.6(a) (21 CFR 630.6(a)) requires an establishment to make reasonable attempts to notify any donor who has been deferred as required by Sec. 610.41, or who has been determined not to be eligible as a donor. Section 630.6(d)(1) requires an establishment to provide certain information to the referring physician of an autologous donor who is deferred based on the results of tests as described in Sec. 610.41. Under the recordkeeping requirements, Sec. 606.100(b), in brief, requires that written SOPs be maintained for all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components used for transfusion and further manufacturing purposes. Section 606.100(c) requires the review of all records pertinent to the lot or unit of blood prior to release or distribution. Any unexplained discrepancy or the failure of a lot or unit of final product to meet any of its specifications must be thoroughly investigated, and the investigation, including conclusions and followup, must be recorded. In brief, Sec. 606.110(a) provides that the use of plateletpheresis and leukapheresis procedures to obtain a product for a specific recipient may be at variance with the additional standards for that specific product if, among other things, the physician certifies in writing that the donor's health permits plateletpheresis or leukapheresis. Section 606.110(b) requires establishments to request prior approval from CBER for plasmapheresis of donors who do not meet donor requirements. The information collection requirements for Sec. 606.110(b) are approved under OMB control number 0910-0338 and, therefore, are not reflected in tables 1 and 2. Section 606.151(e) requires that SOPs for compatibility testing include procedures to expedite transfusion in life-threatening emergencies; records of all such incidents must be maintained, including complete documentation justifying the emergency action, which must be signed by a physician. So that each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components can be clearly traced, Sec. 606.160 requires that legible and indelible contemporaneous records of each such step be made and maintained for no less than 10 years. Section 606.160(b)(1)(viii) requires records of the quarantine, notification, testing and disposition performed under the HIV and HCV ``lookback'' provisions. Furthermore, Sec. 606.160(b)(1)(ix) requires a blood collection establishment to maintain records of notification of donors deferred or determined not to be eligible for donation, including appropriate followup. Section 606.160(b)(1)(xi) requires an establishment to maintain records of notification of the referring physician of a deferred autologous donor, including appropriate followup. Section 606.165, in brief, requires that distribution and receipt records be maintained to facilitate recalls, if necessary. Section 606.170(a) requires records to be maintained of any reports of complaints of adverse reactions arising as a result of blood collection or transfusion. Each such report must be thoroughly investigated, and a written report, including conclusions and followup, must be prepared and maintained. Section 606.170(a) also requires that when an investigation concludes that the product caused the transfusion reaction, copies of all such written reports must be forwarded to and maintained by the manufacturer or collecting facility. Section 610.40(g)(1) requires an establishment to appropriately document a medical emergency for the release of human blood or blood components prior to completion of required testing. In addition to the CGMP regulations in part 606, there are regulations in 21 CFR part 640 that require additional standards for certain blood and blood components as follows: Sections 640.3(a)(1), (a)(2), and (f); 640.4(a)(1) and (a)(2); 640.25(b)(4) and (c)(1); 640.27(b); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and (b). The information collection requirements and estimated burdens for these regulations are included in the part 606 burden estimates, as described in tables 1 and 2. Respondents to this collection of information are licensed and unlicensed blood establishments that collect blood and blood components, including Source Plasma and Source Leukocytes, inspected by FDA, and other transfusion services inspected by Centers for Medicare and Medicaid Services (CMS). Based on information received from CBER's database systems, there are approximately 416 licensed Source Plasma establishments with multiple locations and approximately 1,265 licensed blood collection establishments, for an estimated total of 1,681 licensed blood collection establishments. Also, there are an estimated total of 680 unlicensed, registered blood collection establishments for an approximate total of 2,361 collection establishments (416 + 1,265 + 680 = 2,361 establishments). Of these establishments, approximately 990 perform plateletpheresis and leukapheresis. These establishments annually collect approximately 40 million units of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and are required to follow FDA ``lookback'' procedures. In addition, there are another 4,961 establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578) (formerly referred to as facilities approved for Medicare reimbursement) that transfuse blood and blood components. The following reporting and recordkeeping estimates are based on information provided by industry, CMS, and FDA experience. Based on information received from industry, we estimate that there are approximately 25 million donations of Source Plasma from approximately 2 million donors and approximately 15 million donations of Whole Blood, including approximately 225,000 (approximately 1.5 percent of 15 million) autologous donations, from approximately 10.9 million donors. Assuming each autologous donor makes an average of 2 donations, FDA estimates that there are approximately 112,500 autologous donors. FDA estimates that approximately 5 percent (3,600) of the 72,000 donations [[Page 11447]] that are donated specifically for the use of an identified recipient would be tested under the dedicated donors' testing provisions in Sec. 610.40(c)(1)(ii). Under Sec. Sec. 610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes, a licensed product that is used in the manufacture of interferon, which requires rapid preparation from blood, is currently shipped prior to completion of testing for evidence of certain communicable disease agents. Shipments of Source Leukocytes are preapproved under a biologics license application (BLA) and each shipment does not have to be reported to the Agency. Based on information from CBER's database system, FDA receives less than one application per year from manufacturers of Source Leukocytes. However, for calculation purposes, we are estimating one application annually. Under Sec. Sec. 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA estimates that each manufacturer would ship an estimated 1 unit of human blood or blood components per month (12 per year) that would require two labels; one as reactive for the appropriate screening test under Sec. 610.40(h)(2)(ii)(C), and the other stating the exempted use specifically approved by FDA under Sec. 610.40(h)(2)(ii)(D). According to CBER's database system, there are approximately 40 licensed manufacturers that ship known reactive human blood or blood components. Based on information we received from industry, we estimate that approximately 18,000 donations: (1) Annually test reactive by a screening test for syphilis; (2) are determined to be biological false positives by additional testing; and (3) are labeled accordingly (Sec. 610.40(h)(2)(vi)). Human blood or a blood component with a reactive screening test, as a component of a medical device, is an integral part of the medical device, e.g., a positive control for an in vitro diagnostic testing kit. It is usual and customary business practice for manufacturers to include on the container label a warning statement that identifies the communicable disease agent. In addition, on the rare occasion when a human blood or blood component with a reactive screening test is the only component available for a medical device that does not require a reactive component, then a warning statement must be affixed to the medical device. To account for this rare occasion under Sec. 610.42(a), we estimate that the warning statement would be necessary no more than once a year. FDA estimates that approximately 3,500 repeat donors will test reactive on a screening test for HIV. We also estimate that an average of three components was made from each donation. Under Sec. Sec. 610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 10,500 (3,500 x 3) notifications of the HIV screening test results to consignees by collecting establishments for the purpose of quarantining affected blood and blood components, and another 10,500 (3,500 x 3) notifications to consignees of subsequent test results. We estimate that Sec. 610.46(b)(3) will require 4,961 consignees to notify transfusion recipients, their legal representatives, or physicians of record an average of 0.35 times per year resulting in a total number of 1,755 (585 confirmed positive repeat donors x 3) notifications. Also under Sec. 610.46(b)(3), we estimate and include the time to gather test results and records for each recipient and to accommodate multiple attempts to contact the recipient. Furthermore, we estimate that approximately 7,800 repeat donors per year would test reactive for antibody to HCV. Under Sec. Sec. 610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would notify the consignee 2 times for each of the 23,400 (7,800 x 3 components) components prepared from these donations, once for quarantine purposes and again with additional HCV test results for a total of 46,800 notifications as an annual ongoing burden. Under Sec. 610.47(b)(3), we estimate that approximately 4,961 consignees would notify approximately 2,050 recipients or their physicians of record annually. Based on industry estimates, approximately 13 percent of approximately 10 million potential donors (1.3 million donors) who come to donate annually are determined not to be eligible for donation prior to collection because of failure to satisfy eligibility criteria. It is the usual and customary business practice of approximately 1,945 (1,265 + 680) blood collecting establishments to notify onsite and to explain why the donor is determined not to be suitable for donating. Based on such available information, we estimate that two-thirds (1,297) of the 1,945 blood collecting establishments provided onsite additional information and counseling to a donor determined not to be eligible for donation as usual and customary business practice. Consequently, we estimate that only one-third, or 648, approximately, blood collecting establishments would need to provide, under Sec. 630.6(a), additional information and onsite counseling to the estimated 433,333 (one-third of approximately 1.3 million) ineligible donors. It is estimated that another 4.5 percent of 10 million potential donors (450,000 donors) are deferred annually based on test results. We estimate that approximately 95 percent of the establishments that collect 99 percent of the blood and blood components notify donors who have reactive test results for HIV, Hepatitis B Virus, HCV, Human T- Lymphotropic Virus, and syphilis as usual and customary business practice. Consequently, 5 percent of the 1,681 establishments (84) collecting 1 percent (4,500) of the deferred donors (450,000) would notify donors under Sec. 630.6(a). As part of usual and customary business practice, collecting establishments notify an autologous donor's referring physician of reactive test results obtained during the donation process required under Sec. 630.6(d)(1). However, we estimate that approximately 5 percent of the 1,265 blood collection establishments (63) may not notify the referring physicians of the estimated 2 percent of 112,500 autologous donors with the initial reactive test results (2,250) as their usual and customary business practice. The recordkeeping chart reflects the estimate that approximately 95 percent of the recordkeepers, which collect 99 percent of the blood supply, have developed SOPs as part of their customary and usual business practice. Establishments may minimize burdens associated with CGMP and related regulations by using model standards developed by industries' accreditation organizations. These accreditation organizations represent almost all registered blood establishments. Under Sec. 606.160(b)(1)(ix), we estimate the total annual records based on the approximately 1.3 million donors determined not to be eligible to donate and each of the estimated 1.75 million (1.3 million + 450,000) donors deferred based on reactive test results for evidence of infection because of communicable disease agents. Under Sec. 606.160(b)(1)(xi), only the 1,945 registered blood establishments collect autologous donations and, therefore, are required to notify referring physicians. We estimate that 4.5 percent of the 112,500 autologous donors (5,063) will be deferred under Sec. 610.41, which in turn will lead to the notification of their referring physicians. FDA has concluded that the use of untested or incompletely tested but appropriately documented human blood or blood components in rare medical emergencies should not be prohibited. We estimate the recordkeeping under Sec. 610.40(g)(1) to be minimal with one or fewer occurrences per year. The reporting of test results to the consignee [[Page 11448]] in Sec. 610.40(g) is part of the usual and customary business practice or procedure to finish the testing and provide the results to the manufacturer responsible for labeling the blood products. The average burden per response (hours) and average burden per recordkeeping (hours) are based on estimates received from industry or FDA experience with similar reporting or recordkeeping requirements. In the Federal Register of October 20, 2014 (79 FR 62629), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received five comments; however, the comments were not responsive to the comment request on the four specified aspects of the collection of information and did not provide any data or explanation that would support a change regarding the information collection estimates. 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 Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 606.170(b) \2\.................. 72 1 72 20 1,440 610.40(g)(2).................... 1 1 1 1 1 610.40(h)(2)(ii)(A)............. 1 1 1 1 1 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,442 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ The reporting requirement in Sec. 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for Sec. 606.170(b). Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of records per Total annual Average burden Total hours recordkeepers recordkeeper records per recordkeeping ---------------------------------------------------------------------------------------------------------------- 606.100(b) \2\................ \5\ 366 1 366 24............... 8,784 606.100(c).................... \5\ 366 10 3,660 1................ 3,660 606.110(a) \3\................ \6\ 50 1 50 0.5 (30 minutes). 25 606.151(e).................... \5\ 366 12 4,392 0.08 (5 minutes). 351 606.160 \4\................... \5\ 366 1,046.45 383,000 0.75 (45 minutes) 287,250 606.160(b)(1)(viii)........... 1,945 10.80 21,000 0.17 (10 minutes) 3,570 HIV consignee notification.... 4,961 4.23 21,000 0.17 (10 minutes) 3,570 606.160(b)(1)(viii)........... 1,945 24.06 46,800 0.17 (10 minutes) 7,956 HCV consignee notification.... 4,961 9.43 46,800 0.17 (10 minutes) 7,956 HIV recipient notification.... 4,961 0.35 1,755 0.17 (10 minutes) 298 HCV recipient notification.... 4,961 0.41 2,050 0.17 (10 minutes) 349 606.160(b)(1)(ix)............. 2,361 741.21 1,750,000 0.05 (3 minutes). 87,500 606.160(b)(1)(xi)............. 1,945 2.6 5,063 0.05 (3 minutes). 253 606.165....................... \5\ 366 1,046.45 383,000 0.08 (5 minutes). 30,640 606.170(a).................... \5\ 366 12 4,392 1................ 4,392 610.40(g)(1).................. 2,361 1 2,361 0.5 (30 minutes). 1,180 --------------------------------------------------------------------------------- Total..................... .............. ............. .............. ................. 447,734 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ The recordkeeping requirements in Sec. Sec. 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for Sec. 606.100(b). \3\ The recordkeeping requirements in Sec. 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in the estimate for Sec. 606.110(a). \4\ The recordkeeping requirements in Sec. Sec. 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the maintenance of various records, are included in the estimate for Sec. 606.160. \5\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 + 2,361 = 366). \6\ Five percent of plateletpheresis and leukapheresis establishments (0.05 x 990 = 50). Table 3--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 606.170(a).................... \2\ 366 1.2 439 0.5 (30 minutes). 220 610.40(c)(1)(ii).............. 2,361 1.52 3,600 0.08 (5 minutes). 288 610.40(h)(2)(ii)(C) and 40 12 480 0.2 (12 minutes). 96 (h)(2)(ii)(D). 610.40(h)(2)(vi).............. 2,361 7.62 18,000 0.08 (5 minutes). 1,440 610.42(a)..................... 1 1 1 1................ 1 610.46(a)(1)(ii)(B)........... 1,945 5.40 10,500 0.17 (10 minutes) 1,785 610.46(a)(3).................. 1,945 5.40 10,500 0.17 (10 minutes) 1,785 610.46(b)(3).................. 4,961 0.35 1,755 1................ 1,755 610.47(a)(1)(ii)(B)........... 1,945 12.03 23,400 0.17 (10 minutes) 3,978 [[Page 11449]] 610.47(a)(3).................. 1,945 12.03 23,400 0.17 (10 minutes) 3,978 610.47(b)(3).................. 4,961 0.41 2,050 1................ 2,050 630.6(a) \3\.................. 648 668.72 433,333 0.08 (5 minutes). 34,667 630.6(a) \4\.................. 84 53.57 4,500 1.5 (90 minutes). 6,750 630.6(d)(1)................... 63 35.71 2,250 1................ 2,250 --------------------------------------------------------------------------------- Total..................... .............. ............. .............. ................. 61,043 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 + 2,361 = 366). \3\ Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. \4\ Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents. Dated: February 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-04381 Filed 3-2-15; 8:45 am] BILLING CODE 4164-01-P
![11444 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices
should also contain information on ensure that they comply with the comment on the proposed collection of
analytical methodology for the nutrient criteria established by the FD&C Act. information. No comments were
that is the subject of a claim based on In the Federal Register of November received in response to the notice.
an authoritative statement. We intend to 21, 2014 (79 FR 69494), FDA published FDA estimates the burden of this
review the notifications we receive to a 60-day notice requesting public collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Section of the FD&C Act responses per burden per Total hours
respondents responses
respondent response
403(r)(2)(G) (nutrient content claims) .................................. 1 1 1 250 250
403(r)(2)(C) (health claims) ................................................. 1 1 1 450 450
Guidance for notifications .................................................... 2 1 2 1 2
Total .............................................................................. ........................ ........................ ........................ ........................ 702
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on our a nutrient content claim notification. that a proposed collection of
experience with health claims, nutrient Further, we estimate that one information has been submitted to the
content claims, and other similar respondent will take 450 hours to Office of Management and Budget
notification procedures that fall under collect and assemble the information (OMB) for review and clearance under
our jurisdiction. To avoid estimating the required by the statute for a health claim the Paperwork Reduction Act of 1995.
number of respondents as zero, we notification. DATES: Fax written comments on the
estimate that there will be one or fewer Under the guidance, notifications collection of information by April 2,
respondents annually for nutrient should also contain information on 2015.
content claim and health claim analytical methodology for the nutrient
notifications. We estimate that we will that is the subject of a claim based on ADDRESSES: To ensure that comments on
receive one nutrient content claim an authoritative statement. The the information collection are received,
notification and one health claim guidance applies to both nutrient OMB recommends that written
notification per year over the next 3 content claim and health claim comments be faxed to the Office of
years. notifications. We have determined that Information and Regulatory Affairs,
Section 403(r)(2)(G) and (r)(3)(C) of this information should be readily OMB, Attn: FDA Desk Officer, FAX:
the FD&C Act requires that the available to a respondent and, thus, we 202–395–7285, or emailed to oira_
notification include the exact words of estimate that it will take a respondent 1 submission@omb.eop.gov. All
the claim, a copy of the authoritative hour to incorporate the information into comments should be identified with the
statement, a concise description of the each notification. We expect there will OMB control number 0910–0116. Also
basis upon which such person relied for be two respondents for a total of 2 include the FDA docket number found
determining that this is an authoritative hours. in brackets in the heading of this
statement as outlined in the FD&C Act, Dated: February 24, 2015. document.
and a balanced representation of the Leslie Kux, FOR FURTHER INFORMATION CONTACT: FDA
scientific literature relating to the PRA Staff, Office of Operations, Food
Associate Commissioner for Policy.
relationship between a nutrient and a and Drug Administration, 8455
[FR Doc. 2015–04380 Filed 3–2–15; 8:45 am]
disease or health-related condition to Colesville Rd., COLE–14526, Silver
BILLING CODE 4164–01–P
which a health claim refers or to the Spring, MD 20993–0002, PRAStaff@
nutrient level to which the nutrient fda.hhs.gov.
content claim refers. This balanced
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In
representation of the scientific literature
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA
is expected to include a bibliography of
the scientific literature on the topic of Food and Drug Administration has submitted the following proposed
the claim and a brief, balanced account collection of information to OMB for
or analysis of how this literature either [Docket No. FDA–2005–N–0161] review and clearance.
supports or fails to support the Current Good Manufacturing Practices
authoritative statement. Agency Information Collection
Activities; Submission for Office of and Related Regulations for Blood and
Since the claims are based on
Management and Budget Review; Blood Components; and Requirements
authoritative statements of a scientific
Comment Request; Current Good for Donor Testing, Donor Notification,
body of the U.S. Government or NAS,
Manufacturing Practices and Related and ‘‘Lookback’’—(OMB Control
we believe that the information that is
Regulations for Blood and Blood Number 0910–0116)—Extension
required by the FD&C Act to be
submitted with a notification will be Components; and Requirements for All blood and blood components
Donor Testing, Donor Notification, and
mstockstill on DSK4VPTVN1PROD with NOTICES
readily available to a respondent. introduced or delivered for introduction
However, the respondent will have to ‘‘Lookback’’ into interstate commerce are subject to
collect and assemble that information. AGENCY: Food and Drug Administration, section 351(a) of the Public Health
Based on communications with firms HHS. Service Act (PHS Act) (42 U.S.C.
that have submitted notifications, we ACTION: Notice. 262(a)). Section 351(a) requires that
estimate that one respondent will take manufacturers of biological products,
250 hours to collect and assemble the SUMMARY: The Food and Drug which include blood and blood
information required by the statute for Administration (FDA) is announcing components intended for further
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![Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11449
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
Number of Total annual
21 CFR section responses per Average burden per response Total hours
respondents responses
respondent
610.47(a)(3) ...................................... 1,945 12.03 23,400 0.17 (10 minutes) ............................. 3,978
610.47(b)(3) ...................................... 4,961 0.41 2,050 1 ....................................................... 2,050
630.6(a) 3 ........................................... 648 668.72 433,333 0.08 (5 minutes) ............................... 34,667
630.6(a) 4 ........................................... 84 53.57 4,500 1.5 (90 minutes) ............................... 6,750
630.6(d)(1) ........................................ 63 35.71 2,250 1 ....................................................... 2,250
Total ........................................... ........................ ........................ ........................ ........................................................... 61,043
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 ×
4,961 + 2,361 = 366).
3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
4 Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents.
Dated: February 25, 2015. Spring, MD 20993–0002, PRAStaff@ revisions of clinical investigation plans,
Leslie Kux, fda.hhs.gov. and information on a drug’s safety or
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: In effectiveness. In addition, the sponsor is
[FR Doc. 2015–04381 Filed 3–2–15; 8:45 am] compliance with 44 U.S.C. 3507, FDA required to give FDA an annual
BILLING CODE 4164–01–P has submitted the following proposed summary of the previous year’s clinical
collection of information to OMB for experience.
review and clearance. Submissions are reviewed by medical
DEPARTMENT OF HEALTH AND officers and other Agency scientific
HUMAN SERVICES Investigational New Drug (IND) reviewers assigned responsibility for
Regulations—21 CFR Part 312 (OMB overseeing the specific study. The IND
Food and Drug Administration Control Number 0910–0014)—Extension regulations also contain recordkeeping
[Docket No. FDA–2014–N–1721] FDA is requesting OMB approval for requirements that pertain to the
the reporting and recordkeeping responsibilities of sponsors and
Agency Information Collection requirements contained in FDA investigators. The detail and complexity
Activities; Submission for Office of regulations entitled ‘‘Investigational of these requirements are dictated by the
Management and Budget Review; New Drug Application’’ in part 312 (21 scientific procedures and human subject
Comment Request; Investigational CFR part 312). Part 312 implements safeguards that must be followed in the
New Drug Applications provisions of section 505(i) of the clinical tests of investigational new
Federal Food, Drug, and Cosmetic Act drugs.
AGENCY: Food and Drug Administration,
(the FD&C Act) (21 U.S.C. 355(i)) to The IND information collection
HHS.
issue regulations under which the requirements provide the means by
ACTION: Notice. which FDA can monitor the clinical
clinical investigation of the safety and
SUMMARY: The Food and Drug effectiveness of unapproved new drugs investigation of the safety and
Administration (FDA) is announcing and biological products can be effectiveness of unapproved new drugs
that a proposed collection of conducted. and biological products, including the
information has been submitted to the FDA is charged with implementing following: (1) Monitor the safety of
Office of Management and Budget statutory requirements that drug ongoing clinical investigations; (2)
(OMB) for review and clearance under products marketed in the United States determine whether the clinical testing of
the Paperwork Reduction Act of 1995. be shown to be safe and effective, a drug should be authorized; (3) ensure
DATES: Fax written comments on the properly manufactured, and properly production of reliable data on the
collection of information by April 2, labeled for their intended uses. Section metabolism and pharmacological action
2015. 505(a) of the FD&C Act provides that a of the drug in humans; (4) obtain timely
new drug may not be introduced or information on adverse reactions to the
ADDRESSES: To ensure that comments on delivered for introduction into interstate drug; (5) obtain information on side
the information collection are received, commerce in the United States unless effects associated with increasing doses;
OMB recommends that written FDA has previously approved a new (6) obtain information on the drug’s
comments be faxed to the Office of drug application (NDA). FDA approves effectiveness; (7) ensure the design of
Information and Regulatory Affairs, an NDA only if the sponsor of the well-controlled, scientifically valid
OMB, Attn: FDA Desk Officer, FAX: application first demonstrates that the studies; and (8) obtain other information
202–395–7285, or emailed to oira_ drug is safe and effective for the pertinent to determining whether
submission@omb.eop.gov. All conditions prescribed, recommended, or clinical testing should be continued,
comments should be identified with the suggested in the product’s labeling. and information related to the
OMB control number 0910–0014. Also
mstockstill on DSK4VPTVN1PROD with NOTICES
Proof must consist, in part, of adequate protection of human subjects. Without
include the FDA docket number found and well-controlled studies, including the information provided by industry as
in brackets in the heading of this studies in humans, that are conducted required under the IND regulations,
document. by qualified experts. The IND FDA cannot authorize or monitor the
FOR FURTHER INFORMATION CONTACT: FDA regulations establish reporting clinical investigations which must be
PRA Staff, Office of Operations, Food requirements that include an initial conducted prior to authorizing the sale
and Drug Administration, 8455 application as well as amendments to and general use of new drugs. These
Colesville Rd., COLE–14526, Silver that application, reports on significant reports enable FDA to monitor a study’s
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Document Created: 2015-12-18 11:55:52
Document Modified: 2015-12-18 11:55:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by April 2, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 11444 |
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