10582 Federal Register / Vol. 86, No. 33 / Monday, February 22, 2021 / Notices

SUPPLEMENTARY INFORMATION: In controversies. A scientific controversy following the established procedures compliance with 44 U.S.C. 3507, FDA involves issues concerning a specific discussed in the guidance. has submitted the following proposed product regulated by CVM related to CVM encourages applicants to begin collection of information to OMB for matters of technical expertise and the resolution of science-based disputes review and clearance. requires specialized education, training, with discussions with the review team/ or experience to be understood and group, including the Team Leader or Dispute Resolution Procedures for Division Director. The Center prefers Science-Based Decisions on Products by resolved. The guidance details information on how CVM intends to that differences of opinion regarding the Center for Veterinary Medicine—21 science or science-based policy be CFR 10.75 apply provisions of existing regulations regarding internal review of Agency resolved between the review team/group OMB Control Number 0910–0566— decisions. In addition, the guidance and the applicant. If the matter is not Extension outlines the established procedures for resolved by this preferred method, then CVM recommends that the applicant persons who are sponsors, applicants, or The Center for Veterinary Medicine follow the procedures found in GFI #79. manufacturers of animal drugs or other (CVM) Guidance for Industry (GFI) #79, In the Federal Register of August 18, ‘‘Dispute Resolution Procedures for products regulated by CVM who wish to 2020 (85 FR 50827), FDA published a Science-Based Decisions on Products submit a request for review of a 60-day notice requesting public Regulated by the Center for Veterinary scientific dispute. When a sponsor, comment on the proposed collection of Medicine’’ (https://www.fda.gov/media/ applicant, or manufacturer has a information. No comments were 70279/download), describes the process scientific disagreement with a written received. by which CVM formally resolves decision by CVM, they may submit a FDA estimates the burden of this disputes relating to scientific request for a review of that decision by collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Total Average 21 CFR part; activity Number of responses per annual burden per Total respondents respondent responses response hours

10.75, Request for review of a scientific dispute ...... 1 4 4 10 40 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We note that the 60-day notice SUMMARY: The Food and Drug considered timely if they are included an inadvertent error in the Administration (FDA, Agency, or we) is postmarked or the delivery service estimated burden, which has been announcing an opportunity for public acceptance receipt is on or before that corrected in table 1. Based on a review comment on the proposed collection of date. of the information collection since our certain information by the Agency. Electronic Submissions last request for OMB approval, we have Under the Paperwork Reduction Act of made no adjustments to our burden 1995 (PRA), Federal agencies are Submit electronic comments in the estimate. required to publish notice in the following way: • Dated: February 11, 2021. Federal Register concerning each Federal eRulemaking Portal: proposed collection of information, https://www.regulations.gov. Follow the Lauren K. Roth, including each proposed extension of an instructions for submitting comments. Acting Principal Associate Commissioner for existing collection of information, and Comments submitted electronically, Policy. to allow 60 days for public comment in including attachments, to https:// [FR Doc. 2021–03431 Filed 2–19–21; 8:45 am] response to the notice. This notice www.regulations.gov will be posted to BILLING CODE 4164–01–P solicits comments on the collection of the docket unchanged. Because your information requirements relating to comment will be made public, you are FDA’s regulation of current good solely responsible for ensuring that your DEPARTMENT OF HEALTH AND manufacturing practice (CGMP) and comment does not include any HUMAN SERVICES related regulations for blood and blood confidential information that you or a Food and Drug Administration components; and requirements for third party may not wish to be posted, donation testing, donor notification, and such as medical information, your or ‘‘lookback’’. anyone else’s Social Security number, or [Docket No. FDA–2017–N–6931] DATES: Submit either electronic or confidential business information, such Agency Information Collection written comments on the collection of as a manufacturing process. Please note Activities; Proposed Collection; information by April 23, 2021. that if you include your name, contact Comment Request; Current Good ADDRESSES: You may submit comments information, or other information that Manufacturing Practices and Related as follows. Please note that late, identifies you in the body of your Regulations for Blood and Blood untimely filed comments will not be comments, that information will be Components; and Requirements for considered. Electronic comments must posted on https://www.regulations.gov. • Donation Testing, Donor Notification, be submitted on or before April 23, If you want to submit a comment and ‘‘Lookback’’ 2021. The https://www.regulations.gov with confidential information that you electronic filing system will accept do not wish to be made available to the AGENCY: Food and Drug Administration, comments until 11:59 p.m. Eastern Time public, submit the comment as a HHS. at the end of April 23, 2021. Comments written/paper submission and in the received by mail/hand delivery/courier manner detailed (see ‘‘Written/Paper ACTION: Notice. (for written/paper submissions) will be Submissions’’ and ‘‘Instructions’’).

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Written/Paper Submissions Docket: For access to the docket to Current Good Manufacturing Practices read background documents or the and Related Regulations for Blood and Submit written/paper submissions as electronic and written/paper comments Blood Components; and Requirements follows: for Donation Testing, Donor • received, go to https:// Mail/Hand Delivery/Courier (for www.regulations.gov and insert the Notification, and ‘‘Lookback’’ written/paper submissions): Dockets docket number, found in brackets in the Management Staff (HFA–305), Food and OMB Control Number 0910–0116— heading of this document, into the Drug Administration, 5630 Fishers Extension ‘‘Search’’ box and follow the prompts Lane, Rm. 1061, Rockville, MD 20852. This information collection supports and/or go to the Dockets Management • For written/paper comments Agency regulations. All blood and blood Staff, 5630 Fishers Lane, Rm. 1061, submitted to the Dockets Management components introduced or delivered for Rockville, MD 20852, 240–402–7500. Staff, FDA will post your comment, as introduction into interstate commerce well as any attachments, except for FOR FURTHER INFORMATION CONTACT: are subject to section 351(a) of the information submitted, marked and Amber Sanford, Office of Operations, Public Health Service Act (PHS Act) (42 identified, as confidential, if submitted Food and Drug Administration, Three U.S.C. 262(a)). Section 351(a) requires as detailed in ‘‘Instructions.’’ White Flint North, 10A–12M, 11601 that manufacturers of biological Instructions: All submissions received Landsdown St., North Bethesda, MD products, which include blood and must include the Docket No. FDA– 20852, 301–796–8867, PRAStaff@ blood components intended for further manufacturing into products, have a 2017–N–6931 for ‘‘Current Good fda.hhs.gov. Manufacturing Practices and Related license, issued upon a demonstration Regulations for Blood and Blood SUPPLEMENTARY INFORMATION: Under the that the product is safe, pure, and potent Components; and Requirements for PRA (44 U.S.C. 3501–3521), Federal and that the manufacturing Donation Testing, Donor Notification, Agencies must obtain approval from the establishment meets all applicable and ‘Lookback’.’’ Received comments, Office of Management and Budget standards, including those prescribed in those filed in a timely manner (see (OMB) for each collection of the FDA regulations designed to ensure the continued safety, purity, and ADDRESSES), will be placed in the docket information they conduct or sponsor. potency of the product. In addition, and, except for those submitted as ‘‘Collection of information’’ is defined under section 361 of the PHS Act (42 ‘‘Confidential Submissions,’’ publicly in 44 U.S.C. 3502(3) and 5 CFR U.S.C. 264), by delegation from the viewable at https://www.regulations.gov 1320.3(c) and includes Agency requests Secretary of Health and Human or at the Dockets Management Staff or requirements that members of the Services, FDA may make and enforce between 9 a.m. and 4 p.m., Monday public submit reports, keep records, or regulations necessary to prevent the through Friday, 240–402–7500. provide information to a third party. • introduction, transmission, or spread of Confidential Submissions—To Section 3506(c)(2)(A) of the PRA (44 communicable diseases from foreign submit a comment with confidential U.S.C. 3506(c)(2)(A)) requires Federal countries into the States or possessions, information that you do not wish to be Agencies to provide a 60-day notice in or from one State or possession into any made publicly available, submit your the Federal Register concerning each other State or possession. comments only as a written/paper proposed collection of information, Section 351(j) of the PHS Act states submission. You should submit two including each proposed extension of an that the Federal Food, Drug, and copies total. One copy will include the existing collection of information, Cosmetic Act (FD&C Act) also applies to information you claim to be confidential before submitting the collection to OMB biological products. Blood and blood with a heading or cover note that states for approval. To comply with this components for transfusion or for ‘‘THIS DOCUMENT CONTAINS requirement, FDA is publishing notice further manufacturing into products are CONFIDENTIAL INFORMATION.’’ The of the proposed collection of drugs, as that term is defined in section Agency will review this copy, including 201(g)(1) of the FD&C Act (21 U.S.C. information set forth in this document. the claimed confidential information, in 321(g)(1)). Because blood and blood its consideration of comments. The With respect to the following components are drugs under the FD&C second copy, which will have the collection of information, FDA invites Act, blood and plasma establishments claimed confidential information comments on these topics: (1) Whether must comply with the provisions and redacted/blacked out, will be available the proposed collection of information related regulatory scheme of the FD&C for public viewing and posted on is necessary for the proper performance Act. For example, under section 501 of https://www.regulations.gov. Submit of FDA’s functions, including whether the FD&C Act (21 U.S.C. 351(a)), drugs both copies to the Dockets Management the information will have practical are deemed ‘‘adulterated’’ if the Staff. If you do not wish your name and utility; (2) the accuracy of FDA’s methods used in their manufacturing, contact information to be made publicly estimate of the burden of the proposed processing, packing, or holding do not available, you can provide this collection of information, including the conform to CGMP and related information on the cover sheet and not validity of the methodology and regulations. in the body of your comments and you assumptions used; (3) ways to enhance The CGMP regulations (part 606) (21 must identify this information as the quality, utility, and clarity of the CFR part 606) and related regulations ‘‘confidential.’’ Any information marked information to be collected; and (4) implement FDA’s statutory authority to as ‘‘confidential’’ will not be disclosed ensure the safety, purity, and potency of ways to minimize the burden of the except in accordance with 21 CFR 10.20 blood and blood components. The collection of information on and other applicable disclosure law. For public health objective in testing human more information about FDA’s posting respondents, including through the use blood donations for evidence of relevant of comments to public dockets, see 80 of automated collection techniques, transfusion-transmitted infections and FR 56469, September 18, 2015, or access when appropriate, and other forms of in notifying donors is to prevent the the information at: https:// information technology. transmission of relevant transfusion- www.govinfo.gov/content/pkg/FR-2015- transmitted infections. For example, the 09-18/pdf/2015-23389.pdf. ‘‘lookback’’ requirements are intended

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to help ensure the continued safety of referred to as facilities approved for These units would be labeled according the blood supply by providing necessary Medicare reimbursement) that transfuse to § 610.40(h)(2)(vi). information to consignees of blood and blood and blood components. Human blood or a blood component blood components and appropriate The following reporting and with a reactive screening test, as a notification of recipients of blood recordkeeping estimates are based on component of a medical device, is an components that are at increased risk for information provided by industry, CMS, integral part of the medical device, e.g. transmitting human immunodeficiency and FDA experience. Based on a positive control for an in vitro virus (HIV) or hepatitis C virus (HCV) information from industry, we estimate diagnostic testing kit. It is usual and infection. that there are approximately 53.5 customary business practice for The information collection million donations of Source Plasma manufacturers to include on the requirements in the CGMP, donation from approximately 2.5 million donors container label a warning statement testing, donor notification, and and approximately 12.3 million indicating that the product was ‘‘lookback’’ regulations provide FDA donations of Whole Blood and apheresis manufactured from a donation found to with the necessary information to Red Blood Cells including be reactive for the identified relevant perform its duty to ensure the safety, approximately 10,000 (approximately transfusion-transmitted infection(s). In purity, and potency of blood and blood 0.081 percent of 12.3 million) addition, on the rare occasion when a components. These requirements autologous donations, from human blood or blood component with establish accountability and traceability approximately 9 million donors. a reactive screening test is the only in the processing and handling of blood Assuming each autologous donor makes component available for a medical and blood components and enable FDA an average of 1.1 donations, FDA device that does not require a reactive to perform meaningful inspections. estimates that there are approximately component, then a warning statement The recordkeeping requirements serve 9,090 autologous donors (10,000 must be affixed to the medical device. preventive and remedial purposes. The autologous/1.1 average donations). To account for this rare occasion under third-party disclosure requirements FDA estimates that approximately ÷ § 610.42(a), we estimate that the identify various blood and blood 0.53 percent (56,000 10,654,000) of the warning statement would be necessary components and important properties of 77,000 donations that are donated no more than once a year. the product, demonstrate that the CGMP specifically for the use of an identified FDA estimates that approximately requirements have been met, and recipient would be tested under the 3,100 repeat donors will test reactive on facilitate the tracing of a product back dedicated donors’ testing provisions in a screening test for HIV. We also to its original source. The reporting § 610.40(c)(1)(ii). estimate that an average of three requirements inform FDA’s Center for Under §§ 610.40(g)(2) and components was made from each Biologics Evaluation and Research (h)(2)(ii)(A), Source Leukocytes, a (CBER) of certain information that may licensed product that is used in the donation. Under §§ 610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 9,300 require immediate corrective action. manufacture of interferon, which × Respondents to this collection of requires rapid preparation from blood, (3,100 3) notifications of the HIV information are licensed and unlicensed is currently shipped prior to completion screening test results to consignees by blood establishments that collect blood of testing for evidence of relevant collecting establishments for the and blood components, including transfusion-transmitted infections. purpose of quarantining affected blood Source Plasma and Source Leukocytes, Shipments of Source Leukocytes are and blood components, and another × inspected by FDA, and transfusion approved under a biologics license 9,300 (3,100 3) notifications to services inspected by Centers for application and each shipment does not consignees of subsequent test results. Medicare and Medicaid Services (CMS). have to be reported to the Agency. We estimate that approximately 4,961 Based on information received from Based on information from CBER’s consignees will be required under CBER’s database systems, there are database system, FDA receives less than § 610.46(b)(3) to notify transfusion approximately 864 licensed Source one application per year from recipients, their legal representatives, or Plasma establishments and manufacturers of Source Leukocytes. physicians of record an average of 0.35 approximately 1,789 licensed blood However, for calculation purposes, we times per year resulting in a total collection establishments, for an are estimating one application annually. number of 1,755 (585 confirmed estimated total of 2,653 (864 + 1,789) According to CBER’s database system, positive repeat donors × 3) notifications. licensed blood collection there are approximately 15 licensed Also, under § 610.46(b)(3), we estimate establishments. Also, there are an manufacturers that ship known reactive and include the time to gather test estimated total of 817 unlicensed, human blood or blood components results and records for each recipient registered blood collection under §§ 610.40(h)(2)(ii)(C) and (D). and to accommodate multiple attempts establishments for an approximate total FDA estimates that each manufacturer to contact the recipient. of 3,470 collection establishments (864 would ship an estimated 1 unit of Furthermore, we estimate that + 1,789 + 817 = 3,470 establishments). human blood or blood components per approximately 6,800 repeat donors per Of these establishments, approximately month (12 per year) that would require year would test reactive for antibody to 856 perform plateletpheresis (777) and two labels; one as reactive for the HCV. Under §§ 610.47(a)(1)(ii)(B) and leukapheresis (79). These appropriate screening test under 610.47(a)(3), collecting establishments establishments annually collect § 610.40(h)(2)(ii)(C), and the other would notify the consignee 2 times for approximately 73.7 million units of stating the exempted use specifically each of the 20,400 (6,800 × 3 Whole Blood and blood components, approved by FDA under components) components prepared from including Source Plasma and Source § 610.40(h)(2)(ii)(D). these donations, once for quarantine Leukocytes, and are required to follow Based on information received from purposes and again with additional FDA ‘‘lookback’’ procedures. In industry, we estimate that HCV test results for a total of 40,800 (2 addition, there are another estimated approximately 7,500 donations that test × 20,400) notifications as an annual 4,961 establishments that fall under the reactive by a screening test for syphilis ongoing burden. Under § 610.47(b)(3), Clinical Laboratory Improvement and are determined to be biological false we estimate that approximately 4,961 Amendments of 1988 (CLIA) (formerly positives by additional testing annually. consignees would notify approximately

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2,050 recipients or their physicians of usual and customary business practice. evidence of infection because of record annually. Consequently, 5 percent of the 2,653 relevant transfusion-transmitted Based on industry estimates, licensed establishments (133) collecting infections. Under § 606.160(b)(1)(xi), approximately 18.15 percent of 1 percent (841) of the deferred donors only the 1,789 registered blood approximately 14,018,000 million (84,108) would notify donors under establishments collect autologous potential donors (2,544,000 donors) who § 630.40(a). donations and, therefore, are required to come to donate annually are determined As part of usual and customary notify referring physicians. We estimate not to be eligible for donation prior to business practice, collecting that 4.5 percent of the 9,090 autologous collection because of failure to satisfy establishments notify an autologous donors (409) will be deferred under eligibility criteria. It is the usual and donor’s referring physician of reactive § 610.41, which in turn will lead to the customary business practice of test results obtained during the donation notification of their referring physicians. approximately 2,606 (1,789 + 817) blood process required under § 630.40(d)(1). Under § 610.41(b), FDA estimates that collecting establishments to notify However, we estimate that there would be 25 submissions for onsite and to explain why the donor is approximately 5 percent of the 1,789 requalification of donors each requiring determined not to be suitable for blood collection establishments (89) 7 hours per submission. In addition, donating. Based on such available may not notify the referring physicians FDA estimates that there would be only information, we estimate that two-thirds of the estimated 2 percent of 10,000 3 notifications for requalification of (1,737) of the 2,606 blood collecting autologous donors with the initial donors under § 630.35(b) which would establishments provided onsite reactive test results (200) as their usual also require 7 hours for each additional information and counseling and customary business practice. submission. to a donor determined not to be eligible The recordkeeping chart reflects the for donation as usual and customary estimate that approximately 95 percent FDA permits the shipment of untested business practice. Consequently, we of the recordkeepers, which collect 99 or incompletely tested human blood or estimate that only approximately one- percent of the blood supply, have blood components in rare medical third, or 869 of the 2,606 blood developed standard operating emergencies and when appropriately collecting establishments would need to procedures (SOPs) as part of their documented (§ 610.40(g)(1)). We provide, under § 630.40(a), additional customary and usual business practice. estimate the recordkeeping under information and onsite counseling to the Establishments may minimize burdens § 610.40(g)(1) to be minimal with one or estimated 848,000 (one-third of associated with CGMP and related fewer occurrences per year. The approximately 2,544,000) ineligible regulations by using model standards reporting of test results to the consignee donors. developed by industries’ accreditation in § 610.40(g) is part of the usual and It is estimated that another 0.6 percent organizations. These accreditation customary business practice of blood of 14,018,000 potential donors (84,108 organizations represent almost all establishments. donors) are deferred annually based on registered blood establishments. The average burden per response test results. We estimate that Under § 606.160(b)(1)(ix), we estimate (hours) and average burden per approximately 95 percent of the the total annual records based on the recordkeeping (hours) are based on establishments that collect 99 percent of approximately 2,544,000 donors estimates received from industry or FDA the blood and blood components notify determined not to be eligible to donate experience with similar reporting or donors who have reactive test results for and each of the estimated 2,628,108 recordkeeping requirements. HIV, Hepatitis B Virus, HCV, Human T- (2,544,000 + 84,108) donors deferred FDA estimates the burden of this Lymphotropic Virus, and syphilis as based on reactive test results for collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average 21 CFR section; activity Number of responses per Total annual burden per Total hours respondents respondent responses response

606.170(b)2; Donor or recipient fatality reporting ...... 81 1 81 20 1,620 610.40(g)(2); Application for approval to ship ...... 1 1 1 1 1 610.41(b); Request for requalification of donor ...... 2,653 0.0094 25 7 175 610.40(h)(2)(ii)(A); Application for approval for shipment or use ...... 1 1 1 1 1 630.35(b); Request for requalification of donor ...... 2,653 0.00113 3 7 21

Total ...... 1,818 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Average 21 CFR section; activity Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping

606.100(b); 2 Maintenance of SOPs ...... 5 422 1 422 24 ...... 10,128 606.100(c); Records of investigations ...... 5 422 10 4,220 1 ...... 4,220 606.110(a); 3 Documentation donor’s health permits 6 43 1 43 0.5 (30 minutes) 22 plateletpheresis or leukapheresis. 606.151(e); Records of emergency transfusions ...... 5 422 12 5,064 0.08 (5 minutes) 405

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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued

Number of Average 21 CFR section; activity Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping

606.160; 4 Records of collection, processing, compat- 5 422 907.583 383,000 0.75 (45 minutes) 287,250 ibility testing, storage, and distribution of each unit of blood and blood components. 606.160(b)(1)(viii); HIV consignee notification ...... 1,789 10.4533 18,701 0.17 (10 minutes) 3,179 4,961 3.6537 18,126 0.17 (10 minutes) 3,081 606.160(b)(1)(viii); HCV consignee notification ...... 1,789 22.8060 40,800 0.17 (10 minutes) 6,936 4,961 8.2241 40,800 0.17 (10 minutes) 6,936 HIV recipient notification ...... 4,961 0.3538 1,755 0.17 (10 minutes) 298 HCV recipient notification ...... 4,961 0.4132 2,050 0.17 (10 minutes) 349 606.160(b)(1)(ix); Donor notification records ...... 3,470 757.380 2,628,109 0.05 (3 minutes) 131,405 606.160(b)(1)(xi); Physician notification records ...... 1,789 0.2286 409 0.05 (3 minutes) 20.5 606.165; Distribution and receipt records ...... 5 422 907.583 383,000 0.08 (5 minutes) 30,640 606.170(a); Adverse reaction records ...... 5 422 12 5,064 1 ...... 5,064 610.40(g)(1); Documentation of medical emergency ..... 3,470 1 3,470 0.5 (30 minutes) 1,735 630.15(a)(1)(ii)(B); Documentation required for dedi- 1,789 1 1,789 1...... 1,789 cated donation. 630.20(c); Documentation of exceptional medical need 1,789 1 1,789 1 ...... 1,789

Total ...... 495,247 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The recordkeeping requirements in §§ 606.171, 630.5(d), 630.10(c)(1) and (2), and 640.66, which address the maintenance of SOPs, are in- cluded in the estimate for § 606.100(b). 3 The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in the estimate for § 606.110(a). 4 The recordkeeping requirements in §§ 606.110(a)(2), 630.5(b)(1)(i), 630.10(f)(2) and (4), 630.10(g)(2)(i), 630.15(a)(1)(ii)(A) and (B), 630.15(b)(2), (b)(7)(i) and (iii), 630.20(a) and (b), 640.21(e)(4), 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), 630.15(b)(2), 640.65(b)(2)(i), 640.65(b)(2)(i), 640.71(b)(1), 640.72, 640.73, and 640.76(a) and (b), which address the mainte- nance of various records are included in the estimate for § 606.160. 5 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 3,470 = 422). 6 Five percent of plateletpheresis and leukapheresis establishments (0.05 × 856 = 43).

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of Average 21 CFR section; activity Number of disclosures per Total annual burden per Total hours respondents respondent disclosures disclosure

606.145(c); Notification of bacterial contamination of 4,961 0.2822 1,400 0.02 (90 sec- 28 platelets. onds). 606.170(a); Reports of transfusion reaction ...... 2 422 12 5,064 0.5 (30 minutes) 2,532 610.40(c)(1)(ii); Labeling of donation dedicated to sin- 3,470 0.0395 137 0.08 (5 minutes) 11 gle recipient. 610.40(h)(2)(ii)(C) and (D); Labeling of reactive blood 15 12 180 0.2 (12 minutes) 36 and blood components. 610.40(h)(2)(vi); Labeling of reactive blood and blood 3,470 2.1614 7,500 0.08 (5 minutes) 600 components. 610.42(a); Warning statement for medical devices ...... 1 1 1 1 ...... 1 610.46(a)(1)(ii)(B); Notification to consignees to quar- 1,789 5.1984 9,300 0.17 (10 minutes) 1,581 antine (HIV ‘‘lookback’’). 610.46(a)(3); Notification to consignees of further test- 1,789 5.1984 9,300 0.17 (10 minutes) 1,581 ing. 610.46(b)(3); Notification to recipients ...... 4,961 0.3528 1,750 1 ...... 1,750 610.47(a)(1)(ii)(B); Notification to consignees to quar- 1,789 11.4030 20,400 0.17 (10 minutes) 3,468 antine (HCV ‘‘lookback’’). 610.47(a)(3); Notification to consignees of further test- 1,789 11.4030 20,400 0.17 (10 minutes) 3,468 ing. 610.47(b)(3); Notification to recipients ...... 4,961 0.4132 2,050 1 ...... 2,050 630.40(a); Notification of donors determined not to be 869 975.834 848,000 0.08 (5 minutes) 67,840 eligible for donation. 630.40(a); Notification of donors deferred based on 133 6.323 841 1.5...... 1,262 reactive test results. 630.40(d)(1); Notification to physician of autologous 89 2.247 200 1...... 200 donor.

Total ...... 86,408 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 + 3,470 = 422).

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The burden for this information The Council was established to provide Dated: February 11, 2021. collection has changed since the last advice, information, and B. Kaye Hayes, OMB approval. FDA estimates that the recommendations to the Secretary Executive Director, Presidential Advisory total burden for this collection will be regarding programs and policies Council on HIV/AIDS, Office of the Assistant 583,473 hours (1,818 reporting + intended to promote effective Secretary for Health, Department of Health 495,247 recordkeeping + 86,408 third- prevention and care of HIV infection and Human Services. party disclosure). Our estimated burden and AIDS. The functions of the Council [FR Doc. 2021–03524 Filed 2–19–21; 8:45 am] for the information collection reflects an are solely advisory in nature. BILLING CODE 4150–43–P overall increase of 79,024 hours. We attribute this adjustment to an increase The Council consists of not more than in the number of blood establishments 25 members. Council members are DEPARTMENT OF HEALTH AND during the last 3 years. selected from prominent community HUMAN SERVICES leaders with particular expertise in, or [Document Identifier: OS–0990–0330] Dated: February 10, 2021. knowledge of, matters concerning HIV Lauren K. Roth, and AIDS, public health, global health, Agency Information Collection Acting Principal Associate Commissioner for philanthropy, marketing or business, as Policy. Request; 60-Day Public Comment well as other national leaders held in Request [FR Doc. 2021–03434 Filed 2–19–21; 8:45 am] high esteem from other sectors of BILLING CODE 4164–01–P society. Council members are appointed AGENCY: Office of the Secretary, HHS. by the Secretary or designee, in ACTION: Notice. consultation with the White House. The DEPARTMENT OF HEALTH AND SUMMARY: In compliance with the meeting will be open to the public; a HUMAN SERVICES requirement of the Paperwork public comment session will be held Reduction Act of 1995, the Office of the Meeting of the Presidential Advisory during the meeting and PACHA Secretary (OS), Department of Health Council on HIV/AIDS members would like to hear from you, and Human Services, is publishing the specifically: AGENCY: Office of the Assistant following summary of a proposed Secretary for Health, Office of the (1) What are the most meaningful collection for public comment. Secretary, Department of Health and actions that can be taken to implement DATES: Comments on the ICR must be Human Services . the HIV National Strategic Plan and received on or before April 23, 2021. ACTION: Notice of a virtual meeting. improve implementation of the Ending ADDRESSES: Submit your comments to the HIV Epidemic initiative at the [email protected] or by calling SUMMARY: As stipulated by the Federal national level and in your community to (202) 795–7714. Advisory Committee Act, the U.S. meet the goal of ending HIV; and FOR FURTHER INFORMATION CONTACT: Department of Health and Human (2) How can domestic HIV/AIDS When submitting comments or Service is hereby giving notice that the requesting information, please include Presidential Advisory Council on HIV/ programs better meet the needs of the document identifier 0990–0330– AIDS (PACHA or the Council) will be underserved communities and address 60D, and project title for reference, to holding the 70th full Council meeting the systemic barriers that communities Sherrette Funn, the Reports Clearance utilizing virtual technology on March 8– face in order to achieve the goals of the Officer, [email protected], or call March 9, 2021. President’s Executive Order Advancing 202–795–7714. DATES: The meeting will be held on Racial Equity and Support for SUPPLEMENTARY INFORMATION: Interested Monday, March 8 and Tuesday, March Underserved Communities? The persons are invited to send comments 9, 2021, from approximately 2:00 p.m. Executive Order can be found here: regarding this burden estimate or any to 5:00 p.m. (ET) on both days. This https://www.whitehouse.gov/briefing- other aspect of this collection of meeting will be conducted utilizing room/presidential-actions/2021/01/20/ information, including any of the virtual technology. executive-order-advancing-racial- equity-and-support-for-underserved- following subjects: (1) The necessity and ADDRESSES: Instructions on attending utility of the proposed information this meeting virtually will be posted one communities-through-the-federal- government/. collection for the proper performance of week prior to the meeting at: https:// the agency’s functions; (2) the accuracy www.hiv.gov/federal-response/pacha/ Pre-registration is required to provide of the estimated burden; (3) ways to about-pacha. public comment during the meeting. To enhance the quality, utility, and clarity FOR FURTHER INFORMATION CONTACT: Ms. pre-register to attend or to provide of the information to be collected; and Caroline Talev, MPA, Public Health public comment, please send an email (4) the use of automated collection Analyst, Presidential Advisory Council to [email protected] and include your techniques or other forms of information on HIV/AIDS, 330 C Street SW, Room name, organization, and title by close of technology to minimize the information L609A, Washington, DC 20024; (202) business Monday, March 1, 2021. If you collection burden. 795–7622 or [email protected]. decide you would like to provide public Title of the Collection: Appellant Additional information can be obtained comment but do not pre-register, you Climate Survey. by accessing the Council’s page on the may submit your written statement by Type of Collection: Revision. HIV.gov site at www.hiv.gov/pacha. emailing [email protected] by close of OMB No. 0990–0330. SUPPLEMENTARY INFORMATION: PACHA business Tuesday, March 16, 2021. The Abstract: The annual OMHA was established by Executive Order meeting agenda will be posted on the Appellant Climate Survey is a survey of 12963, dated June 14, 1995, as amended PACHA page on HIV.gov at https:// Medicare beneficiaries, providers, by Executive Order 13009, dated June www.hiv.gov/federal-response/pacha/ suppliers, or their representatives who 14, 1996 and is currently operating about-pacha prior to the meeting. participated in a hearing before an under the authority given in Executive Administrative Law Judge (ALJ) from Order 13889, dated September 27, 2019. OMHA. Appellants dissatisfied with the

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