Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3165 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Joshua Silverstein, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 66, Rm. 1615, Silver Spring, 

MD 20993–0002, 301–796–5155; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 15, 2017, 

FDA published a notice of availability 

with a 60-day comment period to 

request comments on draft guidance for 

industry and FDA staff entitled ‘‘The 

Least Burdensome Provisions: Concept 

and Principles.’’ 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the guiding principles and 

recommended approach for FDA staff 

and industry to facilitate consistent 

application of least burdensome 

principles to the activities pertaining to 

products meeting the statutory 

definition of a device regulated under 

the Federal Food, Drug, and Cosmetic 

Act. It does not establish any rights for 

any person and is not binding on FDA 

or the public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. This draft guidance is not 

subject to Executive Order 12866. 

The Agency has received a request for 

a 30-day extension of the comment 

period. The request conveyed concern 

that the current 60-day comment period 

does not allow sufficient time to 

develop a meaningful or thoughtful 

response. 

FDA has considered the request and 

is extending the comment period for the 

notice of availability for 30 days, until 

March 15, 2018. The Agency believes 

that a 30-day extension allows adequate 

time for interested persons to submit 

comments without significantly 

delaying guidance on these important 

issues. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01122 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6931] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donation Testing, Donor Notification, 

and ‘‘Lookback’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (the PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the collection of 

information requirements relating to 

FDA’s regulation of current good 

manufacturing practice (CGMP) and 

related regulations for blood and blood 

components; and requirements for 

donation testing, donor notification, and 

‘‘lookback’’. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 26, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 26, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 26, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–6931 for ‘‘Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donation Testing, Donor Notification, 

and ‘Lookback’.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 


sradovich on DSK3GMQ082PROD with NOTICES
3166 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Current Good Manufacturing Practices 

and Related Regulations for Blood and 

Blood Components; and Requirements 

for Donation 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 

manufacturing into 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 Act (FD&C Act) also applies to 

biological products. Blood and blood 

components for transfusion or for 

further manufacturing into 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 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 CGMP and related 

regulations. 

The CGMP regulations (part 606) (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 donations for evidence of relevant 

transfusion-transmitted infections and 

in notifying donors is to prevent the 

transmission of relevant transfusiontransmitted infections. For example, the 

‘‘lookback’’ requirements are intended 

to help ensure the continued safety of 

the blood supply by providing necessary 

information to consignees of blood and 

blood components and appropriate 

notification of recipients of blood 

components that are at increased risk for 

transmitting human immunodeficiency 

virus (HIV) or hepatitis C virus (HCV) 

infection. 

The information collection 

requirements in the CGMP, donation 

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 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, 

§ 606.170(b), in brief, requires that 

facilities notify FDA’s Center for 

Biologics Evaluation and Research 


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Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3167 

(CBER), as soon as possible after a 

complication of blood collection or 

transfusion is confirmed to be fatal. The 

collecting facility is required 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 2016, 

FDA received 81 fatality 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 relevant transfusiontransmitted infections. 

Section 610.41(b) allows for a 

previously deferred donor to 

subsequently be found to be an eligible 

donor of blood and blood components 

by a requalification method or process 

found acceptable for such purposes by 

FDA. 

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 infection due to a 

relevant transfusion-transmitted 

infection(s) or collected from a donor 

deferred under § 610.41(a). 

In addition, § 630.35(b) (21 CFR 

630.35(b)) allows for a previously 

deferred donor, deferred for reasons 

other than § 610.41(b) to become 

requalified for donation by a method or 

process found acceptable for such 

purpose by FDA. 

Under the third-party disclosure 

requirements, § 606.145(c) requires 

transfusion services to notify certain 

blood collection establishments 

concerning bacterial contamination of 

platelets. In table 3, FDA estimates that 

for the approximately 4,961 transfusion 

services, there would be 1,400 total 

notifications per year to blood collection 

establishments (700 notifications that 

platelets are bacterially contaminated 

and 700 notifications per year 

concerning the identity or non-identity 

of the species of the contaminating 

organism). 

Section 610.40(c)(1)(ii) in part 610, in 

brief, requires that each donation 

dedicated to a single identified recipient 

be labeled as required under § 606.121 

and with a label containing the name 

and identifying information of the 

recipient. The information collection 

requirements under § 606.121 are part of 

usual and customary business practice. 

Sections 610.40(h)(2)(ii)(C) and (D), in 

brief, require an establishment to label 

certain reactive human blood and blood 

components with the appropriate 

screening test results for evidence of 

infection due to the identified relevant 

transfusion-transmitted infection(s), 

and, if they are intended for further 

manufacturing use into products, to 

include a statement on the label 

indicating the exempted use specifically 

approved by FDA. Also, 

§ 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 relevant transfusiontransmitted infection(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 relevant 

transfusion-transmitted infection(s) or 

syphilis. 

In addition, § 630.35(b) allows for a 

previously deferred donor, deferred for 

reasons other than § 610.41(b) to become 

requalified for donation by a method or 

process found acceptable for such 

purpose by FDA. 

In brief, §§ 610.46 and 610.47 require 

blood collecting establishments to 

establish, maintain, and follow an 

appropriate system for performing HIV 

and HCV ‘‘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 (see §§ 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 

(§§ 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 (§§ 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 

establishment is made aware of other 

reliable test results or information 

indicating evidence of HIV or HCV 

infection in a donor (§§ 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 (§§ 610.46(b)(3) 

and 610.47(b)(3)). 

Section 630.40(a) requires an 

establishment to make reasonable 

attempts to notify any donor who has 

been deferred as required by § 610.41(a), 

or who has been determined not to be 

eligible as a donor. Section 630.40(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 § 610.41. 

Under the recordkeeping 

requirements, § 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 


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3168 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

to meet any of its specifications must be 

thoroughly investigated, and the 

investigation, including conclusions 

and followup, must be recorded. 

In brief, § 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 

determines and documents 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 § 606.110(b) 

are approved under OMB control 

number 0910–0338 and, therefore, are 

not reflected in the tables of this 

document. 

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. 

Section 606.171 requires 

establishments to establish and 

maintain procedures related to product 

deviations. The burden for the 

recordkeeping requirements under 

§ 606.171 are included under § 606.100. 

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, § 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, 

§ 606.160(b)(1)(x) 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 

determines 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. 

Under § 630.15(a)(1)(ii)(B), FDA 

requires that for a dedicated donation 

based on the intended recipient’s 

documented exceptional medical need, 

the responsible physician determines 

and documents that the health of the 

donor would not be adversely affected 

by donating. 

Under § 630.20(c), a collection 

establishment may collect blood and 

blood components from a donor who is 

determined to be not eligible to donate 

under any provision of § 630.10(e) and 

(f) or § 630.15(a), if the donation is 

restricted for use solely by a specific 

transfusion recipient based on 

documented exceptional medical need 

and the responsible physician 

determines and documents that the 

donor’s health permits the collection 

procedure, and that the donation 

presents no undue medical risk to the 

transfusion recipient. 

In addition to the CGMP regulations 

in part 606, there are regulations in part 

630 that include requirements for blood 

and blood components intended for 

transfusion or further manufacturing 

use, and part 640 that require additional 

standards for certain blood and blood 

products as follows: Sections 

630.5(b)(1)(i), 630.5(d), 630.10(c)(1) and 

(2), 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); 

640.25(b)(4) and (c)(1); 640.21(e)(4); 

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); 640.66; 

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 transfusion 

services inspected by Centers for 

Medicare and Medicaid Services (CMS). 

Based on information received from 

CBER’s database systems, there are 

approximately 569 licensed Source 

Plasma establishments and 

approximately 1,054 licensed blood 

collection establishments, for an 

estimated total of 1,623 (569 + 1,054) 

licensed blood collection 

establishments. Also, there are an 

estimated total of 680 unlicensed, 

registered blood collection 

establishments for an approximate total 

of 2,303 collection establishments (569 

+ 1,054 + 680 = 2,303 establishments). 

Of these establishments, approximately 

901 perform plateletpheresis and 

leukopheresis. These establishments 

annually collect approximately 53.3 

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 estimated 4,961 establishments 

that fall under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (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 from industry, we estimate 

that there are approximately 38.3 

million donations of Source Plasma 

from approximately 2 million donors 

and approximately 15 million donations 

of Whole Blood and apheresis Red 

Blood Cells including approximately 

34,500 (approximately 0.23 percent of 

15 million) autologous donations, from 

approximately 10.9 million donors. 

Assuming each autologous donor makes 

an average of 1.1 donations, FDA 

estimates that there are approximately 

31,364 autologous donors (34,500 

autologous/1.1 average donations). 

FDA estimates that approximately 

0.19 percent (21,000/10,794,000) of the 

72,000 donations that are donated 

specifically for the use of an identified 

recipient would be tested under the 

dedicated donors’ testing provisions in 

§ 610.40(c)(1)(ii). 

Under §§ 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 relevant 

transfusion-transmitted infections. 

Shipments of Source Leukocytes are 

approved under a biologics license 

application and each shipment does not 

have to be reported to the Agency. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3169 

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. 

According to CBER’s database system, 

there are approximately 15 licensed 

manufacturers that ship known reactive 

human blood or blood components 

under §§ 610.40(h)(2)(ii)(C) and (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 

§ 610.40(h)(2)(ii)(C), and the other 

stating the exempted use specifically 

approved by FDA under 

§ 610.40(h)(2)(ii)(D). 

Based on information received from 

industry, we estimate that 

approximately 7,544 donations that test 

reactive by a screening test for syphilis 

and are determined to be biological false 

positives by additional testing annually. 

These units would be labeled according 

to § 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 

indicating that the product was 

manufactured from a donation found to 

be reactive for the identified relevant 

transfusion-transmitted infection(s). 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 

§ 610.42(a), we estimate that the 

warning statement would be necessary 

no more than once a year. 

FDA estimates that approximately 

3,021 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 §§ 610.46(a)(1)(ii)(B) 

and (a)(3), this estimate results in 9,063 

(3,012 × 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 

9,063 (3,021 × 3) notifications to 

consignees of subsequent test results. 

We estimate that approximately 4,961 

consignees will be required under 

§ 610.46(b)(3) 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 × 3) notifications. 

Also under § 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 6,799 repeat donors per 

year would test reactive for antibody to 

HCV. Under §§ 610.47(a)(1)(ii)(B) and 

610.47(a)(3), collecting establishments 

would notify the consignee 2 times for 

each of the 20,397 (6,799 × 3 

components) components prepared from 

these donations, once for quarantine 

purposes and again with additional 

HCV test results for a total of 40,794 (2 

× 20,397 notifications) as an annual 

ongoing burden. Under § 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 14.3 percent of 

approximately 9 million potential 

donors (1,287,000 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 1,734 (1,054 + 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 

(1,156) of the 1,734 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 approximately onethird, or 578 of the 1,734 blood 

collecting establishments would need to 

provide, under § 630.40(a), additional 

information and onsite counseling to the 

estimated 429,000 (one-third of 

approximately 1,287,000) 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 TLymphotropic Virus, and syphilis as 

usual and customary business practice. 

Consequently, 5 percent of the 1,623 

licensed establishments (81) collecting 1 

percent (4,050) of the deferred donors 

(405,000) would notify donors under 

§ 630.40(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 § 630.40(d)(1). 

However, we estimate that 

approximately 5 percent of the 1,054 

blood collection establishments (53) 

may not notify the referring physicians 

of the estimated 2 percent of 31,364 

autologous donors with the initial 

reactive test results (627) 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 § 606.160(b)(1)(ix), we estimate 

the total annual records based on the 

approximately 1,287,000 donors 

determined not to be eligible to donate 

and each of the estimated 1,692,000 

(1,287,000 + 405,000) donors deferred 

based on reactive test results for 

evidence of infection because of 

relevant transfusion-transmitted 

infections. Under § 606.160(b)(1)(xi), 

only the 1,734 registered blood 

establishments collect autologous 

donations and, therefore, are required to 

notify referring physicians. We estimate 

that 4.5 percent of the 31,364 autologous 

donors (1,411) will be deferred under 

§ 610.41, which in turn will lead to the 

notification of their referring physicians. 

Under § 610.41(b), FDA estimates that 

there would be 25 submissions for 

requalification of donors each requiring 

7 hours per submission. In addition, 

FDA estimates that there would be only 

3 notifications for requalification of 

donors under § 630.35(b) which would 

also require 7 hours for each 

submission. 

FDA permits the shipment of untested 

or incompletely tested human blood or 

blood components in rare medical 

emergencies and when appropriately 

documented (§ 610.40(g)(1). We estimate 

the recordkeeping under § 610.40(g)(1) 

to be minimal with one or fewer 

occurrences per year. The reporting of 

test results to the consignee in 

§ 610.40(g) is part of the usual and 


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3170 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

customary business practice of blood 

establishments. 

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. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

606.170(b) 2 .......................................................................... 81 1 81 20 1,620 

610.40(g)(2) ......................................................................... 1 1 1 1 1 

610.41(b) .............................................................................. 1,623 0.015 25 7 175 

610.40(h)(2)(ii)(A) ................................................................. 1 1 1 1 1 

630.35(b) .............................................................................. 1,623 0.002 3 7 21 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,818 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2The 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

21 CFR section/activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

606.100(b) 2 .................................................................. 5 363 1 363 24 .......................... 8,712 

606.100(c) .................................................................... 5 363 10 3,630 1 ............................ 3,630 

606.110(a) 3 .................................................................. 6 45 1 45 .5 (30 min.) ........... 23 

606.151(e) .................................................................... 5 363 12 4,356 .08 (5 min.) ........... 348 

606.160 4 ...................................................................... 5 363 1,055.096 383,000 .75 (45 min.) ......... 287,250 

606.160(b)(1)(viii) HIV consignee notification .............. 1,734 10.4533 18,126 .17 (10 min.) ......... 3,081 

4,961 3.6537 18,126 .17 (10 min.) ......... 3,081 

606.160(b)(1)(viii) HCV consignee notification ............ 1,734 23.5259 40,794 .17 (10 min.) ......... 6,935 

4,961 8.2229 40,794 .17 (10 min.) ......... 6,935 

HIV recipient notification .............................................. 4,961 0.3538 1,755 .17 (10 min.) ......... 298 

HCV recipient notification ............................................. 4,961 0.4132 2,050 .17 (10 min.) ......... 349 

606.160(b)(1)(ix) ........................................................... 2,303 734.6939 1,692,000 .05 (3 min.) ........... 84,600 

606.160(b)(1)(xi) ........................................................... 1,734 0.8137 1,411 .05 (3 min.) ........... 71 

606.165 ......................................................................... 5 363 1,055.096 383,000 .08 (5 min.) ........... 30,640 

606.170(a) .................................................................... 5 363 12 4,356 1 ............................ 4,356 

610.40(g)(1) .................................................................. 2,303 1 2,303 .5 (30 min.) ........... 1,152 

630.15(a)(1)(ii)(B) ......................................................... 1,734 1 1,734 1 ............................ 1,734 

630.20(c) ...................................................................... 1,734 1 1,734 1 ............................ 1,734

Total ...................................................................... ........................ ........................ ........................ ............................... 444,930 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2The recordkeeping requirements in §§ 606.171, 630.5(d), 630.10(c)(1) and (2), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b). 3The 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). 4The recordkeeping requirements in §§ 606.110(a)(2), 630.5(b)(1)(i), 630.109(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); 640.71(b)(1); 640.72; 640.73 and 640.76(a) and (b), which address the maintenance of various 

records are included in the estimate for § 606.160. 5Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 

4,961 + 2,303 = 363). 6Five percent of plateletpheresis and leukopheresis establishments (0.05 × 901 = 45). 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

606.145(c) .................................................................... 4,961 0.2822 1,400 .02 ......................... 28

606.170(a) .................................................................... 2 363 12 4,356 .5 (30 min.) ........... 2,178 

610.40(c)(1)(ii) .............................................................. 2,303 0.0595 137 .08 (5 min.) ........... 11 

610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) ............................... 15 12 180 .20 (12 min.) ......... 36 

610.40(h)(2)(vi) ............................................................. 2,303 3.28 7,554 .08 (5 min.) ........... 604 

610.42(a) ...................................................................... 1 1 1 1 ............................ 1 

610.46(a)(1)(ii)(B) ......................................................... 1,734 5.2266 9,063 .17 (10 min.) ......... 1,541 

610.46(a)(3) .................................................................. 1,734 5.2266 9,063 .17 (10 min.) ......... 1,541 

610.46(b)(3) .................................................................. 4,961 0.3538 1,755 1 ............................ 1,755 

610.47(a)(1)(ii)(B) ......................................................... 1,734 11.7630 20,397 .17 (10 min.) ......... 3,467 


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Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3171 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

610.47(a)(3) .................................................................. 1,734 11.7630 20,397 .17 (10 min.) ......... 3,467 

610.47(b)(3) .................................................................. 4,961 0.4132 2,050 1 ............................ 2,050 

630.40(a) 3 .................................................................... 578 742.214 429,000 .08 (5 min.) ........... 34,320 

630.40(a) 4 .................................................................... 81 50.00 4,050 1.5 ......................... 6,075 

630.40(d)(1) .................................................................. 53 11.83 627 1 ............................ 627 

Total ...................................................................... ........................ ........................ ........................ ............................... 57,701 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 

4,961 + 2,303 = 363). 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 relevant transfusion-transmitted infections. 

The burden for this information 

collection has changed since the last 

OMB approval. Because of a slight 

decrease in the number of blood 

establishments during the last 3 years, 

FDA has decreased our recordkeeping 

and third party disclosure burden 

estimates. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01123 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Tick-Borne Disease 

Working Group 

AGENCY: Office of HIV/AIDS and 

Infectious Disease Policy, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) announces the 

third meeting of the Tick-Borne Disease 

Working Group (Working Group) on 

February 12, 2018, from 12:00 p.m. to 

4:00 p.m., Eastern Time. For this third 

meeting, the Working Group will focus 

on mapping out the work of the six 

Subcommittee Meeting Working Groups 

that were established on December 12, 

2017. These subcommittees were 

established to assist the Working Group 

with the development of the report to 

Congress and the HHS Secretary as 

required by the 21st Century Cures Act. 

The subcommittees are: 

1. Disease Vectors, Surveillance and 

Prevention (includes epidemiology of 

tick-borne diseases); 

2. Pathogenesis, Transmission, and 

Treatment; 

3. Testing and Diagnostics (including 

laboratory-based diagnoses and clinicaldiagnoses); 

4. Access to Care Services and 

Support to Patients; 

5. Vaccine and Therapeutics; and 

6. Other Tick-Borne Diseases and Coinfections. 

DATES: February 12, 2018, from 12:00 

p.m. to 4:00 p.m., Eastern Time. 

ADDRESSES: This will be a virtual 

meeting that is held via webcast. 

Members of the public may attend the 

meeting via webcast and instructions for 

attending this virtual meeting will be 

posted one week prior to the meeting at: 

https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: 

James Berger, Office of HIV/AIDS and 

Infectious Disease Policy, Office of the 

Assistant Secretary for Health, 

Department of Health and Human 

Services; via email at tickbornedisease@

hhs.gov or by phone at 202–795–7697. 

SUPPLEMENTARY INFORMATION: At this 

meeting, the Working Group will also 

hear about one or more examples of 

other efforts that have been successfully 

undertaken to define a national or 

statewide approach to preventing, 

monitoring, diagnosing, and treating 

people with tick-borne diseases. In 

addition, federal resources, within and 

outside of HHS, that may be of use to 

the subcommittees as they do their 

work, such as the Department of Health 

and Human Services Internal Working 

Group on Lyme and Other Tick-Borne 

Diseases, will be presented. 

The Working Group invites public 

comment on issues related to the 

Working Group’s charge. Comments 

may be provided over the phone during 

the meeting or in writing. Persons who 

wish to provide comments by phone 

should review directions at https://

www.hhs.gov/ash/advisory-committees/ 

tickbornedisease/meetings/index.html 

before submitting a request via email at 

tickbornedisease@hhs.gov on or before 

February 7, 2018. Phone comments will 

be limited to three minutes each to 

accommodate as many speakers as 

possible. A total of 30 minutes will be 

allocated to public comments. If more 

requests are received than can be 

accommodated, speakers will be 

randomly selected. The nature of the 

comments will not be considered in 

making this selection. Public comments 

may also be provided in writing. 

Individuals who would like to provide 

written comment should review 

directions at https://www.hhs.gov/ash/ 

advisory-committees/tickbornedisease/ 

meetings/index.html before sending 

their comments to tickbornedisease@

hhs.gov on or before February 7, 2018. 

Background and Authority: The TickBorne Disease Working Group was 

established on August 10, 2017, in 

accordance with section 2062 of the 21st 

Century Cures Act, and the Federal 

Advisory Committee Act, 5 U.S.C. App., 

as amended, to provide expertise and 

review all HHS efforts related to tickborne diseases to help ensure 

interagency coordination and minimize 

overlap, examine research priorities, 

and identify and address unmet needs. 

In addition, the Working Group will 

report to the Secretary and Congress on 

their findings and any recommendations 

for the federal response to tick-borne 

disease prevention, treatment and 

research, and addressing gaps in those 

areas. 

Dated: January 17, 2018. 

James Berger, 

Alternate Designated Federal Officer, Office 

of HIV/AIDS and Infectious Disease Policy, 

Tick-Borne Disease Working Group. 

[FR Doc. 2018–01149 Filed 1–22–18; 8:45 am] 

BILLING CODE 4150–28–P 


sradovich on DSK3GMQ082PROD with NOTICES