Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 62629 

frequency is yearly, once, and 

occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 56; Total Responses: 

1,540 (3-year total); Total Hours: 86,240 

(3-year total). (For policy questions 

regarding this collection contact 

Annette Pearson at 410–786–6858). 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Quarterly 

Medicaid and CHIP Budget and 

Expenditure Reporting for the Medical 

Assistance Program, Administration and 

CHIP; Use: At the request of OMB, this 

action would consolidate the following 

three OMB control numbers for forms 

CMS–21 and –21B (OMB control 

number: 0938–0731), CMS–37 (OMB 

control number: 0938–0101), and CMS– 

64 (OMB control number: 0938–0067) 

into a single control number that will be 

assigned upon OMB approval. It is 

important to emphasize that the 

consolidation of the control numbers 

does not consolidate any of the forms 

required for Medicaid and CHIP Budget 

and Expenditure Reporting. 

While the overall package has been 

assigned a new CMS identification 

number (CMS–10529), the individual 

forms will retain their respective CMSspecific identification numbers, namely 

CMS–21, CMS–21B, CMS–37, and 

CMS–64. Supporting materials (see 

ADDRESSES) can be found under parent 

identification number, namely CMS– 

10529. 

This action also revises CMS–37 and 

–64 while CMS–21 and –21B remain 

unchanged. Forms CMS–21 and –21B 

provide CMS with the information 

necessary to issue quarterly grant 

awards, monitor current year 

expenditure levels, determine the 

allowability of state claims for 

reimbursement, develop Children’s 

Health Insurance Program (CHIP) 

financial management information, 

provide for state reporting of waiver 

expenditures, and ensure that the 

federally established allotment is not 

exceeded. They are also necessary in the 

redistribution and reallocation of 

unspent funds over the federally 

mandated timeframes. 

Form CMS–37 due dates are 

November 15, February 15, May 15 and 

August 15 of each fiscal year. While all 

submissions represent equally 

important components of the grant 

award cycle, the May and November 

submissions are particularly significant 

for budget formulation. The November 

submission introduces a new fiscal year 

to the budget cycle and serves as the 

basis for the formulation of the 

Medicaid portion of the President’s 

Budget, which is presented to Congress 

in January. The February and August 

submissions are used primarily for 

budget execution in providing interim 

updates to our Office of Financial 

Management, the Department of Health 

and Human Services, the Office of 

Management and Budget and Congress 

depending on the scheduling of the 

national budget review process in a 

given fiscal year. The submissions 

provide us with base information 

necessary to track current year 

obligations and expenditures in relation 

to the current year appropriation and to 

notify senior managers of any 

impending surpluses or deficits. 

Form CMS–64 is used to issue 

quarterly grant awards, monitor current 

year expenditure levels, determine the 

allowability of state claims for 

reimbursement, develop Medicaid 

financial management information 

provide for state reporting of waiver 

expenditures, ensure that the federallyestablished limit is not exceeded for 

HCBS waivers, and to allow for the 

implementation of the Assignment of 

Rights and Part A and Part B Premium 

(i.e., accounting for overdue Part A and 

Part B Premiums under state buy-in 

agreements)—Billing Offsets. 

Form Number: CMS–10529 (OMB 

control number: 0938—New); 

Frequency: Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 56; Total 

Annual Responses: 672; Total Annual 

Hours: 17,920. (For policy questions 

regarding this collection contact 

Abraham John at 410–786–4519). 

Dated: October 15, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–24862 Filed 10–17–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–N–0161] 

Agency Information Collection 

Activities; Proposed Collection; 

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 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 

donor testing, donor notification, and 

‘‘lookback.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 19, 2014. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in the 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, 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. 


tkelley on DSK3SPTVN1PROD with NOTICES
62630 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 

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 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 

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 

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 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, 

§ 606.170(b), in brief, requires that 

facilities notify FDAs 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) 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, § 610.40(c)(1)(ii) in part 

610 (21 CFR 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 

(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, § 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, §§ 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 §§ 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 


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Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 62631 

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 630.6(a) (21 CFR 630.6(a)) 

requires an establishment to make 

reasonable attempts to notify any donor 

who has been deferred as required by 

§ 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 § 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 

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 leukaphesis 

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 § 606.110(b) are approved under 

OMB control number 0910–0338 and, 

therefore, are not reflected in tables 1 

and 2 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. 

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)(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 part 

640 (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 


tkelley on DSK3SPTVN1PROD with NOTICES
62632 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 

leukopheresis. 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) (Public Law 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 

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 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 §§ 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 § 610.40(h)(2)(ii)(C), and the 

other stating the exempted use 

specifically approved by FDA under 

§ 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 

(§ 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 § 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 §§ 610.46(a)(1)(ii)(B) 

and (a)(3), this estimate results in 10,500 

(3,500 × 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 × 3) notifications to 

consignees of subsequent test results. 

We estimate that § 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 × 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 7,800 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 23,400 (7,800 × 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 § 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 § 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 (HBV), HCV, 

Human T-Lymphotropic Virus (HTLV), 

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 § 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 § 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. 


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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 1.3 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 

§ 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 § 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 

§ 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 

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. 

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 .......................................................................... 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 

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 Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

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 2.60 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 

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

2The recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), 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 §§ 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 § 606.160. 5Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 

4,961 + 2,361 = 366). 6Five percent of plateletpheresis and leukopheresis establishments (0.05 × 990 = 50). 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

606.170(a) ................................................................ 2 366 12 4,392 0.5 (30 minutes) ........ 2,196 


tkelley on DSK3SPTVN1PROD with NOTICES
62634 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 

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

21 CFR section No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.40(c)(1)(ii) .......................................................... 2,361 1.52 3,600 0.08 (5 minutes) ........ 288 

610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) .......................... 40 12 480 0.20 (12 minutes) ...... 96 

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 

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 .................................................................. ........................ ........................ ........................ .................................... 63,019 

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 + 2,361 = 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: October 14, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24797 Filed 10–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0960] 

Kelvin Soto: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Kelvin Soto from providing services in 

any capacity to a person that has an 

approved or pending drug product 

application for a period of 6 years. We 

base this order on a finding that Mr. 

Soto was convicted of four felony 

counts under Federal law for conduct 

involving health care fraud and 

conspiracy to commit health care fraud 

and that this pattern of conduct is 

sufficient to find that there is reason to 

believe he may violate requirements 

under the FD&C Act relating to drug 

products. Mr. Soto was given notice of 

the proposed debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

Mr. Soto failed to request a hearing. Mr. 

Soto’s failure to request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is effective October 

20, 2014. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs, Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., Rm. 

4144, Rockville, MD 20857, 301–796– 

4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(ii)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)) 

permits debarment of an individual if 

FDA finds that the individual has been 

convicted of a felony under Federal law 

for conduct that involves bribery; 

payment of illegal gratuities; fraud; 

perjury; false statement; racketeering; 

blackmail; extortion; falsification or 

destruction of records; interference 

with, obstruction of an investigation 

into, or prosecution of any criminal 

offense; and FDA finds, on the basis of 

the conviction and other information, 

that such individual has demonstrated a 

pattern of conduct sufficient to find that 

there is reason to believe the individual 

may violate requirements under the 

FD&C Act relating to drug products. 

On November 6, 2012, the U.S. 

District Court for the Southern District 

of Florida entered judgment against Mr. 

Soto after a jury found him guilty of four 

counts of health care fraud in violation 

of 18 U.S.C. 1347 and one count of 

conspiracy to commit health care fraud 

in violation of 18 U.S.C. 1349. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein. The 

factual basis for these convictions is as 

follows: Mr. Soto was a registered nurse 

working for Ideal Home Health Inc. 

(Ideal), which was a business in MiamiDade County, FL. Ideal purportedly 

provided skilled nursing services to 

Medicare beneficiaries who required 

home health services. As a registered 

nurse in the home health field, it was 

Mr. Soto’s duty to provide skilled 

nursing services to patients and 

maintain proper documentation of all 

treatments provided to patients. 

Mr. Soto conspired with others to 

defraud Medicare. Mr. Soto and his 

coconspirators, among other things, 

submitted and caused the submission of 

false and fraudulent claims to Medicare 

and concealed the submission of these 

false and fraudulent claims. 

Mr. Soto and his co-conspirators 

falsified and caused Medicare 

beneficiaries to falsify weekly visit/time 

record sheets, falsified skilled nursing 

progress notes representing that Mr. 

Soto had administered insulin 

injections and provided various other 

medical services to Medicare 

beneficiaries, and caused Ideal to 

submit false and fraudulent claims to 

Medicare for home health benefits by 

falsely representing that they had 

provided these home health services. As 

a result of these fraudulent claims, Mr. 

Soto caused Medicare to make payments 


tkelley on DSK3SPTVN1PROD with NOTICES