11444 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. We intend to 

review the notifications we receive to 

ensure that they comply with the 

criteria established by the FD&C Act. 

In the Federal Register of November 

21, 2014 (79 FR 69494), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received in response to the notice. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of the FD&C Act Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

403(r)(2)(G) (nutrient content claims) .................................. 1 1 1 250 250 

403(r)(2)(C) (health claims) ................................................. 1 1 1 450 450 

Guidance for notifications .................................................... 2 1 2 1 2 

Total .............................................................................. ........................ ........................ ........................ ........................ 702 

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

These estimates are based on our 

experience with health claims, nutrient 

content claims, and other similar 

notification procedures that fall under 

our jurisdiction. To avoid estimating the 

number of respondents as zero, we 

estimate that there will be one or fewer 

respondents annually for nutrient 

content claim and health claim 

notifications. We estimate that we will 

receive one nutrient content claim 

notification and one health claim 

notification per year over the next 3 

years. 

Section 403(r)(2)(G) and (r)(3)(C) of 

the FD&C Act requires that the 

notification include the exact words of 

the claim, a copy of the authoritative 

statement, a concise description of the 

basis upon which such person relied for 

determining that this is an authoritative 

statement as outlined in the FD&C Act, 

and a balanced representation of the 

scientific literature relating to the 

relationship between a nutrient and a 

disease or health-related condition to 

which a health claim refers or to the 

nutrient level to which the nutrient 

content claim refers. This balanced 

representation of the scientific literature 

is expected to include a bibliography of 

the scientific literature on the topic of 

the claim and a brief, balanced account 

or analysis of how this literature either 

supports or fails to support the 

authoritative statement. 

Since the claims are based on 

authoritative statements of a scientific 

body of the U.S. Government or NAS, 

we believe that the information that is 

required by the FD&C Act to be 

submitted with a notification will be 

readily available to a respondent. 

However, the respondent will have to 

collect and assemble that information. 

Based on communications with firms 

that have submitted notifications, we 

estimate that one respondent will take 

250 hours to collect and assemble the 

information required by the statute for 

a nutrient content claim notification. 

Further, we estimate that one 

respondent will take 450 hours to 

collect and assemble the information 

required by the statute for a health claim 

notification. 

Under the guidance, notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. The 

guidance applies to both nutrient 

content claim and health claim 

notifications. We have determined that 

this information should be readily 

available to a respondent and, thus, we 

estimate that it will take a respondent 1 

hour to incorporate the information into 

each notification. We expect there will 

be two respondents for a total of 2 

hours. 

Dated: February 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04380 Filed 3–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–N–0161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donor Testing, Donor Notification, and 

‘‘Lookback’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 2, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0116. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Current Good Manufacturing Practices 

and Related Regulations for Blood and 

Blood Components; and Requirements 

for Donor Testing, Donor Notification, 

and ‘‘Lookback’’—(OMB Control 

Number 0910–0116)—Extension 

All blood and blood components 

introduced or delivered for introduction 

into interstate commerce are subject to 

section 351(a) of the Public Health 

Service Act (PHS Act) (42 U.S.C. 

262(a)). Section 351(a) requires that 

manufacturers of biological products, 

which include blood and blood 

components intended for further 

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Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11445 

manufacture into injectable products, 

have a license, issued upon a 

demonstration that the product is safe, 

pure, and potent and that the 

manufacturing establishment meets all 

applicable standards, including those 

prescribed in the FDA regulations 

designed to ensure the continued safety, 

purity, and potency of the product. In 

addition, under section 361 of the PHS 

Act (42 U.S.C. 264), by delegation from 

the Secretary of Health and Human 

Services, FDA may make and enforce 

regulations necessary to prevent the 

introduction, transmission, or spread of 

communicable diseases from foreign 

countries into the States or possessions, 

or from one State or possession into any 

other State or possession. 

Section 351(j) of the PHS Act states 

that the Federal Food, Drug, and 

Cosmetic (FD&C) Act also applies to 

biological products. Blood and blood 

components for transfusion or for 

further manufacture into injectable 

products are drugs, as that term is 

defined in section 201(g)(1) of the FD&C 

Act (21 U.S.C. 321(g)(1)). Because blood 

and blood components are drugs under 

the FD&C Act, blood and plasma 

establishments must comply with the 

substantive provisions and related 

regulatory scheme of the FD&C Act. For 

example, under section 501 of the FD&C 

Act (21 U.S.C. 351(a)), drugs are deemed 

‘‘adulterated’’ if the methods used in 

their manufacturing, processing, 

packing, or holding do not conform to 

current good manufacturing practice 

(CGMP) and related regulations. 

The CGMP regulations for blood and 

blood components (21 CFR part 606) 

and related regulations implement 

FDA’s statutory authority to ensure the 

safety, purity, and potency of blood and 

blood components. The public health 

objective in testing human blood donors 

for evidence of infection due to 

communicable disease agents and in 

notifying donors is to prevent the 

transmission of communicable disease. 

For example, the ‘‘lookback’’ 

requirements are intended to help 

ensure the continued safety of the blood 

supply by providing necessary 

information to users of blood and blood 

components and appropriate 

notification of recipients of transfusion 

who are at increased risk for 

transmitting human immunodeficiency 

virus (HIV) or hepatitis C virus (HCV) 

infection. 

The information collection 

requirements in the CGMP, donor 

testing, donor notification, and 

‘‘lookback’’ regulations provide FDA 

with the necessary information to 

perform its duty to ensure the safety, 

purity, and potency of blood and blood 

components. These requirements 

establish accountability and traceability 

in the processing and handling of blood 

and blood components and enable FDA 

to perform meaningful inspections. 

The recordkeeping requirements serve 

preventive and remedial purposes. The 

third-party disclosure requirements 

identify the various blood and blood 

components and important properties of 

the product, demonstrate that the CGMP 

requirements have been met, and 

facilitate the tracing of a product back 

to its original source. The reporting 

requirements inform FDA of certain 

information that may require immediate 

corrective action. 

Under the reporting requirements, 

§ 606.170(b), in brief, requires that 

facilities notify FDA’s Center for 

Biologics Evaluation and Research 

(CBER), as soon as possible after 

confirming a complication of blood 

collection or transfusion to be fatal. The 

collecting facility is to report donor 

fatalities, and the compatibility testing 

facility is to report recipient fatalities. 

The regulation also requires the 

reporting facility to submit a written 

report of the investigation within 7 days 

after the fatality. In fiscal year 2013, 

FDA received 72 of these reports. 

Section 610.40(g)(2) (21 CFR 

610.40(g)(2)) requires an establishment 

to obtain written approval from FDA to 

ship human blood or blood components 

for further manufacturing use prior to 

completion of testing for evidence of 

infection due to certain communicable 

disease agents. 

Section 610.40(h)(2)(ii)(A), in brief, 

requires an establishment to obtain 

written approval from FDA to use or 

ship human blood or blood components 

found to be reactive by a screening test 

for evidence of certain communicable 

disease agent(s) or collected from a 

donor with a record of a reactive 

screening test. 

Under the third-party disclosure 

requirements, § 610.40(c)(1)(ii), 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 

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 

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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 

leukapheresis procedures to obtain a 

product for a specific recipient may be 

at variance with the additional 

standards for that specific product if, 

among other things, the physician 

certifies in writing that the donor’s 

health permits plateletpheresis or 

leukapheresis. Section 606.110(b) 

requires establishments to request prior 

approval from CBER for plasmapheresis 

of donors who do not meet donor 

requirements. The information 

collection requirements for § 606.110(b) 

are approved under OMB control 

number 0910–0338 and, therefore, are 

not reflected in tables 1 and 2. 

Section 606.151(e) requires that SOPs 

for compatibility testing include 

procedures to expedite transfusion in 

life-threatening emergencies; records of 

all such incidents must be maintained, 

including complete documentation 

justifying the emergency action, which 

must be signed by a physician. 

So that each significant step in the 

collection, processing, compatibility 

testing, storage, and distribution of each 

unit of blood and blood components can 

be clearly traced, § 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 21 

CFR part 640 that require additional 

standards for certain blood and blood 

components as follows: Sections 

640.3(a)(1), (a)(2), and (f); 640.4(a)(1) 

and (a)(2); 640.25(b)(4) and (c)(1); 

640.27(b); 640.31(b); 640.33(b); 

640.51(b); 640.53(b) and (c); 640.56(b) 

and (d); 640.61; 640.63(b)(3), (e)(1), and 

(e)(3); 640.65(b)(2); 640.66; 640.71(b)(1); 

640.72; 640.73; and 640.76(a) and (b). 

The information collection requirements 

and estimated burdens for these 

regulations are included in the part 606 

burden estimates, as described in tables 

1 and 2. 

Respondents to this collection of 

information are licensed and unlicensed 

blood establishments that collect blood 

and blood components, including 

Source Plasma and Source Leukocytes, 

inspected by FDA, and other transfusion 

services inspected by Centers for 

Medicare and Medicaid Services (CMS). 

Based on information received from 

CBER’s database systems, there are 

approximately 416 licensed Source 

Plasma establishments with multiple 

locations and approximately 1,265 

licensed blood collection 

establishments, for an estimated total of 

1,681 licensed blood collection 

establishments. Also, there are an 

estimated total of 680 unlicensed, 

registered blood collection 

establishments for an approximate total 

of 2,361 collection establishments (416 

+ 1,265 + 680 = 2,361 establishments). 

Of these establishments, approximately 

990 perform plateletpheresis and 

leukapheresis. These establishments 

annually collect approximately 40 

million units of Whole Blood and blood 

components, including Source Plasma 

and Source Leukocytes, and are 

required to follow FDA ‘‘lookback’’ 

procedures. In addition, there are 

another 4,961 establishments that fall 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578) (formerly 

referred to as facilities approved for 

Medicare reimbursement) that transfuse 

blood and blood components. 

The following reporting and 

recordkeeping estimates are based on 

information provided by industry, CMS, 

and FDA experience. Based on 

information received from industry, we 

estimate that there are approximately 25 

million donations of Source Plasma 

from approximately 2 million donors 

and approximately 15 million donations 

of Whole Blood, including 

approximately 225,000 (approximately 

1.5 percent of 15 million) autologous 

donations, from approximately 10.9 

million donors. Assuming each 

autologous donor makes an average of 2 

donations, FDA estimates that there are 

approximately 112,500 autologous 

donors. 

FDA estimates that approximately 5 

percent (3,600) of the 72,000 donations 

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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, HCV, Human 

T-Lymphotropic Virus, and syphilis as 

usual and customary business practice. 

Consequently, 5 percent of the 1,681 

establishments (84) collecting 1 percent 

(4,500) of the deferred donors (450,000) 

would notify donors under § 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. 

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 

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11448 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

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. 

In the Federal Register of October 20, 

2014 (79 FR 62629), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received five 

comments; however, the comments 

were not responsive to the comment 

request on the four specified aspects of 

the collection of information and did 

not provide any data or explanation that 

would support a change regarding the 

information collection estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

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 .6 5,063 0.05 (3 minutes) ............................... 253 

606.165 ............................................. 5 366 1,046 .45 383,000 0.08 (5 minutes) ............................... 30,640 

606.170(a) ......................................... 5 366 12 4,392 1 ....................................................... 4,392 

610.40(g)(1) ...................................... 2,361 1 2,361 0.5 (30 minutes) ............................... 1,180 

Total ........................................... ........................ ........................ ........................ ........................................................... 447,734 

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 leukapheresis establishments (0.05 × 990 = 50). 

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 

606.170(a) ......................................... 2 366 1 .2 439 0.5 (30 minutes) ............................... 220 

610.40(c)(1)(ii) ................................... 2,361 1 .52 3,600 0.08 (5 minutes) ............................... 288 

610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) ... 40 12 480 0.2 (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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11449 

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) ...................................... 1,945 12 .03 23,400 0.17 (10 minutes) ............................. 3,978 

610.47(b)(3) ...................................... 4,961 0 .41 2,050 1 ....................................................... 2,050 

630.6(a) 3 ........................................... 648 668 .72 433,333 0.08 (5 minutes) ............................... 34,667 

630.6(a) 4 ........................................... 84 53 .57 4,500 1.5 (90 minutes) ............................... 6,750 

630.6(d)(1) ........................................ 63 35 .71 2,250 1 ....................................................... 2,250 

Total ........................................... ........................ ........................ ........................ ........................................................... 61,043 

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: February 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04381 Filed 3–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1721] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Investigational 

New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 2, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0014. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Investigational New Drug (IND) 

Regulations—21 CFR Part 312 (OMB 

Control Number 0910–0014)—Extension 

FDA is requesting OMB approval for 

the reporting and recordkeeping 

requirements contained in FDA 

regulations entitled ‘‘Investigational 

New Drug Application’’ in part 312 (21 

CFR part 312). Part 312 implements 

provisions of section 505(i) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 355(i)) to 

issue regulations under which the 

clinical investigation of the safety and 

effectiveness of unapproved new drugs 

and biological products can be 

conducted. 

FDA is charged with implementing 

statutory requirements that drug 

products marketed in the United States 

be shown to be safe and effective, 

properly manufactured, and properly 

labeled for their intended uses. Section 

505(a) of the FD&C Act provides that a 

new drug may not be introduced or 

delivered for introduction into interstate 

commerce in the United States unless 

FDA has previously approved a new 

drug application (NDA). FDA approves 

an NDA only if the sponsor of the 

application first demonstrates that the 

drug is safe and effective for the 

conditions prescribed, recommended, or 

suggested in the product’s labeling. 

Proof must consist, in part, of adequate 

and well-controlled studies, including 

studies in humans, that are conducted 

by qualified experts. The IND 

regulations establish reporting 

requirements that include an initial 

application as well as amendments to 

that application, reports on significant 

revisions of clinical investigation plans, 

and information on a drug’s safety or 

effectiveness. In addition, the sponsor is 

required to give FDA an annual 

summary of the previous year’s clinical 

experience. 

Submissions are reviewed by medical 

officers and other Agency scientific 

reviewers assigned responsibility for 

overseeing the specific study. The IND 

regulations also contain recordkeeping 

requirements that pertain to the 

responsibilities of sponsors and 

investigators. The detail and complexity 

of these requirements are dictated by the 

scientific procedures and human subject 

safeguards that must be followed in the 

clinical tests of investigational new 

drugs. 

The IND information collection 

requirements provide the means by 

which FDA can monitor the clinical 

investigation of the safety and 

effectiveness of unapproved new drugs 

and biological products, including the 

following: (1) Monitor the safety of 

ongoing clinical investigations; (2) 

determine whether the clinical testing of 

a drug should be authorized; (3) ensure 

production of reliable data on the 

metabolism and pharmacological action 

of the drug in humans; (4) obtain timely 

information on adverse reactions to the 

drug; (5) obtain information on side 

effects associated with increasing doses; 

(6) obtain information on the drug’s 

effectiveness; (7) ensure the design of 

well-controlled, scientifically valid 

studies; and (8) obtain other information 

pertinent to determining whether 

clinical testing should be continued, 

and information related to the 

protection of human subjects. Without 

the information provided by industry as 

required under the IND regulations, 

FDA cannot authorize or monitor the 

clinical investigations which must be 

conducted prior to authorizing the sale 

and general use of new drugs. These 

reports enable FDA to monitor a study’s 

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