Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 73081 

Dated: December 2, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28713 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1814] 

Bacterial Detection Testing by Blood 

Collection Establishments and 

Transfusion Services To Enhance the 

Safety and Availability of Platelets for 

Transfusion; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Bacterial Detection Testing by Blood 

Collection Establishments and 

Transfusion Services to Enhance the 

Safety and Availability of Platelets for 

Transfusion’’ dated December 2014. The 

draft guidance document provides blood 

collection establishments and 

transfusion services with 

recommendations for initial testing 

(primary testing) for bacterial 

contamination of platelets intended for 

transfusion, and provides additional 

considerations for blood collection 

establishments and transfusion services 

for subsequent retesting (secondary 

testing) of platelets prior to transfusion. 

The recommendations for primary 

testing of platelets and the additional 

considerations for secondary testing of 

platelets described in this guidance are 

expected to enhance the detection of 

bacteria in platelet products and thus 

enhance transfusion safety. The draft 

guidance, when finalized, is intended to 

supersede the recommendation in 

section VII.A.2, in regard to bacterial 

contamination testing in the document 

entitled ‘‘Guidance for Industry and 

FDA Review Staff: Collection of 

Platelets by Automated Methods’’ dated 

December 2007. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by March 9, 2015. 

Submit either electronic or written 

comments on the collection of 

information by February 9, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance and information 

collection to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan McKnight, 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: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Bacterial 

Detection Testing by Blood Collection 

Establishments and Transfusion 

Services to Enhance the Safety and 

Availability of Platelets for Transfusion’’ 

dated December 2014. The draft 

guidance document provides blood 

collection establishments and 

transfusion services with 

recommendations for primary testing for 

bacterial contamination of platelets 

intended for transfusion and additional 

considerations for blood collection 

establishments and transfusion services 

for secondary testing of platelets prior to 

transfusion. FDA also provides 

recommendations to licensed blood 

establishments for submitting Biologics 

License Application supplements to 

include bacterial testing of platelet 

components. Furthermore, the guidance 

informs transfusion services that are 

currently exempt from registration and 

blood product listing that if they choose 

to perform secondary testing of platelets 

to extend the dating period, should this 

option become available, they must 

register with FDA and list the blood 

products they manufacture. 

The draft guidance addresses all 

platelet products, including platelets 

manufactured from Whole Blood 

(Whole Blood Derived (WBD) platelets), 

platelets collected by automated 

methods from a single donor (apheresis 

platelets), pooled platelets, and platelets 

stored in additive solutions. The 

recommendations for primary testing of 

platelets and the additional 

considerations for secondary testing of 

platelets described in this guidance are 

expected to enhance the detection of 

bacteria in platelet products and thus 

enhance transfusion safety. The draft 

guidance, when finalized, is intended to 

supersede the recommendation in 

section VII.A.2, in regard to bacterial 

contamination testing in the document 

entitled ‘‘Guidance for Industry and 

FDA Review Staff: Collection of 

Platelets by Automated Methods’’ dated 

December 2007. 

Platelets are associated with a higher 

risk of sepsis and are related to more 

fatalities than any other transfusable 

blood component. The risk of bacterial 

contamination of platelets stands out as 

a leading risk of infection from blood 

transfusion. This risk has persisted 

despite numerous interventions 

including the introduction, in the last 

decade, of analytically sensitive culturebased bacterial detection methods, 

which are widely used to test platelets 

prior to their release from blood 

collection establishments to transfusion 

services. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 


rljohnson on DSK3VPTVN1PROD with NOTICES
73082 Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 

of the proposed collections of 

information set forth in this document. 

With respect to the following 

collections 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. 

Bacterial Detection Testing by Blood 

Collection Establishments and 

Transfusion Services To Enhance the 

Safety and Availability of Platelets for 

Transfusion 

We have identified the following 

recommendations in the draft guidance 

document as collections of information. 

In section V, the draft guidance 

recommends that blood collection 

establishments have in place measures 

to promptly alert the transfusion 

services in the event that a distributed 

platelet product is subsequently 

identified as positive for bacterial 

contamination. In section IX.A.2, the 

draft guidance recommends that 

following secondary testing, a tie-tag 

should be attached to the platelet 

products to relay the following 

information: Type of bacterial detection 

test performed (rapid or culture); date 

and time the bacterial detection test was 

performed; and, the results of the 

bacterial detection testing. The draft 

guidance also recommends that a single 

tie-tag may be attached to a pooled 

platelet product. 

Description of Respondents: The 

third-party disclosure and one-time 

recordkeeping recommendations 

described in the draft guidance affect 

blood collection establishments and 

transfusion services that collect and 

manufacture platelet products for 

transfusion, including WBD platelets, 

platelets collected by automated 

methods from a single donor (apheresis 

platelets), pooled platelets, and platelets 

stored in additive solutions. 

Burden Estimate: The Agency believes 

the information collection provision for 

licensed blood collection establishments 

in section V does not create a new 

burden for respondents and is part of 

usual and customary business practice. 

Blood collection establishments 

currently have in place standard 

operating procedures for notifying 

consignees (transfusion services) if a 

distributed platelet product has 

subsequently tested positive for 

bacterial contamination. 

In section IX.A.2, the draft guidance 

recommends that following secondary 

testing, a tie-tag should be attached to 

the platelet products to relay certain 

information related to the bacterial 

detection test. FDA estimates the burden 

of this collection of information as 

follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Labeling Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Under section IX.A.2, a tie-tag to the platelet product relaying specific information following secondary testing 

should be attached ........................................................... 150 1,250 187,500 .05 9,375 

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

Table 1 of this document provides an 

estimate of the annual third-party 

disclosure burden for the information to 

be submitted in accordance with the 

draft guidance. Based on FDA data and 

information submitted by industry, FDA 

believes that there are approximately 2 

million platelet transfusions per year 

and that 75 percent or 1.5 million 

transfusions occur at large volume 

transfusion services. FDA also believes 

that on average, the large volume 

transfusion services perform about 5,000 

platelet transfusions annually. 

Furthermore, FDA approximates that 

150 transfusion services, most of which 

will be large volume transfusion 

services, may elect to perform secondary 

testing. We expect that secondary 

testing will be used primarily for the 

extension of dating up to 7 days at large 

volume transfusion services. However, 

while each of the 150 transfusion 

services may issue, on average, 5,000 

platelets a year, secondary testing will 

be performed on only a portion of these 

platelets. Based on FDA experience, we 

estimate that secondary testing will be 

performed on approximately 25 percent 

or 1,250 platelets to permit transfusion 

beyond day 5. Thus, the total estimated 

annual burden of 9,375 hours for 

transfusion services to implement the 

recommendation in Table 1 is based on 

FDA’s experience and industry 

information. 

TABLE 2—ESTIMATED ONE-TIME RECORDKEEPING BURDEN 1

Creation of SOPs Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Under section IX.A.2, a tie-tag to the platelet product relaying specific information following secondary testing 

should be attached. .......................................................... 150 1 150 16 2,400 

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


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 73083 

Table 2 of this document provides a 

one-time recordkeeping burden estimate 

for the information to be submitted in 

accordance with the draft guidance. As 

described in the proceeding paragraphs, 

based on FDA’s experience and industry 

information, FDA anticipates that 150 

respondents, mainly from large volume 

transfusion services, will implement the 

recommendations set forth in section 

IX.A.2. Thus, based on FDA data and 

industry recordkeeping information, 

FDA estimates that the total estimated 

one-time recordkeeping burden is 2,400 

hours. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR 601.12 and 610.60 have been 

approved under OMB control number 

0910–0338; the collections of 

information in 21 CFR 606.65, 606.100, 

606.120, 606.121, 606.122, and 606.140 

have been approved under OMB control 

number 0910–0116; and the collections 

of information in 21 CFR 607.3, 607.7 

and 607.65 have been approved under 

OMB control number 0910–0052. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit either electronic comments 

regarding this document to http:// 

www.regulations.gov or written 

comments to the Division of Dockets 

Management (see ADDRESSES). It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulations.gov. 

Dated: December 4, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28809 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2083] 

Draft Guidance for Industry on Drug 

Supply Chain Security Act 

Implementation: Annual Reporting by 

Prescription Drug Wholesale 

Distributors and Third-Party Logistics 

Providers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Drug Supply Chain 

Security Act Implementation: Annual 

Reporting by Prescription Drug 

Wholesale Distributors and Third-Party 

Logistics Providers.’’ This draft 

guidance addresses new provisions in 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Drug Supply Chain Security Act 

(DSCSA). The draft guidance describes 

FDA’s expectations for prescription 

drug wholesale distributors (wholesale 

distributors) and third-party logistics 

providers (3PLs) about reporting to FDA 

under the DSCSA. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 9, 

2015. Submit either electronic or 

written comments concerning the 

collection of information proposed in 

the draft guidance by February 9, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, 4147, Silver Spring, MD 

20993; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne Barone, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, wdd3plrequirements@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Drug Supply Chain Security Act 

Implementation: Annual Reporting by 

Prescription Drug Wholesale 

Distributors and Third-Party Logistics 

Providers.’’ This guidance is being 

issued to facilitate implementation of 

new reporting provisions under the 

DSCSA. On November 27, 2013, the 

DSCSA (Title II of Pub. L. 113–54) was 

signed into law. The DSCSA outlines 

new requirements for the licensing of 

prescription drug wholesale distributors 

and 3PLs. 

Section 204 of the DSCSA amends 

section 503(e) of the FD&C Act (21 

U.S.C. 353(e)) and outlines requirements 

for reporting by wholesale distributors. 

Section 503(e)(2)(A) of the FD&C Act (as 

amended) requires wholesale 

distributors to report annually, 

beginning on January 1, 2015. 

Information to be reported includes 

State licensure information and contact 

information for each facility. Wholesale 

distributors are also to report to FDA 

any significant disciplinary actions 

taken by the State or Federal 

Government, such as revocation or 

suspension of a license. Section 204 of 

the DSCSA also amends section 

503(e)(2)(B) of the FD&C Act and 

requires FDA to make information about 

wholesale distributors’ licensure 

available to the public on FDA’s Web 

site. Updates to the public information 

are to be made on a schedule to be 

determined by FDA. 

Section 205 of the DSCSA adds 

section 584 to the FD&C Act. Section 

584 sets forth requirements for licensure 

and reporting by 3PLs. Under section 

584 of the FD&C Act (as amended) (21 

U.S.C. 360eee–3), 3PLs are required to 

report annually to FDA, beginning on 

November 27, 2014 (1 year after the date 

of enactment of the DSCSA). Thirdparty logistic providers are required to 

report State licensure information, name 

and address for each facility, and all 

trade names under which each facility 

conducts business. 


rljohnson on DSK3VPTVN1PROD with NOTICES