73080 Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 

support findings of effectiveness and 

safety and helps identify appropriate 

doses in pediatric populations. The 

draft guidance also describes the use of 

quantitative approaches (i.e., 

pharmacometrics) to employ disease 

and exposure-response knowledge from 

relevant prior clinical studies to design 

and evaluate future pediatric studies. 

The draft guidance does not describe: 

(1) Standards for approval of drugs and 

biological products in the pediatric 

population, (2) criteria to allow a 

determination that the course of a 

disease and the effects of a drug or a 

biologic are the same in adults and 

pediatric populations, or (3) clinical 

pharmacology studies for vaccine 

therapy, blood products, or other 

products not regulated by the Center for 

Drug Evaluation and Research. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

Agency’s current thinking on the 

general clinical pharmacology 

considerations for pediatric studies for 

drugs and biological products. 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 requirement of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance includes 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act (PRA) of 

1995 (44 U.S.C. 3501–3520) (PRA). The 

collections of information referenced in 

this draft guidance that are related to the 

burden for the submission of 

investigational new drug applications 

are covered under 21 CFR part 312 and 

have been approved under OMB control 

number 0910–0014. The collections of 

information referenced in this draft 

guidance that are related to the burden 

for the submission of new drug 

applications are covered under 21 CFR 

part 314 and have been approved under 

OMB control number 0910–0001. The 

submission of prescription drug product 

labeling under 21 CFR 201.56 and 

201.57 is approved under OMB control 

number 0910–0572. 

In accordance with the PRA, prior to 

publication of any final guidance 

document, FDA intends to solicit public 

comment and obtain OMB approval for 

any information collections 

recommended in this guidance that are 

new or that would represent material 

modifications to those previously 

approved collections of information 

found in FDA regulations or guidances. 

III. Comments 

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 document at http://www.

fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances or 

http://www.regulations.gov. 

Dated: December 2, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28716 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–1492] 

Two-Phased Chemistry, 

Manufacturing, and Controls Technical 

Sections; Draft Guidance for Industry; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period for a notice of 

availability of draft guidance for 

industry (GFI #227) entitled ‘‘TwoPhased Chemistry, Manufacturing, and 

Controls Technical Sections’’ that 

appeared in the Federal Register of 

October 20, 2014. In that notice, FDA 

made available for comment the draft 

guidance, which provides 

recommendations to sponsors 

submitting chemistry, manufacturing, 

and controls (CMC) data submissions. 

The Agency is taking this action in 

response to a request for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period on the draft guidance. Submit 

either electronic or written comments 

on the draft guidance by February 17, 

2015. 

ADDRESSES: Submit electronic 

comments on the draft guidance to 

http://www.regulations.gov. Submit 

written comments on the draft guidance 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Heather Longstaff, Center for Veterinary 

Medicine (HFV–145), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0651, 

email: heather.longstaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 20, 

2014 (79 FR 62635) FDA published a 

notice announcing the availability of 

draft guidance for industry (GFI #227) 

entitled ‘‘Two-Phased Chemistry, 

Manufacturing, and Controls (CMC) 

Technical Sections.’’ It is intended to 

provide recommendations to industry 

regarding CMC data submitted to the 

Center for Veterinary Medicine to 

support approval of a new animal drug 

or abbreviated new animal drug. The 

notice invited comments on the draft 

guidance by December 19, 2014. 

The Agency received a request for a 

60-day extension of the comment period 

for the draft guidance. The request 

conveyed concern that the current 60- 

day comment period does not allow 

sufficient time to respond. 

FDA has considered the request and 

is extending the comment period for the 

draft guidance for 60 days, until 

February 17, 2015. The Agency believes 

that a 60-day extension allows adequate 

time for interested persons to submit 

comments without significantly 

delaying further FDA action on this 

guidance document. 

II. Request for Comments 

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. 


rljohnson on DSK3VPTVN1PROD with NOTICES
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