Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 73079 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0987] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Clearance 

for the Collection of Qualitative Data 

on Tobacco Products and 

Communications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document entitled ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Generic 

Clearance for the Collection of 

Qualitative Data on Tobacco Products 

and Communications’’ that appeared in 

the Federal Register of August 1, 2014. 

The document announced the generic 

clearance for the collection of 

qualitative data on tobacco products and 

communications. The document was 

published with the incorrect docket 

number. This document corrects that 

error. 

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 FR Doc. 

2014–18195, appearing on page 44779 

in the Federal Register of August 1, 

2014 (79 FR 44779), FDA is making the 

following correction: 

1. On page 44779, in the second 

column, in the Docket No. heading, 

‘‘FDA–2014–N–0005’’ is corrected to 

read ‘‘FDA–2014–N–0987.’’ 

Dated: December 3, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28714 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–2013–D–1275] 

General Clinical Pharmacology 

Considerations for Pediatric Studies 

for Drugs and Biological Products; 

Draft Guidance for Industry; 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availability of a draft guidance for 

industry entitled ‘‘General Clinical 

Pharmacology Considerations for 

Pediatric Studies for Drugs and 

Biological Products.’’ The draft 

guidance is intended to assist those 

sponsors of new drug applications 

(NDAs), biologics license applications 

(BLAs) for therapeutic biologics, and 

supplements to such applications who 

are planning to conduct clinical studies 

in pediatric populations. Effectiveness, 

safety, or dose finding studies in 

pediatric patients involve gathering 

clinical pharmacology information, such 

as information regarding a product’s 

pharmacokinetics and 

pharmacodynamics pertaining to dose 

selection and individualization. This 

draft guidance addresses general clinical 

pharmacology considerations for 

conducting studies so that the dosing 

and safety information for drugs and 

biologic products can be sufficiently 

characterized, leading to well-designed 

trials to evaluate effectiveness. 

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. 

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, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist those offices 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: 

Gilbert J. Burckart, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3184, 

Silver Spring, MD 20993–0002, 301– 

796–2065. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘General Clinical Pharmacology 

Considerations for Pediatric Studies for 

Drugs and Biological Products.’’ During 

the past two decades, FDA has worked 

to address the problem of inadequate 

pediatric testing and inadequate 

pediatric use information in drug and 

biological product labeling. The Food 

and Drug Administration Modernization 

Act of 1997 (Pub. L. 105–115) addressed 

the need for improved information 

about drug use in the pediatric 

population (codified at 21 U.S.C. 355a) 

by establishing incentives for 

conducting pediatric studies on drugs 

while exclusivity or patent protection 

exists. Congress subsequently passed 

the Best Pharmaceuticals for Children 

Act (BPCA) in 2002 and the Pediatric 

Research Equity Act (PREA) in 2003. 

Both BPCA and PREA were 

reauthorized in 2007 and were made 

permanent under Title V of the Food 

and Drug Administration Safety and 

Innovation Act of 2012 (Public Law 

112–144). 

Under BPCA, sponsors of certain 

applications and supplements filed 

under section 505 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355) 

(the FD&C Act) can obtain an additional 

6 months of exclusivity if, in accordance 

with the requirements of the statute, the 

sponsor submits information responding 

to a written request from the Secretary 

relating to the use of a drug in the 

pediatric population. 

Under PREA, sponsors of certain 

applications and supplements filed 

under section 505 of the FD&C Act or 

section 351 of the Public Health Service 

Act are required to submit pediatric 

assessments, unless they receive an 

applicable waiver or deferral of this 

requirement. If applicable, sponsors 

must submit a request for a deferral or 

waiver as part of an initial pediatric 

study plan. 

This draft guidance focuses on the 

clinical pharmacology information (e.g., 

exposure-response, pharmacokinetics, 

and pharmacodynamics) needed to 


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