Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Notices 63189 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Early Clinical 

Trials with Live Biotherapeutic 

Products: Chemistry, Manufacturing, 

and Control Information’’ dated 

September 2010. The draft guidance 

provides investigational new drug 

application (IND) sponsors with 

recommendations on the submission of 

INDs for early clinical trials with live 

biotherapeutic products (LBPs). 

DATES: Although you can comment on 

any guidance at any time (21 CFR 

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

considers your comments 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on the draft guidance by December 13, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. 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The draft guidance may also be obtained 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 301–827–1800. 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electronic access to the draft guidance 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draft guidance to http:// 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: 

Benjamin A. Chacko, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Early Clinical Trials with Live 

Biotherapeutic Products: Chemistry, 

Manufacturing, and Control 

Information’’ dated September 2010. The 

draft guidance provides IND sponsors 

with recommendations on the 

submission of INDs for early clinical 

trials with LBPs. 

Regulations in part 312 (21 CFR part 

312) require sponsors who wish to study 

LBPs in humans to submit an IND to 

FDA, unless the sponsor falls into one 

of the exemptions for clinical 

investigations found under § 312.2(b). 

The general principles underlying the 

IND submission and the general 

requirements for an IND’s content and 

format are contained in §§ 312.22 and 

312.23, respectively. This draft guidance 

focuses on the chemistry, 

manufacturing, and control information 

that should be provided in an IND in 

order to meet the requirements under 

§ 312.23 for early clinical trials 

evaluating LBPs. This draft guidance is 

applicable to all INDs of LBPs, whether 

clinical trials are conducted 

commercially, in an academic setting, or 

otherwise (§ 312.2). 

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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 312 have been approved under 

the Office of Management and Budget 

(OMB) control number 0910–0014. 

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 to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: October 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25850 Filed 10–13–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0503] 

Draft Guidance for Industry on 

Investigational New Drug 

Applications—Determining Whether 

Human Research Studies Can Be 

Conducted Without an Investigational 

New Drug Application; 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 ‘‘Investigational New 

Drug Applications (INDs)—Determining 

Whether Human Research Studies Can 

Be Conducted Without an IND.’’ This 

draft guidance is intended to assist 

clinical investigators, sponsors, and 

sponsor-investigators in determining 

whether planned human research 

studies must be conducted under an 

investigational new drug application 

(IND). The guidance describes the basic 

criteria for when an IND is required, 

describes specific situations in which an 

IND is not required, and discusses a 

range of issues that, in FDA’s 

experience, have been the source of 

confusion or misperceptions about the 

application of the IND requirements. 

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 comments 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 January 12, 

2011. Submit either electronic or 

written comments concerning proposed 

collection of information by December 

13, 2010. 

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, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002, or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation Research (CBER), 

Food and Drug Administration, 1401 


jlentini on DSKJ8SOYB1PROD with NOTICES
63190 Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Notices 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448. The draft guidance 

may also be obtained by mail by calling 

CBER at 1–800–835–4709 or 301–827– 

1800. Send one self-addressed adhesive 

label to assist the 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: 

Sandy Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4204, 

Silver Spring, MD 20993–0002, 301– 

796–1077, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

1401 Rockville Pike, Suite 200N, 

Rockville, MD 20852–1448, 301–827– 

6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Investigational New Drug Applications 

(INDs)—Determining Whether Human 

Research Studies Can Be Conducted 

Without an IND.’’ FDA receives frequent 

inquiries from external constituents, in 

particular the academic research 

community (e.g., clinical investigators, 

Institutional Review Boards (IRBs)) and 

the pharmaceutical industry, concerning 

whether various types of human 

research studies can be conducted 

without an IND. Because of the volume 

and nature of the inquiries, this 

guidance is intended to be a resource to 

assist potential sponsors and clinical 

investigators in determining whether an 

IND should be submitted for their 

planned research. Generally, clinical 

investigations in which a drug is 

administered to study subjects must be 

conducted under an IND as required by 

part 312 (21 CFR part 312). This 

guidance explains the general 

requirements for when an IND is 

needed, describes the types of clinical 

studies that are exempt by regulation 

from the IND requirements, and 

addresses a range of issues that 

commonly arise in inquiries to FDA 

concerning the application of the IND 

requirements. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on determining whether human 

research studies can be conducted 

without an IND. 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. The Paperwork Reduction Act of 

1995 

Under the Paperwork Reduction Act 

(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 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comment 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 on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Title: Draft Guidance for Industry on 

Investigational New Drug Applications 

(INDs)—Determining Whether Human 

Research Studies Can Be Conducted 

Without an IND. 

Description: The draft guidance 

would assist clinical investigators, 

sponsors, and sponsor-investigators in 

determining whether human research 

studies must be conducted under an 

IND as described in part 312, 

Investigational New Drug Application. 

The draft guidance describes the basic 

criteria for when an IND is required, 

specific situations in which an IND is 

not required, and a range of issues that 

have been the source of confusion or 

misperceptions about the application of 

the IND regulations. Section VIII of the 

draft guidance, ‘‘Process for Addressing 

Inquiries Concerning the Application of 

the IND Requirements,’’ provides a 

process for seeking advice from FDA 

concerning the application of the IND 

regulations to a planned clinical 

investigation. Under § 312.2(e), FDA, on 

request, will advise on the applicability 

of part 312 to a planned clinical 

investigation. 

Part 312 contains an information 

collection that has been approved by 

OMB under OMB control number 0910– 

0014, and this approval would extend to 

the recommendations in the draft 

guidance. However, requests for FDA 

advice, under § 312.2(e), on the 

application of the IND regulations to a 

planned clinical investigation has not 

been part of this approval by OMB. 

Therefore, we are requesting OMB 

approval of the information collection 

in Section VIII of the draft guidance. As 

indicated in table 1 of this document, 

based on FDA’s experience with the 

requests it has received for advice on 

the application of the IND regulations to 

planned clinical investigations, we 

estimate that we will receive annually 

approximately 45 formal inquiries as 

described in Section VIII of the draft 

guidance from approximately 20 

sponsors and/or investigators, and 

approximately 110 informal inquiries as 

described in Section VIII from 

approximately 40 sponsors and/or 

investigators. We also estimate that it 

will take approximately 8 hours to 

prepare and submit each formal inquiry 

and approximately 30 minutes to 

prepare and submit each informal 

inquiry. 

FDA requests comments on this 

analysis of information collection 

burdens: 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Notices 63191 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Hours per 

response Total hours 

Formal Inquiry ...................................................................... 20 2.25 45 8 hours ........... 360 

Informal Inquiry .................................................................... 40 2.75 110 30 minutes ..... 55 

Total .............................................................................. ........................ ........................ ........................ ........................ 415 

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

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding the draft guidance, 

including comments regarding proposed 

collection of information. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of any mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: October 6, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25851 Filed 10–13–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

[Docket No. TSA–2009–0018] 

Intent To Request Renewal From OMB 

of One Current Public Collection of 

Information: Certified Cargo Screening 

Program 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: 60-Day notice. 

SUMMARY: The Transportation Security 

Administration (TSA) invites public 

comment on one currently approved 

Information Collection Request (ICR), 

OMB control number 1652–0053, 

abstracted below that we will submit to 

the Office of Management and Budget 

(OMB) for renewal in compliance with 

the Paperwork Reduction Act. The ICR 

describes the nature of the information 

collection and its expected burden. The 

collections include: (1) Applications 

from entities that wish to become 

Certified Cargo Screening Facilities 

(CCSF) or operate as a TSA-approved 

validation firm; (2) personal information 

to allow TSA to conduct security threat 

assessments on key individuals 

employed by the CCSFs and validation 

firms; (3) implementation of a standard 

security program or submission of a 

proposed modified security program; (4) 

information on the amount of cargo 

screened; (5) recordkeeping 

requirements for CCSFs and validation 

firms; and (6) submission of validation 

reports to TSA. TSA is seeking the 

renewal of the ICR for the continuation 

of the program in order to secure 

passenger aircraft carrying cargo by the 

deadlines set out in the Implementing 

Recommendations of the 9/11 

Commission Act of 2007. 

DATES: Send your comments by 

December 13, 2010. 

ADDRESSES: Comments may be e-mailed 

to TSAPRA@dhs.gov or delivered to the 

TSA Paperwork Reduction Act (PRA) 

Officer, Office of Information 

Technology (OIT), TSA–40, 

Transportation Security Administration, 

601 South 12th Street, Arlington, VA 

20598–6040. 

FOR FURTHER INFORMATION CONTACT: 

Please email TSA.PRA@dhs.gov with 

questions or comments. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a valid OMB control 

number. The ICR documentation is 

available at http://www.reginfo.gov. 

Therefore, in preparation for OMB 

review and approval of the following 

information collection, TSA is soliciting 

comments to— 

(1) Evaluate whether the proposed 

information requirement is necessary for 

the proper performance of the functions 

of the agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including using 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Information Collection Requirement 

OMB Control Number 1652–0053, 

Certified Cargo Screening Program, 49 

CFR Parts 1515, 1520, 1522, 1540, 1544, 

1546, 1548, and 1549 

TSA is seeking renewal of an expiring 

collection of information. Section 1602 

of the Implementing Recommendations 

of the 9/11 Commission Act of 2007 

(Pub. L. 110–53, 121 Stat. 266, 278, 

August 3, 2007) requires the 

development of a system to screen 50 

percent of the cargo transported on a 

passenger aircraft by February 2009, and 

to screen 100 percent of such cargo by 

August 2010. In September 2009, TSA 

issued an interim final rule (IFR) 

amending 49 CFR to implement this 

statutory requirement. See 74 FR 47672 

(September 16, 2009). TSA received 

approval from OMB for the collections 

of information contained in the IFR. 

TSA now seeks to extend this approval 

from OMB. Accordingly, TSA must 

proceed with this ICR for this program 

in order to continue to meet the 

Congressional mandate. The ICR will 

allow TSA to collect several categories 

of information as explained below. 

Data Collection 

TSA certifies qualified facilities as 

CCSFs. Companies seeking to become 

CCSFs are required to submit an 

application to TSA at least 90 days 

before the intended date of operation. 

All CCSF applicants submit 

applications and related information 

either electronically through email or 

through the online Air Cargo Document 


jlentini on DSKJ8SOYB1PROD with NOTICES