Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17051 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

request for additional comments on the 

chemistry, manufacturing, and control 

(CMC) information that a sponsor of an 

investigational new drug application 

(IND) should provide in its IND in order 

to meet regulatory requirements when 

commercially available foods or dietary 

supplements containing live 

biotherapeutic products (LBPs) are used 

as investigational new drugs in early 

phase clinical trials. The request for 

additional comments on the CMC 

information is related to the guidance 

entitled, ‘‘Early Clinical Trials with Live 

Biotherapeutic Products: Chemistry, 

Manufacturing, and Control 

Information; Guidance for Industry,’’ 

dated February 2012 (February 2012 

guidance). 

DATES: Submit either electronic or 

written comments on the requested 

CMC information by May 29, 2015. 

ADDRESSES: Submit written requests for 

single copies of the February 2012 

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 guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

requested CMC information 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: 

Jessica T. Walker, 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 a request for 

additional comments on the CMC 

information that a sponsor of an IND 

should provide in its IND in order to 

meet the requirements under § 312.23 

(21 CFR 312.23), when commercially 

available foods or dietary supplements 

containing LBPs are subject to study as 

investigational new drugs in early phase 

clinical trials. 

In the Federal Register of February 

21, 2012 (77 FR 9947), FDA announced 

the publication of a final guidance 

entitled ‘‘Early Clinical Trials with Live 

Biotherapeutic Products: Chemistry, 

Manufacturing, and Control 

Information; Guidance for Industry,’’ 

dated February 2012. The guidance 

provides IND sponsors with 

recommendations regarding CMC 

information that should be included in 

IND submissions for early clinical trials 

with LBPs, including LBPs lawfully 

marketed as foods or dietary 

supplements in the United States and 

proposed for clinical uses regulated 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262). The 

guidance also outlines the Drug 

Substance and Drug Product 

information that should be provided in 

the CMC section of an IND to meet the 

requirements under § 312.23 and to 

support proceeding to clinical 

evaluation of an LBP in human subjects. 

II. CMC Information 

FDA is considering modifying the 

February 2012 guidance to address the 

CMC information that should be 

provided in an IND, under certain 

conditions. Specifically, FDA is 

considering whether to revise the 

guidance to address when the label on 

the commercially available product(s) 

would be considered adequate to satisfy 

the requirement for CMC information 

under § 312.23. For example, we are 

considering whether the label would be 

adequate to satisfy the CMC information 

when the following conditions are met: 

(1) The LBP product that is proposed for 

investigational use is a commercially 

available food or dietary supplement; (2) 

the investigation does not involve a 

route of administration, dose, patient 

population, or other factor that 

significantly increases the risk (or 

decreases the acceptability of risk) 

associated with the use of the food or 

dietary supplement; (3) the investigation 

is not intended to support a marketing 

application for a drug claim for the food 

or dietary supplement; and (4) the 

investigation is conducted in 

compliance with the requirements for 

INDs (part 312), the requirements for 

review by an institutional review board 

(21 CFR part 56), and with the 

requirements for informed consent (21 

CFR part 50). FDA is seeking public 

comment on this issue. 

III. Comments 

Interested persons may submit either 

electronic comments regarding the 

requested CMC information 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 February 2012 guidance 

at either http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://www.regulations.

gov. 

Dated: March 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07273 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1439] 

Critical Path Innovation Meetings; 

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 guidance for industry 

entitled ‘‘Critical Path Innovation 

Meetings.’’ This guidance describes a 

Critical Path Innovation Meeting 

(CPIM), a means by which FDA’s Center 

for Drug Evaluation and Research 

(CDER) and investigators from industry, 

academia, government, and patient 

advocacy groups can communicate to 

improve efficiency and success in drug 

development. The goals of the CPIM are 

to discuss a methodology or technology 

proposed by the meeting requester and 

for CDER to provide general advice on 

how this methodology or technology 

might enhance drug development. The 

discussions and background 

information submitted through the 

CPIM are nonbinding on both FDA and 

CPIM requesters. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
17052 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, 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 guidance document. 

Submit electronic comments on the 

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: 

Alicia Barbieri Stuart, Office of 

Translational Sciences, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 4547, 

Silver Spring, MD 20993–0002, 301– 

796–3852. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Critical Path Innovation Meetings.’’ 

The guidance describes the purpose and 

scope of a CPIM and how to request 

such a meeting. A CPIM provides the 

opportunity to discuss a methodology or 

technology proposed by the meeting 

requester and for CDER to provide 

general advice on how the methodology 

or technology might enhance drug 

development. During a CPIM, CDER will 

identify some of the larger gaps in 

existing knowledge that requesters 

might consider addressing in the course 

of their work. The discussions and 

background information submitted 

through the CPIM are nonbinding on 

both FDA and CPIM requesters. The 

CPIM initiative meets Prescription Drug 

User Fee Act (PDUFA) V 

Reauthorization Goal IX.A, ‘‘Enhancing 

Regulatory Science and Expediting Drug 

Development’’ by ‘‘Promoting 

Innovation Through Enhanced 

Communication Between FDA and 

Sponsors During Drug Development.’’ 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Critical Path 

Innovation Meetings.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collection of 

information in 21 CFR part 312 

(investigational new drug applications) 

has been approved under OMB control 

number 0910–0014. The collection of 

information in 21 CFR part 314 (new 

drug applications) has been approved 

under OMB control number 0910–0001. 

The collection of information resulting 

from formal meetings between 

interested persons and FDA has been 

approved under OMB control number 

0910–0429. 

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 either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm or http://www.

regulations.gov. 

Dated: March 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07272 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: PulmonaryAllergy Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 12, 2015, from 8 a.m. to 4 

p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD 20877. 

The hotel phone number is 301–977– 

8900. 

Contact Person: Cindy Hong, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, email: 

PADAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

new drug application (NDA) 206038, 

lumacaftor/ivacaftor combination tablets 

for oral use, submitted by Vertex 

Pharmaceuticals, proposed for the 

treatment of cystic fibrosis (CF) in 

patients age 12 years and older who are 

homozygous for the F508del mutation in 

the cystic fibrosis transmembrane 

conductance regulator (CFTR) gene. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 27, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 


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